VALSARTAN 320MG FILM-COATED TABLETS
Active substance: VALSARTAN
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increase of level of potassium in the blood (which can trigger muscle spasms and abnormal heart rhythm in severe cases) elevation of liver function values (which can indicate liver damage) including an increase of bilirubin in the blood (which can trigger yellow skin and eyes in severe cases) 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).
What Valsartan looks like and contents of the pack Valsartan 40 mg Film-coated Tablets are yellow, oval-shaped, film-coated tablets, scored on one side and debossed with V on one side of the score line and 40 on the other side of the score line. Available in pack sizes of 1, 7, 14, 15, 28, 30, 56, 60, 84, 90, 98, 100 and 280 filmcoated tablets. Hospital pack: 50, 56 (56 x 1), 98 (98 x 1) and 280 (280 x 1) film-coated tablets. Valsartan 80 mg Film-coated Tablets are pink, oval-shaped, film-coated tablets, scored on one side and debossed with V on one side of the score line and 80 The frequency of some side effects may on the other side of the score line. vary depending on your condition. For Available in pack sizes of 1, 14, 15, 28, 30, example, side effects such as dizziness, 56, 60, 84, 90, 98, 100 and 280 film- coated and decreased kidney function, were seen tablets. Hospital pack: 50 film-coated less frequently in adult patients treated tablets. Calendar pack of 28 and 98 with high blood pressure than in adult tablets. patients treated for heart failure or after a Valsartan 160 mg Film-coated Tablets are recent heart attack. yellow, oval-shaped, film-coated tablets, scored on one side and debossed with Side effects in children and adolescents V on one side of the score line and are similar to those seen in adults. 160 on the other side of the score line. If any of the side effects gets serious, or if Available in pack sizes of 1, 14, 15, 28, 30, you notice any side effects not listed in 56, 60, 84, 90, 98, 100 and 280 film- coated this leaflet, please tell your doctor or tablets. Hospital pack: 50 film-coated pharmacist. tablets. Calendar pack of 28 and 98 tablets. HOW TO STORE VALSARTAN 5 Valsartan 320 mg Film-coated Tablets are Keep out of the reach and sight of purple, oval-shaped, film-coated tablets, children. scored on one side and debossed with Do not use Valsartan after the expiry date V on one side of the score line and 320 on the other side of the score line. which is stated on the carton and blister after EXP The expiry date refers to the last Available in pack sizes of 1, 7, 10, 14, 15, . 20, 28, 30, 50, 56, 84, 90, 98, 100, 280 day of that month. film-coated tablets. Hospital pack: 50, 56 x Do not store above 25C. Store in the 1, 98 x 1 and 280 x 1 film-coated tablets. original package in order to protect from Not all pack sizes may be marketed. moisture. Do not use Valsartan if you notice that the pack is damaged or shows signs of tampering. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. Marketing Authorisation Holder and Manufacturer Teva UK Limited, Eastbourne, BN22 9AG, United Kingdom. This leaflet was last revised in October 2011 PL 00289/1235, 1236, 1237 & 1238
kidneys, and may result in a stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Lowering your blood Read all of this leaflet carefully before you pressure to normal reduces the risk of start taking this medicine. developing these disorders. Keep this leaflet. You may need to read it to treat adult patients after a recent again. heart attack (myocardial infarction). If you have any further questions, ask Recent here means between 12 hours your doctor or pharmacist. and 10 days. This medicine has been prescribed for you. Do not pass it on to others. It may to treat symptomatic heart failure in adult patients. Valsartan is used when a harm them, even if their symptoms are group of medicines called Angiotensin the same as yours. Converting Enzyme (ACE) inhibitors (a If any of the side effects gets serious, or medication to treat heart failure) cannot if you notice any side effects not listed be used or it may be used in addition to in this leaflet, please tell your doctor or ACE inhibitors when beta blockers pharmacist. (another medication to treat heart failure) IN THIS LEAFLET: cannot be used. Heart failure symptoms include shortness of breath, and swelling 1. What Valsartan is and what it is used of the feet and legs due to fluid build-up. for It is caused when the heart muscle cannot 2. Before you take Valsartan pump blood strongly enough to supply all 3. How to take Valsartan the blood needed throughout the body. 4. Possible side effects
PACKAGE LEAFLET: INFORMATION FOR THE USER
VALSARTAN 40 mg FILM-COATED Valsartan 80 mg film-coated tablets can be used for three different conditions: TABLETS VALSARTAN 80 mg FILM-COATED to treat high blood pressure in adults and in children and adolescents 6 to 18 TABLETS years of age. High blood pressure VALSARTAN 160 mg FILM-COATED increases the workload on the heart and TABLETS arteries. If not treated it can damage the VALSARTAN 320 mg FILM-COATED blood vessels of the brain, heart, and TABLETS
2 BEFORE YOU TAKE VALSARTAN
Do not take Valsartan if you are allergic (hypersensitive) to valsartan (active ingredient) or any of the other ingredients of this medicinal product listed at the end of this leaflet 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 any of these apply to you, do not take Valsartan.
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) lithium, a medicine used to treat some types of psychiatric illness.
Valsartan 80 mg, 160 mg and 320 mg Film-Coated Tablets: Adults with 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 with an additional medicine (e.g. a diuretic). Valsartan 40 mg, 80 mg, 160 mg and 320 mg Film-Coated Tablets: Children and adolescents (6 to 18 years of age) with high blood pressure: In patients who weigh less than 35 kg the usual dose is 40 mg of valsartan once daily. In patients who weigh 35 kg or more the usual 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 40 mg, 80 mg and 160 mg Film-Coated 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 20 mg 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 twice daily. The final dose depends on what you as an individual patient can tolerate. Valsartan can be given together with other treatment 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 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 can be given together with other treatment for heart failure, and your doctor will decide which treatment is suitable for you. 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, 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 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 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, Valsartan 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 angiodema (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, see a doctor immediately. Side effects include: Common dizziness low blood pressure with or without symptoms such as dizziness and fainting when standing up decreased kidney function (signs of renal impairment). Uncommon: angioedema (see section Some symptoms need immediate medical attention) sudden loss of consciousness (syncope) spinning sensation (vertigo) 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: allergic reaction with rash, itching and hives, or symptoms of 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 of level of haemoglobin and decrease of the percentage of red blood cells in the blood (which can lead to anaemia in severe cases)
5. How to store Valsartan 6. Further information
6 FURTHER INFORMATION
What Valsartan contains The active substance is valsartan. 40 mg: Each film-coated tablet contains 40 mg of valsartan 80 mg: Each film-coated tablet contains 80 mg of valsartan 160 mg: Each film-coated tablet contains 160 mg of valsartan 320 mg: Each film-coated tablet contains 320 mg of valsartan The other ingredients are colloidal anhydrous silica, sodium starch glycolate (type A), crospovidone, microcrystalline cellulose, maize starch, magnesium stearate, hypromellose, macrogol, titanium dioxide (E171), talc, 40 mg and 160 mg: yellow iron oxide (E172), 80 mg and 160 mg: red iron oxide (E172), 320 mg: red iron oxide (E172), indigotine (E132), sunset yellow FCF (E110). 88210-B 320 x 323
Valsartan 160 mg film-coated tablets can be used for three different conditions: to treat high blood pressure in adults and in children and adolescents 6 to 18 1 WHAT VALSARTAN IS AND WHAT IT IS USED FOR years of age. High blood pressure increases the workload on the heart and Valsartan belongs to a class of medicines arteries. If not treated it can damage the known as angiotensin II receptor blood vessels of the brain, heart, and antagonist, which help to control high kidneys, and may result in a stroke, blood pressure. Angiotensin II is a heart failure, or kidney failure. High substance in the body that causes vessels blood pressure increases the risk of to tighten, thus causing your blood heart attacks. Lowering your blood pressure to increase. pressure to normal reduces the risk of Valsartan works by blocking the effect of developing these disorders. angiotensin II. As a result, blood vessels to treat adult patients after a recent relax and blood pressure is lowered. heart attack (myocardial infarction). Valsartan 40 mg film-coated tablets can Recent here means between 12 hours be used for three different conditions: and 10 days. to treat high blood pressure in children to treat symptomatic heart failure in and