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NEBILET®

Nebivolol hydrochloride


Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about NEBILET® tablets. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking NEBILET® against the benefits this medicine is expected to have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What NEBILET® is used for

NEBILET® belongs to the group of medicines known as beta-blockers.

NEBILET® is used to treat:

  • high blood pressure (essential hypertension), or
  • chronic heart failure. It is usually used in combination with other medicines.

High Blood Pressure (Hypertension):

NEBILET® can be used to treat high blood pressure. It works by blocking the transmission of messages to the beta receptors in the heart which slows down the activity of the heart. It also relaxes the blood vessels and reduces the resistance that the heart has to pump against.

The blood pressure lowering effects occur after 1 to 2 weeks, although it may take up to 4 weeks for the full effect to occur.

Chronic Heart Failure:

NEBILET® can also be used to treat chronic heart failure. It slows down the heart rate and makes it beat more regularly.

It also reduces the pressure the heart has to pump against and therefore reduces the amount of work that the heart has to do.

This improves the symptoms of chronic heart failure, and reduces the likelihood of you being hospitalized and/or dying from your heart condition.

Ask your doctor if you have any questions about why NEBILET® has been prescribed for you.

Your doctor may have prescribed it for another reason.

NEBILET® is not addictive.

Before you take NEBILET®

When you must not take it

You must not take NEBILET® if you:

  • are allergic to nebivolol hydrochloride or any of the other ingredients listed at the end of this leaflet. Signs of allergic reaction may include a skin rash, itching, shortness of breath or swelling of the face, lips or tongue
  • have liver problems
  • have acute heart failure or cardiogenic shock, a serious heart condition causing low blood pressure
  • have a history of slow heart rate or uneven heart beating
  • have certain other heart conditions
  • have asthma, bronchitis or other lung disease with tightening of the airways
  • have untreated phaeochromocytoma, a rare tumour of the adrenal gland
  • have metabolic acidosis, where there is too much acid in the blood
  • have hypotension, low blood pressure
  • have a severe blood vessel disorder causing poor circulation in the arms and legs
  • are pregnant or are breastfeeding.

Do not take NEBILET® if the packaging is torn or shows signs of tampering or the tablets do not look quite right.

Do not take NEBILET® if the expiry date on the pack has passed.

You should only start taking NEBILET® under direct supervision of your doctor.

Before you start to take it

Tell your doctor if you have:

  • ever had an allergic reaction to this or any other medicine, food, preservatives or dyes
  • low blood pressure or poor circulation
  • a slow heart beat, lower than 60 beats per minute
  • asthma or breathing difficulties
  • angina, chest pain or any other heart problems, or your heart failure has just occurred or worsened recently
  • diabetes
  • a history of psoriasis, a skin disease with thickened patches of red skin, often with silvery scales
  • a severe blood vessel disorder causing poor circulation in the arms and legs
  • thyroid disorders
  • liver problems
  • kidney problems
  • any allergic conditions
  • phaeochromocytoma, a rare tumour of the adrenal gland
  • a lactose intolerance.

Tell your doctor about any of the above before you take NEBILET®.

Tell your doctor if you are pregnant or plan to become pregnant, or if you are breastfeeding or plan to breastfeed.

Your doctor will discuss the risks and benefits of using NEBILET®.

Tell your doctor if you plan to have surgery, even at the dentist's.

Your surgeon and anaesthetist should know well ahead of the date of your surgery so they can allow for your condition and medications.

Taking other medicines

Tell your doctor if you are taking any other medicines, including those that you have bought from a pharmacy, supermarket or health food shop.

Some medicines and NEBILET® may interfere with each other. These medicines include:

  • those used to treat irregular or abnormal heartbeat (eg. quinidine, flecainide, disopyramide, lignocaine, mexiletine, amiodarone)
  • those used to treat high blood pressure (eg. clonidine)
  • calcium channel blockers for high blood pressure or heart problems (eg. verapamil, diltiazem)
  • insulin and tablets used to treat diabetes
  • those used to treat depression and anxiety (eg. phenelzine, tranylcypromine, paroxetine, sertraline, sedatives, phenothiazine)
  • those used to treat excessive stomach acid (e.g. cimetidine). You should take NEBILET® during a meal, and the antacid between meals.
  • digoxin, a medicine used to treat heart failure
  • drugs used to treat asthma, blocked nose or certain eye disorders such as glaucoma or dilation of the pupil
  • dextromethorphan, an ingredient in cough medicines
  • anaesthetics
  • other beta-blocker medicines, including beta-blocker eye drops.

These medicines may be affected by NEBILET®, or may affect how well it works. You may need to take different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.

How to take NEBILET®

You should only start taking NEBILET® under the direct supervision of your doctor.

Your doctor will tell you how much you should take, when and how often. It is important that you take this medicine as directed by your doctor.

