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FEMINAX ULTRA 250 MG GASTRO-RESISTANT TABLETS

Active substance(s): NAPROXEN

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Patient Information Leaflet

Feminax® Ultra
250 mg Gastro-resistant tablets
Naproxen (250 mg)
This leaflet contains important information about Feminax® Ultra 250 mg Gastroresistant tablets (referred to as Feminax® Ultra from now on). Please read it carefully
before you take these tablets.
WHAT IS FEMINAX® ULTRA FOR?

These tablets contain 250 mg of naproxen. This medicine is used to treat period pain
(also called menstrual pain or dysmenorrhoea)
• 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.
WHO SHOULD TAKE FEMINAX® ULTRA?

Only take this medicine if you are between 15 and 50 years old.
Ask your doctor, pharmacist or nurse if you need more information.
THINGS TO KNOW BEFORE TAKING FEMINAX® ULTRA

Do not take this medicine if you have, or have ever had a stomach ulcer, or
other serious stomach problems
• This includes any stomach pain that does not go away and any bleeding in the
stomach (passing blood or black tarry stools, or vomiting blood or dark particles
that look like coffee grounds).
• If you have ever had anything like this then you should not take these tablets.
Do not take this medicine if you are in the last three months of your pregnancy.
Do not take this medicine if you have severe heart, liver or kidney failure.
Do not take this medicine if you are already taking aspirin, low dose aspirin
or any other non-steroidal anti-inflammatory drug (NSAID) like ibuprofen.
This includes cyclo-oxygenase-2 selective inhibitors (COX2) like celecoxib.

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) takes too many tablets, go to the nearest
hospital casualty department or your doctor straight away.
SIDE EFFECTS THAT MIGHT HAPPEN WHILE TAKING FEMINAX® ULTRA

Like all medicines, these tablets can cause side effects, although not everybody gets
them. If you have any side effect, you should seek advice from your doctor, pharmacist
or other healthcare professional.
If any of the following happen to you, stop taking the tablets and tell a doctor,
pharmacist or nurse immediately:
• Sickness or being sick (possibly with blood), diarrhoea (sometimes with blood
and mucus), dark “tarry” stools.
• Stomach pain, indigestion, stomach ulcers and bleeding in the stomach.
• Worsening of stomach problems (ulcerative colitis or Crohn’s disease).
• Sore mouth or unusual painful mouth ulcers.
• Allergic reactions like asthma, wheezing or difficulty breathing. This may be severe.
• Blood in the urine, more or less urine than normal or cloudy urine. Pain around
the kidneys (lower side of your back).
• Severe blisters and bleeding of the skin, nose and mouth (Stevens-Johnson syndrome)
• Skin problems including rashes, itching, nettle rash or a bruise-like rash. There may
also be blistering and flaking of the skin.
• Swelling of the face, lips, tongue and throat (causing difficulty swallowing or breathing).
• Jaundice (yellowing of the skin or whites of the eyes), and/or pale coloured
stools and dark urine.
• Fits (convulsions), altered vision, pins-and-needles or numbness, confusion,
hallucinations, dizziness and vertigo, hearing problems, ringing in the ears.

Do not take this medicine if you have ever had an allergic reaction to:
• Naproxen, aspirin, ibuprofen, or another non-steroidal anti-inflammatory drug (NSAID).
• Anything else in these tablets (look at the list in the ‘What’s in these tablets’
section, at the end of the leaflet).
Allergic reactions can include wheezing, itchy runny nose, nasal polyps (swelling
inside the nose), rashes or swelling of the skin.
Do not take this medicine unless your doctor said you can, if:
• You are breast feeding.
• You started to have period pain more than a year after your first period.
• You are elderly - you may get more side effects.
• You are taking any other painkillers or steroids.
• You have a connective tissue disorder such as SLE (Systemic Lupus Erythematosus).
• You have Stevens-Johnson syndrome or toxic epidermal necrolysis (severe skin
problems).
• You are planning to become pregnant or if you have problems becoming pregnant.
Do not take this medicine, unless your doctor said you can, if you have these
illnesses:
• Heart problems, previous stroke or think you might be at risk of these conditions
(for example if you have high blood pressure, diabetes or high cholesterol or are
a smoker).
• Kidney or liver problems.
• A blood clotting problem.
• Asthma or any allergic illness which makes it hard to breathe.
• Stomach disorders such as ulcerative colitis or Crohn’s disease.
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).
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.
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.

