FOLIFER Film-coated tablet (2018)
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Περιεχόμενα
1. Name of the medicinal product
FOLIFER, 1 mg + 90 mg, film coated tablet.
2. Qualitative and quantitative composition
Each film-coated tablet contains:
Folic acid 1 mg and Iron (as ferrous sulfate) 90 mg.
Excipient(s): Lactose mono-hydrate: 373 mg.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Salmon, circular and biconvex film-coated tablets, engraved "Bial" on one side and "FF" on the other.
4.1. Therapeutic indications
FOLIFER is indicated in the treatment and prophylaxis of folic acid and iron deficiency during pregnancy, lactation and puerperium.
4.2. Posology and method of administration
The recommended dosage is 1 tablet of FOLIFER daily.
Duration of treatment is established by the doctor.
Method of administration
The tablets should not be sucked, chewed or kept in the mouth, but ...
4.3. Contraindications
Hypersensitivity to the folic acid or iron or to any of the excipients.
Iron overload (e.g. haemochromatosis, haemosiderosis).
Patients who have undergone repeated blood transfusions.
Megaloblastic...
4.4. Special warnings and precautions for use
FOLIFER contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. The possibil...
4.5. Interaction with other medicinal products and other forms of interaction
Tetracyclines:
Iron sulfate may interfere with absorption of tetracyclines from the GI and viceversa. Therefore these drugs should be taken within a 2-3 hours interval.
Quinolones:
Ferrous sulfat...
4.6. Pregnancy and lactation
Use of the combination of ferrous sulfate and folic acid during pregnancy and lactation is recommended. Deficiency of both nutrients is very common in such situations, and it is therefore, indicate...
4.7. Effects on ability to drive and use machines
FOLIFER has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Very common (>1/10); Common (>1/100, <1/10); Uncommon (>1/1,000, <1/100); Rare (>1/10,000, <1/1,000); Very rare (<1/10,000), including isolated reports; Not known (cannot be...
4.9. Overdose
Overdose with FOLIFER occurs only rarely in adults, but can occur in children. Toxicity due to an excessive intake is caused by iron overdosage. Initial symptoms result from the contact irritation ...
5.1. Pharmacodynamic properties
Pharmacotherapeutic group:
Iron in combination with Folic Acid
ATC Code:
B03AD03
FOLIFER contains as active substances, two important micronutrients – iron and folic acid. Iron, which appears as...
5.2. Pharmacokinetic properties
Absorption of iron can occur along the entire length of the GI tract, it is greatest in the duodenum and proximal jejunum and becomes progressively less distally. It is influenced by many factors i...
5.3. Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
6.1. List of excipients
Maize starch
Lactose mono-hydrate
Povidone
Talc
Citric acid anhydrous
Magnesium stearate
Eudragit RLPO
Opadry OY-S-33019
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
This medicinal product does not require any special storage conditions.
Store in the original package.
6.5. Nature and contents of container
Blister Alu/Alu. Each pack contains 20 or 60 tablets.
Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Bial –Portela & Ca SA, A Av da Siderurgia Nacional, 4745 – 457, S. Mamede do Coronado, Portugal
8. Marketing authorization number(s)
MA004/00301
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 30
th
April 2007
10. Date of revision of the text
27
th
August 2018
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