STREPSILS INTENSIVE honey and lemon spray 8.75mg/dose solution 15 ml
STREPSILS INTENSIVE HONEY AND LEMON throat spray 15 ml
Strepsils Intensive Spray 8.75 mg/dose spray for oral mucosa, solution
Flurbiprofen
For adults
Strepsils Intensive Spray 8.75 mg/dose oromucosal spray, solution
Flurbiprofen
For use in adults
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. You may need to read it again.
If you need further information or advice, ask your pharmacist.
If you get any side effects, tell your doctor or pharmacist. This also includes any possible side effects not described in this leaflet. See point 4.
If after 3 days you do not feel better or your condition worsens, you should seek medical attention.
What this leaflet contains
1. What Strepsils Intensive Spray is and what it is used for
2. What you should know before using Strepsils Intensive Spray
3. How to use Strepsils Intensive Spray
4. Possible side effects
5. How to store Strepsils Intensive Spray
6. Contents of the package and additional information
1. What Strepsils Intensive Spray is and what it is used for
The active substance of the product is flurbiprofen. Flurbiprofen belongs to a group of non-steroidal anti-inflammatory drugs (NSAIDs), which work by changing the body's response to pain, swelling and fever.
Strepsils Intensive Spray is used for the short-term relief of symptoms characteristic of a red and painful sore throat, such as throat irritation, pain, difficulty swallowing and swelling in adults aged 18 and over.
2. What you should know before using Strepsils Intensive Spray
Do not use Strepsils Intensive Spray if:
you are allergic (hypersensitive) to flurbiprofen, acetylsalicylic acid or other NSAIDs or to any of the other ingredients of Strepsils Intensive Spray specified in item 6
you have had allergic reactions in the past when taking acetylsalicylic acid or other NSAIDs such as asthma, difficulty breathing, rash, itching, runny nose, swelling
you have or have ever had two or more episodes of a stomach ulcer or bleeding, or a small bowel ulcer
you have had severe colitis (inflammation of the large intestine)
you have had problems with blood clotting or bleeding after taking NSAIDs
you are in the last trimester of pregnancy
you have severe liver, kidney or heart failure
Warnings and precautions
Inform your doctor or pharmacist before using Strepsils Intensive Spray if:
you are also taking other NSAIDs or acetylsalicylic acid;
if you have tonsillitis (inflamed tonsils) or if you think you have a bacterial infection (you may need antibiotic treatment);
you are elderly (as the risk of side effects may be higher);
you have asthma or suffer from allergies;
you have an autoimmune skin disease such as systemic lupus erythematosus or another mixed connective tissue disease;
you have suffered from a disease of the large intestine (ulcerative colitis or Crohn's disease);
you have kidney, heart or liver problems;
you have had a stroke;
are in the first or second trimester of pregnancy or are breastfeeding
While using Strepsils Intensive Spray:
stop using flurbiprofen spray at the first appearance of a skin reaction (rash, peeling and blistering of the skin) or any other symptom of allergy and consult a doctor immediately
report any unusual gastrointestinal symptoms (especially bleeding) to your doctor
if symptoms worsen or do not improve, or new symptoms appear, see a doctor
medicines such as Strepsils Intensive Spray may be associated with a slightly increased risk of heart attack, myocardial infarction or stroke. Any risk is more likely at high doses and with long-term treatment. Do not exceed the recommended doses and duration of treatment (see item 3)
Children
This medicine should not be used in children and adolescents under 18 years of age.
