GYNO-CANESTEN 100 mg Vaginal Tablet

Зміст інструкції

1. Gyno-Canesten 2% vaginal cream
   1. What is Gyno-Canesten and what is it used for
   2. What you need to know before using Gyno-Canesten
   3. How to use Gyno-Canesten
   4. Possible side effects
   5. How to store Gyno-Canesten
   6. Contents of the pack and other information
2. Gyno-Canesten
   1. What is Gyno-Canesten and what is it used for
   2. What you need to know before using Gyno-Canesten
   3. How to use Gyno-Canesten
   4. Possible side effects
   5. How to store Gyno-Canesten
   6. Contents of the pack and other information

Gyno-Canesten 2% vaginal cream

clotrimazole

Read this leaflet carefully before using this medicine as it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 7 days.

Contents of this leaflet:

• 1. What Gyno-Canesten is and what it is used for
• 2. What you need to know before using Gyno-Canesten
• 3. How to use Gyno-Canesten
• 4. Possible side effects
• 5. How to store Gyno-Canesten
• 6. Contents of the pack and other information

1. What is Gyno-Canesten and what is it used for

Gyno-Canesten contains clotrimazole, an antifungal agent that inhibits fungal growth.
Gyno-Canesten is used for the treatment of localized symptoms resulting from
vulvovaginal and glans (most distal portion of the penis) infections caused by candida, previously
diagnosed, in adults and adolescents over the age of 12 years. These symptoms
include itching, leukorrhea (whitish vaginal discharge), redness and a feeling of
swelling of the vaginal mucosa and glans, burning during urination.
See your doctor if you do not feel better or if you feel worse after 7 days of treatment

2. What you need to know before using Gyno-Canesten

Do not use Gyno-Canesten

• if you are allergic to clotrimazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Gyno-Canesten if:

• you have suffered from the same disorders less than 2 months ago,
• you have a fever, lower abdominal pain, back pain, foul-smelling vaginal discharge, nausea, vaginal bleeding and/or shoulder pain.

The use, especially if prolonged, of topical products (applied to the skin), can cause
sensitization phenomena (acquiring a greater sensitivity); in this case it is
necessary to interrupt the treatment and consult your doctor or pharmacist.
Avoid contact with eyes. Do not ingest.
It is preferable to start and end the treatment during the intermenstrual period.
During the use of this medicine avoid vaginal intercourse, because the infection could be
transmitted to your partner.
Also, in order to avoid reinfection, in particular in the presence of vulvitis or balanitis due to
Candida, local treatment of the partner is recommended.
During therapy with Gyno-Canesten do not use tampons, vaginal douches, spermicides or other
vaginal products.
During pregnancy, use Gyno-Canesten vaginal tablets and insert them without an applicator.
During treatment with Gyno-Canesten, the effectiveness and safety of latex products, such as condoms and diaphragms may be reduced.

Other medicines and Gyno-Canesten
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Tell your doctor in particular if you are being treated with sirolimus or oral tacrolimus(used for
preventing organ transplant rejection) as Gyno-Canesten may increase the levels of
sirolimus and tacrolimus in the blood. In this case, your doctor will carefully monitor your
condition.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
Clinical data on risk during pregnancy are limited.
Gyno-Canesten may be used during pregnancy only if necessary
and under the supervision of a doctor.

Breastfeeding
Gyno-Canesten can be used during breastfeeding.

Fertility
No studies have been conducted in humans on the effects of clotrimazole on fertility, however
animal studies have not shown any reproductive toxicity effects.

Driving and using machines
The medicine does not alter or negligibly alters the ability to drive vehicles or operate
machinery.

Gyno-Canesten cream contains 20mg/g of benzyl alcohol

• may cause allergic reactions;
• may cause mild local irritation.

Gyno-Canesten cream contains cetostearyl alcohol
May cause local skin reactions (e.g. contact dermatitis).

3. How to use Gyno-Canesten

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Apply as deeply as possible into the vagina once a day, preferably in the evening, at bedtime, for 3 consecutive days. If necessary, treatment may be prolonged for another 3 days.
In case of vulvitis or balanitis due to Candida, apply a thin layer of Gyno-Canesten cream 2-3 times a day over the entire urogenital and anal area. In case of balanitis, apply the cream also to the prepuce (skin covering the glans, the most distal portion of the penis). Facilitate the absorption of the cream applied locally with a gentle massage.

Duration of treatment
The maximum treatment duration is 7 days. If symptoms persist, consult your doctor.
In case of vulvitis or balanitis, treatment should be prolonged for 1-2 weeks.

Mode of use

• 1. Pull the plunger from the single-use applicator until it stops.
• 2. Open the tube. Insert the single-use applicator into it and hold it firmly. Fill the applicator by applying gentle pressure to the tube.
• 3. Once you have assumed a supine position (lying on your back) with your legs slightly bent, remove the single-use applicator, insert it as deeply as possible into the vagina, and empty it by applying regular and continuous pressure on the plunger.
• 4. Remove the applicator and discard it.

