SELECTA 10 MG 30 TAB

1. What this product is and what it is used forSelecta contains a medicine called bisoprolol. This belongs to a group of medicines called beta-blockers.These medicines work by affecting the body’s response to some nerve impulses, especially in the heart.As a result, Selecta™ slows down the heart rate and makes the heart more efficient at pumping blood aroundthe body.Heart failure occurs when the heart muscle is weak and unable to pump enough blood to supply the body’sneeds. Selecta™ is used to treat stable chronic heart failure. They are used in combination with othermedicines suitable for this condition (such as ACE inhibitors diuretics and heart glycosides).2. What you need to know before you use this productDo not take Selecta™ if one of the following conditions applies to you:• allergy (hypersensitivity) to bisoprolol fumarate or to any of the other ingredients (see section 6 ‘WhatSelecta™ tablets contain’). • severe asthma or severe chronic lung disease.• severe blood circulation problems in your limbs (such as Raynaud’s syndrome), which may cause yourfingers and toes to tingle or turn pale or blue.• untreated phaeochromocytoma, which is a rare tumour of the adrenal gland.• metabolic acidosis, which is a condition when there is too much acid in the blood.Do not take Selecta™ if you have one of the following heart problems:• heart failure that suddenly becomes worse and/or that may require hospital treatment.• slow or irregular heart rate. • very low blood pressure.Take special care with Selecta™If you have any of the following conditions tell your doctor before taking Selecta™; he or she may want totake special care (for example give additional treatment or perform more frequent checks):• diabetes (Selecta™ can hide the symptoms of low blood sugar).• strict fasting. • certain heart diseases such as disturbances in heart rhythm, or severe chest pain at rest(Prinzmetal’s angina). • kidney or liver problems. • blood circulation problems in your limbs.• asthma or chronic lung disease. • history of a scaly rash (psoriasis).• tumour of the adrenal gland (phaeochromocytoma).• thyroid disorder (Selecta™ can hide symptoms of an overactive thyroid).In addition, tell your doctor if you are going to have:• desensitization therapy (for example for the prevention of hay fever), because Selecta™ may make it morelikely that you experience an allergic reaction, or such reaction may be more severe.• anaesthesia (for example for surgery), because Selecta™ may influence how your body reacts to thissituation.Taking other medicinesPlease tell your doctor or pharmacist if you are taking or have recently taken any other medicines, includingmedicines obtained without a prescription.Do not take the following medicines with Selecta™ without special advice from your doctor:• Certain medicines used to treat irregular or abnormal heartbeat (medicines such as quinidine, disopyramide,lidocaine, phenytoin, flecainide, propafenone).• Certain medicines used to treat high blood pressure, angina pectoris or irregular heartbeat (calciumantagonists such as verapamil and diltiazem).• Certain medicines used to treat high blood pressure such as clonidine, methyldopa, moxonodine,rilmenidine. However, do not stop taking these medicines without checking with your doctor first.Check with your doctor before taking the following medicines with Selecta™; your doctor may need tocheck your condition more frequently:• Certain medicines used to treat high blood pressure or angina pectoris (felodipine and amlodipine).• Certain medicines used to treat irregular or abnormal heartbeat (medicines such as amiodarone).• Timolol eye drops (and related medicines) for glaucoma treatment.• Certain medicines used to treat for example Alzheimer’s disease or glaucoma (such as tacrine or carbachol)or medicines that are used to treat acute heart problems (such as isoprenaline and dobutamine).• Antidiabetic medicines including insulin.• Anaesthetic agents (for example during surgery). • Digoxin, used to treat heart failure.• Non-steroidal anti-inflammatory medicines (NSAIDs) used to treat arthritis, pain or inflammation (forexample ibuprofen or diclofenac).• Any medicine, that can lower blood pressure such as antihypertensives, certain medicines for depression(such as imipramine or amitriptyline), certain medicines used to treat epilepsy or during anaesthesia (such asphenobarbital), or certain medicines to treat mental illness (such as levomepromazine).• Mefloquine, used for prevention or treatment of malaria.