What Soprobec is and what it is used for

Side Effects

Like all medicines, Soprobec can cause side effects, although not everybody gets them.

Stop using Soprobec and contact your doctor immediately if:

• you get allergic reactions including skin rashes, hives, itching or redness, or swelling of the face, eyes, lips and throat.
• you notice an immediate increase in wheezing, shortness of breath and cough straight after using your inhaler, stop using Soprobec and use a quick-acting ‘reliever’ inhaler immediately. Contact your doctor straightaway. Your doctor will review your asthma and may change your treatment and may prescribe a different inhaler to treat your asthma.

The following side effects have been reported. Tell your doctor as soon as possible if you suffer from any of these side effects but do not stop treatment unless told to do so. Your doctor will try to prevent these effects by prescribing Soprobec in the lowest dose possible to control your asthma.

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

• Candidiasis in the mouth and / or throat (thrush). This is more likely if the daily dose taken is greater than 400 micrograms. Thrush can be treated with anti-fungal medicines whilst you continue to use Soprobec. Brushing your teeth, or thoroughly rinsing your mouth with water immediately after each dose may help prevent thrush.

Common (may affect up to 1 in 10 people)

• Hoarse voice or a sore throat or tongue. Using a Volumatic spacer device or rinsing your mouth with water immediately after using your inhaler may help prevent this.

Uncommon (may affect up to 1 in 100 people)

• Rash, hives, pruritus and / or erythema.

Very rare (may affect up to 1 in 10,000 people)

• Allergies, which manifest with swelling of the eyelids, face, lips and / or throat (angioedema).
• Respiratory disturbances such as dyspnea (feeling of shortness of breath or difficulty breathing) and / or bronchospasm (narrowing of the walls of the bronchi with decreased air intake).
• Anaphylactic or anaphylactoid reactions (severe allergic reactions that can make breathing difficult or alter your level of consciousness).
• Children and adolescents may grow more slowly and may need to have their height checked regularly by their doctor. This occurs particularly after treatment with Soprobec at high doses over a long period of time.
• Rounded face (full moon) (Cushing’s syndrome).
• A decrease in bone mineral density (thinning and weakening of the bones).
• Eye problems which include the formation of cataracts and glaucoma (increased pressure in the eye).
• Paradoxical bronchospasm.

Frequency not known:

• Sleeping problems, depression or feeling worried, restless, nervous, over-excited or irritable. These effects are more likely to appear in children.
• Blurry vision
• Headache
• Nausea

If you become unwell or develop symptoms such as loss of appetite, abdominal pain, weight loss, tiredness, nausea (feeling sick), vomiting (being sick), feeling faint, sweating and possible convulsions (fits), you should consult your doctor. This is particularly important if you have been exposed to stress such as surgery, infection, an acute attack of asthma, or other serious illness.

Your doctor may carry out blood test from time to time to monitor the levels of steroids in your body.

Ingredients

The active substance of your inhaler is beclometasone dipropionate. Each puff contains 50, 100, 200 or 250 micrograms of beclometasone dipropionate.

The other ingredients are glycerol, ethanol and the CFC-free propellant norflurane (HFA-134a).

To help protect the environment, the inhaler contains the CFC-free propellant HFA-134a, which replaces completely the chlorofluorocarbon (CFC) propellants and appears to have a less damaging effect on the ozone layer. The only differences you might notice from your previous CFC-containing inhaler are the taste and the feel of the spray in your mouth.

Patient Information Leaflet

Click here to view the patient information leaflet.