Properties
What is it?
RANEXA ® 1000 1000 mg Ranola zine, prolonged-release tablets Ranola zine Read the package leaflet carefully before you start taking this medicine, as 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 be harmful to 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. Contents of the leaflet: 1. What RANEXA ® is and what it is used for 2. What you need to know before you take RANEXA ® 3. How to take RANEXA ® 4. Possible side effects 5. How to store RANEXA ® 6. Contents of the pack and other information 1. What RANEXA ® is and what it is used for RANEXA ® is a medicine used to treat angina. Angina is pain or discomfort in the chest area, which the patient feels in the upper part of the body, between the neck and the upper abdomen, often after physical exertion or excessive activity. If you do not feel better or feel your condition worsening, you should consult a doctor. 2. What you need to know before taking RANEXA ® Do not take RANEXA ® if: - you are allergic to ranola zine or any of the other ingredients of this medicine, listed in section 6 of this leaflet; - you have severe kidney disease; - you have moderate or severe liver disease; - you are taking certain medicines to treat bacterial infections (clarithromycin, telithromycin), fungal infections (itraconazole, ketoconazole, voriconazole, posaconazole), HIV infections (protease inhibitors), depression (nefazodone) or heart rhythm disorders (e.g., quinidine, dofetilide or sotalol). Warnings and precautions Talk to your doctor before taking RANEXA ® if: - you have mild or moderate kidney disease; - you have mild liver disease; - you have ever had changes on your electrocardiogram (ECG); - you are elderly; - you have a low body weight (60 kg or less); - you have had a heart attack. If any of the above applies to you, your doctor may decide to reduce the dose or take other precautions. Taking other medicines with RANEXA ® Do not take the following medicines while taking RANEXA ®: - certain medicines to treat bacterial infections (clarithromycin, telithromycin), fungal infections (itraconazole, ketoconazole, voriconazole, posaconazole), HIV infections (protease inhibitors), depression (nefazodone) or heart rhythm disorders (e.g., quinidine, dofetilide or sotalol). Talk to your doctor or pharmacist before starting RANEXA ® if you are taking: - certain medicines to treat bacterial infections (erythromycin), fungal infections (fluconazole), medicines to prevent rejection of transplanted organs (cyclosporine), or heart medicines such as diltiazem or verapamil. These medicines may increase the frequency of side effects such as dizziness, nausea or vomiting, which are possible side effects of RANEXA ® (see section 4). Your doctor may decide to reduce the dose. - medicines to treat epilepsy or other neurological disorders (e.g., phenytoin, carbamazepine or phenobarbital); rifampicin to treat infectious diseases (e.g., tuberculosis); the herbal medicine St. John's Wort, as these medicines may reduce the effectiveness of RANEXA ®. - medicines to treat heart disease containing digoxin or metoprolol, as your doctor may decide if the dose of these medicines needs to be changed during treatment with RANEXA ®. - certain medicines to treat allergies (e.g., terfenadine, astemizole, mizolastine), heart rhythm disorders (e.g., disopyramide, procainamide) and depression (e.g., imipramine, doxepin, amitriptyline), as these medicines may cause changes on the ECG. - certain medicines to treat depression (bupropion), psychoses, HIV infections (efavirenz) or cancer (cyclophosphamide). - certain medicines to treat high cholesterol levels (e.g., simvastatin, lovastatin, atorvastatin). These medicines can cause muscle pain and damage. Your doctor may decide if the dose of these medicines needs to be adjusted during treatment with RANEXA ®. - certain medicines to prevent rejection of transplanted organs (e.g., tacrolimus, cyclosporine, sirolimus, everolimus), as your doctor may decide if the dose of these medicines needs to be adjusted during treatment with RANEXA ®. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Taking RANEXA ® with food and drink RANEXA ® can be taken independently of meals. Do not drink grapefruit juice during treatment with RANEXA ®. Pregnancy and breastfeeding Pregnancy You should not take RANEXA ® during pregnancy without your doctor's recommendation. Breastfeeding RANEXA ® is contraindicated during breastfeeding. If you are breastfeeding, consult your doctor. If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to become pregnant, ask your doctor for advice before taking this medicine. Effects on ability to drive and use machines Studies on the effects of RANEXA ® on the ability to drive and use machines have not been conducted. Consult your doctor regarding driving or operating machinery. RANEXA ® can cause side effects such as dizziness (frequent), blurred vision (sometimes), confusion (sometimes), hallucinations (sometimes), double vision (sometimes) and impaired coordination (rare), which may affect the ability to drive or operate machinery. If such symptoms occur, do not drive or operate machinery until these effects have completely disappeared. Each RANEXA ® prolonged-release tablet contains less than 1 mmol (23 mg) of sodium, i.e., it can be considered "practically sodium-free". RANEXA ® 1000 mg prolonged-release tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. 