Valsartan Zentiva
Italy
Table of Contents
Patient Information Leaflet
Valsartan Zentiva 40 mg film-coated tablets, 80 mg film-coated tablets, 160 mg film-coated tablets
Generic medicine
Please read this leaflet carefully before using 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. Never give it to others, even if they have the same symptoms as you, because it could be harmful.
- If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
In this leaflet:
- What Valsartan Zentiva is and what it is used for
- What you need to know before taking Valsartan Zentiva
- How to take Valsartan Zentiva
- Possible side effects
- How to store Valsartan Zentiva
- Contents of the pack and other information
1. What Valsartan Zentiva is and what it is used for
Valsartan Zentiva contains the active substance valsartan and belongs to a class of medicines known as angiotensin II receptor antagonists, which help control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to narrow, thereby increasing blood pressure. Valsartan Zentiva works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure is lowered.
Valsartan Zentiva 40 mg film-coated tablets can be used for three different conditions:
- for the treatment of high blood pressure in children and adolescents aged 6 to less than 18 years. High blood pressure increases the workload on the heart and arteries. If untreated, it can damage the blood vessels in the brain, heart, and kidneys, leading to stroke, heart failure, or kidney failure. High blood pressure also increases the risk of heart attacks. Lowering your blood pressure to normal levels reduces the risk of developing these conditions.
- for the treatment of adult patients after a recent heart attack (myocardial infarction). "Recent" means between 12 hours and 10 days.
- for the treatment of symptomatic heart failure in adult patients. Valsartan Zentiva is used when a group of medicines called angiotensin-converting enzyme (ACE) inhibitors (medicines for the treatment of heart failure) cannot be taken, or it may be used in addition to ACE inhibitors when other heart failure medicines cannot be administered. Symptoms of heart failure include shortness of breath and swelling of the feet and legs due to fluid accumulation. This condition is caused by the heart muscle being unable to pump blood strongly enough to circulate it throughout the body.
Valsartan Zentiva 80 mg and 160 mg film-coated tablets can be used for three different conditions:
- for the treatment of high blood pressure in adults and in children and adolescents aged 6 to less than 18 years. High blood pressure increases the workload on the heart and arteries. If untreated, it can damage the blood vessels in the brain, heart, and kidneys, leading to stroke, heart failure, or kidney failure. High blood pressure also increases the risk of heart attacks. Lowering your blood pressure to normal levels reduces the risk of developing these conditions.
- for the treatment of adult patients after a recent heart attack (myocardial infarction). "Recent" means between 12 hours and 10 days.
- for the treatment of symptomatic heart failure in adult patients. Valsartan Zentiva is used when a group of medicines called angiotensin-converting enzyme (ACE) inhibitors (medicines for the treatment of heart failure) cannot be taken, or it may be used in addition to ACE inhibitors when beta-blockers (other medicines for the treatment of heart failure) cannot be administered. Symptoms of heart failure include shortness of breath and swelling of the feet and legs due to fluid accumulation. This condition is caused by the heart muscle being unable to pump blood strongly enough to circulate it throughout the body.
2. What you should know before taking Valsartan Zentiva
Do not take Valsartan Zentiva:
- if you are allergic to valsartan or to any of the other ingredients of this medicine (listed in section 6);
- if you have severe liver disease;
- if you are more than 3 months pregnant (it is also better to avoid Valsartan Zentiva in early pregnancy – see section “Pregnancy”);
- if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.
If any of the above conditions apply to you, consult your doctor and do not take Valsartan Zentiva
Warnings and precautions
Talk to your doctor or pharmacist before taking Valsartan Zentiva:
- if you have liver disease.
- if you have severe kidney disease or are undergoing dialysis.
- if you suffer from renal artery stenosis (narrowing of the artery to the kidney).
- if you have recently undergone a kidney transplant (received a new kidney).
- if you have severe heart disease other than heart failure or heart attack.
- if you have previously experienced swelling of the tongue or face due to an allergic reaction called angioedema while taking other medicines (including ACE inhibitors), speak to your doctor. If these symptoms occur while taking Valsartan Zentiva, stop taking it immediately and do not take it again. See also section 4, “Possible side effects”.
- if you are taking medicines that increase potassium levels in the blood. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing diuretics, and heparin. You may need regular blood tests to monitor your potassium levels.
- if you have hyperaldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. In such cases, use of Valsartan Zentiva is not recommended.
- if you have lost a lot of fluid (dehydration) due to diarrhoea, vomiting, or high doses of diuretic tablets (water pills).
- if you are taking any of the following medicines for 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).
Your doctor may check your kidney function, blood pressure, and levels of electrolytes (such as potassium) in your blood at regular intervals.
See also the section "Do not take Valsartan Zentiva".
You must inform your doctor if you think you may be pregnant (or could become pregnant). Valsartan Zentiva is not recommended during early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your unborn baby if used after the third month of pregnancy (see section “Pregnancy”).
Other medicines and Valsartan Zentiva
The effect of treatment may be altered if Valsartan Zentiva is taken together with certain other medicines. Your doctor may consider it necessary to adjust the dose and/or take other precautions, or in some cases discontinue one of the medicines. This applies to both prescription and non-prescription medicines, particularly:
- other medicines that lower blood pressure, especially diuretic tablets ("water pills").
- if you are taking an ACE inhibitor (such as enalapril, lisinopril, etc.) or aliskiren (see also the sections "Do not take Valsartan Zentiva" 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, etc.) or beta-blockers (e.g. metoprololo).
- medicines that increase potassium levels in the blood. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing diuretics, and heparin;
- certain types of painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs).
- certain antibiotics (rifampicin group), a medicine used to prevent transplant rejection (cyclosporine), or an antiretroviral medicine used to treat HIV/AIDS infections (ritonavir). These medicines may increase the effect of Valsartan Zentiva.
- Lithium, a medicine used to treat certain psychiatric disorders.
In addition:
- if you are being treated after a heart attack, combination with ACE inhibitors (medicines for treating heart attack) is not recommended. If you are being treated for heart failure, triple combination therapy with ACE inhibitors and other heart failure medicines known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone) or beta-blockers (e.g. metoprololo) is not recommended.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
You must inform your doctor if you think you may be pregnant (or could become pregnant). Your doctor will advise you to stop taking Valsartan Zentiva before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Valsartan Zentiva. Valsartan Zentiva is not recommended in early pregnancy, and must not be taken if you are more than three months pregnant, as the medicine may cause serious harm to the unborn child if taken after the third month of pregnancy.
Breast-feeding
Inform your doctor if you are breast-feeding or planning to breast-feed. Valsartan Zentiva is not recommended for breastfeeding mothers. Your doctor may choose another treatment if you wish to breast-feed, especially if your baby is a newborn or was born prematurely.
Driving and using machines
Before driving, operating tools or machinery, or performing any activity requiring concentration, make sure you are aware of how Valsartan Zentiva affects you. Like many other medicines used to treat high blood pressure, Valsartan Zentiva may, in rare cases, cause dizziness and affect your ability to concentrate.
Valsartan Zentiva contains lactose monohydrate, sorbitol, and sodium
This medicine contains lactose monohydrate and sorbitol (E420), both sugars. If your doctor has informed you of an intolerance to certain sugars, consult your doctor before taking this medicine.
Valsartan Zentiva 40 mg: This medicine contains 4.6 mg of sorbitol per tablet.
Valsartan Zentiva 80 mg: This medicine contains 9.25 mg of sorbitol per tablet.
Valsartan Zentiva 160 mg: This medicine contains 18.50 mg of sorbitol per tablet.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially 'sodium-free'.
3. How to take Valsartan Zentiva
Take this medicine exactly as directed by your doctor or pharmacist to achieve the best results and reduce the risk of unwanted side effects. If you have any doubts, consult your doctor or pharmacist. People with high blood pressure often do not notice any symptoms. Many feel quite well. This makes it even more important for you to keep your medical appointments, even if you feel well.
Valsartan Zentiva 80 mg and 160 mg film-coated tablets
Adult patients with high blood pressure
The recommended dose is 80 mg once daily. In some cases, your doctor may prescribe higher doses (for example, 160 mg or 320 mg). Your doctor may also prescribe another medicine together with Valsartan Zentiva (for example, a diuretic).
Valsartan Zentiva 40 mg, 80 mg and 160 mg film-coated tablets
Children and adolescents (from 6 to less than 18 years of age) with high blood pressure
In patients weighing less than 35 kg, the recommended starting dose is 40 mg of valsartan once daily. In patients weighing 35 kg or more, the recommended starting dose is 80 mg of valsartan once daily.
In some cases, your doctor may prescribe higher doses (the dose may be increased to 160 mg and up to a maximum of 320 mg).
For children and adolescents who are unable to swallow tablets, it is recommended to use another suitable formulation available on the market.
Adult patients after a recent heart attack
After a heart attack, treatment is usually started within 12 hours, generally at a low dose of 20 mg twice daily. The 20 mg dose can be obtained by splitting a 40 mg tablet. Your doctor will gradually increase this dose over several weeks up to a maximum of 160 mg twice daily. The final dose depends on how well you, as an individual patient, tolerate the medicine.
Valsartan Zentiva may be given together with other treatments for heart attack, and your doctor will decide which treatment is suitable for you.
Adult patients with heart failure
Treatment usually starts with 40 mg twice daily. Your doctor will gradually increase the dose over several weeks up to a maximum of 160 mg twice daily. The final dose depends on how well you, as an individual patient, tolerate the medicine.
Valsartan Zentiva may be given together with other treatments for heart failure, and your doctor will decide which treatment is suitable for you.
You may take Valsartan Zentiva with or without food. Swallow the tablet with a glass of water.
Take Valsartan Zentiva at approximately the same time each day.
The tablets may be divided into two equal doses.
If you take more Valsartan Zentiva than you should
If you experience severe dizziness and/or fainting, contact your doctor immediately and lie down. If you have accidentally taken too many tablets, contact your doctor, pharmacist, or hospital.
If you forget to take Valsartan Zentiva
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Valsartan Zentiva
Stopping treatment with Valsartan Zentiva may cause your condition to worsen. Do not stop taking this medicine unless your doctor tells you to.
If you have any questions about how to use 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 can be serious and require immediate medical treatment.
You may experience symptoms of angioedema (a specific allergic reaction), such as:
- Swelling of the face, lips, tongue or throat.
- Difficulty breathing or swallowing.
- Hives, itching.
If you experience any of these symptoms, stop taking Valsartan Zentiva and contact your doctor immediately (see also section 2 “Warnings and precautions”).
Other side effects include
Common (may affect up to 1 in 10 people):
- Dizziness.
- Low blood pressure with or without symptoms such as dizziness and fainting when standing up.
- Reduced kidney function (signs of impaired kidney function).
Uncommon (may affect up to 1 in 100 people):
- Angioedema (see “Some symptoms require immediate medical treatment”).
- Sudden loss of consciousness (syncope).
- Sensation of spinning (vertigo).
- Severely reduced kidney function (signs of acute kidney failure).
- Muscle cramps, abnormal heart rhythm (signs of hyperkalaemia).
- Shortness of breath, breathlessness when lying down, swelling of feet or legs (signs of heart failure).
- Headache.
- Cough.
- Abdominal pain.
- Nausea.
- Diarrhoea.
- Fatigue.
- Weakness.
Frequency not known (frequency cannot be estimated from the available data):
Blisters on the skin (signs of bullous dermatitis).
-
Allergic reactions with skin rash, itching and hives; symptoms such as fever, joint swelling and joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms may occur (signs of serum sickness).