The applicator should be used only once and then discarded, in order to avoid possible
re-infections.
Health education notes
It is important to follow some personal hygiene rules for prevention:

• avoid wearing very tight clothing;

• avoid wearing nylon or other synthetic fiber underwear: preferably use cotton or natural fiber clothing;
• avoid using alkaline pH soaps for intimate hygiene: it is recommended to use acidic pH (pH 5) detergents to respect the normal acidity of the vaginal environment;
• avoid using vaginal douches, which can alter the vaginal environment and therefore promote the attachment of infections;
• if using tampons, change them frequently and avoid use during the night; it is still preferable to use external sanitary pads.

If you use more Gyno-Canesten than you should
There is no risk of acute poisoning as it is unlikely to occur after a single vaginal or cutaneous application of an excessive dose (application to an extensive area under favorable absorption conditions) or by accidental oral intake. There is no specific antidote. In case of ingestion/accidental intake of an excessive dose of Gyno-Canesten, immediately inform your doctor or go to the nearest hospital.

If you forget to use Gyno-Canesten
Continue treatment as recommended dosage.
If you have any doubts about the use of Gyno-Canesten, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
With the use of this medicine, the following side effects may occur with unknown frequency (frequency cannot be estimated based on available data):

• anaphylactic reaction (severe allergic reaction),
• angioedema (swelling of the face, lips, mouth, tongue and throat that can cause problems with breathing and swallowing),
• hypersensitivity (allergy)
• syncope (fainting),
• hypotension (low blood pressure),
• dyspnea (difficulty breathing),
• abdominal pain,
• nausea,
• skin rash,
• urticaria (skin irritation),
• exfoliation in the genital area,
• vaginal discharge,
• vaginal bleeding,
• discomfort in the genital area,
• erythema (redness) in the genital area,
• burning sensation in the genital area,
• itching in the genital area,
• pain in the genital area,
• irritation, pain and edema (fluid accumulation) at the application site.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
inform your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Gyno-Canesten

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month. The expiry date refers to the product in
intact packaging, correctly stored.
Do not use Gyno-Canesten 2% cream after 3 months from first opening.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
It is important to always have the information about the medicine available, therefore keep both the

6. Contents of the pack and other information

What Gyno-Canesten contains

• The active ingredient is clotrimazole. 5 g of vaginal cream contains 100 mg of clotrimazole.
• The other ingredients are: sorbitan monostearate, polysorbate 60, cetyl palmitate, cetostearyl alcohol, octyldodecanol, benzyl alcohol, purified water.

Description of the appearance of Gyno-Canesten and contents of the pack
Gyno-Canesten is presented as vaginal cream for gynecological use.
The pack contains 30 g with 6 single-use applicators.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bayer Spa – Viale Certosa 130 – Milan

Manufacturer
Kern Pharma SL – Barcelona - Spain
or
GP Grenzach Produktions GmbH -Germany
in

Gyno-Canesten

100 mg vaginal tablets
clotrimazole

Read this leaflet carefully before you start to use this medicine as it contains important information for you.
Always use this medicine exactly as described in this leaflet, or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if your symptoms do not improve or get worse after 7 days.

Contents of this leaflet:

• 1. What Gyno-Canesten is and what it is used for
• 2. What you need to know before you use Gyno-Canesten
• 3. How to use Gyno-Canesten
• 4. Possible side effects
• 5. How to store Gyno-Canesten
• 6. Contents of the pack and other information

1. What is Gyno-Canesten and what is it used for

Gyno-Canesten contains clotrimazole, an antifungal agent that inhibits fungal growth. Gyno-
Canesten is used for the treatment of localised symptoms resulting from vulvovaginal infections
caused by candida, diagnosed in adults and adolescents over 12 years of age.
These symptoms include itching, leucorrhoea (whitish vaginal discharge), redness and
a sensation of swelling of the vaginal mucosa, burning when passing urine.
Consult a doctor if you do not feel better or if you feel worse after 7 days of treatment

2. What you need to know before using Gyno-Canesten

Do not use Gyno-Canesten

• if you are allergic to clotrimazole or any of the other ingredients of this medicine (listed in section 6). Warnings and precautionsConsult your doctor or pharmacist before using Gyno-Canesten if:
• you have suffered from the same disorders less than 2 months ago,
• you have a fever, lower abdominal pain, back pain, foul-smelling vaginal discharge, nausea, vaginal bleeding and/or shoulder pain. The use, especially if prolonged, of topical products (applied to the skin) can cause sensitization phenomena (acquisition of greater sensitivity); in this case it is necessary to interrupt the treatment and consult your doctor or pharmacist. Avoid contact with eyes. Do not ingest. It is preferable to start and end the treatment during the intermenstrual period. During the use of this medicine avoid vaginal intercourse, because the infection could be transmitted to your partner.

