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1. Phyllosan Tablets
2. Phyllosan Tablets

SUMMARY OF PRODUCT CHARACTERISTICS 1    NAME OF THE MEDICINAL PRODUCT

Phyllosan Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Ferrous fumarate    35.0mg/tablet

Nicotinic acid    8.5mg/tablet

Thiamine mononitrate    0.166mg/tablet

Riboflavine    0.333mg/tablet

Ascorbic acid    5.0mg/tablet

3 PHARMACEUTICAL FORM

Tablet

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Prophylaxis of deficiency states of iron, B vitamins and vitamin C

4.2    Posology and method of administration

Route of administration: oral

Adults and children aged 12 years and over

Two tablets three times daily, after meals

Not to be given to children under 12 years of age except on medical advice

The elderly

The normal adult dose may be taken

4.3 Contraindications

The product is contra-indicated for anaemias, other than iron deficiency anaemia and known hypersensitivity to any of the ingredients.

4.4 Special warnings and precautions for use

The label will state

Important warning: contains iron. Keep out of the reach and sight of children, as overdose may be fatal. This will appear on the front of the pack within a

rectangle in which there is no other information.

Keep out of the reach of children

If symptoms persist, consult your doctor

4.5 Interaction with other medicinal products and other forms of interaction

Absorption of iron may be decreased by tetracyclines (and vice versa), and antacids.

4.6 Pregnancy and lactation

The product is not contraindicated during pregnancy and lactation. However, as with all medicines during this period, caution should be exercised.

4.7 Effects on ability to drive and use machines

None known

4.8 Undesirable effects

Oral doses of iron preparations rarely produce gastro-intestinal irritation with nausea and vomiting. Occasionally, continued administration may cause constipation, particularly in the elderly.

4.9 Overdose

Symptoms

Initial symptoms of iron overdose include nausea, vomiting, diarrhoea, abdominal pain, haematemesis, rectal bleeding, lethargy and circulatory collapse. Hyperglycaemia and metabolic acidosis may occur in severe cases. After a latent phase, relapse may occur, manifested by hypotensions, coma and liver necrosis and renal failure.

Treatment

In children: Administer an emetic (syrup of ipecac) followed by gastric lavage with desferrioxamine solution (2g/l) followed by instillation of desferrioxamine 5g in 50-l00ml water into the stomach. In severe poisoning 15mg/kg of desferrioxamine should be given by slow intravenous infusion to a maximum 80mg/kg/24 hours, together with supportive measures. In less severe poisoning, intramuscular desferrioxamine 1g, 4 - 6 hourly is recommended. Serum iron levels should be monitored throughout.

In adults: Administer an emetic. Gastric lavage with desferrioxamine solution (2g/l) may be necessary, followed by desferrioxamine 5g in 50-l00ml water instilled into the stomach. A drink of mannitol or sorbitol should be given to induce bowel emptying. In severe poisoning 15mg/kg of desferrioxamine should be given by slow intravenous infusion to a maximum of 80mg/kg/24 hours. In less severe poisoning, intramuscular injection of desferrioxamine 50mg/kg up to maximum dose of 4g should be given. Serum iron levels should be monitored throughout.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Ferrous fumarate: provides an easily absorbable source of iron.

5.2 Pharmacokinetic properties

B + C vitamins Are well absorbed from the gastrointestinal tract and are widely distributed in the body tissues. That in excess of the body’s requirements is excreted in the urine.

Ferrous fumarate is irregularly and incompletely absorbed from the gastrointestinal tract and eliminated in the faeces. Absorption increases in conditions of iron deficiency.

5.3 Preclinical safety data

Not applicable

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Calcium phosphate, icing sugar, starch, powdered acacia, talc, magnesium stearate, sucrose, calcium carbonate, gum sandarac substitute, special wax WG 10765, titanium dioxide (E171), opalux black dye AS 8110 (E153)

Incompatibilities

None known

6.3 Shelf life

3 years — blister strips/HDPE bottle with polypropylene screw cap 2 years — HDPE bottle with child resistant tamper evident closure

6.4 Special precautions for storage

Store below 25°C

6.5 Nature and contents of container

a 250p opaque PVC blister strips with a 20p aluminium foil backing containing 30 tablets per strip. The strips are contained in a boxboard carton of 60 or 150 tablets

b cylindrical white polyethylene (HDPE) bottle with a laminate membrane neck seal, a polypropylene screw cap and polyether wad containing 90 or 150 tablets

c cylindrical white polyethylene (HDPE) bottle with a red polyethylene child resistant tamper evident lined closure. The bottle is fitted with a polyether wad containing 90 tablets

6.6 Special precautions for disposal

None stated

7    MARKETING AUTHORISATION HOLDER

Ayrton Saunders Ltd 9 Arkwright Road