ALUTRIL FORTE Chewable tablet Ref.[27494] Active ingredients: Aluminium hydroxide Magnesium silicate

Source: Υπουργείο Υγείας (CY)  Revision Year: 2018  Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

4.3. Contraindications

Alutril Forte is contra-indicated in patients with hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

Prolonged use of antacids containing aluminium in patients undergoing chronic haemodialysis carries the risk of encephalopathy.

Alutril Forte should not be given for prolonged or intensive therapy to patients with severe renal dysfunction, since hypermagnesaemia may develop.

This product contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicine contains less than 1 mmol sodium (23 mg) per dose (maximum daily dose), that is to say essentially ‘sodium-free’.

4.5. Interaction with other medicinal products and other forms of interaction

Care is necessary when giving drugs to patients receiving antacids. Gastro-intestinal absorption can be reduced by adsorption on insoluble antacids or changes in gastric emptying time and the effects of a drug may be diminished or enhanced by alterations in the intestinal pH or by the formation of complexes.

Antacids usually interfere with the absorption of tetracycline, pivampicillin, penicillamine, mexiletine, chlorpromazine, ketoconazole, cimetidine and diflunisal.

4.6. Pregnancy and lactation

The active ingredients of Alutril Forte tablets have been in wide use for many years without apparent ill consequence. However, careful consideration should be taken into account when prescribing Alutril Forte to women who are pregnant, particularly during the first trimester.

4.7. Effects on ability to drive and use machines

None.

4.8. Undesirable effects

No side-effects have been reported at the recommended therapeutic dosage. Hypophosphataemia may occur with prolonged administration of large doses.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.

Cyprus, Pharmaceutical Services, Ministry of Health, CY-1475 Nicosia, Fax: +357 22608649, Website: www.moh.gov.cy/phs

6.2. Incompatibilities

None.

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