Coldetom

Package leaflet: Information for the user

COLDETOM 0.3% + 0.1% ear drops, solution

Tobramycin and Dexamethasone
Generic medicine
Please read all of this leaflet carefully before you start 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, 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 using 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 medicines: dexamethasone, 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 (external otitis) when an anti-inflammatory agent (corticosteroid) is required, in cases 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 tuberculosis of the skin, Herpes simplex, or another viral skin disease, or fungal ear infection (otomycosis);
• if you have or suspect a perforation of the eardrum;
• if you are breastfeeding;
• in children under 2 years of age.

Warnings and precautions

• Consult your doctor before using COLDETOM.

• Use COLDETOM only in the ear; do not inject it.

• Before applying COLDETOM drops, clean the ear canal.

• During treatment with COLDETOM, follow the usual precautions related to corticosteroid use as advised by your doctor.

• Consult your doctor if you have or have ever had conditions such as myasthenia gravis or Parkinson’s disease. This type of antibiotic may worsen muscle weakness.

• In patients who have received systemic (injected) aminoglycoside antibiotics such as tobramycin, serious toxic effects on the nervous system, ears, and kidneys have occurred. Be cautious and consult your doctor if you are using Coldetom together with systemically administered (injected) aminoglycoside antibiotics.

• Undesirable effects typically associated with systemic (oral or injected) corticosteroid administration, such as suppression of the adrenal glands, may also occur with local corticosteroid use, especially in children (see section “Children”).

• The tobramycin contained in COLDETOM may cause ear-related toxic effects: if, after instillation of COLDETOM, symptoms such as dizziness, vertigo, tinnitus (ringing in the ear), or hearing loss occur, stop treatment immediately and consult your doctor.

• To reduce the risk of toxic effects, do not apply COLDETOM to wounds or burns, and do not use the medicine for more than 7 days.

• Prolonged use of antibiotics such as tobramycin may promote the growth of microorganisms against which the medicine is no longer effective, including fungi. If you do not notice improvement in your condition within a short time, stop using the medicine and consult your doctor.

• If you are simultaneously receiving tobramycin or other aminoglycoside antibiotics systemically (by injection) while using COLDETOM, your doctor may perform blood tests to monitor the total amount of antibiotic in your blood.

• If irritation or sensitization (allergic reaction) occurs, discontinue treatment and consult your doctor. Sensitization may also occur with the use of other antibiotics belonging to the aminoglycoside class, whether administered locally or systemically (by injection).

• Closer medical monitoring is required in elderly patients, patients already receiving aminoglycoside antibiotics, patients with kidney disease, and those receiving concomitant treatment with loop diuretics.

• Contact your doctor if you experience blurred vision or other visual disturbances.

• Consult your doctor if you notice swelling and weight gain around the trunk and face, as these are often the first signs of a condition 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 in patients treated with a medicine called ritonavir.

Children
COLDETOM can be used in children from the age of 2 years. Children may be more sensitive than adults to the adverse effects of corticosteroids, even after local administration. Effects such as suppression of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome, weight gain delay, growth retardation, and increased intracranial pressure with headache and bulging fontanelles may occur. Follow your doctor’s instructions exactly when administering COLDETOM to a child.
Other medicines and COLDETOM
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Consult your doctor if you are taking ritonavir or cobicistat, as they may increase the level of dexamethasone in the blood.
Incompatibilities
The component tyloxapol, contained in COLDETOM ear drops, is incompatible with tetracyclines. Do not use COLDETOM together with other ear medicines containing tetracyclines.
Driving and using machines
No effects of COLDETOM on the ability to drive or operate machinery are known.
Fertility, pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Fertility
No studies have been conducted to evaluate the effect of COLDETOM administration on human fertility.
Pregnancy
Data on the use of corticosteroids in the ears during pregnancy are lacking or limited in number. Therefore, during pregnancy, the use of COLDETOM should be decided by your doctor, who will weigh the benefits for the mother against the risks for 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 following oral or injectable administration. Risk to infants cannot be ruled out. The use of COLDETOM is contraindicated during breastfeeding.

