Muciclar

Krajina: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktívna zložka:

AMBROXOL HYDROCHLORIDE

Dostupné z:

PIAM Farmaceutici S.p.A. Via Fieschi, 8/7 1-16124, Genoa, Italy

ATC kód:

R05CB06

INN (Medzinárodný Name):

AMBROXOL HYDROCHLORIDE 75 mg

Forma lieku:

MODIFIED-RELEASE CAPSULE

Zloženie:

AMBROXOL HYDROCHLORIDE 75 mg

Typ predpisu:

OTC

Terapeutické oblasti:

COUGH AND COLD PREPARATIONS

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2006-09-14

Príbalový leták

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MUCICLAR 15MG/5ML SYRUP
MUCICLAR 75 MG PROLONGED RELEASE CAPSULES
Ambroxol hydrochloride
Generic medicine
PLEASE READ THIS LEAFLET CAREFULLY BEFORE TAKING THIS MEDICINE, AS IT
CONTAINS IMPORTANT INFORMATION FOR
YOU.
Always take this medicine exactly as described in this leaflet or as
instructed by your doctor or pharmacist.
-
Keep this leaflet. You may need to read it again.
-
If you would like any further information or advice, please consult
your pharmacist.
-
If any of the side effects occur, including any effects not listed in
this leaflet, please consult your
doctor or pharmacist. See section 4.
-
Please consult your doctor if you see no improvement or if you notice
a worsening of symptoms after a
few days.
CONTENTS OF THIS LEAFLET:
1.
What is MUCICLAR and what is it used for
2.
What you need to know before taking MUCICLAR
3.
How to take MUCICLAR
4.
Possible side effects
5.
How to store MUCICLAR
6.
Contents of the pack and other information
1.
WHAT IS MUCICLAR AND WHAT IS IT USED FOR
This medicine contains the active ingredient ambroxol hydrochloride,
which belongs to a group of medicines
called mucolytics, used to facilitate the elimination of mucus in the
airways.
MUCICLAR is used for the treatment of acute and chronic secretions in
diseases of the bronchi and the
lungs (in case of cough and catarrh).
Please consult your doctor if you do not see an improvement, or if you
begin to feel worse.
2.
WHAT YOU NEED TO KNOW BEFORE TAKING MUCICLAR
DO NOT TAKE MUCICLAR
-
if you are allergic to ambroxol hydrochloride or any of the other
ingredients of this medicine (listed in
section 6);
-
if you suffer from serious liver or kidney problems.
MUCICLAR must not be used in children under 2 years of age.
WARNINGS AND PRECAUTIONS
Please consult your doctor or pharmacist before taking MUCICLAR.
Take this medicine with caution and inform your doctor:
-
if you suffer from a problem with the stomach or the intestines called
peptic ulcers;
-
if you suffer from kidney problems (ren

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
MUCICLAR 15 mg/5 ml syrup
MUCICLAR 75 mg slow-release capsule
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
MUCICLAR 15 mg/5 ml syrup
100 ml of syrup contains:
Active ingredient: Ambroxol hydrochloride 300 mg
MUCICLAR 75 mg slow-release capsules
One capsule contains:
Active ingredient: Ambroxol hydrochloride 75 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Syrup; Slow-release capsule.
4. CLINICAL INFORMATION
4.1. THERAPEUTIC INDICATIONS
Secretion problems in acute and chronic bronchopulmonary disorders.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
MUCICLAR 15 MG/5 ML SYRUP: adults: 5-10 ml syrup 3 times a day,
children over two years old: 5 ml
of syrup 2 or 3 times a day.
MUCICLAR
75
MG
SLOW-RELEASE
CAPSULE:
adults:
we
recommend
2
capsules
in
a
single
administration after breakfast in the morning for 8 days (treatment of
attack). Thereafter, the dose
can be reduced to a single capsule until the end of the treatment.
4.3.
CONTRAINDICATIONS
Hypersensitivity to ambroxol hydrochloride or to any of the
excipients. Serious changes to liver
and/or kidney function.
Taking the medicinal product is contraindicated in the case of rare
hereditary disorders that may be
incompatible with one of the excipients (see para. 4.4.).
The drug is contraindicated in children under the age of 2 years (for
oral forms).
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Ambroxol must be administered with caution in patients with peptic
ulcer disease.
In very few cases, while taking mucolytic substances such as ambroxol,
serious skin lesions were
observed such as Stevens-Johnson syndrome and toxic epidermal
necrolysis (TEN). Most of these
could be explained by the severity of underlying diseases or other
concomitant medications.
Also, in the initial phase of Stevens-Johnson syndrome or toxic
epidermal necrolysis (TEN),
patients may initially feel non-specific symptoms similar to those of
flu, such as, for example fever,
chills, rhinitis, cough and sore