Package leaflet: Information for the patient

Diathynil 5 mg tablets

D(+) 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 instructed you.

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, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice any improvement or if your symptoms worsen.

Contents of this leaflet:

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

1. What Diathynil is and what it is used for

Diathynil contains the active substance D(+) biotin. D(+) biotin is a B-complex vitamin essential
for the metabolism of carbohydrates, fats, and purines.
Diathynil is indicated for the treatment of skin disorders causing excessive sebum production or
desquamation.

Indications in adults:

skin inflammation characterized by mild redness, scaling, and patches in various areas of the body (seborrheic dermatitis);
acne;
hair loss of various causes (alopecia).

Indications in children:

localized skin inflammations: diaper dermatitis, redness in skin folds, or cradle cap;
generalized skin inflammations: widespread and persistent skin redness, often with desquamation, typical in infants (Leiner-Moussous syndrome, also known as exfoliative erythroderma of infancy);
diseases related to vitamin deficiency or inflammation of the tongue associated with digestive problems.

Consult your doctor if you do not feel better or if you feel worse.

2. What you should know before taking Diathynil

Do not take Diathynil

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

Warnings and precautions
Talk to your doctor or
pharmacist before taking Diathynil.
During treatment with Diathynil, you must not eat raw egg white, because it contains a
protein called avidin that binds to the active substance in Diathynil, rendering it inactive.

Other medicines and Diathynil
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
To date, no interactions between Diathynil and other medicines are known.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding,
please consult your doctor or pharmacist before taking this medicine.
Diathynil may be used during pregnancy and breastfeeding.

Driving and using machines
Diathynil does not affect the ability to drive or operate machinery.

Diathynil contains lactose
Diathynil contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her
before taking this medicine.
Diathynil contains 5 mg of biotin per tablet. If you are scheduled to undergo laboratory tests, you must
inform your doctor or laboratory personnel that you are taking or have recently taken Diathynil, because
biotin can interfere with test results. Depending on the test used, results may be falsely elevated or falsely low due to biotin. Your doctor may ask you to stop taking Diathynil 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 personnel if you are taking such products.

3. How to take Diathynil

Take this medicine exactly as stated in this leaflet or as instructed by your
doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose depends on the condition being treated.

Treatment of hair loss and excessive sebum production from the scalp
Your doctor will prescribe Diathynil tablets after an initial treatment period with Diathynil
injectable solution.
The recommended dose is 3 tablets daily for 2 months.

Treatment of other conditions
Use in adults
The recommended dose is 2–4 tablets daily for the duration prescribed by the doctor.

Use in children
The recommended dose is 1–2 tablets daily for the duration prescribed by the doctor.
For breastfed infants, the tablets may be dissolved in the feeding bottle.

If you take more Diathynil than you should
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital.

If you forget to take Diathynil
Do not take a double dose to make up for the missed dose.

If you stop taking Diathynil
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 will experience them.
Very rare cases of intolerance with skin redness or urticaria-like reactions have been reported.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform 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 Diathynil

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is 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. Pack contents and other information

What Diathynil contains

The active substance is D(+) biotin. Each tablet contains 5 mg of D(+) biotin.
The other components are lactose, corn starch, talc, stearic acid, magnesium stearate.

Description of the appearance of Diathynil and pack contents
Each pack contains 20 or 30 white tablets in blisters.
Marketing Authorization Holder
Alfasigma S.p.A. - Via Ragazzi del ’99, n. 5 - 40133 Bologna (BO)
Manufacturer
CENEXI – Fontenay-sous-Bois (France)