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PARACETAMOL 500 MG EFFERVESCENT TABLETS

Active substance(s): PARACETAMOL

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Artwork No.

-

Colours Used

Customer

Accord

Black

Description

Paracetamol Effervescent 500 mg Tablets

Market

UK

Language

English

Size

170 x 300 mm PIL

Min. Font Size

9

Version No.

22 (Page 1 of 2) (04-16-spc)

Date

25_10_16 (Para 500 mg Effervescent Tab(UK)NL-04-16-PIL)

Prepared By
Regulatory Affairs

Checked By
Regulatory Affairs

PACKAGE LEAFLET: INFORMATION FOR THE
USER

Paracetamol 500 mg
Effervescent Tablets
Paracetamol

Read all of this leaflet carefully because it
contains important information for you.
• This medicine is available without prescription.
However, you still need to take Paracetamol
Effervescent tablets carefully to get the best
result 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 3 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 Tablets is and
what it is used for
2. What you need to know before you take
Paracetamol Effervescent Tablets
3. How to take Paracetamol Effervescent Tablets
4. Possible side effects
5. How to store Paracetamol Effervescent Tablets
6. Contents of the pack and other information

1. What Paracetamol Effervescent
Tablets is and what it is used for
Paracetamol Effervescent Tablets contain
Paracetamol, which is a mild pain killer and
reduces the body temperature in fever. The
tablets are recommended for use in treatment of
mild to moderate pain and/or fever.

2. What you need to know before you
take Paracetamol Effervescent
Tablets
Do not take Paracetamol Effervescent Tablets
• If you are allergic (hypersensitive) to
Paracetamol, or any of the ingredients of
Paracetamol effervescent tablets.
Warnings and precautions
Tell your doctor if you:
• Are suffering from liver problems including liver
problems due to excessive alcohol
consumption.
• Gilbert’s syndrome (mild jaundice)
• Are suffering from kidney problems
• Are suffering from dehydration and chronic
malnutrition
• Suffer from asthma and are sensitive to aspirin
• Are taking any other paracetamol containing
medicines
• Have a fever that does not improve after taking
this medicine
• Have glucose-6-phosphatedehydrogenase
deficiency (enzyme deficiency)
• Have hemolytic anemia (abnormal breakdown
of red blood cells).
Other medicines and Paracetamol
Effervescent Tablets
Please tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines, including those you have bought
without a prescription.
Tell your doctor before you take Paracetamol
Effervescent Tablets if you are taking:
• Drugs to thin the blood (anti-coagulant drugs
e.g. Warfarin ,other coumarins)
• Medicines used to relieve sickness (e.g.
Metoclopramide, Domperidone)

Approved By
Quality Assurance

• Medicines used to treat high cholesterol
(Cholestyramine)
• Probenecid (Medicine used to treat high levels
of uric acid in the blood stream(gout))
• Medicine to treat fever or mild pain (Aspirin,
Salicylamide)
• Barbiturates and tricyclic antidepressants (to
treat depression)
• Medicines used to treat epilepsy (Lamotrigine)
• Medicines to treat tuberculosis (Isoniazid)
Effects of paracetamol on laboratory tests
Uric acid and blood sugar tests may be affected.
Paracetamol Effervescent Tablets with food
and drink
This medicine may be taken with or without food.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before
taking any medicine.
If you are pregnant see your doctor before you
take Paracetamol effervescent Tablets.
Small amounts of paracetamol pass into breast
milk. This medicine may be taken, as instructed
(see section 3), by mothers who are breastfeeding.
Driving and using machines
Paracetamol has no influence on the ability to
drive and use machines.
Paracetamol Effervescent Tablets contains
sodium and sorbitol
This medicinal product contains 503mg of
sodium. The maximum recommended daily dose
of this medicinal product contains 4024mg
sodium (found in table salt). This is equivalent to
201.2% of the adult recommended maximum
daily dietary intake for sodium.
Talk to your pharmacist or doctor if you need
Paracetamol Effervescent Tablets on a daily basis
for a prolonged period of time, especially if you
have been advised to have a low salt diet.
This medicinal product contains sorbitol. If you
have been told by your doctor that you have
intolerance to some sugars, contact your doctor
before taking this medicinal product.

3. How to take Paracetamol
Effervescent Tablets
Method of Administration
Paracetamol 500 mg Effervescent Tablets are for
oral administration. The tablet(s) should be
placed in a full tumbler of water and allowed to
dissolve completely before swallowing.
This presentation is reserved for use in adults
and in adolescents aged 12 years and above.
Children and adolescents:
Children below 12 years of age: Do not give to
children younger than 12 years.
Adolescents of 12 to 15 years and weighing 41 to
50 kg, the recommended dose is one tablet to be
taken every 4-6 hours when necessary to a
maximum of 4 doses in 24 hours. Maximum
single dose is 500mg ( 1 effervescent tablet)
Adolescents of 16 to 18 years and weighing more
than 50kg: as adults.
Adults and children 16 years and older :
The recommended dose is one or two tablets
every 4 – 6 hours when necessary up to four times
daily. Maximum dose of 8 tablets in 24 hours.
Maximum single dose is 1g (2 effervescent tablets)
If the pain persists for more than 5 days or the
fever lasts for more than 3 days, or gets
worse or other symptoms appear, you should
stop the treatment and consult a doctor.
Do not take more medicine than the label or
leaflet tells you too.
If you take more Paracetamol Effervescent
Tablets than you should:
Talk to a doctor at once if you take too much of
this medicine even if you feel well. This is

Artwork No.

-

Colours Used

Customer

Accord

Black

Description

Paracetamol Effervescent 500 mg Tablets

Market

UK

Language

English

Size

170 x 300 mm PIL

Min. Font Size

9

Version No.

22 (Page 2 of 2) (04-16-spc)

Date

25_10_16 (Para 500 mg Effervescent Tab(UK)NL-04-16-PIL)

Prepared By
Regulatory Affairs

Checked By
Regulatory Affairs

because too much paracetamol can cause
delayed, serious liver damage.
If you forget to take Paracetamol Effervescent
Tablets:
If you forget to take a dose, take another as soon
as you remember, unless it is almost time for your
next dose. Remember to leave atleast four hours
between doses. Never double-up on a dose to
make up for the one you have missed.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Paracetamol Effervescent
Tablets can cause side effects, although not
everybody gets them.
Very rare cases of serious skin reactions have
been reported.
• accumulation of fluid in the larynx including an
itchy rash, throat swelling (severe allergic reaction),
• swelling on the face, mouth, hands (angioedema)
You should stop taking Paracetamol
Effervescent Tablets and see your doctor
immediately if you experience symptoms like:
• Serious skin disease causing rash, skin peeling
and sores.
• severe blistering and peeling of the skin.
The frequency using the following convention:
Rare (may affect up to 1 in 1,000 people):
Oedema (abnormal accumulation of fluid under the
skin), abnormal vision, simple skin rash or urticaria
(dark red rash on the skin), haemorrhage (bleeding),
abdominal pain, diarrhoea, nausea, vomiting,
dizziness, fever, reduction of irritability or agitation
(sedation), platelet disorders (clotting disorders),
stem cell disorders (disorders of the blood forming
cell in the bone marrow), abnormal liver function,
liver failure, hepatic necrosis (death of liver cells),
jaundice, overdose and poisoning, tremor,
headache, depression, confusion, hallucinations,
sweating, pruritus (itching), feeling lousy (malaise).
Very rare (may affect up to 1 in 10,000 people):
hepatotoxicity (damage caused to the liver),
thrombocytopenia (reduction in blood platelets,
which increases the risk of bleeding or bruising),
leucopenia (frequent infections due to poorly
functioning white blood cells or decrease in white
blood cells), neutropenia (reduced neutrophil count
in blood), agranulocytosis (severe decrease in
white blood cells which may lead to severe
infections), hemolytic anemia (abnormal breakdown
of red blood cells, which may cause weakness or
pale skin), hypoglycemia (low levels of glucose in
the blood), cloudy urine and kidney disorders.
Other adverse reactions of paracetamol whose
frequency cannot be estimated from available data
are: anaemia (decrease in red blood cells),
problems with the way your kidneys work (kidney
alteration), problems with the way your liver works
(liver alteration), haematuria (blood in urine),
anuresis (inability to urinate), gastrointestinal
effects, vertigo. There have been cases of difficulty
breathing, wheezing, coughing, and shortness of
breath with paracetamol, but these are more likely
in asthmatics sensitive to aspirin or other NSAIDs
such as ibuprofen.
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.
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

Approved By
Quality Assurance

By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Paracetamol
Effervescent Tablets
• Keep this medicine out of the sight and reach of
children.
• Do not use Paracetamol Effervescent Tablets
after expiry date which is stated on the label,
blister and carton after EXP. The expiry date
refers to last day of that month.
• Store below 30°C. Keep the polypropylene tube
tightly closed. Store in the original container to
protect from moisture and light.
• Do not use this medicine if you notice visible
signs of deterioration, like brown or black spots
on the tablets, bulging of tablets or discoloration
of the tablets.
• 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. Contents of the pack and other
information
What Paracetamol Effervescent Tablets
contains:
The active substance is Paracetamol. Each
effervescent tablet contains 500 mg of Paracetamol.
The other ingredients are;
Anhydrous citric acid, Sodium hydrogen
carbonate, Sorbitol E420, Sodium carbonate
anhydrous, Povidone K25 (E1201), Simethicone,
Saccharin sodium, Lemon flavour (containing
maize maltodextrin, acacia gum (E 414),
alpha-tocopherol (E 307), Macrogol 6000
What Paracetamol Effervescent Tablets looks
like and content of the pack:
Paracetamol 500 mg Effervescent Tablets are
white to off white round, flat, beveled edged plain
on both sides.
Polypropylene tube pack: Paracetamol 500 mg
Effervescent Tablets are packed in white opaque
plain polypropylene tube and white opaque
tamper evident polyethylene cap with inbuilt
desiccant containing 24 tablets, 20 tablets, 10
tablets or 8 tablets.
Pack size: 60 (3 x 20) tablets per carton, 20 (1 x
20) tablets per carton, 10 (1 x 10) tablets per
carton, 16 (2 x 8) tablets per carton, 30 (3 x 10)
tablets per carton, 24 (3 x 8) tablets per carton,
100 (5 x 20) tablets per carton and 24(1x24)
tablets per carton.
Pack size(s) for tube pack: 20 tablets in a tube
10 tablets in a tube
Alu-Alu strip pack: The strip packs are made of
aluminium- aluminium foils
Pack Size:
10 tablets per carton
16 tablets per carton
20 tablets per carton
24 tablets per carton
30 tablets per carton
60 tablets per carton
100 tablets per carton
‘Not all pack sizes may be marketed’.
CAUTION for tube pack: Cap contains
desiccant. Do not eat.
Marketing Authorisation Holder & Manufacturer:
Accord Healthcare Limited, Sage House, 319 Pinner
Road, North Harrow, Middlesex, HA1 4HF, U.K.
The leaflet was last revised in 10/2016.
P
INP070
10 00000 0 000000

Artwork No.

-

Colours Used

Customer

Accord (Fawdon)

Pantone Black

Description

Paracetamol Effervescent 500 mg

Market

UK

Language

English

Size

175 x 275 mm PIL

Min. Font Size

8

Version No.

4 (Page 1 of 2)

Date

25_10_16 (Paracetamol 500mg Eff(ACC-FAW-UK)PIL)

Prepared By
Regulatory Affairs

Checked By
Regulatory Affairs

PACKAGE LEAFLET: INFORMATION FOR THE USER

Paracetamol 500 mg
Effervescent Tablets
Paracetamol

Read all of this leaflet carefully because it contains
important information for you.
• This medicine is available without prescription. However,
you still need to take Paracetamol Effervescent tablets
carefully to get the best result 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 3 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 Tablets is and what it is
used for
2. What you need to know before you take Paracetamol
Effervescent Tablets
3. How to take Paracetamol Effervescent Tablets
4. Possible side effects
5. How to store Paracetamol Effervescent Tablets
6. Contents of the pack and other information

1. What Paracetamol Effervescent Tablets
is and what it is used for
Paracetamol Effervescent Tablets contain Paracetamol,
which is a mild pain killer and reduces the body
temperature in fever. The tablets are recommended for
use in treatment of mild to moderate pain and/or fever.

2. What you need to know before you take
Paracetamol Effervescent Tablets
Do not take Paracetamol Effervescent Tablets
• If you are allergic (hypersensitive) to Paracetamol, or any
of the ingredients of Paracetamol effervescent tablets.
Warnings and precautions
Tell your doctor if you:
• Are suffering from liver problems including liver problems
due to excessive alcohol consumption.
• Gilbert’s syndrome (mild jaundice)
• Are suffering from kidney problems
• Are suffering from dehydration and chronic malnutrition
• Suffer from asthma and are sensitive to aspirin
• Are taking any other paracetamol containing medicines
• Have a fever that does not improve after taking this medicine
• Have glucose-6-phosphatedehydrogenase deficiency
(enzyme deficiency)
• Have hemolytic anemia (abnormal breakdown of red
blood cells).
Other medicines and Paracetamol Effervescent Tablets
Please tell your doctor or pharmacist if you are taking,
have recently taken or might take any other medicines,
including those you have bought without a prescription.
Tell your doctor before you take Paracetamol Effervescent
Tablets if you are taking:
• Drugs to thin the blood (anti-coagulant drugs e.g.
Warfarin ,other coumarins)
• Medicines used to relieve sickness (e.g.
Metoclopramide, Domperidone)
• Medicines used to treat high cholesterol (Cholestyramine)
• Probenecid (Medicine used to treat high levels of uric
acid in the blood stream(gout))

Front Side

Approved By
Quality Assurance

• Medicine to treat fever or mild pain (Aspirin,
Salicylamide)
• Barbiturates and tricyclic antidepressants (to treat
depression)
• Medicines used to treat epilepsy (Lamotrigine)
• Medicines to treat tuberculosis (Isoniazid)
Effects of paracetamol on laboratory tests
Uric acid and blood sugar tests may be affected.
Paracetamol Effervescent Tablets with food and drink
This medicine may be taken with or without food.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any
medicine.
If you are pregnant see your doctor before you take
Paracetamol effervescent Tablets.
Small amounts of paracetamol pass into breast milk. This
medicine may be taken, as instructed (see section 3), by
mothers who are breastfeeding.
Driving and using machines
Paracetamol has no influence on the ability to
drive and use machines.
Paracetamol Effervescent Tablets contains sodium
and sorbitol
This medicinal product contains 503mg of sodium. The
maximum recommended daily dose of this medicinal
product contains 4024mg sodium (found in table salt). This
is equivalent to 201.2% of the adult recommended
maximum daily dietary intake for sodium.
Talk to your pharmacist or doctor if you need Paracetamol
Effervescent Tablets on a daily basis for a prolonged period of
time, especially if you have been advised to have a low salt diet.
This medicinal product contains sorbitol. If you have been told
by your doctor that you have intolerance to some sugars,
contact your doctor before taking this medicinal product.

3. How to take Paracetamol Effervescent
Tablets
Method of Administration
Paracetamol 500 mg Effervescent Tablets are for oral
administration. The tablet(s) should be placed in a full tumbler
of water and allowed to dissolve completely before swallowing.
This presentation is reserved for use in adults and in
adolescents aged 12 years and above.
Children and adolescents:
Children below 12 years of age: Do not give to children
younger than 12 years.
Adolescents of 12 to 15 years and weighing 41 to 50 kg, the
recommended dose is one tablet to be taken every 4-6 hours
when necessary to a maximum of 4 doses in 24 hours.
Maximum single dose is 500mg (1 effervescent tablet)
Adolescents of 16 to 18 years and weighing more than
50kg: as adults.
Adults and children 16 years and older :
The recommended dose is one or two tablets every 4 – 6
hours when necessary up to four times daily. Maximum
dose of 8 tablets in 24 hours. Maximum single dose is 1g
(2 effervescent tablets)
If the pain persists for more than 5 days or the fever lasts
for more than 3 days, or gets worse or other symptoms
appear, you should stop the treatment and consult a doctor.
Do not take more medicine than the label or leaflet tells
you too.
If you take more Paracetamol Effervescent Tablets
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.

Artwork No.

-

Colours Used

Customer

Accord (Fawdon)

Pantone Black

Description

Paracetamol Effervescent 500 mg

Market

UK

Language

English

Size

175 x 275 mm PIL

Min. Font Size

8

Version No.

4 (Page 2 of 2)

Date

25_10_16 (Paracetamol 500mg Eff(ACC-FAW-UK)PIL)

Prepared By
Regulatory Affairs

Checked By
Regulatory Affairs

If you forget to take Paracetamol Effervescent Tablets:
If you forget to take a dose, take another as soon as you
remember, unless it is almost time for your
next dose. Remember to leave atleast four hours between
doses. Never double-up on a dose to make up for the one
you have missed.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Paracetamol Effervescent Tablets can
cause side effects, although not everybody gets them.
Very rare cases of serious skin reactions have been reported.
• accumulation of fluid in the larynx including an itchy rash,
throat swelling (severe allergic reaction),
• swelling on the face, mouth, hands (angioedema)
You should stop taking Paracetamol Effervescent
Tablets and see your doctor immediately if you
experience symptoms like:
• Serious skin disease causing rash, skin peeling and
sores.
• severe blistering and peeling of the skin.
The frequency using the following convention:
Rare (may affect up to 1 in 1,000 people):
Oedema (abnormal accumulation of fluid under the skin),
abnormal vision, simple skin rash or urticaria (dark red
rash on the skin), haemorrhage (bleeding), abdominal
pain, diarrhoea, nausea, vomiting, dizziness, fever,
reduction of irritability or agitation (sedation), platelet
disorders (clotting disorders), stem cell disorders
(disorders of the blood forming cell in the bone marrow),
abnormal liver function, liver failure, hepatic necrosis
(death of liver cells), jaundice, overdose and poisoning,
tremor, headache, depression, confusion, hallucinations,
sweating, pruritus (itching), feeling lousy (malaise).
Very rare (may affect up to 1 in 10,000 people):
hepatotoxicity (damage caused to the liver),
thrombocytopenia (reduction in blood platelets, which
increases the risk of bleeding or bruising), leucopenia
(frequent infections due to poorly functioning white blood
cells or decrease in white blood cells), neutropenia
(reduced neutrophil count in blood), agranulocytosis
(severe decrease in white blood cells which may lead to
severe infections), hemolytic anemia (abnormal
breakdown of red blood cells, which may cause weakness
or pale skin), hypoglycemia (low levels of glucose in the
blood), cloudy urine and kidney disorders.
Other adverse reactions of paracetamol whose frequency
cannot be estimated from available data are: anaemia
(decrease in red blood cells), problems with the way your
kidneys work (kidney alteration), problems with the way
your liver works (liver alteration), haematuria (blood in
urine), anuresis (inability to urinate), gastrointestinal
effects, vertigo. There have been cases of difficulty
breathing, wheezing, coughing, and shortness of breath
with paracetamol, but these are more likely in asthmatics
sensitive to aspirin or other NSAIDs such as ibuprofen.
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.
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
By reporting side effects you can help provide more

Back Side

Approved By
Quality Assurance

information on the safety of this medicine.

5. How to store Paracetamol Effervescent
Tablets
• Keep this medicine out of the sight and reach of children.
• Do not use Paracetamol Effervescent Tablets after expiry
date which is stated on the label, blister and carton after
EXP. The expiry date refers to last day of that month.
• Store below 30°C. Keep the polypropylene tube tightly
closed. Store in the original container to protect from
moisture and light.
• Do not use this medicine if you notice visible signs of
deterioration, like brown or black spots on the tablets,
bulging of tablets or discoloration of the tablets.
• 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. Contents of the pack and other
information
What Paracetamol Effervescent Tablets contains:
The active substance is Paracetamol. Each effervescent
tablet contains 500 mg of Paracetamol.
The other ingredients are;
Anhydrous citric acid, Sodium hydrogen carbonate,
Sorbitol E420, Sodium carbonate anhydrous, Povidone
K25 (E1201), Simethicone, Saccharin sodium, Lemon
flavour (containing maize maltodextrin, acacia gum (E
414), alpha-tocopherol (E 307), Macrogol 6000
What Paracetamol Effervescent Tablets looks like and
content of the pack:
Paracetamol 500 mg Effervescent Tablets are white to off
white round, flat, beveled edged plain on both sides.
Polypropylene tube pack: Paracetamol 500 mg
Effervescent Tablets are packed in white opaque plain
polypropylene tube and white opaque tamper evident
polyethylene cap with inbuilt desiccant containing 24
tablets, 20 tablets, 10 tablets or 8 tablets.
Pack size: 60 (3 x 20) tablets per carton, 20 (1 x 20)
tablets per carton, 10 (1 x 10) tablets per carton, 16 (2 x 8)
tablets per carton, 30 (3 x 10) tablets per carton, 24 (3 x 8)
tablets per carton, 100 (5 x 20) tablets per carton and
24(1x24) tablets per carton.
Pack size(s) for tube pack:

20 tablets in a tube
10 tablets in a tube

Alu-Alu strip pack: The strip packs are made of aluminiumaluminium foils
Pack Size:
10 tablets per carton
16 tablets per carton
20 tablets per carton
24 tablets per carton
30 tablets per carton
60 tablets per carton
100 tablets per carton
‘Not all pack sizes may be marketed’.
CAUTION for tube pack: Cap contains desiccant. Do not
eat.
Marketing Authorisation Holder & Manufacturer:
Accord Healthcare Limited
Sage House, 319 Pinner Road, North Harrow,
Middlesex, HA1 4HF, U.K.
The leaflet was last revised in 10/2016.

P

UKP001
00 00000 0 000000

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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