Other medicines and Strepsils Intensive Spray
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. In particular:
other NSAIDs, including selective cyclooxygenase-2 inhibitors
relieve pain or inflammation, as this may lead to an increased risk of bleeding from the stomach or intestines;
warfarin, aspirin (acetylsalicylic acid) and other medicines that thin the blood or prevent the formation of blood clots;
diuretics (facilitating fluid excretion), including potassium-sparing diuretics;
ACE inhibitors, angiotensin-H antagonists (medicines to treat high blood pressure);
SSRIs (selective serotonin reuptake inhibitors) to treat depression;
cardiac glycosides (medicines that stimulate the heart) such as digoxin;
cyclosporine (to prevent organ rejection after transplantation);
corticosteroids (to reduce infections);
lithium (medicine for depression);
methotrexate (medicine for psoriasis, arthritis and cancer);
mifeprieton (for termination of pregnancy) NSAIDs should not be taken until 8-12 days after administration of mifeprietone, as NSAIDs may reduce the effect of mifeprietone;
oral antidiabetic drugs;
phenytoin (to treat epilepsy);
probenecid and sulfinpyrazone (for gout and arthritis);
quinolone antibiotics (antibacterial medicines) such as ciprofloxacin, levofloxacin;
tacrolimus (medicines that suppress the immune system after organ transplantation);
zidovudine (medicine to treat AIDS).
Strepsils Intensive Spray with food, drinks and alcohol
Avoid drinking alcohol while using this medicine as it may increase the risk of stomach or intestinal bleeding.
Pregnancy, lactation and fertility
Do not take this medicine in the last 3 months of pregnancy
If you are pregnant in the first six months of pregnancy or breast-feeding, ask your doctor before taking this medicine
This medicinal product belongs to the group of medicinal products (NSAIDs) that may impair the ability to conceive in women. This effect is reversible after stopping the drug. Episodic use of this medicinal product is unlikely to affect the possibility of pregnancy; however, tell your doctor before taking the medicinal product if you have problems conceiving.
Ask your doctor or pharmacist before using any medicine.
Driving and using machines
In general, this medicine does not affect the ability to drive and use machines. However, when taking NSAIDs, the appearance of dizziness or blurred vision is sometimes possible. If these symptoms occur, do not drive or operate machinery.
Strepsils Intensive Spray contains methyl parahydroxybenzoate (B218) and propyl parahydroxybenzoate (E216).
Can cause allergic reactions (sometimes with late onset).
3. How to use Strepsils Intensive Spray
Always use this medicine exactly as described in this leaflet or as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Recommended dosage
In adults aged 18 and over:
One dose of 3 sprays is administered in the back of the throat every 3-6 hours as needed, but no more than 5 doses in 24 hours.
One dose (3 sprays) contains flurbiprofen 8.75 mg.
Do not use this medicine in children and adolescents under 18 years of age.
For use only on the mucous membrane of the mouth
Spray only at the back of the throat
Do not inhale during injection.
Do not take more than 5 doses (15 sprays) in 24 hours.
Strepsils Intensive Spray is for short-term use only
You should take the lowest dose for the shortest possible time needed to control symptoms. If throat irritation occurs, flurbiprofen should be discontinued.
Do not take this medicinal product for more than 3 days unless prescribed by a doctor. If your throat does not improve or symptoms worsen or new ones appear, consult a doctor or pharmacist.
Preparing the pump
When using the pump for the first time (or after storing for a long period of time) you must first activate the pump.
Point the tip away from you and spray a minimum of four times until a fine, steady mist forms. In this position, the pump is activated and ready for use. If the medication has not been used for an extended period of time, point the tip away from you and spray at least once to ensure that a fine, consistent mist is formed. Before each dosing of the medicinal product, you should always ensure that a fine, continuous mist is formed.
Using the spray
Aim the tip at the back of the throat.
In quick, smooth motions, push the pump three times, making sure the pump is pushed all the way down with each push, moving your finger away from the tip of the pump between pushes.
Do not inhale during the injection.
If you have used more than the required dose of Strepsils Intensive Spray
Consult your doctor or go to the nearest hospital immediately. Overdose symptoms may include: feeling sick and feeling sick, stomach pain or, less commonly, diarrhea. Tinnitus, headache, gastrointestinal bleeding are also possible.
If you have any further questions, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Strepsils Intensive Spray can cause side effects, although not everybody gets them.
