Folik

Package Leaflet: Information for the User

Folik, 0.4 mg, Tablets

Folic Acid

Read the Leaflet Carefully Before Taking the Medication, as it Contains

Important Information for the Patient.
This medication should always be taken exactly as described in this patient leaflet or as advised by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

• 1. What is Folik and what is it used for
• 2. Important information before taking Folik
• 3. How to take Folik
• 4. Possible side effects
• 5. How to store Folik
• 6. Package contents and other information

1. What is Folik and what is it used for

The active substance of Folik is folic acid, which is a vitamin from the B group.
Pregnant and breastfeeding women have an increased need for folic acid. Meeting this increased need solely through diet is difficult to achieve. Folic acid deficiencies during this period can lead to the development of congenital defects of the central nervous system and face in newborns.
Folic acid is used preventively to prevent its deficiencies in women for at least one month before expected conception and in the first 12 weeks of pregnancy. In states of increased demand, diet may be an insufficient source of folic acid.

Indications for the Use of Folik

Prevention of folic acid deficiencies in women before conception and in early pregnancy to reduce the risk of neural tube defects in offspring.

2. Important Information Before Taking Folik

When Not to Take Folik

If the patient is allergic to folic acid or any of the other ingredients of this medication (listed in section 6). An allergic reaction may manifest as a rash, itching, swelling of the face, lips, tongue, or difficulty breathing (if such symptoms occur, a doctor should be consulted).

Warnings and Precautions

Except during pregnancy and breastfeeding, folic acid should not be taken in doses greater than 0.4 mg per day (1 tablet of Folik) without first ruling out megaloblastic anemia by a doctor.
Women who have previously given birth to a child with a congenital nervous system defect are at increased risk of having another child with such a defect. Before another pregnancy, they should receive genetic counseling.
Such women should take folic acid for at least three months before planned pregnancy, in doses of 4 to 5 mg per day.
A doctor should be consulted even if the above warnings relate to past situations.

Folik and Other Medications

The doctor or pharmacist should be informed about all medications the patient is currently taking or has recently taken, as well as any medications the patient plans to take.
If Folik is administered simultaneously with: oral contraceptives (containing estrogens),
antitubercular medications, alcohol, and ion exchange resins used in diseases with excess lipids (fats) in the blood;

• these medications may reduce the effectiveness of Folik.

If Folik is administered simultaneously with: medications known as folic acid antagonists (sulfonamides, trimethoprim, pyrimethamine, sulfasalazine) and anticancer medications (methotrexate);

• these medications may also reduce the effectiveness of Folik, but through a different mechanism.

If Folik is administered simultaneously with antiepileptic medications (phenobarbital, phenytoin, primidone),
it may reduce their effectiveness, leading to a recurrence of seizures.

Taking Folik with Food and Drink

Food does not affect the absorption of Folik.

Pregnancy and Breastfeeding

If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medication.
Folik may be used during pregnancy.
Women taking Folik may breastfeed.

Driving and Operating Machinery

Folik does not affect the ability to drive or operate machinery.

3. How to Take Folik

This medication should always be taken as advised by a doctor. In case of doubts, a doctor or pharmacist should be consulted.
Usually, the recommended dose of Folik is 1 tablet (0.4 mg of folic acid) once a day, for at least one month before conception and in the first trimester (first 3 months) of pregnancy.
Method of administration:
Tablets are best taken during a meal, with a glass of water.
If the patient feels that the effect of Folik is too strong or too weak, they should consult a doctor.

Taking a Higher Than Recommended Dose of Folik

In case of taking a higher dose of the medication than recommended, the patient should immediately contact a doctor or go to the hospital. The patient should show the doctor the package with the tablets.

Missing a Dose of Folik

If a dose is missed, the next scheduled dose should be taken at the appointed time.
A double dose should not be taken to make up for a missed dose.

Stopping the Use of Folik

Treatment should not be stopped without consulting a doctor, even if the patient feels better.
In case of any further doubts related to the use of this medication, a doctor or pharmacist should be consulted.

4. Possible Side Effects

Like all medications, Folik can cause side effects, although not everyone will experience them.
Folik is a well-tolerated medication. It rarely causes side effects, and they are usually mild. The most common side effects are skin allergic reactions. However, very rare but serious allergic reactions such as angioedema or bronchospasm can occur.
Uncommon: may occur in up to 1 in 100 people

• skin allergic reactions (rash, itching).

Rare: may occur in up to 1 in 1,000 people

• bitter taste in the mouth,
• bloating,
• nausea,
• vomiting,
• diarrhea,
• loss of appetite,
• difficulty sleeping,
• drowsiness,
• excessive nervous excitability,
• depression.

Very rare: may occur in up to 1 in 10,000 people

• angioedema,
• bronchospasm.

Frequency not known: cannot be estimated from the available data

• severe allergic reaction (anaphylactic reaction).

In Case of Any of the Above Very Rare and Serious Side Effects, the Patient Should Immediately Stop Taking the Medication and Consult a Doctor or Go to the Hospital.

Reporting Side Effects

If any side effects occur, including those not listed in this leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: 22 49 21 301
Fax: 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medication.

5. How to Store Folik

The medication should be stored out of sight and reach of children.
This medication should not be used after the expiry date stated on the carton.
It should not be stored at temperatures above 25°C.
It should be stored in the original packaging to protect it from light.
Medications should not be disposed of in wastewater or household waste. A pharmacist should be asked how to dispose of unused medications. This will help protect the environment.

6. Package Contents and Other Information

What Folik Contains

• The active substance is folic acid.
• The other ingredients are: microcrystalline cellulose, corn starch, magnesium stearate, calcium phosphate anhydrous, colloidal anhydrous silica, Maracuja flavor.

What Folik Looks Like and What the Package Contains

Light yellow tablets, round, flat on both sides.
The package of Folik contains 30, 60, or 90 tablets and an information leaflet.

Marketing Authorization Holder and Manufacturer

GEDEON RICHTER POLSKA Sp. z o.o.
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
For more detailed information, please contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Phone: +48 (22)755 96 48
lekalert@grodzisk.rgnet.org

Date of Last Update of the Leaflet:

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