Medebiotin Fuerte solution for injection
SpainTable of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Medebiotin Fuerte injectable solution
Biotin
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Contents of the leaflet:
- What Medebiotin Fuerte solution is and what it is used for
- Before using Medebiotin Fuerte solution
- How to use Medebiotin Fuerte solution
- Possible side effects
- How to store Medebiotin Fuerte solution
- Further information
1. What Medebiotin Fuerte Solution is and what it is used for
Biotin, the active component, belongs to the group of water-soluble B vitamins.
Medebiotin Fuerte Solution is indicated for the treatment of biotin deficiency states or when there is an increased requirement for this vitamin, in adults and children.
Biotin deficiency may cause symptoms such as seborrheic dermatitis (skin rash with inflammation and scaling), alopecia (hair loss), or glossitis (inflammatory lesion of the tongue). Biotin requirements may be increased in cases such as patients undergoing long-term antiepileptic treatment and in patients receiving parenteral nutrition (nutrition by a route other than the digestive tract) that is not adequately supplemented. It is also indicated for the treatment of biotin metabolism disorders.
2. Before using Medebiotin Fuerte Solution
Do not use Medebiotin Fuerte solution
- if you are allergic (hypersensitive) to biotin.
Take special care with Medebiotin Fuerte solution
- Recommended doses must not be exceeded.
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 undergoing laboratory tests, you must inform your doctor or laboratory personnel that you are receiving or have recently received Medebiotin Forte injectable solution, as biotin may interfere with test results. Depending on the test, results may show false elevations or false reductions due to biotin. Your doctor may 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 interfere with laboratory test results. Inform your doctor or laboratory personnel if you are taking these types of products.
Use of other medicines
Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.
If you are taking any medication for epilepsy, it may reduce blood levels of biotin.
Pregnancy and breastfeeding
Consult your doctor or pharmacist before using any medicine.
The recommended dietary intake of biotin is approximately 30 micrograms/day during pregnancy and 35 micrograms/day during breastfeeding.
Driving and using machines
Medebiotin Fuerte does not affect your ability to drive or operate machinery.
Important information about some of the components of Medebiotin Fuerte solution
This medicine contains less than 23 mg (1 mmol) of sodium per ampoule and is therefore essentially “sodium-free”.
3. How to use Medebiotin Fuerte Solution
Follow exactly the administration instructions for Medebiotin Fuerte provided by your doctor. Consult your doctor or pharmacist if you have any doubts.
Medebiotin Fuerte can be administered intramuscularly; however, upon medical indication, it may also be used intravenously or orally by mixing the ampoule contents with liquids or soft foods.
The usual dosage is:
Adults
- In cases of deficiency with dermatological symptoms: 5 mg per day (one ampoule), usually administered orally.
- In metabolic disorders: 10 mg per day (two ampoules) are recommended, although the dose may be increased up to 40 mg per day depending on the type of deficiency. The maintenance dose is 5 to 20 mg per day, although doses of 40 mg or higher may be required depending on the severity of the condition.
Use in children
- In newborns with deficiency: 5 mg per day (one ampoule) is recommended, administered orally or by slow intravenous route, with dose adjustments based on clinical response; older patients may require 10 mg per day.
- In biotin metabolism disorders: 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 physician's discretion depending on the severity of the condition.
Your doctor will determine the duration of treatment with Medebiotin Fuerte based on your clinical progress.
If you use more Medebiotin Fuerte solution than you should
If you use more Medebiotin Fuerte than prescribed, you may not experience symptoms, as no toxic reactions to biotin have been observed in humans.
In case of overdose, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and amount taken.
If you forget to use Medebiotin Fuerte solution
Do not use a double dose to make up for missed doses.
If you have any further questions about the use of this product, consult your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Medebiotin Fuerte may cause adverse effects, although not everyone experiences 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 experience to be serious, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.
Reporting of 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 mentioned in this leaflet. You may also report them directly through 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. Storage of Medebiotin Fuerte Solution
Keep out of the reach and sight of children.
Do not use Medebiotin Fuerte after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Additional information
Composition of Medebiotin Fuerte solution
- The active substance 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 injections.
Appearance of the medicinal product and contents of the container
Medebiotin Fuerte is an injectable solution which may also be administered orally (see section 3), presented in amber-coloured glass ampoules containing 1 ml of solution.
Each pack contains 10 ampoules.
Other presentations:
Medebiotin Fuerte tablets.
Marketing Authorisation Holder and Manufacturer
LABORATORIO REIG JOFRÉ, S.A.
Gran Capità, 10,
08970 Sant Joan Despí (Barcelona) - Spain
This Patient Information Leaflet was last approved in March 2019.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicinal Products and Medical Devices (AEMPS) http://www.aemps.es/