Active ingredients: Folic acid
Folifill 5 mg folic acid tablets
Why is Folifill used? What is it for?
Folifill contains the active ingredient folic acid. This substance belongs to the group of B vitamins (or folates).
Folifill is used to treat folate deficiency states in the body, which occur when:
- increases the need for folate;
- the absorption of folate contained in the diet is insufficient;
- the body has a reduced ability to use folate;
- the dietary folate intake is lacking.
Contraindications When Folifill should not be used
Do not take Folifill
- if you are allergic to folic acid or any of the other ingredients of this medicine (listed in section 6);
- if you have a tumor;
- if you have pernicious anemia (severe form of anemia caused by vitamin B12 deficiency) (see "Warnings and precautions").
Precautions for use What you need to know before taking Folifill
Talk to your doctor or pharmacist before taking Folifill.
Your doctor will order you to regularly check your blood tests while you are taking this medicine.
Take special care with this medicine:
- if you have megaloblastic anemia of unknown origin, as folic acid can make the diagnosis of pernicious anemia more difficult by causing the progression of its neurological complications. This can cause severe neurological damage before the correct diagnosis is made.
Do not take Folifill if you have a particular type of anemia (pernicious anemia due to vitamin B12 deficiency) as this medicine can mask the worsening of the symptoms of your disease by improving the results of your blood tests without treating it.
Interactions Which drugs or foods can modify the effect of Folifill
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor if you are taking:
- Antiepileptics (phenytoin, primidone, sodium valproate, carbamazepine, barbiturates including phenobarbital) as this medicine may reduce their effect;
- methotrexate (used to treat rheumatoid arthritis, psoriasis and some cancers) and sulfasalazine (used to treat inflammatory bowel diseases and rheumatoid arthritis) as they may decrease the activity of this medicine;
- chloramphenicol (an antibiotic) as it may decrease the activity of this medicine;
- acetylsalicylic acid (used as an anti-inflammatory, pain reliever and fever killer, eg aspirin) as it may decrease the effectiveness of this medicine.
Tell your doctor if you are going to have an operation involving anesthesia as nitrous oxide (gas used to induce anesthesia) can cause a sharp decrease in folic acid in your body.
Folifill with alcohol
Do not take this medicine with alcohol. Alcohol may reduce the effectiveness of this medicine.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Folifill 5 mg tablets can be used in pregnancy.
Induced folic acid deficiency or abnormal folate metabolism is linked to birth defects and some neural tube defects. Deficiency of this vitamin or its metabolites can also be responsible for some cases of spontaneous abortion and intrauterine growth retardation.
However, there are no safety data for use at doses higher than 4-5 mg per day; therefore in such situations the daily dose should not exceed 5 mg.
Feeding time
This medicine can be used during breastfeeding. Folic acid passes into breast milk but this has no adverse effects on breastfed babies.
Driving and using machines
FOLIFILL has no or negligible influence on the ability to drive or use machines.
Folifill contains lactose
If you have been told by your doctor that you have "intolerance to some sugars, contact your doctor before taking this medicinal product.
Dose, Method and Time of Administration How to use Folifill: Posology
Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
Adults
The recommended dose is: 1-2 tablets per day, as directed by the doctor.
Use in children
1-2 tablets a day, as for adults, or modified according to the doctor's instructions.
Use in pregnancy
The daily dose should not exceed 5 mg: 1 tablet per day.
If you forget to take Folifill
Do not take a double dose to make up for a forgotten previous dose.
If you stop taking Folifill
Do not stop taking Folifill without consulting your doctor first. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Overdose What to do if you have taken too much Folifill
If you accidentally take an overdose of Folifill, notify your doctor immediately or go to the nearest hospital.
Side Effects What are the side effects of Folifill
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Patients taking this medicine have experienced the following rare side effects (may affect up to 1 in 1000 people):
- Skin irritation (erythema), rash, itching, itchy swelling on the skin (hives), difficulty in breathing (dyspnoea) and anaphylactic shock (severe allergic reaction involving difficulty in breathing, swelling of the face, lips, tongue and other parts of the body): in the latter case contact your doctor immediately.
- Sleep disturbances, nightmares.
- Loss of appetite (anorexia), nausea, swollen stomach (abdominal distension) and flatulence.
- Malaise, irritability.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at www.agenziafarmaco.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package after "EXP". The expiry date refers to the last day of that month. The expiry date refers to the unopened product, correctly stored.
Store below 25 ° C.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
This will help protect the environment.
Other information
What Folifill contains
- The active ingredient is folic acid. Each tablet contains 5 mg of folic acid.
- The other ingredients are: lactose monohydrate, maize starch, povidone, colloidal anhydrous silica, magnesium stearate, talc.
What Folifill looks like and contents of the pack
Folifill comes in the form of tablets.
Pack of 28 tablets of 5 mg.
Pack of 120 tablets of 5 mg.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
FOLIFILL 5 MG TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains
Active ingredient: Folic acid 5 mg
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Tablets
The tablets are flat and yellow.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
In all cases of folic deficiency due to increased demand, insufficient absorption, reduced utilization and insufficient dietary intake of the vitamin.
04.2 Posology and method of administration
1-2 tablets per day, on prescription.
Pediatric population
In children, the daily dose may be the same as that of adults or in any case commensurate, according to the doctor's opinion, with therapeutic needs.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Patients with malignancies (see section 4.4 "Special warnings and precautions for use").
Pernicious anemia (vitamin B12 deficiency) (see section 4.4 "Special warnings and precautions for use").
04.4 Special warnings and appropriate precautions for use
The treatment must be carried out under haematological control.
Folic acid should be administered with extreme caution to patients with megaloblastic anemia of unknown origin, as folic acid can make the diagnosis of pernicious anemia more difficult by reducing the haematological manifestations of the disease, instead progressing neurological complications.
