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RAWEL XL PROLONGED-RELEASE TABLETS 1.5 MG

Active substance(s): INDAPAMIDE

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Package leaflet: Information for the patient

Rawel XL 1.5 mg
prolonged-release tablets
Indapamide

Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
• 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 if their 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. See section 4.
What is in this leaflet
1. What Rawel XL is and what it is used for
2. What you need to know before you take Rawel XL
3. How to take Rawel XL
4. Possible side effects
5. How to store Rawel XL
6. Contents of the pack and other information
1. What Rawel XL is and what it is used for
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.
2. What you need to know before you take Rawel XL
Do not take Rawel XL:
• if you are allergic to indapamide or any of the other ingredients of this medicine or to other drugs of the same type (called
sulphonamides) (listed in section 6).
• if you have severe impairment of kidney function.
• if you have severe impairment of liver or suffer from a condition called hepatic encephalopathy (degenerative disease of
the brain).
• if you have low level of potassium in your blood.
Warnings and precautions
Talk to your doctor or pharmacist before taking Rawel XL.
• If you have impairment of liver function.
• if you have diabetes.
• if you have gout.
• if you have impairment of kidney function.
• if you have any heart rhythm problems.
• if you need to have a test to check how well your parathyroid gland is working.
You should tell your doctor if you had photosensitivity reactions.
Your doctor may give you blood tests to check for low sodium or potassium levels or high calcium levels.
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.
Athletes should be aware that this medicine contains an active ingredient, which may give a positive reaction in doping tests.
Other medicines and Rawel XL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
You should not take Rawel XL with lithium (used to treat depression) due to the risk of increased levels of lithium in the blood.
Make sure to tell your doctor if you are taking any of the following medicines, as special care may be required:
• medicines used for heart rhythm problems (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide,
dofetilide, digitalis),
• medicines used to treat mental disorders such as depression, anxiety, schizophrenia… (e.g. tricyclic antidepressants,
antipsychotic drugs, neuroleptics),
• bepridil (used to treat angina pectoris, a condition causing chest pain),
• cisapride, diphemanil (used to treat gastro-intestinal problems),
• sparfloxacin, moxifloxacin, erythromycin by injection (antibiotics used to treat infections),
• vincamine by injection (used to treat symptomatic cognitive disorders in elderly including memory loss),
• halofantrine (antiparasitic drug used to treat certain types of malaria),
• pentamidine (used to treat certain types of pneumonia),
• mizolastine (used to treat allergic reactions, such as hay fever),
• non-steroidal anti-inflammatory drugs for pain relief (e.g. ibuprofen) or high doses of acetylsalicylic acid,
• angiotensin converting enzyme (ACE) inhibitors (used to treat high blood pressure and heart failure),
• amphotericin B by injection (anti-fungal medicines),
• oral corticosteroids used to treat various conditions including severe asthma and rheumatoid arthritis,
• stimulant laxatives,
• baclofen (to treat muscle stiffness occurring in diseases such as multiple sclerosis),
• potassium-sparing diuretics (amiloride, spironolactone, triamterene),
• metformin (to treat diabetes),
• iodinated contrast media (used for tests involving X-rays),
• calcium tablets or other calcium supplements,
• ciclosporin, tacrolimus or other medicines to depress the immune system after organ transplantation, to treat autoimmune
diseases, or severe rheumatic or dermatological diseases,
• tetracosactide (to treat Crohn’s disease).
Rawel XL with food and drink
Food and drink have no influence on the effect of Rawel XL.
Pregnancy and breast-feeding
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.
This medicine is not recommended during pregnancy. When a pregnancy is planned or confirmed, the switch to an alternative
treatment should be initiated as soon as possible.
Please tell your doctor if you are pregnant or wish to become pregnant.
The active ingredient is excreted in milk. Breastfeeding is not advisable if you are taking this medicine.
Driving and using machines
This medicine can cause side effects due to low blood pressure such as dizziness or tiredness (see section 4). These side effects
are more likely to occur at beginning of therapy or increasing the dose. If this occurs you should refrain from driving or other
activities requiring alertness. However, under good control, these side effects are unlikely to occur.
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 this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are
not sure.
The recommended 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. The tablets can be taken irrespective of meals. Do not crush or chew them. Treatment for
high blood pressure is usually life-long.

