HYFTOR 2 mg /G Żel

Treść ulotki

1. Hyftor 2 mg/g gel
   1. What is Hyftor and what is it 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

Hyftor 2 mg/g gel

sirolimus

Read this leaflet carefully before you start using this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you use 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 is Hyftor and what is it 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 that regulates the immune
system called m-TOR, is hyperactive. By blocking the activity of m-TOR, 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 6 years of age with angiofibromas on the face
that result from tuberous sclerosis complex. Tuberous sclerosis complex is a rare genetic disease
that causes the growth of non-cancerous tumors in various organs of the body, including the
brain and skin. In many patients, the disease causes lesions (formations) that are non-cancerous on the skin and
on the mucous membranes (the moist surfaces of the body, such as the lining of the mouth) of the face, called
facial angiofibromas.

2. What you need to know before using Hyftor

Do not use Hyftorif you are allergic to sirolimus or to any of the other ingredients of this
medicine (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 letting Hyftor come into contact with your eyes, the inside of your mouth and nose, or with wounds. Similarly, the medicine should not be used on irritated skin, or on skin that is infected or otherwise
damaged.
If accidental contact occurs, it is recommended to wash the gel off immediately.
Avoid exposing the skin treated with Hyftor to direct sunlight, as this may cause
undesirable effects on the skin. By sunlight, we mean both natural and artificial light (e.g., from a solarium). Your doctor will suggest the most appropriate methods of sun protection, such as using
a sunscreen or clothing to cover the skin, or even wearing a hat.

Children
Hyftor is not recommended in children under 6 years of age because it has not been sufficiently
studied in this age group.

Other medicines and Hyftor
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Do not apply any other medicines to the skin area treated with Hyftor.

Pregnancy and breastfeeding
Hyftor is not recommended during pregnancy unless your doctor considers that the benefits of
treatment outweigh the risks. There is no information regarding the use of Hyftor in pregnant women.
Women of childbearing potential must use effective contraceptive measures during treatment with Hyftor.
It is not known whether sirolimus is excreted in human milk after treatment with Hyftor. Your doctor will
help you decide whether to discontinue breastfeeding or discontinue/abstain from therapy with
Hyftor, taking into consideration the benefit of breastfeeding for the child and the benefit of
therapy for the mother.
If you are pregnant, suspect you are pregnant, are planning a pregnancy or are breastfeeding, ask your
doctor or pharmacist for advice before using this medicine.

Driving and using machines
It is not believed that the medicine has effects on the ability to drive and use machines.

Hyftor contains alcohol
This medicine 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 following the instructions of your doctor or pharmacist exactly. If you have any
doubts, consult your doctor or pharmacist.

The recommended dose is
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 strip of gel of approximately 0.5 cm is recommended, twice
a day.
The maximum recommended dose on the face is:

• children aged between 6 and 11 years: no more than a 1 cm strip of gel twice a day
• adults and children from 12 years of age: no more than a 1.25 cm strip of gel twice a day

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

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

If you use more Hyftor than you should
Hyftor is applied to the skin and absorption into the body is minimal. For this reason, it is very
unlikely that an overdose will occur.
If you apply too much gel to a lesion, carefully remove the excess gel with a paper towel,
then throw the towel in the trash.
If, by mistake, you or someone else were to ingest the gel, contact your doctor immediately.

If you forget to use Hyftor
If you forget to use the medicine in the morning, apply the gel immediately as soon as you
remember, before the evening meal of that 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 more gel to make up for the missed dose.

If you stop using Hyftor
Your doctor will tell you how long you will need to use Hyftor and when you can stop the
treatment. Do not stop treatment without first talking to your doctor.
If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• dry skin
• itchy skin
• 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
• strange sensation, even at the application site, such as numbness, tingling, prickling and itching
• swelling of the application site
• eczema characterized by changes in the skin that becomes excessively dry, red, itchy and cracked
• epidermal cyst (a cyst that contains solid tissues or structures, e.g. hairs)
• skin rash, itchy rash
• skin peeling
• skin irritation
• redness
• skin bleeding
• dermatitis (skin inflammation), including contact dermatitis (skin inflammation after contact with the medicine), acneiform dermatitis (skin inflammation with small bumps similar to acne), seborrheic dermatitis (skin condition affecting the scalp, causing redness and scaling of the skin), solar dermatitis (inflammation of the

skin after exposure to the sun)

• dry, hardened and scaly skin
• urticaria
• nodules
• boils
• tinea versicolor(a skin infection caused by a fungus)
• inflammation of the inside of the mouth
• increased sensitivity to light
• redness of the eyelids
• redness of the eye
• eye irritation
• conjunctivitis (redness and discomfort of the eye)
• inflammation of hair follicles
• sensations such as numbness, tingling and prickling
• nasal discomfort

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects you can help to 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 which is stated on the pack and on the tube after Scad.
The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C - 8 °C).
Store 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 any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Hyftor contains

• The active ingredient is sirolimus. Each gram of gel contains 2 mg of sirolimus.
• The other ingredients are: carbomer, anhydrous ethanol, trolamine and purified water (see section 2 “Hyftor contains alcohol”).

Description of the appearance of Hyftor and contents of the pack
Hyftor is a transparent and colorless gel. It is supplied in an aluminum tube containing 10 g of gel.
Pack: 1 tube

Marketing authorization 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 medicine is available on the website of the European
Medicines Agency, http://www.ema.europa.eu. Furthermore, links to other websites on rare diseases
and related therapeutic treatments are provided.