• Depression treatment medicines called monoamine oxidase inhibitors (except MAO-B inhibitors) such asmoclobemide. • Some medicines for migraine (ergotamine derivatives).Pregnancy and breast-feedingThere is a risk that use of Selecta™ during pregnancy may harm the baby. If you are pregnant or planning tobecome pregnant, tell your doctor. He or she will decide whether you can take Selecta™ during pregnancy.It is not known whether Selecta™ passes into human breast milk. Therefore, breastfeeding is notrecommended during therapy with Selecta™.Driving and using machinesYour ability to drive or use machinery may be affected depending on how well you tolerate the medicine.Please be especially cautious at the start of treatment, when the dose is increased or the medication ischanged, as well as in combination with alcohol.3. How to use this product.Always take Selecta™ exactly as your doctor has told you. Check with your doctor or pharmacist if you arenot sure.Treatment with Selecta™ requires regular monitoring by your doctor. This is particularly necessary at thestart of treatment and during dose increase.Take the tablet with some water in the morning, with or without food. Do not crush or chew the tablet.Treatment with Selecta™ is usually long-term.Adults including the elderly:Treatment with Selecta™ must be started at a low dose and increased gradually. Your doctor will decide howto increase the dose, and this will normally be done in the following way:1- (1.25mg) Selecta™ once daily for one week. 2- (2.5mg) Selecta™ once daily for one week.3- (3.75mg) Selecta™ once daily for one week. 4- (5mg) Selecta™ once daily for four weeks.6- (7.5mg) Selecta™ once daily for four weeks.• 10mg Selecta™ once daily for maintenance (on-going) therapy.The maximum recommended daily dose is 10 mg bisoprolol.Depending on how well you tolerate the medicine, your doctor may also decide to lengthen the time between dose increases. If your condition gets worse or you no longer tolerate the drug, it may be necessary toreduce the dose again or to interrupt treatment. In some patients a maintenance dose lower than 10 mgSelecta™ may be sufficient. Your doctor will tell you what to do.If you have to stop treatment entirely, your doctor will usually advise you to reduce the dose gradually,as otherwise your condition may become worse.Children: Selecta™ is not recommended for use in children.If you take more Selecta™ than you shouldIf you have taken more Selecta™ than you should, tell your doctor immediately. Your doctor will decidewhat measures are necessary.Symptoms of an overdose may include dizziness, light-headedness, fatigue, breathlessness and/orwheezing. Also, there may be reduced heart rate, reduced blood pressure, insufficient action of the heartand a low blood glucose level (which may involve feelings of hunger, sweating and palpitations).If you forget to take Selecta™Do not take a double dose to make up for a forgotten dose. Take your usual dose the next morning.If you stop taking Selecta™Never stop taking Selecta™ unless on your doctor’s advice. Otherwise your condition could becomemuch worse. If you have any further questions on the use of this product, ask your doctor or pharmacist.4. Possible side effectsLike all medicines, Selecta™ can cause side effects, although not everybody gets them.To prevent serious reactions, speak to a doctor immediately if a side effect is severe, occurred suddenlyor gets worse rapidly.The most serious side effects are related to the heart function:• Slowing of heart rate (affects more than 1 person in 10).• worsening of heart failure (affects less than 1 person in 10).• slow or irregular heartbeat (affects less than 1 person in 100).If you feel dizzy or weak, or have breathing difficulties please contact your doctor as soon as possible.Further side effects are listed below according to how frequently they may occur:Common: (affects less than 1 person in 10)• tiredness, feeling weak, dizziness, headache.• feeling of coldness or numbness in hands or feet. • low blood pressure.• Stomach or intestine problems such as nausea, vomiting, diarrhoea, or constipation.Uncommon: (affects less than 1 person in 100)• sleep disturbances. • breathing problems in patients with asthma or chronic lung disease.• depression. • muscle weakness, muscle cramps.Rare: (affects less than 1 person in 1,000)• hearing problems. • allergic runny nose. • dry eyes from reduced tear flow (can be troublesome ifyou use contact lenses). • inflammation of the liver which can cause yellowing of the skin or whites ofthe eyes. • allergy-like reactions such as itching, flush, rash. • reduced sexual performance (potencydisorder). • nightmares, hallucinations. • fainting.Very Rare: (affects less than 1 person in 10, 000)• irritation and redness of the eye (conjunctivitis). • hair loss.• appearance or worsening of scaly skin rash (psoriasis); psoriasis-like rash.Tell your doctor or your pharmacist if you notice any of the side effects listed above or any otherunwanted or unexpected effects.5. How to store this productKeep out of the reach and sight of children.Do not store above 30 ºC. Store in the original package.Do not use Selecta™ after the expiry date which is stated on the carton and blister.Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how todispose medicines no longer required. These measures will help to protect the environment.