adolescents 6 to 18 years of age. adult patients. Valsartan is used when a High blood pressure increases the group of medicines called Angiotensin workload on the heart and arteries. If Converting Enzyme (ACE) inhibitors (a not treated it can damage the blood medication to treat heart failure) cannot vessels of the brain, heart, and kidneys, be used or it may be used in addition to and may result in a stroke, heart failure, ACE inhibitors when beta blockers or kidney failure. High blood pressure (another medication to treat heart increases the risk of heart attacks. failure) cannot be used. Heart failure Lowering your blood pressure to symptoms include shortness of breath, normal reduces the risk of developing and swelling of the feet and legs due to these disorders. fluid build-up. It is caused when the to treat adults patients after a recent heart muscle cannot pump blood heart attack (myocardial infarction). strongly enough to supply all the blood Recent here means between 12 hours needed throughout the body. and 10 days. Valsartan 320 mg film-coated tablets can to treat symptomatic heart failure in adult patients. Valsartan is used when a be used to treat high blood pressure in adults group of medicines called Angiotensin and in children and adolescents 6 to 18 Converting Enzyme (ACE) inhibitors (a years of age. High blood pressure medication to treat heart failure) cannot increases the workload on the heart and be used or it may be used in addition to arteries. If not treated it can damage the ACE inhibitors when beta blockers blood vessels of the brain, heart, and (another medication to treat heart failure) kidneys, and may result in a stroke, heart cannot be used. Heart failure symptoms failure, or kidney failure. High blood include shortness of breath, and swelling pressure increases the risk of heart attacks. of the feet and legs due to fluid build-up. Lowering your blood pressure to normal It is caused when the heart muscle cannot reduces the risk of developing these pump blood strongly enough to supply all disorders. the blood needed throughout the body.
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In addition for Valsartan 40 mg, 80 mg and 160 mg Film-Coated Tablets: if you are being treated after a heart attack, a combination with ACE Take special care with Valsartan inhibitors (a medication to treat heart Talk to your doctor before you start to attack) is not recommended take this medicine: if you are being treated for heart failure, if you have liver disease a triple combination with ACE inhibitors if you have a severe kidney disease or if and beta blockers (medications to treat you are undergoing dialysis heart failure) is not recommended. if you are suffering from a narrowing of the kidney artery Taking Valsartan with food and drink if you have recently had a kidney You can take Valsartan with or without transplantation (received a new kidney) food. if you are treated after a heart attack or for heart failure, your doctor may check Pregnancy and breast-feeding Ask your doctor or pharmacist for advice your kidney function before taking any medicine. if you have severe heart disease other You must tell your doctor if you think than heart failure or heart attack you are (or might become) pregnant. if you are taking medicines that increase Your doctor will normally advise you to the amount of potassium in your blood. stop taking Valsartan before you become These include potassium supplements pregnant or as soon as you know you or salt substitutes containing potassium, are pregnant, and will advise you to potassium-sparing medicines and take another medicine instead of heparin. It may be necessary to check Valsartan. Valsartan is not the amount of potassium in your blood recommended in early pregnancy, and at regular intervals must not be taken when more than 3 if you are below 18 years of age and months pregnant, as it may cause you take Valsartan in combination with serious harm to your baby if it is used other medicines that inhibit the renin after the third month of pregnancy. angiotensin aldosterone system (medicines that lower blood pressure), Tell your doctor