Trachisan Lozenges, lozenges

Quốc gia: Malta

Ngôn ngữ: Tiếng Anh

Nguồn: Medicines Authority

Thành phần hoạt chất:

CHLORHEXIDINE GLUCONATE, TYROTHRICIN, LIDOCAINE HYDROCHLORIDE

Sẵn có từ:

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

Mã ATC:

R02A

INN (Tên quốc tế):

TYROTHRICIN 0.5 mg LIDOCAINE HYDROCHLORIDE 1 mg CHLORHEXIDINE GLUCONATE 1 mg

Dạng dược phẩm:

LOZENGE

Thành phần:

TYROTHRICIN 0.5 mg LIDOCAINE HYDROCHLORIDE 1 mg CHLORHEXIDINE GLUCONATE 1 mg

Loại thuốc theo toa:

OTC

Khu trị liệu:

THROAT PREPARATIONS

Tình trạng ủy quyền:

Authorised

Ngày ủy quyền:

2007-03-02

Tờ rơi thông tin

Trachisan Tab Exp Pb1643202 20.12.2006 8:15 Uhr Seite 1
BSBSS
-
-
Package leaflet: Information for the user
Trachisan®
LOZENGES
Lidocaine hydrochloride 1 H
2
0, chlorhexidine digluconate, tyrothricin
Read all of this leaflet carefully before you start taking this
medicine
because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as
your
doctor or pharmacist has told you.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
lf you get any side effects, talk to your doctor or pharmacist. This
in-
cludes any possible side effects not listed in this leaflet. See
section 4.
-
What is in this leaflet
1.
What Trachisan® Lozenges are and what they are used for
2.
What you need to know before you take Trachisan® Lozenges
3. How to take Trachisan® Lozenges
4.
Possible side effects
5.
How to store Trachisan® Lozenges
6. Contents of the pack and other information
1. What Trachisan® Lozenges are and what they are used for
Trachisan® Lozenges are used for: lnflammations and infections in
the oral cavity and throat, such as stomatitis, gingivitis,
parodontitis,
glossitis, tonsillitis and pharyngitis; dysphagia. For prophylaxis
against
infections before and after surgery in the oral cavity and throat
(tooth
extraction, surgical treatment of the gingiva, tonsillectomy).
2.
What you need to know before you take Trachisan® Lozenges
Do not use Trachisan® Lozenges
The preparation should not be used in the case of known hypersen-
sivity to any of the ingredients, non-bleeding desquamation of the
oral
mucosa (erosive and desquamative changes), larger, fresh wounds in
the oral and pharyngeal cavities.
Precautions for use
lngredients
Each lozenge contains 0.69 g sorbitol, corresp. to 0.057 BU.
Therefore this drug should not be administered to patients with the
rare
congenital fructose intolerance.
Trachisan® Lozenges contain lidocaine. Cross-allergy to lidocaine hy-
drochloride is expected in patients

Đặc tính sản phẩm

Page 1 of 7
1.
NAME OF THE MEDICINAL PRODUCT
Trachisan Lozenges, lozenges
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION (ACTIVE INGREDIENTS)
Each lozenge contains:
Tyrothricin
0.5 mg
Lidocaine hydrochloride 1 H
2
O
1.0 mg
Chlorhexidine gluconate
1.0 mg
Excipients see under point 6.1.
3.
PHARMACEUTICAL FORM
Lozenges.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Inflammations in the oral cavity and throat, such as stomatitis,
gingivitis, parodontitis,
glossitis, tonsillitis and pharyngitis; disphagia. For prophylaxis
against infections before and
after surgery in the oral cavity and throat (tooth extraction,
surgical treatment of the gingiva,
tonsillectomy).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults suck one lozenge at two hour intervals, up to 8 times daily,
children up to 6 times
daily.
With regular use of preparation, the indications generally subside
after a few days. In order
to ensure lasting succsess of treatment, Trachisan
®
Lozenges should be taken for a further 2-
3 days even when symptoms have subsided. However, if there is no
significant improvement
after 5 days, a physician should be consulted at all events.
Trachisan
®
Lozenges should not be used for more than 2 weeks without
interruption, unless
otherwise prescribed by a doctor or dentist.
4.3
CONTRAINDICATIONS
The preparation should not be used in the case of
known hypersensivity to the active constituents contained in Trachisan
®
Lozenges,
non-bleeding desquamation of the oral mucosa (erosive and desquamative
changes),
larger, fresh wounds in the oral and pharyngeal cavities
Page 2 of 7
4.4
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
None.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Adverse effects associated with the concomitant use of other drugs in
conjunction with
Trachisan
®
Lozenges have so far not become known.
4.6
PREGNANCY AND LACTATION
Although the active constituent combination contained in Trachisan
®
Lozenges is safe in
therapeutic doses due to its pharmacological properties, the p