Canesten Cream Combi (Internal & External Creams)

Canesten Cream Combi Internal & External Creams

Canesten Combi 10% Internal Cream contains Clotrimazole 10% w/w.

Canesten Combi 2% External Cream contains Clotrimazole 2% w/w.

The internal cream is recommended for the treatment of candidal vaginitis.

The external cream is recommended for the treatment of candidal vulvitis. It should be used as an adjunct to treatment of candidal vaginitis.

These products should only be used if candidal vulvovaginitis (thrush) was previously diagnosed by a doctor.

Adults

The internal cream should be administered intravaginally using the applicator supplied. The contents of the filled applicator (5g) should be inserted as deeply as possible into the vagina, preferably at night.

The external cream should be thinly applied to the vulva and surrounding area, two or three times daily and rubbed in gently.

Treatment with the external cream should be continued until symptoms of the infection disappear. However, if after concomitant treatment of the vaginitis, the symptoms do not improve within seven days, the patient should consult a physician.

Generally:

Treatment during the menstrual period should be avoided due to the risk of the cream being washed out by the menstrual flow. The treatment should be finished before the onset of menstruation.

Do not use tampons, intravaginal douches, spermicides or other vaginal products while using this product.

Children

Not for use in children under 16.

Contraindications

Hypersensitivity to clotrimazole and any of the other ingredients.

Hypersensitivity to cetostearyl alcohol.

Do not use to treat nail or scalp infections.

Special warnings and precautions for use

These products contain cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).

Before using Canesten Cream Combi Internal & External Creams medical advice must be sought if any of the following are applicable: -

- more than two infections of candidal vaginitis in the last 6 months

- previous history of a sexually transmitted disease or exposure to partner with sexually transmitted disease

- pregnancy or suspected pregnancy

- aged under 16 or over 60 years

- known hypersensitivity to imidazoles or other vaginal antifungal products

The creams should not be used if the patient has any of the following symptoms whereupon medical advice should be sought: -

- irregular vaginal bleeding

- abnormal vaginal bleeding or a blood-stained discharge

- vulval or vaginal ulcers, blisters or sores

- lower abdominal pain or dysuria

- any adverse events such as redness, irritation or swelling associated with the treatment

- fever or chills

- nausea or vomiting

- diarrhoea

- foul smelling vaginal discharge

If no improvement in symptoms is seen after 7 days the patient should consult their doctor.

Interaction with other medicinal products and other forms of interaction

Laboratory tests have suggested that this product may cause damage to latex contraceptives. Consequently the effectiveness of such contraceptives may be reduced. Patients should be advised to use alternative precautions for at least five days after using this product.

Concomitant medication with vaginal clotrimazole and oral tacrolimus (FK-506; immunosuppressant) might lead to increased tacrolimus plasma levels. Patients should thus be closely monitored for signs and symptoms of tacrolimus overdosage, if necessary by determination of the respective plasma levels.

Pregnancy and lactation

Data on a large number of exposed pregnancies indicate no adverse effects of Clotrimazole on pregnancy or on the health of the foetus/newborn child. To date, no relevant epidemiological data are available.

Well-conducted epidemiological studies indicate no adverse effects of clotrimazole on pregnancy or on the health of the fetus/newborn child.

Clotrimazole can be used during pregnancy, but only under the supervision of a physician or midwife.

During pregnancy the treatment should be carried out with clotrimazole pessary, since these can be inserted without using an applicator.

Undesirable effects

As the listed undesirable effects are based on spontaneous reports, assigning accurate frequency of occurrence for each is not possible.

Immune system disorders:

allergic reaction (syncope, hypotension, dyspnea, urticaria, pruritus)

Canesten Internal Cream

Reproductive system and breast disorders:

genital peeling, pruritus, rash, oedema, discomfort, burning, irritation, pelvic pain

Gastrointestinal disorders:

abdominal pain

Canesten Cream

Skin and subcutaneous tissue disorders: blisters, discomfort/pain, oedema, irritation, peeling/exfoliation, pruritus, rash, stinging/burning.

List of excipients

Canesten Combi 10% Internal Cream contains:

Sorbitan stearate

Polysorbate 60

Cetyl palmitate

Cetostearyl alcohol

Isopropyl myristate

Benzyl alcohol

Purified water

Canesten Combi 2% External Cream contains:

Sorbitan stearate

Polysorbate 60

Cetyl palmitate

Cetostearyl alcohol

Octyldodecanol

Benzyl alcohol

Purified Water