VALSARTAN 80 mg /12.5 Mg Film-Coated Tablets

Содержание инструкции

1. Valsartan and Hydrochlorothiazide TecniGen 80 mg/ 12.5 mg film-coated tablets
   1. What is Valsartan and Hydrochlorothiazide TecniGen and what is it used for
   2. What you need to know before taking Valsartan and Hydrochlorothiazide TecniGen
   3. How to take Valsartan and Idroclorotiazide TecniGen
   4. Possible side effects
   5. How to store Valsartan and Idroclorotiazide Tecnigen
   6. Package Contents and Other Information
2. Valsartan and Hydrochlorothiazide TecniGen 160 mg/ 12.5 mg film-coated tablets
   1. What is Valsartan and Hydrochlorothiazide TecniGen and what it is used for
   2. What you need to know before taking Valsartan and Hydrochlorothiazide TecniGen
   3. How to take Valsartan and Idroclorotiazide TecniGen
   4. Possible side effects
   5. How to store Valsartan and Idroclorotiazide Tecnigen
   6. Contents of the pack and other information
3. Valsartan and Hydrochlorothiazide Tecnigen 160 mg/12.5 mg film-coated tablets are
4. Valsartan and Hydrochlorothiazide TecniGen 160 mg/ 25 mg film-coated tablets
   1. What is Valsartan and Idroclorotiazide TecniGen and what is it used for
   2. What you need to know before taking Valsartan and Hydrochlorothiazide TecniGen
   3. How to take Valsartan and Idroclorotiazide TecniGen
   4. Possible side effects
   5. How to store Valsartan and Idroclorotiazide Tecnigen
   6. Package contents and other information
5. Valsartan and Hydrochlorothiazide TecniGen 320 mg/ 12.5 mg film-coated tablets
   1. What is Valsartan and Hydrochlorothiazide TecniGen and what is it used for
   2. What you need to know before taking Valsartan and Hydrochlorothiazide TecniGen
   3. How to take Valsartan and Idroclorotiazide TecniGen
   4. Possible side effects
   5. How to store Valsartan and Idroclorotiazide Tecnigen
   6. Package contents and other information
6. Valsartan and Hydrochlorothiazide TecniGen 320 mg/25 mg film-coated tablets
   1. What is Valsartan and Hydrochlorothiazide TecniGen and what is it used for
   2. What you need to know before taking Valsartan and Hydrochlorothiazide TecniGen
   3. How to take Valsartan and Idroclorotiazide TecniGen
   4. Possible side effects
   5. How to store Valsartan and Idroclorotiazide Tecnigen
   6. Contents of the pack and other information

Valsartan and Hydrochlorothiazide TecniGen 80 mg/ 12.5 mg film-coated tablets

Valsartan/Hydrochlorothiazide
Generic medicine

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Valsartan and Hydrochlorothiazide TecniGen is and what it is used for.
• 2. What you need to know before you take Valsartan and Hydrochlorothiazide TecniGen.
• 3. How to take Valsartan and Hydrochlorothiazide TecniGen.
• 4. Possible side effects.
• 5. How to store Valsartan and Hydrochlorothiazide TecniGen.
• 6. Contents of the pack and other information.

1. What is Valsartan and Hydrochlorothiazide TecniGen and what is it used for

Valsartan and Hydrochlorothiazide TecniGen film-coated tablets contains two active ingredients
called valsartan and hydrochlorothiazide. Both of these substances help to control high blood pressure (hypertension).

• Valsartanbelongs to a class of medicines known as “angiotensin II receptor antagonists” which help to control high blood pressure. Angiotensin II is a substance present in the body that causes the narrowing of blood vessels, thereby increasing blood pressure. Valsartan works by blocking the effect of angiotensin II. The result is that blood vessels relax and blood pressure decreases.
• Hydrochlorothiazidebelongs to a group of medicines called thiazide diuretics (also known as “water tablets”). Hydrochlorothiazide increases urine production and, in doing so, reduces blood pressure.

Valsartan and Hydrochlorothiazide TecniGen is used in the treatment of high blood pressure when the
blood pressure is not adequately controlled by a single medicine.
High blood pressure increases the workload of the heart and arteries. Without adequate
treatment, this can damage the blood vessels of the brain, heart and kidneys and can lead to stroke,
heart failure or kidney failure.
High blood pressure increases the risk of heart attack. Bringing blood pressure to normal levels
reduces the risk of developing these disorders.

2. What you need to know before taking Valsartan and Hydrochlorothiazide TecniGen

Do not take Valsartan and Hydrochlorothiazide TecniGen

• If you are allergic to valsartan, hydrochlorothiazide, sulfonamide derivatives (chemically related substances to hydrochlorothiazide) or any of the excipients of this medicine (listed in section 6).
• if you are pregnant for more than 3 months(it is advisable to avoid the use of Valsartan and Hydrochlorothiazide TecniGen even during the first months of pregnancy - see the section relating to pregnancy).
• if you suffer from a severekidney disease.
• if you are unable to urinate (anuria).
• if you are undergoing treatment with an artificial kidney.
• if your potassium or sodium levels in the blood are lower than normal or if your calcium level in the blood is higher than normal despite treatment.
• if you have gout.
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.

If you think you may have any of these conditions, do not take this medicine and ask your
doctor for advice.

Warnings and precautions
Consult your doctor, pharmacist or nurse before taking Valsartan and Hydrochlorothiazide
TecniGen.

• if you are taking potassium-sparing medicines, potassium supplements, salt substitutes containing potassium or other medicines that increase potassium levels in the blood, such as heparin. Your doctor may need to check your potassium level in the blood at regular intervals.
• if your potassium levels in the blood are low.
• if you have diarrhea or severe vomiting.
• if you are taking high doses of medicines that increase fluid elimination (diuretics).
• if you suffer from serious heart problems.
• if you suffer from heart failure or have had a heart attack. Carefully follow your doctor's instructions on the starting dose of therapy. Your doctor will also check your kidney function.
• if you suffer from a narrowing of the renal artery.
• if you have recently undergone a kidney transplant.
• if you suffer from hyperaldosteronism, a disease in which the adrenal glands produce too much aldosterone hormone. If this applies to you, the use of Valsartan and Hydrochlorothiazide TecniGen is not recommended.
• if you have liver or kidney disease.
• if you have previously experienced swelling of the tongue and face caused by an allergic reaction called angioedema when taking other medicines (including ACE inhibitors), tell your doctor. If these symptoms occur when you take Valsartan and Hydrochlorothiazide TecniGen, stop taking Valsartan and Hydrochlorothiazide TecniGen immediately and never take it again. See section 4, “Possible side effects” if you have fever, rash and joint pain, which may be signs of systemic lupus erythematosus (SLE, an autoimmune disease).
• if you have diabetes, gout, high levels of cholesterol or triglycerides in the blood.
• if you have had allergic reactions with the use of other medicines that lower blood pressure belonging to the same class (angiotensin II receptor antagonists) or if you suffer from allergies or asthma.
• if you experience a decrease in vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure and can occur from a few hours to weeks after taking Valsartan and Hydrochlorothiazide TecniGen. If left untreated, this can lead to permanent vision loss. If you have previously had an allergy to penicillins or sulfonamides, you may have a higher risk of developing this disorder.
• it may cause increased sensitivity of the skin to the sun.
• If you are taking any of the following medicines used to treat high blood pressure:
• an "ACE inhibitor" (for example enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren
• if you have had skin cancer in the past or if you are developing an unexpected skin lesion during treatment. Long-term use with high doses of hydrochlorothiazide may increase the risk of certain types of skin cancer and lips (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Irbesartan and Hydrochlorothiazide TecniGen.

The doctor may check your kidney function, blood pressure, and the amount of
electrolytes (e.g. potassium) in the blood at regular intervals.
See also what is reported under "Do not take Valsartan and Hydrochlorothiazide TecniGen"

If any of these cases apply to you, consult your doctor.
For those who play sports: the use of the drug without a therapeutic need constitutes doping and
may still result in positive doping tests.
The use of Valsartan and Hydrochlorothiazide TecniGen is not recommended in children and adolescents
(under 18 years of age).
Tell your doctor if you suspect (or are planning) a pregnancy. Valsartan and Hydrochlorothiazide
TecniGen is not recommended in early pregnancy and should not be taken if you are pregnant for
more than 3 months as it can cause serious harm to the baby if taken during this period (see the
section relating to pregnancy).

Other medicines and Valsartan and Hydrochlorothiazide TecniGen
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
The effect of the treatment may be affected if Valsartan and Hydrochlorothiazide TecniGen is
taken with some other medicines. It may be necessary to change the dose, take other
precautions or, in some cases, stop taking one of the medicines. This applies in
particular to the following medicines:

• Lithium, a medicine used to treat some types of mental disorders
• medicines or substances that can increase the amount of potassium in the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines and heparin
• medicines that can decrease the amount of potassium in the blood, such as diuretics (medicines that increase fluid elimination), corticosteroids, laxatives, carbenoxolone, amphotericin or penicillin G
• some antibiotics (rifampicin group), a drug used against rejection in transplantation (cyclosporine) and an antiretroviral drug used to treat HIV/AIDS infections (ritonavir). These drugs can increase the effect of Valsartan and Hydrochlorothiazide TecniGen
• medicines that can induce “torsades de pointes” (irregular heartbeat), such as antiarrhythmics (medicines used to treat heart problems) and some antipsychotics
• medicines that can reduce the amount of sodium in the blood, such as antidepressants, antipsychotics, antiepileptics
• medicines for the treatment of gout, such as allopurinol, probenecid, sulfinpyrazone
• therapeutic vitamin D and calcium supplements
• medicines used to treat diabetes (oral use such as metformin or insulins)
• other medicines that lower blood pressure, including methyldopa, ACE inhibitors (such as enalapril, lisinopril, etc.) or aliskiren
• medicines that increase blood pressure, such as norepinephrine or epinephrine
• digoxin or other cardiac glycosides (medicines used to treat heart problems) medicines that can increase blood sugar levels, such as diazoxide or beta-blockers
• cytotoxic medicines (used for cancer treatment), such as methotrexate or cyclophosphamide
• pain relievers such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (Cox-2) inhibitors and acetylsalicylic acid > 3 g muscle relaxants, such as tubocurarine
• anticholinergic medicines, (medicines used to treat various disorders such as gastrointestinal cramps, bladder spasm, asthma, motion sickness, muscle spasms, Parkinson's disease and to facilitate anesthesia) amantadine (medicine used to treat Parkinson's disease and also to treat or prevent some viral diseases) cholestramine and colestipol (medicines used mainly in the treatment of high lipid levels in the blood)
• cyclosporine, a medicine used in organ transplantation to prevent organ rejection
• alcohol, sleeping pills and anesthetics (medicines with a narcotic or analgesic effect used, for example, during surgery) iodine-based contrast agents (used for radiological examinations)

The doctor may need to change the dose and/or take other precautions.
If you are taking an ACE inhibitor or aliskiren (see also what is reported under: "Do not
take Valsartan and Hydrochlorothiazide TecniGen” and "Warnings and precautions”).

Valsartan and Hydrochlorothiazide TecniGen with food, drinks and alcohol
Valsartan and Hydrochlorothiazide TecniGen can be taken with or without food.
Avoid drinking alcohol before talking to your doctor.
Alcohol can further lower blood pressure and/or increase the risk of dizziness or fainting.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist before taking this medicine.

Pregnancy
Consult your doctor if you suspect (or are planning) a pregnancy
Normally your doctor will advise you to stop treatment with Valsartan and Hydrochlorothiazide
TecniGen before you become pregnant or as soon as pregnancy is confirmed and will advise you to
take another medicine instead of Valsartan and Hydrochlorothiazide TecniGen. The use of Valsartan and Hydrochlorothiazide TecniGen is not recommended during the early stages of pregnancy and
the medicine should not be taken if you are pregnant for more than 3 months as, if taken after the third month of
pregnancy, it could cause serious harm to your baby (see the
section relating to pregnancy).

Breastfeeding
Consult your doctor if you are breastfeeding or if you intend to start breastfeeding.
For breastfeeding mothers Valsartan and Hydrochlorothiazide TecniGen is not recommended. In
the case you want to continue breastfeeding, your doctor may decide to prescribe an alternative treatment
especially if the baby is newborn or premature.

Driving and operating machinery
Before driving a vehicle, using tools or machinery or performing other activities that require
concentration, make sure you know how you react to Valsartan and Hydrochlorothiazide TecniGen.
Like many other medicines used to treat high blood pressure, Valsartan and
Hydrochlorothiazide TecniGen can occasionally cause dizziness and affect the ability to concentrate.

3. How to take Valsartan and Idroclorotiazide TecniGen

Take this medicine following exactly the instructions of your doctor or pharmacist.
This will help you to obtain the best results and to reduce the risk of undesirable effects. If you have doubts
consult your doctor or pharmacist.
Those suffering from high blood pressure often do not notice any sign of this problem. Many
may feel as well as usual. For this reason it is very important that you make regular
appointments with your doctor, even if you feel well.
The doctor will tell you exactly how many tablets of Valsartan and Idroclorotiazide TecniGen you must
take. Based on your response to treatment, the doctor may suggest a higher or
lower dose.

• The usual dose of Valsartan and Idroclorotiazide TecniGen is equivalent to one tablet a day.
• Do not change the dose and do not interrupt the treatment without consulting your doctor.
• This medicine must be taken every day at the same time, usually in the morning.
• You can take Valsartan and Idroclorotiazide TecniGen with or without food.
• Swallow the tablet with a glass of water.

If you take more Valsartan and Idroclorotiazide TecniGen than you should
In case of severe dizziness and/or fainting it is good to lie down and contact your doctor immediately.
If you have accidentally taken too many tablets, consult your doctor, pharmacist or hospital.

If you forget to take Valsartan and Idroclorotiazide TecniGen
If you forget to take a tablet, take it as soon as you remember. However, if it is almost the
time of the next dose, skip the forgotten dose. Do not take a double dose to
compensate for the forgotten dose.

If you stop taking Valsartan and Idroclorotiazide TecniGen
Stopping the treatment with Valsartan and Idroclorotiazide TecniGen can cause
worsening of high blood pressure. Do not stop taking the medicine unless your
doctor has decided so.
If you have any doubts about the use of this medicine , consult your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Side effects can occur with varying frequencies which are defined as follows:

• Very common: affects more than 1 in 10 people
• Common: affects 1 to 10 people in 100
• Uncommon: affects 1 to 10 people in 1,000
• Rare: affects 1 to 10 people in 10,000
• Very rare: affects less than 1 in 10,000
• Not known: the frequency cannot be estimated from the available data

Some side effects may be serious and require immediate medical attention:
Seek immediate medical help if you experience symptoms of angioedema, such as

• Swelling of the face, tongue or throat
• Difficulty swallowing
• Hives and difficulty breathing

If you experience any of these symptoms, stop taking Valsartan and Idroclorotiazide
TecniGen and contact your doctor immediately (see also section 2 “Warnings and
precautions”).
Other side effects include:

Uncommon

• Cough
• lowering of blood pressure
• feeling of lightheadedness
• dehydration (with symptoms such as thirst, dry mouth and tongue, infrequent urination, dark urine, dry skin)
• muscle pain
• fatigue
• tingling or numbness
• blurred vision
• ringing in the ears (e.g. buzzing, whistling)

Very rare

• dizziness
• diarrhoea
• joint pain

Not known

• difficulty breathing
• significant decrease in the amount of urine
• low sodium levels in the blood (which can cause fatigue, confusion, muscle contractions and/or convulsions in severe cases)
• low potassium levels in the blood (sometimes with muscle weakness, muscle spasms, abnormal heart rhythm)
• low levels of white blood cells in the blood (with symptoms such as fever, skin infections, sore throat or mouth ulcers due to infections, weakness)
• increased bilirubin levels in the blood (which can, in severe cases, cause yellowing of the skin and eyes)
• increased levels of urea and creatinine in the blood (which may be an indication of kidney malfunction)
• increased levels of uric acid in the blood (which can, in severe cases, cause gout)
• syncope (fainting)

Side effects reported with valsartan or hydrochlorothiazide alone, but not observed with
Valsartan and Idroclorotiazide TecniGen:
Valsartan

Uncommon

• feeling of spinning
• abdominal pain

Not known

• appearance of blisters on the skin (sign of bullous dermatitis)
• rash with or without itching together with some of the following signs or symptoms: fever, joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms
• rash, reddish-purple spots, fever, itching (symptoms of inflammation of blood vessels)
• low platelet levels in the blood (sometimes with unusual bleeding or bruising)
• increased potassium levels in the blood (sometimes with muscle spasms, abnormal heart rhythm)
• allergic reactions (with symptoms such as rash, itching, hives, difficulty breathing or swallowing, dizziness)
• swelling especially of the face and throat; rash; itching
• increased liver function values
• decrease in hemoglobin levels and percentage of red blood cells in the blood (which, in severe cases, can both cause anemia)
• renal failure
• low sodium levels in the blood (which can cause fatigue, mental confusion, muscle contractions and/or convulsions in severe cases)

Hydrochlorothiazide

Very common

• low potassium levels in the blood
• increased lipids in the blood

Common

• low sodium levels in the blood
• low magnesium levels in the blood
• high uric acid levels in the blood
• itchy rashes and other types of rashes
• loss of appetite
• mild nausea and vomiting
• dizziness, fainting when getting up
• inability to achieve or maintain an erection

Rare

• swelling and blistering of the skin (due to increased sensitivity to the sun)
• high calcium levels in the blood
• high sugar levels in the blood
• sugar in the urine
• worsening of the metabolic state of diabetes
• constipation, diarrhoea, stomach or intestinal disorders, liver disorders that can manifest with yellowing of the skin and eyes
• irregular heartbeat
• headache
• sleep disorders
• sadness (depression)
• low levels of platelets in the blood (sometimes with bleeding or bruising under the skin)
• dizziness
• tingling or numbness
• visual disturbances

Very rare

• inflammation of blood vessels with symptoms such as rashes, reddish-purple spots, fever (vasculitis)
• rash, itching, hives, difficulty breathing or swallowing, dizziness (severe hypersensitivity reactions) severe skin diseases causing rash, redness of the skin, formation of blisters on lips, eyes or mouth, peeling of the skin, fever (toxic epidermal necrolysis) rashes on the face, joint pain, muscle disorders, fever (lupus erythematosus)
• severe pain in the upper abdomen (pancreatitis)
• difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory distress, including pneumonia and pulmonary edema)
• fever, sore throat, more frequent infections (agranulocytosis)
• paleness, fatigue, shortness of breath, dark urine (hemolytic anemia)
• fever, sore throat or mouth ulcers due to infections (leukopenia)
• confusion, fatigue, tremor and muscle spasm, rapid breathing (hypochloremic alkalosis)

Not known

• fatigue, bruising and frequent infections (aplastic anemia)
• severe decrease in the amount of urine (possible sign of kidney disorder or renal failure)
• decreased vision or eye pain due to high pressure inside the eye (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
• rash, redness of the skin, formation of blisters on lips, eyes or mouth, peeling of the skin, fever (possible signs of erythema multiforme)
• muscle spasm
• fever (pyrexia)
• weakness (asthenia)
• skin and lip cancer (non-melanoma skin cancer)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or
nurse. You can also report side effects directly through your national reporting system. By reporting
side effects you can help provide more information on the safety of this medicine.

5. How to store Valsartan and Idroclorotiazide Tecnigen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Scad.”. The
expiry date refers to the last day of that month.
Do not store above 30°C.
Do not use this medicine if the pack is damaged or shows signs of tampering.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Valsartan and Hydrochlorothiazide Tecnigen contains

• The active ingredients are valsartan and hydrochlorothiazide. Each film-coated tablet contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide.
• The other ingredients (excipients) are: microcrystalline cellulose, crospovidone, magnesium stearate. The tablet coating contains: hypromellose 6cP, talc, macrogol 8000, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Valsartan and Hydrochlorothiazide Tecnigen and package contents
Valsartan and Hydrochlorothiazide Tecnigen80 mg/12.5 mg film-coated tablets are film-coated
tablets, oblong, convex and pink in colour.
Valsartan and Hydrochlorothiazide Tecnigen80 mg/12.5 mg is available in blister packs of 28
tablets.

Marketing Authorisation Holder and manufacturer

Marketing Authorisation Holder:
TECNIMEDE Sociedade Técnico-Medicinal S.A.
Rua da Tapada Grande n. 2, Abrunheira
2710-089 Sintra
Portugal

Manufacturers:
West Pharma – Produções de Especialidades Farmacêuticas S.A.
Rua João de Deus n. 11, Venda Nova
2700-486 Amadora
Portugal
Atlantic Pharma - Produções Farmacêuticas, S.A.
Rua da Tapada Grande, nº 2, Abrunheira,
2710-089 Sintra
Portugal

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Portugal: Valsartan/Hydrochlorothiazide Pentafarma
Italy: Valsartan e Idroclorotiazide Tecnigen80 mg/12.5 mg film-coated tablets

Valsartan and Hydrochlorothiazide TecniGen 160 mg/ 12.5 mg film-coated tablets

Valsartan/Hydrochlorothiazide
Generic medicine

Read this leaflet carefully before you start taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours because it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Valsartan and Hydrochlorothiazide TecniGen is and what it is used for.
• 2. What you need to know before you take Valsartan and Hydrochlorothiazide TecniGen.
• 3. How to take Valsartan and Hydrochlorothiazide TecniGen.
• 4. Possible side effects.
• 5. How to store Valsartan and Hydrochlorothiazide TecniGen.
• 6. Contents of the pack and other information.

1. What is Valsartan and Hydrochlorothiazide TecniGen and what it is used for

Valsartan and Hydrochlorothiazide TecniGen film-coated tablets contain two active ingredients
called valsartan and hydrochlorothiazide. Both of these substances help to control high blood pressure (hypertension).

• Valsartanbelongs to a class of medicines known as “angiotensin II receptor antagonists” which help to control high blood pressure. Angiotensin II is a substance present in the body that causes the narrowing of blood vessels, thereby increasing blood pressure. Valsartan works by blocking the effect of angiotensin II. The result is that blood vessels relax and blood pressure decreases.
• Hydrochlorothiazidebelongs to a group of medicines called thiazide diuretics (also known as “water tablets”). Hydrochlorothiazide increases urine production and, in doing so, reduces blood pressure.

Valsartan and Hydrochlorothiazide TecniGen is used in the treatment of high blood pressure when the
blood pressure is not adequately controlled by a single medicine.
High blood pressure increases the workload of the heart and arteries. Without adequate
treatment, this can damage the blood vessels of the brain, heart and kidneys and can lead to stroke,
heart failure or kidney failure.
High blood pressure increases the risk of heart attack. Bringing blood pressure to normal levels
reduces the risk of developing these disorders.

2. What you need to know before taking Valsartan and Hydrochlorothiazide TecniGen

Do not take Valsartan and Hydrochlorothiazide TecniGen

• If you are allergic to valsartan, hydrochlorothiazide, sulfonamide derivatives (chemicals related to hydrochlorothiazide) or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant for more than 3 months(it is advisable to avoid using Valsartan and Hydrochlorothiazide TecniGen even during the first months of pregnancy - see the section on pregnancy).
• if you have severe liver problems, destruction of the small bile ducts within the liver (biliary cirrhosis) leading to bile accumulation in the liver (cholestasis)
• if you suffer from a severekidney disease.
• if you are unable to urinate (anuria).
• if you are undergoing artificial kidney treatment
• if your potassium or sodium levels in the blood are lower than normal or if your calcium level in the blood is higher than normal despite treatment.
• if you have gout.
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.

If you think you may have any of these conditions, do not take this medicine and ask
your doctor for advice.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Valsartan and Hydrochlorothiazide
TecniGen.

• if you are taking potassium-sparing medicines, potassium supplements, salt substitutes containing potassium or other medicines that increase potassium levels in the blood, such as heparin. Your doctor may need to check your potassium level in the blood at regular intervals.
• if your potassium levels in the blood are low.
• if you have diarrhea or severe vomiting.
• if you are taking high doses of medicines that increase fluid elimination (diuretics).
• if you suffer from serious heart problems.
• if you suffer from heart failure or have had a heart attack. Carefully follow your doctor's instructions on the starting dose of therapy. Your doctor will also check your kidney function.
• if you suffer from narrowing of the renal artery.
• if you have recently had a kidney transplant.
• if you suffer from hyperaldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. If this applies to you, the use of Valsartan and Hydrochlorothiazide TecniGen is not recommended.
• if you have liver or kidney disease.
• if you have previously experienced swelling of the tongue and face caused by an allergic reaction called angioedema when taking other medicines (including ACE inhibitors), tell your doctor. If these symptoms occur when taking Valsartan and Hydrochlorothiazide TecniGen, stop taking Valsartan and Hydrochlorothiazide TecniGen immediately and never take it again. See section 4, “Possible side effects”
• if you have fever, rash and joint pain, which may be signs of systemic lupus erythematosus (SLE, an autoimmune disease).
• if you have diabetes, gout, high cholesterol or triglyceride levels in the blood.
• if you have had allergic reactions with the use of other medicines that lower blood pressure belonging to the same class (angiotensin II receptor antagonists) or if you suffer from allergies or asthma.
• if you experience decreased vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure and can occur from a few hours to weeks after taking Valsartan and Hydrochlorothiazide TecniGen. If left untreated, this can lead to permanent vision loss. If you have previously had an allergy to penicillins or sulfonamides, you may have a higher risk of developing this disorder.
• it may cause increased sensitivity of the skin to the sun.
• If you are taking any of the following medicines used to treat high blood pressure:
• an "ACE inhibitor" (e.g. enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren
• if you have had skin cancer in the past or if you are developing an unexpected skin lesion during treatment. Long-term use of hydrochlorothiazide, especially at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Irbesartan and Hydrochlorothiazide TecniGen

Your doctor may need to check your kidney function, blood pressure, and the amount of
electrolytes (e.g. potassium) in your blood at regular intervals.
See also what is stated under "Do not take Valsartan and Hydrochlorothiazide TecniGen”

If any of these applies to you, talk to your doctor.
For athletes: the use of the drug without a therapeutic need constitutes doping and
may still result in positive doping tests.
The use of Valsartan and Hydrochlorothiazide TecniGen is not recommended in children and adolescents
(under 18 years of age).
Tell your doctor if you suspect (or are planning) a pregnancy. Valsartan and Hydrochlorothiazide
TecniGen is not recommended in early pregnancy and should not be taken if you are pregnant for
more than 3 months as it can cause serious harm to the baby if taken during this period (see the
section on pregnancy).

Other medicines and Valsartan and Hydrochlorothiazide TecniGen
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
The effect of the treatment may be affected if Valsartan and Hydrochlorothiazide TecniGen is
taken with certain other medicines. It may be necessary to change the dose, take other
precautions or, in some cases, stop taking one of the medicines. This applies in
particular to the following medicines:

• Lithium, a medicine used to treat some types of mental disorders
• medicines or substances that can increase the amount of potassium in the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines and heparin
• medicines that can decrease the amount of potassium in the blood, such as diuretics (medicines that increase fluid elimination), corticosteroids, laxatives, carbenoxolone, amphotericin or penicillin G
• some antibiotics (rifampicin group), a medicine used against rejection in transplantation (cyclosporine) and an antiretroviral medicine used to treat HIV/AIDS infections (ritonavir). These medicines can increase the effect of Valsartan and Hydrochlorothiazide TecniGen
• medicines that can induce “torsades de pointes” (irregular heartbeat), such as antiarrhythmics (medicines used to treat heart problems) and some antipsychotics
• medicines that can reduce the amount of sodium in the blood, such as antidepressants, antipsychotics, antiepileptics
• medicines for the treatment of gout, such as allopurinol, probenecid, sulfinpyrazone
• therapeutic vitamin D and calcium supplements
• medicines used to treat diabetes (oral use such as metformin or insulins)
• other medicines that lower blood pressure, including methyldopa, ACE inhibitors (such as enalapril, lisinopril, etc.) or aliskiren
• medicines that increase blood pressure, such as norepinephrine or epinephrine
• digoxin or other cardiac glycosides (medicines used to treat heart problems)
• medicines that can increase blood sugar levels, such as diazoxide or beta-blockers
• cytotoxic medicines used for cancer treatment, such as methotrexate or cyclophosphamide
• pain relievers such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (Cox-2) inhibitors and acetylsalicylic acid > 3 g muscle relaxants, such as tubocurarine
• anticholinergic medicines (medicines used to treat various disorders such as gastrointestinal cramps, bladder spasm, asthma, motion sickness, muscle spasms, Parkinson's disease and to facilitate anesthesia)
• amantadine (a medicine used to treat Parkinson's disease and also to treat or prevent some viral diseases) colestyramine and colestipol (medicines used primarily to treat high lipid levels in the blood)
• cyclosporine, a medicine used in organ transplantation to prevent organ rejection
• alcohol, hypnotics and anesthetics (medicines with a narcotic or analgesic effect used, for example, during surgery) iodinated contrast media (used for radiological examinations)

Your doctor may need to adjust the dose and/or take other precautions.
If you are taking an ACE inhibitor or aliskiren (see also "Do not
take Valsartan and Hydrochlorothiazide TecniGen” and "Warnings and precautions”).

Valsartan and Hydrochlorothiazide TecniGen with food, drinks and alcohol
Valsartan and Hydrochlorothiazide TecniGen can be taken with or without food.
Avoid drinking alcohol before talking to your doctor.
Alcohol can further lower blood pressure and/or increase the risk of dizziness
or fainting.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Talk to your doctor if you suspect (or are planning) a pregnancy
Usually your doctor will advise you to stop treatment with Valsartan and Hydrochlorothiazide
TecniGen before you become pregnant or as soon as pregnancy is confirmed and will advise you to
take another medicine instead of Valsartan and Hydrochlorothiazide TecniGen. The use of Valsartan and Hydrochlorothiazide TecniGen is not recommended during the early stages of pregnancy and
the medicine should not be taken if you are pregnant for more than 3 months as it can cause serious harm to your baby if taken during this period (see the
section on pregnancy).

Breastfeeding
Talk to your doctor if you are breastfeeding or intend to start breastfeeding.
Valsartan and Hydrochlorothiazide TecniGen is not recommended for mothers who are breastfeeding. In
the case you want to continue breastfeeding, your doctor may decide to prescribe an alternative
treatment.

Driving and operating machinery
Before driving a vehicle, using tools or machinery or performing other activities that require
concentration, make sure you know how you react to Valsartan and Hydrochlorothiazide TecniGen.
Like many other medicines used to treat high blood pressure, Valsartan and
Hydrochlorothiazide TecniGen can occasionally cause dizziness and affect your ability to concentrate.

3. How to take Valsartan and Idroclorotiazide TecniGen

Take this medicine following exactly the instructions of your doctor or pharmacist.
This will help you to obtain the best results and to reduce the risk of undesirable effects. If you have doubts
consult your doctor or pharmacist.
Those suffering from high blood pressure often do not notice any sign of this problem. Many
may feel as well as usual. For this reason it is very important that you keep regular
appointments with your doctor, even if you feel well.
The doctor will tell you exactly how many tablets of Valsartan and Idroclorotiazide TecniGen you must
take. Based on your response to treatment, the doctor may suggest a higher or
lower dose.

• The usual dose of Valsartan and Idroclorotiazide TecniGen is equivalent to one tablet a day.
• Do not change the dose and do not interrupt the treatment without consulting your doctor.
• This medicine must be taken every day at the same time, usually in the morning.
• You can take Valsartan and Idroclorotiazide TecniGen with or without food.
• Swallow the tablet with a glass of water.

The score line is to facilitate breaking the tablet if you have difficulty swallowing it
whole.

If you take more Valsartan and Idroclorotiazide TecniGen than you should
In case of severe dizziness and/or fainting it is good to lie down and contact your doctor immediately.
If you have accidentally taken too many tablets, contact your doctor, pharmacist or hospital.

If you forget to take Valsartan and Idroclorotiazide TecniGen
If you forget to take a tablet, take it as soon as you remember. However, if it is almost the
time of the next dose, skip the forgotten dose. Do not take a double dose to
compensate for the forgotten dose.

If you stop taking Valsartan and Idroclorotiazide TecniGen
Stopping treatment with Valsartan and Idroclorotiazide TecniGen may cause
worsening of high blood pressure. Do not stop taking the medicine unless your
doctor has decided so.
If you have any doubts about the use of this medicine , consult your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Side effects can occur with varying frequencies which are defined as follows:

• Very common: affects more than 1 in 10 people
• Common: affects 1 to 10 people in 100
• Uncommon: affects 1 to 10 people in 1,000
• Rare: affects 1 to 10 people in 10,000
• Very rare: affects less than 1 in 10,000
• Not known: the frequency cannot be estimated based on available data

Some side effects may be serious and require immediate medical attention:
Seek immediate medical help if you experience symptoms of angioedema, such as

• Swelling of the face, tongue or throat
• Difficulty swallowing
• Hives and difficulty breathing

If you experience any of these symptoms, stop taking Valsartan and Idroclorotiazide
TecniGen and contact your doctor immediately (see also section 2 “Warnings and
precautions”).
Other side effects include:

Uncommon

• Cough
• lowering of blood pressure
• feeling of lightheadedness
• dehydration (with symptoms such as thirst, dry mouth and tongue, infrequent urination, dark urine, dry skin)
• muscle pain
• fatigue
• tingling or numbness
• blurred vision
• ringing in the ears (e.g. buzzing, whistling)

Very rare

• dizziness
• diarrhoea
• joint pain

Not known

• difficulty breathing
• significant decrease in the amount of urine
• low sodium levels in the blood (which can cause fatigue, confusion, muscle contractions and/or convulsions in severe cases)
• low potassium levels in the blood (sometimes with muscle weakness, muscle spasms, irregular heartbeat)
• low levels of white blood cells in the blood (with symptoms such as fever, skin infections, sore throat or mouth ulcers due to infections, weakness)
• increased levels of bilirubin in the blood (which can, in severe cases, cause yellowing of the skin and eyes)
• increased levels of urea and creatinine in the blood (which may indicate kidney dysfunction)
• increased levels of uric acid in the blood (which can, in severe cases, cause gout)
• syncope (fainting)

Side effects reported with valsartan or hydrochlorothiazide alone, but not observed with
Valsartan and Idroclorotiazide TecniGen:
Valsartan

Uncommon

• feeling of dizziness
• abdominal pain

Not known

• appearance of blisters on the skin (sign of bullous dermatitis)
• rash with or without itching together with some of the following signs or symptoms: fever, joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms
• rash, reddish-purple spots, fever, itching (symptoms of inflammation of blood vessels)
• low platelet levels in the blood (sometimes with unusual bleeding or bruising)
• increased potassium levels in the blood (sometimes with muscle spasms, irregular heartbeat)
• allergic reactions (with symptoms such as rash, itching, hives, difficulty breathing or swallowing, dizziness)
• swelling, especially of the face and throat; rash; itching
• increased liver function values
• decrease in hemoglobin levels and percentage of red blood cells in the blood (which, in severe cases, can both cause anemia)
• kidney failure
• low sodium levels in the blood (which can cause fatigue, mental confusion, muscle contractions and/or convulsions in severe cases)

Hydrochlorothiazide

Very common

• low potassium levels in the blood
• increased lipids in the blood

Common

• low sodium levels in the blood
• low magnesium levels in the blood
• high uric acid levels in the blood
• itchy rashes and other types of rashes
• loss of appetite
• mild nausea and vomiting
• dizziness, fainting when getting up
• inability to achieve or maintain an erection

