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STIRLESCENT 250 MG EFFERVESCENT TABLETS

Active substance(s): NAPROXEN / NAPROXEN / NAPROXEN

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Package leaflet: Information for the patient

Stirlescent 250 mg Effervescent Tablets

Naproxen
Children and adolescents
Read all of this leaflet carefully before you
start taking this medicine because it contains This medicine should not be used by children
and adolescents under 18 years of age.
important information for you.
- Keep this leaflet. You may need to read
Other medicines and Stirlescent 250 mg
it again.
Effervescent Tablets
- If you have any further questions, ask
Tell your doctor or pharmacist if you are
your doctor or pharmacist.
- This medicine has been prescribed for you. taking or have recently taken any other
medicines. This includes medicines that
Do not pass it on to others. It may harm
you buy without a prescription and herbal
them even if their symptoms are the same
medicines. In particular, tell your doctor or
as yours.
pharmacist if you are taking:
- If you get any side effects, talk to your
• Other pain killers, like aspirin, ibuprofen,
doctor or pharmacist. This includes any
diclofenac and paracetamol.
possible side effects not listed in this
• Medicine to stop your blood clotting, like
leaflet. See section 4.
warfarin, heparin or clopidogrel.
• A hydantoin (for epilepsy), like phenytoin.
What is in this leaflet:
• Sulfonamide medicines, like
1 What Stirlescent 250 mg Effervescent
hydrochlorothiazide, acetazolamide,
Tablets is and what it is used for
indapamide and including sulfonamide
2 What you need to know before you take
antibiotics (for infections).
Stirlescent 250 mg Effervescent Tablets
• A sulfonylurea (for diabetes), like
3 How to take Stirlescent 250 mg
glimepiride or glipizide.
Effervescent Tablets
• An ‘ACE inhibitor’ or any other medicine for
4 Possible side effects
high blood pressure like cilazapril, enalapril
5 How to store Stirlescent 250 mg
or propranolol.
Effervescent Tablets
6 Contents of the pack and other information • An angiotensin-II receptor antagonist, like
candesartan, eprosartan or losartan (for
1 What Stirlescent 250 mg Effervescent
treating high blood pressure).
• A diuretic (water tablet) (for high blood
Tablets is and what it is used for
pressure), like furosemide.
Stirlescent 250 mg Effervescent Tablets
• A ‘cardiac glycoside’ (for heart problems),
contains the drug naproxen. This is a ‘Non
like digoxin.
Steroidal Anti Inflammatory Drug’ or NSAID.
• A steroid (for swelling and inflammation),
like hydrocortisone, prednisolone and
Stirlescent 250 mg Effervescent Tablets
dexamethasone.
can lessen pain and inflammation (swelling,
• A ‘quinolone antibiotic’ (for infections), like
redness and heat) and is used to treat adults
ciprofloxacin or moxifloxacin.
for:
• Certain medicines for mental health
• Pain in your muscles, joints and tendons,
problems like lithium or ‘SSRIs’ like
like strains, gout, arthritis and ankylosing
fluoxetine or citalopram.
spondylitis.
• Probenecid (for gout).
• Period pain.
• Methotrexate (used to treat skin problems,
2 What you need to know before you take
arthritis or cancer).
• Ciclosporin or tacrolimus (for skin problems
Stirlescent 250 mg Effervescent Tablets
or after an organ transplant).
Do not take Stirlescent 250 mg Effervescent
• Zidovudine (used to treat AIDS and HIV
Tablets
infections).
• If you are allergic to naproxen or any of the
• Mifepristone (used to end pregnancy or to
other ingredients of this medicine (listed in
bring on labour if the baby has died).
section 6).
• If you are allergic to aspirin, other NSAIDs
If any of the above apply to you, or if you are
or any other pain relief medicines (such as
not sure, talk to your doctor or pharmacist
ibuprofen or diclofenac).
before you take this medicine.
• If you have a peptic ulcer (ulcer in your
stomach or duodenum) or bleeding in your
stomach, or have had two or more episodes Pregnancy, breast-feeding and fertility
• DO NOT TAKE this medicine if you are in the
of peptic ulcers, stomach bleeding or
last three months of pregnancy, as it can
perforation.
harm your baby.
• If you have previously experienced bleeding
• Talk to your doctor BEFORE taking this
or perforation in your stomach while taking
medicine if you are in the first six months
NSAIDs.
of pregnancy, think you are pregnant, plan
• If you have severe problems with your
to get pregnant or are breast-feeding. Your
kidneys, liver or heart.
doctor will decide if you should take this
• If you are in the last three months of
medicine.
pregnancy.
• This medicine may make it more difficult
to become pregnant. You should tell your
Do not take this medicine if any of the above
doctor if you are planning to become
apply to you. If you are not sure, talk to your
pregnant or if you have problems becoming
doctor or pharmacist before taking this
pregnant.
medicine.
If you suffer from any of the following at any
time during your treatment, STOP TAKING the
medicine and seek immediate medical help:
• Pass blood in your stools (faeces / 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.
• Pains in your stomach or other abnormal
stomach symptoms.
Warnings and precautions
Take special care with Stirlescent 250 mg
Effervescent Tablets
If you have heart problems or have had a
stroke, or if you think that you might be at risk
of these conditions (because, for example,
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 this medicine if you have any of the
following:
• Asthma or allergies (like hay fever).
• Previous swelling of the face, lips, eyes or
tongue.
• A feeling of weakness (perhaps because of
an illness) or you are elderly.
• Lumps in your nose (polyps), or if you sneeze
a lot or have a runny, blocked or itchy nose.
• Other problems with your kidneys or liver.
• An autoimmune condition, such as
‘systemic lupus erythematosus’ (SLE,
causes joint pain, skin rashes and fever)
and colitis or Crohn’s disease (conditions
causing inflammation of the bowel, bowel
pain, diarrhoea, vomiting and weight loss).
• Your blood does not clot normally.
• Too much fat in your blood (hyperlipidaemia).
• Problems with the blood vessels (arteries)
anywhere in your body.
If any of the above apply to you, or if you are
not sure, talk to your doctor or pharmacist
before you take this medicine.

Driving and using machines
This medicine can make you tired, drowsy
or dizzy, and could make you depressed or
confused. It may also cause problems with
your eyesight and balance. Talk to your
doctor if any of these happen to you and,
if affected, do not drive or use any tools or
machines.
Stirlescent 250 mg Effervescent Tablets
contain sodium
Each Stirlescent 250 mg Effervescent Tablet
contains 342 mg of sodium. To be taken
into consideration by patients on a sodium
controlled diet.
3 How to take Stirlescent 250 mg
Effervescent Tablets
Medicines containing naproxen may be linked
with a small increased risk of heart attack
or stroke. Any risk is more likely with higher
doses and prolonged (longer term) treatment.
Do not exceed the recommended dose or
length of your treatment. Check with your
doctor if you are not sure.

Dissolve 1 to 2 tablets in a glass (150 ml) of
water and drink, doses of 3 tablets should
be dissolved in 300 ml. To make sure there is
no medicine left, rinse the empty glass with
a small amount (10 ml) of water and drink it.
Take with or after food. Make sure that you
have enough to drink and stay well hydrated
when taking this medicine. This is particularly
important for people who have problems
with their kidneys. While you are taking this
medicine, 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 elderly.
The recommended dose for adults
Muscle, joint or tendon pain and period pain
• The usual starting dose is 2 tablets,
followed by a tablet every 6 to 8 hours as
needed.
Arthritis and ankylosing spondylitis
• The usual dose is between 2 to 4 tablets.
• The dose should be split in two and taken
twice a day.

Gout
• The usual starting dose is 3 tablets,
followed by a tablet every 8 hours as
needed.
Use in children
Stirlescent 250 mg Effervescent Tablets are
not for use in children under 18 years of age.
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 Stirlescent 250 mg
Effervescent Tablets than you should
If you take more of this medicine 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 Stirlescent 250 mg
Effervescent Tablets
If you forget to take a dose, skip the missed
dose and then take your next dose as normal.
Do not take a double dose to make up for a
forgotten dose.
4 Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets
them. Medicines containing naproxen may
be associated with a small increased risk of
heart attack or stroke.

Important side effects to look out for:
Stop taking this medicine 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:
• Blood in your vomit, or bits that look like
coffee grounds.
• Black sticky bowel motions (stools) or
bloody diarrhoea.
• 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.
• Blistering of skin when exposed to
sunlight, mostly seen on the 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 and tightening 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 this medicine
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, difficult and/or painful
swallowing, a feeling of something being
stuck in the throat.
Blood
• Blood problems, like anaemia or changes
to the numbers of white blood cells.
• High levels of potassium in the blood
(hyperkalaemia).
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. This
may be with chest pains, tiredness or
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.
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
or pharmacist. This includes any possible
side effects not listed in this leaflet. You can
also report side effects directly via:
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel:
+353 1 6764971
Fax:
+353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
Malta
ADR Reporting
Website: www.medicinesauthority.gov.mt/
adrportal
United Kingdom
Yellow Card Scheme
Website: 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 Stirlescent 250 mg
Effervescent Tablets
This medicine does not require any special
storage conditions. Keep out of the sight and
reach of children. Do not use this medicine
after the expiry date which is stated 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 Stirlescent 250 mg Effervescent Tablets
contains
The active substance in this medicine is
naproxen. Each tablet contains 250 mg
(milligrams) of naproxen. Each tablet also
contains 342 mg sodium.

The other ingredients in the tablets are citric
acid, sodium hydrogen carbonate, sodium
carbonate, sodium cyclamate, saccharin
sodium, sodium citrate, povidone, macrogol
6000, mannitol (E421), simeticone, docusate
sodium, blackcurrant flavour.
What Stirlescent 250 mg Effervescent Tablets
looks like and contents of the pack
Stirlescent 250 mg Effervescent Tablets are
large, round, white tablets. The tablets are
supplied in plastic tubes or aluminium paper
foil containing 10, 12, 15, 20, 24 or 30 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Stirling Anglian Pharmaceuticals Ltd.
Hillington Park Innovation Centre,
1 Ainslie Road, Hillington Park,
Glasgow G52 4RU,
United Kingdom
Manufacturer:
HERMES ARZNEIMITTEL GmbH,
Georg-Kalb-Strasse 5-8,
82049 Großhesselohe/Munich,
Germany
This medicinal product is authorised in
the Member States of the EEA under the
following names:
Ireland Stirlescent 250 mg Effervescent Tablets
Malta Stirlescent 250 mg Effervescent Tablets
UK
Stirlescent 250 mg Effervescent Tablets
This leaflet was last revised in 02/2017
XXXXX-XXXX

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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