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NEXOCIN EC 375 MG GASTRO-RESISTANT TABLETS

Active substance(s): NAPROXEN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Nexocin EC 250 mg Gastro-resistant Tablets
Nexocin EC 375 mg Gastro-resistant Tablets
Nexocin EC 500 mg Gastro-resistant Tablets
Naproxen

Read all of these 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 only. Do not pass it on to others.
It may harm them, even if their signs of illness are the same as yours
• If you get any side effects talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See section 4
What is in this leaflet:
1. What Naproxen Tablets are and what are they used for
2. What you need to know before you take Naproxen Tablets
3. How to take Naproxen Tablets
4. Possible side effects
5. How to store Naproxen Tablets
6. Contents of the pack and other information
1. What Naproxen Tablets are and what are they used for
Naproxen Tablets contain a medicine called naproxen. This is a ‘Non Steroidal
Anti Inflammatory Drug’ or NSAID.
Naproxen Tablets can lessen pain, swelling, redness and heat (inflammation)
and is used to treat adults for:
• Problems with your muscles, joints and tendons, like strains, back pain,
ankylosing spondylitis (pain and stiffness in the neck and back) or arthritis
• Women, while having period pain
2. What you need to know before you take Naproxen Tablets
Do not take Naproxen Tablets if you are allergic (hypersensitive):
• You have now or have ever had any problems with your stomach or gut
(intestine) like an ulcer or bleeding
• You have previously experienced bleeding or perforation in your
stomach while taking NSAIDs
• You have severe problems with your kidneys, liver or heart
• You are in the last three months of pregnancy
Do not take Naproxen Tablets if any of the above apply to you. If you are
not sure, talk to your doctor or pharmacist before taking Naproxen Tablets.
Warnings and precautions
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.
Talk to your doctor or pharmacist before taking Naproxen Tablets if any of
the following apply to you:
• 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 an
older person
• 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 that your blood clots
• Problems with the blood vessels (arteries) anywhere in your body
• Too much fat (lipid) in your blood (hyperlipidaemia)
• An autoimmune condition, such as ‘systemic lupus erythematosus’
(SLE, causes joint pain, skin rashes and fever) and ulcerative colitis or
Crohn’s disease (conditions causing inflammation of the bowel, bowel
pain, diarrhoea, vomiting and weight loss)
If any of the above apply to you, or if you are not sure, talk to your doctor
or pharmacist before you take Naproxen Tablets.
Children and adolescents
Naproxen tablets is not recommended for use in children under 16 years of age
Other medicines and Naproxen Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines. This includes medicines that you buy
without a prescription and herbal 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)

6 mm

11.16 mm

28.33 mm

50 mm

18.5 mm

36.5 mm

• 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 antagonist, 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 Tablets.
Pregnancy, breast-feeding and fertility.
• Do not Naproxen Tablets if you are in the last three months of pregnancy,
as it can harm your baby
• If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice
before taking this medicine
• Naproxen Tablets 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
Naproxen Tablets may make you tired, drowsy, dizzy, have problems with
your eyesight and balance, depressed or have difficulty sleeping. Talk to
your doctor if any of these happen to you and do not drive or use any tools
or machines.
3. How to take Naproxen Tablets
Always take this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
The tablets should be taken with or after food, and should be swallowed
whole (not to be broken or crushed) preferably with a drink of water. 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 recommended dose is:
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 in two and taken twice a day
Older people and people with liver and kidney problems
Your doctor will decide your dose, it will usually be lower than that for
other adults
Use in children and adolescents
Naproxen Tablets are not for use in children under 16 years of age.
Medicines such as Naproxen Tablets 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. Do not
crush or chew the tablets.
You should make sure that you have enough to drink (stay well hydrated)
when you are taking Naproxen Tablets. This is particularly important for
people who have problems with their kidneys.
While you are taking Naproxen Tablets your doctor will want to see you to
check you are on the right dose for you and look for any side effects. This
is particularly important if you are an older person.
If you take more Naproxen Tablets than you should
If you take more Naproxen Tablets than you should, talk to a doctor or go
to a hospital straight away. Take the medicine pack with you.
If you forget to take Naproxen Tablets
• 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
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist

4. Possible side effects
Like all medicines this medicine can cause side effects, although not
everybody gets them.
Medicines such as Naproxen Tablets 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 Tablets 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 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. Fever, headache,
cough and aching body may happen at the same time
• Skin blistering 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

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
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.
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 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 Naproxen Tablets
Keep this medicine out of the sight and reach of children
This medicinal product does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the carton
and the blister strip. 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 Tablets contains
500
• The active substance in Naproxen Tablets is naproxen. Each enteric
coated tablet contains naproxen 500 mg
• The other ingredients are: microcrystalline cellulose PH 101, croscarmellose sodium, povidone, magnesium stearate, methacrylic acid
ethylacrylate copolymer (1:1) dispersion 30%, sodium hydroxide,
triethyl citrate and talc
375
• The active substance in Naproxen Tablets is naproxen. Each enteric
coated tablet contains naproxen 375 mg
• The other ingredients are: microcrystalline cellulose PH 101,
croscarmellose sodium, povidone, magnesium stearate, methacrylic acid
ethylacrylate copolymer (1:1) dispersion 30%, sodium hydroxide,
triethyl citrate and talc

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 Tablets and tell your doctor straight away.

250
• The active substance in Naproxen Tablets is naproxen. Each enteric
coated tablet contains naproxen 250 mg
• The other ingredients are: microcrystalline cellulose PH 101,
croscarmellose sodium, povidone, magnesium stearate, methacrylic acid
ethylacrylate copolymer (1:1) dispersion 30%, sodium hydroxide,
triethyl citrate and talc

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

What Nexocin EC Gastro-resistant Tablets looks like and contents of
the pack

Mental illness
• Having difficulty sleeping or changes 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 lightheaded 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 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

500
Nexocin EC 500 mg Gastro-resistant Tablets are white colour, capsule
shaped biconvex enteric coated tablets debossed with “500” on one side
and plain on the other side.
Naproxen Tablets are supplied in Alu/PVC 4 blister packs of 14 tablets.
375
Nexocin EC 375 mg Gastro-resistant Tablets are white colour, oval shaped
biconvex enteric coated tablets debossed with “375” on one side and plain
on the other side.
Naproxen Tablets are supplied in Alu/PVC 4 blister packs of 14 tablets.
250
Nexocin EC 250 mg Gastro-resistant Tablets are White colour, circular
shaped biconvex enteric coated tablets debossed with “250” on one side
and plain on the other side.
Naproxen Tablets are supplied in Alu/PVC 4 blister packs of 14 tablets.
(Not all pack sizes may be marketed).
Marketing Authorization Holder:
NOUMED LIFE SCIENCES LIMITED
Noumed House, Shoppenhangers Road
Maidenhead, Berkshire, SL6 2RB, United Kingdom.

POM

Manufacturer:
MEDREICH PLC
Warwick House, Plane Tree Crescent,
Feltham TW13 7HF, UK
E-mail : info@medreich.co.uk

To listen to or request a copy of this leaflet in Braille,
large print or audio please call,
020 33998960 (UK only)
Please be ready to give the following information:
Product name
Reference number
Nexocin EC 250mg Gastro-resistant Tablets
PL 44041/0041
Nexocin EC 375mg Gastro-resistant Tablets
PL 44041/0042
Nexocin EC 500mg Gastro-resistant Tablets
PL 44041/0043
This leaflet was last revised in July 2017

Expand Transcript

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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