Folacid

Leaflet attached to the packaging: patient information

Folacid, 5 mg, tablets

Folic acid

Folacid, 15 mg, tablets

Folic acid

You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• You should consult a doctor or pharmacist if you have any further doubts.
• This medicine has been prescribed specifically for you. Do not pass it on to others.
• The medicine may harm another person, even if their illness symptoms are the same.
• If any of the side effects get worse or if you notice any side effects not listed in the leaflet, you should tell your doctor or pharmacist.

Table of contents of the leaflet:

• 1. What is Folacid and what is it 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 packaging and other information

1. What is Folacid and what is it used for

Folacid 5 mg and Folacid 15 mg come in the form of tablets and contain folic acid.
Folic acid (pteroylglutamic acid) is a vitamin from the B group. It is necessary for the proper functioning and development of the body. In the body, it is converted by reduction into its active form - tetrahydrofolic acid, which, as a coenzyme of many enzymatic reactions, participates in the synthesis of pyrimidine and purine compounds, deoxyribonucleic acid, and in the metabolism of amino acids and formic acid.
Folic acid plays an important role in tissues where numerous cell divisions occur (hematopoietic system, gastrointestinal tract epithelium, fetal tissues).
Folic acid is necessary in the process of myelination of nerve fibers.
Taking folic acid in a dose of 0.4 mg per day and higher reduces the risk of congenital nervous system defects in offspring, such as spina bifida and other central nervous system defects resulting from disorders of neural tube formation. Disorders of neural tube closure during fetal development can lead to anencephaly and meningomyelocele.
Folic acid deficiency manifests as megaloblastic anemia with leukopenia and thrombocytopenia.
The daily requirement for folic acid in an adult is about 0.4 mg. It increases twofold in pregnant and breastfeeding women, as well as in people who abuse alcohol.
Higher doses of folic acid (5 mg per day) are recommended for use for at least three months before planned pregnancy in women who have given birth to a child with a genetic defect of the neural tube.
Folacid is used in the prevention and treatment of conditions resulting from folic acid deficiency, such as megaloblastic anemia, hemolytic anemia.

2. Important information before taking Folacid

When not to take Folacid

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

Warnings and precautions

Before starting to take Folacid, you should consult a doctor or pharmacist.
Particular caution should be exercised when taking Folacid:
in the treatment of inadequately diagnosed megaloblastic anemia, due to the possibility of masking the causes of the disease;
in people with epilepsy;
in people with brain tissue damage;
in people with spinal cord damage.

Other medicines and Folacid

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Antiepileptic drugs (phenytoin, phenobarbital, primidone), anti-tuberculosis drugs, alcohol (ethanol), oral contraceptives, folic acid antagonists (sulfonamides, methotrexate, trimethoprim, aminopterin, pyrimethamine, salazosulfapyridine) may lead to folic acid deficiency in the body.
When taking folic acid and antiepileptic drugs at the same time, it is necessary to monitor their concentration due to changes in their metabolism rate and the possibility of worsening epilepsy symptoms.
Antacids containing aluminum or magnesium compounds may reduce folic acid absorption. A 2-hour interval should be maintained when taking these medicines.

Folacid with food and drink

The medicine can be taken before a meal, during a meal, or after eating.

Pregnancy and breastfeeding

In pregnancy and during breastfeeding, or if you suspect you are pregnant, or if you plan to become pregnant, you should consult a doctor or pharmacist before taking this medicine.
Folacid can be safely used during pregnancy.
Folacid can be safely used during breastfeeding. Folic acid passes into breast milk.

Driving and using machines

Folacid does not affect the ability to drive vehicles and operate machines.

Folacid contains lactose

The medicine contains lactose. If you have been diagnosed with intolerance to some sugars, you should consult a doctor before taking the medicine.

3. How to take Folacid

This medicine should always be taken as described in the patient information leaflet or as directed by a doctor or pharmacist. If you are unsure, you should consult a doctor or pharmacist.
The recommended dose is:

Folacid, 5 mg, tablets

In megaloblastic anemia: adults 5 mg per day for 4 months to 15 mg per day in absorption disorders.
Women who have given birth to a child with a genetic defect of the neural tube: 5 mg per day for at least three months before planned pregnancy.

Folacid, 15 mg, tablets

In megaloblastic anemia: 15 mg per day for 4 months in absorption disorders.
The medicine should be taken orally with a sufficient amount of liquid, e.g., a glass of water.

Taking a higher dose of Folacid than recommended

No severe symptoms of folic acid overdose have been observed after oral administration. In case of overdose, side effects (listed in point 4) may occur.

Missing a dose of Folacid

You should continue taking the medicine in the prescribed doses.
You should not take a double dose to make up for a missed dose.
If you have any further doubts about taking this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Folic acid is generally well-tolerated. Allergic reactions (skin rash, skin redness, bronchospasm, fever), malaise, gastrointestinal disorders, nausea, vomiting, sleep disorders, depression, excitement may occur. If you experience side effects, you should stop taking the medicine and consult a doctor.
In some people, other side effects may occur during Folacid treatment. If you experience any side effects, including any possible side effects not listed in the leaflet, you should consult a doctor or pharmacist.

5. How to store Folacid

Store in a temperature below 25°C.
Store in the original packaging to protect from light.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after the words "Expiry date".
The expiry date stated is the last day of the given month.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Folacid contains

• The active substance of the medicine is folic acid (Acidum folicum).
• The other excipients are: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose, colloidal silicon dioxide, magnesium stearate, sodium lauryl sulfate.

What Folacid looks like and what the packaging contains

Folacid, 5 mg, tablets, are round, biconvex tablets of light yellow color.
Folacid, 15 mg, tablets, are round, biconvex tablets of yellow color.
The tablets are packaged in PVC/PVDC/Aluminum blisters in a cardboard box.
30 pieces - 1 blister of 30 tablets
60 pieces - 2 blisters of 30 tablets
Not all packaging types may be marketed.

Responsible entity and manufacturer

SYNTEZA Pharmaceutical and Chemical Company Ltd.
ul. Św. Michała 67/71, 61-005 Poznań
tel. +48 61 879 20 81
fax +48 61 876 51 79
e-mail [email protected]

Date of the last update of the leaflet: