Symbicort

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

- Shaking, usually of the hands (tremor).
- Awareness of your heartbeat (palpitations).
- Headache.
- Yeast infection of the mouth (oral thrush).
- Throat irritation.
- Cough and hoarseness.
- Dizziness and nausea.
- Muscle cramps.
- Increased heart rate (tachycardia).
- Disturbed sleep.
- Agitation.
- Nervousness.
- Bruises.
- Rash or itching.
- Low blood potassium level (hypokalaemia).
- High blood glucose level (hyperglycaemia).
- Chest pain (angina).
- Depression.
- Behavioural disturbances in children.
- Systemic effects (eg, Cushing's syndrome, suppression of the adrenal glands, slowed growth in children and adolescents, decreased bone mineral density, cataracts and glaucoma) may occur after taking high doses for prolonged periods - see warning above.

The side effects listed above may not include all of the side effects reported by the drug's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while using this one, to ensure that the combination is safe.

Beta-blockers such as atenolol, propranolol or timolol should not generally be taken with this medicine. This is because beta-blockers have an opposite action to formoterol and can cause the airways to narrow, which can result in breathing difficulties for people with asthma. This problem has sometimes been seen with eye drops containing beta-blockers, eg used for glaucoma.

This medicine may potentially decrease the amount of potassium in the blood. If it is taken in combination with any of the following medicines, which can also lower potassium in the blood, the risk of a low blood potassium level (hypokalaemia) is increased:

- other beta 2 agonists, such as salbutamol and salmeterol
- oral corticosteroids, such as prednisolone
- diuretics, eg bendroflumethiazide and furosemide
- xanthine derivates, eg theophylline.

A low blood potassium level can have serious effects, which is why people with severe asthma, who may be taking several of these medicines, should have their blood potassium level monitored regularly.

People taking digoxin may have an increased risk of abnormal heart rhythms if they experience abnormally low blood potassium levels while taking this medicine.

There may be an increased risk of abnormal heart rhythms (prolonged QT interval on the heart monitoring trace or ECG) if this medicine is taken in combination with other medicines that can have this effect, such as the following:

- certain antihistamines (terfenadine, astemizole, mizolastine)
- certain medicines for abnormal heartbeats (antiarrhythmics, eg quinidine, disopyramide, procainamide)
- certain antidepressants, eg amitriptyline, imipramine, maprotiline
- certain antipsychotics, eg thioridazine, chlorpromazine, sertindole, haloperidol
- certain antimalarials, eg halofantrine, chloroquine, quinine
- erythromycin.

The following medicines may increase the amount of budesonide that is found in the bloodstream after inhaling this medicine:

- the antifungals ketoconazole and itraconazole
- protease inhibitors for HIV infection, such as ritonavir.

These medicines can therefore increase your exposure to budesonide and so increase the risk of side effects on the rest of the body (systemic side effects, for example, decreased production of natural steroid hormones by the adrenal glands (adrenal suppression) and Cushing's syndrome.) Due to this risk, these medicines should be avoided where possible in people using Symbicort. Symbicort maintenance and reliever therapy is not recommended for people having long-term treatment with any of these medicines.

If this medicine is taken with the following medicines there may be a risk of a rise in blood pressure:

- furazolidone
- monoamine oxidase inhibitor antidepressants (MAOIs), eg phenelzine
- procarbazine.

Other medicines containing the same active ingredients

There are currently no other medicines available in the UK that contain both budesonide and formoterol. Both these medicines are available as separate inhalers.

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