Hyftor – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Hyftor, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
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 further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
ℹ️ 1. What Hyftor is and what it is used for
Hyftor contains the active substance sirolimus , which is a medicine that reduces the activity of the immune system .
In patients with tuberous sclerosis complex a protein that regulates the immune system, m -TOR, is overactive. By blocking the activity of m-TOR, Hyftor regulates cell growth and reduces the number or size of angiofibromas .
Hyftor is a medicine used to treat adults and children from 6 years of age with angiofibroma on the face resulting from tuberous sclerosis complex. Tuberous sclerosis com plex is a rare genetic disease causing non -cancerous tumours to grow in different organs of the body, including the brain and skin.
The disease causes facial angiofibromas, non -cancerous lesions (growths) of the skin and mucous membranes (moist body surfac es, such as the lining of the mouth) in the face, in many patients.
⚠️ 2. What you need to know before you use Hyftor
Do not use Hyftor if you are allergic to sirolimus or 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
- severely reduced liver function Avoid contact of Hyftor with the eyes, the lining of the mouth and nose, or wounds. Similarly, it should not be used on irritated skin or skin that is infected or otherwise damaged.
In case of accidental contact it is recommended to immediately wash the gel off.
Avoid expos ing skin treated with Hyftor to direct sunlight since it may cause side effects on the skin .
This includes both natural and artificial (for example in the solarium) sunlight. Your doctor will advise you about appropriate sun protection, like the use of sunscreen and clothing to cover the skin or wearing headgear .
Children
Hyftor is not recommen ded for children under 6 years since the product has not been sufficiently studied in this age group .
Other medicines and Hyftor
Tell your doctor or pharmacist if you are 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 breast-feeding
Hyftor is not recommended during pregnancy unless your doctor thinks that the benefits of treatment are greater than the risks . There is no information on the use of Hyftor in pregnant women.
Women of childbearing potential should use safe contraception during treatment with Hyftor.
It is not known, whether sirolim us is excreted into human milk after treatment with Hyftor. You and your doctor should made a decision whether to discontinue breast -feeding or to discontinue/abstain from Hyftor therapy taking into account the benefit of breast feeding for your child and the benefit of therapy for you.
If you are pregnant or breast -feeding, think you may be pregnant , or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Driving and using machines
This medicine is not expected to affect t he ability to drive or use machines.
Hyftor contains alcohol
This medicine contains 4 58 mg alcohol (ethanol) in each gram. It may cause a burning sensation when applied to damaged skin .
💊 3. How to use Hyftor
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is Your doctor or pharmacist will show you how much gel you should use.
About 0.5 cm of the gel strand twice daily is recommended for a lesion of around 7 by 7 cm (50 cm2).
The maximum recommended dose on the face is:
- children 6 to 11 years: no more than 1 cm gel strand twice daily
- adults and children from 12 years: no more than 1.25 cm gel strand twice daily How to apply the gel Apply a thin layer of Hyftor twice daily (morning and evening) to the affected skin area and rub in gently. The application should be done once in the morning and once in the evening before going to bed. Limit the use to skin areas affected by angiofibroma. Do not cover the affected skin after application of Hyftor.
Wash your hands carefully before and immediately after using the gel to avoid any unintentional spread or ingestion .
Duration of use Your doctor will tell you how long you should use Hyftor for.
22 If you use more Hyftor than you should Hyftor is applied to the skin and absorption into the body is minimal. This makes overdose very unlikely.
If you apply too much gel to a lesion , carefully wipe of f the excess gel with a paper towel and throw away the towel.
If you or anybody else accidentally swallows some gel, contact your doctor immediately.
If you forget to use Hyftor
If you forget to use the medicine in the morning, apply the gel as soon as you r emember immediately before your meal in the evening of the same day. After your meal in the evening , only administer Hyftor at bedtime on that day. If you forget to use the medicine at bedtime, skip that dose. Do not apply more gel to make up for a missed dose.
If you stop using Hyftor
Your doctor will tell you how long you should use Hyftor and when you can stop treatment. Do not stop using it without consulting your doctor.
If you have any further questions on the use of 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
- itching skin
- acne
- irritation at the application site, such as reddening, burning stinging, itching, swelling and/or numbness
Common (may affect up to 1 in 10 people)
- bleeding at application site
- abnormal sensation , including at the application site , such as numbness, prickling, tingling and itchiness
- application site swelling
- eczema characterised by changes that occur when skin becomes abnormally dry, red, itchy and cracked
- dermal cyst ( a cyst containing solid tissue or structures such as hair)
- rash, itchy rash
- peeling of skin
- skin irritation
- reddening
- bleeding of the skin
- dermatitis (inflammation of the skin), including contact dermatitis (inflammation of the skin after contact with the medicine), acneiform dermatitis (inflammation of the skin with small acne-like bumps), seborrhoeic dermatitis (skin condition affecting the head with scaly and red skin), solar dermatitis (inflammation of the skin after exposure to sunlight)
- dry, hard and scaly skin
- hives
- nodules
- boils
- tinea versicolour (a fungal infection of the skin)
- inflammation of the lining of the mouth
- increased sensitivity to light
- reddening of the eyelid 23 • red eye
- eye irritation
- conjunctivitis ( redness and discomfort in the eye)
- inflammation of hair follicle s
- sensations like numbness, tingling and pins and needles
- nasal discomfort
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist . This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix 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 which is stated on the carton and on the tube after EXP.
The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C).
Store in the original tube in order to protect from light.
Keep away from fire.
Throw away the tube and any remaining gel 4 weeks after opening.
Do not throw away any medicines via wastewater or household waste . Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
📦 6. Contents of the pack and other information
What Hyftor contains
- The active substance 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 ”).
What Hyftor looks like and contents of the pack
Hyftor is a transparent, colourless gel. It is supplied in an aluminium tube containing 10 g of gel.
Pack size: 1 tube
Marketing Authorisation Holder
Plusultra pharma GmbH Fritz-Vomfelde -Str. 36 40547 Düsseldorf Germany
Manufacturer
HWI pharma services GmbH Straßburger Straße 77 77767 Appenweier Germany
This leaflet was last revised in
Other sources of information 24 Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu . There are also links to other websites about rare diseases and treatments.
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Hyftor (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/23/1723).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.