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STIRLESCENT 250 MG EFFERVESCENT TABLETS

Active substance(s): NAPROXEN

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Package leaflet: Information for the patient

Stirlescent 250 mg Effervescent Tablets
Naproxen
Read all of this leaflet carefully before you
not sure, talk to your doctor or pharmacist
start taking this medicine because it contains before you take this medicine.
important information for you.
- Keep this leaflet. You may need to read
Children and adolescents
it again.
This medicine should not be used by children
- If you have any further questions, ask
and adolescents under 18 years of age.
your doctor or pharmacist.
- This medicine has been prescribed for you. Other medicines and Stirlescent 250 mg
Do not pass it on to others. It may harm
Effervescent Tablets
them even if their symptoms are the same
Tell your doctor or pharmacist if you are
as yours.
taking or have recently taken any other
- If you get any side effects, talk to your
medicines. This includes medicines that
doctor or pharmacist. This includes any
you buy without a prescription and herbal
possible side effects not listed in this
medicines. In particular, tell your doctor or
leaflet. See section 4.
pharmacist if you are taking:
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What is in this leaflet:
diclofenac and paracetamol.
1 What Stirlescent 250 mg Effervescent
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Tablets is and what it is used for
warfarin, heparin or clopidogrel.
2 What you need to know before you take
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Stirlescent 250 mg Effervescent Tablets
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3 How to take Stirlescent 250 mg
%5!/, %),/,1%&6&!"A "16,)*&!"A
Effervescent Tablets
indapamide and including sulfonamide
4 Possible side effects
antibiotics (for infections).
5 How to store Stirlescent 250 mg
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Effervescent Tablets
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6 Contents of the pack and other information å +ß&+%&&1,/à,/+5,1%"/*"!& &+"#,/
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1 What Stirlescent 250 mg Effervescent
or propranolol.
Tablets is and what it is used for
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Stirlescent 250 mg Effervescent Tablets
candesartan, eprosartan or losartan (for
contains the drug naproxen. This is a ‘Non
treating high blood pressure).
Steroidal Anti Inflammatory Drug’ or NSAID.
å !&Ĝ/"1& ³31"/1)"1´³#,/%&$%),,!
pressure), like furosemide.
Stirlescent 250 mg Effervescent Tablets
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can lessen pain and inflammation (swelling,
like digoxin.
redness and heat) and is used to treat adults
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for:
like hydrocortisone, prednisolone and
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dexamethasone.
like strains, gout, arthritis and ankylosing
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spondylitis.
ciprofloxacin or moxifloxacin.
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problems like lithium or ‘SSRIs’ like
2 What you need to know before you take
fluoxetine or citalopram.
Stirlescent 250 mg Effervescent Tablets
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Do not take Stirlescent 250 mg Effervescent
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Tablets
arthritis or cancer).
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other ingredients of this medicine (listed in
or after an organ transplant).
section 6).
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infections).
or any other pain relief medicines (such as
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ibuprofen or diclofenac).
bring on labour if the baby has died).
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stomach or duodenum) or bleeding in your
If any of the above apply to you, or if you are
stomach, or have had two or more episodes not sure, talk to your doctor or pharmacist
of peptic ulcers, stomach bleeding or
before you take this medicine.
perforation.
å #5,Ĝ%2"-/"2&,Ĝ0)5"4-"/&"+ "!)""!&+$ Pregnancy, breast-feeding and fertility
or perforation in your stomach while taking
å DO NOT TAKE this medicine if you are in the
NSAIDs.
last three months of pregnancy, as it can
å #5,Ĝ%2"severe problems with your
harm your baby.
kidneys, liver or heart.
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medicine if you are in the first six months
pregnancy.
of pregnancy, think you are pregnant, plan
to get pregnant or are breast-feeding. Your
Do not take this medicine if any of the above
doctor will decide if you should take this
apply to you. If you are not sure, talk to your
medicine.
doctor or pharmacist before taking this
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medicine.
to become pregnant. You should tell your
doctor if you are planning to become
If you suffer from any of the following at any
pregnant or if you have problems becoming
time during your treatment, STOP TAKING the
pregnant.
medicine and seek immediate medical help:
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Driving and using machines
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This medicine can make you tired, drowsy
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,/!&665A+! ,Ĝ)!*("5,Ĝ!"-/"00"!,/
like coffee grounds.
confused. It may also cause problems with
your eyesight and balance. Talk to your
STOP TAKING the medicine and tell your
doctor if any of these happen to you and,
doctor if you experience:
if affected, do not drive or use any tools or
å +!&$"01&,+,/%"/1Ĝ/+B
machines.
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stomach symptoms.
Stirlescent 250 mg Effervescent Tablets
contain sodium
Warnings and precautions
Each Stirlescent 250 mg Effervescent Tablet
Take special care with Stirlescent 250 mg
contains 342 mg of sodium. To be taken
Effervescent Tablets
into consideration by patients on a sodium
If you have heart problems or have had a
controlled diet.
stroke, or if you think that you might be at risk
3 How to take Stirlescent 250 mg
of these conditions (because, for example,
Effervescent Tablets
you have high blood pressure, diabetes or
"!& &+"0 ,+1&+&+$+-/,4"+*5")&+("!
high cholesterol or are a smoker) you should
with a small increased risk of heart attack
discuss your treatment with your doctor or
or stroke. Any risk is more likely with higher
pharmacist.
doses and prolonged (longer term) treatment.
Do not exceed the recommended dose or
Check with your doctor or pharmacist before
length of your treatment. Check with your
taking this medicine if you have any of the
doctor if you are not sure.
following:
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Dissolve 1 to 2 tablets in a glass (150 ml) of
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water and drink, doses of 3 tablets should
tongue.
å #"")&+$,#3"(+"00³-"/%-0" Ĝ0",# be dissolved in 300 ml. To make sure there is
no medicine left, rinse the empty glass with
an illness) or you are elderly.
å Ĝ*-0&+5,Ĝ/+,0"³-,)5-0´A,/&#5,Ĝ0+""6" a small amount (10 ml) of water and drink it.
a lot or have a runny, blocked or itchy nose. ("3&1%,/#1"/#,,!B("0Ĝ/"1%15,Ĝ
have enough to drink and stay well hydrated
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when taking this medicine. This is particularly
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important for people who have problems
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with their kidneys. While you are taking this
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medicine, your doctor will want to see you to
and colitis or Crohn’s disease (conditions
check you are on the right dose for you and
causing inflammation of the bowel, bowel
look for any side effects. This is particularly
pain, diarrhoea, vomiting and weight loss).
important if you are elderly.
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The recommended dose for adults
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Muscle, joint or tendon pain and period pain
anywhere in your body.
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by a tablet every 6 to 8 hours as needed.
If any of the above apply to you, or if you are

Arthritis and ankylosing spondylitis
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å %"!,0"0%,Ĝ)!"0-)&1&+13,+!1("+
twice a day.
Gout
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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
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side effects, although not everybody gets
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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:
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coffee grounds.
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bloody diarrhoea.
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feeling or being sick.
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include severe stomach pain which
spreads to your back.
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disease, seen as pain, diarrhoea, vomiting
and weight loss.
Allergic reactions, signs include:
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hands or feet.
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chest.
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Severe skin rashes, signs include:
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with blisters or peeling of your skin and
possibly blisters in your mouth, throat or
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body may happen at the same time.
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sunlight, mostly seen on the arms, face
and hands.
Liver problems, signs include:
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 5,Ĝ/"5"0³'Ĝ+!& "´B
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or being sick and pale coloured stools
(hepatitis) and problems (including
hepatitis) shown in blood tests.
Heart attack, signs include:
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spread to your neck and shoulders and
down your left arm.
Stroke, signs include:
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may only be on one side of your body.
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hearing or vision, confusion.
Meningitis, signs include:
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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
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feeling sick or being sick, constipation,
!&//%,"A3&+!A!&#Ě Ĝ)1+!¸,/-&+#Ĝ)
swallowing, a feeling of something being
stuck in the throat.
Blood
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to the numbers of white blood cells.
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(hyperkalaemia).
Mental illness
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your patterns of dreaming.
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things that are not there (hallucinations).
Nervous system
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headed or sleepy.

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hands and feet.
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concentration.
Eyes and ears
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in the ears (tinnitus) and hearing loss.
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balance.
Heart and circulation
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may be with chest pains, tiredness or
shortness of breath (cardiac failure).
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(palpitations), slow heart beat or high
blood pressure.
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blood around the body or damage to
your blood vessels. Signs may include
tiredness, shortness of breath, feeling
faint, general pain.
Chest
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/"1%A3%""6&+$,/ ,Ĝ$%&+$B
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Skin and hair
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pimples and blisters on your body and face.
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more sensitive to the sun or hair loss.
Urinary
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problems.
Other
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å 0,/"*,Ĝ1%,/*,Ĝ1%Ĝ) "/0B
å Ĝ0 )"-&+,/3"(+"00B
å /,)"*0#,/3,*"+&+$"11&+$-/"$++1B
å ß501"*& )Ĝ-Ĝ0"/51%"*1,0Ĝ0à³´B
Signs include fever, rash, problems with
5,Ĝ/(&!+"50+!',&+1-&+B
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
·Ĝ)&+9
Tel:
+353 1 6764971
4C
¶:<:8=>=9<8>
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
Malta
ADR Reporting
"0&1"C333B*"!& &+"0Ĝ1%,/&15B$,2B*1¸
adrportal
United Kingdom
Yellow Card Scheme
"0&1"C333B*%/B$,2BĜ(¸5")),3 /!
5/"-,/1&+$0&!""##" 105,Ĝ +%")-
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.
,1))- (0&6"0*5"*/("1"!B
Marketing Authorisation Holder and
Manufacturer
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Hillington Park Innovation Centre, 1 Ainslie
,!A &))&+$1,+/(A
)0$,3
<9;A
+&1"!&+$!,*
This medicinal product is authorised in
the Member States of the EEA under the
following names:
Ireland Stirlescent 250 mg Effervescent Tablets
)1 1&/)"0 "+19<7*$##"/2"0 "+1)"10

1&/)"0 "+19<7*$##"/2"0 "+1)"10
This leaflet was last revised in 11/2015
XXXXX-XXXX

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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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