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BOOTS JOINT PAIN RELIEF 12.5 MG FILM-COATED TABLETS

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Double Action Pain Relief
12.5mg Tablets
Diclofenac potassium

In this leaflet
1 What Double Action Pain Relief is
and what it is used for
2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 Further information

1 What Double Action Pain Relief is and what it is
used for
Double Action Pain Relief contains diclofenac which belongs to a
group of medicines called non-steroidal anti-inflammatory drugs
(NSAIDs). Double Action Pain Relief is a pain reliever which also,
reduces inflammation (swelling) and fever.

Double Action Pain Relief provides relief from:
• backache, rheumatic pain, muscular pain, headache, dental pain
and period pain.
• symptoms of colds and flu. This medicine also reduces fever.

2 Before you take

Do not take Double Action Pain Relief but see a doctor
instead if you:

• are allergic to diclofenac, medicines containing diclofenac
potassium or to any of the other ingredients in Double Action Pain
Relief (see section 6)
• are allergic to peanut or soya, as this medicine contains soya
• are allergic to aspirin, ibuprofen or other non-steroidal antiinflammatory medicines (NSAIDs), or you have developed signs
of asthma (wheezing), runny nose, swelling of the skin or rash
when taking these medicines
• have or have had stomach or duodenal (gut) ulcers, bleeding in
the stomach or intestines (gastrointestinal bleeding) or have had
two or more episodes of a stomach ulcer, perforation or bleeding
• have severe heart failure, liver or kidney failure
• use other non-steroidal anti-inflammatory medicines (NSAIDs),
or aspirin with a daily dose above 75mg, or any medication which
may cause bleeding or ulcers in the stomach
• are taking medicines that thin the blood, such as warfarin
• are or may be pregnant or are breast feeding.

Check with your doctor or pharmacist before taking
Double Action Pain Relief if you:

• have a history of gastrointestinal disease e.g. ulcerative colitis,
Crohn’s disease
• are elderly
• have or have had high blood pressure, a stroke or any heart,
liver or kidney problems
• if you have kidney or liver problems you should only take Double
Action Pain Relief under the supervision of your doctor, for
monitoring of your kidney or liver function.
• have asthma , diabetes, high cholesterol
• are a smoker
• have systemic lupus erythematosus or other connective tissue
disorders
• have any blood clotting disorders
• have porphyria a genetic/inherited disorder of the red blood
pigment haemoglobin
• are on a controlled potassium diet. Each tablet contains 0.0374
mmol (1.46mg) of potassium, this should be taken into account if
you are on a controlled potassium diet.
• are a women trying to become pregnant or undergoing
investigation of infertility
• diclofenac belongs to a group of medicines which may impair
fertility in women. This effect is reversible on stopping the
medicine. It is unlikely that diclofenac, used occasionally, will
affect your chances of becoming pregnant. However, tell
your doctor before taking this medicine if you have problems
becoming pregnant.

Other warnings

•  edicines such as diclofenac may be associated with a small
M
increased risk of heart attack (myocardial infarction) or stroke.
Any risk is more likely with high doses and prolonged treatment.
Do not exceed the recommended dose or duration of treatment.
• f you are elderly or frail, you have a higher risk of getting side
I

effects, especially of the stomach. If you experience any unusual
symptoms from the stomach, you must tell your doctor about it.
•  ouble Action Pain Relief may hide the symptoms of an
D
infection.

