Valsartan 80mg Capsules
Assessed against UK
Final draft mock up
PIL dated April 2013
Package Leaflet: Information for the User
By kariri at 1:50 pm, Jun 11, 2015
• 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.
• Your medicine is available using either of the above names but will be referred to as Diovan throughout the remainder of this leaflet.
• Diovan is also available in the 40mg and 160mg strengths.
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
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.
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.
• 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 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 Diovan, stop taking Diovan 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 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).
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
• 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 Diovan.
• lithium, a medicine used to treat some types of psychiatric illness.
• 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.
You can take Diovan with or without food.
Ask your doctor or pharmacist for advice before taking any 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 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 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 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 newborn, or was born prematurely.
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.
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.
This low dose is provided by 40 mg divisible tablets. 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 experience severe dizziness and/or fainting, lie down and contact your doctor immediately. If you have accidentally taken too many capsules, contact your doctor, pharmacist, or hospital.
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.
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.
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.
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 symptoms, stop taking Diovan and contact your doctor straight away (see also section 2 “Take special care with Diovan”).
• dizziness, postural dizziness
• low blood pressure with symptoms such as dizziness
• decreased kidney function (signs of renal impairment)
• 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)
• abdominal pain
• 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.
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.
• Keep out of the sight and reach of children.
• Do not store above 30oC.
• Do not use Diovan after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
• Store in the original package to protect from moisture and heat.
• If your capsules become discoloured or show any signs of deterioration, return them to your pharmacist.
• 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.
The active substance is valsartan. Each capsule contains 80mg valsartan.
The other ingredients are:
microcrystalline cellulose, povidone, crospovidone type A, sodium lauryl sulphate and magnesium stearate.
The capsule shell contains gelatin, titanium dioxide (E171), black iron oxide (E172), red iron oxide (E172). The printing ink contains shellac, industrial methylated spirit 74 OP, black iron oxide (E172).
Diovan 80mg Capsules have a pale grey cap and flesh pink body.
Novartis Farma S.p.A., Via Provinviale Schito 131,80058 Torre Annuziata (NA), Italy.
FAMAR L'Aigle, Zone industrielle No 1, Route de Crulai, 61303 L'Aigle, France
It is procured from within the EU by the product licence holder: MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge, Walsall WS9 8ER
Repackaged by MPT Pharma Ltd
Leaflet dated 23rd April 2015 Leaflet coded xxxxxxxx
Diovan® is a registered trademark of xxxxxxxxxxxxxxxxxxxx