Fusacid H

Package Leaflet: Information for the Patient

FUSACID H, (20 mg + 10 mg)/g, Cream

Fusidic acid + Hydrocortisone acetate

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Fusacid H and what is it used for
• 2. Important information before using Fusacid H
• 3. How to use Fusacid H
• 4. Possible side effects
• 5. How to store Fusacid H
• 6. Contents of the pack and other information

1. What is Fusacid H and what is it used for

Fusacid H is a cream for topical application to the skin.
The medicine contains the active substances fusidic acid – a strong antibacterial antibiotic from the fusidan group, and hydrocortisone acetate – a corticosteroid with mild action.
Fusidic acid acts mainly on Staphylococcus aureusbacteria, and also on bacteria from the Streptococcusspp., Corynebacteriumspp., Neisseriaspp., and some species of Clostridiumspp.
Hydrocortisone acetate has anti-inflammatory and antipruritic effects.
Indications for use
Fusacid H is used for the local treatment of inflammatory skin conditions with present or possible bacterial infection, caused by bacteria sensitive to fusidic acid.

2. Important information before using Fusacid H

When not to use Fusacid H

• if you are allergic to fusidic acid, sodium fusidate, hydrocortisone acetate, or any of the other ingredients of this medicine (listed in section 6);
• if you have an infection caused by bacteria resistant to fusidic acid, especially Pseudomonas aeruginosa;
• in case of bacterial, fungal, or viral skin infections (e.g., herpes and chickenpox);
• on syphilitic or tuberculous skin lesions;
• in perioral dermatitis and rosacea;
• during the period after vaccinations.

Warnings and precautions

Before starting to use Fusacid H, discuss it with your doctor or pharmacist.
Avoid long-term use of the medicine.
Use the medicine with special caution in children and infants, and do not use it for a long time, as it may lead to adrenal gland suppression.
If there is no improvement after 7 days of using the medicine, consult your doctor – the doctor will recommend other treatment.
If you experience any allergic reactions or skin irritation, consult your doctor.
Use the medicine with caution near the eyes. Protect your eyes from contact with the medicine, as it may cause glaucoma.
Long-term use of the medicine may lead to the development of additional infections caused by medicine-resistant microorganisms, including fungi.
Do not use the medicine for a long time on the skin of the face.
Do not use the medicine for a long time in patients with diabetes.
Do not use the medicine:

• in case of atrophic dermatitis, skin ulcers, acne, fragile blood vessel walls, itching in the anal and genital areas;
• on open wounds or mucous membranes.

Fusacid H and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about the medicines you plan to take.
No studies have been conducted on the interaction of Fusacid H with other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Pregnancy
Fusacid H should not be used during pregnancy, unless your doctor considers it absolutely necessary.
Breastfeeding
The safety of using Fusacid H in breastfeeding women has not been established.
If the medicine is applied to the breasts, it must be removed before breastfeeding.

Driving and using machines

Fusacid H has no influence or negligible influence on the ability to drive and use machines.

Fusacid H contains butylhydroxyanisole (E 320), cetyl alcohol, potassium sorbate (E 202), and polysorbate 60 (E 435).

Due to the presence of butylhydroxyanisole (E 320), cetyl alcohol, and potassium sorbate (E 202) in the medicine, it may cause local skin reactions (e.g., contact dermatitis).
Additionally, due to the presence of butylhydroxyanisole (E 320) in the medicine, it may cause eye and mucous membrane irritation.
The medicine contains polysorbate 60 (E 435). Polysorbates may cause allergic reactions.

3. How to use Fusacid H

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Clean, affected skin is usually covered with a small amount of the medicine 2 times a day.
Do not use the medicine for more than 2 weeks.
After using the medicine, wash your hands.

Using more than the recommended dose of Fusacid H

In case of overdose, contact your doctor.

Missing a dose of Fusacid H

Do not use a double dose to make up for a forgotten dose.

Stopping the use of Fusacid H

If you have any further questions about 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.
The frequency of side effects is defined as follows:
very common (occurring in more than 1 in 10 patients);
common (occurring in 1 to 10 in 100 patients);
uncommon (occurring in 1 to 10 in 1,000 patients);
rare (occurring in 1 to 10 in 10,000 patients);
very rare (occurring in less than 1 in 10,000 patients);
not known (frequency cannot be estimated from the available data).
Uncommon:
increased rash, itching, skin irritation, burning or stinging sensation.
Unknown frequency:
allergic reactions, rash, allergic contact dermatitis, skin discoloration.
Due to the presence of hydrocortisone (corticosteroid) in the medicine, the following may occur:
skin atrophy, telangiectasia (dilation of small blood vessels), skin striae, folliculitis, excessive hair growth, perioral dermatitis, contact dermatitis, skin discoloration, and adrenal gland disorders.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Fusacid H

Store in a temperature below 25°C. Store the tube tightly closed.
Do not store in the refrigerator or freeze.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
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 Fusacid H contains

• The active substances of the medicine are: fusidic acid in the form of fusidic acid hemihydrate and hydrocortisone acetate. 1 g of cream contains 20 mg of fusidic acid in the form of fusidic acid hemihydrate (20.3 mg) and 10 mg of hydrocortisone acetate.
• The other ingredients are: white petrolatum, glycerol, polysorbate 60 (E 435), butylhydroxyanisole (E 320), liquid paraffin, cetyl alcohol, potassium sorbate (E 202), purified water.

What Fusacid H looks like and contents of the pack

Fusacid H is a homogeneous, white or almost white cream.
The packaging of the medicine is an aluminum tube with a membrane, internally coated with epoxy-phenolic lacquer, with a PE screw cap, containing 5 g or 20 g of cream. The tube, along with the patient leaflet, is placed in a cardboard box.

Marketing authorization holder and manufacturer

CHEMA-ELEKTROMET
Cooperative
ul. Przemysłowa 9
35-105 Rzeszów
phone: 17 862 05 90
e-mail: chema@chema.rzeszow.pl

Date of last revision of the leaflet: