Strepsils intensive direct

Patient Information Leaflet

Strepsils Intensive Direct, 8.75 mg/dose, oral spray, solution
(Flurbiprofen)
Please read all of this leaflet carefully before you start using this medicine, as it contains
important information for you.
Always use this medicine exactly as described in this 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, please contact your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if you feel worse, you should consult your doctor.

Contents of the leaflet

1. What Strepsils Intensive Direct is and what it is used for
2. What you need to know before you use 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 Strepsils Intensive Direct is and what it is used for
The active substance is flurbiprofen. Flurbiprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which work by altering the body's response to pain, swelling, and fever.
Strepsils Intensive Direct is intended for short-term relief of symptoms of inflammatory sore throat, such as throat pain, difficulty swallowing, and swelling, in adults aged 18 years and over.

2 What you need to know before you use Strepsils Intensive Direct
Do not use Strepsils Intensive Direct:

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

Warnings and precautions
Before using Strepsils Intensive Direct, consult your doctor or pharmacist if:

• you are already taking any other non-steroidal anti-inflammatory drugs (NSAIDs) or acetylsalicylic acid;
• you have tonsillitis or suspect you may have a bacterial throat infection (which may require antibiotics);
• you have an infection – see subsection “Infections” below;
• you are elderly (you may be more susceptible to side effects);
• you have or have had asthma or suffer from allergies;
• you suffer from a skin disease called systemic lupus erythematosus or mixed connective tissue disease;
• you have been diagnosed with high blood pressure;
• you have or have had intestinal disease (ulcerative colitis, Crohn’s disease);
• you suffer from heart, kidney, or liver disease;
• you have had a stroke;
• you are in the first or second trimester of pregnancy or are breastfeeding.

Infections
Non-steroidal anti-inflammatory drugs (NSAIDs) may mask symptoms of infection, such as fever and pain. This may delay appropriate treatment of infections, potentially increasing the risk of complications. If you are using this medicine during an ongoing infection and your symptoms persist or worsen, you should consult your doctor or pharmacist immediately.

While using Strepsils Intensive Direct

• At the first sign of any hypersensitivity reaction (rash, peeling, blisters) or other allergic symptoms, stop using the spray immediately and consult your doctor.
• Report any unusual gastrointestinal symptoms (especially bleeding) to your doctor.
• If there is no improvement or new symptoms appear, consult your doctor.
• Medicines such as flurbiprofen may slightly increase the risk of heart attack (myocardial infarction) or stroke. The risk is greater with higher doses or prolonged use. 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 currently taking, have recently taken, or plan to take, including those available without a prescription. In particular:

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

Strepsils Intensive Direct with food, drink, and alcohol
Avoid alcohol while using this medicine, as it may increase the risk of gastrointestinal bleeding.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby,
consult your doctor or pharmacist before using this medicine.

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

This medicine belongs to a group of drugs (NSAIDs) that may impair fertility in women. This effect is reversible upon discontinuation of the medicine.

Driving and using machines
This medicine is unlikely to affect your ability to drive or operate machinery. However, dizziness and visual disturbances may occur after taking NSAIDs. If this happens, do not drive or operate machinery.

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, meaning it is essentially "sodium-free".
The medicine contains flavouring substances: citral, d-limonene, linalool, and eugenol.
Citral, d-limonene, linalool, and eugenol may cause allergic reactions.

3 How to use Strepsils Intensive Direct
Always use this medicine exactly as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

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

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

• Spray only onto the back of the throat.
• Do not inhale during spraying.
• Do not exceed 5 doses (15 sprays) in 24 hours.

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

Priming the pump
Before first use (or after prolonged storage), prime the pump for use.
Point the nozzle away from you and spray at least four times until a fine, even mist is produced. The pump is now ready for use. If the product has not been used for some time, point the nozzle away and spray at least once to produce a fine, even mist. Always ensure a fine, even mist is produced before each use.

Using the spray
Direct the nozzle towards the back of the throat.
Correct Incorrect

Press the pump three times quickly and smoothly, ensuring the pump is fully depressed with each spray, and removing your finger from the top of the pump between each spray.

Do not inhale while spraying.

Missed dose
Do not use a double dose to make up for a missed dose.

Overdose
Contact your doctor, pharmacist, or go to the nearest hospital immediately. Symptoms of overdose may include nausea or vomiting, stomach pain, or less commonly diarrhoea. Tinnitus, headache, and gastrointestinal bleeding may also occur.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

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

STOP TAKING THE MEDICINE and contact your doctor immediately if you experience any of the following:

• severe skin reactions, e.g. blistering reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (rare conditions due to severe adverse drug reactions or infections, involving severe skin and mucous membrane reactions). Frequency unknown (cannot be estimated from available data);
• symptoms of anaphylactic shock: swelling of the face, tongue, or throat causing breathing difficulties, palpitations, low blood pressure leading to shock (may occur even with first use of the medicine). Rare (may occur in 1 in 1,000 people);
• hypersensitivity and skin reactions such as redness, swelling, peeling, blistering, or ulceration of the skin and mucous membranes. Uncommon (may occur in 1 in 100 people);
• symptoms of allergic reactions, e.g. asthma, unexplained wheezing or shortness of breath, itching, rhinitis, or skin rash. Uncommon (may occur in 1 in 100 people).

If you experience any of the following symptoms or any side effects not listed in this leaflet, consult your doctor or pharmacist:

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• drowsiness
• blisters in the mouth or throat, numbness in the throat
• abdominal bloating, stomach pain, flatulence, 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 unknown (cannot be estimated from available data)

• anaemia, thrombocytopenia (low platelet count, which may cause bruising and bleeding)
• swelling, high blood pressure, heart failure, or heart attack
• hepatitis (liver inflammation)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can also be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +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 authorisation holder.
Reporting side effects helps 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 the stated month.
Do not store in a refrigerator or freeze.
Do not use this medicine more than 6 months after first use.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. These measures 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) contains 8.75 mg flurbiprofen, equivalent to 16.2 mg/ml flurbiprofen.
Other ingredients: Betadex, disodium phosphate dodecahydrate, citric acid monohydrate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium hydroxide, mint flavour (containing flavouring substances, propylene glycol (E1520), and glyceryl triacetate (Triacetin) (E1518)), cherry flavour (containing flavouring 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, colourless to slightly yellow solution with a cherry and mint flavour.
Strepsils Intensive Direct consists of an opaque white plastic bottle containing the solution with a pump and a protective polypropylene cap.
Each bottle contains 15 ml of oral spray solution, sufficient for approximately 83 sprays.

Marketing Authorisation Holder and Importer
Marketing Authorisation 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 authorised for sale in the European Economic Area under the following names: