Fusidic acid Redoxpharma 20 mg/g cream

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Fusidic Acid Redoxfarma 20 mg/g cream

Read the entire leaflet carefully before you start 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 questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Ácido fusídico Redoxfarma 20 mg/g cream is and what it is used for

The active substance in Ácido fusídico Redoxfarma 20 mg/g cream is fusidic acid. This medicine is an antibiotic (it acts against bacteria that cause infection).

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

2. What you need to know before starting to 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 to any of the other ingredients of this medicine, listed in section 6 of this leaflet.

Always inform your doctor about any medicines or substances you are allergic to.

Warnings and precautions

• If you are applying Fusidic Acid Redoxfarma 20 mg/g cream on the face. The cream must not be applied in or around the eyes, as it may cause stinging in the eyes.
• If you use the cream for long periods or in large amounts, the likelihood of experiencing adverse effects may increase. In addition, your skin may become more sensitive to the cream.

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

Use of Fusidic Acid Redoxfarma 20 mg/g cream with other medicines

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

There are no known interactions between Fusidic Acid Redoxfarma 20 mg/g cream and other medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

There is insufficient evidence to confirm that the use of this medicine during pregnancy is safe. Depending on the circumstances, your doctor will assess the risks and benefits of using this medicine. You and your doctor will decide whether you should 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 may be used during breastfeeding, but application to the breast area should be avoided.

You should only use this medicine during breastfeeding if advised by your doctor.

Fertility

There is insufficient evidence to show 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 would affect fertility in women of reproductive age.

Driving and using machines

Fusidic Acid Redoxfarma 20 mg/g cream does not affect the ability to drive or operate machinery.

Fusidic Acid 20 mg/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).

In addition, butylhydroxyanisole may cause irritation of the eyes and mucous membranes.

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

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Dosage

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

Children and adults

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

If you think that 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 swallow the medicine.

1. Always wash your hands before using the cream
2. Unscrew the cap
3. Check that the seal on the tube is intact before first use
4. Pierce the seal of the tube with the spike on the cap
5. Carefully apply the cream to the skin
6. If applying the cream to the face, do so carefully to avoid the eyes
7. Always wash your hands after using the cream, unless the hands are the area being treated

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

Duration of treatment

Your doctor will decide the duration of treatment. Usually, treatment lasts 1 or 2 weeks, although it may last longer. This depends on the type of infection and the response to treatment. Take special care if you use the cream for a prolonged period or in large amounts, as there is a higher likelihood of experiencing adverse 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 accidentally ingested Fusidic Acid Redoxfarma 20 mg/g cream, it is unlikely to cause harm. However, if you notice any effects 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 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 missed dose.

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

Always use Fusidic Acid Redoxfarma 20 mg/g cream for the length of time prescribed by your doctor. If in doubt, consult your doctor. If you stop treatment with Fusidic Acid Redoxfarma 20 mg/g cream earlier than advised, the skin infection may recur or may not be fully cured.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The most common adverse effects are skin reactions, particularly at the site of application.

The classification of adverse 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 adverse effects when using this medicine, inform your doctor or go to hospital immediately:

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

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

Uncommon

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

Rare

• Blisters
• Skin inflammation
• Urticaria
• Conjunctivitis

Reporting of adverse effects

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

5. Storage of 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Store below 25°C.

Discard the tube 4 weeks after first opening, even if there is still cream remaining.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This helps 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 components 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.

Nature of the product and pack sizes

Fusidic acid cream is a white to off-white cream, available in an aluminum tube with a screw cap made of HDPE.

Contents: 15 grams and 30 grams.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

REDOX FARMA S.L.U.

Ctra. Fuencarral 22,

Edificio Net-pharma

28108, Alcobendas,

Madrid, Spain

Manufacturer

Basic Pharma Manufacturing BV,

Burgemeester Lemmensstraat 352, 6163 JT Geleen,

The Netherlands

This medicinal product is authorized in the European Economic Area member states 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 has been approved: November 2018

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