Active ingredients: Folic Acid
Folina 5 mg soft capsules
Why is Folina used? What is it for?
Folina contains the active ingredient folic acid, which belongs to the group of B vitamins (or folates).
This medicine 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 Folina should not be used
Don't take Folina
- if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
- if you have a tumor;
- if you have pernicious anemia (vitamin B12 deficiency (see "Warnings and precautions");
- If you are allergic to peanuts or soy, do not use this medicine.
Precautions for use What you need to know before you take Folina
Talk to your doctor or pharmacist before taking Folina. Your doctor will order you to regularly check your blood tests while you are taking this medicine.
Do not take Folina 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 Folina
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, before taking this medicine, tell your doctor if you are taking:
- Antiepileptics (phenobarbital, phenytoin, primidone, sodium valproate, carbamazepine and barbiturates), as this medicine may reduce its effect;
- Methotrexate (used to treat some cancers) and sulfasalazine (used as an anti-inflammatory against ulcerative colitis, Crohn's disease or rhemautoid arthris), as they can 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 against fever, eg aspirin) as it may decrease the effectiveness of this medicine;
- Lithium (a medicine used to treat mood disorders), as folic acid enhances the effects of lithium therapy.
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.
Folina 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 using this medicine.
Pregnancy
Folina 5 mg soft capsule 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. 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
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
This medicine has no or negligible influence on the ability to drive or use machines.
Folina contains:
- Sodium ethyl parahydroxybenzoate and sodium propyl parahydroxybenzoate: they can cause allergic reactions (even delayed).
- Sorbitol: if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
- Soy: If you are allergic to peanuts or soy, do not use this medicine.
Dose, Method and Time of Administration How to use Folina: Posology
Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
The recommended doses are:
Adults
1-3 capsules per day, as directed by the doctor.
Use in children
1-3 capsules per day, as for adults, or reduced according to the doctor's instructions.
Use in pregnancy
The daily dose should not exceed 5 mg: 1 capsule per day.
Overdose What to do if you have taken too much Folina
If you take more Folina than you should
If you have accidentally swallowed / taken too much of this medicine, notify your doctor immediately or go to the nearest hospital.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Folina
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 bumps on the skin (hives), difficulty in breathing (dyspnoea) and anaphylactic shock (severe allergic reaction involving difficulty in breathing, swelling of the face and lips, tongue and other parts of the body): in this case, contact your doctor immediately.
- Sleep disturbances, nightmares.
- Loss of appetite (anorexia), nausea, swollen stomach (abdominal distension) and flatulence.
- Malaise, irritability.
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.gov.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 store above 30 ° C.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not throw 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 "> Other information
What Folina contains
- The active ingredient is folic acid. Each soft capsule contains 5 mg of folic acid.
- The other ingredients are: Capsule contents: beeswax, refined soybean oil, soy lecithin in soybean oil. Outer shell: gelatin, glycerol, sodium ethyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, sorbitol, titanium dioxide (E171 ), erythrosine (E127), black iron oxide (E172), purified water.
Description of the appearance of Folina and contents of the package
Folina is presented in a package containing 1 blister of 20 capsules, 1 blister of 28 capsules or 6 blisters of 10 capsules each, placed in a cardboard box.
Not all pack sizes may be marketed.
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 -
FOLINA
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
Folina 15 mg / 2 ml solution for injection
A 2ml vial contains:
Active principle: folic acid 15 mg
Excipients with known effects: sodium hydroxide (4 mg), sodium chloride (1.1 mg), methyl parahydroxybenzoate (0.400 mg), ethyl parahydroxybenzoate (0.415 mg), propyl parahydroxybenzoate (0.160 mg), butyl parahydroxybenzoate (0.020 mg), benzyl parahydroxybenzoate (0.005 mg) ).
Folina 5 mg soft capsules
One soft capsule contains:
Active principle: folic acid 5 mg.
Excipients with known effects: refined soybean oil (80.55 mg), soy lecithin in soybean oil (0.45 mg), sodium ethyl parahydroxybenzoate (0.210 mg), sodium propyl parahydroxybenzoate (0.105 mg), sorbitol (4.707 mg).
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM -
Injectable solution; soft capsules.
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 -
Folina 15 mg / 2 ml solution for injection
Dosage
1 ampoule per day according to medical prescription, intramuscularly.
Folina 5 mg soft capsules
Dosage
1-3 capsules per day according to medical prescription.
Pediatric population
In children, the daily dose of Folina soft capsules 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 tumors (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).
