PANADOL EXTRA TABLETS
Active substance(s): CAFFEINE / PARACETAMOL
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PARTICULARS TO APPEAR ON THE OUTER PACKAGING
CARTON
1.
NAME OF THE MEDICINAL PRODUCT
Panadol® Extra Tablets
Paracetamol + Caffeine
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
Outer carton:
Each tablet contains Paracetmol 500 mg and Caffeine 65 mg.
Inner carton:
Active ingredients: Each tablet contains Paracetmol 500 mg and Caffeine 65 mg.
3.
LIST OF EXCIPIENTS
Outer carton:
Also contains potassium sorbate (E 202).
Inner carton:
Other ingredients: Starch pregelatinised, maize starch,
polyvinyl pyrollidone, potassium sorbate (E 202),
purfied talc, stearic acid, croscarmellose sodium,
hypromellose and triacetin.
4.
PHARMACEUTICAL FORM AND CONTENTS
Outer carton:
Tablet
16
Inner carton:
Packs of Panadol Extra Tablets contain 8, 16 or 32 tablets.
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
< see Instructions On Use section below >
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
Outer carton:
Please read right through the information on the outside and inside of this pack before
you start using this medicine.
If you have any questions, or if there is anything you do not understand, ask your pharmacist.
TAKE SPECIAL CARE
Contains paracetamol. Do not take with any other paracetamol-containing products.
Ask your doctor before you take this medicine:
• if you have liver or kidney disease, inlcuding alcoholic liver disease.
Do not take more frequently than every 4 hours.
Do not take more than the recommended dose.
Do not take if you are under 12 years of age.
Avoid too much caffeine in drinks like coffee and tea.
High caffeine intake can cause difficulty in sleeping, shaking and an uncomfortable feeling
in the chest.
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.
Inner carton:
2. CHECK BEFORE YOU TAKE PANADOL EXTRA TABLETS
<X symbol>
Do not take Panadol Extra Tablets:
• if you have ever had an allergic reaction
to paracetamol, caffeine or to any of the other
ingredients (listed in Section 4).
<! symbol>
If you are taking other medicines
Talk to your doctor or pharmacist before taking
these tablets if you are taking any prescribed
medicines; particularly metoclopromide 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 Panadol Extra Tablets at the
same time as anticoagulants.
<! symbol>
Pregnancy and breast-feeding
Do not take Panadol Extra Tablets if you are
pregnant or breast feeding.
3. POSSIBLE SIDE EFFECTS
Like all medicines, Panadol Extra 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, tell your doctor or pharmacist.
If your symptoms continue or your headache becomes persistent, see your doctor.
8.
EXPIRY DATE
DO NOT USE AFTER THE EXP DATE:
9.
SPECIAL STORAGE CONDITIONS
Store below 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
Outer carton:
GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, Brentford, TW8 9GS, U.K.
<Company logo>
Inner carton
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.
Panadol and the Roundel device are registered trade marks owned by or licensed to
the GSK group of companies
<Company logo>
12.
MARKETING AUTHORISATION NUMBER(S)
PL 44673/0087
13.
BATCH NUMBER
BN:
14.
GENERAL CLASSIFICATION FOR SUPPLY
< not applicable – GSL >
15.
INSTRUCTIONS ON USE
Outer carton:
Backache
Muscular aches
Migraine headache
Easy on the stomach
Panadol Extra Tablets provide extra effective pain relief.
● headache
● toothache
● backache
● migraine
● sore throat
● period pain
● helps reduce temperature
● aches and pains of colds and flu
● rheumatic pain
● fever
HOW TO TAKE
Adults and children 16 years and over:
Swallow 2 tablets every 4 hours as needed. Do not take more than 8 tablets in 24 hours.
Children aged 12-15 years:
Swallow 1 tablet every four hours as needed. Do not give more than 4 tablets in 24 hours.
Inner carton
4. WHAT PANADOL EXTRA TABLETS DO
Panadol Extra Tablets are used for the relief of headache,
migraine, backache, rheumatic pain, toothache
and period pain. They also relieve sore throat and the fever, aches and pains of colds
and flu.
The tablets contain two active ingredients. Paracetamol is a
painkiller and also reduces your temperature when you have
a fever. Caffeine acts to further help the effectiveness of
paracetamol.
This information was last revised in September 2016.
16.
INFORMATION IN BRAILLE
panadol extra tablets
PARTICULARS TO APPEAR ON THE INNER PACKAGING
FOIL
1.
NAME OF THE MEDICINAL PRODUCT
Panadol® Extra Tablets
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
Paracetamol + Caffeine
3.
LIST OF EXCIPIENTS
< not applicable >
4.
PHARMACEUTICAL FORM AND CONTENTS
< not applicable >
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
< not applicable >
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED
OUT OF THE REACH AND SIGHT OF CHILDREN
< not applicable >
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
< not applicable >
8.
EXPIRY DATE
< not applicable >
9.
SPECIAL STORAGE CONDITIONS
< not applicable >
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
12.
MARKETING AUTHORISATION NUMBER(S)
< not applicable >
13.
BATCH NUMBER
< not applicable >
14.
GENERAL CLASSIFICATION FOR SUPPLY
< not applicable >
15.
INSTRUCTIONS ON USE
< not applicable >
16.
