Scheduling Status<\/p>\n\n\n\n
S4<\/strong><\/p>\n\n\n\n FLAGYL SUSPENSION 200 mg\/5 mL oral suspension<\/strong><\/p>\n\n\n\n Metronidazole<\/strong><\/p>\n\n\n\n FLAGYL SUSPENSION contains sugar: sucrose 3 g\/5 mL<\/strong>.<\/p>\n\n\n\n Read the patient information carefully before you or your child start taking FLAGYL.<\/p>\n\n\n\n Keep this information because it may be needed again. If further questions arise, ask a doctor, pharmacist, nurse or other healthcare provider.<\/p>\n\n\n\n FLAGYL has been prescribed personally for you or your child and should not be shared with other people. It may harm them, even if their symptoms appear to be the same.<\/p>\n\n\n\n FLAGYL contains metronidazole<\/strong>.<\/p>\n\n\n\n Metronidazole works by killing certain bacteria and parasites that cause infections in the body.<\/p>\n\n\n\n FLAGYL can be used to:<\/p>\n\n\n\n If more information is needed about the illness being treated, speak to a doctor.<\/p>\n\n\n\n Do not take or give FLAGYL in the following situations:<\/p>\n\n\n\n If unsure whether any of these apply, speak to a doctor or pharmacist before using FLAGYL.<\/p>\n\n\n\n Special care is needed with FLAGYL in the following situations:<\/p>\n\n\n\n Patients with Cockayne syndrome require careful monitoring of liver function during and after treatment.<\/p>\n\n\n\n Stop taking FLAGYL and tell a doctor immediately if any of the following occur:<\/p>\n\n\n\n Serious skin reactions have been reported with FLAGYL. These include:<\/p>\n\n\n\n Seek medical help immediately and stop using FLAGYL if serious skin symptoms occur.<\/p>\n\n\n\n Possible warning signs may include:<\/p>\n\n\n\n The highest risk of serious skin reactions is usually within the first week of treatment, often within the first 48 hours.<\/p>\n\n\n\n Some people using metronidazole may experience mental health symptoms.<\/p>\n\n\n\n These may include:<\/p>\n\n\n\n These symptoms can occur even in people who have not had similar problems before.<\/p>\n\n\n\n If these symptoms are noticed, stop taking FLAGYL and seek medical advice immediately.<\/p>\n\n\n\n Do not drink alcoholic beverages or take medicines containing alcohol during treatment with FLAGYL and for at least 1 to 3 days after finishing treatment<\/strong>.<\/p>\n\n\n\n Alcohol may cause unpleasant reactions during this period.<\/p>\n\n\n\n Pseudomembranous colitis has been reported with FLAGYL.<\/p>\n\n\n\n Tell a doctor immediately if watery and severe diarrhoea occurs. The diarrhoea may also be bloody.<\/p>\n\n\n\n Always tell a healthcare provider if you or your child are taking any other medicine, including complementary or traditional medicines.<\/p>\n\n\n\n Tell the doctor especially if any of the following are being used:<\/p>\n\n\n\n Metronidazole may interfere with some blood tests, including tests for liver function, cholesterol and glucose.<\/p>\n\n\n\n Tell the doctor that FLAGYL is being taken if blood tests are required.<\/p>\n\n\n\n Do not drink alcohol or take medicines containing alcohol while taking FLAGYL and for 1 to 3 days after completing the course<\/strong>.<\/p>\n\n\n\n Alcohol during FLAGYL treatment may cause:<\/p>\n\n\n\n Safety during pregnancy and breastfeeding has not been established.<\/p>\n\n\n\n If pregnant, breastfeeding, possibly pregnant or planning to have a baby, consult a doctor, pharmacist or other healthcare provider before taking FLAGYL.<\/p>\n\n\n\n FLAGYL may cause side effects that can affect driving or machine use.<\/p>\n\n\n\n Do not drive, use machinery or operate tools if any of the following occur:<\/p>\n\n\n\n FLAGYL contains sucrose, methyl hydroxybenzoate, propyl hydroxybenzoate and alcohol.