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OTOL H
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- Stock: Zabrana online prodaje
- Brand: HEMOFARM-EN
- Model: BR-6057156541
Otol H 1 mg/g + 0.1 mg/g + 10 mg/g is an ear-drop solution containing prednisolone, tyrothricin and tetracaine hydrochloride. Prednisolone reduces inflammation, tyrothricin is a locally acting antibiotic and tetracaine is a local anaesthetic that helps relieve pain.
According to the latest available Serbian patient leaflet, the medicine was intended to relieve pain and inflammatory reactions in the external ear canal associated with uncomplicated acute otitis externa.
Otol H must not be applied if the eardrum is perforated or if perforation is suspected. Ear discharge, bleeding, sudden hearing reduction or a previous eardrum injury require medical examination before any ear drops are used.
Otol H ear drops – indication, application and precautions
What was Otol H used for?
The available product information lists symptomatic treatment of pain and inflammation in the external ear canal accompanying uncomplicated acute otitis externa.
Symptoms of outer ear inflammation may include:
- ear pain and tenderness;
- pain when touching or moving the outer ear;
- itching or burning in the ear canal;
- a blocked or full sensation;
- redness and swelling of the external ear canal;
- discharge or temporary hearing reduction.
These symptoms do not by themselves confirm a bacterial infection. Examination is required to assess the ear canal and eardrum and to exclude fungal infection, impacted earwax, a foreign object or middle-ear inflammation.
How do the ingredients work?
- Prednisolone 1 mg/g: a corticosteroid that locally reduces inflammation, redness, swelling and itching.
- Tyrothricin 0.1 mg/g: an antibiotic for local use against certain susceptible bacteria.
- Tetracaine hydrochloride 10 mg/g: a local anaesthetic used to relieve pain.
- Glycerol: an excipient contributing to the thick consistency of the solution.
Dosage in the latest available leaflet
The latest available packaging classified Otol H as a prescription-only medicine. The dose, frequency and duration must be determined by a doctor after examining the ear and confirming that the eardrum is intact.
| Users | Dose stated in the leaflet | Important information |
|---|---|---|
| Adults | 5–6 drops into the affected ear every hour, or sterile gauze soaked with the solution | Only according to an individual medical prescription |
| Children over 2 years | 2–4 drops | Insufficient safety and efficacy data are available for children under 12 years |
| Children under 2 years | Do not use | Use is contraindicated |
The high frequency stated in the historical leaflet must not be copied or followed without a current medical instruction. Do not use leftover medicine from an earlier treatment.
If there is no improvement after two days, the leaflet advises stopping treatment and consulting a doctor immediately.
How are the drops applied?
- Wash and dry your hands.
- Clean the outer ear only as instructed by a healthcare professional. Do not push cotton swabs or other objects deep into the canal.
- Warm the bottle in your hand for several minutes.
- Lie down with the affected ear facing upwards.
- Allow the thick drops to slide slowly along the edge of the ear canal.
- Remain in this position for approximately 15 minutes.
- Do not touch the ear with the dropper tip.
Do not insert soaked gauze deeply into the ear canal unless a healthcare professional has shown you exactly how to do so.
When must Otol H not be used?
- allergy to prednisolone, tyrothricin, tetracaine or glycerol;
- confirmed or suspected perforation of the eardrum;
- children under two years of age;
- without medical examination and prescription;
- as the only treatment for middle-ear inflammation;
- in the eyes, nose or mouth;
- on the skin or other parts of the body.
Why must the eardrum be examined?
Ear drops intended for the external canal may pose a risk if they pass through a damaged eardrum into the middle ear. Do not use the medicine without an ENT examination if pain is accompanied by discharge, bleeding, sudden hearing loss, dizziness or previous ear surgery.
Otol H and middle-ear inflammation
Otol H must not be used as the only treatment for otitis media. Middle-ear pain may result from bacterial or viral infection, Eustachian tube dysfunction or another condition requiring different treatment.
Possible side effects
The latest available leaflet lists local hypersensitivity to one of the ingredients as a possible adverse effect.
Stop treatment and consult a doctor if you develop marked redness, swelling, itching, stinging, burning, rash, worsening pain, discharge, bleeding, dizziness or a sudden change in hearing.
- severe or rapidly worsening ear pain;
- high fever, chills or marked weakness;
- purulent, bloody or clear ear discharge;
- sudden hearing reduction or hearing loss;
- dizziness, vomiting or balance problems;
- redness and swelling behind the ear;
- difficulty breathing or swelling of the face, lips, tongue or throat.
