Feminax Ultra 250 Mg Gastro-Resistant Tablets
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Patient Information Leaflet
Feminax® Ultra
250 mg Gastro-resistant tablets
| TEVA UK Ref: 231-30-86492-Y LEA NAPROXEN (FEMINAX) 250mg TAB BAYER Version: 1 28 October 2014
*
Naproxen (250 mg)
This leaflet contains important information about Feminax® Ultra 250 mg Gastro-resistant tablets (referred to as Feminax® Ultrafrom now on). Please read it carefully before you fake these tablets.
WHAT IS FEMINAX® ULTRA FOR?
Thesefablefs contain 250 mgof naproxen. This medicine is used to treat period pain (also called menstrual pain or dysmenorrhoea)
I * Naproxen belongs to a group of painkillers called Non-Steroidal Anti-inflammatory
Drugs (also called NSAIDs).
I * 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.
\sk your doctor, pharmacist or nurse ifyou 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
I * 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).
I * 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
ibuprofen.
This includes cyclo-oxygenase-2 selective inhibitors (COX2) like celecoxib.
Do not take this medicine if you have ever had an allergic reaction to:
* Naproxen, aspirin, ibifjrofen, or another non-steroidal anti-rflammatory 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 arefaking any other painkillers or steroids.
* You have a connective tissue disorder such as SLE (Systemic Lupus Erythematosus).
* You have Sfevens-Johnson syndromeortoxic 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.
* Abloodcloftingproblem.
* Asthma or any allergic illness which makes if 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: Thesetabletsmay 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.
other
medicines:
* Ciclosporin or tacrolimus - medicines used after organ transplants.
* Steroids (also called corticosteroids) - like prednisolone.
* ^inolone antibiota (ci^ofloracin, rorfoxacin or levofloxacin) or sulphonamides
(like co-trimoxazole).
* Painkillers.
* Colestyramine - medicineto 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-amedicineforgout.
* Watertablets(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-amedicineforepilepsy.
* 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(forHIVinfection).
HOW TO TAKE FEMINAX® ULTRA
First day:
* When the pain starts, take two tablets.
* Then after 6to8 hours, take one more tablet that day, if you need it.
Second day:
* Take one tablet every 6to8 hours if needed.
Third day:
* Take one tablet every 6to8 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
Taking the tablets:
* Swallowthetabletswholewith adrink ofwater. Do not chew or crush them.
| * Take the tablets with or after food.
I * Only takethe tablets for aslong asyou need them forthe 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 thismedicine.
* Overdose: If you (or someone else) takes too many tablets, go to the nearest hospital casualty department or your doctor straight away.
|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 lor other healthcare professional. In addition, you can help to make sure that medicines Iremain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard; alternativelyyou can call Freephone 0808 100 3352 [(available between 10 am - 2 pm Monday to Friday) or fill In a paper form available 'from your local pharmacy. You may also contact Medical Information given in the contact details at the end of this leaflet,
If any of the following happen to you, stop taking the tablets and tell a doctor, pharmacist or nurse immediately:
I * 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.
I * 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 urinethan normal or cloudy urine. Pain around
the kidneys (lower side of your back).
I * Severe blisters and bleeding ofthe skin, nose and mouth (Stevens-Johnson syndrome) I * 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).
Pharma Code 1611 - 105mm from top edge.
_ * Jaundice(yellowing otthe skin or whites ofthe 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.
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 anMes.
* 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 ofthe 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 causefemale 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: Thetabletsmay interfere with these tests-check with your doctor before the test. _
* Do not use this medicine after the use-by date.
* Keep these tablets in their original packaging and do not store above 25°C.
* Storeyourmedidne in asafeplace, out ofthe 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.
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 I of 9 tablets. The tablet is gastro-resistant. This means that it is covered with a coating 1 which stops the tablet dissolving in the stomach, so that the naproxen is released further down in your gut.
Thetablets alsohaveinactivecontents: lactose, maizestarch, polyvidone, sodium starch glycolate and magnesium stearate. Also, the coating contains colloidal silicon i dioxide, polyvinyl acetate phthalate, polyethylene glycol, stearic acid, hydroxypropyl I methylcellulose, sodium alginate, sodium bicarbonate, purified talc, triethyl citrate, the
colourtitanium 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 TEVAUKLimited, Eastbourne, BN22 9AG, England.
Distributed by: Bayerplc, ConsumerCare Division, Newbury, Berkshire, RG14 1JA
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REMEMBER | |
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This leaflet does not contain all the information about these tablets. Please ask your doctor, nurse or pharmacist if you have any questions. Revised: September2014 |
Bayer |
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Contact details: Medical Information, Bayer pic, Consumer Care Division, Newbury, Berkshire, RG14 1JA. Tel 01635 563000 email: consumer.care@bayer.co.uk | |
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4005464 |
86492-Y |
This is a representation of an electronic record that was signed electronically and this
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE
Teva Pharmaceuticals Europe B.V
1.3.2
m
ayer(feminax-ultra)
Approvals
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Signed by |
Meaning of Signature |
Server Date |
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Vivekananda Bhatlapenumart |
Regulatory Affairs Approval |
16-Jan-2015 09:49:44 AM |
REG0077940 Version 3.4 Approved Page 2 of 2