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. 2^nd and 3^rd 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.

Inform your doctor if you have or develop one of the following problems:

• abnormally slow heartbeat
• a type of chest pain due to spontaneously occurring heart cramp called Prinzmetal angina
• untreated chronic heart failure
• 1^st 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
• 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 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 Tablets is not recommended for use in them.

Other medicines and Nebivolol Tablets

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

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, nifedipine, nicardipine, 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 of these medicines as well as nebivolol may influence the blood pressure and/or your heart function if you are using or receiving any of the following medicines:

• Anti malarials (mefloquine).
• Medicines for treating excessive stomach acid or ulcers (antacid drug), you should take Nebivolol Tablets during a meal and the antacid medicine between meals.

Nebivolol Tablets with food and drink

Please refer to section 3.

Pregnancyand breast-feeding

Pregnancy

Nebivolol Tablets should not be taken during pregnancy unless clearly necessary.

Breast-feeding

It is not recommended for use while 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.

Driving and using machines

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

Nebivolol Tablets contains lactose

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

Nebivolol Tablets contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.