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ACETYLCYSTEINE 600MG EFFERVESCENT TABLETS

Active substance(s): ACETYLCYSTEINE

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e-mail : prasad.pdp@gmail.com
Ph : +91-9845609386

Artwork No.

140115/3

Colours Used

Customer

Ennogen

Pantone 2582 C

Description

Mucolight 600mg tabs_Carton 10's

Pantone 388 C

Market

UK

Pantone 137 C
Black

Language

English

Size

125 x 68 x 65 mm

Min. Font Size

8 pt

Page No.

1 of 1

Version No.

3

Date

22-04-15

Software

Coreldraw 12

Packaging Development

Quality Assurance (QA)

Keyline
Quality Control (QC)

BN No

600mg

Effervescent Tablets
Mucolight
(Acetylcysteine)
Effervescent
Tablets

10
TABLETS

600mg

Mucolight
Effervescent Tablets (Acetylcysteine)
Keep out of the sight and reach of children.
Store product in its original packaging below 25°C.
Protect from moisture and light.

10

Effervescent Tablets (Acetylcysteine)
Each effervescent tablet contains 600mg acetylcysteine.
Also contains sorbitol (E420) and sodium.
For oral administration only. Use
Put dispensing label here
as directed by your doctor.
Dissolve tablet in glass of water
and drink. Allow tablet to
completely dissolve before
drinking.
Please read enclosed Patient
Information Leaflet before use.

Mucolight

600mg

Effervescent Tablets (Acetylcysteine)
PL 40739/0031
MA Holder:
Ennogen Healthcare Limited
Unit G4, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS, UK.
POM

Mucolight
Effervescent
Tablets

Mucolight
Effervescent
Tablets

10 Tablets

600mg

Effervescent Tablets
(Acetylcysteine)

Mucolight

Mucolight

TABLETS

600mg

EXP.

Mucolight

Production

e-mail : prasad.pdp@gmail.com
Ph : +91-9845609386

Artwork No.

240614/1

Colours Used

Customer

Ennogen

Pantone 2582 C

Description

Mucolight 600mg tabs_Carton 30's

Pantone 388 C

Market

UK

Pantone 137 C
Black

Language

English

Size

125 x 68 x 65 mm

Min. Font Size

8 pt

Page No.

1 of 1

Version No.

6

Date

22-04-15

Software

Coreldraw 12

Packaging Development

Quality Assurance (QA)

Keyline
Quality Control (QC)

BN No

600mg

Effervescent Tablets
Mucolight
(Acetylcysteine)
Effervescent
Tablets

20
TABLETS

600mg

Mucolight
Effervescent Tablets (Acetylcysteine)
Keep out of the sight and reach of children.
Store product in its original packaging below 25°C.
Protect from moisture and light.

20

Effervescent Tablets (Acetylcysteine)
Each effervescent tablet contains 600mg acetylcysteine.
Also contains sorbitol (E420) and sodium.
For oral administration only. Use
Put dispensing label here
as directed by your doctor.
Dissolve tablet in glass of water
and drink. Allow tablet to
completely dissolve before
drinking.
Please read enclosed Patient
Information Leaflet before use.

Mucolight

600mg

Effervescent Tablets (Acetylcysteine)
PL 40739/0031
MA Holder:
Ennogen Healthcare Limited
Unit G4, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS, UK.
POM

Mucolight
Effervescent
Tablets

Mucolight
Effervescent
Tablets

20 Tablets

600mg

Effervescent Tablets
(Acetylcysteine)

Mucolight

Mucolight

TABLETS

600mg

EXP.

Mucolight

Production

e-mail : prasad.pdp@gmail.com
Ph : +91-9845609386

Artwork No.

240614/1

Colours Used

Customer

Ennogen

Pantone 2582 C

Description

Mucolight 600mg Tabs Label 30's

Pantone 388 C

Market

UK

Pantone 137 C

Language

English

Black

Size

58 x 60mm

Min. Font Size

8 pt

Page No.

