Rawel sr

Patient Information Leaflet

Rawel SR, 1.5 mg, prolonged-release tablets
indapamidum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Rawel SR is and what it is used for
2. What you need to know before taking Rawel SR
3. How to take Rawel SR
4. Possible side effects
5. How to store Rawel SR
6. Contents of the pack and other information

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

Rawel SR is a prolonged-release tablet containing 1.5 mg of indapamidum as the active substance.
Indapamidum is a diuretic medicine. Most diuretics increase the amount of urine produced by the kidneys. However, indapamidum differs from other diuretics in that it causes only a slight increase in urine production.
This medicine is used in the treatment of high blood pressure (hypertension).

2. Important information before using Rawel SR

When not to use Rawel SR

• if the patient is allergic to indapamide, sulfonamides, or any of the other ingredients of this medicine (listed in section 6), or to other medicines of the same type (called sulfonamides);
• if the patient has severe kidney disease;
• if the patient has severe liver disease or a condition called hepatic encephalopathy (a brain disorder caused by liver disease);
• if the patient has low potassium levels in the blood.

Warnings and precautions
Before starting treatment with Rawel SR, discuss this with your doctor or pharmacist if:

• the patient has liver problems;

• the patient has diabetes;

• the patient has gout;

• the patient has any heart rhythm disorders or kidney problems;

• the patient experiences blurred vision or eye pain. These may be symptoms of fluid accumulation in the uvea (the vascular layer surrounding the eye), excessive fluid buildup between the choroid and sclera, or increased intraocular pressure — which may occur from several hours to weeks after taking Rawel SR. If left untreated, these conditions may lead to permanent vision loss. Patients who previously experienced an allergic reaction to penicillin or sulfonamides may be at higher risk of developing this condition.

• the patient has muscle disorders, including muscle pain, tenderness, weakness, or cramps;

• the patient is scheduled for tests assessing parathyroid function.

Inform your doctor if the patient has previously experienced photosensitivity reactions.
Your doctor may recommend monitoring blood tests to check for decreased potassium or sodium levels, or increased calcium levels.
If any of the above situations apply to the patient, or if you have any questions or doubts about using this medicine, consult your doctor or pharmacist.
Important information for athletes
Athletes should be warned that this medicine contains an active substance that may result in a positive doping test.
Children and adolescents
Due to lack of data on safety and efficacy, this medicine is not recommended for use in children and adolescents.
Rawel SR and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Do not take Rawel SR together with lithium preparations (used to treat depression), as this increases the risk of elevated lithium levels in the blood.
Inform your doctor if the patient is taking any of the following medicines
(special precautions may be required):

• medicines used for heart rhythm disorders (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, cardiac glycosides, bretylium),
• medicines used to treat psychiatric disorders such as depression, anxiety, schizophrenia (e.g. tricyclic antidepressants, antipsychotics, neuroleptics (such as amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol)),
• bepridil (used to treat angina pectoris, a condition causing chest pain),
• cisapride, difemanil (used to treat gastrointestinal disorders),
• antibiotics used to treat bacterial infections (e.g. sparfloxacin, moxifloxacin, intravenous erythromycin),
• intravenous vincamine (used for symptomatic treatment of cognitive disorders in elderly patients, including memory loss),
• halofantrine (an antiparasitic agent used to treat certain types of malaria),
• pentamidine (used to treat certain types of pneumonia),
• antihistamines used to treat allergic reactions such as hay fever (e.g. mizolastine, astemizole, terfenadine),
• non-steroidal anti-inflammatory drugs used to treat pain (e.g. ibuprofen) or high doses of acetylsalicylic acid,
• angiotensin-converting enzyme (ACE) inhibitors (used to treat hypertension and heart failure),
• intravenous amphotericin B (used to treat fungal infections),
• oral corticosteroids used to treat various diseases, including severe asthma and rheumatoid arthritis,
• stimulant laxatives,
• baclofen (used to treat muscle stiffness in conditions such as multiple sclerosis),
• allopurinol (used to treat gout),
• potassium-sparing diuretics (e.g. amiloride, spironolactone, triamterene),
• metformin (used to treat diabetes),
• iodine-containing contrast agents (used in radiological diagnostics),
• calcium tablets or other calcium supplements,
• cyclosporine, tacrolimus, or other immunosuppressive agents used after organ transplantation, in autoimmune diseases, or in severe rheumatic or dermatological conditions,
• tetracosactide (used to treat Crohn's disease),
• methadone (used in addiction treatment).

Rawel SR with food and drink
Food and drink do not affect the action of Rawel SR.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Use of this medicine during pregnancy is not recommended. If pregnancy is planned or confirmed, alternative treatment should be initiated as soon as possible. Inform your doctor if you are pregnant or planning pregnancy.
The active substance passes into breast milk. Use of this medicine during breastfeeding is not recommended.
Driving and operating machinery
This medicine may cause adverse effects related to lowering of blood pressure, such as dizziness or fatigue (see section 4). These adverse effects occur more frequently at the beginning of treatment or after dose increase. In such cases, patients should refrain from driving and performing other tasks requiring concentration. However, these symptoms are rare when treatment is well controlled.
Rawel SR contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to use Rawel SR

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
The recommended dose of Rawel SR is one tablet per day, preferably taken in the morning. Tablets
may be taken regardless of meals. Swallow the tablet whole with water.
Do not crush or chew the tablets. Treatment of high blood pressure usually continues for the rest of life.

