Parmenol 1.5 mg/ml oral solution

Страна: Мальта

мова: англійська

Джерело: Medicines Authority

Доступна з:

Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus

Код атс:

R05DB13

ІПН (Міжнародна Ім'я):

BUTAMIRATE CITRATE 1.5 mmol/ml

Фармацевтична форма:

ORAL SOLUTION

Склад:

BUTAMIRATE CITRATE 1.5 mmol/ml

Тип рецепту:

POM

Терапевтична области:

COUGH AND COLD PREPARATIONS

Огляд продуктів:

Licence number in the source country: NOT APPLICAPABLE

Статус Авторизація:

Authorised

Дата Авторизація:

2022-07-21

інформаційний буклет

Pil-buramirate-citrate-v1.0-MT
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PARMENOL 1.5 MG/ML ORAL SOLUTION
butamirate citrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
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.
WHAT IS IN THIS LEAFLET
1.
What Parmenol is and what it is used for
2.
What you need to know before you take Parmenol
3.
How to take Parmenol
4.
Possible side effects
5.
How to store Parmenol
6.
Contents of the pack and other information
1.
WHAT PARMENOL IS AND WHAT IT IS USED FOR
Parmenol contains butamirate citrate, which is a central cough
suppressant that is chemically and
pharmacologically unrelated to opium alkaloids.
Parmenol is indicated in acute non-productive (dry) cough due to a
variety of causes.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARMENOL
DO NOT TAKE PARMENOL
-
if you are allergic to butamirate citrate or any of the other
ingredients of this medicine (listed in
section 6).
-
in children under 3 years of age.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Parmenol
-
with expectorants (a type of cough medicine used to help clear mucus)
which may lead to the
stagnation of mucus in the respiratory tract and an increased risk of
bronchospasm (narrowing of
the airways) and airways infection.
-
if you have kidney or liver problems, because you may be more likely
to get side effects.
OTHER MEDICINES AND PARMENOL
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other
medicines, for example:
-
other cough medicines, such as expectorants (see section “Warnings
and precautions”)
P

Характеристики продукта

Spc-butamirate-citrate-v1.0-MT
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Parmenol 1.5 mg/ml oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of oral solution contains 1.5 mg butamirate citrate.
Excipients with known effect: sorbitol, sodium benzoate.
This medicine contains 290.5 mg sorbitol in each ml oral solution.
This medicine contains 1.1325 mg sodium benzoate in each ml oral
solution.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution
Colourless to slightly brownish-yellow liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Parmenol is indicated in adults, adolescents and children over 3 years
of age for the symptomatic
treatment of non-productive cough of various origin.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
15 ml oral solution 4 times daily.
_Paediatric population _
_Adolescents (over 12 years of age)_
: 15 ml oral solution 3 times daily.
_Children 6 to 12 years of age_
: 10 ml oral solution 3 times daily
_Children 3 to 6 years of age_
: 5 ml oral solution 3 times daily.
The maximum duration of treatment without indicated by doctor is 1
week.
_Patients with renal or hepatic impairment _
Data is lacking in patients with impaired renal or hepatic function.
Patients with renal and/or liver
disease may be at greater risk for adverse effects from butamirate due
to drug and metabolite
accumulation.
Method of administration
For oral use.
The graduated cup has to be washed and dried after each use and
between different users.
4.3
CONTRAINDICATIONS
Spc-butamirate-citrate-v1.0-MT
2
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Children under 3 years of age.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Due to inhibition of the cough reflex by butamirate, the simultaneous
administration of expectorants
has to be avoided, because it may lead to the stagnation of mucus in
the respiratory tract, which
increases the risk of bronchospasm and airways infection.
If this