Document: document 0 change

• document 0
• document 1

---

PACKAGE LEAFLET: INFORMATION FOR THE USER

Rawel XL prolonged-release tablets 1.5 mg

Indapamide

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

In this leaflet:

1.    What Rawel XL is and what it is used for

2.    Before you take Rawel XL

3.    How to take Rawel XL

4.    Possible side effects

5.    How to store Rawel XL

6.    Further information

Rawel XL is a drug that reduces blood pressure by promoting the excretion of urine and by dilating blood vessels. Rawel XL is used to treat increased blood pressure.

Do not take Rawel XL

•    If you are allergic (hypersensitive) to indapamide or any of the other ingredients of Rawel XL or to other drugs of the same type (called sulphonamides).

•    If you have severe impairment of kidney function.

•    If you have severe impairment of liver function.

•    If you have a low level of potassium in your blood.

Take special care with Rawel XL

•    If you have impairment of liver function.

•    If you have disorders of blood electrolyte levels or body water depletion.

•    If you have diabetes.

•    If you have gout.

•    If you have impairment of kidney function.

•    If you have a skin reaction when exposed to sunlight.

•    If you are an athlete. Rawel XL can interfere with results of doping tests.

•    You should monitor your blood pressure and heart rate regularly during treatment.

•    If you are an elderly person, your doctor will check your kidney function before the start of therapy.

•    If you are a child or an adolescent, this medicine is not recommended for you.

Your doctor will give you a detailed explanation and instructions.

Taking other medicines

Concomitant use of Rawel XL and some other drugs may increase the effect of one or the other drug and cause side effects.

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. In particular, tell your doctor if you are taking any of the following:

•    Drugs containing lithium.

•    Drugs for treating heart rhythm disorders (e.g. quinidine, amiodarone).

•    Drugs for treating cardiovascular diseases (e.g. ACE inhibitors).

•    Drugs for treating infections (e.g. erythromycin).

•    Baclofen, a drug for treating muscular spasms.

•    Metformin, a drug for treating diabetes mellitus.

•    Drugs for treating mental disorders (e.g. some antipsychotics, some antidepressants).

•    Drugs for treating rheumatic diseases (non-steroid anti-inflammatory drugs, acetyl- salicylic acid).

•    Drugs that may decrease potassium levels in the body (corticosteroids, tetracosactide, certain laxatives).

Taking Rawel XL with food and drink    ^{DpMockUp042490}_l

Food and drink have no influence on the effect of Rawel XL.

Pregnancy and breast-feeding

Ask your doctor for advice before taking any medicine.

You are recommended against taking Rawel XL during pregnancy and breast-feeding.

Driving and using machines

Rawel XL does not affect vigilance; however different reactions in relation with the decrease in blood pressure may occur.

This is more likely at the start of the treatment or when another drug for lowering blood pressure is added. In such cases the ability to drive and use machines may be impaired.

Important information about some of the ingredients of Rawel XL

Rawel XL 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 RAWEL XL

Always take Rawel XL exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The dose of Rawel XL is one tablet a day. Take the drug every day at the same time, preferably in the morning; swallow it whole with some liquid. It is important that you take the drug regularly, as it may help you to keep feeling well.

If you have the impression that the effect of the drug is too strong or too weak, consult your physician or pharmacist.

If you take more Rawel XL than you should

If you have taken a higher dose of the drug than you should, consult your doctor or pharmacist immediately.

Signs of overdosing include: nausea, vomiting, dizziness, confusion, convulsions, drowsiness, increased or decreased urine excretion.

Your doctor will determine appropriate treatment (gastric lavage, administration of activated charcoal, restoration of lost liquid and electrolytes, correction of acid-base balance). If you cannot visit the doctor, try to induce vomiting to prevent the drug from passing into the blood.

If you forget to take Rawel XL

If you forget to take Rawel XL at the right time, follow your usual dosing schedule by taking your next dose at the scheduled time. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Rawel XL

If you stop taking the drug for a short period of time, there is no immediate danger. However, after a longer period of time, different forms of cardiovascular disease may develop or recur due to untreated high blood pressure.

If you want to stop taking this drug, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Rawel XL can cause side effects, although not everybody gets them.

Vomiting appears uncommonly.

The following undesirable effects are rare:

Tiredness, dizziness, headache, tingling, dizziness when getting up, feelings of sickness, constipation and dry mouth.

If you have a predisposition to hypersensitivity reactions (allergies, asthma), skin rash may commonly occur. Less commonly, purpura, a small hemorrhage in the skin (a bruise) appears. Very rarely, urticaria, facial and neck swelling and severe skin conditions called toxic epidermic necrolysis and Stevens-Johnson syndrome may appear in the hypersensitivity setting.

In some cases, alterations of the blood composition and changes in the blood electrolytes levels (potassium, sodium, calcium) may occur. Anaemia, a feeling of irregular heart beat, decreased blood pressure, abnormal liver function and pancreatitis occur very rarely.

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

5. HOW TO STORE RAWEL XL

Keep out of the reach and sight of children.

This medicinal product does not require any special storage conditions.

Expiry date

Do not use after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.

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 Rawel XL contains

•    The active substance is indapamide. Each prolonged-release tablet contains 1.5 mg indapamide.

•    The other ingredients are hypromellose, powdered cellulose, lactose monohydrate, colloidal anhydrous silica, magnesium stearate, macrogol 400, titanium dioxide (E171).

What Rawel XL looks like and contents of the pack

Prolonged-release tablets are white, round, slightly biconvex. The tablets are available in boxes of 10, 14, 15, 20, 30, 50, 60, 90 and 100 tablets in blister packs. Not all pack sizes will be marketed.

Marketing Authorisation Holder & Manufacturer :

KRKA, d.d., Novo mesto, Smarjeska cesta 6, 8501 Novo mesto, Slovenia.

Distributed by : Consilient Health (UK) Ltd, No.1 Church Road, Richmond upon Thames, Surrey. TW9 2QE.

Prescribing information : On physician's prescription only.

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

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

United Kingdom Rawel XL prolonged-release tablets 1.5 mg Portugal    Indapamida TAD 1,5 mg

This leaflet was last revised in July 2014