Rare

• swelling and blistering of the skin (due to increased sensitivity to the sun)
• high calcium levels in the blood
• high sugar levels in the blood
• sugar in the urine
• worsening of the metabolic state of diabetes
• constipation, diarrhoea, stomach or intestinal disorders, liver disorders that can manifest with yellowing of the skin and eyes
• irregular heartbeat
• headache
• sleep disturbances
• sadness (depression)
• low platelet levels in the blood (sometimes with bleeding or bruising under the skin)
• dizziness
• tingling or numbness
• vision disturbances

Very rare

• inflammation of blood vessels with symptoms such as rashes, reddish-purple spots, fever (vasculitis)
• rash, itching, hives, difficulty breathing or swallowing, dizziness (severe hypersensitivity reactions) severe skin diseases causing rash, redness of the skin, formation of blisters on lips, eyes or mouth, peeling of the skin, fever (toxic epidermal necrolysis) rashes on the face, joint pain, muscle disorders, fever (lupus erythematosus) severe pain in the upper abdomen (pancreatitis)
• difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory distress,

including pneumonia and pulmonary edema)
fever, sore throat, more frequent infections (agranulocytosis)

• paleness, fatigue, shortness of breath, dark urine (hemolytic anemia)
• fever, sore throat or mouth ulcers due to infections (leukopenia)
• confusion, fatigue, tremor and muscle spasm, rapid breathing (hypochloremic alkalosis)

Not known

• fatigue, bruising and frequent infections (aplastic anemia)
• severe decrease in the amount of urine (possible sign of kidney disorder or kidney failure)
• decreased vision or eye pain due to high eye pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
• rash, redness of the skin, formation of blisters on lips, eyes or mouth, peeling of the skin, fever (possible signs of erythema multiforme)
• muscle spasm
• fever (pyrexia)
• weakness (asthenia)
• skin and lip cancer (non-melanoma skin cancer)

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects
not listed in this leaflet. You can also report side effects directly through your national reporting
system. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Valsartan and Idroclorotiazide Tecnigen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Scad.”. The
expiry date refers to the last day of that month.
Do not store above 30°C.
Do not use this medicine if the pack is damaged or shows signs of tampering.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Valsartan and Idroclorotiazide Tecnigen contains

• The active ingredients are valsartan and hydrochlorothiazide. Each film-coated tablet contains 160 mg of valsartan and 12.5 mg of hydrochlorothiazide.
• The other ingredients (excipients) are: microcrystalline cellulose, crospovidone, magnesium stearate. The tablet coating contains: hypromellose 6cP, talc, macrogol 8000, titanium dioxide (E171), iron oxide red (E172).

Description of the appearance of Valsartan and Idroclorotiazide Tecnigen and contents of the pack

Valsartan and Hydrochlorothiazide Tecnigen 160 mg/12.5 mg film-coated tablets are

red, oblong, convex film-coated tablets with a score line on one side.
Valsartan and Hydrochlorothiazide Tecnigen160 mg/12.5 mg is available in blister packs of 28
tablets.

Marketing Authorisation Holder and manufacturer

Marketing Authorisation Holder:
TECNIMEDE Sociedade Técnico-Medicinal S.A.
Rua da Tapada Grande n. 2, Abrunheira
2710-089 Sintra
Portugal

Manufacturers:
West Pharma – Produções de Especialidades Farmacêuticas S.A.
Rua João de Deus n. 11, Venda Nova
2700-486 Amadora
Portugal
Atlantic Pharma - Produções Farmacêuticas, S.A.
Rua da Tapada Grande, nº 2, Abrunheira,
2710-089 Sintra
Portugal

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Portugal: Valsartan/Hydrochlorothiazide Pentafarma
Italy: Valsartan and Hydrochlorothiazide Tecnigen160 mg/12.5 mg film-coated tablets

Valsartan and Hydrochlorothiazide TecniGen 160 mg/ 25 mg film-coated tablets

Valsartan/Hydrochlorothiazide
Generic medicine

Read this leaflet carefully before you start taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours because it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Valsartan and Hydrochlorothiazide TecniGen is and what it is used for.
• 2. What you need to know before you take Valsartan and Hydrochlorothiazide TecniGen.
• 3. How to take Valsartan and Hydrochlorothiazide TecniGen.
• 4. Possible side effects.
• 5. How to store Valsartan and Hydrochlorothiazide TecniGen.
• 6. Contents of the pack and other information.

1. What is Valsartan and Idroclorotiazide TecniGen and what is it used for

Valsartan and Idroclorotiazide TecniGen film-coated tablets contains two active ingredients
called valsartan and hydrochlorothiazide. Both of these substances help to control high blood pressure (hypertension).

• Valsartanbelongs to a class of medicines known as “angiotensin II receptor antagonists” which help to control high blood pressure. Angiotensin II is a substance present in the body that causes the narrowing of blood vessels, thereby increasing blood pressure. Valsartan works by blocking the effect of angiotensin II. The result is that blood vessels relax and blood pressure decreases.
• Hydrochlorothiazidebelongs to a group of medicines called thiazide diuretics (also known as “water tablets”). Hydrochlorothiazide increases urine production and, in doing so, reduces blood pressure.

Valsartan and Idroclorotiazide TecniGen is used in the treatment of high blood pressure when the
blood pressure is not adequately controlled by a single medicine.
High blood pressure increases the workload of the heart and arteries. Without adequate
treatment, this can damage the blood vessels of the brain, heart and kidneys and can lead to stroke,
heart failure or kidney failure.
High blood pressure increases the risk of heart attack. Bringing blood pressure to normal levels
reduces the risk of developing these disorders.

2. What you need to know before taking Valsartan and Hydrochlorothiazide TecniGen

Do not take Valsartan and Hydrochlorothiazide TecniGen

• If you are allergic to valsartan, hydrochlorothiazide, sulfonamide derivatives (chemically related substances to hydrochlorothiazide) or any of the excipients of this medicine (listed in paragraph 6).
• if you are pregnant for more than 3 months(it is advisable to avoid the use of Valsartan and Hydrochlorothiazide TecniGen even during the first months of pregnancy - see the section relating to pregnancy).
• if you have severe liver disorders, destruction of the small bile ducts within the liver (biliary cirrhosis) leading to bile accumulation in the liver (cholestasis) if you suffer from a severekidney disease.
• if you are unable to urinate (anuria).
• if you are undergoing treatment with an artificial kidney
• if your potassium or sodium levels in the blood are lower than normal or if your calcium level in the blood is higher than normal despite treatment.
• if you have gout.
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.

If you think you may have any of these conditions, do not take this medicine and ask
your doctor for advice.

Warnings and precautions
Consult your doctor, pharmacist or nurse before taking Valsartan and Hydrochlorothiazide
TecniGen.

• if you are taking potassium-sparing medicines, potassium supplements, salt substitutes containing potassium or other medicines that increase potassium levels in the blood, such as heparin. Your doctor may need to check your potassium level in the blood at regular intervals.
• if your potassium levels in the blood are low.
• if you have diarrhea or severe vomiting.
• if you are taking high doses of medicines that increase fluid elimination (diuretics).
• if you suffer from serious heart problems.
• if you suffer from heart failure or have had a heart attack. Carefully follow your doctor's instructions on the starting dose of therapy. Your doctor will also check your kidney function.
• if you suffer from a narrowing of the renal artery.
• if you have recently undergone a kidney transplant.
• if you suffer from hyperaldosteronism, a disease in which the adrenal glands produce too much aldosterone hormone. If this applies to you, the use of Valsartan and Hydrochlorothiazide TecniGen is not recommended.
• if you have liver or kidney disease.
• if you have previously experienced swelling of the tongue and face caused by an allergic reaction called angioedema when taking other medicines (including ACE inhibitors), inform your doctor. If these symptoms occur when taking Valsartan and Hydrochlorothiazide TecniGen, stop taking Valsartan and Hydrochlorothiazide TecniGen immediately and never take it again. See paragraph 4, “Possible side effects”
• if you have fever, rash and joint pain, which may be signs of systemic lupus erythematosus (SLE, a so-called autoimmune disease).
• if you have diabetes, gout, high cholesterol or triglyceride levels in the blood.
• if you have had allergic reactions with the use of other medicines that lower blood pressure belonging to the same class (angiotensin II receptor antagonists) or if you suffer from allergies or asthma.
• if you experience a decrease in vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure and can occur from a few hours to weeks after taking Valsartan and Hydrochlorothiazide TecniGen. If left untreated, this can lead to permanent vision loss. If you have previously had an allergy to penicillins or sulfonamides, you may have a higher risk of developing this disorder.
• it may cause increased sensitivity of the skin to the sun.
• If you are taking any of the following medicines used to treat high blood pressure:
• an "ACE inhibitor" (for example enalapril, lisinopril, ramipril), especially if you suffer from kidney problems related to diabetes.
• aliskiren
• if you have previously had skin cancer or are developing an unexpected skin lesion during treatment. Long-term use of hydrochlorothiazide, especially at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Irbesartan and Hydrochlorothiazide TecniGen.

Your doctor may need to check your kidney function, blood pressure, and the amount of
electrolytes (e.g. potassium) in your blood at regular intervals.
See also what is reported in the section "Do not take Valsartan and Hydrochlorothiazide TecniGen"

If any of these cases apply to you, consult your doctor.
For those who play sports: the use of the drug without a therapeutic need constitutes doping and
may still result in positive doping tests.
The use of Valsartan and Hydrochlorothiazide TecniGen is not recommended in children and adolescents
(under 18 years of age).
Tell your doctor if you suspect (or are planning) a pregnancy. Valsartan and Hydrochlorothiazide
TecniGen is not recommended in early pregnancy and should not be taken if you have been pregnant for
more than 3 months as it can cause serious harm to the baby if taken during this period (see the
section relating to pregnancy).

Other medicines and Valsartan and Hydrochlorothiazide TecniGen
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
The effect of the treatment may be affected if Valsartan and Hydrochlorothiazide TecniGen is
taken with certain other medicines. It may be necessary to change the dose, take other
precautions or, in some cases, stop taking one of the medicines. This applies in
particular to the following medicines:

• Lithium, a medicine used to treat certain types of mental disorders
• medicines or substances that can increase the amount of potassium in the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines and heparin
• medicines that can decrease the amount of potassium in the blood, such as diuretics (medicines

that increase fluid elimination), corticosteroids, laxatives, carbenoxolone,
amphotericin or penicillin G

• some antibiotics (rifampicin group), a drug used against rejection in transplantation (cyclosporine) and an antiretroviral drug used to treat HIV/AIDS infections (ritonavir). These drugs may increase the effect of Valsartan and Hydrochlorothiazide TecniGen
• medicines that can induce torsades de pointes (irregular heartbeat), such as antiarrhythmics (medicines used to treat heart problems) and some antipsychotics
• medicines that can reduce the amount of sodium in the blood, such as antidepressants, antipsychotics, antiepileptics
• medicines for the treatment of gout, such as allopurinol, probenecid, sulfinpyrazone
• therapeutic vitamin D and calcium supplements
• medicines used to treat diabetes (oral use such as metformin or insulins)
• other medicines that lower blood pressure, including methyldopa, ACE inhibitors (such as enalapril, lisinopril, etc.) or aliskiren
• medicines that increase blood pressure, such as norepinephrine or epinephrine
• digoxin or other cardiac glycosides (medicines used to treat heart problems) pain relievers such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (Cox-2) inhibitors and acetylsalicylic acid > 3 g muscle relaxants, such as tubocurarine
• anticholinergic medicines (medicines used to treat various disorders such as gastrointestinal cramps, bladder spasm, asthma, motion sickness, muscle spasms, Parkinson's disease and to facilitate anesthesia)
• amantadine (a medicine used to treat Parkinson's disease and also to treat or prevent some diseases caused by viruses) cholestyramine and colestipol (medicines used mainly in the treatment of high lipid levels in the blood)
• cyclosporine, a medicine used in organ transplantation to prevent organ rejection
• alcohol, sleeping pills and anesthetics (medicines with a narcotic or analgesic effect used, for example, during surgery)
• iodinated contrast agents (used for radiological examinations)

Your doctor may need to change the dose and / or take other precautions.
If you are taking an ACE inhibitor or aliskiren (see also "Do not
take Valsartan and Hydrochlorothiazide TecniGen” and "Warnings and precautions”).

