Flurbiprofen 8.75 Mg Lozenges
Package Leaflet: Information for the User
Flurbiprofen 8.75 mg lozenges
Flurbiprofen 8.75 mg
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
• Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
• Keep this leaflet. Y ou may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to you doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel better or if you feel worse after 3 days.
What is in this leaflet
1 What Flurbiprofen 8.75 mg lozenges are and what they are used for
2 What you need to know before you take Flurbiprofen 8.75 mg lozenges
3 How to take Flurbiprofen 8.75 mg lozenges
4 Possible side effects
5 How to store Flurbiprofen 8.75 mg lozenges
6 Contents of the pack and other information
1 What Flurbiprofen 8.75 mg lozenges are and what they are used for
Flurbiprofen 8.75 mg lozenges contain flurbiprofen. Flurbiprofen is a non-steroidal anti-inflammatory drug (NSAID) which has analgesic, antipyretic and anti-inflammatory properties. Flurbiprofen 8.75 mg lozenges are used for the short-term relief of symptoms of sore throat such as throat pain, soreness and swelling, and difficulty in swallowing in adults and children over the age of 12 years
You must talk to a doctor if you do not feel better or if you feel worse after 3 days.
2 What you need to know before you use Flurbiprofen 8.75 mg lozenges Do not take these lozenges if you:
• are allergic (hypersensitive) to Flurbiprofen or to any of the or any of the other ingredients of of this medicine (listed in section 6)
• have ever had asthma, unexpected wheezing or shortness of breath, a runny nose, facial swelling or itchy rash (hives) after taking aspirin or any other NSAID medicine
• currently have or have ever had two or more episodes of a stomach ulcer, intestinal ulcers, or gastrointestinal bleeding
• have had gastrointestinal bleeding or perforation, severe colitis (inflammation of the bowel) or bleeding disorders when taking NSAID medicines in the past
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• are taking high dose aspirin or another NSAID medicine (such as celecoxib, ibuprofen, diclofenac sodium, etc.)
• are in the last 3 months of pregnancy
• have severe heart, severe kidney or severe liver failure
Warnings and precautions
Talk to your doctor or pharmacist before taking Flurbiprofen 8.75 mg lozenges if you:
• have ever had asthma or suffer from allergies
• have tonsillitis (inflamed tonsils) or think you may have a bacterial throat infection (as you may need antibiotics)
• have heart, kidney or liver problems
• have had a stroke
• have a history of bowel disease (ulcerative colitis, Crohn’s disease)
• suffer from chronic autoimmune disease such as systemic lupus erythematosus and mixed connective tissue disease
• are elderly, as you are more likely to experience the side effects listed in this leaflet
• are in the first 6 months of pregnancy or breastfeeding
Whilst using Flurbiprofen 8.75 mg lozenges
• At the first sign of any skin reaction (rash, peeling, blistering) or other sign of an allergic reaction, stop using the lozenge and consult a doctor at once.
• Report any unusual abdominal symptoms (especially bleeding) to your doctor.
• If you do not get better, you get worse, or develop new symptoms, talk to a doctor.
• Medicines such as Flurbiprofen 8.75 mg 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).
Children
This medicine should not be used by children under the age of 12 years.
Other medicines and Flurbiprofen 8.75 mg lozenges
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine. In particular, tell them if you are taking:
• low dose aspirin (up to 75 mg daily)
• medicines for high blood pressure or heart failure (antihypertensives, cardiac glycosides)
• water tablets (diuretics, including potassium sparing drugs)
• medicines for thinning the blood (anticoagulants, antiplatelet agents)
• medicines for gout (probenecid, sulfinpyrazone)
• Other NSAID medicines or corticosteroids (such as celecoxib, ibuprofen, diclofenac sodium or prednisolone)
• mifepristone (a medicine used for pregnancy termination)
• quinolone antibiotics (such as ciprofloxacin)
• cyclosporine or tacrolimus (to suppress the immune system)
• phenytoin (to treat epilepsy)
• methotrexate (to treat autoimmune diseases or cancer)
• lithium or SSRIs (for depression)
• oral antidiabetics (to treat diabetes)
• zidovudine (to treat HIV)
Taking Flurbiprofen 8.75 mg lozenges with food, drink and alcohol.
Alcohol should be avoided during treatment with Flurbiprofen 8.75 mg lozenges as it increases the risk of bleeding in the stomach or intestines.
Pregnancy, breast-feeding and fertility
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.
Flurbiprofen belongs to a group of medicines which may impair fertility in women. This effect is reversible on stopping the medicine. It is unlikely that the lozenges, used occasionally, will affect your chances of becoming pregnant; however, tell your doctor before taking this medicine if you have problems becoming pregnant.
Driving and using machines
No studies on the effects on the ability to drive and use of machines have been performed.However, dizziness and visual disturbances are possible side effects after taking NSAIDs. If affected, do not drive or operate machinery.
Important information about some of the ingredients of Flurbiprofen 8.75 mg lozenges
Flurbiprofen 8.75 mg lozenges contains Isomalt (E953) 2034mg/lozenge and Liquid Maltitol (E965)
508.5mg/lozenge
May have a mild laxative effect
Calorific value 2.3 kcal/g maltitol or isomalt
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3 How to take Flurbiprofen 8.75 mg lozenges
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose: Adults and children over the age of 12 years:
• Take one lozenge by mouth and suck slowly.
• Always move the lozenge around whilst sucking.
• The lozenges should start to work within 30 minutes.
