Valsartan 40mg Film-Coated Tablets

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Document: leaflet MAH GENERIC_PL 18909-0301 change

PACKAGE LEAFLET

Valsartan 40 mg Film-coated Tablets Valsartan 80 mg Film-coated Tablets Valsartan 160 mg Film-coated Tablets Valsartan 320 mg Film-coated Tablets

Valsartan

Read all of 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 further questions, ask your doctor or pharmacist.

- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even

if their signs of illness are the same as yours.

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Valsartan Tablets are and what they are used for

2. What you need to know before you take Valsartan Tablets

3. How to take Valsartan Tablets

4. Possible side effects

5. How to store Valsartan Tablets

6. Contents of the pack and other information

1. What Valsartan Tablets are and what they are used for

Valsartan Tablets contain the active substance valsartan and belongs 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 blood vessels to tighten, causing your blood pressure to increase. Valsartan Tablets work by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure is lowered.

Valsartan 40mg Tablets can be used for three different conditions:

- to treat high blood pressure in children and adolescents 6 to 18 years of age. High blood pressure increases the workload on the heart and arteries. If not treated it can damage the blood vessels of the brain, heart, and kidneys, and may result in a stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Lowering your blood pressure to normal reduces the risk of developing these disorders.

- to treat adult patients after a recent heart attack (myocardial infarction). “Recent” here means between 12 hours and 10 days.

- to treat symptomatic heart failure in adult patients. Valsartan is used when a group of medicines called Angiotensin Converting Enzyme (ACE) inhibitors (a medication to treat heart failure) cannot be used or it may be used in addition to ACE-inhibitors when other medication to treat heart failure cannot be used.

Heart failure symptoms include shortness of breath, and swelling of the feet and legs due to fluid build-up. It is caused when the heart muscle cannot pump blood strongly enough to supply all the blood needed throughout the body.

Valsartan 80mg and 160mg Tablets can be used for three different conditions:

- to treat high blood pressure in adults and in children and adolescents 6 to 18 years of age. High blood pressure increases the workload on the heart and arteries. If not treated it can damage the

blood vessels of the brain, heart, and kidneys, and may result in a stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Lowering your blood pressure to normal reduces the risk of developing these disorders.

to treat adult patients after a recent heart attack (myocardial infarction). “Recent” here means between 12 hours and 10 days.

to treat symptomatic heart failure in adult patients. Valsartan is used when a group of medicines called Angiotensin Converting Enzyme (ACE) inhibitors (a medication to treat heart failure) cannot be used or it may be used in addition to ACE-inhibitors when other medication to treat heart failure cannot be used.

Valsartan 320mg Tablets can be used:

- to treat high blood pressure in adults and in children and adolescents 6 to 18 years of age. High blood pressure increases the workload on the heart and arteries. If not treated it can damage the blood vessels of the brain, heart, and kidneys, and may result in a stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Lowering your blood pressure to normal reduces the risk of developing these disorders.

2. What you need to know before you take Valsartan Tablets

Do not take Valsartan Tablets:

- if you are allergic to valsartan or 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 Tablets in early pregnancy - see pregnancy section).

- if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor or pharmacist before taking Valsartan Tablets:

- if you have liver disease

- if you have severe kidney disease or if you are undergoing dialysis

- if you are suffering from a narrowing of the kidney artery

- if you have recently undergone kidney transplantation (received a new kidney)

- if you are being treated after a heart attack or heart failure, your doctor may check your kidney function

- if you have severe heart disease other than heart failure or heart attack

- if you have ever experienced swelling of the tongue and face caused by an allergic reaction called angioedema when taking another drug (including ACE inhibitors), tell your doctor. If these symptoms occur when you are taking Valsartan Tablets, stop taking Valsartan Tablets immediately and never take it again. See also section 4, “Possible side effects”

- if you are taking medicines that increase the amount of potassium in your blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines and heparin. It may be necessary to check the amount of potassium in your blood at regular intervals.

- if you suffer from aldosteronism. This is a disease in which your adrenal glands make too much of the hormone aldosterone. If this applies to you, the use of Valsartan Tablets is not recommended.

- if you have lost a lot of fluid (dehydration) caused by 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 (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.

- aliskiren

- if you are being treated with an ACE-inhibitor together with certain other medicines to treat your heart failure, which are known as mineralocorticoid receptors antagonists (MRA) (for example spironolactone, eplerenone) or betablockers (for example metoprolol).

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

See also information under the heading “Do not take Valsartan Tablets”

You must tell your doctor if you think you are (or might become) pregnant. Valsartan Tablets are not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section)

Other medicines and Valsartan Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

The effect of the treatment can be influenced if Valsartan Tablets are taken together with certain other medicines. Your doctor may need to change your dose and/or take other precautions, or in some cases to stop taking one of the medicines. This applies to both prescription and non-prescription medicines, especially:

- other medicines that lower blood pressure, especially “water” tablets (diuretics)

- medicines that increase the amount of potassium in your blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines and heparin.

- certain type of pain killers called non-steroidal anti-inflammatory medicines (NSAIDs)

- some antibiotics (rifamycin group), a drug used to protect against transplant rejection (ciclosporin) or an antiretroviral drug used to treat HIV/AIDS infection (ritonavir). These drugs may increase the effect of Valsartan Tablets.

- lithium, a medicine used to treat some types of psychiatric illness.

- if you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Valsartan Tablets and “Warnings and precautions”

In addition (40mg, 80mg and 160mg Tablets only):

- if you are being treated after a heart attack, a combination with ACE inhibitors (a medication to treat heart attack) is not recommended.

Valsartan Tablets with food and drink

You can take Valsartan Tablets with or without food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine

You must tell your doctor if you think that you are (or might become) pregnant .

Your doctor will normally advise you to stop taking Valsartan Tablets before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Valsartan

Tablets. Valsartan Tablets are not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as they may cause serious harm to your baby if it is used after the third month of pregnancy.

Tell your doctor if you are breast-feeding or about to start breast-feeding. Valsartan Tablets are not recommended if you are breast-feeding. Your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Driving and using machines

Before you drive a vehicle, use tools or operate machines, or carry out other activities that require concentration, make sure you know how this medicine affects you. Like many other medicines used to treat high blood pressure, Valsartan tablets may in rare cases cause dizziness and affect the ability to concentrate.

Valsartan Tablets contain Sunset yellow

Valsartan 80mg and 160mg Tablets contain a colourant known as Sunset yellow (E110) which may cause allergic reactions.

Valsartan Tablets contain Allura Red

Valsartan 320mg Tablets contain a colourant known as Allura Red (E129) which may cause allergic reactions.

3. How to take Valsartan Tablets

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

People with high blood pressure often do not notice any signs of this problem. Many may feel quite normal. This makes it all the more important for you to keep your appointments with the doctor even if you are feeling well.

You can take Valsartan Tablets with or without food. Swallow Valsartan Tablets with a glass of water. Take Valsartan tablets at about the same time each day.

Valsartan 40ms, 80ms and 160ms Tablets:

Adult patients after a recent heart attack:

After a heart attack the treatment is generally started as early as after 12 hours, usually at a low dose of one 20 mg tablet twice daily. You obtain the 20 mg dose by dividing the 40 mg tablet. Your doctor will increase this dose gradually over several weeks to a maximum of 160 mg tablet twice daily.The final dose depends on what you as an individual patient can tolerate.

Valsartan Tablets can be given together with certain other treatments for heart attack, and your doctor will decide which treatment is suitable for you.

Adult patients with heart failure:

Treatment starts generally with 40 mg tablet twice daily. Your doctor will increase the dose gradually over several weeks to a maximum of 160 mg tablet twice daily. The final dose depends on how you respond to treatment.

Valsartan Tablets can be given together with other treatments for heart failure, and your doctor will decide which treatment is suitable for you.

Children and adolescents (6 to 18 years of age) with high blood pressure

In patients who weigh less than 35 kg the recommended dose is 40 mg of valsartan once daily. In patients who weigh 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 can be increased to 160 mg and to a maximum of 320 mg).

Valsartan 80ms and 160ms Tablets:

Adult patients with high blood pressure:

The recommended dose is 80 mg tablet daily. In some cases your doctor may prescribe higher doses (e.g. 160 mg or 320 mg). You may also be prescribed an additional medicine to take e.g. “water tablets” (a diuretic).

Valsartan 320ms Tablets:

Adult patients with high blood pressure:

Children and adolescents (6 to 18 years of age) with high blood pressure

If you take more Valsartan Tablets than you should

You may experience severe dizziness and/or fainting. If this happens, you should 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 Tablets

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 dose you missed.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Valsartan Tablets

Stopping your treatment with Valsartan Tablets may cause your disease to get worse. Do not stop taking your medicine unless your doctor tells you to.

If you have any further questions on 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 can be serious and need immediate medical attention:

You may experience symptoms of angioedema (a specific allergic reaction), such as

- swollen face, lips, tongue or throat

- difficulty in breathing or swallowing

- hives, itching

If you get any of these symptoms, stop taking Valsartan Tablets and contact your doctor straight away.

