Metronidazole 200 mg/5 ml Oral Suspension – patient leaflet, side effects, dosage

1. What Metronidazole Oral Suspension is and what it is used for

The name of this medicine is Metronidazole 200 mg/5 ml Oral Suspension (called Metronidazole Oral Suspension in this leaflet). It contains metronidazole benzoate. This belongs to a group of medicines called antibacterials.

Metronidazole Oral Suspension 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 - 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 years only

• 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

It can be used in full term newborns for treating bacterial infections and preventing infections after an operation.

2. What you need to know before you take Metronidazole Oral Suspension

Do not take Metronidazole Oral Suspension and tell your doctor if:

• You are allergic to metronidazole, nitroimidazoles (e.g. tinidazole) or any of the ingredients of this medicine (listed in section 6.) Signs of an allergic reaction include a rash, itching or shortness of breath
• You are pregnant, think you are pregnant or are 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 Oral Suspension.

Warnings and precautions

Talk to your doctor before taking Metronidazole Oral Suspension if: • You have liver problems

• You have a disease of the nervous system
• You are having haemodialysis.

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 Oral Suspension.

Cases of severe liver toxicity/acute liver failure, including cases with fatal outcome in patients with Cockayne Syndrome. have been reported with products 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) and acute generalised exanthematous pustulosis (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 flu-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 Oral Suspension 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 Oral Suspension

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 Oral Suspension can affect the way some other medicines work. Also, some medicines can affect the way Metronidazole Oral Suspension 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 Oral Suspension with food and drink

Do not drink alcohol whilst you are taking Metronidazole Oral Suspension 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 flushes, palpitations and headaches.

Pregnancy and breast-feeding

You should not take Metronidazole Oral Suspension if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby. Ask your doctor for advice before taking this medicine.

Driving and using machines

Metronidazole Oral Suspension 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.

Metronidazole Oral Suspension contains methyl parahydroxybenzoate, sucrose, sorbitol and propylene glycol

• Methyl parahydroxybenzoate. This may cause an allergic reaction. This allergy may not happen straight away.
• Sucrose. If you have been told by your doctor that you have an intolerance to some sugars, you must contact you doctor before taking this medicine. It may also be harmful to teeth.
• Sorbitol. This medicine contains 128 mg sorbitol 70% (E420) in each ml. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine. • Propylene glycol. This medicine contains 10.4 mg propylene glycol (E1520) in each ml.
• If your child is less than 5 years old, talk to your doctor or pharmacist before giving them this medicine, in particular if they use other medicines that contain propylene glycol or alcohol.
• If you are pregnant, breast-feeding, suffer from liver or kidney disease, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine.

This medicine contains 0.9 mg methyl parahydroxybenzoate in each ml which may cause allergic reactions (possibly delayed).

This medicine contains 10.35 mg sodium (main component of cooking/table salt) in each 5 ml. This is equivalent to 0.5% of the recommended maximum daily dietary intake of sodium for an adult.

This medicine contains 124.2 mg sodium (main component of cooking/table salt) in the maximum daily dose of 800 mg (20 ml) three times daily. This is equivalent to 6.2% of the recommended maximum daily dietary intake of sodium for an adult.

3. How to take Metronidazole Oral Suspension

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Taking this medicine

• This medicine contains 200 mg of metronidazole in each 5 ml. • Take this medicine by mouth.
• Always shake the bottle before use.
• Complete the full course of this medicine.
• Take this medicine using the measuring spoon provided. This spoon is marked in ml (millilitres) to help you measure out the correct amount of medicine.

Recommended dose

The recommended doses for adults and children are:

Other infections

Adults and children over 10 years of age:

Children under 10 years of age:

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 500 mg twice a day.

People having kidney dialysis

Kidney dialysis removes Metronidazole Oral Suspension 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 prescribe a lower dose than that given to adults. This is because you may be more sensitive to the medicine.

If you take more Metronidazole Oral Suspension than you should

Talk to a doctor or go to the nearest hospital straight away. Take the medicine pack with you so the doctor knows what you have taken.

If you forget to take Metronidazole Oral Suspension

Do not take a double dose 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 almost time for your next dose, skip the missed dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Metronidazole Oral Suspension can cause side effects although not everybody gets them.

Stop taking Metronidazole Oral Suspension 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 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 feeling confused • You get 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)
• 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 to Metronidazole Oral Suspension.
• 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 the skin 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 the initiation of treatment (acute generalised exanthematous pustulosis). Stop using Metronidazole if you develop these symptoms and contact your doctor or seek medical attention immediately. See 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 in 10,000 people

• Fits (convulsions)
• Feeling confused
• Seeing or hearing things that are not there (hallucinations) • Temporary effects on your eyesight such as difficulty in focusing • Drowsiness and dizziness
• Clumsiness or poor coordination
• Pain and swelling of your skin, skin rashes or flushing
• Headache
• Itching
• Darkening of your urine
• Pains in your joints or muscles
• Liver problems including life-threatening liver failure (hepatocellular liver injury).

Not known: frequency cannot be estimated from the available data

• Numbness, tingling, pain or feeling of 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)
• 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 • Acute liver failure in patients with Cockayne Syndrome (see section 2 “Warnings and precautions”).

If any of the side effects get 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, 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Metronidazole 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 shown on the bottle label and packaging. The expiry date refers to the last day of that month. • Do not use Metronidazole Oral Suspension if you notice a change in the appearance or smell of the medicine. Talk to your pharmacist. • Store your medicine in the original packaging in order to protect them from light.
• Once opened: Use within 12 weeks.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information What Metronidazole Oral Suspension contains

• The active substance is metronidazole benzoate. Each 5 ml of Metronidazole Oral Suspension contains 320 mg metronidazole benzoate. This is equivalent to 200 mg of metronidazole.
• The other ingredients are microcrystalline cellulose and carmellose sodium (90:10), carboxymethylcellulose sodium (E468), sucrose, sorbitol 70% (E420), sodium saccharin (E954), polysorbate 80 (E433), propylene glycol (E1520), colloidal anhydrous silica, sodium dihydrogen phosphate dihydrate (E339) (for pH adjustment), sodium citrate dihydrate (E331) (for pH adjustment), methyl parahydroxybenzoate (E218), lemon flavour, orange flavour and purified water.

What Metronidazole Oral Suspension looks like and contents of the pack

The suspension is white to cream-coloured with a sweet taste and an orange-lemon flavour. It is available in 100 ml amber coloured glass bottles with a white polypropylene cap.

Marketing Authorisation Holder

Dawa Limited,

5 Sandridge Close,

Harrow, Middlesex,

HA1 1XD, UK.

Manufacturer

Drugsrus Limited,

5 Sandridge Close,

Harrow, Middlesex,

HA1 1XD, UK.

This leaflet was last revised in April 2026.

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