PATIENT INFORMATION LEAFLET

Folic Acid Qualigen 5 mg Tablets

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

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

2.What you need to know before starting to take 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 additional information

Folic Acid Qualigen 5 mg tabletsbelongs to a group of medicines called antianemic preparations and is indicated for:

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

Do not take Qualigen Folic Acid

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

Warnings and precautions

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

-if you have anemia of unknown origin

Other medications and Qualigen Folic Acid:

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Qualigen 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, long-term corticosteroids, and alcohol.

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

The needs for folic acid may increase if you are taking any of those medications.

Interference with diagnostic tests:

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

Pregnancyand breastfeeding

Qualigen Folic Acid can be used safely during pregnancy and breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

Qualigen Folic Acid contains sodium

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

Follow exactly the administration instructions for Qualigen Folic Acid as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

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

- 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 5mg/day for 4 months is recommended; 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 pregnancy.

If you take more Qualigen Folic Acid than you should:

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

However, Qualigen Folic Acid is well tolerated at usual doses, with no possibility of acute, chronic, or accidental poisoning.

If you forgot to take Qualigen Folic Acid:

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Qualigen Folic Acid:

Your doctor will indicate the duration of treatment.

Do not discontinue treatment prematurely, as this will not provide the expected efficacy.

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

Like all medications, Qualigen Folic Acid may have adverse effects, although not everyone will experience them.

The following adverse effects have been observed, classified by organ and system and by frequency. Frequencies are defined as rare (may affect up to 1 in 1,000 patients) or unknown frequency (cannot be estimated from available data):

Immune System Disorders:

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

Unknown: Severe allergic reaction (anaphylactic reaction).

Gastrointestinal Disorders:

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

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication

Keep this medication out of the sight and reach of children

No special storage conditions are required.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointofthe pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Qualigen Folic Acid:

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

Appearance of the product and contents of the packaging:

Qualigen Folic Acid is presented in the form of yellow-orange, round, bisected, and convex tablets, marked with a “5” on one face and with a groove on the other.

Qualigen Folic Acid is available in Al/PVC/PVDC blister packaging. The packaging contains 28 tablets.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Responsible for manufacturing:

SANTA SA

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

Brasov, jud. Brasov, cod 500419

Romania

Last review date of this leaflet: April 2019

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).