• 50 mg phenazone
• 10 mg procaine hydrochloride

• 0.1 mg butyl hydroxyanisole
• 939.9 mg glycerol

Indication / OTALGAN phenazone ear inflammation drops application

• Pain relieving, anti-inflammatory ear drops.
• The medicine is used:
  • For the local symptomatic treatment of pain in the external auditory canal, ie for external ear infections and acute otitis media. It may only be used if the eardrum is intact.

OTALGAN phenazone ear inflammation drops dosage

• Always use this medicine exactly as directed. Please ask your doctor or pharmacist if you are not sure.
• Unless otherwise prescribed by your doctor, the usual dose is:
  • Infants and school children up to 14 years
    • Single dose: 2 - 3 drops
    • Total daily dose: 3 - 4 times 2 - 3 drops
  • Adolescents from 15 years and adults
    • Single dose: 5 drops
    • Total daily dose: 3 - 4 times 5 drops

• Duration of application:
  • The usual duration of treatment is 5 days. The duration of treatment is unlimited under the supervision of a doctor. This medicinal product is only intended for short-term symptomatic pain relief. If the pain does not subside within 2 days during the treatment, a doctor must be consulted, as earache can have a variety of causes. The same applies to an intensification of the symptoms during the treatment. Medical treatment is required if fever and / or dizziness occurs as a result of the inflammatory disease of the ear.

• Administration frequency:
  • The recommended daily dose is 3 to 4 times the administration of a single dose. Please talk to your doctor or pharmacist if you have the impression that the effect is too strong or too weak.

• If you use more than you should:
  • When used locally on the ear, overdosing or intoxication are unlikely. If in doubt, contact your doctor.

• If you forget to use it,
  • do not use a double dose. Carry out the next application with the specified single dose.

• If you cancel the application,
  • Earache may recur because the underlying disease may not have healed.

• If you have any further questions on the use of the medicinal product, ask your doctor or pharmacist.

OTALGAN phenazone ear inflammation drops way

• Drip ear drops into the ear canal of the affected ear at body temperature (e.g. warming by enclosing them with your hand. Do not heat!) While lying on the side. The side position should then be kept for about 15 minutes so that the ear drops can take effect. Then the ear is loosely closed with cotton wool. No cotton swab is required after the end of the treatment.

Side effects

• Like all medicines, this medicine can cause side effects, although not everybody gets them. The frequency of side effects is based on the following categories:
  • Very common: affects more than 1 in 10 people
  • Common: affects 1 to 10 users in 100
  • Uncommon: affects 1 to 10 users in 1,000
  • Rare: affects 1 to 10 users in 10,000
  • Very rare: less than 1 in 10,000 patients treated
  • Not known: frequency cannot be estimated from the available data.
• Significant side effects or signs to look out for and what to do if they're affected:
  • If you or your child experience any of the side effects listed below, stop using this medicine and contact your doctor as soon as possible. Very rare: Hypersensitivity reactions such as skin changes or nettle rash in the form of itching or swelling of the tissue. If the eardrum is damaged and / or the ear canal is injured, painful discomfort may occur when this medicine is used.
• Other possible side effects:
  • Please inform your doctor or pharmacist if you or your child get seriously affected by any of the side effects listed, or if you notice side effects that are not listed.

OTALGAN phenazone ear inflammation drops Interactions

• When using the preparation with other drugs:
  • Please inform your doctor or pharmacist if you or your child are using or have recently used any other medicines, including medicines obtained without a prescription. Depending on the nature of the disease, your doctor may give you another drug to use at the same time as this medicine.
  • Concomitant use with sulfonamides and benzylpenicillin should be avoided because of the potential for drug interaction.
• When used with food and drink:
  • There are no special precautions required.

OTALGAN phenazone ear inflammation drops Contraindications

• The drug must not be used in:
  • Pyrazolone allergy (hypersensitivity e.g. to drugs containing metamizole, isopropylaminophenazone, propyphenazone or phenazone).
  • Hypersensitivity (allergy) to drugs containing phenylbutazone.
  • Certain metabolic diseases (hepatic porphyria, congenital glucose-6-phosphate dehydrogenase deficiency).
  • Known hypersensitivity to any component of this drug.
  • Damaged eardrum, inflammation of the ear canal with skin damage.

pregnancy and breast feeding period

• Ask your doctor or pharmacist for advice before taking / using any medicine. There is no experience with the use of this drug in pregnant women and there are no animal studies on the possible effects of the combination of active ingredients on pregnancy and on child development. Therefore, you must not use this medicinal product during pregnancy unless your attending doctor deems it absolutely necessary. In this case, you should only use the medicine for a short time and in the lowest dose.

Patient OTALGAN phenazone ear inflammation drops information

• Special care is required when using:
  • Use in chronic otitis media may only be used under medical supervision.
  • What to consider with children
    • This medicinal product may only be used in children under 3 years of age after medical supervision.
  • Important information about the other ingredients of Otalgan:
    • Butylated hydroxyanisole can cause local skin irritation (e.g. contact dermatitis) and irritation of the eyes and mucous membranes.

• Driving and using machines:
  • No influence on the ability to drive or use machines has been observed with the use of this medicine.
  • Because the ear canal is sealed with cotton wool after using this drug when used as intended, you are not allowed to sit behind the wheel of a vehicle. This can affect hearing and thus the ability to react in traffic, operating machines or working without a secure footing.