Acidum folicum richter

Patient Information Leaflet

Acidum Folicum Richter, 5 mg, tablets
Acidum Folicum Richter, 15 mg, tablets
Acidum folicum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

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

Table of contents

1. What Acidum Folicum Richter is and what it is used for
2. What you need to know before taking Acidum Folicum Richter
3. How to take Acidum Folicum Richter
4. Possible side effects
5. How to store Acidum Folicum Richter
6. Contents of the pack and other information

1. What Acidum Folicum Richter is and what it is used for

Acidum Folicum Richter contains folic acid, a member of the B group of vitamins.
This vitamin is particularly important for the normal formation of blood cells in the bone marrow.
Folic acid deficiency may manifest, among others, as anemia.
Pregnant and breastfeeding women, chronically ill patients, and individuals with alcohol-related disorders have an increased requirement for folic acid. Meeting this increased demand solely through diet is practically impossible.

Indications for Acidum Folicum Richter

Prophylaxis and treatment of folic acid deficiency in the following conditions and diseases:

• Chronic blood disorders associated with massive destruction of red blood cells (thalassemias, sickle cell anemia, malaria);
• Megaloblastic anemia (a type of anemia);
• Chronic malnutrition, alcoholism;
• In patients undergoing dialysis and in patients taking certain medications (barbiturates, primidone, cyclosporine, sulfasalazine, trimethoprim);
• In women using oral contraceptives.

2. What you need to know before taking Acidum Folicum Richter

When not to take Acidum Folicum Richter

• If you are allergic to folic acid or any of the other ingredients of this medicine (listed in section 6). Allergic reactions may include rash, itching, swelling of the face, lips, tongue, or difficulty breathing (if such symptoms occur, contact your doctor immediately);
• If you have certain malignant diseases (your doctor will decide whether this medicine should be used in case of cancer).

Warnings and precautions

Before starting treatment with Acidum Folicum Richter, discuss it with your doctor.
Regular blood tests should be performed periodically to assess the effectiveness of treatment.

If megaloblastic anemia has been diagnosed

In megaloblastic anemia due to vitamin B_{12} deficiency (including pernicious anemia), folic acid should be used with caution and vitamin B_{12} should be administered simultaneously. Folic acid used in such cases, especially in high doses and without vitamin B_{12}, may lead to partial improvement in blood test results, but may worsen neurological symptoms. For this reason, it is essential that the underlying cause of megaloblastic anemia is accurately diagnosed by a doctor.

If epilepsy has been diagnosed

If you are taking anticonvulsant medications together with folic acid, regular monitoring of blood levels of these drugs is recommended. There is a risk of decreased blood concentration of anticonvulsants, potentially leading to seizures. To prevent this, a dose adjustment of the anticonvulsant may be necessary.

Please consult your doctor, even if the above warnings relate to conditions you had in the past.

Acidum Folicum Richter and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.

If Acidum Folicum Richter is taken at the same time as: oral contraceptives (containing estrogens), anti-tuberculosis drugs, alcohol, and ion-exchange resins used in lipid metabolism disorders (diseases with excess fats in the blood)

• These medicines may reduce the effectiveness of folic acid.

If Acidum Folicum Richter is taken at the same time as: medicines known as folic acid antagonists (sulfonamides, trimethoprim, pyrimethamine, sulfasalazine) and anticancer drugs (methotrexate)

• These medicines may also reduce the effectiveness of folic acid, but through a different mechanism.

If Acidum Folicum Richter is taken at the same time as: anticonvulsant medicines (phenobarbital, phenytoin, primidone)

• Folic acid may reduce their effectiveness, leading to recurrence of seizures.

Acidum Folicum Richter with food and drink

The type of food consumed does not affect the absorption of the medicine.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before taking this medicine.
Folic acid may be used during pregnancy.
Women taking folic acid may breastfeed.

Driving and using machines

Acidum Folicum Richter has no effect on the ability to drive or operate machinery.

3. How to use Acidum Folicum Richter

This medicine should always be used as directed by the physician. In case of doubts, consult your
doctor.
Use in adult patients:
The usual dose of Acidum Folicum Richter is:
10 mg to 45 mg of folic acid per day (from 2 tablets of 5 mg to 3
tablets of 15 mg).
In megaloblastic anemia:
10 mg to 20 mg of folic acid per day for 14 to 21 days, until improvement in blood tests is observed,
followed by maintenance doses of up to 10 mg of folic acid per day.
In hemolytic anemia:
5 mg per day or once weekly, depending on diet and severity of red blood cell breakdown.
Use in children:
In children, folic acid is usually administered in a daily dose of 5 mg to 15 mg, depending on
the indication.
Treatment duration:
The duration of treatment is determined based on the patient's response to therapy and laboratory
test results.
Method of administration:
Tablets should preferably be taken during meals, swallowed whole. Daily doses exceeding
15 mg should be taken in 2–3 divided doses, at equal intervals throughout the
day.
If you feel that the effect of Acidum Folicum Richter is too strong or too weak, consult your doctor.
Taking more than the recommended dose of Acidum Folicum Richter
If more than the recommended dose of the medicine is taken, contact your doctor immediately
or go to the hospital. Show the doctor the medicine packaging with the tablets.
Missed dose of Acidum Folicum Richter
If a dose has been missed, take the next prescribed dose at the scheduled time.
Do not take a double dose to make up for a missed dose.
Stopping treatment with Acidum Folicum Richter
Do not stop treatment without consulting your doctor, even if the patient feels better.
If you have any further doubts regarding the use of this medicine, consult your
doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Acidum Folicum Richter is well tolerated. It rarely causes adverse reactions, and these are usually
mild. The most commonly occurring adverse reactions are skin allergic reactions. However, very
rarely, severe allergic reactions such as angioedema or bronchospasm may occur.
The occurrence of severe adverse symptoms may require immediate medical attention and hospital treatment.
Uncommon: may occur in up to 1 in 100 people

• Allergic skin 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,
• bronchospasm.

Frequency not known: cannot be estimated from the available data

• severe allergic reaction (anaphylactic reaction)

If any of the above very rare and serious adverse reactions marked with a line occur,
discontinue use of the medicine immediately and
contact a doctor or go to hospital

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 of 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 directly to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Acidum Folicum Richter

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box.
Do not store above 25°C.
Store in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Acidum Folicum Richter contains

• The active substance is folic acid.
• The other ingredients are: microcrystalline cellulose, maize starch, magnesium stearate, anhydrous calcium hydrogen phosphate, colloidal anhydrous silicon dioxide.

What Acidum Folicum Richter looks like and contents of the pack
The tablets are light yellow in colour, with a marbled surface, round and flat, embossed with the marking "5" or "15" on one side, depending on the amount of folic acid in the tablet.
The packaging of Acidum Folicum Richter contains 30 tablets.

Marketing Authorisation Holder and Manufacturer
GEDEON RICHTER POLSKA Sp. z o.o.
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland
Tel.: +48 (22) 755 50 81

For further information about this medicinal product, please contact:
GEDEON RICHTER POLSKA Sp. z o.o.
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Tel. +48 (22) 755 96 48
[email protected]

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