Ferrous Fumarate, Vitamin B12 & Folic Acid Capsules
“For Medical/Pharmacy Professionals only”
DOSAGE FORMS STRENGTH
Oral Dosage Form: Capsules
Ferrous Fumarate: 200mg
Vitamin B12: 100mcg
Folic Acid: 1000mcg
HISTORY OF ACTIVE INGREDIENTS
Iron (II) fumurate, also known as ferrous fumarate, is the iron (ll) of, occurring as a reddish-powder, used to iron intake.
Vitamin B12 also called cobalamin, is a water-soluble vitamin with a key role in the normal functioning of the brain and for the formation of blood. It is one of the eight. It is normally involved in the metabolism of every of the human body, especially affecting DNA synthesis and regulation, but also synthesis and energy production.
Folic acid is itself not biologically active, but its biological importance is due to tetrahydrofolate and other derivatives after its conversion in the liver.
Each hard gelatin capsule contains:
Ferrous Fumarate BP 200mg
Vitamin B12 BP 100mcg
Folic Acid BP 1000mcg
Approved colours used in empty capsule shells
Ferrous Fumarate: BO3AA2
Vitamin B12: B03BA01
Folic Acid: B03BB01
Ferrous Fumarate supplies iron in ferric form to the body. Ferric is complexed with polymaltose with better absorption. It rapidly supplements iron so that iron deficiency is quietly controlled, thus leading to faster correction of anaemia and replenishment of tissue iron stores. CyanocobaIamin is used to ensure there are adequate levels of Vitamin B12 deficiency. Folic acid is important in aiding rapid cell division and growth.
Folic acid is rapidly absorbed, mainly from the proximal part of the small intestine. Iron is irregularly and incompletely absorbed from the gastro-intestinal tract, the main site of absorption being the duodenum and Jejunum. Absorption is aided by the acid secretion of the stomach or by dietary acids, and is more readily affected when the iron is in the ferrous state. Absorption is also increased in conditions of iron deficiency or in the fasting state but is decreased if body stores are overloaded.
INDICATION AND USAGE
As an adjuvant therapy in iron deficiency anaemia during pregnancy.
Iron deficiency related anaemia in children and adults.
General fatigue and weakness.
As dietary supplement
Contra-indicated in patients with a known hypersensitivity to the product or its ingredients.
Antibiotics (e.g., Penicillamine, Chloramphenicol, Quinolones such as Ciprofloxacin/Norfloxacin), Bisphosphonates (e.g., Alendronate), Levodopa, Methyldopa and Levothyroxine.
Iron overload disorder (e.g., hemochromatosis, hemosiderosis), medical history especially of liver problems, stomach/intestinal problems (e.g., ulcer, colitis).
Ferrolab 12 capsules is suitable for use during pregnancy.
Ferrolab 12 capsules is suitable for use during Lactation.
KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN
Iron preparations should be used with caution in patients with erythropoietic protoporphyria.
Constipation, rash, itching, diarrhoea, nausea and vomiting other gastro-intestinal disturbances.
Rarely, folic acid may cause allergic reactions.
DRUG ABUSE AND DEPENDENCE
SYMPTOMS OF OVERDOSE AND TREATMENT
Initial symptoms of iron overdosage include nausea, vomting, diarrhoea, abdominal pain, haematemesis, rectal bleeding, lethargy and circulatory collapse. Hyperglycemia and metabolic acidosis may occur. However, if overdosage is suspected, treatment should be implemented immediately. In severe cases, after a latent phase, relapse may occur after 24-48 hours manifested by hypotension, coma, hypothermia, hepatocellular necrosis, renal failure, pulmonary oedema, diffuse vascular congestion, coagulopathy and/or convulsions. In many cases, full recovery may be complicated by long-term effects such as hepatic necrosis, toxic encephalitis, CNS damage and pyloric stenosis.
The following steps are recommended to minimise or prevent further absorption of the medication.
1. Administer an emetic such as syrup of ipecac.
2. Emesis should be followed by gastric lavage with desferrioxamine solution (2g/l). This should then be followed by the installation of desferrioxamine 5g in 50 – 100 ml water, to be retained in the stomach. Inducing diarrhoea in children may be dangerous and should not be undertaken in young children. Keep the patient under constant surveillance to detect possible aspiration of vomitus – maintain suction apparatus and standby emergency oxygen in case of need.
3.Severe poisoning: in the presence of shock and/or coma with high serum iron levels (serum iron > 90umol/l) immediate supportive measure plus IV infusion of desferrioxamine should be administered every hour by slow IV infusion to a maximum 80mg/kg/24 hours.
DOSAGE AND ADMINISTRATION
For oral administration
Adults: One capsule daily throughout pregnancy or as directed by a physician.
Children: Not applicable.
Elderly: Not applicable.
THE PREPARATION FOR USE
3 x 10 capsule packed in a unit carton along with patient information leaflet
Store in a cool, dry & dark place.
NAFDAC Reg. No.: 04-5887
MANUFACTURED IN INDIA BY
LABORATE PHARMACEUTICAL (INDIA)
E-11, IND. AREA, PANIPAT-132103
Embassy Pharmaceuticals and Chemicals Ltd.