FUCIDINE 250 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Fucidine 250 mg film-coated tablets

Sodium Fusidate

Contents of the package leaflet:

1. What is Fucidine tablets and what is it used for
2. What you need to know before you take Fucidine tablets
3. How to take Fucidine tablets
4. Possible side effects
5. Storage of Fucidine tablets
6. Contents of the pack and further information

1. What is Fucidine tablets and what is it used for

Fucidine tablets contain an antibiotic, 250 mg of sodium fusidate.

Fucidine tablets are indicated for the treatment of infections caused by sensitive germs (staphylococci), both local and generalized, especially when other antibiotics have not been effective or have caused an allergic reaction.

You should consult a doctor if it worsens or does not improve.

2. What you need to know before you take Fucidine tablets

Do not take Fucidine tablets

• if you are allergic to sodium fusidate/fusidic acid or any of the other ingredients of this medicine (listed in section 6).
• if you are taking statins (medicines to lower cholesterol).

Warnings and precautions

Consult your doctor or pharmacist before taking Fucidine tablets:

• if you are being treated with statins, as you will need to stop treatment and not take statins again until 7 days after finishing treatment with Fucidine tablets.

Tell your doctor if you feel weakness, pain, or muscle sensitivity.

• if you have any liver or bile duct disorders, as some controls may be necessary.
• if you are being treated with medicines used to treat acquired immunodeficiency syndrome or AIDS. Inform your doctor before starting treatment with Fucidine tablets.
• if the medicine is to be given to a newborn, as it may cause a yellowish coloration of the skin (kernicterus).

Contact your doctor immediately if you experience symptoms of skin reactions, which usually appear in the first few weeks after the first intake of Fucidine. These symptoms include rash or redness of the skin, including generalized rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals, fever, eye itching, and discomfort when swallowing.

Taking Fucidine tablets with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Fucidine tablets should not be taken with medicines used to lower blood cholesterol levels, such as statins, as it may cause rhabdomyolysis (muscle tissue destruction) which can be fatal. If you are being treated with statins, you will need to stop treatment and not take statins again until 7 days after finishing treatment with Fucidine tablets.

Tell your doctor if you feel weakness, pain, or muscle sensitivity.

Fucidine tablets may alter the effect of some oral anticoagulants (such as Sintrom or anticoagulants with similar actions) when taken at the same time. Therefore, during treatment with Fucidine tablets, as well as after treatment, your doctor may adjust the dose of the anticoagulant.

It may also interact with medicines used to treat acquired immunodeficiency syndrome or AIDS (such as ritonavir or saquinavir), leading to liver damage (hepatotoxicity) due to increased blood levels of both medicines. It is recommended not to take these medicines with Fucidine tablets.

Taking Fucidine tablets with food and drinks

The tablets can be taken with a little water after meals.

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 taking this medicine.

If you are pregnant or think you may be pregnant, or are breastfeeding, do not take this medicine without your doctor assessing whether you can take it.

Driving and using machines

This medicine does not affect your ability to drive or use machines.

Fucidine tablets contain lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Fucidine tablets contain sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Fucidine tablets

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist again.

Administer orally.

The recommended dose is:

• Generalized infections:

• Adults: two tablets (500 mg of sodium fusidate), 3-4 times a day.
• Children: one tablet (250 mg of sodium fusidate), 3-4 times a day.

• Infections of the skin and soft tissues:

• Adults and children over 12 years: one tablet (250 mg of sodium fusidate), 2 times a day.

The number of tablets per day may be changed if your doctor considers it necessary.

If you take more Fucidine tablets than you should

If you have taken more Fucidine tablets than you should, contact your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, you can also contact the Toxicology Information Service. Telephone 91 562 04 20.

If you forget to take Fucidine tablets

If you forget a dose, take another as soon as possible. Then continue as indicated.

Do not take a double dose to make up for forgotten doses.

If you stop taking Fucidine tablets

Your doctor will indicate the duration of your treatment with Fucidine tablets. Take the medicine until the end of the treatment. Do not stop treatment before, as it may be harmful to your health.

If you have any other 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 following side effects have been observed with the administration of this medicine:

Common: may affect up to 1 in 10 people

Vomiting

Diarrhea

Abdominal pain

Feeling of indigestion (dyspepsia)

Nausea

Abdominal discomfort

Lethargy

Fatigue

Weakness (asthenia)

Uncommon: may affect up to 1 in 100 people

Decrease in the number of some blood cells (pancytopenia, leucopenia, thrombocytopenia)

Anemia

Generalized allergic reactions (anaphylactic reactions)

Headache

Drowsiness

Decreased liver function

Bile retention in the gallbladder (cholestasis)

Hepatitis

Yellowish coloration of the skin and mucous membranes (jaundice)

High levels of bilirubin in the blood

Altered results in blood tests of liver function

Appearance of small, infected, red ulcers on the skin

Hives

Skin rash (rash)

Muscle fiber destruction (rhabdomyolysis)

Decreased kidney function (kidney failure)

Rare: may affect up to 1 in 1,000 people

Allergic reactions

Liver function alteration

Facial swelling/throat tightness and breathing difficulties (angioedema)

Itching

Redness

Frequency not known

Some cases of severe skin reactions have been reported after taking Fucidine, which can be life-threatening if not treated.

Contact your doctor immediately if you experience any of the following symptoms:

• rash or redness of the skin, including generalized rash with blisters and skin peeling, especially around the mouth, throat, nose, eyes, and genitals (Stevens-Johnson syndrome)
• generalized skin peeling of more than 30% of the body surface (toxic epidermal necrolysis)
• skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell). (Drug Reaction with Eosinophilia and Systemic Symptoms, also known as DRESS syndrome).

These severe skin reactions are often preceded by symptoms similar to those of the flu, such as fever, headache, and body pain.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fucidine tablets

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

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Fucidine tablets

• The active substance is sodium fusidate.

Each tablet contains 250 mg of sodium fusidate.

• The other ingredients are microcrystalline cellulose, lactose monohydrate, crospovidone, talc, hypromellose, magnesium stearate, anhydrous colloidal silica, α-tocopherol, and titanium dioxide (E-171).

Appearance of the product and pack contents

White or greyish-white, biconvex, oval, film-coated tablets.

Each pack contains 10 or 20 tablets in aluminum blisters.

Not all pack sizes may be marketed.

Marketing authorization holder

LEO Pharma Laboratories, S.A.

Via Laietana 33, 7th floor

08003 Barcelona

Spain

Manufacturer

LEO Laboratories, S.A., 39 Route de Chartres, 28501 Vernouillet Cedex (France).

Date of last revision of this leaflet: October 2024

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