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STREFEN HONEY AND LEMON

Active substance(s): FLURBIPROFEN

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Strefen Honey and Lemon

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient flurbiprofen 8.75mg
For excipients, see 6.1.

3

PHARMACEUTICAL FORM
Lozenge
A round, pale yellow to brown lozenge with an icon intagliated on both sides of the
lozenge.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Strefen Honey and Lemon are indicated for the symptomatic relief of sore throat.

4.2

Posology and method of administration
Adults the elderly and children over the age of 12 years:
One lozenge sucked/dissolved slowly in the mouth every 3 - 6 hours as required.
Maximum 5 lozenges in a 24 hour period.
The lowest effective dose should be used for the shortest duration necessary to relieve
symptoms. The patient should consult a doctor if symptoms persist or worsen, or if
the product is required for more than 3 days.
It is recommended that this product should be used for a maximum of three days
As with all lozenges, to avoid local irritation, Strefen Honey and Lemon should be
moved around the mouth whilst sucking.

4.3

Contraindications
Hypersensitivity to flurbiprofen or any of the excipients in the product.

Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis,
angioedema, or urticaria) in response to aspirin or other non-steroidal antiinflammatory drugs.
Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct
episodes of proven ulceration or bleeding).
History of gastrointestinal bleeding or perforation, related to previous NSAIDS
therapy.
Severe heart failure, renal failure or hepatic failure (see section 4.4)
Last trimester of pregnancy.

4.4

Special warnings and precautions for use
Undesirable effects may be minimised by using the lowest effective dose for the
shortest possible duration necessary to control symptoms (see GI and cardiovascular
risks below).
The elderly have an increased frequency of adverse reactions to NSAIDs, especially
gastrointestinal bleeding and perforation, which may be fatal.

Respiratory: Bronchospasm may be precipitated in patients suffering from, or
with a history of, bronchial asthma or allergic disease.
Other NSAIDs: The use of Strefen Honey and Lemon with concomitant NSAIDS
including cyclooxygenase-2 selective inhibitors should be avoided (see section 4.5).
SLE and mixed connective tissue disease: Systemic lupus erythematosus and mixed
connective tissue disease – increased risk of aseptic meningitis (see Section 4.8)
Renal: Renal impairment as renal function may further deteriorate (see sections 4.3
and 4.8)
Hepatic: Hepatic dysfunction (see sections 4.3 and 4.8)
Cardiovascular and cerebrovascular effects:
Caution (discussion with doctor or pharmacist) is required prior to starting treatment
in patients with a history of hypertension and/or heart failure as fluid retention,
hypertension and oedema have been reported in association with NSAID therapy.
Clinical trial and epidemiological data suggest that the use of NSAIDs particularly at
high doses (2400 mg daily) and in long-term treatment may be associated with a
small increased risk of arterial thrombotic events (for example myocardial infarction
or stroke).
Impaired female fertility: There is some evidence that drugs which inhibit cyclooxygenase/ prostaglandin synthesis may cause impairment of female fertility by an
effect on ovulation. This is reversible on withdrawal of treatment.
Gastrointestinal: NSAIDs should be given with care to patients with a history of
gastrointestinal disease (ulcerative colitis, Crohn’s disease) as these conditions may
be exacerbated (see section 4.8)
GI bleeding, ulceration or perforation, which can be fatal has been reported with all
NSAIDs at anytime during treatment, with or without warning symptoms or a
previous history of GI events.

The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID
doses, in patients with a history of ulcer, particularly if complicated with
haemorrhage or perforation (see Section 4.3), and in the elderly. These patients
should commence treatment on the lowest dose available.
Patients with a history of GI toxicity, particularly the elderly, should report any
unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages
of treatment.
Caution should be advised in patients receiving concomitant medications which could
increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants
such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as
aspirin (see section 4.5).
When GI bleeding or ulceration occurs in patients receiving flurbiprofen, the
treatment should be withdrawn.
Dermatological:
Serious skin reactions, some of them fatal, including exfoliative dermatitis, StevensJohnson syndrome and toxic epidermal necrolysis, have been reported very rarely in
association with the use of NSAIDSs (see section 4.8). Patients appear to be at
highest risk of these reactions early in the course of therapy, the onset of the reaction
occurring in the majority of cases within the first month of treatment. Strefen Honey
and Lemon should be discontinued at the first appearance of skin rash, mucosal
lesions, or any other sign of hypersensitivity.






The label will include:
Read the enclosed leaflet before taking this product
Do not take if you:
have (or have had two or more episodes of) a stomach ulcer,
perforation or bleeding
are allergic to flurbiprofen, to any of the ingredients, or to aspirin or
other painkillers
are taking other NSAID pain killers or aspirin with a daily dose above
75mg
or the patient is under 12 years of age.

