MEDEBIOTIN FUERTE Injectable Solution

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Medebiotin Forte solution for injection

Biotin

Contents of the package leaflet:

1. What Medebiotin Forte solution is and what it is used for
2. Before you use Medebiotin Forte solution
3. How to use Medebiotin Forte solution
4. Possible side effects
5. Storage of Medebiotin Forte solution
6. Further information

1. What is Medebiotin Forte Solution and what is it used for

Biotin, the active component, belongs to the group of water-soluble vitamins of the B group.

Medebiotin Forte solution is indicated for the treatment of biotin deficiency states or when there is an increased need for this vitamin, in adults and children.

Biotin deficiency can cause symptoms of seborrheic dermatitis (skin eruption with inflammation and scaling), alopecia (hair loss), or glossitis (inflammatory lesion of the tongue). The need for biotin may be increased in cases such as patients undergoing prolonged treatment with antiepileptics and in parenteral nutrition (by a route other than the digestive tract) that is not properly supplemented. It is also indicated for the treatment of biotin metabolism disorders.

2. Before using Medebiotin Forte Solution

Do not use Medebiotin Forte solution

• if you are allergic (hypersensitive) to biotin.

Take special care with Medebiotin Forte solution

• Do not exceed the recommended doses.

Warnings and precautions

Medebiotin Forte solution for injection contains 5 mg of sodium biotin (equivalent to 4.6 mg of biotin) per 1 ml ampoule. If you are going to have laboratory tests, you should inform your doctor or the laboratory personnel that you are receiving or have recently received Medebiotin Forte solution, as biotin may affect the results of these tests. Depending on the test, the results may show false elevations or false reductions due to biotin. Your doctor may indicate that you should stop receiving Medebiotin Forte solution before having laboratory tests. You should also be aware that other products you may be taking, such as multivitamin preparations or supplements for hair, skin, and nails, may also contain biotin and affect the results of laboratory tests. Inform your doctor or laboratory personnel if you are taking this type of product.

Use of other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

If you are taking any medication for epilepsy, it may decrease the level of biotin in your blood.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

The recommended intake of biotin through the diet is about 30 micrograms/day during pregnancy and 35 micrograms/day during breastfeeding.

Driving and using machines

Medebiotin Forte does not affect your ability to drive or use machines.

Important information about some of the components of Medebiotin Forte solution

This medicine contains less than 23 mg (1 mmol) of sodium per ampoule, so it is considered essentially "sodium-free".

3. How to use Medebiotin Forte Solution

Follow the administration instructions for Medebiotin Forte exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Medebiotin Forte can be administered intramuscularly, although it may also be used intravenously or orally, by mixing the contents of the ampoule with liquids or pap, as indicated by your doctor.

The normal dose is:

Adults

• In case of deficiency with dermatological symptoms: 5 mg per day (one ampoule), usually orally.
• In metabolic disorders: 10 mg per day (2 ampoules) are recommended, although the dose may be up to 40 mg per day depending on the type of deficiency. The maintenance dose is 5 to 20 mg per day, although doses up to 40 mg or more may be necessary depending on the intensity of the condition.

Use in children

• In newborns with deficiency, 5 mg per day (one ampoule) is recommended orally or by slow intravenous route, adjusting the dose according to the response obtained; older patients may require 10 mg per day.
• In biotin metabolism disorders: in general, 5 to 10 mg per day or less are recommended, but the dose may need to be increased up to 20 mg per day or more, depending on the deficiency. The usual maintenance dose is 5 to 20 mg/day.

All indicated doses may be modified at the doctor's discretion, according to the intensity of the condition.

Your doctor will indicate the duration of treatment with Medebiotin Forte according to the evolution.

If you use more Medebiotin Forte solution than you should

If you use more Medebiotin Forte than indicated by your doctor, you may not show symptoms because no toxic reactions to biotin have been observed in people.

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

If you forget to use Medebiotin Forte solution

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

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

4. Possible side effects

Like all medicines, Medebiotin Forte can cause side effects, although not everyone gets them.

Adverse reactions are generally infrequent, mild, and transient. Rarely, allergic reactions and gastrointestinal discomfort may occur.

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 of side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Medebiotin Forte Solution

Keep out of the reach and sight of children.

Do not use Medebiotin Forte after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

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

6. Further information

Composition of Medebiotin Forte solution

• The active ingredient is Biotin.

Each ampoule contains 5 mg of sodium biotin (equivalent to 4.6 mg of biotin).

• The other components are: sodium hydroxide and water for injectable preparations.

Appearance of the product and packaging content

Medebiotin Forte is an injectable solution that can also be administered orally (see section 3) and is presented in 1 ml amber glass ampoules.

Each package contains 10 ampoules.

Other presentations:

Medebiotin Forte tablets.

Marketing authorization holder and manufacturer

LABORATORIO REIG JOFRÉ, S.A.

Gran Capità, 10,

08970 Sant Joan Despí (Barcelona)-Spain

This leaflet was approved in March 2019.

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