Folic acid Mylan

Package leaflet: Information for the patient

Folic Acid Mylan 5 mg tablets

folic acid
Read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Folic Acid Mylan is and what it is used for
2. What you need to know before taking Folic Acid Mylan
3. How to take Folic Acid Mylan
4. Possible side effects
5. How to store Folic Acid Mylan
6. Contents of the pack and other information

1. What Acido Folico Mylan is and what it is used for

Folic acid belongs to a group of medicines called vitamin B.
Acido Folico Mylan can be used in adults for the prevention of:

• folic acid deficiency caused by certain medicines, for example phenytoin, phenobarbital and primidone, used to treat epilepsy;
• neural tube defects in the fetus (such as spina bifida), in women who are planning a pregnancy and who are at risk of having a child with this defect.

2. What you need to know before taking Acido Folico Mylan

Do not take Acido Folico Mylan

• if you are allergic to folic acid or to any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include skin rash, itching, difficulty breathing, or swelling of the face, lips, throat, or tongue;
• if you have been diagnosed with anaemia due to unknown causes or with untreated or inadequately treated pernicious anaemia.

Warnings and precautions
Talk to your doctor or pharmacist before taking Acido Folico Mylan

• if you have a malignant disease or a tumour;
• if you suffer from vitamin B12 deficiency. Patients with vitamin B12 deficiency should not be treated with folic acid unless adequate amounts of hydroxocobalamin are administered, as this medicine, if given alone, could worsen or trigger the onset of symptoms of your condition, potentially leading to severe neurological damage;
• if you are a healthy pregnant woman without risk of having a child with neural tube defects. In this case, your doctor will prescribe a medicine containing a lower amount of folic acid;
• if you are taking antiepileptic medicines.

Children and adolescents
Acido Folico Mylan must not be used in children and adolescents.
Other medicines and Acido Folico Mylan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines, including those not requiring a prescription.
This particularly concerns the following medicines:

• medicines used to treat epileptic seizures such as phenytoin, phenobarbital and primidone, carbamazepine;
• medicines used to treat infections such as chloramphenicol, cotrimoxazole, sulfonamides, and trimethoprim;
• sulfasalazine used to treat ulcerative colitis, Crohn's disease, or rheumatoid arthritis;
• medicines used to treat cancer such as fluorouracil, methotrexate, and capecitabine;
• oral contraceptives;
• medicines used to treat tuberculosis;
• alcohol;
• glucarpidase; a medicine used to reduce excessive methotrexate levels in the blood;
• triamterene (a medicine used to reduce fluid retention and blood pressure);
• pyrimethamine used to treat parasitic infections;
• antacids such as cimetidine.

Prolonged use of high doses of folic acid may lead to decreased serum levels of cyanocobalamin.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
This medicine is not intended for use in healthy pregnant women for whom lower doses are recommended, but for pregnant women with folic acid deficiency or women at risk of recurrence of neural tube defects.
Folic acid is excreted in breast milk.
Driving and using machines
Acido Folico Mylan has no effect or has a negligible effect on the ability to drive and use machines.
Acido Folico Mylan contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this
medicine.

3. How to take Folic Acid Mylan

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Adults
To prevent folic acid deficiency caused by certain medicines, the recommended dose is: from 1 tablet
(containing 5 mg) once a week to 1 tablet (containing 5 mg) daily.
The dose and duration of treatment depend on the individual clinical condition and the patient's response.
To prevent neural tube defects in the fetus of women who are planning pregnancy and for whom risk is known:
1 tablet (containing 5 mg) daily, starting preferably at least 3 months before conception (and in any case at least 1 month before conception) and continuing throughout the first trimester of pregnancy.
Not all dosage recommendations can be achieved with this product. In such cases, your doctor will prescribe another folic acid-containing medicine.
Dose adjustments are not required in the elderly and, based on limited data, in patients with renal or hepatic impairment.
Use in children and adolescents
Folic Acid Mylan must not be used in children and adolescents.
Route and method of administration
Oral use:

• Swallow the tablet whole with water.
• Take this medicine for the length of time prescribed by your doctor.

If you take more Folic Acid Mylan than you should
If you (or someone else) swallow several tablets at once, or if you think a child has ingested any tablets, contact immediately the nearest hospital emergency department or your doctor.
If you forget to take Folic Acid Mylan
If you forget to take a tablet, take it as soon as you remember, unless it is almost time for the next dose. Do not take a double dose to make up for the forgotten tablet.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Rare side effects (may affect up to 1 in 1,000 people)

• Allergic reaction that may present as: skin rash, swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing.
• Stomach problems: nausea, loss of appetite, diarrhoea, vomiting and flatulence.
• Sleep disturbances, nightmares.
• Malaise, irritability.
• Itching, erythema, urticaria.

Other side effects that have occurred in a very small number of people, but whose exact frequency is unknown
(frequency cannot be estimated from the available data)

• Severe allergic reaction (anaphylactic reaction).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Folic Acid Mylan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Acido Folico Mylan contains

• The active substance is hydrated folic acid, equivalent to 5 mg of folic acid.
• The other ingredients are maize starch, monohydrate lactose, microcrystalline cellulose, anhydrous colloidal silicon dioxide, magnesium stearate.

Description of the appearance of Acido Folico Mylan and pack contents
Tablet.
Yellow, circular, biconvex, film-coated tablets of 5.5 mm diameter, marked with the letters "FO" on one side.
Pack sizes:
Blister packs: 20, 28, 60 and 120 tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan
Italy

Manufacturer
Fine Foods and Pharmaceuticals NTM SpA
Via Grignano, 43
24041 Brembate (BG)
Italy