Flagyl S 200mg/5ml Oral Suspension
Patient Information leaflet
Flagyl® S 200mg/5ml Oral Suspension
(metronidazole benzoate)
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1) What Flagyl is and what it is used for
2) Before you take Flagyl
3) How to take Flagyl
4) Possible side effects
5) How to store Flagyl
6) Further information
1) WHAT FLAGYL IS AND WHAT IT IS USED FOR
The name of this medicine is Flagyl S 200mg/5ml Oral Suspension (called Flagyl in this leaflet). Flagyl contains a medicine called metronidazole benzoate. This belongs to a group of medicines called antibiotics.
It works by killing bacteria and parasites that cause infections in your body.
It can be used to:
• Treat infections of the blood, brain, lung, bones, genital tract, pelvic area, stomach and intestines
• Treat gum ulcers and other dental infections
• Treat infected leg ulcers and pressure sores
• Prevent infections after surgery
If you need any further information on your illness, speak to your doctor.
2) BEFORE YOU TAKE FLAGYL
Do not take Flagyl and tell your doctor if:
• You are allergic (hypersensitive) to metronidazole, nitroimidazoles (e.g. tinidazole) or any of the other ingredients in your medicine (listed in Section 6: Further information).
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
Do not take Flagyl if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Flagyl.
Take special care with Flagyl and check with your doctor or pharmacist before using your medicine if:
• You have or have ever had a liver problem.
• You are having kidney dialysis (see section 3: ‘People having kidney dialysis')
• You have a disease of the nervous system
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking your medicine. Do this even if they have applied in the past.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Flagyl can affect the way some other medicines work. Also, some other medicines can affect the way Flagyl works.
In particular tell your doctor if you are taking any of the following medicines:
• Medicines used to thin the blood such as warfarin
• Lithium for mental illness
• Phenobarbital or phenytoin for epilepsy
• 5 fluorouracil for cancer
• Busulfan for leukaemia (cancer of the blood cells)
• Ciclosporin - to prevent the rejection of organs after transplant
• Disulfiram for alcoholism
If you are not sure, talk to your doctor or pharmacist before taking Flagyl. Taking Flagyl with food and drink
Do not drink any alcohol while you are taking Flagyl and for 48 hours after finishing your course. Drinking alcohol while using Flagyl might cause unpleasant side effects, such as feeling sick (nausea), being sick (vomiting), stomach pain, hot flushes, very fast or uneven heartbeat (palpitations) and headache.
Pregnancy and breast-feeding
Tell your doctor before using Flagyl if:
• You are pregnant, might become pregnant or think you may be pregnant. Flagyl should not be taken during pregnancy unless considered absolutely necessary.
• You are breast-feeding. It is better not to use Flagyl if you are breastfeeding. This is because small amounts may pass into the mother's milk.
Driving and using machines
While taking Flagyl you may feel sleepy, dizzy, confused, see or hear things that are not there (hallucinations), have fits (convulsions) or temporary eyesight problems (such as blurred or double vision). If this happens, do not drive or use any machinery or tools.
Tests
Your doctor may wish to carry out some tests if you have been using this medicine for more than 10 days.
Important information about some of the ingredients of your medicine
• Sucrose: This is a type of sugar. If you have been told by your doctor that you cannot tolerate some sugars, talk to your doctor before taking this medicine.
• Methyl hydroxybenzoate (E218) and propyl hydroxybenzoate (E216): These are preservatives that are added to Flagyl to make the medicine last longer. These can cause an allergic reaction in some people.
• Alcohol: Flagyl contains 0.8% alcohol (ethanol) by volume; this is equivalent to 32mg alcohol per 5ml dose. At high doses this could be harmful for those suffering from alcoholism, liver disease or epilepsy.
3) HOW TO TAKE FLAGYL Taking your medicine
Always take Flagyl exactly as your doctor has told you. It is important to finish a full course of treatment. The length of a course will depend on your needs and the illness being treated.
Check with your doctor or pharmacist if you are not sure.
• Take Flagyl Suspension by mouth
• The dose of Flagyl will depend on your needs and the illness being treated
• The length of your treatment will depend on the type of illness you have and how bad it is
• Your doctor or pharmacist may dilute your Flagyl Suspension. In this case the pharmacist's label on the packaging will tell you how exactly much to take and how often.
