This information is intended for use by health professionals

1. Name of the medicinal product

Otigo 40 mg/10 mg/g ear drops, solution

2. Qualitative and quantitative composition

1 g of solution contains:

phenazone

40 mg

lidocaine hydrochloride

10 mg

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Ear drops, solution

Clear, colourless to yellow-brown solution.

4. Clinical particulars
4.1 Therapeutic indications

This medicinal product is intended for local symptomatic treatment and relief of pain in the following diseases of the middle ear without tympanic perforation:

- acute, congestive otitis media;

- otitis in influenza, the so called viral bullous otitis;

- barotraumatic otitis.

4.2 Posology and method of administration

Posology

Bottle with a dropper applicator.

Instil 4 drops two or three times daily into the external auditory canal of the affected ear, slightly pressing the elastic part of the dropper.

Taking into account that Otigo acts locally, dosage adjustments based on age are not necessary.

Otigo is suitable for use both in adults and children.

Duration of treatment

If symptoms do not improve within 7 days or worsen rapidly or significantly at any time, the therapy should be re-evaluated.

Method of administration

For auricular use only.

To avoid the unpleasant contact of the ear with the cold solution, warm the vial before use between your hands.

4.3 Contraindications

This medicinal product should not be administered in the following cases:

- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1;

- Infectious or traumatic perforation of the tympanic membrane (including myringotomy) (see section 4.4).

4.4 Special warnings and precautions for use

Before the beginning of treatment with the medicinal product, it is recommended to check if there is perforation of the tympanic membrane. If the tympanic membrane is perforated, intra-auricular administration may lead to contact of the product with middle ear structures and cause undesirable effects in these tissues.

The product should not be used in the presence of a perforated tympanic membrane, which would include the presence of a myringotomy, in case of penetration of the active substances into the middle ear, risking ototoxicity. The patient should be advised that treatment should be stopped, and medical advice sought, if ear discharge develops during the course of treatment, which may indicate perforation.

If symptoms do not improve within 7 days or worsen rapidly or significantly at any time, the therapy should be re-evaluated.

Methemoglobinemia has been reported following the topical use of local anaesthetics. Caution should be exercised in patients who are susceptible to methemoglobinemia, including infants under 3 months of age and patients with haemoglobinopathies or Glucose-6-phosphate dehydrogenase (G6PD) deficiency.

This medicinal product contains an active substance that can be a reason for positive results of anti-doping tests.

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

4.6 Fertility, pregnancy and lactation

In case of intact tympanic membrane, systemic absorption is unlikely.

If the recommended dosage (4 drops two or three times daily) and therapy duration (should not exceed 7 days) are observed, the product can be administered during pregnancy and breast-feeding, if necessary. However, women during pregnancy or during breast-feeding should consult their doctor or pharmacist before using Otigo. There is limited pharmacokinetic information available. It is not known if Otigo active substances passes into breast milk or/and crosses the placenta.

4.7 Effects on ability to drive and use machines

Otigo does not affect the ability to drive and use machines.

4.8 Undesirable effects

The undesirable effects listed below are classified according to the affected system or organ and to their frequency. Depending on their frequency, the undesirable effects can be very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).

Ear and labyrinth disorders:

Rare: local allergic reactions (itching, maculopapular rash), auditory canal hyperaemia.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

4.9 Overdose

No cases of overdose have been reported.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Otologicals; analgesics and anaesthetics; combinations

ATC code: S02DA30

Otigo is a combined medicinal product that contains phenazone and lidocaine.

Phenazone is a pyrazolone derivative with analgesic and anti-inflammatory properties.

Lidocaine is a local anaesthetic from the amide group.

5.2 Pharmacokinetic properties

Due to the external administration and application of the active substances at low doses, systemic absorption is unlikely (in case of intact tympanic membrane), and for that reason no pharmacokinetic studies have been performed.

5.3 Preclinical safety data

No data available.

6. Pharmaceutical particulars
6.1 List of excipients

Sodium thiosulfate

Ethanol

Glycerol

Purified water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

Shelf life after first opening of the bottle – 6 months.

6.4 Special precautions for storage

Store in the original package, in order to protect from light.

This medicinal product does not require any special temperature storage conditions.

6.5 Nature and contents of container

Primary package:

15 ml (16.65 g) of the solution are dosed in brown glass (Type III) bottles with capacity of 15 ml. Bottles are closed with polyethylene screw caps with tamper evident rings and sealing inserts.

To dose the medicinal product use a dropper applicator (polypropylene (PP) screw capsule/ thermoplastic elastomer (TPE) reservoir/ low density polyethylene (LDPE) cap), which should be fixed on the bottle after the first opening of the container.

Secondary package:

One bottle with a dropper applicator and a package leaflet in a cardboard carton.

6.6 Special precautions for disposal and other handling

Any unused product or waste materials from it should be disposed in accordance with local requirements.

Instructions for use for patient

- Unscrew the cap of the bottle.

- Screw the dropper applicator on the place of the cap.

- Remove the protective cap from the dropper.

- Turn the bottle upside down and slightly press the dropper until a drop is formed.

- Lie flat on your side.

- Press again until you obtain the required number of drops.

- Place back the white protective cap on the dropper after use.

7. Marketing authorisation holder

Renascience Pharma Ltd

11 George Street West,

Luton Bedfordshire,

LU1 2BJ,

United Kingdom

8. Marketing authorisation number(s)

PL 44696/0009

9. Date of first authorisation/renewal of the authorisation

June 2019

10. Date of revision of the text

May 2020