What Strefen lozenges are and what they are used for
Strefen lozenges contain flurbiprofen. flurbiprofen belongs to a group of pain-relieving drugs called non-steroidal anti-inflammatory drugs ( NSAIDs ), which have analgesic, antipyretic and anti-inflammatory properties. These drugs work by changing the body’s response to pain, swelling, and fever.
The flurbiprofen found in Strefen may also be approved to treat other conditions not mentioned in this product information. Ask a doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before taking Strefen lozenges
Do not take these lozenges if you:
• have or have ever had two or more episodes of stomach ulcers, ulcers in the intestines, or bleeding in the gastrointestinal tract
• have had bleeding or holes in the stomach or intestines, severe colitis (inflammation of the colon), or blood disorders when you have previously taken an NSAID preparation.
• during the last three months of pregnancy.
• have or have ever had severe heart, kidney, or liver disease.
Warnings and precautions
• have ever had asthma or suffered from allergies
• have tonsillitis (strep throat) 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 chronic ( autoimmune ) disease where the body’s immune system attacks its own body, such as systemic lupus erythematosus and mixed connective tissue disease.
• are older, as the likelihood of you developing the side effects listed in this leaflet increases
• are you in the first 6 months of pregnancy or are breastfeeding
While using Strefen lozenges
• At the first sign of a skin reaction (rash, scaly skin, blisters) or other signs of an allergic reaction, stop taking the lozenge and contact a doctor immediately.
• Report any unusual symptoms (especially bleeding) to a doctor.
• If you do not improve, get worse or if new symptoms appear, contact a doctor.
• Medicines such as Strefen lozenges may be associated with a slightly increased risk of suffering a heart attack ( myocardial infarction ) or stroke. All risks increase with higher doses and long-term treatment. Do not exceed the recommended dose or duration of treatment (3 days).
Children should not use the medicine under 12 years of age.
If you have heart problems, have had a stroke, or think you may be at risk of these conditions (eg if you have high blood pressure, diabetes, high cholesterol, or smoke) you should discuss the treatment with your doctor or pharmacist.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, even those without a prescription. In particular, tell them if you are taking:
• low-dose aspirin (up to 75 mg a day)
• medicines for high blood pressure or heart failure (antihypertensive medicines, cardiac glycosides)
• diuretics ( diuretics, including potassium-sparing drugs)
• medicines that thin the blood ( anticoagulants, platelet inhibitors)
• mifepristone (a medicine used to terminate a pregnancy)
• quinolone antibiotics (such as ciprofloxacin )
• lithium or SSRI preparations (for depression)
Strefen lozenges with food and drink
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnant women should not use Strefen during the last three months of pregnancy.
If you are in the first 6 months of pregnancy or breastfeeding, talk to your doctor before taking these lozenges.
Ingestion of Strefen should be avoided by women planning a pregnancy or who are pregnant.
Driving ability and use of machinery
No studies on the effects on the ability to drive or use machines have been performed. Dizziness and visual disturbances are, however, possible side effects after taking NSAIDs. If you experience these symptoms, do not drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
Strefen lozenges contain glucose and sucrose
If you have an intolerance to certain sugars, you should consult your doctor before taking these lozenges.
This medicine contains only very low levels of gluten (from wheat starch) and is considered “gluten-free”. It is very unlikely that it will cause problems if you have gluten intolerance ( celiac disease ) 1 lozenge contains no more than 21.38 micrograms of gluten.
If you are allergic to wheat (a disease other than gluten intolerance) you should not use this medicine.
This medicine contains fragrances with citral, citronellol, d-limonene, farnesol, geraniol, and linalool.
Citral, citronellol, d-limonene, farnesol, geraniol, and linalool can cause allergic reactions.
Sulfur dioxide (E220) can in rare cases cause serious hypersensitivity reactions and spasms in the trachea.
Butylhydroxyanisole (E320) can cause local skin reactions (e.g. contact dermatitis) or be irritating to the eyes and mucous membranes
How to take Strefen lozenges
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
The recommended dose is for Adults and children from the age of 12:
• Take a lozenge in your mouth and let it dissolve slowly.
• Keep moving the lozenge around in your mouth while it dissolves.
• The lozenges should start working within 30 minutes.
• Then take a lozenge every 3-6 hours, if needed.
• Do not take more than 5 lozenges per day.
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 the symptoms.
If irritation occurs in the mouth, treatment with flurbiprofen should be discontinued.
If you have taken too many Strefen lozenges
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to take Strefen lozenges
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP TAKING this medicine and call your doctor immediately if you develop:
• swelling of the face, tongue, or throat leading to breathing difficulties, palpitations, and a drop in blood pressure leading to shock (These may occur when the medicine is first used).
• serious skin reactions such as scaly skin, blisters, or peeling skin.
Talk to your doctor or pharmacist if you notice any of the following other side effects or any side effects not mentioned:
Common (affects 1 in 10 users) :
• throat irritation
• mouth ulcers or pain in the mouth
• discomfort or abnormal sensation in the mouth (warming sensation, burning sensation, tingling sensation, etc.)
• nausea, diarrhea
• tingling and itching sensation in the skin
Uncommon (affects 1 in 100 users)
• blisters in the mouth or throat, numbness in the throat
• burning sensation in the mouth, changes in taste
• skin rash, itchy skin
• sleepiness or difficulty sleeping
• worsened asthma, wheezing, shortness of breath
• reduced feeling in the throat
Rare (occurs in 1 in 1,000 users)
• acute allergic reaction
Frequency not known ( cannot be calculated from available data)
• anemia, thrombocytopenia (low number of blood platelets which can cause bruising and bleeding)
• swelling ( edema ), high blood pressure, heart failure, heart attack.
• serious skin reactions, for example, bullous reactions, including Stevens-Johnson syndrome, Lyell’s syndrome, and toxic epidermal necrolysis.
• hepatitis (inflammation of the liver).
How Strefen lozenges should be stored
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the packaging after EXP. The expiration date is the last day of the specified month.
Store in the original packaging.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
- The active substance (which makes the medicine effective) is flurbiprofen 8.75 mg.
- Other ingredients are macrogol 300, potassium hydroxide (E525), lemon flavor (contains butyl hydroxyanisole (E320)), levomenthol, invert sugar (honey), and liquid glucose (contains wheat starch and sulfur dioxide (E220)), and liquid sucrose.
Appearance and package sizes of the medicine
The lozenges are round and embossed with the brand’s logo on both sides and are opaque from pale yellow to brown.
The packages contain
8 lozenges (over-the-counter)
16 lozenges (over-the-counter)
24 lozenges (prescription)
36 lozenges (prescription)
Marketing Authorisation Holder
Reckitt Benckiser Healthcare (Scandinavia) A/S
DK-2860 Søborg Denmark
Phone: 08-20 00 70
RB NL Brands BV
WTC Schiphol Airport,
Schiphol Boulevard 207,
1118 BH Schiphol,