Combitimor - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Unwanted Effects Shelf Life and Storage Other Information

Active ingredients: Tobramycin, Dexamethasone

COMBITIMOR 0.3% + 0.1% ear drops, solution

Combitimor package inserts are available for pack sizes:
  • COMBITIMOR 0.3% + 0.1% ear drops, solution
  • COMBITIMOR 0.3% + 0.1% eye drops, solution

Indications Why is Combitimor used? What is it for?

PHARMACOTHERAPEUTIC CATEGORY

Corticosteroids and antimicrobials in combination.

THERAPEUTIC INDICATIONS

COMBITIMOR is indicated for the treatment of inflammation of the external auditory canal when the use of a corticosteroid is considered necessary, in the presence of infection caused by bacteria sensitive to tobramycin or when there is a risk of an infection.

Contraindications When Combitimor should not be used

Hypersensitivity to the active substances or to any of the excipients.

COMBITIMOR should not be used in children under 2 years of age. In patients suffering from cutaneous tuberculosis and Herpes simplex as well as from viral disease with skin localization.

Feeding time.

Precautions for use What you need to know before taking Combitimor

Use precautions related to the use of steroids; avoid prolonged use of the product. In case of irritation or sensitization related to the use of the product, discontinue treatment.

Prolonged use of antibiotics can favor the development of resistant microorganisms; if clinical improvement is not observed in a reasonable period of time, it is advisable to discontinue use of the product and consult a doctor.

If topical administration of tobramycin is accompanied by systemic treatment with aminoglycoside antibiotics, the total serum concentration should be carefully monitored.

The product must not be applied on wounds and burns.

To be used under direct medical supervision

Interactions Which drugs or foods may change the effect of Combitimor

Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.

The tyloxapol component is incompatible with tetracycline.

Warnings It is important to know that:

Any of the undesirable effects described for systemic corticosteroids, including hypoadrenalism, can also occur with topical corticosteroids, especially in pediatric patients.

Pediatric patients may be more sensitive than adults to the effects of exogenous corticosteroids and in particular to depression of the hypothalamic-pituitary-adrenal axis induced by topical cortisone. In children treated with topical corticosteroids, depression of the hypothalamic-pituitary-adrenal axis has been described. , Cushing's syndrome, growth and weight retardation and intracranial hypertension.

In children, manifestations of secondary hypoadrenalism include low cortisol levels and unresponsiveness to ACTH stimulation.

Manifestations of intracranial hypertension include tension of the fontanelles, headache, and bilateral parsilledema.

As with all antibiotics, prolonged use can favor the growth of resistant germs. Closer medical monitoring is required in patients of advanced age, in patients already on concomitant treatment with aminoglycoside antibiotics or with impaired renal function and in patients under concomitant treatment. with cyclic structure diuretics The product should not be injected Keep the medicine out of reach of children.

USE IN PREGNANCY AND NURSING

Ask your doctor or pharmacist for advice before taking any medicine.

The safety of corticosteroids has not been established in pregnant women, therefore, during pregnancy, the use of drugs belonging to this class should be limited to cases where the expected benefit justifies the potential risk to the fetus.

In pregnant patients, these drugs should not be used intensively, in high doses or for long periods of time. As it is not known whether topical administration of corticosteroids can result in sufficient systemic absorption to produce measurable concentrations in breast milk, a decision must be made whether to discontinue breastfeeding or to discontinue therapy, taking into account the importance of the drug to the mother.

Effects on ability to drive and use machines

No studies on the ability to drive and use machines have been performed.

COMBITIMOR "0.3% + 0.1% ear drops, multidose solution":

COMBITIMOR contains benzalkonium chloride, an irritant that can cause local skin reactions.

Dosage and method of use How to use Combitimor: Dosage

Instill in the external ear canal four drops three times a day or according to medical prescription.

