Nebivolol 5 Mg Tablets

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Package leaflet: Information for the patient Taking any of these medicines and Nebivolol may lower your blood pressure too much or Nebivolol 5 mg Tablets cause heart problems: (nebivolol) • medicines to lower your blood pressure such as verapamil, diltiazam, clonidine, guanfacin, Read all of this leaflet carefully before you moxonidine, methyldopa, rilmenidine, start taking this medicine because it might amlodipine, felodipine, lacidipine, nifedipine, contain important information for you. nicardipine, nimodipine, nitrendipine). • Keep this leaflet. You may need to read • medicines to treat abnormal heart it again. rhythms such as amiodarone, • If you have any further questions, ask your quinidine, hydroquinidine, cibenzoline, doctor or pharmacist. flecainide, disopyramide, lidocaine, • This medicine has been prescribed for you mexiletine, propafenone only. Do not pass it on to others. It may harm • medicines to treat depression or other them, even if their signs of illness are the mental problems such as paroxetine, same as yours. fluoxetine, thioridazine. • If you get any side effects talk to your doctor • barbiturates (used for epilepsy, anxiety or pharmacist. This includes any possible side or insomnia) effects not listed in this leaflet. See section 4. • baclofen (a muscle relaxant), • amifostine (used in cancer therapy) What is in this leaflet: • Mefloquine (antimalaria drug) 1. What Nebivolol is and what it is used for • Organic nitrates (to treat chest pain) 2. What you need to know before you • Quinidine (used to slow down the heart) take Nebivolol • Terbinafine (for fungal or yeast infections), 3. How to take Nebivolol • Bupropion (to help in cessation of smoking), 4. Possible side effects • Chloroquine (for malaria or 5. How to store Nebivolol rheumatoid arthritis) 6. Contents of the pack and other information • Levomepromazine (for mental health problems) 1. What Nebivolol is and what it is Also: used for • stimulants containing dopamine or decongestants containing ephedrine as they Nebivolol belongs to a group of medicines may increase your blood pressure too much or called beta-blockers that are used to lower cause heart problems. blood pressure. Nebivolol is used to treat: • insulin or any oral anti-diabetic medicines • high blood pressure (hypertension) because Nebivolol may mask symptoms of • elderly patients suffering from mild to hypoglycaemia (low sugar level of the blood) moderate heart failure in addition to standard like a racing heart beat or palpitations therapy (e.g. with diuretics, digoxin, ACE inhibitors, angiotensin II antagonists). Surgery Nebivolol may react with certain anaesthetics 2. What you need to know before you used in operations. So in the event that you take Nebivolol need any form of surgery, you should tell your doctor, dentist or the medical staff at the Do not take Nebivolol if you: hospital that you are taking Nebivolol. • are allergic to nebivolol or any of the other Pregnancy and breast-feeding ingredients of this medicine (listed in section Nebivolol should not be given to pregnant or 6). An allergic reaction may include rash, breast-feeding mothers unless the benefits to itching, swelling or difficulty breathing the mother outweigh the risks to the baby. • have liver problems • have had a heart attack, have heart failure If you are pregnant or breast-feeding, think which might be getting worse or have you may be pregnant or are planning to have a had intravenous medical treatment for baby, ask your doctor or pharmacist for advice heart failure. before taking this medicine. • have missed heart beats (conditions such as Driving and using machines sick sinus syndrome, sinoatrial block or second This medicine may cause dizziness or fainting as or third degree heart block) but have not been a result of a reduction in blood pressure. If these fitted with a pacemaker occur, do not drive or operate machinery. These • have or have had asthma or other serious effects are more likely to occur at the start