Canesten Soft Gel 500mg Pessary & 2% External Cream

Canesten Soft Gel 500mg Pessary & 2% External Cream is a complete treatment for vaginal thrush, designed to treat both the internal vaginal infection and the external symptoms of thrush such as itching, soreness, redness and swelling around the vulva.

Both products contain clotrimazole, an antifungal medicine that kills the Candida fungi responsible for vaginal thrush.

The 500mg Soft Gel Pessary provides a single-dose internal treatment, while the 2% External Cream is applied to the vulva to relieve and treat external symptoms.

Key features:

• Complete internal and external treatment for vaginal thrush
• Contains the antifungal medicine clotrimazole
• 500mg clotrimazole Soft Gel Pessary
• Single-dose internal treatment
• Clotrimazole 2% External Cream
• Treats external vulval symptoms of thrush
• Helps relieve:
  • Itching
  • Burning
  • Redness
  • Swelling
  • Soreness
• Soft gel formulation designed for easy vaginal insertion
• External cream supplied in a 10g tube
• Applicator included
• Suitable for adults aged 16–60 years for self-treatment where vaginal thrush has previously been diagnosed by a doctor
• General Sales List (GSL) medicine

Active ingredients:

Soft Gel Pessary:

• Clotrimazole 500mg per soft vaginal capsule

External Cream:

• Clotrimazole 2% w/w
• Equivalent to 20mg clotrimazole per gram of cream
• 10g tube contains 200mg clotrimazole

Clotrimazole is an azole antifungal medicine. It works by damaging the fungal cell membrane, preventing the Candida fungus from growing and ultimately killing the infection.

Other ingredients:

Soft Gel Pessary contains:

• White soft paraffin
• Liquid paraffin
• Gelatin
• Glycerol
• Water
• Titanium dioxide (E171)
• Quinoline yellow (E104)
• Sunset yellow (E110)
• Lecithin
• Medium-chain triglycerides

External Cream contains:

• Sorbitan stearate
• Polysorbate 60
• Cetyl palmitate
• Cetostearyl alcohol
• Octyldodecanol
• Benzyl alcohol
• Purified water

The cream contains cetostearyl alcohol, which may cause local skin reactions such as contact dermatitis.

It also contains benzyl alcohol, which may cause allergic reactions or mild local irritation.

How to use:

Soft Gel Pessary

For adults:

• Insert one 500mg Soft Gel Pessary into the vagina at bedtime
• This is a single-dose treatment

Using the applicator provided:

1. Wash your hands.
2. Remove the Soft Gel Pessary from the blister.
3. Place it into the applicator as directed.
4. Lie on your back with your knees bent.
5. Carefully insert the applicator as deeply into the vagina as is comfortable.
6. Release the Soft Gel Pessary.
7. Remove and dispose of the applicator as instructed.
8. Wash your hands after use.

The Soft Gel Pessary should be inserted as high as possible into the vagina, preferably immediately before going to bed.

External Cream

Apply the cream thinly to the vulva and surrounding affected external area 2–3 times daily.

Rub in gently.

Continue using the external cream until the external symptoms of the infection have disappeared.

If symptoms have not improved within 7 days, consult a doctor.

When to use:

Canesten Soft Gel Pessary & External Cream is intended for vaginal thrush where symptoms may include:

• Persistent vulval or vaginal itching
• Burning
• Redness
• Swelling
• Soreness
• A white or creamy vaginal discharge which is usually odourless

This product should only be used for self-treatment if vaginal thrush has previously been diagnosed by a doctor.

Do not use during your period:

Treatment with the Soft Gel Pessary should not be carried out during menstruation, as menstrual flow may wash the treatment out of the vagina.

The treatment should be completed before your period begins.

While using the treatment:

Do not use:

• Tampons
• Vaginal douches
• Spermicides
• Other vaginal products

during treatment.

Avoid vaginal intercourse while you have vaginal thrush and while using the treatment, as the infection may potentially be passed to your partner.