If symptoms persist or worsen, consult your doctor.
Taking other medicines

Please tell your doctor or pharmacist if you are taking or have
recently taken, any other medicines obtained with or without a
prescription. Especially:
•  ther non-steroidal anti-inflammatory drugs (NSAIDs) e.g.
o
ibuprofen, COX II inhibitors and aspirin (used for pain and
inflammation)
•  edicines to treat high blood pressure including ACE inhibitors
m
such as captopril, ramipril or propranolol
• diuretics (‘water tablets’), such as furosemide
• cardiac glycosides (for heart failure), such as digoxin
• lithium (used for some mental health problems)
• methotrexate (to treat some cancers)
• ciclosporin, tacrolimus (to suppress the immune system)
•  ifepristone (for termination of pregnancy). Double Action Pain
m
Relief tablets should not be taken within 8-12 days of taking
mifepristone

Continued top of next column
WASPL008

Continued over page

Advanced Pain Relief Tablets (UK)

colours/plates:
1. Black

item no:

WASPL008

dimensions: 148 x 210

print proof no:

5

pharmacode:

2.
3.
4.

origination date: 13.08.09

MOCK UP
ONLY

5.

originated by:

R.Paul

6.

revision date:

11.06.10

revised by:

LW

min pt size:

Wasdell

technically app. date:

supplier:

Non Printing Colours
1.
2.
3.

Pharmacode
Position

Read all of this leaflet carefully before
you start taking this medicine.
•  eep this leaflet. You may need to read it

K
again.
• f you have any further questions, ask
I
your doctor or pharmacist.
• f any of the side effects get serious, or
I
if you notice any side effects not listed
in this leaflet, please tell your doctor or
pharmacist.

• corticosteroids (used in many different diseases), such as prednisolone
•  edicines which thin the blood or which prevent blood clotting such as
m
warfarin
• SSRI antidepressants (for depression), such as fluoxetine
• quinolone antibiotics (to treat bacterial infections), such as ciprofloxacin
• antidiabetics (to treat diabetes), such as metformin
• Zidovudine (anti-viral).

Pregnancy and breast-feeding

If you are pregnant, planning to become pregnant or breast-feeding you must
not take Double Action Pain Relief tablets. Speak to your doctor or pharmacist
before you use any medication.

Driving and using machines

Double Action Pain Relief does not normally cause any effects however
you may experience dizziness, drowsiness, spinning sensation, difficulty in
sleeping, depression or disturbed vision. If you are affected do not drive or
operate machinery.

Important information about one of the ingredients of Double
Action Pain Relief 12.5mg Tablets

Double Action Pain Relief contains soya lecithin. If you are allergic to peanut or
soya, do not use this medicinal product.

3 How to take

Swallow whole with water, with or after food. Do not crush or chew the
tablets.
You should take the lowest dose that controls your symptoms for the shortest
amount of time. This will reduce any side effects you may experience.

Adults and children aged 14 years and over:

Initially take two tablets (25mg) then if needed, one or two tablets (12.5mg or
25mg) every 4-6 hours.
Leave at least 4 – 6 hours between doses and do not take more than the
maximum dose of six tablets (75mg) in any 24 hour period.
Double Action Pain Relief should not be used for longer than 3 days. If
symptoms persist or worsen consult your doctor.

If you take more Double Action Pain Relief than you should

It is important not to take too many tablets. Contact your doctor, pharmacist
or nearest hospital casualty department immediately if you have taken more
tablets than you should.
Symptoms of an overdose are feeling or being sick, stomach pain or bleeding,
diarrhoea, ringing in the ears, headache.

If you forget to take the tablets

If you forget to take a dose, take it as soon as you remember, unless it is nearly
time for your next dose. Then go on as before. Never double up on the next
dose to make up for the one missed.

4 Possible side effects

Like all medicines, Double Action Pain Relief can cause side-effects, although
not everybody gets them. If any of the side effects get worse, or if you notice
any not listed in this leaflet, please tell your doctor or pharmacist. Also you can
help to make sure that medicines remain as safe as possible by reporting any
unwanted side effects via the internet at www.yellowcard.gov.uk or you can
call Freephone 0808 100 3352 (available between 10am – 2pm Monday to
Friday) or fill in a paper form available from your local pharmacy.

