COLDETOM 0.3% + 0.1% Глазные капли, раствор

Содержание инструкции

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

COLDETOM 0.3% + 0.1% ear drops, solution

Tobramycin and Desamethasone

Generic medicine
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 for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may 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 COLDETOM is and what it is used for
• 2. What you need to know before you use COLDETOM
• 3. How to use COLDETOM
• 4. Possible side effects
• 5. How to store COLDETOM
• 6. Contents of the pack and other information

1. What is COLDETOM and what is it used for

COLDETOM ear drops contain a combination of two drugs: desamethasone, which belongs to the
class of corticosteroids and has an anti-inflammatory effect, and tobramycin which belongs to the class of
aminoglycoside antibiotics and acts against various bacteria that can cause ear infections.
COLDETOM is used in adults and children over 2 years of age for the treatment of
inflammation of the external ear canal (otitis externa) when the use of an anti-
inflammatory (corticosteroid) is necessary, in the presence of infections caused by bacteria sensitive to tobramycin or
when there is a risk of infection.

2. What you need to know before using COLDETOM

Do not use COLDETOM

• if you are allergic (hypersensitive) to tobramycin, dexamethasone, or any of the other ingredients of this medicine (listed in section 6);
• if you have skin tuberculosis, Herpes simplexor another viral skin disease, fungal ear infection (ear mycosis);
• if you have or suspect a perforation of the eardrum;
• if you are breastfeeding;
• in children under 2 years of age.

Warnings and precautions

• Talk to your doctor before using COLDETOM.
• Use COLDETOM only in the ear, do not inject it.
• Before applying COLDETOM drops, clean the ear canal.
• During the use of COLDETOM, follow the normal precautions related to the administration of corticosteroids that your doctor has told you about.
• With local administration of corticosteroids, side effects usually described following systemic administration of corticosteroids (by mouth or by injection) may occur, including a decrease in the activity of the glands called adrenal glands, especially in children (see section “Children”).
• The tobramycin contained in COLDETOM may cause toxic effects at the ear level: if symptoms such as dizziness, vertigo, tinnitus (ringing in the ears) and hearing loss appear after instillation of COLDETOM, stop treatment and consult your doctor immediately.
• To reduce the risk of toxic effects, do not apply COLDETOM to wounds and burns and do not use the medicine for more than 7 days.
• Prolonged use of antibiotics such as tobramycin may promote the development of microorganisms against which the medicine is no longer effective, including fungi. If you do not notice an improvement in your condition within a short period of time, stop using the medicine and consult your doctor.
• If you are simultaneously taking tobramycin or other aminoglycoside antibiotics systemically (by injection) while using COLDETOM, your doctor will have you undergo tests to check the total amount of antibiotic in your blood.
• If irritation or sensitization (allergic reaction) occurs, stop treatment and consult your doctor. Sensitization may also occur with the use of other antibiotics belonging to the same class of aminoglycosides, administered locally or systemically (by injection).
• More careful medical monitoring is required in elderly patients, patients already being treated with aminoglycoside antibiotics, patients with kidney disease and those undergoing concomitant treatment with loop diuretics.
• Contact your doctor if you experience blurred vision or other visual disturbances.
• Consult your doctor if you experience swelling and weight gain around the trunk and face, as these are usually the first manifestations of a syndrome called Cushing's syndrome. Suppression of adrenal gland function may develop after discontinuation of prolonged or intensive treatment with COLDETOM. Consult your doctor before stopping treatment on your own. These risks are particularly important in children and patients treated with a medicine called ritonavir.

Children
COLDETOM can be used in children starting from 2 years of age. Children may be more
sensitive than adults to the side effects of corticosteroids even after local administration.
Suppression of the hypothalamus-pituitary-adrenal axis, Cushing's syndrome, delayed
weight gain and growth retardation, increased pressure inside the skull with headache and
tense fontanelles may occur. Follow your doctor's instructions exactly if you need to administer COLDETOM to
a child.

Other medicines and COLDETOM
Tell your doctor or pharmacist if you are taking or have recently taken or may take any
other medicine.
Consult your doctor if you are using ritonavir or cobicistat, as they may increase the level of dexamethasone
in the blood.
Incompatibilities
The tyloxapol component contained in COLDETOM ear drops is incompatible with tetracyclines.
Do not use COLDETOM together with other ear medicines that contain tetracyclines.

