VALSARTAN 80 mg /12.5 Mg Film-Coated Tablets

Содержание инструкции

1. VALSARTAN E IDROCLOROTIAZIDE PENSA 80 mg/12,5 mg film-coated tablets, 160 mg/12,5 mg film-coated tablets, 160 mg/25 mg film-coated tablets, 320 mg/12,5 mg film-coated tablets, 320 mg/25 mg film-coated tablets
   1. WHAT VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA IS AND WHAT IT IS USED FOR
   2. BEFORE TAKING VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA
   3. HOW TO TAKE VALSARTAN E IDROCLOROTIAZIDE PENSA
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE VALSARTAN E IDROCLOROTIAZIDE PENSA
   6. OTHER INFORMATION

VALSARTAN E IDROCLOROTIAZIDE PENSA 80 mg/12,5 mg film-coated tablets, 160 mg/12,5 mg film-coated tablets, 160 mg/25 mg film-coated tablets, 320 mg/12,5 mg film-coated tablets, 320 mg/25 mg film-coated tablets

p.a. Valsartan and Hydrochlorothiazide
Generic medicine

Read this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• 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 or pharmacist.

Contents of this leaflet:

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

1. WHAT VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA IS AND WHAT IT IS USED FOR

VALSARTAN E IDROCLOROTIAZIDE PENSA 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 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 the amount of urine you produce and, in doing so, reduces blood pressure. VALSARTAN E IDROCLOROTIAZIDE PENSA is used to treat high blood pressure when blood pressure is not sufficiently controlled by a single medicine.

When blood pressure is high, the workload on the heart and arteries increases. Over time,
this can damage the blood vessels in 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 back to normal values reduces the risk of developing these conditions.

2. BEFORE TAKING VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA

Do not take VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA:

• if you are allergic (hypersensitive) to valsartan, hydrochlorothiazide, sulfonamide derivatives (chemicals related to hydrochlorothiazide), soy, peanuts or any of the excipients of VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA (listed in section 6)
• if you are pregnant for more than 3 months(it is best to avoid taking VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA even in the early stages of pregnancy - see the Pregnancy section)
• if you have severeliver disease, destruction of the small bile ducts within the liver (biliary cirrhosis) leading to bile accumulation in the liver (cholestasis)
• if you have 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 levels in the blood are 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 any of these applies to you, do not take this medicine and consult your doctor.
Warnings and precautions
Consult your doctor before taking VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA

• if you are taking potassium-sparing drugs, 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 have severe heart disease
• if you suffer from heart failure or have had a heart attack. Carefully follow your doctor's instructions regarding 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 received a new kidney
• 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 PENSA 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 PENSA, stop taking VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA immediately and never take it again. See section 4, “Possible side effects”
• if you have fever, rash and joint pain, which may be a sign of systemic lupus erythematosus (SLE, an autoimmune disease)
• if you have diabetes, gout, high cholesterol or fat 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 PENSA. 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.
• 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
• may cause increased sensitivity of the skin to the sun
• if you have had skin cancer in the past or if you are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use with 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 VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA. Your doctor may check your kidney function, blood pressure and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

The use of VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA is not recommended in children and adolescents (under 18 years of age).
You should inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA 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 Pregnancy section).

Taking VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA with other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those available without a prescription.
The effect of the treatment may be affected if VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA is taken with certain other medicines.
It may be necessary to adjust the dosage, take other precautions or, in some cases, stop taking one of the medicines. This applies particularly to the following medicines:

