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PARACETAMOL EFFERVESCENT 500MG TABLETS

Active substance(s): PARACETAMOL / PARACETAMOL

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Paracetamol 500mg (PIL)
Size: 280 x 190mm

CIPLA

280mm
2D
Code
Area

PATIENT INFORMATION LEAFLET
PARACETAMOL EFFERVESCENT 500mg TABLETS
The name of this medicine is Paracetamol Effervescent 500mg Tablets, which will be
referred to as Paracetamol Effervescent throughout this leaflet.
Read all of this leaflet carefully because it contains important information for
you.
• This medicine is available without prescription. However, you still need to use
Paracetamol Effervescent carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor if your symptoms worsen or do not improve after three
days.
• If any of the side effects gets serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.

The active ingredient in Paracetamol Effervescent is paracetamol.
Paracetamol Effervescent is used to relieve pain, including muscular and rheumatic
pains, headache, migraine, neuralgia (severe burning or stabbing pain following the
line of a nerve), toothache, sore throat, period pains, aches and pains, discomfort
associated with influenza (flu), feverishness and feverish colds.

2. BEFORE YOU TAKE PARACETAMOL EFFERVESCENT
2D
Code
Area

Do not take Paracetamol Effervescent if you:
• are allergic (hypersensitive) to paracetamol or any of the other ingredients in
the tablets (these are listed in Section 6, Further Information)
• are already taking other medicines containing paracetamol
• are on a low sodium diet
Page 1

Please tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription.
Certain medicines can interfere with the effectiveness of each other. It is particularly
important to tell your doctor or pharmacist before taking this medicine if you are also
on:
• metoclopramide or domperidone (often taken for sickness or stomach problems)
• colestyramine (used to treat high cholesterol)
• blood thinning medicines (anticoagulants) such as warfarin
• chloramphenical an antibiotic to treat eye infections
It may still be all right for you to take Paracetamol Effervescent and your doctor will be
able to decide what is suitable for you.
Taking your medicine with food and drink
Paracetamol should be dissolved in at least half a glass of water and can be taken
with or without a meal.
Pregnancy and breast-feeding
Although there is no evidence that these tablets cause any ill effects, your doctor
should advise you about taking them if you are pregnant, likely to become pregnant
or are breast-feeding. Ask your doctor or pharmacist for advice before taking any
medicines.
Driving and using machinery
The effect of paracetamol on the ability to drive and operate machinery is not known.
If you feel dizzy or drowsy do not drive or operate machinery.
Important information about some of the ingredients of Paracetamol
Effervescent
Each of these tablets contains about 438 mg of sodium and may interfere if you are
on a low sodium diet.
This product also contains aspartame (a source of phenylalanine), which should
not be given to anyone with phenylketonuria.

AXP065FUF

Customer: Fannin PL 20417/0065
Change: Pediatric Wording
Colour: Pantone Black C
Size: 280 x 190mm Proof: 1
Date: 14 Sep 16

1. WHAT PARACETAMOL EFFERVESCENT IS AND WHAT IT
IS USED FOR

2D
Code
Area

Taking other medicines
Do not take these tablets if you are already taking other medicines containing
paracetamol.

Page 2
2D
Code
Area

190mm

In this leaflet:
1. What Paracetamol Effervescent is and what it is used for
2. Before you take Paracetamol Effervescent
3. How to take Paracetamol Effervescent
4. Possible side effects
5. How to store Paracetamol Effervescent
6. Further information

Take special care with Paracetamol Effervescent if:
• you have kidney or liver problems, including alcoholic liver disease
Taking a painkiller for headaches too often or for too long can make them worse.

Paracetamol 500mg (PIL)
Size: 280 x 190mm

280mm
2D
Code
Area

3. HOW TO TAKE PARACETAMOL EFFERVESCENT

If you take more Paracetamol Effervescent than you should:
Talk to a doctor at once if you take too much of this medicine even if you feel well.
This is because too much paracetamol can cause delayed, serious liver damage.
Remember to take the pack and any remaining tablets with you.
If you have any further questions about this product ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Paracetamol Effervescent can cause side effects although not
everybody gets them. If you get any of the following symptoms after taking these
tablets, you should contact your doctor immediately:
• any sudden wheeziness, difficulty in breathing or dizziness, swelling of the
eyelids, face, lips or throat
• an acute allergic reaction (anaphylaxis) or swelling of the skin

5. HOW TO STORE PARACETAMOL EFFERVESCENT
Do not store your tablets above 25°C. Store in the original package and protect from
moisture.
Do not take this medicine after the expiry date stated on the carton. The expiry date
refers to the last day of that month.
Keep all medicines out of the sight and reach of children.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.

