4.1. Therapeutic indications

The soft gel pessary is indicated for the treatment of candidal vaginitis.

The cream is indicated 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.

4.2. Posology and method of administration

Adults

One soft gel pessary should be inserted into the vagina at night. Using the applicator provided, the soft gel pessary should be inserted as high as possible into the vagina. This is best achieved when lying back with legs bent up.

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

Treatment with the 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.

Children

Not for use in children under 16.

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Do not use to treat nail or scalp infections.

4.4. Special warnings and precautions for use

This product contains cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis). The product also contains benzyl alcohol which may cause allergic reactions and mild local irritation.

Before using Canesten Thrush Combi Soft Gel Pessary & External Cream, 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 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 soft gel pessary and cream 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.

Treatment during the menstrual period should be avoided due to the risk of the soft gel pessary 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.

Vaginal intercourse should be avoided in case of vaginal infection and while using this product because the partner could become infected.

When used in pregnancy, the soft gel pessary should be inserted without using an applicator (see “Pregnancy”).

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

4.5. Interaction with other medicinal products and other forms of interaction

Laboratory tests have suggested that, when used together, 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 treatment with vaginal clotrimazole and oral tacrolimus (FK-506; immunosuppressant) might lead to increased tacrolimus plasma levels and similarly with sirolimus. Patients should thus be closely monitored for signs and symptoms of tacrolimus or sirolimus overdosage, if necessary by determination of the respective plasma levels.

4.6. Fertility, pregnancy and lactation

Pregnancy:

There are limited amount of data from the use of clotrimazole in pregnant women. Animal studies with clotrimazole have shown reproductive toxicity at high oral doses (see section 5.3). At the low systemic exposures of clotrimazole following vaginal treatment, harmful effects with respect to reproductive toxicity are not predicted.

Clotrimazole can be used during pregnancy, but only under the supervision of a physician or midwife. During pregnancy the soft gel pessary should be inserted without using an applicator.

Lactation:

There are no data on the excretion of clotrimazole into human milk. However, systemic absorption is minimal after administration and is unlikely to lead to systemic effects. Clotrimazole may be used during lactation.

Fertility:

No human studies of the effects of clotrimazole on fertility have been performed, however, animal studies have not demonstrated any effects of the drug on fertility.

4.7. Effects on ability to drive and use machines

The medication has no or negligible influence on the ability to drive or use machinery.

4.8. Undesirable effects

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

Immune system disorders: anaphylactic reaction, angioedema, hypersensitivity.

Canesten Soft Gel Pessary

Vascular disorder: syncope, hypotension

Respiratory, thoracic and mediastinal disorders: dyspnea

Gastrointestinal disorders: abdominal pain, nausea.

Skin and Subcutaneous Tissue Disorders: rash, urticaria, pruritus

Reproductive system and breast disorders: vaginal exfoliation, vaginal discharge, vaginal haemorrhage, vulvovaginal discomfort, vulvovaginal erythema, vulvovaginal burning sensation, vulvovaginal pruritus, vulvovaginal pain.

General disorders and administration site conditions: application site irritation, oedema, pain.

Canesten Cream

Vascular disorder: syncope, hypotension

Respiratory, thoracic and mediastinal disorders: dyspnea

Skin and subcutaneous tissue disorders: blister, dermatitis contact, erythema, paraesthesia, skin exfoliation, pruritus, rash, urticaria, stinging skin/burning sensation skin.

General disorders and administration site conditions: application site irritation, application site reaction, oedema, pain.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

No risk of acute intoxication is seen as it is unlikely to occur following a single vaginal or dermal application of an overdose (application over a large area under conditions favourable to absorption) or inadvertent oral ingestion. There is no specific antidote.

However, in the event of accidental oral ingestion, routine measures such as gastric lavage should be performed only if clinical symptoms of overdose become apparent (e.g. dizziness, nausea or vomiting). Gastric lavage should be carried out only if the airway can be protected adequately.