250 mg film-coated tablets
sodium fusidate

What FUCIDIN is and what it is used for

Fucidin is an antibiotic and is used to treat infections of the skin, soft tissues, and bones caused by bacteria.

2. What you need to know before you use FUCIDIN

Do not use FUCIDIN

  • when taking statins (medicines to lower blood cholesterol), see also Other medicines and Fucidin.
  • if you are allergic to sodium fusidate or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor or pharmacist before using Fucidin:

  • if you have or have had bile stasis (obstruction to the normal outflow of bile from the liver to the intestines).
  • if you have impaired liver function

Isolated cases of severe skin reactions that can develop into potentially life-threatening skin reactions if left untreated have been reported. Contact a doctor immediately if you experience any of these symptoms that usually occur during the first few weeks of Fucidin treatment. Symptoms that may occur include skin rash or redness as well as widespread rashes with blisters and scaly skin, especially around the mouth, nose, eyes, and genitals, as well as fever, eye burn, and difficulty swallowing.

Other medicines and FUCIDIN

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

Do not use statins (medicines to lower blood cholesterol) while you are taking Fucidin. This can in rare cases lead to muscle weakness, muscle soreness, or pain. See also Any side effects.

Fucidin can affect and be affected by other drugs e.g.

  • certain blood thinners (coumarin derivatives or anticoagulants with similar mechanism of action)
  • anti- HIV drugs (ritonavir and saquinavir)
  • rifampicin (anti-tuberculosis drug )

Therefore, always consult a doctor if you are being treated with drugs other than Fucidin.

fucidine with food, drink, and alcohol

Fucidin should not be taken with a meal.

Pregnancy and breastfeeding

Pregnancy

Avoid using Fucidin during pregnancy. There is a risk that the fetus is affected.

Breast-feeding

Fucidin passes into breast milk, the risk to the breast-fed baby cannot be ruled out.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Fucidin has no or negligible influence on the ability to drive and use machines.

Fucidin contains lactose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains 11 mg of sodium (the main ingredient in table salt/table salt) per tablet. This corresponds to 0.5% of the maximum recommended daily sodium intake for adults.

3. How to use FUCIDIN

Infection in the skin and soft parts:

Adults and children over 12 years: 1 tablet twice daily.

Infection in joints and bones:

Adults and children over 12 years: 2 tablets three times daily.

If the doctor has specified a different dosage, it is the doctor’s instructions that must be followed.

If you use more FUCIDIN than you should  

If you have used too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to use FUCIDIN

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The most common side effects are gastrointestinal problems. Although hypersensitivity reaction you have reported.

Stop taking Fucidin and contact a doctor immediately if you get any of the following symptoms ( angioedema, a rare side effect, affects less than 1 user in 1,000):

swelling of the face, tongue, or throat; difficulty swallowing; hives, and difficulty breathing.

Stop taking Fucidin and contact a doctor as soon as possible if you experience unexplained muscle soreness, muscle pain, muscle cramps, or muscle weakness. This may be a sign of muscle wasting ( rhabdomyolysis, less common side effect, affects less than 1 user in 100).

Fucidin can in rare cases affect the white blood cells so that the defense of infection deteriorates. If you get an infection with symptoms such as fever with severe general deterioration or fever with local infection symptoms such as sore throat/pharynx/mouth or urination problems, you should see a doctor as soon as possible so that blood tests can rule out a lack of white blood cells ( agranulocytosis ). It is important that you then information about your medication.

Isolated cases of severe skin reactions that can develop into potentially life-threatening skin reactions if left untreated have been reported. Contact a doctor immediately if you get any of the following symptoms:

  • skin rash or redness and widespread rash with blisters and scaly skin, especially around mouth, throat, nose, eyes, and genitals ( Stevens-Johnson syndrome )
  • extensive skin peeling corresponding to more than 30% of the body surface ( toxic epidermal necrolysis )
  • Widespread rash affecting the liver, blood, and other organs (drug reaction with eosinophilia and systemic symptoms also known as DRES’s syndrome)

These severe skin rashes are often preceded by flu-like symptoms such as fever, headache, and body aches.

Common (affects more than 1 user in 100): Nausea, vomiting, diarrhea, indigestion, stomach pain, fatigue, listlessness, weakness.

Uncommon (affects less than 1 user in 100)Anemia, decreased white and red blood cell count and decreased platelet count, extensive skin rash with small blisters, skin rash, hives, drowsiness, headache. renal failure, allergic reaction (including anaphylactic shock ), liver failure, bile stasis, hepatitis, jaundice, increased levels of liver enzymes, and bilirubin in the blood.

Rare (affects less than 1 user in 1,000): Hypersensitivity, itching, reddening of the skin, and severe hepatic impairment.

5. How to store FUCIDIN

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

No special storage instructions.

Do not use this medicine after the expiry date which is stated on the carton after EXP.

The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

– The active substance is: Sodium fusidate 250 mg per tablet

The other ingredients are Titanium dioxide (dye E171), lactose monohydrate 71.9 mg per tablet, magnesium stearate, all-rac-alpha-tocopherol, talc, crospovidone, anhydrous colloidal silica, hypromellose, microcrystalline cellulose.

What the medicine looks like and the contents of the pack

Gray-white, marbled oval biconvex film-coated tablet without pressure.

Pack size: 20 pcs, 40 pcs, 100 pcs.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

LEO Pharma AB

Box 404

201 24 Malmö

Tel. 040 – 35 22 00.

Muhammad Nadeem

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