Strefen spray 8,75 mg/dosis solucion para pulverizacion bucal sabor menta
Introduction
Leaflet: information for the user
Strefen spray 8.75 mg/dose oral solution for buccal spraypeppermint flavor
flurbiprofen
Read this leaflet carefully before you start using this medicine, because it contains important information for you.
Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or more information, consult your pharmacist.
- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.See section 4.
- You should consult a doctor if it worsens or does not improve after 3 days.
Contents of the pack and additional information.
1. What is Strefen mint-flavored spray and what is it used for
The active ingredient is flurbiprofen. Flurbiprofen belongs to a group of medications called nonsteroidal anti-inflammatory drugs (NSAIDs) that act by modifying the body's response to pain, inflammation, and fever.
Strefen spraymint-flavoredis used for the relief of symptoms of acute sore throat such as irritation, pain, difficulty swallowing, and inflammation in adults aged 18 years and older.
2. What you need to know before using Strefen spray
Do not use Strefen spray mint flavor:
- If you areallergic to flurbiprofen, to othernonsteroidal anti-inflammatory drugs (NSAIDs)(NSAIDs),to acetylsalicylic acidor to any of the other ingredients listed in section 6.
- If after takingnonsteroidal anti-inflammatory drugs (NSAIDs)(NSAIDs) oracetylsalicylic acidyou have had anallergic reaction; e.g., asthma, wheezing, itching, nasal discharge, skin rashes, swelling.
- If you have or have had two or more episodes ofstomach or intestinal ulcersorintestinal bleeding.
- If you have hadsevere colitis(intestinal inflammation).
- If you have hadblood clotting problemsorbleeding problems after taking NSAIDs.
- If you are in thelast trimester of pregnancy.
- If you havesevere heart, kidney, or liver failure.
- Children and adolescents under 18 years old.
Warnings and precautions.
Consult your doctor or pharmacist before starting to use Strefen spray mint flavor:
- If you are takinganother Nonsteroidal Anti-Inflammatory Drug (NSAID) oracetylsalicylic acid.
- If you havetonsillitis(inflammation of the tonsils) or think you may have abacterial throat infection(as you may need antibiotics).
- If you have an infection - see the section «Infections» below.
- If you are anelderly patient(as you are more likely to experience side effects).
- If you have or have hadasthmaorallergies.
- If you have a skin disease calledsystemic lupus erythematosus or mixed connective tissue disease.
- If you havehigh blood pressure(elevated blood pressure).
- If you have a history ofintestinal disease(ulcerative colitis, Crohn's disease).
- If you haveheart, kidney, or liver problems.
- If you have had astroke.
- If you are in thefirst 6 months of pregnancy or are breastfeeding.
Infections
Nonsteroidal anti-inflammatory drugs (NSAIDs) may mask signs of infections such as fever and pain. This may delay the start of appropriate treatment for the infection, leading to a higher risk of complications. If you take this medicine while you have an infection and your symptoms persist or worsen, consult your doctor or pharmacist without delay.
While using Strefen spray mint flavor
- At the first sign of a skin reaction (rash, exfoliation, blisters) or other signs of an allergic reaction, stop using this medicine and consult a doctor immediately.
- Inform your doctor of any unusual abdominal symptoms that may occur (especially bleeding).
- Consult your doctor if you do not improve, worsen, or if new symptoms appear.
- The use of medicines containing flurbiprofen may be associated with a small increase in the risk of having a heart attack or stroke. Any risk is more likely at high doses and with prolonged treatment.Do not exceed the recommended dose or treatment durationindicated in this leaflet (see section 3).
Children and adolescents
This medicine should not be used by children or adolescents under 18 years old.
Use of Strefen spray mint flavor with other medicines
Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take other medicines, including those obtained without a prescription. In particular, if you are taking:
- OtherNonsteroidal Anti-Inflammatory Drugs (NSAIDs)(NSAIDs), includingcyclooxygenase-2 inhibitorsfor pain or inflammation, as they may increase the risk of bleeding in the stomach or intestines
- Warfarin,acetylsalicylic acid, and other anticoagulant medicines
- ACE inhibitors, angiotensin II antagonists(medicines that lower blood pressure)
- Diuretics(includingpotassium-sparing diuretics)
- SSRIs(selective serotonin reuptake inhibitors), for depression treatment
- Cardiac glycosides(for heart problems) such as digoxin
- Ciclosporin(to prevent organ rejection after a transplant)
- Corticosteroids(to reduce inflammation)
- Lithium(for depression)
- Methotrexate(for psoriasis, arthritis, and cancer)
- Mifepristone(a medicine used for abortion): as NSAIDs may reduce the effect of mifepristone, they should not be used in the 8-12 days following mifepristone administration
- Oral antidiabetics.
- Phenytoin(for epilepsy treatment)
- Probenecid, sulfinpyrazone(for gout and arthritis)
- Quinolone antibiotics(for bacterial infections) such as ciprofloxacin, levofloxacin
- Tacrolimus(immunosuppressant used after organ transplant)
- Zidovudine(for HIV).
