Acifolik

Leaflet attached to the packaging: patient information

ACIFOLIK

0.4 mg, tablets

Folic acid

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed 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 any possible side effects not listed in the 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 Acifolik and what is it used for
• 2. Important information before taking Acifolik
• 3. How to take Acifolik
• 4. Possible side effects
• 5. How to store Acifolik
• 6. Package contents and other information

1. What is Acifolik and what is it used for

Acifolik contains folic acid, which is a vitamin from the B group. Folic acid is essential for the proper functioning and development of the body. It affects the condition of fetal tissues, the epithelium of the digestive tract, and the hematopoietic system. Folic acid is used prophylactically to prevent its deficiencies in women during early pregnancy and before conception, in order to reduce the risk of neural tube defects in offspring.

2. Important information before taking Acifolik

When not to take Acifolik

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

Warnings and precautions

Except during pregnancy and breastfeeding, folic acid should not be administered in doses greater than 0.4 mg per day without first excluding megaloblastic anemia (caused by vitamin B12 deficiency), as it may alleviate hematological symptoms while continuing to develop neurological symptoms.

Acifolik and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Antiepileptic drugs, oral contraceptives, anti-tuberculosis drugs, alcohol, and folic acid antagonists, such as aminopterin, methotrexate, pyrimethamine, trimethoprim, and sulfonamides (including sulfasalazine), increase the demand for folic acid. Folic acid weakens the effect of anticonvulsant hydantoin derivatives.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. The medicine can be used during pregnancy and breastfeeding.

Driving and operating machinery

Acifolik does not affect the ability to drive and operate machinery.

Acifolik contains lactose

If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking the medicine.

3. How to take Acifolik

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist. Oral administration. 1 tablet (0.4 mg) per day, for at least one month before becoming pregnant and during the first trimester of pregnancy.

Taking a higher dose of Acifolik than recommended

Folic acid is relatively harmless. Overdosing on Acifolik is not dangerous.

Missing a dose of Acifolik

A double dose should not be taken to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Folic acid is well-tolerated. In rare cases, gastrointestinal disorders or allergic reactions (rash, redness, itching) may occur. Severe allergic reaction (anaphylactic reaction) - frequency unknown. If any of the side effects worsen or the patient experiences any side effects not listed in the leaflet, they should inform their doctor.

Reporting side effects

If any side effects occur, including any possible side effects not listed in the 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, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl.

5. How to store Acifolik

Store in a temperature below 25°C, in the original packaging to protect from light. Store in a place out of sight and reach of children. Do not use the medicine after the expiry date stated on the box. The expiry date refers to the last day of the specified month. Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Acifolik contains

• The active substance of the medicine is folic acid. 1 tablet of Acifolik contains 0.4 mg of folic acid.
• The other ingredients (excipients) are: lactose monohydrate, microcrystalline cellulose, povidone, sodium carboxymethyl cellulose, magnesium stearate, anhydrous colloidal silica.

What Acifolik looks like and what the package contains

Acifolik is a tablet with a double-sided flat round shape with a beveled edge, light yellow in color. 30 or 60 tablets

Responsible entity and manufacturer

"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A., 51-131 Wrocław, ul. Żmigrodzka 242 E, tel. (71) 352 95 22, fax. (71) 352 76 36

• Information about the medicine, tel. +48 (22) 742 00 22, email: informacjaoleku@hasco-lek.pl

Date of last update of the leaflet:09.05.2018