Medine.co.uk

Panadol 1000mg Tablets

Document: label-leaflet MAH BRAND_PL 44673-0089 change

PARTICULARS TO APPEAR ON THE OUTER PACKAGING PEEL BACK LABEL


1. NAME OF THE MEDICINAL PRODUCT


Panadol® OA 1000 mg Tablets paracetamol


2. STATEMENT OF ACTIVE SUBSTANCE(S)


ONE Panadol OA Tablet contains paracetmol 1000 mg, the same amount of paracetamol as TWO standard paracetamol tablets.

Active ingredient: Each tablet contains Paracetamol 1000 mg.


3. LIST OF EXCIPIENTS


Other ingredients: Maize starch, pregelatinised starch, povidone, potassium sorbate (E 202), talc, stearic acid, hypromellose and triacetin.


4. PHARMACEUTICAL FORM AND CONTENTS


Tablet

100

Packs of Panadol OA Tablets contain 100 tablets.


5. METHOD AND ROUTE(S) OF ADMINISTRATION


Take 1 tablet as prescribed.


6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN


Keep out of the reach and sight of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY


Peel back label and read instructions carefully before taking these tablets.

Do not exceed the stated dose.

CONTAINS PARACETAMOL. Do not take with any other paracetamol-containing products.

Immediate medical advice should be sought in the event of an overdose, even if you feel well.

Please read right through this information carefully before you start using this medicine. This medicine is available on prescription only.

•    Keep this information, you may need to read it again.

•    Do not remove the information from the pack.

•    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 you have questions, or if there is anything else you do not understand, ask your doctor or pharmacist.

2. Check before you take Panadol OA Tablets

<X symbol> Do not take Panadol OA Tablets:

   if you have ever had an allergic reaction

to paracetamol or to any of the other ingredients (listed in Section 5)

•    if you are taking other medicines containing paracetamol.

<! symbol> Ask your doctor before you take this medicine:

•    if you have liver or kidney disease, inlcuding alcoholic liver disease.

<! symbol> Pregnancy and breast-feeding Talk to your doctor before taking Panadol OA Tablets if you are pregnant. You can take this product whilst breast feeding.

<! symbol> If you are taking other medicines

Talk to your doctor or pharmacist before taking these tablets if you are taking any other medicines, including medicines obtained without prescription; particularly metoclopromide or domperidone (for nausea [feeling sick] or vomiting [being sick]) or colestyramine (to lower blood cholesterol).

You should also talk to your doctor if you take blood thinning drugs (anticoagulants

e.g. warfarin) and you need to take a pain reliever on a daily basis over a long period of time. But you can still take occasional doses of Panadol OA Tablets at the same time as anticoagulants.

•    ONE Panadol OA Tablet contains Paracetamol 100mg, the same amount as TWO standard paracetamol tablets.

•    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 paracetamol containing products.

•    Do not give to children under 12 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.

4. Possible side effects

Like all medicines, Panadol OA 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 do get any side effects, even those not mentioned in this information or if any of the side effects get serious, tell your doctor or pharmacist.


Do not use this medicines after the ‘EXP’ date shown on the side of the pack.


8. EXPIRY DATE


EXP:


9. SPECIAL STORAGE CONDITIONS


Do not store above 25°C.


10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL

PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE


< not applicable >


11.    NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER


GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, Brentford, TW8 9GS, U.K. Panadol is a registered trade mark owned by or licensed to the GSK group of companies <Company logo>

The marketing authorisation holder is

GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, Brentford, TW8 9GS, U.K. and all enquiries should be sent to this address.

The manufacturer is GlaxoSmithKline Dungarvan Ltd., Co. Waterford, Ireland or Catalent UK Packaging Limited, Corby,

Northamptonshire, NN18 8HS, U.K.

< Company logo >


12. MARKETING AUTHORISATION NUMBER(S)


PL 44673/0089


13. BATCH NUMBER


BN:


14. GENERAL CLASSIFICATION FOR SUPPLY


POM


15. INSTRUCTIONS ON USE


Peel here but do not remove

In this information

1.    What Panadol OA Tablets do

2.    Check before you take Panadol OA Tablets


3.    How to take Panadol OA Tablets

4.    Possibe side effects

5.    Further information

1. What Panadol OA Tablets do

Panadol OA Tablets are used for the management of mild to moderate pain, including osteoarthritis. They can also be used to reduce fever.

The active ingredeint is apracetamol which is a painkiller and also reduces your temperature when you have a fever.

3. How to take Panadol OA Tablets

<! symbol> Adults and children 12 years and over:

Take 1 tablet as prescribed.

5. Further information

Panadol OA Tablets are white Capsule shaped tablets.

How to store Panadol OA Tablets

This information was prepared in July 2016.

16. INFORMATION IN BRAILLE


PANADOL OA #1000 MG