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1 Package Leaflet: Information for the Patient Pentoxifyllin-Tchaikapharma

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1 Package Leaflet: Information for the Patient Pentoxifyllin-Tchaikapharma Package Leaflet: Information for the patient Pentoxifyllin-Tchaikapharma 400 mg prolonged-release tablets pentoxifylline 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 symptoms 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 section4. What is in this leaflet: 1. What Pentoxifyllin-Tchaikapharma is and what it is used for 2. What you need to know before you take Pentoxifyllin-Tchaikapharma 3. How to take Pentoxifyllin-Tchaikapharma 4. Possible side effects 5. How to store Pentoxifyllin-Tchaikapharma 6. Contents of the pack and other information 1. What Pentoxifyllin-Tchaikapharma is and what it is used for Pentoxifylline acts on the viscosity of the blood by reducing the binding of its components and increases the deformability of erythrocytes. This has a beneficial effect on blood circulation in diseases of the peripheral and cerebral arteries. This has a beneficial effect on blood circulation in diseases of the peripheral and cerebral arteries. This has a beneficial effect on the circulatory system diseases of the peripheral and cerebral arteries. Improves the blood supply to small blood vessels and the supply of tissues with oxygen. This medicine is used in: - Advanced disorders of peripheral arterial circulation of the limbs caused by atherosclerosis and diabetes and vascular spasms (intermittent claudication, diabetic macro- and microangiopathy, Raynaud's syndrome); - Diseases associated with venous circulation disorders; - Treatment of impaired blood supply to the brain and eyes. 2. What you need to know before you take Pentoxifyllin-Tchaikapharma Do not take Pentoxifyllin-Tchaikapharma - if you are allergic (hypersensitive) to pentoxifylline or to any of the other ingredients of this medicine (listed in section 6); - if you are hypersensitive to pentoxifylline-like medicines such as theophylline, theophyllinate, caffeine, choline, aminophylline or theobromine; - if you have recently had a heart attack; - if you are bleeding heavily; - if you have extensive retinal bleeding (risk of increased bleeding). Warnings and precautions Talk to your doctor or pharmacist before using Pentoxifyllin-Tchaikapharma: 1 - if you have or have had heart rhythm disorders; - if you have been treated for heart failure; - if you have high or low blood pressure; - if you have diabetes; - if you are being treated for atherosclerosis; - if you have kidney failure (or are on dialysis); - if you have severe liver failure; - if you have planned surgery (including tooth extraction) or a diagnostic procedure involving a risk of bleeding; - if you are under 18 years of age. Other medicines and Pentoxifyllin-Tchaikapharma Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Tell your doctor if you are taking medicines for: - treatment of high blood pressure, - prevention of blood clotting (anticoagulants), - treatment of diabetes, - treatment of gastrointestinal ulcers, - treatment of bacterial infections, - treatment of asthma and/or chronic bronchitis, - pain relief. Please consult your doctor even if you have taken such medicines in the past. Pentoxifyllin-Tchaikapharma with food and drink Food intake does not affect the effectiveness of the medicine. Fertility, 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. The effect of Pentoxifyllin-Tchaikapharma on the fetus has not been studied, so you should not take it during pregnancy unless your doctor decides that it is necessary. Pentoxifylline and its metabolites pass into breast milk. The doctor will assess the benefit/risk balance of treatment during breast-feeding. Driving and using machines Do not drive or use machines until you know how you respond to treatment. In individual patients, the drug may cause dizziness and thus indirectly impair the psycho-physical ability to drive and use machines. 3. How to take Pentoxifyllin-Tchaikapharma Always take Pentoxifyllin-Tchaikapharma exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The dosage is determined by the severity of the disease. The recommended dose is 1 tablet of 400 mg 3 times a day. Take the tablets whole, with liquid, during or after a meal. Thus, the frequency of side effects can be reduced. The effect of the drug is manifested from 2 to 4 weeks, gradually increases and stabilizes at 8 weeks of treatment. Take the medicine regularly, at the same time each day. Make sure that you have enough of the medicine to continue treatment. 