1. Name Of The Medicinal Product
Canesten Combi Pessary & Cream
2. Qualitative And Quantitative Composition
Canesten Combi 500mg Pessary contains Clotrimazole 500mg.
Canesten Combi 2% Cream contains Clotrimazole 2% w/w.
For excipients, see 6.1.
3. Pharmaceutical Form
Pessary and cream
4. Clinical Particulars
4.1 Therapeutic Indications
The pessary is recommended for the treatment of candidal vaginitis.
The cream is recommended for the treatment of candidal vulvitis. It should be used as an adjunct to treatment of candidal vaginitis.
These products should only be used if candidal vulvovaginitis (thrush) was previously diagnosed by a doctor.
4.2 Posology And Method Of Administration
Adults
One pessary should be inserted into the vagina at night. Using the applicator provided, the pessary should be inserted as high as possible into the vagina. This is best achieved when lying back with legs bent up.
Canesten pessaries need moisture in the vagina in order to dissolve completely, otherwise undissolved pieces of the pessary might crumble out of the vagina. Pieces of undissolved pessary may be noticed by women who experience vaginal dryness. To help prevent this it is important that the pessary is inserted as high as possible in to the vagina at bedtime.
Treatment during the menstrual period should be avoided due to the risk of the pessary 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.
The cream should be thinly applied to the vulva and surrounding area, two or three times daily and rubbed in gently.
Treatment with the cream 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 physician.
Children
Not for use in children under 16.
4.3 Contraindications
Hypersensitivity to clotrimazole or any of the other ingredients.
Hypersensitivity to cetostearyl alcohol.
Do not use to treat nail or scalp infections.
4.4 Special Warnings And Precautions For Use
This product contains cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).
Before using Canesten Combi Pessary & 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 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.
The pessary and cream should not be used if the patient has any of the following symptoms where upon 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.
If no improvement in symptoms is seen after 7 days the patient should consult their doctor.
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 (FK-506; immunosuppressant) might lead to increased tacrolimus plasma levels. Patients should thus be closely monitored for signs and symptoms of tacrolimus overdosage, if necessary by determination of the respective plasma levels.
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.
During pregnancy the pessary should be inserted without using an applicator.
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 disorders:
allergic reaction (syncope, hypotension, dyspnea, urticaria, pruritus)
Canesten Pessary
Reproductive system and breast disorders:
genital peeling, pruritus, rash, oedema, discomfort, burning, irritation, pelvic pain
Gastrointestinal disorders:
abdominal pain
Canesten Cream
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 only be carried out only if the airway can be protected adequately.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
ATC Code: G01A F18 Gynecological antiinfectives and antiseptics – imidazole derivatives
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.
Under appropriate test conditions, the MIC values for these types of fungi are in the region of less than 0.062 – 4 (-8) 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.
In addition to its antimycotic action, clotrimazole also acts on Trichomonas vaginalis, gram-positive microorganisms (Streptococci/Staphylococci) and gram-negative microorganisms (Bacteroides/Gardnerella vaginalis). It has no effect on lactobacilli.
In vitro, clotrimazole inhibits the multiplication of Corynebacteria and gram-positive cocci – with the exception of Enterococci – in concentrations of 0.5 – 10 μg/ml substrate and exerts a trichomonacidal action at 100 μg/ml.
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.
Pharmacokinetic investigations after dermal application have shown that clotrimazole is practically not 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 μg/ml, reflecting that clotrimazole applied topically does not 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 SmPC.
6. Pharmaceutical Particulars
6.1 List Of Excipients
The pessary contains:
Lactose monohydrate
Microcrystalline cellulose
Lactic acid
Maize Starch
Crospovidone
Calcium lactate pentahydrate
Magnesium stearate
Silica, colloidal anhydrous
Hypromellose
The cream contains:
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
The pessary is packed into a blister consisting of 25µm PA (Polyamide) / 45µm Soft Aluminium / 60µm PVC and 20µm Hard Aluminium / 7 GSM HSL (Heat sealing lacquer) and is supplied with an applicator
The cream is filled into Aluminium tubes (10g) with internal lacquer coating, latex stopper and HDPE screw top.
The blister, an applicator and tube are enclosed in a cardboard carton.
6.6 Special Precautions For Disposal And Other Handling
The pessary is inserted as follows:
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There are no special instructions for use of the cream
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 00010/0300
9. Date Of First Authorisation/Renewal Of The Authorisation
18th March 2004
10. Date Of Revision Of The Text
12/08/2010
LEGAL CATEGORY
GSL
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