-
Red-purple spots, fever, itching (signs of inflammation of blood vessels also called vasculitis).
-
Unusual bleeding or bruising (signs of thrombocytopenia).
-
Muscle pain (myalgia).
-
Fever, sore throat or mouth ulcers due to infections (symptoms of low white blood cell count also known as neutropenia).
-
Reduction in haemoglobin levels and decreased percentage of red blood cells in the blood (which may lead to anaemia in severe cases). Increased potassium levels in the blood (which may cause muscle cramps and abnormal heart rhythm in severe cases).
-
Increase in liver function test values (which may indicate liver damage), including increased bilirubin in the blood (which may cause yellowing of the skin and eyes in severe cases).
-
Increased blood urea nitrogen and increased serum creatinine levels (which may indicate abnormal kidney function). Low sodium levels in the blood (which may cause fatigue, confusion, muscle cramps and/or seizures in severe cases).
The frequency of some side effects may vary depending on your condition. For example, side effects such as dizziness and reduced kidney function have been observed less frequently in adult patients treated for high blood pressure compared to adult patients treated for heart failure or after a recent heart attack.
Side effects in children and adolescents are similar to those observed in adults.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website
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 Zentiva
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging or blister after Exp. The
expiry date refers to the last day of that month.
Store below 30 °C.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer in use. This will help protect the environment.
6. Package contents and other information
What Valsartan Zentiva contains
The active substance is valsartan.
Valsartan Zentiva 40 mg film-coated tablets: each film-coated tablet contains 40 mg of valsartan.
Valsartan Zentiva 80 mg film-coated tablets: each film-coated tablet contains 80 mg of valsartan.
Valsartan Zentiva 160 mg film-coated tablets: each film-coated tablet contains 160 mg of
valsartan.
The other components are: microcrystalline cellulose, anhydrous colloidal silica, sorbitol (E 420), magnesium carbonate (heavy), pregelatinized maize starch, povidone K 25, sodium stearyl fumarate, sodium lauryl sulfate, crospovidone Type A.
Tablet coating: lactose monohydrate, hypromellose, titanium dioxide (E 171), macrogol 4000.
Valsartan Zentiva 40 mg film-coated tablets additionally contain yellow iron oxide (E 172).
Valsartan Zentiva 80 mg film-coated tablets additionally contain red iron oxide (E 172).
Valsartan Zentiva 160 mg film-coated tablets additionally contain yellow iron oxide (E 172) and brown iron oxide (E 172).
Description of the appearance of Valsartan Zentiva and package contents
Valsartan Zentiva 40 mg film-coated tablets are yellow, oblong, biconvex, film-coated tablets with a breakline on both sides, measuring 8.8 – 9.2 mm in length and 3.3 – 3.7 mm in width. The tablets can be divided into two equal doses.
Valsartan Zentiva 80 mg film-coated tablets are pink, cylindrical, biconvex, film-coated, divisible tablets with a breakline on one side, with a diameter of 7.8 – 8.6 mm. The tablets can be divided into two equal doses.
Valsartan Zentiva 160 mg film-coated tablets are yellowish-brown, oblong, biconvex, film-coated, divisible tablets with a breakline on one side, measuring 14.8 – 15.2 mm in length and 5.8 – 6.2 mm in width. The tablets can be divided into two equal doses.
Pack sizes of 14, 28, 30, 56, 90, 98 or 280 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Zentiva Italia S.r.l.
Viale L. Bodio n. 37/B
20158 Milan, Italy
Manufacturer
Sanofi-Aventis Sp. z o.o.
Drug Production and Distribution Plant
ul. Lubelska 52, 35-233 Rzeszów
Poland
This medicinal product is authorized in the European Economic Area countries under the following names:
France, Italy, Romania: Valsartan Zentiva
Package leaflet: information for the patient
Valsartan Zentiva 320 mg film-coated tablets
Equivalent medicine
Please read this leaflet carefully before using 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. Never give it to other people, even if their symptoms are the same as yours, because it could be dangerous.
