Metronidazole Powder For Oral Suspension 125mg/5ml
Metronidazole Powder For Oral Suspension 125mg/5ml
Read all of this leaflet carefully before you start taking this medicine because it containsimportant information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leafl¬et
What Metronidazole Powder For Oral Suspension is and what it is used for
What you need to know before you take Metronidazole Powder For Oral Suspension
How to take Metronidazole Powder For Oral Suspension
Possible side effects
How to store Metronidazole Powder For Oral Suspension
Contents of the pack and other information
What Metronidazole Powder For Oral Suspension is and what it is used for
The name of your medicine is Metronidazole Powder For Oral Suspension 125mg/5ml Oral Suspension (called Metronidazole in this leaflet). It contains metronidazole benzoate. This belongs to a group of medicines called antibacterials. Metronidazole can be used for:
Adults and children over 1 year
preventing infections after you have an operation
treating infections, including infections of your blood, brain, lungs, bones, lining of your abdomen, pelvis and infections following childbirth or around the area where you had an operation
treating trichomoniasis. This is a sexually transmitted infection, in both males and females
treating amoebiasis – an infection of your intestine or liver caused by a parasite
treating giardiasis – an infection that causes swelling of your intestines. Adults and children over 10 yearsonly
treating vaginosis – an infection and swelling of your vagina
treating swollen gums and ulcers in your mouth (gingivitis) and other dental infections
treating ulcers and pressure sores on your leg. Children It can also be used in children to treat a bacterial infection in the stomach (Helicobacter pylori). Newborns (full term) It can be used in full term newborns for treating bacteria infections and preventing infections after an operation.
What you need to know before you take Metronidazole Powder For Oral Suspension
Do not take Metronidazole and tell your doctor if:
you are allergic to metronidazole, nitroimidazoles (e.g. tinidazole) or any of the other ingredients of this medicine(listed in section 6). Signs of an allergic reaction include a rash, itching or shortness of breath
treating infections, including infections of your blood, brain, lungs, bones, lining of your abdomen, pelvis and infections following childbirth or around the area where you had an operation
you are pregnant, think you are pregnant or breast feeding. Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor before taking Metronidazole.
Warnings and precautions
Talk to your doctor before taking Metronidazole if:
you have liver problems
you have a disease of the nervous system
you are having haemodialysis.
Warnings and precautions
If you are on this medicine for more than 10 days, your doctor may give you some tests.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Metronidazole.
Cases of severe liver toxicity/acute liver failure, including cases with a fatal outcome, in patients with Cockayne syndrome have been reported with product containing metronidazole.
If you are affected by Cockayne syndrome, your doctor should also monitor your liver function frequently while you are being treated with metronidazole and afterwards.
Serious skin reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute generalised exanthematouspustulosis (AGEP) have been reported with the use of Metronidazole.
SJS/TEN can appear initially as reddish target-like spots or circular patches often with central blisters on the trunk.
Also, ulcers of the mouth, throat, nose, genitals and eyes (red and swollen eyes) can occur. These serious skin rashes are often preceded by fever and/or ¬u-like symptoms. The rashes may progress to widespread peeling of the skin and life- threatening complications or be fatal.
AGEP appears at the initiation of treatment as a red, scaly widespread rash with bumps under the skin and blisters accompanied by fever. The most common location: mainly localised on the skin folds, trunk, and upper extremities.
The highest risk for occurrence of serious skin reactions is within one week, typically, within 48 hours after start of treatment. If you develop a serious rash or another of these skin symptoms, stop taking Metronidazole and contact your doctor or seek medical attention immediately.
Tell your doctor immediately and stop taking metronidazole if you develop: stomach pain, anorexia, nausea, vomiting, fever, malaise, fatigue, jaundice, dark urine, putty or mastic coloured stools or itching.
Other medicines and Metronidazole
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Metronidazole can affect the way some other medicines work. Also, some medicines can affect the way Metronidazole works.
In particular, tell your doctor if you are taking any of the following:
warfarin – used to thin your blood
lithium – used to treat depression
phenobarbital, phenytoin or carbamazepine – used to treat epilepsy
5-¬fluorouracil – used to treat cancer
busulfan – used to treat leukaemia
ciclosporin or tacrolimus – used after organ transplants
disulfiram – used to treat alcoholism.
Metronidazole with food and drink
Do not drink alcohol whilst taking Metronidazole and for 48 hours after finishing the treatment. Drinking alcohol may cause unpleasant side effects such as nausea, vomiting, pain in and around your stomach area (the abdomen), hot ushes, palpitations and headaches.
Driving and using machines
Metronidazole may make you feel drowsy, dizzy or confused. It may cause you to see and hear things that are not there (hallucinations), have fits or give you blurred or double vision. If you are affected, do not drive or operate machines.
These may cause an allergic reaction. This allergy may not happen straight away
If you have been told by your doctor that you have intolerance to some sugars, you mustcontact you doctor before taking this medicine. It may also be harmful to teeth.
If you are pregnant, breast-feeding, suffer from a liver or kidney disease, do not take this medicine unlessrecommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine.
How to take Metronidazole Powder For Oral Suspension
Take this medicine as your doctor or pharmacist has told you. Look on the label and ask the doctor orpharmacist if you are not sure. The different routines you might follow are shown below.
Taking this medicine
This medicine contains 125mg of metronidazole in each 5ml.
Take this medicine by mouth.
Always shake the bottle before use.
Complete the full course of this medicine.
