SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Canesten Thrush Cream

(also available in the combination products Canesten 500mg Pessary and 2% Cream Canesten Cream Combi 10% VC & 2% External Cream and Canesten Oral & Cream Duo)

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Clotrimazole 2% w/w.

Excipient with known effect: cetostearyl alcohol For excipients, see 6.1

3.    PHARMACEUTICAL FORM

Cream for topical use.

4.    CLINICAL PARTICULARS

4.1.    Therapeutic indications

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 reinfection.

4.2.    Posology and Method of Administration

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.

4.3    Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4    Special warnings and precautions for use

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).

4.5. Interactions 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.

4.6    Fertility, pregnancy and 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.

Pregnancy:

There is a limited amount of data from the use of clotrimazole in pregnant women. Animal studies with clotrimazole have shown reproductive at high oral doses (see section 5.3). At the low systemic exposures of clotrimazole following topical 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

Lactation:

Available pharmacodynamic/toxicological data in animals have shown excretion of clotrimazole/metabolites in milk after intravenous administration (see section 5.3). A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from clotrimazole therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

4.7    Effects on ability to drive and use machines

Clotrimazole cream has no or negligible influence on the ability to drive or use machines.

4.8 Undesirable effects

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

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

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

4.9 Overdose

No risk of acute intoxication is seen as it is unlikely to occur following a single 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.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Pharmacotherapeutic group: Antifungals for topical use - imidazole and triazole derivatives

ATC Code: D01A C01

Mechanism of Action

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

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

Under appropriate test conditions, the MIC values for these types of fungi are in the region of less than 0.062-8.0 pg/ml substrate. The mode of action of clotrimazole is primarily 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.

In addition to its antimycotic action, clotrimazole also acts on gram-positive microorganisms (Streptococci / Staphylococci / Gardnerella vaginalis), and gram-negative microorganisms (Bacteroides).

In vitro clotrimazole inhibits the multiplication of Corynebacteria and grampositive cocci - with the exception of Enterococci - in concentrations of 0.5-10 pg/ml substrate.

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.

5.2 Pharmacokinetic properties

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.

5.3. Preclinical Safety Data

Non-clinical data reveal no special hazard for humans based on studies of repeated dose toxicity, genotoxicity and carcinogenicity.

Clotrimazole was not teratogenic in reproductive toxicity studies in mice, rats and rabbits. In rats high oral doses were associated with maternal toxicity, embryotoxicity, reduced fetal weights and decreased pup survival.

In rats clotrimazole and/or its metabolites were secreted into milk at levels higher than in plasma by a factor of 10 to 20 at 4 hrs after administration, followed by a decline to a factor of 0.4 by 24 hrs.

6.    PHARMACEUTICAL PARTICULARS

6.1.    List of excipients

Canesten Thrush Cream contains the following excipients:

Sorbitan stearate Polysorbate 60 Cetyl palmitate Cetostearyl alcohol Octyldodecanol Benzyl alcohol

Purified Water

6.2.    Incompatibilities

None known.

6.3.    Shelf life

36 months.

6.4.    Special precautions for storage

Do not store above 25°C.

6.5    Nature and contents of container

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 500mg Pessary and 2% Cream (Legal Category: POM)

2)    with a filled applicator (5g) of 10% cream as 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).

6.6    Special precautions for disposal

No special requirements.

7.    MARKETING AUTHORISATION HOLDER

Bayer plc

Consumer Care Division Bayer House Strawberry Hill Newbury, Berkshire

RG14 1JA.

8. MARKETING AUTHORISATION NUMBER

PL 0010/0077

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

29 December 1980 / 18 April 1997

10 DATE OF REVISION OF THE TEXT

28/11/13