PACKAGE LEAFLET: INFORMATION FOR THE USER

MAPEMID XL 1.5 mg tablets    ratiopharm

Indapamide

In this leaflet:

1.    What Mapemid XL 1.5 mg tablets are and what they are used for

2.    Before you take Mapemid XL 1.5 mg tablets

3.    How to take Mapemid XL 1.5 mg tablets

4.    Possible side effects

5.    How to store Mapemid XL 1.5 mg tablets

6.    Further information

1. What Mapemid XL 1.5 mg tablets are and what they are used for

The active substance in these tablets is called Indapamide. It belongs to a group of medicines called diuretics. Diuretics increase the amount of urine produced by the kidneys and are sometimes called water tablets.

This medicine is used to treat high blood pressure without well-known cause (essential hypertension).

2. Before you take Mapemid XL 1.5 mg tablets

Do not take Mapemid XL 1.5 mg tablets

•    if you are allergic (hypersensitive) to Indapamide, to sulphonamides (antibiotic compounds) or any of the other ingredients in the tablet

•    if you have severe kidney or liver problems

•    if you have been told you have a low level of potassium in your blood

Take special care with Mapemid XL 1.5 mg tablets

Before starting to take this medicine, inform your doctor of the following:

•    if you have any kidney or liver problems

•    if you suffer from diabetes or gout

•    if you suffer from heart disease

•    if you have been told you have a low level of sodium in your blood

•    if you need to have a test to check how well your parathyroid gland is working

This medicine affects the levels of potassium and sodium in the blood. Your doctor may conduct blood tests to monitor levels of potassium and sodium in your blood before and during your treatment. This is especially important in patients, who are at high risk to develop electrolyte disturbances (such as elderly, patients who are taking many medicines or malnourished patients).

This medicine may increase the sensitivity of your skin to sunlight. If this happens you should tell your doctor as he/she may decide to stop your treatment. When treated with this medicine, it is recommended to protect exposed areas of skin from the sun or to artificial UVA.

Athletes should be aware that this medicine contains an active ingredient which may give a positive reaction in drug tests.

If you think any of these situations may apply to you, or you have any questions or doubts about taking your medicine, you should consult your doctor or pharmacist.

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 (e.g. from the supermarket).

Especially:

Combinations that are not recommended:

•    Medicine used to treat mania and depression (Lithium)

•    Some diuretics (water tablets) that cause a decrease in blood potassium concentration such as bumetanide, furosemide, piretanide, thiazides and xipamide

Combinations requiring precautions for use:

•    Certain medicines for treatment of irregular heartbeat (quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide)

•    Certain medicines to treat psychiatric conditions (chlorpromazine, cyamemazine, levomepromazine, thioridazine, trifluoperazine, droperidol, haloperidol, amisulpride, sulpiride, sultopride, tiapride)

•    Certain medicines to treat depression (tricyclic antidepressants)

•    Some antibiotics (intravenous erythromycin, sparfloxacin, moxifloxacin)

•    Medicnes used to treat chest pain (angina) (Bepridil)

•    Medicines used to treat heart burn and esophagitis (cisapride)

•    Medicine used to treat very slow heart rate in infants (diphemanil)

•    Antimalaria medicine (halofantrine)

•    Certain antihistamines (mizolastine)

•    Medicines used to treat pneumonia (pentamidine)

•    Intravenous vincamine (medicine used to treat brain disorders such as dementia and stroke)

•    Medicines for relieving inflammation and/or pain

•    Other medicines for treating high blood pressure and/or heart failure (ACE-inhibitors, digitalis preparations, potassium-sparing diuretics ["water pills"])

•    Intravenous steroids

•    Medicines that help relax the bowels (Laxatives)

•    Medicine to treat fungal infections (Intravenous amphotericine B)

•    Hormones for diagnosis or therapy (Tetracosactide)

•    Medicine for relaxing the muscles (Baclofen)

•    Medicine for treatment of diabetes (Metformin)

•    Certain medicines for diagnosis (iodinated contrast media)

•    Calcium supplements

•    Medicines for lowering the body's immune response (ciclosporine, tacrolimus)

Taking Mapemid XL 1.5 mg tablets with food and drink

Food and drink have no impact on the way that your medicine works. You may take it with or after food or on an empty stomach.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

It is not recommended to take this medicine during pregnancy or while breast-feeding. Small amounts of this medicine may pass to the baby in breast milk.

Driving and using machines

You may feel dizzy or drowsy when you take this medicine. This could happen especially at the beginning of the treatment or if you take another blood pressure-lowering medicine at the same time. If this occurs, you should not drive or use machines.

Important information about some of the ingredients of Mapemid XL 1.5 mg tablets

This medicine contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Mapemid XL 1.5 mg tablets

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

The usual dose is 1 tablet daily, preferably in the morning, with or without food.

Patients with impaired Kidney function

Patients with severe Kidney failure (creatinin-clearance below 30 ml/min) must not be treated with this medicine (see section 2. "Do not take Mapemid XL 1.5 mg tablets"). This medicine is fully effective only when Kidney function is normal or only minimally impaired.

