Acidum folicum Rihter

Leaflet attached to the packaging: information for the user

Acidum Folicum Richter, 5 mg, tablets

Acidum Folicum Richter, 15 mg, tablets

(Acidum folicum)

Read the leaflet carefully before using the medicine, as it contains

important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Acidum Folicum Richter and what is it used for
• 2. Important information before using Acidum Folicum Richter
• 3. How to use Acidum Folicum Richter
• 4. Possible side effects
• 5. How to store Acidum Folicum Richter
• 6. Contents of the packaging and other information

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

Acidum Folicum Richter contains folic acid, which belongs to the group of B vitamins.
This vitamin is particularly important for the proper formation of blood cells in the bone marrow.
A deficiency of folic acid may manifest as anemia, among other things.
Pregnant and breastfeeding women, people with chronic diseases, and people with alcoholism have an increased need for folic acid. Meeting this increased need solely through diet is practically impossible.

Indications for using Acidum Folicum Richter

Prevention and treatment of folic acid deficiency in the body, in the following conditions and diseases:

• chronic blood diseases associated with massive breakdown of red blood cells (thalassemia, sickle cell anemia, malaria);
• megaloblastic anemia (one form 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. Important information before using Acidum Folicum Richter

When not to use Acidum Folicum Richter

• if the patient is allergic to folic acid or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may manifest as a rash, itching, swelling of the face, lips, tongue, or difficulty breathing (if such symptoms occur, the doctor should be consulted);
• if the patient has certain types of cancer (the use of the medicine in patients with cancer is decided by the doctor).

Warnings and precautions

Before starting to use Acidum Folicum Richter, the doctor should be consulted.
Periodic blood tests should be performed to assess the effectiveness of the treatment.
If the patient has been diagnosed with megaloblastic anemia
In the case of megaloblastic anemia associated with a deficiency of vitamin B (including the type called pernicious anemia), folic acid should be used with caution and vitamin B should be taken at the same time. Folic acid used in this case, especially in high doses and without vitamin B, may provide partial improvement in blood tests but may worsen neurological symptoms. Therefore, in the case of megaloblastic anemia, it is very important for the doctor to determine the cause of the disease.
If the patient has been diagnosed with epilepsy
If the patient is taking antiepileptic drugs at the same time as folic acid, it is recommended to regularly measure the concentration of these drugs in the blood. There is a risk of decreased concentration of antiepileptic drugs in the blood and the occurrence of epileptic seizures. To avoid this, it may be necessary to increase the dose of these drugs.
The doctor should be consulted, even if the above warnings refer to situations that have occurred in the past.

Acidum Folicum Richter and other medicines

The doctor or pharmacist should be informed about all medicines currently or recently taken by the patient, as well as any medicines that the patient plans to take.
If Acidum Folicum Richter is administered at the same time as:

• -oral contraceptives (containing estrogens), anti-tuberculosis drugs, alcohol, and ion exchange resins used in diseases with an excess of lipids (fats) in the blood
• these medicines may reduce the effectiveness of folic acid.

If Acidum Folicum Richter is administered 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 administered at the same time as:

• -antiepileptic drugs (phenobarbital, phenytoin, primidone)
• folic acid may reduce their effectiveness, leading to a 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 the patient is pregnant or breastfeeding, suspects that she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.
Folic acid may be used during pregnancy.
Women taking folic acid may breastfeed.

Driving and operating machinery

Acidum Folicum Richter does not affect the ability to drive and operate machinery.

3. How to use Acidum Folicum Richter

This medicine should always be used in accordance with the doctor's recommendations. In case of doubts, the doctor should be consulted.
Use in adult patients:
Usually, the recommended dose of Acidum Folicum Richter is:
10 mg to 45 mg per day (from 2 tablets of 5 mg to 3 tablets of 15 mg).
In megaloblastic anemia:
10 mg to 20 mg per day for 14 to 21 days, until improvement is seen in blood tests, then maintenance doses of up to 10 mg per day.
In hemolytic anemia:
5 mg per day or once a week, depending on the diet and the severity of red blood cell breakdown.
Use in children:
Children usually take folic acid in a daily dose of 5 mg to 15 mg, depending on the indications.
Duration of treatment:
The duration of treatment is determined based on the patient's response and laboratory test results.
Method of administration:
Tablets are best taken during a meal, swallowed whole. Daily doses greater than 15 mg should be divided into 2-3 parts and taken at equal intervals throughout the day.
If it feels like the effect of Acidum Folicum Richter is too strong or too weak, the doctor should be consulted.

Using a higher dose of Acidum Folicum Richter than recommended

In case of using a much higher dose of the medicine than recommended, the doctor or hospital should be contacted immediately. The doctor should be shown the packaging of the tablets.

Missing a dose of Acidum Folicum Richter

If a dose of the medicine is missed, the next scheduled dose should be taken at the scheduled time. A double dose should not be taken to make up for the missed dose.

Stopping the use of Acidum Folicum Richter

Treatment should not be stopped without consulting the doctor, even if the patient feels better.
In case of any further doubts about the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although they may not occur in everyone.
Acidum Folicum Richter is well tolerated. It rarely causes side effects, and they are usually mild. The most common side effects are skin allergic reactions. However, very rare and severe side effects, such as angioedema or bronchospasm, may occur.
The occurrence of severe side effects may require immediate medical attention and hospital treatment.
If the following side effects are mentioned as occurring: very common - this means that they occur in at least 1 in 10 patients; common - at least 1 in 100, but less than 1 in 10; uncommon - at least 1 in 1,000, but less than 1 in 100; rare - at least 1 in 10,000, but less than 1 in 1,000, and very rare - less than 1 in 10,000, including single cases, frequency not known (cannot be estimated based on available data).

Uncommon side effects include:
Immune system disorders-
skin allergic reactions (rash, itching)
Rare side effects include:
Gastrointestinal disorders-
bitter taste in the mouth, bloating, nausea, vomiting, diarrhea
Psychiatric disorders-
loss of appetite, difficulty sleeping, drowsiness, excessive nervous excitability, depression
Very rare side effects include:
Immune system disorders -
angioedema, bronchospasm
Frequency not known:
Immune system disorders-severe allergic reaction (anaphylactic reaction)

In case of occurrence of any of the above very rare and severe side effects, the use of the medicine should be stopped immediately and the doctor or hospital should be contacted

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. 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
Al. 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Acidum Folicum Richter

The medicine should be stored in a place that is out of sight and reach of children.
The medicine should not be used after the expiry date stated on the carton.
The medicine should not be stored at a temperature above 25°C.
The medicine should be stored in its original packaging to protect it from light.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Acidum Folicum Richter contains

• The active substance of the medicine is folic acid.
• The other ingredients are: microcrystalline cellulose, corn starch, magnesium stearate, calcium phosphate anhydrous, colloidal silica anhydrous.

What Acidum Folicum Richter looks like and what the packaging contains

The tablets are light yellow in color, with a marbled surface, round, flat, with the inscription "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 authorization 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
To obtain more detailed 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
lekalert@grodzisk.rgnet.org
fax: +48 (22) 755 96 24

Date of last update of the leaflet:

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