ANAESTHETIC

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

PHENAZONE; TETRACAINE HYDROCHLORIDE

Available from:

VITAMED PHARMACEUTICAL INDUSTRIES LTD

ATC code:

S02DA30

Pharmaceutical form:

DROPS

Composition:

TETRACAINE HYDROCHLORIDE 0.5 %W/W; PHENAZONE 5 %W/W

Administration route:

OTIC

Prescription type:

Not required

Manufactured by:

VITAMED LTD, ISRAEL

Therapeutic group:

COMBINATIONS

Therapeutic area:

COMBINATIONS

Therapeutic indications:

For the relief of pain in acute otitis media and the external, auditory canal.

Authorization date:

2014-02-28

Patient Information leaflet

Patient package insert according to
Pharmacists' Regulations (Preparations)- 1986
This medicine can be sold without a physician’s prescription
ANAESTHETIC, Ear Drops
Composition:
Phenazone 5% W/W, Tetracaine Hydrochloride 0.5% W/W.
Each 1 ml contains: 50 mg Phenazone and 5 mg Tetracaine Hydrochloride.
Inactive ingredients and allergens in the medicine- see section 6
"Additional information".
Read the entire leaflet carefully before using this medicine.
This leaflet contains concise information about the medicine. If you
have any
further questions, refer to the doctor or pharmacist.
Take this medicine according to the instructions in section 3 "How to
use this medicine?" in this leaflet. Consult the pharmacist if you
need
additional information.
Refer to a doctor if the symptoms of your illness get worse or if they
do not improve after 2-3 days .
1. What is the medicine intended for?
The medicine is intended for the relief of pain in acute otitis media
and the external, auditory canal.
Therapeutic group:
Phenazone- Pyrazolone derivative, analgesic and anti-inflammatory.
Tetracaine Hydrochloride- Local anaesthetic.
2. Before using this medicine
Do not use this medicine if:
Special warnings regarding the use of this medicine
• Do not use this medicine frequently or for a prolonged period.
• If there is an infection present, consult your doctor.
Drug interactions:
If you are taking or have recently taken other medicines, including
nonprescription medicines and nutritional supplements, tell the
doctor or pharmacist. Especially if you are taking:
• "Sulphonamides" class medicines, used to treat bacterial infection
or diabetes.
• Accidental swallowing of the medicine may affect the metabolism of
medicines broken down by liver enzymes. Little absorption is expected
from
topical application into the ear canal.
Pregnancy and breastfeeding:
Safety for use in pregnancy and breastfeeding has not been
established.
If you are pregnant, think you may be pregnant or are breastfeeding,
consult the doctor or pharmacist be