if you are breast-feeding or about to start your doctor may check your kidney breast-feeding. Valsartan is not function and the amount of potassium recommended for mothers who are in your blood at regular intervals breast-feeding, and your doctor may if you suffer from aldosteronism. This is choose another treatment for you if you a disease in which your adrenal glands wish to breast-feed, especially if your make too much of the hormone baby is newborn, or was born aldosterone. If this applies to you, the prematurely. use of Valsartan is not recommended if you have lost a lot of fluid (dehydration) Driving and using machines caused by diarrhoea, vomiting, or high Before you drive a vehicle, use tools or doses of water tablets (diuretics) operate machines, or carry out other you must tell your doctor if you think activities that require concentration, make you are (or might become) pregnant. sure you know how Valsartan affects you. Valsartan is not recommended in early pregnancy, and must not be taken if you Like many other medicines used to treat are more than 3 months pregnant, as it high blood pressure, Valsartan may in rare may cause serious harm to your baby if cases cause dizziness and affect the ability to concentrate. used at that stage (see pregnancy section). Important information about some If any of these apply to you, tell your ingredients of Valsartan 320 mg doctor before you take Valsartan. Film-Coated Tablets: This medicinal product contains sunset Taking other medicines yellow FCF (E110) and may cause allergic Please tell your doctor or pharmacist if you are taking or have recently taken any reactions. other medicines, including medicines 3 HOW TO TAKE VALSARTAN obtained without a prescription. The effect of the treatment can be Always take Valsartan exactly as your influenced if Valsartan is taken together doctor has told you in order to get the with certain other medicines. It may be best results and reduce the risk of side necessary to change the dose, to take effects. You should check with your doctor other precautions, or in some cases to or pharmacist if you are not sure. People stop taking one of the medicines. This with high blood pressure often do not applies to both prescription and notice any signs of this problem. Many non-prescription medicines, especially: may feel quite normal. This makes it all other medicines that lower blood the more important for you to keep your pressure, especially water tablets appointments with the doctor even if you (diuretics) are feeling well.
Pharma code 123
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PAGE 1: AFTER FOLDING FRONT FACE (INSIDE OF REEL AFTER FOLDING AND TACKING)
PAGE 2: LEFT HAND INSIDE FACE AFTER FOLDING AND TACKING
FOLD LINE.
PAGE 3: RIGHT HAND INSIDE FACE AFTER FOLDING AND TACKING
increase of level of potassium in the blood (which can trigger muscle spasms and abnormal heart rhythm in severe cases) elevation of liver function values (which can indicate liver damage) including an increase of bilirubin in the blood (which can trigger yellow skin and eyes in severe cases) 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).
What Valsartan looks like and contents of the pack Valsartan 40 mg Film-coated Tablets are yellow, oval-shaped, film-coated tablets, scored on one side and debossed with V on one side of the score line and 40 on the other side of the score line. Available in pack sizes of 1, 7, 14, 15, 28, 30, 56, 60, 84, 90, 98, 100 and 280 filmcoated tablets. Hospital pack: 50, 56 (56 x 1), 98 (98 x 1) and 280 (280 x 1) film-coated tablets. Valsartan 80 mg Film-coated Tablets are pink, oval-shaped, film-coated tablets, scored on one side and debossed with V on one side of the score line and 80 The frequency of some side effects may on the other side of the score line. vary depending on your condition. For Available in pack sizes of 1, 14, 15, 28, 30, example, side effects such as dizziness, 56, 60, 84, 90, 98, 100 and 280 film- coated and decreased kidney function, were seen tablets. Hospital pack: 50 film-coated less frequently in adult patients treated tablets. Calendar pack of 28 and 98 with high blood pressure than in adult tablets. patients treated for heart failure or after a Valsartan 160 mg Film-coated Tablets are recent heart attack. yellow, oval-shaped, film-coated tablets, scored on one side and debossed with Side effects in children and adolescents V on one side of the score line and are similar to those seen in adults. 