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Valsartan/Hydrochlorothiazide 160mg/12.5mg Film-Coated Tablets

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Valsartan/Hydrochlorothiazide 80mg/12.5mg Film-coated Tablets Valsartan/Hydrochlorothiazide 160mg/12.5mg Film-coated Tablets Valsartan/Hydrochlorothiazide 160mg/25mg Film-coated Tablets

Valsartan/Hydrochlorothiazide

Read all of this leaflet carefully before you start taking this medicine.

•    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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Valsartan/Hydrochlorothiazide Tablets are and what they are used for

2.    Before you take Valsartan/Hydrochlorothiazide Tablets

3.    How to take Valsartan/Hydrochlorothiazide Tablets

4.    Possible side effects

5.    How to store Valsartan/Hydrochlorothiazide Tablets

6.    Further information


•    if you have severe liver disease.

•    if you have severe kidney disease.

•    if you are unable to urinate.

•    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.


1. WHAT VALSARTAN/HYDROCHLOROTHIAZIDE TABLETS ARE AND WHAT THEY ARE USED FOR_

Your tablets contain two active substances called valsartan and hydrochlorothiazide. Both of these substances help to control high blood pressure (hypertension).

Valsartan belongs to a group 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, 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.

Valsartan/Hydrochlorothiazide Tablets are 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. BEFORE YOU TAKE VALSARTAN/HYDROCHLOROTHIAZIDE TABLETS Do not take Valsartan/Hydrochlorothiazide Tablets:

•    if you are allergic (hypersensitive) to valsartan, hydrochlorothiazide, sulphonamide derivatives (substances chemically related to hydrochlorothiazide) or to any of the other ingredients of these tablets.

•    if you are more than 3 months pregnant (it is also better to avoid Valsartan/Hydrochlorothiazide Tablets in early pregnancy - see pregnancy section).

If any of the above apply to you, do not take this medicine and speak to your doctor.

Take special care with Valsartan/Hydrochlorothiazide Tablets:

Tell your doctor before you take Valsartan/Hydrochlorothiazide Tablets 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.

•    have low levels of potassium in your blood.

•    have diarrhoea or severe vomiting.

•    are taking high doses of water tablets (diuretics).

•    have severe heart disease.

•    suffer from a narrowing of the kidney artery.

•    have recently had a kidney transplant.

•    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 Tablets is not recommended.

•    have liver or kidney disease.

•    have a fever, rash and joint pain, which may be signs of systemic lupus erythematosus (SLE, a so-called autoimmune disease).

•    have diabetes, gout, high levels of cholesterol or fats in your blood.

•    have had allergic reactions with the use of other blood pressure-lowering agents of this class (angiotensin II receptor antagonists) or if you have any allergies or asthma.

This medicine may increase the sensitivity of your skin to sunlight. Speak to your doctor before sunbathing or using UV tanning lamps.

Valsartan/Hydrochlorothiazide Tablets are not recommended in children and adolescents (below the age of 18 years).

You must tell your doctor if you think you are (or might become) pregnant. Valsartan/Hydrochlorothiazide Tablets are 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).

Taking other medicines

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 Valsartan/Hydrochlorothiazide tablets

are 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 illness)

•    medicines that affect or can be affected by potassium blood levels, such as digoxin,

(a medicine to control the heart rhythm) and some antipsychotic medicines

•    medicines that may increase the amount of potassium in your blood, such as potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines, or heparin

•    medicines that may reduce the amount of potassium in your blood, such as corticosteroids and some laxatives

•    diuretics (water tablets), medicines for the treatment of gout, such as allopurinol, therapeutic vitamin D and calcium supplements, medicines for the treatment of diabetes (oral medicines or insulins)

•    other medicines to lower your blood pressure, such as beta blockers or methyldopa, or medicines that tighten your blood vessels or stimulate your heart, such as noradrenaline or adrenaline

•    medicines to increase blood sugar levels, such as diazoxide

•    medicines to treat cancer, such as methotrexate or cyclophosphamide

•    pain killers

•    arthritis medicines

•    muscle relaxing medicines, such as tubocurarine

•    anti-cholinergic medicines, such as atropine or biperiden

•    amantadine (a medicine used to prevent influenza)

•    cholestyramine and colestipol (medicines used to treat high levels of fats in the blood)

•    ciclosporin (a medicine used for organ transplant to avoid organ rejection)

•    some antibiotics (tetracyclines), anaesthetics and sedatives

•    carbamazepine (a medicine used to treat seizure conditions).

Taking Valsartan/Hydrochlorothiazide Tablets with food and drink

You can take Valsartan/Hydrochlorothiazide Tablets with or without food.

Avoid taking alcohol until you have talked to your doctor. Alcohol may make your blood

pressure fall too much and/or increase the risk of you becoming dizzy or feeling faint.

Pregnancy and breast-feeding

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 these tablets 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 Tablets. Valsartan/Hydrochlorothiazide Tablets are not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as they may cause serious harm to your baby if they are used after the third month of pregnancy.

Tell your doctor if you are breast-feeding or about to start breast-feeding

Valsartan/Hydrochlorothiazide Tablets are 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, 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 Tablets may in rare cases cause dizziness and affect the ability to concentrate.

3. HOWTO TAKE VALSARTAN/HYDROCHLOROTHIAZIDE TABLETS

Always take Valsartan/Hydrochlorothiazide Tablets 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. There are other strengths available.