of breathing problems the treatment or after dose increases (see also • have a tumour of the adrenal gland called a section 4). phaeochromocytoma that is not being treated • have a condition called metabolic acidosis Nebivolol contains lactose • suffer from a slow heart beat (fewer than If you have been told by your doctor that you 60 beats per minute, known as bradycardia) have an intolerance to some sugars, such as • you suffer from low blood pressure or have lactose, contact your doctor before taking this medicine. very poor circulation • use medicines containing floctafenine 3. How to take Nebivolol or sultopride Warnings and precautions Always take this medicine exactly as your doctor Talk to your doctor or pharmacist before taking or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Nebivolol if you: • have ongoing heart problems that are Always check that you have enough tablets and not being treated as Nebivolol may make do not run out. Try to take your tablets at the these worse. same time each day. Swallow the tablet with a • have Raynaud’s disease, poor circulation glass of water. You may take your tablets with or in the arms or legs or have periods when without food. walking is difficult, including bouts of limping The tablet can be divided into 4 equal doses. or lameness, as Nebivolol may make these conditions worse. Treatment for high blood pressure • have been told by a doctor that you have a Use in adults: The usual dose is 5 mg of first degree heart block (missed heart beats) Nebivolol once a day. It usually takes 1 – 2 weeks as Nebivolol may make this worse or slow for the medicine to work but occasionally it may down your heart rate. Your doctor may want take up to 4 weeks. to monitor your heart rate and if necessary Elderly: If you are over 65 years and taking change your dosage. Nebivolol to lower your blood pressure the • suffer from Prinzmetal’s angina as Nebivolol usual starting dose is 2.5 mg per day. However, may make your angina attacks worse. your doctor may increase this to 5 mg per day if • are diabetic as Nebivolol may mask some of they feel this is necessary. the signs that your blood sugar levels are low (hypoglycaemia). Patients with kidney disease: The usual dose is • have an over active thyroid gland 2.5 mg once a day. However, your doctor may (hyperthyroidism) as Nebivolol may mask some increase your dose to 5 mg per day if required. of the signs of this condition such as a fast heart Patients taking Nebivolol and another rate (tachycardia). medicine to lower your blood pressure • have problems with your lungs as Nebivolol When taken with hydrochlorothiazide the usual can cause further breathing difficulties. Your daily dose is 5 mg of Nebivolol and 12.5 – 25 mg doctor will advise you if you are at risk. of hydrochlorothiazide per day. • have a skin condition called psoriasis or if you suffer from hay fever or have other allergies Treatment for heart failure because Nebivolol may make these conditions Use in adults and the elderly: Your doctor will worse. Talk to your doctor if you are unsure start you on a low dose and gradually increase about whether to take this medication. your dose over 1 – 2 weekly intervals until your • wear contact lenses, as Nebivolol may cause condition has stabilised. The usual starting dose is 1.25 mg once daily for 1 –2 weeks, this may dry eyes. be increased to 2.5 mg once daily, then to 5 mg Other medicines and Nebivolol once daily and then to 10 mg once daily. The Tell your doctor or pharmacist if you are taking, maximum recommended dose is 10 mg once have recently taken or might take any other daily. Your doctor will tell you how much to take. medicines, including medicines obtained without a prescription or the following. Patients with kidney disease Nebivolol is not recommended for use in Do not take Nebivolol if you are taking any patients with severe kidney disease. Your doctor medicines containing floctafenine or sultopride will advise you whether Nebivolol is suitable for (see section ‘Do not take’ above). your condition. 1128741 50063018

