Nebivolol 5mg Tablets
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PACKAGE LEAFLET: INFORMATION FOR THE USER Nebivolol 5 mg tablets
Nebivolol
Read all of this leaflet carefully before you start using 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 gets 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 contains nebivolol which is a selective beta blocker and it dilates blood vessels (vasodilator). It is used for the treatment of raised blood pressure (hypertension).
Nebivolol is also used to treat chronic heart failure in patients aged 70 or over.
2. BEFORE YOU TAKE NEBIVOLOL
Do not take Nebivolol
• if you are allergic (hypersensitive) to nebivolol or to any of the other ingredients of Nebivolol (see section 6 of this leaflet),
• if you have low blood pressure (the systolic or “upper” pressure is less than 90 mmHg)
• if you have poor circulation in the arms or legs
• if you have a very slow heartbeat (less than 60 heart beats per minute before having started this medication)
• if you have been diagnosed with conduction disorders in your heart (such as sick sinus syndrome or atrio-ventricular blockade) and you do not have a functioning pacemaker
• if you have acute heart failure, or you are receiving treatment into a vein (by intravenous ‘drip’) to help your heart work
• if you have difficulty in breathing or wheezing (or history of)
• if you have a tumour of the adrenal gland called phaeochromocytoma
• if you have severe liver disease or liver function impairment
• if you have a metabolic acidosis (such as in diabetic patients when the blood sugar has risen too much and blood has become too acidic)
• if you use either floctafenine or sultopride containing medications.
Take special care with Nebivolol
- If you have or develop one of the following conditions:
• heart failure (inability of heart to pump enough blood for body's needs)
• a mild (first degree) atrioventricular blockade in your heart
• chest pain caused by cramping of the coronary arteries (called Prinzmetal's angina or variant angina)
• poor circulation in the arms or legs, e.g. Raynaud’s disease or syndrome, cramplike pains on walking
• prolonged breathing problems
• diabetes: Nebivolol has no effect on blood sugar, but it could mask the signs of a low sugar level (e.g. trembling, fast heartbeat).
• overactive thyroid gland: Nebivolol may mask the signs of an abnormally fast heart rate due to this condition
• allergy, as the allergic reactions may become stronger and more medicines may be needed to treat them
• a skin condition known as psoriasis, as Nebivolol may aggravate the symptoms
• wear contact lenses, as Nebivolol may reduce lacrimation and make the eyes dryer.
Use in children and adolescents below 18 years old is not recommended.
In these cases, your doctor may need to adapt your treatment or check you more often.
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.
If you have kidney problems, do not take this medicine for heart failure and inform your doctor.
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, herbal remedies and strong vitamins and minerals.
Always tell your doctor or pharmacist if you are using or receiving any of the following medicines in addition to Nebivolol:
• diltiazem or verapamil (used for high blood pressure and other heart problems). During Nebivolol treatment, verapamil should not be injected into a vein
• other medicinal products known as calcium channel blockers for high blood pressure or other heart problems such as amlodipine, felodipine, lacidipine, nifedipine, nicardipine, nimodipine, nitrendipine
• other antihypertensive medications or organic nitrates to treat chest pain
• clonidine, guanfacin, moxonidine, methyldopa, rilmenidine used for the treatment of high blood pressure
• medicinal products for cardiac arrhythmias (irregular heartbeat) such as quinidine, hydroquinidine, amiodarone, cibenzoline, flecainide, disopyramide, lidocaine, mexiletine, propafenone
• tricyclic antidepressants (for depression), phenothiazines (for psychoses), or barbiturates (for epilepsy)
• medicinal products for diabetes mellitus (insulins and oral preparations)
• digoxin or other so called digitalis glycosides (to treat heart failure)
• anti-inflammatory analgesics (NSAIDs) for pain and inflammation- please note that small daily antithrombotic doses of acetylsalicylic acid (e.g., 50 or 100 mg) can be used safely with Nebivolol
• medicinal products for asthma, blocked nose or certain eye disorders such as glaucoma (increased pressure in the eye) or dilation of the pupil
• anaesthetics: always inform your anaesthetist that you are on Nebivolol before being anaesthetized
• cimetidine (to treat excessive stomach acid)- you should take Nebivolol during a meal, and the antacid drug between meals
• medicinal products affecting the metabolism of nebivolol namely terbinafine (for fungal or yeast infections), bupropion (to help in cessation of smoking), chloroquine (for malaria or rheumatoid arthritis), levomepromazine (for psychoses), paroxetine, fluoxetine, thioridiazine (for depression)
• amifostine (a protecting substance during chemo- or radiation therapy)
• baclofen (a muscle relaxant)
• mefloquine (an antimalarial).
Taking Nebivolol with food and drink
Nebivolol 5 mg tablets can be taken before, during or after a meal, but also you can take
them without food. The tablet or its parts should be swallowed with some water or another liquid.
Pregnancy and breast-feeding
Pregnancy
Nebivolol should not be used during pregnancy unless instructed to do so by a doctor. Breast-feeding
Breast-feeding is not recommended during administration of Nebivolol.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed. When driving vehicles or operating machinery it should be taken into account that dizziness or fatigue may occasionally occur. 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 product contains lactose. If your doctor has told you that you have intolerance to some sugars, 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.
Treatment of raised blood pressure (hypertension)
• The usual dose is 1 tablet per day.
• Elderly patients and patients with a kidney disorder will usually start with 1/2 tablet daily.
• It may take up to 4 weeks for this medicine to have full effect.
Treatment of chronic heart failure
• Your treatment will be started and monitored by an experienced physician.
• Your doctor will start your treatment with 1/4 tablet per day. This may be increased after 1-2 weeks to 1/2 tablet per day, then to 1 tablet per day and then to 2 tablets per day until the correct dose is reached for you.
• The maximum recommended dose is 10 mg (2 tablets a day).
• You will need to be monitored 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, and you should not stop abruptly as this can worsen heart failure.
• 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 your tablets with other medicine for your condition. Nebivolol is not recommended in children and adolescents.
If you take more Nebivolol than you should
If you accidentally take too many tablets (overdose), you may experience slow heart beat, low blood pressure or other heart problems, or difficulty in breathing or wheezing.
Contact your nearest hospital casualty department or tell your doctor or pharmacist immediately.
Poisoning Information Centre telephones: <To be completed nationally, if applicable>
If you forget to take Nebivolol
If you forget to take your medicine, but remember to take it after a short time, take the next tablet normally, when it is the time to take it. However, if a long delay has occurred (e.g. all day) skip that dose and take the next dose the next day at the usual time and skip the forgotten dose. Do not take a double or a larger dose to make up for a forgotten dose. Repeated skipping is to be avoided.
If you stop taking Nebivolol
Do not stop taking Nebivolol without consulting your doctor first. If the medication is terminated abruptly, the patient may experience dangerous worsening of the symptoms. This concerns especially the patients with angina pectoris.
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.
When Nebivolol is used for the treatment of raised blood pressure, the possible side effects are:
Common side effects (estimatedfrequency is less than 1 person out of 10 but more than 1 out of 100):
• Headache
• Dizziness
• Tiredness
• An unusual itching or tingling feeling
• Diarrhoea
• Constipation
• Nausea
• Shortness of breath
• Swollen hands or feet
Uncommon side effects (estimated frequency is less than 1 person out of 100 but more than 1 out of1000):
• Slow heartbeat or other heart complaints
• Low blood pressure
• Cramp like leg pains on walking
• Abnormal vision
• Impotence (difficulty in getting an erection)
• Depressive feelings
• Indigestion, gas in stomach or bowel
• Vomiting
• Skin rash
• Itchiness
• Tightness of the chest, difficulty in breathing or wheezing
• Nightmares
Very rare side effects (estimatedfrequency is less than 1 person out of 10000):
• Fainting
• Psoriasis aggravated.
Not known (cannot be estimate from the available data):
• Whole body allergic reactions, with generalised skin eruption (hypersensitivity reactions)
• Angioneurotic oedema: Rapid onset swelling of the skin of the face or extremities, lips, tongue, mucous membranes of the throat and airway, resulting in shortness of breath or difficult to swallow - contact a doctor immediately!
In a clinical study for chronic heart failure, the side effects seen were slow heart beat, dizziness, worsening of heart failure, low blood pressure (such as feeling faint when getting up quickly), inability to tolerate medicine, irregular heart beat, swelling (such as swollen ankles).
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 after the expiry date which is stated on the carton after <EXP>.
The expiry date refers to the last day of that month.
Do not store above 30°C.
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 contains
The active substance is nebivolol.
Each Tablet contains 5 mg of nebivolol equivalent to 5.45 mg of nebivolol hydrochloride.
The other ingredients are:
Lactose Monohydrate,
Crospovidone Type A,
Poloxamer 188,
Povidone K 30,
Cellulose, Microcrystalline,
Magnesium Stearate
What Nebivolol looks like and contents of the pack
Nebivolol tablets are white, round, biconvex tablets, cross-scored on one side, with a diameter of 9 mm approximately.
Nebivolol can be divided into equal quarters.
Tablets are provided in PVC/PE/PVDC//Aluminium blisters of 7, 10 and 14 Pack sizes:
For DK/H/1143/001/DC:
7, 10, 14, 20, 28, 30, 50, 56, 60, 90, 100, 120 tablets For DK/H/1144/001/DC:
7, 10, 14, 20, 28, 30, 50, 56, 60, 90, 100, 120 tablets For DK/H/1160/001/DC:
7, 10, 14, 20, 28, 30, 50, 56, 60, 90, 100, 120 tablets For DK/H/1161/001/DC:
7, 10, 14, 20, 28, 30, 50, 56, 60, 90, 100, 120 tablets For DK/H/1162/001/DC:
7, 10, 14, 20, 28, 30, 50, 56, 60, 90, 100, 120 tablets
For DK/H/1256/001/DC:
7, 10, 14, 20, 28, 30, 50, 56, 60, 90, 100, 120 tablets Not all pack sizes may be marketed.
Marketing Authorisation Holder
PLIVA Pharma Limited Vision House, Bedford Road Petersfield
Hampshire GU32 3QB United Kingdom
Manufacturers
Specifar S.A.
1,28 Octovrioi str.,
Ag. Varcara 123 51 Athen Greece
This leaflet was last revised in August 2011
PL 10622/0310
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