STREPSILS 8.75 mg/dose Aerosol

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
   3. 1 What is Strepsils Intensive Direct and what is it used for
   4. 2 Important information before using Strepsils Intensive Direct
   5. When not to use Strepsils Intensive Direct:
   6. Warnings and precautions
   7. Before starting to use Strepsils Intensive Direct, discuss with your doctor or pharmacist:
   8. During the use of Strepsils Intensive Direct
   9. Children and adolescents
   10. Strepsils Intensive Direct and other medicines
   11. Strepsils Intensive Direct with food, drink, and alcohol
   12. Pregnancy and breastfeeding
   13. If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before using this medicine.
   14. Driving and using machines
   15. 3 How to use Strepsils Intensive Direct
   16. Recommended dose
   17. Do not use this medicine in children and adolescents under 18 years of age.
   18. For oral use only
   19. Preparing the pump
   20. Using the spray
   21. Missing a dose of Strepsils Intensive Direct
   22. Taking more than the recommended dose of Strepsils Intensive Direct
   23. 4 Possible side effects
   24. STOP USING THE MEDICINE AND CONTACT YOUR DOCTOR IMMEDIATELY IF YOU EXPERIENCE ANY OF THE FOLLOWING SYMPTOMS:
   25. IF YOU EXPERIENCE ANY OF THE FOLLOWING SYMPTOMS OR SIDE EFFECTS NOT LISTED IN THIS LEAFLET, TELL YOUR DOCTOR OR PHARMACIST:
   26. Reporting side effects
   27. 5 How to store Strepsils Intensive Direct
   28. 6 Contents of the pack and other information
   29. What Strepsils Intensive Direct contains
   30. What Strepsils Intensive Direct looks like and contents of the pack
   31. Marketing authorization holder and importer
   32. Marketing authorization holder
   33. Importer
   34. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   35. Date of last revision of the leaflet: 02/2024

Leaflet attached to the packaging: information for the user

Strepsils Intensive Direct, 8.75 mg/dose, oral spray, solution
(Flurbiprofen)

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, you should contact your doctor.

Table of contents of the leaflet

• 1. What is Strepsils Intensive Direct and what is it used for
• 2. Important information before using Strepsils Intensive Direct
• 3. How to use Strepsils Intensive Direct
• 4. Possible side effects
• 5. How to store Strepsils Intensive Direct
• 6. Contents of the pack and other information

1 What is Strepsils Intensive Direct and what is it used for

The active substance is flurbiprofen. Flurbiprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which work by changing the body's response to pain, swelling, and high temperature.
Strepsils Intensive Direct is used for the short-term relief of symptoms of throat inflammation, such as sore throat, difficulty swallowing, and swelling in adults from 18 years of age.

2 Important information before using Strepsils Intensive Direct

When not to use Strepsils Intensive Direct:

• if you are allergic to flurbiprofen, other non-steroidal anti-inflammatory drugs (NSAIDs), acetylsalicylic acid, or any of the ingredients (listed in section 6);
• ;
• if you have had an allergic reaction to non-steroidal anti-inflammatory drugs (NSAIDs)or acetylsalicylic acid in the past, such as asthma, wheezing, itching, rhinitis, skin rash, swelling;
• if you have or have had two or more episodes of stomach ulcers or bleedingor intestinal ulcers;
• if you have ever had severe colitis (inflammation of the large intestine);
• if you have ever had bleeding or clotting disorders after taking NSAIDs;
• if you are in the last trimester of pregnancy;
• if you have severe heart, kidney, or liver failure.
• children and adolescents under 18 years of age.

Warnings and precautions

Before starting to use Strepsils Intensive Direct, discuss with your doctor or pharmacist:

• if you are already taking any other non-steroidal anti-inflammatory drugs (NSAIDs) or acetylsalicylic acid;
• if you have tonsillitisor suspect you may have a bacterial throat infection(may require an antibiotic);
• if you have an infection - see "Infections" below.
• if you are elderly(may be more prone to side effects);
• if you have or have had asthmaor suffer from allergies;
• if you have a skin disease called systemic lupus erythematosusor mixed connective tissue disease;
• if you have high blood pressure;
• if you have had intestinal disease(ulcerative colitis, Crohn's disease);
• if you have heart, kidney, or liver disease;
• if you have had a stroke;
• if you are in the first or second trimester of pregnancyor breastfeeding.

