Valsartan 80mg Capsules

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Document: leaflet MAH BRAND_PLPI 18799-0733 change

PACKAGE LEAFLET:

INFORMATION FOR THE USER

Diovan® 80mg capsules

(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.

The name of your medicine is Diovan 80mg capsules but it will be referred to as Diovan throughout this leaflet. Please note that this leaflet also contains information about other strengths such as Diovan 40mg capsules and Diovan 160mg capsules.

What is in this leaflet:

1. What Diovan is and what it is used for

2. What you need to know before you take Diovan

3. How to take Diovan

4. Possible side effects

5. How to store Diovan

6. Contents of the pack and other information

1. WHAT DIOVAN IS AND WHAT IT IS USED FOR

Diovan contains 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 vessels to tighten, thus causing your blood pressure to increase.

Diovan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure is lowered. Diovan 40, 80 and 160mg Capsules can be used

• to treat people after a recent heart attack (myocardial infarction). ‘Recent’ here means between 12 hours and 10 days.

• to treat symptomatic heart failure.

Diovan 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 beta-blockers (another medications 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.

In addition

Diovan 80 and 160mg Capsules can be used

• to treat high blood pressure. 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 DIOVAN Do not take Diovan:

• if you are allergic (hypersensitive) 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 Diovan 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.

If any of the above apply to you, tell your doctor and do not take Diovan.

Warnings and precautions:

Talk to your doctor

• 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 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 Diovan, stop taking Diovan 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 Diovan is not recommended.

• If you have lost a lot of fluid (dehydration) caused by diarrhoea, vomiting, or high doses of water pills (diuretics).

• The use of Diovan in children and adolescents below the age of 18 years is not recommended.

• if you are taking any of the following medicines used to treat high blood pressure:

- an ACE inhibitors (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 beta-blockers (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 Diovan’

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

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 Diovan is taken together with certain other medicines. It may be necessary to change the dose, to 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 pills (diuretics), ACE inhibitors (such as enalapril, lisinopril, etc.) or aliskiren (see also information under the headings ‘Do not take Diovan’ and (‘Warnings and precautions’).

• 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 antiinflammatory 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 Diovan.

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

In addition:

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

• if you are being treated for heart failure, a triple combination with ACE inhibitors and other medicines to treat your heart failure which are known as mineralocorticoid receptors antagonists (MRA) (for example spironolactone, epleronone) or beta blockers (for example metoprolol) is not recommended.

Pregnancy and breast-feeding

• You must tell your doctor if you think that you are (or might become) pregnant. Your doctor will normally advise you to stop taking Diovan before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Diovan. Diovan is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it 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. Diovan is not recommended for mothers who are breast-feeding, and 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 Diovan affects you. Like many other medicines used to treat high blood pressure, Diovan may in rare cases cause dizziness and affect the ability to concentrate.

3. HOW TO TAKE DIOVAN

Always take this medicine exactly as your doctor has told you in order to get the best results and reduce the risk of side effects. 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.

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 20mg twice daily. This low dose is provided by 40mg divisible tablets. Your doctor will increase this dose gradually over several weeks to a maximum of 160mg twice daily. The final dose depends on what you as an individual patient can tolerate.

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

Heart failure: Treatment starts generally with 40mg twice daily. Your doctor will increase the dose gradually over several weeks to a maximum of 160mg twice daily. The final dose depends on what you as an individual patient can tolerate. Diovan can be given together with other treatments for heart failure, and your doctor will decide which treatment is suitable for you.

High blood pressure: The recommended dose is 80mg daily. In some cases your doctor may prescribe higher doses (e.g. 160mg or 320mg). He may also combine Diovan with an additional medicine (e.g. a diuretic).

You can take Diovan with or without food. Swallow Diovan with a glass of water.

Take Diovan at about the same time each day.

If you take more Diovan than you should

If you experience severe dizziness and/or fainting, lie down and contact your doctor immediately.

If you have accidentally taken too many capsules, contact your doctor, pharmacist, or hospital.

