Artwork No. - Colours Used Customer Accord (BST to ONE) Pantone Black Description Nebivolol hyd Market UK Language English Size 170 x 550 (PIL) Min. Font Size 10 Version No. 1 (Page 1 of 2) Keyline Date 08_09_20 (Nebivolol hyd (ACC-UK) PIL) Prepared By Checked By Approved By Regulatory Affairs Regulatory Affairs Quality Assurance

If you take more Nebivolol 5mg tablets Do not use Nebivolol 5mg tablets Package lea et: Information for the patient than you should after the expiry date which is stated If you accidentally take an overdose of this on the carton after Exp. The expiry medicine, tell your doctor or pharmacist date refers to the last day of that Nebivolol 5mg tablets immediately. The most frequent month. symptoms and signs of a Nebivolol (nebivolol hydrochloride) overdose are very slow heart beat Do not throw away any medicines via (bradycardia), low blood pressure with possible wastewater or household waste. Ask your Read all of this lea et carefully before as verapamil, diltiazem, amlodipine, felodipine, fainting (hypotension), breathlessness such as in pharmacist how to throw away medicines you you start taking this medicine because it lacidipine, nifedipine, nicardipine, nimodipine asthma (bronchospasm), and acute heart failure. no longer use. These measures will help to contains important information for you. and nitrendipine. It is particularly important You can take activated charcoal (which is protect the environment. that verapamil is not injected into a vein • Keep this leaflet. You may need to read it available at your pharmacy) while you wait for during treatment with nebivolol. the arrival of the doctor. again. • Clonidine, guanfacine, moxonidine, 6 Contents of the pack and other • If you have any further questions, ask methyldopa and rilmenidine, which are used If you forget to take Nebivolol 5mg tablets information your doctor or pharmacist. to treat high blood pressure. If you forget to take a dose, take one as soon as • This medicine has been prescribed for • Quinidine, hydroquinidine, amiodarone, you remember, unless it is almost time for your cibenzoline, flecainide, disopyramide, What Nebivolol 5mg tablets contain you only. Do not pass it on to others. It next dose. Then go on as before. Do not take a The active substance is nebivolol hydrochloride lidocaine, mexiletine and propafenone, which double dose to make up for a forgotten dose. may harm them, even if their signs of are used to treat cardiac arrhythmias (irregular corresponding to 5mg nebivolol. The other ingredients are silica colloidal illness are the same as yours. heartbeat). If you stop taking Nebivolol 5mg tablets • Barbiturates and phenothiazine, which are hydrated, magnesium stearate, croscarmellose • If you get any side effects, talk to your You should not stop treatment abruptly as this sodium, polyethylene glycol 6000, and lactose. doctor or pharmacist. This includes any used to treat anxiety and levomepromazine for can worsen heart failure. Your doctor will reduce schizophrenia. your dose of nebivolol gradually. possible side effects not listed in this • Amitriptyline, trazodone, paroxetine, fluoxetine What Nebivolol 5mg tablets look like and contents of the pack leaflet. See section 4. and thioridiazine, which are used to treat If you have any further questions on the use of depression. Round, white, convex cross-scored tablets this medicine, ask your doctor or pharmacist. (snap-tab cross score), marked “NE3” on the What is in this lea et: • Asthma medications, medications for blocked nose (e.g. pseudoephedrine) or for certain eye other side. The tablets can be divided into equal 1 What Nebivolol 5mg tablets are and quarters. disorders such as glaucoma (increased 4 Possible side eects what they are used for pressure in the eye) or dilation of the pupil. 