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.