- If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
In this leaflet:
- What Valsartan Zentiva is and what it is used for
- What you need to know before taking Valsartan Zentiva
- How to take Valsartan Zentiva
- Possible side effects
- How to store Valsartan Zentiva
- Contents of the pack and other information
1. What Valsartan Zentiva is and what it is used for
Valsartan Zentiva contains the active substance valsartan and belongs to a group of medicines known
as angiotensin II receptor antagonists, which help control high blood pressure.
Angiotensin II is a substance in the body that causes blood vessels to narrow, thereby increasing blood pressure. Valsartan Zentiva works by blocking
the effect of angiotensin II.
As a result, blood vessels relax and blood pressure is lowered.
Valsartan Zentiva 320 mg film-coated tablets can be used for the treatment of high blood pressure in adults and children and adolescents aged 6 to less than 18 years. High
blood pressure increases the workload on the heart and arteries. If left untreated, it may damage blood vessels in the brain, heart, and kidneys, leading to stroke, heart failure, or
kidney failure. High blood pressure also increases the risk of heart attacks. Lowering
your blood pressure to normal levels reduces the risk of developing these conditions.
2. What you need to know before taking Valsartan Zentiva
Do not take Valsartan Zentiva
- if you are allergic to valsartan or to any of the other ingredients of this medicine (listed in section 6);
- if you have severe liver disease;
- if you are more than 3 months pregnant (it is also advisable to avoid Valsartan Zentiva in early pregnancy – see section “Pregnancy”);
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.
If any of the above conditions apply to you, consult your doctor and do not take Valsartan Zentiva.
Warnings and precautions
Talk to your doctor or pharmacist before taking Valsartan Zentiva:
- if you have liver disease;
- if you have severe kidney disease or are undergoing dialysis;
- if you suffer from narrowing of the renal artery;
- if you have recently undergone a kidney transplant (you have received a new kidney);
- if you have severe heart disease other than heart failure or heart attack; if you have previously experienced swelling of the tongue or face due to an allergic reaction called angioedema while taking other medicines (including ACE inhibitors), speak to your doctor. If these symptoms occur while taking Valsartan Zentiva, stop taking it immediately and do not take it again. See also section 4, “Possible side effects”;
- if you are taking medicines that increase potassium levels in the blood. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medications, and heparin. You may need to have your blood potassium levels checked regularly;
- if you have hyperaldosteronism. This is a condition in which the adrenal glands produce excessive amounts of the hormone aldosterone. If this applies to you, the use of Valsartan Zentiva is not recommended;
- if you have lost a large amount of fluid (dehydration) due to diarrhoea, vomiting, or high doses of "water tablets" (diuretics); if you are taking any of the following medicines used to treat high blood pressure:
- an "ACE inhibitor" (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes
- aliskiren. if you are being treated with an ACE inhibitor together with other medicines for heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone) or beta-blockers (e.g. metoprolol).
Your doctor may monitor your kidney function, blood pressure, and blood levels of electrolytes (e.g. potassium) at regular intervals.
See also the section "Do not take Valsartan Zentiva".
You must inform your doctor if you think you may be pregnant (or could become pregnant). Valsartan Zentiva is not recommended during early pregnancy, and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if used beyond the third month of gestation (see section “Pregnancy”).
Other medicines and Valsartan Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of treatment may be affected if Valsartan Zentiva is taken together with certain other medicines. Your doctor may consider it necessary to adjust the dose and/or take other precautions, or in some cases, discontinue one of the medicines. This applies to both prescription and non-prescription medicines, particularly:
- other medicines that lower blood pressure, especially water tablets (diuretics); if you are taking an ACE inhibitor (such as enalapril, lisinopril, etc.) or aliskiren (see also the sections: "Do not take Valsartan Zentiva" and "Warnings and precautions"); if you are being treated with an ACE inhibitor together with other medicines for heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone, etc.) or beta-blockers (e.g. metoprololo).