Speak to your doctor or pharmacist before use if you
• Have or have had asthma, diabetes, high cholesterol, high blood
pressure, a stroke, heart, liver, kidney or bowel problems,
• Are a smoker
• Are pregnant
If symptoms persist or worsen, or if new symptoms occur, consult your
doctor or pharmacist.
4.5

Interaction with other medicinal products and other forms of interaction
Flurbiprofen should be avoided in combination with:

Aspirin: unless low-dose aspirin (not above 75mg daily) has been advised by a
doctor, as this may increase the risk of adverse reactions (see Section 4.4).
Other NSAIDs, including ibuprofen and cyclooxygenase-2 selective inhibitors:
Avoid concomitant use of two or more NSAIDs as this may increase the risk
of adverse effects (see Section 4.4)
Flurbiprofen should be used with caution in combination with:
Anticoagulants: NSAIDs may enhance the effects of anti-coagulants, such as warfarin
(see section 4.4)
Antihypertensives and diuretics since NSAIDs may diminish the effects of these
drugs. Diuretics can increase the risk of nephrotoxicity of NSAIDs.

Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding. (see
section 4.4).
Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): increased
risk of gastrointestinal bleeding (see section 4.4)
Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and
increase plasma glycoside levels.
Lithium: There is evidence for potential increase in plasma levels of lithium.
Methotrexate: There is evidence for the potential increase in plasma levels of
methotrexate.
Ciclosporin: Increased risk of nephrotoxicity
Mifepristone. NSAIDs should not be used for 8-12 days after mifepristone
administration as NSAIDs can reduce the effect of mifepristone.
Tacrolimus; Possible increased risk of nephrotoxicity when NSAIDs are given with
tacrolimus.
Zidovudine: Increased risk of hematological toxicity when NSAIDs are given with
zidovudine. There is evidence of an increased risk of haemarthroses and haematoma
in HIV (+) haemophiliacs receiving concurrent treatment with zidovudine and
ibuprofen.
Quinolone antibiotics: Animal data indicate that NSAIDs can increase the risk of
convulsions associated with quinolone antibiotics. Patients taking NSAIDs and
quinolones may have an increased risk of developing convulsions.

4.6

Pregnancy and lactation
Whilst no teratogenic effects have been demonstrated in animal experiments, the use
of Strefen Honey and Lemon should, if possible, be avoided during the first 6 months
of pregnancy.
During the 3rd trimester, flurbiprofen is contraindicated as there is a risk of premature
closure of the foetal ductus arteriosus with possible persistent pulmonary
hypertension. The onset of labour may be delayed and the duration increased with an
increased bleeding tendency in both mother and child. (See section 4.3
Contraindications).

Flurbiprofen appears in the breast milk in very low concentration and is unlikely to
affect the breast-fed infant adversely.
See section 4.4 regarding female fertility.

4.7

Effects on ability to drive and use machines
None expected at recommended doses and duration of therapy.

4.8

Undesirable effects
Strefen Honey and Lemon have the potential for inducing transient local irritation of
the buccal mucosa. The most frequently reported adverse event in clinical trials was
taste perversion.
Hypersensitivity reactions have been reported and these may consist of

(a) non-specific allergic reactions and anaphylaxis
(b) respiratory tract reactivity e.g. asthma, aggravated asthma, bronchospasm,
dyspnoea
(c) various skin reactions e.g. pruritus, urticaria, angioedema and more rarely
exfoliative and bullous dermatoses (including epidermal necrolysis and
erythema multiforme)
The list of the following adverse effects relates to those experienced with NSAIDS at
doses available over the counter for short-term use. In the treatment of chronic
conditions, under long-term treatment, additional adverse effects may occur.
Hypersensitivity reactions:
Uncommon: Hypersensitivity reactions with urticaria and pruritis
Very rare: severe hypersensitivity reactions. Symptoms could be facial, tongue and
laryngeal swelling, dyspnoea, tachycardia, hypotension, (anaphylaxis, angioedema or
severe shock).
Exacerbation of asthma and bronchospasm.
Gastrointestinal:
The most commonly observed adverse events are gastrointestinal in nature.
Uncommon: abdominal pain, nausea, dyspepsia
Rare: Diarrhoea, flatulence, constipation and vomiting
Very rare: peptic ulcer, perforation or gastrointestinal haemorrhage, melaena,
haematemesis, sometimes fatal, particularly in the elderly. Ulcerative stomatitis,
gastritis.
Exacerbation of colitis and Crohn’s disease (section 4.4).
Nervous System:

Uncommon: Headache
Very rare: Aseptic meningitis – single cases have been reported very rarely.
Renal:
Very rare: Acute renal failure, papillary necrosis, especially in long-term use,
associated with increased serum and oedema.
Hepatic:
Very rare: liver disorders.
Haematological:
Very rare: Haematopoietic disorders (anaemia, leucopenia, thrombocytopenia,
pancytopenia, agranulocytosis). First signs are fever, sore throat, superficial mouth
ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising.

