Patient Information Leaflet: Folic Acid Aristo 5 mg Tablets

Read this leaflet carefully before you start taking 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. Do not give it to others even if they have similar 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 Aristo 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 side effects

5. Storage of Folic Acid Aristo

6. Contents of the pack and additional information

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

Folic acid can be used for:

Treatment of

• States of folic acid deficiency (for example, folic acid deficiency anemia) confirmed in a blood test that includes checking the levels of vitamin B12, in adults, children (from 6 years old) and adolescents.

Prevention of

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

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 unknown anemia.
• 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

Arsito Folic Acid should not be used in children under 6 years old.

Other medications and Aristo Folic Acid

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

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

• phenytoin, phenobarbital, primidone, and possibly carbamazepine (used to control epileptic seizures);
• fluorouracil, glucarpidase, methotrexate, capecitabine (used to treat 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 - a parasite 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 operating machines

The effects of this medication on driving or operating machines are unknown.

This medication contains lactose and sucrose

If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

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

Treatment of acid folic 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 old.

To treat folic acid deficiency anemia: The recommended dose is 5 mg daily for 4 months.

Older patients and patients with renal or hepatic insufficiency

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 case of treatment with methotrexate, 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 per day started at least 4 weeks before conception and at least the first three months of pregnancy.

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 folic acid deficiency and the success of treatment.

The effect of treatment should be monitored by a doctor.

If you take more Folic Acid Aristo than you should

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

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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Folic Acid Aristo

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 compensate for the missed dose.

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

It is unlikely that folic acid will cause adverse effects, unless you are allergic to folic acid or any of the other components 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, vomiting, diarrhea, flatulence;
• Rash, itching, urticaria, skin redness, facial swelling, swelling of the lips, tongue, or throat (facial angioedema).

Unknown frequency(frequency that cannot be estimated from available data):

• Severe allergic reaction (causing difficulty breathing or dizziness)

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 https://www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

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

Store in the original packaging to protect it from light.

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

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 components are: lactose monohydrate, pregelatinized cornstarch, macrogol, sucrose, stearic acid (E570) and magnesium stearate.

Appearance of the product and contents of the package

Yellow or yellow-orange speckled, round, biconvex tablets with a notch on one face, diameter of approximately 7.0 mm and a thickness of approximately 2.75 mm.

It is available in blister packs of 20, 28, 50, 60, 84, 100 and 120 tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Responsible for manufacturing

G.L. Pharma GmbH

Schlossplatz 1

8502 Lannach, Austria

or

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Further information about this medicinal product can be obtained by contacting the local representative of the holder of the marketing authorization:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid. Spain

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

DenmarkFolsyre Aristo 5 mg tablets

GermanyFolsäure Aristo 5 mg Tablets

SpainAristo Folic Acid 5 mg tablets

ItalyAcido Folico Aristo 5 mg Compresse

PortugalAristo Folic Acid 5 mg Tablet

Last review date of this leaflet:December 2021

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