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PARACETAMOL 1000MG SOLUBLE TABLETS

Active substance(s): PARACETAMOL

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Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Paracetamol 1000 mg Soluble Tablets

Market

UK

Language

English

Size

170 x 550 mm (PIL)

Min. Font Size

9

Version No.

11 (Page 1 of 2) (IB013)

Date

08_06_16 (Paral 1000mg eff (ACC-UK)-NEW-PIL)

Prepared By
Regulatory Affairs

Checked By
Regulatory Affairs

Approved By
Quality Assurance

• Medicines used to treat epilepsy (lamotrigine)
• Medicines to treat tuberculosis (isoniazid)
• Antibiotics like (chloramphenicol)
PACKAGE LEAFLET: INFROMATION FOR THE
USER

Paracetamol 1000 mg
Soluble Tablets
Paracetamol
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you

Effects of Paracetamol Soluble Tablets on
laboratory tests
Uric acid and blood sugar tests may be affected.
Paracetamol Soluble Tablets with food and
drink
Meals will not affect how much Paracetamol gets
into the body.
Pregnancy and breast-feeding

• Always take this medicine exactly as described
in this leaflet or as your doctor or pharmacist
has told you.Keep this leaflet. You may need to
read it again.
• Ask your pharmacist if you need more
information or advice.
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet.
• You must talk to a doctor if you do not feel
better or if you feel worse after 3 days.
The name of your medicine is “Paracetamol
1000 mg Soluble Tablets”, but will be referred to
as “Paracetamol Soluble Tablets” throughout the
rest of this leaflet
What is in this leaflet:
1. What Paracetamol Soluble Tablets are and
what they are used for
2. What you need to know before you take
Paracetamol Soluble Tablets
3. How to take Paracetamol Soluble Tablets
4. Possible side effects
5. How to store Paracetamol Soluble Tablets
6. Contents of the pack and other information

1. What Paracetamol Soluble
Tablets are and what they are
used for
Paracetamol Soluble 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.

2. What you need to know
before you take Paracetamol
Soluble Tablets
Do not take Paracetamol Soluble Tablets

Ask your doctor or pharmacist for advice before
taking any medicine.
If you are pregnant see your doctor before you
take Paracetamol Soluble Tablets.
The dose of Paracetamol recommended for this
product is acceptable if you are breast –feeding.
Driving and using machines
Paracetamol Soluble Tablets have no influence
on the ability to drive and use machines.
Paracetamol Soluble Tablets contains Sodium
The maximum recommended daily dose of this
medicinal product contains 2127.12 mg
sodium (found in table salt). This is equivalent to
53.18 % of the adult recommended maximum
daily dietary intake for sodium.
Talk to your doctor if you need Paracetamol
Soluble Tablets on daily basis for a prolonged
period of time, especially if you have been
advised to have a low salt diet.
Paracetamol Soluble Tablets contains sorbitol
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
Soluble Tablets
This medicine exactly as your doctor or
pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
Paracetamol Soluble 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 are allergic to paracetamol or any of the
ingredients of this medicine (listed in section 6).

If you have doubts on the correct dose of
Paracetamol Soluble Tablets to use please
consult your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking
Paracetamol Soluble Tablets:

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

• 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 Soluble Tablets without first
speaking to your doctor or a pharmacist.
Never take more Paracetamol Soluble 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
Soluble Tablets than recommended in this leaflet.
Do not take anything else containing
Paracetamol while taking this medicine. 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.
Children and adolescents
Do not use Paracetamol 1000 mg Soluble Tablets
in children and adolescents below 16 years of
age and under 50 kg body weight.
Other medicines and Paracetamol Soluble
Tablets
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines, including medicines obtained without
a prescription.
Tell your doctor before you take Paracetamol
Soluble 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).

Adults and adolescents > 50 kg of body weight
Take one tablet (1000 mg) every four to six
hours, upto a maximum of 3 tablets (3000 mg) in
24 hours.
Maximum daily dose:
• The maximum daily dose of Paracetamol must
not exceed 3 tablets (3000 mg).
• Maximum single dose is 1000 mg (1 Soluble
tablet)
The minimum time interval between two doses
should be 4 to 6 hours.
If the pain persists for more than 3 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.
Always take this medicine exactly as described in
this leaflet or as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if
you are not sure.
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
Paracetamol 1000mg tablets are not suitable
for patients with renal and hepatic
insufficiency when a reduced dose is
required. 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 take more medicine that the label tells you
to. If you do not get better, talk to your doctor.
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 Soluble 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.

Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Paracetamol 1000 mg Soluble Tablets

Market

UK

Language

English

Size

170 x 550 mm (PIL)

Min. Font Size

9

Version No.

11 (Page 2 of 2) (IB013)

Date

08_06_16 (Paral 1000mg eff (ACC-UK)-NEW-PIL)

Prepared By
Regulatory Affairs

Checked By
Regulatory Affairs

If you forget to take Paracetamol Soluble
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 this medicine can cause side
effects, although not everybody gets them.
You should stop taking Paracetamol Soluble
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.
Rare (may affect up to 1 in 1,000 people):
 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.
Very rare (may affect up to 1 in 10,000
people):
 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.
 Very rare cases of serious skin reactions have
been reported.
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
Soluble Tablets
• Keep this medicine out of the sight and reach of
children and adolescents.
• Do not use this medicine 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 this medicine if you notice visible
signs of deterioration, like brown or black spots,
bulging of tablets or discoloration.
• Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away of medicines you
no longer used. These measures will help to
protect the environment.

6. Contents of the pack and
other information
What Paracetamol Soluble Tablets contains:
The active substance is Paracetamol. Each
Soluble 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, Powdarome Lemon Premium.

Approved By
Quality Assurance

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 Soluble Tablets look like
and contents of the pack:
Paracetamol 1000 mg Soluble 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 Soluble 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 Soluble tablets are packed in white
polypropylene tube with tamper evident
polyethylene cap containing an inbuilt desiccant.
Each tube contains 10 tablets. One tube (1 x 10)
is packed in a carton.
CAUTION:
Cap contains desiccant. Do not eat.
Not all pack sizes may be marketed.
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 revised in 06/2016.

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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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