Hyftor

Package leaflet: Information for the user

Hyftor 2 mg/g gel

sirolimus
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Hyftor is and what it is used for
2. What you need to know before using Hyftor
3. How to use Hyftor
4. Possible side effects
5. How to store Hyftor
6. Contents of the pack and other information

1. What Hyftor is and what it is used for

Hyftor contains the active substance sirolimus, a medicine that reduces the activity of the immune system.
In patients with tuberous sclerosis complex, one of the proteins regulating the immune system, called m-TOR, is overactive. By inhibiting m-TOR activity, Hyftor is able to regulate cell growth and reduce the number or size of angiofibromas.
Hyftor is a medicine used to treat adults and children from the age of 6 years with facial angiofibromas due to tuberous sclerosis complex. Tuberous sclerosis complex is a rare genetic disease causing the growth of non-cancerous tumours in various organs of the body, including the brain and skin. In many patients, the disease causes non-cancerous skin lesions (growths) and on mucous membranes (the moist surfaces of the body, such as the lining of the mouth) of the face, known as facial angiofibromas.

2. What you need to know before using Hyftor

Do not use Hyftor if you are allergic to sirolimus or to any of the other ingredients of this
medicinal product (listed in section 6).
Warnings and precautions
Talk to your doctor before using Hyftor:

• if you have a weakened immune system
• if you have severely impaired liver function

Avoid contact of Hyftor with the eyes, inside of the mouth and nose, or with open wounds. Likewise,
the medicine should not be used on irritated, infected, or otherwise damaged skin.
In case of accidental contact, it is recommended to wash the gel off immediately.
Avoid exposing skin treated with Hyftor to direct sunlight, as this could cause unwanted skin effects.
Sunlight includes both natural sunlight and artificial light (for example, from a sunbed). Your doctor
will advise you on appropriate sun protection methods, such as using a sunscreen, wearing protective
clothing, or wearing a hat.
Children
Hyftor is not recommended in children under 6 years of age, as it has not been sufficiently studied in
this age group.
Other medicines and Hyftor
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any
other medicines.
Do not apply other medicines to the area of skin treated with Hyftor.
Pregnancy and breastfeeding
Hyftor is not recommended during pregnancy unless your doctor considers the benefits of treatment
to outweigh the risks. There is no information available on the use of Hyftor in pregnant women.
Women of childbearing age must use effective contraception during treatment with Hyftor.
It is not known whether sirolimus is excreted in breast milk following treatment with Hyftor. Your
doctor will help you decide whether to discontinue breastfeeding or to discontinue/abstain from
treatment with Hyftor, taking into account the benefits of breastfeeding for the infant and the benefits
of therapy for the mother.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding,
consult your doctor or pharmacist before using this medicinal product.
Driving and using machines
Hyftor is not expected to have an effect on the ability to drive or operate machinery.
Hyftor contains alcohol
This medicinal product contains 458 mg of alcohol (ethanol) per gram. It may cause a burning sensation when applied to damaged skin.

3. How to use Hyftor

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Recommended dose
Your doctor or pharmacist will tell you how much gel to use.
For a lesion of approximately 7 cm by 7 cm (50 cm²), a thin strip of gel about 0.5 cm long is recommended, applied twice daily.
The maximum recommended dose for the face is:

• children aged 6 to 11 years: no more than a 1 cm strip of gel twice daily
• adults and children aged 12 years and older: no more than a 1.25 cm strip of gel twice daily

How to apply the gel
Apply a thin layer of Hyftor twice daily (morning and evening) to the affected skin area, then gently massage it in. The medicine should be applied once in the morning and once in the evening, before going to sleep. Limit application to the skin areas affected by angiofibroma. Do not cover the treated skin area after applying Hyftor.
Wash your hands thoroughly before and after using the gel, to avoid unintentional transfer or ingestion.

Duration of use
Your doctor will tell you how long you should use Hyftor.

If you use more Hyftor than you should
Hyftor is applied to the skin and absorption into the body is minimal. Therefore, overdose is very unlikely.
If you apply too much gel to a lesion, carefully wipe off the excess gel with a paper towel, then dispose of the towel in the trash.
If, by mistake, you or someone else swallows the gel, contact your doctor immediately.

If you forget to use Hyftor
If you forget to apply the medicine in the morning, apply the gel as soon as you remember, before the evening meal of the same day. After the evening meal, apply Hyftor only at bedtime that day. If you forget to use the medicine at bedtime, skip that dose. Do not apply extra gel to make up for the missed dose.

If you stop using Hyftor
Your doctor will advise you on how long you should use Hyftor and when you can stop treatment. Do not stop treatment without first discussing it with your doctor.

If you have any questions about how to use 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.

Very common (may affect more than 1 in 10 people)

• dry skin
• skin itching
• acne
• irritation at the application site, such as redness, burning, stinging sensation, itching, swelling and/or numbness

Common (may affect up to 1 in 10 people)

• bleeding at the application site
• unusual sensations, including at the application site, such as numbness, tingling, prickling, or itching
• swelling at the application site
• eczema characterized by changes in the skin becoming excessively dry, red, itchy, and cracked
• dermal cysts (a cyst containing solid tissues or structures, e.g., hairs)
• skin rash, itchy skin rash
• peeling of the skin
• skin irritation
• redness
• skin bleeding
• dermatitis (skin inflammation), including contact dermatitis (skin inflammation after contact with the medicine), acneiform dermatitis (skin inflammation with small acne-like bumps), seborrheic dermatitis (a skin condition affecting the scalp, causing redness and skin flaking), solar dermatitis (skin inflammation after sun exposure)
• dry, hardened, and scaly skin
• hives
• nodules
• boils
• tinea versicolor (a fungal skin infection)
• inflammation of the inside of the mouth
• increased sensitivity to light
• redness of the eyelids
• eye redness
• eye irritation
• conjunctivitis (redness and discomfort in the eye)
• inflammation of hair follicles
• sensations such as numbness, tingling, and prickling
• nasal discomfort

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Hyftor

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and tube after "Exp".
The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C - 8 °C).
Keep in the original tube to protect the medicine from light.
Keep away from fire.
Dispose of the tube and any remaining gel 4 weeks after first opening.
Do not dispose of medicines 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 Hyftor contains

• The active substance is sirolimus. Each gram of gel contains 2 mg of sirolimus.
• The other components are: carbomer, anhydrous ethanol, tromethamine and purified water (see section 2, "Hyftor contains alcohol").

Description of the appearance of Hyftor and contents of the pack
Hyftor is a clear, colourless gel. It is supplied in an aluminium tube containing 10 g of gel.
Pack: 1 tube
Marketing Authorisation Holder
Plusultra pharma GmbH
Fritz-Vomfelde-Str. 36
40547 Düsseldorf
Germany
Manufacturer
MSK Pharmalogistic GmbH
Donnersbergstraße 4
64646 Heppenheim
Germany
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu. Links to other websites on rare diseases and their therapeutic treatments are also provided.