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Actonorm 220mg/200mg/25mg In 5ml Oral Suspension

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Patient Information Leaflet

Actonorm

220mg / 200mg / 25mg in 5ml Oral Suspension

ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETICONE

Please read this leaflet carefully before using this medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

This leaflet contains the following information.

1.    What is Actonorm and why is it used?

2.    What should I know before taking Actonorm?

3.    How do I take Actonorm?

4.    Does Actonorm have any side effects?

5.    How do I store Actonorm?

6.    Further information.

1.    What is Actonorm and why is it used?

Actonorm is an oral treatment for the relief of indigestion and trapped wind pains. It contains aluminium hydroxide and magnesium hydroxide to neutralize excess stomach acid and simeticone which helps expulsion of trapped gas from the stomach by burping.

2.    What should I know before taking Actonorm?

When shouldn't I use Actonorm?

Do not use Actonorm if you are allergic to any of the ingredients listed in section 6 of this leaflet.

Seek medical advice before using Actonorm if you suffer from any kidney problems.

What else should I know before using Actonorm?

Actonorm contains parahydroxybenzoates which may cause allergic reactions (possibly delayed).

Are there any foods or medicines that interact with Actonorm?

Consult your doctor or pharmacist before taking Actonorm if you are taking any of the following medicines because they may become less effective:

® pivampicillin

(used with antibiotics)

® tetracyclines

(types of antibiotics)

£ ketoconazole

(an antifungal medicine)

® chlorpromazine

(used in psychiatric disorders)

® penicillamine

(used to treat rheumatoid arthritis)

® cimetidine

(used to treat heartburn and stomach ulcers).

Can I use Actonorm if I am pregnant or breast-feeding?

Always consult with a healthcare professional before using Actonorm during pregnancy. Actonorm is safe to use when breast-feeding.

Is it safe to drive or operate machinery after using Actonorm?

This product is safe to use prior to driving or operating machinery.

Important information about one of the ingredients of Actonorm.

Actonorm contains sorbitol. 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 do I take Actonorm?

Adults, the elderly and children over 12 years of age:

One to four 5ml spoonfuls taken after meals or at night as required.

Children 1 to 12 years of age:

One to two 5ml spoonfuls taken after meals or at night as required.

Actonorm is not suitable for children under one year of age.

If symptoms of indigestion or trapped wind persist for more than 7 days, discontinue use and consult your doctor.

What should I do if I accidentally take too much Actonorm?

Accidental overdose is unlikely to require medical attention. If you do feel unwell after taking an overdose then seek medical advice. You should, if possible, take the medicine and this leaflet with you provided it doesn't cause a delay.

What should I do if I miss a treatment with Actonorm?

If you have missed a treatment then you can take a dose immediately if required.

4.    Does Actonorm have any side effects?

All medicines can cause side effects. Although not common the following side effect has been reported to the ingredients of Actonorm:

® Occasional and mild disturbance of bowel function.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package 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 do I store Actonorm?

Do not use after the expiry date marked on the pack. Keep all medicines out of the sight and reach of children, preferably in a locked cupboard.

Store below 25°C, do not freeze.

6.    Further information.

What is in Actonorm?

The active ingredients are aluminium hydroxide 220mg, magnesium hydroxide 200mg, simeticone 25mg. In addition Actonorm also contains the following non-active ingredients: sorbitol solution, sodium saccharin, methyl, ethyl, propyl and butyl parahydroxybenzoates, propylene glycol, peppermint oil, buttermint flavouring and water.

How is Actonorm supplied?

Actonorm is supplied in packs of 200ml.

Who is responsible for Actonorm?

The marketing authorisation holder is:

Wallace Manufacturing Chemists Ltd., 51-53 Stert Street, Abingdon,

Oxfordshire OX14 3JF, UK

The manufacturer is:

Laleham Health and Beauty Ltd., Bradshaw Lane, Greenhalgh,

Kirkham, Lancashire PR4 3JA, UK

This Leaflet was revised December 2015 PL 00400/0008R

Wallace#

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