Trachitol Lozenges, lozenges

Nazione: Malta

Lingua: inglese

Fonte: Medicines Authority

Principio attivo:

ALUM, LIDOCAINE HYDROCHLORIDE, PROPYL HYDROXYBENZOATE

Commercializzato da:

Engelhard Arzneimittel GmbH & Co. KG Herzbergstrasse 3 61138 Niederdorfelden, Germany

Codice ATC:

R02AD02

INN (Nome Internazionale):

ALUM 1 mg LIDOCAINE HYDROCHLORIDE 1 mg PROPYL HYDROXYBENZOATE 1.8 mg

Forma farmaceutica:

LOZENGE

Composizione:

ALUM 1 mg LIDOCAINE HYDROCHLORIDE 1 mg PROPYL HYDROXYBENZOATE 1.8 mg

Tipo di ricetta:

OTC

Area terapeutica:

THROAT PREPARATIONS

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2006-08-28

Foglio illustrativo

PATIENT INFORMATION
HOW DO INFLAMMATORY DISEASES IN THE ORAL AND PHARYNGEAL CAVITIES COME
ABOUT?
Inflammation in the mouth and throat is caused by germs such as
bacteria,
viruses or fungi, particularly when the body’s natural defensive
powers are
weakened (e.g. in the case of a cold). Symptoms are reddening and
hyper-
sensivity of the mucosae, which can be accompanied by a burning
sensation
in the mouth, difficulty in swallowing, sore throat and hoarseness.
TRACHITOL
®
ACTS RAPIDLY AND EFFECTIVELY
The active ingredients combined in Trachitol
®
have anti-bacterial, painrelieving
and antiseptic properties. The antiseptic component in Trachitol
®
Lozenges tar-
gets the germs causing inflammation by effectively fighting the
infection. Pain
in the mouth and throat is rapidly and effectively relieved by the
local 
anaesthetic lidocaine.
GOOD TOLERANCE – AN IMPORTANT FACTOR
The active ingredients contained in Trachitol
®
Lozenges are generally very well
tolerated, if the preparation is taken according to the directions of
use.
HELPS IN THE EVENT OF TROUBLESOME BAD BREATH
Bad breath is an upleasant symptom, which often accompanies
inflammatory
diseases in the oral and pharyngeal cavities. The product Trachitol
®
Lozenges
eradicates bad breath through its peppermint aroma. Trachitol
®
Lozenges are
SUGAR-FREE
, thus kind to the teeth and help to prevent caries.
We wish you a speedy recovery.
PACK SIZE: 
Boxes of 20 lozenges.
Engelhard Arzneimittel GmbH & Co. KG
Herzbergstraße 3
D-61138 Niederdorfelden, Germany
MA048/00202
PAIN-RELIEVING, ANTI-INFLAMMATORY, ANTISEPTIC
SUGAR-FREE – KIND TO THE TEETH
Information for use. Please read carefully!
COMPOSITION:
Each lozenge contains 1.0 mg of lidocaine HCI 1 H
2
O 1.8 mg
of propyl hydroxybenzoate, 1.0 mg of alum, 2.5 mg of peppermint oil
as 
taste corrigent and 0.69 g of the sugar substitute sorbitol,
corresponding to 
0.057 BU.
INDICATIONS:
Inflammatory diseases of the oral and pharyngeal cavities:
inflammation of the oral mucosa and the gums

Scheda tecnica

1.
NAME OF THE MEDICINAL PRODUCT
Trachitol
®
lozenges 1 mg + 1.8 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Trachitol
®
lozenge contains 1.0 mg of Lidocaine hydrochloride (as monohydrate)
and 1.8 mg
of Propyl-4-hydroxybenzoate.
Excipient: Each lozenge contains 0.69 g Sorbitol
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lozenge
White, round, flat lozenge with bevelled edge.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Inflammatory diseases of the oral and pharyngeal cavities:
Inflammation of the oral mucosa and
the gums, tonsillitis, laryngitis, sore throat and infections of the
upper respiratory tract.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: Oropharyngeal
Let dissolve one lozenge every 2 hours slowly in the mouth.
The maximum daily dose of 8 lozenges (adults) respectively 6 lozenges
(children) should not be
exceeded.
Not suitable for very small children, who are not able to suck a
lozenge.
If there is no significant improvement after 7 (3-10) days, a
physician should be consulted.
4.3
CONTRAINDICATIONS
Hypersensitivity to lidocaine hydrochloride and
propyl-4-hydroxybenzoate or to any of the
excipients.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Trachitol
®
contains 0.69 mg sorbitol, corresponding to 0.057 BU. Patients with
rare hereditary
problems of fructose intolerance should not take this medicine after
consultation with the doctor.
Trachitol Lozenges contain Lidocaine. Cross-allergy to lidocaine
hydrochloride is expected in
patients with a history of known allergy to other local amide type
anaesthetics
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
1
Adverse effects associated with the concomitant use of other drugs in
conjunction with Trachitol®
Lozenges have not become known so far.
4.6
PREGNANCY AND LACTATION
_ _
Trachitol should only be used during pregnancy or lactation after
consulting a doctor.
4.7
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
If Trachitol is used according to the instructions no co