1. Name Of The Medicinal Product
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)
2. Qualitative And Quantitative Composition
Clotrimazole 2% w/w.
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 re-infection.
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 clotrimazole or any other ingredient in this medicine.
Hypersensitivity to cetostearyl alcohol.
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 Interaction 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 Pregnancy And Lactation
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.
4.7 Effects On Ability To Drive And Use Machines
Not applicable.
4.8 Undesirable Effects
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
4.9 Overdose
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.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
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.
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
There are no pre-clinical data of relevance to the prescriber which are additional to the information included in other sections of the SPC.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Sorbitan stearate
Polysorbate 60
Cetyl palmitate
Cetostearyl alcohol
Octyldodecanol
Benzyl alcohol
Purified Water
6.2 Incompatibilities
Not applicable.
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 (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).
6.6 Special Precautions For Disposal And Other Handling
No special requirements.
7. Marketing Authorisation Holder
Bayer plc
Bayer House
Strawberry Hill
Newbury, Berkshire
RG14 1JA.
Trading as Bayer plc, Consumer Care Division
8. Marketing Authorisation Number(S)
PL 0010/0077
9. Date Of First Authorisation/Renewal Of The Authorisation
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10. Date Of Revision Of The Text
2 July 2010
Legal Category
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
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