<\/p>\n\n\n\n Do not share medicines prescribed for you or your child with any other person.<\/p>\n\n\n\n Always take or give FLAGYL exactly as instructed by the doctor. It is important to complete the full course of treatment.<\/p>\n\n\n\n The length of treatment will depend on the illness being treated and individual needs.<\/p>\n\n\n\n Ask a doctor or pharmacist if unsure.<\/p>\n\n\n\n Tell a doctor or pharmacist if the effect of FLAGYL seems too strong or too weak.<\/p>\n\n\n\n The dose and duration of treatment depend on the illness and how severe it is.<\/p>\n\n\n\n In case of overdose, consult a doctor or pharmacist.<\/p>\n\n\n\n If neither is available, contact the nearest hospital or poison centre.<\/p>\n\n\n\n If a dose is forgotten, take it as soon as remembered.<\/p>\n\n\n\n If it is almost time for the next dose, skip the missed dose.<\/p>\n\n\n\n Do not take a double dose to make up for a forgotten dose.<\/p>\n\n\n\n FLAGYL can have side effects.<\/p>\n\n\n\n Not all side effects reported for FLAGYL are included here. If general health worsens or any unwanted effects occur while taking FLAGYL, consult a doctor, pharmacist or other healthcare provider.<\/p>\n\n\n\n If side effects occur, speak to a doctor, pharmacist or nurse.<\/p>\n\n\n\n Side effects may also be reported to the Pharmacovigilance Unit at Sanofi or to SAHPRA through the Med Safety App and eReporting platform.<\/p>\n\n\n\n Reporting side effects helps provide more information on the safety of FLAGYL.<\/p>\n\n\n\n Store all medicines out of reach of children.<\/p>\n\n\n\n Store at or below 25 \u00b0C<\/strong>.<\/p>\n\n\n\n Store in the original container to protect from light.<\/p>\n\n\n\n Do not use FLAGYL after the expiry date shown on the packaging.<\/p>\n\n\n\n Return unused medicine to a pharmacist.<\/p>\n\n\n\n Do not dispose of unused medicine in drains or sewerage systems, including toilets.<\/p>\n\n\n\n The active substance is metronidazole<\/strong>, present as benzoyl metronidazole<\/strong>.<\/p>\n\n\n\n The other ingredients are:<\/p>\n\n\n\n FLAGYL is an off-white, coarse oral suspension<\/strong> with an orange and lemon flavour.<\/p>\n\n\n\n FLAGYL is packed in amber glass bottles.<\/p>\n\n\n\nProduct Name<\/h2>\n\n\n\n
Active Ingredient<\/h2>\n\n\n\n
Sugar Content<\/h2>\n\n\n\n
\n\n\n\nRead Before Taking FLAGYL<\/h1>\n\n\n\n
\n\n\n\nWhat Is in This Article<\/h1>\n\n\n\n
\n
\n\n\n\n1. What FLAGYL Is and What It Is Used For<\/h1>\n\n\n\n
Use<\/th><\/tr><\/thead> Treat infections caused by certain bacteria<\/td><\/tr> Prevent infections after surgery<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\n2. What You Need to Know Before You Take or Give FLAGYL to Your Child<\/h1>\n\n\n\n
Do Not Take FLAGYL or Give FLAGYL to Your Child<\/h2>\n\n\n\n
Do not use FLAGYL if<\/th> Details<\/th><\/tr><\/thead> You or your child are allergic to metronidazole<\/td> Signs of allergy may include rash, difficulty swallowing or breathing, or swelling of the lips, face, throat or tongue<\/td><\/tr> You or your child are allergic to any other ingredient in FLAGYL<\/td> Check the contents section before use<\/td><\/tr> You or your child are taking busulfan<\/td> Busulfan is used for cancer of the blood cells<\/td><\/tr> You are taking disulfiram<\/td> Disulfiram is used to treat chronic alcoholism<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\nWarnings and Precautions<\/h2>\n\n\n\n