3. How to use COLDETOM

Apply COLDETOM ear drops only into the ears.
Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or
pharmacist.
Recommended dose
Adults and children over 2 years of age
Instil 4 drops into the external auditory canal 3 times a day, or as prescribed by the doctor.
Do not use the medicine for longer than 7 days (see section “Warnings and precautions”).
If you use more COLDETOM than you should
If you use more COLDETOM than you should, consult your doctor or pharmacist. Excessive or prolonged use of topical corticosteroids may lead to Cushing's syndrome, particularly asthenia (weakness), adynamia (marked weakness), increased blood pressure, cardiac rhythm disturbances, decreased blood potassium levels, and metabolic alkalosis (increased blood pH).
If you forget to use COLDETOM
If you forget to use COLDETOM, do not worry; apply it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and return to your regular dosing schedule. Do not use a double dose to make up for the forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Uncommon side effects (may affect up to 1 in 100 people)
Eye disorders: blurred vision.

Side effects with unknown frequency (frequency cannot be estimated from the available data)
Hormonal problems: increased body hair growth (especially in women), muscle weakness and atrophy, purple stretch marks on the skin, 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 with weight gain in the body and face (called "Cushing's syndrome") (see section 2, "Warnings and precautions").

Following local use of aminoglycoside antibiotics, cases of ear toxicity (ototoxicity) have been reported; the frequency of this effect is unknown.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the packaging after "Exp".
The expiry date refers to the last day of that month.
No special storage precautions are required.
The medicine does not contain preservatives; after administration, the vial must be discarded even if it has been only partially used.
The expiry date refers to the product in its original, undamaged packaging, properly stored.
The medicine must be used within 28 days from the first opening of the pouch containing the vials.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What COLDETOM contains

• The active substances 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 components are: tyloxapol, edetate disodium, anhydrous sodium sulfate, sodium chloride, sulfuric acid (pH regulator), water for injections.

Description of the appearance of COLDETOM and package contents
Coldetom is an ear solution available in a pack containing 20 single-dose containers of 0.25 ml each.
Marketing Authorization Holder
Scharper S.p.A. – Viale Ortles, 12 – 20139 Milan (MI)
Manufacturer
Genetic S.p.A. – Contrada Canfora – 84084 Fisciano (SA)

Package leaflet: information for the user

COLDETOM 0.3% + 0.1% ear drops, solution

Tobramycin and Dexamethasone
Generic medicine
Please 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult 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 using 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 contains a combination of two medicines: dexamethasone, which belongs to the class of corticosteroids and has an anti-inflammatory effect, and tobramycin, which belongs to the aminoglycoside antibiotics class 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 (external otitis) when an anti-inflammatory agent (corticosteroid) is required, in cases of infections caused by bacteria sensitive to tobramycin or when there is a risk of infection.

2. What you should know before using COLDETOM

Do not use COLDETOM

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

Warnings and precautions

• Consult your doctor before using COLDETOM.
• Use COLDETOM only in the ear; do not inject it.
• Before applying COLDETOM drops, clean the ear canal.
• During treatment with COLDETOM, follow the usual precautions related to corticosteroid use as advised by your doctor.
• Consult your doctor if you have or have ever had conditions such as severe myasthenia or Parkinson’s disease. This type of antibiotic may worsen muscle weakness.
• In patients who have received systemic aminoglycoside antibiotics (by injection), such as tobramycin, serious toxic effects on the nervous system, ears, and kidneys have occurred.

Be cautious and consult your doctor if you are using Coldetom together with aminoglycoside antibiotics administered systemically (by injection).