2 What you need to know before you • Medicines for diabetes (insulin and medicines Pack size: 28 tablets Like all medicines, this medicine can cause side take Nebivolol 5mg tablets for oral use). effects, although not everybody gets them. Marketing Authorisation Holder 3 How to take Nebivolol 5mg tablets • Anaesthetics. Always inform your anaesthetist that you are on nebivolol before being Accord Healthcare Limited 4 Possible side eects If any of the following happen, stop taking anaesthetised. Sage House Nebivolol and tell your doctor immediately or 5 How to store Nebivolol 5mg tablets • Antacids (e.g. cimetidine), which are used to 319 Pinner Road go to your nearest hospital emergency 6 Contents of the pack and other treat excessive stomach acid. If you are being North Harrow department: treated for excessive stomach acid, you should Middlesex information • whole-body allergic reaction, with generalised take nebivolol during a meal, and the antacid HA1 4HF skin eruption (hypersensitivity reactions) drug between meals. United Kingdom • rapid-onset swelling, especially around the • Dextromethorphan (found in cough 1 What Nebivolol 5mg tablets are and lips, eyes, or of the tongue with sudden medicines). Manufacturer what they are used for difficulty breathing (angioedema). • Non-Steroidal Anti-Inflammatory Drugs Balkanpharma – Dupnitsa AD, 3 Samokovsko (NSAIDs) such as ibuprofen and diclofenac, Shosse Str., Dupnitsa 2600, Bulgaria Nebivolol 5mg tablets belong to a group of Hypertension which are used to treat certain types of pain medicines known as beta-blockers. They work by The side effects reported in people taking and inflammation. Accord Healthcare Limited, blocking the activity of specific proteins in the nebivolol for hypertension are listed below: • Baclofen (a muscle relaxant). Sage House, 319 Pinner Road, North Harrow, heart, lungs, pancreas, liver, and blood • Amifostine (used to treat some infections), Middlesex, HA1 4HF, United Kingdom circulation system. Common side eects (may aect up to 1 in 10 chloroquine (used to treat malaria) and Nebivolol 5mg tablets are used to treat: people) terbinafine (for fungal infections). Accord, Barnstaple, EX32 8NS, UK • high blood pressure (hypertension) • Headache • Bupropion for smoking cessation. • chronic heart failure in patients aged 70 years • Dizziness This lea et was last revised January 2021 or older. • Tiredness Taking Nebivolol 5mg tablets with food and • An unusual itching or tingling feeling drink • Diarrhoea Nebivolol can be taken with or without food • Constipation 2 What you need to know before you unless you take antacids (see “Taking other • Nausea (feeling sick) take Nebivolol 5mg tablets medicines”). The tablet should be swallowed • Shortness of breath with a glass of water or other liquid. • Swollen hands or feet Do not take Nebivolol 5mg tablets if you: • are allergic to nebivolol or any of the other Pregnancy and breast-feeding Uncommon side eects (may aect up to 1 in ingredients of this medicine (listed in section Nebivolol should not be used during pregnancy, 100 people) 6). unless clearly necessary. It is not recommended • Slow heartbeat or other heart complaints • suffer from liver problems. for use while breast-feeding. • Low blood pressure • have low blood pressure or poor circulation • Cramp-like leg pains on walking in the arms or legs. Ask your doctor or pharmacist for • Abnormal vision • have a very slow heart beat (less than 60 advice before taking any medicine. • Impotence beats per minute). • Depressive feelings • have certain serious heart rhythm problems. Driving and using machines • Indigestion • have the condition heart failure which has Nebivolol may cause tiredness and/or • Gas in stomach or bowel just occurred or which has recently become dizziness and if you are affected you • Vomiting worse. should not drive or use any machines • Skin rash • have asthma or wheezing (now or in the past). or tools. • Tightness in the throat • have been told by your doctor that you have a • Nightmares tumour in your adrenal gland which is located Nebivolol 5mg tablets contain lactose • Itching on top of the kidneys (the medical term for this If you have been told by your doctor that you is an untreated phaeochromocytoma). have an intolerance to some sugars, contact Very rare side eects (may aect up to 1 in • have metabolic acidosis such as diabetic your doctor before taking this medicine. 10,000 people) ketoacidosis. • fainting This medicine contains less than 1mmol sodium • worsening of psoriasis (a skin disease - scaly If you are unsure, contact your doctor. (23 mg) per 5mg tablet, that is to say essentially pink patches) ‘sodium-free’. Warnings and precautions The following side eects have been reported Talk to your doctor or pharmacist before taking only in some isolated cases during Nebivolol Nebivolol 5mg tablets if you: 3 How to take Nebivolol 5mg tablets treatment • notice that your heart rate is abnormally slow • skin rash notable for pale red, raised, itchy or you experience shortness of breath or Always take this medicine exactly as your doctor bumps of allergic or non allergic causes dizziness. or pharmacist has told you. Check with your (urticaria). • have ischaemic heart disease such as angina doctor or pharmacist if you are not sure. (chest pains). Chronic Heart Failure • have been told you suffer from any of the Nebivolol 5mg tablets may be taken before, The side effects reported in people taking following conditions: during or after the meal, but, alternatively, you nebivolol for chronic heart failure are listed - Poor blood circulation which makes the toes can take it independently of meals. The tablet is below: and fingers numb and pale (Raynaud’s best taken with some water. disease). Very common side eects (may aect more - A type of chest pain due to spontaneously Treatment of high blood pressure than 1 in 10 people) occurring heart cramp called Prinzmetal (hypertension) • Slow heartbeat angina. The recommended dose is one tablet (5mg) • Dizziness - Pain, tension and weakness in the legs when daily, although elderly patients and patients walking which is relieved by rest with kidney problems may begin treatment on a Common side eects (may aect up to 1 in 10 (intermittent claudication). lower dose. people) - A persistent obstruction of your airway such • Worsening of heart failure as chronic bronchitis. The blood pressure lowering effect may take up • Low blood pressure (with symptoms such as - Diabetes, as it can hide the warning signs of to 1-2 weeks of treatment to become evident. feeling faint when you get up quickly) low sugar levels. Occasionally, the optimal effect is only reached • Inability to tolerate the medicine - Overactivity of the thyroid gland after 4 weeks. • Irregular heartbeat (hyperthyroidism). • Swollen legs, ankles, or feet - A skin condition known as psoriasis. Treatment of chronic heart failure - Impairment of the electrical conduction of The recommended initial dose is 1.25mg daily. Reporting of side eects signals in the heart (rst degree heart block). This may be increased after 1-2 weeks to half a If you get any side effects, talk to your doctor, • are being treated with any other drugs which tablet daily (2.5mg) and then to 1 tablet daily pharmacist or nurse. This includes any possible lower your blood pressure. (5mg). This may be further increased to a side effects not listed in this leaflet. You can also maximum recommended dose of 2 tablets daily report side effects directly via the Yellow Card If you need to have an operation and need an (10mg). Scheme at: www.mhra.gov.uk/yellowcard or anaesthetic, it is important that you tell the surgeon search for MHRA Yellow Card in the Google Play or dentist that you are taking this medicine. Your doctor may reduce your dose if necessary. or Apple App Store. Every time your dose is changed, your doctor Other medicines and Nebivolol 5mg tablets will monitor you for approximately two hours. By reporting side effects you can help provide Tell your doctor or pharmacist if you are taking, more information on the safety of this medicine. have recently taken or might take any other Your doctor may decide to combine your tablets medicines. with other medicines for your condition. 5 How to store Nebivolol 5mg tablets The following medicines may interact with Use in children and adolescents nebivolol by decreasing or increasing its effects: There are limited data in children and hence Keep out of the sight and reach of children. Nebivolol 5mg tablets are not recommended in • Calcium channel blockers, used to treat high children and adolescents under 18 years of age. This medicinal product does not require any blood pressure or other heart problems, such special storage conditions. continued top of next column continued over page

