OTODEC 0,3% + 0,1% Ear drops, suspension

Зміст інструкції

1. OTODEC 0.3% + 0.1% ear drops, suspension
   1. What is OTODEC and what is it used for
   2. What you need to know before using OTODEC
   3. How to use OTODEC
   4. Possible side effects
   5. How to store OTODEC
   6. Contents of the pack and other information

OTODEC 0.3% + 0.1% ear drops, suspension

Tobramycin and Desamethasone

Read this leaflet carefully before using this medicine as 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 only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is OTODEC and what is it used for

OTODEC contains tobramycin, an antibiotic active against some bacteria, and dexamethasone, a
corticosteroid that reduces inflammation.
This medicine is used in the treatment of 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 ingredients 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 (mycosis) infection in the ear
• if you are breastfeeding.
• in children under 2 years of age.
• if you are using antibiotic drugs containing tetracyclines.
• if you have wounds and burns in the external auditory canal and the ear.
• if you have or suspect a perforated eardrum

Warnings and precautions
Consult 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 the use of Otodec, follow the normal precautions related to the administration of
corticosteroids that your doctor has told you.
The use, especially if prolonged, of this medicine can give rise to sensitization
(excessive reaction of the body to foreign substances with which it has come into contact) and promote the
proliferation of resistant bacteria or fungi that are not sensitive to its action. In this case

stop treatment and consult your doctorto start appropriate therapy.
The tobramycin contained in Otodec may cause toxic effects at the ear level: if
after application of Otodec symptoms such as dizziness, vertigo, ringing in the ears
(tinnitus) and hearing loss appear, stop treatment and consult your doctor immediately.
To reduce the risk of toxic effects, do not apply Otodec to wounds and burns and do not use the
medicine for more than 7 days.
Contact your doctor if you experience blurred vision or other visual disturbances.
Pay particular attention and inform your doctor

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

Children
OTODEC must notbe used in children under 2 years of age.
Even children over 2 years of age are more sensitive to the effects of corticosteroids (such as
dexamethasone) than adults and therefore it is recommended to follow the instructions in this leaflet.

Other medicines and OTODEC
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
OTODEC must notbe used at the same time as antibiotic drugs of the tetracycline family.

Pay attention and inform your doctor:

• if you are using or have used in the past other antibiotics of the aminoglycoside family:
• for the possibility of irritation or allergic reactions
• in case of taking other aminoglycosides by injection, your doctor may subject you to blood tests to check the total amount of antibiotic;
• if you are taking loop diuretic drugs (e.g. hydrochlorothiazide). Some medicines can increase the effects of Otodec and your doctor may want to monitor you closely if you are taking these medicines (including some medicines for the treatment of HIV: ritonavir, cobicistat). Fertility, pregnancy and breastfeedingIf you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. FertilityNo studies have been conducted to evaluate the effect on human fertility after administration of Otodec.

Pregnancy
If you are pregnant, suspect you are pregnant or are planning a pregnancy ask your doctor or
pharmacistfor advice before using this medicine.

Breastfeeding
This medicine must notbe used during breastfeeding.

Driving and operating machinery
Not known

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

3. How to use OTODEC

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose is 4 drops 3 times a day or as prescribed by your doctor, to be instilled into the
external auditory canal.
OTODEC must notbe injected.

If you use more OTODEC than you should
If you use a dose of OTODEC higher than that prescribed immediately inform your doctor or
pharmacist.
Excessive and prolonged use of OTODEC may cause:

• decreased function of the adrenal glands (secondary adrenal insufficiency);
• Cushing's syndrome (a disease due to excess circulating corticosteroid hormones);
• asthenia;
• weakness (asthenia);
• increased blood pressure (arterial hypertension);
• heart rhythm disturbances;
• decreased potassium in the blood (hypokalemia);
• alterations of the acid-base balance of the blood (metabolic alkalosis).

If you forget to use OTODEC
Do notuse a double dose to make up for a missed dose.

If you stop using OTODEC
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Following topical administration of aminoglycosides, reactions of auditory function toxicity have occurred, with an unknown frequency.
If, during treatment with OTODEC, phenomena of irritation or skin sensitization occur (excessive reaction of the body to foreign substances it has come into contact with)

stop treatment and inform 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, please
inform 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

The product must notbe used for more than 30 days after the first opening of the container.
This medicine does not require any particular storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Exp.”. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What OTODEC contains

• The active ingredients are: tobramycin 3 mg, dexamethasone 1 mg.
• The excipients are: tyloxapol, benzalkoniumchloride, ethylenediaminetetraacetic 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 polyethylene droppers and polypropylene cap.

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

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