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4.8.      Undesirable effects

…

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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

10.       DATE OF REVISION OF THE TEXT

May 2014March 2015

5.1              Pharmacodynamic properties

            Pharmacotherapeutic group: Gynaecological antiinfectives and antiseptics – imidazole derivatives. Antifungals for topical use – imidazole and triazole derivatives.

            ATC Code: D01A CF01 G01AF02

10.       DATE OF (PARTIAL) REVISION OF THE TEXT

            February May 2014

Section 4.2

The following text was deleted:

‘A second treatment may be carried out if necessary.’

and the following text was added:

’…and children of 12 years of age and over:

If symptoms persist for more than 7 days the patient may have a medical condition that requires treatment by a doctor.

The treatment can be repeated if necessary, however, recurrent infections may

indicate an underlying medical cause, including diabetes or HIV infection.

Patient should seek medical advice if symptoms return within 2 months.

Do not use tampons, intravaginal douches, spermicides or other vaginal products

while using this product.

Avoidance of vaginal intercourse is recommended while using this product

because the infection could be transferred to your partner, and the effectiveness

and safety of latex products such as condoms and diaphragms may be reduced.

Children under 12 years of age:

To insert the pessary:

1.      Pull out plunger  until it stops. Place the pessary  into the applicator.

2.      Carefully insert the applicator containing the pessary as deeply as is comfortable into the vagina. This is best done with the patient  lying on her back with the knees bent up.

3.      Push plunger A until it stops, thereby depositing the pessary into the vagina. Withdraw the applicator and dispose of it hygienically.’

Section 4.4

The following text was deleted:

Patients should be advised to consult their physician if the symptoms have not been relieved within one week of using Canesten Pessary. Canesten Pessary 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.

and the following text was added:

Canesten Pessaries should not be used if the patient has any of the following symptoms whereupon medical advice should be sought:

abnormal vaginal bleeding (vaginal haemorrhage)

fever (temperature of 38^oC or above)

back pain.

associated shoulder pain.

Avoid contact with eyes and do not swallow.

Section 4.5

The following text was added:

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

Section 4.8

The entire section was revised to the following:

The listed adverse drug reactions are based on spontaneous reports, thus an organisation according to CIOMS III categories is not possible.

Immune system disorders

Allergic reaction (ME) with symptoms such as dyspnea (PT), hypotension (PT),

syncope (PT), and urticaria (ME),

Reproductive system and breast disorders

Vulvovaginal discomfort (PT), edema (PT), burning (PT), genital peeling, irritation, pruritus (ME), pelvic pain (PT), rash (ME)

Gastrointestinal disorders

Abdominal pain (ME)

Section 5.1

The following text was updated to:

Under appropriate test conditions, the MIC values for these types of fungi are in the region of less than 0.062 – 8.0 mg/ml substrate.

Section 6.6:

The diagrams were deleted and the following statement was added:

Medicines should not be disposed of via wastewater or household waste. Ask your

pharmacist how dispose of medicines no longer required. These measures will

help to protect the environment.