Nebivolol 5mg Tablets
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Nebivolol 2.5 mg Tablets Nebivolol 5 mg Tablets
Nebivolol
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Nebivolol Tablets is and what it is used for
2. What you need to know before you take Nebivolol Tablets
3. How to take Nebivolol Tablets
4. Possible side effects
5. How to store Nebivolol Tablets
6. Contents of the pack and other information
Nebivolol Tablets contains nebivolol, a cardiovascular drug belonging to the group of selective beta-blocking agents (i.e. with a selective action on the cardiovascular system). It prevents increased heart rate, controls heart pumping strength. It also exerts a dilating action on blood vessels, which contributes to lowering the blood pressure.
It is used to treat raised blood pressure (hypertension).
Nebivolol Tablets is also used to treat mild and moderate chronic heart failure in patients aged 70 years or over, in addition to other therapies.
Do not take Nebivolol Tablets:
• If you are allergic to nebivolol or any of the other ingredients of this medicine (listed in section 6).
• If you have one or more of the following disorders:
- low blood pressure
- serious circulation problems in the arms or legs
- very slow heartbeat (less than 60 heart beats per minute)
- certain other serious heart rhythm problems (e.g. 2nd and 3rd degree atrioventricular block, heart conduction disorders)
- heart failure, which has just occurred or which has recently become worse, or you are receiving treatment for circulatory shock due to acute heart failure by intravenous drip feed to help your heart work
- asthma or wheezing (now or in the past) untreated phaeochromocytoma, a tumour located on top of the kidneys (in the adrenal glands)
- liver function disorder
- a metabolic disorder (metabolic acidosis), for example, diabetic ketoacidosis.
Warnings and precautions
Talk to your doctor or pharmacist before taking Nebivolol Tablets.
Tell your doctor if you have or develop any one of the following medical problems:
• abnormally slow heartbeat
• a type of chest pain due to spontaneously occurring heart cramp called Prinzmetal angina
• untreated chronic heart failure
• 1st degree heart block (a kind of light heart conduction disorder that affects the heart rhythm)
• poor circulation in the arms or legs, e.g. Raynaud’s disease or syndrome, cramp-like pains on walking
• prolonged breathing problems
• diabetes: this medicine has no effect on blood sugar, but it could conceal the warning signs of a low sugar level (e.g. palpitations, fast heartbeat)
• overactive thyroid gland: this medicine may mask the signs of an abnormally fast heart rate due to this condition
• allergy: this medicine may intensify your reaction to pollen or other substances you may be allergic to
• if you have or previously had psoriasis (a skin disease - scaly pink patches)
• if you intend to have surgery, tell your doctor that you are taking Nebivolol Tablets before undergoing any surgery.
If you have a serious kidney problem do not take Nebivolol Tablets for heart failure and tell your doctor for further advice.
You will be regularly monitored at the beginning of your treatment for chronic heart failure by your physician (see section 3).
This treatment should not be stopped abruptly unless recommended by your doctor (see section 3).
Children and adolescents
Nebivolol Tablets is not recommended for use in children and adolescents because of the lack of data on the use of this medicine.
Other medicines and Nebivolol Tablets
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including those medicines obtained without a prescription. Certain medicines cannot be used at the same time, while other medicines may require specific changes in the dose, for example.
Always tell your doctor or pharmacist if you are using or receiving any of the following medicines in addition to Nebivolol Tablets:
• Medicines for controlling the blood pressure or medicines used to treat heart problems (such as amiodarone, amlodipine, cibenzoline, clonidine, digoxin, diltiazem, disopyramide, felodipine, flecainide, guanfacin, hydroquinidine, lacidipine, lidocaine, methyldopa, mexiletine, moxonidine, nifedipine, nicardipine, nimodipine, nitrendipine, propafenone, quinidine, rilmenidine, verapamil).
• Sedatives and therapies used in the treatment of psychosis (a mental illness) e.g. barbiturates (also used for epilepsy), phenothiazine (also used for vomiting and nausea) and thioridazine.
• Medicines used to treat depression e.g. amitriptyline, paroxetine, fluoxetine.
• Medicines used for anaesthesia during an operation.
• Medicines used to treat asthma, blocked nose or certain eye disorders such as glaucoma (increased pressure in the eye) or dilation (widening) of the pupil.
• Baclofen (an antispasmodic drug); Amifostine (a protective medicine used during cancer treatment).
