Tropex 5% w/v Ear Drops Solution

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Phenazone

Tilgjengelig fra:

Rowa Pharmaceuticals Limited

ATC-kode:

S02DA; S02DA03

INN (International Name):

Phenazone

Dosering :

5 percent weight/volume

Legemiddelform:

Ear drops, solution

Resept typen:

Product not subject to medical prescription

Terapeutisk område:

Analgesics and anesthetics; phenazone

Autorisasjon status:

Marketed

Autorisasjon dato:

1976-03-24

Informasjon til brukeren

TROPEX
®
5% W/V EAR DROPS SOLUTION
PACKAGE LEAFLET: INFORMATION FOR THE USER
PHENAZONE
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription. However, you still
need to use Tropex Ear
Drops carefully to get the best results from it.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
You must contact a doctor if your symptoms worsen or do not improve
after 24 hours.
-
If any of the side effects gets serious, or if you notice any side
effect not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.What Tropex Ear Drops is and what it is used for
2.Before you use Tropex Ear Drops
3.How to use Tropex Ear Drops
4.Possible side effects
5.How to store Tropex Ear Drops
6.Further Information
1. WHAT TROPEX EAR DROPS IS AND WHAT IT IS USED FOR
These ear drops contain Phenazone which is an analgesic (painkiller)
and an
anti-inflammatory agent. Tropex Ear Drops is used to provide relief of
the symptoms
associated with inflammation of the ear. Glycerol is used to soften
and remove any ear wax.
2. BEFORE YOU USE TROPEX EAR DROPS
Do not use Tropex Ear Drops:
- if you have a perforated (burst) ear drum
- if you are allergic (hypersensitive) to Phenazone or any of the
other ingredients of Tropex
Ear Drops (see section 6 "Further Information" for details).
TAKE SPECIAL CARE WITH TROPEX EAR DROPS
If improvement does not occur within 24 hours consult your doctor. If
there is an infection
present consult your doctor.
USING OTHER MEDICINES
Please tell your doctor or pharmacist if you are taking or have
recently taken any other
medicines, including medicines obtained without a prescription. Tropex
Ear Drops is unlikely
to interfere with other medicines; however, accidental swallowing of
Tropex may affect the
metabolism of medicines broken down by liver enzymes. Little
absorption is expected from
topical application into the ear canal.
PREGNANCY AND BREAST-FEEDING

Preparatomtale

Health Products Regulatory Authority
07 January 2020
CRN009JV4
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tropex 5% w/v Ear Drops Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of solution contains Phenazone 50mg (5% w/v).
Excipient(s) with known effect
Each ml also contains 1mg methylparahydroxybenzoate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ear drops, solution
Clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the management of the symptoms of otitis media and other
inflammatory conditions of the ear. Also for the softening and
removal of earwax.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: For auricular use.
Recommended Dosage Schedule:
4-6 drops to be introduced into the ear three to four times a day
according to the severity of the inflammation.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance(s) or to any of the
excipients listed in section 6.1
Tropex should not be used in patients who have perforated eardrums.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If improvement does not occur within 24 hours the doctor should be
consulted.
If infection is present the doctor should be consulted.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
Oral phenazone affects the metabolism of drugs broken down by liver
enzymes. However, little absorption is expected from
topical application into the auditory canal.
Health Products Regulatory Authority
07 January 2020
CRN009JV4
Page 2 of 3
4.6 FERTILITY, PREGNANCY AND LACTATION
There is no information to contraindicate the use of Tropex during
pregnancy or lactation.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None known.
4.8 UNDESIRABLE EFFECTS
Phenazone may give rise to skin eruptions and hypersensitivity
reactions.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the
medicinal product is important. It allows continued
monitoring of the b