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(6004463) Date: 03_10_20, 31_10_20, 20_11_20, 30_12_20, 11_01_21 Artwork No. - Colours Used Customer Accord (BST to ONE) Pantone Black Description Nebivolol hyd Market UK Language English Size 170 x 550 (PIL) Min. Font Size 10 Version No. 1 (Page 2 of 2) Keyline Date 08_09_20 (Nebivolol hyd (ACC-UK) PIL) Prepared By Checked By Approved By Regulatory Affairs Regulatory Affairs Quality Assurance

If you take more Nebivolol 5mg tablets Do not use Nebivolol 5mg tablets than you should after the expiry date which is stated If you accidentally take an overdose of this on the carton after Exp. The expiry medicine, tell your doctor or pharmacist date refers to the last day of that immediately. The most frequent month. symptoms and signs of a Nebivolol overdose are very slow heart beat Do not throw away any medicines via (bradycardia), low blood pressure with possible wastewater or household waste. Ask your Read all of this lea et carefully before as verapamil, diltiazem, amlodipine, felodipine, fainting (hypotension), breathlessness such as in pharmacist how to throw away medicines you you start taking this medicine because it lacidipine, nifedipine, nicardipine, nimodipine asthma (bronchospasm), and acute heart failure. no longer use. These measures will help to contains important information for you. and nitrendipine. It is particularly important You can take activated charcoal (which is protect the environment. that verapamil is not injected into a vein • Keep this leaflet. You may need to read it available at your pharmacy) while you wait for during treatment with nebivolol. the arrival of the doctor. again. • Clonidine, guanfacine, moxonidine, 6 Contents of the pack and other • If you have any further questions, ask methyldopa and rilmenidine, which are used If you forget to take Nebivolol 5mg tablets information your doctor or pharmacist. to treat high blood pressure. If you forget to take a dose, take one as soon as • This medicine has been prescribed for • Quinidine, hydroquinidine, amiodarone, you remember, unless it is almost time for your cibenzoline, flecainide, disopyramide, What Nebivolol 5mg tablets contain you only. Do not pass it on to others. It next dose. Then go on as before. Do not take a The active substance is nebivolol hydrochloride lidocaine, mexiletine and propafenone, which double dose to make up for a forgotten dose. may harm them, even if their signs of are used to treat cardiac arrhythmias (irregular corresponding to 5mg nebivolol. The other ingredients are silica colloidal illness are the same as yours. heartbeat). If you stop taking Nebivolol 5mg tablets • Barbiturates and phenothiazine, which are hydrated, magnesium stearate, croscarmellose • If you get any side effects, talk to your You should not stop treatment abruptly as this sodium, polyethylene glycol 6000, and lactose. doctor or pharmacist. This includes any used to treat anxiety and levomepromazine for can worsen heart failure. Your doctor will reduce schizophrenia. your dose of nebivolol gradually. possible side effects not listed in this • Amitriptyline, trazodone, paroxetine, fluoxetine What Nebivolol 5mg tablets look like and contents of the pack leaflet. See section 4. and thioridiazine, which are used to treat If you have any further questions on the use of depression. Round, white, convex cross-scored tablets this medicine, ask your doctor or pharmacist. (snap-tab cross score), marked “NE3” on the What is in this lea et: • Asthma medications, medications for blocked nose (e.g. pseudoephedrine) or for certain eye other side. The tablets can be divided into equal 1 What Nebivolol 5mg tablets are and quarters. disorders such as glaucoma (increased 4 Possible side eects what they are used for pressure in the eye) or dilation of the pupil. 