Canesten Cream Combi Internal and External Creams

Canesten Cream Combi Internal and External Creams

For women who have previously been diagnosed as suffering from vaginal thrush

 

Patient Information Leaflet

Please read your own leaflet before using Canesten Cream Combi Internal and External Creams

 

Vaginal thrush is a common infection that most women have at some time in their lives. It is not caused by a lack of personal hygiene.

 

It is caused by a yeast (fungus) called candida which may live harmlessly in the vagina without you even noticing it. However, the natural pH balance of the vagina that keeps candida under control can be upset by many factors such as perfumed soaps, hormonal changes (menstruation, contraceptive pill, pregnancy, menopause), poor health, antibiotics, bath additives and tight clothing.

 

If the natural pH balance is altered the level of yeast increases and can develop into a thrush infection causing any of the following symptoms: persistent burning itching around the vagina and vulva, redness, swelling and soreness of the tissues of the vagina and vulva and a whitish, odourless discharge from the vagina. If your discharge is green coloured, and/or foul smelling consult your doctor as you may have another type of infection which can be effectively treated with a different medicine.

 

What does   Cream Combi Internal & External Creams Contain?

The applicator of internal cream contains 10% w/w Clotrimazole as the active ingredient.

 

Other ingredients are benzyl alcohol, polysorbate 60, sorbitan stearate, cetyl palmitate, cetostearyl alcohol, isopropyl myristate and purified water.

 

The 10g tube of external cream contains 2% w/w Clotrimazole.

 

Other ingredients are sorbitan stearate, polysorbate 60, cetyl palmitate, cetostearyl alcohol, octyldodecanol, benzyl alcohol and purified water.

 

Clotrimazole is an antifungal agent which fights he cause of infections such as vaginal thrush.

 

Marketing Authorisation Holder: Bayer plc, Consumer Care Division

Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, United Kingdom

 

Manufacturer: Kern Pharma S.L., Terrassa, Spain.

 

What is Canesten Cream Combi Internal and External Creams?

This product is a complete treatment for vaginal thrush because it treats both the internal cause and external symptoms.

 

It contains:

· an intravaginal cream in a pre-filled applicator for treatment at the site of infection.

· a tube of soothing cream to start relieving the external itch immediately.

 

Only use this product if you have been previously diagnosed by your doctor as having vaginal thrush.

 

When not to use Canesten Cream Combi Internal and External Creams?

Do not use the creams if you have previously had an allergic reaction to the active ingredient, clotrimazole, or any of the other ingredients in the product. If you are unsure about this, ask your doctor.

 

You must consult your doctor as soon as possible and do not use the creams if you have any of the following symptoms:

· irregular vaginal bleeding

· abnormal vaginal bleeding or a blood-stained discharge

· ulcers, blisters or sores of the vagina or vulva

· lower abdominal pain

· pain or difficulty in passing urine

· fever or chills

· feeling sick or vomiting

· diarrhoea

· a foul smelling discharge from the vagina

· redness, irritation or swelling associated with treatment

 

This is because Canesten Cream Combi Internal & External Creams may not be the right treatment for you.

 

If you are unsure whether you have vaginal thrush, check with your doctor before using the product.

 

Do not use this product to treat nail or scalp infections.

 

Before using Canesten Cream Combi Internal and External Creams

Consult your doctor before using the product if

· you have had more than 2 infections of vaginal thrush in the last 6 months

· you or your partner have ever had a sexually transmitted disease

· you are aged under 16 or over 60 years

· you have ever had an allergic reaction to Canesten or any other vaginal antifungal products

 

This product contains cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).

 

What special precautions should be taken?

If you are pregnant or are trying for a baby, tell your doctor before using Canesten Cream Combi internal & External Creams. If you have informed your doctor already, follow his/her instructions carefully During pregnancy extra care should be taken when using the pre-filled applicator

 

As with other creams this product may reduce the effectiveness of rubber contraceptives such as condoms or diaphragms Consequently you should use alternative precautions for at least five days after using this product

 

When and how to use Canesten Cream Combi Internal and External Creams

This product is for women who have suffered from vaginal thrush before. The full course of treatment consists of a single dose of internal cream contained in a pre-filled applicator in a foil blister pack and a tube of soothing external cream.

 

Not for use in children under 16

 

The Internal Cream

The cream should be inserted into the vagina preferably at night so that it can work whilst you sleep.

 

1 Remove the applicator from the foil packaging. Keeping the red cap in place insert the tip of plunger A into applicator B (approximately 1cm).

 

 

2 Twist and pull to remove the red cap C. Be careful not to press the plunger in any further before you have inserted the applicator into the vagina This will avoid wasting any cream.

 

 

3 Carefully put the applicator as deep as is comfortable into the vagina (this is easiest when lying on your back with your knees bent up). Holding the applicator in place, slowly press the plunger until it stops so that the pre-measured dose of cream is deposited into the vagina.

 

 

Remove the applicator. Dispose of the applicator in a safe place, out of the reach of children. The applicator cannot be flushed down the toilet.

 

The cream is deposited in the vagina, but it is quite common to notice a slight discharge after using it and therefore it may be helpful to wear a panty liner. This does not mean that the treatment has not worked.

 

The External Cream

Before use, pierce the tube seal by inverting the cap over the end of the tube and press. For the treatment of the itching and soreness (vulvitis), the cream should be thinly and evenly applied to the area around the entrance of the vagina, 2 or 3 times a day and smoothed in gently

 

The symptoms of vaginal thrush should disappear within 3 days of treatment. If no improvement is seen after 7 days, tell your doctor.

 

Do not use this product more than 2 times in 6 months before consulting a doctor.

 

The internal cream should be used in the vagina only.

 

The external cream is for external use only.

 

Do not put the creams in your mouth or swallow them. If the creams are swallowed accidentally tell your doctor straight away or contact the Accident and Emergency Department of your nearest hospital.

 

What side effects may I experience?

Rarely, the creams may cause side effects in some people. The side effects may be similar to the symptoms of vaginal thrush. If the redness, burning, irritation or swelling get worse, see your doctor as soon as possible.

 

As with all medicines, some people may be allergic to this product. If you are allergic, a reaction will occur soon after you start using the creams. An allergic reaction may appear as a rash, itching, nausea, faintness or facial swelling. If you experience any of these effects, tell your doctor immediately.

 

If you feel you are reacting badly to the creams in any other way, discuss this with your doctor.

 

How to avoid future attacks

 wear cotton knickers, and loose clothing

 wash daily

 after going to the toilet, wipe yourself from front to back, as a thrush infection may be transferred from the bowel

 change your sanitary protection regularly  

 

x try to avoid washing with perfumed soaps or using vaginal deodorants

x do not wash vigorously with sponges or flannels and avoid hot baths with strong perfumed oils

x try to avoid wearing tights, nylon knickers and close fitting jeans

 

If you arc still worried or have any further questions about the symptoms or the treatment of vaginal thrush, do not hesitate to ask your doctor or pharmacist.

 

Important:

This product should be stored in the original carton. Do not store above 25°C

Keep out of the reach and sight of children

Do not use the creams after their expiry date (this will be printed at one end of the carton, on the end of the tube of cream, on the applicator and on the applicator foil wrapping).