Skip to Content

UK Edition. Click here for US version.

PARACETAMOL 1000 MG FILM COATED TABLETS

Active substance(s): PARACETAMOL

View full screen / Print PDF » Download PDF ⇩
Transcript
Pharma
code

PACKAGE LEAFLET: INFORMATION FOR THE USER

Paracetamol 1000mg film coated tablets
Paracetamol

Read all of this leaflet carefully before you starts taking this medicine
because it contains important information for you.
- Keep this leaflet, you may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
- If you get any side effects, talk to your doctor or pharmacist. This
includes ant possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Paracetamol film coated tablets are and what they are used for
2. What you need to know before you take Paracetamol film coated tablets
3. How to take Paracetamol film coated tablets
4. Possible side effects
5. How to store Paracetamol film coated tablets
6. Contents of the pack and other information
1. WHAT PARACETAMOL FILM COATED TABLETS ARE AND WHAT
THEY ARE USED FOR
Paracetamol 1000 mg film coated tablets are used for the management of
mild to moderate pain and fever. The active ingredient is paracetamol
which is a painkiller and also reduces your temperature when you have a
fever.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL
FILM COATED TABLETS
Do not take Paracetamol 1000mg film coated 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 when using Paracetamol 1000 mg film coated
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 film coated tablets without first speaking to your doctor or
pharmacist.
Taking other medicines with Paracetamol film coated tablets
Refer your doctor or pharmacist if you are taking or have recently taken
other medicines, including medicines obtained without a prescription.
Some other medicines may affect or be influenced by Paracetamol film
coated tablets. 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) but not by local
application of eye drops.

- 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).
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 film coated 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 film coated Tablets with food and drink
You should not drink alcohol whilst taking these tablets. Taking
Paracetamol 1000 mg film coated 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 film coated Tablets have not been shown to affect
your ability to drive or operate machinery.
3. HOW TO TAKE PARACETAMOL FILM COATED TABLETS
Adults and children aged 16 years and over:
Take 1 tablets as per prescribed
- Do not take more frequently than every 4 hours.
- Do not take more than 4 tablets in 24 hours.
- Do not exceed the stated dose.
- Do not take with other paracetarnol containing products.
- Do not give to children under 16 years.
If you take too many tablets immediate medical advice should be sought
in the event of an overdose, even if you feel well because of the risk of
delayed serious liver damage.
- If symptoms persist consult your doctor.
If you take more Paracetamol 1000 mg Tablets than you should
Immediate medical advice should be sought in the event of over dosage
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 film coated tablets cause side effects,
although not everybody is affected. 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.

Pharma
code

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.
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 FILM COATED TABLETS
Keep out of the sight and reach of children.
This medicine does not require any special storage condition. Do not use
after the expiration date of Paracetamol film coated tablets as indicated on
the package.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What is Paracetamol film coated tablets
Active ingredient is Paracetamol.
Each Paracetamol 1000 mg film coated tablets contains 1000 mg of
Paracetamol
The other ingredients are: Pregelatinized starch, Maize starch, Povidone,
Magnesium stearate, Hypromellose (E464), Titanium Dioxide (E171),
Macrogol (E1521)
What Paracetamol film coated tablets looks and contents of the pack
Paracetamol 1000 mg film coated tablets
White coloured, caplet shaped, film coated tablets, with ‘K’, Bisect break
line ‘02’on one side and break line on the other side.
Paracetamol 1000 film coated tablets are available in Blister packs of 12,
16 & 100 tablets and HDPE Bottles of 32, 100, 300 & 500 tablets.
Marketing Authorization Holder
Dawa Limited
5 Sandridge Close
Harrow
Middlesex
HA1 1XD
UK
Manufacturer
Drugsrus Limited
5 Sandridge Close
Harrow
Middlesex
HA1 1XD
UK
This leaflet was last revised on 05/2015.

Expand view ⇕

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.

Hide