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PARACETAMOL 1000MG EFFERVESCENT TABLETS

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Effects of Paracetamol Effervescent Tablets
on laboratory tests
PACKAGE LEAFLET: INFROMATION FOR THE
USER

Paracetamol 1000 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
results from them.
• 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.
The name of your medicine is "Paracetamol
1000mg Effervescent Tablets", but will be
referred to as "Paracetamol Effervescent Tablets"
throughout the rest of this leaflet
In this leaflet:
1. What Paracetamol Effervescent Tablets are
and what they are 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 are and
what they are used for
Paracetamol Effervescent Tablets contain
Paracetamol, which relieves pain (analgesic) and
reduces the body temperature in fever
(antipyretic).
The tablets are recommended for use in
treatment of mild to moderate pain and/or fever.

Uric acid and blood sugar tests may be affected.
Taking Paracetamol Effervescent Tablets with
food and drink
Meals will not affect how much Paracetamol gets
into the body.
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.
The dose of Paracetamol recommended for this
product is acceptable if you are breast –feeding.
Driving and using machines
Paracetamol Effervescent Tablets have no
influence on the ability to drive and use
machines.
Important information about some of the
ingredients of Paracetamol Effervescent
Tablets
This medicinal product contains 657mg of
sodium. This should be taken into consideration
by patients on a controlled sodium (salt) diet.
This medicinal product also 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
You should take Paracetamol Effervescent
Tablets exactly as your doctor has told you. You
should check with your doctor or pharmacist if
you are not sure.
Paracetamol Effervescent Tablets are for oral
administration. Place the tablet in a full glass of
water. Allow it to completely dissolve. Then drink
the solution straight away.
If you have doubts on the correct dose of
Paracetamol Effervescent Tablets to use please
consult your doctor.

2. Before you take Paracetamol
Effervescent Tablets

This medicinal product is for use, only in adults
and adolescents aged 16 years and above.

Do not take Paracetamol Effervescent Tablets

Adults and adolescents > 50 kg of body weight

• If you are allergic (hypersensitive) to
Paracetamol or any of the ingredients of
Paracetamol Effervescent Tablets.

Take one tablet (1000 mg) every four to six
hours, upto a maximum of 3 tablets (3000 mg) in
24 hours.

Take special care with Paracetamol
Effervescent Tablets

Maximum daily dose:

Tell your doctor:
• If you are suffering from kidney problems
• If you are suffering from liver problems
including liver problems due to excessive
alcohol consumption.
• If you have Gilbert’s syndrome (mild jaundice)
• If you have hemolytic anemia (abnormal
breakdown of red blood cells)
• If you are an asthmatic and sensitive to aspirin.
• If you are suffering from dehydration or chronic
malnutrition.
• If you are on paracetamol containing drugs
• If you have fever after paracetamol therapy
• If you suffer from glucose-6-phosphate
dehydrogenase deficiency(enzyme deficiency)
Do not use paracetamol unless prescribed by
your doctor if you have an addiction to alcohol or
liver damage. If this concerns you do not use with
alcohol. If you are already taking other pain
medication containing paracetamol do not use
Paracetamol Effervescent Tablets without first
speaking to your doctor or a pharmacist.
Never take more Paracetamol Effervescent
Tablets than recommended. A higher dose does
not increase pain relief; instead it can cause
severe liver damage. The symptoms of liver
damage occur first after a few days. It is
important therefore that you contact your doctor
as soon as possible if you have taken more
Paracetamol Effervescent Tablets than
recommended in this leaflet.
Do not use Paracetamol 1000 mg Effervescent
Tablets in children and adolescents below 16
years of age and under 50 kg body weight.
Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained 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)
• 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 i.e gout)
• Medicine to treat fever or mild pain (Aspirin,
salicylamide)
• Drugs such as rifampicin (drug that helps to
fight infection) and some antiepileptics such as
carbamazepine, phenytoin, phenobarbital,
primidone (drugs used to treat or cure
convulsions).
• Medicines used to treat epilepsy (lamotrigine)
• Medicines to treat tuberculosis (isoniazid)
• Antibiotics like (chloramphenicol)

• The maximum daily dose of Paracetamol must
not exceed 3 tablets (3000 mg).
• Maximum single dose is 1000 mg (1
effervescent tablet)
The minimum time interval between two doses
should be 4 to 6 hours.
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.
Kidney problems:
In moderate kidney problems: The usual dose is
500 mg repeated every 6 hours.
In severe kidney problems: The usual dose is
500 mg repeated every 8 hours
Liver problems :
In case of problems with your liver please consult
your doctor. Your doctor may decide to reduce
the dose.
In chronic alcoholics, a dose of 2000 mg per day
should not be exceeded
Do not divide the 1000 mg tablet into two equal
halves for the lower doses. Paracetamol tablets
of lower strengths are available in the market.
Do not exceed the stated dose. Do not give to
adolescents of 16 years of age and younger.
Cap contains desiccant. Do not eat.
If you take more Paracetamol Effervescent
Tablets than you should:
Symptoms of paracetamol overdose in the first
24 hours may include paleness, nausea (feeling
sick), vomiting, lack of desire to eat and stomach
pain. If you or someone you know accidentally
takes more than the stated dose (overdose) you
should contact a doctor immediately even if you
feel well, because there is risk of serious,
delayed liver damage.
If you forget to take Paracetamol Effervescent
Tablets:
If you forget to take a dose, take it as soon as
you remember, unless it is almost time for your
next dose. The minimum time interval between
two doses should be 4 to 6 hours. Never take a
double dose to make up for the one you have
missed.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines Paracetamol Effervescent
Tablets can cause side effects, although not
everybody gets them.
You should stop taking Paracetamol
Effervescent Tablets and see your doctor
immediately if you experience symptoms like
swelling in the face, tongue or throat,

difficulty swallowing, red and itchy swellings
on the skin and difficulty in breathing.