How much to take The usual doses for adults and children are:
What you’re taking the medicine for
Number of days you will take the medicine for
How much to take – Adults and children over 12 years of age
How much to take – Children under 12 years of age
Prevention of infections after surgery
1
16ml (400mg) three times during the day before the operation
Your doctor will work out the right dose based on your child’s weight.$4.00
Bacterial infections
–
A 32ml (800mg) dose followed by 400mg (16ml) three times a day
Other infections Adults and children over 10 years of age:
What you’re taking the medicine for
Number of days you will take the medicine for
How much to take – Adults and children over 10 years of age
Trichomoniasis
1
80ml (2000mg) once a day
or 5 to 7
16ml (400mg) twice a day
or 7
8ml (200mg) three times a day
Vaginosis
1
80ml (2000mg) once a day
or 5 to 7
16ml (400mg) twice a day
Amoebiasis
5 to 10
16ml (400mg) to 32ml (800mg) three times a day
Giardiasis
3
80ml (2000mg) once a day
or 5
16ml (400mg) three times a day
or 7 to 10
20ml (500mg) twice a day
Gingivitis
3
8ml (200mg) three times a day
Dental infections
3 to 7
8ml (200mg) three times a day
Leg ulcers and pressure sores
7
16ml (400mg) three times a day
Children under 10 years of age:
What you’re taking the medicine for
Number of days you will take the medicine for
How much to take – Children aged 7-10 years
How much to take – Children aged 3-7 years
How much to take – Children aged 1-3 years
Trichomoniasis
7
Your doctor will work out the right dose based on your child’s weight. This should not exceed 2000mg a day.
Amoebiasis
5 to 10
8ml (200mg) to 16ml (400mg) three times a day
4ml (100mg) to 8ml (200mg) four times a day
4ml (100mg) to 8ml (200mg) four times a day
Your doctor will work out the right dose based on your child’s weight. This should not exceed 2400mg a day.
Giardiasis
3
40ml (1000mg) once a day
24ml (600mg) to 32ml (800mg)once a day
20ml (500mg) once a day
Your doctor will work out the right dose based on your child’s weight.
Gingivitis
3
4ml (100mg) three
times a day
4 (100mg) twicea day
2ml (50mg) threetimes a day
Children – treatment for a bacterial infection in the stomach (Helicobacter pylori)
Your child will be given Metronidazole with other medicines. Your doctor will work out the right dose based on your child’s weight.
This should not exceed 500mg twice a day.
Older people and those with liver problems
Your doctor may prescribe a lower dose than that given to adults. This is because you may be more sensitive to the medicine.
If you forget to take Metronidazole
Do not take a double dose (two doses at the same time) to make up for a forgotten dose. Take your next dose as soon as you remember, then go on as before. However, if it is nearly time for the next dose, skip the missed dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
If you take more Metronidazole than you should
Talk to a doctor or go to a hospital straight away. Take the medicine pack with you so the doctor knows what you have taken.
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 a brain disease (encephalopathy) which is a serious but very rare side effect. Symptoms vary but you mightget a fever, stiff neck, headache, see or hear things that aren’t there. You might also have problems using yourarms and legs, problems with speaking or feeling confused
you get a group of symptoms together including: fever, nausea, vomiting, headache, stiff neck and extreme sensitivityto bright light. This may be caused by an inflammation of the membranes that cover the brain and spinal cord(meningitis)
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 or nettle rash. This may mean you are having an allergic reaction toMetronidazole
blistering or bleeding of the skin around the lips, eyes, mouth, nose and genitals. Also ¬flu-like symptoms and fever.
This may be something called `Steven Johnson Syndrome’ which is a severe blistering rash where layers of theskin may peel off to leave large areas of raw exposed skin over the body. Also a feeling of being generally unwell,fever, chills and aching muscles. Sometimes called Toxic epidermal necrolysis.
you develop a red, scaly widespread rash with bumps under the skin and blisters accompanied by fever at theinitiation of treatment (acute generalised exanthematouspustulosis). Stop using Metronidazole if you developthese symptoms and contact your doctor or seek medical attention immediately. See also section 2.
Talk to your doctor straight away if you notice the following side effects:
yellowing of your skin and the whites of your eyes (jaundice)
blood problems. You may notice signs such as high temperature or chills, unexpected infections, bruising, sore throat,ulcers in your mouth or throat, bleeding gums and unusual tiredness
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 : may affect up to 1 in10,000 people
fits (convulsions)
feeling confused
seeing or hearing things that are not there (hallucinations)
temporary affects on your eyesight, such as difficulty in focusing
drowsiness and dizziness
clumsiness or poor co-ordination
pain and swelling of your skin, skin rashes or ¬ushing
headache
itching
darkening of your urine
pains in your joints or muscles
liver problems including life-threatening liver failure (hepatocellular liver injury).
Frequency not known
numbness, tingling, pain or feeling weak in your arms and legs
unpleasant taste in your mouth or a furry tongue
feeling or being sick, upset stomach or diarrhoea
loss of appetite
fever
feeling depressed
pain in your eyes (optic neuritis)
hearing impairment/ hearing loss
ringing in the ears (tinnitus)
Frequency not known
you get a rash or skin discolouration with or without raised areas which often reoccurs at the same location each time the drug is taken.
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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in thisleaflet.
5. How to store Metronidazole Powder For Oral Suspension
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date which is stated on the label and carton (Exp: month, year).
The expiry date refers to the last day of that month.
Do not use Metronidazole Powder For Oral Suspension if you notice a change in the appearance or smell of the medicine. Talk to your pharmacist.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw awaymedicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Metronidazole Powder For Oral Suspension contains
The active substance is metronidazole benzoate. Each 5ml contains 320mg metronidazole benzoate. This is equivalent to 125mg metronidazole.
What Metronidazole Powder For Oral Suspension looks like and contents of the pack
A white color powder filled in a white plastic bottle.