Toularynx Bromhexine 5mg/5 ml, syrup

Country: Malta

Language: English

Source: Malta Medicines Authority

Available from:

Laboratoria Qualiphar N.V/S.A Rijksweg 9 2880 Bornem, Belgium

ATC code:

R05CB02

INN (International Name):

BROMHEXINE HYDROCHLORIDE 5 mg/5ml

Pharmaceutical form:

SYRUP

Composition:

BROMHEXINE HYDROCHLORIDE 5 mg/5ml

Prescription type:

OTC

Therapeutic area:

COUGH AND COLD PREPARATIONS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2023-05-12

Patient Information leaflet

Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE USER
TOULARYNX BROMHEXINE, 5MG/5ML, SYRUP
Bromhexine Hydrochloride
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
have told you.
WHAT IS IN THIS LEAFLET
1.
What Toularynx Bromhexine is and what it is used for?
2.
What you need to know before you take Toularynx Bromhexine.
3.
How to take Toularynx Bromhexine?
4.
Possible side effects.
5
How to store Toularynx Bromhexine?
6.
Contents of the pack and other information.
1.
WHAT TOULARYNX BROMHEXINE IS AND WHAT IT IS USED FOR?
Toularynx Bromhexine belongs to the group of drugs that liquefy mucous
in the airways, nose
and bronchial tubes.
Toularynx Bromhexine is used for the treatment of bronchial disorders
that are caused by the
secretion of viscous mucus: acute and chronic bronchitis, inflammation
of the windpipe and
bronchioles
(tracheobronchitis),
chronic
disorders
of
the
lungs
and
bronchioles
(chronic
bronchopulmonic disorders); acute and chronic inflammation of the
paranasal sinuses (sinusitis).
Toularynx
Bromhexine
is
also
used
with
dry
eyes
(keratoconjunctivitis
sicca,
Sjögren's
syndrome).
Toularynx Bromhexine is sugarless and can therefore be used by
diabetics.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
-
You must talk to a doctor if you do not feel better or if you feel
worse after 4 to 5 days.
Page 2 of 5
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TOULARYNX BROMHEXINE.
DO NOT TAKE TOULARYNX BROMHEXINE
-
If you are allergic to bromhexine hydrochloride or any of the other
ingredients of
Toularynx Bromhexine (listed in section 6).
-
Do not use in children under the age of 2 years old.
WARNINGS AND PRECAUTIONS
Talk to your doctor

Summary of Product characteristics

Page 1 of 5
1.
NAME OF THE MEDICINAL PRODUCT
Toularynx Bromhexine 5mg/5 ml, syrup
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
5 ml syrup contains 5 mg Bromhexine hydrochloride
Excipients with known effect: Sorbitol (E420) (2,8 g/5 ml), Methyl
parahydroxybenzoate (E218) (3,5
mg/5 ml), Propyl parahydroxybenzoate (E216) (0,9 mg/5 ml) and
Propylene glycol (E1520) (39,5 mg/5
ml).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Syrup
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Indicated for the symptomatic treatment of affections of the airways
linked to a disorder of the
mucal separation or elimination:
-
acute bronchitis, trachea-bronchitis, chronic bronchitis
-
chronic obstructive broncho-pulmonic disorders, bronchiectasis
-
acute sinusitis, chronic sinusitis
Indicated for keratoconjunctivitis sicca (Sjögren's syndrome).
This drinkable solution is sugar-free and can be taken by diabetics.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Dosage
Adults and children older than 15 years: 3 x a day 15ml after meals
_Paediatric population: _
Children from 10 to 15 years old: 3 x a day 10 ml after meals
Children from 5 to 10 years old: 3 x a day 5 ml after meals
Children from 2 to 5 years old: 2 to 3 x a day 2 to 5 ml after meals.
Toularynx Bromhexine is tolerated well and may be taken for extended
periods in chronic cases
without harmful side-effects.
Adults should take no more than 32 mg on any one occasion and no more
than 96 mg per day.
Page 2 of 5
Method of administration
Oral use.
4.3.
CONTRAINDICATIONS
-
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
-
Not for children under the age of 2.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
-
This medicine contains sorbitol (E420). Patients with rare genetic
conditions such as fructose-
intolerance should not use Toularynx Bromhexine .
-
This medicine contains Methyl parahydroxybenzoate (E218) and Propyl
parahydroxybenzoate
(E216). These substances might provoke an allergic reaction (possibly
delayed