Canesten 1 Vt 500mg Vaginal Tablet
Clinical Summary
Quick overview from the medicine insert
Indication
Relief of vaginal itching, burning, and discharge from yeast infections.
Dosage (summary)
Single dose of 500 mg vaginal tablet, preferably at night.
Special Populations
- Pregnant women
- Girls under 12
Pregnancy & Breastfeeding
Use only on medical advice; not recommended in the first trimester.
Key Drug Interactions
- May reduce effectiveness of latex products
Contraindications
- Hypersensitivity to clotrimazole
Common side effects
- Local irritation
- Burning
- Contact dermatitis
Counselling Points
- Insert tablet deeply at night
- Avoid use during menstruation
- Partner treatment recommended
Serious warnings
- Not for oral use
- Consult if no improvement in 3 days
- Discontinue if rash occurs
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Clinical Particulars
Section 4 of the official insert — extracted exactly as issued, no alterations
4.1 Therapeutic indications
For the relief of vaginal itching, burning and discharge associated with recurrent vaginal yeast infections (vaginal candidiasis).
4.2 Posology and method of administration
In general, a single dose treatment will be sufficient for Candida vaginitis. The CANESTEN 1 Vaginal Tablet should be inserted, preferably at night, into the vagina as deeply as possible (see instructions for use of applicator). This is best achieved when lying back with the legs slightly drawn up. If necessary, a second treatment may be carried out. It is recommended that the treatment should be timed so as to avoid the menstrual period. For prevention of re-infection, the partner should be treated locally with clotrimazole cream at the same time, in as far as symptoms (e.g. pruritus, inflammation, etc.) are present. In individual cases where disintegration of the tablet does not occur, such as in dry vagina associated with menopause, it is recommended that clotrimazole vaginal cream be used.
4.3 Contraindications
Possible hypersensitivity to clotrimazole.
4.4 Special warnings and precautions for use
i) Not for oral use.
ii) Use only if you have already had a vaginal yeast infection diagnosed by a medical practitioner and you have the same symptoms now, otherwise consult your doctor. These symptoms include itching and burning of the vagina and sometimes a white discharge.
iii) If there is no improvement in 3 days or if symptoms have not disappeared in 7 days, then consult a medical practitioner as not all vaginal infections are caused by yeasts.
iv) Consult a medical practitioner if you have abdominal pain, fever or a foul-smelling vaginal discharge before or during the use of this medication.
v) If symptoms recur within 2 months, consult a medical practitioner.
vi) If you are pregnant or think you may be pregnant or are nursing, do not use this medication except on the advice of a medical practitioner.
vii) Do not use in girls under 12 years of age, except on the advice of a medical practitioner.
viii) If skin rash or new irritation occurs, discontinue use.
ix) Canesten u00ae 1 Vaginal Tablets may reduce the effectiveness and safety of latex products such as condoms and diaphragms. The effect is temporary and occurs only during treatment.
4.6 Fertility, pregnancy and lactation
CANESTEN 1 Vaginal Tablet should not be administered to pregnant women during the first trimester, since the safety in this regard has not been established. During pregnancy the CANESTEN 1 Vaginal Tablet 500 mg should be inserted without using an applicator. CANESTEN 1 Vaginal Tablet may only be used during pregnancy on the advice of a medical doctor. The possibility of absorption of clotrimazole when administered vaginally cannot be excluded.
4.8 Undesirable effects
Local reactions including irritation and burning may occur. Contact allergic dermatitis has been reported. In the case of systemic absorption, lower abdominal cramps, increase in urinary frequency or skin rash may occur. In isolated cases there may be generalised hypersensitivity reactions of varying degrees of severity. These reactions may affect the skin (e.g. itching, redness), breathing (shortness of breath), the circulation (e.g. a drop in blood pressure requiring treatment or even impaired consciousness) or the gastrointestinal tract (e.g.nausea, diarrhoea).
4.9 Overdose
See side effects. Gastro-intestinal disturbances and central nervous system depression may follow accidental ingestion. Treatment is symptomatic and supportive.