Valsartan 320 Mg Film-Coated Tablets
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Valsartan 320 mg film-coated tablets
valsartan
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet.You may need to read it again.
• Ifyou have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Valsartan 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 belongs to a class of medicines known as angiotensin II receptor antagonist, 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 320 mg film-coated tablets can be used
• to treat high blood pressure in adults and in children and adolescents 6 to 18 years of age. High blood pressure increases the workload on the heart and arteries. If not treated it can damage the blood vessels of the brain, heart, and kidneys, and may result in a stroke, heart failure, or kidney failure.
High blood pressure increases the risk of heart attacks. Lowering your blood pressure to normal reduces the risk of developing these disorders.
2. What you need to know before you take Valsartan Do not take Valsartan:
• if you are allergic to valsartan or any of the other ingredients of Valsartan (listed in section 6).
• ifyouhave 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 called aliskiren.
If any of these apply to you, do not take Valsartan.
Warnings and precautions
Talk to your doctor or pharmacist before taking Valsartan:
• ifyouhave liver disease.
• ifyouhave severe kidney disease or ifyou are undergoing dialysis.
• ifyou are suffering from a narrowing of the kidney artery.
• ifyou have recently undergone kidney transplantation (received a new kidney).
• if you are treated after a heart attack or for heart failure, your doctor may check your kidney function.
• ifyouhave 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 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 are below 18 years of age and you take Valsartan in combination with other medicines that inhibit the renin angiotensin aldosterone system (medicines that lower blood pressure), your doctor may check your kidney function and 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 ofValsartan is not recommended.
• if you have lost a lot of fluid (dehydration) caused by diarrhoea, vomiting, or high doses ofwaterpills (diuretics).
• 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 ifyou are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
• ifyou are taking any of the following medicines used to treat high blood pressure:
o an “ACE inhibitor” (for example enalapril, lisinopril, ramipril, etc.), in particular ifyou have diabetes related kidney problems. o aliskiren.
If any of these apply to you, tell your doctor before you take Valsartan.
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”.
Other medicines and Valsartan
Tell your doctor or pharmacist ifyou 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 nonprescription medicines, especially:
• other medicines that lower blood pressure, especially water tablets (diuretics), ACE inhibitors (such as enalapril, lisinopril, etc.,) or aliskiren (see also information under the heading “Do not take Valsartan” 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 anti-inflammatory medicines (NSAIDs).
• some antibiotics (rifamycin group), a drug used to protect against transplant rejection (ciclosporin) or an antiretroviral drug used to treat HIV/AIDS infection (ritonavir). These drugs may increase the effect ofValsartan.
• lithium, amedicine used to treat some types ofpsychiatric illness.
Valsartan with food and drink
You can take Valsartan 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 before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead ofValsartan. 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.
Valsartan contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Valsartan
Always take Valsartan 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.
Adult patients with high blood pressure: The recommended 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. adiuretic).
Children and adolescents (6 to 18 years of age) with high blood pressure
In patients who weigh less than 35 kg the recommended dose is 40 mg of valsartan once daily.
In patients who weigh 35 kg or more the recommended starting dose is 80 mg of valsartan once daily.
In some cases your doctor may prescribe higher doses (the dose can be increased to 160 mg and to a maximum of320 mg).
You can take Valsartan with or without food. Swallow Valsartan with a glass of water.
Take Valsartan at about the same time each day.
Ifyou 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 tablets, contact your doctor, pharmacist, or hospital.
Ifyou 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.
Ifyou 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.
Ifyouhave 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 symptoms need immediate medical attention:
You may experience symptoms of angioedema (a specific allergic reaction), such as
• swollen face, lips, tongue orthroat
Sweden:
Cyprus:
Denmark:
Germany:
Italy:
The Netherlands: United Kingdom:
• difficulty in breathing or swallowing
• hives, itching
If you get any of these, see a doctor immediately.
Other side effects include:
Common (may affect 1 to 10 users in 100):
• dizziness
• low blood pressure with or without symptoms such as dizziness and fainting when standing up
• decreased kidney function (signs of renal impairment)
Uncommon (may affect up to 1 in 100 people):
• angioedema (see section “Some symptoms need immediate medical attention”)
• suddenloss 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 ofcardiac failure)
• headache
• cough
• abdominal pain
• nausea
• diarrhoea
• tiredness
• weakness
Not known (frequency cannot be estimated from the available data):
• 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)
• purplished-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 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 blood sodium (which can trigger tiredness, confusion, muscle twitching and/or convulsions in severe cases)
Side effects in children and adolescents are similar to those seen in adults.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly:
Yellow Card Scheme
Website: 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
• Keep this medicine out of the sight and reach of children.
• PVC/PE/PVDC blister: Store below 30°C.
Al/Al blister: This medicinal product does not require any special storage conditions.
• 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 if you notice that the pack is damaged or shows signs of tampering.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Valsartan 320 mg film-coated tablets contains
• The active substance is valsartan.
Each film-coated tablet contains 320 mg valsartan.
• The other ingredients are:
Microcrystalline cellulose (E460), crospovidone (E1202), dental type silica, magnesium stearate (E470b), lactose anhydrous, hypromellose (E464), titanium dioxide (E171), macrogol and iron oxide yellow (E172).
What Valsartan 320 mg film-coated tablets looks like and contents of the pack
Valsartan 320 mg film-coated tablets are yellow coloured, oval shaped, biconvex film-coated tablets of approximately 20,45 mm length and 9,65 mm width, debossed with 'C5' on one side and plain on the other side.
The tablets are available in blister packs of28,56 or 98 tablets.
Not all pack sizes may be marketed.
MarketingAuthorisation Holder and Manufacturer
Marketing Authorisation Holder Jubilant Pharmaceuticals nv Axxes Business Park Guldensporenpark 22 - Block C 9820 Merelbeke Belgium
Manufacturer
PSI supply nv
Axxes Business Park
Guldensporenpark 22 - Block C
9820 Merelbeke
Belgium
For any information about this medicine, please contact the Marketing Authorisation Holder.
This medicinal product is authorised in the Member States of the EEA under the following names:
Valsartan Jubilant 320 mg Filmdragerade Tabletter Valsartan Jubilant 320 mg Film-coated tablets Valsartan Jubilant 320 mg Filmovertrukket tablet Valsartan Jubilant 320 mg Filmtabletten Valsartan Jubilant 320 mg Compressa rivestita con film Valsartan Jubilant 320 mg filmomhulde tabletten Valsartan 320 mg film-coated tablets
This leaflet was last revised in 09/2014.