patient information leaflet bricanyl injection

PATIENT INFORMATION LEAFLET

Bricanyl® INJECTION 0.5 mg/ml

Solution for Injection or Infusion

terbutaline sulphate

WHAT YOU SHOULD KNOW ABOUT BRICANYL® INJECTION terbutaline sulphate

This leaflet applies only to Bricanyl Injection. If you have any questions, or are not sure about anything, ask your doctor or pharmacist (chemist). Remember, this medicine is only for you. Do not give it to anyone else, even if their symptoms are similar to yours.

WHAT IS IN YOUR MEDICINE?

Bricanyl Injection is a clear, aqueous solution for injection containing 0.5 mg of the active ingredient, terbutaline sulphate, per millilitre (ml). The solution also contains sodium chloride, hydrochloric acid and water for injection.

Bricanyl Injection is available in glass ampoules containing either 1 ml or 5 ml of solution. The 1 ml ampoules are available in packs of five and the 5 ml ampoules are available in packs of ten.

Terbutaline sulphate belongs to a group of medicines called beta2-agonists. These relax certain muscles, for example they open up the airways in the lungs or relax the muscles of the womb (uterus) during pregnancy.

WHAT IS YOUR MEDICINE FOR?

Bricanyl Injection helps to relieve bronchospasm (tightening of the chest and difficulty breathing) in breathing disorders such as asthma.

It is also used in pregnancy to prevent premature labour.

BEFORE BEING GIVEN BRICANYL INJECTION

Make sure that you have told your doctor about any other medicines that you are taking, including those you have bought without a prescription.

Please read the following questions carefully. They are being asked to help check that the medicine is suitable for you to take. If the answer to any of these questions is YES, you should talk to your doctor BEFORE being given this medicine.

Are you thinking of becoming pregnant? If so, you must talk to your doctor about this before doing so.
Are you already pregnant? If so, have you had any problems with your pregnancy?
Are you breast-feeding?
Are you diabetic? If so, you may need some additional blood sugar tests when you start receiving Bricanyl.
Do you have a heart problem?
Do you have an overactive thyroid gland?
Are you taking any steroid medicines (e.g. prednisolone) or xanthines (e.g. theophylline)?
Are you taking a beta-blocker (e.g. propranolol), including eye drops (e.g. timolol)?
Are you taking diuretics or water pills (e.g. frusemide)?

Important: You should not be given Bricanyl Injection if you have had problems in the past when taking medicines containing terbutaline sulphate or any of the other ingredients in this medicine, listed earlier.

BEING GIVEN YOUR MEDICINE

Your medicine will be given by your doctor who will decide the correct dose.

Dosage

For asthma and breathing problems, the usual dose (for adults and elderly) is 0.5 to 1 ml (0.25 mg to 0.5 mg) up to four times a day. For children aged 2-15 years, the usual dose is 0.01 mg/kg body weight to a maximum of 0.3 mg in total.

If given by infusion, the adult dose is 3 to 5 ml (1.5 to 2.5 mg) in 500 ml of dextrose, saline or dextrose/saline given at a rate of 10 to 20 drops (0.5 to 1 ml) per minute for 8 to 10 hours. A reduction in dosage should be made for children.

For prevention of premature labour, initially 5 micrograms/min should be infused during the first 20 minutes, increasing by 2.5 micrograms/min at 20 minute intervals until the contractions stop. More than 10 micrograms/min should seldom be given and the dose should not exceed 20 micrograms/min.

The infusion should be stopped if labour progresses despite treatment at the maximum dose. If successful, the infusion should continue for 1 hour at the chosen rate and then be decreased by 2.5 micrograms every 20 minutes to the lowest dose that reduces the contractions. The infusion should be kept at this rate for 12 hours and then treatment continued with maintenance therapy. The doctor will usually ask you to lie on your side whilst being given the infusion.

As an alternative, your doctor can give subcutaneous injections (injections under the skin) at a dose of 0.25 mg four times a day for a few days before oral treatment is started.

AFTER BEING GIVEN YOUR MEDICINE

Like all medicines, as well as the effects that are needed, Bricanyl Injection may sometimes cause side-effects such as:

Trembling or shaking
Headache
Nausea (feeling sick)
Cramp or feeling tense
Mouth and throat irritation
Palpitations

These side effects, if they do occur, usually go away within the first week of treatment.

Rarely, you may experience the effects of low levels of potassium in your blood e.g. muscle weakness, thirst, pins and needles.

If you are being treated for premature labour, you may rarely get a cough or experience shortness of breath. The doctor may need to monitor your baby's blood sugar.

Changes in sleeping patterns and changes in behaviour, such as agitation, hyperactivity and restlessness, have sometimes been seen.

Rarely, fast heart beats occur with drugs of this type. Other heart problems such as unusual heart beats have occurred, usually only in susceptible patients.

Very rarely, allergic reactions such as swollen face, rash, breathing problems, low blood pressure and collapse have occurred with beta2-agonist treatment. If these occur, tell your doctor or nurse immediately.

If you experience any of these effects, or if you notice anything else unusual, tell your doctor or pharmacist or nurse.

STORING THIS MEDICINE

Keep in a safe place, out of the reach and sight of children.
Do not store above 25°C. Keep containers in the outer carton.
Do not use this medicine after the expiry date printed on the packaging.

Medicine: bricanyl injection