Folacid 0,4 mg

Package Leaflet: Information for the Patient

Folacid 0.4 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 you can read it again if you need to.
• You should consult a doctor or pharmacist if you have any further doubts.
• 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 0.4 mg and what is it used for
2. How to take Folacid 0.4 mg
3. Possible side effects
4. How to store Folacid 0.4 mg
5. Contents of the pack and other information

1. What is Folacid 0.4 mg and what is it used for

Folacid 0.4 mg comes in the form of tablets and contains folic acid.
Folic acid (pteroylglutamic acid) is a vitamin of the B group. It is essential 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 purine and pyrimidine compounds, deoxyribonucleic acid, in amino acid and urea metabolism.
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 developmental defects of the nervous system, as it stops folic acid synthesis in the first trimester of pregnancy.
Folacid 0.4 mg is used:

• To supplement folic acid deficiency, e.g., in the case of megaloblastic anemia (Addison-Biermer anemia) caused by folic acid deficiency.
• During pregnancy planning and in the first trimester of pregnancy to prevent neural tube defects in the fetus.
• In conditions of increased demand for folic acid.

When not to use Folacid 0.4 mg:
Do not use Folacid 0.4 mg if you are hypersensitive to folic acid or any of the other ingredients of the preparation.
Do not use in the case of untreated vitamin B12 deficiency, as folic acid may mask the symptoms of pernicious anemia.
Caution when using Folacid 0.4 mg:
Caution should be exercised when using Folacid 0.4 mg in patients with renal impairment.
Can Folacid 0.4 mg be used during pregnancy and breastfeeding:
During pregnancy and breastfeeding, use only if clearly necessary and under medical supervision.
Using other medicines:
You should inform your doctor about all medicines you are taking, including those available without a prescription.
Folic acid may interact with certain medicines, such as:

• Phenobarbital, primidone, phenytoin - may weaken the effect of folic acid.
• Methotrexate - folic acid may reduce the effect of methotrexate.
• Sulfasalazine - may reduce folic acid absorption.
• Probenecid - may increase folic acid levels in the blood.

How to take Folacid 0.4 mg:
Use only as directed by your doctor.
Dosage:

• Usually, the daily dose for adults and children over 3 years of age is 0.4 mg (1 tablet).
• During pregnancy planning and in the first trimester of pregnancy, the daily dose is 0.4 mg (1 tablet).
• In the case of folic acid deficiency, the daily dose is determined individually by the doctor.

The tablet should be taken orally, with a small amount of water.
Do not exceed the recommended dose.
What to do if you miss a dose:
If you miss a dose, take it as soon as possible, unless it is close to the time of the next dose. In this case, skip the missed dose and take the next dose at the usual time.
Do not take a double dose to make up for the missed dose.
Possible side effects:
Like all medicines, Folacid 0.4 mg can cause side effects, although they do not occur in all patients.
Possible side effects:

• Rarely: allergic reactions (e.g., rash, itching, angioedema, dyspnea).
• Very rarely: hypersensitivity to folic acid (e.g., skin redness, urticaria).

If you experience any side effects, stop taking the medicine and consult your doctor.
How to store Folacid 0.4 mg:
Store at room temperature (15-25°C), in a dry and dark place.
Store in the original packaging to protect from light and moisture.
The medicine should be stored in a place inaccessible to children.
Do not use the medicine after the expiration date stated on the packaging.

5. Contents of the pack and other information

What Folacid 0.4 mg contains:

• Active substance: folic acid 0.4 mg.
• Other ingredients: microcrystalline cellulose, cornstarch, colloidal anhydrous silica, talc, magnesium stearate.

What Folacid 0.4 mg looks like and what the pack contains:
Yellow, round, scored tablets.
Packaging: 30 tablets
Responsible person:
Manufacturer:
Date of last update of the leaflet:

2. Important information before taking Folacid 0.4 mg

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

Warnings and precautions

Particular caution should be exercised when using Folacid 0.4 mg:

• in the treatment of undiagnosed megaloblastic anemia due to the possibility of masking the cause of the disease;
• in patients with suspected or diagnosed megaloblastic anemia;
• in patients with brain tissue damage;
• in patients with spinal cord damage.

Other medicines and Folacid 0.4 mg

You should tell your doctor or pharmacist about all medicines you are 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 together, it is necessary to monitor their levels 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 between taking these medicines.

Folacid 0.4 mg with food and drink

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

Pregnancy and breastfeeding

In pregnancy and breastfeeding, or if you think you may be pregnant, or if you are planning to become pregnant, you should consult your doctor or pharmacist before taking this medicine.
Folacid 0.4 mg can be safely used during pregnancy.
Folacid 0.4 mg can be safely used during breastfeeding. Folic acid passes into breast milk.

Dosage and administration

Folacid 0.4 mg:Adults and children over 3 years of age: usually 1 tablet (0.4 mg) once a day.
The medicine should be taken orally, with a small amount of liquid.

If no improvement is seen

If symptoms persist or worsen, you should consult your doctor.

3. How to take Folacid 0.4 mg

This medicine should always be taken as described in the patient information leaflet or as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
If your doctor does not advise otherwise, the recommended dose is 1 tablet per day, at least one month before conception and in the first trimester of pregnancy.
The medicine should be taken orally, with an adequate amount of liquid, e.g., a glass of water.
Taking more than the recommended dose of Folacid 0.4 mg
No severe symptoms of folic acid overdose have been observed after oral administration.
In the case of overdose, side effects may occur (listed in section 4).
Missing a dose of Folacid 0.4 mg
You should continue taking the medicine as directed.
Do not take a double dose to make up for the missed dose.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although they do not occur in all patients.
Folic acid is generally well-tolerated. Allergic reactions may occur (skin rash, skin redness, bronchospasm, fever). If you experience any side effects, you should stop taking the medicine and consult your doctor.
In some people, other side effects may occur during treatment with Folacid 0.4 mg. If you experience any side effects, including those not listed in the leaflet, you should consult your doctor or pharmacist.

5. How to store Folacid 0.4 mg

Store at a temperature below 25°C.
Store in the original packaging to protect from light.
The medicine should be stored in a place inaccessible to children.
Do not use this medicine after the expiration date stated on the packaging.
The expiration date refers to the last day of the specified month.
Do not use the medicine if you notice any changes in the appearance or consistency of the tablets.
If you experience any side effects, you should inform your doctor or pharmacist.

6. Contents of the pack and other information

What Folacid 0.4 mg contains

• The active substance of the medicine is folic acid (Acidum folicum).
• Other ingredients are:
• lactose monohydrate,
• microcrystalline cellulose,
• sodium carboxymethyl cellulose,
• colloidal anhydrous silica,
• magnesium stearate,
• sodium lauryl sulfate.

What Folacid 0.4 mg looks like and what the pack contains
Folacid 0.4 mg is a light yellow, round, biconvex tablet.
The tablets are packaged in PVC/PVDC/Aluminum blisters in a cardboard box.
30 tablets - 1 blister of 30 tablets
60 tablets - 2 blisters of 30 tablets
Not all pack sizes may be marketed.
Responsible person and manufacturer
Pharmaceutical-Chemical Enterprise "SYNTEZA" 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 last update of the leaflet:
2012-10-11