COMBITIMOR <3 mg/ml + 1 mg/ml Krople do oczu, roztwór

Treść ulotki

1. COMBITIMOR 3mg/ml + 1mg/ml eye drops, solution
   1. What is Combitimor and what is it used for
   2. What you need to know before using Combitimor
   3. How to use Combitimor
   4. Possible side effects
   5. How to store Combitimor
   6. Contents of the pack and other information
2. Combitimor 3 mg/ml + 1 mg/ml ear drops, solution
   1. What is Combitimor and what is it used for
   2. What you need to know before using Combitimor
   3. How to use Combitimor
   4. Possible side effects
   5. Contents of the pack and other information

COMBITIMOR 3mg/ml + 1mg/ml eye drops, solution

Tobramycin and Dexamethasone
Generic medicine

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

1. What is Combitimor and what is it used for

Combitimor contains a combination of two substances: dexamethasone and tobramycin. Dexamethasone belongs to the class of corticosteroids and has an anti-inflammatory action, while tobramycin is an antibiotic that acts against various bacteria that can cause eye infections.
Combitimor is indicated in adults and children from two years of age for the treatment of eye inflammations when a corticosteroid is necessary and when an ocular infection exists or the risk of ocular infection.

2. What you need to know before using Combitimor

Do not use Combitimor:

• if you are allergic to tobramycin, dexamethasone or any of the other ingredients of this medicine (listed in section 6);
• if you have inflammation of the cornea (the transparent membrane covering the front of the eye) caused by the Herpes Simplex virus (Herpes simplex keratitis);
• in case of smallpox vaccination, chickenpox or other viral infections of the cornea and conjunctiva (the transparent membrane covering the front of the eye and the inside of the eyelids)
• if you have eye infections caused by fungi (mycosis), or untreated parasitic eye infections;
• if you have eye infections from mycobacteria (tuberculosis of the eye);
• if you have high pressure inside the eye (intraocular hypertension);
• if you have an eye inflammation with pus production in the acute phase (acute purulent ophthalmia, purulent conjunctivitis, purulent blepharitis and herpetic) which may be masked or aggravated by the use of this medicine
• if you have inflammation of the sebaceous glands at the base of the eyelashes (stye).

Warnings and precautions
Talk to your doctor or pharmacist before using Combitimor.

• In some patients, sensitization (allergic reaction) to aminoglycoside antibiotics such as tobramycin, administered to the eyes, may occur, which manifests with local reactions (itching, redness) up to generalized allergic reactions (anaphylactic reactions). If these symptoms occur during the use of Combitimor, stop treatment and consult your doctor. Also, be aware that this allergic sensitivity may also occur with other antibiotics belonging to the same class of aminoglycosides, administered both to the eyes and systemically (by injection);
• Talk to your doctor if you have or have ever had conditions such as myasthenia gravis or Parkinson's disease. These types of antibiotics may worsen muscle weakness.
• In patients who have taken aminoglycoside antibiotics, such as tobramycin, systemically (by injection), serious toxic effects have occurred at the level of the nervous system, ears and kidneys. Be careful and consult your doctor if you are using Combitimor together with aminoglycoside antibiotics taken systemically (by injection);
• Long-term application to the eyes of corticosteroids may cause increased pressure in the eyes (including a condition called glaucoma, with damage to the optic nerve), vision problems and cataract formation (clouding of the lens inside the eye, called the crystalline lens). If you use Combitimor for a long time, you should check your eye pressure regularly and frequently. This is particularly important in children, as the risk of increased eye pressure caused by corticosteroids may be greater in children under six years of age and may occur sooner than it occurs in adults. Ask your doctor for advice, especially if you need to use Combitimor in children. The risk of increased eye pressure induced by corticosteroids and/or cataract formation is increased in predisposed patients (e.g. in diabetic patients);
• Talk to your doctor if you feel 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 Combitimor. Consult your doctor before stopping treatment on your own. These risks are particularly important in children and patients treated with a medicine called ritonavir or cobicistat;
• With the use of Combitimor, you may become more susceptible to eye infections caused by bacteria, viruses or fungi or parasites: if your symptoms worsen or suddenly recur, consult your doctor;
• If you suffer from a corneal ulcer that does not heal, stop therapy and consult your doctor;
• Talk to your doctor before using this medicine if you suffer from diseases that cause thinning of the tissues of the eye, as perforation may occur with the administration of corticosteroids to the eyes;
• Corticosteroids applied to the eyes may slow down the healing of corneal wounds. NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) applied to the eyes are also known to slow down or delay healing. Concurrent application of NSAIDs and corticosteroids to the eyes may potentially increase the problems of eye wound healing (see section “Other medicines and Combitimor”).;
• Do not wear contact lenses during the treatment of an eye inflammation or infection. Also read the section “Combitimor eye drops, multi-dose solution contains benzalkonium chloride”;
• Use Combitimor under the direct supervision of a doctor;
• Use Combitimor eye drops only for application to the eyes.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Children
Do not use Combitimor in children under 2 years of age as the safety and efficacy of the medicine
has not been demonstrated in this age group (see “Do not use Combitimor”).
During treatment, have the child undergo frequent checks by an ophthalmologist, especially if he/she is less than 6
years old, due to the risk of increased pressure inside the eye induced by steroids (see “Warnings and
precautions”).

