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))
• 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)
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality
(high anion gap metabolic acidosis) that must have urgent treatment, and which
may occur particularly in case of severe renal impairment, sepsis (when bacteria
and their toxins circulate in the blood leading to organ damage), malnutrition,
chronic alcoholism, and if the maximum daily doses of paracetamol are used.

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. If necessary,
paracetamol effervescent tablets can be used during pregnancy. You should use the
lowest possible dose that reduces your pain and/or your fever and use it for the
shortest time possible. Contact your doctor if the pain and/or fever are not reduced or
if you need to take the medicine more often.
Driving and using machines
Paracetamol has no influence on the ability to drive and use machines.

Important information about some of the ingredients of Paracetamol

Effervescent Tablets
This medicine contains 418.5mg sodium (main component of cooking/table salt) in
each tablet. This is equivalent to 20.92 % of the recommended daily dietary intake of
sodium for an adult..
 Talk to your pharmacist or doctor if you need 5 or more tablets daily for a
prolonged period , especially if you have been advised to follow a low salt (sodium)
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.

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 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.
• In-use shelf life (polypropylene tube): Use within 1 month of first opening the
tube.
• 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:

The 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 (1 x 24) tablets per
carton.
Pack size(s) for tube pack: 8, 10, 20 or 24 tablets in a tube

Strip packs:
The Effervescent Tablets are also available in Paper/PE/Aluminium/Surlyn Strip in
following pack sizes.
Pack Size: 10, 16, 20, 24, 30, 32, 60 and 100 tablets per carton
Pack size(s) for strip: 4 or 10 tablets in a strip

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, United Kingdom.

The leaflet was last revised in 04/2022.