Overdose What to do if you have taken too much Combitimor

Symptoms: the excessive and prolonged use of topical corticosteroids can depress the pituitary-adrenal function, causing secondary hypoadrenalism and manifestations of hypercorticism including Cushing's syndrome, in particular asthenia, adynamia, arterial hypertension, heart rhythm disturbances, hypokalaemia, alkalosis metabolic.

In case of accidental intake of an excessive dose of COMBITIMOR, notify your doctor immediately or go to the nearest hospital.

If you have any further questions on the use of COMBITIMOR, ask your doctor or pharmacist.

Side Effects What are the side effects of Combitimor

Like all medicines, COMBITIMOR can cause side effects, although not everybody gets them.

There may be cases of local hypersensitivity. In these cases, stop treatment and consult your doctor.

In case of undesirable effects, especially if different from those described, the patient is invited to communicate them to his doctor.

Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.

Expiry and Retention

Expiry: see the expiry date indicated on the package.

The expiry date refers to the product in intact packaging, correctly stored. The expiry date refers to the last day of the month.

Warning: do not use the medicine after the expiry date shown on the package.

No special storage precautions.

Validity after opening

Single-dose containers

The product must be used immediately after opening the single-dose container. Any residue will be thrown away.

The product must be used within 28 days of opening the foil pouch.

5 ml bottle

The product must be used within 28 days of first opening the bottle.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.

Deadline "> Other information

COMPOSITION

A single-dose container contains:

  • Active ingredients: tobramycin 0.75 mg, dexamethasone sodium phosphate 0.329 mg (equal to dexamethasone 0.25 mg).
  • Excipients: tyloxapol, disodium edetate, anhydrous sodium sulfate, sodium chloride, sulfuric acid (pH regulator), water for injections.

A 5ml bottle contains:

  • Active ingredients: tobramycin 15 mg, dexamethasone sodium phosphate 6.58 mg (equivalent to dexamethasone 5 mg).
  • Excipients: tyloxapol, benzalkonium chloride, disodium edetate, anhydrous sodium sulfate, sodium chloride, sulfuric acid (pH regulator), water for injections.

PHARMACEUTICAL FORM AND CONTENT

Ear drops, solution - 20 single-dose containers of 0.25 ml.

Ear drops, solution - 1 bottle of 5 ml dropper.

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

Further information on Combitimor can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT - 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION - 03.0 PHARMACEUTICAL FORM - 04.0 CLINICAL PARTICULARS - 04.1 Therapeutic indications - 04.2 Posology and method of administration - 04.3 Contraindications - 04.4 Special warnings and appropriate precautions for use - 04.5 Interactions with other medicinal products and other forms of interaction - 04.6 Pregnancy and lactation - 04.7 Effects on the ability to drive and use machines - 04.8 Undesirable effects - 04.9 Overdose - 05.0 PHARMACOLOGICAL PROPERTIES - 05.1 "Pharmacodynamic properties - 05.2 Pharmacokinetic properties" - 05.3 Preclinical safety data - 06.0 PHARMACEUTICAL PARTICULARS - 06.1 Excipients - 06.2 Incompatibility "- 06.3 Shelf life" - 06.4 Special precautions for storage - 06.5 Nature of the primary packaging and contents of the package - 06.6 Instructions for use and handling - 07.0 AUTHORIZATION HOLDER ALL "PLACING ON THE MARKET - 08.0 MARKETING AUTHORIZATION NUMBER - 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION - 10.0 DATE OF REVISION OF THE TEXT - 11.0 FOR RADIO DRUGS, COMPLETE DATA ON INTERNAL RADIATION DOSIMETRY - 12.0 INSTRUCTIONS FOR RADIOPHONES ON EXTEMPORARY PREPARATION AND QUALITY CONTROL -

01.0 NAME OF THE MEDICINAL PRODUCT -

COMBITIMOR 0.3% + 0.1% EARPHONE DROPS, SOLUTION

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -

A single-dose container contains:

Active principles : tobramycin 0.75 mg, dexamethasone sodium phosphate 0.329 mg (equivalent to dexamethasone 0.25 mg).

A 5ml bottle contains:

Active principles : tobramycin 15 mg, dexamethasone sodium phosphate 6.58 mg (equivalent to dexamethasone 5 mg).

1 ml of ear drops contains:

Active principles : tobramycin 3 mg, dexamethasone sodium phosphate 1.316 mg (equivalent to dexamethasone 1 mg).

03.0 PHARMACEUTICAL FORM -

Sterile solution for topical auricular use.

04.0 CLINICAL INFORMATION -

04.1 Therapeutic indications -

COMBITIMOR 0.3% + 0.1% ear drops, solution is indicated in the treatment of inflammations of the external auditory canal and of the middle ear when the use of a corticosteroid is deemed necessary, in the presence of infection caused by bacteria sensitive to tobramycin or when there is a risk of an infection.

04.2 Posology and method of administration -

Instill in the external ear canal four drops three times a day or according to medical prescription.

04.3 Contraindications -

Hypersensitivity to the components or to other closely related substances from a chemical point of view.

COMBITIMOR 0.3% + 0.1% ear drops, solution should not be used in children under 2 years of age.

In patients suffering from cutaneous tuberculosis and Herpes simplex as well as from viral disease with skin localization.

Feeding time.

04.4 Special warnings and appropriate precautions for use -

Any of the undesirable effects described for systemic corticosteroids, including hypoadrenalism, may also occur with topical cortcosterioids, especially in pediatric patients.

Pediatric patients may be more sensitive than adults to the effects of exogenous corticosteroids and in particular to the depression of the hypothalamic-pituitary-adrenal axis induced by topical corticosteroids.

In children treated with topical corticosteroids, depression of the hypothalamic-pituitary-adrenal axis, Custhing syndrome, growth and weight retardation, and intracranial hypertension have been described.

In children, manifestations of secondary hypoadrenalism include tension of the fontanelles, headache, and bilateral parsilledema.

As with all antibiotics, prolonged use can promote the growth of resistant germs.

Closer medical supervision is required in patients of advanced age, in patients already being treated with aminoglycoside antibiotics or with impaired renal function and in patients under concomitant treatment with cyclic structure diuretics.

Use the precautions related to the use of steroids, avoid prolonged use of the product. In case of irritation or sensitization related to the use of the product, stop the treatment.

Prolonged use of antibiotics can favor the development of resistant microorganisms; if clinical improvement is not observed in a reasonable period of time, it is advisable to discontinue use of the product and consult a doctor.

If topical administration of tobramycin is accompanied by systemic treatment with aminoglycoside antibiotics, the total serum concentration should be carefully monitored.

The product should not be applied to wounds and burns.

To be used under direct medical supervision.

The product must not be injected.

Keep this medicine out of the reach of children.

04.5 Interactions with other medicinal products and other forms of interaction -

The tyloxapol component is incompatible with tetracycline.

COMBITIMOR ear drops solution contains benzalkonium chloride, an irritant that can cause local skin reactions.

04.6 Pregnancy and breastfeeding -

The safety of topical corticosteroids has not been established in pregnant women; therefore, during pregnancy, the use of drugs belonging to this class must be limited to cases where the expected benefit justifies the potential risk for the fetus. In pregnant patients these drugs should not be used intensively, at high doses or for long periods of time. As it is not known whether topical administration of corticosteroids can result in sufficient systemic absorption to produce measurable concentrations in breast milk, a decision must be made whether to discontinue breastfeeding or to discontinue therapy, taking into account the importance of medication for the mother.

04.7 Effects on ability to drive and use machines -

No studies on the ability to drive and use machines have been performed.

04.8 Undesirable effects -

Cases of hypersensitivity may occur.

