Monuril 3 g Granules

MONURIL is a broad-spectrum bactericidal antibiotic. MONURIL is used to treat urinary tract infections such as bladder infections in women and female adolescents over the age of twelve years. MONURIL is used to prevent infections in men undergoing urinary surgical procedures.

Do not take MONURIL:

• if you are hypersensitive (allergic) to fosfomycin trometamol or any of the other ingredients of MONURIL (listed in section 6).
• if you have kidney disease: The effects of fosfomycin may be increased because of slower removal from the body.

Warnings and precautions

Take special care with MONURIL:

• When you experience any allergic type reactions (as certain allergic reactions may be fatal). You should stop treatment with MONURIL, and you should go to your nearest hospital.
• If you have diarrhoea or if you previously had diarrhoea after taking antibiotics.
• If you have persistent bladder infections, especially if you are male, your doctor may need to check for more serious infections before using MONURIL.

Children

Safety and efficacy in children under the age of twelve years has not yet been established.

Other medicines and MONURIL

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

• Tell your doctor if you are taking metoclopramide (used to treat nausea (feeling sick) and vomiting (being sick)).
• If you are taking anticoagulants, as their ability to prevent your blood from clotting might be altered by fosfomycin and other antibiotics.

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

The usual dose for uncomplicated urinary tract infections in women and female adolescents over the age of twelve years and women up to the age of seventy-five years, is a single 3 g dose. The recommended dose to prevent a bacterial infection before a urinary surgical procedure in adult men, including the elderly, is two doses of 3 g. The first dose should be taken three hours before surgery. The second dose should be taken twenty-four hours after surgery.

Dissolve MONURIL in a glass containing 90–120 mL of water and drink it as soon as it has been dissolved. Take MONURIL on an empty stomach (2-3 hours before or 2-3 hours after a meal), preferably before going to bed after emptying the bladder.

If you have the impression that the effect of MONURIL is too strong or too weak, tell your doctor or pharmacist.

If you take more MONURIL than you should

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

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

If any of the following happens, tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting.

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

Tell your doctor if you notice any of the following:

• headache, dizziness,
• sore throat, runny or stuff nose,
• diarrhoea, nausea (feeling sick),
• stomach pain, heartburn,
• skin rash, hives, itching
• back pain,
• vaginal discharge,
• vaginal redness, itching, irritation, burning,
• painful periods (menstruation)
• pain, weakness,
• allergic reactions,
• vomiting,
• rapid swelling of the area beneath the skin especially of the face, throat, hands, feet and genitals.

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 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 MONURIL. You may also report side effects directly to Adcock Ingram Limited by emailing [email protected].

• Store at or below 30 °C.
• Store in the original packaging until required for use.
• Store all medicines out of reach of children.
• Do not store in a bathroom.
• Do not use this medicine after the expiry date which is stated on the carton after <EXP>. The expiry date refers to the last day of that month.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).