FOLICIL Tablet (2018)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

FOLICIL, 5 mg, tablet.

2. Qualitative and quantitative composition

Each tablet contains Folic acid, 5 mg. Excipient(s): Lactose. For a full list of excipients, see section 6.1.

3. Pharmaceutical form

Tablet. Yellow, scored, circular and biconvex tablet, engraved Bial on one side and F|O on the other. The tablet can be divided into equal halves.

4.1. Therapeutic indications

FOLICIL is used to treat or prevent folic acid deficiency, especially in pregnancy, lactation and rapid growth periods. Treatment with folic acid is also indicated in the prevention of neural tube defects ...

4.2. Posology and method of administration

Dosage and treatment duration should be established by the physician. Adults: ½ to 1 tablet, once or twice daily, according to the clinical situation. Prevention of neural tube defects: ½ tablet, ...

4.3. Contraindications

Hypersensitivity to folic acid or to any excipient.

4.4. Special warnings and precautions for use

Folic acid should not be administered in cases of anaemia of unknown etiology, since folic acid may mask pernicious anaemia. FOLICIL contains lactose. Patients with rare hereditary problems of galactose ...

4.5. Interaction with other medicinal products and other forms of interaction

Chloramphenicol: The concurrent administration of folic acid and chloramphenicol in folate-deficient patients may result in antagonism of the hematopoietic response to folic acid. Phenytoin: ...

4.6. Pregnancy and lactation

Folic acid can safely be used in pregnancy and lactation. Folic acid deficiency in such situations may occur and therefore prophylaxis with FOLICIL is indicated.

4.7. Effects on ability to drive and use machines

Folic acid has no 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 estimated from the available ...

4.9. Overdose

Situations of overdose are unknown. When high doses are administered, folic acid is eliminated in the urine.

5.1. Pharmacodynamic properties

ATC classification: B03B B01 – Folic acid Folic acid is an important coenzyme for cellular metabolism. After its absorption in the digestive tract, folic acid is rapidly reduced, giving way to active ...

5.2. Pharmacokinetic properties

Folic acid is absorbed rapidly from the GI tract following oral administration, mainly from the proximal portion of the small intestine. Naturally occurring folate polyglutamates are enzymatically hydrolized ...

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

Ludipress (Lactose monohydrate; povidone (Kollidon K30), crospovidone (Kollidon CL) and magnesium stearate.

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Do not store above 25ºC. Store in the original package.

6.5. Nature and contents of container

PVC and aluminium blisters containing 10 tablets. Each box contains 2, 5 or 6 blisters.

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

BIAL Portela & Cª, S.A., À Av. da Siderurgia Nacional, 4745-457 S.Mamede do Coronado Portugal

8. Marketing authorization number(s)

MA004/00701

9. Date of first authorization / renewal of the authorization

7th April 2007

10. Date of revision of the text

August 2018

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