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GALPHARM PERIOD PAIN RELIEF 250MG GASTRO-RESISTANT TABLETS

Active substance(s): NAPROXEN

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PATIENT INFORMATION LEAFLET

Galpharm Period Pain Relief

250 mg Gastro-Resistant Tablets
Naproxen








This medicine is used for treatment of period
pain (menstrual pain or dysmenorrhoea). This
medicine is available without prescription to
treat period pain. However, you still need to
take it carefully to get the best results from it.
• Read this leaflet carefully before you take
these tablets.
• Keep this leaflet, you may need to read it
again.
Ask your pharmacist if you need more
information or advice.







Do not take this medicine:
For any other pain except period pain.
If you are not between 15 and 50 years of age.
If you are allergic to any of the ingredients in
this tablet. See section 6.
Follow the dosage instructions carefully.
See section 3.





Your period is unusually painful.
Your period is more heavy than normal.
Your period is longer than normal.
Your period is later than normal.
Your period pain becomes gradually worse
during each subsequent period.
The pain begins more than one day before
the onset of bleeding.
The pain is severe over the whole time of
your period.
You experience bleeding between your
periods.
You have noticed any changes in the
normal pattern of your periods such as the
intensity or duration of the pain, or changes
in the volume and duration of blood flow.
Your period pain has not responded
adequately to more than one kind of pain
killer.
You have a thick or foul-smelling vaginal
discharge.
You experience pain during or just after,
sexual intercourse.
You have fever.

Other warnings
Medicines containing 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 (3 tablets a day) or duration of treatment
(3 days) for any naproxen containing product.

Speak to your doctor
If you suffer from any of the conditions
mentioned in section 2.
If you are taking any other medicines. See
section 2.
If your symptoms have not improved within 3
days of taking these tablets.
1. WHAT THIS MEDICINE IS AND WHAT
IT IS USED FOR
These tablets contain 250 mg of naproxen.
• Naproxen belongs to a group of painkillers
called Non-Steroidal Anti-Inflammatory
Drugs (also called NSAIDs).
• Other medicines in this group include
ibuprofen and aspirin.
This medicine is used to treat period pain (also
called menstrual pain or dysmenorrhoea).
Period pain or dysmenorrhoea is usually felt as
painful muscle cramps in the lower tummy,
which can sometimes spread to the back and
thighs. Sometimes the pain comes in intense
spasms, while at other times the pain may be
dull but more constant.
2. WHAT YOU NEED TO KNOW
BEFORE YOU TAKE THIS MEDICINE
Only take this medicine for period pain.
Only take this medicine if you are between 15
and 50 years old.
Do not take this medicine if you:
• have or have ever had a stomach ulcer,
perforation or gastrointestinal bleeding of
the stomach or intestines
• are allergic to naproxen or any other
ingredient of the product (see section 6) or
have ever had an allergic reaction to other
NSAID painkillers such as aspirin, ibuprofen
or diclofenac. Allergic reactions can include
wheezing, itchy runny nose, rashes or
swelling of the skin
• are taking other NSAID painkillers (e.g.
aspirin, ibuprofen, diclofenac)
• have used it before and not experienced
relief of your symptoms
• have or have ever had severe heart failure,
liver or kidney failure
• if you are pregnant, or planning on becoming
pregnant
• if you are breastfeeding.
Do not take this medicine unless your
doctor said you can, if you:
• started to have period pain more than a
year after your first period
• are over 20 years of age and this is the first
time that you have suffered from period pain
• use an intrauterine device (IUD) as a
contraceptive
• have had a previous stroke or think you
might be at risk of stroke (for example if you
have high blood pressure, diabetes, high
cholesterol or are a smoker)
• have kidney, heart or liver problems
• have a blood clotting problem
• have asthma or any allergic illness which
makes it hard to breathe
• have a stomach disorder such as ulcerative
colitis or Crohn's disease.
Talk to your doctor before using this
medicine if you have experienced any of
the following symptoms. This is because
you may have an underlying condition
and you should discuss your symptoms
with a doctor.
• Your periods are irregular.

