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NAPROXEN 250MG GASTRO-RESISTANT TABLETS

Active substance(s): NAPROXEN

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Period Pain Reliever 250mg
Gastro-Resistant Tablets
Naproxen

In this leaflet
1 What Period Pain Reliever
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 Period Pain Reliever is and what it is used for
Naproxen belongs to a group of medicines called non-steroidal
anti-inflammatory drugs (NSAIDs). Period Pain Reliever is used to
treat period pains (primary dysmenorrhoea) in women aged 15 to
50 years old.

2 Before you take

Do not take Period Pain Reliever but see a doctor instead
if you:
• are allergic to naproxen, medicines containing naproxen sodium
or to any of the other ingredients in Period Pain Reliever (see section
6)
• 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 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 pregnant or are breast feeding.

Check with your doctor or pharmacist before taking
Period Pain Reliever if you:
• are on a low potassium diet, as this product contains potassium
sorbate. High blood levels of potassium can cause stomach upset
and diarrhoea
• have a history of gastrointestinal disease e.g. ulcerative colitis,
Crohn’s disease
• are elderly

Continued top of next column
L19877WAS-30

• h ave 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
Period Pain Reliever under the supervision of your doctor, for
monitoring of your kidney or liver function.
• have asthma, diabetes, high cholesterol
• are a smoker
• drink alcohol
• have systemic lupus erythematosus or other connective tissue
disorders
• have any blood clotting disorders
• first experienced period pain more than a year after starting your
periods.
• are a women trying to become pregnant or undergoing
investigation of infertility
- naproxen belongs to a group of medicines which may impair
fertility in women. This effect is reversible on stopping the
medicine. It is unlikely that naproxen, 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
• Medicines such as naproxen may be associated with a small
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.
• If you are elderly or frail, you have a higher risk of getting side
effects, especially of the stomach. If you experience any unusual
symptoms from the stomach, you must tell your doctor about it.
• Period Pain Reliever may hide the symptoms of an 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:
• other non-steroidal anti-inflammatory drugs (NSAIDS) e.g.
ibuprofen, COX II inhibitors and aspirin (used for pain and
inflammation)
• medicines to treat high blood pressure including angiotensin II
receptor antagonists or ACE inhibitors, such as captopril, ramapril 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)
• mifepristone (used for termination of pregnancy). Period Pain
Reliever should not be taken within 8-12 days of taking mifepristone
• corticosteroids (used in many different diseases), such as
prednisolone
• medicines which thin the blood or which prevent blood clotting
such as warfarin
• SSRI antidepressants (for depression), such as fluoxetine
• quinolone antibiotics (to treat bacterial infections), such as
ciprofloxacin
• probenecid (used for gout)
• hydantoins (in epilepsy), such as phenytoin
• Zidovudine (anti-viral)
• bisphosphonates (for osteoporosis)
• colestyramine (for high cholesterol) (take naproxen 1 hour before
or 4 to 6 hours after colestyramine to avoid interference with
absorption).
Continued over page

Pharmacode
Position

Read all of this leaflet carefully before you
start taking this medicine.
• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
doctor or pharmacist.
• If any of the side effects get serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

Pregnancy and breast-feeding
If you are pregnant, planning to become pregnant or breast-feeding you
must not take Period Pain Reliever. Speak to your doctor or pharmacist before
you use any medication.

Driving and using machines
Period Pain Reliever 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.

Sugar intolerance
If your doctor has told you that you have an intolerance to some sugars,
contact your doctor before taking this medicine, as it contains a sugar called
lactose.

Tests
If you need any blood or urine tests, tell your doctor you are taking Period
Pain Reliever. The tablets may need to be stopped 48 hours before a test, as
they may interfere with the results.

3 How to take

Swallow whole with water, with or after food. Do not crush or chew the
tablets.
You should take the lowest effective dose for the shortest amount of time, to
control your symptoms. This will reduce any side effects you may experience.
Women aged 15 to 50 years old:
First day of treatment
Initially take two tablets (500mg) then if needed, one tablet (250mg) after
6-8 hours.
Second and third day of treatment
If needed, take one tablet (250mg) every 6-8 hours.
Do not take more than the maximum dose of three tablets a day for longer
than three days during each month (menstrual cycle).

If you take more Period Pain Reliever 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, Period Pain Reliever 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 Period Pain Reliever and contact your doctor or
pharmacist immediately if you develop:

• An allergic reaction: skin reactions such as rash, itching, pale or red
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, which may be caused by
an increase in white blood cells in the lungs (eosinophilic pneumonitis).
• Severe rash involving reddening, peeling and swelling of the skin that
resembles severe burns (toxic epidermal necrolysis), circular, irregular red
patches on the skin of the hands and arms (erythema multiforme) and
severe form of skin rash with flushing, fever, blisters or ulcers (StevensJohnson Syndrome).
• Dark blood-stained stools, vomiting blood, indigestion, heartburn,
abdominal pain (signs of ulceration, bleeding and perforation of the
stomach and intestines).
• Blistering of mucous membranes e.g. eye, mouth or anus.
· Aseptic meningitis (stiff neck, headache, feeling or being sick, fever,
Continued top of next column
L19877WAS-30

disorientation).

