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CANESTEN THRUSH INTERNAL CREAM 10% W/W VAGINAL CREAM

Active substance(s): CLOTRIMAZOLE / CLOTRIMAZOLE / CLOTRIMAZOLE

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Canesten Thrush Internal Cream 10% w/w vaginal cream

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Clotrimazole 10% w/w
Excipients with known effects: cetostearyl alcohol
For the full list of excipients, see 6.1.

3

PHARMACEUTICAL FORM
Vaginal cream.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Canesten Thrush Internal Cream is indicated for the treatment of candidal
vaginitis.

4.2

Posology and method of administration
The cream should be administered intravaginally using the applicator supplied.
Adults:
The contents of the filled applicator (5g) should be inserted as deeply as possible
into the vagina, preferably at night. A second treatment may be carried out if
necessary.
Generally:

treatment during the menstrual period should not be performed due to the risk of
the cream being washed out by the menstrual flow. The treatment should be
finished before the onset of menstruation.
Do not use tampons, intravaginal douches, spermicides or other vaginal
products while using this product.
Vaginal intercourse should be avoided in case of vaginal infection and while
using this product because the partner could become infected.

Children:
Not for use in children under 16.

4.3

Contraindications
Hypersensitivity to clotrimazole or any other 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 Internal Cream, medical advice must be sought if
any of the following are applicable:






more than two infections of candidal vaginitis in the last 6 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 Internal 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

Patients should be advised to consult their physician if the symptoms have not
been relieved within one week of using Canesten Thrush Internal Cream.
Canesten Thrush Internal Cream 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.
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.
Concomitant medication with vaginal clotrimazole and oral tacrolimus (FK506; immunosuppressant) might lead to increased tacrolimus plasma levels
levels and similarly with sirolimus. Patients should thus be closely monitored
for signs and symptoms of tacrolimus or sirolimus overdosage, if necessary by
determination of the respective plasma levels.

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 are limited amount of data from the use of clotrimazole in pregnant
women. Animal studies with clotrimazole have shown reproductive toxicity at
high oral doses (see section 5.3). At the low systemic exposures of
clotrimazole following vaginal 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.
During pregnancy the treatment should be carried out with clotrimazole
pessary, since these can be inserted without using an applicator.

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
The medication has no or negligible influence on the ability to drive or use
machinery.

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 disorders:
allergic reaction (syncope, hypotension, dyspnea, urticaria, pruritus).
Reproductive system and breast disorders:
genital peeling, pruritus, rash, oedema, erythema, discomfort, burning,
irritation, pelvic pain, vaginal haemorrhage.
Gastrointestinal disorders:
abdominal pain.
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 the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.

4.9

Overdose
No risk of acute intoxication is seen as it is unlikely to occur following a single
vaginal or 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: Gynaecological antiinfectives and antiseptics –
imidazole derivatives
ATC Code: G01A F02
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 μg/ml substrate. 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 vaginal application have shown that only a
small amount of clotrimazole (3 – 10% of the dose) 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 ng/ml, reflecting that

clotrimazole applied intravaginally does not 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
Sorbitan stearate
Polysorbate 60
Cetyl palmitate
Cetostearyl alcohol
Isopropyl myristate
Benzyl alcohol
Purified water

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
24 months.

6.4

Special precautions for storage
Do not store above 25°C.

6.5

Nature and contents of container

A single dose applicator consisting of a body of HDPE, piston of LDPE, cap of
LDPE, with a separate plunger of polystyrene. One applicator is contained in a blister
pack. Pack size 5g.
6.6

Special precautions for disposal
No special requirements.

7

MARKETING AUTHORISATION HOLDER
Bayer plc
Bayer House
Strawberry Hill
Newbury, Berkshire
RG14 1JA

8

MARKETING AUTHORISATION NUMBER(S)
PL 0010/0654

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
07/01/2016

10

DATE OF REVISION OF THE TEXT
04/07/2017

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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