Package Leaflet: Information for the User

Strefen Direct 8.75 mg Oromucosal Spray

Flurbiprofen For use in adults.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What is in this leaflet

1.    What Strefen Direct 8.75 mg Oromucosal Spray is and what it is used for

2.    What you need to know before you use Strefen Direct 8.75 mg Oromucosal Spray

3.    How to use Strefen Direct 8.75 mg Oromucosal Spray

4.    Possible side effects

5.    How to store Strefen Direct 8.75 mg Oromucosal Spray

6.    Contents of the pack and other information

1    WHAT STREFEN DIRECT 8.75 MG OROMUCOSAL SPRAY IS AND WHAT IT IS USED FOR

The active substance is flurbiprofen. Flurbiprofen belongs to a group of medicines called NonSteroidal Anti-Inflammatory Drugs (NSAIDs), which work by changing how the body responds to pain, swelling and high temperature.

Strefen Direct is used for the short term relief of symptoms of sore throats such as throat soreness, pain, difficulty swallowing and swelling.

2    WHAT YOU NEED TO KNOW BEFORE YOU USE STREFEN DIRECT 8.75 MG OROMUCOSAL SPRAY

Do not use Strefen Direct 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 last three months of pregnancy.

•    have severe heart failure, severe kidney failure or severe liver failure.

Warnings and precautions

Talk to your doctor or pharmacist before using Strefen Direct 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.

•    suffer from a skin condition called systemic lupus erythematosus or mixed connective tissue disease.

•    have hypertension (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.

Whilst using Strefen Direct

•    At the first sign of any skin reaction (rash, peeling, blistering) or other sign of an allergic reaction, stop using the spray and consult a doctor at once.

•    Report any unusual abdominal symptoms (especially bleeding) to your doctor.

•    If you do not get better, you get worse, or develop new symptoms, talk to a doctor.

•    Medicines such as Flurbiprofen may be associated with a small increased risk of heart attack or stroke. Any risk is more likely with higher doses or prolonged treatment. Do not exceed the recommended dose or duration of treatment (See Section 3).

Children

This medicine should not be used by children or adolescents under the age of 18 years.

Other medicines and Strefen Direct

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. In particular,

•    other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) including cyclooxygenase-2 selective inhibitors for pain or inflammation, as these may increase the risk of bleeding from the stomach or intestines

•    warfarin, aspirin (acetylsalicylic acid) and other blood thinning or anti-clotting medicines

•    ACE inhibitors, angiotensin-II-antagonists (medicines which lower blood pressure)

•    diuretics (water tablets) including potassium sparing diuretics

•    SSRIs (selective serotonin re-uptake inhibitors) for depression

•    cardiac glycosides (for heart problems) such as digoxin

•    cyclosporine (to prevent organ rejection after transplant)

•    corticosteroids (to reduce inflammation)

•    lithium (for mood disorders)

•    methotrexate ( for psoriasis, arthritis and cancer)

•    mifepristone (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 antidiabetic medicines

•    phenytoin (for epilepsy)

•    probenecid, sulfinpyrazone (for gout and arthritis)

•    quinolone antibiotics (for bacterial infections) such as ciprofloxacin, levofloxacin

•    tacrolimus (immunosuppressant used after organ transplant)

•    zidovudine (for HIV).

Taking Strefen Direct with food, drink and alcohol

Avoid alcohol whilst using this medicine, as it may increase the risk of bleeding in the stomach or intestines.

Pregnancy, breast-feeding and fertility

•    Do not take this medicine if you are in the last 3 months of pregnancy.

•    If you are in the first 6 months of pregnancy or are breast-feeding, speak to your doctor before taking this medicine.

Flurbiprofen belongs to a group of medicines which may impair fertility in women. This effect is reversible when the medicine is stopped being taken. It is unlikely that the occasional use of this medicine will affect your chances of becoming pregnant; however, tell your doctor before taking this medicine if you have problems becoming pregnant.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

This medicine should not affect your ability to drive or use machines. However, dizziness and visual disturbances are possible side effects after taking NSAIDs. If affected, do not drive or operate machinery.

Strefen Direct contains Methyl parahydroxybenzoate (E218) and Propyl parahydroxybenzoate (E216)

May cause allergic reactions (possibly delayed).

3 HOW TO USE STREFEN DIRECT 8.75 MG/DOSE OROMUCOSAL SPRAY, SOLUTION

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist 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 oromucosal 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.

Strefen Direct 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 unless instructed to do so by your doctor.

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 Strefen Direct than you should

Talk to a doctor or pharmacist or go to your nearest hospital 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.

4 POSSIBLE SIDE EFFECTS

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

STOP TAKING this medicine and contact a doctor 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.

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

•    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 100people)

•    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

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

•    anaemia, thrombocytopenia (low platelet count in the blood that can give rise to bruising and bleeding)

•    swelling (oedema), high blood pressure, heart failure or attack

•    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)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5 HOW TO STORE STREFEN DIRECT 8.75 MG/DOSE OROMUCOSAL SPRAY, SOLUTION

Keep this medicine out of the sight and reach of children.

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

Do not refrigerate or freeze.

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

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6 CONTENTS OF THE PACK AND OTHER INFORMATION

What Strefen Direct contains:

The active substance is flurbiprofen. One dose (3 sprays) contains 8.75 mg. flurbiprofen, 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 flavour, Cherry flavour, N, 2,3-Trimethyl-2-isopropylbutanamide, Saccharin sodium, Hydroxypropylbetadex and Purified water.

What Strefen Direct looks like and contents of the pack

The oromucosal spray, solution is clear colourless to slightly yellow solution with a taste of cherry and mint.

Pack size: 15 ml oromucosal spray, solution.

Marketing Authorisation Holder

Reckitt Benckiser Healthcare (UK) Limited 103 - 105 Bath Road Slough SL1 3UH

Manufacturer

RECKITT BENCKISER HEALTHCARE INTERNATIONAL Ltd,

Nottingham, NG90 2DB

This leaflet was last revised in 09/2014