VALSARTAN 80 mg /12,5 Mg Фильм-Coated Таблетки

Содержание инструкции

1. Valsartan and Hydrochlorothiazide Almus 80 mg/12.5 mg film-coated tablets, 160 mg/12.5 mg film-coated tablets, 160 mg/25 mg film-coated tablets
   1. What is Valsartan and Idroclorotiazide Almus and what it is used for
   2. What you need to know before taking Valsartan and Idroclorotiazide Almus
   3. How to take Valsartan and Idroclorotiazide Almus
   4. Possible side effects
   5. How to store Valsartan and Idroclorotiazide Almus
   6. Package Contents and Other Information

Valsartan and Hydrochlorothiazide Almus 80 mg/12.5 mg film-coated tablets, 160 mg/12.5 mg film-coated tablets, 160 mg/25 mg film-coated tablets

Generic medicine

Read this leaflet carefully before 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 or pharmacist.
• 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 or pharmacist. See section 4.

Contents of this leaflet:

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

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

Valsartan and Idroclorotiazide Almus film-coated tablets contain two active ingredients called
valsartan and idroclorotiazide. 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.
• Idroclorotiazidebelongs to a group of medicines called thiazide diuretics. Idroclorotiazide increases the amount of urine eliminated and, in doing so, reduces blood pressure.

Valsartan and Idroclorotiazide Almus is used in the treatment of 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. If left untreated,
it 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 conditions.

2. What you need to know before taking Valsartan and Idroclorotiazide Almus

Do not takeValsartan and Idroclorotiazide Almus:

• If you are allergic (hypersensitive) 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 best to avoid taking Valsartan and Idroclorotiazide

Almus even in the early stages of pregnancy - see the Pregnancy section).

• If you have severeliver disorders, destruction of the small bile ducts within the liver (biliary cirrhosis) leading to bile accumulation in the liver (cholestasis).
• If you have severekidney disorders.
• 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 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 the above applies to you, do not take this medicine and consult your
doctor.
Warnings and precautions
Consult your doctor:

• 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 blood potassium level 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 serious heart problems.
• 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 monitor your kidney function.
• If you suffer from a 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 Idroclorotiazide Almus 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 Idroclorotiazide Almus, stop taking Valsartan and Idroclorotiazide Almus 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, 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 Idroclorotiazide Almus. 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.
• If you are being treated with an ACE inhibitor together with other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone) or beta-blockers (e.g. metoprolol).
• 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 lip cancer (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Valsartan and Idroclorotiazide Almus.
• If you have had breathing or lung problems (including inflammation or fluid in the lungs) following the use of hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Valsartan and Idroclorotiazide Almus, consult a doctor immediately.

Consult your doctor if, after taking Valsartan and Idroclorotiazide Almus, you experience abdominal pain,
nausea, vomiting or diarrhea. The doctor will decide on the continuation of treatment. Do not stop
taking Valsartan and Idroclorotiazide Almus on your own.
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 Idroclorotiazide Almus”.
Valsartan and Idroclorotiazide Almus may cause increased sensitivity of the skin to the sun.
You should inform your doctor if you think you may be pregnant (or if there is a possibility of becoming
pregnant). Valsartan and Idroclorotiazide Almus 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).
Caution for those who play sports: the use of the drug without a therapeutic need constitutes doping and
may still result in positive doping tests. Different administration, dosage scheme and route of administration than
those reported are prohibited.

Children and adolescents
The use of Valsartan and Idroclorotiazide Almus is not recommended in children and adolescents (under 18 years of
age).

Other medicines and Valsartan and Idroclorotiazide Almus
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including those available without a prescription.
The effect of the treatment may be affected if Valsartan and Idroclorotiazide Almus 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 particularly 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 Idroclorotiazide Almus.
• 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 (see also what is reported under: “Do not take Valsartan and Idroclorotiazide Almus” and “Warnings and precautions”).
• 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 infections).
• Cholestyramine and colestipol (medicines mainly used in the treatment of 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 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 Idroclorotiazide Almus” and “Warnings and precautions”). If you are being treated with an ACE inhibitor together
with other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g.
spironolactone, eplerenone) or beta-blockers (e.g. metoprolol).

Taking Valsartan and Idroclorotiazide Almus with food and drink
Avoid drinking alcohol unless you have first discussed it with your doctor. Alcohol can further reduce
blood pressure and/or increase the risk of dizziness or fainting.

Pregnancy and breastfeeding

• You should tell 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 Idroclorotiazide Almus 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 Idroclorotiazide Almus. Valsartan and Idroclorotiazide Almus 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.
• Tell your doctor if you are breastfeeding, or if you are about to start breastfeeding. Valsartan and Idroclorotiazide Almus is not recommended for women who are breastfeeding and your doctor may choose another treatment for you if you want to breastfeed, especially if the baby is newborn or premature.

Driving and using machines
Before driving a vehicle, using machines or performing other activities that require concentration, it
is good to know your reaction to Valsartan and Idroclorotiazide Almus. Like many other medicines used
to treat high blood pressure, Valsartan and Idroclorotiazide Almus can rarely cause dizziness and
affect your ability to concentrate.

Valsartan and Idroclorotiazide Almus contains lactose.
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with intolerance to
some sugars, contact him before taking this medicine.

Valsartan and Idroclorotiazide Almus contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e.
essentially ‘sodium-free’.

Valsartan and Idroclorotiazide Almus contains soybean oil
This medicine contains soybean oil. If you are allergic to peanuts or soy, do not use this medicine.

Valsartan and Idroclorotiazide Almus contains yellow sunset (E110)
Valsartan and Idroclorotiazide Almus 160/12.5 mg contains the yellow sunset FCF (E110) dye which may
cause allergic reactions.

3. How to take Valsartan and Idroclorotiazide Almus

Take this medicine following exactly the instructions of your doctor. This will help you to obtain
better 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 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 and Idroclorotiazide Almus you must take. Based on
your response to the treatment, the doctor may suggest a higher or lower dose.

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

If you take more Valsartan and Idroclorotiazide Almus 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 and Idroclorotiazide Almus
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 forgotten dose.
Do not take a double dose to compensate for the forgotten dose.

If you stop taking Valsartan and Idroclorotiazide Almus
Stopping the treatment with Valsartan and Idroclorotiazide Almus 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects may be serious and require immediate medical attention

• Consult a doctor immediately if you experience symptoms of angioedema, such as:
• Swelling of the face, tongue or throat
• Difficulty swallowing
• Hives and difficulty breathing
• 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).
• Decreased vision or eye pain due to high eye pressure (possible sign of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).
• Fever, sore throat, more frequent infections (agranulocytosis).
• Severe shortness of breath, fever, weakness and confusion (acute respiratory distress).

These side effects are very rare or of unknown frequency.

If you experience any of these symptoms, stop taking Valsartan and Idroclorotiazide Almus and
contact your doctor immediately (see also section 2 “Warnings and precautions”).
Other side effects are:
Not common(may affect up to 1 in 100 people)

• Cough
• Low blood pressure
• Feeling lightheaded
• Dehydration (with symptoms of 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(may affect up to 1 in 10,000 people)

• Dizziness
• Diarrhea
• Joint pain

Not known(frequency cannot be estimated from available data)

• Difficulty breathing
• Significant reduction in the amount of urine
• Low sodium levels in the blood (which can cause fatigue, mental 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 levels of bilirubin in the blood (which in severe cases can 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 in severe cases can cause gout)
• Syncope (fainting)

The following side effects have been reported with medicines containing valsartan or
hydrochlorothiazide alone
Valsartan

Not common(may affect up to 1 in 100 people)

• Feeling of spinning
• Abdominal pain

Very rare(may affect up to 1 in 10,000 people)

• Intestinal angioedema: swelling in the intestine that presents with symptoms such as abdominal pain, nausea, vomiting and diarrhea

