Nebivolol 5mg Tablets
Out of date information, search another1. What Nebivolol is and what it is used for
2. What you need to know before you take Nebivolol
3. How to take Nebivolol
4. Possible side effects
5. How to store Nebivolol
6. Contents of the pack and other information
OWhat Nebivolol is and what it is used for
Nebivolol 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 as well to lower blood pressure.
Nebivolol is used for the treatment of patients with:
• high blood pressure (hypertension)
• mild and moderate chronic heart failure in patients aged 70 or over, in addition to other therapies.
OWhat you need to know before you take Nebivolol
Do not take Nebivolol if you:
• are allergic (hypersensitive) to nebivolol hydrochloride or any of the other ingredients of this medicine (listed in section 6)
• have problems with your liver • suffer from heart failure, which has just occurred or which has recently become worse, or if you are receiving treatment for circulatory shock due to acute heart failure by intravenous drip feed to help your heart work
• suffer from heart rhythm disorders (such as sick sinus syndrome including sino-atrial block)
• suffer from heart conduction disorders (such as second and third degree heart block and do not have a pacemaker)
• have asthma or have ever suffered from difficulty in breathing or wheezing • have severe chronic obstructive pulmonary disease
• have high blood pressure, flushing or diarrhoea caused by an untreated tumour of the adrenal medulla (phaeochromocytoma)
• have a metabolic disorder where there is a change in the acid/base balance of the body (metabolic acidosis)
• have a slow heart rate (less than 60 beats per minute before you start taking this medicine)
• have low blood pressure (systolic blood pressure less than 90 mmHg)
• have poor circulation in the arms or legs • are treated with floctafenine (used for relieving pain and swelling) or sultopride (used for treating nervous system disorders) (see section 'Other medicines and Nebivolol').
Warnings and precautions
Talk to your doctor before taking Nebivolol: if you are to have an operation requiring an anaesthetic, your doctor may ask you to stop taking this medicine 24 hours before your operation if you suffer from congestive heart failure which is not being treated or has not been stabilised
if you find your heart rate slows down while taking Nebivolol if you suffer from circulation problems in the arms or legs (such as Raynaud's disease or syndrome, intermittent claudication), these may become worse when you take Nebivolol if you suffer from first degree heart block if you suffer from heart chest pain at rest that occurs in cycles (Prinzmetal's angina). Nebivolol may increase the duration of the chest pain and the number of times it occurs if you are diabetic, as nebivolol may hide the symptoms of low blood sugar (hypoglycaemia)
if you suffer thyroid problems, as nebivolol may hide the symptoms of high heart rate (tachycardia); these symptoms may become worse if you suddenly stop taking Nebivolol if you have patches of thickened and sore skin (psoriasis)
NEBIVOLOL 5 mg TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 of the 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:
• if you suffer from allergic reactions, as nebivolol may increase the severity of these reactions
• in patients with chronic obstructive pulmonary disorders, beta-adrenergic antagonists should be used with caution as airway constriction may be aggravated
• if you suffer from prolonged breathing problems.
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).
Other medicines and Nebivolol
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take Nebivolol with the following medicinal products:
• Floctafenine (used for relieving pain and swelling)
• Sultopride (used to treat nervous system disorders).
Talk to your doctor if you are taking any of the following:
• medicines used to treat heart rate rhythm disorders such as quinidine, hydroquinidine, cibenzoline, flecainide, disopyramide, lidocaine, mexiletine, propafenone and amiodarone
• medicines known as calcium channel antagonists which slow the heart rate and lower blood pressure such as verapamil and diltiazem
• medicines known as centrally-acting antihypertensives such as clonidine, guanfacin, moxonidine, methyldopa and rilmenidine
• anaesthetics
• insulin and oral antidiabetic drugs
• medicines used to treat congestive heart failure such as digitalis glycosides
• medicines known as dihydropyridine calcium antagonists such as amlodipine, felodipine, lacidipine, nifedipine, nicardipine, nimodipine and nitrendipine
• other antihypertensive medication or organic nitrates that treat chest pain
• antipsychotics (such as phenothiazines) and antidepressants (such as fluoxetine or imipramine), these may increase the blood pressure lowering effect of nebivolol
• medicines to relieve pain and inflammation such as non steroidal anti-inflammatory drugs
• medicines known as sympathicomimetic agents that mimic or block the action of norepinephrine and epinephrine in the body
• medicines known to inhibit the cytochrome P450 isoenzyme CYP2D6, such as paroxetine, fluoxetine, thioridazine, quinidine, terbinafine, bupropion, chloroquine and levopromazine
• cimetidine, a medicine used to treat peptic ulcers
• medicines used to treat high blood pressure and angina such as nicardipine
• amifostine, a protecting substance used during chemo or radiation therapy
• baclofen, a muscle relaxant
• mefloquine, an antimalarian drug.
Nebivolol with food and drink
Nebivolol can be taken with meals.
Pregnancy and breast-feeding
Nebivolol should not be taken during pregnancy or while breast-feeding. Breast-feeding is not recommended during administration of Nebivolol.
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.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
No studies on the effects of nebivolol on the ability to drive and use machines have been performed. Nebivolol may cause dizziness and fatigue. If this happens to you, do not drive or take on activities where impaired alertness may put you or others at risk of serious injury or death (e.g. operating machines) until the dizziness and fatigue has disappeared.