Infections
Non-steroidal anti-inflammatory drugs (NSAIDs) may mask the symptoms of infection, such as fever and pain. This may delay the appropriate treatment of infections, which can lead to increased risk of complications. If you are taking this medicine while you have an infection and your symptoms persist or worsen, you should consult your doctor or pharmacist immediately.

During the use of Strepsils Intensive Direct

• At the first signs of any hypersensitivity reaction (rash, scaling, blisters) or other allergic reaction symptoms, stop using the spray and consult your doctor.
• Report any unusual abdominal symptoms (especially bleeding) to your doctor.
• If there is no improvement or new symptoms appear, consult your doctor.
• Medicines like flurbiprofen may slightly increase the risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with higher doses or longer treatment. Do not exceed the recommended dose or duration of treatment(see section 3).

Children and adolescents

This medicine must not be used in children and adolescents under 18 years of age.

Strepsils Intensive Direct and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or recently, and about any medicines you plan to take, including those obtained without a prescription. In particular

• other non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitorsfor pain or inflammation, as they may increase the risk of stomach or intestinal bleeding;
• warfarin, acetylsalicylic acid, and other blood-thinning or anticoagulant medicines;
• angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists(blood pressure-lowering medicines);
• diuretics(water tablets), including potassium-sparing diuretics;
• SSRIs (selective serotonin reuptake inhibitors)for depression;
• digitalis glycosides(for heart conditions) such as digoxin;
• cyclosporin(to prevent organ rejection after transplantation);
• corticosteroids(to reduce inflammation);
• lithium(for mood disorders);
• methotrexate(for psoriasis, arthritis, or cancer);
• mifepristone(used to terminate pregnancy): do not use NSAIDs during the 8-12 days after mifepristone administration, as they may reduce the effect of mifepristone;
• oral antidiabetic medicines;
• phenytoin(for epilepsy);
• probenecid, sulfinpyrazone(for gout or arthritis);
• quinolone antibiotics(for bacterial infections), such as ciprofloxacin, levofloxacin;
• tacrolimus(immunosuppressant used after organ transplantation);
• zydovudine(for HIV infection).

Strepsils Intensive Direct with food, drink, and alcohol

While using this medicine, you should avoid drinking alcohol, as it may increase the risk of stomach or intestinal bleeding.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before using this medicine.

• Do not use this medicine in the last trimester of pregnancy.
• Avoid using this medicine in the first 6 months of pregnancy or during breastfeeding, unless your doctor advises otherwise.

This medicine belongs to a group of medicines (NSAIDs) that may impair fertility in women. This effect is reversible after stopping the medicine.

Driving and using machines

This medicine is unlikely to affect your ability to drive or use machines. However, after taking NSAIDs, dizziness and visual disturbances may occur. In this case, do not drive or use machines.
Strepsils Intensive Direct contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), which may cause allergic reactions (possibly delayed).
This medicine contains less than 1 mmol sodium (23 mg) per dose, which is essentially "sodium-free".
The medicine contains a flavoring substance with citral, d-limonene, linalool, and eugenol.
Citral, d-limonene, linalool, and eugenol may cause allergic reactions.

3 How to use Strepsils Intensive Direct

This medicine should always be used exactly as advised by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

Recommended dose

Adults over 18 years:One dose (3 sprays of the spray) on the back of the throat every 3-6 hours, as needed. Do not take more than 5 doses in 24 hours.
One dose (3 sprays of the spray) contains 8.75 mg of flurbiprofen.

Do not use this medicine in children and adolescents under 18 years of age.

For oral use only

• Spray the spray only on the back of the throat.
• Do not inhale while spraying the spray.
• Do not take more than 5 doses (15 sprays of the spray) in 24 hours.

Strepsils Intensive Direct is for short-termuse only.
Use the smallest effective dose for the shortest duration necessary to relieve symptoms. If you have an infection, consult your doctor or pharmacist immediately if your symptoms (such as fever and pain) persist or worsen (see section 2). In case of oral mucosal irritation, discontinue use of flurbiprofen.
Do not use this medicine for more than 3 days, unless advised by your doctor.
If there is no improvement or you feel worse or new symptoms appear, consult your doctor or pharmacist.

Preparing the pump

Before first use (or after a long period of storage), prepare the pump for use.
Point the nozzle away from you and spray the spray at least four times, until a uniform, light mist is obtained. The pump is ready for use. If the product is not used for some time, point the nozzle away from you and spray the spray at least once to obtain a uniform, light mist.
Before administering the product, always make sure that a uniform, light mist is produced.

