What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

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Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: 17901/0116 .

Bricanyl Tablets 5mg

Package leaflet: Information for the patient

Bricanyl® Tablets 5 mg

terbutaline sulfate

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. What Bricanyl Tablets are and what they are used for
2. What you need to know before you take Bricanyl Tablets
3. How to take Bricanyl Tablets
4. Possible side effects
5. How to store Bricanyl Tablets
6. Contents of the pack and other information

1. What Bricanyl Tablets are and what they are used for

Bricanyl Tablets contain a medicine called terbutaline sulfate. This belongs to a group of medicines called beta-agonists. These work by relaxing certain muscles. For example, they open up the airways in the lungs.

  • Bricanyl Tablets are used for the regular treatment of breathing disorders such as asthma. They help to relieve tightening of the chest and difficulty breathing (bronchospasm). Bricanyl should not be used alone for the regular treatment of asthma or other breathing conditions. If you are using Bricanyl every day then your doctor should have also prescribed you another type of medication such as an “inhaled corticosteroid”, which helps reduce the swelling and inflammation in your lungs.

2. What you need to know before you take Bricanyl Tablets

Do not take Bricanyl Tablets:

  • If you are allergic to terbutaline sulfate or any of the other ingredients of this medicine (listed in Section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Bricanyl Tablets if:

  • You are pregnant and you have had problems with your pregnancy.
  • You are diabetic. If so, you may need some additional blood sugar tests when you start taking Bricanyl Tablets.
  • You have a history of heart disease, irregular heart rhythm or angina.
  • You have an overactive thyroid gland.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Bricanyl Tablets.

Other medicines and Bricanyl Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines.

Bricanyl Tablets can affect the way that some medicines work and some medicines can have an effect on Bricanyl Tablets.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

  • Steroid medicines (such as prednisolone).
  • Xanthine medicines (such as theophylline or aminophylline).
  • Beta-blocker medicines (such as atenolol or propranolol), including eye drops (such as timolol).
  • Water tablets, also known as diuretics (such as frusemide).

If you are to undergo surgery with general anaesthetics it is important that you inform your doctor about all medicine you use, including Bricanyl to protect you from adverse effects (e.g. irregular heart beat).

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.

Bricanyl should be used with caution at the end of pregnancy since it relaxes the womb.

Driving and using machines

Bricanyl Tablets are not likely to affect you being able to drive or use machines.

Bricanyl Tablets contain Lactose

Bricanyl 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 Bricanyl 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 instructions on the label should remind you of what the doctor said.

For asthma and breathing problems

Adults and young people over 16 years

  • The recommended starting dose is half a tablet three times in 24 hours. This dose is usually taken for the first 1 to 2 weeks.
  • Your doctor may increase the dose to one tablet three times a day.

Use in Children (7 to 15 years)

  • The recommended starting dose is half a tablet twice a day.
  • The doctor may increase the dose to half a tablet three times a day.

Contact your doctor straight away if:

  • Your breathing is getting worse.
  • You often wake up at night with asthma.
  • You start getting chest tightness.
  • You are not getting relief from your current dose.

These signs could mean your asthma is not being controlled and you may need different or additional treatment straight away.

If you take more Bricanyl Tablets than you should

If you have accidentally taken too much of this medicine, contact your doctor or pharmacist for advice.

If you forget to take Bricanyl Tablets

If you forget to have a dose, have it as soon as you remember. However, if it is almost time for the next dose, wait until then and take the next dose as normal. Do not take a double dose to make up for a forgotten dose.

If you stop taking Bricanyl Tablets

Do not stop taking your medicine without first discussing it with 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, this medicine can cause side effects, although not everybody gets them.

Important side effects to look out for:

  • Allergic reactions. The signs may include a swollen face, skin rash, breathing problems, low blood pressure (feeling faint) and collapse. It is not known exactly how often this happens. If this happens to you, stop taking Bricanyl Tablets and see a doctor straight away.
  • Sudden wheezing soon after taking Bricanyl Tablets. It is not known exactly how often this happens. If this happens to you, stop taking Bricanyl Tablets and see a doctor straight away.

Other possible side effects:

Very common (may affect more than 1 in 10 people)

  • Trembling or shaking.
  • Headache.

Common (may affect up to 1 in 10 people)

  • Fast heart beats.
  • Pounding heart beats (palpitations).
  • Cramp or feeling tense.
  • Low levels of potassium in your blood which may cause muscle weakness, thirst, or ‘pins and needles’.

Not known (frequency cannot be estimated from the available data)

  • Unusual or irregular heart beats.
  • Chest pain (due to heart problems such as angina). Tell your doctor if you develop this symptom whilst receiving treatment with Bricanyl Tablets, but do not stop using this medicine unless told to.
  • Feeling sick (nausea).
  • Mouth and throat irritation.
  • Changes in sleeping patterns and changes in behaviour, such as feeling agitated, restless or “hyperactive”.

Do not be concerned by this list of side effects. You may not get any of them. 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 report side effects directly via the Yellow Card Scheme at: 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 Bricanyl Tablets

  • Keep this medicine out of the sight and reach of children.
  • Do not take this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month
  • Do not store above 25°C.
  • Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Bricanyl Tablets contain

The active substance is terbutaline sulfate. Each Bricanyl Tablet contains 5 mg of terbutaline sulfate.

The other ingredients are lactose monohydrate (see section 2 “Bricanyl Tablets contain Lactose”), maize starch, povidone, microcrystalline cellulose and magnesium stearate.

What Bricanyl Tablets look like and the contents of the pack

Bricanyl Tablets are off-white. They have ‘A/BT’ and a score on one side and the symbol ‘5’ on the other side.

Bricanyl Tablets are available in glass bottles or securitainers of 100 and 500 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation for Bricanyl Tablets is held by

AstraZeneca UK Ltd
600 Capability Green
Luton
LU1 3LU
UK

Bricanyl Tablets are manufactured by

AstraZeneca AB
SE-151 85 Södertälje
Sweden

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 Bricanyl Tablets

Reference number 17901/0116

This is a service provided by the Royal National Institute of Blind People.

This leaflet was last revised in November 2017.

Bricanyl is a trademark of the AstraZeneca group of companies.

© AstraZeneca 2017

RSP 17 0124