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METROLYL (METRONIDAZOLE) SUPPOSITORIES 1G

Active substance(s): METRONIDAZOLE / METRONIDAZOLE / METRONIDAZOLE

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Sandoz Ltd
Metrolyl (Metronidazole) Suppositories 500mg & 1g

December 2016
PL 04416/0053 & 0054

Package leaflet: Information for the user
METROLYL® Metronidazole Suppositories 500mg and 1g
(Metronidazole)
Read all of this leaflet carefully before you start to use your medicine.

Keep the leaflet. You may want to read it again.

If you have any further questions, 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 Metrolyl® are and what they are used for
2.
Before you use Metrolyl®
3.
How to use Metrolyl®
4.
Possible side effects
5.
How to store Metrolyl®
6.
Further Information
1
What Metrolyl® are and what they are used for
The name of your medicine is Metrolyl® (Metronidazole) Suppositories 500 mg or 1 g.
Metrolyl® (Metronidazole) Suppositories are antibacterials used to treat infections.
Metrolyl® works by killing the bacteria in our body.
It can be used to treat:
 Treat infections in the blood, brain, lung, bones, genital tract, pelvic area and stomach
 Prevent infections after surgery
If you need any further information about your illness, speak to your doctor.

2
Before you use Metrolyl®
Do not use Metrolyl® if:

You are allergic to metronidazole, or any of the other ingredients in this medicine (see
section 6 Further Information). Signs of an allergic reaction are: rash, swallowing or
breathing problems, swelling of the face, lips, tongue or throat. Do not use Metrolyl®
if any of the above applies to you, if you are not sure ask your doctor or pharmacist.
Take special care with Metrolyl®:

If you have or have had a liver disease.

If you have kidney failure and are having dialysis (see section 3. People having
kidney dialysis).

If you have a disease of the nervous system.
If you are not sure speak to you doctor or pharmacist.
PIL.0053-4.006.0d

V018 ; Updated PIL and SPC
in line with PRAC
recommendations

SL

Sandoz Ltd
Metrolyl (Metronidazole) Suppositories 500mg & 1g

December 2016
PL 04416/0053 & 0054

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.
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.

Taking other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription. This includes herbal
medicines.
It is important that you tell your doctor if you are taking:

Phenobarbitone, primidone, phenytoin (used for epilepsy and convulsions),

Anticoagulants such as warfarin (used to prevent blood clots),

Lithium (used to treat depressive illness),

Cimetidine (used to treat stomach ulcers),

Cytotoxics such as fluorouracil and busulfan (used to treat cancer),

Disulfiram (used to treat alcohol abuse),

Ciclosporin to prevent rejection of organs after transplant.
If you are not sure speak to your doctor or pharmacist before using Metrolyl®.
Using Metrolyl® with food and drink
Do not drink alcohol while taking metronidazole and for 48 hours after the course of the
medicine has finished as you may get an unpleasant reaction, such as feeling or being sick,
stomach pain, hot flushes, palpitations (sensation of feeling your heart beating) and
headaches.
Pregnancy and breast-feeding
Talk to your doctor before using Metrolyl® (Metronidazole) Suppositories if you are
pregnant or think you may be pregnant.
Do not use Metronidazole while breast-feeding as it is secreted in breast milk in small
amounts.
Driving and using machines
If you experience any dizziness, drowsiness, hallucinations (seeing or hearing things that are
not there), confusion, have fits (convulsions), blurred or double vision, if you are affected do
not drive or operate machinery until you have consulted a doctor.
Your doctor may want to carry out some laboratory tests if you are using this medicine for
more than 10 days.

PIL.0053-4.006.0d

V018 ; Updated PIL and SPC
in line with PRAC
recommendations

SL

Sandoz Ltd
Metrolyl (Metronidazole) Suppositories 500mg & 1g

December 2016
PL 04416/0053 & 0054

3
How to use Metrolyl®
Always use Metrolyl® exactly as your doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
The usual doses are shown below. Doctors sometimes prescribe different doses to these: if
this applies to you, discuss it with the doctor, if you have not already done so.
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.
Metrolyl® should be inserted into the anus (rectum). They may be given on their own or with
other medicines which kill bacteria.
The usual dose is:
 Suppositories are normally used for 3 days
 As soon as possible after starting treatment with the suppositories, your doctor will
suggest changing to a medicine taken by mouth.
 After 3 days, if you r doctor wants your child to continue using the suppositories, you
will probably be told to use the suppositories every 12 hours.
The usual dose for adult and children using suppositories are below:

For the treatment of infections
Metrolyl® may be used to treat a number of different infections. Your doctor will decide on
the appropriate dosage depending on the type of infection.
The usual dosage is as follows:
Adults and children over 10 years:
● Use one 1 g suppository every 8 hours for 3 days. See above for the dosing over 3
days.
Children aged 5 – 10 years:
 Use one 500 mg suppository, every 8 hours for 3 days See above for the dosing over 3
days.
Children aged 1-5 years:
 Use one half of a 500 mg suppository, every 8 hours for 3 days See above for the
dosing over 3 days.
Infants under 1 year old:
 Use one quarter of a 500 mg suppository, every 8 hours for 3 days See above for the
dosing over 3 days.
To prevent infections form happening after surgery
Adults and children over 10 years
PIL.0053-4.006.0d
V018 ; Updated PIL and SPC
in line with PRAC
recommendations

SL

Sandoz Ltd
Metrolyl (Metronidazole) Suppositories 500mg & 1g



December 2016
PL 04416/0053 & 0054

Use one 1 g suppository 2 hours before surgery.
Repeat every 8 hours up to 3 days. See above for dosing after 3 days.

Children aged 5-10 years
 Use one 500 mg suppository 2 hours before surgery.
 Repeat every 8 hours up to 3 days. See above for dosing after 3 days.
People having kidney dialysis
Your doctor may tell you to stop using Metrolyl® during dialysis and start using it again once
you gave finished.
People with liver problems
Your doctor may give you a lower dose or tell you to use this medicine less often.
If you use more Metrolyl® than you should
If you use more suppositories than you should, tell your doctor or go to a hospital casualty
department straight away, taking the pack and the suppositories you have left with you, to
show your doctor what you have used.
If you forget to use Metrolyl®
If you forget to take a dose, take the missed dose as soon as you remember. If is nearly time
for your next dose, have a single dose straight away and skip the next.
If you stop using Metrolyl®
You should always complete the prescribed course, unless your doctor tells you to stop.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4
Possible side effects
Like all medicines, Metrolyl® can cause side effects, although not everybody gets them.
Stop using Metrolyl® and seek immediate medical help if:
 You get swelling of the hands, feet, ankles, face, lips, mouth or throat, this could cause
breathing or swallowing problems, itchy lumpy rash (hives) or nettle rash (urticaria).
This could be caused by an allergic reaction to Metrolyl®.
 A very rare serious side effect is a brain disease (encephalopathy, the symptoms include
stiff neck, fever, headaches, seeing or hearing things that are not there, confusion,
problems using your arms or legs, speech problems.
Talk your doctor straight away if you notice the following side effects:
 Yellowing of the whites of the eyes and the skin, this could be due to jaundice (liver
problem)
 Unexpected infections, mouth ulcers, bruising, bleeding gums or severe tiredness (could
be blood problems)
 Severe stomach pain which may reach through to your back (pancreatitis)
Tell your doctor or pharmacist f you notice any of the following side effects:
PIL.0053-4.006.0d

V018 ; Updated PIL and SPC
in line with PRAC
recommendations

SL

Sandoz Ltd
Metrolyl (Metronidazole) Suppositories 500mg & 1g

December 2016
PL 04416/0053 & 0054

Very rare (effects less than 1 in 10,000 people)





Fits (convulsions)
Darkening of the urine
Feeling sleepy or dizzy
Pains in the muscles or joints

Not known (frequency 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 pain or diarrhoea
 Loss of appetite
 Fever
 Feeling depressed
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.
5.
How to store Metrolyl®
Keep all medicines out of the reach and sight of children.
Do not use Metrolyl® (Metronidazole) Suppositories 500 mg or 1 g after the expiry date shown
on the label. The expiry date refers to the last day of that month. Any out of date medicines
should be returned to your pharmacist for disposal.
Do not store above 25°C. Protected from light.
If you notice any defects in the suppositories, take them to your pharmacist for advice before
using them.
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 Metrolyl® contain:
Each suppository contains 500 mg or 1 g of the active ingredient metronidazole BP.
The other ingredient is hard fat suppository base.
The suppositories are supplied in packs of 10.
Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder and manufacturer is:
Sandoz Ltd, Frimley business Park, Frimley, Camberley, Surrey, GU16 7SR
PIL.0053-4.006.0d

V018 ; Updated PIL and SPC
in line with PRAC
recommendations

SL

Sandoz Ltd
Metrolyl (Metronidazole) Suppositories 500mg & 1g

December 2016
PL 04416/0053 & 0054

This leaflet was last revised on: 13/12/2016.

PIL.0053-4.006.0d

V018 ; Updated PIL and SPC
in line with PRAC
recommendations

SL

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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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