Other medicines
No specific interactions were listed in the available product information. However, do not use other antibiotic, antifungal, antiseptic or pain-relieving ear drops in the same ear unless a doctor has provided a clear treatment plan.
Pregnancy and breastfeeding
There are insufficient data regarding use during pregnancy and breastfeeding. Pregnant or breastfeeding patients should not use Otol H without an explicit medical assessment of the expected benefits and potential risks.
Composition, pack and manufacturer
- Prednisolone: 1 mg per gram of solution.
- Tyrothricin: 0.1 mg per gram of solution.
- Tetracaine hydrochloride: 10 mg per gram of solution.
- Excipient: glycerol.
- Pharmaceutical form: ear drops, solution.
- Pack: 10 g dark-glass bottle with a dropper.
- Former manufacturer and authorisation holder: Hemofarm AD Vršac, Serbia.
- ATC code: S02CA01.
- Status on the latest available packaging: prescription-only medicine.
Storage
Keep out of the sight and reach of children. Store below 25°C in the original packaging to protect the solution from light.
The latest available leaflet states that the bottle may be used for up to 28 days after first opening. Record the opening date and discard any remaining solution after this period.
Current marketing-authorisation status and regular availability in Serbia could not be confirmed from the publicly accessible registry information. Do not display the medicine as available or publish a current price until its status has been verified with ALIMS, a wholesaler and the pharmacy.
According to the latest available packaging, it was a prescription-only medicine and was not intended for online sale.
The biggest mistake with ear pain is using different drops before the eardrum has been examined. Trapped water, earwax, bacterial or fungal infection, injury to the canal and middle-ear inflammation may cause similar symptoms but require different treatment.
Do not clean a painful ear canal with cotton swabs. Keep the ear dry and seek medical assessment, particularly when discharge, hearing reduction or fever is present.
Ljubica Barbulović, Master of Pharmacy
Related category and expert guide
Explore: Outer ear inflammation and swimmer’s ear – otitis externa.
Read more in: Ear pain after swimming – infection or trapped water?
Related ear-care products
Note: these products do not have the same composition and are not therapeutic substitutes for Otol H. Do not combine multiple ear products without professional advice.
Is Otol H an antibiotic?
It is a combination medicine containing the local antibiotic tyrothricin, the corticosteroid prednisolone and the local anaesthetic tetracaine.
Can Otol H be used for any ear pain?
No. The cause of the pain and the condition of the eardrum must first be assessed.
Can it be used when there is ear discharge?
Not without medical examination. Discharge may indicate eardrum perforation or a more serious infection.
Can children use Otol H?
The available leaflet contraindicates use under two years of age. Older children should use it only when prescribed by a doctor.
How long can the bottle be used after opening?
The available leaflet states 28 days after first opening.
What should be done if symptoms do not improve?
Stop treatment and consult a doctor if there is no improvement after two days.
Source: Patient leaflet, Summary of Product Characteristics and packaging text approved by ALIMS in February 2019. View the latest available official leaflet.
Sources and current registry checked: 2 August 2026.
This information does not replace an ENT examination, professional advice or the original leaflet supplied with a specific pack.
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For all orders received up to 12h from Monday to Friday, the approximate delivery time is 2-4 business days for the whole territory of the Republic of Serbia. In case the order is placed on weekends (Saturdays and Sundays), the delivery is done as well as for the orders received on Monday - so next business day.
Deliveries are not made on Saturdays and Sundays.
Additional information
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Delivery restrictions on goods
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Shipping cost
For the territory of the Republic of Serbia:
For goods ordered up to 5.000,00 RSD, delivery charge is 260.00 RSD (VAT included). For goods over 5.000,00 RSD, shipping is free of charge.
For international delivery:
For the export of goods abroad through the PostExport service of Post of Serbia, the shipping price is for:
- Zone I (Slovenia, Croatia, Bosnia and Herzegovina, Montenegro, Northern Macedonia) - 1,280.00 RSD
- Zone II (Other European countries) - 1,790.00 RSD
- Zone III (Asia, Africa, America, Australia and other countries) - 2,650.00 RSD
Delivery time is 15 days or more (depending on the country of delivery)
For export of goods abroad through DHL service, the shipping price is 2,700.00 RSD. Delivery time is 1-5 business days (depending on the country of delivery)
Shipping cost is with tax. The price includes the delivery of the parcel to the buyer's address with the associated tax and customs at the seller's expense. A possible additional cost may be a customs charge against the buyer, depending on the country to which the package is being shipped.
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