Strepsils Intensive 8,75 mg Spray

The active substance is flurbiprofen. Flurbiprofen belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), which work by changing how the body responds to pain, swelling and high temperature. Strepsils Intensive Spray is used for the short-term relief of symptoms of sore throats such as throat soreness, pain, difficulty swallowing and swelling.

Do not use Strepsils Intensive Spray if you:

• are allergic to flurbiprofen, other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), aspirin (acetylsalicylic acid), or to any of the ingredients listed in section 6.
• have had a previous allergic reaction after taking Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or aspirin (acetylsalicylic acid); e.g. asthma, wheezing, itching, runny nose, skin rashes, swelling
• currently have or have ever had two or more episodes of stomach ulcers or bleeding or intestinal ulcers.
• have ever had severe colitis (inflammation of the bowel).
• have ever had blood clotting problems or bleeding problems after taking NSAIDs
• are in the first, second or in the last three months of pregnancy
• have severe heart failure, severe kidney failure or severe liver failure.

Warnings and precautions

Take special care with Strepsils Intensive Spray if you:

• are already taking any other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or aspirin.
• have tonsillitis (inflamed tonsils) or think you may have a bacterial throat infection (as you may need antibiotics).
• are elderly (as you may be more likely to have side effects).
• have or have ever had asthma or suffer from allergies.

Do not share medicines prescribed for you with any other person. Always use Strepsils Intensive Spray exactly as described in this leaflet or as your doctor, or pharmacist, or nurse have told you. Check with your doctor or pharmacist or nurse if you are not sure.

Recommended dose

Adults aged 18 years and over: One dose of 3 sprays to the back of the throat every 3 - 6 hours as required, up to a maximum of 5 doses in a 24 hour period. One dose (3 sprays) contains 8.75 mg of Flurbiprofen. Do not use this medicine in children or adolescents under 18 years.

For throat use only

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

Strepsils Intensive Spray is for short-term use only. You should use as few doses as you need for the shortest time necessary to relieve your symptoms. If mouth irritation occurs, flurbiprofen treatment should be withdrawn. Do not use this medicine for more than 3 days. If you do not get better, you get worse, or if new symptoms occur, talk to a doctor or pharmacist.

Priming the pump

When using the pump for the first time (or after storage for a long period of time) you must first prime the pump. Point the nozzle away from you and spray a minimum of four times until a fine, consistent mist is produced. The pump is then primed and ready for use. If the product is not used for a period of time, point the nozzle away from you and spray a minimum of once ensuring a fine, consistent mist is produced. Always ensure a fine consistent mist is produced before dosing the product.

Using the spray

Aim the nozzle towards the back of the throat. Using a smooth rapid motion, depress the pump three times, taking care to fully depress the pump for each spray, whilst removing the finger from the top of the pump between each spray. Do not inhale whilst spraying.

If you use more Strepsils Intensive Spray than you should: Talk to a doctor or pharmacist or go to your nearest hospital or poison centre straight away. Symptoms of overdose may include: feeling sick or being sick, stomach ache or more rarely, diarrhoea. Ringing in the ears, headache and gastrointestinal bleeding is also possible. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. If you forget to use Strepsils Intensive Spray: Do not use double dose to make up for forgotten individual doses.

Strepsils Intensive Spray can have side effects. Not all side effects reported for Strepsils Intensive Spray are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking Strepsils Intensive Spray, please consult your health care provider for advice.

Stop taking this medicine and contact a doctor or go to the casualty department at your nearest hospital immediately if you develop:

• signs of an allergic reaction such as asthma, unexplained wheezing or shortness of breath, itching, runny nose, or skin rashes.
• swelling of the face, tongue or throat causing difficulty in breathing, racing heart, drop in blood pressure leading to shock (these can happen even on the first use of the medicine).
• signs of hypersensitivity and skin reactions such as redness, swelling, peeling, blistering, flaking or ulceration of skin and mucous membrane.
• DRESS syndrome: life-threatening reaction which may resemble a flu-like infection, other signs may include rash, facial swelling, abdominal pain and abnormal heartbeat.

These are all very serious effects. If you have them, you may have had a serious reaction to Strepsils Intensive Spray. You may need urgent medical attention or hospitalisation.

Tell your doctor or pharmacist if you notice any of the following effects or any effects not listed:

Common (may affect up to 1 in 10 people)

• dizziness, headache
• throat irritation
• mouth ulcers, pain or numbness in the mouth
• throat pain
• discomfort (warm or burning feeling or tingling) in the mouth
• nausea and diarrhoea
• prickling and itching sensation in skin

Uncommon (may affect up to 1 in 100 people)

• drowsiness
• blistering in the mouth or throat, numbness in the throat
• stomach bloating, abdominal pain, wind, constipation, indigestion, being sick
• dry mouth
• burning sensation in the mouth, altered sense of taste
• skin rashes, itchy skin
• fever, pain
• feeling sleepy or difficulty in falling asleep
• worsening of asthma, wheezing, shortness of breath
• reduced sensation in the throat

Rare (may affect up to 1 in 1000 people)

• anaphylactic reaction (face, tongue or throat swelling, shortness of breath, wheezing, dizziness and rash).

Not known (frequency cannot be estimated from the available data)

• anaemia (fatigue, shortness of breath), thrombocytopenia (low platelet count in the blood that can give rise to bruising and bleeding)
• swelling (oedema), high blood pressure, heart failure (shortness of breath, leg or ankle swelling, fatigue) or heart attack (chest pain, shortness of breath)
• severe forms of skin reaction such as bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (rare medical conditions due to severe adverse reactions to medication or infection where skin and mucous membrane react severely)
• hepatitis (inflammation of the liver)
• high blood pressure

Store all medicines out of reach of children. Store at or below 25 ºC. Do not refrigerate or freeze. Protect from light/moisture. Do not store in a bathroom. Do not use after the expiry date stated on the bottle and the carton. Do not use this medicine for more than 6 months after the first use. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).