Solvazinc

1. Name Of The Medicinal Product

Solvazinc^® Effervescent Tablets.

2. Qualitative And Quantitative Composition

Each Solvazinc^® tablet contains the following active ingredient: Zinc sulphate monohydrate: 125mg (equivalent to 45mg elemental zinc).

3. Pharmaceutical Form

Effervescent tablet.

4. Clinical Particulars

4.1 Therapeutic Indications

Zinc sulphate is a source of zinc which is an essential trace element and involved in a number of body enzyme systems.

Indications: For the treatment of zinc deficiency.

4.2 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 three times daily after meals.

10-30kg: ½ tablet, dissolved in water, once to three times daily after meals.

Less than 10kg: ½ tablet, dissolved in water, once daily after meals.

4.3 Contraindications

None.

4.4 Special Warnings And Precautions For Use

Accumulation of zinc may occur in cases of renal failure.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

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.

4.6 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.

4.7 Effects On Ability To Drive And Use Machines

Solvazinc^® is not expected to affect ability to drive and use machines.

4.8 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.

4.9 Overdose

Zinc sulphate 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 and emesis should be avoided. Demulcents such as milk should be given. Chelating agents such as sodium calcium edetate may be useful.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Zinc is an essential trace element involved in many enzyme systems. Severe deficiency causes skin lesion, alopecia, diarrhoea, increased susceptibility to infections and failure to thrive in children. Symptoms of less severe deficiency include distorted or absent perceptions of taste and smell and poor wound healing.

5.2 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, kidney and muscle. In blood 80% is found in erythrocytes. Plasma zinc levels range from 70 to 110μg/dL and about 50% of this is loosely bound to albumin. About 7% is amino-acid bound and the rest is tightly bound to alpha 2-macroglobulins and other proteins.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Solvazinc^® contains the following excipients:

Sorbitol, mannitol, sodium hydrogen carbonate, citric acid, saccharin sodium, povidone K25, sodium citrate and sodium carbonate anhydrous.

6.2 Incompatibilities

None.

6.3 Shelf Life

Three years.

6.4 Special Precautions For Storage

Store below 25^oC, protect from moisture.

6.5 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.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Galen Limited

Seagoe Industrial Estate

Craigavon

BT63 5UA

UK

8. Marketing Authorisation Number(S)

PL 27827/0003.

9. Date Of First Authorisation/Renewal Of The Authorisation

01 November 1983.

10. Date Of Revision Of The Text

29 March 2010