6. FURTHER INFORMATION
What Paracetamol Effervescent 500mg Tablets contain:
The active ingredient is paracetamol. Each tablet contains 500 mg paracetamol.
The other ingredients are anhydrous citric acid (E330), povidone, sodium hydrogen
carbonate (E500), saccharin sodium, anhydrous sodium carbonate, simeticone
(E900), polysorbate 80 (E433), aspartame (E951) (a source of phenylalanine).
Each tablet contains 438 mg of sodium.
What Paracetamol Effervescent 500mg Tablets look like and the contents of the
pack:
Paracetamol Effervescent 500mg Tablets are white, circular effervescent tablets.
Your medicine is available in blister packs of 24, 32, 60 and 100 tablets (not all pack
sizes may be marketed).
Marketing Authorisation Holder:
Fannin (UK) Limited, 42-46 Booth Drive, Park Farm South, Wellingborough,
Northamptonshire, NN8 6GT, UK.
Manufacturer responsible for batch release:
Kent Pharmaceuticals Limited, Crowbridge Road, Ashford, Kent, TN24 0GR, U.K.
Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K.
This leaflet was last approved in September 2016.

Page 3

AXP065FUF

2D
Code
Area

The following side effects have also been reported:
• Very rare cases of serious skin reactions have been reported.
• Very rare reports of blood problems, so if you notice unusual bleeding, you bruise
more easily than normal, or you seem to be more susceptible to infections than
usual, tell your doctor as soon as possible.
• Yellowing of the skin or eyes, pale stools or upper abdominal pain (these may be
signs of liver problems so tell your doctor if this happens to you) blood tests may
show abnormal liver function.

2D
Code
Area

190mm

Do not exceed the recommended doses. If painful symptoms are not relieved in a
few days, consult your doctor.
Dosage
The usual doses for Paracetamol Effervescent are as follows:
Adults and children over 16 years:
Take 1 or 2 tablets up to 4 times a day, or as instructed by your doctor.
Children 12-15 years of age: One tablet maximum.
The dose should not be repeated more frequently than every 4 hours, and not more
than 4 doses should be taken in any 24-hour period. Do not continue to take these
tablets for more than 3 days unless instructed by your doctor.
Not recommended for children under 12 years of age.
Method of Administration
For oral administration only. These tablets should be dissolved in at least half a glass
of water before taking them. These tablets are meant to be dissolved first so don’t try
to swallow them whole. Stir before use.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly
via United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard

Page 4
2D
Code
Area

No printing area

9 mm Pharmacode

Paracetamol packinsert keylines back side
Size - 297 x 210 mm
OPP inventory code & artwork representation as
xxxxxxx
xx

GSM paper : NLT 60gsm

OMAN
Pharmacode

In this leaflet:
1. What Paracetamol Effervescent is and what it is used for
2. Before you take Paracetamol Effervescent
3. How to take Paracetamol Effervescent
4. Possible side effects
5. How to store Paracetamol Effervescent
6. Further information

10 mm free
space for
Laetus Pharmacode
System

Taking a painkiller for headaches too often or for too long can make them worse.

Taking other medicines
Do not take these tablets if you are already taking other medicines containing
paracetamol.
Please tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription.
Certain medicines can interfere with the effectiveness of each other. It is particularly
important to tell your doctor or pharmacist before taking this medicine if you are also
on:
• metoclopramide or domperidone (often taken for sickness or stomach problems)
• colestyramine (used to treat high cholesterol)
• blood thinning medicines (anticoagulants) such as warfarin
It may still be all right for you to take Paracetamol Effervescent and your doctor will be
able to decide what is suitable for you.

The active ingredient in Paracetamol Effervescent is paracetamol.
Paracetamol Effervescent is used to relieve pain, including muscular and rheumatic
pains, headache, migraine, neuralgia (severe burning or stabbing pain following the line
of a nerve), toothache, sore throat, period pains, aches and pains, discomfort associated
with influenza (flu), feverishness and feverish colds.