Taking more Rawel SR than recommended
If too many tablets have been taken, contact your doctor or pharmacist immediately.
Very high doses of Rawel SR may cause nausea, vomiting, low blood pressure, muscle cramps,
dizziness, drowsiness, disorientation, and changes in the amount of urine produced by the kidneys.

Missing a dose of Rawel SR
If a dose is missed, take the next dose at the usual time.
Do not take a double dose to make up for a missed dose.

Stopping Rawel SR
Since treatment of high blood pressure is usually long-term, you should consult your doctor before
discontinuing the medicine.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur in a patient, which may be
serious, treatment must be discontinued immediately and medical advice should be sought without delay:

• Angioedema and (or) urticaria. Angioedema is characterised by swelling of the skin of the limbs or face, swelling of the lips or tongue, or swelling of the mucous membranes of the throat or airways, causing breathlessness or difficulty in swallowing. If such symptoms occur, immediate medical attention must be sought (very rare – may occur in no more than 1 in 10,000 patients);
• Severe skin reactions, including intense rash, redness of the entire body's skin, severe itching, formation of blisters, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome), or other allergic reactions (very rare – may occur in no more than 1 in 10,000 patients);
• Life-threatening heart rhythm disorders (frequency unknown);
• Pancreatitis, which may cause severe upper abdominal pain radiating to the back and a very poor general condition (very rare – may occur in no more than 1 in 10,000 patients);
• Liver disease-induced brain disorder (hepatic encephalopathy; frequency unknown);
• Hepatitis (frequency unknown);
• Muscle weakness, cramps, tenderness or muscle pain, particularly when the patient simultaneously feels unwell or has a high temperature, which may be due to abnormal muscle breakdown (frequency unknown).

Other adverse reactions, grouped by decreasing frequency:
Common (may occur in no more than 1 in 10 patients):

• Low blood potassium levels;
• Raised, red skin rash;
• Allergic reactions, mainly dermatological, such as skin rashes in patients with a predisposition to hypersensitivity reactions or asthma.

Uncommon (may occur in no more than 1 in 100 patients):

• Low blood sodium levels, which may cause dehydration and low blood pressure;
• Vomiting;
• Small red spots on the skin (petechiae);
• Impotence (inability to achieve or maintain an erection).

Rare (may occur in no more than 1 in 1,000 patients):

• Low blood chloride levels;
• Low blood magnesium levels;
• Feeling of fatigue, headache, tingling and numbness (paraesthesia), dizziness;
• Gastrointestinal disturbances (such as nausea, constipation), dry mouth;

Very rare (may occur in no more than 1 in 10,000 patients):

• Changes in blood cell counts, such as thrombocytopenia (reduced platelet count causing easier bruising and nosebleeds), leukopenia (reduced white blood cell count, which may lead to unexplained fever, sore throat or other flu-like symptoms – medical advice should be sought if these occur), and anaemia (reduced red blood cell count);
• High blood calcium levels;
• Heart rhythm disorders (causing palpitations, sensation of rapid heartbeat), low blood pressure;
• Kidney disorders (causing extreme fatigue, increased frequency of urination, itching, nausea, limb swelling);
• Abnormal liver function.

Frequency unknown (cannot be estimated from available data):

• Fainting;
• In patients with systemic lupus erythematosus (an immune system disorder leading to inflammation and damage of joints, tendons and organs, with symptoms such as skin rashes, fatigue, loss of appetite, weight gain and joint pain), symptoms may worsen;
• Photosensitivity reactions (skin changes) following exposure to sunlight or artificial UVA light have also been reported;
• Myopia;
• Blurred vision;
• Visual disturbances;
• Visual impairment or eye pain due to elevated pressure (possible symptoms of fluid accumulation in the vascular membrane surrounding the eye – excessive fluid buildup between the choroid and sclera – or acute angle-closure glaucoma);
• Changes in laboratory test results (blood tests) may occur, and your doctor may recommend blood testing. The following changes in laboratory results may occur:
• Increased serum uric acid levels, a substance which may cause or exacerbate gout (pain in one or more joints, especially in the feet);
• Increased blood glucose levels in patients;
• Increased liver enzyme activity;
• Heart rhythm disorders detectable on ECG.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: + 48 22 49-21-301
fax: + 48 22 49-21-309
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Rawel SR

Keep this medicine out of the reach and sight of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to
the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Rawel SR contains

• The active substance is indapamide. Each prolonged-release tablet contains 1.5 mg of indapamide.
• The other ingredients are hypromellose, celacose (α-lactose monohydrate, cellulose), colloidal anhydrous silica, and magnesium stearate in the tablet core, and hypromellose, macrogol 400, and titanium dioxide in the tablet coating. For more information about lactose, see section 2 "Rawel SR contains lactose".

What Rawel SR looks like and contents of the pack
The prolonged-release tablets are white, round and slightly biconvex.
Packs: 20, 30, 60 or 90 tablets in blisters, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

For further information about trade names of medicinal products in other European Economic Area countries, please contact the representative of the marketing authorisation holder:
KRKA-POLSKA Sp. z o.o.
Równoległa Street 5
02-235 Warsaw, Poland
Tel. 22 57 37 500