Nebivolol contains lactose
Patients who are intolerant to lactose should note that Nebivolol tablets contain 142.21 mg of lactose monohydrate. 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 Nebivolol
Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Method of administration:
The tablet should be swallowed with a sufficient amount of fluid (e.g. one glass of water).The tablet can be taken with or without food.
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Hypertension
Adults
The recommended dose is 5 mg (one tablet) daily, preferably at the same time of the day. The blood pressure lowering effect becomes evident after 1-2 weeks of treatment. Occasionally, the optimal effect is reached only after 4 weeks.
Combination with other antihypertensive agents
Beta-blockers can be used alone or alongside other antihypertensive agents. To date, an additional antihypertensive effect has been observed only when nebivolol is combined with hydrochlorothiazide 12.5/25 mg.
Patients with kidney problems If you have kidney problems, the recommended starting dose is 2.5 mg daily (half a tablet). If needed your doctor will increase your daily dose to 5 mg.
Patients with liver problems
Patients with serious liver problems should not take this medicine.
Older people
If you are over 65 years old, the recommended starting dose is 2.5 mg daily (half a tablet).
If needed, your doctor will increase your daily dose to 5 mg. If you are over 75 years old, your doctor will monitor you carefully whilst you are on this medication.
Use in children and adolescents
Nebivolol is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.
Chronic heart failure
Treatment of stable chronic heart failure with nebivolol is generally a long-term treatment.
Adults
The initial dose is 1.25 mg (quarter of a tablet) per day. The dose may be increased until the correct dose is reached for you. The dose may be increased after 1-2 weeks to 2.5 mg (half a tablet) per day, then to 5 mg (one tablet) per day and then to 10 mg (2 tablets) per day. The maximum recommended dose is 10 mg (two tablets) nebivolol once daily. 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.
Patients with kidney problems
In patients with mild to moderate kidney problems no dose adjustment is required as your dose will be tailored to what you need. Nebivolol is not recommended for patients with severe kidney problems.
Patients with liver problems
Patients with serious liver problems should not take this medicine.
Older people
No adjustment of your dose is required as you will be carefully monitored to determine what dose you need by your physician.
Use in children and adolescents
Nebivolol is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.
If you stop taking Nebivolol
The treatment with nebivolol is not recommended to be stopped abruptly since this might lead to a transitory worsening of heart failure. If discontinuation is necessary, the dose should be gradually decreased, divided into halves weekly.
If you take more Nebivolol than you should
If you (or someone else) swallow a lot of the tablets all together or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately.
The most frequent symptoms and signs of a nebivolol overdose are very slow heart beat (bradycardia), low blood pressure with possible fainting (hypotension), breathlessness such as in asthma (bronchospasm), and acute heart failure.
Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.
If you forget to take Nebivolol
If you forget a dose of Nebivolol, 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. for 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. Repeated skipping, however, should be avoided.
If you stop taking Nebivolol
Do not stop taking Nebivolol without talking to your doctor. Suddenly stopping this medicine may make your condition worse; therefore your doctor will gradually reduce your dose. Contact your doctor if your symptoms get worse when you stop taking Nebivolol or if you have any further questions on the use of this product.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
ossible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following, stop taking this medicine immediately and seek urgent medical advice.
Not known (cannot be estimated from the available data):
• allergic reactions such as swelling of the face, lips, mouth and throat which may cause difficulty in breathing.
Uncommon (may affect up to 1 in 100 people):
• difficulty in breathing
• heart problems which may cause shortness of breath or ankle swelling
• 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).
The following side effects have been reported at the approximate frequencies shown:
Common (may affect up to 1 in 10 people):
• headache or dizziness
• tingling or numbness in the hands and feet
• shortness of breath
• constipation, nausea or diarrhoea
• tiredness or water retention (oedema or swelling).
Uncommon (may affect up to 1 in 100 people):
slow heart beat problems with vision wheezing
indigestion, flatulence or vomiting itching, rash or redness of the skin low blood pressure
cramp like pain in the calves brought on by exercise
impotence (erectile dysfunction) nightmares depression
Very rare (may affect up to 1 in 10,000 people):
• fainting
• worsening of psoriasis (skin rash).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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.
How to store Nebivolol
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister foil and carton. 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 protect the environment.
©Contents of the pack and other information
What Nebivolol contains
The active substance is nebivolol (as hydrochloride). Each tablet contains 5 mg nebivolol equivalent to 5.45 mg of nebivolol hydrochloride.
The other ingredients are lactose monohydrate, maize starch, croscarmellose sodium, cellulose microcrystalline, hypromellose (E464), silica colloidal anhydrous and magnesium stearate.
What Nebivolol looks like and contents of the pack
Nebivolol 5 mg is a white to off-white, round, biconvex tablet, with quartering lines on one side and plain on the other.
Tablets are provided in PVC-PVDC/Aluminium clear/transparent blisters. Pack sizes: 7, 8, 10, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98, 100, 500 and 50 x 1 unit dose blisters (hospital pack).
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
TEVA UK Ltd., Eastbourne, BN22 9AG, UK.
Manufacturer
TEVA Pharmaceutical Works Private Limited Company, Pallagi ut 13, 4042 Debrecen, Hungary.
This leaflet was last revised in 12/2013
PL 00289/1207
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TEVA UK LIMITED
88425-A 160 x 460 mm
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