This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.

How to use FUCIDINE 250 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Fucidine 250 mg film-coated tablets

Sodium Fusidate

Read all of this leaflet carefully before you start taking 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.

In the text of this leaflet, the term Fucidine tablets will be used to refer to “Fucidine 250 mg film-coated tablets”.

Contents of the package leaflet:

What is Fucidine tablets and what is it used for
What you need to know before you take Fucidine tablets
How to take Fucidine tablets
Possible side effects
Storage of Fucidine tablets
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.

How much does FUCIDINE 250 mg FILM-COATED TABLETS cost in Spain ( 2025)?

The average price of FUCIDINE 250 mg FILM-COATED TABLETS in December, 2025 is around 9.8 EUR. Prices may vary depending on the region, pharmacy, and whether a prescription is required. Always check with a local pharmacy or online source for the most accurate information.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques.

For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance.

Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults.

In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions.

Patients commonly seek his care for:

seasonal and perennial allergies
allergic rhinitis and chronic nasal symptoms
asthma and breathing difficulties
food and medication allergies
urticaria, atopic dermatitis and skin reactions
recurrent infections in children
sports-related health questions
general family medicine concerns

Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.

FUCIDINE 250 mg FILM-COATED TABLETS

Tarek Agami

Abdullah Alhasan

Tarek Agami

Abdullah Alhasan