Package leaflet: Information for the user

Hylosept, 20 mg/g, cream
Acidum fusidicum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

What Hylosept is and what it is used for
What you need to know before using Hylosept
How to use Hylosept
Possible side effects
How to store Hylosept
Contents of the pack and other information

1. What Hylosept is and what it is used for

The active substance in Hylosept is fusidic acid. It is an antibiotic (which means it kills bacteria that cause infections).
Hylosept is for topical use on the skin. The cream is indicated for the local treatment of skin infections caused by bacteria sensitive to fusidic acid (especially staphylococcal infections), such as: impetigo (moist, crusted and swollen patches on the skin), folliculitis (inflammation of one or more hair follicles), sycosis barbae (infection of the bearded skin), paronychia (infection of the tissues surrounding the nails of the hands or feet), and seborrhoeic dermatitis (infection with brown, scaling skin patches, especially in skin folds).

2. Important information before using Hylosept medicine

When not to use Hylosept

if the patient is allergic to fusidic acid or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Hylosept, discuss this with your doctor or pharmacist.

If Hylosept cream is applied to the face. The cream must not be used in or around the eyes, as it may cause a stinging sensation in the eye.
If the cream is used for a prolonged period or in large amounts, as this may lead to more pronounced adverse effects. The patient's skin may also become more sensitive to the cream.

You should inform your doctor if any of the above warnings apply to you or
have applied in the past.
Hylosept and other medicines
Tell your doctor or pharmacist about any medicines you are currently taking, have recently taken, or plan to take.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
Pregnancy
Systemic exposure to fusidic acid after topical application is negligible; therefore, no adverse effects of Hylosept cream on the skin are expected during pregnancy.
Hylosept may be used topically on the skin during pregnancy.
Breastfeeding
It is unlikely that topically applied Hylosept would harm the breastfed infant. Hylosept cream may be used during breastfeeding, but it should not be applied to the skin of the breasts.
Fertility
There is insufficient evidence to confirm any effect of Hylosept on fertility. However, it is unlikely that Hylosept would affect fertility in women of reproductive age.
Driving and operating machinery
Hylosept has no influence on the ability to drive or operate machinery.
Hylosept contains butylhydroxyanisole, cetyl alcohol and potassium sorbate.
Cetyl alcohol and potassium sorbate may cause local skin reactions (e.g. contact dermatitis).
Butylhydroxyanisole may cause a local skin reaction (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.

3. How to use Hylosept

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt,
please consult your doctor or pharmacist.
Recommended dose
Children and adults
Your doctor will decide the appropriate dose of Hylosept to use.
Typically, a small amount of the cream is applied to the infected skin three or four times daily. If
your doctor recommends using a sterile dressing or protective covering, the frequency of application
may usually be reduced.
If you feel that Hylosept is too strong or not strong enough, consult your doctor or pharmacist.
Use in children
A diaper on a small child may act like clothing. Follow the advice provided by your doctor.
How to use Hylosept
Hylosept cream should be applied to the skin. Do not swallow the cream.

Always wash your hands before using the cream.
Remove the cap.
Before first use, check that the seal is intact.
Push the spike in the cap through the seal of the tube.
Gently rub the cream into the skin.
If applying the cream to the face, avoid contact with the eyes.
Always wash your hands after using the cream, unless the cream is being used to treat the hands.

If the cream accidentally gets into the eye, rinse immediately with cold water. Then, if possible,
rinse the eye with eye irrigation solution. The eye may feel stinging.
If any problems with vision or eye pain occur, contact your doctor immediately.
Duration of treatment
Your doctor will determine how long treatment should last. Treatment usually lasts from 1 to 2 weeks,
although it may be longer. This depends on the type of infection and the response to treatment.
Particular caution is required when using the cream for prolonged periods or in large amounts, as this
increases the risk of adverse effects. Therefore, always follow your doctor's instructions.
Use of more than the recommended dose of Hylosept
If too much of the medicine is used or if Hylosept cream is accidentally swallowed, harmful effects
are unlikely. However, if the patient notices any symptoms causing concern, they should contact
their doctor or pharmacist.
Contact your doctor if a child accidentally swallows Hylosept cream.
Missed dose of Hylosept
If the patient forgets to apply the cream, they should apply the usual dose of Hylosept as soon as
they remember. Do not apply a double dose to make up for a missed dose.
Stopping Hylosept treatment
Always use Hylosept for the length of time prescribed by your doctor. If the patient has any doubts,
they should discuss this with their doctor. Stopping treatment too early may cause the skin infection
to return or prevent complete healing.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
The most commonly occurring adverse reaction is various skin reactions, particularly reactions
at the site of application of the medicine.
If any of the following rare adverse reactions occur while using the medicine, you should
immediately inform your doctor or go straight to hospital:

Severe allergic reaction, which may include: red, lumpy rash, difficulty breathing, swelling of the face, mouth, lips or eyelids, unexplained high temperature (fever and weakness). If swelling of the throat occurs and breathing or swallowing becomes difficult, go immediately to hospital.

Not very common (affects no more than 1 in 100 patients)

itching
rash
eczema
skin hypersensitivity reactions (contact dermatitis)
skin irritation at the site of application (including: pain, stinging, burning and redness of the skin).

Rare (affects no more than 1 in 1,000 patients)

blisters
skin swelling
urticaria
conjunctivitis.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, tell your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store the Hylosept medication

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box or
tube after "EXP". The expiry date refers to the last day of the stated month.
Do not store at temperatures above 25°C.
Discard the tube 4 weeks after first opening, even if there is still cream remaining in the tube.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Hylosept contains

The active substance is fusidic acid. Each 1 g of cream contains 20 mg of fusidic acid.
Other ingredients: cetyl alcohol, white vaseline, liquid paraffin, glycerol (85%), butylated hydroxyanisole (E 320), polysorbate 60, potassium sorbate (E 202), purified water, hydrochloric acid. Some of these ingredients may cause skin reactions, see section 2 of this leaflet.

What Hylosept looks like and contents of the pack
Hylosept is a white to almost white cream available in an aluminium tube with an HDPE cap, packed in a cardboard box.
Pack sizes: 15 g and 30 g.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Aristo Pharma Sp. z o.o.
Baletowa 30 Street
02-867 Warsaw
Poland
Manufacturer
Basic Pharma Manufacturing B.V.
Burgemeester Lemmensstraat 352
6163JT Geleen
The Netherlands
This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Belgium, Luxembourg Affusine
Netherlands Fusidinezuur Basic Pharma 20 mg/g crème
Poland Hylosept
United Kingdom (Northern Ireland) Fusidic acid 20 mg/g cream