FUSIDIC ACID REDOXFARMA 20 mg/g CREAM

Introduction

Package Leaflet: Information for the Patient

Fusidic Acid Redoxfarma 20 mg/g Cream

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.

Contents of the pack

1. What is Fusidic Acid Redoxfarma 20 mg/g Cream and what is it used for
2. What you need to know before you use Fusidic Acid Redoxfarma 20 mg/g Cream
3. How to use Fusidic Acid Redoxfarma 20 mg/g Cream
4. Possible side effects
5. Storing Fusidic Acid Redoxfarma 20 mg/g Cream
6. Contents of the pack and other information

1. What is Fusidic Acid Redoxfarma 20 mg/g Cream and what is it used for

The active substance of Fusidic Acid Redoxfarma 20 mg/g Cream is fusidic acid. This medicine is an antibiotic (it acts on bacteria that cause infection).

Fusidic Acid Redoxfarma 20 mg/g Cream is applied to the skin. The cream is indicated for the local treatment of skin infections caused by bacteria sensitive to fusidic acid (especially infections produced by staphylococcus) such as impetigo (a skin lesion that is swollen, suppurating, and crusty), impetiginized dermatitis (underlying non-inflammatory skin disease with secondary impetigo), folliculitis (inflammation of one or more hair follicles), pseudofolliculitis of the beard (skin infection in the beard area), paronychia (infection of the tissue surrounding the fingernails or toenails), erythrasma (infection with brown and scaly lesions, especially in skin folds).

2. What you need to know before you use Fusidic Acid Redoxfarma 20 mg/g Cream

Do not use Fusidic Acid Redoxfarma 20 mg/g Cream

• if you are allergic to fusidic acid or any of the other ingredients of this medicine, including those listed in section 6 of this leaflet.

Always inform your doctor of the medicines and substances you are allergic to.

Warnings and precautions

• If you use Fusidic Acid Redoxfarma 20 mg/g Cream on the face. The cream should not be applied to the eyes or around them, as it may cause eye irritation.
• If you use the cream for long periods or in large quantities, it may increase the likelihood of side effects. Additionally, your skin may become more sensitive to the cream.

Inform your doctor if any of the above warnings apply to you or have occurred in the past.

Using Fusidic Acid Redoxfarma 20 mg/g Cream with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription.

No interactions with other medicines are known for Fusidic Acid Redoxfarma 20 mg/g Cream.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

There is not enough evidence to demonstrate that the use of this medicine during pregnancy is safe. Depending on the circumstances, your doctor will weigh the risks and benefits of using this medicine. You and your doctor will decide if you will use this medicine during pregnancy.

You should only use this medicine during pregnancy if your doctor considers it necessary.

Breastfeeding

It is unlikely that the topical use of Fusidic Acid Redoxfarma 20 mg/g Cream during breastfeeding will harm the newborn/child. Fusidic Acid Redoxfarma 20 mg/g Cream can be used during breastfeeding, but application to the breast should be avoided.

You should only use this medicine during breastfeeding if your doctor advises you to do so.

Fertility

There is not enough evidence to demonstrate that Fusidic Acid Redoxfarma 20 mg/g Cream affects fertility. However, it is unlikely that the use of Fusidic Acid Redoxfarma 20 mg/g Cream will affect the fertility of women of childbearing age.

Driving and using machines

Fusidic Acid Redoxfarma 20 mg/g Cream does not affect the ability to drive or use machines.

Fusidic Acid 20mg/g Cream contains butylhydroxyanisole, cetyl alcohol, and potassium sorbate

This medicine contains butylhydroxyanisole, potassium sorbate, and cetyl alcohol, which may cause local skin reactions (such as contact dermatitis).

Additionally, it may cause eye and mucous membrane irritation because it contains butylhydroxyanisole.

3. How to use Fusidic Acid Redoxfarma 20 mg/g Cream

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Dose

Your doctor will tell you how much Fusidic Acid Redoxfarma 20 mg/g Cream to use.

Children and adults

Apply a small amount of cream to the infected skin area three or four times a day. If your doctor advises you to use a dressing or sterile bandage, you may reduce the number of applications. In babies, the diaper can act as a "dressing". Follow your doctor's advice.

If you think the effect of Fusidic Acid Redoxfarma 20 mg/g Cream is too strong or too weak, consult your doctor or pharmacist.

How to apply Fusidic Acid Redoxfarma 20 mg/g Cream

Fusidic Acid Redoxfarma 20 mg/g Cream should be applied to the skin. Do not ingest the medicine.