• Undesirable effects usually associated with systemic administration (by mouth or injection) of corticosteroids may occur with local corticosteroid use, including reduced activity of the adrenal glands, especially in children (see section “Children”).
• The tobramycin contained in COLDETOM may cause toxic effects in the ear: if, after instillation of COLDETOM, symptoms such as dizziness, vertigo, tinnitus (ringing in the ear), or hearing loss occur, stop treatment immediately and consult your doctor.
• To reduce the risk of toxic effects, do not apply COLDETOM on wounds or burns, and do not use the medicine for longer than 7 days.
• Prolonged use of antibiotics such as tobramycin may promote the growth of microorganisms resistant to the medicine, including fungi. If you do not notice improvement in your condition within a short time, stop using the medicine and consult your doctor.
• If you are simultaneously receiving systemic (by injection) tobramycin or other aminoglycoside antibiotics while using COLDETOM, your doctor will perform tests to monitor the total antibiotic levels 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 aminoglycoside class, whether administered locally or systemically (by injection).
• Closer medical monitoring is required in elderly patients, patients already receiving aminoglycoside antibiotics, patients with kidney disease, and those receiving concomitant treatment with loop diuretics.
• Contact your doctor if you experience blurred vision or other visual disturbances.
• Consult your doctor if you notice swelling and weight gain around the trunk and face, as these are often the first signs of a condition 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 in patients treated with a medicine called ritonavir.

Children
COLDETOM may be used in children from the age of 2 years. Children may be more sensitive than adults to the adverse effects of corticosteroids, even after local administration. Effects such as suppression of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome, delayed weight gain, growth retardation, increased intracranial pressure with headache and bulging fontanelles may occur. Follow your doctor’s instructions exactly when administering COLDETOM to a child.

Other medicines and COLDETOM
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Consult your doctor if you are taking ritonavir or cobicistat, as they may increase the blood levels of dexamethasone.

Incompatibilities
The component tyloxapol, contained in COLDETOM ear drops, is incompatible with tetracyclines. Do not use COLDETOM together with other ear medicines containing tetracyclines.

Driving and using machines
No effects of COLDETOM on the ability to drive or operate machinery are known.

Fertility, pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.

Fertility
No studies have been conducted to evaluate the effect of COLDETOM on human fertility.

Pregnancy
Data on the use of corticosteroids in the ears during pregnancy are lacking or limited. Therefore, during pregnancy, the use of COLDETOM should be decided by the doctor, who will weigh the benefits for the mother against the risks for 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 injectable administration. Risk to infants cannot be ruled out. 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 into the ears.
Use this medicine exactly as directed by your doctor. 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 ear canal 3 times a day, or as otherwise prescribed by your doctor.
Do not use this medicine for longer 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, using your thumb and middle finger.
• Lie down with the affected ear facing upwards.
• Bring the tip of the bottle close to the ear canal.
• Avoid contact between the dropper tip and the earlobe, ear canal, surrounding areas, or any other surface, as this could contaminate the drops.
• Gently press on the base of the bottle to allow 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 drops in both ears, repeat the procedure for the other ear.
• Immediately after use, securely screw the cap back onto the bottle and keep the bottle tightly closed when not in use.
• If a drop does not enter the ear, try again.

If you use more COLDETOM than you should
If you use more COLDETOM than recommended, consult your doctor or pharmacist. Excessive or prolonged use of topical corticosteroids may lead to Cushing's syndrome, particularly weakness, fatigue, increased blood pressure, heart rhythm disturbances, decreased blood potassium levels, and metabolic alkalosis (increased blood pH).
If you forget to use COLDETOM
If you forget to use COLDETOM, do not worry—apply it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and return to your regular dosing schedule. Do not use a double dose to make up for the missed one.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Uncommon side effects (may affect up to 1 in 100 people)
Eye disorders: blurred vision.

Side effects with unknown frequency (frequency cannot be estimated from the available data)
Hormonal problems: increased body hair growth (especially in women), muscle weakness and atrophy, purple stretch marks on the skin, 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 with weight gain in 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 been reported, although the frequency is unknown.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the pack after "Exp".
The expiry date refers to the last day of that month.
The expiry date applies to the product in its original, undamaged packaging and correctly stored.
The medicine must be used within 28 days of first opening the bottle. Any remaining product should be discarded.
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 COLDETOM contains

• The active substances 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 components are: tyloxapol, benzalkonium chloride, edetate disodium, anhydrous sodium sulfate, sodium chloride, sulfuric acid (pH regulator), water for injections.

Description of the appearance of COLDETOM and contents of the pack
Coldetom is an ear solution available in a 5 ml dropper bottle.
Marketing Authorization Holder
Scharper S.p.A. – Viale Ortles, 12 – 20139 Milan (MI)
Manufacturer
Genetic S.p.A. – Contrada Canfora – 84084 Fisciano (SA)