• lithium, a medicine used in the treatment of some mental illnesses
• medicines that can increase the amount of potassium in the blood, such as potassium supplements, salt substitutes containing potassium, potassium-sparing medicines, 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 medicines can increase the effect of VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA
• medicines that can induce torsades de pointes, such as antiarrhythmics (medicines used to treat heart problems) and some antipsychotic medicines
• 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 or insulin)
• other medicines that lower blood pressure, such as beta-blockers or methyldopa, ACE inhibitors (such as enalapril, lisinopril, etc.) or aliskiren (see also the section: “Do not take VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA” and “Warnings and precautions”) or medicines that constrict blood vessels or stimulate the heart, such as norepinephrine or epinephrine
• digoxin or other cardiac glycosides (medicines used to treat heart problems)
• medicines that increase blood sugar levels, such as diazoxide
• cancer treatments, 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, such as atropine or biperiden (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 infections)
• cholestyramine and colestipol (medicines used to treat high fat levels in the blood)
• cyclosporine, a medicine used in organ transplantation to prevent organ rejection
• alcohol, anesthetics and sedatives (medicines with narcotic or analgesic effect used, for example, during surgery)
• carbamazepine, a medicine used to treat seizures
• iodinated contrast agents (used for radiological examinations).

Taking VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA with food and drink
VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA can be taken with or without food.
Avoid drinking alcohol unless you have discussed it with your doctor. Alcohol can further lower blood pressure and/or increase the risk of dizziness or fainting.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy

• You should inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant)Usually, your doctor will advise you to stop taking VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA before becoming pregnant or as soon as you find out you are pregnant and will advise you to take another medicine instead of VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA. VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA 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 after the third month of pregnancy. Breastfeeding
• Inform your doctor if you are breastfeeding, or are about to start breastfeedingVALSARTAN AND HYDROCHLOROTHIAZIDE PENSA is not recommended for women who are breastfeeding and your doctor may choose another treatment for you if you wish to breastfeed, especially if the baby is newborn or premature.

Driving and operating machinery
Before driving a vehicle, using machinery or performing other activities that require concentration, you should know your reaction to VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA. Like many other medicines used to treat high blood pressure, VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA can rarely cause dizziness and affect your ability to concentrate.

Important information about some excipients of VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA
This medicine contains lactose, if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA contains soybean oil. If you are allergic to peanuts or soy, do not take this medicine.
VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA 160 mg/12.5 mg also contains Yellow Sunset FCF (E110) which may cause allergic reactions.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially ‘sodium-free’.
For those who engage in sports: the use of the drug without therapeutic necessity constitutes doping and may still result in positive doping tests

3. HOW TO TAKE VALSARTAN E IDROCLOROTIAZIDE PENSA

Always take VALSARTAN E IDROCLOROTIAZIDE PENSA exactly as your doctor has instructed. This will help you to obtain the best results and reduce the risk of side effects. If you have any doubts, consult your doctor or pharmacist.
Those suffering from high blood pressure often do not notice any signs of this problem and many feel as well as usual. For this reason, it is very important that you keep regular appointments with your doctor, even when you feel well.
The doctor will tell you exactly how many tablets of VALSARTAN E IDROCLOROTIAZIDE PENSA you should take. Based on your response to treatment, the doctor may suggest a higher or lower dose.

• The usual dose of VALSARTAN E IDROCLOROTIAZIDE PENSA is one tablet a day.
• Do not change the dose and do not stop taking the tablets without first consulting your doctor.
• This medicine should be taken every day at the same time, usually in the morning.
• You can take VALSARTAN E IDROCLOROTIAZIDE PENSA with or without food.
• Swallow the tablet with a glass of water.

If you take more VALSARTAN E IDROCLOROTIAZIDE PENSA 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 inadvertently taken too many tablets, contact your doctor, pharmacist or hospital.

If you forget to take VALSARTAN E IDROCLOROTIAZIDE PENSA
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next tablet, skip the missed dose.
Do not take a double dose to make up for the missed dose.

If you stop taking VALSARTAN E IDROCLOROTIAZIDE PENSA
Stopping treatment with VALSARTAN E IDROCLOROTIAZIDE PENSA may cause worsening of high blood pressure.
Do not stop using the medicine unless you have been told to do so by your doctor.

