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VAGINYL/METRONIDAZOLE TABLETS 200MG

Active substance(s): METRONIDAZOLE

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PATIENT INFORMATION LEAFLET

VAGINYL
PLEASE READ THIS LEAFLET CAREFULLY
BEFORE YOU START TAKING THIS MEDICINE
KEEP THIS LEAFLET UNTIL YOU HAVE FINISHED ALL
THE PRESCRIBED COURSE OF VAGINYL
IF YOU HAVE ANY QUESTIONS CONCERNING YOUR
MEDICINE ASK YOUR DOCTOR OR PHARMACIST FOR
MORE INFORMATION
What is in your medicine?
The name of this medicine is VAGINYL. Each tablet
contains 200 mg Metronidazole, together with the following
ingredients: maize starch, magnesium stearate, lactose,
sodium starch glycollate and purified water.
VAGINYL tablets are round, white, bevelled edge, engraved
VAGINYL on one side, with a break-line on the other.
VAGINYL is available in plastic containers of 28, 30, 50, 56,
60, 84, 90, 100, 112, 120, 140, 150, 168, 180, 500, 1000,
5000 and 50,000 tablets.
How does VAGINYL work?
VAGINYL contains a medicine called metronidazole, which
belongs to a group of medicines called antibiotics. It works
by killing bacteria and parasites that cause infections in
your body.
The name and address of the Product Licence holder is:
Chelonia Healthcare Ltd.
Boumpoulinas 11, 3rd Floor, Nicosia, P.C.1060 CYPRUS
The manufacturer of VAGINYL tablets is:
DDSA Pharmaceuticals Ltd.
310 Old Brompton Road, London SW5 9JQ.
Treatment with VAGINYL
VAGINYL is used in the treatment of:
 bacterial infections of the blood, brain, bone, lung,
stomach lining or pelvic area
 urinary or genital infections caused by the parasite
Trichomonas
 genital infections in women caused by bacteria
 the parasitic diseases, amoebiasis (gastrointestinal
infections that may cause symptoms such as diarrhoea
and mucus or blood in the faeces)
 the disease giardiasis (an infection of the small
intestines causing diarrhoea and stomach pain)
 a painful bacterial infection of the gums that can cause
swelling and ulcers or other dental infections
 infected leg ulcers or pressure sores
VAGINYL is also used to prevent infections occurring after
operations.
Before taking this medicine
Tell your doctor if you have ever had any unusual or allergic
reactions to VAGINYL, or to any of the ingredients of
VAGINYL tablets.
Also tell your doctor or pharmacist if you are allergic to any

other substances such as foods, preservatives or dyes.
The presence of other medical problems may affect the use
of VAGINYL. Make sure, therefore, to tell your doctor if you
have any other medical problems, especially if you have:
 Liver disease, disease of the central nervous system or
a gonococcal infection.
 An intolerance to some sugars (including lactose)
Precautions while using this medicine
Before you begin using any new medicine (whether it is
prescription or non-prescription) or if you develop any new
medical problem while using this medicine, check with your
doctor or pharmacist.
It is important for your doctor and pharmacist to know if you
are taking any of the following:
 Warfarin for thinning the blood
 Phenobarbitone or phenytoin for epilepsy
 Lithium for depression
 Medicines for treating stomach ulcers such as
Cimetidine
 Florouracil for some types of cancer
 Alcohol
Some of the drugs listed above may interact with VAGINYL
so that the action of VAGINYL may be affected, and your
doctor may therefore wish to consider an alternative
medicine to VAGINYL.
You should not take any alcohol during treatment with
VAGINYL, as this may cause an unpleasant reaction. The
dosage of warfarin or lithium may need to be reduced if you
are taking either of these drugs.
Phenobarbitone may reduce the duration of affect of
Metronidazole.
Dosage should be reduced for patients with severe liver
disease.
Because dizziness, drowsiness, confusion, convulsions or
hallucinations may occur when taking VAGINYL, your ability
to drive or use machines may be impaired. It is therefore
inadvisable to drive or operate machinery if these
symptoms occur.
Use in pregnancy and breast feeding
There is insufficient evidence about the safety of
Metronidazole in pregnancy. Metronidazole should therefore
not be given during pregnancy or breast feeding unless
considered necessary by your doctor.
Proper use of this medicine
Take this medicine by mouth and only in the doses
prescribed by your doctor. Do not take more of it, and do
not take it more often or for a longer time than your doctor
ordered. If treatment is for more than 10 days you may be
required to have blood tests.
VAGINYL tablets should be swallowed, without chewing,
with half a glassful of water during or after meals.
Urogenital trichomoniasis: To prevent re-infection in adults,
the partner should also receive a course of treatment at the
same time.
Your dosage will depend on the reason you are being
prescribed these tablets.