This can result in severe neurological damage before the correct diagnosis is made.
In case of pernicious anemia, folic acid must not be administered alone or in association with inadequate doses of cyanocobalamin. In fact, although it causes a hematopoietic response, it does not carry out any preventive action on the subacute bone marrow degeneration present in these forms. of folic acid must be subject to a precise haematological diagnostic assessment.
The medicine should not be used as an antianemic in people with cancer.
The concomitant use of Folifill with phenobarbital, phenytoin or primidone is not recommended (see section 4.5 "Interaction with other medicinal products or other forms of interaction").
Important information about some of the excipients:
The medicinal product contains lactose, must not be taken by patients with hereditary galactose intolerance problems, with Lapp lactase deficiency, and with glucose / galactose malabsorption syndrome.
04.5 Interactions with other medicinal products and other forms of interaction
Folic acid in high doses can reduce the plasma concentrations of phenobarbital, phenytoin and primidone by increasing their metabolism. Consequently, the concomitant use of folic acid with phenobarbital, phenytoin or primidone is not recommended (see section 4.4 "special warnings and precautions. d "use"). If necessary, careful monitoring of the plasma concentration of these antiepileptics should be performed.A similar but less marked relationship is expected with other anti-convulsant medicinal products including sodium valproate, carbamazepine and barbiturates.
Methotrexate and sulfasalazine may decrease folic acid activity due to their antagonistic activity. Concomitant administration of chloramphenicol can lead to antagonism in the hematopoietic response to folic acid.
Nitrous oxide anesthesia can cause acute folic acid deficiency.
Ethanol and aspirin can lead to increased elimination of folic acid.
04.6 Pregnancy and breastfeeding
Pregnancy
There are no known dangers of using folic acid in pregnancy. Induced folic acid deficiency or abnormal folate metabolism is linked to birth defects and some neural tube defects. its metabolites may also be responsible for some cases of spontaneous abortion and intrauterine growth retardation.
There are no safety data for use at doses higher than 4-5 mg / day; therefore in such situations the daily dose should not exceed 5 mg.
Feeding time
Folic acid is excreted in breast milk.
No adverse effects were observed in breastfed infants whose mothers took folic acid.
04.7 Effects on ability to drive and use machines
FOLIFILL has no or negligible influence on the ability to drive or use machines.
04.8 Undesirable effects
The undesirable effects that may be associated with FOLIFILL are listed in the following table by organ system and system classification and frequency: common (≥ 1/100 and
Disorders of the immune system
Rare (≥1 / 10,000 -
Allergic reactions, including erythema, rash, pruritus, urticaria, dyspnoea, and anaphylactic reactions (including shock).
Psychiatric disorders
Rare (≥1 / 10,000 -
Sleep disturbances, nightmares
Gastrointestinal disorders
Rare (≥1 / 10,000 -
Anorexia, nausea, abdominal distension, flatulence
General disorders and administration site conditions
Rare (≥1 / 10,000 -
Malaise, irritability
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose
There have been no reports of acute overdose with FOLIFILL, although mental disturbances, sleep disturbances and gastrointestinal disturbances may occur with folic acid dosages higher than those recommended.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: anti-anemic drugs: folic acid and derivatives.
ATC code: B03BB01.
Pharmacodynamic effects: folic acid intervenes in numerous biochemical reactions as a carrier of mono-carbon units in an activated form. The lack of folic acid gives rise to macrocytic anemia.
05.2 Pharmacokinetic properties
Oral folic acid is largely absorbed as such and partly after reduction and methylation. By penetrating into the tissues, folic acid displaces the reduced intracellular folates by introducing 5-CH3-FH4 into the circulation. After 180 "from the administration of 5 mg of folic acid orally in animals and humans, the serum levels of folic acid are still elevated. The metabolization of folic acid is related to the amount of folate deposits by adjusting to a homeostasis of saturation of these.
05.3 Preclinical safety data
Acute toxicity.
According to the Toxnet database, the following LD50 were found for folic acid:
• guinea pig, intravenously: 120 mg / kg;
• mouse, intraperitoneally: 85 mg / kg; intravenously: 282 mg / kg; oral: 10000 mg / kg; subcutaneous route: 200 mg / kg;
• rabbit, intravenously: 410 mg / kg;
• rat, intravenously: 500 mg / kg.
Chronic toxicity.
In chronic toxicity studies, folic acid did not cause significant toxic effects.
In rats, administration of high doses can cause deposits and obstructions in the renal tubules, and seizures. In rats, renal hyperplasia and epithelial cell hyperplasia have also been described after high doses.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Lactose monohydrate
Cornstarch
Povidone
Anhydrous colloidal silica
Magnesium stearate
Talc
06.2 Incompatibility
The action of Folifill is inhibited by the simultaneous use of drugs with antipholic action.
06.3 Period of validity
2 years.
06.4 Special precautions for storage
Store at a temperature not exceeding 25 ° C
06.5 Nature of the immediate packaging and contents of the package
Cardboard box containing 28 tablets in opaque PVC / AL blisters or 120 tablets in opaque PVC / AL blisters (4 blisters containing 30 tablets each).
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
Italfarmaco S.p.A.
Viale F. Testi, 330
20126 Milan
Italy
08.0 MARKETING AUTHORIZATION NUMBER
Folifill 5 mg tablets, 28 tablets - AIC N. 040627010
Folifill 5 mg tablets, 120 tablets - AIC 040627022
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
First authorization: Determination of AIFA V & A.N. 1265/2011 of 02/11/2011
Renewal: 21 March 2017
10.0 DATE OF REVISION OF THE TEXT
March 2017