Other medicines and Combitimor
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. In particular, tell your doctor if you are taking other medicines for the eyes that
contain drugs belonging to the class of NSAIDs (Non-Steroidal Anti-Inflammatory Drugs).
Concurrent application of NSAIDs and corticosteroids to the eyes may potentially increase the problems
of healing of the cornea. If you are using other eye drops, allow at least 5 minutes between
instillation of each 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 Combitimor is incompatible with tetracycline. Do not use
Combitimor together with other products for the eyes that contain tetracycline.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Data relating to the use of tobramycin or dexamethasone in the eyes in pregnant women are lacking or
limited. Studies in animals have shown reproductive toxicity following
systemic administration (by mouth or by injection) of dexamethasone and tobramycin.
Combitimor is not recommended during pregnancy. Consult your doctor, who will decide whether you should
use Combitimor during pregnancy.
Breastfeeding
It is not known whether tobramycin or dexamethasone are excreted in breast milk after administration
to the eyes. Tobramycin is excreted in breast milk after systemic administration (by mouth or by
injection). The risk to infants cannot be excluded. Combitimor eye drops should not be used during
breastfeeding. Consult your doctor, who will assess the appropriateness of using Combitimor during
breastfeeding.
Fertility
Studies have not been conducted to evaluate the effect of ophthalmic administration of tobramycin
on human or animal fertility. Clinical data to evaluate the effect of ophthalmic administration of
dexamethasone on male or female fertility are limited.

Driving and using machines
For a certain period of time after instillation of Combitimor, you may experience
blurred vision or other visual disturbances that may impair your ability to drive vehicles and
use machines. If you experience these effects, wait until your vision returns to clear before driving
vehicles and using machines.

Combitimor eye drops, multi-dose solution contains benzalkonium chloride
This medicine contains 0.5 mg of benzalkonium chloride per bottle equivalent to 0.1 mg/ml.
Benzalkonium chloride can be absorbed by soft contact lenses and can lead to a change
in their color. Remove contact lenses before using this medicine and wait 15 minutes
before re-applying them.
Benzalkonium chloride can also cause irritation to the eyes, especially if you have dry eyes or corneal disorders (the most superficial transparent layer of the eye). If you experience an abnormal sensation in the eye, burning or pain after using this medicine, talk to your doctor.

3. How to use Combitimor

Apply Combitimor eye drops only to the eyes.
Use this medicine following exactly the instructions of your doctor. If you have any doubts
consult your doctor or pharmacist.