If you have any doubts about the use of this product, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, VALSARTAN E IDROCLOROTIAZIDE PENSA can cause side effects,
although not everybody gets them.
These side effects can occur with certain frequencies, defined as follows:

• very common: affects more than 1 in 10 people
• common: affects 1-10 people in 100
• uncommon: affects 1-10 people in 1,000
• rare: affects 1-10 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 can be serious and require immediate medical attention:

• Seek immediate medical help if you experience symptoms of angioedema (allergic reaction), such as:
• swelling of the face, tongue or throat
• difficulty swallowing
• urticaria and difficulty breathing
• Severe skin diseases causing rash, redness of the skin, formation of blisters on lips, eyes or mouth, skin peeling, fever (toxic epidermal necrolysis)
• Decreased vision or eye pain due to high pressure in the eye (possible sign of acute angle-closure glaucoma)
• Fever, sore throat, more frequent infections (agranulocytosis)

Ifyouexperienceanyofthesesymptoms,stoptakingVALSARTANE
IDROCLOROTIAZIDE PENSA and contact your doctor immediately (see also section 2
“Warnings and precautions”).
Other side effects are:

Uncommon

• cough
• low 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
• diarrhea
• joint pain

Not known

• difficulty breathing
• significant decrease in the amount of urine
• low level of sodium in the blood (sometimes with nausea, fatigue, confusion, feeling unwell, convulsions)
• low level of potassium in the blood (sometimes with muscle weakness, muscle spasms, abnormal heart rhythm)
• low level of white blood cells in the blood (with symptoms such as fever, skin infections, sore throat or mouth ulcers due to infections, weakness)
• increased level of bilirubin in the blood (which can, in severe cases, cause yellowing of the skin and eyes)
• increased level of urea and creatinine in the blood (which may be a sign of kidney dysfunction)
• increased level 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 E IDROCLOROTIAZIDE PENSA:
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 level of platelets in the blood (sometimes with unusual bleeding or bruising)
• increased level of potassium in the blood (sometimes with muscle spasms, abnormal heart rhythm)
• allergic reactions (with symptoms such as rash, itching, urticaria, difficulty breathing or swallowing, dizziness)
• swelling especially of the face and throat, rash, itching
• increased liver function values
• decrease in levels of hemoglobin and percentage of red blood cells in the blood (which, in severe cases, can both cause anemia)
• kidney failure
• low level of sodium in the blood (which can cause fatigue, mental confusion, muscle contractions and/or convulsions in severe cases) Hydrochlorothiazide

Very common

• low level of potassium in the blood
• increased lipids in the blood

Common

• low level of sodium in the blood
• low level of magnesium in the blood
• high level of uric acid in the blood
• skin rashes with itching or other types of rashes
• loss of appetite
• mild nausea and vomiting
• dizziness, fainting when getting up
• impotence

Rare

• swelling and formation of blisters on the skin (due to increased sensitivity to the sun)
• high level of calcium in the blood
• high level of sugar in the blood
• sugar in the urine
• worsening of the metabolic state of diabetes
• constipation, stomach or intestinal disorders, liver disorders (yellowing of the skin or eyes)
• irregular heartbeat
• headache
• sleep disturbances
• sadness (depression)
• low level of platelets 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 skin rashes, reddish-purple spots, fever (vasculitis)
• rash, itching, urticaria, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
• rashes on the face, 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)
• 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, labored breathing (hypochloremic alkalosis) Not known
• fatigue, bruising and frequent infections (aplastic anemia)
• severe decrease in the amount of urine (possible sign of a kidney disorder or renal failure)
• rash, redness of the skin, formation of blisters on lips, eyes or mouth, skin peeling, fever (possible signs of erythema multiforme)
• muscle spasm
• fever (pyrexia)
• weakness (asthenia)
• decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
• skin and lip cancer (non-melanoma skin cancer)

If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. HOW TO STORE VALSARTAN E IDROCLOROTIAZIDE PENSA

• Keep out of the reach and sight of children.
• Do not use VALSARTAN E IDROCLOROTIAZIDE PENSA after the expiry date which is stated on the carton or blister. The expiry date refers to the last day of the month. VALSARTAN E IDROCLOROTIAZIDE PENSA 80 mg/12.5 mg, 160 mg/12.5 mg and 160 mg/25 mg film-coated tablets:
• PVC/PE/PVDC-Al blisters: Do not store at a temperature above 30 °C. VALSARTAN E IDROCLOROTIAZIDE PENSA 320 mg/12.5 mg and 320 mg/25 mg film-coated tablets:
• PVC/PE/PVDC-Al blisters: Do not store at a temperature above 25 °C.
• Do not use this medicine if the package is damaged or shows signs of tampering.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. OTHER INFORMATION

