Document: leaflet MAH BRAND_PL 33414-0026 change

• leaflet MAH BRAND_PL 33414-0026
• leaflet MAH GENERIC_PL 33414-0026

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PATIENT INFORMATION LEAFLET

Albican 100 mg Pessaries

(Clotrimazole)

Please read this leaflet carefully before you start taking this medicine. If you have any questions or are not sure about anything ask your doctor or pharmacist

About your medicine

The name of this medicine is Albican 100 mg Pessaries. It contains 100 mg of the active ingredient Clotrimazole. Albican 100

mg Pessaries also contain the following inactive ingredients:

Lactose monohydrate, adipic acid, sodium bicarbonate, povidone, maize starch, Magnesium stearate, staric acid, colloidal

anhydrous silica and polysorbate 80.

Albican 100 mg Pessaries are available as PVC and aluminium foil blister packs of six pessaries (vaginal tablets). An applicator

for insertion of the pessary into the vagina is also provided.

The name and address of the Product Licence Holder is:

Chelonia Healthcare Limited, Boumpoulinas 11,3 ^rd Floor, Nicosia, P.C. 1060, Cyprus

The Manufacturer of Albican is:

DDSA Pharmaceuticals Ltd., Chatfield Road, Off York Road, London SW11 3SE

How does Albican Pessaries work?

Clotrimazole belongs to a group of medicines called imidazoles; it is a broad spectrum antifingal agent which kills the yeasts causing your symptoms

What are Albican Pessaries for?

Albican Pessaries contain an antifungal medicine used for the treatment of Thrush (vaginal candidiasis). This is a common infection caused by a yeast or fungus which may be present in the vagina without you noticing it. Albican Pessaries are also used for vaginal candidiasis where a sexually-transmitted disease called trichomonas is present. Under certain conditions it may develop into a vaginal infection which may spread to the surrounding tissues of the vagina known as the vulva. The symptoms of Vaginal Thrush are one or more of the following:

Itching of the vagina and vulva

Soreness of the vagina

Swelling and redness of the vagina and vulva

• A white, odourless, vaginal discharge Consult your doctor or pharmacist before using this treatment if this is the first time you have had any of the above symptoms.

Check before you use Albican Pessaries

If you are not sure whether you have Thrush, check with your doctor. Likewise, if you have ever had any unusual or allergic reactions to Clotrimazole or other ingredients of Albican 100 mg Pessaries, or other imidazole medicines.

Use in pregnancy and lactation

Do not use Albican Pessaries during pregnancy unless your doctor considers it essential. If used during pregnancy extra care should be taken when using the applicator to prevent the possibility of mechanical injury. Effects during breast-feeding are not known.

Can you use Albican Pessaries with other medicines?

Although you can take these pessaries with other medicines, it is important to tell your doctor or pharmacist about all the medicines that you are taking, whether or not any medicines were prescribed by your doctor or bought without a prescription from the pharmacy or elsewhere.

When and how to use Albican Pessaries

Adults including the elderly:

Before going to sleep at night place one pessary in the applicator according to the following instructions (see diagram):

Remove the applicator from the carton. Pull out the plunger until it stops. Having removed the pessary from the

strip-pack, place

it firmly into the applicator.

While lying on your back with your knees bent up, carefully introduce the applicator into the vagina as far as is comfortable.

While holding the applicator in place, slowly press the plunger so that the pessary is deposited into the vagina. Remove the applicator and dispose of it in a safe place out of the reach of children.

You must use this medicine for 6 nights in a row. Not recommended for use in children

What to do in the case of accidental swallowing?

Albican pessaries should be used only in the vagina. If you accidently swallow an Albican pessary, contact your doctor or the Accident & Emergency Department of your nearest hospital at once.

What side effects can Albican Pessaries have?

A small number of patients using Albican 100 mg Pessaries may experience local itching or burning. It is rarely required to discontinue treatment if this happens as these symptoms are usually mild and disappear. If, however, these symptoms become troublesome, then see your doctor as soon as possible. Should you react to this medicine in any other way, then seek the advice of your doctor or pharmacist

Storing your medicine

You must keep the medicine in a safe place where children cannot get it. Your medicine could harm them Do not store above 25°C. Store in the original package. Both on the carton and the blister-strip, you will find the words “use by_ followed by numbers indicating the month and year. This is the date after which the medicine is no longer fit for use. Do not use the medicine after this date, but return it to your doctor or pharmacist.

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 anything,

ask your doctor or pharmacist who have access to additional information.

PL 33414/0026

This leaflet was revised in: December 2002

Use of the applicator To load applicator

1    Pull out applicator about an inch.

2    Place pessary in open end of applicatoe.

To insert applicator with pessary 1 Lie on your back and bend your knees up.

Insert pessary end of applicator into the vagina as high as it will go without causing any discomfort. Press plunger with index finger so that pessary is expelled into the vagina.

Withdraw applicator.