Hilosept

Package Leaflet: Information for the User

Hylosept, 20 mg/g, Cream

Fusidic Acid

Read All of This Leaflet Carefully Before Using This Medicine Because It Contains Important Information for You.

• You should 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. Do not pass it on to others. It may harm them, even if their symptoms 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.

Contents of the Pack

• 1. What is Hylosept and What is it Used For
• 2. Before You Use Hylosept
• 3. How to Use Hylosept
• 4. Possible Side Effects
• 5. How to Store Hylosept
• 6. Contents of the Pack and Other Information

1. What is Hylosept and What is it Used For

The active substance of Hylosept is fusidic acid. It is an antibiotic (which means it kills bacteria that cause infections).
Hylosept is used on the skin. The cream is used to treat local skin infections caused by bacteria sensitive to fusidic acid (especially staphylococcal infections), such as: impetigo (wet, crusty, and swollen patches on the skin), folliculitis (inflammation of one or more hair follicles), sycosis barbae (infection of the hairy part of the beard), paronychia (infection of the tissues surrounding the fingernails or toenails), pityriasis (infection with brown, flaky skin patches, especially in skin folds).

2. Before You Use Hylosept

When Not to Use Hylosept

Warnings and Precautions

Before using Hylosept, you should discuss it with your doctor or pharmacist.

• If Hylosept cream is used on the face. The cream must not be used in the eyes or near the eyes, as it may cause a stinging sensation in the eye.
• If the cream is used for a long time or in large amounts, as this may cause more severe side 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

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

Pregnancy, Breast-Feeding, and Fertility

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.
Pregnancy
It is not expected that the use of Hylosept cream on the skin during pregnancy will have any effect, as the systemic exposure to fusidic acid from the skin is minimal.
Hylosept can be used locally on the skin during pregnancy.
Breast-Feeding
It is unlikely that Hylosept used locally on the skin during breast-feeding will harm your baby. Hylosept cream can be used during breast-feeding, but you should avoid applying it to the breast skin.
Fertility
There is not enough evidence to confirm the effect of Hylosept on fertility. However, it is unlikely that Hylosept will affect fertility in women of childbearing age.

Driving and Using Machines

Hylosept does not affect the ability to drive or use machines.

Hylosept Contains Butylhydroxyanisole, Cetostearyl Alcohol, and Potassium Sorbate.

Cetostearyl 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 eye and mucous membrane irritation.

3. How to Use Hylosept

This medicine should always be used exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Recommended Dose
Children and Adults
Your doctor will decide what dose of Hylosept to use.
Usually, a small amount of cream is applied to the infected skin three or four times a day. If your doctor recommends using a sterile bandage or protective dressing, you can usually reduce the number of applications of the medicine.
If you feel that the effect of Hylosept is too strong or too weak, talk to your doctor or pharmacist.

Use in Children

A diaper can act like a dressing on a small child. You should follow the advice given by your doctor.
How to Use Hylosept
Hylosept cream should be applied to the skin. Do not swallow the cream.

• 1. Always wash your hands before using the cream.
• 2. Remove the cap.

• 3. Before using the cream for the first time, check that the seal is not broken.
• 4. Push the spike in the cap through the seal on the tube.
• 5. Gently rub the cream into the skin.
• 6. If the cream is used on the face, avoid contact with the eyes.
• 7. Always wash your hands after using the cream, unless the cream is used to treat your hands.

If the cream accidentally gets into the eye, rinse it immediately with cold water. Then, if possible, rinse the eye with an eye wash solution. The eye may sting.
If you experience any problems with your vision or eye pain, contact your doctor immediately.
Duration of Treatment
Your doctor will decide how long you should use Hylosept. Treatment usually lasts from 1 to 2 weeks, although it may last longer. This depends on the type of infection and the result of the treatment. You should be careful when using the cream for a long time or in large amounts, as this increases the risk of side effects. Therefore, you should always follow your doctor's advice.

Using More Hylosept Than You Should

If you use too much of the medicine or accidentally swallow the cream, it is unlikely that you will experience any harmful effects. However, if you notice any effects that worry you, you should contact your doctor or pharmacist.
You should contact your doctor if the cream is accidentally swallowed by a child.

Forgetting to Use Hylosept

If you forget to use the cream, apply the usual dose as soon as you remember. Do not use a double dose to make up for a forgotten dose.

Stopping Hylosept Treatment

You should always use Hylosept for the duration of time prescribed by your doctor. If you have any doubts, you should talk to your doctor. Stopping the use of Hylosept too early may cause the skin infection to come back or not be fully treated.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Hylosept can cause side effects, although not everybody gets them.
The most common side effect is various skin reactions, particularly reactions at the site of application.

If You Experience Any of the Following Rare Side Effects, Tell Your Doctor or Go to the Hospital Immediately:

• Severe allergic reaction, which may include: red and lumpy skin rash, difficulty breathing, swelling of the face, mouth, lips, or eyelids, unexplained high temperature (fever and weakness).

If You Experience Swelling of the Throat and Have Difficulty Breathing or Swallowing, Go to the Hospital Immediately.

Not Very Common (Affects No More Than 1 in 100 People)

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

Rare (Affects No More Than 1 in 1,000 People)

• blisters
• skin swelling
• hives
• conjunctivitis.

Reporting Side Effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Hylosept

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 tube after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
Discard the tube after 4 weeks of first opening, even if some cream remains.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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.
• The other ingredients are cetostearyl alcohol, white petrolatum, liquid paraffin, glycerol (85%), butylhydroxyanisole (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 and is available in an aluminum tube with an HDPE cap, in a cardboard box.
Pack sizes: 15 g and 30 g.
Not all pack sizes may be marketed.

Marketing Authorization Holder

Aristo Pharma Sp. z o.o.
Baletowa 30
02-867 Warsaw

Manufacturer

Basic Pharma Manufacturing B.V.
Burgemeester Lemmensstraat 352
6163JT Geleen
Netherlands

This Medicinal Product is Authorized 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
Date of Last Revision of the Leaflet:February 2022