Bambec 10mg Tablets
Ref: 0117/251114/1 /F
Bambec® 10mg Tablets
(bambuterol hydrochloride)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine because its 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.
Your medicine is called Bambec 10mg Tablets but will be referred to as Bambec Tablets throughout this leaflet.
What is in this leaflet
0 What Bambec Tablets are and what they are used for 0 What you need to know before you take Bambec Tablets 0 How to take Bambec Tablets 0 Possible side effects 0 How to store Bambec Tablets 0 Contents of the pack and other information
0 What Bambec Tablets are and what they are used for
Bambec Tablets contain bambuterol hydrochloride. They belong to a group of medicines called bronchodilators.
* Bronchodilators work by relaxing the airways of your lungs, making them wider.
* Bambec Tablets are used to treat breathing problems in people with asthma and similar conditions.
0 What you need to know before you take Bambec Tablets
Do not take Bambec Tablets
If you are allergic to bambuterol hydrochloride or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Bambec Tablets if:
* You are diabetic. You may need some additional blood sugar tests when you start taking Bambec Tablets.
* You have a history of heart disease, irregular heart rhythm or chest pains (angina).
* You have an overactive thyroid gland.
* You have problems with your liver or kidneys.
* You are going to have a general anaesthetic for an operation, including for dental work.
* You have a family history of glaucoma (increased pressure in the eye). Other medicines and Bambec Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. In particular, tell your doctor before taking Bambec Tablets if you are taking:
* Steroid medicines (such as prednisolone).
* Theophylline or aminophylline medicines (for breathing problems)
* Beta-blocker medicines (such as propranolol and timolol) including eye drops.
* Water tablets (diuretics).
* Adrenaline, also known as epinephrine (a medicine that stimulates the heart).
* Medicines containing ipratropium.
Pregnancy, breast-feeding and fertility
* 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.
* If you get pregnant when taking Bambec Tablets, talk to your doctor straight away.
* It is not known if Bambec Tablets pass into breast milk. Talk to your doctor before breast-feeding if you are taking Bambec Tablets.
Bambec Tablets contain lactose
Bambec Tablets contain lactose which is a type of sugar. If you have been
told by your doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicinal product.
Driving and using machines
Bambec Tablets are not likely to affect you being able to drive or use any
tools or machines.
0 How to take Bambec Tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
* The recommended dose is one tablet just before bedtime.
* Do not chew or crush the tablets.
* Swallow the tablets whole with a drink of water.
* If necessary, the tablets can be broken in half.
Contact your doctor straight away if:
* Your breathing is getting worse.
* You often wake up at night with wheezing or difficulty in breathing.
* You start to get a tight chest.
* The Bambec Tablets do not make your breathing any easier.
If any of these happen, it could mean your asthma is not being controlled. You may need different treatment or extra treatment straight away.
Use in children
Bambec Tablets should not be taken by children.
If you take more Bambec Tablets than you should
If you have taken more Bambec Tablets than prescribed by your doctor, tell the doctor or go to the nearest hospital straight away. Take the Bambec Tablets with you.
If you forget to take Bambec Tablets
If you forget to take a dose, take it as soon as you remember. If it is almost time to take the next dose, wait until then. Do not take a double dose to make up for a forgotten dose.
If you stop taking Bambec Tablets
Do not stop taking your medicine without first talking to your doctor.
0 How to store Bambec Tablets
Expiry date
Do not use this medicine after the expiry date shown on the carton label or blister strip.
If your doctor tells you to stop taking this medicine, return any unused tablets to your pharmacist (chemist) for safe disposal. Only keep this medicine, if your doctor tells you to.
If your tablets become discoloured or show any other signs of deterioration, consult your pharmacist (chemist) who will tell you what to do.
Storing your medicine
* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
* Do not store above 30°C.
* Do not take your tablets out of the blister strip until it is time to take your dose.
Important Information
Remember this medicine is for you. Only a doctor can prescribe it.
Never give your medicine to other people. It may harm them, even if their symptoms are the same as yours.
0 Contents of the pack and other information
What Bambec Tablets contain
*The active substance is bambuterol hydrochloride. Each tablet contains 10mg of the active ingredient.
*The other ingredients are lactose monohydrate, maize starch, povidone, microcrystalline cellulose, magnesium stearate.
What Bambec Tablets look like and contents of the pack
They are a white, oval shaped tablet, marked 'A/BM' on one side, and scored on the other. Each blister pack contains 30 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by AstraZeneca Farmaceutica Spain, S.A.,
O Porrino (Pontevedra), Spain and are procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited,
Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire,
B98 0RE
If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.
POM PL 15184/0117 Bambec 10mg Tablets
Bambec ® 10mg Tablets
(bambuterol hydrochloride)
Patient Information Leaflet (continued)
Q Possible side effects
Like all medicines, Bambec Tablets can cause side effects, although not everybody gets them.
Allergic (hypersensitive) reactions:
An allergic reaction may happen with medicines like Bambec Tablets. It is not known exactly how often this happens. If you think Bambec Tablets are causing an allergic reaction, stop taking your tablets and contact your doctor straight away.
An allergic reaction could cause:
* A swollen face
* Skin rash
* Breathing problems, low blood pressure (feeling faint) and collapse
You may experience Bronchospasm (tightening of the muscles in the airways which causes wheezing). It is not known exactly how often this happens. If the wheezing comes on suddenly after taking your dose of Bambec Tablets stop taking your tablets and contact your doctor straight away.
Contact your doctor if you notice any of the following:
* Muscle weakness, thirst or pins and needles. This may mean that you have low levels of potassium in your blood. It is not known exactly how often this happens. It is more likely to happen if you have severe asthma or if you are taking steroid medicines, theophylline or aminophylline, or water tablets (diuretics).
* Heart problems, such as an irregular heart beat. These have occurred with medicines of this type in susceptible patients.
Other possible side effects:
Very common (may affect more than 1 in 10 people)
Trembling or shaking.
Headache.
Being restless.
Common (may affect up to 1 in 10 people)
Awareness of your heart beating (palpitations).
Sudden painful muscle tightness (cramp).
Difficulty in sleeping.
Uncommon (may affect up to 1 in 100 people)
Feeling agitated.
Faster heartbeats.
Irregular heartbeats.
Not known (frequency cannot be estimated from the available data)
Feeling sick (nausea).
Feeling hyperactive.
High levels of sugar in your blood.
Feeling dizzy.
Although it is not known exactly how often this happens, some people may occasionally experience chest pain (due to heart problems such as angina). Tell your doctor if you develop these symptoms whilst receiving treatment with Bambec, but do not stop using this medicine unless told to do so.
Some of the side effects listed above may go away within 1 or 2 weeks of starting Bambec tablets.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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.
Bambec is a registered trademark of AstraZeneca AB.
Revision date: 25/11/14