Stop taking Double Action Pain Relief and contact your doctor or
pharmacist immediately if you develop:
•  n allergic reaction: skin reactions such as rash, itching, pale or red
A
irregular raised patches with severe itching (hives), disorder characterised
by blood spots, bruising and discolouring to skin (purpura), swelling of the
face, lips, tongue or throat. Development or worsening of asthma, difficulty
breathing or narrowing of the airways.
Continued top of next column
WASPL008

•  evere rash involving reddening, peeling and swelling of the skin that
S
resembles severe burns (toxic epidermal necrolysis), circular, irregular red
patches on the skin of the hands and arms (erythema multiforme) and
severe skin rash with flushing, fever, blisters or ulcers (Stevens-Johnson
Syndrome).
•  ark blood-stained stools, vomiting blood, indigestion, heartburn,
D
abdominal pain (signs of ulceration, bleeding and perforation of the
stomach and intestines).
•  listering of mucous membranes e.g. eye, mouth or anus.
B
•  septic meningitis (stiff neck, headache, feeling or being sick, fever,
A
disorientation).
Tell your doctor or pharmacist if you notice any of the following side effects:
•  ommon (less than 1 in 10 users): headache, dizziness, a spinning
C
sensation, feeling or being sick, diarrhoea, wind.
•  are (less than 1 in 1000 users): inflammation of the stomach lining
R
(gastritis), water retention, abnormal liver function, inflammation of the liver
(hepatitis), yellowing of the skin or whites of the eyes (jaundice).
•  ery rare (less than 1 in 10,000 users): constipation, mouth ulcers,
V
worsening of colitis and Crohn’s disease, inflammation of the pancreas
causing pain and tenderness in the abdomen and back (pancreatitis),
kidney inflammation or failure, increased protein in urine and fluid
retention (nephrotic syndrome), blood in the urine, high blood pressure
or heart failure, inflammation of the optic nerve, disturbed vision, tingling
or “pins and needles”, depression, confusion, ringing in the ears, sensing
things that are not there, feeling of general discomfort and illness, tiredness,
drowsiness, sensitivity to light, reduced sexual potency in men. Changes in
the numbers or types of blood cells causing increased bruising, nosebleeds,
sore throats, infections, excessive tiredness, breathlessness on exertion, or
abnormal paleness of the skin.
Medicines such as Double Action Pain Relief may be associated with a small
increased risk of heart attack (“myocardial infarction”) or stroke (see page 1
‘Other warnings’).

If you notice any side effects, they get worse, or if you notice
any not listed, please tell your doctor or pharmacist.

5 How to store

Keep out of the reach and sight of children.
Do not store above 25ºC. Store in the original package.
Do not use Double Action Pain Relief after the expiry date stated on the
carton. The expiry date refers to the last day of that month.
Medicines should not be disposed of 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 Double Action Pain Relief 12.5mg tablets contain

•  he active substance (the ingredient that makes the medicine work) is
T
diclofenac potassium. Each tablet contains 12.5mg of the active substance.
•  he other ingredients are silica colloidal anhydrous, sodium starch
T
glycollate, povidone, starch maize, calcium hydrogen phosphate
anhydrous, magnesium stearate, polyvinyl alcohol partially hydrolysed,
titanium dioxide (E171), talc, lecithin soya (E322), xanthan gum (E415).

What Double Action Pain Relief 12.5mg tablets look like and
contents of the pack
The tablets are white round, unscored biconvex film coated tablet.
Pack size: 18 tablets

Marketing Authorisation Holder
Actavis Group PTC ehf,
Reykjavíkurvegi 76-78,
220 Hafnarfjordur,
Iceland.

Manufacturer

Actavis, Barnstaple EX32 8NS, UK.
This leaflet was last revised in April 2010

Advanced Pain Relief Tablets (UK)

colours/plates:
1. Black

item no:

WASPL008

dimensions: 148 x 210

print proof no:

5

pharmacode:

2.
3.
4.

origination date: 13.08.09

MOCK UP
ONLY

5.

originated by:

R.Paul

6.

revision date:

11.06.10

revised by:

LW

min pt size:

Wasdell

technically app. date:

supplier:

Non Printing Colours
1.
2.
3.

Double Action Pain Relief
12.5mg Tablets
Diclofenac potassium

In this leaflet
1 What Double Action Pain Relief is
and what it is used for
2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 Further information

1 What Double Action Pain Relief is and what it is
used for
Double Action Pain Relief contains diclofenac which belongs to a
group of medicines called non-steroidal anti-inflammatory drugs
(NSAIDs). Double Action Pain Relief is a pain reliever which also,
reduces inflammation (swelling) and fever.

Double Action Pain Relief provides relief from:
• backache, rheumatic pain, muscular pain, headache, dental pain
and period pain.
• symptoms of colds and flu. This medicine also reduces fever.

2 Before you take

Do not take Double Action Pain Relief but see a doctor
instead if you:

• are allergic to diclofenac, medicines containing diclofenac
potassium or to any of the other ingredients in Double Action Pain
Relief (see section 6)
• are allergic to peanut or soya, as this medicine contains soya
• are allergic to aspirin, ibuprofen or other non-steroidal antiinflammatory medicines (NSAIDs), or you have developed signs
of asthma (wheezing), runny nose, swelling of the skin or rash
when taking these medicines
• have or have had stomach or duodenal (gut) ulcers, bleeding in
the stomach or intestines (gastrointestinal bleeding) or have had
two or more episodes of a stomach ulcer, perforation or bleeding
• have severe heart failure, liver or kidney failure
• use other non-steroidal anti-inflammatory medicines (NSAIDs),
or aspirin with a daily dose above 75mg, or any medication which
may cause bleeding or ulcers in the stomach
• are taking medicines that thin the blood, such as warfarin
• are or may be pregnant or are breast feeding.

Check with your doctor or pharmacist before taking
Double Action Pain Relief if you:

• have a history of gastrointestinal disease e.g. ulcerative colitis,
Crohn’s disease
• are elderly
• have or have had high blood pressure, a stroke or any heart,
liver or kidney problems
• if you have kidney or liver problems you should only take Double
Action Pain Relief under the supervision of your doctor, for
monitoring of your kidney or liver function.
• have asthma , diabetes, high cholesterol
• are a smoker
• have systemic lupus erythematosus or other connective tissue
disorders
• have any blood clotting disorders
• have porphyria a genetic/inherited disorder of the red blood
pigment haemoglobin
• are on a controlled potassium diet. Each tablet contains 0.0374
mmol (1.46mg) of potassium, this should be taken into account if
you are on a controlled potassium diet.
• are a women trying to become pregnant or undergoing
investigation of infertility
• diclofenac belongs to a group of medicines which may impair
fertility in women. This effect is reversible on stopping the
medicine. It is unlikely that diclofenac, used occasionally, will
affect your chances of becoming pregnant. However, tell
your doctor before taking this medicine if you have problems
becoming pregnant.

Other warnings

•  edicines such as diclofenac may be associated with a small
M
increased risk of heart attack (myocardial infarction) or stroke.
Any risk is more likely with high doses and prolonged treatment.
Do not exceed the recommended dose or duration of treatment.
• f you are elderly or frail, you have a higher risk of getting side
I

effects, especially of the stomach. If you experience any unusual
symptoms from the stomach, you must tell your doctor about it.
•  ouble Action Pain Relief may hide the symptoms of an
D
infection.

If symptoms persist or worsen, consult your doctor.
Taking other medicines

Please tell your doctor or pharmacist if you are taking or have
recently taken, any other medicines obtained with or without a
prescription. Especially:
•  ther non-steroidal anti-inflammatory drugs (NSAIDs) e.g.
o
ibuprofen, COX II inhibitors and aspirin (used for pain and
inflammation)
•  edicines to treat high blood pressure including ACE inhibitors
m
such as captopril, ramipril or propranolol
• diuretics (‘water tablets’), such as furosemide
• cardiac glycosides (for heart failure), such as digoxin
• lithium (used for some mental health problems)
• methotrexate (to treat some cancers)
• ciclosporin, tacrolimus (to suppress the immune system)
•  ifepristone (for termination of pregnancy). Double Action Pain
m
Relief tablets should not be taken within 8-12 days of taking
mifepristone

