Acidum folicum Hasco

Package Leaflet: Information for the Patient

ACIDUM FOLICUM HASCO

5 mg, tablets

Folic acid hydrate

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is ACIDUM FOLICUM HASCO and what is it 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 is ACIDUM FOLICUM HASCO and what is it 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 fetal tissues, the epithelium of the digestive tract, and the hematopoietic system.
ACIDUM FOLICUM HASCO is used prophylactically and therapeutically in states of folic acid deficiency:

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

2. Important information before taking ACIDUM FOLICUM HASCO

When not to take ACIDUM FOLICUM HASCO:

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

Warnings and precautions

Before starting treatment with ACIDUM FOLICUM HASCO, discuss it with your doctor, pharmacist, or nurse.
Except during pregnancy, 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 neurological symptoms continue to develop.

ACIDUM FOLICUM HASCO and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or 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 antiepileptic drugs derived from hydantoin.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Pregnancy
The medicine can be used in pregnant women only with the doctor's consent.
Breastfeeding
The medicine can be used in breastfeeding women only with the doctor's consent.

Driving and using machines

The medicine does not impair psychophysical abilities, the ability to drive vehicles, or operate machinery.

ACIDUM FOLICUM HASCO contains lactose

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take ACIDUM FOLICUM HASCO

Take this medicine always as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Folic acid is taken orally

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

Taking a higher dose of ACIDUM FOLICUM HASCO than recommended

As a result of taking high doses, sleep disorders, irritability, overexcitement, malaise, excessive activity, accelerated breathing, nausea, bloating, and zinc absorption disorders may occur.

Missing a dose of ACIDUM FOLICUM HASCO

Do not take a double dose 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 not known.
Reporting side effects
If you experience any side effects, including any possible side effects not listed in this leaflet, please inform your doctor, pharmacist, or nurse. 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
Aleje Jerozolimskie 181C, 02-222 Warsaw
tel.: 22 49 21 301, fax: 22 49 21 309
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ACIDUM FOLICUM HASCO

Store in the original package, 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 package. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What ACIDUM FOLICUM HASCO contains

• The active substance of the medicine is folic acid hydrate. One tablet contains 5 mg of folic acid hydrate.
• The other ingredients (excipients) are: lactose monohydrate, microcrystalline cellulose, povidone, sodium carboxymethylcellulose, magnesium stearate, anhydrous colloidal silica.

What ACIDUM FOLICUM HASCO looks like and contents of the pack

Tablets are round, flat on both sides with a beveled edge, yellow in color, and have a smooth uniform surface. One package of the medicine contains 30, 60, or 90 tablets.

Marketing authorization holder and manufacturer

"HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242E
Information about the medicine
tel.: 22 742 00 22
e-mail: informacjaoleku@hasco-lek.pl
Date of last revision of the leaflet:04.2020