Caginol

Package Leaflet: Information for the User

Cagynol 300 mg vaginal capsules

Sertaconazole nitrate

Read the package leaflet carefully before using this medicine because it contains important information for you.

This medicine should always be used exactly as described in this leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Table of Contents of the Leaflet

• 1. What is Cagynol and what is it used for
• 2. Important information before using Cagynol
• 3. How to use Cagynol
• 4. Possible side effects
• 5. How to store Cagynol
• 6. Contents of the pack and other information

1.

What is Cagynol and what is it used for

This medicine is indicated for the local treatment of vaginal candidiasis (a disease caused by microscopic fungal infections).
You should talk to your doctor if you do not feel better or 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),
• in case of use with male condoms and diaphragms (membranes) made of latex.

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 contact your doctor or pharmacist.
Local treatment of fungal infection is only one part of the treatment. To avoid recurrence of the disease, it is necessary for your doctor to examine the causes of the infection.

Precautions for use

You should not use acidic soap for local hygiene (acidity accelerates the development of fungal infections) (see: "How to use Cagynol").
Using the medicine may cause a feeling of local burning and intensify itching.
These symptoms usually go away on their own during treatment.
If the symptoms persist for more than 24 to 48 hours, you should consult your doctor.
If you have any questions, you should contact your doctor or pharmacist.

Children and adolescents

Cagynol is not recommended for use in people under 18 years of age.

Cagynol and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have recently taken, as well as the medicines you plan to take.
Cagynol should not be used with spermicides (risk of reduced efficacy of the medicine).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
You should not use this medicine during pregnancy unless advised by your doctor. If you become pregnant during treatment, you should consult your doctor, as only he can assess the need to continue treatment.

Driving and using machines

No effects on the ability to drive and use machines have been reported.

3. How to use Cagynol

Cagynol should always be used exactly as directed by your doctor. If you are unsure, you should contact your doctor or pharmacist.

Dosage

The recommended dose is one capsule, once, in the evening, before bedtime.

Method of administration

Vaginally. You should insert the capsule deep into the vagina, in a lying position. The easiest way is to lie on your back with your knees bent and apart.
Practical tips
When washing with neutral or alkaline pH soap to avoid infecting your family, you should use your own bathroom towels (glove, towel). Your doctor may also:

• treat your sexual partner to avoid re-infection,
• prescribe an antifungal medicine for local use.

You should wear cotton underwear,
You should avoid wearing internal tampons during treatment,
You should avoid vaginal showers,
Treatment is possible during the menstrual period.

Frequency of use

The capsule should be used in the evening before bedtime.

Duration of treatment

The duration of treatment is theoretically one day.
However, if clinical symptoms persist, your doctor may prescribe a second capsule to be used after 7 days from the first application.

Using more than the recommended dose of Cagynol

Using the medicine too frequently carries the risk of intensifying side effects. If you have used an additional dose of Cagynol not in accordance with the recommendations and are experiencing side effects not listed in this leaflet, you should contact your doctor.
4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Rare (may affect up to 1 in 1,000 people):

• Local feeling of burning or slight itching,
• Possible allergic reaction.

If you experience any side effects not listed in this leaflet or if some side effects are severe, you should inform your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C, 02-222 Warsaw
Phone: +48 22 49 21 301, Fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Cagynol

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

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6. Contents of the pack and other information

What Cagynol contains

• The active substance is sertaconazole nitrate. Each capsule contains 300 mg of sertaconazole nitrate.
• The other ingredients are: solid fat with additives (glycerol ricinoleate additive) (WITEPSOL H19), solid fat (SUPPOCIRE NAI 50), anhydrous colloidal silica.

What Cagynol looks like and contents of the pack

Cagynol is a white to off-white torpedo-shaped capsule.
The capsules are available in a blister pack of PVC/PE film containing 1 capsule in a carton box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder

Orivas, UAB
J. Jasinskio 16B
LT–03163 Vilnius
Lithuania
Phone: +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 authorized in the Member States of the EEA under the following names:

Estonia: Cagynol
Latvia: Cagynol
Lithuania: Cagynol 300 mg ovulė
Poland: Cagynol

Date of revision of the leaflet: