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PANADOL 1000 MG TABLETS - patient leaflet, side effects, dosage

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Patient leaflet - PANADOL 1000 MG TABLETS

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

1. NAME OF THE MEDICINAL PRODUCT

Panadol® OA 1000 mg Tablets

paracetamol

2. STATEMENT OF ACTIVE SUBSTANCE(S)

ONE Panadol OA Tablet contains paracetamol 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 sight and reach of children.

  • 7. OTHER SPECIAL WARNING(S), IF NECESSARY

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

Do not take more medicine than the label tells you to.

CONTAINS PARACETAMOL. Do not take anything else containing paracetamol while taking this medicine.

Talk to a doctor at once if you take too much medicine, 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 doctoror 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 otheringredients (listed in Section 5)
  • if you are taking any other prescription or non-prescription medicines containing paracetamol to treat pain, fever, symptoms of cold and flu, or to aid sleep..

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

  • if you have liver or kidney problems.
  • if you are underweight or malnourished
  • if you regularly drink alcohol
  • if you have a severe infection as this may increase the risk of metabolic acidosis.
  • Signs of metabolic acidosis include:
  • deep, rapid, difficult breathing
  • feeling sick (nausea), being sick (vomiting)
  • loss of appetite

Contact a doctor immediately if you get a combination of these symptoms.

You may need to avoid using this product altogether or limit the amount of paracetamol that you take.

  • < ! symbol> Pregnancy and breast-feeding

Talk to your health care professional before taking Panadol OA Tablets if you are pregnant. If necessary, Panadol OA Tablets can be used during pregnancy. Consider taking the lowest effective dose for the shortest period of time. You can take this product whilst breastfeeding.

  • < ! symbol> If you are taking other medicines

Talk to your doctor or pharmacist before taking these tablets if you are taking anyother 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 16 years.

If you take too many tablets

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 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. Very rare cases of serious skin reactions have been reported.

Stop taking the medicine and tell your doctor immediately if you experience:

  • Allergic reactions which may be severe such as skin rash and itching sometimeswith 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 whentaking 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 or search for MHRA Yellow Card in the Google Play or Apple App store. By reporting side effects you can help provide more information on the safety of this medicine.

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 MEDICINALPRODUCTS 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. Trade

marks are 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. Possible 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 ingredient is paracetamol which is a painkiller and also reduces yourtemperature when you have a fever.

3. How to take Panadol OA Tablets

| <! symbol> Adults and children 16 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 May 2019.

16. INFORMATION IN BRAILLE

PANADOL OA #1000 MG