Strepsils 8.75 mg/dose Spray for use in the oral cavity, solution

The active substance is flurbiprofen.

Application

What is Strepsils Spray and what is it used for?

The active ingredient is flurbiprofen. Flurbiprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These medicines work by affecting the body's response to pain, swelling and increased temperature.

Strepsils spray is used for the short-term relief of symptoms of sore throats, such as inflammation of the throat lining, pain, difficulty swallowing and swelling.

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How is it applied?

What is Strepsils Spray and what is it used for?

The active ingredient is flurbiprofen. Flurbiprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These medicines work by affecting the body's response to pain, swelling and increased temperature.

Strepsils spray is used for the short-term relief of symptoms of sore throat such as inflammation of the throat lining, pain, difficulty swallowing and swelling in adults aged 18 and over.

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What should you pay attention to before taking it?

What should you be aware of before using Strepsils Spray?

Strepsils Spray must not be used if you
- are allergic to flurbiprofen, other non-steroidal anti-inflammatory drugs (NSAIDs), acetylsalicylic acid or any of the other ingredients of this medicine listed in section 6. are allergic to flurbiprofen, other non-steroidal anti-inflammatory medicines (NSAIDs) or any of the other ingredients of this medicine mentioned in section 6.
- have previously had an allergic reaction after taking a non-steroidal anti-inflammatory medicine (NSAID) or acetylsalicylic acid, such as. Asthma, shortness of breath, itching, runny nose, skin rashes, swelling.
- Have or have had an ulcer or bleeding in the stomach/intestinal area (two or more occurrences).
- ever had severe colitis.
- ever suffered from blood clotting disorders or bleeding after taking NSAIDs.
- are in the last three months of your pregnancy.
- have a serious heart, kidney or liver condition.
Warnings and Precautions
Please talk to your doctor or pharmacist before using Strepsils Spray if you

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• already taking another non-steroidal anti-inflammatory drug (NSAID) or acetylsalicylic acid,
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• have inflamed tonsils (tonsillitis) or think they have a bacterial throat infection (because they may need antibiotics),
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• are older (as side effects are more likely to occur in you),
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• Have or ever had asthma or suffer from allergies,
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• Have skin diseases called systemic lupus erythematosus or mixed connective tissue disease,
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• Have high blood pressure,
• have a 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 breastfeeding,

During the application of Strepsils Spray.

• Stop using the spray at the first signs of skin reactions (rash, peeling of the skin, blistering) or other signs of an allergic reaction and consult a doctor immediately.
• Inform your doctor if you have any unusual symptoms in your abdomen (especially bleeding).
• Talk to a doctor if you do not feel better, if you get worse or if new symptoms occur.
• The use of medicines such as flurbiprofen may be associated with a
  slightly increased 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.

Use of Strepsils Spray with other medicines.
Inform your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.

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 may increase the risk of stomach or intestinal bleeding,
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• Warfarin, acetylsalicylic acid and other blood-thinning or anticoagulant medicines,
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• ACE inhibitors, angiotensin II antagonists (medicines that lower blood pressure),
• Diuretics (dehydration tablets) including potassium-saving diuretics,
• Selective serotonin reuptake inhibitors (SSRIs) (for the treatment of depression),
• Heart-acting glycosides such as digoxin (against heart disease),
• Ciclosporin (to prevent organ rejection after a transplant),
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• Corticosteroids (for anti-inflammation),
• Lithium (for mood disorders),
• Methotrexate (for the treatment of psoriasis, arthritis and cancer),
• Mifepristone (a medicine used to terminate pregnancy). NSAIDs should not be used for 8 - 12 days after taking mifepristone, as they can reduce the effect of mifepristone.
• Oral antidiabetics (for the treatment of diabetes),
• Phenytoin (for the treatment of epilepsy),
• Probenecid, sulfinpyrazone (against gout and arthritis),
• Chinolone antibiotics such as ciprofloxacin, levofloxacin (for bacterial infections),
• Tacrolimus (immunosuppressant after organ transplantation),
• Zidovudine (for the treatment of HIV).

Use of Strepsils Spray together with alcohol.
Avoid alcohol during treatment with Strepsils Spray as it may increase the risk of stomach or intestinal bleeding.

Pregnancy, lactation and reproductive capacity.