Strefen spray mint flavor with food, drinks, and alcohol
It is recommended to avoid drinking alcohol during treatment with this medicine, as it may increase the risk of bleeding in the stomach or intestines.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
- Do not take this medicine if you are in the last trimester of pregnancy.
- Avoid using this medicine if you are in the first trimester of pregnancy or are breastfeeding, unless your doctor tells you otherwise.
This product belongs to a group of medicines (NSAIDs) that may affect fertility in women. This effect is reversible when the medicine is stopped.
Driving and operating machinery
This medicine should not affect your ability to drive or operate machinery. However, if you experience side effects such as dizziness and/or visual disturbances, do not drive or operate machinery.
Strefen spray mint flavor contains parahydroxybenzoate (E218) and parahydroxybenzoate propyl (E216) soit may cause allergic reactions (possibly delayed).
This medicine contains less than 23 mg of sodium (1mmol) per dose; that is, it is essentially “sodium-free”.
This medicine contains fragrances with citral, d-limonene, eugenol, and linalol.
Citral, d-limonene, eugenol, and linalol may cause allergic reactions.
3. How to use Strefen spray peppermint flavor
Follow exactly the administration instructions of the medication contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.
The recommended dose is:
Adults 18 years and older:
Apply 3 pulses in the back of the throat every 3-6 hours as needed, up to a maximum of 5 applications (15 pulses) in 24 hours.
1 dose (3 pulses) contains 8.75 mg of flurbiprofen.
Do not use this medication in children or adolescents under 18 years old.
Only for oral spray use.
- Perform the spray only in the back of the throat.
- Do not inhale while performing the pulse.
- Do not apply more than 5 doses (15 pulses) every 24 hours.
Strefen mint spray is only for short-term use.
The effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor or pharmacist without delay if symptoms (such as fever and pain) persist or worsen (see section 2). If mouth irritation appears, discontinue flurbiprofen treatment.
Do not use this medication for more than 3 days, unless your doctor prescribes it.
If it does not improve, worsens, or new symptoms appear, consult your doctor or pharmacist.
Preparation (priming) of the pump
You must prime the pump before using it for the first time (or after storing it for a prolonged period).
Point the nozzle away from you and perform a minimum of 4 pulses until a fine and homogeneous spray appears. The pump is ready for use (primed).
If you have not used the medication for a prolonged period, point the nozzle away from you and perform a minimum of 1 spray, ensuring a fine and homogeneous spray appears.
Always ensure a fine and homogeneous spray appears before using the medication.
Performing the pulse
Place the bottle in a vertical position with the nozzle directed towards the back of the throat.
Correct Incorrect
Press the pump3 times, with a quick and smooth movement, ensuring you press it firmly each time. Remove your finger from the top of the pump between each pulse.
Do not inhale while performing the pulse.
If you forgot to take Strefen mint spray
Do not take a double dose to compensate for the missed doses.
If you use more Strefen mint spray than you should
In case of overdose or accidental ingestion, consult a doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.
The symptoms of overdose may be: nausea or vomiting, stomach pain, or, less frequently, diarrhea. You may also experience tinnitus, headache, and gastrointestinal bleeding.
If you have any other questions about the use of this medication, ask your doctor or pharmacist.
4. Possible Adverse Effects
Like all medicines, this medicine may cause side effects, although not everyone will experience them.
STOP TAKING this medicine and consult a doctor immediately if you notice:
- Severe forms of skin reactions such as blisters, including Stevens-Johnson syndrome and toxic epidermal necrolysis (rare medical conditions caused by severe adverse reactions to medications or infections that produce a severe skin and mucous membrane reaction). Frequency: Unknown (cannot be estimated from available data).
- Signs of anaphylactic shock characterized by swelling of the face, tongue, or throat that causes difficulty breathing, palpitations, a drop in blood pressure that causes shock (all effects can occur even when the medicine is used for the first time). Frequency: Rare (may affect up to 1 in 1,000 people).
- Signs of hypersensitivity and skin reactions such as redness, swelling, peeling, blisters, scaling, or ulceration of the skin and mucous membranes. Frequency: Infrequent (may affect up to 1 in 100 people).
- Signs of an allergic reaction such as asthma, unexplained wheezing, or shortness of breath, itching, nasal discharge, or skin eruptions. Frequency: Uncommon (may affect up to 1 in 100 people).
Inform your doctor or pharmacist if you observe any of the following effects or any effect not described in this leaflet:
Frequent(may affect up to 1 in 10 people)
- Dizziness, headache.
- Throat irritation.
- Mouth ulcers, mouth pain, or numbness.
- Throat pain.
- Discomfort in the mouth (sensation of heat or burning or tingling).
- Nausea and diarrhea.
- Sensation of itching and pruritus on the skin.
Infrequent(may affect up to 1 in 100 people)
- Numbness.
- Blisters in the mouth or throat, throat numbness.
- Abdominal distension, abdominal pain, gas, constipation, indigestion, vomiting.
- Dry mouth.
- Sensation of burning in the mouth, altered sense of taste.
- Fever, pain.
