Nebivolol 5mg Tablets
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NEBIVOLOL 5 mg TABLETS
(nebivolol)
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:
1. What Nebivolol is and what it is used for.
2. Before you take Nebivolol.
3. How to take Nebivolol.
4. Possible side effects.
5. How to store Nebivolol.
6. Further information.
1. WHAT NEBIVOLOL IS AND WHAT IT IS USED FOR
Nebivolol belongs to a group of medicines called beta blockers that are used to lower blood pressure. Nebivolol is used to treat:
• high blood pressure (hypertension)
• elderly patients suffering from mild to moderate heart failure in addition to standard therapy (e.g. with diuretics, digoxin, ACE inhibitors, angiotensin II antagonists).
2. BEFORE YOU TAKE NEBIVOLOL
Do not take Nebivolol if you:
• are allergic (hypersensitive) to nebivolol or any of the other ingredients of this medicine (an allergic reaction may include rash, itching, swelling or difficulty breathing)
• have liver problems
• have had a heart attack, a severe heart failure or have had intravenous medical treatment for heart failure.
• have missed heart beats (conditions such as sick sinus syndrome, sinoatrial block or second or third degree heart block) but have not been fitted with a pacemaker
• have severe asthma or other serious breathing problems
• have a tumour of the adrenal gland called a phaeochromocytoma that is not being treated
• have a condition called metabolic acidosis
• suffer from a slow heart beat (known as bradycardia)
• you suffer from low blood pressure or have very poor circulation
• use medicines containing Floctafenine or Sultopride.
Take special care with Nebivolol - You should tell your doctor before taking this medicine if you:
• have ongoing heart problems that are not being treated as Nebivolol may make these worse
• have Raynaud's disease or have periods when walking is difficult, including bouts of limping or lameness, as Nebivolol may make these conditions worse
• have been told by a doctor that you have a first degree block (missed heart beats) as Nebivolol may make this worse or slow down your heart rate. Your doctor may want to monitor your heart rate and if necessary change your dosage
• suffer from Prinzmetal's angina as Nebivolol may make your angina attacks worse
• are diabetic as Nebivolol may mask some of the signs that your blood sugar levels are low (hypoglycaemia)
• have an over active thyroid gland as Nebivolol may mask some of the signs of this condition such as a fast heart rate (tachycardia)
• have problems with your lungs as Nebivolol can cause further breathing difficulties.
Your doctor will advise you if you are at risk
• have a skin condition called Psoriasis or if you suffer from hay fever or have other allergies because Nebivolol may make these conditions worse. Talk to your doctor if you are unsure about whether to take this medication
• wear contact lenses, as Nebivolol may cause dry eyes.
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 or the following.
Do not take Nebivolol if you are taking any medicines containing Floctafenine or Sultopride (see Section 'Do not take' above).
Taking any of these medicines and Nebivolol may lower your blood pressure too much or cause heart problems:
• medicines to lower your blood pressure such as Verapamil, Diltiazam, Clonidine, Guanfacin, Moxonidine, Methyldopa, Rilmenidine, Amlodipine, Felodipine, Lacidipine, Nifedipine, Nicardipine, Nimodipine, Nitrendipine)
• medicines to treat abnormal heart rhythms such as Amiodarone, Quinidine, Hydroquinidine, Cibenzoline, Flecainide, Disopyramide, Lidocaine, Mexiletine, Propafenone
• medicines to treat depression or other mental problems such as Paroxetine, Fluoxetine, Thioridizine
• Baclofen (a muscle relaxant)
• Amifostine (used in cancer therapy)
• Mefloquine (antimalaria drug)
• organic nitrates (to treat chest pain)
• quinidine (used to slow down the heart)
• Terbinafine (for fungal or yeast infections)
• Bupropion (to help in cessation of smoking)
• Chloroquine (for malaria or rheumatoid arthritis)
• Levomepromazine (for mental health problems).
Also:
• stimulants containing dopamine or decongestants containing ephedrine as they may increase your blood pressure too much or cause heart problems
• insulin or any oral anti-diabetic medicines because Nebivolol may mask symptoms of hypoglycaemia (low sugar level of the blood) like a racing heart beat or palpitations.
Surgery - Nebivolol may react with certain anaesthetics used in operations. So in the event that you need any form of surgery, you should tell the medical staff at the hospital that you are taking Nebivolol.
Pregnancy and breast-feeding - Nebivolol should not be given to pregnant or breast-feeding mothers unless the benefits to the mother outweigh the risks to the baby. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines - This medicine may cause dizziness or fainting as a result of reduction in blood pressure. If these occur, do not drive or operate machinery. These effects are more likely to occur after initiation of the treatment or after dose increases (see also Section 4).
Important information about some of the ingredients of Nebivolol - This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, such as lactose, contact your doctor before taking this medicine.
3. HOW TO TAKE NEBIVOLOL
Always take Nebivolol exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Always check that you have enough tablets and do not run out. Try to take your tablets at the same time each day. Swallow the tablet with a glass of water. You may take your tablets with or without food.
Treatment for high blood pressure:
Adults - The usual dose is 5 mg of Nebivolol once a day. It usually takes 1-2 weeks for the medicine to work but occasionally it may take up to 4 weeks.