What VALSARTAN E IDROCLOROTIAZIDE PENSA contains

• The active ingredients are valsartan and hydrochlorothiazide. Each tablet contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide. Each tablet contains 160 mg of valsartan and 12.5 mg of hydrochlorothiazide. Each tablet contains 160 mg of valsartan and 25 mg of hydrochlorothiazide. Each tablet contains 320 mg of valsartan and 12.5 mg of hydrochlorothiazide. Each tablet contains 320 mg of valsartan and 25 mg of hydrochlorothiazide.
• The excipients are: tablet core: Microcrystalline cellulose, Lactose monohydrate, Sodium croscarmellose, Povidone K29-K32, Talc, Magnesium stearate, Anhydrous colloidal silica, Film coating: [80 mg/12.5 mg tablets] Polyvinyl alcohol, Talc, Titanium dioxide (E171), Macrogol 3350, Lecithin (contains soybean oil) (E322), Red iron oxide (E172), Yellow iron oxide (E172), Black iron oxide (E172) [160 mg/12.5 mg tablets] Polyvinyl alcohol, Talc, Macrogol 3350, Titanium dioxide (E171), Red iron oxide (E172), Aluminum lake Yellow Sunset FCF (E110), Lecithin (contains soybean oil) (E322) [160 mg/25 mg tablets] Polyvinyl alcohol, Talc, Titanium dioxide (E171), Macrogol 3350, Yellow iron oxide (E172), Lecithin (contains soybean oil) (E322), Red iron oxide (E172), Black iron oxide (E172) [320 mg/12.5 mg tablets] Polyvinyl alcohol, Talc, Titanium dioxide (E171), Macrogol 3350, Yellow iron oxide (E172), Lecithin (contains soybean oil) (E322), Red iron oxide (E172) [320 mg/25 mg tablets] Polyvinyl alcohol, Talc, Titanium dioxide (E171), Macrogol 3350, Yellow iron oxide (E172), Lecithin (contains soybean oil) (E322), Red iron oxide (E172)

Description of the appearance of VALSARTAN E IDROCLOROTIAZIDE PENSA and contents of the pack
VALSARTAN E IDROCLOROTIAZIDE PENSA 80 mg/12.5 mg film-coated tablets: pink,
oval, biconvex, film-coated tablets, measuring 11 x 5.8 mm, with “V” on one side and “H”
on the other.
VALSARTAN E IDROCLOROTIAZIDE PENSA 160 mg/12.5 mg film-coated tablets: red,
oval, biconvex, film-coated tablets, measuring 15 x 6 mm, with “V” on one side and “H”
on the other.
VALSARTAN E IDROCLOROTIAZIDE PENSA 160 mg/25 mg film-coated tablets: orange,
oval, biconvex, film-coated tablets, measuring 15 x 6 mm, with “V” on one side and “H”
on the other.
VALSARTAN E IDROCLOROTIAZIDE PENSA 320 mg/12.5 mg film-coated tablets: pink,
oval, biconvex, film-coated tablets, measuring 18.9 x 7.5 mm, with “V” on one side and
“H” on the other.
VALSARTAN E IDROCLOROTIAZIDE PENSA 320 mg/25 mg film-coated tablets: yellow,
oval, biconvex, film-coated tablets, measuring 18.9 x 7.5 mm, with a fracture line on one
side and lateral engravings, namely “V” on one side and “H” on the other. The tablet can be divided into two
equal halves.

Packs:
Blisters: 28 film-coated tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Pensa Pharma S.p.A.
Via Ippolito Rosellini 12
20124 Milano

Manufacturer responsible for batch release
Actavis Ltd.
BLB016, Bulebel Industrial Estate
Zejtun, ZTN3000
Malta
Balkanpharma – Dupnitsa AD
3 Samokovsko Schosse Str.
Dupnitsa 2600
Bulgaria