Clotic

Package leaflet: Information for the patient

Clotic 10 mg/mL ear drops, solution in single-dose container

Clotrimazole
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Clotic is and what it is used for

Clotic is used to treat fungal infections of the outer ear (otomycosis) in adults, adolescents, and children over 1 month of age.
The active substance in this medicine is clotrimazole. Clotrimazole belongs to a group of medicines called imidazoles and is an antifungal agent that acts against the most common types of fungi responsible for fungal ear infections.

2. What you need to know before using Clotic

Do not use Clotic

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

Warnings and precautions

• Use this medicine only in the ears. Avoid getting the medicine into the eyes. In case of accidental exposure of the eyes to clotrimazole, wash them thoroughly with water and, if necessary, consult an ophthalmologist.
• Consult your doctor before using this medicine if you have a perforated eardrum.

Other medicines and Clotic
Inform your doctor or pharmacist if you are taking/using, have recently taken/used, or might take/use any other medicines, including those not requiring a prescription.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before using this medicine.
Clotic may be used during breastfeeding.
Driving and using machines
Clotic does not affect the ability to drive or operate machinery.

3. How to use Clotic

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
This medicine is intended for ear use only (aural use).
The recommended dose in adults and children is one single-dose container into the affected ear
twice daily (morning and evening), preferably 12 hours apart, for 14 days.
Use the medicine in both ears only if directed by your doctor. In this case, use one single-dose container for each ear.
Instructions for use

1. Wash your hands with water and soap.

Gently clean any fluid (discharge) coming out of the external ear with a clean cloth or tissue.
Do not insert any object or cotton swab into the ear canal.

3. Remove Clotic from the protective pouch. Detach one single-dose container of Clotic by tearing along the dotted lines (perforations) until it is completely separated from the others.

4. Warm the single-dose container by holding it in your hand for 1–2 minutes. This helps prevent discomfort or dizziness that may occur if a cold solution is instilled into the ear.
5. Remove the cap from the single-dose container.

6. The person receiving the medicine should lie on their side with the infected ear facing upwards, as shown in Figure 6.

7. Hold the container in your hand and position it close to the ear. Instil the entire dose into the affected ear canal.
8. Gently pull the outer earlobe upward and outward. This helps the ear drops flow down into the ear canal.

9. The person receiving the medicine should remain lying on their side with the affected ear facing upwards for 1 minute. After administration, discard the single-dose container.
10. If necessary, repeat all steps for the other ear.

It is extremely important to follow these instructions to allow the medicine to work properly.
If you use more Clotic than you should
Symptoms of overdose are unknown. In case of overdose or accidental ingestion
of the medicine, contact your doctor or pharmacist immediately.
If you forget to use Clotic
Do not use a double dose to make up for the missed dose. If you miss a dose, use the
medicine as soon as possible and continue treatment as usual.
If you stop using Clotic
If you stop using the medicine before the time prescribed by your doctor, your condition may
worsen. To prevent the infection from returning, do not stop treatment prematurely, even if
your ears have improved. If you need to stop using this medicine, contact your doctor immediately.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using the medicine and inform your doctor immediately if you notice symptoms of an allergic
reaction such as:

• itching, skin rash or hives
• swelling of the face, lips or throat
• difficulty breathing or wheezing

Uncommon: may affect up to 1 in 100 people

• Rupture of the eardrum
• Ear pain
• Sensation of ringing or buzzing in the ears (tinnitus)
• Headache
• Dizziness
• Sensations of numbness, tingling or pins and needles (paraesthesia)
• Pain at the site of application

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the website
. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Clotic

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Keep the single-dose containers in the original packaging to protect the medicine from excess moisture.
After opening the pouch, the single-dose containers should be used within 30 days and stored at a temperature below 25°C.
After first opening a single-dose container: use immediately and discard the single-dose container after use.
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 Clotic contains

• The active substance is clotrimazole. Each millilitre of this medicinal product contains 10 mg of clotrimazole. Each single-dose container delivers approximately 0.17 mL of solution, equivalent to 1.7 mg of clotrimazole.
• The other component is Macrogol 400.

Description of the appearance of Clotic and contents of the package
Clotic is a clear, colourless solution in single-dose containers, each containing 0.2 mL of solution.
The single-dose containers are packed in an outer protective pouch made of aluminium foil.
Each pack contains 3 pouches with 10 single-dose containers, for a total of 30 single-dose containers in a box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
INFECTOPHARM Arzneimittel und Consilium GmbH
Von-Humboldt-Str. 1
64646 Heppenheim
Germany

Manufacturers
Laboratorios SALVAT, S.A.
C/. Gall, 30-36
08950 Esplugues de Llobregat
Barcelona – Spain
Pharmaloop, S.L.
Calle de Bolivia 15
Poligono Industrial Azque
28806 Alcala de Henares
Madrid - Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria OtoMyk 10 mg/ml Ohrentropfen, Lösung im Einzeldosisbehältnis
Denmark Clotic 10 mg/ml Øredråber, opløsning i endosebeholder
Finland Clotic 10 mg/ml Korvatipat, liuos, kerta-annospakkaus
Germany OtoMyk 10 mg/ml Ohrentropfen, Lösung im Einzeldosisbehältnis
Italy Clotic
Norway Clotic
Poland Dromyc 10 mg/ml krople do uszu, roztwór w pojemniku jednodawkowym
Portugal Clotic 10 mg/ml gotas auriculares, solução em recipiente unidose
Spain Clotic 10 mg/ml gotas óticas en solución en envase unidosis
Sweden Clotic 10 mg/ml Örondroppar, lösning i endosbehållare