Valsartan 160mg Capsules
S235-236 LEAFLET Diovan 20140106
PACKAGE LEAFLET: INFORMATION FOR THE USER DIOVAN 80mg CAPSULES DIOVAN 160mg CAPSULES (valsartan)
Your medicine is known by either of the above names but will be referred to as Diovan throughout the following leaflet.
Information regarding other strength i.e. 40mg is also present in the below leaflet
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Diovan is and what it is used for
2. Before you take Diovan
3. How to take Diovan
4. Possible side effects
5. How to store Diovan
6. Further information
1. WHAT DIOVAN IS AND WHAT IT IS USED FOR
Diovan 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 160 mg 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 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.
In addition
Diovan 80 and 160 mg 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. BEFORE YOU TAKE DIOVAN
Do not take Diovan:
• if you are allergic (hypersensitive) to valsartan or any of the other ingredients of Diovan. These are 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 any of these apply to you, speak to your doctor.
You must be especially careful and talk to your doctor before
taking Diovan if any of the following apply to you.
• 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 for heart failure. Your doctor may check your kidney function.
• If you have severe heart disease other than heart failure or heart attack.
• 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
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).
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
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).
• 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.
• if you are being treated for heart failure, a triple combination with ACE inhibitors and beta blockers (medications to treat heart failure) is not recommended.
Taking Diovan with food and drink
You can take Diovan with or without food.
Pregnancy and breast feeding Pregnancy
You must tell your doctor if you think 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 Comp 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 used after the third month of pregnancy.
Breastfeeding
Tell your doctor if you are breast-feeding or about to start breastfeeding. Diovan is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is new born, 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 Diovan exactly as your doctor has told you in order to get the best results and reduce the risk of side effects. You should 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 20 mg twice daily.
Your doctor will increase this dose gradually over several weeks to a maximum of 160 mg 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 attack, and your doctor will decide which treatment is suitable for you.
Heart failure: Treatment starts generally with 40 mg twice daily. Your doctor will increase the dose gradually over several weeks to a maximum of 160 mg 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 failure, and your doctor will decide which treatment is suitable for you.
High blood pressure: The usual dose is 80 mg daily. In some cases your doctor may prescribe higher doses (e.g. 160 mg or 320 mg). 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 tablets, 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, Diovan can cause side effects, although not everybody gets them.
These side effects may occur with certain frequencies, which are defined as follows:
• very common: affects more than 1 user in 10
• common: affects 1 to 10 users in 100
• uncommon: affects 1 to 10 users in 1,000
• rare: affects 1 to 10 users in 10,000
• very rare: affects less than 1 user in 10,000
• not known: frequency cannot be estimated from the available data.
Some symptoms need immediate medical attention:
You may experience symptoms of angioedema, such as
• swollen face, tongue or throat
• difficulty in swallowing
• hives and difficulties in breathing
If you get any of these, see a doctor immediately.
Other side effects include:
Common:
• dizziness, postural dizziness
• low blood pressure with symptoms such as dizziness
• decreased kidney function (signs of renal impairment) Uncommon:
• 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
• diarrhea
• tiredness
• weakness
Not known:
• 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, 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.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE DIOVAN
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Do not use Diovan after the expiry date which is stated on the carton and blister strip. The expiry date refers to the last day of that month.
• If the capsules show any signs of deterioration check with your pharmacist who will tell you what to do.
• Do not store above 30°C.
• Protect from moisture and heat.
• If your doctor tells you to stop taking Diovan, please take any unused capsules back to your pharmacist to be destroyed. Do not throw them away with your normal household water or waste. This will help to protect the environment.
6. FURTHER INFORMATION
What Diovan contains
• Each Diovan 80mg hard gelatin capsule contains 80mg of the active ingredient valsartan.
• Each Diovan 160mg hard gelatin capsule contains 160mg of the active ingredient valsartan.
• Diovan 80mg Capsules also contains: microcrystalline cellulose, povidone, sodium lauryl sulphate, crospovidone and magnesium stearate. The capsule shell is made of gelatin, titanium dioxide (E171), red iron oxide (E172), and black iron oxide (E172). The black printing ink contains shellac, methylated spirit 74 OP and black iron oxide (E172).
