ALPAC Effervescent Tablet 600mg

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

N-Acetylcysteine

Boleh didapati daripada:

Mansa Healthcare Sdn Bhd

INN (Nama Antarabangsa):

N-Acetylcysteine

Unit dalam pakej:

3x10 Tablets; 10 Tablets; 2x10 Tablets

Dikeluarkan oleh:

ALPEX PHARMA SA

Risalah maklumat

Consumer Medication Information Leaflet (RiMUP)
ALPAC Effervescent Tablet 600mg
N-Acetylcysteine (600mg)
1
What is in this leaflet
1.
What ALPAC is used for
2.
How ALPAC works
3.
Before you use ALPAC
4.
How to use ALPAC
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of ALPAC
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
What ALPAC is used for
ALPAC is used to reduce the thickness
and secretions from the respiratory tract.
How ALPAC works
ALPAC contains the active ingredient
known as N-Acetylcysteine, belonging
to a group of medicines called
mucolytic which works by thinning the
mucus (phlegm) in the respiratory tract
so that it can be coughed up more easily.
Before you use ALPAC
When you must not use it
You must not use ALPAC if:

You are allergic to N-
Acetylcysteine or any of the
other ingredients in this
medicine

You are a child under 2 years
of age
Before you start use it
Talk to your doctor or pharmacist
before taking ALPAC if:

If you suffer from asthma.
You may need to be monitored
closely while taking this
medication. Treatment with N-
acetylcysteine should be
stopped when breathing
difficulties occur

If you are an elderly or
debilitated patient with severe
respiratory insufficiency

If you have or had history of
peptic ulceration as ALPAC
may irritate your gastric wall.
In particular if you use other
drugs known to irritate the
gastric wall.

If you need to be on a
controlled sodium (low
sodium/ low salt) diet

If you have histamine
intolerance as N-
Acetylcysteine may cause
symptoms of intolerance
(headache, vasomotor rhinitis,
itching)

If you are due to have any
blood or urine tests, as N-
Acetylcysteine can interfere
with some laboratory test

You are pregnant or
breastfeeding, think you may
be pregnant or are planning to
have a baby
Taking other medicines
Tell your doctor if you are taking any
other medicines, including any that you
buy from a pharmacy, supermarket or
health food shop without a prescription

Ciri produk

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MY-SG_rev1
PACKAGE INSERT
ALPAC Effervescent Tablet 600mg
1.
NAME OF THE MEDICINAL PRODUCT
ALPAC Effervescent Tablet 600mg.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ALPAC Effervescent Tablet 600mg contains 600 mg of
N-Acetylcysteine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Effervescent tablet.
Round, flat, white to yellowish effervescent tablet (1500 mg/tablet; ~
17 x 4.25mm). Clear with
air bubbles after dissolve in water
4.
CLINICAL PARTICULARS
4.1 Therapeutic indications
All respiratory tract diseases leading to the formation of thick
secretions difficult to be
expectorated, such as acute and chronic bronchitis, laryngitis,
sinusitis, tracheitis, influenza,
bronchial asthma and (as complementary treatment) mucoviscidosis
4.2 Posology and method of administration
Posology
Adults
1 effervescent tablet of 600 mg once daily.
Method of administration
Precautions to be taken before handling or administering the medicinal
product.
For patients with a reduced cough reflex (elderly and weakened
patients) are advised to take the
effervescent tablet in the mornings.
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Dissolve ALPAC Effervescent Tablet 600mg in a glass of water. This
produces a solution that
may be consumed immediately.
ALPAC Effervescent Tablet 600mg are contraindicated in children under
2 years of age (see
section 4.3). Other forms and strengths of N-Acetylcysteine are more
suitable for
are more
suitable for children >2 and adolescents.
4.3 Contraindications
- Hypersensitivity to N-Acetylcysteine or to any of the excipients
listed in section 6.1.
- The tablets should not be used by children under 2 years of age.
4.4 Special warnings and precautions for use
Bronchospasms may occur with the use of N-Acetylcysteine. If
bronchospasm occur, the
medicinal product should be discontinued immediately.
Caution is advised in patients with a history of peptic ulcer,
especially when used
concomitantly with other medicinal products known to irritate the
mucous membrane of the
gastrointestinal tract.
Serio