Valsartan 160mg Capsules
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Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
^ What Valsartan Capsules are and what they are used for What you need to know before you take Valsartan Capsules
How to take Valsartan Capsules
Possible side effects
How to store Valsartan Capsules
« Contents of the pack and other information
j What Valsartan Capsules are and what they are used for
Valsartan Capsules contain the active ingredient valsartan.
Valsartan belongs to a class of medicines known as angiotensin II receptor antagonists, which help to control high blood pressure. Angiotensin II is a substance in the body that causes the blood vessels to tighten, causing your blood pressure to increase.
Valsartan Capsules work by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure is lowered.
Valsartan 40mg Capsules can be used to:
• treat high blood pressure in children and adolescents 6 to 18 years of age. High blood pressure increases the workload on the heart and arteries. Ifnot 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 ofheart attacks. Lowering your blood pressure to normal reduces the risk of developing these disorders.
• treat adult patients after a recent heart attack (myocardial infarction). "Recent" means the patient had a heart attack at least 12 hours ago but no more than 10 days ago.
• treat symptomatic heart failure in adult patients. Valsartan 40mg 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 other 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.
Valsartan 80mg and 160mg Capsules can be used to:
• treat high blood pressure in adults and in children and adolescents 6 to 18 years of age. High blood pressure increases the workload on the heart and arteries. Ifnot treated it can damage the blood vessels ofthe brain, heart, and kidneys, and may result in a stroke, heart failure, or kidney failure.
High blood pressure increases the risk ofheart attacks. Lowering your blood pressure to normal reduces the risk of developing these disorders.
• treat adult patients after a recent heart attack (myocardial infarction). "Recent" means the patient had a heart attack at least 12 hours ago but no more than 10 days ago.
• treat symptomatic heart failure in adult patients. Valsartan 80mg and 160mg Capsules is used when a group of medicines called Angiotensin Converting Enzyme (ACE) inhibitors (a medication to treat heart failure) cannot be used or it may be used in addition to ACE-inhibitors when other medications to treat heart failure cannot be used.
Heart failure symptoms include shortness ofbreath, 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.
What you need to know before you take Valsartan Capsules
Do not take Valsartan Capsules if you:
• are allergic to valsartan or any of the other ingredients ofthis medicine (listed in section 6).
• have severe liver disease.
• are more than 3 months pregnant (it is also better to avoid Valsartan Capsules in early pregnancy - see pregnancy section).
• have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
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Warnings and precautions
Talk to your doctor before taking Valsartan Capsules
• 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 blood vessel to the kidney.
• if you have recently undergone kidney transplantation (received a new kidney).
• ifyou have severe heart disease other than heart failure or heart attack.
• if you are treated after a heart attack or for heart failure, your doctor may check your kidney function.
• 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 ofthe hormone aldosterone. If this applies to you, the use ofValsartan Capsules is not recommended.
• if you have lost a lot of fluid (dehydration) caused by diarrhoea, vomiting, or high doses of water pills (diuretics).
• 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 they may cause serious harm to your baby if used at that stage (see pregnancy section).
• if you have history of angioedema
• if you are taking any of the following medicines used to treat high blood pressure:
- an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
- aliskiren
• if you are being treated with an ACE-inhibitor together with certain other medicines to treat your heart failure, which are known as mineralocorticoid receptors antagonists (MRA) (for example spironolactone, eplerenone) or betablockers (for example metoprolol).
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.
See also information under the heading "Do not take Valsartan Capsules if you"
Other medicines and Valsartan Capsules
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 ifValsartan Capsules are taken together with certain other medicines. Your doctor may need to change your dose and/or take other precautions, or in some cases to stop taking one ofthe medicines. This applies to both prescription and non-prescription medicines, especially:
• other medicines that lower blood pressure, especially"water tablets" (diuretics).
• medicines that increase the amount ofpotassium 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.
• if you are taking an ACE-inhibitor or aliskiren (see also information under the headings "Do not take Valsartan Capsules ifyou" and "Warnings and precautions'.
In addition:
• if you are being treated with an ACE-inhibitor together with certain other medicines to treat your heart failure, which are known as mineralocorticoid receptors antagonists (MRA) (for example spironolactone, eplerenone) or betablockers (for example metoprolol).
• if you are being treated after a heart attack, a combination with medicines known as ACE inhibitors (medicines to treat heart attack) is not recommended.
Valsartan Capsules with food and drink
You can take Valsartan Capsules with or without food.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
You must tell your doctor if you think that you are (or might become) pregnant.
Your doctor will normally advise you to stop taking Valsartan Capsules before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead ofValsartan Capsules.
Valsartan Capsules are not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as they may cause serious harm to your baby if they are used after the third month of pregnancy.
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Tell your doctor if you are breast-feeding or about to start breast-feeding.
Valsartan Capsules are not recommended ifyou are breast-feeding. Your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Driving and using machines
Before you drive a vehicle, use tools or operate machines, or carry out other activities that require concentration, make sure you know how Valsartan Capsules affect 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.
How to take Valsartan Capsules
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 ifyou 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.
Take Valsartan Capsules at about the same time each day. Swallow the capsules with a glass of water. You can take the capsules with or without food.
Dosage:
Children and adolescents (6 to 18 years of age) with high blood pressure
In patients who weigh less than 35kg the usual dose is 40mg of valsartan once daily. In patients who weigh 35kg or more the usual starting dose is 80mg of valsartan once daily. In some cases your doctor may prescribe higher doses (the dose can be increased to 160mg and to a maximum of320mg).
