Patient Information Leaflet

Fucidine 250 mg Film-Coated Tablets

Sodium Fusidate

1.What Fucidine tablets are and what they are used for

2.What you need to know before you start taking Fucidine tablets

3.How to take Fucidine tablets

4.Possible side effects

5.Storage of Fucidine tablets

6.Contents of the pack and additional information

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 the germs are those for which other antibiotics have not been effective or have led to an allergic reaction when used.

You should consult a doctor if you get worse or do not improve.

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 (cholesterol-lowering medicines).

Warnings and precautions

Consult your doctor or pharmacist before starting to takeFucidine tablets:

-if you are being treated with statins, as you will need to stop treatment and not restart statins until seven days after completing treatment with Fucidine tablets.

Inform your doctor if you feel weakness, pain, or muscle tenderness.

-if you have any liver or bile duct disorders, as it may be necessary to perform some monitoring.

-if you are being treated with medicines used to treat acquired immunodeficiency syndrome (AIDS). Inform your doctor before starting treatment with Fucidine tablets.

-if the medicine is to be administered to a newborn, as it may cause a yellow discoloration of the skin (kernicterus).

Contact your doctor immediately if you experience symptoms of skin reactions, which usually appear in the first weeks after the first dose of Fucidine. These symptoms include skin rash or redness, 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

Inform your doctor or pharmacist if you are taking,have takenrecentlyor may need to take any other medicine.

Fucidine tablets should not be taken concurrently with medicines used to lower blood cholesterol levels, such as statins, as it may cause rhabdomyolysis (muscle tissue destruction) that can be fatal. If you are being treated with statins, treatment should be discontinued and not restarted until seven days after completing treatment with Fucidine tablets.

Inform your doctor if you feelweakness, pain, or muscle tenderness.

Fucidinetablets may modify 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 has been completed, your doctor may adjust the dose of the anticoagulant.

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

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, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

If you are pregnant or think you may be, or are breastfeeding, do not take this medicine without your doctor's prior evaluation.

Driving and operating machinery

This medicine does not affect your ability to drive or operate machinery.

Fucidine tablets contain lactose

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

Fucidine tablets contain sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, 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.

• Skin and soft tissue infections:

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

The daily number of tablets may be modified 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, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, you can also consult the Toxicological Information Service. Phone 91 562 04 20.

If you forgot to take Fucidine tablets

In case of forgotten dose, take another as soon as possible. Then continue as indicated.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Fucidine tablets

Your doctor will indicate the duration of your treatment with Fucidine tablets. Take the medication until you finish the treatment. Do not suspend the treatment beforehand, as it may be harmful to your health.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

With the administration of this medicine, the following side effects have been observed:

Frequent: may affect up to 1 in 10 people

Nausea

Diarrhea

Abdominal pain

Bad digestion sensation (dyspepsia)

Nausea

Abdominal discomfort

Letargy

Fatigue

Weakness (asthenia)

Rare: may affect up to 1 in 100 people

Decreased number of some blood cells (pancytopenia, leukopenia, thrombocytopenia)

Anemia

Generalized allergic reactions (anaphylactic reactions)

Headache

Drowsiness

Decreased liver function

Bile retention in the gallbladder (cholestasis)

Hepatitis

Yellow discoloration of the skin and mucous membranes (jaundice)

Elevated bilirubin levels in the blood

Altered liver function test results

Appearance of small, inflamed, and infected ulcers on the skin

Urticaria

Skin rash

Muscle fiber destruction (rhabdomyolysis)

Decreased kidney function (renal failure)

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

Allergic reactions

Liver function alteration

Swelling of face/throat and respiratory problems (angioedema)

Pruritus

Redness

Unknown frequency

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:

-skin eruption or redness, including generalized eruption 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 eruption, 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 the flu, such as fever, headache, and body aches.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use: https://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.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Fucidine tablets composition

-The active ingredient is fusidic acid sodium.

Each tablet contains 250 mg of fusidic acid sodium.

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

Product appearance and packaging contents

Biconvex, oval, white or light grayish beige speckled tablets.

Each package contains 10 or 20 tablets conditioned in aluminum blisters.

Only some package sizes may be commercially marketed.

Marketing authorization holder

LEO Pharma, S.A.

Via Laietana 33, 7th floor

08003 Barcelona

Spain

Responsible for manufacturing

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

Last review date of this leaflet: October 2024

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es.