Tell your doctor or pharmacist if you notice any of the following
side effects:

• Stomach and intestines: feeling or being sick, diarrhoea, wind,
constipation, mouth ulcers, worsening of colitis and Crohn’s disease,
inflammation of the stomach lining, inflammation of the pancreas causing
pain and tenderness in the abdomen and back.
• Heart: water retention, high blood pressure or heart failure. Medicines
such as naproxen may be associated with a small increased risk of heart
attack (“myocardial infarction”) or stroke.
• Kidneys: kidney inflammation or failure, increased protein in urine and
fluid retention (nephrotic syndrome), blood in the urine.
• Liver: abnormal liver function, inflammation of the liver (hepatitis),
yellowing of the skin or whites of the eyes (jaundice).
• Nervous system: headache, dizziness, feeling of general discomfort and
illness, tiredness, drowsiness, ringing in the ears, hearing impairment, a
spinning sensation, inflammation of the optic nerve, disturbed vision (you
should go for an eye test if you notice changes in vision), tingling or “pins
and needles”, depression, confusion, sensing things that are not there.
• Blood: too much potassium in the blood (may occur as muscle cramps or
pain, irregular heartbeats, unusual tiredness or weakness). 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.
• Skin: sensitivity to light, hair loss.
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 Period Pain Reliever 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 Period Pain Reliever tablets contain
• The active substance (the ingredient that makes the medicine work) is
naproxen. Each tablet contains 250mg of the active substance.
• The tablet is gastro-resistant this means that it is covered
with a coating which stops the tablet dissolving in the
stomach, so that the naproxen is released further down in
your gut.
• The other ingredients are methacrylic acid-ethylacrylate
copolymer (1:1), lactose, magnesium stearate, maize starch,
crospovidone, propylene glycol, sodium hydroxide, triethyl
citrate, titanium dioxide (EI71), potassium sorbate (E202),
sodium citrate (E331), xanthan gum (E415), hydroxypropyl
cellulose (E463), purified talc (E553), beeswax.

What Period Pain Reliever tablets look like and
contents of the pack
The tablets are white, round, biconvex, gastro-resistant
(enteric-coated) tablets.
Pack size: 9 tablets
Marketing Authorisation Holder:
Actavis Group PTC ehf, Reykjavíkurvegi 76-78, 220
Hafnarfjordur, Iceland.
Manufacturer:
Wasdell Packaging Ltd ,
Units 6, 7, 8 Euro Way, Blagrove,
Swindon, SN5 8YW, United Kingdom
This leaflet was last revised in March 2011.

Period Pain Reliever 250mg
Gastro-Resistant Tablets
Naproxen

In this leaflet
1 What Period Pain Reliever
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 Period Pain Reliever is and what it is used for
Naproxen belongs to a group of medicines called non-steroidal
anti-inflammatory drugs (NSAIDs). Period Pain Reliever is used to
treat period pains (primary dysmenorrhoea) in women aged 15 to
50 years old.

2 Before you take

Do not take Period Pain Reliever but see a doctor instead
if you:
• are allergic to naproxen, medicines containing naproxen sodium
or to any of the other ingredients in Period Pain Reliever (see section
6)
• 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 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 pregnant or are breast feeding.

Check with your doctor or pharmacist before taking
Period Pain Reliever if you:
• are on a low potassium diet, as this product contains potassium
sorbate. High blood levels of potassium can cause stomach upset
and diarrhoea
• have a history of gastrointestinal disease e.g. ulcerative colitis,
Crohn’s disease
• are elderly

Continued top of next column
L19875WAS-30

• 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
Period Pain Reliever under the supervision of your doctor, for
monitoring of your kidney or liver function.
• have asthma, diabetes, high cholesterol
• are a smoker
• drink alcohol
• have systemic lupus erythematosus or other connective tissue
disorders
• have any blood clotting disorders
• first experienced period pain more than a year after starting your
periods.
• are a women trying to become pregnant or undergoing
investigation of infertility
- naproxen belongs to a group of medicines which may impair
fertility in women. This effect is reversible on stopping the
medicine. It is unlikely that naproxen, 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
• Medicines such as naproxen may be associated with a small
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.
• If you are elderly or frail, you have a higher risk of getting side
effects, especially of the stomach. If you experience any unusual
symptoms from the stomach, you must tell your doctor about it.
• Period Pain Reliever may hide the symptoms of an 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:
• other non-steroidal anti-inflammatory drugs (NSAIDs) e.g.
ibuprofen, COX II inhibitors and aspirin (used for pain and
inflammation)
• medicines to treat high blood pressure including angiotensin II
receptor antagonists or ACE inhibitors, such as captopril, ramapril 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)
• mifepristone (used for termination of pregnancy). Period Pain
Reliever should not be taken within 8-12 days of taking mifepristone
• corticosteroids (used in many different diseases), such as
prednisolone
• medicines which thin the blood or which prevent blood clotting
such as warfarin
• SSRI antidepressants (for depression), such as fluoxetine
• quinolone antibiotics (to treat bacterial infections), such as
ciprofloxacin
• probenecid (used for gout)
• hydantoins (in epilepsy), such as phenytoin
• Zidovudine (anti-viral)
• bisphosphonates (for osteoporosis)
• colestyramine (for high cholesterol) (take naproxen 1 hour before
or 4 to 6 hours after colestyramine to avoid interference with
absorption).
Continued over page

Pharmacode
Position

Read all of this leaflet carefully before you
start taking this medicine.
• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
doctor or pharmacist.
• If any of the side effects get serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

Pregnancy and breast-feeding
If you are pregnant, planning to become pregnant or breast-feeding you
must not take Period Pain Reliever. Speak to your doctor or pharmacist before
you use any medication.

Driving and using machines
Period Pain Reliever 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.

Sugar intolerance

If your doctor has told you that you have an intolerance to some sugars,
contact your doctor before taking this medicine, as it contains a sugar called
lactose.

Tests
If you need any blood or urine tests, tell your doctor you are taking Period
Pain Reliever. The tablets may need to be stopped 48 hours before a test, as
they may interfere with the results.

3 How to take

Swallow whole with water, with or after food. Do not crush or chew the
tablets.
You should take the lowest effective dose for the shortest amount of time, to
control your symptoms. This will reduce any side effects you may experience.
Women aged 15 to 50 years old:
First day of treatment
Initially take two tablets (500mg) then if needed, one tablet (250mg) after
6-8 hours.
Second and third day of treatment
If needed, take one tablet (250mg) every 6-8 hours.
Do not take more than the maximum dose of three tablets a day for longer
than three days during each month (menstrual cycle).

If you take more Period Pain Reliever 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 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, Period Pain Reliever 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 Period Pain Reliever and contact your doctor or
pharmacist immediately if you develop:

• An allergic reaction: skin reactions such as rash, itching, pale or red
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, which may be caused by
an increase in white blood cells in the lungs (eosinophilic pneumonitis).
• Severe rash involving reddening, peeling and swelling of the skin that
resembles severe burns (toxic epidermal necrolysis), circular, irregular red
patches on the skin of the hands and arms (erythema multiforme) and
severe form of skin rash with flushing, fever, blisters or ulcers (StevensJohnson Syndrome).
• Dark blood-stained stools, vomiting blood, indigestion, heartburn,
abdominal pain (signs of ulceration, bleeding and perforation of the
stomach and intestines).
• Blistering of mucous membranes e.g. eye, mouth or anus.
· Aseptic meningitis (stiff neck, headache, feeling or being sick, fever,
disorientation).
Continued top of next column
L19875WAS-30

Tell your doctor or pharmacist if you notice any of the following
side effects:

• Stomach and intestines: feeling or being sick, diarrhoea, wind,
constipation, mouth ulcers, worsening of colitis and Crohn’s disease,
inflammation of the stomach lining, inflammation of the pancreas causing
pain and tenderness in the abdomen and back.
• Heart: water retention, high blood pressure or heart failure. Medicines
such as naproxen may be associated with a small increased risk of heart
attack (“myocardial infarction”) or stroke.
• Kidneys: kidney inflammation or failure, increased protein in urine and
fluid retention (nephrotic syndrome), blood in the urine.
• Liver: abnormal liver function, inflammation of the liver (hepatitis),
yellowing of the skin or whites of the eyes (jaundice).
• Nervous system: headache, dizziness, feeling of general discomfort and
illness, tiredness, drowsiness, ringing in the ears, hearing impairment, a
spinning sensation, inflammation of the optic nerve, disturbed vision (you
should go for an eye test if you notice changes in vision), tingling or “pins
and needles”, depression, confusion, sensing things that are not there.
• Blood: too much potassium in the blood (may occur as muscle cramps or
pain, irregular heartbeats, unusual tiredness or weakness). 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.
• Skin: sensitivity to light, hair loss.
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 Period Pain Reliever 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 Period Pain Reliever tablets contain
• The active substance (the ingredient that makes the medicine work) is
naproxen. Each tablet contains 250mg of the active substance.
• The tablet is gastro-resistant this means that it is covered
with a coating which stops the tablet dissolving in the
stomach, so that the naproxen is released further down in
your gut.
• The other ingredients are methacrylic acid-ethylacrylate
copolymer (1:1), lactose, magnesium stearate, maize starch,
crospovidone, propylene glycol, sodium hydroxide, triethyl
citrate, titanium dioxide (EI71), potassium sorbate (E202),
sodium citrate (E331), xanthan gum (E415), hydroxypropyl
cellulose (E463), purified talc (E553), beeswax.

What Period Pain Reliever tablets look like and
contents of the pack
The tablets are white, round, biconvex, gastro-resistant
(enteric-coated) tablets.
Pack size: 9 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 June 2011.

Expand view ⇕

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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