Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Otigo 40 mg/10 mg/g ear drops, solution
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Lidocaine hydrochloride, Phenazone may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
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 inflammation of the middle ear; middle ear inflammation as a complication after flu; barotraumatic damage of the middle ear (so-called barotraumatic otitis). If in doubt, it is essential to seek the advice of your doctor or your pharmacist. 2.
What you need to know before you take it
e Otigo
Do not use Otigo if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6); if you have perforated or burst ear drum (tympanic perforation) this includes cases when your ear drum has been perforated during a surgical manipulation (myringotomy) (see Section: Warnings and precautions). Warnings and precautions Talk to your doctor or pharmacist before using Otigo. If you have perforated ear drum membrane (even when the ear drum membrane was perforated during surgical manipulation) this medicine may cause side effects in the middle ear. Except ear pain, other common symptoms of perforated ear drum are: vertigo (spinning sensation); hearing change or loss, often with ringing, buzzing, or clicking; fluid or blood draining from the ear. It is recommended that the doctor checks if your tympanic membrane (ear drum) is intact, before prescribing this medicine. Stop using this product and tell your doctor if ear discharge develops during the course of treatment. If symptoms do not improve within 7 days or worsen rapidly or significantly at any time, consult your doctor, who may decide to change your treatment.
The attention of athletes should be drawn to the fact that this medicine contains an active ingredient which may give a positive result in anti-doping tests. Otigo contains lidocaine (a local anaesthetic) used for pain relief as an active ingredient. Methemoglobinemia (a blood disorder characterized by elevated levels of methemoglobin in the blood, which leads to tissue hypoxia) has been reported following the topical use of local anaesthetics. Otigo should be used with caution 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. If in doubt, do not hesitate to seek the advice of your doctor or your pharmacist. Otigo ear drops is a medicinal product intended only for local use in the ear. It should not be used in the eyes or nose and should not be swallowed. Other medicines and Otigo Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. Driving and using machines Otigo does not affect the ability to drive and use machines. Pregnancy, breast-feeding and fertility Ask your doctor or pharmacist for advice before using any medicine. Otigo can be used by pregnant and breast-feeding women, if necessary. 3.
How to take it
Otigo
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. To avoid the unpleasant contact of the ear with the cold solution, warm the vial before use between your hands. Dosage: Otigo is suitable for use both in adults and children. The recommended dose is 4 drops, 2 or 3 times daily into the outer ear canal of the affected ear. If symptoms do not improve within 7 days or worsen rapidly or significantly at any time, the therapy should be re-evaluated, so consult a doctor. Instructions for use Unscrew the bottle cap. Screw the dropper applicator. Remove the protective dropper cap. Tilt your head on one side with your affected ear facing upwards. Turn the bottle down and gently squeeze the dropper until a drop is dispensed into the ear. Press again to dispense the required number of drops. Lie flat on your side. Place back the white protective dropper cap after use. Otigo ear drops is a medicinal product intended only for local use in the ear.
It should not be used in the eyes or nose and should not be swallowed. If you use more Otigo than you should There are no reports of overdose cases, when Otigo is properly used. If you forget to use Otigo
Do not use a double dose to make up for a missed one. If you have any further questions on 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 everyone gets them. The following frequencies are used in evaluating side effects: Rare side effects (may affect up to 1 in 1,000 people): local allergic reactions (itching, maculopapular rash), auditory canal hyperaemia. Reporting side effects If you get any side effects, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via at: www.mhra.gov.uk/yellowcard or search MHRA Yellow Card in the Google Play or Apple App. By reporting side effects you can help provide more information on the safety of this medicine. 5.
How to store it
Otigo
Keep this medicine out of the sight and reach of children. Store in the original package, in order to protect from light. This medicinal product does not require any special temperature storage conditions. You can use Otigo 6 months after first opening of the bottle. Do not use this medicine after the expiry date which is stated on the label and the carton after "EXP". The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacists how to throw away medicines you no longer use. These measures will help protect the environment. 6.
Contents of the pack and other information
What Otigo contains The active substances are: phenazone and lidocaine hydrochloride. The other ingredients are: sodium thiosulfate, ethanol, glycerol and water. What Otigo looks like and contents of the pack Clear, colourless to yellow-brown solution. 15 ml (16.65 g) of the solution are dosed in brown glass (Type ІІІ) 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. One bottle with a dropper applicator and a package leaflet in a cardboard carton. Marketing Authorisation Holder Renascience Pharma Limited The Urban Building Second Floor, 3-9 Albert Street, Slough, Berkshire, SL1 2BE, United Kingdom
Manufacturer Sopharma AD Industrial zone, Sandanski, 2800, Bulgaria This leaflet was last revised in: May 2025
Frequently asked questions about Otigo 40 mg/10 mg/g ear drops, solution
How do I take Otigo 40 mg/10 mg/g ear drops, solution?
Otigo 40 mg/10 mg/g ear drops, solution comes as ear drops containing 40mg / 10mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Otigo 40 mg/10 mg/g ear drops, solution?
The active substance in Otigo 40 mg/10 mg/g ear drops, solution is lidocaine hydrochloride, phenazone.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Otigo 40 mg/10 mg/g ear drops, solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Otigo 40 mg/10 mg/g ear drops, solution without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: lidocaine hydrochloride, phenazone
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
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 the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
4.9. Overdose
No cases of overdose have been reported.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Not the same combination. This medicine contains Lidocaine hydrochloride, Phenazone. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- LIDOCAINA NORIDEM 10 mg/ml prescription partial — not the same combinationLIDOCAINUM · injection / infusion
- LIDOCAINA NORIDEM 20 mg/ml (vezi N01BB02) prescription partial — not the same combinationLIDOCAINUM · injection / infusion
- LIDOCAINA KABI 10 mg/ml prescription partial — not the same combinationLIDOCAINUM · injection / infusion
- LIVOHEP 20 mg/ml prescription partial — not the same combinationLIDOCAINUM · injection / infusion
- LIVOHEP 10 mg/ml prescription partial — not the same combinationLIDOCAINUM · injection / infusion
- VERSATIS 700 mg prescription partial — not the same combinationLIDOCAINUM · skin / topical
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Not the same combination. This medicine contains Lidocaine hydrochloride, Phenazone. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
- Ophtesic partial — not the same combinationLidocaini hydrochloridum · eye / ear / nose
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Otigo 40 mg/10 mg/g ear drops, solution. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.