1. Always wash your hands before using the cream.
2. Remove the cap.
3. Check that the tube seal is intact before using the cream for the first time.
4. Press the tube seal with the pin on the cap.
5. Apply the cream carefully to the skin.
6. If you use the cream on the face, apply it carefully to avoid the eyes.
7. Always wash your hands after using the cream, unless your hands are the treated area.

If the cream comes into contact with the eyes, rinse them with cold water immediately. Then, rinse with eye wash if possible. Your eyes may sting. If you experience vision problems or eye pain, consult your doctor immediately.

Treatment duration

Your doctor will decide the treatment duration. The treatment is usually 1 or 2 weeks, although it may last longer. This depends on the type of infection and the treatment outcome. Be careful if you use the cream for a prolonged period or in large quantities, as there is a higher likelihood of side effects. Therefore, always follow your doctor's advice.

If you use more Fusidic Acid Redoxfarma 20 mg/g Cream than you should

If you have applied more cream than you should or have ingested Fusidic Acid Redoxfarma 20 mg/g Cream by accident, it is unlikely to cause any harm. However, if you notice any effect or are concerned, consult your doctor or pharmacist. In case of accidental ingestion of Fusidic Acid Redoxfarma 20 mg/g Cream by a child, consult your doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Fusidic Acid Redoxfarma 20 mg/g Cream

If you forget to apply the cream, apply the usual amount of Fusidic Acid Redoxfarma 20 mg/g Cream as soon as possible. Do not use a double dose to make up for the forgotten dose.

If you stop using Fusidic Acid Redoxfarma 20 mg/g Cream

Always use Fusidic Acid Redoxfarma 20 mg/g Cream for the duration indicated by your doctor. In case of doubt, consult your doctor. If you stop the treatment with Fusidic Acid Redoxfarma 20 mg/g Cream before the indicated time, it is possible that the skin infection may reappear or not be completely cured.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most common side effects are skin reactions, specifically at the application site.

The classification of side effects by frequency is as follows:

• Very common: may affect more than 1 in 10 people.
• Common: may affect up to 1 in 10 people.
• Uncommon: may affect up to 1 in 100 people.
• Rare: may affect up to 1 in 1,000 people.
• Very rare: may affect up to 1 in 10,000 people.

If you experience any of the following rare side effects when using the medicine, inform your doctor or go to the hospital immediately:

Severe allergic reaction, which can include inflamed and reddened skin rash, difficulty breathing, swelling of the face, mouth, lips, or eyelids, elevated temperature without apparent cause (fever and feeling of fainting).

If the inflammation affects the throat and causes difficulty swallowing and breathing, go to the hospital immediately.

Uncommon

• Itching.
• Skin rash.
• Eczema.
• Skin sensitivity reactions (contact dermatitis).
• Irritation at the application site (including pain, itching, burning, and redness of the skin).

Rare

• Blisters.
• Skin inflammation.
• Hives.
• Conjunctivitis.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Fusidic Acid Redoxfarma 20 mg/g Cream

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 after EXP. The expiry date is the last day of the month shown.

Store below 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. Place the empty packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fusidic Acid Redoxfarma 20 mg/g Cream

• The active substance is fusidic acid. Each gram of cream contains 20 mg of fusidic acid.

The other ingredients are butylhydroxyanisole (E-320), cetyl alcohol, glycerol (E-422), liquid paraffin, potassium sorbate (E-202), polysorbate 60 (E435), white soft paraffin, hydrochloric acid (for pH adjustment), and purified water. Some of these ingredients may cause skin reactions; see section 2 of the leaflet.

Appearance of the product and pack contents

Fusidic Acid Cream is a white to off-white cream, available in an aluminum tube with an HDPE screw cap.

Contents: 15 grams and 30 grams.

Not all pack sizes may be marketed.

Marketing authorization holder

REDOX FARMA S.L.U.

Ctra. Fuencarral 22,

Edificio Net-pharma

28108, Alcobendas,

Madrid

Manufacturer

Basic Pharma Manufacturing BV,

Burgemeester Lemmensstraat 352, 6163 JT Geleen,

Netherlands

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany FusiGalen 20 mg/g Crème

Netherlands Fusidinezuur Basic Pharma 20 mg/g crème

Spain Acido Fusidico Redoxfarma 20 mg/g Crema

This leaflet was approved: November 2018

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/