PACKAGE LEAFLET Page 1 of 6

Transcription

1 PACKAGE LEAFLET Page 1 of 6

2 Package leaflet: Information for the patient Pindolol 5 mg Tablets pindolol 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 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. What is in this leaflet: 1. What Pindolol is and what it is used for 2. What you need to know before you take Pindolol 3. How to take Pindolol 4. Possible side effects 5. How to store Pindolol 6. Contents of the pack and other information 1. What Pindolol is and what it is used for Pindolol belongs to a class of medicines called beta-blockers, which help slow the heartbeat and relax blood vessels. This reduces blood pressure and the heart s demand for oxygen. Pindolol is used to treat the following conditions: high blood pressure (hypertension) chest pain (angina): Pindolol helps prevent or reduce chest pains which may occur when your heart cannot get enough oxygen, such as when doing exercise. 2. What you need to know before you take Pindolol Do not take Pindolol: if you are allergic to pindolol or any of the other ingredients of this medicine (listed in section 6) if you have a history of breathing difficulties or wheezing, asthma or other lung disorders if you have heart problems such as uncontrolled heart failure, unstable angina (Prinzmetal s angina), heart block, a slow heart rate (less than beats per minute) or irregular heart beat, low blood pressure or bad circulation if you have a type of tumour called a phaeochromocytoma that is not being treated if you have severe kidney failure if you are fasting for a long time if you have metabolic acidosis (when your blood becomes too acid) if you are also taking a type of medicine called a calcium channel blocker (e.g. verapamil). Warnings and precautions Talk to your doctor or pharmacist before taking Pindolol: if you have asthma or chronic obstructive lung disease. Pindolol should not be taken unless your doctor tells you to, as this could make your condition worse (see section 4 Possible side effects ) if you have allergies as beta-blockers may increase allergies and the seriousness of an allergic reaction Page 2 of 6

3 if you suffer from heart conditions such as heart failure, a slow heart rate (50-55 beats per minute), heart block (due to abnormal heart function) or not enough blood supply to your heart (ischaemic heart disease) if you have recently suffered a myocardial infarction (heart attack) if you have low blood sugar levels or are using medicines for diabetes. Pindolol may hide an increase in your heart rate, which is one of the warning signs of low blood sugar levels if you suffer from attacks of headache, sweating, palpitations, flushing of the face or pains in the chest or stomach caused by a rare tumour called a phaeochromocytoma if you have a history of a common skin disorder known as psoriasis if you have kidney problems. You may require a lower dose than stated if you have an overactive thyroid gland, as Pindolol can hide some of the symptoms associated with this condition if you need any form of surgery. Pindolol may react with certain anaesthetics used in operations (e.g. halothane, cyclopropane, trichloroethylene, ether, chloroform); therefore you should tell the medical staff at the hospital or dentist that you are taking Pindolol.. Beta-blockers can cause skin rashes and/or dry eyes. If you have these symptoms do not stop taking your medicine but tell your doctor or pharmacist. Stopping this medicine must be done gradually. Children and adolescents Pindolol is not recommended for use in children or adolescents. Other medicines and Pindolol Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular tell your doctor if you are taking any of the following medicines: calcium channel blockers for high blood pressure or chest pains (angina) such as verapamil or diltiazem, Do not take Pindolol at the same time as these medicines medicines for depression, such as moclobemide (MAO inhibitors), tricyclic antidepressants barbiturates, used for epilepsy or to help you sleep medicines for feeling sick (nausea) or mental problems, such as chlorpromazine (phenothiazines) reserpine (used for mental problems and high blood pressure but only available outside the UK market) clonidine (for high blood pressure or migraine). If you are taking clonidine and Pindolol together, do not stop taking clonidine unless your doctor tells you to do so. If you have to stop taking clonidine, your doctor will give you careful instructions about how to do it other medicines for high blood pressure or chest pains (angina)such as nifedipine or hydralazine medicines for regulating the heartbeat such as quinidine, disopyramide, amiodarone medicines for heart failure, such as digoxin (digitalis glycosides), adrenaline, ephedrine, dopamine (sympathomimetic amines) xanthines (used for asthma, e.g. theophylline) cimetidine (for stomach ulcers and indigestion) medicines to relieve pain and inflammation, such as ibuprofen, indomethacin, naproxen, diclofenac (non-steroidal anti-inflammatory drugs NSAIDs) insulin and oral antidiabetic medicines to treat diabetes, such as metformin. Surgery Pindolol may react with certain anaesthetics used in operations (e.g. halothane, cyclopropane, trichloroethylene, ether, chloroform). So in the event that you need any form of surgery, you should tell the medical staff at the hospital that you are taking Pindolol. Pindolol with alcohol Do not drink alcohol as it may increase the effect of this medicine. Pregnancy and breast-feeding Do not take this medicine if you are pregnant. As small amounts of pindolol may pass into the breast-milk, do not take this medicine while you are breast-feeding. Page 3 of 6