Dermatological:
Uncommon: Various skin rashes
Very rare: Severe forms of skin reactions such as bullous reactions including StevensJohnson syndrome, erythema multiforme and toxic epidermal necrolysis can occur.
Immune System:
In patients with existing auto-immune disorders (such as systemic lupus
erythematosus, mixed connective tissue disease) during treatment with ibuprofen,
single cases of symptoms of aseptic meningitis, such as stiff neck, headache, nausea,
vomiting, fever or disorientation have been observed (see section 4.4).
Cardiovascular and Cerebrovascular
Oedema, hypertension and cardiac failure, have been reported in association with
NSAID treatment.
Clinical trial and epidemiological data suggest that the use of NSAIDS (particularly at
high doses 2400 mg daily) and in long-term treatment may be associated with a small
increased risk of arterial thrombotic events (for example myocardial infarction or
stroke) (see section 4.4).

4.9

Overdose
Symptoms Most patients who have ingested clinically important amounts of NSAIDs
will develop no more than nausea, vomiting, epigastric pain, or more rarely diarrhoea.
Tinnitus, headache and gastrointestinal bleeding are also possible. In more serious
poisoning, toxicity is seen in the central nervous system, manifesting as drowsiness,
occasionally excitation and disorientation or coma. Occasionally patients develop
convulsions. In serious poisoning metabolic acidosis may occur and the prothrombin
time/ INR may be prolonged, probably due to interference with the actions of
circulating clotting factors. Acute renal failure and liver damage may occur.
Exacerbation of asthma is possible in asthmatics.
Management
Management should be symptomatic and supportive and include the maintenance of a
clear airway and monitoring of cardiac and vital signs until stable. Consider oral
administration of activated charcoal if the patient presents within 1 hour of ingestion

of a potentially toxic amount. If frequent or prolonged, convulsions should be treated
with intravenous diazepam or lorazepam. Give bronchodilators for asthma.

5.1

Pharmacodynamic properties
Pharmacotherapeutic Group: Other throat preparations, throat preparations.
ATC Code: R02AX01
Flurbiprofen is a non-steroidal anti-inflammatory drug which has potent analgesic,
antipyretic and anti-inflammatory properties which are thought to result from the
drug's ability to inhibit prostaglandins synthesis.
The onset of pain relief, reduction in throat soreness and reduction in throat swelling
was observed 30 minutes after taking a lozenge and duration of action extended to 2-3
hours.

5.2

Pharmacokinetic properties
Flurbiprofen is rapidly absorbed following the use of STREFEN with plasma
concentrations peaking at 30 - 40 minutes. Peak concentrations are achieved more
rapidly than, but are of similar magnitude to, those achieved after an equivalent
swallowed dose.
Flurbiprofen is rapidly distributed throughout the body. It is mainly metabolised by
hydroxylation and excreted via the kidneys.
It is extensively bound to plasma proteins and has an elimination half-life of 3 to 6
hours.
Flurbiprofen is excreted in very small amounts in human milk (less than 0.05ug/ml).

5.3

Preclinical safety data
In rats exposed to 0.4mg/kg/day and above during pregnancy an increased incidence
of stillborn pregnancy has been observed. However, the relevance of this fact to
humans is doubtful and not reflected in human experience with flurbiprofen so far.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Macrogol 300
Potassium hydroxide
Lemon flavour
Levomenthol
Liquid sucrose
Liquid glucose
Honey

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
36 months.

6.4

Special precautions for storage
Store in the original package

6.5

Nature and contents of container
A push through strip consisting of 250 microns opaque PVC/PVdC (polyvinyl
chloride/polyvinyl di-chloride) blister, heat sealed to hard tempered 20 micron
aluminium foil. Blisters are enclosed in a cardboard carton in pack sizes of 2, 4, 6, 8,
10, 12, or 16 lozenges

6.6

Special precautions for disposal
None

7

MARKETING AUTHORISATION HOLDER
Crookes Healthcare Limited
1 Thane Road West
Nottingham
NG2 3AA
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 00327/0135

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
19/09/2006

10

DATE OF REVISION OF THE TEXT
07/06/2011

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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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