Boehringer Ingelheim

PACKAGE LEAFET: INFORMATION
FOR THE USER
_
Boehringer
Ingelheim
Ambroxol
30mg/Sml
Active
hydrochloride
substance:
Ambroxol
Read all of this leaflet
•
•
•
•
hydrochloride
carefully
because
it contains
important
information
for you.
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 4 - :: cays.
If any of the side effects gets serious, or if yOU notice any side effects not listed -: IS lea let, please tell your
d
aci
In this leaflet:
1. What MUCOSOLVAN
syrup 30 mg/S
ml is and w a'
is used for
2. Before you take MUCOSOLVAN
syrup 30 mg/S m
3. How to take MUCOSO VA
syrup 30 mg/S ml
4. Possible side effects
5. How to store MUCOSOLVAN syrup 30 mg/S ml
6. Further information
1. What MUCOSOLVAN
syrup 30 mg/S ml is and
what it is used for
MUCOSOLVAN syrup 30 mg/S m san e oectorant which
is used to thin the mucus in acute and c-'or c bronchial
and lung diseases where thick, tenaci
s - c
s
a problem.
2. Before you take MUCOSOLVAN
Do not take MUCOSOLVAN
syrup 30 m
In some rare bronchial diseases which are associated with
excessive accurr-., a: - o· sec-e 0 s (such as pnrnarv
ciia
s
g
I
should only be used unoa
ec.ce supervision because
of the risk that secretions ma acc mu ate.
MUCOSOLVAN syrup 3 mg 5 ml must not ce sed In
children under 2 years 0 age except on mea C3 advice.
.5
syrup 30 mg/S ml:
Taking other
• if you are hypersensitive
(allergic) to the ac I e
substance (ambroxol hydrochloride)
or to an
other ingredients of MUCOSOLVAN syrup 30...,g
Special care must be taken with MUCOSOLVAN
30 mg/5 ml in the following
circumstances:
Patients with impaired kidney or liver 'unction
If you have impaired kidney function or severe liver
disease, you must not take MUCOSO VAN cou-gh syrup
30 mg/S ml except on medical advice, With ambroxol,
as with any medicine which is broke
down in the liver
and then eliminated via the kidneys, accumulation
of the
breakdown products which are formed in the liver can
be expected to occur in patients with severely impaired
kidney function.
he
5 ml,
syrup
In a very sma I number of cases, there have been reports
of severe skin reactions such as Stevens-Jo-hnson
syndrome and oxic epidermal necrolys s
EN) occurr ng
in temporal association with the use o' expectorants
such as ambroxol hydrochloride.
os o" hese cases
were attributable
0 he undertyi
g a sease and/or
0
other medication being taken conco
tantly, In add' 0
during the early p ase of stevens-Jonnson
syndrome or
TEN, patients may I I a Iy experie cen
-specific
influenza-like
symptoms such as e er, 0 nt pain, rhl • s
cough and sore hroa
Because o'
ese non-specif c
influenza-like
initial sympto
s. symp oma ic reatme '
with cough and cold medications, which is inappropriate,
may be started. If new skin or mucosal lesions appear,
therefore, medical advice should be sought immediately
and the use of ambroxol hydrochloride
discontinued.
medicines
Please tell your doctor or p arrnacist if yOu are ta ins/
usrnq or have recently ta"e
sed any 0 er me-o CI es,
ncluding medicines obta
ed Without a prescrrption
Ambroxol and cough suppressants
Simultaneous
use of MUCOSOLVAN syrup 30 mg/S ml
and coug
suppres
s may ead to the development
of a dangerous acc - • t.or- of secretions OWing'
reduction o· --3 C
e 3 3-::: s ould be"
de aken
only a er C3-a--_
s -oene'rt =
Pregnancy
a
<east-feed"
eresst-reea ng
Ambroxol has been shown to pass into breast milk in
animal studies. Use while breast-feeding
is not
reco
e ded
--
Driving
If you forget
and using machines
There is no evidence of any effect on the ability to drive
or use machines. No relevant studies have been
performed.