People with high blood pressure often do not notice any signs of their condition.

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 to take. Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose.

•    The usual dose 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 your tablets with or without food.

•    Swallow the tablet with a glass of water.



If you take more Valsartan/Hydrochlorothiazide Tablets than you should

If you experience severe dizziness and/or fainting, lay 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 Tablets

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/Hydrochlorothiazide Tablets

Stopping your treatment with Valsartan/Hydrochlorothiazide Tablets may cause your disease 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 product, ask your doctor or pharmacist.


4. POSSIBLE SIDE EFFECTS

Like all medicines, Valsartan/Hydrochlorothiazide Tablets 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: uncommon: rare:


very rare: not known:


affects 1 to 10 users in 100

affects 1 to 10 users in 1,000

affects 1 to 10 users in 10,000

affects less than 1 user in 10,000

Frequency cannot be estimated from the available data


Hydrochlorothiazide

Common:

•    itchy rash and other types of rash

•    reduced appetite

•    mild nausea and vomiting

Rare:

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

•    constipation, discomfort of the stomach or bowels, liver disorders (yellow skin or eyes)

•    irregular heart beat

Very rare:

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

•    itching or red skin

•    blistering of the lips, eyes or mouth

•    skin peeling

•    fever

•    facial rash associated with joint pain


•    faintness, fainting on standing up

•    impotence.


•    headache •sleep disturbances •sad mood (depression)

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

•    muscle disorder

•fever (cutaneous lupus erythematosus) •severe upper stomach pain; lack or low levels of different blood cells

•    severe allergic reactions

•    difficulty breathing

•    lung infection; breathlessness.


If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.


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    •hives and difficulties in breathing.

•    difficulty in swallowing

Other side effects which may occur:


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

•    blurred vision

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


5. HOWTO STORE VALSARTAN/HYDROCHLOROTHIAZIDE TABLETS

Keep out of the reach and sight of children.

Do not use Valsartan/Hydrochlorothiazide Tablets after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.

Store below 25°C. Store in the original package in order to protect from moisture.

Do not use any Valsartan/Hydrochlorothiazide Tablets if the pack is damaged or shows signs of tampering.

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


6. FURTHER INFORMATION What Valsartan/Hydrochlorothiazide Tablets contain


Very rare:

• dizziness    •diarrhoea    •joint pain.


Not known

•    breathing difficulty

•    severely decreased urine output

•    low level of sodium in the blood (sometimes with nausea, tiredness, confusion, malaise, convulsions)

•    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).


The active substances are valsartan and hydrochlorothiazide.

Each film-coated tablet contains 80mg/12.5mg or 160mg/12.5mg or 160mg/25mg of valsartan/hydrochlorothiazide.

The other ingredients in the tablet core are Microcrystalline cellulose, Croscarmellose sodium, Sodium lauril sulphate, Hydroxypropycellulose, Silica, colloidal anhydrous, Low substituted hydroxypropylcellulose, Magnesium stearate


The other ingredients in the tablet film-coat for different strengths are: Valsartan/hydrochlorothiazide 80mg/12.5mg Tablets

Colourant Opadry II 85F64732 Pink which contains Polyvinyl alcohol, Titanium dioxide (E171), Macrogol 3350, Talc (E553b), Yellow Iron oxide (E172), Allura Red (E129), Black Iron oxide (E172).


Valsartan/hydrochlorothiazide 160mg/12.5mg Tablets

Colourant Opadry II 85F66815 Brown which contains Polyvinyl alcohol, Macrogol 3350, Titanium dioxide (E171), Talc (E553b), Iron Oxide Red (E172), Allura Red (E129), Iron Oxide Yellow (E172), Iron Oxide Black (E172).


The following side effects have been reported with valsartan or hydrochlorothiazide when taken alone, but have not been observed with Valsartan/Hydrochlorothiazide Tablets:

Valsartan

Uncommon:

• spinning sensation    • abdominal pain.


Valsartan/hydrochlorothiazide 160mg/25mg Tablets

Colourant Opadry II 85F66775 Brown which contains Polyvinyl alcohol, Titanium dioxide (E171), Macrogol 3350, Talc (E553b), Iron Oxide Black (E172), Iron Oxide Red (E172), Iron Oxide Yellow (E172).


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, purplish-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 anaemia).

•    kidney failure.


What Valsartan/Hydrochlorothiazide Tablets look like and contents of the pack

Valsartan/Hydrochlorothiazide 80 mg/12.5 mg Film-coated Tablets

Light orange oval coated tablets with "VH 1" on one side and ">" logo on the other side

Valsartan/Hydrochlorothiazide 160 mg/12.5 mg Film-coated Tablets

Dark red oval coated tablets with "VH 2" on one side and ">" logo on the other side

Valsartan/Hydrochlorothiazide 160 mg/25 mg Film-coated Tablets

Brown oval coated tablets with "VH 3" on one side and ">" logo on the other side

The tablets are packed in aluminium foil blisters.

Pack sizes: 14, 28, 30, 56, 90, 98.


Not all pack sizes may be marketed Marketing Authorisation Holder

Arrow Generics Limited, Unit 2, Eastman Way, Stevenage SG1 4SZ, U.K. Manufacturer

Arrow Pharm (Malta) Limited, 62 Hal Far Industrial Estate, Birzebbugia, BBG3000, Malta.

For any information about this medicine, please contact the Marketing Authorisation Holder.


This leaflet was last approved in 05/2011.