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STREFEN SUGAR FREE ORANGE 8.75MG LOZENGE

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Strefen Sugar Free
PACKAGE LEAFLET: INFORMATION FOR THE USER

Strefen Sugar Free Orange 8.75mg lozenge
Flurbiprofen 8.75mg
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to take this medicine carefully to get the best results
from it.
• Keep this leaflet. You may need to read it again.
• Ask your doctor or pharmacist if you need more information or advice.
• You must contact a doctor if your symptoms worsen or do not improve after 3 days.
• If any side effects get serious, or if you notice any side effects not listed in this leaflet,
stop taking this medicine and tell your doctor or pharmacist.
In this Leaflet
1. What Strefen Sugar Free Orange Lozenges are and what they are used for
2. Before you take Strefen Sugar Free Orange Lozenges
3. How to take Strefen Sugar Free Orange Lozenges
4. Possible side effects
5. How to store Strefen Sugar Free Orange Lozenges
6. Further information
1. What Strefen Sugar Free lozenges are and what they
are used for:
Strefen Sugar Free Orange lozenges contain flurbiprofen. Flurbiprofen
belongs to a group of medicines called Non-Steroidal
Anti-Inflammatory Drugs (NSAIDs). These medicines work
by changing how the body responds to pain, swelling and high
temperature.Strefen Sugar Free Orange lozenges are used to
relieve the symptoms of sore throats such as throat soreness,
pain and swelling.
2. Before you take Strefen Sugar Free lozenges:
Do not take these lozenges:
• if you are allergic (hypersensitive) to flurbiprofen or to any
of the other ingredients (see Section 6: Further Information)
• if you are allergic (hypersensitive) to aspirin or to any other
NSAID medicine
• if you are taking aspirin at doses of above 75mg daily. If you
are on low-dose aspirin (up to 75mg daily) speak to your doctor
or pharmacist before you take Strefen Sugar Free Orange Lozenges
• if you have ever had wheezing, an irritated nose or itchy rash
(hives) after taking aspirin or any other NSAID medicine
• if you have or have ever had an ulcer or bleeding in the
stomach or intestines, or severe colitis
• if you have ever had blood problems including where your
blood did not clot properly
• if you are taking another NSAID medicine (including COX-2
inhibitors such as celecoxib)
• if you are in the last three months of pregnancy
• if you are under 12 years of age
Take special care with flurbiprofen: Speak to your doctor or
pharmacist before taking these lozenges:
• if you have ever had asthma
• if you have kidney or liver problems
• 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)
• if you have problems with the time your blood takes to clot
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription. In particular, tell them if you are taking:
• medicines for high blood pressure or heart failure
• water tablets (diuretics, including potassium sparing drugs)
• medicines for thinning the blood (anti-coagulants)
• medicines for gout
• another NSAID medicine or steroids (such as prednisolone)
• ciclosporin (a medicine used to suppress the immune system)
• phenytoin (a medicine for treating epilepsy)
• methotrexate (a medicine for treating cancer)
• lithium (a medicine for treating depression)
Pregnancy and breast-feeding
Strefen Sugar Free Orange lozenges belong to a group of medicines
which may impair fertility in women. This effect is reversible on
stopping the medicine. It is unlikely that Strefen Sugar Free Orange
Lozenges, used occasionally, will affect your chances of becoming
pregnant, however, tell your doctor before taking this medicine if
you have problems becoming pregnant.
Do not take this medicine if you are in the last 3 months of
pregnancy. If you are in the first 6 months of pregnancy or are
breast-feeding, speak to your doctor before taking these lozenges.
Ask your doctor or pharmacist for advice before taking any medicine
Driving and Using Machines
Strefen Sugar Free Orange lozenges should not affect your ability to

drive or use machines.
Important information about some of the ingredients of
Strefen Sugar Free Orange lozenges
Medicines such as Strefen Sugar Free Orange Lozenges 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 (3 days).
Strefen Sugar Free Orange lozenges contain sugars. Talk to your doctor
before taking this medicine if you have been told that you have an
intolerance to some sugars.
3. How to take Strefen Sugar Free lozenges:
Adults, the elderly and children over 12 years.
These lozenges are intended for short-term use only.
You should take as few lozenges as you need for the shortest
time necessary to relieve your symptoms. This will decrease
the chances of side effects. If you do not get better or you get
worse, or if new symptoms occur such as a bacterial infection,
talk to a doctor or pharmacist.
• Take 1 lozenge and suck slowly in the mouth.
• Then take 1 lozenge every three to six hours, if needed.
• Always move the lozenge around the mouth whilst sucking.
Do not take more than 5 lozenges in 24 hours.
Do not give these lozenges to children under 12 years.
The lozenges should start to work within 30 minutes.
• Do not take Strefen Sugar Orange Free lozenges for longer than 3
days, unless your doctor tells you to.
If you take more Strefen Sugar Free Orange lozenges than you
should, talk to your doctor or pharmacist or go to your nearest
hospital straight away.
Symptoms of overdose may include:
• Nausea
• Vomiting
• Stomach ache or more rarely diarrhoea
• Tinnitus
• Headache
• Gastrointestinal bleeding
If you have any further questions on the use of this product, ask
your doctor or pharmacist.
4. Possible side effects:
Like all medicines, flurbiprofen can cause side effects, although
not everybody gets them.
Allergic reactions
If you have any of the following, you may be having an allergic
reaction to this medicine:
• asthma, unexpected wheezing or shortness of breath (rare)
• swelling of the face, lips or tongue (very rare)
• skin reaction (including hives and itching) (very rare)
• fainting (very rare)
If you get any of these at any time, stop taking the medicine
and talk to your doctor straightaway.
Other side effects that may occur include:
Stomach and bowel problems such as;
• stomach ache (common)
• feeling sick (nausea), being sick (vomiting) (common)
• diarrhoea (common)
• indigestion, wind (flatulence) (uncommon)
Mouth problems such as;
• a warm or burning feeling or tingling in the mouth (common)
• mouth ulcers (common)
• dry mouth (common)
Problems with the nervous system such as;
• headache (uncommon)
• dizziness (uncommon)
• feeling very sleepy, or not being able to sleep (rare)
If you get any of these side effects, stop taking the medicine
and talk to your doctor or pharmacist.
Some other side effects have been reported when flurbiprofen
was used at a higher dose or for a longer time than Strefen
Sugar Free Orange lozenges. These include:
• severe allergic reactions and skin reactions (very rare)
• stomach bleeding, stomach ulcers, or inflammation and ulcers
in the mouth (rare)
• liver problems including jaundice (yellowing of the skin)
(very rare)
• kidney problems (changes in your urine, back pain and
swelling) (rare)
• a small increased risk of heart attack ("myocardial infarction")
or stroke (very rare)
• changes in the blood (which may cause bruising, fever, sore
throat, mouth ulcers or pale skin and weakness) (very rare).
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 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 your stomach) or other abnormal
stomach symptoms.
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.
5. How to store Strefen Sugar Free lozenges:
• Keep out of the reach and sight of children.
• Do not use this medicine after the expiry date, which is stated
on the pack.
• Store in the original carton.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6. Further information:
What Strefen Sugar Free Orange lozenges contain:
The active ingredient is flurbiprofen 8.75mg. The other
ingredients are: Orange flavour, Calcium carbonate, Povidone,
Colloidol Anhydrous Silica, Magnesium stearate, Isopropyl
alcohol, Maltitol liquid, Isomalt, Purified water.
What Strefen Sugar Free Orange lozenges look like and contents
of the pack:
The lozenges are circular in shape with an embossed brand logo
and an opaque white to off white colour.
The pack contains 16 or 24 lozenges. Not all pack sizes may
be marketed.
Marketing Authorisation Holder and Manufacturer
Reckitt Benckiser Healthcare (UK) Limited
103 – 105 Bath Road
Slough
SL1 3UH
This leaflet was last drafted in July 2010

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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