SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Surolan Ear Drops and Cutaneous Suspension

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains:

Active substances:

Miconazole Nitrate	23 mg
Prednisolone Acetate	5 mg
Polymyxin B Sulfate	0.5293 mg

Excipients:

Qualitative composition of excipients and other constituents

Silica colloidal anhydrous

Liquid paraffin

White suspension

3. CLINICAL INFORMATION

3.1 Target species

Dogs and cats

3.2 Indications for use for each target species

For the topical treatment of otitis externa and skin infections caused by Grampositive bacteria e.g. Staphylococcus aureus and Streptococcus spp. and Gramnegative bacteria Escherichia coli and Pseudomonas aeruginosa.

For the topical treatment of otitis externa and skin infections caused by fungi and yeasts: Trichophyton spp., Microsporum spp., Malassezia pachydermatis, Candida spp.

For the topical treatment of otitis externa caused by the ear mite Otodectes cynotis. The product also has anti-inflammatory and anti-pruritic activity.

3.3 Contraindications

Do not use in animals with perforated ear drums since Polymyxin B is known to be a potential ototoxic agent.

Do not use in cases of hypersensitivity to the active substances or to any of the excipients.

3.4 Special warnings

As the product is a prescription only medicine, treatment should be closely supervised by a veterinary practitioner.

3.5 Special precautions for use

Special precautions for safe use in the target species:

For external use only.

Due to the likely variability (temporal, geographical) in the emergence of bacterial resistance to polymyxin B, bacteriological sampling and sensitivity testing (antibiogram) is recommended.

If there is overgrowth of resistance bacteria and/or fungi, treatment with this product should be discontinued and treatment with an appropriate alternative should be initiated.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

Do not handle the product if you are allergic to the ingredients in the product. Accidental spillage on the skin should be washed off immediately with soap and water. Wash hands after use.

Corticosteroids may produce irreversible effects in the skin. They can be absorbed and may have harmful effects, especially with frequent and extensive contact or in pregnancy. Personal protective equipment consisting of single use disposable gloves should always be worn when applying the product to animals.

Special precautions for the protection of the environment:

Not applicable.

3.6 Adverse events Dogs and cats:

Very rare (<1 animal / 10,000 animals treated, including isolated reports):

Deafness[1] Impaired hearing1

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

3.7 Use during pregnancy, lactation or lay

Corticosteroids are not recommended for use in pregnant animals.

3.8 Interaction with other medicinal products and other forms of interaction

Do not use concomitantly with medicines that induce ototoxicity.

3.9 Administration routes and dosage

This product is for topical administration. Shake the bottle vigorously and ensure the product is fully resuspended before use.

At the beginning of treatment, hair surrounding or covering the lesions must be clipped; this should be repeated during treatment if necessary.

Ears: Clean the auditory canal and place a few drops of the product into the ear twice daily. For infections caused by Otodectes cynotis, instill five drops twice daily for 14 days.

Massage the ear and the auditory canal gently but thoroughly to ensure proper distribution.

Skin: Having ensured the area to be treated is clean, apply a few drops of the product (depending on lesion size) twice a day and rub well.

Treatment should be continued until a few days after complete disappearance of the clinical symptoms. In some obstinate cases, treatment may be required for 2 to 3 weeks (see also 3.6).

Where ear mite infestation is present, consideration should be given to treating both ears even if infestation is only apparent in one ear.

3.10 Symptoms of overdose (and where applicable, emergency procedures and antidotes)

Topical use. In case of accidental ingestion by licking, no toxic effects were observed.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

3.12 Withdrawal periods

Not applicable

4. PHARMACOLOGICAL INFORMATION

4.1 ATCvet code: QS02CA01

4.2 Pharmacodynamics

Miconazole nitrate is a synthetic imidazole derivative with a pronounced antifungal activity and a potent activity against Gram-positive bacteria. Miconazole selectively inhibits the synthesis of ergosterol, which is an essential component of the membrane of yeasts and fungi.

Polymyxin B sulfate is a polypeptide antibiotic with bactericidal activity against Gramnegative bacteria. It binds to phospholipids in the cytoplasmic membrane, whereby the membrane permeability is disturbed. This results in lysis of the bacteria.

Prednisolone acetate is a glucocorticoid with strong anti-inflammatory activity which results from its reduction of the permeability of capillaries and vascular proliferation and from the inhibition of fibroblast action.

4.3 Pharmacokinetics

After topical application of miconazole nitrate, virtually no systemic absorption takes place through the skin or mucus membranes.

Systemic absorption of prednisolone on normal or abraded skin is minimal. Absorption of polymyxin B via the skin is also negligible. Excretion is almost completely via the kidneys.

5. PHARMACEUTICAL PARTICULARS

5.1 Major incompatibilities

None known.

5.2 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years. Shelf life after first opening the immediate packaging: 3 months.

5.3 Special precautions for storage

Do not store above 25 °C

Keep the dropper bottle in the outer carton.

5.4 Nature and composition of immediate packaging

Bottle: 15 ml or 30 ml white, opaque low-density polyethylene squeeze dropper bottle.

Closure: White, opaque high-density polyethylene child resistant cap (screwfit) with tamper evident ring or white, opaque high-density polyethylene tamper evident (screw fit) cap.

Dropper (Dosing Device): White, low-density polyethylene and thermoplastic elastomer or white, low density polyethylene.

Not all pack sizes may be marketed.

5.5 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Medicines should not be disposed of via wastewater.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

6. NAME OF THE MARKETING AUTHORISATION HOLDER

Elanco GmbH

7. MARKETING AUTHORISATION NUMBERS

UK(GB) – Vm 52127/5083

UK(NI) - Vm 52127/3018

8. DATE OF FIRST AUTHORISATION

05 September 1985

9. DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

July 2026

10. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Gavin Hall Approved: 30 July 2026

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