2 What you need to know before you • Medicines for diabetes (insulin and medicines Pack size: 28 tablets Like all medicines, this medicine can cause side take Nebivolol 5mg tablets for oral use). effects, although not everybody gets them. Marketing Authorisation Holder 3 How to take Nebivolol 5mg tablets • Anaesthetics. Always inform your anaesthetist that you are on nebivolol before being Accord Healthcare Limited 4 Possible side eects If any of the following happen, stop taking anaesthetised. Sage House Nebivolol and tell your doctor immediately or 5 How to store Nebivolol 5mg tablets • Antacids (e.g. cimetidine), which are used to 319 Pinner Road go to your nearest hospital emergency 6 Contents of the pack and other treat excessive stomach acid. If you are being North Harrow department: treated for excessive stomach acid, you should Middlesex information • whole-body allergic reaction, with generalised take nebivolol during a meal, and the antacid HA1 4HF skin eruption (hypersensitivity reactions) drug between meals. United Kingdom • rapid-onset swelling, especially around the • Dextromethorphan (found in cough 1 What Nebivolol 5mg tablets are and lips, eyes, or of the tongue with sudden medicines). Manufacturer what they are used for difficulty breathing (angioedema). • Non-Steroidal Anti-Inflammatory Drugs Balkanpharma – Dupnitsa AD, 3 Samokovsko (NSAIDs) such as ibuprofen and diclofenac, Shosse Str., Dupnitsa 2600, Bulgaria Nebivolol 5mg tablets belong to a group of Hypertension which are used to treat certain types of pain medicines known as beta-blockers. They work by The side effects reported in people taking and inflammation. Accord Healthcare Limited, blocking the activity of specific proteins in the nebivolol for hypertension are listed below: • Baclofen (a muscle relaxant). Sage House, 319 Pinner Road, North Harrow, heart, lungs, pancreas, liver, and blood • Amifostine (used to treat some infections), Middlesex, HA1 4HF, United Kingdom circulation system. Common side eects (may aect up to 1 in 10 chloroquine (used to treat malaria) and Nebivolol 5mg tablets are used to treat: people) terbinafine (for fungal infections). Accord, Barnstaple, EX32 8NS, UK • high blood pressure (hypertension) • Headache • Bupropion for smoking cessation. • chronic heart failure in patients aged 70 years • Dizziness This lea et was last revised January 2021 or older. • Tiredness Taking Nebivolol 5mg tablets with food and • An unusual itching or tingling feeling drink • Diarrhoea Nebivolol can be taken with or without food • Constipation 2 What you need to know before you unless you take antacids (see “Taking other • Nausea (feeling sick) take Nebivolol 5mg tablets medicines”). The tablet should be swallowed • Shortness of breath with a glass of water or other liquid. • Swollen hands or feet Do not take Nebivolol 5mg tablets if you: • are allergic to nebivolol or any of the other Pregnancy and breast-feeding Uncommon side eects (may aect up to 1 in ingredients of this medicine (listed in section Nebivolol should not be used during pregnancy, 100 people) 6). unless clearly necessary. It is not recommended • Slow heartbeat or other heart complaints • suffer from liver problems. for use while breast-feeding. • Low blood pressure • have low blood pressure or poor circulation • Cramp-like leg pains on walking in the arms or legs. Ask your doctor or pharmacist for • Abnormal vision • have a very slow heart beat (less than 60 advice before taking any medicine. • Impotence beats per minute). • Depressive feelings • have certain serious heart rhythm problems. Driving and using machines • Indigestion • have the condition heart failure which has Nebivolol may cause tiredness and/or • Gas in stomach or bowel just occurred or which has recently become dizziness and if you are affected you • Vomiting worse. should not drive or use any machines • Skin rash • have asthma or wheezing (now or in the past). or tools. • Tightness in the throat • have been told by your doctor that you have a • Nightmares tumour in your adrenal gland which is located Nebivolol 5mg tablets contain lactose • Itching on top of the kidneys (the medical term for this If you have been told by your doctor that you is an untreated phaeochromocytoma). have an intolerance to some sugars, contact Very rare side eects (may aect up to 1 in • have metabolic acidosis such as diabetic your doctor before taking this medicine. 