STOP TAKING THIS MEDICINAL PRODUCT and seek medical attention immediately if:
severe forms of skin reactions such as bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (rare conditions due to severe adverse drug reactions or infection in which the skin and mucous membranes react severely). Frequency: Not known (frequency cannot be estimated from the available data).
signs of anaphylactic shock characterized by swelling of the face, tongue or throat leading to difficulty breathing, rapid heartbeat, low blood pressure leading to shock (this can happen even at the first dose of the drug). Frequency: Rare (affects up to 1 in 1,000 users).
signs of hypersensitivity and skin reactions such as redness, swelling, peeling, scaling, blistering or ulceration of the skin and mucous membranes. Frequency: Uncommon (affects up to 1 in 100 users).
signs of an allergic reaction such as: asthma, unexplained wheezing or shortness of breath, itching, runny nose or skin rash. Frequency: Uncommon (affects up to 1 in 100 users).
Tell your doctor if any of the following side effects occur or if you notice other effects not listed:
Common (affects up to 1 in 10 users):
headache, dizziness;
throat irritation;
mouth sores, pain or numbness in the mouth;
sore throat;
discomfort (a feeling of warmth or burning or tingling) in the mouth;
nausea or diarrhea;
tingling or itching of the skin.
Uncommon (affects up to 1 in 100 users):
drowsiness
blisters in the mouth and throat, sore throat;
bloating, abdominal pain, flatulence, constipation, indigestion, heartburn, nausea, vomiting;
dry mouth;
burning sensation in the mouth, altered taste fever, pain;
drowsiness or insomnia;
worsening of asthma, wheezing, shortness of breath;
decreased sensitivity in the throat.
Not known (frequency cannot be estimated from the available data)
anemia, thrombocytopenia (a low number of platelets in the blood, which can lead to a tendency to bruise or bleed easily);
swelling (edema), high blood pressure, heart failure or heart attack
hepatitis (inflammation of the liver)
Reporting adverse reactions
If you get any side effects, tell your doctor or pharmacist.
This includes all possible side effects not described in this leaflet. You can also report side effects directly through the national reporting system at:
Medicines Executive Agency (EMA)
8 Damyan Gruev St
1303, Sofia
R. Bulgaria
phone: +359 2 8903 417,
fax: +359 2 8903 434
e-mail: bda@bda.bg
wvvw.bda.bg/Form for reporting adverse drug reactions by non-medical persons.
By reporting side effects, you can contribute to getting more information about the safety of this medicine.
5. How to store Strepsils Intensive Spray
Keep out of the reach of children.
Do not use Strepsils Intensive Spray after the expiry date which is stated on the bottle and carton after EXP. The expiration date corresponds to the last day of the specified month. Do not refrigerate or freeze.
Do not use this medicine for more than 6 months after first opening. Medicines should not be disposed of down the drain or in the household waste container. Ask your pharmacist how to dispose of your unwanted medicines. These measures will help protect the environment.
6. Contents of the package and additional information
What Strepsils Intensive Spray contains
The active substance is: flurbiprofen. One dose (3 sprays) contains flurbiprofen 8.75 mg, corresponding to 16.2 mg/ml flurbiprofen.
The other ingredients are: betadex, disodium phosphate dodecahydrate, citric acid monohydrate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium hydroxide, mint flavor, cherry flavor, M,2,3-trimethyl-2-isopropylbutanamide, saccharin sodium. , hydroxypropylbetadex, purified water.
What Strepsils Intensive Spray looks like and what the package contains
Oral mucosal spray, solution, is a clear colorless to pale yellow solution with a honey and lemon flavor.
Strepsils Intensive Spray consists of a solution bottle and a mechanical spray pump.
Each bottle contains 15 ml of the solution, which provides approximately 83 sprays.
Marketing Authorization Holder:
Reckitt Benckiser (Romania) SRL, Romania
Manufacturers:
Reckitt Benckiser Healthcare international Ltd., UK
RB NL Brands BV, The Netherlands