Adult patients with high blood pressure:
The recommended dose is one 80mg capsule daily. In some cases your doctor may prescribe higher doses (e.g. 160mg or 320mg). You may also be prescribed an additional medicine to take e.g. "water tablets” (a diuretic).
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 20mg twice daily. You obtain the 20mg dose by dividing a 40mg tablet (obtained from a different source).
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.
Valsartan Capsules can be given together with certain other treatments for heart attack, and your doctor will decide which treatment is suitable for you.
Adult patients with heart failure:
Treatment starts generally with one 40mg capsule twice daily. Your doctor will increase the dose gradually over several weeks to a maximum of one 160mg capsule 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 failure, and your doctor will decide which treatment is suitable for you.
If you take more Valsartan Capsules than you should
Ifyou 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 Capsules
Ifyou 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 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.
Ifyou have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some symptoms need immediate medical attention:
You may experience symptoms of angioedema (a specific allergic reaction), such as
• swollen face, lips, tongue or throat
• difficulty in breathing or swallowing
• hives, itching
If you get any of these, see a doctor immediately.
Other side-effects include:
Common (may affect up to 1 in 10 people):
• dizziness
• low blood pressure with or without symptoms such as dizziness and fainting when standing up
• decreased kidney function (signs of renal impairment)
Uncommon side effects (may affect up to 1 in 100 people):
• angioedema (see section "Some symptoms need immediate medical attention”)
• sudden loss of consciousness (syncope)
• spinning sensation (vertigo)
• severely decreased kidney function (signs ofacute kidney failure)
• muscle spasms, abnormal heart rhythm (signs of hyperkalaemia)
• breathlessness, difficulty breathing when lying down, swelling ofthe feet or legs (signs of cardiac failure)
• headache
• cough
• abdominal pain
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• nausea
• diarrhoea
• tiredness
• weakness
Not known (frequency cannot be estimated from the available data):
• blistering skin (sign of dermatitis bullous)
• allergic reactions with rash, itching and hives; 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 ofthrombocytopenia)
• muscle pain (myalgia)
• fever, sore throat or mouth ulcers due to infections (symptoms of low level of white blood cells also called neutropenia)
• decrease in level ofhaemoglobin and decrease ofthe percentage of red blood cells in the blood (which can, in severe cases, lead to anaemia)
• increase in level of potassium in the blood (which can, in severe cases, trigger muscle spasms, abnormal heart rhythm), decrease in blood sodium
• elevation of liver function values (which can indicate liver damage) including an increase ofbilirubin in the blood (which can, in severe cases, trigger yellow skin and eyes)
• increase in level of blood urea nitrogen and increase of level of serum creatinine (which can indicate abnormal kidney function)
• low level of sodium in the blood (which can trigger tiredness, confusion, muscle twitching and/or convulsions in severe cases)
• rash
• itching
The frequency of some side effects may vary depending on your condition. For example, side effects such as dizziness, and decreased kidney function, were seen less frequently in adult patients treated with high blood pressure than in adult patients treated for heart failure or after a recent heart attack.
Side effects in children and adolescents are similar to those seen in adults.
Reporting of side effects
If you get any side effects, talk to your doctor, 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/vellowcard. By reporting side effects you can help provide more information on the safety of this medicine
How to store Valsartan Capsules
Store below 30oC.
Keep this medicine out ofthe sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry date refers to the last day of that month.
Do not use this medicine ifyou notice that the pack is damaged or shows signs oftampering.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Contents of the pack and other information What Valsartan Capsules contain
The active substance is Valsartan.
Each capsule contains 40mg valsartan.
Each capsule contains 80mg valsartan.
Each capsule contains 160mg valsartan.
The other ingredients in capsules are Microcrystalline cellulose (101), Croscarmellose Sodium, Sodium laurilsulfate, Povidone (K30), Magnesium stearate, Gelatin, Titanium dioxide (E171), Red iron oxide (E172(ii)) and Black iron oxide (E172(i)).
The black printing ink contains Shellac, Ethanol, Isopropanol, butanol, propylene glycol, purified water, strong ammonia solution, potassium hydroxide and black iron oxide (E172).
What Valsartan Capsules look like and contents of the pack
Valsartan 40mg Capsules are a hard gelatin, light grey opaque / light grey opaque capsule with 'VS3' over' 'on the cap and no markings on the body.
Valsartan 80mg Capsules are a hard gelatin, light grey opaque / flesh opaque capsule with 'VS2' over ' ' on the cap and no markings on the body.
Valsartan 160mg Capsules are a hard gelatin, dark grey opaque / flesh opaque capsule with 'VS1' over' ' on the cap and no markings on the body.
The capsules are packed in aluminium foil blisters.
Pack sizes: 7, 28, 98
Not all pack sizes may be marketed
Marketing Authorisation Holder
Arrow Generics Limited
Whiddon Valley, Barnstaple, Devon, EX32 8NS, United Kingdom
Manufacturer
Actavis Ltd
BLB 016, Bulebel Industrial Estate, Zejtun, ZTN 3000, Malta This leaflet was last revised in February 2015
If you would like a leaflet with larger text, please contact 01271 385257.
Actavis, Barnstaple, EX32 8NS, UK