Kansen vaginal tablets, 3x200mg

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Kansen®
, 200 mg, vaginal tablets
clotrimazole
Read this instruction carefully before you start using this medicine, because it contains
information that is important to you.
Always use this medicine exactly as stated in these instructions or as explained to you by your doctor
doctor or pharmacist.
 Save the instructions. You may need to read it again.
 If you have additional questions or need advice, contact your pharmacist.
 If you experience any side effects, contact your doctor or pharmacist. This
includes any side effects not listed in this guide. See section 4.
 If you do not feel better or feel worse after 7 days, you must contact your doctor.
In this guide you will read:
1. What is the drug Kansen and what is it for?
2. What you need to know before you use Kansen
3. How Kansen is administered
4. M
about
less side effects
5. How to store Kansen medicine
6. Contents of the package and other information
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1. What is the drug Kansen and what is it for?
The drug Kansen contains the active substance clotrimazole, which belongs to the group of drugs called antimycotics
(medicines to treat fungal infections).
Kansen, a vaginal tablet is a medicine for the treatment of candidiasis vaginitis, an infection of the vagina caused by it
fungi from the genus Candida.
The drug is intended for adults and children over 12 years of age. For use in children aged 12 to 16 years
it is necessary to consult a doctor.
2. What you need to know before you use Kansen
You must not use Kansen:
 if you are allergic (hypersensitive) to clotrimazole or any of the auxiliary substances of this medicine
(listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Kansen vaginal tablets:
 if you have a fever (body temperature 38 °C or above), lower abdominal pain, back pain,
foul-smelling vaginal discharge, nausea, vaginal bleeding and/or shoulder pain.
 if you use latex contraceptives such as condoms and diaphragms, because the drug
Kansen, vaginal tablets in combined treatment with cream can reduce their effectiveness
and security.
Keep the medicine out of the sight and reach of children.
Avoid contact with eyes. Do not swallow.
Other medicines and Kansen
Inform your doctor or pharmacist if you are taking, have recently taken or may take any
what other medicines.
Simultaneous administration of the drug Kansen vaginally and tacrolimus and sirolimus orally (drugs used
to prevent rejection of the transplanted organ) may lead to an increase in tacrolimus concentrations in
plasma, and similarly sirolimus. It is necessary to carefully monitor the appearance of symptoms of tacrolimus overdose
or sirolimus, if necessary by determining plasma concentrations.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you are pregnant or are planning to become pregnant, contact your doctor or
pharmacist for advice before using this medicine.
Pregnancy
It is advised to avoid the use of clotrimazole during the first three months of pregnancy.
Breastfeeding
During treatment with this drug, breastfeeding must be stopped.
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Driving vehicles and operating machines
The drug Kansen has no or negligible influence on the ability to drive and operate vehicles
machines.
3. How Kansen is administered
Always use this medicine exactly as stated in this Medication Guide or as it has been explained to you
Your doctor or pharmacist. If you are not sure, check with your doctor or pharmacist. If you don't wake up
If you follow the instructions exactly, the medicine will not work properly.
Do not use tampons, intravaginal douches, spermicides or others while using this medicine
vaginal products, as well as latex products (condoms, diaphragms; if you also use a cream for
external use).
It is recommended to avoid vaginal intercourse while using this medicine in case of vaginal infection
as the infection can be passed on to a partner.
The drug Kansen is intended for vaginal use.
For three consecutive evenings, one vaginal tablet should be inserted as deeply as possible into the vagina, before going to bed, as it is
is described below. Symptoms caused by a yeast infection of the vagina usually do not last more than 7 days.
If the signs of infection do not disappear completely, the condition worsens or the symptoms reappear in the period from
2 months, consult a doctor.
If the labia and the area around them are infected at the same time, apart from the application of the medicine into the vagina (cream or
vaginal tablet) additional treatment with a cream for external use (combined treatment) is also required.
If your partner has symptoms, e.g. itching, inflammation, he should also start treatment.
The use of vaginal tablets during menstruation is not recommended. Treatment should be completed before starting
menstrual cycle.
Instructions for proper use of Kansen, vaginal tablets:
The vaginal tablet should be inserted in the evening, before going to bed, with washed hands as deep as possible into the vagina. It's best to
while lying on your back with your legs bent upwards.
