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, 3^rd 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.

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.

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.

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.

Elderly:

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

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

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.

Storing your medicine

Store in a dry place below 25°C in well closed containers. Protect from light.

Do not use this medicine after the expiry date, which is printed on the container.

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.

PL number: 33414/0064

This leaflet was revised in March 2011