• Diovan 160mg Capsules also contains: microcrystalline cellulose, povidone, sodium lauryl sulphate, crospovidone and magnesium stearate. The capsule shell is made of gelatin, titanium dioxide (E171), red iron oxide (E172) and black iron oxide (E172). The white printing ink contains shellac, methylated spirt 74 OP and titanium dioxide (E171).
• The ink is not present in the capsules produced by the site Famar L'Aigle (France)
What Diovan looks like and contents of the pack
Diovan 80mg capsules have a pink body and a light grey cap marked ‘CG FZF' in black printing ink or with no marking. Diovan160mg Capsules have a pink body and a dark grey cap marked ‘CG GOG' in white printing ink and filled with a white powder or with no marking.
Diovan is available as calendar blister packs of 28 capsules. Product Licence holder
Procured from within the EU and repackaged by the Product Licence holder: S & M Medical Ltd., Chemilines House, Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by
• Novartis Farma S.p.A., Via Provinciale Schito 131,80058 Torre Annunziata (NA), Italy. Or
• FAMAR L'Aigle, Zone industrielle No 1, Route de Crulai, 61303 L'Aigle, France.
|POM | PL No: 19488/0235 Diovan 80mg Capsules
PL No: 19488/0236 Diovan 160mg Capsules
Leaflet revision date: 06 January 2014
Diovan is a registered trade mark of Novartis AG, Switzerland.
S235-236 LEAFLET Diovan 20140106
S235-236 LEAFLET Valsartan 20140106
PACKAGE LEAFLET: INFORMATION LEAFLET FOR THE USER VALSARTAN 80mg CAPSULES VALSARTAN 160mg CAPSULES (valsartan)
Your medicine is known by either of the above names but will be referred to as Valsartan Capsules throughout the following leaflet. Information regarding other strength i.e. 40mg is also present in the below leaflet
Read all of this leaflet carefully before you start taking this medicine.
• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Valsartan Capsules are and what they are used for
2. Before you take Valsartan Capsules
3. How to take Valsartan Capsules
4. Possible side effects
5. How to store Valsartan Capsules
6. Further information
1. WHAT VALSARTAN CAPSULES ARE AND WHAT THEY ARE USED FOR
Valsartan Capsules 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 Capsules works by blocking the effect of angiotensin II.
As a result, blood vessels relax and blood pressure is lowered.
Valsartan Capsules 40, 80 and 160 mg 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 Capsules are 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 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.
In addition
Valsartan Capsules 80 and 160 mg 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. BEFORE YOU TAKE VALSARTAN CAPSULES
Do not take Valsartan Capsules:
• if you are allergic (hypersensitive) to valsartan or any of the other ingredients of Valsartan Capsules. These are 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 Capsules in early pregnancy — see pregnancy section).
If any of these apply to you, speak to your doctor.
You must be especially careful and talk to your doctor before
taking Valsartan Capsules if any of the following apply to you.
• 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 for heart failure. Your doctor may check your kidney function.
• If you have severe heart disease other than heart failure or heart attack.
• 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 Capsules are 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 Capsules in children and adolescents below the age of 18 years is not recommended
You must tell your doctor if you think you are (or might become) pregnant. Valsartan Capsules 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).
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
The effect of the treatment can be influenced if Valsartan Capsules are 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).
• 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.
• if you are being treated for heart failure, a triple combination with ACE inhibitors and beta blockers (medications to treat heart failure) is not recommended.
Taking Valsartan Capsules with food and drink
You can take Valsartan Capsules with or without food.
Pregnancy and breast feeding Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Valsartan Capsules before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Valsartan Capsules. Valsartan Capsules are 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 used after the third month of pregnancy.
Breastfeeding
Tell your doctor if you are breast-feeding or about to start breastfeeding. Valsartan Capsules are 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 new born, 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 Capsules affects you. Like many other medicines used to treat high blood pressure, Valsartan Capsules may in rare cases cause dizziness and affect the ability to concentrate.
3. HOW TO TAKE VALSARTAN CAPSULES
Always take Valsartan Capsules exactly as your doctor has told you in order to get the best results and reduce the risk of side effects. You should 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 20 mg twice daily. Your doctor will increase this dose gradually over several weeks to a maximum of 160 mg twice daily. The final dose depends on what you as an individual patient can tolerate.
Valsartan Capsules can be given together with other treatments for heart attack, and your doctor will decide which treatment is suitable for you.
