TABLETS
Prescription only medicine
1. PRESENTATION:
Each Film coated Tablet contains:
Ferrous Fumarate ……..310mg (equivalent to 100mg Ferrous Iron)
Folic Acid ………………0,35mg
Excipients: Microcrystalline Cellulose, Macrogol 6000, Glycerol, Sodium Starch Glycollate, Magnesium Stearate, Sodium Lauryl Sulphate, Povidone, Hypromellose, Macrogol 400, Titanium Dioxide, Talc, Carmoisine E122.
WHAT IS Folihem AND WHAT ARE ITS USES
Folihem contains a combination of Ferrous Fumarate and Folic Acid.
Ferrous Fumarate and Folic acid belong to the group of medicines used in anaemias.
Ferrous is an element necessary for the production of red blood cells by the body. When our body does not receive sufficient quantities of iron then it cannot produce the normal number of red blood cells which is necessary for maintaining our health in a good condition. This deficiency of iron in our body is called sideropenic anaemia.
Iron deficiency can lead to unusual tiredness, dyspnoea (difficulty in breathing), diminution of the physical activity, learning problems in children and it can enhance the danger of infections.
Folic acid belongs to the B complex vitamins. Vitamins are substances in our body necessary for its development and health. They are necessary in very small quantities and usually we get them through food. Folic acid is necessary for strong blood.
Folic acid deficiency can cause anaemia. This anaemia is treated with folic acid.
2. INDICATIONS
Folihem is indicated for the prophylaxis and treatment of anaemia due to iron and folic acid deficiency during pregnancy.
3. DOSAGE AND ADMINISTRATION
Please follow your doctor’s instructions.
Adults: One tablet daily from the 13th week of pregnancy and three months after delivery.
Children: Not recommended.
In case you receive a larger dose than normal:
In case you take a dose larger than normal, stop taking the medicine and contact your doctor immediately.
Overdosage symptoms: Gastro-intestinal disorders.
Treatment: Inducing vomiting, gastric lavage preferably during the first 4 hours after ingestion and administration of a chelating agent for capturing iron (e.g. desferrioxamine).
What should you know if you miss taking a dose:
If you have to take the medication continuously and you miss to take a dose, take the missed dose as soon as possible. However, if it almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take double doses. Consult your doctor in case you missed more than one doses.
4. CONTRAIDICATIONS
Folihem is contra-indicated in patients with allergy to the active substances or to any of the excipients of the product, in patients with a B12 vitamin deficiency, in patients with paroxysmal nocturnal haemoglobinuria, haemosiderosis, haemochromatosis, stomach ulcer, repeated blood transfusion, enteritis and ulcerative colitis.
Folihem should not be used for the treatment of anaemias other than those due to iron deficiency.
5. WARNINGS & PRECAUTIONS:
Special warnings and precautions:
Folihem must not be administered to patients taking tetracycline antibiotics or antacids, or to patients with a stomach ulcer.
Folihem is contra-indicated in patients with megaloblastic anaemia which is due to vitamin B12 deficiency.
This product contains Carmoisine E122, therefore may cause allergic reactions.
6. PREGNACY AND LACTATION:
Pregnancy:
Folihem is indicated during pregnancy. However, taking of large quantities of iron during the first trimester of pregnancy should be avoided because it may harm the mother or/and the foetus.
Consult your doctor or pharmacist before taking any medication.
Lactation:
Folihem is excreted into mother’s milk and, therefore, you must consult your doctor before taking Folihem.
Consult your doctor or pharmacist before taking any medication.
7. DRIVING AND OPERATING MACHINERY
Folihem does not influence the ability of driving and operating machinery.
8. UNDESIRABLE EFFECTS
As with all medicines Folihem can cause undesirable effects.
Most common are:
Nausea, vomiting, gastro-intestinal symptoms (stomach ache), constipation, diarrhea. Very rarely. haemosiderosis may be caused in chronic administration, allergic reactions, anorexia and darkening of the stools.
