Patient Information Leaflet

OTODEC 0.3% + 0.1% ear drops, suspension

Tobramycin and Dexamethasone
Please read all of this leaflet carefully before you start 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 others, even if they have the same symptoms as yours, as it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What OTODEC is and what it is used for
What you need to know before using OTODEC
How to use OTODEC
Possible side effects
How to store OTODEC
Contents of the pack and other information

1. What OTODEC is and what it is used for

OTODEC contains tobramycin, an antibiotic active against certain bacteria, and dexamethasone, a corticosteroid that reduces inflammation.
This medicinal product is used to treat ear inflammations (outer ear and middle ear) in the presence of bacterial infections sensitive to tobramycin.

2. What you need to know before using OTODEC

Do not use OTODEC

if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6).
if you have Herpes Simplex.
if you have cutaneous tuberculosis.
if you have a viral skin disease.
if you have a fungal infection (mycosis) in the ear.
if you are breastfeeding.
in children under 2 years of age.
if you are taking antibiotics containing tetracyclines.
if you have wounds or burns in the external auditory canal or ear.
if you have or suspect a perforated eardrum.

Warnings and precautions
Talk to your doctor or pharmacist before using OTODEC.
Use Otodec only in the ear; do not inject it.
Before applying Otodec drops, clean the ear canal.
During treatment with Otodec, follow the usual precautions related to corticosteroid use as advised by your doctor.
Use of this medicine, especially if prolonged, may lead to sensitization (an excessive reaction of the body to foreign substances it has been exposed to) and may encourage the growth of antibiotic-resistant bacteria or fungi not sensitive to its action. If this occurs, discontinue treatment and consult your doctor to start appropriate therapy.
The tobramycin contained in Otodec may cause toxic effects in the ear: if, after applying Otodec, you experience symptoms such as dizziness, vertigo, ringing in the ear (tinnitus), or hearing loss, stop treatment immediately and contact your doctor.
To reduce the risk of toxic effects, do not apply Otodec on wounds or burns and do not use the medicine for longer than 7 days.
Contact your doctor if you experience blurred vision or other visual disturbances.
Exercise particular caution and inform your doctor

if you have impaired kidney function.
if you are elderly.

Children
OTODEC must not be used in children under 2 years of age.
Children over 2 years of age are more sensitive than adults to the effects of corticosteroids (such as dexamethasone); therefore, it is recommended to strictly follow the instructions in this leaflet.

Other medicines and OTODEC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
OTODEC must not be used at the same time as antibiotics belonging to the tetracycline family.
Be cautious and inform your doctor

if you are currently using or have previously used other antibiotics belonging to the aminoglycoside family;
about the possibility of experiencing irritation or allergic reactions;
if you are receiving other aminoglycosides by injection, your doctor may perform blood tests to monitor the total antibiotic levels;
if you are taking diuretic medicines with a cyclic structure (e.g., hydrochlorothiazide). Some medicines may increase the effects of Otodec, and your doctor may need to monitor you closely if you are taking these medicines (including certain HIV treatments: ritonavir, cobicistat).

Fertility, pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Fertility
No studies have been conducted to evaluate the effect of Otodec on human fertility.

Pregnancy
If you are pregnant, think you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before using this medicine.
Breastfeeding
This medicine must not be used during breastfeeding.

Driving and using machines
None known.

OTODEC contains benzalkonium chloride
Irritant, may cause local skin reactions.

3. How to use OTODEC

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose is 4 drops 3 times daily, or as otherwise prescribed by your doctor, to be instilled into the
external auditory canal.
OTODEC must not be injected.
If you use more OTODEC than you should
If you use more OTODEC than prescribed, inform your doctor or pharmacist immediately.
Excessive and prolonged use of OTODEC may cause:

decreased adrenal gland function (secondary adrenal insufficiency);
Cushing's syndrome (a disorder caused by an excess of circulating corticosteroid hormones);
asthenia;
weakness (adynamia);
increased blood pressure (arterial hypertension);
cardiac rhythm disturbances;
decreased potassium levels in the blood (hypokalaemia);
disturbances in the blood acid-base balance (metabolic alkalosis).

If you forget to use OTODEC
Do not use a double dose to make up for the missed dose.
If you stop treatment with OTODEC
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
After topical administration of aminoglycosides, reactions causing toxicity to hearing function have occurred, with unknown frequency.
If during treatment with OTODEC skin irritation or sensitization phenomena occur (excessive reaction of the body to foreign substances it has come into contact with), stop treatment and consult your doctor or go to the nearest hospital.
Blurred vision: frequency not known

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist.
You can also report side effects directly via the website
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store OTODEC

This product must not be used more than 30 days after first opening the container.
This medicine does not require any special storage conditions.
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.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What OTODEC contains

The active substances are: tobramycin 3 mg, dexamethasone 1 mg.
The excipients are: tyloxapol, benzalkonium chloride, edetic acid (EDTA), anhydrous sodium sulfate, sodium chloride, hydroxyethylcellulose, purified water.

Description of the appearance of OTODEC and contents of the pack
5 ml PVC bottle with a dropper made of polyethylene and a cap made of polypropylene.

Marketing Authorization Holder
Laboratorio Chimico Deca Dr. Capuani S.r.l.
Via Balzaretti 17
20133, Milan, Italy.

Manufacturer
Laboratorio Italiano Biochimico Farmaceutico Lisapharma S.p.A.
Via Licinio 11
22036, Erba (CO), Italy.