Not known(frequency cannot be estimated from available data)

• 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 blood vessel inflammation)
• 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
• Decreased levels of hemoglobin 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

Common(may affect up to 1 in 10 people)

• Low sodium levels in the blood
• Low magnesium levels in the blood
• High uric acid levels in the blood
• Itchy rashes or other types of rashes
• Loss of appetite
• Mild nausea and vomiting
• Dizziness, fainting when getting up
• Inability to achieve or maintain an erection

Rare(may affect up to 1 in 1,000 people)

• 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, diarrhea, 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(may affect up to 1 in 10,000 people)

• Inflammation of blood vessels with symptoms such as rashes, reddish-purple spots, fever (vasculitis)
• Rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
• Facial rash, 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)
• 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(frequency cannot be estimated from available data)

• Fatigue, bruising and frequent infections (aplastic anemia)
• Severe decrease in the amount of urine (possible sign of kidney disorder or kidney failure)
• 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)
• Rapid onset of distant vision impairment (acute myopia), 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).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at “https://www.aifa.gov.it/en/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 and Idroclorotiazide Almus

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 packaging after “EXP.”.
The expiry date refers to the last day of that month.
Blisters:
Do not store at a temperature above 30°C.
Tablet containers:
This medicine does not require any special storage conditions.
After the first opening of the bottle: use within 100 days.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What the medicine containsValsartan and Hydrochlorothiazide Almus
80/12.5 mg Tablets

• The active ingredients are valsartan and hydrochlorothiazide. Each tablet contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide.
• The other ingredients are: Tablet core:microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, povidone K29-K32, talc, magnesium stearate, anhydrous colloidal silicon dioxide. Coating: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).

160/12.5 mg Tablets

• The active ingredients are valsartan and hydrochlorothiazide. Each tablet contains 160 mg of valsartan and 12.5 mg of hydrochlorothiazide.
• The other ingredients are: Tablet core:microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, povidone K29-K32, talc, magnesium stearate, anhydrous colloidal silicon dioxide. Coating:polyvinyl alcohol, talc, titanium dioxide (E171), macrogol 3350, lecithin (contains soybean oil) (E322), red iron oxide (E172), sunset yellow FCF, aluminium lake (E110).

160/25 mg Tablets

• The active ingredients are valsartan and hydrochlorothiazide. Each tablet contains 160 mg of valsartan and 25 mg of hydrochlorothiazide.
• The other ingredients are: Tablet core:microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, povidone K29-K32, talc, magnesium stearate, anhydrous colloidal silicon dioxide. Coating: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).

Description of the appearance of Valsartan and Hydrochlorothiazide Almus and contents of the pack
Valsartan and Hydrochlorothiazide Almus 80 mg/12.5 mg film-coated tablets, oval in shape,
biconvex, film-coated, pink in colour, 11 x 5.8 mm, with the marking “V” on one side and “H” on the other.
Valsartan and Hydrochlorothiazide Almus 160 mg/12.5 mg film-coated tablets, oval in shape,
biconvex, film-coated, red in colour, 15 x 6 mm, with the marking “V” on one side and “H” on the other.
Valsartan and Hydrochlorothiazide Almus 160 mg/25 mg film-coated tablets, oval in shape,
biconvex, film-coated, orange in colour, 15 x 6 mm, with the marking “V” on one side and “H” on the other.
Blisters: 7, 14, 28, 30, 56, 98 and 280 tablets.
Tablet containers: 7, 14, 28, 30, 56, 98 and 280 tablets.

Marketing Authorisation Holder
Almus S.r.l. - Via Cesarea 11/10, 16121 Genoa

Manufacturer
Actavis Ltd. - BLB016 Bulebel Industrial Estate, Zejtun ZTN3000 (Malta)
Balkanpharma Dupnitsa AD - 3, Samokovsko Shosse Str., 2600 Dupnitsa (Bulgaria)