If you forget to take Diovan

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

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.

If you stop taking Diovan

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

If you have further questions on the use of this product, 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, tongue or throat

• difficulty in swallowing

• hives and difficulties in breathing

If you get any of these symptoms, stop taking Diovan and contact your doctor straight away (see also section 2 ‘Warnings and precautions’).

Other side effects include:

Common (may affect up to 1 in 10 people):

• dizziness, postural dizziness

• low blood pressure with symptoms such as dizziness

• decreased kidney function (signs of renal impairment)

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

• allergic reaction with symptoms such as rash, itching, dizziness, swelling of face or lips or tongue or throat, difficulty breathing or swallowing (signs of angioedema)

• sudden loss of consciousness

• spinning sensation

• severely decreased kidney function (signs of acute renal 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

• diarrhoea

• tiredness

• weakness

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

• blistering skin (sign of dermatitis bullous)

• rash, itching, together with some of the following signs or symptoms: fever, joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms (signs of serum sickness)

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

• increase of 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 of 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 patients treated with high blood pressure than in patients treated for heart failure or after a recent heart attack.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:www.mhra.qov.uk/vellowcard.

By reporting side effects, you can help provide more information on the safety of this medicine.

Keep out of the sight and reach of children.

Do not take your capsules after the expiry date which is stated on the carton and blister label after ‘Exp’. The expiry date refers to the last day of that month.

Remember if your doctor tells you to stop taking this medicine, return any unused tablets to your pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.

If your capsules become discoloured or show any signs of deterioration, seek the advice of your pharmacist.

REMEMBER: This medicine is for you. Only a doctor can prescribe it for you. Never give it to someone else. It may not suit them even if they have the same condition as your self.

6. CONTENTS OF THE PACK AND OTHER INFORMATION What Diovan contains

Diovan contain 80mg of the active ingredient valsartan.

They also contain the following inactive ingredients: microcrystalline cellulose, povidone K30, sodium lauril sulphate, crospovidone, magnesium stearate, methylated spirit, gelatin, shellac and colourings (titanium dioxide E171, red and black iron oxides E172).

What Diovan looks like and contents of the pack

Diovan 80mg capsules are hard gelatin capsules consisting of an opaque pink unprinted body and an opaque light grey cap printed ‘CG FZF’ in black. The capsules contain a white powder and come in blister packs containing 14 capsules.

Manufactured by: Novartis Pharma A.G, Stein, Switzerland.

Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4,

Bradfield Road, Ruislip, Middlesex, HA4 ONU, UK.

Diovan®80mg capsules

POM

PL 18799/0733

Leaflet date: 18.02.2016

Diovan is a registered trademark of Novartis Pharmaceuticals UK Limited

Valsartan 80mg capsules

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.

The name of your medicine is Valsartan 80mg capsules but it will be referred to as Valsartan throughout this leaflet. Please note that this leaflet also contains information about other strengths such as Valsartan 40mg capsules and Valsartan 160mg capsules.

What is in this leaflet:

1. What Valsartan is and what it is used for

2. What you need to know before you take Valsartan

3. How to take Valsartan

4. Possible side effects

5. How to store Valsartan

6. Contents of the pack and other information

1. WHAT VALSARTAN IS AND WHAT IT IS USED FOR

Valsartan contains 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 vessels to tighten, thus causing your blood pressure to increase.

Valsartan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure is lowered. Valsartan 40, 80 and 160mg Capsules can be used

• to treat people after a recent heart attack (myocardial infarction). ‘Recent’ here means between 12 hours and 10 days.

• to treat symptomatic heart failure.

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 beta-blockers (another medications 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.

In addition

Valsartan 80 and 160mg Capsules can be used

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VALSARTAN Do not take Valsartan:

• if you are allergic (hypersensitive) 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 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.

If any of the above apply to you, tell your doctor and do not take Valsartan.

Warnings and precautions:

Talk to your doctor

• 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 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, stop taking Valsartan immediately and never take it again. See also section 4, ‘Possible side effects’.

• 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 is not recommended.

• If you have lost a lot of fluid (dehydration) caused by diarrhoea, vomiting, or high doses of water pills (diuretics).

• The use of Valsartan in children and adolescents below the age of 18 years is not recommended.

• if you are taking any of the following medicines used to treat high blood pressure:

- an ACE inhibitors (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.

- aliskiren

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’

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

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 is taken together with certain other medicines. It may be necessary to change the dose, to take other precautions, or in some cases to stop taking one of the medicines. This applies to both prescription and non-prescription medicines, especially:

• 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 antiinflammatory medicines (NSAIDs).

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

In addition:

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

Pregnancy and breast-feeding

• 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 before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Valsartan.

Valsartan is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it 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 is not recommended for mothers who are breast-feeding, and 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 Valsartan affects you. Like many other medicines used to treat high blood pressure, Valsartan may in rare cases cause dizziness and affect the ability to concentrate.

3. HOW TO TAKE VALSARTAN

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

Heart failure: Treatment starts generally with 40mg twice daily. Your doctor will increase the dose gradually over several weeks to a maximum of 160mg twice daily. The final dose depends on what you as an individual patient can tolerate. Valsartan can be given together with other treatments for heart failure, and your doctor will decide which treatment is suitable for you.

High blood pressure: The recommended dose is 80mg daily. In some cases your doctor may prescribe higher doses (e.g. 160mg or 320mg). He may also combine Valsartan with an additional medicine (e.g. a diuretic).

You can take Valsartan with or without food. Swallow Valsartan with a glass of water.

Take Valsartan at about the same time each day.

If you take more Valsartan than you should

If you experience severe dizziness and/or fainting, lie down and contact your doctor immediately.

If you have accidentally taken too many capsules, contact your doctor, pharmacist, or hospital.

If you forget to take Valsartan

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

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.

If you stop taking Valsartan

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

If you have further questions on the use of this product, 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, tongue or throat

• difficulty in swallowing

• hives and difficulties in breathing

If you get any of these symptoms, stop taking Valsartan and contact your doctor straight away (see also section 2 ‘Warnings and precautions’).

Other side effects include:

Common (may affect up to 1 in 10 people):

• dizziness, postural dizziness

• low blood pressure with symptoms such as dizziness

• decreased kidney function (signs of renal impairment)

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

• allergic reaction with symptoms such as rash, itching, dizziness, swelling of face or lips or tongue or throat, difficulty breathing or swallowing (signs of angioedema)

• sudden loss of consciousness

• spinning sensation

• severely decreased kidney function (signs of acute renal 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

• diarrhoea

• tiredness

• weakness

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

• blistering skin (sign of dermatitis bullous)

• rash, itching, together with some of the following signs or symptoms: fever, joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms (signs of serum sickness)

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

• increase of 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 of 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)

Reporting of side effects

By reporting side effects, you can help provide more information on the safety of this medicine.

Keep out of the sight and reach of children.

Do not take your capsules after the expiry date which is stated on the carton and blister label after ‘Exp’. The expiry date refers to the last day of that month.

Remember if your doctor tells you to stop taking this medicine, return any unused tablets to your pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.

If your capsules become discoloured or show any signs of deterioration, seek the advice of your pharmacist.

REMEMBER: This medicine is for you. Only a doctor can prescribe it for you. Never give it to someone else. It may not suit them even if they have the same condition as your self.

6. CONTENTS OF THE PACK AND OTHER INFORMATION What Valsartan contains

Valsartan contain 80mg of the active ingredient valsartan.

What Valsartan looks like and contents of the pack

Valsartan 80mg capsules are hard gelatin capsules consisting of an opaque pink unprinted body and an opaque light grey cap printed ‘CG FZF’ in black. The capsules contain a white powder and come in blister packs containing 14 capsules.

Manufactured by: Novartis Pharma A.G, Stein, Switzerland.

Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4,

Bradfield Road, Ruislip, Middlesex, HA4 ONU, UK.