Foruri 3 g Oral Solution

FORURI is a broad-spectrum antibiotic that is used in women and adolescent women to treat urinary tract and bladder infections. It is used in adult men to prevent infection from urinary surgery.

Do not take FORURI:

• if you are hypersensitive (allergic) to fosfomycin or any of the other ingredients of FORURI (listed in section 6, “What FORURI contains”);
• if you suffer from severe kidney problems;
• if you are undergoing haemodialysis (a procedure used to clean the blood from wastes and extra fluids, when the kidneys are not working).

Warnings and special precautions

Take special care with FORURI:

• if you have an allergic reaction on FORURI. See section 4, “Possible side effects” for some signs of an allergic reaction. Contact your doctor immediately if you have such symptoms.
• Tell your doctor, pharmacist or nurse before taking FORURI if you have previously experienced diarrhoea upon administration of any other antibiotics. FORURI may cause severe diarrhoea and inflammation of the bowel in some patients (see section 4).
• Tell your doctor if you have kidney disease. The effects of FORURI may be increased because of slower removal from the body.

Children

FORURI 3 g is not indicated for children between the ages of 5 and 12 years, as the sachets cannot be divided.

Other medicines and FORURI

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

Tell your doctor if you take:

• a medicine called metoclopramide (a medicine to stop you from feeling sick) as this may influence FORURI;
• medicines that reduce blood clotting (such as warfarin).

FORURI with food and drink

Food delays and reduces the absorption of FORURI, resulting in reduced blood and urinary concentrations. FORURI should be taken on an empty stomach at least 2 hours before the next meal, or at least 2 to 3 hours after a meal.

Pregnancy and breastfeeding

Safety has not been established for use in pregnancy. Do not take FORURI if you are pregnant or breastfeeding. If you are pregnant or breastfeeding your baby please consult your doctor, pharmacist or other healthcare provider for advice. Fosfomycin is excreted into human milk. You should not breastfeed your baby if you take FORURI, or you should not take FORURI if you breastfeed your baby.

Driving and using machines

You may experience side effects such as dizziness which may affect your ability to drive or use machines. Do not drive or use machines if you are affected.

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

The usual dose is:

Adult and adolescent women (> 12 years of age):

Only one dose is taken: One 3 g sachet of FORURI as a single dose, at least 2 hours before the next meal, on an empty stomach.

Adult men:

Two doses are usually taken:

• One 3 g sachet 3 hours before surgery
• One 3 g sachet 24 hours after surgery.

Directions for use:

Dissolve the contents of the sachet in a glass of water and drink all the contents immediately. If you have the impression that the effect of FORURI is too strong or too weak, tell your doctor or pharmacist.

If you take more FORURI than you should

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

If you forget to take a dose

If you forget to take the dose, take it as soon as you remember. Do not take a double dose to make up for forgotten individual doses.

If you stop taking FORURI

Women only take a single dose. For effective prevention of infection, men should take both their doses as directed in section 3, “How to take FORURI”.

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

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

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing;
• rash, itching or hives on the skin;
• abdominal pain, nausea with yellowing of the skin and eyes, which may be due to jaundice or liver failure;
• severe abdominal cramps, bloody stools, rapid heart rate and/or fever. These symptoms may mean that you have an infection of the large intestine (pseudomembranous colitis) or a toxic megacolon (an abnormal dilation of the large intestine). These are all very serious side effects. If you have them, you may have had a serious reaction to FORURI. 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:

• signs of infections, such as a sore throat, vaginal inflammation, or combined vaginal and vulvar inflammation;
• worsening of asthma. These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects

• headache
• dizziness
• runny nose
• diarrhoea
• nausea (feeling sick)
• dyspepsia (heartburn)
• abdominal pain
• back pain
• painful menstruation
• general pain
• abnormal physical weakness

Less frequent side effects

• vomiting
• pain in the eye, vision loss (inflammation of the optic nerve)

Blood tests may show:

• Low white blood cell count
• Low numbers of red blood cells
• Low blood platelet count
• Increase in certain enzymes in the body (aminotransferases, alkaline phosphatase)
• Increase in bilirubin (an orange-yellow pigment formed in the liver).

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 Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/health-products-vigilance/. By reporting side effects, you can help provide more information on the safety of FORURI.

Store all medicines out of reach of children. Store at room temperature (at or below 25 °C). Do not store in a bathroom. Use entire contents immediately once opened. 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).