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.
A very large dose of Rawel XL could cause nausea, vomiting, low blood pressure, cramps, dizziness, drowsiness, confusion and
changes in the amount of urine produced by the kidneys.
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
As the treatment for high blood pressure is usually life-long, you should discuss with your doctor before stopping this
medicinal product.
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, although not everybody gets them.
Stop taking the medicinal product and see a doctor immediately, if you experience any of the following side
effects:
• angioedema and/or utricaria. Angioedema is characterised by swelling of the skin extremities or face, swelling of the skin
of extremities or face, swelling of the lips or tongue, swelling of the mucous membranes of the throat or airways resulting
in shortness of the breath or difficulty of swallowing. It this occurs, contact your doctor immediately. (Very rare) (may
affect up to 1 in 10,000 people)
• severe skin reactions including intense skin rash, reddening of the skin over your whole body, severe itching, blistering,
peeling and swelling of the skin, inflammation of mucous membranes (Steven Johnson syndrome) or other allergic
reactions. (Very rare) (may affect up to 1 in 10,000 people)
• life-threatening irregular beat. (Not known)
• inflamed pancreas which may cause severe abdominal and back pain accompanied with feeling very unwell. (Very rare)
(may affect up to 1 in 10,000 people)
• disease of the brain caused by liver illness (hepatic encephalopathy). (Not known)
• inflammation of the liver (Hepatitis). (Not known)
The frequency of side effects listed below is defined according to the following categories:
Common (may affect up to 1 in 10 people):
• red raised skin rash;
• allergic reactions, mainly dermatological, in subjects with a predisposition to allergic and asthmatic reactions.
Uncommon (may affect up to 1 in 100 people):
• vomiting;
• red pinpoints on skin.
Rare (may affect up to 1 in 1,000 people):
• feeling of tiredness, headache, pins and needles (paraesthesia), vertigo;
• gastro-intestinal disorders (such as nausea, constipation), dry mouth.
Very rare (may affect up to 1 in 10,000 people):
• changes in blood cells, such as thrombocytopenia (decrease in the number of platelets which causes easy bruising and
nasal bleeding), leucopenia (decrease of white blood cells which may cause unexplained fever, soreness of the throat or
other flu-like symptoms – if this occurs, contact your doctor) and anaemia (decrease in red blood cells);
• high level of calcium in blood;
• heart rhythm irregularities (causing palpitations, feeling of the heart pounding), low blood pressure;
• kidney disease (causing symptoms of tiredness, increased need to urinate, itchy skin, feeling sick, swollen extremities);
• abnormal hepatic function.
Not known (frequency cannot be estimated from the available data):
• fainting;
• if you suffer from systemic lupus erythematosus (a disorder of the immune system leading to inflammation and damage
to the joints, tendons and organs with symptoms including skin rashes, tiredness, loss of appetite, weight gain and joint
pain), this might get worse;
• cases of photosensitivity reactions (change in skin appearance) after exposure to the sun or artificial UVA have also been
reported;
• short sightedness (myopia);
• blurred vision;
• visual impairment;
• changes may occur in your blood and your doctor may need to give you blood tests to check your condition. The following
changes in laboratory parameters may occur:
• low potassium 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 joint(s) especially in the feet),
• increase in blood glucose levels in diabetic patients,
• increased levels of liver enzymes;
• abnormal ECG heart tracing.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Rawel XL
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 packaging after EXP. The expiry date refers to the last day
of that month.
This medicine does not require any special storage conditions.
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 Rawel XL contains
• The active substance is indapamide.
Each prolonged-release tablet contains 1.5 mg indapamide.
• The other ingredients (excipients) are:
Tablet core: hypromellose, powdered cellulose, lactose monohydrate, anhydrous colloidal silica and magnesium stearate.
Film coating: hypromellose, macrogol 400 and titanium dioxide (E171).
What Rawel XL looks like and contents of the pack
Prolonged-release tablets are white, round, slightly biconvex film-coated tablets.
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 may be marketed.
Marketing Authorisation Holder & Manufacturer :
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia.
Distributed by : Consilient Health (UK) Ltd, No.1 Church Road, Richmond upon Thames, Surrey. TW9 2QE.
This leaflet was last revised in 03/2016

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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