Valsartan 320 Mg Film-Coated Tablets
SZ00000LT000
3 SANDOZ
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.
• 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:
1. What Valsartan is and what it is used for
2. What you need to know before you take Valsartan
3. How to take Valsartan
4. Possible side effects
5. How to store Valsartan
6. Contents of the pack and other information
1. WHAT VALSARTAN IS AND WHAT IT IS USED FOR
Valsartan contains the active substance: valsartan and belongs to a class of medicines known as angiotensin II receptor 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 (hypersensitive) to valsartan or any of the other ingredients of this medicine (listed in section 6).
• if you have severe liver disease.
• if you are more than 3 months pregnant (it is
also better to avoid Valsartan in early pregnancy - see pregnancy section).
• if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
If any of the above apply to you, tell your
doctor and do not take Valsartan.
Warnings and precautions:
Talk to your doctor
• if you have liver disease.
• if you have severe kidney disease or if you are undergoing dialysis.
• if you are suffering from a narrowing of the kidney artery.
• if you have recently undergone kidney transplantation (received a new kidney).
• if you have severe heart disease other than heart failure or heart attack.
• if you have ever experienced swelling of the tongue and face caused by an allergic reaction called angioedema when taking another drug (including ACE inhibitors), tell your doctor. If these symptoms occur when you are taking Valsartan, stop taking Valsartan immediately and never take it again. See also section 4, “Possible side effects”.
• if you 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 is not recommended.
• if you have lost a lot of fluid (dehydration) caused by diarrhoea, vomiting, or high doses of water tablets (diuretics).
• 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”
You must tell your doctor if you think you are (or might become) pregnant. Valsartan is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
Other medicines and Valsartan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of the treatment can be influenced if Valsartan is taken together with certain other medicines. It may be necessary to change the dose, to take other precautions, or in some cases to stop taking one of the medicines. This applies to both prescription and non-prescription medicines, especially:
■ other medicines that lower blood pressure,
especially water tablets (diuretics), ACE inhibitors (such as enalapril, lisinopril, etc.) or aliskiren (see also information under the headings “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 of Valsartan.
• lithium, a medicine used to treat some types of psychiatric illness.
Pregnancy, breast-feeding and fertility
■ You must tell your doctor if you think that you are (or might become) pregnant. Your doctor will normally advise you to stop taking Valsartan before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Valsartan. Valsartan is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if it is used after the third month of pregnancy.
■ Tell your doctor if you are breast-feeding or about to start breast-feeding. Valsartan is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
• Patients who are concerned about their fertility while taking Valsartan are advised to consult with their doctor.
Driving and using machines
Before you drive a vehicle, use tools or operate machines, or carry out other activities that require concentration, make sure you know how Valsartan affects you. Like many other medicines used to treat high blood pressure, Valsartan may in rare cases cause dizziness and affect the ability to concentrate.
3. HOW TO TAKE VALSARTAN
Always take this medicine exactly as your doctor has told you in order to get the best results and reduce the risk of side effects. Check with your doctor or pharmacist if you are not sure.
People with high blood pressure often do not notice any signs of this problem. Many may feel quite normal. This makes it all the more important for you to keep your appointments with the doctor even if you are feeling well.
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. a diuretic).
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
0000000-SDZ 00B/B-GB
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 of 320 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.
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 medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious and need immediate medical attention:
You may experience symptoms of angioedema (a specific allergic reaction), such as
• swollen face, lips, tongue or throat
• difficulty in breathing or swallowing
• hives, itching.
If you get any of these symptoms, stop taking Valsartan and contact your doctor straight away (see also section 2 “Warnings and precautions”).
Other side effects include:
Common (may affect up to 1 in 10 people):
• dizziness
• 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”)
• 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 (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 of thrombo cytopenia)
• 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)
• 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).
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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below. By reporting side effects you can help provide more information on the safety of this medicine.
United Yellow Card Scheme
Kingdom Website: www.mhra.gov.uk/yellowcard
5. HOW TO STORE VALSARTAN
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
• Do not store above 30°C. Store in the original package in order to protect from moisture.
• 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 protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Valsartan contains
The active substance is valsartan.
Each film-coated tablet contains 320 mg valsartan. The other ingredients are microcrystalline cellulose, crospovidone type A, colloidal anhydrous silica, magnesium stearate.
The tablet coating contains hypromellose, titanium dioxide (E171), macrogol 8000, iron oxide red (E172), iron oxide yellow (E172), iron oxide black (E172).
What Valsartan looks like and contents of the pack
Valsartan 320 mg film-coated tablets are grey-violet, ovaloid with bevelled edges and scored on one side. They have the letters “DC” on one side of the score and “DC” on the other side of the score and “NVR” on the reverse side of the tablet. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
The tablets are supplied in blister packs of 7, 14, 28, 30, 56, 90 or 98 tablets and in calendar blister packs of 14, 28, 56, 98 and 280 tablets. Perforated unit dose blister packs of 56x1, 98x1 or 280x1 tablets are also available.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The product licence holder is:
Novartis Pharmaceuticals UK Limited
Trading as:
Ciba Laboratories, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom.
Valsartan Tablets are released onto the market by: Novartis Pharmaceuticals UK Limited,
Wimblehurst Road, Horsham, West Sussex,
RH12 5AB, United Kingdom or
Novartis Pharmaceuticals UK Limited,
Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom.
Distributed by:
Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom.
If you would like any more information, or would like this leaflet in a different format, please contact Medical Information at Novartis Pharmaceuticals UK Ltd, telephone number 01276 698370.
This leaflet was last revised in April 2015.
SZ00000LT000 0000000-SDZ 00B/B-GB