Mixotone

Package leaflet: Information for the patient

Mixotone 10 ml ear drops, powder and solvent for suspension

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

Contents of this leaflet:

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

1. What Mixotone is and what it is used for

Mixotone contains the following active substances:

• neomycin sulfate and polymyxin B sulfate, two antibiotics that kill bacteria causing ear infections;
• sodium hydrocortisone hemisuccinate, an anti-inflammatory substance belonging to the corticosteroid class, which helps reduce inflammation and irritation caused by the infection;
• lidocaine hydrochloride, an anesthetic substance that reduces local pain.

Mixotone is a medicine used to treat bacterial infections of the outer ear surface (ear canal) that are sensitive to neomycin and polymyxin, when there is a clear inflammatory reaction present.

2. What you should know before using Mixotone

DO NOT use Mixotone

• if you are allergic to neomycin sulfate, polymyxin B sulfate, sodium hydrocortisone succinate, lidocaine hydrochloride, or any of the other ingredients of this medicine (listed in section 6);
• if you have tuberculosis;
• if you have chickenpox or a viral infection caused by Herpes simplex;
• if you have other skin diseases caused by fungi or viruses that require treatment.

Warnings and precautions
Talk to your doctor or pharmacist before using Mixotone.
The sodium hydrocortisone succinate contained in Mixotone may reduce the skin's resistance to bacteria, viruses, and fungi and may mask an allergic reaction to neomycin.
If concomitant antibiotic treatment is inadequate, there may be only an apparent improvement in the condition due to the anti-inflammatory effect of hydrocortisone. If the treatment proves ineffective, your doctor will instruct you to stop treatment and will prescribe other medicines to treat the infection.
Do not use Mixotone for more than 7 days.
Take particular care:

• if you use the medicine locally for a prolonged period, as allergies may develop or bacterial or fungal infections may occur that are not controlled by neomycin and polymyxin;
• do not use the product in the eyes;
• using Mixotone for more than 7 days may cause undesirable effects due to absorption of the medicine into the body, such as:
  o Cushing's syndrome (excess of a hormone called cortisol in the blood),
  o disruption of the regulation of the production of certain hormones (inhibition of the hypothalamic-pituitary-adrenal axis),
  o ear and kidney toxicity (due to neomycin). (See section “If you use more Mixotone than you should”). This is especially likely in patients with kidney problems (renal insufficiency) or in patients who are simultaneously taking other medicines that may cause ear or kidney problems;
• if blurred vision or other visual disturbances occur, contact your doctor.

Children
Mixotone may be used in the earliest infancy only if strictly necessary and under direct medical supervision.
Other medicines and Mixotone
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
The use of Mixotone with other aminoglycoside antibiotics may cause hypersensitivity reactions to this group of antibiotics.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Mixotone may be used during pregnancy only if strictly necessary and under direct medical supervision.
Driving and using machines
Currently, no effects of Mixotone on the ability to drive vehicles or operate machinery are known.
Mixotone contains propylene glycol
The solvent vial of Mixotone contains 516.21 mg of propylene glycol per maximum daily dose, equivalent to 500 mg/ml. Propylene glycol may cause skin irritation.

3. How to use Mixotone

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Instill 3-4 drops into the ear canal 3-4 times a day, after cleaning the ear with a dry cotton swab.
Do not exceed one week of treatment (see section on warnings and precautions).

How to prepare the solution before use

• Add the solvent to the powder.
• Insert the dropper.
• Shake until the components are completely dissolved.

The resulting solution should be stored in the refrigerator or in a cool place, protected from light, for a maximum of 30 days.

Instructions for opening
Apply pressure on the cap while simultaneously unscrewing it counterclockwise.

If you use more Mixotone than you should
If Mixotone is accidentally ingested or if an excessive dose is used, inform your doctor immediately or go to the nearest hospital.
If you use more Mixotone than recommended, adverse effects due to systemic absorption of the drug may occur, such as:

• Cushing's syndrome (excess cortisol hormone in the blood),
• disruption of the regulation of production of certain hormones (inhibition of the hypothalamic-pituitary-adrenal axis),
• ototoxicity and nephrotoxicity (due to neomycin).

If you forget to use Mixotone
Do not use a double dose to make up for the forgotten dose.

If you stop treatment with Mixotone
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.

Signs of allergy that may occur locally:

• increased blood flow to an area of the body,
• swelling due to fluid accumulation (oedema),
• itching and skin flaking (desquamation).

After prolonged treatment beyond the recommended limit, the following may occur:

• thinning of the skin,
• increased hair growth and number of hairs,
• acne-like eruptions,
• capillary fragility,
• purplish or red-brown patches on the skin.

Reactions caused by an excess of corticosteroids include:

• fatigue,
• marked weakness (lack of strength),
• high blood pressure,
• heart rhythm disturbances,
• low potassium levels in the blood,
• excessive concentration of bicarbonates in the blood.

Blurred vision may occur, with a frequency not known.

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 Mixotone

Keep this medicine out of the sight and reach of children.
The reconstituted solution (prepared as described in section 3 “How to use Mixotone”) must be stored in the refrigerator or in a cool place, protected from light, for up to 30 days.
Do not use this medicine after the expiry date stated on the carton after "Exp". The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Mixotone contains
Vial of powder

• The active substances are neomycin sulfate, polymyxin B sulfate, sodium hydrocortisone hemisuccinate. Each vial contains 50 mg of neomycin sulfate; 11.9 mg (100.00 IU) of polymyxin B sulfate; 125.70 mg of anhydrous hydrocortisone hemisuccinate (equivalent to 94 mg of hydrocortisone).
• The other components are anhydrous sodium carbonate, sodium metabisulfite, sodium hydroxide and sodium phosphate.

Vial of solvent, 10 ml

• The active substance is lidocaine hydrochloride. Each vial contains 185 mg of lidocaine hydrochloride.
• The other components are sodium citrate, propylene glycol, sodium chloride, distilled water.

Description of the appearance of Mixotone and contents of the pack
Each pack contains 1 vial of powder and 1 vial of solvent (10 ml).
Marketing Authorization Holder
TEOFARMA S.r.l.
Via F.lli Cervi, 8
27010 Valle Salimbene (PV)
Manufacturer
TEOFARMA S.r.l.
Viale Certosa, 8/A
27100 Pavia