Prospect: information for the patient

Redoxfarma Fusidic Acid 20 mg/g cream

Read this prospect carefully before starting to use this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1. What isRedoxfarma Fusidic Acid 20 mg/gcreamand for what it is used

2. What you need to know before starting to useRedoxfarma Fusidic Acid 20 mg/gcream

3. How to useRedoxfarma Fusidic Acid 20 mg/gcream

4. Possible adverse effects

5. Storage ofRedoxfarma Fusidic Acid 20 mg/gcream

6. Contents of the package and additional information

The active ingredient of Fusidic Acid Redoxfarma 20 mg/g Cream is fusidic acid. This medication is an antibiotic (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 swollen, suppurative, and crusty skin lesion), impetigo 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 and scaly lesions, especially in skin folds).

Do not use Redoxfarma Fusidic Acid 20 mg/g cream

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

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

Warnings and precautions

• If you use Redoxfarma Fusidic Acid 20 mg/g cream on your 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 a long time or in large quantities, it may increase the risk of side effects. Your skin may also become more sensitive to the cream.

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

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

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medicine, including those purchased without a prescription.

No interactions of Redoxfarma Fusidic Acid 20 mg/g cream with other medicines are known.

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 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 whether 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 Redoxfarma Fusidic Acid 20 mg/g cream during breastfeeding will harm the baby/child.Redoxfarma Fusidic Acid 20 mg/g cream may be used during breastfeeding, but it should be avoided on the breast.

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

Fertility

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

Driving and operating machines

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

Redoxfarma 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).

It may also cause eye and mucous membrane irritation due to the presence of butylhydroxyanisole.

Follow exactly the administration instructions of this medication 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 bandage or sterile dressing, you can 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 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 medication.

1. Wash your hands before using the cream
2. Remove the cap
3. Check that the seal on the tube is intact before using the cream for the first time
4. Press the seal on the tube with the cap's pin
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 your eyes, rinse them with cold water immediately. Then, rinse them with eye wash if possible. You may experience tearing. In case of vision problems or eye pain, consult your doctor immediately.

Treatment duration

Your doctor will decide on the treatment duration. Normally, the treatment is 1 or 2 weeks, although it may last longer. This depends on the type of infection and the treatment outcome. Be especially careful if you use the cream for a prolonged period or in large quantities, as there is a higher risk of 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 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot 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 compensate for the missed dose.

If you interrupt the treatment with Fusidic Acid Redoxfarma 20 mg/g cream

Always use Fusidic Acid Redoxfarma 20 mg/g cream for the time indicated by your doctor. In case of doubt, consult your doctor. If you interrupt the treatment with Fusidic Acid Redoxfarma 20 mg/g cream before the indicated time, it is possible that the skin infection will recur or not be fully cured.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience 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 1000 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 may include inflamed and red skin rash, difficulty breathing, facial, mouth, lip, or eyelid inflammation, unexplained high temperature (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
• Contact dermatitis (skin sensitivity reactions)
• Irritation at the application site (including pain, stinging, burning, and redness of the skin)

Rare

• Blisters
• Skin inflammation
• Urticaria
• Conjunctivitis

Reporting side effects

If you experience any type of side effect, 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 theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store below 25°C

Dispose of the tube after 4 weeks after the first opening, even if there is still cream left.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Redoxfarma 20 mg/g Fusidic Acid Cream

• The active ingredient 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 prospectus. .

Appearance of the product and contents of the packaging and contents of the packaging

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.

Only some packaging sizes may be marketed.

Marketing Authorization Holder

REDOX FARMA S.L.U.

Ctra. Fuencarral 22,

Edificio Net-pharma

28108, Alcobendas,

Madrid

Responsible for manufacturing

Basic Pharma Manufacturing BV,

Burgemeester Lemmensstraat 352, 6163 JT Geleen,

Netherlands

This medicine is authorized in the member states of the European Economic Area with the following names:

Germany FusiGalen 20 mg/g Crème

Netherlands Fusidinezuur Basic Pharma 20 mg/g crème

Spain Fusidic Acid Redoxfarma 20 mg/g Cream

This prospectus has been approved: November 2018

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