If you have adverse reactions that are not mentioned above, please inform your doctor immediately
9. DRUG INTERACTIONS:
Iron reduces the absorption of penicillamide. Iron also reduces the bioavailability of fluroquinolones, levodopa, carbidopa, thyroxine and bisphosphonates.
The absorption of iron and antibiotic concurrently is reduced if Folihem is administered with tetracycline. If iron and zinc are administered concurrently the absorption of both of them is reduced.
The concomitant administration of antacids reduces the absorption of iron. Co-trimoxazole, chloramphenicol, sulphasalazine, aminopterin, methotrexate, pyrimethamine or sulphonamides interfere with folic acid metabolism. Oral administration of chloramphenicol delays the elimination of serum iron, the incorporation of iron in the red blood cells, and interferes with erythropoietin.
Partial inhibition of iron absorption may be caused when taken concurrently with cholestyramine, trientine, tea, eggs or milk.
Administration of iron to patients taking methyldopa may cause an increase in arterial pressure.
Coffee is an agent that can reduce the bioavailability of iron.
Neomycin may alter the absorption of iron.
10. PHARMACODYNAMIC PROPERTIES
Ionic iron is a component of a number of enzymes necessary for energy tranfer (e.g. cytochrome oxidase, xanthine oxidase, and succinic dehydrogenase) and is also present in compounds necessary for transport and utilization of oxygen (e.g. hemoglobin and myoglobin).
Administration of iron preparations corrects erythropoietic abnormalities which are due to deficiency of iron. Administration of iron also relieves other symptoms of iron deficiency such as soreness of the tongue, dysphagia, dystrophy of the nails and skin, and fissuring of the angles of the lips.
There is evidence that a daily dose of 100mg of elemental iron in the ferrous form is adequate to prevent development of iron deficiency in expectant mothers. If a mild iron deficiency is present when Folihem administration is started, this will be corrected by increased absorption of iron. The daily folate requirement rises steeply during the final trimester of pregnancy, and evidence of maternal depletion may be found. To ensure normal tissue folate levels in the mother after delivery a daily supplement of about 300 micrograms is required during the second and third trimester of pregnancy. This does not obscure the blood picture of addisonian pernicious anaemia.
11. PHARMACOKINETIC PROPERTIES
Iron is absorbed chiefly in the duodenum and jejunum, absorption being aided by the acid secretion of the stomach and being more readily effected when the iron is in the ferrous state
Following absorption the majority of iron is bound to transferrin and transported to the bone marrow where it is incorporated into haemoglobin. The remainder is contained within the storage forms, ferritin or haemosiderin or as myoglobin.
Only very small amounts of iron are excreted as the majority is released after the destruction of the haemoglobin molecule.
Folic acid is absorbed mainly from the proximal part of the small intestine. Folate polyglutamates are considered to be de-conjugated to monoglutamates during absorption. Folic acid rapidly appears in the blood, where it is extensively bound to plasma proteins. The amounts of folic acid absorbed from normal diets are rapidly distributed in body tissues and about 4 to 5 micrograms is excreted in the urine daily. When larger amounts are absorbed, a high proportion is metabolized in the liver to other active forms of folate and a proportion is stored as reduced and methylated folate. Larger amounts of folate are rapidly excreted in the urine.
12. SHELF LIFE: 36 months
13. STORAGE: Keep below 25°C, away from light and moisture and in a safe place out of the reach of children.
14. SPECIFICATION: BP Current Edition
Name and Address of Manufacturer
Remedica Ltd
Limassol Industrial Estate, Limassol, Cyprus, EU
Name and Address of Registrationer:
Nhat Anh Pharmaceutical Co., Ltd
122/7-9 Dang Van Ngu Str., Ward 14, Phu Nhuan Dist., HCMC
Please read carefully before use.
Further more information please ask your doctor or pharmacist
