Fidicid 200 mg Film-Coated Tablets

FIDICID 200 mg is used in adults to treat infections of the lining of the colon (large intestine) with certain bacteria called Clostridium difficile. This serious illness can result in painful, severe diarrhoea. FIDICID 200 mg works by killing the bacteria that cause the infection and helps to reduce the associated diarrhoea.

Do not take FIDICID 200 mg:

• if you are hypersensitive (allergic) to the active ingredient, fidaxomicin or to any of the other ingredients of FIDICID 200 mg (see section 6).

Warnings and precautions

Take special care with FIDICID 200 mg. If you feel that you might have a severe allergic reaction such as trouble breathing (dyspnoea), swelling of the face or throat (angioedema), severe rash or severe itching (pruritus), stop taking FIDICID 200 mg and seek medical advice urgently from your doctor, pharmacist or at your local hospital emergency department (see section 4).

Talk to your doctor or pharmacist before taking FIDICID 200 mg:

• if you are allergic to macrolides (a class of antibiotics e.g. erythromycin), ask your doctor for advice before using this medicine. Your doctor will tell you whether this medicine is suitable for you;
• if you have kidney or liver problems, ask your doctor for advice before taking FIDICID 200 mg. Your doctor will tell you whether FIDICID 200 mg is suitable for you.

There are limited data available on the use of FIDICID 200 mg in severe cases of the disease (e.g., pseudomembranous colitis). Your doctor will know whether your disease falls in the severe categories and will tell you whether FIDICID 200 mg is suitable for you.

Children and adolescents

Do not give FIDICID 200 mg to children below the age of 18 years because the safety and efficacy has not yet been established.

Do not share medicines prescribed for you with any other person.

Instructions for proper use

Always take FIDICID 200 mg exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The usual dose is one tablet (200 mg) twice daily (one tablet every 12 hours) for 10 days. Swallow the tablets whole with a glass of water. You can take FIDICID 200 mg before, during or after meals. Your doctor will tell you how long your treatment with FIDICID 200 mg will last. If you have the impression that the effect of FIDICID 200 mg is too strong or too weak, talk to your doctor or pharmacist.

If you take more FIDICID 200 mg than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Take the medicine pack with you so the healthcare professional knows what you have taken.

If you forget to take FIDICID 200 mg

Take the tablet as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking FIDICID 200 mg

Do not stop taking FIDICID 200 mg, unless your doctor has advised you to do so. Keep taking FIDICID 200 mg until the course is finished, even if you feel better. If you stop taking FIDICID 200 mg too soon, the infection may come back.

FIDICID 200 mg can have side effects. Not all side effects reported for FIDICID 200 mg are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking FIDICID 200 mg, please consult your healthcare provider for advice.

If any of the following happens, stop taking FIDICID 200 mg and tell your doctor immediately or go to the casualty department at your nearest hospital:

• trouble breathing (dyspnoea);
• swelling of the face or throat (angioedema);
• severe rash or severe itching (pruritus).

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to FIDICID 200 mg. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

Frequent side effects:

• vomiting, nausea and constipation;
• certain blood tests might show changed levels, e.g., increased or abnormal liver enzymes (alanine aminotransferase).

Less frequent side effects:

• decreased appetite;
• dizziness, headache;
• dry mouth, altered taste (dysgeusia);
• bloated feeling, wind (flatulence);
• rash, itching (pruritus).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to you doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of FIDICID 200 mg.

• Store all medicines out of reach of children.
• Do not use FIDICID 200 mg after the expiry date which is stated on the carton, blister or bottle after EXP. The expiry date refers to the last day of that month.
• Store at or below 25 °C.
• 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.