Driving and operating machinery
There are no known effects of COLDETOM on the ability to drive vehicles and operate machinery.

Fertility, pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.
Fertility
No studies have been conducted to evaluate the effect on human fertility of the administration of
COLDETOM.
Pregnancy
Data relating to the use of corticosteroids in the ears in pregnant women are lacking or limited. Therefore, during
pregnancy, the use of COLDETOM should be decided by the doctor, who will assess the
benefits for the mother and the risks to the fetus.
Breastfeeding
It is not known whether tobramycin or dexamethasone administered in the ears are excreted in breast milk. Corticosteroids
and tobramycin are excreted in breast milk after oral or
injection administration. The risk to infants cannot be excluded. The use of COLDETOM is contraindicated
during breastfeeding.

3. How to use COLDETOM

Apply COLDETOM ear drops only to the ears.
Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your doctor
or pharmacist.

Recommended dose
Adults and children over 2 years of age
Instill 4 drops into the external auditory canal 3 times a day or as prescribed by your doctor.
Do not use the medicine for more than 7 days (see section “Warnings and precautions”).

• If you use more COLDETOM than you shouldIf you use more COLDETOM than you should, ask your doctor or pharmacist for advice. Excessive or prolonged use of local corticosteroids can lead to the development of Cushing's syndrome, in particular asthenia (fatigue), adynamia (marked weakness), increased blood pressure, heart rhythm disturbances, decreased potassium in the blood, metabolic alkalosis (increased blood pH).

If you forget to use COLDETOM
If you forget to use COLDETOM, do not worry and apply it as soon as you remember. However, if it is almost time
to administer the next dose, skip the forgotten dose and return to the regular dosing schedule.
Do not use a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist

4. Possible side effects

Like all medicines, COLDETOM can cause side effects, although not everybody gets them.
Cases of local allergy (hypersensitivity) may occur. In these cases, stop treatment and
consult your doctor.

Side effects with uncommon frequency (may affect up to 1 in 100 people)
Eye effects: blurred vision.

Side effects with frequency not known (frequency cannot be estimated based on available data)

Hormonal problems: increased growth of body hair (especially in women), weakness and muscle atrophy,
stretch marks on the skin of the body, increased blood pressure, irregular or
absent menstrual cycle, changes in protein and calcium levels in the body, delayed growth in children and
adolescents and swelling and weight gain of the body and face (called “Cushing’s syndrome”) (see
section 2, “Warnings and precautions”).
Following local use of aminoglycoside antibiotics, ear toxicity reactions
(ototoxicity) have occurred, the frequency of which is unknown.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at
www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you can help provide more
information on the safety of this
medicine.

5. How to store COLDETOM

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 packaging after “Expiry”.
The expiry date refers to the last day of that month.
No special storage precautions.
The medicine does not contain preservatives, after administration the vial should be discarded even if only
partially used.
The medicine must be used within 28 days of first opening the sachet containing the vials.
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 COLDETOM contains

• The active ingredients are tobramycin and dexamethasone. Each single-dose container contains 750 micrograms of tobramycin and 329 micrograms of dexamethasone sodium phosphate (equivalent to 250 micrograms of dexamethasone).
• The other ingredients are: tyloxapol, disodium edetate, anhydrous sodium sulfate, sodium chloride, sulfuric acid (pH adjuster), water for injections.

Description of the appearance of COLDETOM and contents of the pack
Coldetom is an otic solution available in a pack containing 20 single-dose containers of 0.25
ml.

Marketing Authorisation Holder
Scharper S.p.A. – Viale Ortles, 12 – 20139 Milan (MI)

Manufacturer
Genetic S.p.A. – Contrada Canfora – 84084 Fisciano (SA)

COLDETOM 0.3% + 0.1% ear drops, solution

Tobramycin and Desamethasone

Generic medicine
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 for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What COLDETOM is and what it is used for

COLDETOM ear drops contain a combination of two drugs: desamethasone, which belongs to the
class of corticosteroids and has an anti-inflammatory effect, and tobramycin which belongs to the class of
aminoglycoside antibiotics and acts against various bacteria that can cause ear infections.
COLDETOM is used in adults and children over 2 years of age for the treatment of
inflammation of the external auditory canal (otitis externa) when the use of an anti-
inflammatory (corticosteroid) is necessary, in the presence of infections caused by bacteria sensitive to tobramycin or
when there is a risk of infection.