- medicines that increase potassium levels in the blood. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medications, and heparin;
- certain types of painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs); certain antibiotics (rifampicin group), a medicine used to prevent transplant rejection (cyclosporine), or an antiretroviral medicine used to treat HIV/AIDS infections (ritonavir). These medicines may increase the effect of Valsartan Zentiva; Lithium, a medicine used to treat certain psychiatric disorders.
In addition:
- if you are being treated after a heart attack, combination with ACE inhibitors (medicines for treating heart attack) is not recommended. If you are being treated for heart failure, a triple combination with ACE inhibitors and other medicines for heart failure known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone) or beta-blockers (e.g. metoprololo) is not recommended.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
You must inform your doctor if you think you may be pregnant (or could become pregnant). Your doctor will advise you to stop taking Valsartan Zentiva before pregnancy or as soon as you know you are pregnant, and will recommend an alternative medicine. Valsartan Zentiva is not recommended during early pregnancy, and must not be taken after the third month of pregnancy, as it may cause serious harm to the baby if taken after the third month of gestation.
Breastfeeding
Inform your doctor if you are breastfeeding or are planning to breastfeed. Valsartan Zentiva is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if the baby is a newborn or was born prematurely.
Driving and using machines
Before driving, operating tools or machinery, or performing other activities requiring concentration, make sure you are aware of how Valsartan Zentiva affects you. Like many other medicines used to treat high blood pressure, Valsartan Zentiva may, in rare cases, cause dizziness and affect your ability to concentrate.
Valsartan Zentiva contains lactose monohydrate, sorbitol and sodium
This medicine contains lactose monohydrate and sorbitol (E420), both sugars. If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains 37 mg of sorbitol in each tablet.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially 'sodium-free'.
3. How to take Valsartan Zentiva
Take this medicine exactly as directed by your doctor or pharmacist to achieve the best results and reduce the risk of unwanted side effects. If you have any doubts, consult your doctor or pharmacist. People with high blood pressure often do not notice any symptoms. Many feel quite well. This makes it even more important for you to keep your medical appointments, even if you feel well.
Adult patients with high blood pressure
The recommended dose is 80 mg once daily. In some cases, your doctor may prescribe higher doses (for example, 160 mg or 320 mg). Your doctor may also combine Valsartan Zentiva with another medicine (for example, a diuretic).
Children and adolescents (from 6 to less than 18 years of age) with high blood pressure
In patients weighing less than 35 kg, the recommended starting dose is 40 mg of valsartan once daily.
In patients weighing 35 kg or more, the recommended starting dose is 80 mg of valsartan once daily.
In some cases, your doctor may prescribe higher doses (the dose may be increased to 160 mg and up to a maximum of 320 mg).
For children and adolescents who are unable to swallow tablets, it is recommended to use another suitable formulation available on the market.
You may take Valsartan Zentiva with or without food. Swallow the tablet with a glass of water.
Take Valsartan Zentiva at approximately the same time each day.
The tablets may be divided into two equal doses.
If you take more Valsartan Zentiva than you should
If you experience severe dizziness and/or fainting, contact your doctor immediately and lie down. If you have accidentally taken too many tablets, contact your doctor, pharmacist, or hospital.
If you forget to take Valsartan Zentiva
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.
Do not take a double dose to make up for the forgotten dose.
If you stop taking Valsartan Zentiva
Stopping treatment with Valsartan Zentiva may cause your condition to worsen. Do not stop taking this medicine unless your doctor tells you to.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Some side effects may be serious and require immediate medical attention.
You may experience symptoms of angioedema (a specific allergic reaction), such as:
- Swelling of the face, lips, tongue, or throat.
- Difficulty breathing or swallowing.
- Hives, itching.
If you experience any of these symptoms, stop taking Valsartan Zentiva immediately and contact your doctor
without delay (see also section 2 “Warnings and precautions”).
