16.2 mg/ml oral spray, solution
flurbiprofen
What Strefen Honey & Lemon is and what it is used for
The active ingredient is flurbiprofen. Flurbiprofen belongs to a group of pain relievers called non-steroidal anti-inflammatory drugs ( NSAIDs ), which affect how the body responds to pain, swelling, and fever. Strefen Honey & Lemon is used for short-term symptom relief in sore throats, such as sore, painful and swollen throats and swallowing difficulties in adults aged 18 and over.
What you need to know before using Strefen Honey & Lemon
Do not use Strefen Honey & Lemon
– are allergic to flurbiprofen, other non-steroidal anti-inflammatory drugs ( NSAIDs ), acetylsalicylic acid, or any other ingredient in this medicine (see section 6).
– have previously had an allergic reaction after taking non-steroidal anti-inflammatory drugs ( NSAIDs ) or acetylsalicylic acid, e.g. asthma, wheezing, itching, runny nose, skin rash, or swelling
– have or have previously had stomach ulcers or bleeding or ulcers in the gastrointestinal tract on at least two occasions.
– has had severe colitis (intestinal inflammation).
– have ever suffered from blood clotting problems or bleeding problems after taking NSAIDs
– are in the last three months of pregnancy.
– have severe heart failure, severe kidney failure, or severe liver failure.
Warnings and precautions
Talk to your doctor or pharmacist before using Strefen Honey & Lemon if you:
• already using any other type of non-steroidal anti-inflammatory drugs ( NSAIDs ) or acetylsalicylic acid.
• have strep throat (inflamed tonsils) or suspect you have a bacterial throat infection (as you may need antibiotics ).
• are older (as you may be at greater risk of side effects ).
• have or have ever had asthma or allergies?
• Suffer from a skin disease called systemic lupus erythematosus or mixed connective tissue disease.
• have high blood pressure.
• have had any history of bowel disease ( ulcerative colitis, Crohn’s disease ).
• have heart, kidney, or liver problems.
• have had a stroke.
• are in the first 6 months of pregnancy or are breastfeeding.
When using Strefen Honey & Lemon
• At the first sign of any type of skin reaction (rash, peeling skin, blistering) or signs of an allergic reaction, stop using the spray immediately and consult a doctor.
• Inform the doctor of any abnormal abdominal symptoms (especially bleeding).
• If you do not get better, if you get worse or develop new symptoms, talk to a doctor.
• Medicines such as flurbiprofen may cause a small increase in the risk of suffering a heart attack or stroke. All risks increase with higher doses or long-term treatment. Do not exceed the recommended dose or duration of treatment (see section 3).
Children and young people
This medicine should not be used by children or adolescents under 18 years of age.
Other medicines and Strefen Honey & Lemon
Tell your doctor or pharmacist if you are using, have recently used, or may be thinking about using other medicines, including non-prescription ones. This applies in particular to the following medicines:
• other non-steroidal anti-inflammatory drugs ( NSAIDs ) including selective cyclooxygenase -2 inhibitors for pain or inflammation, as these drugs can increase the risk of bleeding in the gastrointestinal tract
• warfarin, acetylsalicylic acid, and other blood-thinning or coagulation-inhibiting medicines
• ACE inhibitors, angiotensin II antagonists (medicines that lower blood pressure, etc.)
• diuretics (fluid-reducing drugs) including potassium-sparing diuretics • SSRI drugs (selective serotonin reuptake inhibitors) for depression
• cardiac glycosides (for heart problems), for example, digoxin
• ciclosporin (which prevents rejection after an organ transplant)
• corticosteroids ( anti-inflammatory )
• lithium (mood stabilizer)
• methotrexate (for psoriasis, arthritis, or cancer)
• mifepristone (used to terminate a pregnancy) NSAIDs should not be used for 8-12 days after taking mifepristone, as they may make mifepristone less effective
• diabetes medicines are taken by mouth
• phenytoin (to treat epilepsy )
• probenecid, sulfinpyrazone (for gout and joint inflammation)
• quinolone antibiotics (against bacterial infections), for example, ciprofloxacin or levofloxacin
• tacrolimus (medicine that suppresses the immune system and is used after organ transplantation)
Strefen Honey & Lemon with alcohol
Avoid alcohol while using this medicine, as alcohol can increase the risk of bleeding in the gastrointestinal tract.
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.
Ingestion of Strefen should be avoided by women planning a pregnancy or who are pregnant.
Flurbiprofen belongs to a group of drugs ( NSAIDs ) that can make it harder to get pregnant. This effect ceases when the treatment is discontinued.
Driving ability and use of machinery
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. 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 your doctor or pharmacist if you are unsure.
This medicine should not affect your ability to drive or use machines. Dizziness and visual disturbances are, however, possible side effects of NSAID medicines. If you experience this type of side effect, do not drive or use machines.
Important information about some of the ingredients in Strefen Honey & Lemon:
Strefen Honey & Lemon contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216). May cause an allergic reaction (possibly delayed).
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is almost “sodium-free”.
This medicine contains fragrances with anisyl alcohol, citral, citronellol, d-limonene, geraniol, and linalool. It May cause allergic reactions.
How to use Strefen Honey & Lemon
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.