Situation requiring special care<\/th> Details<\/th><\/tr><\/thead> Family history of certain heart conditions<\/td> This includes congenital long QT syndrome, torsades de pointes and cardiac dysrhythmias<\/td><\/tr> Use with medicines that may prolong the QT interval<\/td> Metronidazole may affect heart rhythm when combined with certain medicines<\/td><\/tr> Blood disorders<\/td> This includes blood dyscrasias or low levels of certain blood cells<\/td><\/tr> Nervous system disease<\/td> This includes active or chronic disease of the central or peripheral nervous system<\/td><\/tr> Hepatic encephalopathy<\/td> This is worsening brain function caused by the liver not removing toxins properly<\/td><\/tr> Cockayne syndrome<\/td> Severe liver toxicity and acute liver failure, including fatal cases, have been reported<\/td><\/tr> Cancer treatment with busulfan<\/td> Combined use may lead to severe toxicity and death<\/td><\/tr> Treatment lasting more than 10 days<\/td> Monitoring may be required<\/td><\/tr> Severe liver disease<\/td> Dose reduction may be needed<\/td><\/tr> Syphilis<\/td> FLAGYL may affect the immune response seen in untreated early syphilis<\/td><\/tr> Dark urine<\/td> FLAGYL may cause urine to darken because of a substance formed when the medicine is broken down<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\nLiver Warning in Cockayne Syndrome<\/h2>\n\n\n\n
Possible liver warning signs<\/th><\/tr><\/thead> Stomach pain<\/td><\/tr> Loss of appetite<\/td><\/tr> Nausea<\/td><\/tr> Vomiting<\/td><\/tr> Fever<\/td><\/tr> Feeling unwell<\/td><\/tr> Fatigue<\/td><\/tr> Yellowing of the skin or eyes<\/td><\/tr> Dark urine<\/td><\/tr> Pale stools<\/td><\/tr> Itching<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\nSerious Skin Reactions<\/h2>\n\n\n\n
Serious skin reaction<\/th><\/tr><\/thead> Stevens-Johnson syndrome<\/td><\/tr> Toxic epidermal necrolysis<\/td><\/tr> Acute generalised exanthematous pustulosis<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n Warning signs<\/th><\/tr><\/thead> Reddish target-like spots<\/td><\/tr> Circular patches with central blisters<\/td><\/tr> Ulcers of the mouth, throat, nose, genitals or eyes<\/td><\/tr> Red and swollen eyes<\/td><\/tr> Fever or flu-like symptoms<\/td><\/tr> Skin peeling<\/td><\/tr> Widespread red, scaly rash<\/td><\/tr> Bumps under the skin<\/td><\/tr> Blisters with fever<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\nMental Health Effects<\/h2>\n\n\n\n
Possible mental health symptoms<\/th><\/tr><\/thead> Irrational thoughts<\/td><\/tr> Hallucinations<\/td><\/tr> Confusion<\/td><\/tr> Depression<\/td><\/tr> Thoughts of self-harm<\/td><\/tr> Suicidal thoughts<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\nAlcohol Warning<\/h2>\n\n\n\n
\n\n\n\nPseudomembranous Colitis<\/h2>\n\n\n\n
\n\n\n\nOther Medicines and FLAGYL<\/h1>\n\n\n\n
Medicine<\/th> Use or concern<\/th><\/tr><\/thead> Disulfiram<\/td> Used to treat alcoholism; combined use may cause acute confusion<\/td><\/tr> Warfarin or similar blood thinners<\/td> FLAGYL may increase the blood-thinning effect and cause uncontrolled bleeding<\/td><\/tr> Lithium<\/td> Blood levels of lithium may increase<\/td><\/tr> Phenytoin or phenobarbital<\/td> These may reduce the effectiveness of FLAGYL<\/td><\/tr> 5-Fluorouracil<\/td> FLAGYL may increase harmful effects<\/td><\/tr> Busulfan<\/td> Used for leukaemia; combined use may cause severe toxicity<\/td><\/tr> Medicines that prolong the QT interval<\/td> Examples include certain antipsychotics, antiarrhythmics and antibiotics<\/td><\/tr> Ciclosporin<\/td> FLAGYL may increase ciclosporin blood levels<\/td><\/tr> Cimetidine<\/td> May increase the effects of FLAGYL<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\nInterferences With Laboratory and Diagnostic Tests<\/h1>\n\n\n\n
