Rawel SR 1.5 mg. 30 tablets

What is Rawel SR and what is it used for?
Rawel SR is used to lower high blood pressure (hypertension). This is a prolonged-release tablet containing indapamide as an active ingredient. Indapamide is a diuretic. Most diuretics increase the amount of urine produced by the kidneys. However, indapamide is different from other diuretics, as it only causes a slight increase in urine output.

2. What should you know before you take Rawel SR?

Do not take Rawel SR:
if you are allergic (hypersensitive) to the active substance or any of the other ingredients of this medicine or to other medicines of the same type (called sulphonamides) if you have severe kidney disease,
if you have severe liver disease or if you suffer from a condition called hepatic encephalopathy (degenerative brain disease) if you have low potassium levels in the blood.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ravel SR.

Please tell your doctor:

if you have liver problems; if you have diabetes; if you suffer from gout;
if you have impaired kidney function;
if you have any problems with heart rhythm;
if you need a study to check how your gynecologist works.
Tell your doctor if you have had photosensitivity reactions (to light).
If you think any of these things may apply to you, or if you have any questions or doubts about taking this medicine, talk to your doctor or pharmacist.
Your doctor may appoint you a lab to check for low sodium or potassium levels or for high calcium levels.

Important information for athletes
Athletes should keep in mind that this drug contains an active substance that can give a positive reaction during a doping test.

Other medicines and Rawel SR
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
You should not take Ravel SR at the same time as lithium (used to treat depression) because of the risk of elevated blood lithium levels.
Tell your doctor if you are taking any of the following medicines, as special care may be required:

medicines used for heart rhythm problems (eg quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitalis),
medicines used to treat mental illnesses such as depression, anxiety, schizophrenia (eg tricyclic antidepressants, antipsychotic medicines, neuroleptics),
bepridil (used to treat angina pectoris, a disease that causes chest pain),
cisapride, difemanil (used to treat gastrointestinal problems), spafloxacin, moxifloxacin, injectable erythromycin (antibiotics used to treat infections),
injectable vincamine (used for the symptomatic treatment of cognitive disorders in the elderly, including memory loss),
halofantrine (a parasitic medicine for the treatment of 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 pain relievers (eg ibuprofen) or high doses of acetylsalicylic acid,
angiotensin converting enzyme (ACE) inhibitors (used to treat high blood pressure and heart failure),
injectable amphotericin B (antifungal medicines)
oral corticosteroids used to treat various diseases including severe asthma and rheumatoid arthritis,
stimulating laxatives,
baclofen (for the treatment of muscular stiffness occurring in a disease such as multiple sclerosis),
potassium-sparing diuretics (amiloride, spironolactone, triamterene),
metformin (for the treatment of diabetes), iodine-containing contrast agents (used for X-ray studies),
calcium supplements, ciclosporin, tacrolimus or other medicines that suppress the immune system after transplantation of organs, to treat autoimmune diseases or severe rheumatic and dermatological diseases, tetracosactide (for the treatment of Crohn's disease).
Ravel SR with food and drink
Food and beverages do not affect the effect of Ravel SR. Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, talk to your doctor before taking this medicine.
This medicine is not recommended during pregnancy. When pregnancy is planned or confirmed, alternative treatment should be switched as quickly as possible. Please tell your doctor if you are pregnant or want to become pregnant. The active substance passes into the milk. If you take this medicine, breast-feeding is not recommended.

Driving and using machines
This medicine can cause side effects
How to take Rawel SR?
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

The recommended dose of Rawel SR is one tablet a day. Take the medicine every day at the same time, preferably in the morning; swallow the tablets whole with a little liquid. Tablets can be taken regardless of diet. Do not break or chew them. The treatment of high blood pressure usually lasts throughout life.

If you take more Ravel SR than you should
If you have taken too many tablets, contact your doctor or pharmacist immediately. Very high doses of Ravel SR can cause nausea, vomiting, lowering of blood pressure, cramps, dizziness, drowsiness, confusion and a change in the amount of urine produced by the kidneys.

If you forget to take Ravel SR
If you forget to take a dose of your medicine, take the next dose at the usual time.
Do not take a double dose to make up for the missed tablet. If you stop taking Ravel SR
Since high blood pressure usually lasts throughout your life, talk to your doctor before stopping taking this medicine.
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 everyone gets them.

Stop taking the medicine and consult a doctor immediately if you experience any of the following side effects:

angioedema and / or urticaria. Angioedema is characterized by swelling of the skin of the limbs or face, swelling of the lips or tongue, edema of the lining of the throat or the airways leading to shortness of breath or difficulties in swallowing. If this happens, contact your doctor immediately. (Very rare) (may affect up to 1 in 10,000 people)
severe skin reactions, including severe skin rash, redness of the skin throughout the body, severe itching, blistering, scaling and swelling of the skin, mucosal irritation (Stevens-Johnson syndrome) or other allergic reactions. (Very rare) (may affect up to 1 in 10,000 people)
life-threatening heart rhythm disturbance (not known)
inflammation of the pancreas that can cause severe pain in the abdomen and back, accompanied by a feeling of being very unwell (very rare) (may affect up to 1 in 10,000 people)
brain disease caused by liver disease (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 rash on the skin,
- allergic reactions, mostly skin, in people predisposed to allergic and asthmatic reactions.

Uncommon (may affect up to 1 in 100 people):
- vomiting,
- red spots on the skin (purple).

Rare (may affect up to 1 in 1,000 people):
- feeling tired, headache, tingling (paresthesia), vertigo,
- gastrointestinal 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 (decreased platelet counts, which can easily cause bruising in minor trauma and also nose bleeds), leucopenia (a decrease in white blood cells that can cause fever of unknown origin, pain in the throat or other flu-like symptoms - if this occurs, contact your doctor) and anemia (reduction of red blood cells)
- high levels of calcium in the blood,
- heart rhythm disorders (causing heart beat - feeling of heartbeat),
- kidney disease (causes symptoms of fatigue, frequent urination, itchy skin, nausea, swelling of the limbs),
- abnormal liver function.

Not known (frequency can not be estimated from the available data):
- fainting,
- if you suffer from systemic lupus erythematosus (a disorder of the immune system that causes inflammation and damage to joints, tendons and organs with symptoms, including skin rashes, fatigue, loss of appetite, weight gain, and joint pain). get worse,
- cases of hypersensitivity reactions to light (change in skin type) after exposure to sunlight or artificial UVA rays,
- myopathy (myopathy),
- blurred vision,
- visual disturbances,
- Some blood changes may occur and your doctor may direct you to do blood tests to check your condition. The following lab changes may occur:
low potassium levels in the blood,
low sodium levels in the blood, which can lead to dehydration and low blood pressure,
- Increase in uric acid - a condition that can cause it
How to store Ravel SR?
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Store below 25 ° C.
Store in the original package in order to protect from moisture.
Do not dispose of medicines in the sewage system or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Package Contents and Additional Information

What does Ravel SR contain:

The active substance is indapamide. Each prolonged-release tablet contains 1.5 mg indapamide.
The other ingredients are: hypromellose, powdered cellulose, lactose monohydrate, povidone, silica, colloidal anhydrous, magnesium stearate in the tablet core and hypromellose, macrogol 400, titanium dioxide (E171) in the film coating.
What Raven SR looks like and contents of the pack:
The prolonged-release tablets are white, round, slightly biconvex. The tablets are supplied in cartons of 20, 30 and 90 tablets in blisters.
Not all pack sizes may be marketed.

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