Acidum folicum Rihter

Package Leaflet: Information for the User

Acidum Folicum Richter, 5 mg, tablets

Acidum Folicum Richter, 15 mg, tablets

(Acidum folicum)

Read the package leaflet carefully before taking the medicine, as it contains

important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Package Leaflet Contents:

• 1. What is Acidum Folicum Richter and what is it used for
• 2. Important information before taking Acidum Folicum Richter
• 3. How to take Acidum Folicum Richter
• 4. Possible side effects
• 5. How to store Acidum Folicum Richter
• 6. Package contents 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 itself, among other things, as anemia.
Pregnant and breastfeeding women, people with chronic diseases, and people with alcoholism have an increased
need for folic acid. Meeting the increased demand solely through diet is practically impossible.

Indications for the use of 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 taking oral contraceptives.

2. Important information before taking Acidum Folicum Richter

When not to take Acidum Folicum Richter

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

Warnings and precautions

Before starting treatment with Acidum Folicum Richter, you should discuss it with your doctor.
Periodic blood tests should be performed to assess the effectiveness of the treatment.
If you have been diagnosed with megaloblastic anemia
In the case of megaloblastic anemia associated with vitamin B deficiency (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 to determine the cause of the disease by the doctor.
If you have been diagnosed with epilepsy
If you are 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.
You should talk to your doctor, even if the above warnings apply to situations that have occurred in the past.

Acidum Folicum Richter and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
If Acidum Folicum Richter is administered at the same time:

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

If Acidum Folicum Richter is administered at the same time:

• -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, but through a different mechanism.

If Acidum Folicum Richter is administered at the same time:

• -with antiepileptic drugs (phenobarbital, phenytoin, primidone)
• folic acid may reduce their effectiveness, leading to the 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 or breastfeeding, think you may be pregnant, or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Folic acid may be used during pregnancy.
Women taking folic acid can breastfeed.

Driving and using machines

Acidum Folicum Richter does not affect the ability to drive and use machines.

3. How to take Acidum Folicum Richter

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.
Administration in adults:
Usually, the 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.
Administration 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 meals, swallowed whole. Daily doses greater than 15 mg should be divided into 2-3 parts and taken at equal intervals throughout the day.
If you feel that the effect of Acidum Folicum Richter is too strong or too weak, you should consult your doctor.

Overdose of Acidum Folicum Richter

If you have taken much more than the recommended dose of the medicine, you should immediately contact your doctor or go to the hospital. You should show the doctor the package with the tablets.

Missed dose of Acidum Folicum Richter

If you have missed a dose, you should take the next scheduled dose at the scheduled time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Acidum Folicum Richter

Do not stop treatment without consulting your doctor, even if you feel better.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Acidum Folicum Richter is well tolerated. It rarely causes side effects and usually, they are mild. The most common side effects are skin allergic reactions. However, very rare and severe side effects may occur, such as angioedema or bronchospasm.
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 1000, but less than 1 in 100; rare - at least 1 in 10,000, but less than 1 in 1000, and very rare - less than 1 in 10,000, including single cases, frequency not known (cannot be estimated from 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, you should immediately stop taking the medicine and contact your doctor or go to the hospital

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 to gather more information on the safety of the medicine.

5. How to store Acidum Folicum Richter

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton.
Do not store above 25°C.
Store in the original package to protect from light.
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. Package contents and other information

What Acidum Folicum Richter contains

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

What Acidum Folicum Richter looks like and contents of the package

Light yellow tablets 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 package 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 revision of the package leaflet:

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