Valsartan and Hydrochlorothiazide TecniGen with food, drinks and alcohol
Valsartan and Hydrochlorothiazide TecniGen can be taken with or without food.
Avoid drinking alcohol before talking to your doctor.
Alcohol can further lower blood pressure and/or increase the risk of dizziness
or fainting.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Consult your doctor if you suspect (or are planning) a pregnancy
Generally, your doctor will advise you to stop treatment with Valsartan and Hydrochlorothiazide
TecniGen before you become pregnant or as soon as pregnancy is confirmed and will advise you to
take another medicine instead of Valsartan and Hydrochlorothiazide TecniGen. The use of Valsartan and Hydrochlorothiazide TecniGen is not recommended during the early stages of pregnancy and
the medicine should not be taken if you are pregnant for more than 3 months as, if taken after the third month of
pregnancy, it could cause serious harm to your baby (see the
section relating to pregnancy).

Breastfeeding
Consult your doctor if you are breastfeeding or intend to start breastfeeding.
Valsartan and Hydrochlorothiazide TecniGen is not recommended for mothers breastfeeding. In
the event that you wish to continue breastfeeding, your doctor may decide to prescribe an alternative
treatment.

Driving and operating machinery
Before driving a vehicle, using tools or machinery or performing other activities that require
concentration, make sure you know how you react to Valsartan and Hydrochlorothiazide TecniGen.
Like many other medicines used to treat high blood pressure, Valsartan and
Hydrochlorothiazide TecniGen can occasionally cause dizziness and affect your ability to concentrate.

3. How to take Valsartan and Idroclorotiazide TecniGen

Take this medicine following exactly the instructions of your doctor or pharmacist.
This will help you to obtain the best results and to reduce the risk of undesirable effects. If you have doubts
consult your doctor or pharmacist.
Those suffering from high blood pressure often do not notice any signs of this problem. Many
may feel as well as usual. For this reason, it is very important that you make regular
appointments with your doctor, even if you feel well.
The doctor will tell you exactly how many tablets of Valsartan and Idroclorotiazide TecniGen you must
take. Based on your response to treatment, the doctor may suggest a higher or
lower dose.

• The usual dose of Valsartan and Idroclorotiazide TecniGen is equivalent to one tablet per day.
• Do not change the dose and do not interrupt the treatment without consulting your doctor.
• This medicine must be taken every day at the same time, usually in the morning.
• You can take Valsartan and Idroclorotiazide TecniGen with or without food.
• Swallow the tablet with a glass of water.

The score line is to facilitate breaking the tablet if you have difficulty swallowing it
whole.

If you take more Valsartan and Idroclorotiazide TecniGen than you should
In case of severe dizziness and/or fainting, it is good to lie down and contact your doctor immediately.
If you have accidentally taken too many tablets, consult your doctor, pharmacist or hospital.

If you forget to take Valsartan and Idroclorotiazide TecniGen
If you forget to take a tablet, take it as soon as you remember. However, if it is almost the
time for the next dose, skip the forgotten dose. Do not take a double dose to
compensate for the missed dose.

If you stop taking Valsartan and Idroclorotiazide TecniGen
Stopping treatment with Valsartan and Idroclorotiazide TecniGen may cause
worsening of high blood pressure. Do not stop taking the medicine unless your
doctor has decided so.
If you have any doubts about the use of this medicine , consult your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects can occur with varying frequencies which are defined as follows:

• Very common: affects more than 1 in 10 people
• Common: affects 1 to 10 people in 100
• Uncommon: affects 1 to 10 people in 1,000
• Rare: affects 1 to 10 people in 10,000
• Very rare: affects less than 1 in 10,000
• Not known: the frequency cannot be estimated from the available data

Some side effects may be serious and require immediate medical attention:
Seek immediate medical help if you experience symptoms of angioedema, such as

• Swelling of the face, tongue or throat
• Difficulty swallowing
• Hives and difficulty breathing

If you experience any of these symptoms, stop taking Valsartan and Idroclorotiazide
TecniGen and contact your doctor immediately (see also section 2 “Warnings and
precautions”).
Other side effects include:

Uncommon

• Cough
• lowering of blood pressure
• feeling of lightheadedness
• dehydration (with symptoms such as thirst, dry mouth and tongue, infrequent urination, dark urine, dry skin)
• muscle pain
• fatigue
• tingling or numbness
• blurred vision
• ringing in the ears (e.g. buzzing, whistling)

Very rare

• dizziness
• diarrhoea
• joint pain

Not known

• difficulty breathing
• significant decrease in the amount of urine
• low sodium levels in the blood (which can cause fatigue, confusion, muscle contractions and/or seizures in severe cases)
• low potassium levels in the blood (sometimes with muscle weakness, muscle spasms, abnormal heart rhythm)
• low levels of white blood cells in the blood (with symptoms such as fever, skin infections, sore throat or mouth ulcers due to infections, weakness)
• increased levels of bilirubin in the blood (which can, in severe cases, cause yellowing of the skin and eyes)
• increased levels of urea and creatinine in the blood (which may be an indication of kidney dysfunction)
• increased levels of uric acid in the blood (which can, in severe cases, cause gout)
• syncope (fainting)

Side effects reported with valsartan or hydrochlorothiazide alone, but not observed with
Valsartan and Idroclorotiazide TecniGen:
Valsartan

Uncommon

• feeling of spinning
• abdominal pain

Not known

• appearance of blisters on the skin (sign of bullous dermatitis)
• rash with or without itching together with some of the following signs or symptoms: fever, joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms
• rash, reddish-purple spots, fever, itching (symptoms of inflammation of blood vessels)
• low platelet levels in the blood (sometimes with unusual bleeding or bruising)
• increased potassium levels in the blood (sometimes with muscle spasms, abnormal heart rhythm)
• allergic reactions (with symptoms such as rash, itching, hives, difficulty breathing or swallowing, dizziness)
• swelling especially of the face and throat; rash; itching
• increased liver function values
• decrease in haemoglobin levels and red blood cell percentage in the blood (which, in severe cases, can both cause anaemia)
• renal failure
• low sodium levels in the blood (which can cause fatigue, mental confusion, muscle contractions

and/or seizures in severe cases)
Hydrochlorothiazide

Very common

• low potassium levels in the blood
• increased lipids in the blood

Common

• low sodium levels in the blood
• low magnesium levels in the blood
• high uric acid levels in the blood
• itchy rashes and other types of rashes
• loss of appetite
• mild nausea and vomiting
• dizziness, fainting when getting up
• inability to achieve or maintain an erection

Rare

• swelling and blister formation on the skin (due to increased sensitivity to the sun)
• high calcium levels in the blood
• high sugar levels in the blood
• sugar in the urine
• worsening of the metabolic state of diabetes
• constipation, diarrhoea, stomach or intestinal disorders, liver disorders that can manifest with yellowing of the skin and eyes
• irregular heartbeat
• headache
• sleep disorders
• sadness (depression)
• low platelet levels in the blood (sometimes with bleeding or bruising under the skin)
• dizziness
• tingling or numbness
• visual disturbances

Very rare

• inflammation of blood vessels with symptoms such as rashes, reddish-purple spots, fever (vasculitis)
• rash, itching, hives, difficulty breathing or swallowing, dizziness (severe hypersensitivity reactions) severe skin diseases causing rash, redness of the skin, blisters on lips, eyes or mouth, peeling of the skin, fever (toxic epidermal necrolysis) rashes on the face, joint pain, muscle disorders, fever (lupus erythematosus) severe pain in the upper abdomen (pancreatitis)
• difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory distress, including pneumonia and pulmonary oedema) fever, sore throat, more frequent infections (agranulocytosis)
• paleness, fatigue, shortness of breath, dark urine (haemolytic anaemia)
• fever, sore throat or mouth ulcers due to infections (leucopenia)
• confusion, fatigue, tremor and muscle spasm, rapid breathing (hypochloraemic alkalosis)

Not known

• fatigue, bruising and frequent infections (aplastic anaemia)
• severe decrease in the amount of urine (possible sign of kidney disorder or renal failure)
• decreased vision or eye pain due to high eye pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
• rash, redness of the skin, blisters on lips, eyes or mouth, peeling of the skin, fever (possible signs of erythema multiforme)
• muscle spasm
• fever (pyrexia)
• weakness (asthenia)
• skin and lip cancer (non-melanoma skin cancer).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Valsartan and Idroclorotiazide Tecnigen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Scad.”. The
expiry date refers to the last day of that month.
Do not store above 30°C.
Do not use this medicine if the pack is damaged or shows signs of tampering.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Valsartan and Hydrochlorothiazide Tecnigen contains

• The active ingredients are valsartan and hydrochlorothiazide. Each film-coated tablet contains 160 mg of valsartan and 25 mg of hydrochlorothiazide.
• The other ingredients (excipients) are: microcrystalline cellulose, crospovidone, magnesium stearate. The tablet coating contains: hypromellose 6cP, talc, macrogol 8000, titanium dioxide (E171), iron oxide red (E172), iron oxide black (E172).

Description of the appearance of Valsartan and Hydrochlorothiazide Tecnigen and package contents
Valsartan and Hydrochlorothiazide Tecnigen160 mg/25 mg film-coated tablets are film-coated
tablets orange in color, oblong, convex, with a score line on one side.
Valsartan and Hydrochlorothiazide Tecnigen160 mg/25 mg is available in blister packs of 28
tablets.

Marketing Authorisation Holder and manufacturer

Marketing Authorisation Holder:
TECNIMEDE Sociedade Técnico-Medicinal S.A.
Rua da Tapada Grande n. 2, Abrunheira
2710-089 Sintra
Portugal

Manufacturers:
West Pharma – Produções de Especialidades Farmacêuticas S.A.
Rua João de Deus n. 11, Venda Nova
2700-486 Amadora
Portugal
Atlantic Pharma - Produções Farmacêuticas, S.A.
Rua da Tapada Grande, nº 2, Abrunheira,
2710-089 Sintra
Portugal

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Portugal: Valsartan/Hydrochlorothiazide Pentafarma
Italy: Valsartan e Idroclorotiazide Tecnigen160 mg/25 mg film-coated tablets

Valsartan and Hydrochlorothiazide TecniGen 320 mg/ 12.5 mg film-coated tablets

Valsartan/Hydrochlorothiazide
Generic medicine

Read this leaflet carefully before you start taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours because it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Valsartan and Hydrochlorothiazide TecniGen is and what it is used for.
• 2. What you need to know before you take Valsartan and Hydrochlorothiazide TecniGen.
• 3. How to take Valsartan and Hydrochlorothiazide TecniGen.
• 4. Possible side effects.
• 5. How to store Valsartan and Hydrochlorothiazide TecniGen.
• 6. Contents of the pack and other information.

1. What is Valsartan and Hydrochlorothiazide TecniGen and what is it used for

Valsartan and Hydrochlorothiazide TecniGen film-coated tablets contains two active ingredients
called valsartan and hydrochlorothiazide. Both of these substances help to control high blood
pressure (hypertension).

• Valsartanbelongs to a class of medicines known as “angiotensin II receptor antagonists” which help to control high blood pressure. Angiotensin II is a substance present in the body that causes the narrowing of blood vessels, thereby increasing blood pressure. Valsartan works by blocking the effect of angiotensin II. The result is that blood vessels relax and blood pressure decreases.
• Hydrochlorothiazidebelongs to a group of medicines called thiazide diuretics (also known as “water tablets”). Hydrochlorothiazide increases urine production and, in doing so, reduces blood pressure.

Valsartan and Hydrochlorothiazide TecniGen is used in the treatment of high blood pressure when the
pressure is not adequately controlled by a single medicine.
High blood pressure increases the workload of the heart and arteries. Without adequate
treatment, this can damage the blood vessels of the brain, heart and kidneys and can lead to stroke,
heart failure or kidney failure.
High blood pressure increases the risk of heart attack. Bringing blood pressure to normal values
reduces the risk of developing these disorders.

2. What you need to know before taking Valsartan and Hydrochlorothiazide TecniGen

Do not take Valsartan and Hydrochlorothiazide TecniGen

• If you are allergic to valsartan, hydrochlorothiazide, sulfonamide derivatives (chemicals related to hydrochlorothiazide) or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant for more than 3 months(it is advisable to avoid using Valsartan and Hydrochlorothiazide TecniGen even during the first months of pregnancy - see the section on pregnancy).
• if you have severe liver problems, destruction of the small bile ducts within the liver (biliary cirrhosis) leading to bile accumulation in the liver (cholestasis) if you suffer from a severekidney disease.
• if you are unable to urinate (anuria).
• if you are undergoing treatment with an artificial kidney
• if your potassium or sodium levels in the blood are lower than normal or if your calcium level in the blood is higher than normal despite treatment.
• if you have gout.
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.

If you think you may have any of these conditions, do not take this medicine and ask
your doctor for advice.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Valsartan and Hydrochlorothiazide
TecniGen.

• if you are taking potassium-sparing medicines, potassium supplements, salt substitutes containing potassium or other medicines that increase potassium levels in the blood, such as heparin. Your doctor may need to check your potassium level in the blood at regular intervals.
• if your potassium levels in the blood are low.
• if you have diarrhea or severe vomiting.
• if you are taking high doses of medicines that increase fluid elimination (diuretics).
• if you suffer from heart failure or have had a heart attack. Carefully follow your doctor's instructions on the starting dose of therapy. Your doctor will also check your kidney function.
• if you suffer from serious heart problems.
• if you suffer from narrowing of the renal artery.
• if you have recently undergone a kidney transplant.
• if you suffer from hyperaldosteronism, a disease in which the adrenal glands produce too much aldosterone hormone. If this applies to you, the use of Valsartan and Hydrochlorothiazide TecniGen is not recommended.
• if you have liver or kidney disease.
• if you have previously experienced swelling of the tongue and face caused by an allergic reaction called angioedema when taking other medicines (including ACE inhibitors), tell your doctor. If these symptoms occur when you take Valsartan and Hydrochlorothiazide TecniGen, stop taking Valsartan and Hydrochlorothiazide TecniGen immediately and never take it again. See section 4, “Possible side effects”
• if you have fever, rash and joint pain, which may be signs of systemic lupus erythematosus (SLE, a so-called autoimmune disease).
• if you have diabetes, gout, high cholesterol or triglyceride levels in the blood.
• if you have had allergic reactions with the use of other medicines that lower blood pressure belonging to the same class (angiotensin II receptor antagonists) or if you suffer from allergies or asthma.
• if you experience decreased vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure and can occur from a few hours to weeks after taking Valsartan and Hydrochlorothiazide TecniGen. If left untreated, this can lead to permanent vision loss. If you have previously had an allergy to penicillins or sulfonamides, you may be at a higher risk of developing this disorder.
• it may cause increased sensitivity of the skin to the sun.
• If you are taking any of the following medicines used to treat high blood pressure:
• an "ACE inhibitor" (for example enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren
• if you have had skin cancer in the past or if you are developing an unexpected skin lesion during treatment. Long-term use of hydrochlorothiazide, especially at high doses, may increase the risk of certain types of skin cancer and lips (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Irbesartan and Hydrochlorothiazide TecniGen.

Your doctor may need to check your kidney function, blood pressure, and the amount of
electrolytes (e.g. potassium) in your blood at regular intervals.
See also what is reported under "Do not take Valsartan and Hydrochlorothiazide TecniGen”

If any of these applies to you, talk to your doctor.
For athletes: the use of the drug without a therapeutic need constitutes doping and
may still result in positive doping tests.
The use of Valsartan and Hydrochlorothiazide TecniGen is not recommended in children and adolescents
(under 18 years of age).
Tell your doctor if you suspect (or are planning) a pregnancy. Valsartan and Hydrochlorothiazide
TecniGen is not recommended in early pregnancy and should not be taken if you are pregnant for
more than 3 months as it can cause serious harm to the baby if taken during this period (see the
section on pregnancy).

Other medicines and Valsartan and Hydrochlorothiazide TecniGen
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
The effect of the treatment may be affected if Valsartan and Hydrochlorothiazide TecniGen is
taken with certain other medicines. It may be necessary to change the dose, take other
precautions or, in some cases, stop taking one of the medicines. This applies in
particular to the following medicines:

• Lithium, a medicine used to treat some types of mental disorders
• medicines or substances that can increase the amount of potassium in the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines and heparin
• medicines that can decrease the amount of potassium in the blood, such as diuretics (medicines that increase fluid elimination), corticosteroids, laxatives, carbenoxolone, amphotericin or penicillin G
• some antibiotics (rifampicin group), a drug used against rejection in transplantation (cyclosporine) and an antiretroviral drug used to treat HIV/AIDS infections (ritonavir). These drugs can increase the effect of Valsartan and Hydrochlorothiazide TecniGen
• medicines that can induce torsades de pointes (irregular heartbeat), such as antiarrhythmics (medicines used to treat heart problems) and some antipsychotics
• medicines that can reduce the amount of sodium in the blood, such as antidepressants, antipsychotics, antiepileptics
• medicines for the treatment of gout, such as allopurinol, probenecid, sulfinpyrazone
• therapeutic vitamin D and calcium supplements
• medicines used to treat diabetes (oral use such as metformin or insulins)
• other medicines that lower blood pressure, including methyldopa, ACE inhibitors (such as enalapril, lisinopril, etc.) or aliskiren
• medicines that increase blood pressure, such as norepinephrine or epinephrine
• digoxin or other cardiac glycosides (medicines used to treat heart problems) medicines that can increase blood sugar levels, such as diazoxide or beta-blockers
• cytotoxic medicines used for cancer treatment, such as methotrexate or cyclophosphamide
• pain relievers such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (Cox-2) inhibitors and acetylsalicylic acid > 3 g muscle relaxants, such as tubocurarine
• anticholinergic medicines (medicines used to treat various disorders such as gastrointestinal cramps, bladder spasm, asthma, motion sickness, muscle spasms, Parkinson's disease and to facilitate anesthesia)
• amantadine (a medicine used to treat Parkinson's disease and also to treat or prevent some diseases caused by viruses))
• cholestyramine and colestipol (medicines used mainly in the treatment of high lipid levels in the blood)
• cyclosporine, a medicine used in organ transplantation to prevent organ rejection
• alcohol, sleeping pills and anesthetics (medicines with a narcotic or analgesic effect used, for example, during surgery)
• iodinated contrast agents (used for radiological examinations)

Your doctor may need to change the dose and / or take other precautions.
If you are taking an ACE inhibitor or aliskiren (see also what is reported under: "Do not
take Valsartan and Hydrochlorothiazide TecniGen” and "Warnings and precautions”).

Valsartan and Hydrochlorothiazide TecniGen with food, drinks and alcohol
Valsartan and Hydrochlorothiazide TecniGen can be taken with or without food.
Avoid drinking alcohol before talking to your doctor.
Alcohol can further lower blood pressure and/or increase the risk of dizziness
or fainting.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist before taking this medicine.

Pregnancy
Talk to your doctor if you suspect (or are planning) a pregnancy
Usually your doctor will advise you to stop treatment with Valsartan and Hydrochlorothiazide
TecniGen before you become pregnant or as soon as pregnancy is confirmed and will advise you to
take another medicine instead of Valsartan and Hydrochlorothiazide TecniGen. The use of Valsartan and Hydrochlorothiazide TecniGen is not recommended during the early stages of pregnancy and
the medicine should not be taken if you are pregnant for more than 3 months as it can cause serious harm to your baby if taken during this period (see the
section on pregnancy).

Breastfeeding
Talk to your doctor if you are breastfeeding or intend to start breastfeeding.
Valsartan and Hydrochlorothiazide TecniGen is not recommended for mothers who are breastfeeding.
If you want to continue breastfeeding, your doctor may decide to prescribe an alternative treatment.

Driving and using machines
Before driving a vehicle, using tools or machines or performing other activities that require
concentration, make sure you know how you react to Valsartan and Hydrochlorothiazide TecniGen.
Like many other medicines used to treat high blood pressure, Valsartan and
Hydrochlorothiazide TecniGen can occasionally cause dizziness and affect your ability to concentrate.

3. How to take Valsartan and Idroclorotiazide TecniGen

Take this medicine following exactly the instructions of your doctor or pharmacist.
This will help you to obtain the best results and to reduce the risk of undesirable effects. If you have doubts
consult your doctor or pharmacist.
Those suffering from high blood pressure often do not notice any signs of this problem. Many
may feel as well as usual. For this reason it is very important that you keep regular
appointments with your doctor, even if you feel well.
The doctor will tell you exactly how many tablets of Valsartan and Idroclorotiazide TecniGen you must
take. Based on your response to treatment, the doctor may suggest a higher or
lower dose.

• The usual dose of Valsartan and Idroclorotiazide TecniGen is equivalent to one tablet per day.
• Do not change the dose and do not interrupt the treatment without consulting your doctor.
• This medicine must be taken every day at the same time, usually in the morning.
• You can take Valsartan and Idroclorotiazide TecniGen with or without food.
• Swallow the tablet with a glass of water.

If you take more Valsartan and Idroclorotiazide TecniGen than you should
In case of severe dizziness and/or fainting, it is advisable to lie down and contact your doctor immediately.
If you have accidentally taken too many tablets, consult your doctor, pharmacist or hospital.

If you forget to take Valsartan and Idroclorotiazide TecniGen
If you forget to take a tablet, take it as soon as you remember. However, if it is almost the
time for the next dose, skip the forgotten dose. Do not take a double dose to
compensate for the missed dose.

If you stop taking Valsartan and Idroclorotiazide TecniGen
Stopping the treatment with Valsartan and Idroclorotiazide TecniGen can cause
worsening of high blood pressure. Do not stop taking the medicine unless your
doctor has decided so.
If you have any doubts about the use of this medicine , consult your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects can occur with varying frequencies which are defined as follows:

• Very common: affects more than 1 in 10 people
• Common: affects 1 to 10 people in 100
• Uncommon: affects 1 to 10 people in 1,000
• Rare: affects 1 to 10 people in 10,000
• Very rare: affects less than 1 in 10,000
• Not known: the frequency cannot be estimated from the available data

Some side effects may be serious and require immediate medical attention:
Seek medical attention immediately if you experience symptoms of angioedema, such as

• Swelling of the face, tongue or throat
• Difficulty swallowing
• Hives and difficulty breathing

If you experience any of these symptoms, stop taking Valsartan and Idroclorotiazide
TecniGen and contact your doctor immediately (see also section 2 “Warnings and
precautions”).
Other side effects include:

Uncommon

• Cough
• lowering of blood pressure
• feeling of lightheadedness
• dehydration (with symptoms such as thirst, dry mouth and tongue, infrequent urination, dark urine, dry skin)
• muscle pain
• fatigue
• tingling or numbness
• blurred vision
• ringing in the ears (e.g. buzzing, whistling)

Very rare

• dizziness
• diarrhoea
• joint pain

Not known

• difficulty breathing
• significant decrease in the amount of urine
• low sodium levels in the blood (which can cause fatigue, confusion, muscle cramps and/or convulsions in severe cases)
• low potassium levels in the blood (sometimes with muscle weakness, muscle spasms, abnormal heart rhythm)
• low levels of white blood cells in the blood (with symptoms such as fever, skin infections, sore throat or mouth ulcers due to infections, weakness)
• increased bilirubin levels in the blood (which can, in severe cases, cause yellowing of the skin and eyes)
• increased levels of urea and creatinine in the blood (which may be an indication of kidney dysfunction)
• increased uric acid levels in the blood (which can, in severe cases, cause gout)
• syncope (fainting)

Side effects reported with valsartan or hydrochlorothiazide alone, but not observed with
Valsartan and Idroclorotiazide TecniGen:
Valsartan

