Folic acid olimp

Package leaflet: Information for the patient

Folic Acid OLIMP, 0.8 mg, tablets
Acidum folicum hydricum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet, or as directed by a
physician or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your physician or pharmacist. See section 4.
• If there is no improvement or if you feel worse, contact your physician.

Table of contents of the leaflet

1. What is Folic Acid and what is it used for
2. Important information before taking Folic Acid
3. How to take Folic Acid
4. Possible adverse reactions
5. How to store Folic Acid
6. Contents of the pack and other information

1. What is Folic Acid and what is it used for

Folic acid, the active substance in Folic Acid, is a vitamin of the B group.
Pregnant and breastfeeding women have an increased requirement for folic acid.
Taking folic acid by women in the early stages of pregnancy reduces the risk of neural tube defects in the offspring.
Folic Acid is indicated:

• for the prevention of folic acid deficiency in women during early pregnancy, in order to reduce the risk of neural tube defects in the offspring;
• for the prevention of folic acid deficiency in women after the 12th week of pregnancy and in breastfeeding women.

2. Important information before using Folic Acid OLIMP

When not to use Folic Acid OLIMP
If the patient is allergic to folic acid or to any of the other ingredients of this medicine
(listed in section 6).

Warnings and precautions
Before starting to take Folic Acid OLIMP, discuss it with your doctor or
pharmacist.
In the treatment of unconfirmed diagnosis of megaloblastic anaemia, folic acid should not be administered alone or together with insufficient amounts of vitamin B_. It may cause partial improvement in blood tests and mask the true underlying cause of the disease, but does not prevent degenerative changes in the spinal cord nerves caused by vitamin B_ deficiency and may even worsen them. For this reason, in cases of megaloblastic anaemia, it is very important that the doctor accurately determines the underlying cause of the condition.
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. Please consult your doctor, even if the above warnings refer to conditions that occurred in the past.

Folic Acid OLIMP with other medicines
Tell your doctor or pharmacist about any medicines the patient is currently taking, has recently taken, or plans to take.
If Folic Acid OLIMP is taken simultaneously with: oral contraceptives (containing estrogens), anti-tuberculosis drugs, alcohol, and ion-exchange resins used in lipid metabolism disorders (fatty disorders in blood);

• these medicines may reduce the effectiveness of Folic Acid OLIMP.

If Folic Acid OLIMP is taken simultaneously with: medicines known as folic acid antagonists (sulfonamides, trimethoprim, pyrimethamine, sulfasalazine) and anticancer medicines (methotrexate);

• these medicines may also reduce the effectiveness of Folic Acid OLIMP, but through a different mechanism.

If Folic Acid OLIMP is taken simultaneously with antiepileptic medicines (phenobarbital, phenytoin, primidone), folic acid may reduce their effectiveness, leading to recurrence of seizures.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Folic Acid OLIMP may be used during pregnancy.
Folic Acid OLIMP may be used during breastfeeding.

Driving and operating machinery
Folic Acid OLIMP has no effect or has a negligible effect on the ability to drive and operate machinery.

Folic Acid OLIMP contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, the medicine is considered "sodium-free".

3. How to use the medicine Folic Acid

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Prevention of folic acid deficiency in women during early pregnancy:
1 tablet (0.8 mg folic acid) once daily during the first trimester of pregnancy.

Prevention of folic acid deficiency in women after the 12th week of pregnancy and in women who are breastfeeding:
1 tablet (0.8 mg folic acid) once daily.

Method of administration:
The medicine is taken orally.

Taking more Kwas foliowy (Folic Acid) than recommended
No severe symptoms of folic acid overdose have been observed following oral administration.

If you miss a dose of Kwas foliowy (Folic Acid)
If you miss a dose, take the next prescribed dose at the scheduled time. Do not take a double dose to make up for the missed dose.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this product may cause adverse reactions, although not everyone experiences them.
You should discontinue use of Kwas foliowy OLIMP and contact your doctor immediately
if any of the following symptoms of a severe allergic reaction occur:

• swelling of the face, lips, tongue, larynx or throat (which may lead to breathing difficulties or even suffocation), as well as limbs and joint areas;
• difficulty swallowing;
• hives and breathing difficulties.

Possible adverse reactions associated with the use of Kwas foliowy OLIMP:
Not very common: may occur in up to 1 in 100 people

• skin allergic reactions (rash, itching).

Rare: may occur in up to 1 in 1000 people

Very rare: may occur in no more than 1 in 10,000 people

• Angioedema (manifested as swelling, most commonly affecting the face, limbs and joints, but also the throat, nose and larynx, which may lead to breathing difficulties and even asphyxiation),
• Bronchospasm.

Frequency unknown: cannot be estimated from available data

• Severe allergic reaction (anaphylactic reaction).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: 22 49-21-301, Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions allows continuous monitoring of the benefit-risk balance of the medicinal product.

5. How to store the medicine Folic Acid OLIMP

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the box after EXP. The expiry date refers to the last day of the month indicated.
There are no special storage temperature requirements for this medicine. Store the blister in the original packaging to protect it from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What the medicinal product contains

• The active substance is hydrated folic acid. Each tablet contains 0.8 mg of hydrated folic acid.
• Other ingredients are: microcrystalline cellulose: type 105, microcrystalline cellulose: type 102, talc, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate.

What the medicinal product Kwas foliowy looks like and contents of the packaging
Yellow, round, biconvex tablets with a diameter of approximately 6 mm. Minor variations originating from raw materials may occur.
The tablets are packed in blisters made of white PVC/PVDC/Aluminium foil, placed in a cardboard box.
The packaging contains 30 or 60 tablets.

Marketing Authorisation Holder and Manufacturer
OLIMP LABORATORIES Sp. z o.o.
Pustynia 84F
39-200 Dębica
Tel.: +48 14 680 32 00
{marketing authorisation holder's logo}