NEBIVOLOL 10 MG TABLETS - patient leaflet, side effects, dosage

Package leaflet: Information for the patient

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.

• 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

1. what nebivolol tablets is and what it is used for

Nebivolol Tablets (also referred to as Nebivolol throughout this leaflet) 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.

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 70years or over, in addition to other therapies.

|2. What you need to know before you take Nebivolol Tablets

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:

o low blood pressure

o serious circulation problems in the arms or legs

o very slow heartbeat (less than 60 beats per minute)

o 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 heart rhythm)
• poor circulation in the arms or legs, e.g. Raynaud’s disease or syndrome, cramp-like pains when 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 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 before being anaesthetised.
• If you have serious kidney problems do not take nebivolol 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 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.

• Always tell your doctor or pharmacist if you are taking 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 drug); 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 drug), e.g. cimetidine, you should take nebivolol during a meal and the antacid medicine between meals.

Nebivolol Tablets with food and drink

See section 3.

Pregnancy, breast-feeding and fertility

Pregnancy

Nebivolol should not be used during pregnancy unless clearly necessary.

Breast-feeding

Breast-feeding is not recommended during treatment with nebivolol tablets.

Fertility

There is limited human data on the effect of nebivolol on fertility. No preclinical data are available.

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.

Driving and using machines

This medicine may cause dizziness or fatigue. If affected, do not drive or operate machinery.

Nebivolol Tablets contains lactose

This product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor or pharmacist before taking this medicine.

3. how to take nebivolol tablets

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Treatment of raised blood pressure (hypertension)

• The recommended dose is 5 mg daily, preferably at the same time of the day.
• Elderly patients and patients with a kidney disorder will usually start with 2.5mg 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.
• Your treatment will be started and closely supervised by an experienced physician.
• Your doctor will start your treatment with 1.25mg per day. This may be increased after 1–2 weeks to 2.5mg per day, then to 5mg per day and then to 10mg 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 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

Nebivolol Tablets are not recommended in children and adolescents.

Method of administration

Oral use

The tablet can be divided into equal doses.

Nebivolol Tablets may be taken with meals. The tablet should be swallowed with a sufficient amount of fluid (e.g one glass of 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 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 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.

Repeated skipping, however, should be avoided.

If you stop taking Nebivolol Tablets

You should always consult with your doctor before stopping nebivolol treatment, whether you are taking it for high blood pressure or chronic heart failure.

You should not stop nebivolol treatment abruptly as this can temporarily make your heart failure worse.

If it is necessary to stop nebivolol 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.

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 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).
• 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 (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, 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: or search for MHRA Yellow Card in the Google Play or Apple App Store. 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.
• Do not use this medicine after the expiry date which is stated on the carton and on the blister or on the bottle label after EXP. The expiry date refers to the last day of that month.
• Store in the original container or keep the bottle tightly closed to protect from moisture.
• Do not use this medicine if you notice any discoloration or visible signs of deterioration.
• 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.

|6. Contents of the pack and other information

What Nebivolol Tablets contain

The active substance is nebivolol.

Each tablet contains 10 mg of Nebivolol (as nebivolol hydrochloride).

The other ingredients are: Lactose monohydrate, Pregelatinised starch, Croscarmellose sodium (E468), Hypromellose (E464), Polysorbate 80 (E433), Microcrystalline cellulose (E460), Colloidal anhydrous silica (E551), Magnesium stearate (E572).

What Nebivolol Tablets looks like and contents of the pack

Nebivolol Tablets are round, white color tablets, cross scored on one side and debossed with “N” and “10” on either side of breakline on the other side.

Dimension: 9.10mm x 3.00mm

Nebivolol 10mg Tablets are provided in blisters of Alu/PVC or Alu/PVC/PVDC and pack size of 7, 14, 28, 30, 50, 56, 90tablets.

Nebivolol 10mg Tablets are also available in white opaque HDPE container with screw neck and child resistant white opaque polypropylene outer closure with silica gel and pack size of 100 or white opaque HDPE container with screw neck and white opaque round polypropylene closure with silica gel and pack size of 500.

Not all pack sizes may be marketed.

This leaflet was last revised in March 2019.

P NOUMED LIFE SCIENCES LIMITED

NOUme Noumed House, Shoppenhangers Road, Ma Maidenhead, Berkshire, SL6 2RB, United Kingdom

To listen to or request a copy of this leaflet in braille, large print or audio,

please call 020 33 99 8960 (UK only).

Please be ready to give the following information

Product name Reference number

Nebivolol 10 mg Tablets PL 44041/0052

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.