The recommended dose is: 1 or 2 drops 4-5 times a day, following the indications given to you
by your doctor. Use the product for the period of time prescribed by your doctor.
The following operation is useful to limit the amount of medicine that passes into the blood after
application to the eyes: keep the eyelid closed and at the same time apply gentle pressure with
a finger on the inner corner of the eye near the nose.

Use in children
Do not use Combitimor eye drops in children under two years of age as safety and efficacy have not been established in this population
and no data are available.
Combitimor can be used in children from 2 years of age and older at the same doses as
for adults.

How to apply Combitimor eye drops

• Wash your hands
• If you wear contact lenses, remove the lenses before instilling the eye drops and wait at least 15 minutes before re-applying them.
• Hold the bottle/container upside down between your thumb and middle finger.
• Tilt your head back. Lower the eyelid with a clean finger to form a pouch between the eyelid and the eye. The drop should be instilled in this area.
• Bring the tip of the bottle/container close to the eye.
• Do not touch the eye, eyelid, surrounding areas or other surfaces with the tip of the bottle/container to avoid contaminating the remaining drops in the bottle.
• Gently press the base of the bottle/container releasing one drop of Combitimor at a time.
• If a drop does not enter the eye, try again
• After using COMBITIMOR, keep your eyes closed, apply gentle pressure with a finger to the corner of the eye, near the nose. This helps reduce the absorption of COMBITIMOR into the rest of the body.
• If you instill drops into both eyes, repeat the same operation for the other eye. Eye drops, multi-dose solution in bottle:
• Immediately replace the cap after use, screwing it on tightly.
• The eye drops must be used within 28 days of first opening the bottle. Eye drops, single-dose solution in containers:
• Throw away the container and any remaining contents.
• The product must be used within 28 days of opening the aluminum pouch.

If you use more Combitimor than you should
In case of ingestion/accidental intake of an excessive dose of Combitimor, immediately inform your
doctor or go to the nearest hospital.
Considering that the medicine is administered to the eyes, it is unlikely that cases of
overdose will occur. However, if this should happen, wash the eye thoroughly with
running water.
Do not use the medicine again until the time scheduled for the next administration.

If you forget to use Combitimor
If you forget to use Combitimor, do not worry and apply it as soon as you remember. However, if it is almost time
to administer the next dose, skip the missed dose and return to the regular dosing schedule.
Do not use a double dose to make up for the 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, this medicine can cause side effects, although not everybody gets them.
With the use of tobramicina and desametasone collirio soluzione, the following side effects have been reported.
Uncommon side effects ( may affect up to 1 in 100 people)

• increased pressure in the eye(s);
• eye pain;
• eye itching;
• eye discomfort;
• eye irritation.

Rare side effects ( may affect up to 1 in 1,000 people)

• inflammation of the eye surface;
• eye allergy;
• dry eye;
• redness of the eye;
• unpleasant taste.

Side effects of unknown frequency ( frequency cannot be estimated from available data

)

• swelling of the eyelids;
• redness of the eyelids;
• increased pupil size;
• increased tear production;
• blurred vision;
• allergy (hypersensitivity);
• dizziness;
• headache;
• nausea;
• abdominal discomfort;
• skin rash;
• facial swelling;
• itching;
• erythema multiforme;
• 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 periods, 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”).

Reporting of side effects
If you get any side effects, talk to 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 Combitimor

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 the month.
The expiry date refers to the product in intact packaging, correctly stored.
This medicine does not require any special storage precautions.
Validity after opening

Single-dose containers
Use this medicine immediately after opening the single-dose container. Discard any remaining contents.
The product must be used within 28 days of opening the aluminium sachet.

Multi-dose 5 ml bottle
The product must be used within 28 days of first opening the bottle.
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 Combitimor contains

Single-dose containers

• The active ingredients are tobramycin and dexamethasone. One single-dose container contains 0.75 mg of tobramycin and 0.329 mg of dexamethasone sodium phosphate (equivalent to 0.25 mg of dexamethasone).
• The other components are: tyloxapol, disodium edetate, anhydrous sodium sulfate, sodium chloride, sulfuric acid (pH adjuster), water for injections.

Multi-dose bottle of 5 ml

• The active ingredients are tobramycin and dexamethasone. One 5 ml bottle contains 15 mg of tobramycin and 6.58 mg of dexamethasone sodium phosphate (equivalent to 5 mg of dexamethasone).
• The other components are: tyloxapol, benzalkonium chloride, disodium edetate, anhydrous sodium sulfate, sodium chloride, sulfuric acid (pH adjuster), water for injections.

Description of the appearance of Combitimor and contents of the pack
Combitimor is presented as eye drops, solution.
20 single-dose containers of 0.25 ml.
1 dropper bottle of 5 ml.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fidia Farmaceutici S.p.A., Via Ponte della Fabbrica 3/A, 35031 Abano Terme (PD)

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

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

1. What is Combitimor and what is it used for

Combitimor contains a combination of two substances: dexamethasone and tobramycin. Dexamethasone
belongs to the class of corticosteroids and has an anti-inflammatory action, while tobramycin which
belongs to the class of aminoglycoside antibiotics acts against various bacteria that can cause
ear infections.
Combitimor 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 an infection caused by bacteria sensitive to tobramycin or when there is a
risk of infection.

2. What you need to know before using Combitimor

Do not use Combitimor

• 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 diseases caused by bacterial (cutaneous tuberculosis) or viral (Herpes simplex) infections or other viral diseases located on the skin or fungal ear infection (ear mycosis);
• If you suffer from or suspect the presence of a perforated eardrum;
• if you are breastfeeding (see “Pregnancy and breastfeeding”);
• in children under 2 years of age (see “Children”).

Warnings and precautions

• Talk to your doctor before using Combitimor;
• Use Combitimor only in the ear, do not inject it;
• Before applying Combitimor drops, clean the ear canal;
• During the use of Combitimor, follow the normal precautions related to the administration of corticosteroids that your doctor has told you about;
• Talk to your doctor if you have or have ever had conditions such as myasthenia gravis or Parkinson's disease. These types of antibiotics can worsen muscle weakness.
• In patients who have taken aminoglycoside antibiotics, such as tobramycin, systemically (by injection), serious toxic effects on the nervous system, ears and kidneys have occurred. Be careful and talk to your doctor if you are using Combitimor together with aminoglycoside antibiotics taken systemically (by injection).
• With the local administration of corticosteroids, side effects usually described following the 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 “Children”);
• Tobramycin contained in Combitimor may cause toxic effects on the ear: if symptoms such as dizziness, vertigo, tinnitus (ringing in the ear) and hearing loss appear after instillation of Combitimor, stop treatment and consult your doctor immediately;
• To reduce the risk of toxic effects, do not apply Combitimor to wounds and burns and do not use the medicine for more than 7 days;
• Prolonged use of antibiotics such as tobramycin can 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 Combitimor, 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 can also occur with the use of other antibiotics belonging to the same class of aminoglycosides, administered either 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.
• Talk to your doctor if you feel 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 Combitimor. 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 or cobicistat.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Children
Do not use Combitimor in children under 2 years of age (see “Do not use Combitimor”).
Children may be more sensitive than adults to the side effects of corticosteroids, even after local administration.
Alteration of the functionality of the system of glands called the hypothalamus-pituitary-adrenal axis (suppression of the hypothalamus-pituitary-adrenal axis), a pathology related to prolonged exposure to cortisol (Cushing's syndrome), growth retardation in height and body weight, and high pressure inside the skull with headache and bulging fontanelles (areas of the skull where the bones have not yet fused) may occur.
Follow your doctor's instructions exactly if you need to administer Combitimor to a child.

