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NAPROXEN 250MG GASTRO-RESISTANT TABLETS

Active substance(s): NAPROXEN / NAPROXEN / NAPROXEN

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Period Pain Reliever 250mg Gastro-Resistant Tablets
Naproxen
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.

In this leaflet
1.
2.
3.
4.
5.
6.

1.

2.

What Period Pain Reliever is and what it is used for
Before you take
How to take
Possible side effects
How to store
Further information

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.

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 anti-inflammatory 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
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).

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
(Stevens-Johnson 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).

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








.

5.



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.

How to store

Keep out of the sight and reach 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 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
Accord Healthcare Limited

Sage House
319 Pinner Road
North Harrow
Middlesex
HA1 4HF
United Kingdom

Manufacturer
Actavis, Barnstaple, EX32 8NS, UK
This leaflet was last revised in April 2017

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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