Folina 5 mg soft capsule contains soy: do not use in patients allergic to peanuts or soy.
04.4 Special warnings and appropriate precautions for use -
The treatment must be carried out under haematological control.
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 folic acid with phenobarbital, phenytoin or primidone is not recommended (see section 4.5 "interaction with other medicinal products and other forms of interaction").
Folina 15 mg / 2 ml solution for injection contains:
- Parahydroxybenzoates: they can cause allergic reactions (even delayed) and, exceptionally, bronchospasm.
- Sodium: This medicinal product contains less than 1 mmol (23 mg) sodium per dose ie essentially "sodium free".
Folina 5 mg soft capsule contains:
- Sodium ethyl parahydroxybenzoate and sodium propyl parahydroxybenzoate: they can cause allergic reactions (even delayed).
- Sorbitol: patients with rare hereditary problems of fructose intolerance should not take this medicine.
04.5 Interactions with other medicinal products and other forms of interaction -
Folic acid in high doses can reduce the antiepileptic effect of phenobarbital, fentoin 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 for 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.
Folate supplements enhance the effects of lithium therapy.
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 to using folic acid in pregnancy; folic acid supplements are often beneficial.
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.
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 -
Folina 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 Folina 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 and 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 -
Cases of overdose are not described in the literature.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Pharmacotherapeutic group: antianemic drugs: folic acid and derivatives.
ATC: B03BB01.
Pharmacodynamic effects: folic acid intervenes in numerous biochemical reactions as a transporter of mono-carbon units in activated form. The lack of folic acid gives rise to macrocytic anemia and leukopenia.
05.2 "Pharmacokinetic properties -
Absorption
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.
Biotransformation
The metabolization of folic acid is related to the entity of the folate deposits by adjusting to a homeostasis of saturation of these.
05.3 Preclinical safety data -
It was not possible to establish the LD50 orally in the animal, given the very low toxicity of folic acid. Vitamin administered i.v. it was found to have a LD50 of about 500 mg / kg slightly variable depending on the animal species.
As for chronic toxicity, doses lower than 50 mg / kg in rabbits and intraperitoneum rats did not cause pathological effects. The aforementioned doses are far higher than the usual therapeutic doses in man. Folic acid is not toxic to man even in high dose administration and very prolonged over time as has been shown in the course of epilepsy, by administering 15 mg per day. of folic acid for one year.
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
Folina 15 mg / 2 ml solution for injection
Glycine, sodium hydroxide, sodium chloride, methyl parahydroxybenzoate, ethyl parahydroxybenzoate, propyl parahydroxybenzoate, butyl parahydroxybenzoate, benzyl parahydroxybenzoate, water for injections.
Folina 5 mg soft capsules
Capsule contents: beeswax; refined soybean oil, soy lecithin in soybean oil.
External casing: gelatin, glycerol, sodium ethyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, sorbitol, titanium dioxide (E 171), erythrosine (E127), black iron oxide (E172) and purified water.
06.2 Incompatibility "-
The action of Folina is inhibited by the simultaneous use of drugs with antipholic action.
06.3 Period of validity "-
3 years.
06.4 Special precautions for storage -
Folina 15 mg / 2 ml solution for injection
This medicine does not require any special storage conditions.
Folina 5 mg soft capsules:
Do not store above 30 ° C.
06.5 Nature of the immediate packaging and contents of the package -
Folina 15 mg / 2 ml solution for injection
Yellow glass vials type I F.U. Pack containing 5 ampoules in a PVC case inserted in a lithographed case.
Folina 5 mg soft capsules
Blisters with PVC pockets, sealed with aluminum foil: Pack containing 1 blister of 20 capsules inserted in a lithographed box. Pack containing 1 blister of 28 capsules inserted in a lithographed box. Pack containing 6 blisters of 10 capsules each inserted in a lithographed box.
Not all pack sizes may be marketed.
06.6 Instructions for use and handling -
No special instructions.
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
Teofarma S.r.l. - Via F.lli Cervi, 8 - 27010 Valle Salimbene (PV)
08.0 MARKETING AUTHORIZATION NUMBER -
Folina 15 mg / 2 ml solution for injection AIC 002309033
Folina 5 mg soft capsules, 20 capsules AIC 002309045
Folina 5 mg soft capsules, 60 capsules AIC 002309058
Folina 5 mg soft capsules, 28 capsules AIC 002309060
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
04/08/1982 - 01/06/2010
10.0 DATE OF REVISION OF THE TEXT -
October 2015