2. BEFORE YOU TAKE PARACETAMOL EFFERVESCENT
Do not take Paracetamol Effervescent if you:

Taking your medicine with food and drink
Paracetamol should be dissolved in at least half a glass of water and can be taken
with or without a meal.

• any sudden wheeziness, difficulty in breathing or dizziness, swelling of the
eyelids, face, lips or throat
• an acute allergic reaction (anaphylaxis) or swelling of the skin
The following side effects have also been reported:
• Very rare cases of serious skin reactions have been reported.
• Very rare reports of blood problems, so if you notice unusual bleeding, you bruise
more easily than normal, or you seem to be more susceptible to infections than
usual, tell your doctor as soon as possible.
• Yellowing of the skin or eyes, pale stools or upper abdominal pain (these may be
signs of liver problems so tell your doctor if this happens to you) blood tests may
show abnormal liver function.

Driving and using machinery
The effect of paracetamol on the ability to drive and operate machinery is not known.
If you feel dizzy or drowsy do not drive or operate machinery.
Important information about some of the ingredients of Paracetamol Effervescent
Each of these tablets contains about 438 mg of sodium and may interfere if you are
on a low sodium diet.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. You can also report side effects directly via United
Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard
Page 3

Page 2

Do not take this medicine after the expiry date stated on the carton. The expiry date
refers to the last day of that month.
Keep all medicines out of the sight and reach of children.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.

6. FURTHER INFORMATION
What Paracetamol Effervescent 500mg Tablets contain:
The active ingredient is paracetamol. Each tablet contains 500 mg paracetamol.
The other ingredients are anhydrous citric acid (E330), povidone, sodium hydrogen
carbonate (E500), saccharin sodium, anhydrous sodium carbonate, simeticone
(E900), polysorbate 80 (E433), aspartame (E951) (a source of phenylalanine).
Each tablet contains 438 mg of sodium.
What Paracetamol Effervescent 500mg Tablets look like and the contents of the
pack:
Paracetamol Effervescent 500mg Tablets are white, circular effervescent tablets.
Your medicine is available in blister packs of:
PL 20417/0065 - 24, 32, 60 and 100 tablets
PL 20417/0066 - 12, 16, 24, 28 and 30 tablets
(not all pack sizes may be marketed).
Marketing Authorisation Holder:
Fannin (UK) Limited, 42-46 Booth Drive, Park Farm South, Wellingborough,
Northamptonshire, NN8 6GT, UK.
Manufacturer responsible for batch release:
Kent Pharmaceuticals Limited, Crowbridge Road, Ashford, Kent, TN24 0GR, U.K.
Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K.
This leaflet was last approved in May 2015.

BXP065FUB

xx

Page 4

Pharmacode

xx

Pharmacode

Pharmacode

BXP065FUB

Page 1

Like all medicines, Paracetamol Effervescent can cause side effects although not
everybody gets them. If you get any of the following symptoms after taking these
tablets, you should contact your doctor immediately:

Pregnancy and breast-feeding
Although there is no evidence that these tablets cause any ill effects, your doctor
should advise you about taking them if you are pregnant, likely to become pregnant
or are breast-feeding. Ask your doctor or pharmacist for advice before taking any
medicines.

This product also contains aspartame (a source of phenylalanine), which should not
be given to anyone with phenylketonuria.

Do not store your tablets above 25°C. Store in the original package and protect from
moisture.

4. POSSIBLE SIDE EFFECTS

Pharmacode

• are allergic (hypersensitive) to paracetamol or any of the other ingredients in
the tablets (these are listed in Section 6, Further Information)
• are already taking other medicines containing paracetamol
• are on a low sodium diet

Do not exceed the recommended doses. If painful symptoms are not relieved in a
few days, consult your doctor.
Dosage
The usual doses for Paracetamol Effervescent are as follows:
Adults and children over 16 years:
Take 1 or 2 tablets up to 4 times a day, or as instructed by your doctor.
Children 12-15 years of age: One tablet maximum.
The dose should not be repeated more frequently than every 4 hours, and not more
than 4 doses should be taken in any 24-hour period. Do not continue to take these
tablets for more than 3 days unless instructed by your doctor.
Not recommended for children under 12 years of age.
Method of Administration
For oral administration only. These tablets should be dissolved in at least half a glass
of water before taking them. These tablets are meant to be dissolved first so don’t try
to swallow them whole. Stir before use.
If you take more Paracetamol Effervescent than you should:
Talk to a doctor at once if you take too much of this medicine even if you feel well.
This is because too much paracetamol can cause delayed, serious liver damage.
Remember to take the pack and any remaining tablets with you.
If you have any further questions about this product ask your doctor or pharmacist.

