Folic acid Qualigen 5 mg tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Folic Acid Qualigen 5 mg tablets
- Read the entire leaflet carefully before you start using this medicine, as 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 and must not be given to other people, even if they have the same symptoms, as it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Folic Acid Qualigen is and what it is used for.
- What you need to know before taking Folic Acid Qualigen.
- How to take Folic Acid Qualigen.
- Possible side effects.
- How to store Folic Acid Qualigen.
- Contents of the pack and other information.
1. What is Folic Acid Qualigen and what is it used for
Folic Acid Qualigen 5 mg tablets belong to a group of medicines called antianaemic preparations and is indicated for:
- Prevention and treatment of folic acid deficiency in pregnant women for the 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 neural tube defects, during four weeks before conception and the first three months of pregnancy.
- Treatment of folic acid deficiency occurring in conditions such as megaloblastic anaemias, 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 vitamin B12 deficiency).
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:
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.
Folic Acid may interact with folic acid antagonists (methotrexate, sulfonamides, trimethoprim, pyrimethamine, aminopterin), antiepileptics, zinc supplements, antacids, cholestyramine, colestipol, triamterene, antimalarials, oral contraceptives, sulfasalazine, antituberculosis agents, corticosteroids (long-term use), and alcohol.
Concomitant administration of folic acid or chloramphenicol in patients with folate deficiency may reduce the response to folic acid treatment.
The requirement for folic acid may increase if you are taking any of these medicines.
Interference with diagnostic tests:
Administration of large and continuous doses of folic acid may reduce blood vitamin B12 concentrations.
Pregnancy and breastfeeding
Folic acid may be safely used during pregnancy and breastfeeding.
Consult your doctor or pharmacist before using any medicine.
Driving and using machines
No effects on the ability to drive or operate machinery have been reported.
Folic Acid Qualigen contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; i.e., essentially "sodium-free".
3. How to take Folic Acid Qualigen
Follow exactly the instructions for administration of Folic Acid Qualigen provided by your doctor. If in doubt, consult your doctor or pharmacist again.
Folic Acid is administered orally, preferably before meals. The usual dosage is:
- Treatment of deficiency states: 1 to 3 tablets daily (5–15 mg folic acid) in 1–2 divided doses per day.
- For treatment of megaloblastic anemia (folate deficiency): a dose of 5 mg/day for 4 months is recommended; up to 15 mg may be required in cases of impaired absorption.
- Prevention of neural tube defects: 1 tablet daily for four weeks before conception and during the first three months of pregnancy.
If you take more Folic Acid Qualigen than you should:
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91.562.04.20, indicating the medication and amount ingested.
However, Folic Acid Qualigen is generally well tolerated by the body at usual doses, with no risk of acute, chronic, or accidental intoxication.
If you forget to take Folic Acid Qualigen:
Do not take a double dose to make up for missed doses.
If you stop taking Folic Acid Qualigen:
Your doctor will determine the duration of treatment.
Do not discontinue treatment prematurely, as it may not achieve the intended effectiveness.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Ácido Fólico Qualigen may have adverse effects, although not everyone experiences them.
The following adverse effects have been observed, classified by organ systems and frequencies. Frequencies are defined as rare (may affect up to 1 in 1,000 patients) or frequency not known (cannot be estimated from available data):
Immune system disorders:
Rare: Hypersensitivity reactions (allergy), such as skin erythema, itching (pruritus), and in more severe cases, breathing difficulty associated with bronchospasm.
Not known: Severe allergic reaction (anaphylactic reaction).
Gastrointestinal disorders:
Rare: Gastrointestinal disturbances such as diarrhea, nausea and/or vomiting.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide 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 expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Ácido Fólico 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), sodium croscarmellose, microcrystalline cellulose (E 460i), anhydrous colloidal silica, and stearic acid.
Appearance of the product and contents of the pack:
Ácido Fólico Qualigen is presented as orange-yellow, round, convex tablets, marked with a "5" on one side and a score line on the other.
Ácido Fólico 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
KeVaRo GROUP EOOD
Floor 5, Ulitsa Tsaritsa Eleonora 9 Office 23
Sofia, 1618
Bulgaria
Date of the most recent revision of this leaflet: April 2019
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).