FOLIC ACID LORIEN 5 mg TABLETS

Introduction

Leaflet: information for the patient

Folic Acid Lorien 5 mg tablets

folic acid

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• 1. If you have any doubts, consult your doctor, pharmacist, or nurse.

• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
  • If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Folic Acid Lorien 5 mg tablets are and what they are used for
2. What you need to know before taking Folic Acid Lorien 5 mg tablets
3. How to take Folic Acid Lorien 5 mg tablets
4. Possible side effects
5. Storage of Folic Acid Lorien 5 mg tablets

Contents of the package and additional information

1. What Folic Acid Lorien 5 mg tablets are and what they are used for

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

• Prevention and treatment of folic acid deficiency in pregnant women to prevent 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, and malabsorption syndromes.

2. What you need to know before taking Folic Acid Lorien 5 mg tablets

Do not take Folic Acid Lorien 5 mg tablets

• if you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).

• 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 Lorien 5 mg tablets:

• if you have anemia of unknown origin

Other medications and Folic Acid Lorien 5 mg tablets

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

Folic Acid Lorien 5 mg tablets may interact with folic acid antagonists (methotrexate, sulfonamides, trimethoprim, pyrimethamine, aminopterin), antiepileptics, zinc supplements, antacids, cholestyramine, colestipol, triamterene, antimalarials, oral contraceptives, sulfasalazine, antitubercular agents, 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 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.

Pregnancy and breastfeeding

Folic acid can be used safely during pregnancy and breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and using machines

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

Folic Acid Lorien 5 mg tablets contain lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Folic Acid Lorien 5 mg tablets contain sodium

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

3. How to take Folic Acid Lorien 5 mg tablets

Follow the administration instructions for this medication exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Folic Acid Lorien 5 mg tablets are administered orally, preferably before meals.

The recommended 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 Lorien 5 mg tablets 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 medication and the amount ingested.

However, Folic Acid Lorien 5 mg tablets, at usual doses, are well tolerated by the body, and there is no possibility of acute, chronic, or accidental intoxication.

If you forget to take Folic Acid Lorien 5 mg tablets

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

If you interrupt treatment with Folic Acid Lorien 5 mg tablets

Your doctor will indicate the duration of treatment.

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

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

4. Possible side effects

Like all medications, Folic Acid Lorien 5 mg tablets can cause side effects, although not everyone will experience them.

The following side effects have been observed, which are classified by organs and systems and by frequencies. The frequencies are defined as rare (less than 1 in 10,000 patients) or unknown frequency (cannot be estimated from the available data):

Immune system disorders:

Rare: Hypersensitivity reactions (allergy), such as skin erythema, pruritus, and in more severe cases, difficulty breathing 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 side effects you are experiencing is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting 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 Medication Monitoring System (http://www.notificaRAM.es). By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Folic Acid Lorien 5 mg tablets

Keep this medication out of sight and reach of children.

Store in the outer packaging to protect it from light.

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

Medications should not be thrown away in drains or trash. Deposit the packaging and medications you no longer need in the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the package and additional information

Composition of Folic Acid Lorien 5 mg tablets:

• The active ingredient is folic acid. Each tablet contains 5 mg of folic acid.
  • The other components are microcrystalline cellulose, lactose, sodium carboxymethylcellulose type A, and stearic acid.

Appearance of the product and contents of the package

Folic Acid Lorien 5 mg tablets are presented in the form of circular tablets, yellow in color with spots, with a score line on one face for oral administration in packages of 30 tablets. The score line should not be used to split the tablet.

Marketing authorization holder and manufacturer

Laboratorios Lorien, S.L.

Av. Josep Tarradellas, 8, Ático 1ª 08029 Barcelona

Spain

Manufacturer

Instituto Universitario de Ciencia y Tecnología, S.A.

C/ Álvarez de Castro, 63

08100 Mollet del Vallès

Spain

Date of the last revision of this leaflet: November 2021

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