Important
information
about some of the ingredients
MUCOSOLVAN syrup 30 mg/5 ml
of
This medicine contains approximately 1.2 9 sorbitol per
5 ml (equivalent to 4.9 9 if the maximum recommended
daily dose is taken). f you have been told that you have
an intolerance to some sugars, please consult your
doctor before taking
UCOSOLVAN syrup 30 mg/5 ml.
3. How to take MUCOSOLVAN
Always take MUCOSOL
described in this pac age
your doctor or pharmac
syrup 30 mg 5 m exactly as
eaflet. You sod
check with
s: you are no: sure
Unless otherwise prescnbed by the doc or, the
recommended
doses are as follows:
syrup 30 mg/5
and duration
to
ml
may get
- e '0 lowing ca:egor es are orma Iy used when
rePO'" g the freq eoc es 0' s de e ec s:
More than 1 in 10 patients
Common:
Between
1 in 10 and 1 in 100 patients
Uncommon:
Between
1 in 100 and 1 in 1000 patients
You should contact a doctor 'f your s~
or do oot ire
a e<' <i - - ..;"
use by rinsing
otorns
orsen
If you feel that the effect of MUCOSOLVAN syrup
30 mg/5 ml is too strong or too weak, talk to your
doctor or pharmacist.
syrup 30 mg/5
ml than
No specific symptoms of overdose have been reported
to date. The symptoms observed In cases of accidental
overdose or medication error are co sistent with the
side effects which may occur at recommended
doses
(see section 4). In case of overdose p ease consult
a
r as sy
a ic trea
e<'-.a
patients
be estimated
from
Side ef4ects
S In rash, urticaria (nettle rash)
Swelling of the skin and mucous
membranes, itching, anaphylactic
reactions (severe allergic reactions)
including shock, other hypersensitivity
reactions
Rare:
Not known:
Nervous
th
he
er than 1 in 10,000
Frequency cannot
he available data
of
ml is for ora use.
cup after eac
If you take more MUCOSOLVAN
you should
early, your symptoms
4. Possible side effects
=e
MUCOSOLVAN syrup 30 mg/5 ml can be taxen
or without food and is dispensed with t e aid 0
measuring cup provided.
Please clean the measuring
with warm water.
MUCOSOLVAI'oI syrup 30 mg/5
If you stop treatment
orse
to 30 - 45 mg
For adults and adolescents over 12 years of age, the
l"lo:-.-;th"e,rageutic effect may be enhanced by increasing the
dosage to 10 ml twice daily (equivalent to 120 mg
ambroxol hydrochloride
per day).
MUCOSOLVAN
ml
Between 1 in 1000 and 1 in 10.000 patients
Adults and adolescents over '2 years of age:
The usual dosage is 5 ml three c mes daily (equivalent
90 mg ambroxol hvdrochlor.ce
per day) for the first
2 - 3 days and 5 J twice da
eo
a e-- - 60
ambroxol hydrochlor ae cer ca, t ereafter.
of administration
If you stop taking
ery common:
to 22.5 mg ambroxol
Children from 6 to 12 years 0' age;
2.5 ml two to three times da :I {equivalent
ambroxol hydrochloride
per aay
Route and method
treatment
syrup 30 mg/5
·e all rnedici es ~UCOSOLVAN syrup 30 mg/S ml can
a e Side effects art 0 9
ot everybody gets them.
syrup 30 mg/S ml
Children from 2 to 5 years of age:
1.25 ml three times daily (equivalent
hydrochloride
per day)
to take MUCOSOLVAN
If you forget to take MUCOSOLVAN syrup 30 mg/5 ml
or take too small a dose, wait until it is time to take your
next dose and then continue taking MUCOSOLVAN
syrup 30 mg/5 ml as described in the dosage
instructions above.
system disorders
s:~'
Common:
Taste d
Gastrointestinal
disorders
Common:
Uncommon:
Nausea, 'ee og of numbness in the mouth
Vomiting
a arrhoea, indigestion,
abdorn
a pain, dry mouth
Dry throa
Co+snoet on. ncreased sa ivation
Rare:
Very rare:
::Cesp ret
ry; t:
rac c and mediastinal
Common.
