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

6.     PHARMACEUTICAL PARTICULARS

 

6.3.      Shelf life

 

            43 years.

 

6.4.      Special precautions for storage

 

            Do not store above 25^o C. This medicinal product does not require any special storage conditions.

 

10.       DATE OF REVISION OF THE TEXT

 

May 2014July 2014

 

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, rewording on the warnings on avoidance of vaginal intercourse, with use of this product.
- Section 4.3, rewording of the text of  the contraindciations.
- Section 4.6, inclusion of additional information on Fertility, pregnancy and lactation.  
- Section 4.7, rewording of the effect on the ability to drive and use machines.
- Section 4.8, inclusion of erythema (PT) as an adverse reaction. Rewording of the introduction to the list of adverse reactions.
- Section 5.1, inclusion of pharmacotherapeutic group, updated ATC code, and change of location of Gardnerella vagiinalis.
- Section 5.3, inclusion of information that no special hazards for humans are identified in conventional tests.
- Change to approval date.

Section 4.2

 

The following text was deleted:

 

‘'However, if after concomitant treatment of the vaginitis, the symptoms do not improve within seven days, the patient should consult a doctor.’

 

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:

 

Section 4.4

 

The following text was updated:

 

            Before using Canesten Thrush Cream medical advice must be sought if any of the following are applicable:

 

 ‘ – aged under 16 or over 60 years’ was changed to ‘– aged under 12 or over 60 years’

 

and the following text was added:

 

Canesten Thrush Cream 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 4.8

 

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 urticaria (ME), dyspnoe (PT), hypotension (PT) and syncope (PT)).

                                          

Skin and subcuteaneous tissue disorders

Pruritus (ME), rash (ME), blisters (PT), peeling/exfoliation (PT), discomfort/pain (PT), stinging/burning (PT), edema (PT), burning (PT), irritation.

 

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 5.2

 

This section was revised to read:

 

Pharmacokinetic investigations after vaginal application have shown that only a small amount of clotrimazole (3 – 10%) is absorbed. Due to the rapid hepatic metabolism of absorbed clotrimazole into pharmacologically inactive metabolites the resulting peak plasma concentrations of clotrimazole after vaginal application of a 500mg dose were less than 10 nanog/ml, suggesting that clotrimazole applied intravaginally is unlikely to lead to measurable systemic effects or side effects.

 

 

Section 6.6:

 

‘No special requirements’ was replaced with:

 

‘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.’

Section 7: MA holder is now Bayer Ltd.

Section 8: MA number is now PA  1410/39/12