Gyno-Canesten Monodose
Italy
Table of Contents
Patient Information Leaflet
Gyno-Canesten 500 mg single dose
Soft capsule
Vaginal
clotrimazole
Please 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 instructed.
- Keep this leaflet. You may need to read it again.
- If you need more information or advice, consult your pharmacist.
- If you experience any side effects, contact your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.
- Contact your doctor if you do not notice improvement or if your symptoms worsen after 7 days.
Contents of this leaflet
- What Gyno-Canesten single dose is and what it is used for
- What you need to know before using Gyno-Canesten single dose
- How to use Gyno-Canesten single dose
- Possible side effects
- How to store Gyno-Canesten single dose
- Contents of the pack and other information
1. What Gyno-Canesten monodose is and what it is used for
The active substance of Gyno-Canesten monodose is clotrimazole, which belongs to the group of
imidazoles. It has a broad-spectrum effect against fungi, meaning it destroys them and inhibits their growth. It is
also effective against microorganisms such as dermatophytes, yeasts, and moulds.
Gyno-Canesten monodose is used for the treatment of infections of the vagina and external female
genital organs caused by microorganisms sensitive to clotrimazole. Infections are
usually caused by Candida, a fungus belonging to the yeast type. Symptoms
include itching, burning, thick vaginal discharge, white to yellow in colour, odourless (resembling cottage cheese), redness, swelling, and soreness.
This medicinal product is intended for adults and adolescents aged 16 years and over.
2. What you need to know before using Gyno-Canesten monodose
Do not use Gyno-Canesten monodose:
- if you are allergic to clotrimazole or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor before using Gyno-Canesten monodose if:
- this is the first time you have had a vaginal infection;
- you have a vaginal infection during the first trimester of pregnancy;
- you have recurrent infections, i.e. more than two infections within the previous six months;
- you have a fever of 38 °C or higher;
- you have pain in the lower abdomen or backache;
- you have foul-smelling vaginal discharge;
- you have nausea;
- you have vaginal bleeding and/or shoulder pain at the same time. Gyno-Canesten monodose soft vaginal capsule is not recommended during menstruation. Treatment should be completed before the start of menstruation.
Do not use internal sanitary towels, vaginal douches, spermicides, or other products intended for vaginal use at the same time as Gyno-Canesten monodose.
During treatment with this medicine, avoid sexual intercourse, as the infection could be transmitted to your partner.
If your partner also has symptoms of a fungal infection, they should be treated at the same time. Treating your partner may help prevent reinfection.
The contraceptive properties of latex contraceptives such as condoms and diaphragms may be reduced.
Do not swallow Gyno-Canesten monodose.
Other medicines and Gyno-Canesten monodose
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Consult your doctor if you are taking tacrolimus or sirolimus, medicines used to control the body's immune response after an organ transplant.
The blood concentration of certain medicines may increase when used concomitantly with Gyno-Canesten monodose soft vaginal capsule. However, this is unlikely to occur with a single 500 mg dose. Ask your doctor or pharmacist for advice if you are unsure about using any medicine together with Gyno-Canesten monodose soft vaginal capsule.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
During the first 3 months of pregnancy, you must consult your doctor before using clotrimazole.
During pregnancy, do not use the applicator provided. Therefore, insert the soft vaginal capsule into the vagina with your finger to avoid injury to the uterine cervix.
Breastfeeding
Gyno-Canesten monodose may be used during breastfeeding. Consult your doctor or pharmacist.
Driving and using machines
Gyno-Canesten monodose does not affect the ability to drive or operate machinery.
3. How to use Gyno-Canesten monodose
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
- one vaginal soft capsule inserted deeply into the vagina as a single dose at bedtime. Treatment may be repeated. However, if the infection persists or keeps recurring, this may indicate a more serious condition and you should seek medical advice. Instructions for use The vaginal soft capsule should be inserted as deeply as possible into the vagina using the provided applicator, preferably while lying down, in the evening before going to sleep.
- Pull the plunger of the applicator outward until it stops. Place the vaginal soft capsule into the applicator.
- Securely place the vaginal soft capsule into the holder of the applicator by gently turning it.
- Insert the loaded applicator deeply into the vagina. This is best done while lying down with legs slightly raised. Push the plunger into the applicator until it stops. Remove the applicator with the plunger pressed in.
Inserting the vaginal soft capsule without the applicator:
If you are pregnant, insert the vaginal soft capsule into the vagina with your fingers.
Duration of treatment
Gyno-Canesten monodose is used as a single-dose treatment.
Consult your doctor if symptoms have not improved within 7 days after starting treatment, to confirm the cause of the infection. If symptoms worsen, consult your doctor.
If you have any doubt about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicinal product can cause side effects, although not everyone experiences them.
Side effects may occur with the following frequencies:
Common, may affect 1 in 10 people:
- burning
Uncommon, may affect 1 in 100 people: - abdominal pain
- itching
- skin redness/irritation
Rare, may affect 1 in 1,000 people: - allergic reactions
- swelling
- skin rash
- vaginal bleeding
Frequency not known, based on available data: - vaginal peeling
- vaginal discomfort
- vaginal pain
- nausea
- hives
- vaginal discharge
- pain
Discontinue treatment if localized side effects or allergic reactions occur
(including anaphylactic reactions, angioedema (swelling), low blood pressure, shortness of breath and/or fainting).
Local reactions may resemble symptoms of the disease. Therefore, it may sometimes be difficult to distinguish infection symptoms from side effects caused by the medicine.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: 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 single-dose soft vaginal capsule
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Package contents and other information
What Gyno-Canesten monodose contains
- The active substance is clotrimazole.
- Each vaginal soft capsule contains 500 mg of clotrimazole.
- The other components are:
- gelatin
- glycerol
- white soft paraffin
- liquid paraffin
- purified water
- titanium dioxide (E 171)
- quinoline yellow (E104)
- sunset yellow (E110)
- lecithin (E322)
- medium-chain triglycerides
Description of the appearance of Gyno-Canesten monodose and package contents
One yellow vaginal soft capsule, packaged in an aluminum foil blister with an applicator,
both contained in a cardboard box.
Marketing Authorisation Holder and Manufacturer
- Marketing Authorisation Holder Bayer Spa Viale Certosa 130, 20156 Milano Italy
- Manufacturer GP Grenzach Produktions GmbH Emil-Barell-Strasse 7, 79639 Grenzach-Wyhlen, Germany
This medicinal product is authorised in the Member States of the
European Economic Area under the following names:
Austria: Canesten Clotrimazol 0,5 g Weichkapsel zur vaginalen Anwendung
Croatia: Canesten 1 500 mg meka kapsula za rodnicu
Cyprus: Gyno-Canesten 500 mg κολπικό καψάκιο, μαλακό
Czech Republic: Canesten Gyn 1 den
Estonia: Canesten
Finland: Canesten 500 mg emätinpuikko pehmeä kapseli
Greece: Gyno-Canesten 500 mg κολπικό καψάκιο, μαλακό
Italy: Gyno-Canesten Monodose
Latvia: Canesten
Lithuania: Canesten
Poland: Canesten
Romania: Canesten Gyn Uno 500 mg capsula moale vaginala
Slovakia: Canesten Gyn 1 deň 500 mg mäkká vaginálna kapsula
Slovenia: Canesten 1 500 mg mehka vaginalna kapsula
This leaflet was last revised on