Continued top of next column
WASPL006

Continued over page

Advanced Pain Relief Tablets (UK)

colours/plates:
1. Black

item no:

WASPL006

dimensions: 148 x 210

print proof no:

5

pharmacode:

2.
3.
4.

origination date: 13.08.09

MOCK UP
ONLY

5.

originated by:

R.Paul

6.

revision date:

11.06.10

revised by:

LW

min pt size:

Wasdell

technically app. date:

supplier:

Non Printing Colours
1.
2.
3.

Pharmacode
Position

Read all of this leaflet carefully before
you start taking this medicine.
•  eep this leaflet. You may need to read it

K
again.
• f you have any further questions, ask
I
your doctor or pharmacist.
• f any of the side effects get serious, or
I
if you notice any side effects not listed
in this leaflet, please tell your doctor or
pharmacist.

• corticosteroids (used in many different diseases) , such as prednisolone
•  edicines which thin the blood or which prevent blood clotting such as
m
warfarin
• SSRI antidepressants (for depression), such as fluoxetine
• quinolone antibiotics (to treat bacterial infections) , such as ciprofloxacin
• antidiabetics (to treat diabetes), such as metformin
• Zidovudine (anti-viral).

Pregnancy and breast-feeding

If you are pregnant, planning to become pregnant or breast-feeding you must
not take Double Action Pain Relief tablets. Speak to your doctor or pharmacist
before you use any medication.

Driving and using machines

Double Action Pain Relief does not normally cause any effects however
you may experience dizziness, drowsiness, spinning sensation, difficulty in
sleeping, depression or disturbed vision. If you are affected do not drive or
operate machinery.

Important information about one of the ingredients of Double
Action Pain Relief 12.5mg Tablets

Double Action Pain Relief contains soya lecithin. If you are allergic to peanut or
soya, do not use this medicinal product.

3 How to take
Swallow whole with water, with or after food. Do not crush or chew the
tablets.
You should take the lowest dose that controls your symptoms for the shortest
amount of time. This will reduce any side effects you may experience.

•  evere rash involving reddening, peeling and swelling of the skin that
S
resembles severe burns (toxic epidermal necrolysis), circular, irregular red
patches on the skin of the hands and arms (erythema multiforme) and
severe skin rash with flushing, fever, blisters or ulcers (Stevens-Johnson
Syndrome).
•  ark blood-stained stools, vomiting blood, indigestion, heartburn,
D
abdominal pain (signs of ulceration, bleeding and perforation of the
stomach and intestines).
•  listering of mucous membranes e.g. eye, mouth or anus.
B
•  septic meningitis (stiff neck, headache, feeling or being sick, fever,
A
disorientation).
Tell your doctor or pharmacist if you notice any of the following side effects:
•  ommon (less than 1 in 10 users): headache, dizziness, a spinning
C
sensation, feeling or being sick, diarrhoea, wind.
•  are (less than 1 in 1000 users): inflammation of the stomach lining
R
(gastritis), water retention, abnormal liver function, inflammation of the liver
(hepatitis), yellowing of the skin or whites of the eyes (jaundice).
•  ery rare (less than 1 in 10,000 users): constipation, mouth ulcers,
V
worsening of colitis and Crohn’s disease, inflammation of the pancreas
causing pain and tenderness in the abdomen and back (pancreatitis),
kidney inflammation or failure, increased protein in urine and fluid
retention (nephrotic syndrome), blood in the urine, high blood pressure
or heart failure, inflammation of the optic nerve, disturbed vision, tingling
or “pins and needles”, depression, confusion, ringing in the ears, sensing
things that are not there, feeling of general discomfort and illness, tiredness,
drowsiness, sensitivity to light, reduced sexual potency in men. Changes in
the numbers or types of blood cells causing increased bruising, nosebleeds,
sore throats, infections, excessive tiredness, breathlessness on exertion, or
abnormal paleness of the skin.

