For the use of Registered Medical Practitioner or a Hospital or a Laboratory only
COMPOSITION:
Each 15 ml contains:
Ferric Ammonium Citrate
Pyridoxine Hydrochloride
Cyanocobalamin
Zinc Sulfate Heptahydrate
in a flavoured base
ACTIONS:
Zincofer is an orange flavoured palatable haematinic liquid.
It provides 50 mg of elemental iron and 10 mg of elemental zinc per tablespoonful.
It corrects loss of appetite during pregnancy.
Zincofer corrects commonly occurring anaemias.
INDICATIONS:
Zincofer is indicated in:
Treatment of iron deficiency and iron deficiency anaemia.
Prevention of iron deficiency before, during and after pregnancy.
During the second and third trimester of pregnancy for prophylaxis against iron deficiency and megaloblastic anaemia.
WARNING AND PRECAUTIONS:
Iron overdose may be fatal.
Some post-gastrectomy patients show poor absorption of iron.
Care is needed when treating iron deficiency anaemia in patients with treated or controlled peptic ulceration.
Caution should be exercised when administering folic acid to patients who may have folate dependent tumours.
Since anaemia due to combined iron and Vitamin B12 or folate deficiencies may be microcytic in type, patients with microcytic anaemia resistant to therapy with iron alone should be screened for Vitamin B12 or folate deficiency.
SIDE EFFECTS:
Gastro-intestinal disorders have been reported including:
Gastro-intestinal discomfort
Anorexia
Nausea
Vomiting
Constipation
Diarrhoea
Darkening of the stools may occur.
Rarely allergic reactions may occur.
PREGNANCY AND LACTATION:
Since Zincofer is haematinic, it can be safely given during pregnancy and lactation.
Administration of Zincofer during the first trimester of pregnancy may be undesirable.
It is not known how much iron from Zincofer is passed into mother's milk.
The development of anaemia despite prophylaxis with Zincofer calls for investigation.
DRUG-DRUG INTERACTION:
Concurrent administration of antacids may reduce absorption of iron.
Iron reduces the absorption of penicillamine.
Iron compounds impair the bioavailability of fluoroquinolones, levodopa, carbidopa, thyroxine and bisphosphonates.
Absorption of both iron and antibiotic may be reduced if Zincofer is given with tetracycline.
Absorption of both iron and zinc are reduced if taken concomitantly.
Oral chloramphenicol delays plasma iron clearance, incorporation of iron into red blood cells and interferes with erythropoiesis.
Some inhibition of iron absorption may occur if it is taken with cholestyramine, trientine, tea, eggs or milk.
Administration of oral iron may increase blood pressure in patients receiving methyldopa.
Coffee may be a factor in reducing iron bioavailability.
Neomycin may alter the absorption of iron.
CONTRAINDICATION:
Zincofer is contraindicated in patients with:
Known hypersensitivity to any of the ingredients in the formulation.
Vitamin B12 deficiency.
Paroxysmal nocturnal haemoglobinuria.
Haemosiderosis.
Haemochromatosis.
Active peptic ulcer.
Repeated blood transfusion.
Regional enteritis.
Ulcerative colitis.
Zincofer must not be used in the treatment of anaemias other than those due to iron deficiency.
DOSAGE:
2–5 years: 5 ml
5–12 years: 10 ml
Adults above 12 years: 15–30 ml
All twice a day after meals or as directed by the Physician.
The recommended duration is 3 to 6 months.
OVERDOSAGE:
Signs and symptoms of severe iron poisoning consist largely of:
Abdominal pain
Diarrhoea
Vomiting brown or bloody stomach contents
Pallor or cyanosis
Lassitude
Drowsiness
Hyperventilation due to acidosis
Cardiovascular collapse
If any of the above symptoms appear due to a very high dose, then deferoxamine should be administered.
LIST OF EXCIPIENTS:
Sucrose
Sodium Benzoate
Disodium Edetate
Sorbitol
Glycerol
Propylene Glycol
Citric Acid
Orange Flavour
COLOUR:
Sunset Yellow
CAUTION:
Keep out of reach of children.
PRESENTATION:
200 ml amber bottle with a measuring cup in an attractive carton.
STORAGE CONDITION:
Store at temperatures not exceeding 30°C.
Protect from light and moisture.
DATE OF PUBLICATIONS/REVIEW:
Aug. 2018
Manufactured by:
Apex Laboratories Private Limited
510, Kunnam Village & Post,
(Via) Thenneri,
Sriperumbudur Taluk,
Kancheepuram Dist. - 631604,
Tamil Nadu,
INDIA
P3ZFLV01INDLL01