Using the spray

Point the nozzle towards the back of the throat.
Correctly Incorrectly
With a quick, smooth motion, press the pump three times, making sure to press the pump completely at each spray, removing your finger from the top of the pump between each spray.

Do not inhale while spraying the spray.

Missing a dose of Strepsils Intensive Direct

Do not take a double dose to make up for a missed dose.

Taking more than the recommended dose of Strepsils Intensive Direct

Consult your doctor or pharmacist or go to the nearest hospital. Symptoms of overdose may include: nausea or vomiting, stomach pain or less frequently diarrhea. There may be ringing in the ears, headache, and gastrointestinal bleeding.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4 Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

STOP USING THE MEDICINE AND CONTACT YOUR DOCTOR IMMEDIATELY IF YOU EXPERIENCE ANY OF THE FOLLOWING SYMPTOMS:

• severe forms of skin reactions, such as blistering reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (rare diseases due to severe adverse reactions to medicines or infections, in which there is a severe skin reaction and mucous membrane damage). Frequency not known (cannot be estimated from the available data);
• symptoms of anaphylactic shock: swelling of the face, tongue, or throat, causing difficulty breathing, palpitations, low blood pressure leading to shock (may occur even with the first use of the medicine). Rare (may affect up to 1 in 1000 people);
• symptoms of hypersensitivity and skin reactions, such as redness, swelling, scaling, blistering, or ulceration of the skin and mucous membranes. Uncommon (may affect up to 1 in 100 people);
• symptoms of allergic reactions, such as asthma, unexplained wheezing or shortness of breath, itching, rhinitis, or skin rash. Uncommon (may affect up to 1 in 100 people).

IF YOU EXPERIENCE ANY OF THE FOLLOWING SYMPTOMS OR SIDE EFFECTS NOT LISTED IN THIS LEAFLET, TELL YOUR DOCTOR OR PHARMACIST:

Common(may affect up to 1 in 10 people)

• dizziness, headache
• throat irritation
• mouth ulcers, pain, and numbness in the mouth
• sore throat
• discomfort (feeling of heat, burning, or tingling) in the mouth
• nausea and diarrhea
• tingling and itching of the skin

Uncommon(may affect up to 1 in 100 people)

• drowsiness
• blisters in the mouth or throat, feeling of numbness in the throat
• bloating, stomach pain, gas, constipation, indigestion, vomiting
• dry mouth
• burning sensation in the mouth, taste disturbances
• fever, pain
• drowsiness or difficulty sleeping
• worsening of asthma, wheezing, shortness of breath
• reduced sensation in the throat

Frequency not known(cannot be estimated from the available data)

• anemia, thrombocytopenia (low platelet count, which can cause bruising and bleeding)
• edema, high blood pressure, heart failure, or heart attack
• hepatitis

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5 How to store Strepsils Intensive Direct

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after EXP.
The expiry date refers to the last day of that month.
Do not store in the refrigerator or freeze.
Do not use this medicine for more than 6 months after first opening.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6 Contents of the pack and other information

What Strepsils Intensive Direct contains

The active substance is flurbiprofen. One dose (3 sprays of the spray) contains 8.75 mg of flurbiprofen, equivalent to 16.2 mg/ml of flurbiprofen.
Other ingredients: Betadex, disodium phosphate dodecahydrate, citric acid monohydrate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium hydroxide, peppermint flavor (containing flavoring substances, propylene glycol (E1520), and trioctanoylglycerin (Triacetyne) (E1518)), cherry flavor (containing flavoring substances, propylene glycol (E1520), and water), N,2,3-trimethyl-2-isopropylbutanamide, sodium saccharin, hydroxypropylbetadex, purified water.

What Strepsils Intensive Direct looks like and contents of the pack

The oral spray is a clear, colorless to slightly yellowish solution with a cherry and mint flavor.
Strepsils Intensive Direct consists of a white, opaque plastic bottle with a solution and a pump with a protective cap made of polypropylene
Each bottle contains 15 ml of oral spray solution, sufficient for approximately 83 sprays.

Marketing authorization holder and importer

Marketing authorization holder

Reckitt Benckiser (Poland) S.A.
ul. Okunin 1
05-100 Nowy Dwór Mazowiecki

Importer

RB NL Brands B.V.
WTC Schiphol Airport,
Schiphol Boulevard 207,
1118 BH Schiphol,
Netherlands

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: 02/2024