Uncommon

• feeling of spinning
• abdominal pain

Not known

• appearance of blisters on the skin (sign of bullous dermatitis)
• rash with or without itching together with some of the following signs or symptoms: fever, joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms
• rash, reddish-purple spots, fever, itching (symptoms of inflammation of the blood vessels)
• low platelet levels in the blood (sometimes with unusual bleeding or bruising)
• increased potassium levels in the blood (sometimes with muscle spasms, abnormal heart rhythm)
• allergic reactions (with symptoms such as rash, itching, hives, difficulty breathing or swallowing, dizziness)
• swelling especially of the face and throat; rash; itching
• increased liver function values
• decrease in hemoglobin levels and percentage of red blood cells in the blood (which, in severe cases, can both cause anemia)
• kidney failure
• low sodium levels in the blood (which can cause fatigue, mental confusion, muscle cramps and/or convulsions in severe cases)

Hydrochlorothiazide

Very common

• low potassium levels in the blood
• increased lipids in the blood

Common

• low sodium levels in the blood
• low magnesium levels in the blood
• high uric acid levels in the blood
• itchy rashes and other types of rashes
• loss of appetite
• mild nausea and vomiting
• dizziness, fainting when getting up
• inability to achieve or maintain an erection

Rare

• swelling and blistering of the skin (due to increased sensitivity to the sun)
• high calcium levels in the blood
• high sugar levels in the blood
• sugar in the urine
• worsening of the metabolic state of diabetes constipation, diarrhoea, stomach or intestinal disorders, liver disorders that can manifest with yellowing of the skin and eyes
• irregular heartbeat
• headache
• sleep disorders
• sadness (depression)
• low levels of platelets in the blood (sometimes with bleeding or bruising under the skin)
• dizziness
• tingling or numbness
• vision disorders

Very rare

• inflammation of blood vessels with symptoms such as rashes, reddish-purple spots, fever (vasculitis)
• rash, itching, hives, difficulty breathing or swallowing dizziness (hypersensitivity reactions) severe skin diseases that cause rash, redness of the skin, formation of blisters on lips, eyes or mouth, peeling of the skin, fever (toxic epidermal necrolysis) rashes on the face, joint pain, muscle disorders, fever (lupus erythematosus) severe pain in the upper abdomen (pancreatitis) difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory distress, including pneumonia and pulmonary edema) fever, sore throat, more frequent infections (agranulocytosis)
• paleness, fatigue, shortness of breath, dark urine (hemolytic anemia)
• fever, sore throat or mouth ulcers due to infections (leukopenia)
• confusion, fatigue, tremor and muscle spasm, rapid breathing (hypochloremic alkalosis)

Not known

• fatigue, bruising and frequent infections (aplastic anemia)
• severe decrease in the amount of urine (possible sign of kidney disorder or kidney failure)
• decreased vision or eye pain due to high eye pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
• rash, redness of the skin, formation of blisters on lips, eyes or mouth, peeling of the skin, fever (possible signs of erythema multiforme)
• muscle spasm
• fever (pyrexia)
• weakness (asthenia)
• skin and lip cancer (non-melanoma skin cancer)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or
nurse. You can also report side effects directly through the national reporting system. By reporting
side effects you can help provide more information on the safety of this medicine.

5. How to store Valsartan and Idroclorotiazide Tecnigen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Scad.”. The
expiry date refers to the last day of that month.
Do not store above 30°C.
Do not use this medicine if the pack is damaged or shows signs of tampering.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Valsartan and Hydrochlorothiazide Tecnigen contains

• The active ingredients are valsartan and hydrochlorothiazide. Each film-coated tablet contains 320 mg of valsartan and 12.5 mg of hydrochlorothiazide.
• The other ingredients (excipients) are: microcrystalline cellulose, crospovidone, magnesium stearate. The tablet coating contains: hypromellose 6cP, talc, macrogol 8000, titanium dioxide (E171), iron oxide red (E172).

Description of the appearance of Valsartan and Hydrochlorothiazide Tecnigen and package contents
Valsartan and Hydrochlorothiazide Tecnigen320 mg/12.5 mg film-coated tablets are
orange, oblong, convex, film-coated tablets with a score line on one side.
Valsartan and Hydrochlorothiazide Tecnigen320 mg/12.5 mg is available in blister packs of 28
tablets.

Marketing Authorisation Holder and manufacturer

Marketing Authorisation Holder:
TECNIMEDE Sociedade Técnico-Medicinal S.A.
Rua da Tapada Grande n. 2, Abrunheira
2710-089 Sintra
Portugal

Manufacturers:
West Pharma – Produções de Especialidades Farmacêuticas S.A.
Rua João de Deus n. 11, Venda Nova
2700-486 Amadora
Portugal
Atlantic Pharma - Produções Farmacêuticas, S.A.
Rua da Tapada Grande, nº 2, Abrunheira,
2710-089 Sintra
Portugal

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Portugal: Valsartan/Hydrochlorothiazide Pentafarma
Italy: Valsartan e Idroclorotiazide Tecnigen320 mg/12.5 mg film-coated tablets

Valsartan and Hydrochlorothiazide TecniGen 320 mg/25 mg film-coated tablets

Valsartan/Hydrochlorothiazide
Generic medicine

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Valsartan and Hydrochlorothiazide TecniGen is and what it is used for.
• 2. What you need to know before you take Valsartan and Hydrochlorothiazide TecniGen.
• 3. How to take Valsartan and Hydrochlorothiazide TecniGen.
• 4. Possible side effects.
• 5. How to store Valsartan and Hydrochlorothiazide TecniGen.
• 6. Contents of the pack and other information.

1. What is Valsartan and Hydrochlorothiazide TecniGen and what is it used for

Valsartan and Hydrochlorothiazide TecniGen film-coated tablets contain two active ingredients
called valsartan and hydrochlorothiazide. Both of these substances help to control high blood pressure (hypertension).

• Valsartanbelongs to a class of medicines known as “angiotensin II receptor antagonists” which help to control high blood pressure. Angiotensin II is a substance present in the body that causes the narrowing of blood vessels, thereby increasing blood pressure. Valsartan works by blocking the effect of angiotensin II. The result is that blood vessels relax and blood pressure decreases.
• Hydrochlorothiazidebelongs to a group of medicines called thiazide diuretics (also known as “water tablets”). Hydrochlorothiazide increases urine production and, in doing so, reduces blood pressure.

Valsartan and Hydrochlorothiazide TecniGen is used in the treatment of high blood pressure when the
blood pressure is not adequately controlled by a single medicine.
High blood pressure increases the workload of the heart and arteries. Without adequate
treatment, this can damage the blood vessels of the brain, heart and kidneys and can lead to stroke,
heart failure or kidney failure.
High blood pressure increases the risk of heart attack. Bringing blood pressure to normal levels
reduces the risk of developing these disorders.

2. What you need to know before taking Valsartan and Hydrochlorothiazide TecniGen

Do not take Valsartan and Hydrochlorothiazide TecniGen

• If you are allergic to valsartan, hydrochlorothiazide, sulfonamide derivatives (chemically related substances to hydrochlorothiazide) or any of the excipients of this medicine (listed in section 6).
• if you are pregnant for more than 3 months(it is advisable to avoid the use of Valsartan and Hydrochlorothiazide TecniGen even during the first months of pregnancy - see the section relating to pregnancy).
• if you have severe liver disorders, destruction of the small bile ducts within the liver (biliary cirrhosis) leading to bile accumulation in the liver (cholestasis) if you suffer from a severekidney disease.
• if you are unable to urinate (anuria).
• if you are undergoing treatment with an artificial kidney.
• if your potassium or sodium levels in the blood are lower than normal or if your calcium level in the blood is higher than normal despite treatment.
• if you have gout.
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.

If you think you may be suffering from any of these conditions, do not take this medicine and ask
your doctor for advice.

Warnings and precautions
Consult your doctor, pharmacist or nurse before taking Valsartan and Hydrochlorothiazide
TecniGen.

• if you are taking potassium-sparing medicines, potassium supplements, salt substitutes containing potassium or other medicines that increase potassium levels in the blood, such as heparin. Your doctor may need to check your potassium level in the blood at regular intervals.
• if your potassium levels in the blood are low.
• if you have diarrhea or severe vomiting.
• if you are taking high doses of medicines that increase fluid elimination (diuretics).
• if you suffer from heart failure or have had a heart attack. Carefully follow your doctor's instructions on the starting dose of therapy. Your doctor will also check your kidney function.
• if you suffer from severe heart problems.
• if you suffer from a narrowing of the renal artery.
• if you have recently undergone a kidney transplant.
• if you suffer from hyperaldosteronism, a disease in which the adrenal glands produce too much aldosterone hormone. If this applies to you, the use of Valsartan and Hydrochlorothiazide TecniGen is not recommended.
• if you have liver or kidney disease.
• if you have previously experienced swelling of the tongue and face caused by an allergic reaction called angioedema when taking other medicines (including ACE inhibitors), inform your doctor. If these symptoms occur when taking Valsartan and Hydrochlorothiazide TecniGen, stop taking Valsartan and Hydrochlorothiazide TecniGen immediately and never take it again. See section 4, “Possible side effects”.
• if you have fever, rash and joint pain, which may be signs of systemic lupus erythematosus (SLE, a so-called autoimmune disease).
• if you have diabetes, gout, high cholesterol or triglyceride levels in the blood.
• if you have had allergic reactions with the use of other medicines that lower blood pressure belonging to the same class (angiotensin II receptor antagonists) or if you suffer from allergies or asthma.
• if you experience decreased vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure and may occur from a few hours to weeks after taking Valsartan and Hydrochlorothiazide TecniGen. If left untreated, this can lead to permanent vision loss. If you have previously had an allergy to penicillins or sulfonamides, you may be at greater risk of developing this disorder.
• it may cause increased sensitivity of the skin to the sun.
• If you are taking any of the following medicines used to treat high blood pressure:
• an "ACE inhibitor" (for example enalapril, lisinopril, ramipril), especially if you suffer from kidney problems related to diabetes.
• aliskiren
• if you have had skin cancer in the past or if you are developing an unexpected skin lesion during treatment. Long-term use with high doses of hydrochlorothiazide may increase the risk of some types of skin cancer and lips (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Irbesartan and Hydrochlorothiazide TecniGen.

Your doctor may need to check your kidney function, blood pressure, and the amount of
electrolytes (e.g. potassium) in your blood at regular intervals.
See also what is reported under "Do not take Valsartan and Hydrochlorothiazide TecniGen”

If any of these cases apply to you, consult your doctor.
For those who play sports: the use of the drug without a therapeutic need constitutes doping and
may still result in positive doping tests.
The use of Valsartan and Hydrochlorothiazide TecniGen is not recommended in children and adolescents
(under 18 years of age).
Tell your doctor if you suspect (or are planning) a pregnancy. Valsartan and Hydrochlorothiazide
TecniGen is not recommended in early pregnancy and should not be taken if you are pregnant for
more than 3 months as it can cause serious harm to the baby if taken during this period (see the
section relating to pregnancy).

