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PARACETAMOL 500 MG TABLETS

Active substance(s): PARACETAMOL / PARACETAMOL

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Paracetamol 500 mg
tablets
Paracetamol

Read all of this leaflet carefully before
you start taking this medicine because
it contains important information for
you.
Always take this medicine exactly as
described in this leaflet or as your doctor
or pharmacist have 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 effect, talk to your
doctor or pharmacist. This includes
any possible side effects not listed in
this leaflet. See section 4.
• You must talk to a doctor if you do not
feel better or if you feel worse after
3 days.
What is in this leaflet
1. What Paracetamol is and what is it
used for
2. What you need to know before you
take Paracetamol
3. How to take Paracetamol
4. Possible side effects
5. How to store Paracetamol
6. Contents of the pack and other
information
1. What Paracetamol is and what it is
used for
Paracetamol contains active substance
Paracetamol which belongs to a group of
medicines called analgesics (painkillers).
Paracetamol is used to relieve pain and
help reduce fever. The tablets can treat
mild to moderate pain and/or fever [e.g.
headache and toothache].
Paracetamol tablets may be used in adults
and adolescents but is not suitable for use
in children below 10 years.
2. What you need to know before you
take Paracetamol
Do not take Paracetamol:
• If you are allergic to Paracetamol or
any of the other ingredients of this
medicine (listed in section 6)
Warnings and precautions
Talk to your doctor or pharmacist before
taking Paracetamol
• if you have kidney or liver disease
(including Gilbert’s syndrome or acute
hepatitis)
• if you have a deficiency of a certain
enzyme called glucose-6-phosphatase
• if you have hemolytic anemia
(abnormal breakdown of red blood
cells).
• if you regularly take large amounts of
alcohol. Never take more than 2000
mg a day.
• if you are asthmatic sensitive to
acetylsalicylic acid.
• in case of dehydration or chronic
malnutrition
When you are taking any medication
to treat epilepsy you should consult
your doctor before taking paracetamol,
because when used at the same time,
it decreases the effectiveness and
potentiates the risk of liver damage by
paracetamol, especially in treatments
when using high acetaminophen doses.
In cases of high fever, signs of a
secondary infection, or persistence of
your symptoms for more than three days,
consult your doctor or pharmacist.
Headaches caused by overuse of
analgesics should not be handled by
increasing the dose. In those cases, the
use of analgesics should be taken after
consulting a doctor.
“Do not take more paracetamol than
recommended in section 3. How to
take paracetamol. Concomitant use of
this medication with other medicines
containing paracetamol, such as flu and
cold medicines should be avoided since
high doses may lead to liver damage. Do
not use more than one drug containing
paracetamol without talking to your
doctor”.

Black

Other medicines and Paracetamol
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines.
Do not use Paracetamol in combination
with other paracetamol-containing
medicines.
Please talk to your doctor before you take
paracetamol in case you use one of the
following medicines:
• metoclopramide or domperidone
(medicines used to treat nausea and
vomiting)
• colestyramine (used to lower your
cholesterol)
• warfarin and other coumarin
derivatives (medicines to thin the
blood), particularly in case you need to
take paracetamol on a daily basis over
a long period of time
• salicylamide (a pain killer)
• probenecid (a medicine used to treat
gout)
• isoniazid or rifampicin (a medicine
used to treat tuberculosis)
• lamotrigine or phenytoin (a medicine
used to treat epilepsy)
• barbiturates or carbamazepines
(medicines that cause relaxation and
sleepiness)
• St. John’s wort (a medicine used to
treat depression)
• chloramphenicol (an antibiotic)
• zidovudine (a medicine used to treat
AIDS)
If you are going to have any laboratory
tests (such as a blood test, urine analysis,
skin allergy test, etc.), you should tell your
doctor that you are taking this medicine as
it could affect the results of these tests.
Paracetamol with food and drink and
alcohol
Alcohol should be avoided when taking
Paracetamol
Pregnancy, breast-feeding and fertility
Pregnancy
Studies with Paracetamol do not indicate
that there are adverse effects on the
pregnancy or on the health of the unborn
child. You may take paracetamol in the
recommended doses during pregnancy.
During pregnancy, paracetamol should not
be taken for long periods, at high doses
or in combination with other medicinal
products.
Breast-feeding
Paracetamol is excreted in breast milk
but in insignificant amounts. Therapeutic
doses of paracetamol may be used during
breast-feeding.
Fertility
No detrimental effects on fertility upon
normal use of Paracetamol are known.
If you are pregnant or breast-feeding,
think you may be pregnant or are planning
to have a baby, ask your doctor or
pharmacist for advice before taking this
medicine.
Driving and using machines
Paracetamol is not expected to impair
your ability to drive or to operate
machinery.
3. How to take Paracetamol
Dosage
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.
The recommended dose is:
Adults, the elderly and children 16 years
and over (above 55 kg body weight):
Take one to two Paracetamol 500 mg
tablets at a time, up to 3000 mg per
24 hours.
The maximum daily dose of Paracetamol
must not exceed 6 tablets (3000 mg).
Children 10 to 15 years of age (40-55 kg
body weight)
Take one Paracetamol 500 mg tablet at a
time, up to 2000 mg per
24 hours. The daily dose must not exceed
4 tablets (2000 mg).
Not recommended for children under
10 years of age.
The dose should not be repeated
more frequently than every 4 hours
and not more than 4 doses should be
taken in any 24-hour period.