4 If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Driving and using machines Pindolol are unlikely to have a serious effect on your ability to drive or use machinery. On rare occasions though you may feel a bit dizzy or more tired than usual. If this happens, do not drive or operate machinery. 3. How to take Pindolol Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Adults and the Elderly High blood pressure (hypertension): The recommended starting dose is one 5 mg tablet taken 2 or 3 times per day (10 mg to15 mg daily) or 3 tablets (15 mg) taken once a day with breakfast. Your doctor may gradually increase the dose according to your response. The maximum dose is 45 mg (9 tablets) daily. If necessary your doctor may also prescribe other antihypertensive medicine to help reduce your blood pressure. Chest pain (angina pectoris): The recommended dose is 2.5 mg or 5 mg up to three times a day. Use in children and adolescents Pindolol is not recommended for use in children or adolescents. If you take more Pindolol than you should If you have taken more tablets than you should, you must seek medical help immediately. In case of an overdose you may experience a slow heartbeat. If you forget to take Pindolol Take the next dose as soon as you remember unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten dose. If you stop taking Pindolol Do not stop taking Pindolol unless your doctor has told you to do so. Stopping treatment with beta-blockers such as Pindolol should always be gradual. 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 everybody gets them. If you think you may have any of the following side effects, contact your doctor or go to your nearest hospital emergency room immediately. The frequency of these side effects is not known (frequency cannot be estimated from the available data: allergic skin reactions a severe mental condition in which the person loses contact with reality and is unable to think and judge clearly (psychoses) disease of the heart with shortness of breath and swelling of the feet or legs due to fluid build-up (heart failure) difficulty in breathing or wheezing (bronchospasm) in patients with asthma or a history of asthma. Other side effects Frequency not known (frequency cannot be estimated from the available data): Page 4 of 6

5 seeing, feeling or hearing things that are not there (hallucinations), depression (feeling sad) diarrhoea, nausea (feeling sick) and being sick insomnia (difficulty sleeping), sleep disturbance, nightmares headaches epigastric pain (pain in the abdomen) fatigue dizziness, confusion impaired vision, dry eyes slow or irregular heartbeat hypotension (low blood pressure) a cold or numb feeling in your fingers or toes, which may also have a blue tint (Raynaud s syndrome) or worsening of circulation problems pins and needles, numbness or tingling of hands and feet muscle cramps shaking (tremor) inability to get or maintain an erection (impotence) increase in antibodies in the blood beta-blockers may mask the symptoms of high levels of thyroid hormones in the blood (thyrotoxicosis) or low blood sugar levels (hypoglycaemia). 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 the Yellow Card Scheme, website: By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store Pindolol Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date, which is stated on the label, carton or foil after EXP. The expiry date refers to the last day of that month. Store below 25 ºC. Store in the original package in order to protect from light. Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment. 6. Contents of the pack and other information What Pindolol contains - The active substance is pindolol. Each tablet contains 5 mg pindolol. The other ingredients are cellulose, microcrystalline; starch, pregelatinised; magnesium stearate and colloidal silicon dioxide. What Pindolol looks like and contents of the pack Pindolol Tablets are white, flat bevelled edged tablets, marked PL breakline 5 on one side of the tablet and G on the reverse. Pindolol Tablets are available in containers or blister packs of 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 56, 60, 84, 90, 100, 112, 120, 168, 180, 250, 500 and 1000 tablets. Not all pack sizes may be marketed. Page 5 of 6

6 Marketing Authorisation Holder Mylan, Potters Bar, Hertfordshire, EN6 1TL. United Kingdom Manufacturer Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland. This leaflet was last revised in: 07/2013 Page 6 of 6