Condoms and contraceptive diaphragms:

Canesten vaginal products may temporarily reduce the effectiveness of latex contraceptives, including:

• Latex condoms
• Diaphragms

Use alternative contraceptive precautions for at least 5 days after using the product.

Pregnancy:

If you are pregnant or think you may be pregnant, seek medical advice before using Canesten.

Clotrimazole may be used during pregnancy under the supervision of a doctor or midwife.

During pregnancy, the Soft Gel Pessary should be inserted with the fingers and without using the applicator.

Breastfeeding:

Clotrimazole may be used while breastfeeding.

Systemic absorption following vaginal or external application is very low.

Do not use without medical advice if:

• You are under 16 years
• You are over 60 years
• You are pregnant or think you may be pregnant
• You have had more than 2 episodes of vaginal thrush during the previous 6 months
• You have previously had a sexually transmitted infection
• You have recently been exposed to a partner with a sexually transmitted infection
• You have previously had an allergic reaction to an imidazole antifungal medicine

Do not use and seek medical advice if you have:

• Irregular vaginal bleeding
• Unexplained vaginal bleeding
• Blood-stained vaginal discharge
• Vulval or vaginal ulcers
• Blisters or sores
• Lower abdominal or pelvic pain
• Pain or difficulty when passing urine
• Fever or chills
• Nausea or vomiting
• Diarrhoea
• Foul-smelling vaginal discharge
• Significant redness, swelling or irritation caused by treatment

These symptoms may indicate that the condition is not uncomplicated vaginal thrush and requires medical assessment.

Interactions with medicines:

Speak to a doctor or pharmacist before using vaginal clotrimazole if you are taking:

• Tacrolimus
• Sirolimus

Vaginal clotrimazole can potentially increase blood concentrations of these medicines and additional monitoring may be required.

Possible side effects:

Possible reactions to the Soft Gel Pessary or cream include:

• Burning or stinging
• Irritation
• Redness
• Itching
• Rash
• Swelling
• Vaginal discomfort or pain
• Increased vaginal discharge
• Abdominal discomfort

Allergic reactions are uncommon but can potentially be serious.

Stop using the product and seek urgent medical attention if you develop signs of a severe allergic reaction such as:

• Difficulty breathing
• Swelling of the face, lips, tongue or throat
• Severe dizziness or fainting

Important information:

For vaginal and external use only.

Do not swallow.

Keep out of the sight and reach of children.

If symptoms do not improve within 7 days, consult a doctor.

If symptoms repeatedly return, further investigation may be required rather than repeatedly self-treating.

Storage:

• Store in the original carton
• Keep in a dry place
• Protect from moisture
• Do not store above 30°C
• Do not use after the expiry date shown on the packaging

Product type: Antifungal Thrush Treatment / GSL Medicine

Indication: Vaginal candidiasis / vaginal thrush and associated candidal vulvitis

Active ingredient: Clotrimazole

Internal treatment: Clotrimazole 500mg Soft Gel Pessary

External treatment: Clotrimazole 2% w/w Cream

Internal dose: 1 Soft Gel Pessary as a single dose at bedtime

External dose: Apply thinly 2–3 times daily

External cream size: 10g

Pack contents:

• 1 × 500mg Soft Gel Pessary
• 1 × vaginal applicator
• 1 × 10g tube of 2% External Cream

Suitable age for self-treatment: 16–60 years

Legal status: GSL – General Sales List Medicine

UK Marketing Authorisation: PL 00010/0635

PIP code: 368-6300

EAN: 5010605640148

Brand: Canesten

Marketing Authorisation Holder: Bayer plc, Reading, United Kingdom

Always read the enclosed patient information leaflet before use. If this is your first episode of suspected vaginal thrush, or if you are unsure whether your symptoms are caused by thrush, seek advice from a pharmacist or doctor before treatment.

Product Information Leaflet