SOLVAZINC Effervescent tablet Ref.[9203] Active ingredients: Zinc Zinc sulfate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Galen Limited, Seagoe Industrial Estate, Craigavon, BT63 5UA, UK

Contraindications

Hypersensitivity to the active substance or any of the excipients listed in section 6.1.

Copper deficiency (see section 4.5).

Special warnings and precautions for use

Accumulation of zinc may occur in cases of renal failure.

This product contains sorbitol (E420), therefore patients with rare hereditary problems of fructose intolerance should not take this medicine.

This medicinal product contains 106mg sodium per tablet, equivalent to 5.3% of the WHO recommended maximum daily intake of 2g sodium for an adult.

Interaction with other medicinal products and other forms of interaction

Copper

Zinc may inhibit the absorption of copper (see section 4.3).

Tetracycline Antibacterials

Zinc may reduce the absorption of concurrently administered tetracyclines, also the absorption of zinc may be reduced by tetracyclines; when both are being given an interval of at least three hours should be allowed.

Quinolone Antibacterials

Zinc may reduce the absorption of quinolones; ciprofloxacin, levofloxacin, moxifloxacin, norfloxacin and ofloxacin.

Calcium Salts

The absorption of zinc may be reduced by calcium salts.

Iron

The absorption of zinc may be reduced by oral iron, also the absorption of oral iron may be reduced by zinc.

Penicillamine

The absorption of zinc may be reduced by penicillamine, also the absorption of penicillamine may be reduced by zinc.

Trientine

The absorption of zinc may be reduced by trientine, also the absorption of trientine may be reduced by zinc.

Fertility, pregnancy and lactation

The safety of this product in human pregnancy has not been established. Zinc crosses the placenta and is present in breast milk.

Effects on ability to drive and use machines

Solvazinc has no influence on the ability to drive and use machines.

Undesirable effects

Zinc salts may cause abdominal pain, dyspepsia, nausea, vomiting, diarrhoea, gastric irritation and gastritis. There have also been cases of irritability, headache and lethargy observed.

Zinc may interfere with the absorption of copper, leading to reduced copper levels, and potentially copper deficiency. The risk of copper deficiency may be greater with long-term treatment (e.g. if zinc deficiency is no longer present) and/or with higher doses of zinc.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Incompatibilities

None.

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