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

- decreased kidney function (signs of renal impairment)

Uncommon (may affect up to 1 in 100 people):

- sudden loss of consciousness (syncope)

- spinning sensation (vertigo)

- severely decreased kidney function (signs of acute kidney failure)

- muscle spasms, abnormal heart rhythm (signs of hyperkalaemia)

- breathlessness, difficulty breathing when lying down, swelling of the feet or legs (signs of cardiac failure)

- headache

- cough

- abdominal pain

- nausea (feeling sick)

- diarrhoea

- tiredness

- weakness

Not known (frequency cannot be estimated from the available data):

- blistering skin (sign of dermatitis bullous)

- rash

- itching

- allergic reactions with rash, itching and hives together with some of the following signs or symptoms; fever, swollen joints and joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms may occur (signs of serum sickness)

- purplish-red 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 level of white blood cells also called neutropenia)

- decrease in level of haemoglobin and decrease of the percentage of red blood cells in the blood (which can, in severe cases, lead to anaemia)

- increase in level of potassium in the blood (which can, in severe cases, trigger muscle spasms, abnormal heart rhythm)

- elevation of liver function values (which can indicate liver damage) including an increase of bilirubin in the blood (which can, in severe cases, trigger yellow skin and eyes)

- increase in level of blood urea nitrogen and increase of level of serum creatinine (which can indicate abnormal kidney function)

- low level of sodium in the blood (which can trigger tiredness, confusion, muscle twitching and/or convulsions in severe cases)

The frequency of some side effects may vary depending on your condition. For example, side effects such as dizziness, and decreased kidney function, were seen less frequently in adult patients treated with high blood pressure than in adult patients treated for heart failure or after a recent heart attack.

Side effects in children and adolescents are similar to those seen in adults.

Reporting of side effects

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

5. How to store Valsartan Tablets

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 EXP. The expiry date refers to the last day of that month.

Do not store above 25°C.

Do not use this medicine if you notice that the pack is damaged or shows signs of tampering.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information What Valsartan Tablets contains

The active substance is Valsartan. Each film-coated tablet contains 40 mg or 80 mg or 160 mg or 320 mg of Valsartan.

The other ingredients in tablet core are Microcrystalline cellulose, Crospovidone, Sodium laurilsulfate, Povidone , Silicified microcrystalline cellulose, Magnesium stearate.

The other ingredients in tablet film-coat for different strengths are:

40 mg - consisting of Polyvinyl alcohol, Macrogol, Titanium dioxide (E171), Talc (E553b), Iron Oxide Yellow (E172)

80 mg - consisting of Polyvinyl alcohol, Macrogol Titanium dioxide (E171), Talc (E553b), Iron Oxide Red (E172), Sunset Yellow FCF (E110), Indigo Carmine(E132)

160 mg - consisting of Polyvinyl alcohol, Macrogol, Titanium dioxide (E171), Talc (E553b), Iron Oxide Yellow (E172), Sunset Yellow FCF (E110)

320 mg - consisting of Polyvinyl alcohol, Titanium dioxide (E171), Macrogol, Talc (E553b), Iron Oxide Black (E172), Iron Oxide Red (E172), Iron Oxide Yellow (E172), Allura Red (E129), Indigo Carmine (E132)

What Valsartan Tablets looks like and contents of the pack

Valsartan 40 mg Film-coated Tablets are yellow, oval shaped coated tablet with 'V' breakline 'S' on one side and '>' on the other side

Valsartan 80 mg Film-coated Tablets are pink round convex shaped coated tablet with ‘VS’ over ‘80’ on one side and '> ’ on the other side

Valsartan 160 mg Film-coated Tablets are orange, oval shaped coated tablet with 'VS 160’ on one side and '■ ’ on the other side

Valsartan 320 mg Film-coated Tablets are dark Grey-Violet, oval shaped coated tablet with ‘VS 320’ on one side and '> ’ on the other side

The tablets are packed in PVC/Aclar/Aluminium foil blister packs .

Pack sizes:

7, 14, 28, 30, 50, 56, 84, 90, 98 Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer

<[To be completed nationally]>

For any information about this medicine, please contact the Marketing Authorisation Holder.

This medicinal product is authorised in the Member States of the EEA under the following names:

<[To be completed nationally where applicable as below]>

France Valsartan Arrow 40mg comprime pellicule secable

UK Valsartan 40mg, 80mg, 160mg and 320mg Film-coated Tablets

This leaflet was last revised in <[MM/YYYY]>