Otinum 200 mg/g ear drops (solution), medicine against inflammation, pain, 10 ml
Choline salicylate
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
Do not throw this leaflet away as you may need to read it again.
If you want to know more or consult, ask your pharmacist.
If side effects occur (even if they are not listed in this leaflet), contact your doctor or pharmacist. See Chapter 4.
If your condition has not improved or even worsened within 10 days, consult a doctor.
What is this leaflet about?
What Otinum is and what it is used for
What you need to know before using Otinum
How to use Otinum
Possible side effects
How to store Otinum
Package contents and other information
1. What Otinum is and what it is used for
The active substance of the drug - choline salicylate - belongs to the group of salicylates. It has an anti-inflammatory and pain-relieving effect. The glycerol contained in the medicine softens earwax and makes it easier to remove. When used locally, the drug does not cause systemic effects.
Otinum can be used:
To relieve pain caused by acute inflammation of the external, middle or eardrum.
To soften hardened sulfur plugs before removing them from the outer ear canal.
If your condition has not improved or even worsened within 10 days, consult a doctor.
2. What you need to know before using Otinum ear drops against inflammation
Otinum ear drops should not be used:
- if you are allergic to salicylates or any of the excipients of this medicine (they are listed in section 6);
- if the ear drum is pierced;
- for children younger than 1 year.
Warnings and precautions
Talk to your doctor or pharmacist before taking Otinum.
For children
Otinum should not be used in children under 1 year of age.
Other medicines and Otinum
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, or if you are not sure. There is no evidence that the drug affects the effects of other drugs or that other drugs change its effects.
Pregnancy and breast-feeding
If you are pregnant, breast-feeding, think you may be pregnant or are planning to become pregnant, talk to your doctor or pharmacist before taking this medicine. Animal studies are insufficient to determine effects on pregnancy and/or embryonic or fetal development and/or parturition and/or postnatal development. The potential danger to humans is unknown. Caution should be used in pregnant women.
It is not known whether choline salicylate instilled in the mother's ear will harm the baby. Therefore, the drug is not recommended for breastfeeding women.
Driving and machine control
The drug does not affect the ability to drive and operate machinery.
3. How to use Otinum ear drops for pain
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If in doubt, ask your doctor or pharmacist.
The recommended dose for adults is:
In case of acute inflammation of the external, middle ear or ear drum:
3-4 drops of Otinum medicine should be dripped into the external ear canal 3-4 times a day.
No dose adjustment is required for elderly patients with kidney or liver disease.
Before the sulfur plug removal procedure:
3-4 drops of Otinum medicine should be dripped into the external eardrum 2 times a day for 4 days.
Medicines are administered to the patient lying on his side. After instilling the medicine, the person must lie quietly for a few minutes.
Use in children and adolescents
Children from 1 year of age do not need to adjust the dose.
What to do if you take too much Otinum?
It is impossible to overdose the medicine that is dropped into the ear. One vial contains 2 g of choline salicylate. If the drug is accidentally ingested, this amount would be dangerous only for newborns.
Symptoms of overdose, possible after taking the drug: confusion, dizziness, increased sweating, vomiting, ringing in the ears and hyperventilation. Signs of CNS depression may occur after ingestion of very large amounts of the drug.
In case of overdose, it is necessary to consult a doctor, who will prescribe the appropriate treatment (induce vomiting, wash the stomach, administer activated carbon).
If you forget to take Otinum
Do not take a double dose to make up for a missed dose.
If you stop taking Otinum
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects of Otinum ear drops
This medicine, like all medicines, can cause side effects, although not everybody gets them. Otinum is a well-tolerated drug. Sometimes the skin of the ear may become red and itchy (allergic reaction). Patients with a perforated ear drum may experience hearing loss during the period of use of the drug.
Otinum side effect reporting
If you get any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects to the State Medicines Control Service under the Ministry of Health of the Republic of Lithuania by calling toll-free 8 800 73568 or by filling out the form on the website and submitting it to the State Medicines Control Service under the Ministry of Health of the Republic of Lithuania in one of the following ways: in writing (at Žirmūnų st. 139A, LT- 09120 Vilnius), by free fax number 8 800 20 131, e-mail by mail, as well as through the website of the State Drug Control Service under the Ministry of Health of the Republic of Lithuania (at http://www.vvkt.lt). By reporting side effects, you can help us get more information about the safety of this medicine.
5. How to store Otinum ear drops for sinus pain and inflammation
Keep this medicine out of the sight and reach of children. Store at a temperature not higher than 25 o C. Store in the manufacturer's packaging. Do not use this medicine after the expiry date stated on the bottle label and carton after EXP. The drug is suitable for use until the last day of the specified month.
Medicines must not be disposed of in the sewer or with household waste. Ask your pharmacist how to dispose of unnecessary medicines. These measures will help protect the environment.
6. Package contents and other information
Composition of Otinum
- The active substance of Otinum is choline salicylate. 1 g of ear drops (solution) contains 200 mg of choline salicylate.
- Auxiliary substances of Otinum are glycerol, ethanol (96%), chlorobutanol hemihydrate, purified water.
Appearance and contents of the pack
Otinum 200 mg/g ear drops (solution) is a clear, yellowish liquid with a characteristic odor.
The medicine is supplied in polyethylene bottles (10 g each) with a dispenser and a screw cap. A cardboard box contains one bottle with a label and a package leaflet.