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PARACETAMOL 500 MG FILM COATED TABLETS

Active substance(s): PARACETAMOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Paracetamol 500mg film coated tablets

Paracetamol

Read all of this leaflet carefully before you start 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
any possible side effects not listed in this leaflet.
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
This medicine contains Paracetamol. It belongs to a group of medicines
called analgesics (painkillers) and is used to treat pain (including headache,
toothache, back and period pain) and cold or flu symptoms.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL
FILM COATED TABLETS
Do not take Paracetamol film coated tablets
- If you are allergic to paracetamol or any of the other ingredients in
Paracetamol film coated tablets.
- if you are taking other medicines containing paracetamol.
Take special care when using Paracetamol film coated tablets
- If you are malnourished or have past experience of alcohol abuse.
- Treatment of fever conditions in children.
- Use with caution in renal, liver and kidney function.
- During long-term (> 3 months) use of Paracetamol film coated tablets
with intake every other day or more often, headaches can be caused or
exacerbated and may prevail if not treated properly. Headache suspected
to be induced by use of Paracetamol film coated tablets requires
immediate medical attention.
Taking other medicines with Paracetamol film coated tablets
Refer your doctor or pharmacist if you are taking or have recently taken
other medicines, including prescribed.
Some other medicines may affect or be influenced by Paracetamol film
coated tablets. Some of these drugs are mentioned below
- Medicine for epilepsy.
- Dicoumarol (Blood thinning agents) for example, warfarin.
- Chloramphenicol (antibiotic), but not by local application of eye drops.
- Probenecid (gout medicine).
- Pregnancy and lactation
Refer your doctor or pharmacist if you are taking any medicine.
No adverse effects on the fetus are shown.
It may enter breast milk, but the effect on nursing infants is not likely.
Driving and using machines
The product is not expected to affect the ability drive a car or operate
machinery.
3. HOW TO TAKE PARACETAMOL FILM COATED TABLETS
Adults and children over 16 years:
 Two tablets up to four times daily as required.
Children 12-16 years:
 Half to one tablet three to four times daily as required.
 Do not take more than 4 tablets in 24 hours.
 Do not give for more than 3 days without consulting a doctor.
 Do not take more frequently than every 4 hours.
 Do not take more than the recommended dose.
Use in children: Paracetamol 500mg film coated tablets should not be
given under 12 years of age.

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 your symptoms continue or your headache becomes persistent, see your
doctor.
Symptoms of overdose are observed after 2-3 day. The symptoms are loss
of appetite, nausea, vomiting, pain in abdomen, jaundice and discoloration
of urine and stools. In severe cases, life-threatening liver injury may occur.
If you forget to take Paracetamol film coated tablets
If you forget to take a dose at the right time, take it as soon as you
remember. However, do not take a double dose to make up for a forgotten
dose. Remember to leave at least 4 hours between doses.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Paracetamol film coated tablets can have side effects
but not everybody gets them. A small number of people have had side
effects. Stop taking the medicine and tell your doctor immediately if you
experience:
- Allergic reactions which may be severe such as skin rash and itching
sometimes with swelling of the mouth or face or shortness of breath
- Skin rash or peeling, or mouth ulcers
- Breathing problems. These are more likely if you have experienced them
before when taking other painkillers such as ibuprofen and aspirin
- Unexplained bruising or bleeding
- Nausea, sudden weight loss, loss of appetite and yellowing of the eyes
and skin.
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 500 mg film coated tablets contains 500 mg of
Paracetamol
The other ingredients are:
For the tablet core: Pregelatinized starch, maize starch, Povidone,
Magnesium stearate.
For the tablet coating: Hypromellose (E464), Titanium dioxide (E171),
Macrogol (E1521.
How Paracetamol film coated tablets looks and contents of the pack
Paracetamol 500 mg film coated tablets
White colored, caplet shaped, film coated tablets with ‘K’, Bisect break line
and ‘01’ on one side and plain on other side.
Paracetamol 500 film coated tablets are available in Blister packs of
100 tablets and HDPE Bottles of 100, 300, 500 & 1000 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 07/2015.

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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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