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STREFEN DIRECT 8.75MG OROMUCOSAL SPRAY

Active substance(s): FLURBIPROFEN

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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.
2.
3.
4.
5.
6.

1

What Strefen Direct 8.75 mg Oromucosal Spray is and what it is used for
What you need to know before you use Strefen Direct 8.75 mg Oromucosal Spray
How to use Strefen Direct 8.75 mg Oromucosal Spray
Possible side effects
How to store Strefen Direct 8.75 mg Oromucosal Spray
Contents of the pack and other information

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:

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
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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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