P15XXXXX

PACKAGE LEAFLET:
INFORMATION FOR THE
PATIENT

The tablet should be swallowed
whole with plenty of water.



Paracetamol is not suitable for
children below 10 years.
• Between two intakes should be
at least 4 hours.
• Do not use in combination with
other Paracetamol-containing
preparations.
• Do not exceed the stated dose.
• Paracetamol scored for easy
breaking for use in Children.
If the pain persists for more than 5
days or the fever lasts for more than
3 days exists or gets worse or other
symptoms appear, you should stop the
treatment and consult a doctor.

The maximum daily dose should not
exceed 60 mg/ kg/ day (up to 2 g/ day) in
the following situations:
• adults weighing less than 50 kg
• mild to moderate hepatic insufficiency,
Gilbert’s syndrome (familial nonhemolytic jaundice)
• dehydration
• chronic malnutrition
Follow these instructions unless your
doctor has given you different advice.
If you feel that Paracetamol too strong
or too weak, talk to your doctor or
pharmacist.





Bronchospasm (difficulty in breathing)
in patients sensitive to aspirin and
other anti-inflammatory medicines
Hematuria (blood in urine).
Enuresis (inability to urinate).

Not Known (frequency cannot be
estimated from the available data):
• Acute generalized exanthemateus
pustulosis (drug eruption characterized
by numerous small, primarily nonfollicular, sterile pustules).
• Severe skin rash or peeling of the skin.
• Stevens–Johnson syndrome (a severe
life-threatening skin disorder).
• Reddening of skin, blisters or rash due
to intake of Paracetamol.
Once you stop taking the medicine these
side effects should go away. If any of the
side effects gets serious, please tell your
doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your
doctor or pharmacist. 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

Method of administration:
Swallow the tablet with a glass of water.

Keep this medicine out of the sight and
reach of children.

If you take more Paracetamol than you
should:
SEEK IMMEDIATE MEDICAL ADVICE IN
THE EVENT OF AN OVERDOSE, EVEN
IF YOU FEEL WELL, because of the
risk of delayed, serious liver damage.
Symptoms of Paracetamol overdose are
nausea, vomiting and reduced appetite.
Unconsciousness does not usually occur.

Do not use this medicine after the expiry
date which is stated on the carton after
EXP. The expiry date refers to the last day
of that month.

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 can cause
side effects, although not everybody gets
them.
Possible side effects are listed below and
classified as:
Rare side effects (may affect up to 1 in
1,000 people)
• Several blood disorders including
agranulocytosis, thrombocytopenia,
thrombocytopenic purpura, hemolytic
anemia leukopenia platelet disorders
(clotting disorders) and stem cell
disorders (disorders of the blood
forming cells in bone marrow).
• Allergic reactions.
• Depression, confusion, hallucinations.
• Tremor, headache.
• Disturbed vision.
• Oedema (abnormal accumulation of
fluid under the skin).
• Abdominal pain, stomach or intestinal
bleeding, diarrhea, nausea, vomiting.
• Abnormal liver function, liver failure,
jaundice (with symptoms like yellowing
of the skin and eyes), hepatic necrosis
(death of liver cells).
• Rash, itching, sweating, hives, red
patches on skin, angioedema with
symptoms like swollen face, lips, throat
or tongue.
• Dizziness, generally feeling unwell
(malaise), fever, sedation, interactions
with medicines.
• Overdose and poisoning.
Very rare side effects (may affect up to 1
in 10,000 people):
• Pancytopenia (reduction in the number
of blood cells).
• Allergic reactions where treatment
should be stopped, including
angioedema, difficulty breathing,
sweating, nausea, hypotension, shock,
and anaphylaxis.
• Low level of blood glucose in the
blood.
• Hepatotoxicity (damage caused to the
liver due to chemicals).
• Cloudy urine and kidney disorders.

Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will
help protect the environment.
6. Contents of the pack and other
information
What Paracetamol contains
• The active substance is paracetamol.
Each tablet contains 500 mg
paracetamol.


The other ingredients are:
Pregalatinized starch (maize),
silica colloidal anhydrous,
hydroxypropylcellulose (low viscosity
grade), sodium starch glycolate
(type-A), talc, magnesium stearate.

What Paracetamol looks like and
contents of the pack
Tablet.
White to off-white, uncoated, round
shaped tablets debossed with ‘A’ and ‘8’
separated with break line on one side
and plain on other side. The tablet can be
divided into equal doses.
Paracetamol tablets are available in blister
packs of 10, 12, 16, 20, 24, 30, 32, 40 and
50 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
or
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
or
Generis Farmacêutica, S.A., Rua
João de Deus, 19, 2700-487
Amadora, Portugal
This leaflet was last revised in
06/2017.

P15XXXXX

If you forget to take Paracetamol:
Do not take a double dose to make up
for a forgotten tablet. Instead you should
simply continue with the next dose when
it is due.

This medicinal product does not require
any special storage conditions.

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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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