\n\n\n\nFLAGYL With Food, Drink and Alcohol<\/h1>\n\n\n\n
Possible alcohol-related effects<\/th><\/tr><\/thead> Nausea<\/td><\/tr> Vomiting<\/td><\/tr> Stomach pain<\/td><\/tr> Hot flushes<\/td><\/tr> Very fast or uneven heartbeat<\/td><\/tr> Palpitations<\/td><\/tr> Headache<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\nPregnancy and Breastfeeding<\/h1>\n\n\n\n
\n\n\n\nDriving and Using Machines<\/h1>\n\n\n\n
Possible effects<\/th><\/tr><\/thead> Sleepiness<\/td><\/tr> Dizziness<\/td><\/tr> Confusion<\/td><\/tr> Hallucinations<\/td><\/tr> Fits or convulsions<\/td><\/tr> Temporary eyesight problems<\/td><\/tr> Blurred vision<\/td><\/tr> Double vision<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\nFLAGYL Contains Sucrose and Preservatives<\/h1>\n\n\n\n
Ingredient<\/th> Important information<\/th><\/tr><\/thead> Sucrose<\/td> May affect blood sugar control in patients with diabetes mellitus<\/td><\/tr> Sucrose<\/td> Patients with intolerance to some sugars should speak to a doctor before taking FLAGYL<\/td><\/tr> Methyl hydroxybenzoate<\/td> May cause allergic reactions in some people<\/td><\/tr> Propyl hydroxybenzoate<\/td> May cause allergic reactions in some people<\/td><\/tr> Alcohol \/ ethanol<\/td> FLAGYL contains 0,44 % alcohol by volume, equal to 17,4 mg alcohol per 5 mL dose<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\n3. How to Take or Give FLAGYL<\/h1>\n\n\n\n
\n\n\n\nInstructions for Use<\/h2>\n\n\n\n
Step<\/th> Instruction<\/th><\/tr><\/thead> 1<\/td> Shake well before use<\/td><\/tr> 2<\/td> Take or give FLAGYL oral suspension by mouth<\/td><\/tr> 3<\/td> Take or give the suspension at least 1 hour before food<\/td><\/tr> 4<\/td> Use the dose prescribed by the doctor<\/td><\/tr> 5<\/td> Complete the course unless told otherwise by the doctor<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\nIf You or Your Child Take or Receive More FLAGYL Than You Should<\/h2>\n\n\n\n
\n\n\n\nIf You or Your Child Forgets to Take FLAGYL<\/h2>\n\n\n\n
\n\n\n\n4. Possible Side Effects<\/h1>\n\n\n\n
Side Effects Table<\/h2>\n\n\n\n
Side-effect category<\/th> Side effects \/ symptoms<\/th> Recommended action<\/th><\/tr><\/thead> Very serious side effects<\/td> Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty swallowing or breathing<\/td> Stop taking or giving FLAGYL and seek urgent medical attention immediately<\/td><\/tr> Very serious side effects<\/td> Rash or itching<\/td> Stop taking or giving FLAGYL and seek urgent medical attention immediately<\/td><\/tr> Very serious side effects<\/td> Fainting<\/td> Stop taking or giving FLAGYL and seek urgent medical attention immediately<\/td><\/tr> Serious side effects<\/td> Heart rhythm problems, including QT prolongation seen on an electrocardiogram, especially when used with medicines that may prolong the QT interval<\/td> Tell a doctor immediately or go to the casualty department at the nearest hospital<\/td><\/tr> Serious side effects<\/td> Ventricular tachycardia, including torsades de pointes<\/td> Tell a doctor immediately or go to the casualty department at the nearest hospital<\/td><\/tr> Serious side effects<\/td> Yellowing of the skin and eyes, dark urine and tiredness, which may be symptoms of liver problems<\/td> Tell a doctor immediately or go to the casualty department at the nearest hospital<\/td><\/tr> Serious side effects<\/td> Liver failure<\/td> Tell a doctor immediately or go to the casualty department at the nearest hospital<\/td><\/tr> Serious side effects<\/td> Stevens-Johnson syndrome or toxic epidermal necrolysis, with rash, target-like spots, circular patches