- Somnolence or difficulty falling asleep.
- Worsening of asthma, wheezing, shortness of breath.
- Reduced sensitivity in the throat.
Unknown frequency(cannot be estimated from available data)
- Anemia, thrombocytopenia (low platelet count in the blood that may cause bruising and bleeding).
- Swelling (edema), high blood pressure, heart failure, or heart attack.
- Hepatitis (inflammation of the liver).
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet.
You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use (www.notificaram.es). By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.
5. Conservation of Strefen spray peppermint flavor
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the bottle and on the box afterCAD. The expiration date is the last day of the month indicated.
Do not refrigerate or freeze.
Do not use this medication more than 6 months after its first use.
Composition of Strefen spray cherry and mint The active ingredient is flurbiprofen. A dose (3 sprays) contains 8.75 mg of flurbiprofen, equivalent to 16.2 mg/ml of flurbiprofen. The other components (excipients) are: betadex, disodium dodecahydrate phosphate, citric acid monohydrate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium hydroxide, peppermint flavor (contains d-limonene, eugenol, linalol, propylene glycol (E1520), and triacetin (E1518)), cherry flavor (contains citral, d-limonene, propylene glycol (E1520), and water), N,2,3-trimethyl-2-isopropyl butanamide, sodium saccharin, hydroxypropylbetadex, and purified water. Appearance of Strefen spray cherry and mint and contents of the container Strefen spray cherry and mint is a transparent, colorless, or slightly yellowish solution with a cherry and peppermint flavor. Strefen spray cherry and mint is presented in a white opaque plastic bottle with a mechanical pump spray and a polipropylene protective cap. Each container contains 15 ml of solution, which provides approximately 83 sprays. Holder of the marketing authorization and responsible for manufacturing Holder of the marketing authorization Reckitt Benckiser Healthcare, S.A. c/ Mataró, 28 08403 Granollers Spain RB NL Brands B. V. Schiphol Blvd 207, 1118 BH Schiphol, Netherlands This medicine is authorized in the member states of the European Economic Area with the following names United Kingdom Strefen Direct Cherry and Mint Flavour 8.75 mg Oromucosal Spray Italy Benactivdol Gola 8,75 mg/dose spray per mucosa orale Poland Strepsils Intensive Direct Germany Dobendan Direkt Flurbiprofen Spray 8,75 mg/dosis Spray zur Anwendung in der Mundhöhle, Lösung Czech Republic Strepfen sprej 8,75 mg orální sprej, roztok Slovakia Strepfen sprej 8,75 mg orálna roztoková aerodisperzia Austria Strepsils 8,75 mg /dosis Spray zur Anwendung in der Mundhöhle, Lösung Belgium Strepfen Spray Kers en Munt 8,75 mg/dose spray voor oromucosal gebruik, oplossing - Strepfen Spray Cerise et Menthe 8,75mg/dose, solution pour pulvérisation buccale Strepfen Spray Kirsche und Minze Spray zur 8,75 mg/dose Anwendung in der Mundhöhle, Lösung Luxembourg Strepfen spray 8,75 mg/dose solution pour pulvérisation buccale Netherlands Strepfen Munt & Kers suikervrij 8,75 mg keelspray Hungary Strepfen DIREKT 16,2 mg/ml szájnyálkahártyán alkalmazott oldatos spray Romania S trepsils Intensiv Cirese si Menta 8,75 mg/doza spray bucofaringian solutie Bulgaria Strepsils Intensive Spray 8,75 mg/ dose oromucosal spray, solution ( ????????? ???????? ????? 8,75 mg/ ???? ????? ?? ????? ???????? , ??????? ) Ireland Strepsils Intensive Ch erry & Mint 8.75 mg/dose Oromucosal Spray Spain Strefen spray 8,75 mg/dosis solución para pulverización bucal sabor menta Portugal Strepfen Spray 16,2 mg/ml solução para pulverização bucal Croatia Strepfen za odrasle 8,75 mg po dozi, sprej za usnu sluznicu, otopina Cyprus Strepfen Direct 8,75mg/δ?ση Στοματικ? Εκν?φωμα, Δ ι?λυμα Denmark Strefzap kirsebær og mint, mundhulespray, opløsning Estonia Strepsils Intensive Finland Strefen Kirsikka & Minttu 16,2 mg/ml sumute suuonteloon, liuos Greece Strepfen Direct 8,75 mg/d ose mouth spray solution Iceland Strefen Körsbär & Mint 16,2 mg/ml munnholsúði, lausn Latvia Strepsils Intensive 16,2 mg/ml aerosols izsmidzinašanai mutes dobuma, škidums Lithuania Strefen 16,2 mg/ml burnos gleivines purškalas (tripalas) Norway Stref en 8,75 mg/dose munnspray, oppløsning med peppermynte- og kirsebærsmak Slovenia Strepfen za odrasle 8,75 mg/odmerek oralno pršilo, raztopina Sweden Strefen Körsbär & Mint 16,2 mg/ml munhålespray, lösning Last review date of this leaflet: February 2024 The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es)
Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point
Responsible for manufacturing
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