Fosfomycin 3 g Oral Solution

FOSFOMYCIN 3 g CAMOX contains fosfomycin trometamol. Fosfomycin trometamol is an antibiotic that works by killing bacteria which can cause infections. FOSFOMYCIN 3 g CAMOX is used to treat or prevent uncomplicated bladder infections.

Do not take FOSFOMYCIN 3 g CAMOX:

• if you are hypersensitive (allergic) to fosfomycin or any of the other ingredients of FOSFOMYCIN 3 g CAMOX (listed in section 6)
• if you have severe kidney problems (creatinine clearance below 10 mL/min)
• are undergoing haemodialysis.

If you are uncertain whether any of these apply to you, please discuss this with your doctor or pharmacist before taking FOSFOMYCIN 3 g CAMOX.

Warnings and precautions

Tell your doctor or healthcare professional before taking FOSFOMYCIN 3 g CAMOX if you:

• have previously had diarrhoea after taking any other antibiotics
• have kidney problems, but your creatinine clearance is above 10 mL/min.

Children

Do not give FOSFOMYCIN 3 g CAMOX to children under 12 years.

Other medicines and FOSFOMYCIN 3 g CAMOX

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.)

If you are taking any medicines containing the following:

• metoclopramide (used to treat nausea and vomiting) or other medicines that increase the movement of food through the stomach and intestines as the uptake of fosfomycin by your body may be decreased
• anticoagulants such as warfarin (used to “thin” your blood) as your clotting time may be affected.

Consult your doctor, pharmacist or other healthcare professional as these medicines may interact with FOSFOMYCIN 3 g CAMOX.

FOSFOMYCIN 3 g CAMOX with food and drink

FOSFOMYCIN 3 g CAMOX should be dissolved in water and taken at least two hours prior to the next meal. Food delays and reduces absorption of fosfomycin.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking this medicine. Do not take FOSFOMYCIN 3 g CAMOX if you are pregnant or breastfeeding. There are no known effects of fosfomycin trometamol on fertility.

Driving and using machines

FOSFOMYCIN 3 g CAMOX can cause dizziness. Do not drive or operate machinery until you know how FOSFOMYCIN 3 g CAMOX affects you.

FOSFOMYCIN 3 g CAMOX contains sucrose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking FOSFOMYCIN 3 g CAMOX.

Do not share medicines prescribed for you with any other person. Always take FOSFOMYCIN 3 g CAMOX exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The usual dose is:

• for women (up to seventy-five years of age) with an uncomplicated urinary tract infection, such as a bladder infection: a single 3 g dose is recommended.
• for adult men (including the elderly) needing prophylaxis (prevention of a possible infection) before transurethral surgical and diagnostic procedures: two doses of 3 g are recommended. The first dose should be taken three hours before surgery. The second dose should be taken twenty-four hours after surgery.

If you have the impression that FOSFOMYCIN 3 g CAMOX is too strong or too weak, tell your doctor or pharmacist.

Method of administration

Dissolve the contents of one sachet of FOSFOMYCIN 3 g CAMOX in a glass of water and drink immediately. Take FOSFOMYCIN 3 g CAMOX at least two hours prior to the next meal.

If you take more FOSFOMYCIN 3 g CAMOX than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take FOSFOMYCIN 3 g CAMOX

If you forget to take a dose, take one as soon as you remember. Do not take a double dose to make up for a forgotten dose.

FOSFOMYCIN 3 g CAMOX can have side effects. Not all side effects reported for FOSFOMYCIN 3 g CAMOX are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking FOSFOMYCIN 3 g CAMOX, please consult your health care provider for advice.

If any of the following happens, stop taking FOSFOMYCIN 3 g CAMOX and tell your doctor immediately or go to the casualty department at your nearest hospital:

• difficulty breathing, chest pain or chest tightness, and/or feeling dizzy/faint, severe itching of the skin or raised lumps on the skin, swelling of the face, lips, tongue and/or throat, which may cause difficulty in swallowing, collapse. These are very serious side effects. If you have them, you may have had a serious reaction to FOSFOMYCIN 3 g CAMOX. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• mild to severe abdominal cramps, bloody stools, diarrhoea and/or fever, this may mean you have an infection of the large intestine (antibiotic-associated colitis). This is a serious side effect. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent:

• infection of the female genital organs with symptoms like inflammation, irritation, itching (vulvovaginitis)
• headache, dizziness
• abdominal pain (pain in the stomach area)
• heartburn, indigestion
• sore throat
• runny or stuffy nose
• back pain
• painful menstruation
• pain, unusual tiredness or weakness
• skin rash

Less frequent:

• vomiting
• hives, itchy skin.

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 your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of FOSFOMYCIN 3 g CAMOX.

• Store all medicines out of reach of children.

• Store in the original packaging until required for use.

• Store at or below 25 °C.

• Do not use after the expiry date stated on the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).