1 of 1

Version No.

5

Date

22-04-15

Software

Coreldraw 12

Packaging Development

Quality Assurance (QA)

Keyline
Quality Control (QC)

Mucolight

Mucolight

Effervescent Tablets
(Acetylcysteine)

Effervescent Tablets
(Acetylcysteine)

600mg

600mg

1 Tablet

1 Tablet

Mucolight

600mg

Mucolight

Production

600mg

Effervescent Tablets (Acetylcysteine)

Effervescent Tablets (Acetylcysteine)

Each effervescent tablet contains 600mg
acetylcysteine.
Also contains sorbitol (E420) and sodium.
For oral administration only. Use as directed by your
doctor.
Dissolve tablet in glass of water and drink. Allow tablet
to completely dissolve before drinking.
Please read enclosed Patient Information Leaflet before
use.
Keep out of the sight and reach of children.
Store product in its original packaging below 25°C.
Protect from moisture and light.

Each effervescent tablet contains 600mg
acetylcysteine.
Also contains sorbitol (E420) and sodium.
For oral administration only. Use as directed by your
doctor.
Dissolve tablet in glass of water and drink. Allow tablet
to completely dissolve before drinking.
Please read enclosed Patient Information Leaflet before
use.
Keep out of the sight and reach of children.
Store product in its original packaging below 25°C.
Protect from moisture and light.

PL 40739/0031
POM
MA Holder: Ennogen Healthcare Limited
Unit G4, Riverside Industrial Estate, Riverside Way, Dartford, DA1 5BS, UK.

PL 40739/0031
POM
MA Holder: Ennogen Healthcare Limited
Unit G4, Riverside Industrial Estate, Riverside Way, Dartford, DA1 5BS, UK.

Batch No:

Batch No:

EXP Date:

EXP Date:

e-mail : prasad.pdp@gmail.com
Ph : +91-9845609386

Artwork No.

270115/1

Colours Used

Customer

Ennogen

Pantone 2582 C

Description

Mucolight 600mg Tube Carton_12's

Pantone 388 C

Market

UK

Pantone 137 C

Language

English

Black

Size

97 x 37 x 37 mm

Min. Font Size

8 pt

Page No.

1 of 1

Version No.

5

Date

08-04-16

Software

Coreldraw 12

Packaging Development

Quality Assurance (QA)

Keyline
Quality Control (QC)

Production

600mg

Mucolight

Effervescent Tablets (Acetylcysteine)
PL 40739/0031
MA Holder: Ennogen Healthcare Limited
Unit G4, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS, UK.

Mucolight

12 Tablets

Put dispensing label here

Effervescent Tablets
(Acetylcysteine)

Each effervescent tablet contains 600mg
acetylcysteine. See leaflet for further
information.
Also contains sorbitol (E420) and sodium.
For oral administration only. Use as
directed by your doctor.
Dissolve tablet in glass of water and drink.
Allow tablet to completely dissolve before
drinking.
Please read enclosed Patient Information
Leaflet before use.

Mucolight

600mg

Mucolight
Effervescent Tablets (Acetylcysteine)

600mg

POM

600mg

Effervescent Tablets (Acetylcysteine)
Keep out of the sight and reach of children.
Store below 25°C.
Store product in its original packaging to protect from moisture and light.
Keep tube tightly closed.

BN No

EXP.

Mucolight
Mucolight

12
TABLETS

600mg

Effervescent Tablets
(Acetylcysteine)

Effervescent
12
Tablets

TABLETS

Mucolight
Effervescent
Tablets

Mucolight
Effervescent
Tablets

e-mail : prasad.pdp@gmail.com
Ph : +91-9845609386

Artwork No.

270115/2

Colours Used

Customer

Ennogen

Pantone 2582 C

Description

Mucolight 600mg Label 12's

Pantone 388 C

Market

UK

Pantone 137 C

Language

English

Black

Size

247 x 240 mm

Min. Font Size

8 pt

Page No.

1 of 1

Version No.

4

Date

08-04-16

Software

Coreldraw 12

Packaging Development

Quality Assurance (QA)

Keyline
Quality Control (QC)

Mucolight

Production

600mg

Effervescent Tablets
(Acetylcysteine)
12
TABLETS

Each effervescent tablet contains 600mg acetylcysteine.
Also contains sorbitol (E420) and sodium. See leaflet for further information.
For oral administration only. Use as directed by your doctor.
Dissolve tablet in glass of water and drink. Allow tablet to completely dissolve before drinking.
Please read enclosed Patient Information Leaflet before use.
Keep out of the sight and reach of children.
Store below 25°C.
Store product in its original packaging to protect from moisture and light.
Keep tube tightly closed.
POM

PL 40739/0031
MA Holder: Ennogen Healthcare Limited
Unit G4, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS, UK.

BN No
EXP.

e-mail : artworkcd@yahoo.com
Ph : +91-09845609386

Artwork No.

200315/2

Colours Used

Customer

Ennogen

Black

Description

EP_A-CYS 600mg Leaflet

Keyline

Market

UK

Language

English

Size

160 x 350 mm

Min. Font Size

9 pt

Page No.

1 of 1

Version No.

11

Date

20-12-17

Software

Coreldraw 12

Packaging Development

Quality Assurance (QA)

Quality Control (QC)

