NAPROXEN TABLETS 250MG

Active substance: NAPROXEN

View full screen / Print PDF » Download PDF ⇩

Transcript
59.5 mm

59.5 mm

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same as
yours.
• If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.
What is in this leaflet:
1. What Naproxen is and what it is used for
2. What you need to know before you take Naproxen
3. How to take Naproxen
4. Possible side effects
5. How to store Naproxen
6. Contents of the pack and other information

1. What Naproxen is and what it is used for
Naproxen is a ‘Non Steroidal Anti Inflammatory Drug’ or NSAID.
Naproxen can lessen pain, swelling, redness and heat (inflammation)
and is used for:
• Problems with your muscles, joints and tendons, like strains, gout,
ankylosing spondylitis (pain and stiffness in the neck and back) or
arthritis.
• Women, while having period pain.
• Children over 5 years with rheumatoid arthritis.

2. What you need to know before you take Naproxen
Do not take Naproxen if you:
• are allergic or (hypersensitive) to Naproxen sodium or any of the
other ingredients of Naproxen (see section 6).
• have a history of allergy to NSAIDs (e.g. Aspirin, Diclofenac,
Ibuprofen), which includes attacks of asthma, swelling of the nose
and throat, skin rashes or a runny nose
• have now or have ever had any problems with your stomach or
gut (intestine) like an ulcer or bleeding
• have a history of gastrointestinal bleeding or perforation related to
the use of NSAIDs.

• have severe problems with your kidneys, liver or heart.
• are in the last three months of pregnancy (last trimester).
Do not take Naproxen if any of the above apply to you. If you are not
sure, talk to your doctor or pharmacist before taking Naproxen.
Warnings and Precautions
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 have heart problems, previous stroke or think that you might be
at risk of these conditions (for example if you have high blood pressure,
diabetes or high cholesterol or are a smoker) you should discuss your
treatment with your doctor or pharmacist.
Check with your doctor or pharmacist before taking Naproxen if you
have had or if you are suffering from any of the following conditions.
• Asthma or allergies (like hayfever) or have had swelling of the
face, lips, eyes or tongue in the past.
• A feeling of weakness (perhaps because of an illness) or you are
elderly.
• Lumps in your nose (polyps) or you sneeze a lot or have a runny,
blocked, or itchy nose (rhinitis).
• Problems with your kidneys or liver.
• Problems with the way your blood clots.
• Problems with the blood vessels (arteries) anywhere in your body.
• A history of gastrointestinal disease e.g. ulcerative colitis,
Crohn’s disease (conditions causing inflammation of the
bowel, bowel pain, diarrhoea, vomiting and weight loss).
• Hyperlipidaemia (too much fat (lipid) in your blood).
• An autoimmune condition such as, ‘systemic lupus erythematosus’
(SLE). SLE causes joint pain, skin rashes and fever and mixed
connective tissue disorders.
• Naproxen may make it more difficult to become pregnant.
You should inform your doctor if you are planning to become
pregnant or if you have problems becoming pregnant.
If any of the above apply to you, or if you are not sure, talk to your
doctor or pharmacist before you take Naproxen.
Other medicines and Naproxen
Tell your doctor or pharmacist if you are taking or have
recently taken or might take any other medicines. In particular, tell
your doctor or pharmacist if you are taking:

• Other pain killers like, aspirin, ibuprofen, diclofenac and paracetamol.
• Medicine to stop your blood clotting like, warfarin, heparin or
clopidogrel
• A hydantoin (for epilepsy) like, phenytoin.
• Sulfonamide medicines like, hydrochlorothiazide, acetazolamide,
indapamide and including sulfonamide antibiotics (for infections)
• A sulfonylurea (for diabetes) like, glimepiride or glipizide.
• An ‘ACE inhibitor’ or any other medicine for high blood pressure like
cilazapril, enalapril or propranolol.
• An angiotensin-II receptor anatgonist, like candesartan, eprosartan
or losartan.
• A diuretic (water tablet) (for high blood pressure) like, furosemide.
• A ‘cardiac glycoside’ (for heart problems) like, digoxin.
• A steroid (for swelling and inflammation) like, hydrocortisone,
prednisolone and dexamethasone.
• A ‘quinolone antibiotic’ (for infections) like, ciprofloxacin or
moxifloxacin.
• Certain medicines for mental health problems like, lithium or ‘SSRIs’
like fluoxetine or citalopram.
• Probenecid (for gout).
• Methotrexate (used to treat skin problems, arthritis or cancer).
• Ciclosporin or tacrolimus (for skin problems or after an organ
transplant).
• Zidovudine (used to treat AIDS and HIV infections)
• Mifepristone (used to end pregnancy or to bring on labour if the
baby has died).
If any of the above apply to you, or if you are not sure, talk to your
doctor or pharmacist before you take Naproxen
Pregnancy and breast-feeding
• Do not take Naproxen if you are in the last three months of
pregnancy, as it can harm your baby.
• Talk to your doctor before taking Naproxen if you are up to six
months pregnant, think you are pregnant, plan to get pregnant or are
breast-feeding. Your doctor will decide if you should take Naproxen.
• Naproxen may make it more difficult to become pregnant.
You should tell your doctor if you are planning to become pregnant
or if you have problems becoming pregnant.
Driving and using machines
Naproxen may make you feel tired, drowsy, dizzy, have problems
with your eyesight and balance, depressed or have difficulty sleeping.