Other side effects include
Common (may affect up to 1 in 10 people):
- Dizziness.
- Low blood pressure, with or without symptoms such as dizziness and fainting when standing up.
- Reduced kidney function (signs of impaired kidney function).
Uncommon (may affect up to 1 in 100 people):
- Angioedema (see “Some symptoms require immediate medical attention”).
- Sudden loss of consciousness (syncope).
- Sensation of spinning (vertigo).
- Severely reduced kidney function (signs of acute kidney failure).
- Muscle cramps, abnormal heart rhythm (signs of hyperkalemia).
- Shortness of breath, breathlessness when lying down, swelling of the feet or legs (signs of heart failure).
- Headache.
- Cough.
- Abdominal pain.
- Nausea.
- Diarrhea.
- Fatigue.
- Weakness.
Frequency not known (cannot be estimated from the available data):
Blisters on the skin (signs of bullous dermatitis).
Allergic reactions with skin rash, itching, and hives; fever, joint swelling and joint pain, muscle pain, swollen lymph nodes, and/or flu-like symptoms may also occur (signs of serum sickness).
- Reddish-purple spots, fever, itching (signs of inflammation of blood vessels, also known as vasculitis).
- Unusual bleeding or bruising (signs of thrombocytopenia).
- Muscle pain (myalgia).
- Fever, sore throat, or mouth ulcers due to infections (symptoms of low white blood cell count, also known as neutropenia).
- Decreased hemoglobin levels and reduced percentage of red blood cells in the blood (which may lead to anemia in severe cases).
- Increased potassium levels in the blood (which may cause muscle cramps and abnormal heart rhythm in severe cases).
- Elevated liver function test values (which may indicate liver damage), including increased blood bilirubin levels (which may cause yellowing of the skin and eyes in severe cases).
- Increased blood urea nitrogen (azotemia) and increased serum creatinine levels (which may indicate abnormal kidney function).
- Low sodium levels in the blood (which may cause fatigue, confusion, muscle cramps, and/or seizures in severe cases).
The frequency of some side effects may vary depending on your condition. For example, side effects such as dizziness and reduced kidney function have been observed less frequently in adult patients treated for high blood pressure compared to adult patients treated for heart failure or after a recent heart attack.
Side effects in children and adolescents are similar to those observed in adults.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 Zentiva
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack or blister after Exp. The expiry date refers to the last day of that month.
Store below 30 °C.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Package contents and other information
What Valsartan Zentiva contains
The active substance is valsartan. Each film-coated tablet contains 320 mg of valsartan.
The other components are:
Tablet core: microcrystalline cellulose, anhydrous colloidal silica, sorbitol (E 420), magnesium carbonate (heavy), pregelatinized corn starch, povidone K 25, sodium stearyl fumarate, sodium lauryl sulfate, crospovidone Type A.
Tablet coating: lactose monohydrate, hypromellose, titanium dioxide (E 171), macrogol 4000, red iron oxide (E 172), brown iron oxide (E 172), indigo carmine aluminium lake (E 132).
Description of the appearance of Valsartan Zentiva and pack sizes
Valsartan Zentiva 320 mg film-coated tablets are oblong, biconvex, coated tablets, grey-violet in colour, divisible, with a score line on one side, measuring 15.8 – 16.2 mm in length and 10.8 – 11.2 mm in width. The tablets may be divided into two equal doses.
Available in packs of 7, 14, 28, 30, 56, 90, 98 or 280 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Zentiva Italia S.r.l.
Viale L. Bodio n. 37/B
20158 Milan, Italy
Manufacturer
Sanofi-Aventis Sp. z o.o.
Drug Production and Distribution Plant
ul. Lubelska 52, 35-233 Rzeszów
Poland
Winthrop Arzneimittel GmbH
Brüningstraße 50
65926 Frankfurt am Main
Germany
This medicinal product is authorized in the European Economic Area countries under the following names:
Germany, Italy, Portugal, Spain: Valsartan Zentiva