PACKAGE LEAFLET: INFORMATION FOR THE USER

Mucolight 600mg Effervescent Tablets
(Acetylcysteine)
and peeling of the skin. If you develop a rash or
Read all of this leaflet carefully before you start
these skin symptoms you should stop taking
taking this medicine because it contains
these tablets and contact your doctor
important information for you.
!
immediately.
Keep this leaflet. You may need to read it
again.
Effervescent tablets can be a choking hazard if
!
If you have any further questions, ask your
swallowed whole, especially in the elderly. Ensure
doctor, pharmacist or nurse.
that the tablet is fully dissolved before you take it.
!
This medicine has been prescribed for you
only. Do not pass it on to others. It may harm
Other medicines and Mucolight Effervescent
them, even if their signs of illness are the same
Tablets
as yours.
Please tell your doctor or pharmacist if you are
!
If you get any side effects, talk to your doctor,
taking, have recently taken, or might take any
pharmacist or nurse. This includes any possible
other medicines. In particular:
side effects not listed in this leaflet. See section
!
Cough-relieving medicines (antitussives) used
4.
in combination with acetylcysteine can cause a
dangerous build-up of secretions
What is in this leaflet
!
Activated charcoal can reduce the effects of
1. What Mucolight Effervescent Tablets are
acetylcysteine
and what they are used for
!
Antibiotics (e.g. aminoglycosides, penicillins,
2. What you need to know before you take
tetracycline) may not work as well when taken
Mucolight Effervescent Tablets
at the same time as acetylcysteine. If you need
3. How to take Mucolight Effervescent Tablets
to take antibiotics and acetylcysteine you
4. Possible side effects
should leave at least two hours between taking
5. How to store Mucolight Effervescent Tablets
these medicines. This does not apply to
6. Contents of the pack and other information
antibiotics such as cefixime and loracarbef,
1. WHAT MUCOLIGHT EFFERVESCENT
these medicines can be taken at the same time
TABLETS ARE AND WHAT THEY ARE
as acetylcysteine
USED FOR
!
Glyceryl trinitrate used to treat chest pain
(angina). Simultaneous administration of
acetylcysteine and glyceryl trinitrate may
Mucolight Effervescent Tablets contain a medicine
increase the normal effect of glyceryl trinitrate
called acetylcysteine. This belongs to a group of
which is used to help widen the blood vessels
medicines called mucolytics. It works by making
in patients with chest pain. If your doctor
the mucus (phlegm) less sticky which makes the
considers combined treatment with these
mucus easier to cough up.
medicines to be necessary, you will be
Acetylcysteine is used for problems with the
monitored for possible lowering of blood
breathing passages (respiratory tract).
pressure (hypotension), which can be serious
2. WHAT YOU NEED TO KNOW BEFORE YOU
and may be indicated by headaches.
TAKE MUCOLIGHT EFFERVESCENT
TABLETS
Effects of Mucolight Effervescent Tablets on
laboratory tests
Acetylcysteine may affect a test for salicylate (such
Do NOT take Mucolight Effervescent Tablets if
as aspirin) in the blood. It may also affect the
you:
!
results when testing for ketones in urine. Ketones
Are allergic to acetylcysteine or any of the
are produced by the breakdown of fat in the body,
other ingredients of this medicine (listed in
for example in people with high levels of sugar in
section 6)
!
the blood.
Are under 14 years of age.
Mucolight Effervescent Tablets with food, drink
Warnings and precautions
and alcohol
Talk to your doctor, pharmacist or nurse before
Mucolight Effervescent Tablets should be taken
taking Mucolight Effervescent Tablets:
after food.
!
If you have asthma
!
If you have a history of stomach ulcers
Pregnancy and breast-feeding
!
If you are allergic to histamine. If you are not
If you are pregnant or breast-feeding, think you
able to tolerate food and drinks that contain
may be pregnant or are planning to have a baby,
large amount of histamine such as wine,
ask your doctor or pharmacist for advice before
tomatoes or processed food, then
taking this medicine.
Acetylcysteine Effervescent Tablets are not
suitable for you because acetylcysteine affects
Mucolight Effervescent Tablets should not be taken
how histamine is broken down in the body. The
during pregnancy or breast-feeding.
most common symptoms of histamine
intolerance are migraine headaches, flushing,
If you are unsure you should talk to your doctor
hives and rhinitis (stuffy, runny nose) and
before taking these tablets.
itching.
!
If you are on a restricted salt diet (see
Driving and using machines
Mucolight Effervescent Tablets contain sodium)
Mucolight Effervescent Tablets should not affect
!
If you have hereditary problems with some
your ability to drive or use machinery.
sugars (see Mucolight Effervescent Tablets
contain sorbitol)
Mucolight Effervescent Tablets contain sodium
!
If you have liver or kidney problems.
This medicine contains 356.8 mg sodium (main
component of cooking/table salt) in each
Serious skin rashes (Stevens-Johnson syndrome
effervescent tablet. This is equivalent to 17.84% of
and Lyell's syndrome) have rarely been reported
the recommended maximum daily dietary intake of
with the use of acetylcysteine. The rash can often
sodium for an adult.
involve ulcers of the mouth, throat, nose, genitals
and conjunctivitis (red and swollen eyes). These
serious skin rashes are frequently followed by flulike symptoms of fever, headache and body ache.
The rash may progress to widespread blistering

Production

Mucolight Effervescent Tablets contain sorbitol
Sorbitol is a source of fructose. If your doctor has
told you that you (or your child) have an
intolerance to some sugars or if you have been
diagnosed with hereditary fructose intolerance
(HFI), a rare genetic disorder in which a person
cannot break down fructose, talk to your doctor
before you (or your child) take or receive this
medicine.
3. HOW TO TAKE MUCOLIGHT
EFFERVESCENT TABLETS
Always take this medicine exactly as your doctor
has told you. Check with your doctor or pharmacist
if you are not sure.
For oral administration only. Mucolight Effervescent
Tablets should be dissolved completely in a glass
of water before use and taken after food.
Adults and children aged 14 years and over:
The usual dose is 1 tablet, once daily.
Dissolve the tablet in a glass of water and take
after food.
This medicine can be taken for up to 5 days for
acute respiratory problems. Longer-term treatment
may be needed for chronic respiratory disorders.
Children under the age of 14 years
Mucolight Effervescent Tablets are not suitable for
children under the age of 14.
If you take more Mucolight Effervescent Tablets
than you should
If you take more Mucolight Effervescent Tablets
than you should, talk to your doctor or contact your
nearest hospital casualty department immediately.
Take your tablet pack with you. You may have
diarrhoea, heartburn, stomach ache or feel sick.
If you forget to take Mucolight Effervescent
Tablets
If you have forgotten to take a dose, leave out that
dose completely. Take your next dose at the
normal time. Do not take a double dose to make up
for a forgotten dose. If you have trouble
remembering to take your tablets, tell your doctor
or pharmacist.
If you stop taking Mucolight Effervescent
Tablets
You should talk to your doctor or pharmacist before
stopping taking these tablets.
If you have any further questions on the use of this
medicine, ask your doctor, pharmacist or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects, although not everyone gets them.

