CANESTEN THRUSH INTERNAL

The cream should be administered intravaginally using the applicator supplied.

Adults:

The contents of the filled applicator (5g) should be inserted as deeply as possible into the vagina, preferably at night. A second treatment may be carried out if necessary.

Children:

Not for use in children under 16.

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.

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. 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Medical advice should be sought if this is the first time the patient has experienced symptoms of candidal vaginitis. Before using Canesten Thrush Internal 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 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 Canesten Thrush Internal 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 not be performed 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. Vaginal intercourse should be avoided in case of vaginal infection and while using this product because the partner could become infected.

Patients should be advised to consult their physician if the symptoms have not been relieved within one week of using Canesten Thrush Internal Cream. Canesten Thrush Internal Cream can be used again if the candidal infection returns after 7 days.

However, if the candidal infection recurs more than twice within six months, patients should be advised to consult their physician. g. contact dermatitis). The product also contains benzyl alcohol which may cause allergic reactions and mild local irritation.

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