160 on the other side of the score line. If any of the side effects gets serious, or if Available in pack sizes of 1, 14, 15, 28, 30, you notice any side effects not listed in 56, 60, 84, 90, 98, 100 and 280 film- coated this leaflet, please tell your doctor or tablets. Hospital pack: 50 film-coated pharmacist. tablets. Calendar pack of 28 and 98 tablets. HOW TO STORE VALSARTAN 5 Valsartan 320 mg Film-coated Tablets are Keep out of the reach and sight of purple, oval-shaped, film-coated tablets, children. scored on one side and debossed with Do not use Valsartan after the expiry date V on one side of the score line and 320 on the other side of the score line. which is stated on the carton and blister after EXP The expiry date refers to the last Available in pack sizes of 1, 7, 10, 14, 15, . 20, 28, 30, 50, 56, 84, 90, 98, 100, 280 day of that month. film-coated tablets. Hospital pack: 50, 56 x Do not store above 25C. Store in the 1, 98 x 1 and 280 x 1 film-coated tablets. original package in order to protect from Not all pack sizes may be marketed. moisture. Do not use Valsartan if you notice that the pack is damaged or shows signs of tampering. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. Marketing Authorisation Holder and Manufacturer Teva UK Limited, Eastbourne, BN22 9AG, United Kingdom. This leaflet was last revised in October 2011 PL 00289/1235, 1236, 1237 & 1238
kidneys, and may result in a stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Lowering your blood Read all of this leaflet carefully before you pressure to normal reduces the risk of start taking this medicine. developing these disorders. Keep this leaflet. You may need to read it to treat adult patients after a recent again. heart attack (myocardial infarction). If you have any further questions, ask Recent here means between 12 hours your doctor or pharmacist. and 10 days. This medicine has been prescribed for you. Do not pass it on to others. It may to treat symptomatic heart failure in adult patients. Valsartan is used when a harm them, even if their symptoms are group of medicines called Angiotensin the same as yours. Converting Enzyme (ACE) inhibitors (a If any of the side effects gets serious, or medication to treat heart failure) cannot if you notice any side effects not listed be used or it may be used in addition to in this leaflet, please tell your doctor or ACE inhibitors when beta blockers pharmacist. (another medication to treat heart failure) IN THIS LEAFLET: cannot be used. Heart failure symptoms include shortness of breath, and swelling 1. What Valsartan is and what it is used of the feet and legs due to fluid build-up. for It is caused when the heart muscle cannot 2. Before you take Valsartan pump blood strongly enough to supply all 3. How to take Valsartan the blood needed throughout the body. 4. Possible side effects
PACKAGE LEAFLET: INFORMATION FOR THE USER
VALSARTAN 40 mg FILM-COATED Valsartan 80 mg film-coated tablets can be used for three different conditions: TABLETS VALSARTAN 80 mg FILM-COATED to treat high blood pressure in adults and in children and adolescents 6 to 18 TABLETS years of age. High blood pressure VALSARTAN 160 mg FILM-COATED increases the workload on the heart and TABLETS arteries. If not treated it can damage the VALSARTAN 320 mg FILM-COATED blood vessels of the brain, heart, and TABLETS
2 BEFORE YOU TAKE VALSARTAN
Do not take Valsartan if you are allergic (hypersensitive) to valsartan (active ingredient) or any of the other ingredients of this medicinal product listed at the end of this leaflet 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 any of these apply to you, do not take Valsartan.
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) lithium, a medicine used to treat some types of psychiatric illness.