• Do not use this medicinal product if you are in the last 3 months of your
  pregnancy.
• If you are in the first 6 months of your pregnancy or breast-feeding, talk to your doctor before using this medicine.

Flurbiprofen belongs to a group of medicines that can affect women's fertility. This effect is reversible after discontinuation of the medicinal product. It is unlikely that the occasional use of this medicine will increase the possibility of,
becoming pregnant is influenced. However, talk to your doctor before using this medicine if you have problems getting pregnant.

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

Driving ability and ability to operate machinery.

This medicine should not affect your ability to drive or operate machinery. However, dizziness and visual disturbances are possible side effects after taking NSAIDs. Do not drive or operate machinery if you are affected.

Strepsils Spray contains methyl 4-hydroxybenzoate (E 218) and propyl 4-hydroxybenzoate (E 216)May cause hypersensitivity reactions, including delayed reactions.

How should the medicine be taken?

How to use Strepsils Spray?

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is
Adults 18 years and over
Spray a dose of 3 puffs into the back of the throat every 3-6 hours if needed. Use a maximum of 5 doses in a 24-hour period.

One dose (3 sprays) contains 8.75 mg flurbiprofen.

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

Only for use in the oral cavity

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• Spray only in the back of the throat.
• Do not inhale during spraying.
• Do not apply more than 5 doses (15 sprays) in 24 hours
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Strepsils spray is only intended for short-term use.
Apply as few doses as possible over as short a period as is necessary to relieve your symptoms. If irritation occurs in the mouth, the treatment with flurbiprofen should be discontinued.

Do not use this medicine for more than 3 days unless prescribed by your doctor.

If you do not feel better or even worse, or if new symptoms occur, talk to a doctor or pharmacist.

Preparing the spray pump.
When you use the spray pump for the first time (or after a longer period of storage), you must prepare it first.

Point the nozzle away from you and spray at least four times until a fine, even spray is produced. The spray pump is then prepared and ready for use. If the product is not used for a long time, point the nozzle away from you and spray at least once to be sure that a fine even spray is produced. Always ensure that a fine even spray mist is produced before dosing the spray.

Application of the spray.
Aim the spray nozzle at the back of the throat.


Press the spray pump down three times with a light quick movement. Be sure to press the pump all the way down for each spray and remove your finger from the top of the pump between sprays.

Do not inhale during spraying.

If you have used a larger amount of Strepsils Spray than you should.
Talk to your doctor or pharmacist or go to the nearest hospital immediately. Complaints of an overdose may include nausea, vomiting, stomach pain or, rarely, diarrhoea. Ringing in the ears, headaches and gastrointestinal bleeding are also possible.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

What are the possible side effects?

How to store Strepsils Spray?

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton and bottle after "EXP: or EXP". The expiry date refers to the last day of the month stated.

Do not store in the refrigerator or freeze

Do not use this medicine for more than 6 months after the first use

Do not dispose of medicines in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In doing so, they contribute to the protection of the environment.

Special instructions for storage

How to store Strepsils Spray?

Keep this medicine out of the reach of children.

Do not use this medicinal product after the expiry date which is stated on the carton and bottle after "EXP". The expiry date refers to the last day of the month stated.

Do not store in the refrigerator or freeze

Do not use this medicine for more than 6 months after the first use

Do not dispose of medicines in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In doing so, they contribute to the protection of the environment.

Special notes on the content

Contents of the pack and other information

What Strepsils Spray contains

- The active substance is: Flurbiprofen
-One dose (3 sprays) contains 8.75 ng of flurbiprofen, which is equivalent to 16.2 mg/ml of flurbiprofen.

- The other ingredients are: Betadex, sodium monohydrogen phosphate dodecahydrate, citric acid monohydrate, methyl 4-hydroxybenzoate (E 218), propyl 4-hydroxybenzoate (E 216), sodium hydroxide, mint flavour, cherry flavour, N,2,3-trimethyl-2-(propan-2-yl)butanamide, saccharin sodium, hydroxypropylbetadex, purified water

What Strepsils Spray looks like and contents of the pack

The spray is a clear, colourless to slightly yellowish solution with a cherry and mint flavour.

Strepsils 8.75 mg/dose spray is a solution packaged in a plastic bottle with a mechanical pump.

Each bottle contains 15 ml of solution, equivalent to approximately 83 withdrawable sprays.

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