Nebivolol 2.5 Mg Tablets
Leaflet mockup FRONT
Package leaflet: Information for the patient
MercuryPharma
Nebivolol 2.5 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 Tablet 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
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0 AMDIPHARM |
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Version No.: |
102047/LF/013/02 |
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Product Name: |
Nebivolol 2.5 mg Tablets |
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Pack Size: |
28 Tablets |
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Component: |
Leaflet |
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SKU: |
102047 |
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Market: |
UK |
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Production Site: |
AET Laboratories India |
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Revision No.: |
1 |
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Revision Date: |
30/01/2015 |
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Revised by: |
ADD |
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180 x 420 mm |
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Commodity No.: |
N/A |
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Pharma Code: |
N/A |
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Core Spec Ref: |
N/A |
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DCMF: |
N/A |
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Print Colours: |
Black |
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Non-Print Colours: |
Cutler |
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Tech App. Date: |
06/02/2015 |
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Min. Font Size: |
8.5 pt |
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CRF: |
AMCo.CRF.490.2014 |
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DOA: |
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Nebivolol Tablets contain nebivolol, a cardiovascular medicine 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 as well to lower blood pressure.
It is used to treat raised blood pressure (hypertension).
Nebivolol Tablet is also used to treat mild and moderate chronic heart failure in patients aged 70 or over, in addition to other therapies.
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2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NEBIVOLOL TABLETS
Signature
Do not take Nebivolol
• 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 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 pheochromocytoma, a tumour
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glands)
• liver function disorder
• a metabolic disorder (metabolic acidosis), for example, diabetic ketoacidosis.
Warnings and precautions
mnacist before taking nebivolol. Inform your doctor if you have or develop one of the following problems:
• abnormally slow heartbeat
• a type of chest pain due to spontaneously
d
• untreated chronic heart failure
• 1st degree heart block (a kind of light heart conduction disorder that affects heart rhythm)
m
Raynaud's disease or syndrome, cramp-like pains when walking
• prolonged breathing problems
• diabetes: This medicine has no effect on blood
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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 are allergic to
• psoriasis (a skin disease, scaly pink patches) or if you have ever had psoriasis
• if you have to have surgery, always inform your anaesthetist that you are on Nebivolol Tablets before being anaesthetised.
If you have serious kidney problems do not take Nebivolol Tablets for heart failure and tell your doctor.
You will be regularly monitored at the beginning of your treatment for chronic heart failure by an experienced physician (see section 3).
This treatment should not be stopped abruptly unless clearly indicated and evaluated by your doctor (see section 3).
Children and adolescents
Because of the lack of data on the use of the product in children and adolescents, Nebivolol Tablet is not recommended for use in them.
Other medicines and Nebivolol Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Certain medicines cannot be used at the same time, while other medicines require specific changes (in the dose, for example). Always tell your doctor if you are using or receiving any of the following medicines in addition to Nebivolol Tablets:
• medicines for controlling the blood pressure or medicines for heart problems (such as amiodarone, amlodipine, cibenzoline, clonidine, digoxin, diltiazem, disopyramide, felodipine, flecainide, guanfacin, hydroquinidine, lacidipine, lidocaine, methyldopa, mexiletine, moxonidine, nicardipine, nifedipine, nimodipine, nitrendipine, propafenone, quinidine, rilmenidine, verapamil)
• sedatives and therapies for psychosis (a mental illness) e.g. barbiturates (also used for epilepsy), phenothiazine (also used for vomiting and nausea) and thioridazine
• medicines for depression e.g. amitriptyline, paroxetine, fluoxetine
• medicines used for anaesthesia during an operation
• medicines for asthma, blocked nose or certain eye disorders such as glaucoma (increased pressure in the eye) or dilation (widening) of the pupil
• baclofen (an antispasmodic medicine); Amifostine (a protective medicine used during cancer treatment)
All these medicines as well as nebivolol may influence the blood pressure and/or heart function.
• Medicines for treating excessive stomach acid or ulcers (antacid medicine), e.g. cimetidine: you should take Nebivolol Tablets during a meal and the antacid medicine between meals.
Nebivolol Tablets with food and drink
Nebivolol Tablets can be taken with food or on an empty stomach, but the tablet is best taken with some water.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Nebivolol Tablets should not be used during pregnancy, unless clearly necessary.
It is not recommended for use while breast-feeding.
Driving and using machines
This medicine may cause dizziness or fatigue.
If affected, do not drive or operate machines.
Nebivolol Tablets contain lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
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Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Treatment of raised blood pressure (hypertension)
• the usual dose is 1 tablet per day. The dose should be taken preferably at the same time of the day
• elderly patients and patients with a kidney disorder will usually start with 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.
Treatment of chronic heart failure
• your treatment will be started and closely supervised by an experienced 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) per day, then to 5 mg (two 2.5 mg tablets) per day and then to 10 mg (four 2.5 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 his/her instructions
• the maximum recommended dose is 10 mg (four 2.5 mg tablets) a day
• 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 of day
• your doctor may decide to combine Nebivolol Tablets with other medicines to treat your condition.
Use in children and adolescents
Do not use in children or adolescents.
How to take the tablet
The tablet can be divided into equal doses.
Nebivolol Tablets may be taken before, during or after the meal, but, alternatively, you can take it independently of meals. The tablet is best taken with some water.
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 symptoms and signs of a Nebivolol Tablets overdose are 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 wait for the arrival of the doctor.
If you forget to take Nebivolol Tablets
If you forget a dose of Nebivolol Tablets, but remember a little later on that you should have taken it, take that day’s dose as usual. However, if a long delay has occurred (e.g. several hours), so that the next due dose is near, skip the forgotten dose and take the next, scheduled, normal dose at the usual time. Do not take a double dose to make up for a forgotten tablet. Repeated skipping, however, should be avoided.
If you stop taking Nebivolol Tablets
You should always consult with your doctor before stopping Nebivolol Tablets treatment, 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, at weekly intervals.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
|
/ |
0 AMDIPHARM |
|
Version No.: |
102047/LF/013/02 |
|
Product Name: |
Nebivolol 2.5 mg Tablets |
|
Pack Size: |
28 Tablets |
|
Component: |
Leaflet |
|
SKU: |
102047 |
|
Market: |
UK |
|
Production Site: |
AET Laboratories India |
|
Revision No.: |
1 |
|
Revision Date: |
30/01/2015 |
|
Revised by: |
ADD |
|
V |
y |
|
r Dimension: |
180 x 420 mm |
|
Commodity No.: |
N/A |
|
Pharma Code: |
N/A |
|
Core Spec Ref: |
N/A |
|
DCMF: |
N/A |
|
Print Colours: |
Black |
|
Non-Print Colours: |
Cutler |
|
Tech App. Date: |
06/02/2015 |
|
Min. Font Size: |
8.5 pt |
|
V |
y |
|
c | |
|
CRF: |
AMCo.CRF.490.2014 |
|
DOA: |
N/A |
|
DOI: |
N/A |
|
V |
y |
f \
REGULATORY AUTHORITY APPROVAL CONFIRMATION
Confirmation that this artwork has been approved by the appropriate market authority (if applicable, e.g. MHRA, HPRA, etc.) and that Amdipharm have license approval to distribute this component for sale in the relevant market.
Accept Artwork / Reject Artwork
(Please strike off whichever NOT applicable)
Signature
Name
Date ...........................................................................
V_y
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
When Nebivolol Tablet is used for the treatment of raised blood pressure, the possible side effects are:
Common side effects (may affect up to 1 in 10 people):
• headache
• dizziness
• tiredness
• an unusual itching or tingling feeling
• diarrhoea
• constipation
• nausea
• shortness of breath
• swollen hands or feet.
Uncommon side effects (may affect up to 1 in 100 people):
• slow heartbeat or other heart complaints
• low blood pressure
• cramp-like leg pains on walking
• abnormal vision
• impotence
• feelings of depression
• digestive difficulties (dyspepsia), gas in stomach or bowel, vomiting
• skin rash, itchiness
• breathlessness such as in asthma, due to sudden cramps in the muscles around the airways (bronchospasm)
• nightmares.
Very rare side effects (may affect up to 1 in 10,000 people):
• fainting
• worsening of psoriasis (a skin disease, scaly pink patches).
The following side effects have been reported only in some isolated cases during Nebivolol Tablets treatment:
• 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).
In a clinical study for chronic heart failure, the following side effects were seen:
Very common side effects (may affect more than 1 in 10 people):
• slow heart beat
• dizziness.
Common side effects (may affect up to 1 in 10 people):
• worsening of heart failure
• low blood pressure (such as feeling faint when getting up quickly)
• inability to tolerate this medicine
• a kind of light heart conduction disorder that affects 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 or 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.
5. HOW TO STORE NEBIVOLOL TABLETS
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP The expiry date refers to the last day of that month.
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 protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Nebivolol Tablet contains
The active substance is nebivolol.
Each tablet contains 2.5 mg of nebivolol (as nebivolol hydrochloride).
The other ingredients are Lactose monohydrate, microcrystalline cellulose, crospovidone (type-B), copovidone, magnesium stearate.
What Nebivolol Tablets look like and contents of the pack
Nebivolol Tablets are white to off white, round, plain biconvex tablets with score line on one side. The tablets can be divided in equal halves.
Nebivolol Tablets are provided in blister packs (Alu-Alu or PVC/PE/PVdC-Alu blister) containing
Marketing Authorisation Holder
Mercury Pharmaceuticals Ltd.,
Capital House,
85 King William Street,
London EC4N 7BL, UK
Manufacturers
Corden Pharma
Otto-Hahn-Str., 68723 Plankstadt, Germany
Delorbis Pharmaceutical Ltd.,
17, Athinon Street, Ergates Industrial Area, 2643 Ergates, Cyprus
This leaflet was last revised in January 2015.
102047/LF/013/02