10,000 people) ketoacidosis. • fainting This medicine contains less than 1mmol sodium • worsening of psoriasis (a skin disease - scaly If you are unsure, contact your doctor. (23 mg) per 5mg tablet, that is to say essentially pink patches) ‘sodium-free’. Warnings and precautions The following side eects have been reported Talk to your doctor or pharmacist before taking only in some isolated cases during Nebivolol Nebivolol 5mg tablets if you: 3 How to take Nebivolol 5mg tablets treatment • notice that your heart rate is abnormally slow • skin rash notable for pale red, raised, itchy or you experience shortness of breath or Always take this medicine exactly as your doctor bumps of allergic or non allergic causes dizziness. or pharmacist has told you. Check with your (urticaria). • have ischaemic heart disease such as angina doctor or pharmacist if you are not sure. (chest pains). Chronic Heart Failure • have been told you suffer from any of the Nebivolol 5mg tablets may be taken before, The side effects reported in people taking following conditions: during or after the meal, but, alternatively, you nebivolol for chronic heart failure are listed - Poor blood circulation which makes the toes can take it independently of meals. The tablet is below: and fingers numb and pale (Raynaud’s best taken with some water. disease). Very common side eects (may aect more - A type of chest pain due to spontaneously Treatment of high blood pressure than 1 in 10 people) occurring heart cramp called Prinzmetal (hypertension) • Slow heartbeat angina. The recommended dose is one tablet (5mg) • Dizziness - Pain, tension and weakness in the legs when daily, although elderly patients and patients walking which is relieved by rest with kidney problems may begin treatment on a Common side eects (may aect up to 1 in 10 (intermittent claudication). lower dose. people) - A persistent obstruction of your airway such • Worsening of heart failure as chronic bronchitis. The blood pressure lowering effect may take up • Low blood pressure (with symptoms such as - Diabetes, as it can hide the warning signs of to 1-2 weeks of treatment to become evident. feeling faint when you get up quickly) low sugar levels. Occasionally, the optimal effect is only reached • Inability to tolerate the medicine - Overactivity of the thyroid gland after 4 weeks. • Irregular heartbeat (hyperthyroidism). • Swollen legs, ankles, or feet - A skin condition known as psoriasis. Treatment of chronic heart failure - Impairment of the electrical conduction of The recommended initial dose is 1.25mg daily. Reporting of side eects signals in the heart (rst degree heart block). This may be increased after 1-2 weeks to half a If you get any side effects, talk to your doctor, • are being treated with any other drugs which tablet daily (2.5mg) and then to 1 tablet daily pharmacist or nurse. This includes any possible lower your blood pressure. (5mg). This may be further increased to a side effects not listed in this leaflet. You can also maximum recommended dose of 2 tablets daily report side effects directly via the Yellow Card If you need to have an operation and need an (10mg). Scheme at: www.mhra.gov.uk/yellowcard or anaesthetic, it is important that you tell the surgeon search for MHRA Yellow Card in the Google Play or dentist that you are taking this medicine. Your doctor may reduce your dose if necessary. or Apple App Store. Every time your dose is changed, your doctor Other medicines and Nebivolol 5mg tablets will monitor you for approximately two hours. By reporting side effects you can help provide Tell your doctor or pharmacist if you are taking, more information on the safety of this medicine. have recently taken or might take any other Your doctor may decide to combine your tablets medicines. with other medicines for your condition. 5 How to store Nebivolol 5mg tablets The following medicines may interact with Use in children and adolescents nebivolol by decreasing or increasing its effects: There are limited data in children and hence Keep out of the sight and reach of children. Nebivolol 5mg tablets are not recommended in • Calcium channel blockers, used to treat high children and adolescents under 18 years of age. This medicinal product does not require any blood pressure or other heart problems, such special storage conditions. INP113 continued top of next column 10 4754 0 6004463

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(6004463) Date: 03_10_20, 31_10_20, 20_11_20, 30_12_20, 11_01_21