To prevent infections after surgery
Adults and children over 12 years of age:
Start taking VAGINYL tablets 24 hours before your
operation. Take 400 mg every 8 hours. After the operation
you may be given metronidazole either through a drip into a
vein or rectally as a suppository until you are able to take
tablets again.
Children under 12 years of age:
Your doctor will work out the exact dose for your child
based on your child’s weight. It will usually be given as a
single dose, 1-2 hours before the operation.

cell count always returns to normal after treatment has been
completed. Metronidazole may result in poisoning of the
liver and reactions such as abnormal liver function tests and
jaundice and inflammation of the liver (known as hepatitis)
may occur. This would be seen as yellowing of the skin and
whites of the eyes. These are reversed to normal when the
drug is withdrawn. There have been reports of bone marrow
depression disorders affecting the different types of blood
corpuscles but these may be reversed when the drug is
withdrawn. Metronidazole may also be associated with a
condition known as erythema multiforme (a particular type
of skin rash seen as the skin breaking out in violet-pink
lumps), which may be reversed when the drug is withdrawn.
Rarely, this medicine may cause tightening of the chest
resulting in difficulty in breathing, with swelling of the face,
neck and skin round the eyes. If any of these symptoms
occur, contact your doctor immediately.
As a rare complication you may develop a severe and
persistent sore throat, in which case you should return to
your doctor immediately.
Other side effects not listed above may also occur in some
people. If you notice any other effects, check with your
doctor.

Other types of infections
For the treatment of other infections caused by parasites or
some bacteria your doctor will decide how much
Metronidazole you need to take and how often, as this will
depend on your condition.

Storing your medicine
Store in a dry place below 25ºC in well closed containers.
Protect from light.
Do not use this medicine after the expiry date, which is
printed on the container.

Elderly:
It is particularly important to take the medicine exactly as
your doctor has told you.

A reminder
REMEMBER this medicine is for you. Never give it to
someone else, even if their symptoms are the same as
yours.
This leaflet does not contain the complete information about
your medicine. If you have any questions or are not sure
about anything, ask your doctor or pharmacist who have
access to additional information.

The usual dose for adults and children is given below:
To treat bacterial infection
Adults and children over 12 years of age:
The initial dose is 800 mg. After 8 hours take another dose
of 400 mg and repeat this every 8 hours. Treatment is
usually for 7 days but will depend upon your condition.
Children under 12 years of age:
Your doctor will work out the exact dose for your child
based on your child’s weight and the severity of the
infection. Treatment is usually for 7 days.

Vaginyl tablets are suitable for childrens’ doses in multiples
of 100mg.
Overdose
If you think you may have taken an overdose of this
medicine you must obtain emergency help at once. Go to
your doctor or nearest hospital casualty department straight
away. Take with you any remaining tablets in their container
so that the medicine may be identified.
Undesirable effects that may occur with the use of this
medicine
Unpleasant taste in the mouth, furred tongue, nausea,
vomiting, gastro-intestinal disturbance and anorexia. Hives
and swelling of the soft tissue areas of the body due to an
accumulation of fluid may occur occasionally. Very rarely,
drowsiness, dizziness, headache, disturbances of walking,
skin rashes, itching, joint and muscle pain, darkening of the
urine, confusion and hallucinations have been reported.
During intensive or prolonged treatment a few instances of
inflammation of nerves in the arms and legs and also
seizures of an epileptic type of short duration have been
reported. This usually disappears after the treatment is
either stopped, or the dosage is reduced.
A fall in white cell count has been reported, but the white

PL number: 33414/0064
This leaflet was revised in March 2011

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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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