Canesten Thrush Cream

(also available as Boots Thrush Cream and in the combination products Boots Thrush Relief Combi, Canesten Combi, Canesten 500mg Pessary and 2% Cream, Canesten Complete Cream, Canesten Cream Combi 10% VC & 2% External Cream and Canesten Oral & Cream Duo)

Clotrimazole 2% w/w.

For excipients, see 6.1

Cream for topical use.

Canesten Thrush Cream is recommended for the treatment of candidal vulvitis. It should be used as an adjunct to treatment of candidal vaginitis.

It can also be used for treatment of the sexual partner's penis to prevent re-infection.

Canesten Thrush Cream should be applied to the vulva and surrounding area.

It can also be applied to the sexual partner's penis to prevent re-infection.

Adults

The cream should be applied thinly two or three times daily and rubbed in gently.

Treatment 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 doctor.

If the cream is being used for treatment of the sexual partner's penis it should be applied two or three times daily for up to two weeks.

Children

There is no clinical experience in the use of Canesten Thrush Cream in children.

Hypersensitivity to clotrimazole or any other ingredient in this medicine.

Hypersensitivity to cetostearyl alcohol.

Medical advice should be sought if this is the first time the patient has experienced symptoms of candidal vaginitis.

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

- more than two infections of candidal vaginitis in the last six 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 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

This product contains cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).

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.

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.

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

Not applicable.

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

Immune system disorder: allergic reaction (syncope, hypotension, dyspnea, urticaria)

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

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). It should be carried out only if the airway can be protected adequately.

ATC Code: G01A F02

Clotrimazole is an imidazole derivative with a broad spectrum of antimycotic activity.

Mechanism of Action

Clotrimazole acts against fungi by inhibiting ergosterol synthesis. Inhibition of ergosterol synthesis leads to structural and functional impairment of the cytoplasmic membrane.

Pharmacodynamic Effects

Clotrimazole has a broad antimycotic spectrum of action in vitro and in vivo, which includes dermatophytes, yeasts, moulds, etc.

The mode of action of clotrimazole is fungistatic or fungicidal depending on the concentration of clotrimazole at the site of infection. In-vitro activity is limited to proliferating fungal elements; fungal spores are only slightly sensitive.

Primarily resistant variants of sensitive fungal species are very rare; the development of secondary resistance by sensitive fungi has so far only been observed in very isolated cases under therapeutic conditions.

Pharmacokinetic investigations after dermal application have shown that clotrimazole is minimally absorbed from the intact or inflamed skin into the human blood circulation. The resulting peak serum concentrations of clotrimazole were below the detection limit of 0.001 mcg/ml, suggesting that clotrimazole applied topically is unlikely to lead to measurable systemic effects or side effects.

There are no pre-clinical data of relevance to the prescriber which are additional to the information included in other sections of the SPC.

Sorbitan stearate

Polysorbate 60

Cetyl palmitate

Cetostearyl alcohol

Octyldodecanol

Benzyl alcohol

Purified Water

Not applicable.

36 months.

Do not store above 25°C.

Aluminium tubes (10g and 20g) with internal lacquer coating, latex stopper and HDPE screw top.

The 10g tube of cream is also available in combination packs as follows:

1) with a 500mg pessary as Canesten Combi (Legal Category: P) and Canesten Combi 500mg Pessary and 2% Cream (Legal Category: POM)

2) with a filled applicator (5g) of 10% cream as Canesten Complete Cream (Legal Category: P) and Canesten Cream Combi 10% VC & 2% External Cream (Legal Category: POM)

3) with a fluconazole 150mg capsule as Canesten Oral & Cream Duo (Legal Category: P).

No special requirements.

Bayer plc

Bayer House

Strawberry Hill

Newbury, Berkshire

RG14 1JA.

Trading as Bayer plc, Consumer Care Division

PL 0010/0077

2 July 2010

Canesten Thrush Cream/Boots Thrush Cream, Canesten Combi, Canesten Complete Cream*, Canesten Oral & Cream Duo P

Canesten Combi 500mg Pessary and 2% Cream, Canesten Cream Combi 10% VC & 2% External Cream POM

*Not currently marketed