Package leaflet: Information for the user

Cagynol 300 mg globules
Sertaconazole nitrate
Please read all of this leaflet carefully before using this medicine because it contains
important information for you.
This medicine should always be used according to the instructions in this leaflet or as directed by
your doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

What Cagynol is and what it is used for
Important information before using Cagynol
How to use Cagynol
Possible side effects
How to store Cagynol
Contents of the pack and other information

1. What Cagynol is and what it is used for
This medicine is indicated for the local treatment of vaginal candidiasis (a disease caused by microscopic fungal infections).
You should speak to your doctor if you do not feel better or if you feel worse after 3 days.

2. Important information before using Cagynol

When not to use Cagynol

if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6),
when using with male latex condoms and latex diaphragms (membranes).

If you have any questions or doubts about using this medicine, you should contact your doctor or pharmacist.
Warnings and precautions
Before using Cagynol, you should consult your doctor or pharmacist.
Local treatment of fungal infection is only one aspect of therapy. To prevent recurrence of the disease, it is necessary for a doctor to investigate the underlying causes of the infection.
Precautions for use
Do not use acidic soaps for local hygiene (acidity accelerates the development of fungal infections) (see: "How to use Cagynol").
Use of the medicine may cause a sensation of local burning and may intensify itching.
These symptoms usually resolve spontaneously during treatment.
If symptoms persist for longer than 24 to 48 hours, consult your doctor.
If you have any questions, contact your doctor or pharmacist.
Children and adolescents
Cagynol is not recommended for use in individuals under 18 years of age.
Cagynol and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Cagynol should not be used with spermicidal products (risk of reduced effectiveness of the medicine).
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
This medicine should not be used during pregnancy unless advised by a doctor. If you discover you are pregnant while undergoing treatment, consult your doctor, as only a doctor can assess whether treatment should continue.
Driving and operating machinery
No effects on the ability to drive or operate machinery have been reported.

3. How to use Cagynol

Cagynol must always be used as directed by the physician. In case of doubt, contact your doctor or pharmacist.
Dosage
The recommended dose is one globule, administered once daily in the evening before bedtime.
Method of administration
Vaginally. The globule should be inserted deeply into the vagina while lying down. The easiest way is to lie on your back with knees drawn up and apart.
Practical advice
When washing, use soap with a neutral or alkaline pH. To avoid infecting family members, use individual bath towels (washcloth, towel). The physician may also:

treat the patient's sexual partner to prevent reinfection,
prescribe the patient a topical antifungal medication.

Wear cotton underwear.
Avoid using internal tampons during treatment.
Avoid vaginal douching.
Treatment may be continued during menstruation.
Frequency of administration
The globule should be used in the evening before bedtime.
Duration of treatment
The treatment duration is theoretically one day.
However, if clinical symptoms persist, the physician may prescribe a second globule to be administered 7 days after the first one.
Use of a higher than recommended dose of Cagynol
Using the medication more frequently than recommended may increase the risk of adverse reactions. If the patient uses an additional dose of Cagynol contrary to instructions and experiences adverse reactions not listed in this leaflet, she should contact her doctor.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Rare (may occur in no more than 1 in 1,000 people):

Localized burning sensation or mild itching,
Possibility of allergic reaction.

If any adverse reactions occur, including those not listed in this leaflet, or if any adverse reactions are severe, inform your doctor or pharmacist.
Reporting of adverse reactions
If any adverse symptoms occur, including adverse symptoms not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C, 02-222 Warsaw
Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Cagynol

Q
Keep this medicine out of the sight and reach of children.
D
L
Do not use Cagynol after the expiry date stated on the outer carton and blister pack “Expiry date (EXP)”. The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Cagynol contains

The active substance is sertaconazole nitrate. Each globule contains 300 mg of sertaconazole nitrate.
The other ingredients are: hard fat with additives (glycerol ricinoleate added) (WITEPSOL H19), hard fat (SUPPOCIRE NAI 50), anhydrous colloidal silicon dioxide.

What Cagynol looks like and contents of the pack
Cagynol is a white to off-white torpedo-shaped globule.
The globules are available in PVC/PE foil blisters containing 1 globule in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
Orivas, UAB
J. Jasinskio St. 16B
LT–03163 Vilnius
Lithuania
Tel: +370 5 252 65 70
Manufacturer
Unither Liquid Manufacturing-Colomiers
1-3 Alle De La Neste
Zi D`en Sigal
31770 Colomiers
France
This medicinal product is authorised in the EEA countries under the following names:
Estonia: Cagynol
Latvia: Cagynol
Lithuania: Cagynol 300 mg ovulė
Poland: Cagynol