• chloramphenical an antibiotic to treat eye infections

1. WHAT PARACETAMOL EFFERVESCENT IS AND WHAT IT IS USED FOR

5. HOW TO STORE PARACETAMOL EFFERVESCENT

Pharmacode

• This medicine is available without prescription. However, you still need to use
Paracetamol Effervescent carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor if your symptoms worsen or do not improve after three
days.
• If any of the side effects gets serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.

• you have kidney or liver problems, including alcoholic liver disease

3. HOW TO TAKE PARACETAMOL EFFERVESCENT

Pharmacode

Read all of this leaflet carefully because it contains important information for
you.

Take special care with Paracetamol Effervescent if:

Pharmacode

The name of this medicine is Paracetamol Effervescent 500mg Tablets, which will be
referred to as Paracetamol Effervescent throughout this leaflet.

Pharmacode

Pharmacode

PATIENT INFORMATION LEAFLET
PARACETAMOL EFFERVESCENT 500mg TABLETS

Pharmacode

Customer: Fannin PL 20417/0065 & /0066
Change: Pediatric Wording
Colour: Pantone Black C
Size: 297 x 210mm Proof: 1
Date: 14 Sep 15

Paracetamol packinsert keylines front side (Fannin)
Size - 297 x 210 mm
OPP inventory code & artwork representation as
xxxxxxx
xx

Pharmacode

SPL

The name of this medicine is Paracetamol Effervescent 500mg Tablets,
which will be referred to as Paracetamol Effervescent throughout this
leaflet.

Read all of this leaflet carefully because it contains important
information for you.
• This medicine is available without prescription. However, you still need to
use Paracetamol Effervescent carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor if your symptoms worsen or do not
improve after three days.
• If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Paracetamol Effervescent is and what it is used for
2. Before you take Paracetamol Effervescent
3. How to take Paracetamol Effervescent
4. Possible side effects
5. How to store Paracetamol Effervescent
6. Further information
1. WHAT PARACETAMOL EFFERVESCENT IS AND WHAT IT
IS USED FOR
The active ingredient in Paracetamol Effervescent is paracetamol.
Paracetamol Effervescent is used to relieve pain, including muscular and
rheumatic pains, headache, migraine, neuralgia (severe burning or
stabbing pain following the line of a nerve), toothache, sore throat, period
pains, aches and pains, discomfort associated with influenza (flu),
feverishness and feverish colds.
2. BEFORE YOU TAKE PARACETAMOL EFFERVESCENT

400 mm

Do not take Paracetamol Effervescent if you:
• are allergic (hypersensitive) to paracetamol or any of the other
ingredients in the tablets (these are listed in Section 6, Further
Information)
• are already taking other medicines containing paracetamol
• are on a low sodium diet
Take special care with Paracetamol Effervescent if:
• you have kidney or liver problems, including alcoholic liver disease
Taking a painkiller for headaches too often or for too long can make them
worse.
Taking other medicines
Do not take these tablets if you are already taking other medicines
containing paracetamol.
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription.
Certain medicines can interfere with the effectiveness of each other. It is
particularly important to tell your doctor or pharmacist before taking this
medicine if you are also on:
• metoclopramide or domperidone (often taken for sickness or stomach
problems)

• colestyramine (used to treat high cholesterol)
• blood thinning medicines (anticoagulants) such as warfarin
• chloramphenical an antibiotic to treat eye infections

It may still be all right for you to take Paracetamol Effervescent and your
doctor will be able to decide what is suitable for you.
Taking your medicine with food and drink
Paracetamol should be dissolved in at least half a glass of water and can
be taken with or without a meal.
Pregnancy and breast-feeding
Although there is no evidence that these tablets cause any ill effects, your
doctor should advise you about taking them if you are pregnant, likely to
become pregnant or are breast-feeding. Ask your doctor or pharmacist for
advice before taking any medicines.
Driving and using machinery
The effect of paracetamol on the ability to drive and operate machinery is
not known. If you feel dizzy or drowsy do not drive or operate machinery.
Important information about some of the ingredients of Paracetamol
Effervescent
Each of these tablets contains about 438 mg of sodium and may interfere
if you are on a low sodium diet.
This product also contains aspartame (a source of phenylalanine), which
should not be given to anyone with phenylketonuria.
3. HOW TO TAKE PARACETAMOL EFFERVESCENT
Do not exceed the recommended doses. If painful symptoms are not
relieved in a few days, consult your doctor.

Dosage
The usual doses for Paracetamol Effervescent are as follows:
Adults and children over 16 years:
Take 1 or 2 tablets up to 4 times a day, or as instructed by your doctor.
Children 12-15 years of age: One tablet maximum.
The dose should not be repeated more frequently than every 4 hours,
and not more than 4 doses should be taken in any 24-hour period. Do
not continue to take these tablets for more than 3 days unless
instructed by your doctor.
Not recommended for children under 12 years of age.

12 mm

36 mm

PATIENT INFORMATION LEAFLET
PARACETAMOL EFFERVESCENT 500mg TABLETS

18 mm

18 mm

36 mm

12 mm

Method of Administration
For oral administration only. These tablets should be dissolved in at
least half a glass of water before taking them. These tablets are meant
to be dissolved first so don’t try to swallow them whole. Stir before use.
If you take more Paracetamol Effervescent than you should:
Talk to a doctor at once if you take too much of this medicine even if
you feel well. This is because too much paracetamol can cause
delayed, serious liver damage. Remember to take the pack and any
remaining tablets with you.
If you have any further questions about this product ask your doctor or
pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Paracetamol Effervescent can cause side effects
although not everybody gets them. If you get any of the following
symptoms after taking these tablets, you should contact your doctor
immediately:
• any sudden wheeziness, difficulty in breathing or dizziness,
swelling of the eyelids, face, lips or throat
• an acute allergic reaction (anaphylaxis) or swelling of the skin
The following side effects have also been reported:
• Very rare cases of serious skin reactions have been reported.
• Very rare reports of blood problems, so if you notice unusual
bleeding, you bruise more easily than normal, or you seem to be
more susceptible to infections than usual, tell your doctor as soon as
possible.
• Yellowing of the skin or eyes, pale stools or upper abdominal pain
(these may be signs of liver problems so tell your doctor if this
happens to you) blood tests may show abnormal liver function.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via United Kingdom Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
5. HOW TO STORE PARACETAMOL EFFERVESCENT

400 mm

Do not store your tablets above 25°C. Store in the original package and
protect from moisture.
Do not take this medicine after the expiry date stated on the carton. The
expiry date refers to the last day of that month.
Keep all medicines out of the sight and reach of children.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Paracetamol Effervescent 500mg Tablets contain:
The active ingredient is paracetamol. Each tablet contains 500 mg
paracetamol.
The other ingredients are anhydrous citric acid (E330), povidone,
sodium hydrogen carbonate (E500), saccharin sodium, anhydrous
sodium carbonate, simeticone (E900), polysorbate 80 (E433),
aspartame (E951) (a source of phenylalanine).
Each tablet contains 438 mg of sodium.
What Paracetamol Effervescent 500mg Tablets look like and the
contents of the pack:
Paracetamol Effervescent 500mg Tablets are white, circular
effervescent tablets.
Your medicine is available in blister packs of:
PL 20417/0065 - 24, 32, 60 and 100 tablets
PL 20417/0066 - 12, 16, 24, 28 and 30 tablets
(not all pack sizes may be marketed).
Marketing Authorisation Holder:
Fannin (UK) Limited, 42-46 Booth Drive, Park Farm South,
Wellingborough, Northamptonshire, NN8 6GT, UK.
Manufacturer responsible for batch release:
Special Product’s Line S.p.A., Via Paduni, 240 - 03012 Anagni
(Frosinone) - Italy.
This leaflet was last approved in September 2016.

Customer: Fannin PL 20417/0065-66
Change: Pediatric wording & Joint PIL
Code: SPLXP065FUB
Colour: Pantone Black C
Size: 140 x 400mm
Proof: 1
Date: 13 Sep 16

SPLXP065FUB

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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