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SOLVAZINC Effervescent tablet (2017)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Solvazinc 45mg Effervescent Tablets.

Qualitative and quantitative composition

Each tablet contains 45mg of elemental zinc (equivalent to 125mg of zinc sulfate monohydrate). Excipient(s) with known effect: each tablet contains 115.5mg of sorbitol (E420) and 106mg of sodium. For the ...

Pharmaceutical form

Effervescent tablet.

Therapeutic indications

Zinc sulfate is a source of zinc which is an essential trace element and involved in a number of body enzyme systems. Solvazinc is indicated in adults and children for the treatment of zinc deficiency. ...

Posology and method of administration

Method of Administration Oral after dissolution in water. Adults One tablet, dissolved in water, once to three times daily after meals. Children More than 30kg: One tablet, dissolved in water, once to ...

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. ...

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 ...

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 ...

Overdose

Zinc sulfate is corrosive in overdosage. Symptoms are corrosion and inflammation of the mucous membrane of the mouth and stomach; ulceration of the stomach followed by perforation may occur. Gastric lavage ...

Pharmacodynamic properties

Pharmacotherapeutic Group: Mineral Supplement ATC Code: A12CB01 Zinc is an essential trace element involved in many enzyme systems. Severe deficiency causes skin lesion, alopecia, diarrhoea, increased ...

Pharmacokinetic properties

Zinc is absorbed from the gastrointestinal tract and distributed throughout the body. The highest concentrations occur in hair, eyes, male reproductive organs and bone. Lower levels are present in liver, ...

Preclinical safety data

None stated.

List of excipients

Solvazinc contains the following excipients: Sorbitol (E420) Mannitol (E421) Sodium hydrogen carbonate Citric acid Saccharin sodium Povidone K25 Sodium citrate Sodium carbonate anhydrous

Incompatibilities

None.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Store below 25°C, protect from moisture.

Nature and contents of container

Polypropylene containers with polyethylene caps and packed in cartons of three containers. Each tablet container contains 30 tablets. The tablet containers also contain a desiccant capsule.

Special precautions for disposal and other handling

None.

Marketing authorization holder

Galen Limited, Seagoe Industrial Estate, Craigavon, BT63 5UA, UK

Marketing authorization number(s)

PL 27827/0003

Date of first authorization / renewal of the authorization

01 November 1983

Date of revision of the text

14 December 2017

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