Folik
PolandTable of Contents
Package leaflet: Information for the user
Folik, 0.4 mg, tablets
Acidum folicum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your
doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, please consult your pharmacist.
- If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
- If your symptoms do not improve or if you feel worse, consult your doctor.
Contents of the leaflet
- What Folik is and what it is used for
- What you need to know before taking Folik
- How to take Folik
- Possible side effects
- How to store Folik
- Contents of the pack and other information
1. What Folik is and what it is used for
The active substance in Folik is folic acid, which is a vitamin of the B group.
Women who are pregnant or breastfeeding have an increased requirement for folic acid. Meeting this increased demand through diet alone is difficult to achieve. Folic acid deficiency during these periods may lead to congenital malformations of the central nervous system and face in newborns.
Folic acid is used prophylactically to prevent deficiency in women starting at least one month before expected conception and during the first 12 weeks of pregnancy. In conditions of increased demand, diet may be insufficient as a source of folic acid.
Indications for Folik
Prevention of folic acid deficiency in women before conception and during early pregnancy in order to reduce the risk of neural tube defects in the offspring.
2. Information before using Folik
When not to use Folik
Do not use Folik if the patient is allergic to folic acid or to any of the other ingredients of this medicine (listed in section 6). An allergic reaction may manifest as rash, itching, swelling of the face, lips, tongue, or difficulty breathing (if such symptoms occur, contact a doctor immediately).
Warnings and precautions
Except during pregnancy and breastfeeding, do not use folic acid in doses exceeding 0.4 mg per day (1 tablet of Folik) without prior exclusion of megaloblastic anaemia by a doctor.
Women who previously gave birth to a child with a congenital neural tube defect are at increased risk of having another child with such a defect. Before planning another pregnancy, they should seek genetic counselling.
These women should take folic acid for at least three months before planned pregnancy, at doses of 4 to 5 mg per day.
Consult a doctor even if the above warnings refer to conditions that occurred in the past.
Folik and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
If Folik is taken at the same time with: oral contraceptives (containing estrogens), antituberculosis drugs, alcohol, and ion-exchange resins used in lipid disorders (excess fats in the blood);
- these medicines may reduce the effectiveness of Folik.
If Folik is taken at the same time with: medicines known as folic acid antagonists (sulfonamides, trimethoprim, pyrimethamine, sulfasalazine) and anticancer medicines (methotrexate);
- these medicines may also reduce the effectiveness of Folik, but through a different mechanism.
If Folik is taken at the same time with antiepileptic medicines (phenobarbital, phenytoin, primidone), it may reduce their effectiveness, leading to recurrence of seizures.
Taking Folik with food and drink
Food does not affect the absorption of Folik.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Folik may be used during pregnancy.
Women taking Folik may breastfeed.
Driving and using machines
Folik has no effect on the ability to drive or operate machinery.
3. How to take Folik
Always take this medicine exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.
The usual dose of Folik is 1 tablet (0.4 mg folic acid) once daily, taken for at least one month before conception and during the first trimester (first 3 months) of pregnancy.
Method of administration:
Tablets should preferably be taken during a meal, with water.
If you feel that the effect of Folik is too strong or too weak, consult your doctor.
Taking more Folik than recommended
If you take more Folik than you should, contact your doctor or go to a hospital immediately. Show the doctor the medicine packaging.
If you forget to take Folik
If you miss a dose, take the next prescribed dose at the scheduled time. Do not take a double dose to make up for a missed one.
Stopping Folik
Do not stop treatment without consulting your doctor, even if you feel better.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse effects
Like any medicine, this medicine may cause adverse effects, although not everyone will experience them.
Folik is a well-tolerated medicine. It rarely causes adverse effects, which are usually mild.
Skin allergic reactions are the most commonly observed. However, very rarely, severe allergic reactions such as angioedema or bronchospasm may occur.
Uncommon: may affect up to 1 in 100 people
- skin allergic reactions (rash, itching).
Rare: may affect up to 1 in 1000 people
- bitter taste in the mouth,
- bloating,
- nausea,
- vomiting,
- diarrhoea,
- loss of appetite,
- difficulty falling asleep,
- drowsiness,
- nervous overstimulation,
- depression.
Very rare: may affect up to 1 in 10,000 people
- angioedema,
- bronchospasm.
Frequency not known: cannot be estimated from available data
- severe allergic reaction (anaphylactic reaction).
If any of the above-mentioned very rare and serious adverse effects marked with an underline occur,
discontinue use of the medicine immediately and contact a doctor or go to a hospital.
Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.
5. How to store Folik
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton.
Do not store above 25°C.
Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Contents of the pack and other information
What Folik contains
- The active substance is folic acid.
- The other ingredients are: microcrystalline cellulose, maize starch, magnesium stearate, anhydrous calcium hydrogen phosphate, colloidal anhydrous silica, Maracuja flavor.
What Folik looks like and contents of the pack
Bright yellow, round, biconvex tablets.
The Folik pack contains 30, 60 or 90 tablets and a patient information leaflet.
Marketing Authorisation Holder and Manufacturer
GEDEON RICHTER POLSKA Sp. z o.o.
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
For further information, please contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Tel. +48 (22)755 96 48
[email protected]
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