3. How to take RANEXA ® Always take this medicine exactly as your doctor has told you. If you are unsure about anything, ask your doctor or pharmacist. Swallow the tablets whole with water. Do not crush, chew or break the tablets into pieces, as this may affect the release of the medicinal substance from the tablets into the body. The starting dose for adults is one 500 mg tablet twice a day. After 2-4 weeks, depending on your body's response to treatment, your doctor may increase the dose to achieve the desired effect. The maximum dose of RANEXA ® is 1000 mg twice a day. It is important to inform your doctor about any side effects, such as dizziness, nausea or feeling unwell. Your doctor may reduce the dose or, if this is not sufficient, stop treatment with RANEXA ®. Use in children and adolescents RANEXA ® is contraindicated in children and adolescents under 18 years of age. If you take more RANEXA ® than you should If you accidentally take too many RANEXA ® tablets or exceed the dose recommended by your doctor, inform your doctor immediately. If you cannot contact your doctor, go to the nearest emergency department. Take the remaining tablets, including the packaging and carton, with you so that medical personnel can easily determine what you have taken. If you forget to take RANEXA ® If you forget to take the medicine, take it as soon as you remember, unless it is almost time for your next dose (less than 6 hours before). Do not take a double dose to make up for a missed dose. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking RANEXA ® and seek immediate medical attention if you develop any of the following symptoms of angioedema, a rare but serious condition: - swelling of the face, tongue or throat; - difficulty swallowing; - rash or difficulty breathing. Tell your doctor about common side effects, such as dizziness, nausea or vomiting. Your doctor may reduce the dose or stop treatment with RANEXA ®. Other possible side effects include: Frequent side effects (affecting 1 to 10 patients in 100): Constipation Dizziness Headache Nausea, vomiting Feeling of weakness Side effects that occur sometimes (affecting 1 to 10 patients in 1,000): Changes in sensation Feeling of anxiety, difficulty sleeping, confusion, hallucinations Blurred vision, visual disturbances Changes in perception (touch or taste), tremor, feeling of fatigue or lack of energy, drowsiness or sleepiness, feeling faint or fainting, dizziness upon standing Dark urine, blood in urine, difficulty urinating Dehydration Difficulty breathing, cough, nosebleeds Double vision Increased sweating, itching Feeling of swelling or bloating Hot flashes, low blood pressure Increased levels of creatinine or urea in the blood, increased number of platelets or white blood cells in the blood, changes in ECG Joint swelling, pain in limbs Loss of appetite and/or weight loss Muscle cramps, muscle weakness Ringing in the ears and/or feeling of spinning Pain or discomfort in the stomach area, indigestion, dry mouth or flatulence Rare side effects (affecting 1 to 10 patients in 10,000): Urinary disorders Abnormal liver laboratory test results Acute kidney failure Changes in sense of smell, numbness of the mouth or lips, hearing impairment Cold sweats, rash Impaired coordination Low blood pressure upon standing Depression or loss of consciousness Disorientation Feeling of coldness in hands and feet Rash, allergic skin reactions Impotence Loss of ability to walk due to impaired balance Inflammation of the pancreas or intestines Memory loss Feeling of tightness in the throat Decreased sodium levels in the blood (hyponatremia), which can cause fatigue and confusion, muscle spasms, seizures and coma. Frequency unknown (frequency cannot be estimated from the available data): Myoclonus. 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. By reporting side effects, you can help provide more information about the safety of this medicine. 5. How to store RANEXA ® Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on each blister pack and carton after "EXP". Expiry date: 5 years. This medicine does not require any special storage conditions. Do not throw away medicines down the drain or with household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment. 6. Contents of the pack and other information Composition of RANEXA ® The active substance of RANEXA ® is ranola zine. One tablet contains 500 mg or 1000 mg of ranola zine. Other ingredients: Microcrystalline cellulose, methacrylic acid and ethyl acrylate copolymer (1:1), hypromellose (2910), magnesium stearate (non-bovine), sodium hydroxide. Depending on the dose, the tablet coating also contains: 500 mg tablets: Polyethylene glycol 3350, partially hydrolyzed polyvinyl alcohol, talc, titanium dioxide, iron yellow oxide (E 172), iron red oxide (E 172), carnauba wax. 1000 mg tablets: Glyceryl triacetate, hypromellose 6 mPas, lactose monohydrate, polyethylene glycol 3350, titanium dioxide, iron yellow oxide (E 172), carnauba wax. Description and contents of the pack RANEXA ® prolonged-release tablets are oval-shaped tablets. 500 mg tablets: Light orange tablets, engraved with "500" on one side, smooth on the other. 1000 mg tablets: Pale yellow tablets, engraved with "1000" on one side, smooth on the other. RANEXA ® is available in cartons containing 30, 60 or 100 tablets in PVC/PVDC/aluminum blisters. Not all pack sizes may be marketed. Conditions of dispensing Pharmaceutical product group II, dispensed by prescription № 3. See also: RANEXA - Ranexa 500mg 60 tablets