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 water tests.
• Nervous system: headaches, depression, insomnia, tiredness, muscle
weakness, drowsiness, inability to concentrate, mental slowing, forgetfulness,
abnormal dreams, feeling thirsty, a general feeling of being unwell or fever with a
dislike of light.
• Blood problems – these may cause unusual tiredness or weakness, unusual
bleeding or unexplained bruising, fever or chills, sore throat, ulcers in your throat.
• Sensitivity of the skin to light.
• Hair loss (alopecia).
• Heartburn, flatulence or constipation.
Other side effects
• High blood pressure, a fluttering feeling in your heart 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.
• NSAIDs have been associated with aseptic meningitis which can include
symptoms of headache, stiff neck, disorientation, fever and sensitivity to light in
people with auto-immune disorders.
• May cause female infertility.
• Raised level of potassium in your blood (hyperkalaemia).
• Eosinophilic pneumonitis (lung infection which causes difficulty in breathing and
night sweats).
• Problems with your senses such as vision problems, inflammation of the optic nerve.
If you experience any other symptoms or have concerns about your medicine, talk to
your doctor.
Adrenal function tests: The tablets may interfere with these tests – check with your
doctor before the test.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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.

Talk to your doctor or pharmacist first, if you are taking any of these other
medicines:
• Ciclosporin or tacrolimus - medicines used after organ transplants.
• Steroids (also called corticosteroids) - like prednisolone.
• Quinolone antibiotics (ciprofloxacin, norfloxacin or levofloxacin) or sulphonamides
(like co-trimoxazole).
• Painkillers.
• Colestyramine - medicine to reduce blood fat level.
• Antacids - medicines to treat the symptoms of heartburn.
• Lithium – a medicine for depression.
• Methotrexate – a medicine for cancer and other illnesses.
• Probenecid – a medicine for gout.
• Water tablets (diuretics).
• Medicines for high blood pressure (anti-hypertensives).
• Medicines for your heart (digoxin or glycosides).
• Medicines to stop blood clots (anticoagulants such as warfarin or heparin).
• Phenytoin - a medicine for epilepsy.
• Mifepristone to terminate a pregnancy in the last 8 - 12 days.
• Low dose aspirin – a medicine for “thinning the blood”.
• Antidepressants of the serotonin re-uptake inhibitor (SSRI) type like fluoxetine.
• Medicines to treat Type 2 diabetes (e.g. sulphonylurea).
• Zidovudine (for HIV infection).
HOW TO TAKE FEMINAX® ULTRA

First day:
• When 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.
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).
Please turn over ´

HOW TO STORE FEMINAX® ULTRA







Do not use this medicine after the use-by date.
Keep these tablets in their original packaging and do not store above 25ºC.
Store your medicine in a safe place, out of the reach and sight 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.
WHAT IS IN THESE TABLETS?

Each white, round, biconvex, gastro-resistant tablet is overprinted in black '3N3' and
contains 250 mg of naproxen, which is the active medicine. The tablets come in a box
of 9 tablets. 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 tablets also have inactive contents: lactose, maize starch, polyvidone, sodium
starch glycolate and magnesium stearate. Also, the coating contains colloidal silicon
dioxide, polyvinyl acetate phthalate, polyethylene glycol, stearic acid, hydroxypropyl
methylcellulose, sodium alginate, sodium bicarbonate, purified talc, triethyl citrate, the
colour titanium dioxide (E171), antifoam AF emulsion and printing ink (containing
shellac, black iron oxide (E172), propylene glycol (E1520)).
The marketing authorisation holder and company responsible for manufacture is
TEVA UK Limited, Eastbourne, BN22 9AG, England.
Distributed by: Bayer plc, Consumer Care Division, Newbury, Berkshire, RG14 1JA
REMEMBER

This leaflet does not contain all the information about these tablets.
Please ask your doctor, nurse or pharmacist if you have any questions.
Revised: June 2015.
Contact details:
Medical Information, Bayer plc, Consumer Care Division,
Newbury, Berkshire, RG14 1JA.
Tel 01635 563000
email: consumer.care@bayer.co.uk
4005998

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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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