Rare (may affect up to 1 in 1,000
people)
!
Indigestion
!
Shortness of breath.
Very rare (may affect up to 1 in 10,000
people)
!
Bleeding in the upper respiratory tract.
Not known (frequency cannot be
estimated from the available data)
!
Swelling of the face.
Laboratory tests
Your doctor may want to perform some laboratory
tests while you are taking these tablets.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard or search
for MHRA Yellow Card in the Google Play or Apple
App Store.
By reporting side effects you can help provide
more information on the safety of this medicine.
5. HOW TO STORE MUCOLIGHT
EFFERVESCENT TABLETS
Keep this medicine out of the sight and reach
of children.
Store below 25°C. Store in the original package to
protect from moisture and light. Keep the tube
tightly closed.
Do not use this medicine after the expiry date
which is stated on the blister and carton or label.
The expiry date refers to the last day of that month.
Do not use this medicine if you notice
discolouration of the tablets.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Mucolight Effervescent Tablets contain:
The active substance is acetylcysteine. Each tablet
contains 600 mg acetylcysteine.
The other ingredients are: Ascorbic acid (Vitamin
C), Citric acid, Sodium hydrogen carbonate (see
section 2), Sodium carbonate (see section 2),
Sorbitol (E420) (see section 2), Macrogol 6000,
Sodium citrate (see section 2), Sodium saccharin
(see section 2), Flavour (Lemon).

Stop taking Mucolight Effervescent Tablets and
What Mucolight Effervescent Tablets look like
see a doctor or contact your nearest hospital
and contents of the pack
casualty department immediately:
Mucolight Effervescent Tablets are white flat-faced
!
If you have swelling of the lips, throat or
tablets with bevelled edges 25mm in diameter.
tongue, difficulty in swallowing or breathing.
This could be a sign of an allergic reaction
Mucolight Effervescent Tablets are available in the
!
Any changes to the skin or mucus membranes
following presentations:
(such as your nose, mouth, lips and genitals)
Tubes containing 12 tablets with tamper evident
including skin rashes, blistering or peeling of
plastic caps with inbuilt dessicant.
the skin. These may be accompanied by flu-like
A carton containing 10 tablets packed into
symptoms. These could be signs of serious
individual sachets.
skin reactions such as Stevens-Johnson
A carton containing 20 tablets packed into
Syndrome or Lyell's Syndrome.
individual sachets.
Not all pack sizes may be marketed.
Other side effects reported with this medicine
are shown below:
Marketing Authorisation Holder and
Manufacturer
Uncommon (may affect up to 1 in 100 people)
Ennogen Healthcare Limited
!
Headache
Unit G4, Riverside Industrial Estate,
!
Ringing in the ears (tinnitus)
Riverside Way, Dartford, DA1 5BS, UK
!
Increased heart rate
!
Feeling sick or being sick
This leaflet was last revised in December 2017.
!
Diarrhoea
!
Stomach pains
!
Swelling in the mouth and swelling of the lips
!
Skin rashes and itching
!
Fever
!
Low blood pressure.

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