• All of these medicines as well as nebivolol may influence the blood pressure and/or your heart function.
• Anti malarials (mefloquine).
• Medicines used for treating excessive stomach acid or ulcers (antacid drug), e.g. cimetidine, you should take this medicine during a meal and take the antacid medicine between meals.
Nebivolol Tablets with food and drink
Nebivolol Tablets can be taken with food or on an empty stomach. The tablet should be taken with some water.
Pregnancyand breast-feeding
Pregnancy
Nebivolol Tablets should not be taken during pregnancy unless clearly necessary.
Breast-feeding
Breast-feeding is not recommended during treatment with Nebivolol Tablets. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Driving and using machines
This medicine may cause dizziness or fatigue. If affected, do not drive or operate machinery.
Nebivolol Tablets contains lactose
If your doctor has told you that you have intolerance to some sugars, contact your doctor before taking this medicine.
Always take this medicine exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure.
Nebivolol Tablets may be taken before, during or after the meal. Alternatively,
you can take this medicine independently of meals. The tablet is best taken
with some water.
Treatment of raised blood pressure (hypertension)
• The usual dose is 5 mg (one 5 mg tablet or two 2.5 mg tablets) per day.
• Elderly patients and patients with a kidney disorder will usually start with 2.5 mg (half a 5 mg tablet or one 2.5 mg tablet) daily.
• The therapeutic effect on blood pressure becomes evident after 1-2 weeks of treatment. Occasionally, the optimal effect is reached only after 4 weeks.
• If you are aged over 75 years, your doctor may need to monitor you more closely.
Treatment of chronic heart failure
Your treatment will be closely monitored by your physician.
• Your doctor will start your treatment with 1.25 mg (half a 2.5 mg tablet) per day. This may be increased after 1-2 weeks to 2.5 mg (one 2.5 mg tablet or half a 5 mg tablet) per day, then to 5 mg (two 2.5 mg tablets or one 5 mg tablet) per day and then to 10 mg (four 2.5 mg tablets or two
5 mg tablets) per day until the correct dose is reached for you. Your doctor will prescribe the dose that is right for you at each step and you should closely follow your doctor‘s instructions.
• The maximum recommended dose is 10 mg.
• You will need to be under the close supervision for 2 hours by an experienced physician when you start treatment and every time your dose is increased.
• Your doctor may reduce your dose if necessary.
• You should not stop treatment abruptly as this can make your heart failure worse.
• Patients with serious kidney problems should not take this medicine.
• Take your medicine once daily, preferably at about the same time each day.
• Your doctor may decide to combine your tablets with other medicine for your condition.
Use in children and adolescents
Nebivolol Tablets is not recommended in children and adolescents.
If you take more Nebivolol Tablets than you should
If you accidentally take an overdose of this medicine, tell your doctor or pharmacist immediately.
The most frequent reported symptoms and signs of an overdose relates to a very slow heart beat (bradycardia), low blood pressure with possible fainting (hypotension), breathlessness such as in asthma (bronchospasm), and acute heart failure.
You can take activated charcoal (which is available at your pharmacy) while you are waiting for your doctor to arrive.
If you forget to take Nebivolol Tablets
If you forget to take your medicine, but remember a little later that you should have taken it, take that day’s dose as usual.. However, if a long delay has occurred (e.g. after several hours), so that the next due dose is near, skip the forgotten dose and take the next normal dose at the scheduled usual time.
Do not take a double dose to make up for a forgotten dose. Repeated skipping, however, should be avoided.
If you stop taking Nebivolol Tablets
You should always talk to your doctor before stopping treatment with Nebivolol Tablets, whether you are taking it for high blood pressure or chronic heart failure.
You should not stop Nebivolol Tablets treatment abruptly as this can temporarily make your heart failure worse.
If it is necessary to stop Nebivolol Tablets treatment for chronic heart failure, the daily dose should be decreased gradually, by halving the dose in weekly intervals. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Nebivolol and talk to your doctor immediately if you have any of the following side effects:
• whole-body allergic reactions, with generalised skin eruption (hypersensitivity reactions)
• rapid-onset of swelling, especially around the lips, eyes, or of the tongue with sudden difficulties in breathing (angioedema).
• kind of skin rash notable for pale red, raised, itchy bumps of allergic or non allergic causes (urticaria).
