Fusacid h
Poland
Table of Contents
Package leaflet: information for the patient
FUSACID H, (20 mg + 10 mg)/g, cream
Fusidic acid + Hydrocortisone acetate
Please read this leaflet carefully before using this medicine, as 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. It may harm someone else, 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.
Table of contents
- What Fusacid H is and what it is used for
- Important information before using Fusacid H
- How to use Fusacid H
- Possible side effects
- How to store Fusacid H
- Contents of the pack and other information
1. What Fusacid H is and what it is used for
Fusacid H is a topical cream for application to the skin.
The medicine contains the active substances fusidic acid – an antibiotic with strong antibacterial action belonging to the fusidins group, and hydrocortisone acetate – a corticosteroid with weak activity.
Fusidic acid acts primarily against Staphylococcus aureus bacteria, and also acts against bacteria of the genera Streptococcus spp., Corynebacterium spp., Neisseria spp., and some species of Clostridium spp.
Hydrocortisone acetate has anti-inflammatory and antipruritic effects.
Indications
Fusacid H is indicated for the topical treatment of inflammatory skin conditions associated with, or suspected of being associated with, 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 bacterial, fungal, or viral skin infections (e.g. herpes simplex and varicella);
- on syphilitic or tuberculous skin lesions;
- in perioral dermatitis and rosacea;
- in the period following vaccination.
Warnings and precautions
Before starting treatment with Fusacid H, discuss it with your doctor or pharmacist.
Avoid prolonged use of the medicine.
Use particular caution in children and infants, and do not use long-term, as this may lead to suppression of adrenal function.
If there is no improvement after 7 days of treatment, consult your doctor – your doctor will recommend alternative treatment.
If allergic reactions or skin irritation occur, consult your doctor.
Use with caution near the eyes. Protect the eyes from contact with the medicine, as introduction of the medicine into the eye may cause glaucoma.
Prolonged use of the medicine may lead to superinfection caused by drug-resistant microorganisms, including fungi.
Do not use the medicine long-term on the facial skin.
Do not use the medicine long-term in patients with diabetes.
Do not use the medicine:
- in atrophic dermatitis, skin ulceration, acne, fragile venous walls, anal or genital pruritus;
- on open wounds or mucous membranes.
Fusacid H and other medicines
Tell your doctor or pharmacist about any medicines you are currently taking, have recently taken, or plan to take.
No studies on interactions between Fusacid H and other medicines have been conducted.
Pregnancy and breastfeeding
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
Fusacid H should not be used during pregnancy unless in the opinion of the doctor it is absolutely necessary.
Breastfeeding
The safety of using Fusacid H in breastfeeding women has not been established.
If the medicine is applied to the nipples, it must be removed before breastfeeding.
Driving and operating machinery
Fusacid H has no effect or negligible effect on the ability to drive and operate machinery.
Fusacid H contains butylated hydroxyanisole (E 320), cetyl alcohol, potassium sorbate (E 202), and polysorbate 60 (E 435).
Due to the presence of butylated hydroxyanisole (E 320), cetyl alcohol, and potassium sorbate (E 202), this medicine may cause local skin reactions (e.g. contact dermatitis).
In addition, due to the presence of butylated hydroxyanisole (E 320), this medicine 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
This medicine should always be used as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
The affected, diseased skin should usually be covered with a small amount of the medicine twice daily.
Do not use the medicine for longer than 2 weeks.
After applying the medicine, wash your hands.
Use of a larger than recommended dose of Fusacid H
In case of overdose, contact your doctor.
Missed dose of Fusacid H
Do not use a double dose to make up for a missed dose.
Stopping treatment with Fusacid H
If you have any further doubts regarding the use of this medicine, consult your
doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
The frequency of occurrence of the adverse effects listed below is defined as follows:
very common (affects more than 1 in 10 people);
common (affects 1 to 10 in 100 people);
uncommon (affects 1 to 10 in 1,000 people);
rare (affects 1 to 10 in 10,000 people);
very rare (affects less than 1 in 10,000 people);
unknown (frequency cannot be estimated based on available data).
Uncommon:
intensified rash, itching, skin irritation, burning or stinging sensation.
Unknown frequency:
hypersensitivity reactions, rash, allergic contact dermatitis, skin discolouration.
Since the medicine contains hydrocortisone (a corticosteroid), the following may occur:
skin atrophy, telangiectasia (dilation of small blood vessels), skin stretch marks, folliculitis, excessive hair growth, perioral dermatitis, contact dermatitis, skin discolouration, and disturbances in adrenal cortex function.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.
5. How to store Fusacid H
Store below 25°C. Keep the tube tightly closed.
Do not store in the refrigerator or freeze.
Keep this medicine out of 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 stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Fusacid H contains
- The active substances 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.
- Other ingredients: white soft paraffin, glycerol, polysorbate 60 (E 435), butylated hydroxyanisole (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 medicine is packed in an aluminium tube with a membrane, internally coated with epoxy-phenolic varnish, with a polyethylene (PE) cap, containing 5 g or 20 g of cream. The tube, together with the patient leaflet, is placed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
CHEMA-ELEKTROMET
Spółdzielnia Pracy
Przemysłowa 9
35-105 Rzeszów
Poland
Tel: +48 17 862 05 90
Email: [email protected]