Nebivolol 5mg Tablets
Nebivolol 5mg tablets
(nebivolol hydrochloride)
Read all of this leaflet carefully before you start taking this
medicine.
• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
j What Nebivolol 5mg tablets are and what they are used for Before you take 31 How to take
Possible side effects 3| How to store
Further information
j What Nebivolol 5mg tablets are and what they are used for
Nebivolol 5mg tablets belong to a group of medicines known as beta-blockers. They work by blocking the activity of specific proteins in the heart, lungs, pancreas, liver, and blood circulation system.
Nebivolol 5mg tablets are used to treat.
• high blood pressure (hypertension)
• chronic heart failure in patients aged 70 years or older.
31 Before you take
Do not take Nebivolol 5mg tablets if you:
• are allergic (hypersensitive) to nebivolol or any of the other ingredients of Nebivolol 5mg tablets.
• suffer from liver problems.
• have low blood pressure or poor circulation in the arms or legs.
• have a very slow heart beat (less than 60 beats per minute)
• have certain serious heart rhythm problems.
• have the condition heart failure which has just occurred or which has recently become worse.
• have asthma or wheezing (now or in the past).
• have been told by your doctor that you have a tumour in your adrenal gland which is located on top of the kidneys (the medical term for this is an untreated phaeochromocytoma).
• have metabolic acidosis such as diabetic ketoacidosis.
If you are unsure, contact your doctor.
Take special care with Nebivolol 5mg tablets:
Tell your doctor before you start to take this medicine if you:
• notice that your heart rate is abnormally slow or you experience shortness of breath or dizziness.
• have ischaemic heart disease such as angina (chest pains).
• have been told you suffer from any of the following conditions:
- Poor blood circulation which makes the toes and fingers numb and pale (Raynaud's disease)
- A type of chest pain due to spontaneously occurring heart cramp called Prinzmetal angina.
- Pain, tension and weakness in the legs when walking which is relieved by rest (Intermittent claudication).
- A persistent obstruction of your airway such as chronic bronchitis.
- Diabetes, as it can hide the warning signs of low sugar levels.
- Over activity of the thyroid gland (Hyperthyroidism).
- A skin condition known as psoriasis.
- Impairment of the electrical conduction of signals in the heart (First degree heart block).
• are being treated with any other drugs which lower your blood pressure.
If you need to have an operation and need an anaesthetic, it is important that you tell the surgeon or dentist that you are taking this medicine.
continued top of next column
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
The following medicines may interact with nebivolol by decreasing or increasing its effects:
• Calcium channel blockers, used to treat high blood pressure or other heart problems, such as verapamil, diltiazem, amlodipine, felodipine, lacidipine, nifedipine, nicardipine, nimodipine and nitrendipine. It is particularly important that verapamil is not injected into a vein during treatment with nebivolol.
• Clonidine, guanfacine, moxonidine, methyldopa and rilmenidine, which are used to treat high blood pressure.
• Quinidine, hydroquinidine, amiodarone, cibenzoline, flecainide, disopyramide, lidocaine, mexiletine and propafenone, which are used to treat cardiac arrhythmias (irregular heartbeat).
• Barbiturates and phenothiazine, which are used to treat anxiety and levomepromazine for schizophrenia.
• Amitriptyline, trazodone, paroxetine, fluoxetine and thioridiazine, which are used to treat depression.
• Asthma medications, medications for blocked nose (e.g. pseudoephedrine) or for certain eye disorders such as glaucoma (increased pressure in the eye) or dilation of the pupil.
• Medicines for diabetes (insulin and medicines for oral use).
• Anaesthetics. Always inform your anaesthetist that you are on nebivolol before being anaesthetized.
• Antacids (e.g. cimetidine), which are used to treat excessive stomach acid. If you are being treated for excessive stomach acid, you should take nebivolol during a meal, and the antacid drug between meals.
• Dextromethorphan (found in cough medicines).
• Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen and diclofenac, which are used to treat certain types of pain and inflammation.
• Baclofen (a muscle relaxant).
• Amifostine (used to treat some infections), chloroquine (used to treat malaria) and terbinafine (for fungal infections).
• Bupropion for smoking cessation.
Taking Nebivolol 5mg tablets with food and drink
Nebivolol can be taken with or without food unless you take antacids (see "Taking other medicines”). The tablet should be swallowed with a glass of water or other liquid.
Pregnancy and breast-feeding
Nebivolol should not be used during pregnancy, unless clearly necessary. It is not recommended for use while breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Nebivolol may cause tiredness and/or dizziness and if you are affected you should not drive or use any machines or tools.