Recommended dose
Adults from the age of 18:
One dose (3 sprays) at the back of the throat at 3-6 hour intervals as needed, up to a maximum of 5 doses during 24 hours.
One dose (3 sprays) contains 8.75 mg flurbiprofen.
This medicine should not be used by children or adolescents under 18 years of age.
To be used in the mouth only
• Should only be sprayed at the back of the throat.
• Avoid breathing in when spraying
• Do not take more than 5 doses (total of 15 sprays) in 24 hours.
Strefen Honey & Lemon is intended for short-term use only.
Use as few doses as possible for as short a time to relieve symptoms. If irritation occurs in the mouth, treatment with flurbiprofen should be discontinued.
Do not use this medicine for more than 3 days unless prescribed by a doctor.
If you do not get better, if you get worse or if you develop new symptoms, talk to a doctor or pharmacist.
Prepare the pump
When using the pump for the first time, or after it has been stored without use for a long time, you must prepare the pump.
Point the nozzle away from you and spray at least four times until a fine, even mist is sprayed out. Now the pump is prepared and can be used. If you have not used the product for a long time, prime the pump by pointing the nozzle away and spraying at least once to check that a fine mist is being sprayed out. Always check that a fine mist is sprayed out before using the medicine.
Use the spray
Aim the nozzle at a point at the back of the throat.
Depress the pump three times in quick, even motions, being sure to fully depress the pump with each spray and to lift your finger from the pump between each spray.
Do not inhale when spraying.
If you have used too much Strefen Honey & Lemon
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.
The symptoms of overdose may be nausea or vomiting, stomach pain, or (more rarely) diarrhea. Ringing in the ears, headache, and bleeding in the gastrointestinal tract are also possible symptoms.
If you have any further questions about this medicine, ask your doctor or pharmacist.
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:
• any serious skin reaction, such as blistering (including Stevens-Johnson syndrome and toxic epidermal necrolysis, which are rare conditions with severe skin and mucosal reactions that Correct Error 5 are due to severe side effects caused by drugs or by infection ). Incidence: No known frequency (ie incidence cannot be estimated from available data).
• signs of anaphylactic shock, which causes, for example, swelling of the face, tongue, or throat with subsequent difficulty breathing, palpitations, and a drop in blood pressure leading to shock (note that this can happen even when the medicine is used for the first time). Occurrence: Rare (occurs in no more than 1 in 1,000 people).
• signs of hypersensitivity and skin reactions such as redness, swelling, scaly skin, blisters, peeling skin, or sores on the skin and mucous membranes. Incidence: Uncommon (occurs in up to 1 in 100 people).
• signs of an allergic reaction such as asthma, wheezing or shortness of breath for no reason, itching, runny nose, or skin rash. Incidence: Uncommon (occurs in up to 1 in 100 people).
Talk to your doctor or pharmacist if you notice any of the following side effects or any side effects not mentioned here:
Common (may affect up to 1 in 10 users)
• dizziness, headache
• throat irritation
• mouth sores, pain or numbness in the mouth
• sore throat
• discomfort in the mouth (warming or burning sensation or tingling)
• nausea or diarrhea
• tingling and itching sensation in the skin.
Uncommon (may affect up to 1 in 100 users)
• drowsiness
• blisters in the mouth or throat, numbness in the throat
• bloating, abdominal pain, gas, constipation, indigestion, vomiting
• dry mouth
• burning sensation in the mouth, altered sense of taste
• fever, pain
• feeling sleepy or having trouble falling asleep
• aggravated asthma, wheezing, shortness of breath
• reduced sensation in the throat.
Frequency not known (cannot be estimated from available data)
• anemia ( lack of blood ), thrombocytopenia (low levels of platelets that lead to bruising and bleeding)
• swelling ( edema ), high blood pressure, heart failure, or heart attack
• hepatitis ( inflammation of the liver).
How Strefen Honey & Lemon should be stored
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the bottle and the carton after EXP. The expiration date is the last day of the specified month.
Store protected from cold. Do not freeze.
An opened bottle may be used for a maximum of 6 months.
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
Contents declaration
– The active substance is flurbiprofen. One dose (3 sprays) contains 8.75 mg flurbiprofen, corresponding to 16.2 mg/ml flurbiprofen.
– Other ingredients are Betadex, disodium phosphate dodecahydrate, citric acid monohydrate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium hydroxide, honey flavor (contains flavors and propylene glycol (E1520)), lemon flavor (contains flavors and propylene glycol (E1520)) N, 2,3- trimethyl-2-isopropylbutanamide, saccharin sodium, hydroxypropylbetadex, and purified water.
Appearance and package sizes of the medicine
In the oral spray, the solution is clear, colorless to a slightly yellow solution with a honey and lemon flavor. The product consists of a white, opaque HDPE bottle with a multi-component pump and a polypropylene cap. Each bottle contains 15 ml of solution, which is enough for approximately 83 sprays.
Marketing Authorisation Holder
Reckitt Benckiser Healthcare (Scandinavia) A/S
Vandtårnsvej 83 A 2
860 Søborg Denmark
Manufacturer
RB NL Brands BV
Schiphol Boulevard 207,
1118 BH Schiphol,
Netherlands