FOLIC ACID ARISTO 5 mg TABLETS

Introduction

Patient Information Leaflet

Aristo Folic Acid 5 mg Tablets

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.
• If you have any questions, consult your doctor or pharmacist.
• 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Leaflet

1. What Aristo Folic Acid is and what it is used for
2. What you need to know before taking Aristo Folic Acid
3. How to take Aristo Folic Acid
4. Possible side effects
5. Storage of Aristo Folic Acid
6. Package contents and additional information

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

This medication contains folic acid, a vitamin B necessary for normal blood formation.

Folic acid can be used for:

Treatment of

• States of folic acid deficiency (e.g., megaloblastic anemia due to folic acid deficiency) confirmed by a blood test that includes checking vitamin B12 levels, in adults, children (from 6 years), and adolescents.

Prevention of

• folic acid deficiency in patients taking medications that reduce folic acid levels in the blood (see section 2);
• neural tube defects in unborn babies (such as spina bifida, a congenital defect of the spine), in women planning a pregnancy and known to be at risk.

2. What you need to know before taking Aristo Folic Acid

Do not take Aristo Folic Acid

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

Warnings and precautions

Consult your doctor or pharmacist before taking folic acid

• if you have a vitamin B12 deficiency or anemia of unknown cause.
• if you have cancer or a tumor.
• if you are a healthy pregnant woman without risk of having a baby with a neural tube defect. In this case, your doctor will prescribe a medication with less folic acid.

Children

Folic acid should not be used in children under 6 years of age.

Other medications and Aristo Folic Acid

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

The following medications may affect or be affected by treatment with folic acid:

• phenytoin, phenobarbital, primidone, and possibly carbamazepine (used to control epileptic seizures);
• fluorouracil, glucarpidase, methotrexate, capecitabine (used to treat certain tumors);
• certain antibiotics, e.g., trimethoprim, sulfonamides;
• sulfasalazine (used to treat inflammatory bowel diseases, such as ulcerative colitis and Crohn's disease);
• pyrimethamine (used to treat toxoplasmosis - a parasitic infection);
• triamterene (used to treat hypertension and edema, i.e., fluid accumulation in the body);
• medications for tuberculosis;
• oral contraceptives;
• alcohol.

Pregnancy and breastfeeding

This medication can be taken during pregnancy.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.

Driving and using machines

It is unknown whether this medication affects the ability to drive or use machines.

This medication contains lactose and sucrose

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

3. How to take Aristo Folic Acid

Follow the exact administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Treatment of folic acid deficiency states

Adults

The recommended dose is 5 mg daily for 3-4 months, which may be increased.

Your doctor will prescribe the appropriate dose.

Use in children and adolescents

Folic acid should not be used in children under 6 years of age.

For the treatment of megaloblastic anemia: The recommended dose is 5 mg daily for 4 months.

Elderly patients and patients with renal or hepatic impairment

Your doctor will prescribe the same dose as for healthy adult patients.

Prevention of folic acid deficiency induced by medications (see section 2)

Your doctor will prescribe the appropriate dose.

The recommended dose is 1-5 mg per day or 5 mg once a week.

In the case of treatment with methotrexate, the dose should be taken 24 hours after methotrexate administration.

Prevention of neural tube defects in fetuses in women with known risk

Your doctor will prescribe the appropriate dose.

The recommended dose is 5 mg per day, started at least 4 weeks before conception and at least during the first three months of gestation.

Route and method of administration

Oral route.

The tablet can be taken independently of meals with plenty of liquid.

The tablet can be divided into equal doses.

Duration of treatment

The duration of treatment depends on the cause of the folic acid deficiency and the success of the treatment.

The effect of the treatment should be monitored by a doctor.

If you take more Aristo Folic Acid than you should

Generally, it is unlikely that this medication will cause harm if you take more than you should or if a child has taken this medication by accident, so no medical intervention is necessary.

If you are concerned, contact your doctor or the nearest hospital for advice.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Aristo Folic Acid

If you forget to take a tablet, take it as soon as you remember, unless it is almost time to take the next one.

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

It is unlikely that folic acid will cause side effects, unless you are allergic to folic acid or any of the other components of the tablets.

The following side effects have been reported:

Rare(may affect up to 1 in 1,000 people):

• mild allergic reaction;
• anorexia (eating disorder: fear of gaining weight and a strong desire to be thin), nausea (feeling unwell), vomiting (feeling sick), diarrhea, flatulence (passing gas);
• rash, itching, urticaria, redness of the skin, swelling of the face, lips, tongue, or throat (facial angioedema).

Frequency not known(frequency cannot be estimated from the available data):

• severe allergic reaction (causing difficulty breathing or dizziness)

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use https://www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Aristo Folic Acid

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

Do not use this medication after the expiration date stated on the outer packaging and on the blister pack after "EXP". The expiration date is the last day of the month indicated.

Store in the original packaging to protect from light.

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

6. Package contents and additional information

Composition of Aristo Folic Acid

The active ingredient is folic acid.

Each tablet contains 5 mg of folic acid as folic acid hydrate

The other ingredients are: lactose monohydrate, pregelatinized maize starch, macrogol, sucrose, stearic acid (E570), and magnesium stearate.

Appearance of the product and package contents

Yellow or yellow-orange speckled, round, biconvex tablets; with a score line on one side, diameter of about 7.0 mm and a thickness of about 2.75 mm.

Available in blister packs of 20, 28, 50, 60, 84, 100, and 120 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Manufacturer

G.L. Pharma GmbH

Schlossplatz 1

8502 Lannach, Austria

or

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

You can request more information about this medication from the local representative of the marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

This medication is authorized in the Member States of the European Economic Area under the following names:

Denmark Folsyre Aristo 5 mg tablets

Germany Folsäure Aristo 5 mg tablets

Spain Ácido fólico Aristo 5 mg tablets

Italy Acido Folico Aristo 5 mg tablets

Portugal Ácido fólico Aristo 5 mg tablets

Date of the last revision of this leaflet:December 2021

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