2. What you need to know before using COLDETOM

Do not use COLDETOM

• if you are allergic (hypersensitive) to tobramycin, dexamethasone, or any of the other ingredients of this medicine (listed in section 6);
• if you have skin tuberculosis, Herpes simplexor another viral skin disease, fungal ear infection (ear mycosis);
• if you have or suspect a perforated eardrum;
• if you are breastfeeding;
• in children under 2 years of age.

Warnings and precautions

• Talk to your doctor before using COLDETOM.
• Use COLDETOM only in the ear, do not inject it.
• Before applying COLDETOM drops, clean the ear canal.
• During the use of COLDETOM, follow the normal precautions related to the administration of corticosteroids that your doctor has told you about.
• With local administration of corticosteroids, side effects usually described following systemic administration of corticosteroids (by mouth or by injection) may occur, including a decrease in the activity of the glands called adrenal glands, especially in children (see section “Children”).
• The tobramycin contained in COLDETOM may cause toxic effects at the ear level: if symptoms such as dizziness, vertigo, tinnitus (ringing in the ear) and hearing loss appear after instillation of COLDETOM, stop treatment and consult your doctor immediately.
• To reduce the risk of toxic effects, do not apply COLDETOM to wounds and burns and do not use the medicine for more than 7 days.
• Prolonged use of antibiotics such as tobramycin may promote the development of microorganisms against which the medicine is no longer effective, including fungi. If you do not notice an improvement in your condition within a short period of time, stop using the medicine and consult your doctor.
• If you are simultaneously taking tobramycin or other aminoglycoside antibiotics systemically (by injection) while using COLDETOM, your doctor will have you undergo tests to check the total amount of antibiotic present in the blood.
• If irritation or sensitization (allergic reaction) occurs, stop treatment and consult your doctor. Sensitization may also occur with the use of other antibiotics belonging to the same class of aminoglycosides, administered locally or systemically (by injection).
• More careful medical monitoring is required in elderly patients, in patients already being treated with aminoglycoside antibiotics, in patients with kidney disease and in those undergoing concomitant treatment with loop diuretics.
• Contact your doctor if you experience blurred vision or other visual disturbances.
• Talk to your doctor if you experience swelling and weight gain around the trunk and face, as these are usually the first signs of a syndrome called Cushing's syndrome. Suppression of adrenal gland function may develop after discontinuation of prolonged or intensive treatment with COLDETOM. Talk to your doctor before stopping treatment on your own. These risks are particularly important in children and patients treated with a medicine called ritonavir.

Children
COLDETOM can be used in children starting from 2 years of age. Children may be more
sensitive than adults to the side effects of corticosteroids even after local administration.
Suppression of the hypothalamus-pituitary-adrenal axis, Cushing's syndrome, delayed
weight gain and growth retardation, increased pressure inside the skull with headache and
tense fontanelles may occur. Follow your doctor's instructions exactly if you need to administer COLDETOM to
a child.

Other medicines and COLDETOM
Tell your doctor or pharmacist if you are taking or have recently taken or might take any
other medicines.
Talk to your doctor if you are using ritonavir or cobicistat, as they may increase the level of dexamethasone
in the blood.
Incompatibilities
The tyloxapol component contained in COLDETOM ear drops is incompatible with tetracyclines.
Do not use COLDETOM together with other ear medicines that contain tetracyclines.

Driving and using machines
There are no known effects of COLDETOM on the ability to drive vehicles and operate machinery.

Fertility, pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.
Fertility
No studies have been conducted to evaluate the effect on human fertility of the administration of
COLDETOM.
Pregnancy
Data relating to the use of corticosteroids in the ears in pregnant women are non-existent or limited.
Therefore, during pregnancy, the use of COLDETOM must be decided by the doctor, who will assess the
benefits for the mother and the risks to the fetus.
Breastfeeding
It is not known whether tobramycin or dexamethasone administered in the ears are excreted in breast milk.
Corticosteroids and tobramycin are excreted in breast milk after oral or
injection administration. The risk to infants cannot be excluded. The use of COLDETOM is contraindicated
during breastfeeding.