The usual dose for adults and children is given below:
To treat certain bacterial infection Adults and children over 10 years
• Take 10ml (400mg) of Flagyl Suspension once every 8 hours
Children and infants
• Your doctor will work out how much your child should take depending on their weight
• Repeat the dose every 8 hours
• If your child is a baby under 8 weeks of age, your doctor will give them one daily dose or two separate doses 12 hourly
To prevent infections from happening after surgery Children
• Give your child Flagyl suspension 2-3 hours before their operation
• Your doctor will work out how much your child should take depending on their weight
Other types of infections
For treatment of other infections caused by parasites and some bacteria your doctor will decide how much Flagyl you need to take. This will depend on your illness and how bad it is. The pharmacist's label on the packaging will tell you exactly how much Flagyl Suspension to take and how often.
People having kidney dialysis
Kidney dialysis removes Flagyl from your blood. If you are having kidney dialysis you must take this medicine after your dialysis treatment.
People with liver problems
Your doctor may tell you to use a lower dose or to use the medicine less often.
If you take more Flagyl than you should
If you take more Flagyl than you should, tell your doctor or go to your nearest hospital casualty department straight away. Take the carton and bottle with you. This is so the doctor knows what you have taken.
If you forget to take Flagyl
If you forget to take Flagyl, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not use a double dose to make up for a forgotten dose.
Not known (frequency cannot be estimated from the available data)
• Numbness, tingling, pain, or a feeling of weakness, in the arms or legs
• Unpleasant taste in the mouth
• Furred tongue
• Feeling sick (nausea), being sick (vomiting), upset stomach, stomach pain or diarrhoea
• Loss of appetite
• Fever
• Feeling depressed
• Pain in your eyes (optic neuritis)
• A group of symptoms together including: fever, nausea, vomiting, headache, stiff neck and extreme sensitivity to bright light. This may be caused by an inflammation of the membranes that cover the brain and spinal cord (meningitis)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5) HOW TO STORE FLAGYL
• Keep out of the sight and reach of children.
• Do not store above 25°C.
• Store in the original package to protect from light.
• Do not use Flagyl after the expiry date which is stated on the bottle label and carton. The expiry date refers to the last day of that month.
• After opening, discard any unused suspension after 28 days.
• If your oral suspension becomes discoloured or shows any signs of deterioration, return it to your pharmacist.
• 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.
6) FURTHER INFORMATION
4) POSSIBLE SIDE EFFECTS
Like all medicines, Flagyl can cause side effects, although not everybody gets them.
Stop taking Flagyl and see a doctor or go to a hospital straight away if:
• You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria)
This may mean you are having an allergic reaction to Flagyl.
• A serious but very rare side effect is a brain disease (encephalopathy). Symptoms vary but you might get a fever, stiff neck, headache, see or hear things that aren't there. You might also have problems using your arms and legs, problems with speaking or feel confused.
Talk to your doctor straight away if you notice the following side effects.
• Yellowing of the skin and eyes. This could be due to a liver problem (jaundice).
• Unexpected infections, mouth ulcers, bruising, bleeding gums, or severe tiredness. This could be caused by a blood problem.
• Severe stomach pain which may reach through to your back (pancreatitis)
What Flagyl S 200mg/5ml Oral Suspension contains
The active ingredient is metronidazole benzoate.
Each 5ml of suspension contains 200mg metronidazole (as benzoate).
The other ingredients are:
sucrose, sodium dihydrogen phosphate dihydrate, aluminium magnesium silicate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), ethanol (96%v/v), lemon flavour (contains propylene glycol), orange oil terpeneless and purified water.
What Flagyl S 200mg/5ml Oral Suspension looks like and contents of the pack
White to cream suspension with a slight yellow tinge and an odour of orange and lemon.
Flagyl S 200mg/5ml Oral Suspension comes in an amber glass bottle with a child resistant, tamper evident screw cap.
It is available in 100ml bottles.
Manufacturer:
Unither Liquid Manufacturing, 1-3 Allee de la Neste, Z.I. en Sigal, 31770 Colomiers, France
Tell your doctor or pharmacist if you notice any of the following side effects:
Very rare (affects less than 1 in 10 000 people)
• Fits (convulsions)
• Mental problems such as feeling confused and seeing or hearing things that are not there (hallucinations)
• Problems with your eyesight such as blurred or double vision
• Skin rash or flushing
• Headache
• Darkening of the urine
• Feeling sleepy or dizzy
• Pains in the muscles or joints
• Liver problems including life-threatening liver failure (hepatocellular liver injury)
Procured from within the EU by the Product Licence holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge, Walsall WS9 8ER.
Repackaged by MPT Pharma Ltd.
PL 33532/0559 Flagyl® S 200mg/5ml Oral Suspension
Leaflet date 16th December 2014 Leaflet code xxxxxxxx
Flagyl® is a registered trademark of Aventis Pharma SA.
POM
Metronidazole 200mg/5ml Oral Suspension
(metronidazole benzoate)
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1) What Metronidazole is and what it is used for
2) Before you take Metronidazole
3) How to take Metronidazole
4) Possible side effects
5) How to store Metronidazole
6) Further information
1) WHAT METRONIDAZOLE IS AND WHAT IT IS USED FOR
The name of this medicine is Metronidazole 200mg/5ml Oral Suspension (called Metronidazole in this leaflet). Metronidazole contains a medicine called metronidazole benzoate. This belongs to a group of medicines called antibiotics.
It works by killing bacteria and parasites that cause infections in your body.
It can be used to:
• Treat infections of the blood, brain, lung, bones, genital tract, pelvic area, stomach and intestines
• Treat gum ulcers and other dental infections
• Treat infected leg ulcers and pressure sores
• Prevent infections after surgery
If you need any further information on your illness, speak to your doctor.
2) BEFORE YOU TAKE METRONIDAZOLE
Do not take Metronidazole and tell your doctor if:
• You are allergic (hypersensitive) to metronidazole, nitroimidazoles (e.g. tinidazole) or any of the other ingredients in your medicine (listed in Section 6: Further information).
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
Do not take Metronidazole if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Metronidazole.
Take special care with Metronidazole and check with your doctor or pharmacist before using your medicine if:
• You have or have ever had a liver problem.
• You are having kidney dialysis (see section 3: ‘People having kidney dialysis')
• You have a disease of the nervous system
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking your medicine. Do this even if they have applied in the past.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Metronidazole can affect the way some other medicines work. Also, some other medicines can affect the way Metronidazole works.
In particular tell your doctor if you are taking any of the following medicines:
• Medicines used to thin the blood such as warfarin
• Lithium for mental illness
• Phenobarbital or phenytoin for epilepsy
• 5 fluorouracil for cancer
• Busulfan for leukaemia (cancer of the blood cells)
• Ciclosporin - to prevent the rejection of organs after transplant
• Disulfiram for alcoholism
If you are not sure, talk to your doctor or pharmacist before taking Metronidazole.
Taking Metronidazole with food and drink
Do not drink any alcohol while you are taking Metronidazole and for 48 hours after finishing your course. Drinking alcohol while using Metronidazole might cause unpleasant side effects, such as feeling sick (nausea), being sick (vomiting), stomach pain, hot flushes, very fast or uneven heartbeat (palpitations) and headache.
Pregnancy and breast-feeding
Tell your doctor before using Metronidazole if:
• You are pregnant, might become pregnant or think you may be pregnant. Metronidazole should not be taken during pregnancy unless considered absolutely necessary.
• You are breast-feeding. It is better not to use Metronidazole if you are breast-feeding. This is because small amounts may pass into the mother's milk.
Driving and using machines
While taking Metronidazole you may feel sleepy, dizzy, confused, see or hear things that are not there (hallucinations), have fits (convulsions) or temporary eyesight problems (such as blurred or double vision). If this happens, do not drive or use any machinery or tools.
Tests
Your doctor may wish to carry out some tests if you have been using this medicine for more than 10 days.
Important information about some of the ingredients of your medicine
• Sucrose: This is a type of sugar. If you have been told by your doctor that you cannot tolerate some sugars, talk to your doctor before taking this medicine.
• Methyl hydroxybenzoate (E218) and propyl hydroxybenzoate (E216): These are preservatives that are added to Metronidazole to make the medicine last longer. These can cause an allergic reaction in some people.
• Alcohol: Metronidazole contains 0.8% alcohol (ethanol) by volume; this is equivalent to 32mg alcohol per 5ml dose. At high doses this could be harmful for those suffering from alcoholism, liver disease or epilepsy.
3) HOW TO TAKE METRONIDAZOLE Taking your medicine
Always take Metronidazole exactly as your doctor has told you. It is important to finish a full course of treatment. The length of a course will depend on your needs and the illness being treated.
Check with your doctor or pharmacist if you are not sure.
• Take Metronidazole Suspension by mouth
• The dose of Metronidazole will depend on your needs and the illness being treated
• The length of your treatment will depend on the type of illness you have and how bad it is
• Your doctor or pharmacist may dilute your Metronidazole Suspension. In this case the pharmacist's label on the packaging will tell you how exactly much to take and how often.
