Ravel Sr

Leaflet accompanying the packaging: patient information

Rawel SR, 1.5 mg, prolonged-release tablets

Indapamide

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Rawel SR and what is it used for
• 2. Important information 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 is Rawel SR and what is it used for

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

2. Important information before taking Rawel SR

When not to take Rawel SR

• if you are 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 you have severe kidney disease;
• if you have severe liver disease or a condition called hepatic encephalopathy (a disease that destroys the brain);
• if you have low potassium levels in your blood.

Warnings and precautions

Before taking Rawel SR, discuss with your doctor or pharmacist:

• if you have liver problems;
• if you have diabetes;
• if you have gout;
• if you have any heart rhythm disorders or kidney problems;
• if you have blurred vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased pressure inside the eye — they may occur within a few hours to weeks after taking Rawel SR. If left untreated, they can lead to permanent vision loss. If you have previously been allergic to penicillin or sulfonamides, you may be more likely to develop this disease.

if you have muscle disorders, including pain, tenderness, weakness, or cramps;

• if you are to undergo a test to assess parathyroid function.

Tell your doctor if you have had allergic reactions to light.
Your doctor may recommend tests to assess decreased potassium or sodium levels or increased calcium levels.
If any of the above situations apply to you or if you have questions and doubts about taking the medicine, consult your doctor or pharmacist.

Important information for athletes

Athletes should be warned that the medicine contains an active substance that may give a positive result in anti-doping tests.

Children and adolescents

Due to the 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 you are taking now or have taken recently, as well as any medicines you plan to take.
Do not take Rawel SR with lithium preparations (used to treat depression), as this increases the risk of increased lithium levels in the blood.

Tell your doctor if you are taking any of the following medicines (special precautions may be necessary):

• medicines used to treat heart rhythm disorders (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitalis glycosides, bretylium),
• medicines used to treat mental 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 disease that causes chest pain),
• cisapride, difemanil (used to treat gastrointestinal disorders),
• antibiotics used to treat bacterial infections (e.g. sparfloxacin, moxifloxacin, erythromycin given by injection),
• wincamine given by injection (used to treat symptomatic disorders of cognitive processes in elderly patients, including memory loss),
• halofantrine (an antiparasitic medicine 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 medicines 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),
• amphotericin B given by injection (a medicine used to treat fungal infections),
• oral corticosteroids used to treat various diseases, including severe asthma and rheumatoid arthritis,
• laxatives that stimulate peristalsis,
• baclofen (used to treat muscle stiffness in diseases 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 medicines that suppress the immune response after organ transplantation, in the treatment of autoimmune diseases or severe rheumatic or dermatological diseases,
• tetracosactide (used to treat Crohn's disease),
• methadone (used to treat addiction).

Rawel SR with food and drink

Food and drink do not affect the action of Rawel SR.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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. If you are planning a pregnancy or have confirmed that you are pregnant, you should switch to an alternative treatment as soon as possible. You should inform your doctor if you are pregnant or planning a pregnancy.
The active substance passes into breast milk. This medicine is not recommended during breastfeeding.

Driving and using machines

This medicine may cause side effects related to lowering blood pressure, such as dizziness or fatigue (see section 4). These side effects are more common at the beginning of treatment or after increasing the dose. In such a situation, you should avoid driving and operating machinery. However, these symptoms are rare if treatment is well controlled.

Rawel SR contains lactose

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Rawel SR

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose of Rawel SR is one tablet per day, preferably taken in the morning. The tablets can be taken with or without food. Swallow the tablet whole with water. Do not crush or chew the tablets. Treatment of hypertension usually lasts for life.

Taking a higher dose of Rawel SR than recommended

If you have taken too many tablets, 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 you miss a dose, take the next dose as usual.
Do not take a double dose to make up for a forgotten dose.

Stopping treatment with Rawel SR

Since the treatment of hypertension is usually long-term, consult your doctor before stopping the medicine.
If you have any doubts about taking the medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following serious side effects, stop taking the medicine and contact your doctor immediately:

• angioedema and (or) urticaria. Angioedema is characterized by swelling of the skin of the limbs or face, swelling of the lips or tongue, mucous membranes of the throat or respiratory tract, which can cause shortness of breath or difficulty swallowing. If such symptoms occur, seek medical attention immediately (very rare - may occur in less than 1 in 10,000 patients);
• severe skin reactions, including severe rash, redness of the skin all over the body, severe itching, blistering, peeling, and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome) or other allergic reactions (very rare - may occur in less than 1 in 10,000 patients);
• life-threatening heart rhythm disorders (frequency not known);
• pancreatitis, which can cause severe abdominal pain radiating to the back and very poor general condition (very rare - may occur in less than 1 in 10,000 patients);
• liver disease caused by liver disease (hepatic encephalopathy; frequency not known);
• hepatitis (frequency not known);
• muscle weakness, cramps, tenderness, or pain, especially if you feel unwell or have a high temperature, which may be caused by abnormal muscle breakdown (frequency not known).

Other side effects, grouped by decreasing frequency:

Common (may affect up to 1 in 10 people):

• low potassium levels in the blood;
• red, raised rash;
• allergic reactions, mainly skin-related, such as skin rashes in patients with a tendency to allergic reactions or asthma.

Uncommon(may affect up to 1 in 100 people):

• low sodium levels in the blood, which can cause dehydration and low blood pressure;
• vomiting;
• red spots on the skin (petechiae);
• impotence (inability to achieve or maintain an erection).

Rare (may affect up to 1 in 1,000 people):

• low chloride levels in the blood;
• low magnesium levels in the blood;
• feeling tired, headache, feeling of tingling and numbness (paresthesia), dizziness;
• gastrointestinal disorders (such as nausea, constipation), dry mouth;

Very rare (may affect up to 1 in 10,000 people):

• changes in blood cell count, such as thrombocytopenia (decrease in platelet count, which can cause easy bruising and nosebleeds), leukopenia (decrease in white blood cell count, which can cause unexplained fever, sore throat, or other flu-like symptoms - if they occur, contact your doctor) and anemia (decrease in red blood cell count);
• high calcium levels in the blood;
• heart rhythm disorders (causing palpitations, feeling of rapid heartbeat), low blood pressure;
• kidney disease (causing feeling of tiredness, increased frequency of urination, itching, nausea, swelling of limbs);
• abnormal liver function.

Frequency not known (cannot be estimated from the available data):

• fainting;
• in the case of systemic lupus erythematosus (a disease of the immune system that leads to inflammation and destruction of joints, tendons, and organs, along with the following symptoms: skin rash, fatigue, loss of appetite, weight gain, and joint pain), there may be an exacerbation of symptoms;
• there have also been reports of photosensitivity reactions (changes in skin appearance) after exposure to sunlight or artificial UVA light;
• myopia;
• blurred vision;
• vision disturbances;
• blurred vision or eye pain due to increased pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye - excessive fluid accumulation between the choroid and sclera - or acute angle-closure glaucoma);
• there may be changes in laboratory test results (blood tests) and your doctor may recommend a blood test. The following changes in laboratory test results may occur:
• increased uric acid levels, a substance that can cause the occurrence or exacerbation of gout (pain in the joint or joints, especially the feet);
• increased glucose levels in the blood in patients;
• increased liver enzyme activity;
• heart rhythm disorders visible in the ECG.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rawel SR

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

6. Contents of the pack and other information

What Rawel SR contains

• The active substance of the medicine is indapamide. Each prolonged-release tablet contains 1.5 mg of indapamide.
• The other ingredients of the medicine are hypromellose, celactose (α-lactose monohydrate, cellulose), colloidal anhydrous silica, magnesium stearate in the tablet core, and hypromellose, macrogol 400, titanium dioxide in the tablet coating. More information about lactose can be found in 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.
Packaging: 20, 30, 60, or 90 tablets in blisters, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
To obtain more detailed information on the names of medicinal products in other EU Member States, contact the representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
tel. 22 57 37 500
Date of leaflet approval:13.07.2023