COLDETOM contains benzalkonium chloride
This medicine contains 0.046 mg of benzalkonium chloride (per daily dose of 12 drops of solution)
equivalent to 0.046 mg/477.6 mg (solution weight) or 0.470 ml (solution volume): which may cause
skin irritation.

3. How to use COLDETOM

Apply COLDETOM ear drops only to the ears.
Use this medicine following exactly the instructions of the doctor. If you have doubts consult your doctor
or pharmacist.

Recommended dose
Adults and children over 2 years of age
Instill 4 drops into the external auditory canal 3 times a day or as prescribed by your doctor,
Do not use the medicine for more than 7 days (see section “Warnings and precautions”).

How to apply COLDETOM

• Wash your hands.
• Take the bottle and unscrew the cap.
• Hold the bottle, with the opening facing downwards, holding it with your thumb and middle finger.
• Lie down with the infected ear facing upwards
• Bring the tip of the bottle close to the ear canal.
• Avoid contact of the dropper with the earlobe or ear canal, surrounding areas or other surfaces: they could infect the drops.
• Exert gentle pressure at the base of the bottle so as to cause one drop of COLDETOM to come out at a time.
• Do not squeeze the bottle; it is designed so that light pressure on the bottom is sufficient.
• If using the drops in both ears, repeat the procedure for the other ear as well.
• Screw the cap back on the bottle tightly immediately after use and keep the bottle well closed when not in use.
• If a drop does not enter the ear, try again.
• If you use more COLDETOM than you shouldIf you use more COLDETOM than you should, ask your doctor or pharmacist for advice. Excessive or prolonged use of local corticosteroids can lead to the onset of Cushing's syndrome, in particular asthenia (fatigue), adynamia (marked weakness), increased blood pressure, heart rhythm disturbances, decreased potassium in the blood, metabolic alkalosis (increased blood pH).

If you forget to use COLDETOM
If you forget to use COLDETOM, do not worry and apply it as soon as you remember. However, if it is almost time
to administer the next dose, skip the forgotten dose and return to the regular schedule of
administration.
Do not use a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist

4. Possible side effects

Like all medicines, COLDETOM can cause side effects, although not everybody gets them.
Cases of local allergy (hypersensitivity) may occur. In these cases, stop treatment and
consult your doctor.

Side effects with uncommon frequency (may affect up to 1 in 100 people)
Eye effects: blurred vision.

Side effects with frequency not known (frequency cannot be estimated from available data)

Hormonal problems: increased hair growth on the body (especially in women), weakness and muscle atrophy,
purple stretch marks on the skin of the body, increased blood pressure, irregular or
absent menstrual cycle, changes in protein and calcium levels in the body, delayed growth in children and
adolescents and swelling and weight gain of the body and face (called “Cushing’s syndrome”) (see
section 2, “Warnings and precautions”).
Following local use of aminoglycoside antibiotics, ear toxicity (ototoxicity) reactions have occurred,
the frequency of which is unknown.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store COLDETOM

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 packaging after “Exp”.
The expiry date refers to the last day of that month.
The medicine must be used within 28 days of first opening the bottle. Excess product
must be discarded.
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 COLDETOM contains

• The active ingredients are tobramycin and dexamethasone. 1 ml of solution contains 3 mg of tobramycin and 1.316 mg of dexamethasone sodium phosphate (equivalent to 1 mg of dexamethasone).
• The other ingredients are: tyloxapol , benzalkonium chloride, disodium edetate, anhydrous sodium sulfate, sodium chloride, sulfuric acid (pH adjuster), water for injections.

Description of the appearance of COLDETOM and contents of the pack
Coldetom is an otic solution available in a 5 ml dropper bottle.

Marketing Authorisation Holder
Scharper S.p.A. – Viale Ortles, 12 – 20139 Milan (MI)

Manufacturer
Genetic S.p.A. – Contrada Canfora – 84084 Fisciano (SA)