04.9 Overdose -

Symptoms. Excessive or prolonged use of topical corticosteroids can depress adrenal pituitary function, causing secondary hypoadrenalism and manifestations of hypercoticism including Cushing's syndrome, in particular asthenia, adynamia, arterial hypertension, heart rhythm disturbances, hypokalaemia, metabolic alkalosis.

05.0 PHARMACOLOGICAL PROPERTIES -

05.1 "Pharmacodynamic properties -

Pharmacotherapeutic group: dexamethasone and anti-infectives in combination.

ATC code: S02CA06.

COMBITIMOR 0.3% + 0.1% ear drops, solution contains tobramycin and dexamethasone as active ingredients.

Tobramycin is an aminoglycoside antibiotic active on a large number of Gram-positive and Gram-negative pathogens and in particular Pseudomonas, Proteus, Klebsiella, E.coli and Staphylococcus, also used topically, ocular and systemically. Clinical studies carried out with topical auricular tobramycin, both alone and in combination with dexamethasone, have demonstrated its efficacy in the treatment of external otitis and otitis media and an "excellent tolerability with no ototoxic effects. Dexamethasone is a powerful anti-inflammatory. steroid, of well known clinical use, used in otology and ophthalmology both alone and in combination with antibiotics.

05.2 "Pharmacokinetic properties -

Tobramycin: all aminoglycoside antibiotics are potentially ototoxic following parenteral administration or topical application to wounds and burns, as they are absorbed through mucous membranes and serous surfaces. Ototoxicity is due to the fact that they tend to accumulate progressively in the perilymph and endolymph, from which they are slowly eliminated. Accumulation occurs mainly when plasma levels are high and the outflow into the bloodstream is further reduced. As shown by clinical experience, the use of COMBITIMOR 0.3% + 0.1% ear drops, solution does not present the risk of ototoxic effects as it is administered topically in short-term therapy and at a low daily dose.

05.3 Preclinical safety data -

Dexamethasone: the toxicity of dexamethasone is well documented in the literature. However, the toxic effects related to the use of corticosteroids occur following systemic administration at high doses or following prolonged use. Tobramycin 0.3% + Dexamethasone 0.1% ear drops, solution does not cause secondary effects due to the steroid as it is administered topically, at a low dose and for short periods.

06.0 PHARMACEUTICAL INFORMATION -

06.1 Excipients -

Single-dose containers:

Tyloxapol, disodium edetate, anhydrous sodium sulfate, sodium chloride, sulfuric acid (pH regulator), water for injections.

5 ml bottle:

Tyloxapol, benzalkonium chloride, disodium edetate, anhydrous sodium sulfate, sodium chloride, sulfuric acid (pH regulator), water for injections.

06.2 Incompatibility "-

The tyloxapol component is incompatible with tetracycline.

06.3 Period of validity "-

Single-dose containers:

In intact packaging: 2 years.

The product must be used immediately after opening the single-dose container. Any residue will be thrown away.

The product must be used within 28 days of opening the foil pouch.

Multidose bottle:

In intact packaging: 3 years.

The product must be used within 28 days of first opening the bottle.

06.4 Special precautions for storage -

No special storage precautions.

Do not use after the expiry date indicated on the outer carton and single-dose container.

The expiry date refers to the product in intact packaging, correctly stored.

06.5 Nature of the immediate packaging and contents of the package -

5 ml dropper bottle in low density polyethylene.

0.25 ml single-dose container in low density polyethylene.

Not all pack sizes may be marketed

06.6 Instructions for use and handling -

No special instructions

07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -

Sooft Italia S.p.A. - Contrada Molino, 17 - 63833 Montegiorgio (FM)

08.0 MARKETING AUTHORIZATION NUMBER -

AIC n. 040347039: "0.3% + 0.1% Ear drops, solution" 20 single-dose containers of 0.250 ml

AIC n. 040347041: "0.3% + 0.1% Ear drops, solution" Bottle of 5 ml

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -

10.0 DATE OF REVISION OF THE TEXT -

AIFA determination of 24/01/2013

11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY -

12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL -

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