Elderly - If you are over 65 years and taking Nebivolol to lower your blood pressure the usual starting dose is 2.5 mg per day. However, your doctor may increase this to 5 mg per day if he feels this is necessary.
Patients taking Nebivolol and another medicine to lower your blood pressure -
When taken with Hydrochlorothiazide the usual daily dose is 5 mg of Nebivol and 12.5-25 mg of Hydrochlorothiazide per day.
Treatment for heart failure:
Adults and the Elderly - Your doctor will start you on a low dose and gradually increase your dose over 1 -2 weekly intervals until your condition has stabilised. The usual starting dose is 1.25 mg once daily for 1-2 weeks this my be increased to 2.5 mg once daily, then to 5 mg once daily and then to 10 mg once daily. The maximum recommended dose is 10 mg once daily. Your doctor will tell you how much to take.
Patients with kidney disease - Nebivolol is not recommended for use in patients with severe kidney disease. Your doctor will advise you whether Nebivolol is suitable for your condition.
Patients with liver disease - If you suffer from liver disease do not take Nebivolol.
Children and adolescents - Nebivolol is not recommended for use in children or adolescents below 18 years.
If you take more Nebivolol than you should -Contact your doctor or casualty department immediately. Take the container and any remaining tablets with you. Signs and symptoms of overdose include: a slow heart rate, low blood pressure, wheezing and difficulty breathing and sudden heart problems.
If you forget to take Nebivolol - If you forget to take a dose of Nebivolol do not take a double dose to make up for a forgotten dose. Take the next dose on time. If you miss several doses contact your doctor.
If you stop taking Nebivolol - If you suddenly stop taking Nebivolol you are likely to suffer from side effects. If you need to stop taking this medicine your doctor will reduce your dose slowly over a 2 week period.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Nebivolol can cause side effects, although not everybody gets them.
If any of the following happen, stop taking Nebivolol and tell your doctor immediately or go to your nearest hospital emergency department:
• tightness of the chest and difficulty breathing.
These side effects are rare but serious. You may need medical attention.
Very common side effects (affecting more than 1 user in 10) include:
• dizziness
• slow heart rate.
Common side effects (affecting 1 to 10 users in 100) include:
• headaches
• change in how your heart works, which can be seen during heart exams
• tingling or pins and needles breathlessness
• difficulty breathing
• fainting on standing up
• constipation, feeling sick (nausea) or diarrhoea
• feeling tired
• fluid retention (swelling)
• intolerance to Nebivolol.
Uncommon side effects (affecting 1 to 10 users in 1,000) include:
• nightmares
• depression
• problems with eyesight, dry eyes
• heart failure which may cause shortness of breath, swelling of the feet or legs due to fluid build-up
• missed heart beats
• breathlessness
• low blood pressure
• difficulty walking including limping and lameness
• indigestion, flatulence (passing wind), being sick (vomiting)
• rashes, itchiness and reddening of the skin
• inability to get or maintain an erection.
Very rare side effects (affecting 1 to 10 users in 10,000) include:
• hallucination (seeing, hearing or feeling things that are not there)
• mental health problems
• confusion
• fainting
• cold fingers and toes with bluish discolouration of the skin (Raynaud phenomenon)
• serious allergic reaction which causes swelling of the face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
• worsening of your psoriasis, or skin rash psoriasis-like (thickened patches of red skin, often with silvery scales).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE NEBIVOLOL
Keep out of the reach and sight of children.
Do not use Nebivolol 5 mg Tablets after the expiry date which is stated on the blister, carton or bottle label after 'EXP'. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. Do not use Nebivolol 5 mg Tablets if you notice any discolouration of the tablets. 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.
6. FURTHER INFORMATION
What Nebivolol Tablets contain - The active substance is nebivolol hydrochloride. Each tablet contains 5 mg of nebivolol equivalent to 5.45 mg of nebivolol hydrochloride.
The other ingredients are lactose monohydrate, croscarmellose sodium, maize starch, polysorbate 80, hydroxypropyl methyl cellulose, microcrystalline cellulose, silica colloidal anhydrous, magnesium stearate.
What Nebivolol Tablets look like and contents of the pack - Nebivolol Tablets are white, rectangular, flat-faced, bevelled-edged tablets with 3 breaklines on each side. Each tablet is marked 'N', 'L' '5' on one side only. The tablets can be divided in 4 equal parts.
The medicinal product is available in aluminium/aluminium foil blisters in packs of
7. 10, 14, 28, 30, 50, 56, 60, 84, 90, 98 and 100 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.
Manufacturer: Gerard Laboratories,
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.
Mylan Hungary Kft, H-2900 Komarom,
Mylan utca 1, Hungary.
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria - Nebivolol Arcana 5 mg Tabletten Belgium - Nebivolol Mylan 5 mg tabletten France - Nebivolol Mylan 5 mg comprime quadrisecable
Germany - Nebivolol dura 5 mg Tabletten Greece - Nebivolol Generics 5 mg Tablets Hungary - Nebivogen 5 mg tabletta Ireland - Nelet 5 mg Tablets Italy - Nebivololo Mylan Generics Portugal - Nebivolol Mylan 5 mg comprimidos
Slovenia - Nebivolol Mylan 5 mg tablete Spain - Nebivolol Mylan 5 mg comprimidos The Netherlands - Nebivolol Mylan 5 mg tabletten.
This leaflet was last approved
in: June 2012 10004995