Very rare:
Not known:
Very rare:
General disorders
disorders
Feeling of numbness in the throat
Increased nasal discharge
Shortness of breath (as symptom of
a hypersensitivity
reaction)
Renal and urinary
Uncommon:
ances
disorders
Difficulty
urinating
and administration
site conditions
Fever, mucous membrane
reactions
Action
to be taken in the event of side effects
At the first signs of a hypersensitivity
reaction,
taking MUCOSOLVAN syrup 30 mg/5 ml.
stop
If any of the side effects gets serious, or if you notice
any side effects no lis ed in this leaflet, please tell your
doc or or pharmacist.
5. How to store MUCOSOLVAN
syrup 30 mg/5
ml
Keep out of the reach and sight of children.
Do not use MUCOSOLVAN syrup 30 mg/5 ml after the
expiry date which is stated on the carton and the abel.
Storage
please contact
Boehringer Ingelheim
Middle East & North Africa
(Scientific Office) FZ -LLC
=.o. Box 505123
"f,ca eC
Duba •• UAE
Tel: +971 4 <1230400
Fax: +971 4) 423 3637
To report
any side effect's:
• Saudi Arabia:
conditions
Do not store above 25°C
Shelf life after first opening
the bottle
Use MUCOSOLVAN syrup 30 mg/5
of first opening the bottle.
ml within 6 months
information
What MUCOSOLVAN
syrup 30 mg/5
The active substance
's ambroxol
5 ml of the syrup contains
hydrochloride.
- National Pharmacovig
a e Center (NPC)
• Fax: +966-11-205-7662
• Toll-free: 800249000
• E-mail: npc.drug@sfda ;;
sa
• Website: www.sfda.g
sa '1pC
• Other countries:
Medicines should not be disposed 0
a aste
ter
s
your pharmacist how to dispose of med c es no longer
required. These measures will help 0 protect the
environment.
6. Further
For any information
about this medicine.
t e ocal representative
of the Marketing
Au horisation Holder:
ml contains:
hydrochloride.
30 mg ambroxol
The other ingredients are:
Benzoic acid, liquid sorbitol (non-crystallising).
hydroxye
y ce lulose. 9 cero. 85 - a,•..
potassium. tlavounnc agents, punfieo ware
.,,..,,ol••.•.,•• _
• Plea
This leaflet
"'e
a"'·
au
was last revised in March 2013
This is a Medicament
- Medicament is a product which affects your health
and its consumption
contrary to an Instruction is
dangerous for you.
- Follow strictly the doctor's prescrip ion. the method
of use and the instructions of the Pharmacist who
sold the medicament.
- The doctor and the pharmaclst are the experts in
medicines. their benefits and risks.
- Do not b, y
"Se <
p- - e period of treatment
w.thout
Notes:
MUCOSOLVA
syru 30
5 ~ s
e ,~.
diabetics; 5 ml contains 1.2 g of carbohydrates.
MUCOSOLVAN syrup 30 mg/5 ml does not conta ~
alcohol.
What MUCOSOLVAN syrup 30 mg/5
contents of the pack:
MUCOSOLVAN syrup 30 mg/5
with a fruity odou r.
ml looks Ii e and
ml is a colour ess liquid
MUCOSOLVAN syrup 30 mg/5 ml is available
packs containing 100 ml and 250 ml.
in original
ot all pack sizes may be marketed
Marketing Authorisatio
Boehringer Inge e
Binger StraBe 173
55216 Ingelheim a
0
der
-e
e
.;
c-
Germa
Manufacturer
Delpharm Relms
10. Rue Colonel C aroonneaux
51100 Reims
France
315393-001