Each tube contains 10 tablets. One tube (1 x 10)
is packed in a carton.

Rare (affects less than 1 in 1,000 patients):

CAUTION:

 Bleeding problems or clotting disorders (Platelet
disorders), decreased formation of cells, severe
decrease in white blood cells which may lead to
severe infections (agranulocytosis), frequent
infections due to poorly functioning white blood
cells or decrease in white blood cells
(leucopenia), reduction in blood platelets, which
increases the risk of bleeding or bruising
(thrombocytopenia) abnormal breakdown of red
blood cells, which may cause weakness or pale
skin (haemolytic anaemia), decrease in blood
count (pancytopenia), reduced neutrophil count
in blood (neutropenia).
 Allergies (excluding swelling on the face,
mouth, hands).
 Depression, confusion, sensing unreal things
 Tremor, headache
 Abnormal vision.
 Abnormal accumulation of fluid under the skin
(oedema).
 Stomach pain, diarrhoea, nausea (feeling sick),
vomiting, bleeding (haemorrhage)
 Abnormal liver function, liver failure, death of
liver cells (hepatic necrosis), jaundice
 Dizziness, feeling of general discomfort or
uneasiness (malaise), fever, drowsiness, drug
interaction.
 Overdose and poisoning.
 shortness of breath.

Cap contains desiccant. Do not eat.
Not all pack sizes may be marketed.

Very rare (affects less than 1 in 10,000
patients):
 Damage caused to the liver (hepatotoxicity)
 Immediate severe allergic reaction
(hypersensitivity reaction requiring
discontinuation of treatment)
 Low levels of glucose in the blood
(hypoglycemia)
 Cloudy urine and kidney disorders.
 Life-threatening skin disease causing rash, skin
peeling and sores (epidermal necrolysis)
 Allergic reaction of the skin (erythema
multiforme)
 Severe life-threatening skin disease causing
rash, skin peeling, sores (Stevens–Johnson
syndrome)
 Accumulation of fluid in the voice box (larynx)
 Severe allergic reaction (anaphylactic shock)
 Decrease in red blood cells (anemia)
 Severe kidney impairment (renal alteration)
 Kidney disorder (nephrite interstitial)
 Blood in urine (haematuria)
 Inability to urinate (anuresis)
 Stomach ulcers and bleeding (gastrointestinal
effects)
 Uneasiness.
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
Effervescent Tablets
• Keep out of the reach and sight of children and
adolescents.
• 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.
• For Polypropylene tube: Do not use the product
after 1 month from the date of first opening.
• For Polypropylene Tube: Store below 25°C.
Keep the polypropylene tube tightly closed.
Store in the original container to protect from
moisture and light.
• For Alu-Alu Strip Pack: Store below 25°C. Store
in the original package in order to protect from
moisture and light.
• Do not use the product if you notice visible
signs of deterioration, like brown or black spots,
bulging of tablets or discoloration.
• 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 1000 mg of
Paracetamol.
The other ingredients are;
Anhydrous Citric acid, Sorbitol E420, Sodium
Carbonate Anhydrous, Sodium Hydrogen
Carbonate, Povidone K 25, Simeticone emulsion
(30%), Docusate sodium, Saccharin Sodium,
Macrogol 6000, Monosodium glycine carbonate,
Sodium Benzoate.
Simeticone emulsion 30% contains:
Water, polydimethylsiloxane, polyethylene glycol
stearate, polyethylene glycol, glycerides C14-18
mono- and di Polyethylene glycol distearate,
Polyethylene glycol palmitate,
Octamethylcyclotetrasiloxane.
What Paracetamol Effervescent Tablets look
like and contents of the pack:
Paracetamol 1000 mg Effervescent Tablets are
white to off-white, round, flat faced and bevelled
edged tablets, plain on both sides.
This medicinal product is available in two
different types of packaging: Alu-Alu strip pack or
polypropylene tubes.
Alu-Alu Strip pack:
The effervescent tablets are packed in aluminium
strip foils laminated with LDPE film. Each strip
has 4 tablets or 10 tablets. The strips are packed
in a carton containing 4 tablets (4x1), 8 tablets
(4x2), or (10 x 1) 10 tablets .
Polypropylene Tubes:
The effervescent tablets are packed in white
polypropylene tube with tamper evident
polyethylene cap containing an inbuilt desiccant.

Marketing Authorisation Holder and
Manufacturer:
Accord Healthcare Limited,
Sage House, 319 Pinner road,
North Harrow,
Middlesex,
HA1 4 HF,
United Kingdom
The leaflet was last approved in 05/2012.

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Further information

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