PATIENT INFORMATION LEAFLET

Medebiotin Forte injectable solution

Biotin

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

Medebiotin Fuerte solution is indicated for the treatment of biotin deficiency states or when there is an increase in the needs of 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). Biotin needs may be increased in cases such as patients undergoing prolonged treatment with antiepileptic drugs and in parenteral nutrition (not complemented appropriately). It is also indicated for the treatment of alterations in biotin metabolism.

Do not use Medebiotin Forte solution

• if you are allergic (hypersensitive) to biotin.

Be especially careful with Medebiotin Forte solution

• Do not exceed the recommended doses.

Warnings and precautions

Medebiotin Forte injectable solution contains 5 mg of sodium biotin (equivalent to 4.6 mg of biotin) per 1 ml ampoule. If you are to undergo laboratory tests, inform your doctor or laboratory personnel that you are receiving or have recently received Medebiotin Forte injectable solution, as biotin may affect the results of such tests. Depending on the test, results may show false elevations or false reductions due to biotin. Your doctor will be able to instruct you to stop receiving Medebiotin Forte injectable solution before undergoing 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 medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

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

Driving and operating machinery

Medebiotin Forte does not affect your ability to drive or operate machinery.

Important information about some components of Medebiotin Forte solution

This medication contains less than 23 mg (1 mmol) of sodium per ampoule, making it essentially "sodium-free".

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

Medebiotin Strong can be administered intramuscularly, although by doctor's indication it may also be used intravenously and orally, mixing the contents of the ampule with liquids or papillas.

The normal dose is:

Adults

• In case of deficiency with dermatological symptoms: 5 mg per day (one ampule), usually orally.
• In metabolic alterations: 10 mg per day (two ampules) are recommended, although the dose could reach 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 severity of the condition.

Use in children

• In newborns with deficiency, 5 mg per day (one ampule) orally or intravenously at a slow rate is recommended, adjusting the dose according to the response obtained; older patients may require 10 mg per day.
• In biotin metabolism alterations: generally 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 severity of the condition.

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

If you use more Medebiotin Strong solution than you should

If you use more Medebiotin Strong than your doctor has indicated, it is possible that you will not experience 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount used.

If you forgot to use Medebiotin Strong solution

Do not use a double dose to compensate for the missed doses.

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

Like all medications, Medebiotin Fuerte may produce adverse effects, although not everyone will experience them.

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

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. 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 about the safety of this medication

Keep out of reach and sight of children.

Do not use Medebiotin Strong after the expiration date that appears 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 through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Medebiotin Fuerte 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 Contents of the Package

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

Each package contains 10 ampoules.

Other Presentations:

Medebiotin Fuerte tablets.

Holder of the Marketing Authorization and Responsible for Manufacturing

LABORATORIO REIG JOFRÉ, S.A.

Gran Capità, 10,

08970 Sant Joan Despí (Barcelona)-Spain

This leaflet was approved in March 2019.

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.es/