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

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SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

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

2.    QUALITATAIVE AND QUANTITATIVE    COMPOSTION

Each 5ml contains:

Aluminium Hydroxide    220.0 mg

Magnesium Hydroxide    200.0 mg

Simeticone    25.0 mg

3.    PHARMACEUTICAL FORM

Oral suspension.

White suspension with the odour of peppermint.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Treatment of dyspepsia and flatulence

4.2    Posology and method of administration

Adults, Elderly and children over 12 years One to Four 5ml spoonfuls Children 1 to 12 years One to Two 5ml spoonfuls

To be taken after meals and at night as required

4.3    Contraindications

Not known

4.4    Special warnings and precautions for use

Caution should be exercised when taking magnesium salts in renal failure. Patients should be advised that if symptoms persist for more than 7 days they should consult their doctor.

4.5    Interaction with other medicinal products and other forms of interaction

Reduced absorption may occur if taken simultaneously with pivampicillin, tetracyclines, ketoconazole, chlorpromazine, penicillamine and cimetidine.

4.6    Pregnancy and lactation

There have been no specific studies using Actonorm during pregnancy. To date, no other relevant epidemiological data are available. Caution should be advised when prescribing to pregnant women, who should check with their physicians before using antacids.

4.7    Effects on ability to drive and use machines

Not applicable

4.8    Undesirable effects

Occasional and mild disturbance of bowel function

4.9    Overdose

Not applicable

5.1    Pharmacodynamic properties

Aluminium Hydroxide    Antacid

Magnesium Hydroxide    Antacid

Simeticone    Anti-flatulent

5.2    Pharmacokinetic properties

Aqueous suspension, bioavailable

5.3    Preclinical safety data

None

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sorbitol Solution Sodium Saccharin Methyl hydroxybenzoate Ethyl hydroxybenzoate Propyl hydroxybenzoate Butyl hydroxybenzoate,

Propylene Glycol Buttermint Toffee Flavour Oil of Peppermint Purified Water

6.2    Incompatibilities

Not known

6.3    Shelf life

24 months in original container

6.4 Special precautions for storage

Store below 25°C. Do not freeze.

6.5    Nature and contents of container

Amber Glass bottle of 200ml

6.6    Special precautions for disposal

No special instructions

7    MARKETING AUTHORISATION HOLDER

Wallace Manufacturing Chemists Ltd.

Wallace House 51-53 Stert Street Abingdon Oxfordshire OX14 3JF United Kingdom

8    MARKETING AUTHORISATION NUMBER

PL 00400/0008R

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

23/06/1982 / 28/01/2005

10 DATE OF REVISION OF THE TEXT

16/04/2014