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PACKAGE LEAFLET: INFORMATION FOR THE USER

Valsartan/Hydrochlorothiazide 160 mg/12.5 mg film-coated tablets

Valsartan/hydrochlorothiazide

Read all of this leaflet carefully before you start taking this medicine because it contains important information foryou.

• 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 iftheir 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.

What is in this leaflet:

1.    What Valsartan/Hydrochlorothiazide is and what it is used for

2.    What you need to know before you take Valsartan/Hydrochlorothiazide

3.    How to take Valsartan/Hydrochlorothiazide

4.    Possible side effects

5.    How to store Valsartan/Hydrochlorothiazide

6.    Contents of the pack and other information

1.    What Valsartan/Hydrochlorothiazide is and what it is used for

Valsartan/Hydrochlorothiazide 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.

This medicine 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 Valsartan/Hydrochlorothiazide Do not take Valsartan/Hydrochlorothiazide:

•    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 this medicine 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 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 any of the above applies to you, do not take this medicine and speak to your doctor. Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine

•    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 Valsartan/Hydrochlorothiazide is not recommended.

•    ifyou 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 Valsartan/Hydrochlorothiazide, stop taking Valsartan/Hydrochlorothiazide 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 Valsartan/Hydrochlorothiazide. 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.

• it may cause increased sensitivity of the skin to sun.

Children and adolescents

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

Other medicines and Valsartan/Hydrochlorothiazide

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/Hydrochlorothiazide 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, potassiumsparing 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 ofValsartan/Hydrochlorothiazide.

•    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 or such as metformin).

•    other medicines to lower your blood pressure, including methyldopa.

•    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).

• ciclosporin, a medicine used for organ transplant to avoid organ rejection.

•    alcohol, sleeping pills and anaesthetics (medicines with sleeping or painkilling effect used for example during surgery).

• iodine contrast media (agents used for imaging examinations).

Valsartan/Hydrochlorothiazide with food and drink

You can take this medicine 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, breast-feeding and fertility

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 ifyou think that you are (or might become) pregnant

Your doctor will normally advise you to stop taking this medicine before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Valsartan/Hydrochlorothiazide. This medicine 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 ofpregnancy.

• Tell your doctor ifyou are breast-feeding or about to start breast-feeding

Valsartan/Hydrochlorothiazide 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 this medicine affects you. Like many other medicines used to treat high blood pressure, Valsartan/Hydrochlorothiazide may occasionally cause dizziness and affect the ability to concentrate.

Valsartan/Hydrochlorothiazide 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/Hydrochlorothiazide

Always take this medicine exactly as your doctor has told you. This will help you to get the best results and lower 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 your doctor even if you are feeling well.

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

• The recommended dose of Valsartan/Hydrochlorothiazide 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 Valsartan/Hydrochlorothiazide with or without food.

• Swallow the tablet with a glass of water.

Ifyou take more Valsartan/Hydrochlorothiazide 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 Valsartan/Hydrochlorothiazide

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.

Ifyou stop taking Valsartan/Hydrochlorothiazide

Stopping your treatment with Valsartan/Hydrochlorothiazide 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 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, althoughnot 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 10users in 10,000

•    very rare: affects less than 1 user in 10,000

•    not known: frequency cannot be estimated from the available data

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

•    difficultyinswallowing

•    hives and difficulties in breathing

If you get any of these symptoms, stop taking Valsasrtan/Hydrochlorothiazide and contact your doctor straight away (see also section 2 “Take special care with Valsasrtan/Hydrochlorothiazide”).

Other side effects of Valsasrtan/Hydrochlorothiazide include:

Uncommon

•    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

•    blurredvision

•    noises (e.g. hissing, buzzing) in ears

Very rare

•    dizziness

•    diarrhoea

•    joint pain

Not known

•    breathing difficulty

•    severely decreased urine output

•    low level of sodium in the blood (which can trigger tiredness, confusion, muscle twitching and/or convulsions in severe cases)

•    low level of potassium in the blood (sometimes with muscle weakness, muscle spasms, abnormal heart rhythm)

•    low level of white cells in the blood (with symptoms such as fever, skin infections, sore throat or mouth ulcers due to infections, weakness)

•    the level of bilirubin increased in blood (which can, in severe cases, trigger yellow skin and eyes)

•    the level of blood urea nitrogen and creatinine increased in blood (which can indicate abnormal kidney function)

•    the level of uric acid in blood increased (which can, in severe cases, trigger gout)

•    syncope (fainting)

Side effects reported with valsartan or hydrochlorothiazide alone, but not observed with Valsartan/Hydrochlorothiazide:

Valsartan

Uncommon

•    spinning sensation

•    abdominal pain

Not known

•    skin rash with or without itching together with some of the following signs or symptoms: fever, joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms

•    rash, purplished-red spots, fever, itching (symptoms of inflammation of blood vessels)

•    low level of blood platelets (sometimes with unusual bleeding or bruising)

•    high level of potassium in the blood (sometimes with muscle spasms, abnormal heart rhythm)

•    allergic reactions (with symptoms such as rash, itching, hives, difficulty breathing or swallowing, dizziness)

• swelling mainly of the face and throat; rash; itching

•    elevation of liver function values

•    the level of haemoglobin decreased and the percentage of red cells decreased in the blood (which both can, in severe cases, trigger an anaemia).

•    kidney failure

•    low level of sodium in the blood (which can trigger tiredness, confusion, muscle twitching and/or convulsions in severe cases)

Hydrochlorothiazide

Very common

• low level of potassium in the blood

• increase of lipids in the blood

Common

•    low level of sodium in the blood

•    low level of magnesium in the blood

•    high level of uric acid in the blood

•    itchy rash and other types of rash

•    reduced appetite

•    mild nausea and vomiting

•    dizziness,faintingonstandingup

•    inability to achieve or maintain erection

Rare

•    swelling and blistering of the skin (due to increased sensitivity to sun)

•    high level of calcium in the blood

•    high level of sugar in the blood

•    sugar in the urine

•    worsening ofdiabetic metabolic state

•    constipation, diarrhoea, discomfort of the stomach or bowels, liver disorders which can

occur together with yellow skin and eyes

•    irregular heart beat

•    headache

•    sleep disturbances

•    sad mood (depression)

•    low level of blood platelets (sometimes with bleeding or bruising underneath the skin)

•    dizziness

•    tingling or numbness

•    vision disorder

Very rare

•    inflammation of blood vessels with symptoms such as rash, purplish-red spots, fever (vasculitis)

•    rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)

•    severe skin disease that causes rash, red skin, blistering of the lips, eyes or mouth, skin peeling, fever (toxic epidermal necrolysis)

• facial rash, joint pain, muscle disorder, fever (lupus erythematosus)

•    severe upper stomach pain (pancreatitis)

•    difficulty breathing with fever, coughing, wheezing, breathlessness (respiratory distress including pneumonitis and pulmonary oedema)

•    fever, sore throat, more frequent infections (agranulocytosis)

•    pale skin, tiredness, breathlessness, dark urine (haemolytic anaemia)

•    fever, sore throat or mouth ulcers due to infections (leucopenia)

• confusion, tiredness, muscle twitching and spasm, rapid breathing (hypochloraemic alkalosis)

Not known

•    weakness, bruising and frequent infections (aplastic anemia)

•    severely decreased urine output (possible signs of renal disorder or renal failure)

•    decrease in vision or pain in your eyes due to high pressure (possible signs of acute angle-closure glaucoma)

•    rash, red skin, blistering of the lips, eyes or mouth, skin peeling, fever (possible signs of erythema multiforme)

•    muscle spasm

•    fever (pyrexia)

•    weakness (asthenia)

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5.    How to store Valsartan/Hydrochlorothiazide

•    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 pack after EXP. The expiry date refers to the last day of that month.

•    Blister (Triplex): Do not store above 30 °C. Store in the original package in order to protect from moisture.

•    Blister (Alu/Alu): This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from moisture.

•    Do not use any Valsartan/Hydrochlorothiazide pack that 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/Hydrochlorothiazide contains

•    The active substances are valsartan and hydrochlorothiazide.

Each tablet contains 160 mg valsartan and 12,5mghydrochlorothiazide

•    The other ingredients are:

tablet core: Microcrystalline cellulose (E460), crospovidone (E1202), silica, magnesium stearate (E470b) and anhydrous lactose.

tablet coating:

Hypromellose (E464), titanium dioxide (E171), macrogol, iron oxide red (E172) and talc.

What Valsartan/Hydrochlorothiazide looks like and contents of the pack

Dark red coloured, oval shaped, biconvex, film-coated tablets debossed with '365' on one side and plain on the other.

The tablets are available in blister packs of 14,20,28,30,56,60,90,98 or 100 tablets.

Not all pack sizes may be marketed.

MarketingAuthorisation Holder and Manufacturer

MarketingAuthorisation 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

This medicinal product is authorized in the Member States of the EEA under the following names:

Portugal Denmark

Germany

The Netherlands Sweden

United Kingdom

This leaflet was last approved in 01/2013.