Folic acid hasco

Patient Information Leaflet

ACIDUM FOLICUM HASCO
5 mg, tablets
Acidum folicum hydricum
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are similar.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

1. What ACIDUM FOLICUM HASCO is and what it is used for
2. Important information before taking ACIDUM FOLICUM HASCO
3. How to take ACIDUM FOLICUM HASCO
4. Possible side effects
5. How to store ACIDUM FOLICUM HASCO
6. Contents of the pack and other information

1. What ACIDUM FOLICUM HASCO is and what it is used for

The medicine 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 reproductive tissues, gastrointestinal mucosa, and the hematopoietic system.
ACIDUM FOLICUM HASCO is used prophylactically and therapeutically in conditions of folic acid deficiency:

• in megaloblastic anemia
• in intestinal malabsorption disorders, sprue
• in malnutrition, alcoholism, psoriasis
• in patients taking anticonvulsants or oral contraceptives
• in patients taking antibacterial drugs
• in diseases associated with chronic hemolysis (thalassemia, sickle cell anemia) and during long-term dialysis
• in secondary prevention of congenital neural tube defects (in women at increased risk of neural tube defects in their offspring, one month before planned pregnancy and during the first 3 months of pregnancy).

2. Important information before using the medicinal product ACIDUM FOLICUM HASCO

When not to use ACIDUM FOLICUM HASCO:

• if the patient is allergic to the active substance or to any of the other components of this medicinal product (listed in section 6).

Warnings and precautions
Before starting treatment with ACIDUM FOLICUM HASCO, please discuss this with your doctor,
pharmacist, or nurse.
Except during pregnancy, folic acid should not be administered in doses exceeding 0.4 mg per day
without first excluding megaloblastic anaemia caused by vitamin B deficiency, as it may alleviate haematological symptoms while allowing neurological symptoms to progress.

ACIDUM FOLICUM HASCO and other medicinal products
You must inform your doctor or pharmacist about all medicinal products you are currently taking or have recently taken, as well as any you plan to take.
Antiepileptic drugs, oral contraceptives, antituberculosis drugs, alcohol, and folic acid antagonists such as aminopterin, methotrexate, pyrimethamine, trimethoprim, and sulfonamides (including sulfasalazine) increase the requirement for folic acid.
Folic acid may reduce the effectiveness of anticonvulsant drugs of the hydantoin derivatives.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicinal product.
Pregnancy
This medicinal product may be used in pregnant women only under medical supervision.
Breastfeeding
This medicinal product may be used in breastfeeding women only under medical supervision.

Driving and operating machinery
This medicinal product does not impair psycho-physical performance, or the ability to drive vehicles or operate machinery.

ACIDUM FOLICUM HASCO contains lactose
If the patient has previously been diagnosed with an intolerance to certain sugars, the patient should consult their doctor before taking this medicinal product.

3. How to use ACIDUM FOLICUM HASCO

This medicine should always be taken according to the doctor's or pharmacist's instructions. In case of doubt, consult a doctor or pharmacist.
Folic acid is administered orally:

• in megaloblastic anemia (always in combination with vitamin B₁₂): 5 mg daily for 4 months
• in malabsorption states: 15 mg daily
• in chronic hemolytic conditions (thalassemia, sickle cell anemia): 5 mg every 1 to 7 days for one month; similar doses are used in patients undergoing hemodialysis to prevent folate deficiency
• during pregnancy and the period preceding conception in women at increased risk of neural tube defects in their offspring: 5 mg daily for one month before planned conception, continuing throughout the first trimester of pregnancy.

Use of a higher than recommended dose of ACIDUM FOLICUM HASCO
When high doses are used, sleep disturbances, irritability, hyperexcitability, malaise, excessive activity, rapid breathing, nausea, bloating, and impaired zinc absorption may occur.
Missed dose of ACIDUM FOLICUM HASCO
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Folic acid is well tolerated. In rare cases, gastrointestinal disturbances or allergic reactions (rash, redness, itching) may occur.
Severe allergic reaction (anaphylactic reaction) – frequency not known.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Aleje Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301, Fax: +48 22 49 21 309
Email: [email protected]

Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store ACIDUM FOLICUM HASCO

Keep in the original packaging, at a temperature below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What ACIDUM FOLICUM HASCO contains

• The active substance is folic acid monohydrate. Each tablet contains 5 mg of folic acid monohydrate.
• The other components (excipients) are: monohydrate lactose, microcrystalline cellulose, povidone, sodium carboxymethyl starch, magnesium stearate, colloidal anhydrous silica.

What ACIDUM FOLICUM HASCO looks like and contents of the pack
Round, biconvex tablets with bevelled edges, yellow in colour and with a smooth, uniform surface.
One pack contains 30, 60 or 90 tablets.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242E
Information on the medicinal product
tel.: 22 742 00 22
e-mail: [email protected]