INFORMATION IN BRAILLE
< not applicable >
CARTON
1.
NAME OF THE MEDICINAL PRODUCT
Panadol® Extra Tablets
Paracetamol + Caffeine
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
Outer carton:
Each tablet contains Paracetmol 500 mg and Caffeine 65 mg.
Inner carton:
Active ingredients: Each tablet contains Paracetmol 500 mg and Caffeine 65 mg.
3.
LIST OF EXCIPIENTS
Outer carton:
Also contains potassium sorbate (E 202).
Inner carton:
Other ingredients: Starch pregelatinised, maize starch,
polyvinyl pyrollidone, potassium sorbate (E 202),
purfied talc, stearic acid, croscarmellose sodium,
hypromellose and triacetin.
4.
PHARMACEUTICAL FORM AND CONTENTS
Outer carton:
Tablet
16
Inner carton:
Packs of Panadol Extra Tablets contain 8, 16 or 32 tablets.
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
< see Instructions On Use section below >
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
Outer carton:
Please read right through the information on the outside and inside of this pack before
you start using this medicine.
If you have any questions, or if there is anything you do not understand, ask your pharmacist.
TAKE SPECIAL CARE
Contains paracetamol. Do not take with any other paracetamol-containing products.
Ask your doctor before you take this medicine:
• if you have liver or kidney disease, inlcuding alcoholic liver disease.
Do not take more frequently than every 4 hours.
Do not take more than the recommended dose.
Do not take if you are under 12 years of age.
Avoid too much caffeine in drinks like coffee and tea.
High caffeine intake can cause difficulty in sleeping, shaking and an uncomfortable feeling
in the chest.
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.
Inner carton:
2. CHECK BEFORE YOU TAKE PANADOL EXTRA TABLETS
<X symbol>
Do not take Panadol Extra Tablets:
• if you have ever had an allergic reaction
to paracetamol, caffeine or to any of the other
ingredients (listed in Section 4).
<! symbol>
If you are taking other medicines
Talk to your doctor or pharmacist before taking
these tablets if you are taking any prescribed
medicines; particularly metoclopromide 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 Panadol Extra Tablets at the
same time as anticoagulants.
<! symbol>
Pregnancy and breast-feeding
Do not take Panadol Extra Tablets if you are
pregnant or breast feeding.
3. POSSIBLE SIDE EFFECTS
Like all medicines, Panadol Extra 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, tell your doctor or pharmacist.
If your symptoms continue or your headache becomes persistent, see your doctor.
8.
EXPIRY DATE
DO NOT USE AFTER THE EXP DATE:
9.
SPECIAL STORAGE CONDITIONS
Store below 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
Outer carton:
GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, Brentford, TW8 9GS, U.K.
<Company logo>
Inner carton
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.
Panadol and the Roundel device are registered trade marks owned by or licensed to
the GSK group of companies
<Company logo>
12.
MARKETING AUTHORISATION NUMBER(S)
PL 44673/0087
13.
BATCH NUMBER
BN:
14.
GENERAL CLASSIFICATION FOR SUPPLY
< not applicable – GSL >
15.
INSTRUCTIONS ON USE
Outer carton:
Backache
Muscular aches
Migraine headache
Easy on the stomach
Panadol Extra Tablets provide extra effective pain relief.
● headache
● toothache
● backache
● migraine
● sore throat
● period pain
● helps reduce temperature
● aches and pains of colds and flu
● rheumatic pain
● fever
HOW TO TAKE
Adults and children 16 years and over:
Swallow 2 tablets every 4 hours as needed. Do not take more than 8 tablets in 24 hours.
Children aged 12-15 years:
Swallow 1 tablet every four hours as needed. Do not give more than 4 tablets in 24 hours.
Inner carton
4. WHAT PANADOL EXTRA TABLETS DO
Panadol Extra Tablets are used for the relief of headache,
migraine, backache, rheumatic pain, toothache
and period pain. They also relieve sore throat and the fever, aches and pains of colds
and flu.
The tablets contain two active ingredients. Paracetamol is a
painkiller and also reduces your temperature when you have
a fever. Caffeine acts to further help the effectiveness of
paracetamol.
This information was last revised in September 2016.
16.
INFORMATION IN BRAILLE
panadol extra tablets
PARTICULARS TO APPEAR ON THE INNER PACKAGING
FOIL
1.
NAME OF THE MEDICINAL PRODUCT
Panadol® Extra Tablets
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
Paracetamol + Caffeine
3.
LIST OF EXCIPIENTS
< not applicable >
4.
PHARMACEUTICAL FORM AND CONTENTS
< not applicable >
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
< not applicable >
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED
OUT OF THE REACH AND SIGHT OF CHILDREN
< not applicable >
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
< not applicable >
8.
EXPIRY DATE
< not applicable >
9.
SPECIAL STORAGE CONDITIONS
< not applicable >
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
12.
MARKETING AUTHORISATION NUMBER(S)
< not applicable >
13.
BATCH NUMBER
< not applicable >
14.
GENERAL CLASSIFICATION FOR SUPPLY
< not applicable >
15.
INSTRUCTIONS ON USE
< not applicable >
16.
INFORMATION IN BRAILLE
< not applicable >
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
