Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - hyftor

Document Subject

Generated Narrative: MedicinalProductDefinition mpa0d64103b1c8a608be4329399bf17c80

identifier: http://ema.europa.eu/identifier/EU/1/23/1723/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Hyftor 2 mg/g gel

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-a0d64103b1c8a608be4329399bf17c80

identifier: http://ema.europa.eu/identifier/EU/1/23/1723/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - hyftor

Attesters

What is in 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

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 complex 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 surfaces, such as the lining of the mouth) in the face, in many patients.

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 exposing 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 recommended 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 sirolimus 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 the ability to drive or use machines.

Hyftor contains alcohol This medicine contains 458 mg alcohol (ethanol) in each gram. It may cause a burning sensation when applied to damaged skin.

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.

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 off 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 remember 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.

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
• red eye
• eye irritation
• conjunctivitis (redness and discomfort in the eye)
• inflammation of hair follicles
• 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.

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.

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. 40547 D sseldorf Germany

Manufacturer MSK Pharmalogistic GmbH.
Donnersbergstra e 4
64646 Heppenheim
Germany

This leaflet was last revised in

Other sources of information 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.