Valsartan 320 Mg Film-Coated Tablets
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Read all of this leaflet carefully before you start using 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 you doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
See section 4.
hat 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 called angiotensin II receptor antagonists, which helps to control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to tighten, thus causing an increase in blood pressure. Valsartan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure is lowered.
Valsartan Tablets are used to treat: high blood pressure in adults, 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 or kidney failure and 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 to any of the other ingredients in 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 any of these apply to you, do not take Valsartan Tablets.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Valsartan
• if you have liver disease
• if you have severe kidney disease or are having dialysis
• if you have narrowing of the kidney artery
• if you have recently had a kidney transplant
• If you are already being treated after a heart attack or for heart failure (Your doctor may need to check your kidney function)
• if you have another severe heart disease other than heart failure or heart attack
• If you have narrowing of the mitral valve or aortic valve (stenosis) in the heart
• if you suffer from aldosteronism (when you produce too much of the hormone aldosterone) as the use of Valsartan is not recommended
• if you are taking medicines that increase the amount of potassium in your blood such as potassium supplements, salt substitutes containing potassium, potassium-sparing medicines and heparin. (As it may be necessary to do regular checks of the amount of potassium in your blood)
• if you are dehydrated (have lost a lot of fluid) caused by diarrhoea, vomiting, or due to high doses of 'water' tablets (diuretics)
• if you think you are or (might become) pregnant (as 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 the late stage (see pregnancy section)
• if you are below 18 years of age and take Valsartan in combination with other medicines that inhibit the rennin 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.
Other medicines and Valsartan
T ell 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, especially:
• other medicines that lower blood pressure especially water pills (diuretics)
• medicines that increase the amount of potassium in
the blood such as potassium supplements, or salt substitutes containing potassium, potassium-sparing medicines and heparin
• certain type of pain killers non-steroidal antiinflammatory medicines (NSAIDs)
• lithium (to treat some types of mental illness).
In addition:
• if you are being treated after a heart attack, a combination with ACE inhibitors (a medication to treat a 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.
Valsartan with food and drink
You can take Valsartan Tablets with or without food.
Pregnancy and breastfeeding
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 tablets before you become pregnant or as soon as you know you are pregnant and will advise you to take a different medicine. 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 the baby if 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, 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 your ability to conc entrate.
Valsartan contains lactose
This medicine contains a sugar called lactose. If your doctor has told you that you have intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Valsartan
Always use Valsartan exactly as your doctor has told you in order to get the best results and reduce the risk of side effects. If you are not sure, check with your doctor or pharmacist.
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 your doctor even if you are feeling well.
Adult patients with high blood pressure:
The usual dose is 80 mg once a day. In some cases your doctor may prescribe higher doses (e.g. 160 mg or 320 mg). Your doctor may also combine Valsartan with an additional medicine (e.g. diuretic).
Children and adolecsents (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).
You can take Valsartan Tablets with or without food. Swallow the tablets with a glass of water. Take Valsartan Tablets 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 hosp ital.
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 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 you r d octo r o r 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 serious side effects including:
• angioedema (severe allergic reaction) such as:
• swelling of the face, tongue, lips or throat
• difficulty in breathing or swallowing
• hives, itching
• decreased kidney function (renal impairment) or abnormal kidney function such as:
• weight loss or poor appetite
• swollen ankles, feet or hands due to water retention
• shortness of breath
• blood or protein in your urine
• increased levels of blood urea nitrogen and serum creatinine
• cardiac failure such as:
• breathlessness
• difficulty breathing when lying down
• swelling of the feet or legs
• increased level of potassium in the blood (hyperkalaemia) such as:
• muscle spasms
• abnormal heart rhythm
• serum sickness such as:
• symptoms of fever
• swollen joints and joint pain
• muscle pain
• swollen lymph nodes
• flu-like symptoms
• unusual bleeding or bruising (thrombocytopenia)
• fever, sore throat or mouth ulcers due to infections (symptoms of low levels of white blood cells called neutropenia)
• anaemia
• jaundice due to elevation of liver function values (which can indicate liver damage) including an increase of bilirubin in the blood (which in severe cases can cause yellow skin and eyes).
If you get any of these, see your doctor immediately.
Other side effects are shown below.
If any of the following side effects gets serious, or if you notice any effects not listed in this leaflet, tell your doctor or pharmacist.
Common
• dizziness
• low blood pressure with or without symptoms, such as dizziness or fainting on standing up
• decreased kidney function (signs of renal impairment) (see "Some symptoms need immediate medical attention").
Uncommon
• headache
• angioedema (see "Some symptoms need immediate medical attention")
• sudden loss of consciousness
• spinning sensation (vertigo)
• severely decreased kidney function (signs of acute renal failure)
• muscle spasms, abnormal heart rhythm (signs of hyperkalaemia) (see "Some symptoms need immediate medical attention")
• breathlessness, difficulty breathing when lying down, swelling of the feet or legs (signs of cardiac failure) (see "Some symptoms need immediate medical attention")
• cough
• abdominal pain
• diarrhoea
• nausea
• tiredness
• weakness.
Not known
• 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 (signs of serum sickness) (see "Some symptoms need immediate medical attention")
• purplish-red spots, fever, itching (signs of inflammation of blood vessels also called vasculitis)
• unusual bleeding or bruising (signs of thrombocytopenia) (see "Some symptoms need immediate medical attention")
• muscle pain (myalgia)
• fever, sore throat or mouth ulcers due to infections (symptoms of low levels of white blood cells called neutropenia) (see "Some symptoms need immediate medical attention")
• decreased level of haemoglobin and decrease of the percentage of red blood cells (which can lead to anaemia in severe cases) (see "Some symptoms need immediate medical attention")
• increased 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 in severe cases can cause yellow skin and eyes) (see "Some symptoms need immediate medical attention")
• increased levels of blood urea nitrogen and serum creatinine (which can indicate abnormal kidney function) (see "Some symptoms need immediate medical attention").
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 for high blood pressure than in 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: http://yellowcard.mhra.gov.uk/.
By reporting side effects you can help provide more infomation on the safety of this medicine.
5. How to store Valsartan
Keep out of the sight and reach of children.
Do not use Valsartan if you notice that the pack is damaged or shows signs of tampering.
Store in the original package below 30 C.
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 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 Tablets contain
The active substance (which makes the medicine work) is valsartan. Each tablet contains 320 mg of valsartan.
The other ingredients are lactose monohydrate, cellulose, microcrystalline, maize starch, crospovidone, povidone, colloidal anhydrous silica, magnesium stearate in the tablet core, and hypromellose, titanium dioxide (E171), macrogol and i ron oxides (yellow, black and red; E172) in the tablet coating.
What Valsartan Tablets look like and contents of the pack
Valsartan 320 mg tablets are light brown coloured, oval shaped, film-coated tablets with beveled edge debossed with 'V and 320' on one side of the tablet and breakline on the other side.
The tablets can be divided in to two equal halves
Available pack sizes: 14, 28, 30, 50, 56, 60, 98 or 100 tablets. Not all pack sizes may be available.
Marketing Authorisation Holder and Manufacturer
Dr. Reddy's Laboratories (UK) Ltd., 6 Riverview Road, Beverley, HU17 0LD, United Kingdom
This leaflet was last revised in 07/2014