with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals or eyes, fever or flu-like symptoms<\/td> Stop using FLAGYL and seek urgent medical attention immediately<\/td><\/tr> Frequent side effects<\/td> Nausea, taste disorders, vomiting, diarrhoea, dry mouth, hairy tongue, swelling and inflammation inside the mouth, sore or inflamed mouth<\/td> Tell a doctor if noticed<\/td><\/tr> Less frequent side effects<\/td> Inflammation of the colon with watery diarrhoea and stomach cramps<\/td> Tell a doctor immediately<\/td><\/tr> Less frequent side effects<\/td> Blood disorders such as agranulocytosis, neutropenia or thrombocytopenia, detected by blood tests<\/td> Tell a doctor<\/td><\/tr> Less frequent side effects<\/td> Psychotic disorders, confusion, irritability, hallucinations or mood disorders such as depression<\/td> Stop taking FLAGYL and seek medical advice<\/td><\/tr> Less frequent side effects<\/td> Weakness, dizziness, drowsiness, sleeping problems, muscle contraction problems, slurred or slow speech, abnormal walking pattern, uncontrolled eye movements or shaking<\/td> Tell a doctor<\/td><\/tr> Less frequent side effects<\/td> Visual disorders such as double vision or focusing problems<\/td> Tell a doctor<\/td><\/tr> Less frequent side effects<\/td> Increased liver enzymes detected by liver function tests<\/td> Tell a doctor<\/td><\/tr> Less frequent side effects<\/td> Skin disorders such as blister-like sores, itchy or burning red eruptions and temporary joint pains<\/td> Tell a doctor<\/td><\/tr> Less frequent side effects<\/td> Muscle pain and joint pain<\/td> Tell a doctor<\/td><\/tr> Less frequent side effects<\/td> Burning and pain when urinating, and darkening of urine<\/td> Tell a doctor<\/td><\/tr> Frequency not known<\/td> Blood disorder such as leucopenia, detected by blood test<\/td> Tell a doctor<\/td><\/tr> Frequency not known<\/td> Eating disorder or anorexia<\/td> Tell a doctor<\/td><\/tr> Frequency not known<\/td> Numbness or tingling in the arms or legs, and seizures or fits<\/td> Tell a doctor immediately<\/td><\/tr> Frequency not known<\/td> Stuffy nose<\/td> Tell a doctor if troublesome<\/td><\/tr> Frequency not known<\/td> Inflammation of the pancreas and high liver enzyme levels<\/td> Tell a doctor immediately<\/td><\/tr> Frequency not known<\/td> Redness of the skin or flushing<\/td> Tell a doctor<\/td><\/tr> Frequency not known<\/td> Fever<\/td> Tell a doctor<\/td><\/tr> Frequency not known<\/td> Headache, aseptic meningitis or vertigo<\/td> Tell a doctor<\/td><\/tr> Frequency not known<\/td> Low vision, changes in colour vision or inflammation of the eye nerve<\/td> Tell a doctor immediately<\/td><\/tr> Frequency not known<\/td> Hearing problems, hearing loss or ringing in the ears<\/td> Tell a doctor<\/td><\/tr> Frequency not known<\/td> Pain in the upper stomach area<\/td> Tell a doctor<\/td><\/tr> Side effects not listed<\/td> Any side effect not mentioned or any unexpected health change<\/td> Inform a doctor or pharmacist<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\nReporting of Side Effects<\/h2>\n\n\n\n
\n\n\n\n5. How to Store FLAGYL<\/h1>\n\n\n\n
\n\n\n\n6. Contents of the Pack and Other Information<\/h1>\n\n\n\n
What FLAGYL Contains<\/h2>\n\n\n\n
Other ingredients<\/th><\/tr><\/thead> Ethanol<\/td><\/tr> Lemon flavouring<\/td><\/tr> Methyl hydroxybenzoate<\/td><\/tr> Oil of orange<\/td><\/tr> Propyl hydroxybenzoate<\/td><\/tr> Sodium dihydrogen phosphate<\/td><\/tr> Sucrose<\/td><\/tr> Veegum H.V.<\/td><\/tr> Water<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\nWhat FLAGYL Looks Like and Contents of the Pack<\/h2>\n\n\n\n