Valsartan 80 mg, 160 mg and 320 mg Film-Coated Tablets: Adults with 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 with an additional medicine (e.g. a diuretic). Valsartan 40 mg, 80 mg, 160 mg and 320 mg Film-Coated Tablets: Children and adolescents (6 to 18 years of age) with high blood pressure: In patients who weigh less than 35 kg the usual dose is 40 mg of valsartan once daily. In patients who weigh 35 kg or more the usual 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 40 mg, 80 mg and 160 mg Film-Coated 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 20 mg 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 twice daily. The final dose depends on what you as an individual patient can tolerate. Valsartan can be given together with other treatment 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 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 can be given together with other treatment for heart failure, and your doctor will decide which treatment is suitable for you. 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, 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 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 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, Valsartan 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 angiodema (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, see a doctor immediately. Side effects include: Common dizziness low blood pressure with or without symptoms such as dizziness and fainting when standing up decreased kidney function (signs of renal impairment). Uncommon: angioedema (see section Some symptoms need immediate medical attention) sudden loss of consciousness (syncope) spinning sensation (vertigo) 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: allergic reaction with rash, itching and hives, or symptoms of 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 of level of haemoglobin and decrease of the percentage of red blood cells in the blood (which can lead to anaemia in severe cases)
5. How to store Valsartan 6. Further information
6 FURTHER INFORMATION
What Valsartan contains The active substance is valsartan. 40 mg: Each film-coated tablet contains 40 mg of valsartan 80 mg: Each film-coated tablet contains 80 mg of valsartan 160 mg: Each film-coated tablet contains 160 mg of valsartan 320 mg: Each film-coated tablet contains 320 mg of valsartan The other ingredients are colloidal anhydrous silica, sodium starch glycolate (type A), crospovidone, microcrystalline cellulose, maize starch, magnesium stearate, hypromellose, macrogol, titanium dioxide (E171), talc, 40 mg and 160 mg: yellow iron oxide (E172), 80 mg and 160 mg: red iron oxide (E172), 320 mg: red iron oxide (E172), indigotine (E132), sunset yellow FCF (E110). 88210-B 320 x 323
Valsartan 160 mg film-coated tablets can be used for three different conditions: to treat high blood pressure in adults and in children and adolescents 6 to 18 1 WHAT VALSARTAN IS AND WHAT IT IS USED FOR years of age. High blood pressure increases the workload on the heart and Valsartan belongs to a class of medicines arteries. If not treated it can damage the known as angiotensin II receptor blood vessels of the brain, heart, and antagonist, which help to control high kidneys, and may result in a stroke, blood pressure. Angiotensin II is a heart failure, or kidney failure. High substance in the body that causes vessels blood pressure increases the risk of to tighten, thus causing your blood heart attacks. Lowering your blood pressure to increase. pressure to normal reduces the risk of Valsartan works by blocking the effect of developing these disorders. angiotensin II. As a result, blood vessels to treat adult patients after a recent relax and blood pressure is lowered. heart attack (myocardial infarction). Valsartan 40 mg film-coated tablets can Recent here means between 12 hours be used for three different conditions: and 10 days. to treat high blood pressure in children to treat symptomatic heart failure in and adolescents 6 to 18 years of age. adult patients. Valsartan is used when a High blood pressure increases the group of medicines called Angiotensin workload on the heart and arteries. If Converting Enzyme (ACE) inhibitors (a not treated it can damage the blood medication to treat heart failure) cannot vessels of the brain, heart, and kidneys, be used or it may be used in addition to and may result in a stroke, heart failure, ACE inhibitors when beta blockers or kidney failure. High blood pressure (another medication to treat heart increases the risk of heart attacks. failure) cannot be used. Heart failure Lowering your blood pressure to symptoms include shortness of breath, normal reduces the risk of developing and swelling of the feet and legs due to these disorders. fluid build-up. It is caused when the to treat adults patients after a recent heart muscle cannot pump blood heart attack (myocardial infarction). strongly enough to supply all the blood Recent here means between 12 hours needed throughout the body. and 10 days. Valsartan 320 mg film-coated tablets can to treat symptomatic heart failure in adult patients. Valsartan is used when a be used to treat high blood pressure in adults group of medicines called Angiotensin and in children and adolescents 6 to 18 Converting Enzyme (ACE) inhibitors (a years of age. High blood pressure medication to treat heart failure) cannot increases the workload on the heart and be used or it may be used in addition to arteries. If not treated it can damage the ACE inhibitors when beta blockers blood vessels of the brain, heart, and (another medication to treat heart failure) kidneys, and may result in a stroke, heart cannot be used. Heart failure symptoms failure, or kidney failure. High blood include shortness of breath, and swelling pressure increases the risk of heart attacks. of the feet and legs due to fluid build-up. Lowering your blood pressure to normal It is caused when the heart muscle cannot reduces the risk of developing these pump blood strongly enough to supply all disorders. the blood needed throughout the body.