Other medicines and Valsartan and Hydrochlorothiazide TecniGen
Tell your doctor or pharmacist if you are taking, have recently taken or may take
any other medicines.
The effect of the treatment may be affected if Valsartan and Hydrochlorothiazide TecniGen is
taken with some other medicines. It may be necessary to change the dose, take other
precautions or, in some cases, stop taking one of the medicines. This applies in
particular to the following medicines:

• Lithium, a medicine used to treat some types of mental disorders
• medicines or substances that can increase the amount of potassium in the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines and heparin
• medicines that can decrease the amount of potassium in the blood, such as diuretics (medicines that increase fluid elimination), corticosteroids, laxatives, carbenoxolone, amphotericin or penicillin G
• some antibiotics (rifampicin group), a drug used against rejection in transplantation (cyclosporine) and an antiretroviral drug used to treat HIV/AIDS infections (ritonavir). These drugs can increase the effect of Valsartan and Hydrochlorothiazide TecniGen
• medicines that can induce torsades de pointes (irregular heartbeat), such as antiarrhythmics (medicines used to treat heart problems) and some antipsychotics
• medicines that can reduce the amount of sodium in the blood, such as antidepressants, antipsychotics, antiepileptics
• medicines for the treatment of gout, such as allopurinol, probenecid, sulfinpyrazone
• therapeutic supplements of vitamin D and calcium
• medicines used to treat diabetes (oral use such as metformin or insulins)
• other medicines that lower blood pressure, including methyldopa, ACE inhibitors (such as enalapril, lisinopril, etc.) or aliskiren
• medicines that increase blood pressure, such as norepinephrine or epinephrine
• digoxin or other cardiac glycosides (medicines used to treat heart problems) medicines that can increase blood sugar levels, such as diazoxide or beta-blockers
• cytotoxic medicines used for cancer treatment, such as methotrexate or cyclophosphamide
• painkillers such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (Cox-2) inhibitors and acetylsalicylic acid > 3 g muscle relaxants, such as tubocurarine
• anticholinergic medicines (medicines used to treat various disorders such as gastrointestinal cramps, bladder spasm, asthma, motion sickness, muscle spasms, Parkinson's disease and to facilitate anesthesia)
• amantadine (a medicine used to treat Parkinson's disease and also to treat or prevent some diseases caused by viruses) colestyramine and colestipol (medicines used mainly in the treatment of high lipid levels in the blood)
• cyclosporine, a medicine used in organ transplantation to prevent organ rejection
• alcohol, sleeping pills and anesthetics (medicines with a narcotic or analgesic effect used for example during surgery)
• iodinated contrast agents (used for radiological examinations)

Your doctor may need to change the dose and/or take other precautions.
If you are taking an ACE inhibitor or aliskiren (see also what is reported under: "Do not
take Valsartan and Hydrochlorothiazide TecniGen” and "Warnings and precautions”).

Valsartan and Hydrochlorothiazide TecniGen with food, drinks and alcohol
Valsartan and Hydrochlorothiazide TecniGen can be taken with or without food.
Avoid drinking alcohol before talking to your doctor.
Alcohol can further lower blood pressure and/or increase the risk of dizziness or fainting.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist before taking this medicine.

Pregnancy
Consult your doctor if you suspect (or are planning) a pregnancy
Normally your doctor will advise you to stop treatment with Valsartan and Hydrochlorothiazide
TecniGen before you become pregnant or as soon as pregnancy is confirmed and will advise you to
take another medicine instead of Valsartan and Hydrochlorothiazide TecniGen. The use of Valsartan and Hydrochlorothiazide TecniGen is not recommended during the early stages of pregnancy and the
medicine should not be taken if you are pregnant for more than 3 months as, if taken after the third month of
pregnancy, it could cause serious harm to your baby (see the
section relating to pregnancy).

Breastfeeding
Consult your doctor if you are breastfeeding or intend to start breastfeeding.
For breastfeeding mothers Valsartan and Hydrochlorothiazide TecniGen is not recommended. In
the case you want to continue breastfeeding, your doctor may decide to prescribe alternative
treatment.

Driving and operating machinery
Before driving a vehicle, using tools or machinery or performing other activities that require
concentration, make sure you know your reaction to Valsartan and Hydrochlorothiazide TecniGen.
Like many other medicines used to treat high blood pressure, Valsartan and
Hydrochlorothiazide TecniGen can occasionally cause dizziness and affect your ability to concentrate.

3. How to take Valsartan and Idroclorotiazide TecniGen

Take this medicine following exactly the instructions of your doctor or pharmacist.
This will help you to obtain the best results and to reduce the risk of side effects. If you have doubts
consult your doctor or pharmacist.
Those suffering from high blood pressure often do not notice any signs of this problem. Many
may feel as well as usual. For this reason, it is very important that you make regular
appointments with your doctor, even if you feel well.
The doctor will tell you exactly how many tablets of Valsartan and Idroclorotiazide TecniGen you must
take. Based on your response to treatment, the doctor may suggest a higher or
lower dose.

• The usual dose of Valsartan and Idroclorotiazide TecniGen is one tablet a day.
• Do not change the dose and do not interrupt the treatment without consulting your doctor.
• This medicine must be taken every day at the same time, usually in the morning.
• You can take Valsartan and Idroclorotiazide TecniGen with or without food.
• Swallow the tablet with a glass of water.

If you take more Valsartan and Idroclorotiazide TecniGen than you should
In case of severe dizziness and/or fainting, it is good to lie down and contact your doctor immediately.
If you have accidentally taken too many tablets, contact your doctor, pharmacist or hospital.

If you forget to take Valsartan and Idroclorotiazide TecniGen
If you forget to take a tablet, take it as soon as you remember. However, if it is almost the
time of the next dose, skip the forgotten dose. Do not take a double dose to
compensate for the missed dose.

If you stop taking Valsartan and Idroclorotiazide TecniGen
Stopping the treatment with Valsartan and Idroclorotiazide TecniGen may cause
worsening of high blood pressure. Do not stop taking the medicine unless your
doctor has decided so.
If you have any doubts about the use of this medicine , consult your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects can occur with different frequencies which are defined as follows:

• Very common: affects more than 1 in 10 people
• Common: affects 1 to 10 people in 100
• Uncommon: affects 1 to 10 people in 1,000
• Rare: affects 1 to 10 people in 10,000
• Very rare: affects less than 1 in 10,000
• Not known: the frequency cannot be estimated from the available data

If you experience any of these symptoms, stop taking Valsartan and Idroclorotiazide
TecniGen and contact your doctor immediately (see also section 2 “Warnings and
precautions”).
Some side effects can be serious and require immediate medical attention:
Seek medical attention immediately if you experience symptoms of angioedema, such as

• Swelling of the face, tongue or throat
• Difficulty swallowing
• Hives and difficulty breathing

Other side effects include:

Uncommon

• Cough
• lowering of blood pressure
• feeling of lightheadedness
• dehydration (with symptoms such as thirst, dry mouth and tongue, infrequent urination, dark urine, dry skin)
• muscle pain
• fatigue
• tingling or numbness
• blurred vision
• ringing in the ears (e.g. buzzing, whistling)

Very rare

• dizziness
• diarrhoea
• joint pain

Not known

• difficulty breathing
• significant decrease in the amount of urine
• low sodium levels in the blood (which can cause fatigue, confusion, muscle contractions and/or convulsions in severe cases)
• low potassium levels in the blood (sometimes with muscle weakness, muscle spasms, abnormal heart rhythm)
• low white blood cell count in the blood (with symptoms such as fever, skin infections, sore throat or mouth ulcers due to infections, weakness)
• increased bilirubin levels in the blood (which can, in severe cases, cause yellowing of the skin and eyes)
• increased levels of urea and creatinine in the blood (which may be an indication of kidney malfunction)
• increased uric acid levels in the blood (which can, in severe cases, cause gout)
• syncope (fainting)

Side effects reported with valsartan or hydrochlorothiazide alone, but not observed with
Valsartan and Idroclorotiazide TecniGen:
Valsartan

Uncommon

• feeling of spinning
• abdominal pain

Not known

• appearance of blisters on the skin (sign of bullous dermatitis)
• rash with or without itching together with some of the following signs or symptoms: fever, joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms
• rash, reddish-purple spots, fever, itching (symptoms of inflammation of the blood vessels)
• low platelet count in the blood (sometimes with unusual bleeding or bruising)
• increased potassium levels in the blood (sometimes with muscle spasms, abnormal heart rhythm)
• allergic reactions (with symptoms such as rash, itching, hives, difficulty breathing or swallowing, dizziness)
• swelling especially of the face and throat; rash; itching
• increased liver function values
• decrease in hemoglobin levels and percentage of red blood cells in the blood (which, in severe cases, can both lead to anemia)
• kidney failure
• low sodium levels in the blood (which can cause fatigue, mental confusion, muscle contractions and/or convulsions in severe cases)

Hydrochlorothiazide

Very common

• low potassium levels in the blood
• increased lipids in the blood

Common

• low sodium levels in the blood
• low magnesium levels in the blood
• high uric acid levels in the blood
• itchy rashes and other types of rashes
• loss of appetite
• mild nausea and vomiting
• dizziness, fainting when getting up
• inability to achieve or maintain an erection

Rare

• swelling and blistering of the skin (due to increased sensitivity to the sun)
• high calcium levels in the blood
• high sugar levels in the blood
• sugar in the urine
• worsening of the metabolic state of diabetes constipation, diarrhoea, stomach or intestinal disorders, liver disorders that can manifest with yellowing of the skin and eyes
• irregular heartbeat
• headache
• sleep disturbances
• sadness (depression)
• low platelet levels in the blood (sometimes with bleeding or bruising under the skin)
• dizziness
• tingling or numbness
• vision disturbances

Very rare

• inflammation of blood vessels with symptoms such as rashes, reddish-purple spots, fever (vasculitis)
• rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions) severe skin diseases causing rash, redness of the skin, formation of blisters on lips, eyes or mouth, peeling of the skin, fever (toxic epidermal necrolysis) rashes on the face, joint pain, muscle disorders, fever (lupus erythematosus) peeling of the skin
• fever
• rashes on the face associated with joint pain
• muscle disorders
• fever (Cutaneous lupus erythematosus)
• severe pain in the upper abdomen (pancreatitis) difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory distress, including pneumonia and pulmonary edema) fever, sore throat, more frequent infections (agranulocytosis)
• pallor, fatigue, shortness of breath, dark urine (hemolytic anemia)
• fever, sore throat or mouth ulcers due to infections (leukopenia)
• confusion, fatigue, tremor and muscle spasm, rapid breathing (hypochloremic alkalosis)

Not known

• fatigue, bruising and frequent infections (aplastic anemia)
• severe decrease in the amount of urine (possible sign of kidney disorder or kidney failure)
• decreased vision or eye pain due to high eye pressure (possible signs of fluid buildup in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
• rash, redness of the skin, formation of blisters on lips, eyes or mouth, peeling of the skin, fever (possible signs of erythema multiforme)
• muscle spasm
• fever (pyrexia)
• weakness (asthenia)
• skin and lip cancer (non-melanoma skin cancer)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or
nurse. You can also report side effects directly through the national reporting system. By reporting
side effects you can help provide more information on the safety of this medicine.

5. How to store Valsartan and Idroclorotiazide Tecnigen

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Scad.”. The
expiry date refers to the last day of that month.
Do not store above 30°C.
Do not use this medicine if the pack is damaged or shows signs of tampering.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Valsartan and Idroclorotiazide Tecnigen contains

• The active ingredients are valsartan and hydrochlorothiazide. Each film-coated tablet contains 320 mg of valsartan and 25 mg of hydrochlorothiazide.
• The other ingredients (excipients) are: microcrystalline cellulose, crospovidone, magnesium stearate. The tablet coating contains: hypromellose 6cP, talc, macrogol 8000, titanium dioxide (E171), yellow iron oxide (E172).

Description of the appearance of Valsartan and Idroclorotiazide Tecnigen and contents of the pack
Valsartan and Idroclorotiazide Tecnigen320 mg/25 mg film-coated tablets are tablets
film-coated, yellow, oblong, convex.
Valsartan and Idroclorotiazide Tecnigen320 mg/25 mg is available in blister packs of 28
tablets.

Marketing Authorisation Holder and manufacturer

Marketing Authorisation Holder:
TECNIMEDE Sociedade Técnico-Medicinal S.A.
Rua da Tapada Grande n. 2, Abrunheira
2710-089 Sintra
Portugal

Manufacturers:
West Pharma – Produções de Especialidades Farmacêuticas S.A.
Rua João de Deus n. 11, Venda Nova
2700-486 Amadora
Portugal
Atlantic Pharma - Produções Farmacêuticas, S.A.
Rua da Tapada Grande, nº 2, Abrunheira,
2710-089 Sintra
Portugal

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Portugal: Valsartan/Hydrochlorothiazide Pentafarma
Italy: Valsartan e Idroclorotiazide Tecnigen320 mg/25 mg film-coated tablets