Package leaflet: Information for the patient

Biodermatin 5 mg tablets, 20 mg effervescent granules

biotin
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if you notice worsening of symptoms after a short period of treatment.

Contents of this leaflet:

What Biodermatin is and what it is used for
What you need to know before taking Biodermatin
How to take Biodermatin
Possible side effects
How to store Biodermatin
Contents of the pack and other information

1. What Biodermatin is and what it is used for

Biodermatin contains biotin, a vitamin of the B group essential for the metabolism of fats, sugars, and amino acids.
Biodermatin is indicated for the treatment of biotin deficiency states.
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you should know before taking Biodermatin

Do not take Biodermatin

if you are allergic to biotin or to any of the other ingredients of this medicine (listed in section 6)
if you are allergic to substances chemically similar to biotin or to any of the other ingredients of this medicine.

Warnings and precautions
Talk to your doctor or pharmacist before taking Biodermatin.
Biodermatin contains 5 mg of biotin per tablet and 20 mg of biotin per effervescent granule sachet. If you are scheduled to undergo laboratory tests, you must inform your doctor or laboratory staff that you are taking or have recently taken Biodermatin, because biotin can interfere with test results. Depending on the test used, results may be falsely elevated or falsely decreased due to biotin. Your doctor may instruct you to stop taking Biodermatin before undergoing laboratory tests. You should also be aware that other products you may be taking, such as multivitamin complexes or supplements for hair, skin, and nails, might contain biotin and could affect laboratory test results. Inform your doctor or laboratory staff if you are taking such products.

Other medicines and Biodermatin
Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Biodermatin with food and drink
The biotin in Biodermatin is inactivated by a substance present in raw egg white. Do not take Biodermatin together with raw egg white.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Biodermatin may be used during pregnancy and breastfeeding.

Driving and using machines
To date, no effects on the ability to drive or operate machinery have been reported.

Biodermatin 5 mg tablets contain sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

Biodermatin 20 mg effervescent granules contain sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
This medicine contains 3.234 g of sucrose (sugar) per sachet. This should be taken into account in patients with diabetes mellitus.

Biodermatin 20 mg effervescent granules contain sodium
This medicine contains 26.83 mg of sodium (main component of table salt) per sachet. This corresponds to 1.34% of the maximum recommended daily dietary intake for an adult.

3. How to take Biodermatin

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

5 mg tablets:
In cases of biotin deficiency with effects on the skin, hair, and nails (skin disorders with excessive sebum production and desquamation, hair loss, brittle nails), a daily intake of 5 to 10 mg (1–2 tablets per day) is recommended, up to a maximum of 4 weeks.
For treatments lasting longer than 4 weeks, medical supervision is required.
In cases of diseases present from birth (congenital defects in biotin metabolism), the recommended dose is 5–20 mg/day (1–4 tablets) up to 40 mg/day (8 tablets) as chronic treatment, which must be carried out under medical supervision.

Effervescent granules 20 mg:
In cases of diseases present from birth (congenital defects in biotin metabolism), the recommended dose is 10–20 mg/day (half or one sachet) up to 40 mg/day (2 sachets) as chronic treatment.

If you take more Biodermatin than you should
If you accidentally ingest an excessive dose of Biodermatin, immediately contact your doctor or go to the nearest hospital.
To date, no adverse effects have been reported following overdose of biotin.

If you forget to take Biodermatin
Do not take a double dose to make up for the forgotten dose.

If you stop taking Biodermatin
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Rarely, cases of intolerance with skin manifestations similar to erythema (rashes) or urticaria have been observed.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please consult your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Biodermatin

Do not store above 25°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Exp.”. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Biodermatin contains
Biodermatin 5 mg tablets

The active substance is biotin. Each tablet contains 5 mg of biotin.
The other components are sodium stearate, rice starch.

Biodermatin 20 mg effervescent granulate

The active substance is biotin. Each sachet contains 20 mg of biotin.
The other components are tartaric acid, sodium bicarbonate, citric acid, sucrose, saccharin, orange flavour, polyvinylpyrrolidone.

Description of the appearance of Biodermatin and contents of the pack
Biodermatin 5 mg tablets
Each pack contains 30 tablets of 5 mg.
Biodermatin 20 mg effervescent granulate
Each pack contains 30 sachets of 20 mg.
Marketing Authorization Holder
Alliance Pharma (Ireland) Ltd
United Drug House
Magna Drive
Dublin
D24 X0CT, Ireland
Manufacturer
LA.FA.RE. srl -
Via Sac. Benedetto Cozzolino, 77
Ercolano – Naples
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