What Strefen Apelsin is and what it is used for
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. Strefen Apelsin lozenges are used for short-term symptom relief in sore throats, such as sore, painful, and swollen throats and difficulty swallowing in adults and children over 12 years of age.
The Flurbiprofen contained in Strefen Apelsin may also be approved to treat other conditions not mentioned in this product information. Ask a doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before taking Strefen Orange lozenges
Do not take Strefen Orange lozenges if you:
- are allergic (hypersensitive) to Flurbiprofen or any of the other ingredients in Strefen Apelsin (listed in section 6).
- ever had asthma, unexpected wheezing, shortness of breath, runny nose, facial swelling, or an itchy rash ( hives ) after taking aspirin or any other NSAID preparation.
- have or have ever had two or more episodes of stomach ulcers, ulcers in the intestines, 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.
- taking high doses of acetylsalicylic acid or other NSAID preparations (such as celecoxib, ibuprofen, diclofenac sodium, etc.).
- during the last three months of pregnancy.
- Have have ever had severe heart, kidney, or liver disease?
Warnings and precautions
- have had asthma or suffer from allergies
- have tonsillitis (flu) 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 had any history of bowel disease ( ulcerative colitis, Crohn’s disease )
- 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 in the first 6 months of pregnancy or are breastfeeding.
- Do not tolerate certain sugars.
- 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 Apelsin 8.75 mg 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, or high cholesterol, or smoke) you should discuss the treatment with your doctor or pharmacist.
Other medicines and Strefen Orange
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 (antihypertensives, cardiac glycosides)
- diuretics ( diuretics, including potassium-sparing drugs)
- medicines that thin the blood ( anticoagulants, antiplatelet agents)
- medicines for gout (probenecid, sulfinpyrazone)
- other NSAID preparations include selective cyclooxygenase -2 inhibitors or steroids (such as celecoxib, ibuprofen, diclofenac sodium, or prednisolone )
- mifepristone (a medicine used to terminate a pregnancy)
- quinolone antibiotics (such as ciprofloxacin )
- ciclosporin or tacrolimus (to suppress the immune system).
- phenytoin (to treat epilepsy )
- methotrexate (to treat autoimmune diseases or cancer)
- lithium or SSRIs (for depression)
- oral diabetes medications (to treat diabetes )
- zidovudine (to treat HIV ).
Strefen Orange 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 Apelsin 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 Orange lozenges contain isomalt and maltitol
May have a mild laxative effect.
Calorie value 2.3 kcal/g maltitol or isomalt.
If you have an intolerance to certain sugars, you should consult your doctor before taking these lozenges.
This medicine contains flavors with citral, citronellol, limonene, geraniol, and linalool. Citral, citronellol, limonene, geraniol, and linalool can cause allergic reactions.
How to take Strefen Orange 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 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 as it dissolves.
- The lozenges should start working within 30 minutes.
- Then take one 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 much Strefen Apelsin 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 have further questions about this medicine, contact your doctor or pharmacist.
If you have forgotten to take Strefen Apelsin 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:
- signs of allergic reactions such as asthma, unexpected wheezing, shortness of breath, itching, runny nose, or skin rash.
- 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).
- severe skin reaction 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 ( occurs in 1 in 10 users):
- headache, Dizziness
- throat irritation
- mouth sores or pain in the mouth
- sore throat
- discomfort or abnormal sensation in the mouth (warming sensation, burning sensation, tingling sensation, etc.)
- nausea, diarrhea
- tingling and itching sensation in the skin
Uncommon ( may affect up to 1 in 100 users)
- blisters in the mouth or throat, numbness in the throat
- abdominal distension, abdominal pain, gas, constipation, indigestion, vomiting
- dry mouth
- burning sensation in the mouth, taste changes
- skin rash, itchy skin
- fever, pain
- 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 estimated from available data)
- anemia, thrombocytopenia (low platelet count which can cause bruising and bleeding)
- swelling ( edema ), high blood pressure, heart failure, and 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 Apelsin 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 (E515), orange flavoring, levomenthol, acesulfame potassium (E950), liquid maltitol (E965), and isomalt (E953).
Appearance and package sizes of the medicine
The lozenges are round and embossed with the brand’s logo on both sides and are white to pale yellow.
The packages contain
8 lozenges (over-the-counter)
16 lozenges (over-the-counter)
24 lozenges (prescription)
Marketing Authorisation Holder
Reckitt Benckiser Healthcare (Scandinavia) A/S
Phone: 08-20 00 70
RB NL Brands BV
WTC Schiphol Airport,
Schiphol Boulevard 207,
1118 BH Schiphol,