Description Nebivolol 5 mg 28 Date: 08 Mar 2017 Time: 15:49

Component Type Leaflet Pharma Code 5184 No. of colours 1 Page Count 1/2

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v2/Oct 2016 Patients with liver disease In a clinical study for chronic heart failure, the If you suffer from liver disease do not following side effects were seen take Nebivolol. Very common side effects (may affect more than 1 in 10 people): Use in children and adolescents • dizziness Nebivolol is not recommended for use in • slow heart rate children or adolescents below 18 years. Common side effects (may affect up to 1 in If you take more Nebivolol than you should 10 people): Contact your doctor or casualty department • worsening of heart failure immediately. Take the container and any • low blood pressure (such as feeling faint when remaining tablets with you. Signs and getting up quickly) symptoms of overdose include: a slow heart • intolerance to Nebivolol rate, low blood pressure, wheezing and • a kind of light heart conduction disorder that difficulty breathing and sudden heart problems. affects heart rhythm (1st degree AV-block) If you forget to take Nebivolol • swelling of the lower limbs (such as If you forget to take a dose of Nebivolol do not swollen ankles). take a double dose to make up for a forgotten Reporting of side effects dose. Take the next dose on time. If you miss If you get any side effects, talk to your doctor several doses contact your doctor. or pharmacist. This includes any side effects If you stop taking Nebivolol not listed in this leaflet. You can also report side If you suddenly stop taking Nebivolol you are effects directly via the Yellow Card Scheme at: likely to suffer from side effects, or your illness www.mhra.gov.uk/yellowcard. By reporting side may get worse. If you need to stop taking this effects you can help provide more information medicine your doctor will reduce your dose on the safety of this medicine. slowly over a 2 week period. 5. How to store Nebivolol If you have any further questions on the use of this medicine, ask your doctor or pharmacist. Keep out of the sight and reach of children. 4. Possible side effects Do not use this medicine after the expiry date which is stated on the blister, carton or bottle Possible side effects label after EXP. The expiry date refers to the last Like all medicines, this medicine can cause side day of that month. effects, although not everybody gets them. This medicine does not require any special If any of the following happen, stop storage conditions. taking Nebivolol and tell your doctor Do not use this medicine if you notice any immediately or go to your nearest hospital discolouration of the tablets. emergency department: • tightness of the chest and difficulty breathing. Do not throw away any medicines via • serious allergic reactions which may cause a wastewater or household waste. Ask your rash, itching, hives or swelling of the face, lips, pharmacist how to throw away medicines you mouth or throat, which may cause difficulty in no longer use. These measures will help protect swallowing or breathing the environment. • heart failure which may cause shortness of breath, getting tired easily after light physical 6. Contents of the pack and activity or swelling of the feet or legs due to other information fluid build up • changes in the electrical activity of your heart What Nebivolol contains causing missed heart beats The active substance is nebivolol. Each tablet • problems with your eye such as inflammation, contains 5.45 mg of nebivolol hydrochloride dryness of the eye, redness or gritty-irritation of equivalent to 5 mg of nebivolol. the eyelid which may cause damage to the eye The other ingredients are lactose monohydrate • mental health problems (psychoses) which (see section 2 ‘Nebivolol contains lactose’), may cause you to hear, see or feel things that croscarmellose sodium, maize starch, aren’t there (hallucinations), have false beliefs polysorbate 80, hypromellose, microcrystalline (delusions), be confused, have disturbed or cellulose, colloidal anhydrous silica, unusual thoughts or behaviour magnesium stearate. Other possible side effects include: What Nebivolol look like and contents of Common side effects (may affect up to 1 in the pack 10 people): Nebivolol Tablets are white, rectangular, flat- • headaches faced, bevelled-edged tablets with 3 breaklines • tingling or pins and needles on each side. Each tablet is marked “N”, “L” “5” on • fainting on standing up one side only. • constipation, feeling sick (nausea) or diarrhoea • feeling tired This medicine is available in aluminium/ • fluid retention (swelling) aluminium foil blisters in packs of 7, 10, 14, • shortness of breath 28, 30, 50, 56, 60, 84, 90, 98 and 100 tablets, in opaque plastic bottles containing 100 or Uncommon side effects (may affect up to 1 in 500 tablets or in aluminium/aluminium 100 people): perforated unit dose blisters in pack sizes of 28 x • nightmares 1, 56 x 1, 100 x 1 tablets. • feelings of depression • problems with eyesight Not all pack sizes may be marketed. • slow heartbeat or other heart complaints Marketing Authorisation Holder • other changes in how your heart works, which Mylan, can be seen during heart exams Potters Bar, • low blood pressure Hertfordshire, • difficulty or pain walking including muscle EN6 1TL, cramps, limping or lameness United Kingdom • breathlessness such as in asthma, due to sudden cramps in the muscles around the Manufacturer airways (bronchospasm) Gerard Laboratories, • indigestion, flatulence (passing wind), being 35/36 Baldoyle Industrial Estate, sick (vomiting) Grange Road, • inability to get or maintain an erection Dublin 13, • skin rash, skin itchiness Ireland Very rare side effects (may affect up to 1 in Mylan Hungary Kft, 10,000 people): H-2900 Komárom, • fainting Mylan utca 1, • worsening of your psoriasis, or skin rash Hungary psoriasis-like (thickened patches of red skin, often with silvery scales) Not known (the frequency cannot be estimated from the available data): • whole-body allergic reactions, with generalised skin eruption (hypersensitivity reactions); • rapid-onset swelling, especially around the lips, eyes, or of the tongue with possible sudden difficulty breathing (angioedema); • kind of skin rash notable for pale red, raised, itchy bumps of allergic or non allergic causes (urticaria). The following side effects have been reported with medicines of the same type as nebivolol, so may be seen with this medicine. The frequency cannot be estimated from the available data: • cold fingers and toes with bluish discolouration of the skin (Raynaud’s phenomenon) • dry eyes

This leaflet was last approved in March 2017 1128741 50063018

Description Nebivolol 5 mg 28 Date: 08 Mar 2017 Time: 15:49

Component Type Leaflet Pharma Code 5184 No. of colours 1 Page Count 2/2

v2/Oct 2016