Dromyc

Package leaflet: Information for the patient

Dromyc, 10 mg/mL, ear drops, solution in a single-dose container
Clotrimazolum
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Dromyc is and what it is used for

Dromyc is used in the treatment of fungal infection of the outer ear (otomycosis) in adults, adolescents, and children above 1 month of age.
The active substance of the medicine is clotrimazole. Clotrimazole belongs to a group of medicines called imidazoles and is an antifungal agent effective against the most common types of fungi causing fungal ear infections.

2. Important information before using Dromyc

When not to take Dromyc

• if the patient is allergic to clotrimazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• This medicine is intended for ear use only. Contact with the eyes should be avoided. If clotrimazole gets into the eyes, rinse thoroughly with water and consult an ophthalmologist if necessary.
• If the eardrum is perforated, consult a doctor before using this medicine.

Dromyc and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those obtained without a prescription.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, suspects she may be pregnant, or is planning to have a child, she should seek advice from a doctor or pharmacist before using this medicine.
Dromyc may be used during breastfeeding.

Driving and operating machinery
Dromyc has no effect on the ability to drive or operate machinery.

3. How to use Dromyc

This medicine should always be used exactly as directed by your doctor or pharmacist. If you are unsure,
please consult your doctor or pharmacist.
This medicine is intended for ear use only (ear administration).
The recommended dose for adults and children is one single-dose container administered into the affected ear twice
daily (morning and evening), preferably with a 12-hour interval, for 14 days.
The medicine should be administered into both ears only if directed by a doctor. In such cases, the contents of one single-dose container should be administered into each ear.
Instructions for use

1. Wash your hands with soap and water.

2. Gently clean the outer ear with a clean cloth or tissue to remove any fluid (discharge). Do not insert any objects or cotton swabs into the ear canal.

3. Remove Dromyc from its protective foil pouch. Detach one single-dose container by tearing along the dotted lines (perforations) until completely separated.

4. Warm the single-dose container by holding it in your hand for 1 to 2 minutes. This helps prevent discomfort or dizziness that may occur if cold solution comes into contact with the ear.
5. Unscrew the cap.
6. The person receiving the medicine should lie on their side with the affected ear facing upward, as shown in Figure 6.

7. Holding the container in hand, place the dropper close to the ear. Administer the entire dose into the affected ear canal.
8. Gently pull the outer ear upward and outward. This helps the ear drops flow down the ear canal.

9. The person receiving the medicine should remain lying on their side for one minute, with the affected ear facing upward. After administering the medicine, the single-dose container should be discarded.
10. If necessary, repeat all steps for the other ear.

To ensure effective treatment, it is very important to follow these instructions carefully.
Using more Dromyc than recommended
Symptoms of overdose are not known. In case of overdose or accidental ingestion
of the medicine, contact your doctor or pharmacist immediately.
Missing a dose of Dromyc
Do not administer a double dose to make up for a missed dose. If you miss
a dose, take the medicine as soon as possible, then continue treatment as usual.
Stopping Dromyc treatment prematurely
Stopping treatment earlier than advised by your doctor may lead to worsening of the condition. To ensure the infection does not return, do not stop treatment early, even
if you start to feel better. If you need to discontinue treatment, contact your doctor immediately.
If you have any further questions about the use of this medicine, please consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should stop using the medicine and immediately contact your doctor if symptoms of an
allergic reaction occur, such as:

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

Not very common: may affect up to 1 in 100 people

• Rupture of the eardrum
• Ear pain
• Ringing or buzzing in the ears (tinnitus)
• Headache
• Dizziness
• Sensation of numbness, tingling or prickling (paraesthesiae)
• Pain at the application site

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

5. How to store Dromyc

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP:
{abbreviation used to describe the expiry date}. The expiry date refers to the last day of the
specified month.
This medicinal product does not require any special storage conditions.
Single-dose containers should be stored in the original packaging to protect from excessive
moisture.
After first opening of the sachet, the shelf life of single-dose containers is 30 days. They should
be stored at a temperature below 25°C.
After first opening of the single-dose container: use immediately and discard the single-dose
container after use.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Dromyc contains

• The active substance is clotrimazole. Each millilitre of this medicine contains 10 mg of clotrimazole. Each single-dose container delivers approximately 0.17 ml of solution, corresponding to 1.7 mg of clotrimazole.
• The other ingredient is macrogol 400.

What Dromyc looks like and contents of the pack
Dromyc is a clear, colourless solution supplied in single-dose containers, each containing 0.2 ml of solution.
The single-dose containers are packed in protective aluminium foil sachets. Each pack contains 3 sachets with 10 single-dose containers, making a total of 30 single-dose containers in a cardboard box.

Marketing Authorisation Holder
Laboratorios Salvat, S.A.
Poligono Industrial Esplugues De Llobregat
Calle Gall 30-36
08950 Esplugues de Llobregat (Barcelona)
Spain
tel.: +34 93 394 64 00

Manufacturer
Laboratorios Salvat, S.A.
Poligono Industrial Esplugues De Llobregat
Calle Gall 30-36
08950 Esplugues de Llobregat (Barcelona)
Spain
Pharmaloop S.L.
Poligono Industrial Azque
Calle De Bolivia 15
28806 Alcalá de Henares (Madrid)
Spain

This medicinal product is authorised in the European Economic Area countries 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 10 mg/ml øredråper, oppløsning i endosebeholder
Poland Dromyc
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

Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: https://www.urpl.gov.pl/pl