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INFORMATION FOR CONSUMERS

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Consumer Medicine Information

BAMBEC®

Bambuterol hydrochloride 10 mg tablets

Bambuterol hydrochloride 1 mg/mL oral solution

What is in this leaflet

This leaflet answers some of the common questions people ask about Bambec. It does not contain all the information that is known about Bambec.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor will have weighed the risks of you taking Bambec against the benefits they expect it will 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 Bambec is used for

Bambec gives relief from symptoms such as shortness of breath in patients with asthma and other similar conditions. Bambec is used as regular treatment to prevent breathing problems. However, Bambec will not relieve an acute asthma attack that has already started.

How Bambec works

Bambec widens the airways, enabling you to breathe more easily. Bambec is effective for at least 24 hours.

Before you use Bambec

Inform your doctor if you have had any unusual reaction to any of the ingredients in Bambec tablets or oral solution.

If you have had any unusual reaction to any other medicine, particularly another asthma drug called Bricanyl (terbutaline), inform your doctor.

In some cases Bambec should be used with particular care. You should always tell your doctor about other health problems especially if you have a heart disorder, a liver disease, diabetes, a disturbed thyroid function (thyrotoxicosis), or a disturbed kidney function.

If you become pregnant or if you are breastfeeding you should always be very careful with the use of medicines. There is limited experience with Bambec in pregnant and breastfeeding women. Therefore, if you become pregnant while using Bambec you should contact your doctor as soon as possible.

Taking other medicines

Certain types of medicines, for example beta-blockers (some heart medicines or eye drops) may reduce or block the effect of Bambec when taken at the same time. Therefore, you should always inform your doctor about all medicines you take, including those you have bought without a prescription.
Bambec prolongs the effect of some muscle-relaxing drugs, such as succinylcholine, used in connection with surgery. Therefore, if surgery is planned whilst you are using Bambec, you must inform your doctor about your medication

Using Bambec

The dosage is individual. Follow your doctor's directions carefully. They may differ from the information contained in this leaflet.

You should take Bambec shortly before bedtime unless your doctor tells you otherwise. If you use Bambec tablets you should swallow the tablet with water. If you cannot swallow the tablet intact, it can be divided into two pieces.

Usual doses for adults: The usual starting dose is 10 mg (10 mL oral solution or one 10 mg tablet) once daily.

If necessary to control your symptoms, your doctor may increase your dose to 20 mg (20 mL oral solution or two 10 mg tablets) once daily.

If you have a reduced kidney function, your doctor may decide to reduce your starting dose to 5 mg (5 mL oral solution or half a 10 mg tablet) once daily. This dose may after 1-2 weeks be increased to 10 mg (10mL oral solution or one 10 mg tablet) once daily.

Usual doses for children 2-5 years: The usual dose is 10 mg (10 mL oral solution or one 10 mg tablet) once daily.

In Oriental children the usual dose is 5 mg (5 mL oral solution or half a 10 mg tablet) once daily.

Usual doses for children 6-12 years: The usual starting dose is 10 mg (10 mL oral solution or one 10 mg tablet) once daily. If necessary to control the child's symptoms, the doctor may increase the dose to 20 mg once daily after 1-2 weeks of treatment.

In Oriental children the dose should not be higher than 10 mg (10 mL oral solution or one 10 mg tablet once daily).

Overdose

Do not take a higher dose of Bambec than your doctor has prescribed. Taking more will increase the risk of side effects. The most common symptoms and signs that may occur after overdosage are:

Telephone your doctor or the National Poisons and Hazardous Chemicals Information Centre Ph: 0800 POISON (0800 764 766) or go to Accident & Emergency at your nearest hospital immediately if you think that you or anyone else may have taken too much Bambec. Even if there are no signs of discomfort or poisoning.

While you are using Bambec

You must contact your doctor as soon as possible if your usual dose of Bambec no longer gives you the same relief as earlier. You may then need extra medication to control your asthma. Do not increase the dose of Bambec without discussing it with your doctor.

If you forget to take a dose, take it as soon as you remember. However, if it is very close to the next dosing time, wait until then. Do not take double doses to make up for the dose that you missed.

Bambec has been prescribed for your current condition only. Do not use Bambec for other problems unless your doctor tells you to. Never give your medicine to someone else.

Bambec does not affect the ability to drive or use machines.

Side effects

Side effects, typical of this kind of asthma medication, may appear but will usually disappear by themselves within 1-2 weeks of treatment. However, be sure to tell your doctor if any of the following side effects continue:

More common side effects

Less common side effects

Rare side effects

You should also contact your doctor if you get any other unusual side effects whilst using Bambec.

After using it

Storage

Store below 30 °C.

Keep it where young children cannot reach it.

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

Disposal

Do not use Bambec after the expiry date marked on the label or the outer carton. Ask your pharmacist what to do with any medicine you have left over.

Product description

What Bambec looks like

Tablet 10 mg - a white to faintly yellow, round, biconvex tablet with a score, and the engraving A over BM on the same side.

Oral solution 1 mg/mL - a colourless to faintly yellow solution with the odour and taste of black currant.

Ingredients

Each Bambec tablet contains bambuterol hydrochloride 10 mg as the active ingredient plus, lactose monohydrate, maize starch, polyvidone, microcrystalline cellulose, magnesium sterate.

Bambec Oral solution contains bambuterol hydrochloride 1 mg/mL as the active ingredient plus, sorbitol, glycerol, sodium benzoate, citric acid, sodium hydroxide, essence black currant, water purified.

Marketed by:

AstraZeneca Ltd
PO Box 1301, Auckland.

Ph: (09) 623 6300 or
      0800 363 200.

Trademarks herein are property of the AstraZeneca Group.

26 June 2002