Other medicines and Combitimor
Tell your doctor or pharmacist if you are taking, 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 Combitimor ear drops is incompatible with tetracyclines. Do not use Combitimor together with other ear medicines containing tetracyclines.

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

Fertility, pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, 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 Combitimor.
Pregnancy
Data relating to the use in the ears of tobramycin or dexamethasone in pregnant women are non-existent or limited. Therefore, during pregnancy, the use of Combitimor 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 Combitimor is contraindicated during breastfeeding.

Combitimor ear drops, solution in a multi-dose container contains benzalkonium chloride
The multi-dose container of this medicine contains 0.5 mg of benzalkonium chloride per container equivalent to 0.1 mg/ml.
Benzalkonium chloride can irritate the skin.

3. How to use Combitimor

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

Recommended dose
Adults and children over 2 years of age
The recommended dose is four drops three times a day or as prescribed by your doctor. Instill Combitimor
ear drops into the external auditory canal. Do not use the medicine for more than 7 days (see paragraph
2 “Warnings and precautions”).

How to apply Combitimor

• Wash your hands.
• Hold the bottle/container, with the opening facing downwards, holding it with your thumb and middle finger.
• Lie down with the affected ear facing upwards.
• Bring the tip of the bottle/container close to the ear canal.
• Avoid contact of the tip of the bottle/container with the earlobe or the ear canal, the surrounding areas or other surfaces: they could contaminate the drops.
• Exert gentle pressure on the base of the bottle/container so as to cause one drop of Combitimor to come out at a time.
• If a drop does not enter the ear, try again
• If using the drops in both ears, repeat the procedure for the other ear as well.
• Ear drops, solution in a multi-dose bottle:
• Immediately replace the cap after use, screwing it on tightly.
• The product must be used within 28 days of the first opening of the bottle.
• Ear drops, solution in single-dose containers:
• Throw away the container and any remaining contents.
• The product must be used within 28 days of the first opening of the aluminum sachet.

If you use more Combitimor than you should
If you use more Combitimor 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 Combitimor
If you forget to use Combitimor, do not worry and apply it as soon as you remember. However, if it is almost time to
administer the next dose, skip the missed 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, this medicine can cause side effects, although not everybody gets them.
manifest.

Side effects

• reactions of ear toxicity (ototoxicity) (frequency not known*);
• allergy (local hypersensitivity). In these cases, stop treatment and consult your doctor;
• Hormonal problems: increased growth of body hair (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”) (frequency not known*, see section 2, “Warnings and precautions”).
• blurred vision. (frequency not known*) *frequency not known (the frequency cannot be estimated based on available data)

Reporting of side effects
If you get any side effects, talk to 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 CombitimorKeep 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 the month. The expiry date refers to the product in intact packaging, correctly stored.

This medicine does not require any special storage precautions.
Validity after opening

Single-dose containers
Use the medicine immediately after opening the single-dose container. Discard any residue.
The product must be used within 28 days of opening the aluminum sachet.

Multi-dose 5 ml bottle
The product must be used within 28 days of first opening the bottle.
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 Combitimor contains

Single-dose containers

• The active ingredients are tobramycin and dexamethasone. One single-dose container contains 0.75 mg of tobramycin and 0.329 mg of dexamethasone sodium phosphate (equivalent to 0.25 mg of dexamethasone).
• The other ingredients are: tyloxapol, disodium edetate, anhydrous sodium sulfate, sodium chloride, sulfuric acid (pH adjuster), water for injections.

Multi-dose bottle of 5 ml

• The active ingredients are tobramycin and dexamethasone. One 5 ml bottle contains 15 mg of tobramycin and 6.58 mg of dexamethasone sodium phosphate (equivalent to 5 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 Combitimor and contents of the pack
Combitimor is presented as ear drops, solution.
20 single-dose containers of 0.25 ml.
1 dropper bottle of 5 ml.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fidia Farmaceutici S.p.A., Via Ponte della Fabbrica 3/A, 35031 Abano Terme (PD)

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