Adults and children aged 14 years and over:

Medicines such as Double Action Pain Relief may be associated with a small
increased risk of heart attack (“myocardial infarction”) or stroke (see page 1
‘Other warnings’).

Leave at least 4 – 6 hours between doses and do not take more than the
maximum dose of six tablets (75mg) in any 24 hour period.

If you notice any side effects, they get worse, or if you notice
any not listed, please tell your doctor or pharmacist.

Initially take two tablets (25mg) then if needed, one or two tablets (12.5mg or
25mg) every 4-6 hours.

Double Action Pain Relief should not be used for longer than 3 days. If
symptoms persist or worsen consult your doctor.

If you take more Double Action Pain Relief than you should

It is important not to take too many tablets. Contact your doctor, pharmacist
or nearest hospital casualty department immediately if you have taken more
tablets than you should.
Symptoms of an overdose are feeling or being sick, stomach pain or bleeding,
diarrhoea, ringing in the ears, headache.

If you forget to take the tablets

If you forget to take a dose, take it as soon as you remember, unless it is nearly
time for your next dose. Then go on as before. Never double up on the next
dose to make up for the one missed.

4 Possible side effects

Like all medicines, Double Action Pain Relief can cause side-effects, although
not everybody gets them. If any of the side effects get worse, or if you notice
any not listed in this leaflet, please tell your doctor or pharmacist. Also you can
help to make sure that medicines remain as safe as possible by reporting any
unwanted side effects via the internet at www.yellowcard.gov.uk or you can
call Freephone 0808 100 3352 (available between 10am – 2pm Monday to
Friday) or fill in a paper form available from your local pharmacy.
Stop taking Double Action Pain Relief and contact your doctor or
pharmacist immediately if you develop:
•  n allergic reaction: skin reactions such as rash, itching, pale or red
A
irregular raised patches with severe itching (hives), disorder characterised
by blood spots, bruising and discolouring to skin (purpura), swelling of the
face, lips, tongue or throat. Development or worsening of asthma, difficulty
breathing or narrowing of the airways.

5 How to store

Keep out of the reach and sight of children.
Do not store above 25ºC. Store in the original package.
Do not use Double Action Pain Relief after the expiry date stated on the
carton. The expiry date refers to the last day of that month.
Medicines should not be disposed of 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 Double Action Pain Relief 12.5mg tablets contain

•  he active substance (the ingredient that makes the medicine work) is
T
diclofenac potassium. Each tablet contains 12.5mg of the active substance.
•  he other ingredients are silica colloidal anhydrous, sodium starch
T
glycollate, povidone, starch maize, calcium hydrogen phosphate
anhydrous, magnesium stearate, polyvinyl alcohol partially hydrolysed,
titanium dioxide (E171), talc, lecithin soya (E322), xanthan gum (E415).

What Double Action Pain Relief 12.5mg tablets look like and
contents of the pack
The tablets are white round, unscored biconvex film coated tablet.
Pack size: 18 tablets

Marketing Authorisation Holder
Actavis Group PTC ehf,
Reykjavíkurvegi 76-78,
220 Hafnarfjordur,
Iceland.

Manufacturer

Wasdell Packaging Ltd
Upper Mills Estate, Bristol Road, Stonehouse,
Gloucestershire, GL10 2BJ, United Kingdom
This leaflet was last revised in April 2010

Continued top of next column
WASPL006

Advanced Pain Relief Tablets (UK)

colours/plates:
1. Black

item no:

WASPL006

dimensions: 148 x 210

print proof no:

5

pharmacode:

2.
3.
4.

origination date: 13.08.09

MOCK UP
ONLY

5.

originated by:

R.Paul

6.

revision date:

11.06.10

revised by:

LW

min pt size:

Wasdell

technically app. date:

supplier:

Non Printing Colours
1.
2.
3.

+ Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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