Clotic 10 mg/ml otic solution in single-dose container

Spain
Brand name Clotic 10 mg/ml otic solution in single-dose container
Form solution, otic in single-dose container
Active substance / Dosage
CLOTRIMAZOLE · 2 mg
Prescription type Prescription Only Medicine
ATC code
S02A S02AA
Registration number 90227
Manufacturer Laboratorios Salvat S.A.
Clotic 10 mg/ml otic solution in single-dose container solution, otic in single-dose container

Table of Contents

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

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

clotrimazole

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

  • Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

  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 external 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 fights the most common types of fungi causing 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 contact of the medicine with the eyes. In case of accidental exposure to the eyes, rinse thoroughly with plenty of water and consult an ophthalmologist if necessary.
  • 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 need to take/use any other medicines, including medicines obtained without a prescription.

Pregnancy, breastfeeding and fertility

If you are pregnant, think you might be pregnant, or are planning to become pregnant, 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

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

This medicine is for ear use only (otic route).

The recommended dose in adults and children is one single-dose container in the affected ear twice daily (morning and night), preferably every 12 hours, for 14 days.

Use this medicine in both ears only if your doctor has instructed you to do so. In that case, use one single-dose container for each ear.

Instructions for use

  1. Wash your hands with water and soap.

Two hands hold and manipulate a cylindrical medical device with a flexible tube attached at the top against a gray background

  1. Gently clean any discharge (fluid) from the outer ear using a clean cloth or tissue. Do not insert any object or cotton swab into the external ear canal.

A hand holds a medicine vial close to the

  1. Remove Clotic from the protective aluminum pouch. Detach a single-dose container by cutting along the dotted line (perforations) until fully separated.

A hand grasps the cap of a medical vial among three similar vials, with an arrow indicating a downward removal motion

  1. Warm the single-dose container by holding it in your hand for 1 or 2 minutes. This will help prevent discomfort or dizziness that may occur when a cold solution comes into contact with the ear.

A hand bends a glass vial to snap off the neck of the container, with the number 4 in the top-left corner

  1. Twist off the cap.

A hand twists the top of a vial to remove the cap and access the liquid inside

  1. The person receiving this medication should lie on their side with the affected ear facing upward, as shown in Figure 6.

Medical illustration with a curved arrow indicating the direction of movement toward the top of a person's head

  1. Hold the container in your hand and place the vial close to the ear. Allow the entire dose to drip into the external ear canal of the affected ear.

A hand presses a white medical device against the upper cheek of a person following the direction of a white arrow

  1. Gently pull the earlobe upward and outward. This will allow the ear drops to enter the external ear canal more easily.

A hand gently lifts the skin of the face upward toward the

  1. The person receiving this medication should remain lying on their side with the affected ear facing upward for 1 minute.

Dispose of the single-dose container after administration.

An analog clock showing one minute next to the text '1 min' above a detailed image of a human eye on a gray background with the number 9 in the top-left corner

  1. Repeat all steps, if necessary, for the other ear.

It is very important to follow these instructions so that this medicine can work effectively.

If you use more Clotic than you should

Symptoms of an overdose are unknown. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Clotic

Do not administer a double dose to make up for missed doses. If you forget a dose, take this medicine as soon as possible, then continue with the rest of your treatment as usual.

If you stop treatment with Clotic

If you stop using this medicine before the time prescribed by your doctor, your condition could worsen. To ensure the infection does not return, do not stop treatment early, even if your ear symptoms have improved. If you need to stop using this medicine, consult your doctor immediately.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Stop using this medicine and inform your doctor immediately if you experience 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

  • Perforated eardrum.
  • Ear pain.
  • Ringing in the ears (tinnitus).
  • Headache.
  • Dizziness.
  • Sensations of numbness, tingling or pins and needles (paraesthesia).
  • Pain at the site of application.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 the month indicated.

This medicine does not require any special storage temperature.

Keep the unit-dose packages in the original packaging to protect them from excess moisture.

After opening the pouch, the unit-dose packages should be used within 30 days and stored below 25°C.

After first opening a unit-dose package: use immediately and discard the unit-dose package after use.

Medicines must not be disposed of via wastewater or household waste. Dispose of packaging and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Clotic

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

Nature of the product and pack contents

Clotic is a clear, colourless solution supplied in single-dose containers, each containing 0.2 ml of solution.

The single-dose containers are packed in a protective aluminium pouch. Each carton contains 3 pouches, each pouch holding 10 single-dose containers, making a total of 30 single-dose containers per carton.

Marketing Authorization Holder and Manufacturer

Laboratorios Salvat, S.A.

Gall, 30-36 - 08950

Esplugues de Llobregat (Barcelona)

Spain

Manufacturer

Pharmaloop S.L.

C/Bolivia, 15 – Polig Industrial Azque

28806 Alcalá de Henares,

Madrid – Spain

Or

Laboratorios Salvat, S.A.

Gall, 30-36 - 08950

Esplugues de Llobregat (Barcelona)

Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Austria OtoMyk 10 mg/ml Ohrentropfen, Lösung im Einzeldosisbehältnis

Denmark Clotic 10 mg/ml Øredråber, opløsning i enkeltdosisbeholder

Finland Clotic 10 mg/ml Korvatipat, liuos, kerta-annospakkaus

Germany OtoMyk 10 mg/ml Ohrentropfen, Lösung im Einzeldosisbehältnis

Italy Clotic 10 mg/ml gocce auricolari, soluzione in contenitore monodose

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

Date of the most recent review of this leaflet: August 2024.

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/