Heart failure: Treatment starts generally with 40 mg twice daily. Your doctor will increase the dose gradually over several weeks to a maximum of 160 mg twice daily. The final dose depends on what you as an individual patient can tolerate.
Valsartan Capsules can be given together with other treatment for heart failure, and your doctor will decide which treatment is suitable for you.
High blood pressure: The usual dose is 80 mg daily. In some cases your doctor may prescribe higher doses (e.g. 160 mg or 320 mg). He may also combine Valsartan Capsules with an additional medicine (e.g. a diuretic). You can take Valsartan Capsules with or without food. Swallow Valsartan Capsules with a glass of water. Take Valsartan Capsules at about the same time each day.
If you take more Valsartan Capsules 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 tablets, contact your doctor, pharmacist, or hospital.
If you forget to take Valsartan Capsules
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 Capsules
Stopping your treatment with Valsartan Capsules 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, Valsartan Capsules can cause side effects,
although not everybody gets them.
These side effects may occur with certain frequencies, which are
defined as follows:
• very common: affects more than 1 user in 10
• common: affects 1 to 10 users in 100
• uncommon: affects 1 to 10 users in 1,000
• rare: affects 1 to 10 users in 10,000
• very rare: affects less than 1 user in 10,000
• not known: frequency cannot be estimated from the available data.
Some symptoms need immediate medical attention:
You may experience symptoms of angioedema, such as
• swollen face, tongue or throat
• difficulty in swallowing
• hives and difficulties in breathing
If you get any of these, see a doctor immediately.
Other side effects include:
Common:
• dizziness, postural dizziness
• low blood pressure with symptoms such as dizziness
• decreased kidney function (signs of renal impairment)
Uncommon:
• 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
• diarrhea
• tiredness
• weakness
Not known:
• 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, 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.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE VALSARTAN CAPSULES
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Do not use Valsartan capsules after the expiry date which is stated on the carton and blister strip. The expiry date refers to the last day of that month.
• If the capsules show any signs of deterioration check with your pharmacist who will tell you what to do.
• Do not store above 30°C.
• Protect from moisture and heat.
• If your doctor tells you to stop taking Valsartan, please take any unused capsules back to your pharmacist to be destroyed. Do not throw them away with your normal household water or waste. This will help to protect the environment.
6. FURTHER INFORMATION
What Valsartan Capsules contain
• Each Valsartan 80mg hard gelatin capsule contains 80mg of the active ingredient valsartan.
• Each Valsartan 160mg hard gelatin capsule contains 160mg of the active ingredient valsartan.
• Valsartan 80mg Capsules also contains: microcrystalline cellulose, povidone, sodium lauryl sulphate, crospovidone and magnesium stearate. The capsule shell is made of gelatin, titanium dioxide (E171), red iron oxide (E172), and black iron oxide (E172). The black printing ink contains shellac, methylated spirit 74 OP and black iron oxide (E172).
• Valsartan 160mg Capsules also contains: microcrystalline cellulose, povidone, sodium lauryl sulphate, crospovidone and magnesium stearate. The capsule shell is made of gelatin, titanium dioxide (E171), red iron oxide (E172) and black iron oxide (E172). The white printing ink contains shellac, methylated spirt 74 OP and titanium dioxide (E171).
• The ink is not present in the capsules produced by the site Famar L'Aigle (France)
What Valsartan looks like and contents of the pack
Valsartan 80mg capsules have a pink body and a light grey cap marked ‘CG FZF' in black printing ink or with no marking. Valsartan160mg Capsules have a pink body and a dark grey cap marked ‘CG GOG' in white printing ink and filled with a white powder or with no marking.
Valsartan is available as calendar blister packs of 28 capsules. Product Licence holder
Procured from within the EU and repackaged by the Product Licence holder: S & M Medical Ltd., Chemilines House, Alperton Lane, Wembley, HA0 1 DX.
Manufacturer
This product is manufactured by
• Novartis Farma S.p.A., Via Provinciale Schito 131,80058 Torre Annunziata (NA), Italy. Or
• FAMAR L'Aigle, Zone industrielle No 1, Route de Crulai, 61303 L'Aigle, France.
|POM| PL No: 19488/0235 Valsartan 80mg Capsules
PL No: 19488/0236 Valsartan 160mg Capsules
Leaflet revision date: 06 January 2014
S235-236 LEAFLET Valsartan 20140106