430 mm

Talk to your doctor if any of these happen to you and do not drive or
use any tools or machines.
Naproxen Tablets contain Lactose and Sunset yellow
• If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this
medicinal product.
• Sunset yellow may cause allergic reactions.

3. How to take Naproxen
Medicines such as Naproxen may be associated (linked) with a
small increased risk of heart attack (‘myocardial infarction’) or stroke.
Any risk is more likely with higher doses and prolonged (longer term)
treatment. Do not exceed (take more than) the recommended
dose or duration (length) of treatment. Check with your doctor if
you are not sure.
Swallow the tablets whole with a little water, with or after food.
While you are taking Naproxen, your doctor will want to see you to
check whether you are on the right dose and look for any side effects.
This is particularly important if you are elderly.
Children over 5 years, rheumatoid arthritis
• The usual dose is 10 mg/kg body weight each day.
• The dose is split into two and given 12 hours apart.
Adults
Muscle, joint or tendon problems and period pain
• The usual starting dose is 500 mg, followed by 250 mg tablet every
6 to 8 hours as needed.
Arthritis and ankylosing spondylitis
• The usual dose is between 500 mg and 1000 mg.
• The dose can be taken all at once, or split into two doses and can
be taken twice a day.
Gout
• The usual starting dose is 750 mg, followed by a 250 mg tablet
every 8 hours as needed.
The elderly and people with liver and kidney problems
Your doctor will decide your dose, it will usually be lower than that for
other adults.
If you take more Naproxen than you should
If you take more Naproxen than you should, talk to your doctor or go
to the hospital straight away. Take the original pack with you.

140 mm

Naproxen 250mg and 500mg Tablets

IXXXXXX

PACKAGE LEAFLET: INFORMATION FOR THE USER

59.5 mm

4. Possible side effects
Like all medicines Naproxen can cause side effects, although not
everyone will get them.
Medicines such as Naproxen may be associated with a small
increased risk of heart attack (‘myocardial infarction’) or stroke.
Important side effects to look out for:
Stop taking Naproxen and tell a doctor straight away if any of
the following side effects happen. You may need urgent medical
treatment.
Serious stomach or gut problems, signs include:
• Bleeding from the stomach, seen as vomit which has blood in it, or
bits that look like coffee grounds.
• Bleeding from your back passage (anus), seen as passing black
sticky bowel motions (stools) or bloody diarrhoea.
• Ulcers or holes forming in your stomach or gut. Signs include upset
stomach, stomach pain, fever, feeling or being sick.
• Problems with your pancreas. Signs include severe stomach pain
which spreads to your back.
• Worsening of ulcerative colitis or Crohn’s disease, seen as pain,
diarrhoea, vomiting and weight loss.
Allergic reactions, signs include:
• Sudden swelling of your throat, face, hands or feet.
• Difficulty in breathing, tightness in your chest.
• Skin rashes, blisters or itching.
Severe skin rashes, signs include:
• A severe rash that develops quickly, with blisters or peeling of your
skin and possibly blisters in your mouth, throat or eyes (Stevens
Johnson Syndrome or Toxic epidermal necrolysis)
• Fever, headache, cough and aching body may happen at the
same time.
• Blistering of skin when exposed to sunlight (porphyria cutanea
tarda) seen most on arms, face and hands.
Liver problems, signs include:
• Yellowing of your skin or the whites of your eyes (jaundice).
• Feeling tired, loss of appetite, feeling or being sick and pale coloured
stools (hepatitis) and problems (including hepatitis), shown in blood
tests.

Heart attack, signs include:
• Chest pain which may spread to your neck and shoulders and
down your left arm.
Stroke, signs include:
• Muscle weakness and numbness. This may only be on one side
of your body.
• A suddenly altered sense of smell, taste, hearing or vision, confusion.
Meningitis, signs include:
• Fever, feeling or being sick, a stiff neck, headache, sensitivity to
bright light and confusion (most likely in people with autoimmune
conditions such as ‘systemic lupus erythematosus’).
If you notice any of the serious side effects mentioned above, stop
taking Naproxen and tell your doctor straight away.
Other possible side effects:
Stomach and gut
• Heartburn, indigestion, stomach ache, feeling sick or being sick,
constipation, diarrhoea, wind.
Blood
• Blood problems like, anaemia or changes to the numbers of white
blood cells.
Mental illness
• Having difficulty in sleeping or change in your patterns of dreaming.
• Depression.
• Confusion or seeing and possibly hearing things that are not there
(hallucinations).
Nervous system
• Headache.
• Fits or seizures, feeling dizzy or light-headed or sleepy.
• Pins and needles or numbness of your hands and feet.
• Difficulty with your memory or concentration.
Eyes and ears
• Changes to your eyesight, eye pain.
• Changes to your hearing, including ringing in the ears (tinnitus) and
hearing loss.
• Dizziness that causes problems with your balance.
Heart and circulation
• Swelling of your hands, feet or legs (oedema), this may be with
chest pains, tiredness, shortness of breath (cardiac failure).
• A fluttering feeling in your heart (palpitations), slow heart beat or
high blood pressure.
• Problems with the way your heart pumps blood around the body or

damage to your blood vessels. Signs may include tiredness,
shortness of breath, feeling faint, general pain.
Chest
• Difficulty in breathing, including shortness of breath, wheezing or
coughing.
• Pneumonia or swelling of your lungs.
Skin and hair
• Skin rashes including redness, hives, pimples and blisters on your
body and face.
• Bruising, itching, sweating, skin being more sensitive to the sun or
hair loss.
Urinary
• Blood in your water (urine) or kidney problems.
Other
• Thirst, fever, feeling tired or generally unwell.
• A sore mouth or mouth ulcers.
• Muscle pain or weakness.
• Problems for women in getting pregnant.
• ‘Systemic lupus erythematosus’ (SLE). Signs include fever, rash,
problems with your kidneys and joint pain.
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.

starch, crospovidone, magnesium stearate and the colours quinoline
yellow (E104) and sunset yellow (E110)
What Naproxen looks like and contents of the pack
Naproxen 250 mg tablets: Pale yellow, flat bevelled edge tablets with
N breakline 250 on one side and BL on the other.
Naproxen 500 mg tablets: Pale yellow, oblong tablets with N breakline
500 on one side and BL on the other.
Naproxen 250 mg tablets are supplied in Securitainers of 28, 56, 250
tablets and blisters of 28, 56, 84 and 112 tablets.
Naproxen 500 mg tablets are supplied in Securitainers of 28, 56, 100,
500 tablets and blisters of 28, 56, 84 and 112 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Bristol Laboratories Ltd. Unit 3, Canalside, Northbridge Road,
Berkhamsted, Herts, HP4 1EG, UK
Tel:
0044 (0)1442200922
Fax:
0044 (0)1442873717
e-mail:
info@bristol-labs.co.uk
Naproxen 250mg Tablets; PL 17907/0339
Naproxen 500mg Tablets; PL 17907/0340
This leaflet was last revised in September 2013.

5. How to store Naproxen
• Naproxen Tablets should be kept in their original packaging to
protect them from light. Store below 250C.
• Keep out of the sight and reach of children.
• Do not use Naproxen Tablets after the expiry date which is printed
on the pack. The expiry date refers to the last day of that month.
• Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment

6. Contents of the pack and other information
What Naproxen contains
• The active substance is naproxen. Each tablet contains either
250 mg (milligrams) or 500 mg of naproxen
• The other ingredients are sodium lauryl sulphate, lactose, maize

430 mm

V3 23-09-13 D1

IXXXXX

If you forget to take Naproxen
• If you forget to take a dose, skip the missed dose. Then take
your next dose as normal.
• Do not take a double dose to make up for a forgotten dose.

140 mm

59.5 mm

Expand view ⇕

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.

Hide
(web2)