Sugar intolerance
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
^ How to take
Always take Nebivolol 5mg tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Treatment of high blood pressure (hypertension)
The usual dose is one tablet (5mg) daily, although elderly patients and patients with kidney problems may begin treatment on a lower dose.
The blood pressure lowering effect may take up to 1-2 weeks of treatment to become evident. Occasionally, the optimal effect is only reached after 4 weeks.
Treatment of chronic heart failure
The usual initial dose is 1.25mg daily. This may be increased after 1-2 weeks to half a tablet daily (2.5mg) and then to 1 tablet daily (5mg). This may be further increased to a maximum recommended dose of 2 tablets daily (10mg).
Your doctor may reduce your dose if necessary. Every time your dose is changed, your doctor will monitor you for approximately two hours.
continued over page
Your doctor may decide to combine your tablets with other medicines for your condition.
Children and Adolescents
There are limited data in children and hence Nebivolol 5 mg tablets are not recommended in children and adolescents under 18 years of age.
If you take more Nebivolol 5mg tablets than you should
If you accidentally take too much nebivolol, tell your doctor immediately or go to your nearest accident and emergency department.
If you forget to take Nebivolol 5mg tablets
If you forget to take a dose, take one as soon as you remember, unless it is almost time for your next dose. Then go on as before. Do not take a double dose to make up for a forgotten dose.
If you stop taking Nebivolol 5mg tablets
You should not stop treatment abruptly as this can worsen heart failure. Your doctor will reduce your dose of nebivolol gradually.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
□ Possible Side Effects
Like all medicines, Nebivolol 5mg tablets can cause side effects, although not everybody gets them.
Hypertension
The side effects reported in people taking nebivolol for hypertension are listed below:
The following side effects have been reported only in some isolated cases during Nebivolol treatment
• whole-body allergic reaction, with generalised skin eruption (hypersensitivity reactions)
Very rare Side Effects (that affect fewer than 1 person in every 10,000 treated)
• fainting
• worsening of psoriasis (a skin disease -scaly pink patches)
• rapid-onset swelling, especially around the lips, eyes, or of the tongue with sudden difficulty breathing (angioedema).
Q How to store
Keep out of the reach and sight of children.
This medicinal product does not require any special storage conditions.
Do not use Nebivolol 5mg tablets after the expiry date which is stated on the carton after Exp.. The 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.
B Further information
What Nebivolol 5mg tablets contain
The active substance is nebivolol hydrochloride corresponding to 5mg nebivolol.
The other ingredients are silica colloidal anhydrous, magnesium stearate, croscarmellose sodium, macrogol 6000, and lactose monohydrate.
What Nebivolol 5mg tablets look like and contents of the pack
Round, white, biconvex tablets with a cross-score on one side and marked "N5” on the other. The tablets can be divided into equal quarters.
Pack size: 28 tablets Marketing Authorisation Holder
Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220 Hafnarfjordur, Iceland.
Manufacturer
Balkanpharma - Dupnitsa AD, 3 Samokovsko Shosse Str.,
Dupnitsa 2600, Bulgaria
This leaflet was last revised March 2012
Uncommon Side Effects (that affect more than 1 person in every 1000 but fewer than 1 person in 100)
• Slow heartbeat or other heart complaints
• Low blood pressure
• Cramp-like leg pains on walking
• Abnormal vision
• Impotence
• Depressive feelings
• Indigestion
• Gas in stomach or bowel
• Vomiting
• Skin rash
• Tightness in the throat
• Nightmares
• Itching
Common Side Effects (that affect more than 1 person in every 100 treated but fewer than 1 person in every 10 treated)
• Headache
• Dizziness
• Tiredness
• An unusual itching or tingling feeling
• Diarrhoea
• Constipation
• Nausea (feeling sick)
• Shortness of breath
• Swollen hands or feet
Chronic Heart Failure
The side effects reported in people taking nebivolol for chronic heart failure are listed below:
Common Side Effects (that affect more than 1 person in every 100 treated but fewer than 1 person in every 10 treated)
• Worsening of heart failure
• Low blood pressure (with symptoms such as feeling faint when you get up quickly)
• Inability to tolerate the medicine
• Irregular heartbeat
• Swollen legs, ankles, or feet
Very Common Side Effects (that affect more than 1 person in every 10 treated)
• Slow heartbeat
• Dizziness
^actavis
Actavis, Barnstaple, EX32 8NS, UK
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
AAAD4846