• Then take one lozenge every 3-6 hours, if needed.
• Do not take more than 5 lozenges in 24 hours.
Do not use this product in children under 12 years.
These lozenges are for short-term use only. You should take as few lozenges as you need for the shortest time necessary to relieve your symptoms. If mouth irritation occurs, flurbiprofen treatment should be withdrawn.
Do not take Flurbiprofen 8.75 mg lozenges for more than 3 days unless your doctor tells you to. If
you do not get better, you get worse, or if you develop new symptoms, talk to a doctor or pharmacist.
If you take more Flurbiprofen 8.75 mg lozenges than you should
Talk to a doctor or pharmacist or go to your nearest hospital straight away. Symptoms of overdose may include: feeling sick or being sick, stomach ache or, more rarely, diarrhoea. Ringing in the ears, headache and gastrointestinal bleeding is also possible.
If you have any questions on the use of this product, ask your doctor or pharmacist.
If you forget to take Flurbiprofen 8.75 mg lozenges
If you forget to take this product, do not ‘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.
STOP TAKING this medicine and contact a doctor immediately if you develop:
• signs of an allergic reaction such as asthma, unexplained wheezing or shortness of breath, itchiness, runny nose, skin rashes, etc.
• swelling of the face, tongue or throat causing difficulty in breathing, racing heart and drop in blood pressure leading to shock (These can happen even on the first use of the medicine.)
• severe skin reactions such as peeling, blistering or flaking skin.
Tell your doctor or pharmacist if you notice any of the following effects or any effects not listed: Common (may affect up to 1 in 10people)
• dizziness, headache
• throat irritation
• mouth ulcers or pain in the mouth
• throat pain
• discomfort or unusual sensation in the mouth (such as warmth, burning, tingling, prickling, etc.)
• nausea and diarrhoea
• prickling and itching sensation in skin
Uncommon (may affect up to 1 in 100people)
• drowsiness
• blistering in the mouth or throat, numbness in the throat
• stomach bloating, abdominal pain, wind, constipation, indigestion, vomiting.
• dry mouth
• burning sensation in the mouth, altered sense of taste
• skin rashes, itchy skin
• fever, pain
• feeling sleepy or difficulty in falling asleep
• worsening of asthma, wheezing, shortness of breath
• reduced sensation in the throat
Rare (may affect up to 1 in 1000 people) • anaphylactic reaction
Frequency not known (cannot be estimated from the available data)
• anaemia, thrombocytopenia (low platelet count in the blood that can give rise to bruising and bleeding)
• swelling (oedema), high blood pressure, heart failure or attack
• severe forms of skin reactions such as bullous reactions, including Stevens-Johnson syndrome and Lyell’s syndrome and toxic epidermal necrolysis.
• hepatitis (inflammation of the liver)
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.
5 How to store Flurbiprofen 8.75 mg lozenges
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date refers to the last day of that month
• Store in the original carton.
Medicines should not be disposed off via wastewater or household waste. Ask your pharmacist how to dispose off medicines that are no longer required. These measures will help to protect the environment.
6 Further information
What Flurbiprofen 8.75 mg lozenges contain:
The active ingredient (the ingredient which makes the medicine work) is flurbiprofen 8.75 mg. The other ingredients are: macrogol 300, potassium hydroxide (E525), orange flavour, levomenthol, acesulfame potassium (E950), maltitol liquid (E965) and isomalt (E953).
What Flurbiprofen 8.75 mg lozenges look like and contents of the pack
The lozenges are circular in shape with an embossed brand logo and a white to pale yellow colour.
The pack contains 8, 16 or 24 lozenges. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Reckitt Benckiser Healthcare (UK) Limited
Manufacturer:
RECKITT BENCKISER HEALTHCARE INTERNATIONAL Ltd, Nottingham, NG90 2DB
This medicinal product is authorised in the Member States of the EEA under the following names:
|
United Kingdom |
Strepflam 8.75mg lozenges |
|
Austria |
Strepsils Orange Zuckerfrei |
|
Germany |
Dobendan Direkt Isomalt Flurbiprofen 8,75 mg Lutschtabletten |
|
Portugal |
Strepfen 8,75 mg Pastilhas |
|
Belgium |
Strepfen Suikervrij Sinaasappel 8,75 mg, zuigtablet |
|
Cyprus |
Strepfen Orange Sugar Free |
|
Denmark |
Strefen Appelsin 8,75 mg Sukkerfri, sugetabletter |
|
Estonia |
Strepsils Intensive Orange 8.75 Loseng (suhkruvaba) |
|
Greece |
Strepfen Orange Sugar Free |
|
Spain |
Strefen 8,75 mg pastillas para chupar sabor naranja |
|
Finland |
Strefen Appelsiini 8,75 mg Sokeriton, pastillit / Strefen Apelsin 8,75 mg Sockerfri, sugtabletter |
|
Iceland |
Strefen Appelsinu 8,75 mg Sykurlaust, munnsogstoflur |
|
Lithuania |
Strepsils Intensive Orange 8.75 Kietosios Pastiles (be cukraus) |
|
Luxembourg |
Strepfen Sans Sucre Orange 8,75 mg, patilles |
|
Netherlands |
Strepfen Sinaasappel Suikervrij 8,75 mg zuigtabletten |
|
Sweden |
Strefen Apelsin 8,75 mg sockerfri, sugtabletter |
|
Slovenia |
Strepfen brez sladkorja z okusom pomarance 8,75 mg pastile |
This leaflet was last approved in
June 2015
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