Feminax Ultra 250 Mg Gastro-Resistant Tablets
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NAPROXEN 250 mg AND 500 mg GASTRO-RESISTANT TABLETS
PACKAGE LEAFLET: INFORMATION FORTHE USER
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet.You may need to read it again.
• Ifyou have anyfurther questions, askyour doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if theirsymptoms are the same as yours.
• If any ofthe side effects get serious, or ifyou notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Important safety information about this medicine:
• DO NOT TAKE if you have a peptic ulcer (ulcer in yourstomach or duodenum) or bleeding in your stomach, or have had two or more episodes of peptic ulcers, stomach bleeding or perforation
• STOP TAKING the medicine and seek immediate medical help if you suffer from any of the following at any time during your treatment:
• Pass blood in your faeces (stools/motions)
• Pass black tarry stools
• Vomit any blood or dark particles that look like coffee grounds.
• STOP TAKING the medicine and tell your doctor if you experience indigestion or heartburn, abdominal pain (pains in yourstomach) or other abnormal stomach symptoms
• Your doctor should prescribe the lowest dose which is effective for you for the shortest period necessary. This will help to reduce the possibility of any side effects. Do not exceed the prescribed dose or duration of treatment.
Now read the rest of this leaflet. It includes other important information on the safe and effective use of this medicine that might be especially important for you.
INTHIS LEAFLET:
1. What Naproxen is and what it is used for
2. Before you take Naproxen
3. How to take Naproxen
4. Possible side effects
5. How to store Naproxen
6. Further information
OWHAT NAPROXEN IS AND WHAT IT IS USED FOR
Naproxen isa non-steroidal anti-inflammatorydrug (NSAID).
Naproxen tablets are used:
• to treat rheumatoid arthritis, osteoarthritis (degenerative arthritis), ankylosing spondylitis (inflammation affecting joints between the spine and pelvis), juvenile rheumatoid arthritis, acute gout, injury and short term problems with the joints such as sprains and strains • to relieve stiffness and pain in the back • torelieveperiodpains.
BEFORE YOU TAKE NAPROXEN
DO NOT take Naproxen if you:
• are allergic (hypersensitive) to naproxen or any ofthe other ingredients of this medicine (see section 6)
• are allergic (hypersensitive) to any other NSAID drugs, e.g. aspirin, ibuprofen • have had problems in the past caused by taking
any NSAIDs e.g. gastro-intestinal bleeding or perforation, asthma, an itchy runny nose, nasal polyps (swellings inside the nose), rashes or swelling ofthe skin
• suffer from or have a history of peptic ulcers (ulcers in your stomach or duodenum), or bleeding in your digestive tract
• have severe heart failure, liver or kidney failure • arein the last three months of pregnancy.
Take special care with Naproxen
Talk to your doctor before you start to take this
medicine if you:
• are elderly
• had or have bronchial asthma or allergies (like hayfever)
• suffer from any kidney problems (e.g. kidney inflammation, blood and/or protein in the urine)
• suffer from any liver or heart problems (e.g. high blood pressure, stroke, heart attack)
• have fluid retention • suffer from any blood clotting disorders • have a history of disease or problems with your digestion system (especially ifyou have any bleeding)
• have ulcerated colitis or Crohn's disease • have systemic lupus erythematosus (SLE), or other connective tissue disorders • have Stevens-Johnson syndrome or toxic epidermal necrolysis (severe skin problems)
• area female and trying to get pregnant.
Ifyou are to undergo adrenal function tests or urine tests your doctor may tell you to stop taking Naproxen in case it interferes with these tests. Medicines such as Naproxen may be associated with a small increased risk of heart attack ("myocardial infarction") orstroke. Any risk ismore likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration oftreatment.
If you have heart problems, previous stroke or think that you might be at risk ofthese conditions (for example if you have high blood pressure, diabetes, or high cholesterol or are a smoker) you should discuss your treatment with yourdoctor or pharmacist.
Taking other medicines
DO NOT take Naproxen in combination with the following:
• aspirin or any other NSAID (e.g. ibuprofen, cyclooxygenase-2-selective inhibitor medicines).
Talk to your doctor if you are taking any of the following:
• any other pain killers
• are taking medicines that could increase the risk of ulcers or bleeding in yourstomach such as corticosteroids (e.g. hydrocortisone or prednisolone), anti-coagulants (e.g. heparin, warfarin) or anti-platelets (e.g. aspirin)
• medicines used to treat the symptoms of heartburn (antacids)
• medicines to treat high blood pressure
• ACE inhibitor medicines (e.g. ramipril)
• heart medicines (e.g. digoxin) ciclosporin or tacrolimus (a medicine used following organ transplants)
quinoline antibiotics (e.g. ciprofloxacin,
norfloxacin or levofloxacin)
lithium (a drug used to treat depression)
methotrexate (a treatment for leukaemia and
rheumatoid arthritis)
medicines to treat Type 2 diabetes (e.g.
sulphonylurea)
probenecid (a drug used to treat gout) diuretics ('water tablets') such as furosemide mifepristone in the last 8-12 days, (used to terminatea pregnancy)
• zidovudine (used to treat HIV)
• colestyramine (used to relieve diarrhoea after surgery or radiotherapy, lower cholesterol or other fats in the blood, prevent heart disease, or treat itching)
• SSRIs (used to treat depression).
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Important information about some of the ingredients of Naproxen
• Patients who are intolerant to lactose should note that Naproxen tablets contain a small amount of lactose. Ifyour doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Pregnancy and breast-feeding
• Do not use Naproxen in the last three months of pregnancy or during labour and delivery
• Do not use ifyou are breast-feeding
• Ifyou are pregnant in the earlier stages, askyour doctor for advice before taking this medicine.Your doctor will decide ifyou should take Naproxen
• Naproxen may make it more difficult to become pregnant.You should discuss with your doctor if you are planning to become pregnant or ifyou have problems becoming pregnant.
Driving and using machines
• Naproxen may cause a feeling of dizziness or "spinning" drowsiness, tiredness, difficulty in sleeping, depression or problems with your eyesight. Ifyou are affected, do not drive or operate machinery.
3 HOW TO TAKE NAPROXEN
Always take Naproxen exactly as your doctor has told you. You should checkwith your doctor or pharmacist ifyou are not sure.
The tablets should be taken with or after food, and should be swallowed whole (not to be broken or crushed) preferablywith a drinkofwater. Do not chew the tablets.The tablet is coated with a gastro-resistant coat. This coat allows the tablet to pass undissolved through the stomach into the small intestine, where naproxen is released.
The usual dose is:
Adults
• Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis
The usual dose is 500 mg - 1000 mg dailytaken as 250- 500 mg twice a day at 12-hour intervals. Where 1000 mg is needed, it is recommended that two 500 mg tablets are taken at once, either inthe morning or evening.
• Acute musculoskeletal disorders and period pains
500 mg to start with, then 250 mg every 6-8 hours as needed.The maximum daily dose (after the first day) is 1250 mg.
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• Acute gout
750 mg immediately, then 250 mg every 8 hours until the attack has passed.
The Elderly
• The usual adult dose is suitable.To reduce the possibility of side effects ifyou are elderly, you should usethe minimum dose forthe shortest possible time.Yourdoctor may monitor you for bleeding in the stomach. Ifyou have kidney problems yourdoctor may recommend a reduction in dosage.
Patients with liver and kidney problems Your doctor will decide an appropriate dose, which may be lowerthan for other adults.Yourdose should be reviewed by your doctor at regular intervals. Children over 5 years of age
• Juvenile rheumatoid arthritis
Your doctor will calculate the appropriate dose depending onyour child's bodyweight.The dose should be taken twice a day every 12 hours. Naproxen should not be used to treat anything else in children.
If you take more Naproxen than you should
If you (or someone else) swallow a lot of the tablets all together, orifyouthinkachild has swallowed any ofthe tablets, contact your nearest hospital casualty department or your doctor immediately.
An overdose is likely to cause headaches, drowsiness, heartburn, indigestion or abdominal pain, feeling sick or being sick, bleeding in the digestive tract, diarrhoea, disorientation, irritation, breathing difficulties, coma, dizziness, ringing in the ears, fainting, fits, in some cases kidneyand/or liver problems.
Please take this leaflet, any remaining tablets, and the containerwith you to the hospital or doctor so that they know which tablets were consumed.
If you forget to take Naproxen Ifyou forget to take a tablet, take one as soon as you remember, unless it is nearlytime to take the next one. Do not take a double dose to make up for a forgotten dose.Take the remaining doses at the correct time.
If you stop taking Naproxen
Do not stop taking your medicine without talking to your doctor first even ifyou feel better.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
POSSIBLE SIDE EFFECTS
Like all medicines, Naproxen can cause side effects, although not everybody gets them.
STOP TAKING the tablets and seek immediate medical help ifyou suffer from any ofthe following atanytimeduringyour treatment:
• an allergic reaction causing swelling ofthe lips, face or neck leading to severe difficulty in breathing, skin rash or hives (with symptoms such as itching, nettle rash, bruise like rash), or worsening of existing asthma
• Stevens-Johnson syndrome (severe blisters and bleeding in the mucous membranes ofthe lips, eyes, mouth, nasal passage, and genitals) or a skin reaction causing blistering and flaking ofthe skin
• pass blood in your faeces (stools/motions)
• pass blacktarry stools (a symptom of bleeding in the stomach or intestines)
• vomit any blood or dark particles that look like coffee grounds.
These are very serious side effects. You may need urgent medical attention or hospitalisation.
STOP TAKING the tablets and tell your doctor if you
experience:
• indigestion or heartburn, abdominal pain (pains in your stomach) or otherabnormal stomach symptoms.
The following side effects have also been reported: Most common
• feeling sick and/or being sick
• diarrhoea
• bloating and/or constipation
• abdominal pain, indigestion and/or heartburn
• inflammation ofthe mouth, lips, cheeks, gums or throat.
Less common
• inflammation in the lining ofthe stomach
• ulcers in the stomach and/or intestines
• small holes in the stomach and/or intestines (perforations)
• colitis (inflammation ofthe lining ofthe large intestine).
Very Rare
• pancreatitis (inflammation ofthe pancreas).
Other side effects can include:
• medicines such as Naproxen may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke
• heart problems such as inflammation ofthe blood vessels, water retention, high blood pressure, heart palpitations (a fluttering feeling in your heart), congestive heart failure (heart problems which can cause shortness of breath or ankle swelling) or heart failure
• kidney problems such as inflammation ofthe kidneys, kidney damage or kidney failure, blood in the urine or raised serum creatinine (which may cause changes in blood chemistry)
• liver problems such as abnormal liver function test results, inflammation ofthe liver (hepatitis), jaundice (yellowing ofthe skin orwhites ofthe eyes)
• problems with the senses such as vision problems, inflammation ofthe optic nerve, pins-and-needles or numbness, ringing in the ears or impaired hearing
• aseptic meningitis (inflammation ofthe lining of the brain), especially in patients with an auto-immune disease e.g. Systemic Lupus Erythematosus (SLE) or mixed connective tissue disease; symptoms may include stiff neck, fever, disorientation, depression, confusion or hallucinations, ringing intheearsor hearing problems, dizziness and vertigo, a general feeling of being unwell, unusual tiredness or drowsiness
• eosinophilic pneumonitis (lung infection which causes difficulty in breathing and night sweats)
• blood disorders such as low numbers of red or white blood cells, low levels of calcium in the blood, high levels of potassium (which may cause abnormal heart rhythm), reduction in blood platelets (which may increase the risk of bleeding and bruising), neutropenia (which may cause fever or chills, sore throat, ulcers in your mouth or throat)
• oesophagitis (inflammation ofthe gullet)
• mental illnesses such as difficulty in sleeping, abnormal dreams, depression, confusion, hallucinations
• nervous system problems such as fits, dizziness, headaches, light-headedness, drowsiness, forgetfulness and difficulty concentrating
• female infertility
• sensitivityto light
• hair loss
• a general felling of being unwell, tiredness, fever, sweating,thirst, muscle pain orweakness, bruising
• other skin rashes such as inflammatory skin eruption and red-purple swelling on the legs.
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.
HOW TO STORE NAPROXEN
Keep out of the reach and sight of children.
These tablets should be stored inthe package or container supplied. Do not store above 250C. Do not transfer them to another container.
Do not use Naproxen afterthe expiry date that is stated on the outer packaging.The expiry date refers to the last day ofthat month.
Medicines should not be disposed ofvia wastewater or household waste. Askyour pharmacist howto dispose of medicines no longer required.These measures will help to protect the environment.
FURTHER INFORMATION
What Naproxen Gastro-resistant Tablets contain:
• The active ingredient is naproxen 250 mg or 500 mg.
• The other ingredients are lactose monohydrate, maize starch, povidone, sodium starch glycolate (type A), magnesium stearate (E572), colloidal silicon dioxide, polyvinyl acetate phthalate, purified stearic acid (E570), polyethylene glycol, hydroxypropyl methylcellulose (E464), sodium alginate (E401), sodium bicarbonate (E500), purified talc (E553b), triethyl citrate, titanium dioxide (E171), antifoam AF emulsion, shellac, black iron oxide (E172), propylene glycol (E1520).
What Naproxen Gastro-resistant Tablets look like and contents of the pack:
• Naproxen 250 mg Gastro-resistantTablets are white, round, biconvex, tablets, printed '3N3'.
• Naproxen 500 mg Gastro-resistant Tablets are white, capsule-shaped, tablets, printed '5N3'.
• The product is available in packs sizes of 10, 28, 56, and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation holder and company responsible for manufacture isTEVA UK Limited, Eastbourne, BN22 9AG.
This leaflet was last revised: August 2014
PL 00289/0129-0130
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