Search Results
| نشرة الممارس الصحي | نشرة معلومات المريض بالعربية | نشرة معلومات المريض بالانجليزية | صور الدواء | بيانات الدواء |
|---|
1.WHAT IS Canesten-1 Vaginal Cream 10% AND WHAT IS IT USED FOR? Canesten-1 Vaginal Cream 10% is a single application, full course treatment for vaginal thrush (candidiasis). It is a soothing intravaginal cream with applicator for treatment at the site of infection. The active substance in Canesten-1 Vaginal Cream 10% is clotrimazole. Clotrimazole belongs to a group of medicines called azoles and is an antifungal agent which fights the cause of infections such as vaginal thrush. |
Do not use Canesten-1 Vaginal Cream10%:
• If you are allergic (hypersensitive) to clotrimazole or any of the other ingredients, including cetostearyl alcohol or benzyl alcohol, of Canesten-1 Vaginal Cream 10% (see Section 6. Further Information).
• During your period as it may be less effective.
Important information about some of the ingredients:
This product contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis). The medicine also contains 10mg
benzyl alcohol in each gram of cream. Benzyl alcohol may cause allergic reactions and mild local irritation.
Special precautions:
As with other creams, this product may reduce the effectiveness of rubber contraceptives, such as condoms or diaphragms.
Consequently, you should use alternative precautions for at least five days after using this product.
Do not use tampons, intravaginal douches, spermicides or other vaginal products while using this product.
Avoid vaginal intercourse while you have thrush and during use of this product because your partner could become infected.
Using other medicines: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Inform your doctor if you are taking tacrolimus or sirolimus (used to reduce the immune response to prevent rejection after an organ transplant). Children Do not use in children under the age of 16 years.
Pregnancy and breastfeeding: Canesten-1 Vaginal Cream 10% can be used in pregnancy and breastfeeding. If you are pregnant, breastfeeding or trying for a baby, tell your doctor or midwife before using Canesten-1 Vaginal Cream 10%. If you have informed your doctor or midwife already, follow his/her instructions carefully. To treat internal thrush, your doctor may recommend that you use a treatment that can be inserted in the vagina without the help of an applicator, such as a clotrimazole vaginal tablet.
The symptoms of thrush should disappear within three days of treatment. If no improvement is seen after seven days you must tell your doctor. Canesten-1 Vaginal Cream 10% is for use in the vagina only: Do not put the cream in your mouth or swallow it. If the cream is swallowed accidentally, tell your doctor straight away or contact the Accident and Emergency Department of your nearest hospital.
Like all medicines, Canesten-1 Vaginal Cream 10% can cause side effects, although not everybody gets them. As with all medicines, some people may be allergic to the cream. If you are allergic, a reaction will occur soon after you have used the medicine. If you experience an allergic reaction or the redness, burning, pain, itching or swelling get worse, stop using this product and tell your doctor straight away or contact the Accident and Emergency Department of your nearest hospital. Signs of an allergic reaction may include: • Rash. • Swallowing or breathing problems. • Swelling of your lips, face, throat or tongue. • Weakness, feeling dizzy or faint. • Nausea. After you apply Canesten-1 Vaginal Cream 10% you might experience: • Itching, rash, swelling, redness, discomfort, burning, irritation, vaginal peeling discharge or bleeding. • Pain (eg. abdominal pain, vulvovaginal pain). • Nausea. If you experience any of the above effects, tell your doctor immediately. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine. To report any side effect(s): The National Pharmacovigilance Centre (NPC): Fax: +966-11-205-7662 SFDA Call Center: 19999 E-mail: npc.drug@sfda.gov.sa Website: https://ade.sfda.gov.sa/ |
Not to be stored above 25°C Keep this medicine out of the sight and reach of children. Do not use Canesten-1 Vaginal Cream 10% after the expiry date, which is stated on the package after the abbreviation EXP. The expiry date refers to the last day of the month indicated. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment
The active Ingredient is: clotrimazole. Each gram of cream contains 100 mg of clotrimazole. The other ingredients (excipients) are: Sorbitan stearate, polysorbate 60, cetyl palmitate, cetostearyl alcohol, isopropyl myristate, benzyl alcohol and purified water. See Section 2 ‘Do not use’ and ‘Important information about some of the ingredients’ for cetostearyl alcohol and benzyl alcohol advice
Manufactured by Kern Pharma, S.L., Spain. for Bayer Consumer Care AG, Basel, Switzerland.
هذا الدواء له لون أبيض.
تحتوي العبوة على 5 جرام كريم كانستين-1 كريم مهبلي 10 % المهبلي مع أنبوب إدخال
للاستخدام لمرة واحدة.
المصنع
كيرن فارما، إس إل،
أسبانيا.
لصالح
باير كونسيومر كير ايه جى،
بازل، سويسرا.
Canesten-1 Vaginal Cream 10% is recommended for the treatment of candidal vaginitis.
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.
Children:
Not for use in children under 16.
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.
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 treatment with vaginal clotrimazole and oral tacrolimus (FK- 506; immunosuppressant) might lead to increased tacrolimus plasma 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.
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 vaginal tablet, since these can be inserted without using an applicator.
Lactation:
There are no data on the excretion of clotrimazole into human milk. However, systemic absorption is minimal after administration and is unlikely to lead to systemic effects. Clotrimazole may be used during 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.
The medication has no or negligible influence on the ability to drive or use machinery.
Frequency not known. As the listed undesirable effects are based on spontaneous reports, assigning accurate frequency of occurrence for each is not possible.
Immune system disorders: anaphylactic reaction, angioedema, hypersensitivity.
Vascular disorder: syncope, hypotension.
Respiratory, thoracic and mediastinal disorders: dyspnea.
Gastrointestinal disorders: abdominal pain, nausea.
Skin and Subcutaneous Tissue Disorders: rash, urticaria, pruritus.
Reproductive system and breast disorders: vaginal exfoliation, vaginal discharge, vaginal haemorrhage, vulvovaginal discomfort, vulvovaginal erythema, vulvovaginal burning sensation, vulvovaginal pruritus, vulvovaginal pain.
General disorders and administration site conditions: application site irritation, oedema, 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.
To report side effect(s):
The National Pharmacovigilance Centre (NPC):
Fax: +966-11-205-7662
SFDA Call Center: 19999
E-mail: npc.drug@sfda.gov.sa
Website: https://ade.sfda.gov.sa/
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.
Pharmacotherapeutic group: Gynaecological antiinfectives and antiseptics –
imidazole derivatives
ATC Code: G01A F02
Mechanism of Action
Azoles (e.g. clotrimazole) are usually recommended for the local treatment of vulvovaginal candidosis that is characterized by vulvovaginal symptoms such as itching, burning, discharge, redness, swelling and soreness.
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 microgram/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.
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.
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.
Sorbitan stearate
Polysorbate 60 Cetyl palmitate Cetostearyl alcohol Isopropyl myristate Benzyl alcohol Purified water
Not applicable.
Do not store above 25°C
This medicine is white in colour.
It is presented in a pack of 5 g vaginal cream with a disposable
applicator.
No special requirements.