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In addition for Valsartan 40 mg, 80 mg and 160 mg Film-Coated Tablets: if you are being treated after a heart attack, a combination with ACE Take special care with Valsartan inhibitors (a medication to treat heart Talk to your doctor before you start to attack) is not recommended take this medicine: if you are being treated for heart failure, if you have liver disease a triple combination with ACE inhibitors if you have a severe kidney disease or if and beta blockers (medications to treat you are undergoing dialysis heart failure) is not recommended. if you are suffering from a narrowing of the kidney artery Taking Valsartan with food and drink if you have recently had a kidney You can take Valsartan with or without transplantation (received a new kidney) food. if you are treated after a heart attack or for heart failure, your doctor may check Pregnancy and breast-feeding Ask your doctor or pharmacist for advice your kidney function before taking any medicine. if you have severe heart disease other You must tell your doctor if you think than heart failure or heart attack you are (or might become) pregnant. if you are taking medicines that increase Your doctor will normally advise you to the amount of potassium in your blood. stop taking Valsartan before you become These include potassium supplements pregnant or as soon as you know you or salt substitutes containing potassium, are pregnant, and will advise you to potassium-sparing medicines and take another medicine instead of heparin. It may be necessary to check Valsartan. Valsartan is not the amount of potassium in your blood recommended in early pregnancy, and at regular intervals must not be taken when more than 3 if you are below 18 years of age and months pregnant, as it may cause you take Valsartan in combination with serious harm to your baby if it is used other medicines that inhibit the renin after the third month of pregnancy. angiotensin aldosterone system (medicines that lower blood pressure), Tell your doctor if you are breast-feeding or about to start your doctor may check your kidney breast-feeding. Valsartan is not function and the amount of potassium recommended for mothers who are in your blood at regular intervals breast-feeding, and your doctor may if you suffer from aldosteronism. This is choose another treatment for you if you a disease in which your adrenal glands wish to breast-feed, especially if your make too much of the hormone baby is newborn, or was born aldosterone. If this applies to you, the prematurely. use of Valsartan is not recommended if you have lost a lot of fluid (dehydration) Driving and using machines caused by diarrhoea, vomiting, or high Before you drive a vehicle, use tools or doses of water tablets (diuretics) operate machines, or carry out other you must tell your doctor if you think activities that require concentration, make you are (or might become) pregnant. sure you know how Valsartan affects you. Valsartan is not recommended in early pregnancy, and must not be taken if you Like many other medicines used to treat are more than 3 months pregnant, as it high blood pressure, Valsartan may in rare may cause serious harm to your baby if cases cause dizziness and affect the ability to concentrate. used at that stage (see pregnancy section). Important information about some If any of these apply to you, tell your ingredients of Valsartan 320 mg doctor before you take Valsartan. Film-Coated Tablets: This medicinal product contains sunset Taking other medicines yellow FCF (E110) and may cause allergic Please tell your doctor or pharmacist if you are taking or have recently taken any reactions. other medicines, including medicines 3 HOW TO TAKE VALSARTAN obtained without a prescription. The effect of the treatment can be Always take Valsartan exactly as your influenced if Valsartan is taken together doctor has told you in order to get the with certain other medicines. It may be best results and reduce the risk of side necessary to change the dose, to take effects. You should check with your doctor other precautions, or in some cases to or pharmacist if you are not sure. People stop taking one of the medicines. This with high blood pressure often do not applies to both prescription and notice any signs of this problem. Many non-prescription medicines, especially: may feel quite normal. This makes it all other medicines that lower blood the more important for you to keep your pressure, especially water tablets appointments with the doctor even if you (diuretics) are feeling well.
Pharma code 123
Source: Medicines and Healthcare Products Regulatory Agency
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