PARACETAMOL 1000 MG TABLETS

Active substance: PARACETAMOL

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PACKAGE LEAFLET

PACKAGE LEAFLET: INFORMATION FOR THE USER
PARACETAMOL 1000 MG TABLETS
Paracetamol
Read all of this leaflet carefully before you start taking this medicine
 Keep this leaflet. You may need to read it again.
 If you have further questions, please ask your doctor or pharmacist.
 This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
 If any of the side effects become 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 1000 mg Tablets are and what they are used for
2. Before you take Paracetamol 1000 mg Tablets
3. How to take Paracetamol 1000 mg Tablets
4. Possible side effects
5. How to store Paracetamol 1000 mg Tablets
6. Further information
1. WHAT PARACETAMOL 1000 MG TABLETS ARE AND WHAT THEY ARE USED FOR
Paracetamol 1000 mg Tablets contain paracetamol. Paracetamol belongs to a group of medicines
called analgesics (painkillers) which also help to reduce your temperature when you have a fever.
Paracetamol 1000 mg Tablets provide relief from pain (such as headaches, migraine, toothache,
backache, muscle pain, rheumatic (joint) pain, sore throats and period pain). Paracetamol 1000 mg
Tablets are also used to lower fever. Paracetamol 1000 mg Tablets should only be used by adults and
adolescents aged 16 years and over, whose body weight is greater than 50 kg.
2. BEFORE YOU TAKE PARACETAMOL 1000 MG TABLETS
Do not take Paracetamol 1000 mg Tablets if you:
 are allergic (hypersensitive) to paracetamol or any of the other ingredients of this medicine (listed
in Section 6: Further information)
 are under 16 years old
 have a body weight of less than 50 Kg.
Do not take Paracetamol 1000 mg Tablets if any of the above apply to you. If you are not sure, talk to
your doctor or pharmacist before taking Paracetamol 1000 mg Tablets.

Take special care with Paracetamol 1000 mg Tablets

Talk to your doctor or pharmacist before taking Paracetamol 1000 mg Tablets if:
 you have moderate to severe kidney or liver problems, including acute hepatitis or liver problems
caused by excessive alcohol consumption
 you have a condition called Gilbert’s syndrome which can cause yellowing of the skin or whites
of the eyes (mild jaundice)








you are taking other medicinal products which affect your liver
you have a hereditary enzyme disorder called glucose-6-phosphate dehydrogenase deficiency
you have a blood disorder called haemolytic anaemia which causes a reduced number of red
blood cells, pale yellow skin and weakness or breathlessness
you are suffering from dehydration or nutritional problems (chronic malnutrition)
you have an addiction to alcohol
you are already taking any other products that contain paracetamol. If this applies to you then
do not take Paracetamol 1000 mg Tablets without first speaking to your doctor or pharmacist.

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.
In particular it is important to tell your doctor or pharmacist if you are taking any of the following
medicines:
 medicines used to thin the blood such as warfarin as paracetamol may increase their effect
 medicines used to stop you feeling sick (nausea) or vomiting (e.g. metoclopramide or
domperidone)
 products containing codeine (used to help suppress coughs and relieve pain)
 medicines used to treat high cholesterol (e.g. cholestyramine)
 the antibiotic chloramphenicol (used to treat infections)
 probenecid (a medicine used to treat high levels of uric acid in the blood stream i.e. gout)
 medicine used to treat fever or mild pain (e.g. salicylamide)
 any medicines that might affect your liver function. Examples of which include: cimetidine (used
to treat stomach acid), isoniazid (used to treat tuberculosis), zidovudine (used to treat HIV),
antiepileptic medicines used to treat convulsions (such as phenobarbital, carbamazepine,
phenytoin, primidone and glutethimide), St John’s Wort (a herbal remedy) and rifampicin (used to
treat infections). Always check the leaflet that comes with your other medicine.
Do not take Paracetamol 1000 mg Tablets if you are taking any other medicines containing
paracetamol.
This includes some other painkillers, cough and cold remedies. This also includes a wide range of
other medicines available on prescription and over the counter.
Taking Paracetamol 1000 mg Tablets with food and drink
You should not drink alcohol whilst taking these tablets. Taking Paracetamol 1000 mg Tablets with
alcohol can increase your chances of getting side effects.
Paracetamol 1000 mg Tablets can be taken with or without food.
Pregnancy and breast-feeding
Although there is no evidence that paracetamol causes any ill effects, talk to your doctor or
pharmacist before taking these tablets if:
 you are pregnant, think you may be pregnant or are planning to get pregnant
 you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Paracetamol 1000 mg Tablets have not been shown to affect your ability to drive or operate
machinery.
3. HOW TO TAKE PARACETAMOL 1000 MG TABLETS
Always take Paracetamol 1000mg Tablets exactly as your doctor or pharmacist has told you. You
should check with your doctor or pharmacist if you are not sure.

Do not take more than the recommended dose. If symptoms persist consult your doctor.
Adults and adolescents (16 years of age and over) weighing more than 50 kg
 One tablet to be taken 4 times a day as required.
 Swallow the tablets whole with a drink of water.
 Wait at least 4-6 hours before taking another dose.
 Do not take more than the maximum daily dose of 4 tablets in any 24-hour period.
Do not exceed the stated dose.
Children under 16 years of age
Paracetamol 1000 mg Tablets should not be given to children under 16 years of age.
Kidney problems
In moderate kidney problems: the usual dose is 500 mg (half a tablet) repeated every 6 hours.
In severe kidney problems: the usual dose is 500 mg (half a tablet) repeated every 8 hours.
Liver problems
In case of problems with your liver please consult your doctor. A dose of 2000 mg (2 tablets) per day
should not be exceeded.
Paracetamol 1000 mg Tablets are suitable for patients with kidney and liver problems where a
reduced dose is required, because the tablets can be divided into equal doses.
Reduced daily dose
A dose of 2000 mg (2 tablets) per day should not be exceeded in the following situations:

if you have mild to moderate liver problems

if you have a condition called Gilbert’s syndrome which can cause yellowing of the skin or
whites of the eyes (mild jaundice)

if you are dehydrated

if you have nutrition problems (chronic malnutrition)

if you are addicted to alcohol (chronic alcoholism).
If you take more Paracetamol 1000 mg Tablets than you should
Immediate medical advice should be sought in the event of overdosage because of the risk of
irreversible liver damage. It is important to contact your doctor even if you feel well.
Contact your nearest hospital emergency department or tell your doctor immediately and say
exactly how much you have taken. Your doctor will advise you what to do.
Remember to take the pack and any remaining tablets with you. This is so the doctor knows what you
have taken.
Symptoms of paracetamol overdose in the first 24 hours are paleness of the skin, feeling sick
(nausea), vomiting, lack of appetite, and abdominal pain. Liver damage may become apparent 12 to
48 hours after taking paracetamol.
If you forget to take Paracetamol 1000 mg Tablets
If you forget to take a dose at the right time, take it as soon as you remember. Do not take a double
dose to make up for a forgotten dose. You must allow at least 4-6 hours between doses.
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 1000 mg Tablets can cause side effects, although not everybody gets
them. The frequency of these side effects is not known but experience indicates that side effects with
paracetamol are rare and serious reactions are very rare.
Stop taking Paracetamol 1000 mg Tablets and see a doctor or go to a hospital straight away if:
 you experience a serious allergic reaction (anaphylaxis) such as swelling of the face, lips, tongue
or throat which may cause difficulty in swallowing or breathing
 you have serious illness with blistering of the skin, mouth, eyes and genitals or an itchy, lumpy
skin rash.
The following side effects have also been reported. If you experience any of the following please
tell your doctor or pharmacist:
 blood problems (such as agranulocytosis or thrombocytopenia), increased risk of bleeding,
bruising more easily than usual or getting more infections than usual
 difficulty in breathing or wheezing (particularly if you have asthma and are allergic to aspirin or
anti-inflammatory medicines (NSAIDs))
 liver problems.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

5. HOW TO STORE PARACETAMOL 1000 MG TABLETS
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The
expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. FURTHE

R INFORMATION

What Paracetamol 1000 mg Tablets contain
 The active substance of Paracetamol 1000 mg Tablets is paracetamol. Each tablet contains 1000
mg of paracetamol.
 The other ingredients are: microcrystalline cellulose, croscarmellose sodium, povidone K30,
povidone K90, magnesium stearate and silicone dioxide.

What Paracetamol 1000 mg Tablets look like and contents of the pack
The tablets are white to slightly yellow, oblong with smooth surface and a central score line. The
score line allows the tablet to be divided into equal doses.
Paracetamol 1000 mg Tablets come in blister-packs of 6, 8, 12 or 16 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A
Viale Amelia 70
00181 Roma Italy
Manufacturer:
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.
Via Vecchia del Pinocchio, 22
60131 Ancona
Italy
This medicinal product is authorised in the Member States of the EEA under the following
names:
UK: Paracetamol 1000 mg Tablets
AT: Paracetamol Rockspring 1000 mg Tablette
BG: Paracetamol Rockspring 1000 mg таблетка
CZ: Paracetamol Rockspring 1000 mg Tablety
EL: Paracetamol Rockspring 1000 mg δισκίο
HU: Paracetamol Rockspring 1000 mg Tabletta
IE: Paracetamol Max 1000 mg Tablets
PL: Paracetamol Rockspring
RO: Paracetamol Rockspring 1000 mg Comprimate
SK: Paracetamol Rockspring 1000 mg Tableta

This leaflet was last revised in 11/2013

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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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