Acetylcysteine 200mg oral powder sachets sugar free

Држава: Велика Британија

Језик: Енглески

Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активни састојак:

Acetylcysteine

Доступно од:

Colonis Pharma Ltd

АТЦ код:

R05CB01

INN (Међународно име):

Acetylcysteine

Дозирање:

200mg

Фармацеутски облик:

Powder for oral solution

Пут администрације:

Oral

Класа:

No Controlled Drug Status

Тип рецептора:

Valid as a prescribable product

Резиме производа:

BNF: 03070000; GTIN: 5060380960078

Информативни летак

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, pharmacist or
nurse.
■
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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET
1. What Acetylcysteine 200 mg
Powder is and what it is used for
2. What you need to know before
you take Acetylcysteine 200 mg
Powder
3. How to take Acetylcysteine 200
mg Powder
4. Possible side effects
5. How to store Acetylcysteine 200
mg Powder
6. Contents of the pack and other
information
1. What Acetylcysteine 200
mg Powder is and what it
is used for
This medicine is called
Acetylcysteine 200 mg Powder
for Oral Solution (referred to as
Acetylcysteine 200 mg Powder
throughout this leaflet). Each sachet
contains the active substance
acetylcysteine. Acetylcysteine
belongs to a group of medicines
called mucolytics which work by
thinning the mucus (phlegm) so that
it can be coughed up more easily.
Acetylcysteine 200 mg Powder is
used to treat:
■
breathing difficulties caused by
too much mucus in the lungs
and airways or the mucus being
too thick and sticky to cough up
easily.
2. What you need to
know before you take
Acetylcysteine 200 mg
Powder
DO NOT TAKE ACETYLCYSTEINE 200
MG POWDER:
■
if you are allergic (hypersensitive)
to acetylcysteine, other similar
medicines (such as carbocisteine,
erdosteine or mecysteine), or any
of the other ingredients of this
medicine (listed in section 6).
■
if you have a genetic condition
called phenylketonuria where
you are unable to break down a
substance called phenylalanine.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist
before taking Acetylcysteine 200
mg Powder:
■
if you suffer

Карактеристике производа

OBJECT 1
ACETYLCYSTEINE 200MG POWDER FOR ORAL SOLUTION
Summary of Product Characteristics Updated 14-Mar-2017 | Colonis
Pharma Ltd
1. Name of the medicinal product
Acetylcysteine 200 mg Powder for Oral Solution
2. Qualitative and quantitative composition
Each sachet contains Acetylcysteine 200 mg.
Excipient(s) with known effect:
aspartame (E95l): 26 mg per sachet
sorbitol (E420): 723.34 mg per sachet
sunset yellow (El 10): 0.66 mg per sachet
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for oral solution.
White to slightly pink powder.
4. Clinical particulars
4.1 Therapeutic indications
Mucolytic adjuvant in the therapy of respiratory disorders associated
with thick, viscous, mucus
hypersecretion.
4.2 Posology and method of administration
POSOLOGY
Adults and adolescents over the age of 12 years
200 mg (1 sachet) 3 times a day. Maximum recommended daily dose 600
mg/day.
The duration of therapy is dependent on the nature and severity of the
illness, and should be decided by
the doctor treating the patient for adults and adolescents.
Abundant fluid intake supports the mucolytic effect of acetylcysteine.
METHOD OF ADMINISTRATION
Dissolve the contents of one sachet completely in a glass containing a
little water just before use, stirring
as needed with a teaspoon.
4.3 Contraindications
Acetylcysteine 200 mg Powder for Oral Solution must not be used when:
• Hypersensitivity to the active substance, other chemically similar
substance (for example carbocisteine,
erdosteine or mecysteine) or to any of the excipients listed in
section 6.1, is present
• Phenylketonuria is present, as the product contains aspartame.
4.4 Special warnings and precautions for use
Patients with bronchial asthma should be closely monitored during
therapy; if' bronchospasm occurs,
treatment with Acetylcysteine 200 mg Powder for Oral Solution should
be discontinued immediately.
Administration of acetylcysteine, especially at the beginning of
treatment, may liquefy bronchial
secretions and, at the same time, inc