• Breathlessness such as in asthma, due to sudden cramps in the muscles around the airways. Tightening of the chest, difficulty in breathing or wheezing (bronchospasm)
When Nebivolol Tablets is used for the treatment of raised blood pressure,
the possible side effects are:
Common side effects (affects 1 to 10 users in 100):
• Headache
• Dizziness
• Tiredness
• An unusual itching or tingling feeling
• Diarrhoea
• Constipation
• Nausea
• Shortness of breath
• Swollen hands or feet
Uncommon side effects (affects 1 to 10 users in 1000):
• Slow heartbeat or other heart complaints
• Low blood pressure
• Cramp-like leg pains on walking
• Abnormal vision
• Impotence (difficulty in getting an erection)
• Feeling of depression
• Digestive difficulties (dyspepsia), gas in stomach or bowel (indigestion)
• Vomiting
• Skin rash, itchiness
• Breathlessness such as in asthma, due to sudden cramps in the muscles around the airways. Tightening of the chest, difficulty in breathing or wheezing (bronchospasm)
• Nightmares
Very rare side effects (affects less than 1 user in 10,000):
• Fainting
• Worsening of psoriasis (a skin disease - scaly pink patches).
The following side effects have been reported only in some isolated cases during treatment with this medicine:
- whole-body allergic reactions, with generalised skin eruption (hypersensitivity reactions)
- rapid-onset of swelling, especially around the lips, eyes, or of the tongue with sudden difficulties in breathing (angioedema).
- kind of skin rash notable for pale red, raised, itchy bumps of allergic or non allergic causes (urticaria).
In a clinical study for chronic heart failure, the following side effects were seen:
Very common side effects (affects more than 1 user in 10):
• slow heart beat
• dizziness
Common side effects (affects 1 to 10 users in 100):
• worsening of heart failure
• low blood pressure(such as feeling faint when getting up too quickly)
• inability to tolerate this medicine
• a kind of light heart conduction disorder that affects the heart rhythm (1st degree AV-block)
• swelling of the lower limbs (such as swollen ankles)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/ yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and on the blister 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 throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
What Nebivolol Tablets contains
The active substance is nebivolol.
Each tablet contains 2.5 mg of nebivolol equivalent to 2.725 mg of nebivolol hydrochloride.
Or
Each tablet contains 5 mg nebivolol equivalent to 5.45 mg nebivolol hydrochloride
The other ingredients are:
lactose monohydrate; maize starch; croscarmellose sodium; hypromellose; microcrystalline cellulose; silica colloidal anhydrous; magnesium stearate.
What Nebivolol Tablets looks like and contents of the pack Nebivolol 2.5 mg Tablets: capsule shaped, white, biconvex uncoated tablets with a breakline on one side and plain on the other side. The tablets can be divided into equal halves.
Nebivolol 5 mg Tablets: circular, white, biconvex uncoated tablets engraved with ‘N’ and ‘L’ on either side of the breakline on one side and plain on other side The tablet can be divided into equal halves.
Nebivolol 2.5 mg and 5 mg Tablets are available in PVC/PVdC/aluminium blisters and aluminium/ aluminium blisters of 14, 28, 30, 50, 98, 100 tablets *Not all pack sizes may be marketed.
Marketing Authorisation Holder Glenmark Pharmaceuticals Europe Ltd,
Laxmi House, 2-B Draycott Avenue,
Kenton, Middlesex, hA3 OBU.
UK
Manufacturer
Glenmark Pharmaceuticals Europe Limited,
Building 2, Croxley Green Business Park, Croxley Green, Hertfordshire, WD18 8YA, United Kingdom
This medicinal product is authorised in the Member States of the EEA under the following names:
Bulgaria,
Nebitrix 5 mg Germany
Nebivolol Glenmark 5 mg tabletten
Greece
NOZAC® 2.5 mg NOZAC® 5 mg
Hungary, Poland, Slovak Republic
Nebitrix 5 mg
Romania
Nebinorm 5 mg
Spain
Nebivolol Glenmark 2.5 mg comprimidos EFG Nebivolol Glenmark 5 mg comprimidos EFG
The Netherlands
Nebivolol Glenmark 2.5 mg tabletten Nebivolol Glenmark 5 mg tabletten
United Kingdom
Nebivolol 2.5 mg Tablets Nebivolol 5 mg Tablets
This leaflet was last revised in 04/2015.