2 This medicine has been prescribed for you only and you should not pass it on to others, even if their symptoms are similar to yours. If you have the impression that the effect of this medicine is too strong or too weak, talk to your doctor or pharmacist. Renal impairment If renal function is impaired (creatinine clearance <30 ml/min), your doctor may reduce the daily dose to 1-2 prolonged-release tablets. The dosage in patients with impaired renal function and those on hemodialysis is determined by a physician. Hepatic impairment In severe hepatic impairment, the doctor will also reduce the dose, taking into account the induced effects and tolerability. Elderly patients No dose adjustment is required in elderly patients. Use in children and adolescents The use of Pentoxifyll-Tchaikapharma in children and adolescents is not recommended. If you take more Pentoxifyllin-Tchaikapharma than you should If you take more doses of the medicine than you should, you should consult your doctor or pharmacist immediately. If the patient has received a greater amount of the medicine may occur flushing, dizziness and faint feeling due to excessive lowering of blood pressure (hypotension), drowsiness, loss of consciousness, vomiting, increase in body temperature, agitation and convulsions. If the patient is conscious after taking a large number of tablets, try to induce vomiting and call a doctor immediately. If you forgot to take Pentoxifyllin-Tchaikapharma Do not take a double dose to make up for a forgotten tablet. Try to take the medicine regularly, at the same time each day. If you miss a dose, take it as soon as possible, but not if it is time for your next dose. If there are only a few hours left until the next dose, leave the missed dose and return to the regular dosing schedule. If you stop taking Pentoxifyllin-Tchaikapharma Do not stop taking Pentoxifyllin-Tchaikapharma without talking to your doctor or pharmacist. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. The majority of adverse reactions are dose-dependent. If the dose of Pentoxifyllin-Tchaikapharma is reduced, the side effects weaken or disappear completely. Discontinuation of treatment is necessary in very rare cases. Stop taking Pentoxifyllin-Tchaikapharma and see your doctor or go to a hospital straight away if: - you have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue, - bleeding under the skin; - blood in your vomit or stools (motions); - if you develop a condition called aseptic meningitis. Signs include headache, neck stiffness, eye pain or discomfort in bright light. 3 Common (may affect less than 1 in 10 people): - gastrointestinal disorders (indigestion or heartburn, vomiting, feeling unwell, abdominal bloating, pain, diarrhea). Uncommon (may affect less than 1 in 100 people): - feeling agitated, sleep problems, feeling dizzy, tremor - blurred vision, conjunctivitis - increased or fast heart beat - flushing - itching, erythema, hives - fever. Rare (may affect less than 1 in 1,000 people): - sweating, seizures - chest pain - bleeding under the skin Very rare (may affect less than 1 in 10,000 people): - low blood sugar levels, hypotension - gastrointestinal bleedingв - elevated liver enzymes Unknown (frequency cannot be estimated from the available data): - reduction in the number of platelets (thrombocytopenia), decrease in the number of blood cells, prolonged bleeding time, bleeding (e.g. from vessels of the skin, mucous membranes, stomach, intestines) - allergic reactions (anaphylactic reactions, shock, swelling of the face or throat, difficulty breathing or wheezing, skin rash) - inflammation of the protective membranes of the brain (aseptic meningitis) - bleeding - constipation, producing more saliva than usual - an illness where the removal of bile from the liver is blocked (intrahepatic cholestasis). Signs include jaundice, rash or fever, and the colour of your water (urine) becomes darker - rash. 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: Bulgarian Drug Agency 8 Damyan Gruev Str., 1303 Sofia Tel.: +35 928903417 website: www.bda.bg By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store Pentoxifyllin-Tchaikapharma Keep out of the reach and sight of children. Do not store above 25°С. Do not use Pentoxifyllin-Tchaikapharma after the expiry date which is stated on the carton after EXP. The 4 expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
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