The usual dose for adults and children is given below:
To treat certain bacterial infection Adults and children over 10 years
• Take 10ml (400mg) of Metronidazole Suspension once every 8 hours
Children and infants
• Your doctor will work out how much your child should take depending on their weight
• Repeat the dose every 8 hours
• If your child is a baby under 8 weeks of age, your doctor will give them one daily dose or two separate doses 12 hourly
To prevent infections from happening after surgery Children
• Give your child Metronidazole suspension 2-3 hours before their operation
• Your doctor will work out how much your child should take depending on their weight
Other types of infections
For treatment of other infections caused by parasites and some bacteria your doctor will decide how much Metronidazole you need to take. This will depend on your illness and how bad it is. The pharmacist's label on the packaging will tell you exactly how much Metronidazole Suspension to take and how often.
People having kidney dialysis
Kidney dialysis removes Metronidazole from your blood. If you are having kidney dialysis you must take this medicine after your dialysis treatment.
People with liver problems
Your doctor may tell you to use a lower dose or to use the medicine less often.
If you take more Metronidazole than you should
If you take more Metronidazole than you should, tell your doctor or go to your nearest hospital casualty department straight away. Take the carton and bottle with you. This is so the doctor knows what you have taken.
If you forget to take Metronidazole
If you forget to take Metronidazole, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not use a double dose to make up for a forgotten dose.
4) POSSIBLE SIDE EFFECTS
Like all medicines, Metronidazole can cause side effects, although not everybody gets them.
Stop taking Metronidazole and see a doctor or go to a hospital straight away if:
• You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria)
This may mean you are having an allergic reaction to Metronidazole.
• A serious but very rare side effect is a brain disease (encephalopathy). Symptoms vary but you might get a fever, stiff neck, headache, see or hear things that aren't there. You might also have problems using your arms and legs, problems with speaking or feel confused.
Talk to your doctor straight away if you notice the following side
effects.
• Yellowing of the skin and eyes. This could be due to a liver problem (jaundice).
• Unexpected infections, mouth ulcers, bruising, bleeding gums, or severe tiredness. This could be caused by a blood problem.
• Severe stomach pain which may reach through to your back (pancreatitis)
Tell your doctor or pharmacist if you notice any of the following
side effects:
Very rare (affects less than 1 in 10 000 people)
• Fits (convulsions)
• Mental problems such as feeling confused and seeing or hearing things that are not there (hallucinations)
• Problems with your eyesight such as blurred or double vision
• Skin rash or flushing
• Headache
• Darkening of the urine
• Feeling sleepy or dizzy
• Pains in the muscles or joints
• Liver problems including life-threatening liver failure (hepatocellular liver injury)
Not known (frequency cannot be estimated from the available data)
• Numbness, tingling, pain, or a feeling of weakness, in the arms or legs
• Unpleasant taste in the mouth
• Furred tongue
• Feeling sick (nausea), being sick (vomiting), upset stomach, stomach pain or diarrhoea
• Loss of appetite
• Fever
• Feeling depressed
• Pain in your eyes (optic neuritis)
• A group of symptoms together including: fever, nausea, vomiting, headache, stiff neck and extreme sensitivity to bright light. This may be caused by an inflammation of the membranes that cover the brain and spinal cord (meningitis)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5) HOW TO STORE METRONIDAZOLE
• Keep out of the sight and reach of children.
• Do not store above 25°C.
• Store in the original package to protect from light.
• Do not use Metronidazole after the expiry date which is stated on the bottle label and carton. The expiry date refers to the last day of that month.
• After opening, discard any unused suspension after 28 days.
• If your oral suspension becomes discoloured or shows any signs of deterioration, return it to your pharmacist.
• 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.
6) FURTHER INFORMATION
What Metronidazole 200mg/5ml Oral Suspension contains
The active ingredient is metronidazole benzoate.
Each 5ml of suspension contains 200mg metronidazole (as benzoate).
The other ingredients are:
sucrose, sodium dihydrogen phosphate dihydrate, aluminium magnesium silicate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), ethanol (96%v/v), lemon flavour (contains propylene glycol), orange oil terpeneless and purified water.
What Metronidazole 200mg/5ml Oral Suspension looks like and contents of the pack
White to cream suspension with a slight yellow tinge and an odour of orange and lemon.
Metronidazole 200mg/5ml Oral Suspension comes in an amber glass bottle with a child resistant, tamper evident screw cap.
It is available in 100ml bottles.
Manufacturer:
Unither Liquid Manufacturing, 1-3 Allee de la Neste, Z.I. en Sigal, 31770 Colomiers, France
Procured from within the EU by the Product Licence holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge, Walsall WS9 8ER.
Repackaged by MPT Pharma Ltd.
PL 33532/0559 Metronidazole 200mg/5ml Oral Suspension
Leaflet date 16th December 2014 Leaflet code xxxxxxxx
POM