Strefen Honey and Lemon

1. What Strefen Honey and Lemon is and what it is used for
2. Before you take Strefen Honey and Lemon
3. How to take Strefen Honey and Lemon
4. Possible side effects
5. How to store Strefen Honey and Lemon
6. Contents of the pack and other information

• are allergic (hypersensitive) to Flurbiprofen or to any of the other ingredients of this medicine (see section 6)
• currently have (or have had two or more episodes of) a stomach ulcer, intestinal ulcers, or gastrointestinal bleeding
• have ever had asthma, unexpected wheezing or shortness of breath, a runny nose, facial swelling or itchy rash (hives) after taking aspirin or any other NSAID medicine
• have had gastrointestinal bleeding or perforation, severe colitis (inflammation of the bowel) or bleeding disorders when taking NSAID medicines in the past
• are taking high dose aspirin (more than 75mg of aspirin per day) or another NSAID medicine (such as celecoxib, ibuprofen, diclofenac sodium etc)
• have severe heart failure, severe kidney failure or severe liver failure
• are in the last 3 months of pregnancy

Talk to your doctor or pharmacist before taking Strefen Honey and Lemon if you:

• have or have had asthma or suffer from allergies
• have tonsillitis (inflamed tonsils) or think you may have a bacterial throat infection (as you may need antibiotics)
• have heart, kidney or liver problems
• have an infection - please see heading “Infections” below
• have had a stroke
• have a history of bowel disease (such as ulcerative colitis, Crohn's disease)
• suffer from chronic autoimmune disease such as systemic lupus erythematosus and mixed connective tissue disease
• are elderly, as you are more likely to experience the side effects listed in this leaflet
• are in the first 6 months of pregnancy or breast-feeding

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine. In particular, tell them if you are taking:

• low dose aspirin (up to 75 mg daily)
• medicines for high blood pressure or heart failure (antihypertensives, cardiac glycosides)
• water tablets (diuretics, including potassium sparing drugs)
• medicines for thinning the blood (anticoagulants, antiplatelet agents)
• medicines for gout (probenecid, sulfinpyrazone)
• Other NSAID medicines or corticosteroids (such as celecoxib, ibuprofen, diclofenac sodium or prednisolone)
• mifepristone (a medicine used for pregnancy termination)
• quinolone antibiotics (such as ciprofloxacin)
• cyclosporine or tacrolimus (to suppress the immune system)
• phenytoin (to treat epilepsy)
• methotrexate (to treat autoimmune diseases or cancer)
• lithium or SSRIs (for depression)
• oral antidiabetics (to treat diabetes)
• zidovudine (to treat HIV)

Alcohol should be avoided during treatment with Strefen Honey and Lemon lozenges as it increases the risk of bleeding in the stomach or intestines.

• Liquid Glucose 1069mg and Liquid Sucrose 1407mg per lozenge. This should be taken into account in patients with diabetes mellitus. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
• This medicine contains only very low levels of gluten (from wheat starch), present in liquid glucose. It is regarded as ‘gluten-free’ and is very unlikely to cause problems if you have coeliac disease. One lozenge contains no more than 21.38 micrograms of gluten. If you have a wheat allergy (different from coeliac disease) you should not take this medicine.
• This medicine contains sulphites - Sulphur Dioxide (E220) (present in liquid glucose), which may rarely cause severe hypersensitivity reactions and bronchospasm.
• This medicine contains fragrance with Citral, Citronellol, d-Limonene, Farnesol, Geraniol and Linalool which may cause allergic reactions.
• This medicine contains Butylated Hydroxyanisole (E320) (present in lemon flavour (0-1%)). May cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.

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 these lozenges.

Flurbiprofen belongs to a group of medicines which may impair fertility in women. This effect is reversible on stopping the medicine. It is unlikely that the lozenges, used occasionally, will affect your chances of becoming pregnant; however, tell your doctor before taking this medicine if you have problems becoming pregnant.

Non-steroidal anti-inflammatory drugs (NSAIDs) may hide signs of infections such as fever and pain. This may delay appropriate treatment of infection, which may lead to an increased risk of complications. If you take this medicine while you have an infection and your symptoms of the infection persist or worsen, consult a doctor or pharmacist without delay.

No studies on the effects on the ability to drive and use of machines have been performed. However, dizziness and visual disturbances are possible side effects after taking NSAIDs. If affected, do not drive or operate machinery.

Take one lozenge by mouth and suck slowly. Always move the lozenge around whilst sucking. The lozenges should start to work within 30 minutes. Then take one lozenge every 3-6 hours, if needed.

Do not take more than 5 lozenges in a 24 hour period.

Do not give to children under 12 years.

These lozenges are for short-term use only. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor or pharmacist without delay if symptoms (such as fever and pain) persist or worsen (see section 2). If mouth irritation occurs, flurbiprofen treatment should be withdrawn.

Do not take for longer than 3 days unless your doctor tells you to. If symptoms persist or the pain worsens, or if any new symptoms occur, consult your doctor or pharmacist.

If you take more Strefen Honey and Lemon than you should, you may feel drowsy or nauseous. You should seek immediate medical advice in the event of an overdose, even if you feel well.

If you forget to take this product, do not 'double dose' to make up for a forgotten dose.

• signs of an allergic reaction such as asthma, unexplained wheezing or shortness of breath, itchiness, runny nose, skin rashes, etc.
• swelling of the face, tongue or throat causing difficulty in breathing, racing heart and drop in blood pressure leading to shock (these can happen even on the first use of the medicine).
• severe skin reactions such as peeling, blistering or flaking skin.

Common (may affect up to 1 in 10 people)

• dizziness, headache
• throat irritation
• mouth ulcers or pain in the mouth
• throat pain
• discomfort or unusual sensation in the mouth (such as warmth, burning, tingling, prickling, etc.)
• 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, vomiting
• 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

Frequency not known (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 reactions such as bullous reactions, including Stevens-Johnson syndrome and Lyell’s syndrome and toxic epidermal necrolysis
• hepatitis (inflammation of the liver)

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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

The active ingredient (the ingredient which makes the medicine work) is flurbiprofen 8.75 mg.

Also contains: Macrogol 300, Potassium hydroxide, Lemon flavour, Levomenthol, Liquid sucrose, Liquid glucose, Honey.

The Strefen Honey and Lemon lozenges are round, pale yellow to brown in colour with an icon embossed on both sides of the lozenge. They are available in packs of 2, 4, 6, 8, 10, 12, or 16 lozenges. Not all packs will be marketed.

Marketing Authorisation Holder:

Manufacturer:

Produce licence number: PL 00063/0714