FOLACID

Package leaflet: Information for the user

Folacid, 5 mg, tablets
Acidum folicum hydricum
Please read all of 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 further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Folacid is and what it is used for
2. Important information before taking Folacid
3. How to take Folacid
4. Possible side effects
5. How to store Folacid
6. Contents of the pack and other information

1. What Folacid is and what it is used for

Folacid is available as tablets and contains folic acid.
Folic acid (pteroylglutamic acid) is a vitamin of the B group. It is essential for normal body function and development. In the body, folic acid is reduced to its active form – tetrahydrofolic acid, which acts as a coenzyme in many enzymatic reactions involved in the synthesis of pyrimidine and purine compounds, deoxyribonucleic acid (DNA), amino acid metabolism, and formate transformations.
Folic acid plays an important role in tissues with high rates of cell division (hematopoietic system, gastrointestinal epithelium, fetal tissues).
Folic acid is essential for the myelination of nerve fibers.
Taking folic acid at a dose of 0.4 mg daily or higher reduces the risk of neural tube defects in offspring, such as spina bifida and other congenital malformations of the central nervous system resulting from impaired neural tube closure. Failure of the so-called neural tube to close during fetal development may lead to conditions such as anencephaly and meningomyelocele.
Folic acid deficiency manifests as megaloblastic anemia with leukopenia and thrombocytopenia.
The daily requirement of an adult for folic acid is approximately 0.4 mg. This requirement doubles in pregnant women and during lactation, as well as in individuals who consume excessive amounts of alcohol.
Higher doses of folic acid (5 mg daily) are recommended for use at least three months before planned pregnancy in women who have previously given birth to a child with a genetic neural tube defect.

Indications for the use of Folacid 5 mg tablets are:

• Prevention and treatment of conditions caused by folic acid deficiency:
  • Megaloblastic anemia.
• Planned pregnancy in women who have previously given birth to a child with a genetic neural tube defect.

2. Information before using Folacid

When not to use Folacid

• if the patient is allergic to folic acid monohydrate or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Folacid, discuss this with your doctor or pharmacist.
Special caution is required when using Folacid:
in the treatment of inadequately diagnosed megaloblastic anaemia due to the possibility of masking the underlying cause of the disease;
in patients with epilepsy;
in patients with brain tissue damage;
in patients with spinal cord damage.

Folacid and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
Antiepileptic drugs (phenytoin, phenobarbital, primidone), antituberculosis drugs, alcohol (ethanol), oral contraceptives, and folic acid antagonists (sulfonamides, methotrexate, trimethoprim, aminopterin, pyrimethamine, sulfasalazine) may lead to folic acid deficiency in the body.
When folic acid is used concomitantly with antiepileptic drugs, monitoring of their blood concentrations is necessary due to altered metabolism rates and the risk of increased seizure activity.
Antacids containing aluminium or magnesium compounds may reduce the absorption of folic acid. A 2-hour interval should be maintained between administration of these drugs.

Folacid with food and drink
The medicine may be taken before, during, or after meals.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Folacid may be safely used during pregnancy.
Folacid may be safely used during breastfeeding. Folic acid passes into the breast milk of nursing women.

Driving and operating machinery
Folacid has no effect on the ability to drive or operate machinery.

Folacid contains lactose monohydrate
Each tablet contains 66 mg of lactose monohydrate.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Folacid contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning that the medicine is considered "sodium-free".

3. How to use Folacid

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Recommended dosage:

• In megaloblastic anaemia: adults 5 mg daily for 4 months; if malabsorption is present: up to 15 mg daily. Women who have had a child with a neural tube defect: 5 mg daily for at least three months before a planned pregnancy.

This medicine should be taken orally with an adequate amount of liquid, e.g. a glass of water.
Use of a higher than recommended dose of Folacid
Adverse effects (listed in section 4) may occur in case of overdose.
Missed dose of Folacid
Continue taking the medicine at the recommended doses.
Do not take a double dose to make up for a missed dose.
Stopping Folacid treatment
If you have any further doubts regarding the use of this medicine, consult
your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Folic acid is generally well tolerated. Possible reactions include allergic reactions (skin rash, skin redness, bronchospasm, fever), malaise, gastrointestinal disturbances, nausea, vomiting, sleep disturbances, depression, and agitation.
Frequency unknown: severe allergic reaction (anaphylactic reaction).
If a severe allergic reaction occurs, stop using the medicine immediately and contact a doctor or go to hospital.
If any other adverse symptoms occur, discontinue use of the medicine and contact your doctor.
In some individuals, other adverse reactions may occur during treatment with Folacid.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C,
02-222 Warsaw,
Tel.: + 48 22 49 21 301,
Fax: + 48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Folacid

Keep this medicine out of sight and reach of children.
Store below 25°C.
Keep in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the carton after the words "Expiry date".
The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Folacid contains

• The active substance is folic acid monohydrate (Acidum folicum hydricum). One tablet contains 5 mg of folic acid monohydrate.
• The other ingredients are: monohydrate lactose, microcrystalline cellulose (E 460 I), sodium carboxymethyl starch (E 1450), colloidal anhydrous silica (E 551), magnesium stearate (E 470 b), sodium lauryl sulfate.

What Folacid looks like and contents of the pack
Folacid 5 mg tablets are round, biconvex, light yellow tablets.
The tablets are packed in PVC/PVDC/Aluminium blisters, placed in a cardboard box.
30 tablets – 1 blister containing 30 tablets
60 tablets – 2 blisters containing 30 tablets each
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Pharmaceutical and Chemical Enterprise "SYNTEZA" Sp. z o.o.
ul. Św. Michała 67/71,
61-005 Poznań
tel. +48 61 879 20 81
fax +48 61 876 51 79
e-mail: [email protected]

For further information, please contact the representative of the Marketing Authorisation Holder:
Poland
Pharmaceutical and Chemical Enterprise "Synteza" Sp. z o.o.
ul. Św. Michała 67/71
61-005 Poznań
Tel. 0 61 879-20-81