Zinc Origin Dispersible Tablets

1. Name of the medicinal product:

ZINC ORIGIN dispersible tablet.

2. Qualitative and quantitative composition

Zinc gluconate 139.38 mg equivalent to 20mg zinc Inactive ingredients: See full excipients in section (6.1)

3. Pharmaceutical form

White round shaped biconvex dispersible tablet scored from one side

4. Clinical particulars

4.1 Therapeutic indications

  • Zinc gluconate 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 tablets for swallowing directly or after dissolving in water
  • Adults: two tablet, once to three times daily after meals.
  • Children more than 30kg: two tablet, once to three times daily after meals.
  • Children 10-30kg: one tablet, once to three times daily after meals.
  • Children less than 10kg: one tablet, once daily after meals.

4.3 Contraindications

Hypersensitivity to the active substance or any of the excipients

4.4 Special warnings and precautions for use

  • Accumulation of zinc may occur in cases of renal failure.
  • this product contains Aspartame : source of phenylalanine .May be harmful for people with phenylketonuria
  • this product contains lactose .so :if you have been told by doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

4.5 Interaction with other medicinal products

  • 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

Zinc origin 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.
  • 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.

4.9 Overdose

Zinc gluconate 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

5.1Pharmacodynamic 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.

6. Pharmaceutical particulars

6.1 List of excipients

Cross carmellose sodium / lactose / microcrystalline cellulose / aspartame / colloidal silicon dioxide/ magnesium stearate/peach flavor

6.2 Incompatibilities

None.

6.3 Shelf life

Three years.

6.4 Special precautions for storage

Store at temperature not exceeding 30°C, in dry place Keep out of reach of children.

Packing: Carton box containing two (AL/ opaque white pvc) strips each of 10 dispersible tablet & inner leaflet

Zinc Origin Dispersible Tablets – Arabic Information: زنك أوريجين أقراص قابلة للذوبان