Folic acid Aristo 5 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Folic Acid Aristo 5 mg tablets

Read the entire 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Folic Acid Aristo is and what it is used for
2. What you need to know before taking Folic Acid Aristo
3. How to take Folic Acid Aristo
4. Possible adverse effects
5. How to store Folic Acid Aristo
6. Contents of the pack and other information

1. What Ácido fólico Aristo is and what it is used for

This medicine contains folic acid, a B vitamin necessary for the normal formation of blood.

Folic acid may be used for:

Treatment of

• Folic acid deficiency states (e.g., anemia due to folic acid deficiency) confirmed by a blood test including assessment of vitamin B12 levels, in adults, children (from 6 years of age) and adolescents.

Prevention of

• Folic acid deficiency in patients taking medicines 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 who are planning a pregnancy and are known to be at risk.

2. What you need to know before starting to take Folic Acid Aristo

Do not take Folic Acid Aristo

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

Warnings and precautions

Consult your doctor or pharmacist before taking folic acid

• if you have 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 medicine containing a lower amount of folic acid.

Children

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

Other medicines and Folic Acid Aristo

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

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

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

Pregnancy and breastfeeding

This medicine may be taken during pregnancy.

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

Driving and using machines

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

This medicine contains lactose and sucrose

If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Folic Acid Aristo

Follow exactly the instructions for administration of this medicine as given 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 for you.

Use in children and adolescents

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

For the treatment of folic acid deficiency 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 drug-induced folic acid deficiency (see section 2)

Your doctor will prescribe the appropriate dose.

The recommended dose is 1–5 mg daily or 5 mg once weekly.

When used during methotrexate treatment, the dose should be taken 24 hours after methotrexate intake.

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 daily, started at least 4 weeks before conception and continued for at least the first three months of pregnancy.

Route and method of administration

Oral use.

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

The tablet may be divided into equal doses.

Duration of treatment

The duration of treatment depends on the cause of folic acid deficiency and the response to therapy.

The effect of treatment should be monitored by a physician.

If you take more Folic Acid Aristo than you should

Generally, it is unlikely that this medicine will cause harm if you take more than you should, or if a child has accidentally taken this medicine, so medical intervention is not usually necessary.

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Folic Acid Aristo

If you forget to take a tablet, take it as soon as you remember, unless it is almost time for your next dose.

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.

It is unlikely that folic acid will cause adverse effects unless you are allergic to folic acid or to any of the other ingredients in the tablets.

The following adverse 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 sick), vomiting (being sick), diarrhoea, flatulence (passing gas);
• rash, itching, urticaria, skin redness, 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 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 can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es.

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

5. Folic Acid Aristo Storage Instructions

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

Do not use this medicine after the expiry date stated on the outer packaging and on the blister after "EXP". The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point located at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ácido fólico Aristo

The active substance is folic acid.

Each tablet contains 5 mg of folic acid as folic acid monohydrate.

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

Appearance of the medicinal product and contents of the pack

Yellow or mottled yellow-orange, round, biconvex tablets with a score line on one side, approximately 7.0 mm in diameter and 2.75 mm thick.

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

Only some pack sizes may be commercially available.

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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Aristo Pharma Iberia, S.L.
C/ Solana, 26
28850 Torrejón de Ardoz
Madrid, Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Denmark Folsyre Aristo 5 mg tabletter
Germany Folsäure Aristo 5 mg Tabletten
Spain Ácido fólico Aristo 5 mg comprimidos
Italy Acido Folico Aristo 5 mg Compresse
Portugal Ácido fólico Aristo 5 mg Comprimido

Date of the most recent review of this leaflet: December 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/