FOLIC ACID QUALIGEN 5 mg TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Folic Acid Qualigen 5 mg tablets

• Read the entire leaflet carefully before starting to use this medicine, as it contains important information for you.
• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the package leaflet:

1. What Folic Acid Qualigen is and what it is used for.
2. What you need to know before taking Folic Acid Qualigen.
3. How to take Folic Acid Qualigen.
4. Possible side effects.
5. Storage of Folic Acid Qualigen.
6. Contents of the pack and further information

1. What Folic Acid Qualigen is and what it is used for

Folic Acid Qualigen 5 mg tablets belong to a group of medicines called antianemic preparations and are indicated for:

• Prevention and treatment of folic acid deficiency in pregnant women as a prevention of neural tube defects (spina bifida, anencephaly, encephalocele) and other congenital defects, especially in women with a history of a child or fetus with these defects in the neural tube, during the four weeks prior to conception and the first three months of gestation.
• Treatment of folic acid deficiency that occurs in processes such as megaloblastic anemia, alcoholism, malabsorption syndromes.

2. Before taking Folic Acid Qualigen

Do not take Folic Acid Qualigen

• if you are allergic to the active substance or to any of the components of Folic Acid Qualigen.
• in high doses if you have megaloblastic anemia (a disorder caused by a lack of vitamin B12).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Folic Acid Qualigen:

• if you have anemia of unknown origin.

Other medicines and Folic Acid Qualigen

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medicines.

Folic acid may interact with folic acid antagonists (methotrexate, sulfonamides, trimethoprim, pyrimethamine, aminopterin), antiepileptics, zinc supplements, antacids, cholestyramine, colestipol, triamterene, antimalarials, oral contraceptives, sulfasalazine, antituberculars, corticosteroids (prolonged use), and alcohol.

The simultaneous administration of folic acid or chloramphenicol in patients with folate deficiency may reduce the response to folic acid treatment.

The need for folic acid may increase if you are taking any of these medicines.

Interference with diagnostic tests

The administration of large and continuous doses of folic acid may reduce the concentration of vitamin B12 in the blood.

Pregnancy and breastfeeding

Folic acid can be used safely during pregnancy and breastfeeding.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

No effects on the ability to drive vehicles and use machinery have been described.

Folic Acid Qualigen contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

3. How to take Folic Acid Qualigen

Follow exactly the administration instructions of Folic Acid Qualigen indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Folic acid is administered orally, preferably before meals. The normal dose is:

• Treatments for deficiency states: 1 to 3 tablets daily (5-15 mg of folic acid) in 1-2 doses per day.
• For the treatment of megaloblastic anemia (folate deficiency), a dose of 5 mg/day is recommended for 4 months; up to 15 mg may be necessary in cases of poor absorption.
• Prevention of neural tube defects: 1 tablet per day for four weeks before conception and the first three months of gestation.

If you take more Folic Acid Qualigen than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service. Tel.: 91.562.04.20, indicating the medicine and the amount ingested.

However, Folic Acid Qualigen, at usual doses, is well tolerated by the body, and there is no possibility of acute, chronic, or accidental intoxication.

If you forget to take Folic Acid Qualigen

Do not take a double dose to make up for forgotten doses.

If you stop taking Folic Acid Qualigen

Your doctor will indicate the duration of the treatment.

Do not suspend your treatment before, as it will not have the expected efficacy.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Folic Acid Qualigen can have side effects, although not everyone gets them.

The following side effects have been observed, which are classified by organs and systems and by frequencies. The frequencies are defined as rare (may affect up to 1 in 1,000 patients) or unknown frequency (cannot be estimated from the available data):

Immune system disorders

Rare: Hypersensitivity reactions (allergy), such as skin erythema, itching (pruritus), and in more severe cases, difficulty breathing associated with bronchospasm.

Unknown: Severe allergic reaction (anaphylactic reaction).

Gastrointestinal disorders

Rare: Gastrointestinal disorders, such as diarrhea, nausea, and/or vomiting.

If you consider that any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Folic Acid Qualigen

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Folic Acid Qualigen:

• The active substance is folic acid. Each tablet contains 5 mg of folic acid as folic acid hydrate.
• The other components are hydroxypropylcellulose (E 463), croscarmellose sodium, microcrystalline cellulose (E 460i), colloidal anhydrous silica, and stearic acid.

Appearance of the product and contents of the pack

Folic Acid Qualigen is presented in the form of orange-yellow, round, beveled, and convex tablets, marked with a "5" on one face and with a score line on the other.

Folic Acid Qualigen is available in Al/PVC/PVDC blisters. The packs contain 28 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Manufacturer

SANTA SA

Str. Panselelor nr. 25, nr. 27, nr. 29

Brasov, jud. Brasov, cod 500419

Romania

Date of the last revision of this leaflet: April 2019

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) (http://www.aemps.gob.es/).