Patients with impaired liver function

Patients with severe liver impairment must not be treated with this medicine (see section 2. "Do not take Mapemid XL 1.5 mg tablets").

Elderly

Elderly patients can be treated with this medicine when kidney function is normal or only minimally impaired.

Children and adolescents

This medicine is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.

Method of administration:

For oral use

Swallow the tablets with a glass of water.

Do not crush or chew the tablets, the tablets are designed to release the medicine slowly into the body.

If you take more Mapemid XL 1.5 mg tablets than you should

Tell your doctor or a hospital immediately if you have taken more tablets than your doctor has prescribed. Overdose symptoms may include nausea, drowsiness, dizziness, vomiting, low blood pressure, headache, confusion, rapid pulse, cramps, excessive production of urine or low production of urine.

If you forget to take Mapemid XL 1.5 mg tablets

Take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Mapemid XL 1.5 mg tablets

Do not stop using this medicine until your doctor tells you.

Treatment for high blood pressure is normally life-long. You should not stop taking your medicine without discussing it with your doctor first.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, these tablets can cause side

effects, although not everybody gets them.

Very common (affects more than 1 in 10 patients)

•    decrease in blood potassium level which may cause muscle weakness (mainly at the beginning of the treatment, in the elderly, in undernourished people)

Common (affects 1 in 10 patients)

•    allergic reaction (especially in people who tend to have allergic or asthmatic reactions) leading to skin rashes with macules (flat discoloured area) and papules (small raised lumps)

Uncommon (affects 1 in 100 patients)

•    vomiting

•    allergic reaction (especially in people who tend to have allergic or asthmatic reactions) leading to purple spots or patches on the skin

Rare (affects 1 in 1000 patients)

•    dizziness, fatigue, headache, numbness or tingling in the legs or arms (paresthesia)

•    nausea (feeling sick), constipation, dry mouth

Very rare (affects 1 in 10,000 patients)

•    increase in calcium blood level

•    decrease in certain blood cells (blood platelets, white and/or red blood cells) which causes

•    easy bruising and nasal bleeding (thrombocytopenia)

•    unexplained fever, soreness of the throat or other flu-like symptoms (leucopenia)

•    weakness, paleness, a fast heartbeat and breathlessness (anaemia)

•    irregular heart rhythm, low blood pressure

•    inflammation of the pancreas

•    kidney problems

•    abnormal liver function

•    urticaria, facial and neck swelling and severe skin conditions like blistering of the skin, mouth, eyes and genital organs called toxic epidermic necrolysis or Stevens-Johnson syndrome may appear in the hypersensitive setting

Not known

•    Your doctor may need to give you blood tests to monitor your condition. The following changes in laboratory parameters may occur:

•    low chloride in the blood

•    low sodium in the blood that may lead to dehydration and low blood pressure

•    increase in uric acid, a substance which may cause or worsen gout (painful swelling and redness in the joints, most commonly in the big toe)

•    increase in blood glucose levels in diabetic patients

•    in case of reduced liver function, there is a possibility of brain disorders caused by the reduced liver function (hepatic encephalopathy) (see also 2. "Take special care with MAPEMID XL 1,5 mg prolonged release tablets")

•    worsening of a certain pre-existing autoimmune skin-disease (acute disseminated lupus erythematodus)

•    skin-sensitivity to UV light (photosensitivity reactions)

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 Mapemid XL 1.5 mg tablets

Keep out of the reach and sight of children.

Do not use Mapemid XL 1.5 mg tablets after the expiry date {EXP} which is stated on the carton or blister. The expiry date refers to the last day of that month.

Do not store above 30 °C.

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 Mapemid XL 1.5 mg tablets contains

The active substance is Indapamide.

Each prolonged-release tablet contains 1.5 mg Indapamide.

The other ingredients are:

•    lactose monohydrate

•    hypromellose

•    silica, colloidal anhydrous

•    magnesium stearate

•    glycerol 85%

•    titanium dioxide (E 171)

What Mapemid XL 1.5 mg tablets look like and contents of the pack

White to almost white, round, biconvex film-coated tablets.

They are available in blister packs containing 10, 14, 15, 20, 28, 30, 50, 60, 90, 100 prolonged-release tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

ratiopharm GmbH, Graf-Arco-StraBe 3, D-89079 Ulm, Germany.

Manufacturer:

Merckle GmbH, Ludwig-Merckle- StraBe 3, D-89143 Blaubeuren, Germany.

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

DK    Indapamid ratiopharm

AT    Indapamid-ratiopharm 1,5 mg

Retardtabletten

DE    Indapamid-ratiopharm 1,5mg

Retardtabletten

ES Indapamida retard ratiopharm 1,5 mg comprimidos de liberacion prolongada FR INDAPAMIDE ISOMED LP 1,5 mg, comprime pellicule a liberation prolongee

LU    Indapamid-ratiopharm 1,5mg

Retardtabletten

PL    Indapamid-ratiopharm SR

SK    Indapamid ratiopharm 1,5 mg

UK    Mapemid XL 1.5 mg tablets

For a large print, audio, Braille or CD-rom version of this patient information leaflet, phone 02392 313592.

This leaflet was last approved in September 2009.

ratiopharm