Otalgan drops bottle 12 g

Otalgan is suitable for the treatment of earache caused by inflammation of the middle ear or the external auditory canal.

Swissmedic-approved patient information

What is Otalgan and when is it used?

Otalgan is suitable to treat earache caused by inflammation of the middle ear or the external auditory canal.

When must Otalgan not be used?

Otalgan must not be used if you are hypersensitive to the ingredients or if there is damage, e.g. an eardrum injury.

When to be careful when using Otalgan?

Otalgan should not be used for more than 2 days without a doctor's prescription. If dizziness or fever occurs at the same time, a medical examination is recommended because of possible complications.

Medications administered at the same time can influence each other's effects. A possible impairment due to limited hearing (caused by the disease or by the use of the ear drops) must be taken into account.

This medicine contains butylated hydroxyanisole (E320). This substance can cause local skin irritation (e.g. contact dermatitis), irritation of the eyes and mucous membranes.

Tell your doctor, pharmacist or druggist if you

• suffer from other diseases
• have allergies or
• take other medicines (including those you bought yourself!) or use them externally!

Can Otalgan be used during pregnancy or breastfeeding?

Women who are pregnant, want to become pregnant or are breastfeeding should only use Otalgan after consulting their doctor or apply to your doctor.

How do you use Otalgan?

Instillate into the affected ear every 2-4 hours, or up to 4 times a day whenever the pain-relieving effect wears off:

Adults and adolescents over 12 years: 5 drops.

Children over 2 years: 2-3 drops.

Children under 2 years of age only on medical prescription.

Ear pain in children should always be clarified by a doctor.

Preheat Otalgan to body temperature before use (briefly warm by enclosing your hand. Do not heat!). Instill on your side and stay like that for about 15 minutes. Then seal the ear canal with cotton.

Stick to the dosage given in the package leaflet or as prescribed by your doctor. If you think the medicine is too weak or too strong, talk to your doctor, pharmacist or druggist.

What side effects can Otalgan have?

The following side effects can occur when using Otalgan:

Rare (affects 1 to 10 users in 10,000)

Allergic reactions are possible.

Individual cases

If Otalgan is used despite an injury to the eardrum, the pain and possible damage to middle ear structures may occur (see “When should Otalgan not be used?”). If you notice any abnormal sensation or other changes while using Otalgan, you must inform your doctor.

If you get any side effects, talk to your doctor, pharmacist or druggist. This also applies in particular to side effects that are not listed in this leaflet.

What else needs to be considered?

The medicinal product may only be used up to the date marked «EXP» on the container.

Storage Instructions

Store at room temperature (15-25 °C) and out of the reach of children.

Your doctor, pharmacist or druggist can provide you with further information. These people have the detailed information for specialists.

What is in Otalgan?

Ear drops.

Active ingredients

1 g (approx. 24 drops) contains: 10 mg procaine as procaine hydrochloride and 50 mg phenazone.

Excipients

Glycerol, butylated hydroxyanisole (E 320).

Approval number

10714 (Swissmedic).

Where can you get Otalgan? What packs are available?

In pharmacies and drugstores, without a doctor's prescription.

12 g dropper bottle.

Authorization holder

VERFORA SA, 1752 Villars-sur-Glâne.

This leaflet was last checked by the Medicines Agency (Swissmedic) in June 2020.