METRONIDAZOLE 200MG TABLETS

Active substance: METRONIDAZOLE

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Sandoz Ltd
Metrolyl (Metronidazole) Tablets 200mg and 400mg

March 2011
PL 04416/0060 & 0061

PATIENT INFORMATION LEAFLET
METROLYL® (METRONIDAZOLE) TABLETS BP 200mg AND 400mg
What you should know about Metrolyl®
Please read this carefully before you start to take your medicine. This leaflet provides a summary of the information
available on your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.
The name of your medicine is Metrolyl® (Metronidazole) Tablets BP 200mg or 400mg.
What is in your Medicine?
Each tablet contains 200mg or 400mg of the active ingredient metronidazole BP. They also contain: lactose,
microcrystalline cellulose, magnesium stearate and maize starch. The 200mg tablets also contain gelatin and the
400mg tablets also contain povidone.
The 200mg tablets are supplied in packs of 14, 21 and 250 and the 400mg tablets are supplied in packs of 14, 21 and
100.
The active ingredient, metronidazole, is an antibacterial agent used to treat infections.
The product licence holder and manufacturer is: Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey
GU16 7SR, United Kingdom.
Uses
Metrolyl® (Metronidazole) Tablets are used to treat different types of infections which are due to particular types of
bacteria and some other infectious organisms, or to prevent infection during an operation.
Before taking your Medicine
DO NOT take this medicine before telling your doctor if:
• you are, or might be, pregnant or you are breast-feeding
• you have experienced sensitivity to metronidazole, or any of the other ingredients in this medicine
• you have liver disease
It is very important that you tell your doctor if you are taking any other medication particularly phenobarbitone (used
for epilepsy and convulsions), anticoagulants such as warfarin (used to prevent blood clots), lithium (used to treat
depressive illness); or any other medication you have obtained without a prescription.
Do not drink alcohol while taking metronidazole as you may get an unpleasant reaction.
You should not drive, operate machinery or carry out other activities requiring full alertness if you experience any
dizziness or drowsiness while taking this medicine.
If you have kidney failure and have dialysis while you are taking metronidazole, your doctor may alter the timing of
your next dose.
Metronidazole therapy may affect tests for liver function.
Taking your Medicine
Recommended doses follow. Doctors sometimes prescribe different doses to these: if this applies to you, discuss it
with the doctor, if you have not already done so. You should always follow your doctor’s instructions as to when
and how to take your medicine. Your pharmacist may be able to advise if you are not sure. Exactly how many
tablets and when to take them will be written on the label. Please read it carefully.
Treatment with metronidazole will normally be for 7 days. Shorter or longer treatment may be prescribed if your
doctor feels this is necessary. If treatment is to continue for longer than 10 days your doctor will keep a close eye on
you. You should continue and complete the course of metronidazole prescribed for you even if you are feeling
better.
Metrolyl® (Metronidazole) Tablets should be swallowed with a drink of water during or after a meal.

PIL.0060-61.004d

Paediatric work-sharing

RC

Sandoz Ltd
Metrolyl (Metronidazole) Tablets 200mg and 400mg

March 2011
PL 04416/0060 & 0061

The normal daily doses are as follows.
For the treatment of infections
Metronidazole Tablets may be given on their own or with other medicines which kill bacteria.
General dosage
Adults:
Children 8 weeks to 12 years:

Children under 8 weeks:

400mg, 3 times a day.
20-30mg of metronidazole for each kilogram of the child’s
body weight a day or 7.5mg of metronidazole for each kilogram of the
child’s weight every 8 hours, for 7 days
15mg of metronidazole for each kilogram of the child’s body weight a
day or 7.5mg of metronidazole for each kilogram of the child’s body
weight every 12 hours.

If you have liver problems, your dose may be reduced to one-third of the normal dosage, once a day.
For patients with urogenital infections
Sexual partners should be treated concurrently.
Adults and children over 10 years:

200mg, 3 times a day for 7 days or 400mg twice a day for 5-7 days, or
2,000mg once.

Children under 10 years:

40mg of metronidazole for each kilogram of the child’s body weight
once or 15-30mg of metronidazole for each kilogram of the child’s
body weight, in 2-3 doses, for 7 days.

In bacterial infections of the vagina
Adults and children over 10 years:

400mg twice a day for 5-7 days or 2,000mg once as a single dose.

Dysentery/amoebiasis: invasive intestinal disease
Adults and children over 10 years:
800mg, 3 times a day for 5 days.
Children:

7 to 10 years:
3 to 7 years:
1 to 3 years:

400mg, 3 times a day for 5 days.
200mg, 4 times a day for 5 days.
200mg, 3 times a day for 5 days.

Dysentery/amoebiasis: intestinal disease and chronic amoebic hepatitis
Adults and children over 10 years:
400mg, 3 times a day for 5 to 10 days.
Children:

7 to 10 years:
3 to 7 years:
1 to 3 years:

200mg, 3 times a day for 5 to 10 days.
100mg, 4 times a day for 5 to 10 days.
100mg, 3 times a day for 5 to 10 days.

Dysentery/amoebiasis: amoebic liver abscess and other forms of extra-intestinal amoebiasis
Adults and children over 10 years:
400mg, 3 times a day for 5 days.
Children:

7 to 10 years:
3 to 7 years:
1 to 3 years:

200mg, 3 times a day for 5 days.
100mg, 4 times a day for 5 days.
100mg, 3 times a day for 5 days.

Dysentery/amoebiasis: in patients who have passed cysts but who are otherwise symptomless
Adults and children over 10 years:
400mg to 800mg, 3 times a day for 5 to 10 days.
Children:

7 to 10 years:
3 to 7 years:
1 to 3 years:

PIL.0060-61.004d

200mg to 400mg, 3 times a day for 5 to 10 days.
100mg to 200mg, 4 times a day for 5 to 10 days.
100mg to 200mg, 3 times a day for 5 to 10 days.

Paediatric work-sharing

RC

Sandoz Ltd
Metrolyl (Metronidazole) Tablets 200mg and 400mg
For giardiasis
Adults and children over 10 years:

Children:

7 to 10 years:
3 to 7 years:
1 to 3 years:

March 2011
PL 04416/0060 & 0061

2,000mg, once a day for 3 days, or 400mg 3 times a day for 5 days, or
500mg twice a day for 7-10 days.
1,000mg, once a day for 3 days.
600mg to 800mg, once a day for 3 days.
500mg, once a day for 3 days.

For gum disease (acute ulcerative gingivitis)
Adults and children over 10 years:
200mg, 3 times a day for 3 days.
Children:

7 to 10 years:
3 to 7 years:
1 to 3 years:

100mg, 3 times a day for 3 days.
100mg, twice a day for 3 days.
50mg, three times a day for 3 days.

For acute dental infections
Adults and children over 10 years:

200mg, 3 times a day for 3 to 7 days.

For leg ulcers and pressure sores
Adults and children over 10 years:

400mg, 3 times a day for 7 days.

For the treatment of H.pylori infections
Children:

20mg of metronidazole a day for each kilogram of the child’s body
weight for 7-14 days.

For the prevention of infections
In gynaecological surgery
Adults and children over 12 years:

Children under 12 years:
Newborns:

1,000mg as a single dose, followed by 200mg, 3 times a day until preoperative withholding of solids and liquids by mouth becomes
necessary. 200mg, 3 times a day should be resumed after the
operation and for a period of up to 7 days.
20-30mg of metronidazole for each kilogram of the child’s body
weight 1-2 hours before surgery.
10mg of metronidazole for each kilogram of the child’s body weight
before surgery.

As a pre-operative medication prior to surgery on your colon
Adults and children over 12 years:
200mg every 6 hours, with an aminoglycoside antibiotic for 3 days
before surgery
or

Children under 12 years:
Newborns:

400mg every 8 hours with phthalylsulphathiazole (2,500mg every 6
hours) for 4 days before your operation.
20-30mg of metronidazole for each kilogram of the child’s body
weight 1-2 hours before surgery.
10mg of metronidazole for each kilogram of the child’s body weight
before surgery.

If you forget to have a dose, take the missed dose as soon as you remember. If your next dose is due within 2 hours,
have a single dose straight away and skip the next.
If you take an unintentional extra dose, this should not cause problems. If you or someone else has taken too many
tablets or a large overdose has been taken, seek medical help immediately.

PIL.0060-61.004d

Paediatric work-sharing

RC

Sandoz Ltd
Metrolyl (Metronidazole) Tablets 200mg and 400mg

March 2011
PL 04416/0060 & 0061

As with all medicines, metronidazole may cause unwanted effects in some people, although serious reactions are
rare. An unpleasant taste in the mouth, furred tongue, nausea, vomiting or other gastro-intestinal disturbance has
been reported.
Occasionally, you may feel drowsy, dizzy, have a headache and feel shaky or unsteady while taking metronidazole.
Hypersensitivity reaction can occur including skin rashes, including nettle rash, or itching. Rarely, a more severe
allergic reaction can occur called angioedema, symptoms of which are large, well-defined swellings which suddenly
occur in the skin, particularly around the face and throat. Extremely rarely, a very severe allergic reaction called
anaphylaxis may occur. Symptoms of this may be lowered blood pressure (making you feel dizzy or light-headed),
itchy raised rash, tightness in the chest and breathing difficulties, swelling of the tongue or throat, pain in the stomach
and diarrhoea. If any of these rare reactions occur, contact your hospital accident and emergency department
immediately.
Peripheral neuropathy (a disease of the peripheral nerves, symptoms of which are general weakness and numbness)
and/or convulsions or fits have occurred during prolonged or intensive treatment with metronidazole. In most cases
peripheral neuropathy disappears when treatment is stopped.
Changes to your blood may occur (red cells, white cells, platelets, etc). If there is a tendency to bruise easily, you
notice bleeding into the skin, prolonged bleeding, bleeding from the gums or elsewhere, or you feel tired and look
pale, stop taking the medicine and see your doctor.
Rarely patients may develop liver disease and jaundice (yellowing of the skin and the whites of the eyes), or
darkening of the urine.
If you have any of these effects and they become worse, inconvenient or upsetting; see your doctor or pharmacist. If
you experience any other unpleasant effects which you think could be caused by this medicine you should contact
your doctor or pharmacist for advice.
Storing your Medicine
Do not use Metrolyl® (Metronidazole) Tablets BP 200mg or 400mg after the expiry date shown on the label. Any
out of date medicines should be returned to your pharmacist for disposal.
Do not store above 25°C. Store in the original container.
If you notice any defects in the tablets, such as chips or broken tablets, take them to your pharmacist for advice
before taking them.
Date of revision: March 2011 (to be amended upon approval).
Keep all medicines out of the reach and sight of children. Your medicines can harm them.
REMEMBER this medicine is for you. Only a doctor can prescribe it for you. Never give it to others it may harm
them even if their symptoms are the same as yours.
This leaflet only applies to Metrolyl® (Metronidazole) Tablets BP 200mg or 400mg.
®

trade mark

PIL.0060-61.004d

Paediatric work-sharing

RC

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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