Furthermore, in order to avoid reinfection, particularly in the presence of vulvitis or balanitis due to
Candida, local treatment of the partner with Gyno-Canesten cream is recommended.
During therapy with Gyno-Canesten, do not use tampons, vaginal douches, spermicides or other
vaginal products.
During pregnancy, use Gyno-Canesten vaginal tablets and insert them without an applicator.
During treatment with Gyno-Canesten, the effectiveness and safety of latex-based products,
such as condoms and diaphragms may be reduced.

Other medicines and Gyno-Canesten
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Tell your doctor in particular if you are being treated with sirolimusor oral tacrolimus(used for
preventing organ transplant rejection) as Gyno-Canesten may increase levels of
sirolimus and tacrolimus in the blood. In this case, your doctor will carefully monitor your
condition.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
Clinical data available regarding risk in pregnancy are limited.
Gyno-Canesten may be used during pregnancy only if absolutely necessary and under
medical supervision.

Breastfeeding
Gyno-Canesten can be used during breastfeeding. Fertility
No studies have been conducted in humans on the effects of clotrimazole on fertility, however
studies in animals have not shown any reproductive toxicity effects.

Driving and operating machinery
The medicine does not alter or negligibly alters the ability to drive vehicles or operate
machinery.

3. How to use Gyno-Canesten

Use this medicine following exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply as deeply as possible into the vagina once a day, preferably in the evening, at bedtime, for 6 consecutive days, or alternatively, apply 2 for only 3 consecutive days.
In case of vulvitis or balanitis due to Candida, apply a thin layer of Gyno-Canesten cream 2-3 times a day over the entire urogenital and anal area.
In chronic recurrent forms, the daily dosage may be increased to 2 vaginal tablets in the evening, for a period of 6-12 days.

Duration of treatment
The maximum treatment duration is 7 days; if symptoms persist, consult your doctor.

Method of use
After washing your hands thoroughly, assume a lying position (lying with your stomach facing upwards) with your legs slightly bent, insert the vaginal tablet directly with your finger as deeply as possible into the vagina.
For Gyno-Canesten vaginal tablets to dissolve completely, the vagina must have an adequate degree of moisture. Otherwise, fragments of the tablet that have not dissolved may be expelled. To avoid this, it is important to insert the medicine as deeply as possible into the vagina at bedtime. If, despite this precaution, the tablet does not dissolve completely overnight, you should consider using Gyno-Canesten vaginal cream.

Health education notes
It is important to follow some personal hygiene rules for prevention:

• avoid wearing very tight clothing;
• avoid wearing nylon or other synthetic fiber underwear: preferably use cotton or natural fiber clothing;
• avoid using alkaline pH soaps for intimate hygiene: the use of acidic pH detergents (pH 5) is recommended to respect the normal acidity of the vaginal environment;
• avoid using vaginal douches, which can alter the vaginal environment and therefore promote the attachment of infections;
• if using tampons, change them frequently and avoid using them overnight; the use of external sanitary pads is still preferred.

If you use more Gyno-Canesten than you should
There is no risk of acute poisoning as it is unlikely to occur after a single vaginal or cutaneous application of an excessive dose (application to an extensive area under favorable absorption conditions) or accidental oral intake. There is no specific antidote.
In case of ingestion/accidental intake of an excessive dose of Gyno-Canesten, immediately inform your doctor or go to the nearest hospital.

If you forget to use Gyno-Canesten
Continue the treatment as per the recommended dosage.
If you have any doubts about the use of Gyno-Canesten, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
With the use of this medicine, the following side effects may occur with unknown frequency
(frequency cannot be estimated based on available data):

• anaphylactic reaction (severe allergic reaction),
• angioedema (swelling of the face, lips, mouth, tongue and throat that can cause problems with breathing and swallowing),
• hypersensitivity (allergy)
• syncope (fainting),
• hypotension (low blood pressure),
• dyspnea (difficulty breathing),
• abdominal pain,
• nausea,
• skin rash,
• urticaria (skin irritation),
• exfoliation in the genital area,
• vaginal discharge,
• vaginal bleeding,
• discomfort in the genital area,
• erythema (redness) in the genital area,
• burning sensation in the genital area,
• itching in the genital area,
• pain in the genital area,
• irritation, pain and edema (fluid accumulation) at the application site.

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help to provide more information on the
safety of this medicine.

5. How to store Gyno-Canesten

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month. The expiry date refers to the product in
intact packaging, correctly stored.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
It is important to always have the information about the medicine available, therefore keep both the

6. Contents of the pack and other information

What Gyno-Canesten contains

• The active ingredient is clotrimazole. Each vaginal tablet contains 100 mg of clotrimazole.
• The other ingredients are: lactose monohydrate, corn starch, magnesium stearate, anhydrous colloidal silica, calcium lactate pentahydrate, crospovidone, lactic acid, hypromellose, microcrystalline cellulose.

Description of the appearance of Gyno-Canesten and contents of the pack
Gyno-Canesten is available in the form of vaginal tablets for gynecological use.
The pack contains 12 vaginal tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bayer Spa – Viale Certosa 130 – Milan

Manufacturer
Bayer AG - Leverkusen – Germany
or
GP Grenzach Produktions GmbH -Germany