If you are unsure ask your doctor or pharmacist.

Do not stop taking NEBILET® without speaking to your doctor first. You should not stop treatment with NEBILET® suddenly as this can worsen your condition.

How much to take

High Blood Pressure (Hypertension):

For the treatment of high blood pressure, the usual starting dose is one 5mg NEBILET® tablet each day. Your doctor may start you on a lower dose of NEBILET®.

Chronic Heart Failure:

For the treatment of chronic heart failure, your doctor will start you on a low dose of NEBILET®, and gradually increase the dose depending on how you respond to this medicine.

The usual starting dose is one 1.25mg tablet each day. Your doctor will gradually increase your dose stepwise over a number of weeks, one tablet at a time until you reach the best dose for you.

The highest dose you should take is 10mg each day.

When you take NEBILET® for the first time, and whenever your doctor increases your dose, you should be observed by a doctor for at least 2 hours until the effect of the medicine on you is known.

Your doctor may reduce your dose if necessary, and you should not stop treatment abruptly as this can worsen your condition.

REMEMBER: This medicine is only for you. Only a doctor can prescribe it for you.

When and how should you take the tablets

Swallow the tablets with a little water.

Do not crush or chew the tablets.

Try to take NEBILET® at the same time each day. Taking it at the same time each day will have the best effect. It will also help you to remember when to take it.

You can take NEBILET® with or without meals.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take it as soon as you remember, and then go back to taking NEBILET® as you would normally.

Do not take a double dose to make up for the dose that you missed.

If you are not sure whether to skip the dose, talk to your doctor or pharmacist.

If you miss a whole day, just continue to take your normal daily dose the next day. Repeated skipping is to be avoided.

If you have trouble remembering to take NEBILET®, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13  11  26 in Australia or 0800 764 766 in New Zealand), or go to the emergency department of your nearest hospital.

Do this, even if there are no signs of discomfort or poisoning.

If you take too many NEBILET® tablets, you may need urgent medical attention. Your blood pressure may drop too far and your heart rate might slow down too much.

You will feel faint or may faint, and may have shortness of breath. In extreme cases, serious heart and lung problems may occur.

While you are taking NEBILET®

Things you must do

Be sure to keep all of your doctor's appointments so that your progress can be checked.

If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking NEBILET®.

Tell your doctor if you believe that NEBILET® is not helping your condition.

Your doctor may need to change the dose.

Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.

Your doctor may think it is not working effectively and change your treatment unnecessarily.

If you become pregnant while you are taking NEBILET®, tell your doctor immediately.

If you plan to have surgery, even at the dentist's, tell your doctor, anaesthetist or dentist that you are taking this medicine.

It may affect other medicines used during surgery.

If you are being treated for diabetes, make sure you check your blood sugar level regularly and report any changes to your doctor.

NEBILET® may change how well your diabetes is controlled. It may also cover up some of the symptoms of low blood sugar, called hypoglycaemia, such as fast heart beat. NEBILET® may make hypoglycaemia last longer. Your dose of diabetic medicines, including insulin, may need to change.

If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly.

You may feel light-headed or dizzy when you begin to take NEBILET®. This is because your blood pressure has fallen suddenly.

Standing up slowly, especially when you get up from bed or from sitting, will help your body adjust to the change in position and blood pressure. If this problem continues or gets worse, tell your doctor.

Make sure you drink enough water during exercise and in hot weather when you are taking NEBILET®, especially if you sweat a lot.

If you do not drink enough water while taking NEBILET® you may feel faint or light-headed. This is because your blood pressure is dropping too much. If you continue to feel unwell, talk to your doctor.

If you have any medical test, tell your doctor that you are taking NEBILET®.

NEBILET® may affect the results of some tests.

Visit your doctor regularly so they can check on your progress.

Your doctor may check your eyes, thyroid, lipid and blood glucose levels.

Things you must not do

Do not stop taking NEBILET® without speaking to your doctor first.

You should not stop treatment with NEBILET® suddenly as this can worsen your condition. Your doctor will gradually reduce the amount of NEBILET® you are taking before stopping completely.

Do not give NEBILET® to anyone else, even if they have the same condition as you.

Do not take NEBILET® for any other complaints unless your doctor tells you to.

Things to be careful of

Be careful when driving or operating machinery until you know how NEBILET® affects you.

NEBILET® may cause you to feel drowsy, light-headed or dizzy. Make sure you know how you react to NEBILET® before you drive, operate machinery or do anything else that could be dangerous if you are dizzy or light-headed.

Be careful drinking alcohol while you are taking NEBILET®

If you feel dizzy or light-headed when you take NEBILET®, these conditions may get worse when you drink alcohol.

Be careful getting up from a lying or sitting position.

You may feel dizzy or light-headed if you get up too quickly. Getting up slowly may help.

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking NEBILET®.

If you get any side effects, do not stop taking NEBILET® without first talking to your doctor.

NEBILET® helps most people it is prescribed for, but it may have unwanted side effects in some people.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need to get medical attention if you get some of the side effects.

If you experience severe light-headedness, dizziness or fainting you must go to the Accident and Emergency department of your local hospital at once.

Tell your doctor if you notice any of the following and they worry you:

  • headache, tiredness
  • nausea or vomiting
  • stomach upset, wind, diarrhoea or constipation
  • disturbed sleep or nightmares
  • coldness or numbness in the hands or feet

These side effects are usually mild and will decrease as you get used to your medicine.

Tell your doctor as soon as possible if you notice any of the following:

  • slow heart beat
  • dizziness or fainting
  • tingling or "pins and needles"
  • abnormal thinking, depression or hallucinations
  • sexual problems
  • skin rashes and itching
  • dry eyes or problems with eye sight
  • an increase in a cramp-like pain in one or both legs that develops on walking.

The above list includes serious side effects that may require medical attention.

Tell your doctor immediately or go to Accident and Emergency at the nearest hospital if you notice any of the following:

  • swelling of the face, lips, tongue or throat that may cause difficulty swallowing or breathing
  • chest tightness, shortness of breath or difficulty breathing
  • swelling of the feet and ankles
  • chest pain or changes in heart rate

The above list includes very serious side effects that may require urgent medical attention.

Tell your doctor if you notice anything that makes you feel unwell.

Other side effects not listed above may also occur in some patients

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After using NEBILET®

Storage

Keep NEBILET® tablets in the blister pack until it is time to take them.

If you take NEBILET® out of the blister pack it may not keep well.

Keep your tablets in a cool, dry place where the temperature stays below 30°C.

Do not store NEBILET® tablets in the bathroom or near a sink.

Do not leave them in a car or on a window sill

Heat and dampness can destroy some medicines

Keep NEBILET® tablets where children cannot reach them.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking NEBILET® or the expiry date has passed, ask your pharmacist what to do with any tablets that are left over.

Product description

What NEBILET® looks like

NEBILET® tablets are white to off-white, round and biconvex.

Each pack contains 28 tablets, as 2 blister packs each with 14 tablets. Another pack contains 7 tablets, as 1 blister pack each with 7 tablets.

There are 3 different strengths of NEBILET® tablets.

  • The 1.25mg tablets have a score on one side. The score is for identification purposes only and not to divide the tablet into equal doses.
  • The 5mg tablet is cross-scored.
  • The 10mg tablet is embossed with the number "10" on one side.

Ingredients

Each tablet contains either 1.25mg, 5mg or 10mg of nebivolol (as nebivolol hydrochloride.)

Each tablet also contains the following inactive ingredients:

  • lactose
  • maize starch
  • croscarmellose sodium
  • hypromellose
  • polysorbate
  • microcrystalline cellulose
  • colloidal silica
  • magnesium stearate.

Distributor

NEBILET® is distributed by:

CSL Biotherapies Pty Ltd
45 Poplar Road
Parkville 3052 VIC
AUSTRALIA

NEBILET® is a registered trademark of Johnson and Johnson, used under licence.

NEBILET® is supplied under license by Menarini International Operations Luxembourg S.A., under license of Janssen Pharmaceutica N.V., Beerse, Belgium.

Australian Registration Numbers:

NEBILET® 1.25mg AUST R 148873
NEBILET® 5mg AUST R 148874
NEBILET® 10mg AUST R 148875

This is not all the information available on NEBILET®. If you have any more questions or are unsure about anything, ask your doctor or pharmacist.

This leaflet was prepared in November 2009.

Published by MIMS May 2010

Consumers should be aware that the information provided by the Consumer Medicines Information (CMI) search (CMI Search) is for information purposes only and consumers should continue to obtain professional advice from a qualified healthcare professional regarding any condition for which they have searched for CMI. CMIs are provided by MIMS Australia. CMI is supplied by the relevant pharmaceutical company for each consumer medical product. All copyright and responsibility for CMI is that of the relevant pharmaceutical company. MIMS Australia uses its best endeavours to ensure that at the time of publishing, as indicated on the publishing date for each resource (e.g. Published by MIMS/myDr January 2007), the CMI provided was complete to the best of MIMS Australia's knowledge. The CMI and the CMI Search are not intended to be used by consumers to diagnose, treat, cure or prevent any disease or for any therapeutic purpose. Cirrus Media Pty Limited, its servants and agents shall not be responsible for the continued currency of the CMI, or for any errors, omissions or inaccuracies in the CMI and/or the CMI Search whether arising from negligence or otherwise or from any other consequence arising there from.

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