Bystolic
(Nebivolol Hydrochloride)

What Bystolic is and what it is used for

Nebilet contains nebivolol, a cardiovascular drug belonging to the group of selective betablocking 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). Nebilet is also used to treat mild and moderate chronic heart failure in patients aged 70 or over, in addition to other therapies.

How to take Bystolic

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Nebilet 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. 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 ½ (half) 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 ¼ (quarter) tablet per day. This may be increased after 1-2 weeks to ½ (half) tablet per day, then to 1 tablet per day and then to 2 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 2 tablets (10mg) 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. If you have been told by your doctor to take ¼ (quarter) or ½ (half) tablet daily, please refer to the instructions below on how to break Nebilet 5 mg cross-scored tablets.
• Place the tablets onto a flat, hard surface (e.g. a table or worktop), with the cross score facing up.
• Break the tablet by pushing it with the index fingers of both hands placed along one breakmark (Diagrams 1 and 2).
• Tablet quarters are obtained by breaking the halves in the same way (Diagrams 3 and 4). Diagrams 1 and 2: Easy breaking of the Nebivolol 5 mg cross-scored tablet in half. Diagrams 3 and 4: Easy breaking of half of the Nebivolol 5 mg cross-scored tablet into quarters. 4
•Your doctor may decide to combine Nebilet tablets with other medicines to treat your condition.
•Do not use in children or adolescents. If you take more Nebilet than you should If you accidentally take an overdose of this medicine, tell your doctor of pharmacist immediately. The most frequent symptoms and signs of a Nebilet 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 Nebilet If you forget a dose of Nebilet, 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 Nebilet You should always consult with your doctor before stopping Nebilet treatment, whether you are taking it for high blood pressure or chronic heart failure. You should not stop Nebilet treatment abruptly as this can temporarily make your heart failure worse. If it is necessary to stop Nebilet 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 product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. When Nebilet 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. 5

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 Nebilet 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. Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

How to Store Bystolic

Keep this medicine out of the sight and reach of children. 6 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 label and blister foil after EXP. The expiry date refers to the last day of that month. Do not throw any medicine 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.