In order for the vaginal tablets to dissolve completely in the vagina, they need moisture. Otherwise undissolved
pieces of the vaginal tablet can be crushed from the vagina. Pieces of undissolved vaginal tablets are generally
appear in women with vaginal dryness. To avoid this, it is necessary to vaginally
the tablet is applied as deeply as possible into the vagina, in the evening before going to bed. If the vaginal tablet does not dissolve in
completely in one night, consult your doctor or pharmacist about the possibility of use
vaginal cream.
Application in children and adolescents
The drug is intended for adults and children over 12 years of age. For use in children aged 12 to 16 years
it is necessary to consult a doctor.
If you forget to use Kansen
If you forgot to apply the medicine in the evening, you can do it the next morning, that is, as soon as you remember. Not
administer a double dose to make up for the missed dose.
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If you suddenly stop using Kansen
If you want to completely cure the yeast infection and prevent its recurrence, you must not stop the treatment
without consulting a doctor. If you do, you run the risk of the disease recurring. Treatment does not
you may stop immediately after the disappearance of the symptoms of infection, but you must continue for 3 consecutive days, such as
that prescribed in this instruction.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
patients taking this medicine.
Adverse effects have been identified during the post-marketing period of clotrimazole. Since these
reactions reported voluntarily from a population whose exact size is not known, is not always possible reliably
determine their frequency.
Immune system disorders: allergic reactions (sudden short-term loss of consciousness, drop in blood pressure,
difficulty breathing, hives).
Reproductive system and breast disorders: genital scaling, itching, rash, swelling, redness, discomfort,
burning, irritation, pelvic pain, vaginal bleeding.
Gastrointestinal disorders: abdominal pain.
Reporting adverse reactions
If you experience any unwanted reaction, you should inform your doctor or pharmacist.
This includes any possible side effects that are not listed in this guide. By signing up
adverse reactions can help evaluate the safety of this medicine. They suspect unwanted reactions
you can report to the Agency for Medicines and Medical Devices of Serbia (ALIMS):
Agency for Medicines and Medical Devices of Serbia
National Center for Pharmacovigilance
Vojvode Stepe 458, 11221 Belgrade
Republic of Serbia
website: www.alims.gov.rs
e-mail: nezeljene.reakcije@alims.gov.rs
5. How to store Kansen medicine
Keep the medicine out of the sight and reach of children.
You must not use the medicine Kansen after the expiration date indicated on the package after "Valid until:". Date
the expiration date refers to the last day of the specified month.
Store at a temperature of up to 25 °C, in the original packaging, to protect from light and moisture.
Unusable medicines are handed over to the pharmacy where the notice that they are to be collected is displayed in that pharmacy
unusable medicines from citizens. Unusable medicines must not be thrown into the sewer or together with
communal waste. These measures will help protect the environment.
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6. Contents of the package and other information
What Kansen contains
 The active substance is clotrimazole.
One vaginal tablet contains 200 mg of clotrimazole.
 Auxiliary substances are: lactose, monohydrate; starch, corn; adipic acid; silicon dioxide,
colloidal, anhydrous; polysorbate 80; sodium hydrogen carbonate; povidone K-30; magnesium stearate.
What the drug Kansen looks like and the contents of the package
An oblong, narrowed at one end, smooth vaginal tablet, white in color.
The inner packaging of the drug is an aluminum blister with 3 vaginal tablets.
The outer packaging of the drug is a collapsible cardboard box containing one blister (a total of 3 vaginal
tablets) and Instructions for the drug.
License holder and manufacturer
License holder:
ACTAVIS DOO BELGRADE, Đorđa Stanojevića 12, Belgrade
Manufacturer:
ZDRAVLJE AD LESKOVAC, Vlajkova 199, Leskovac, Republic of Serbia
This instruction was last approved
June, 2019.
Mode of administration of the drug:
The drug is issued without a doctor's prescription.
License number and date:
515-01-04225-18-001 from 14.06.2019

Note: We strive to be as accurate as possible in the description of all products, but we cannot guarantee that all descriptions are complete and error-free. Thank you for your understanding.
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