Paracetamol 500mg Tablets
Reporting of side effects
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 500 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 blister and the carton after EXP Do not store above 25°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information
What Paracetamol 500 mg Tablets contain
The active substance is paracetamol. Each tablet contains 500 mg of paracetamol.
The other ingredients are: magnesium stearate, maize starch, povidone K-30, docusate sodium and anhydrous colloidal silica.
What Paracetamol 500 mg Tablets look like and the contents of the pack
The tablets are white and capsule shaped marked with 'PARA 500' on one side and M+ on the other side. Paracetamol 500 mg Tablets are presented in blister strips which are then packaged into cartons of 1 6, 32 or 100 tablets (8 or 10 tablets per blister strip).
PL Holder and Manufacturer
MEDREICH PLC, Warwick House, Plane Tree Crescent, Feltham TW13 7HF, UK E-mail : info@medreich.co.uk
PL 21880/0014
Leaflet revised August 2016
IpomI 0014/O/PIL/001/1
121XXXX
PACKAGE LEAFLET: INFORMATION FOR THE USER
Paracetamol 500 mg Tablets
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, pharmacist, or nurse has told you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• 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. See section 4.
What is in this leaflet:
1. What Paracetamol 500 mg Tablets are and what they are used for
2. Before you take Paracetamol 500 mg Tablets
3. How to take Paracetamol 500 mg Tablets
4. Possible side effects
5. How to store Paracetamol 500 mg Tablets
6. Further information
1. What Paracetamol 500 mg Tablets are and what they are used for
Paracetamol 500mg Tablets are used for the relief of headache, tension headache, migraine, backache, rheumatic and muscle pain, toothache and period pain.
They also relieve sore throat and the fever, aches and pains of colds and flu and are recommended for the relief of pain due to mild arthritis.
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 500 mg Tablets Do not take Paracetamol 500 mg Tablets:
• If you are allergic (hypersensitive) to paracetamol or to any of the other ingredients listed in section 6
• If you are taking other paracetamol containing products Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Paracetamol 500mg Tablets if:
• You have liver or kidney disease, including non-cirrhotic alcoholic liver disease
• You are on a sodium controlled diet
• If you suffer from mild arthritis and need to take painkillers every day. Children
Do not give this medicine to children aged under 6 years.
Other medicines and Paracetamol 500mg Tablets
Tell your doctor or pharmacist before taking these tablets if you are taking , have recently taken or might take any other medicines; particularly metoclopramide or domperidone (for nausea [feeling sick] or vomiting [being sick] or colestyramine (to lower blood cholesterol). If you take blood thinning drugs (anticoagulants e.g. warfarin) and you need to take a pain reliever on a daily basis, talk to your doctor because of the risk of bleeding. But you can still take occasional doses of Paracetamol 500mg tablets at the same time as anticoagulants.
Pregnancy and breastfeeding
Talk to your doctor or pharmacist before taking these tablets if you are Pregnant or think you may be pregnant. You can take this product whilst breast feeding.
3. How to take Paracetamol 500 mg Tablets
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are not sure.
Dosage in Adults:
One or two tablets every 4 hours when necessary. Do not take more than 8 tablets in any 24 hours. Swallow the tablets whole with a glass of water.
Dosage in children aged 6 to 15 years:
|
Age |
Recommended Dose |
500mg Tablet dose |
How Often |
|
6-8 years |
240-250mg |
Half |
Every 4-6 hours when necessary to a maximum of 4 doses in 24 hours |
|
8-10 years |
360-375mg |
Half - three quarters |
Every 4-6 hours when necessary to a maximum of 4 doses in 24 hours |
©
|
mi |
III | ||
|
10-12 years |
480-500mg |
One |
Every 4-6 hours when necessary to a maximum of 4 doses in 24 hours |
|
12-15 years |
480-750mg |
One -One & half |
Every 4-6 hours when necessary to a maximum of 4 doses in 24 hours |
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Do not give for more than 3 days at a time unless your doctor tells you to. Swallow the tablets whole with a glass of water.
When taking this medicine, it is important to remember the following:
* DO NOT GIVE THESE TABLETS TO CHILDREN AGED UNDER 6 YEARS.
* Do not take more than the recommended dose.
* Do not take more frequently than every 4 hours.
* Do not take other paracetamol containing products whilst taking this medicine.
If you take more Paracetamol 500 mg Tablets than you should
Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage.
If your symptoms continue or your headache becomes persistent, see your doctor.
If you forget to take Paracetamol 500 mg Tablets
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking the medicine and tell your doctor immediately if you
experience:
* Allergic reactions which may be sever 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.
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MEDREICH LIMITED | |||
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Product |
Paracetamol Tablets - S/L - Eng - PIL (PL 21880/0014) | ||
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Customer |
MEDREICH PLC, UK | ||
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Reason for Issue |
New PIF / AWR No.: | ||
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Related FG Codes |
130XXXX Pharmacode No |
5926 | |
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Item Code |
121XXXX (WOA) Layout No.: NA | ||
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Verified By |
Approved By | ||
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PDC: |
PDC: |
Regulatory: | |
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Title: Art Work Approval Form | |||
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Specification: |
Printed on 56 - 60 GSM maplitho paper. | ||
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Colours: |
Single - Black | ||
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Dimensions: |
220 x 140 mm (Open Size) 110 x 35 mm (Folded Size) | ||
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No. of Folds (only for PIL) |
NA |
Artwork made to |
100% |
MED/PAR/PIL/05
Format No.: CO-QA005-F03-02
WIN\\192.168.1.33\pdc\Artworks\Medreich\UK Products\Paracetamol\Tablets\500 mg\100's\PL 21880-0014\PIL\ Paracetamol Tablets SL Eng PIL (PL 21880-0014).ai
Internal Approval issued on
CD issued on
11.07/12.07/13.07(AK)/
02(MA)/23.08.16(MA)