Taking other medicines
Talk to your doctor or pharmacist first, if
you are taking other medicines, especially:
• Other NSAID painkillers (e.g. aspirin,
ibuprofen, diclofenac)
• Anticoagulants (to thin your blood or
prevent clotting e.g. warfarin)
• Diuretics (water tablets) e.g. furosemide
• Lithium (for depression, bipolar disease,
mania)
• Antidepressants of the serotonin re-uptake
inhibitor (SSRI) type e.g. fluoxetine,
paroxetine, citalopram
• Methotrexate, ciclosporin or tacrolimus (to
temporarily suppress your immune system)
• Zidovudine (for HIV/AIDS)
• Steroids (also called corticosteroids) e.g.
prednisolone, hydrocortisone, dexamethasone
• Quinolone antibiotics (ciprofloxacin,
norfloxacin or levofloxacin) or
sulphonamides e.g. co-trimoxazole
• Probenecid used for gout
• Anti-hypertensives (to treat high blood
pressure) e.g. amlodipine, ramipril, losartan
• Medicines for your heart e.g. digoxin or
glycosides
• Phenytoin (for epilepsy)
• Mifepristone (to terminate a pregnancy).
Adrenal function tests: These tablets can
affect the results of laboratory blood or urine
tests. Check with your doctor before the tests.
Important information about some of the
ingredients of this medicine
• This medicine contains lactose. If you have
been told by your doctor that you have an
intolerance to some sugars, contact your
doctor before taking this medicinal product.
Pregnancy, breast-feeding and fertility
Do not take this medicine if you are pregnant,
or planning to become pregnant. Do not take
this medicine if you are breast-feeding.
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.
Driving and using machines: These tablets
may make you dizzy, sleepy or cause vertigo,
loss of concentration, difficulty sleeping,
depression or visual problems. Do not drive or
use machines if this happens to you.
3. HOW TO TAKE THIS MEDICINE
First day:
• As soon as the pain starts, take two tablets.
• Then after 6 to 8 hours, take one more
tablet that day, if you need it.
Second day:
• Take one tablet every 6 to 8 hours if needed.
Third day:
• Take one tablet every 6 to 8 hours if needed.
Do not take more than 3 tablets each day.
Please turn over ➥

Galpharm Period Pain Relief 250mg Gastro-Resistant
Tablets

20

3218

N/A

17/02/16

4000357

130x323mm

AL
BLACK

MAGENTA

YELLOW

Darwin

BLACK

TBC
PANTONE

PANTONE

877

485

TEVA UK Ltd
CUTTER

VARNISH

BRAILLE

Always take the lowest effective dose for
you. Do not take more than the
recommended dose of up to three tablets
in a day. Do not take for longer than three
days in any one month (menstrual cycle).
Taking the tablets:
• Swallow the tablets whole with a drink of
water. Do not chew or crush them.
• Take the tablets with or after food.
• Only take the tablets for as long as you
need them for the period pain. You may not
need to take the tablets all the time for all 3
days. If you still have pain after 3 days of
treatment, talk to your doctor. Do not take
the tablets for more than 3 days in any one
period (cycle).
• If you see a doctor, pharmacist or nurse or
go into hospital, tell them you are taking
this medicine.
• Overdose: If you (or someone else) take too
many tablets, go to the nearest hospital
casualty department or your doctor straight
away.
4. POSSIBLE SIDE EFFECTS
Like all medicines, these tablets can cause side
effects, although not everybody gets them.
If you get any of the following at any time
during your treatment STOP TAKING, and
get medical help straight away:
Allergic reactions, such as:
• wheezing or difficulty breathing. This may
be severe
• severe blisters and bleeding of the skin,
nose and inside of the mouth (StevensJohnson syndrome)
• skin problems including rashes, itching,
nettle rash or a bruise like rash. There may
also be redness, blistering or flaking of the
skin over large areas of the body
• swelling of the face, lips, tongue and throat
(causing difficulty swallowing or breathing).
Stomach and bowel problems including:
• pains in your stomach (abdomen) or other
abnormal stomach problems
• indigestion or heartburn
• passing black tarry stools or motions
• vomiting any blood or dark particles that
look like coffee grounds
• worsening of stomach problems (ulcerative
colitis or Crohn’s disease).
Kidney Problems
• blood in the urine
• more or less urine than normal
• cloudy urine
• pain or swelling around the lower side of
your back.
Nervous system disorders
• fits (convulsions), altered vision,
pins-and-needles or numbness, confusion,
hallucinations, dizziness and vertigo,
hearing problems
• aseptic meningitis (symptoms include stiff
neck, headache, sensitivity to light, feeling
or being sick, fever, disorientation).
If you have any of the following while
taking this medicine, stop taking it and
tell your doctor:
• swelling of the blood vessels and a build up
of fluid which may cause swollen ankles
• kidney or liver problems: these will show up
in blood or urine tests
• nervous system: headaches, depression,
insomnia, ringing in the ears, tiredness,
drowsiness, inability to concentrate, mental
slowing, a general feeling of being unwell
• blood problems – these may cause unusual
tiredness or weakness, unusual bleeding or
unexplained bruising, fever or chills, sore
throat or ulcers in your throat
• sensitivity of the skin to light
• hair loss (alopecia)
• flatulence or constipation.
Other side effects
• High blood pressure and heart failure have
been reported with NSAID use.
• Medicines which contain NSAIDs such as
naproxen may be associated with a small
increased risk of heart attack (“myocardial
infarction”) or stroke.
• Not everyone will respond to NSAIDs. If this
medicine does not work for you, talk to
your pharmacist or doctor.

Reporting of side effects
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: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide
more information on the safety of this medicine.
5. HOW TO STORE THIS MEDICINE
• Do not use this medicine after the use-by
date.
• Keep these tablets in their original
packaging and do not store above 25ºC.
• Keep this medicine out of the sight and
reach of children.
• This medicine is for you ONLY, do not give
it to anyone else.
• Return all unused medicines to your
pharmacist for safe disposal.
6. CONTENTS OF THE PACK AND
OTHER INFORMATION
Each white round coated tablet contains
250 mg of naproxen, which is the active
ingredient. The tablets come in a box of 9
tablets. The tablet is gastro-resistant (also
known as enteric coated). 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 tablets also have inactive contents:
lactose monohydrate, maize starch,
polyvidone, sodium starch glycolate (type A)
and magnesium stearate (E572). Also, the
coating contains colloidal silicon dioxide,
polyvinyl acetate phthalate, polyethylene
glycol, purified stearic acid (E570),
hydroxypropyl methylcellulose (E464), sodium
alginate (E401), sodium bicarbonate (E500),
purified talc (E553(b)), triethyl citrate, the
colour titanium dioxide (E171) and black
printing ink (containing shellac (E904), soya
lecithin (E322), antifoam agent and black iron
oxide (E172)).
Marketing Authorisation holder:
Galpharm Healthcare Limited, Wrafton,
Braunton, Devon, EX33 2DL, United Kingdom.
Manufacturer:
TEVA UK Limited, Eastbourne, BN22 9AG,
England.
Text revised: February 2016.
7. ABOUT PERIOD PAIN
What is period pain (dysmenorrhoea)?
Period pain - or dysmenorrhoea - is usually
felt as painful muscle cramps in the lower
tummy, which can sometimes spread to the
back and thighs. Sometimes the pain comes
in intense spasms, while at other times the
pain may be dull but more constant.
The pain usually starts when your bleeding
begins, and normally lasts for 48-72 hours.
Most cases of period pain can be treated at
home.
Symptoms
Most women experience some form of period
pain during their lifetime. Common symptoms
noticed are as follows:
• Painful muscle cramps in lower abdomen
(tummy).
• Painful abdomen may accompany other
symptoms such as: headaches, nausea,
tiredness, feeling faint, dizziness and
diarrhoea.
Healthy tips to manage period pain
(dysmenorrhoea)
You can manage dysmenorrhoea (period pain)
by one or a combination of the following ways:
• Exercise such as walking or cycling can
help to reduce pain.
• Stopping smoking.
• Applying heat (via hot water bottle) to your
tummy.
• Warm bath or shower.
• Lightly massaging your lower abdomen.
For further information, please contact:
Galpharm Healthcare Limited, Wrafton,
Braunton, Devon, EX33 2DL, United Kingdom.
86714-U

4000357

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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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