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«What is in this leaflet: 1. What Vanatex HCT is and what it is used for 2. What you need to know before you take Vanatex HCT 3. How to take Vanatex ...»

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Package leaflet: Information for the patient

Vanatex HCT 80 mg/12.5 mg film-coated tablets

Vanatex HCT 160 mg/12.5 mg film-coated tablets

Vanatex HCT 160 mg/25 mg film-coated tablets

Valsartan/hydrochlorothiazide

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 Vanatex HCT is and what it is used for

2. What you need to know before you take Vanatex HCT

3. How to take Vanatex HCT

4. Possible side effects

5. How to store Vanatex HCT

6. Contents of the pack and other information

1. What Vanatex HCT is and what it is used for Vanatex HCT film-coated tablets contain two active substances called valsartan and hydrochlorothiazide. Both of these substances help to control high blood pressure (hypertension).

 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 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.

 Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics (also known as “water tablets”). Hydrochlorothiazide increases urine output, which also lowers blood pressure.

Vanatex HCT is used to treat high blood pressure which is not adequately controlled by a single substance alone.

High blood pressure increases the workload of 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 Vanatex HCT

Do not take Vanatex HCT:

 if you are allergic to valsartan, hydrochlorothiazide, sulphonamide derivatives (substances chemically related to hydrochlorothiazide) or to any of the other ingredients of this medicine (listed in section 6)  if you are more than 3 months pregnant (it is also better to avoid Vanatex HCT in early pregnancy - see pregnancy section)  if you have severe liver disease, destruction of the small bile ducts within the liver (biliary cirrhosis) leading to the build up of bile in the liver (cholestasis)  if you have severe kidney disease  if you are unable to produce urine (anuria)  if you are treated with an artificial kidney  if the level of potassium or sodium in your blood is lower than normal, or if the level of calcium in your blood is higher than normal despite treatment  if you have gout  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 Vanatex HCT.

Warnings and precautions

Talk to your doctor before taking Vanatex HCT:

 if you are taking potassium-sparing medicines, potassium supplements, salt substitutes containing potassium or other medicines that increase the amount of potassium in your blood such as heparin. Your doctor may need to check the amount of potassium in your blood regularly.

 if you have low levels of potassium in your blood  if you have diarrhoea or severe vomiting  if you are taking high doses of water tablets (diuretics)  if you have severe heart disease  if you are suffering from heart failure or have experienced a heart attack. Follow your doctor’s instruction for the starting dose carefully. Your doctor may also check your kidney function.

 if you suffer from a narrowing of the kidney artery  if you have recently received a new kidney  if you suffer from hyperaldosteronism. This is a disease in which your adrenal glands make too much of the hormone aldosterone. If this applies to you, the use of Vanatex HCT is not recommended.

 if you have liver or kidney disease  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 Vanatex HCT, stop taking Vanatex HCT immediately and never take it again. See also section 4, “Possible side effects”.

 if you have fever, rash and joint pain, which may be signs of systemic lupus erythematosus (SLE, a so-called autoimmune disease)  if you have diabetes, gout, high levels of cholesterol or triglycerides in your blood  if you have had allergic reactions with the use of other blood pressure-lowering agents of this class (angiotensin II receptor antagonists) or if you have allergy or asthma  if you experience a decrease in vision or eye pain. These could be symptoms of an increase of pressure in your eye and can happen within hours to a week of taking Vanatex HCT. This can lead to permanent vision loss, if not treated. If you earlier have had a penicillin or sulphonamide allergy you can be at higher risk of developing this  if you are taking any of the following medicines used to treat high blood pressure:





- an ACE-inhibitors (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems

- aliskiren.

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 Vanatex HCT”.

Vanatex HCT may cause increased sensitivity of the skin to sun.

The use of Vanatex HCT in children and adolescents (below the age of 18 years) is not recommended.

–  –  –

Other medicines and Vanatex HCT 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 Vanatex HCT 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 especially applies to the following medicines:

 lithium, a medicine used to treat some types of psychiatric diseases  medicines or substances that may increase the amount of potassium in your blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines and heparin.

 medicines that may reduce the amount of potassium in your blood, such as diuretics (water tablets), corticosteroids, laxatives, carbenoxolone, amphotericin or penicillin G.

 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 Vanatex HCT.

 medicines that may induce “torsades de pointes” (irregular heart beat), such as antiarrhythmics (medicines used to treat heart problems) and some antipsychotics  medicines that may reduce the amount of sodium in your blood, such as antidepressants, antipsychotics, antiepileptics  medicines for the treatment of gout, such as allopurinol, probenecid, sulfinpyrazone  therapeutic vitamin D and calcium supplements  medicines for the treatment of diabetes (oral agents such as metformin or insulins)  other medicines to lower your blood pressure including methyldopa, ACE inhibitors (such as enalapril, lisinopril, etc.,) or aliskiren (see also information under the headings “Do not take Vanatex HCT” and “Warnings and precautions”)  medicines to increase blood pressure, such as noradrenaline or adrenaline  digoxin or other digitalis glycosides (medicines used to treat heart problems)  medicines that may increase blood sugar levels, such as diazoxide or beta blockers  cytotoxic medicines (used to treat cancer), such as methotrexate or cyclophosphamide  pain killers such as non-steroidal anti-inflammatory agents (NSAIDs), including selective cyclooxygenase-2 inhibitors (Cox-2 inhibitors) and acetylsalicylic acid 3 g  muscle relaxing medicines, such as tubocurarine  anti-cholinergic medicines (medicines used to treat a variety of disorders such as gastrointestinal cramps, urinary bladder spasm, asthma, motion sickness, muscular spasms, Parkinson's disease and as an aid to anaesthesia)  amantadine (medicine used to treat Parkinson’s disease and also used to treat or prevent certain illnesses caused by viruses)  cholestyramine and colestipol (medicines used mainly to treat high levels of lipids in the blood)  alcohol, sleeping pills and anaesthetics (medicines with sleeping or painkilling effect used for example during surgery)  iodine contrast media (agents used for imaging examinations).

Vanatex HCT with food, drink and alcohol You can take Vanatex HCT with or without food.

Avoid taking alcohol until you have talked to your doctor. Alcohol may make your blood pressure fall more and/or increase the risk of you becoming dizzy or feeling faint.

Pregnancy, breastfeeding and fertility If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

–  –  –

 Tell your doctor if you are breastfeeding or about to start breast-feeding Vanatex HCT 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 Vanatex HCT affects you. Like many other medicines used to treat high blood pressure, Vanatex HCT may occasionally cause dizziness and affect the ability to concentrate.

Vanatex HCT 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.

–  –  –

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

This will help you to get the best results and lower the risk of side effects.

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.

Your doctor will tell you exactly how many tablets of Vanatex HCT to take. Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose.

 The recommended dose of Vanatex HCT is one tablet per day.

 Do not change the dose or stop taking the tablets without consulting your doctor.

 The medicine should be taken at the same time each day, usually in the morning.

 You can take Vanatex HCT with or without food.

 Swallow the tablet with a glass of water.

If you take more Vanatex HCT 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.

If you forget to take Vanatex HCT 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 Vanatex HCT Stopping your treatment with Vanatex HCT may cause your high blood pressure to get worse. Do not stop taking your medicine unless your doctor tells you to.

If you have any further ques tions on the use of this medicine, ask your doctor or pharmacist.

–  –  –

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 should see your doctor immediately if you experience symptoms of angioedema, such as:

 swollen face, tongue or pharynx  difficulty in swallowing  hives and difficulties in breathing  severe skin disease that causes rash, red skin, blistering of the lips, eyes or mouth, skin peeling, fever (toxic epidermal necrolysis)  decrease in vision or pain in your eyes due to high pressure (possible signs of acute angleclosure glaucoma)  fever, sore throat, more frequent infections (agranulocytosis).

These side effects are very rare or of frequency not known.

If you get any of these symptoms, stop taking Vanatex HCT and contact your doctor straight away (see also section 2 “Warnings and precautions”).

Other side effects include:

Uncommon: may affect up to 1 in 100 people  cough  low blood pressure  light-headedness  dehydration (with symptoms of thirst, dry mouth and tongue, infrequent urination, dark colored urine, dry skin)  muscle pain  tiredness  tingling or numbness  blurred vision  noises (e.g. hissing, buzzing) in ears.

Very rare: may affect up to 1 in 10,000 people  dizziness  diarrhoea  joint pain.



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