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Document: leaflet MAH GENERIC_PL 34771-0025 change

• leaflet MAH GENERIC_PL 00289-1234
• leaflet MAH GENERIC_PL 34771-0025
• leaflet MAH GENERIC_PL 40378-0085

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Take special care with Valsartan/Hydrochlorothiazide

•    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 checkthe amount ofpotassium in yourblood regularly.

•    ifyouhave low levels ofpotassium in your blood.

•    ifyou have diarrhoea or severe vomiting.

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

•    ifyou have severe heart disease.

•    if you suffer from a narrowing of the kidney artery.

•    if you have recently received a new kidney.

•    ifyou 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.

•    ifyouhave liver orkidney disease.

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

•    ifyou have diabetes, gout, high levels of cholesterol or fats 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 ifyou have allergy or asthma.

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

•    the use of Valsartan/ Hydrochlorothiazide 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. Valsartan/ Hydrochlorothiazide 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 (seepregnancy section).

Taking other medicines

Please tell your doctor or pharmacist ifyou 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 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 followingmedicines:

•    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, 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, heparin

•    medicines that may reduce the amount of potassium in your blood, such as corticosteroids, 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 agents or insulins).

•    other medicines to lower your blood pressure, such as beta-blockers ormethyldopa, or medicines thattightenyour 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

•    painkillers

•    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 with food and drink

You can take Valsartan/Hydrochlorothiazide 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 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 Valsartan/Hydrochlorothiazide 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. Valsartan/ Hydrochlorothiazide 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 breast-feeding

Valsartan/Hydrochlorothiazide is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you or keep doses as low as possible ifyou wish to breast-feed, especiallyifyourbaby 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 Valsartan/Hydrochlorothiazide affects you. Like many other medicines used to treat high blood pressure, Valsartan/ Hydrochlorothiazide may occasionally cause dizziness and affect the ability to concentrate.

3.    HOW TO TAKE VALSARTAN/ HYDROCHLOROTHIAZIDE

Always take Valsartan/Hydrochlorothiazide exactly as your doctor has told you. This will help you to get the best results and lower the risk of side effects. You should check with your doctor or pharmacist ifyou 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 ifyou 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 usual 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.

If you take more Valsartan/Hydrochlorothiazide than you should

Ifyou experience severe dizziness and/or fainting, lie down and contact your doctor immediately. Ifyou have accidentally taken too many tablets, contact your doctor, pharmacist or hospital.

If you forget to take Valsartan/Hydrochlorothiazide

Ifyou 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 product, ask your doctor or pharmacist.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Valsartan/Hydrochlorothiazide 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 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

Other side effects include:

Uncommon:

•    cough

•    lowbloodpressure

•    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:

•    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)

The following side effects have been reported with products containing valsartan or hydrochlorothiazide alone:

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

Common:

•    itchyrashandothertypesofrash

•    reduced appetite

•    mild nausea and vomiting

•    faintness, fainting on standing up

•    impotence.

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

•    headache

•    sleep disturbances

•    sad mood (depression)

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

Very rare:

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

•    itching or red skin

•    blistering ofthe lips, eyes ormouth

•    skinpeeling

•    fever

•    facial rash associated withjoint pain

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

5. HOW TO STORE VALSARTAN/ HYDROCHLOROTHIAZIDE

•    Keep out ofthe reach and sight of children.

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

•    Keep your tablets in their original pack at a temperature below 25°C and protect from moisture.

•    Do not use any Valsartan/Hydrochlorothiazide pack that 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. FURTHERINFORMATION

What Valsartan/Hydrochlorothiazide contains

The active substances are valsartan and hydrochlorothiazide. Each film-coated tablet contains 160 mg valsartan and 25 mg hydrochlorothiazide.

The other ingredients are

Core: Cellulose, microcrystalline (Avicel PH 101), Crospovidone (Type A), Silica, colloidal anhydrous (Aerosil 200) & Magnesium Stearate.

Coating: Hypromellose 6 cp (E464), Titanium Dioxide (E171), Marogol 8000, Talc, Iron Oxide Red (E172), Iron oxide yellow (E172) and Iron oxide black (E172).

What do Valsartan/Hydrochlorothiazide look like ?

Valsartan/Hydrochlorothiazide 160mg/25 mg film-coated tablets are brown orange, oval shaped, biconvex, film coated tablets debossed with “L 18” on one side and plain on other side (approximately 16.5 x7.7 mm).

What is in a pack ofValsartan/Hydrochlorothiazide ?

Valsartan/Hydrochlorothiazide 160mg/25 mg film-coated tablets are supplied in blister packs containing 28 tablets.

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MarketingAuthorisation Holder

Macleods Pharma UK Limited,

Golden Gate Lodge, Crewe Hall,

Crewe, Cheshire,

CW1 6UL, United Kingdom

Manufacturer

PeckfortonPharmaceuticals Ltd.

UKCrewe Hall, Crewe, Cheshire CW1 6UL, United Kingdom.

PL34771/0025

This medicinal product is authorised in the Member States under the following names:

United Kingdom: Valsartan/Hydrochlorothiazide 160 mg / 25 mg film-coated tablets Germany:    Valsartan/Hydrochlorothiazide Macleods 160 mg / 25mg filmtabletten

Italy:    Valsartan/Hydrochlorothiazide Macleods 160mg/25mg compresse rivestite

con film

Spain:    Valsartan/Hydrochlorothiazide Macleods 160 mg/25 mg comprimidos

recubiertos conpelicula

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This leaflet was last approved in {09/2012}