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BAMBEC TABLETS 10MG

Active substance(s): BAMBUTEROL HYDROCHLORIDE / BAMBUTEROL HYDROCHLORIDE / BAMBUTEROL HYDROCHLORIDE

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Package leaflet: Information for the user

Bambec® Tablets 10 mg and 20 mg
bambuterol hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it
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.
What is in this leaflet
1. W
 hat Bambec Tablets are and what they are used for
2. What you need to know before you take Bambec Tablets
3. How to take Bambec Tablets
4. Possible side effects
5. How to store Bambec Tablets
6. Contents of the pack and other information
1. 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.
• B
 ambec Tablets are used to treat breathing problems in people with asthma and similar
conditions. Bambec Tablets are used as regular treatment to prevent expected breathing
problems. Bambec Tablets should not be used alone for the regular treatment of asthma
or other breathing conditions. Bambec tablets must only be used when your doctor has
prescribed you another type of medication such as an “inhaled corticosteroid”, which
helps reduce the swelling and inflammation in your lungs. However, Bambec Tablets
will not relieve an acute asthma attack that has already started.
2. 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 (e.g. medicines for high blood pressure or heart conditions
such as propranolol and eye drops for glaucoma such as timolol).
• Water tablets (diuretics).
• Adrenaline, also known as epinephrine (a medicine that stimulates the heart).
• Medicines containing ipratropium.
There may also be effects on the salt balance in the blood (low potassium levels) when
Bambec Tablets are used at the same time as certain other medicines. Usually this is of
no importance, but in some cases there can be effects on the heart rhythm.
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.
• Bambec Tablets should be used with caution at the end of pregnancy since it relaxes
the womb.
• It is not known if Bambec Tablets pass into breast milk. Talk to your doctor before
breast-feeding if you are taking Bambec Tablets.
Driving and using machines
Bambec Tablets are not likely to affect you being able to drive or use any tools or machines.
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.
3. 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.
• B
 ambec Tablets must only be used with medication such as Inhaled corticosteroids.
• T
 he recommended dose is one tablet just before bedtime.
• D
 o not chew or crush the tablets.
• S
 wallow the tablets whole with a drink of water.
• If necessary, the tablets can be broken in half.
Contact your doctor straight away if:
• Y
 our breathing is getting worse.
• Y
 ou often wake up at night with wheezing or difficulty in breathing.
• Y
 ou start to get a tight chest.
• T
 he 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.
If you have any further questions on the use of this medicine ask your doctor or Pharmacist.
4. 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.
• B
 reathing 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:
• M
 uscle 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).
• H
 eart 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.
If any of the side effects get serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
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.
5. How to store Bambec Tablets
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton after EXP. The expiry
date refers to the last day of that month.
• Do not store above 30°C.
6. Contents of the pack and other information
What Bambec Tablets contain
• The active substance is bambuterol hydrochloride. Each tablet contains 10 or 20 mg
of the active ingredient.
• The other ingredients are lactose monohydrate, maize starch, povidone, microcrystalline
cellulose, magnesium stearate and purified water.
What Bambec Tablets look like and contents of the pack
Bambec Tablets are off-white in colour and are available in packs containing 28 or
30 tablets. The tablets are packed in blister strips.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisations for Bambec Tablets are held by AstraZeneca UK Ltd.,
600 Capability Green, Luton, LU1 3LU, UK.
Bambec Tablets are manufactured by AstraZeneca UK Ltd., Silk Road Business Park,
Macclesfield, Cheshire, SK10 2NA, UK.

To listen to or request a copy of this leaflet in Braille, large
print or audio please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following information:
Product name Bambec 10 mg Tablets
Bambec 20 mg Tablets
Reference number 17901/0103 or 17901/0104
This is a service provided by the Royal National Institute of the Blind.
This leaflet was last revised in December 2016
© AstraZeneca 2016
Bambec is a trademark of the AstraZeneca group of companies.
RSP 16 0099

197255

C 2540

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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