Patient leaflet - Hyftor 2 mg/g gel

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 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.

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 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.

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.

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.

Package leaflet: Information for the user

Hyftor 2 mg/g gel

sirolimus

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. 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.

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
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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 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 UK Ltd

149 Woodstock Road

Oxford

OX2 7NA

United Kingdom

Manufacturer