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PARACETAMOL 500 MG EFFERVESCENT TABLETS
Active substance(s): PARACETAMOL
Paracetamol 500 mg
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
• 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. 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. Further 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. Before you take Paracetamol
Do not take Paracetamol Effervescent Tablets
• If you are allergic (hypersensitive) to Paracetamol, or
any of the ingredients of Paracetamol effervescent
Warfarin other coumarins)
• Medicines used to relieve sickness (e.g.
• Medicines used to treat high cholesterol
• Probenecid (Medicine used to treat high levels of uric
acid in the blood stream(gout))
• Medicine to treat fever or mild pain (Aspirin,
• Barbiturates and tricyclic antidepressants (to treat
• 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.
Taking Paracetamol Effervescent Tablets with food
There is no significant effect on absorption of
Paracetamol when taken with meal.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking
If you are pregnant see your doctor before you take
Paracetamol effervescent Tablets.
Paracetamol passes into breast milk. Therapeutic
doses of Paracetamol can be administered during
Driving and using machines
Paracetamol has no influence on the ability to drive
and use machines.
Important information about the some of the
ingredients of Paracetamol Effervescent Tablets
This medicinal product contains 503mg of sodium. To
be taken into consideration by patients on a controlled
This medicinal product contains sorbitol. If you have
been told by our doctor that you have intolerance to
some sugars, contact your doctor before taking this
3. How to take Paracetamol
Take special care with Paracetamol Effervescent
This presentation is reserved for use in adults and in
adolescents aged 12 years and above.
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
• Are on long-term treatment with higher doses of
• Are asthmatics sensitive to Aspirin.
• Are on other Paracetamol containing drugs
• Have fever even after Paracetamol therapy
• Glucose-6-phosphatedehydrogenase deficiency
• Have hemolytic anemia (abnormal breakdown of red
• 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 posology is one tablet per dose, repeated
every 4-6 hours if necessary, without exceeding 4
• Adolescents of 16 to 18 years and weighing more
than 50kg: as adults.
Taking other medicines
Please tell your doctor or pharmacist if you are taking
or have recently taken 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.
The usual adult dose is one to two tablets of 500mg,
repeated every 4-6 hours, up to a maximum of 6
tablets (3000 mg) in 24 hours.
Maximum daily dose:
• The maximum daily dose of Paracetamol must not
• 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.
If complaints persist or worsen, you should seek
Do not exceed the stated dose. Cap contains
desiccant. Do not eat.
Paracetamol Effervescent tablet could be taken with or
with out food and drinks.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
If you take more Paracetamol Effervescent Tablets
than you should:
If you or someone you know accidentally takes more
than the stated dose (an overdose) you should contact
a doctor immediately even if you feel well, because
there is risk of delayed, serious liver damage.
If you forget to take Paracetamol Effervescent
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.
4. Possible side effects
Like all medicines Paracetamol Effervescent Tablets
can cause side effects, although not everybody gets
The frequency using the following convention: common:
affects 1 to 10 users in 100; uncommon: affects 1 to 10
users in 1,000; rare: affects 1 to 10 users in 10,000;
very rare: affects less than 1 user in 10,000
not known: frequency cannot be estimated from the
Rare: 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, 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),
angioedema (swelling on the face, mouth, hands).
Very rare: hepatotoxicity (damage caused to the liver
due to chemicals), hypersensitivity reaction requiring
discontinuation of treatment (immediate severe allergic
reaction), thrombocytopenia (reduced platelet count),
leucopenia (decrease in white blood cells), neutropenia
(reduced neutrophil count in blood), agranulocytosis
(decrease in neutrophils in the blood), hemolytic
anemia (abnormal breakdown of red blood cells),
hypoglycemia (low levels of blood glucose in the
blood), cloudy urine and kidney disorders. Very rare
cases of serious skin reactions have been reported.
Other adverse reactions of paracetamol whose
frequency cannot be estimated from available data are:
toxic epidermal necrolysis (life-threatening skin
disorder), erythema multiforme (allergic reaction or
infection of skin), Stevens–Johnson syndrome (a
severe life-threatening skin disorder), accumulation of
fluid in the larynx, anaphylactic shock (severe allergic
reaction), anaemia (decrease in red blood cells), renal
alteration (severe renal impairment, nephrite interstitial
(kidney disorder), haematuria (blood in urine), anuresis
(inability to urinate) gastrointestinal effects (stomach
ulcers and bleeding) and uneasiness. 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.
5. How to store Paracetamol
• Keep out of the reach and sight of children.
• Do not use Paracetamol Effervescent Tablets after
expiry date which is stated on the label 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 the product 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. Further 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
K 25 (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.
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 and 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: 20 tablets and 10 tablets in a tube.
Aluminium Strip pack of 4 tablets made up of plain
Pack Size: 8 tablets per carton, 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: 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 approved in 04/2014.
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.