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STREFEN HONEY AND LEMON

Active substance(s): FLURBIPROFEN / FLURBIPROFEN / 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.

4.1

Therapeutic indications
Strefen Honey and Lemon are indicated for the short term symptomatic relief
of sore throat in adults and children over the age of 12 years.

4.2

Posology and method of administration
Posology
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.
It is recommended that this product should be used for a maximum of three
days
Children: Not indicated for children under 12 years.
Elderly: A general dose recommendation cannot be given, since to date
clinical experience is limited. The elderly are at increased risk of the serious
consequences of adverse reactions.
Impaired hepatic: In patients with mild to moderate impairment of hepatic
function no dose reduction is required. In patients with severe hepatic
insufficiency flurbiprofen is contraindicated (see section 4.3).

Impaired renal: In patients with mild to moderate impairment of renal function
no dose reduction is required. In patients with severe renal insufficiency
flurbiprofen is contraindicated (see section 4.3).

Method of administration
For oromucosal administration and short-term use only.
As with all lozenges, to avoid local irritation, Strefen Honey and Lemon
should be moved around the mouth whilst sucking.
The lowest effective dose should be used for the shortest duration necessary to
relieve symptoms (see section 4.4)
4.3

Contraindications
Hypersensitivity to flurbiprofen or any of the excipients in the product.
Patients who have previously shown hypersensitivity reactions (e.g. asthma,
bronchospasm, rhinitis, angioedema, or urticaria) in response to acetylsalicylic
acid or other NSAIDs.
Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct
episodes of proven ulceration) and intestinal ulceration.
History of gastrointestinal bleeding or perforation, severe colitis,
haemorrhagic or haematopoietic disorders related to previous NSAID therapy.
Last trimester of pregnancy. (See section 4.6)
Severe heart failure, severe renal failure or severe hepatic failure (see section
4.4)

4.4

Special warnings and precautions for use
Undesirable effects may be minimised by using the lowest effective dose for
the shortest duration necessary to control symptoms
Elderly population
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
previous history of bronchial asthma or allergic disease. Flurbiprofen lozenges
should be used with caution in these patients.
Other NSAIDs:

The use of flurbiprofen lozenges with concomitant NSAIDs including
cyclooxygenase-2 selective inhibitors should be avoided (see section 4.5).
Systemic lupus erythematosus and mixed connective tissue disease:
Patients with systemic lupus erythematosus and mixed connective tissue
disease may have an increased risk of aseptic meningitis (see section 4.8),
however this effect is not usually seen with short term limited use products
such as flurbiprofen lozenges.
Cardiovascular, Renal and Hepatic Impairment:
NSAIDs have been reported to cause nephrotoxicity in various forms
including interstitial nephritis, nephrotic syndrome and renal failure. The
administration of an NSAID may cause a dose dependent reduction in
prostaglandin formation and precipitate renal failure. Patients at greatest risk
of this reaction are those with impaired renal function, cardiac impairment,
liver dysfunction, those taking diuretics and the elderly, however, this effect is
not usually seen with short term, limited use products such as flurbiprofen
lozenges.
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 and in long term treatment) may be associated with
a small increased risk of arterial thrombotic events (for example myocardial
infarction or stroke). There are insufficient data to exclude such a risk for
flurbiprofen when given at a daily dose of no more than 5 lozenges.

Hepatic:
Mild to moderate hepatic dysfunction (see sections 4.3 and 4.8)
Nervous System effects
Analgesic induced headache - In the event of prolonged use of analgesics or
use beyond the regulations headache may occur, which must not be treated
with increased doses of the medicinal product.
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)
Gastrointestinal 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 serious 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, however

this effect is not usually seen with short term limited use products such as
flurbiprofen lozenges.
Patients with a history of GI toxicity, particularly the elderly, should report
any unusual abdominal symptoms (especially GI bleeding) to their healthcare
professional. 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 serotoninreuptake inhibitors or anti-platelet agents such as acetylsalicylic acid (see
section 4.5).
If 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,
Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported
very rarely in association with the use of NSAIDSs (see section 4.8).
Flurbiprofen lozenges should be discontinued at the first appearance of skin
rash, mucosal lesions, or any other sign of hypersensitivity.
Infections:
Since in isolated cases an exacerbation of infective inflammations (e.g.
development of necrotising fasciitis) has been described in temporal
association with the use of systemic NSAIDs as a class, the patient is advised
to consult a physician immediately if signs of a bacterial infection occur or
worsen during the flurbiprofen lozenges therapy. It should be considered
whether initiation of an anti-infective antibiotic therapy is indicated.
Sugar intolerance:
Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take
this medicine.
If the symptoms get worse or if new symptoms occur, the treatment should be
re-evaluated.
If mouth irritation occurs, treatment should be withdrawn.

4.5

Interaction with other medicinal products and other forms of interaction
Flurbiprofen should be avoided in combination with:
Other NSAIDS
Avoid concomitant use of two or more NSAIDs as this may
including
increase the risk of adverse effects (esp. gastrointestinal
cyclooxygenase-2
adverse events such as ulcers and bleeding), (see section 4.4).
selective inhibitors:
Unless low-dose aspirin (not above 75mg daily) has been
Acetylsalicylic acid
advised by a doctor, as this may increase the risk of adverse
(low dose)
reactions (see section 4.4).

Flurbiprofen should be used with caution in combination with:
Anticoagulants:
Anti-platelet Agents
Antihypertensive
drugs
(Diuretics, ACE
inhibitors,
angiotensin-IIantagonists):

NSAIDs may enhance the effects of anti-coagulants, such as
warfarin (see section 4.4).
Increased risk of gastrointestinal ulceration or bleeding (see
section 4.4).
NSAIDs may reduce the effect of diuretics and other
antihypertensive drugs may enhance nephrotoxicity caused by
inhibition of cyclooxygenase, especially in patients with
compromised renal function (Patients should be adequately
hydrated)

May increase the risk of adverse reactions, especially of
bleeding in the gastrointestinal tract
NSAIDs may exacerbate cardiac failure, reduce GFR and
Cardiac glycosides: increase plasma glycoside levels - adequate control and, if
necessary, dose adjustment is recommended
Increased risk of nephrotoxicity.
Ciclosporin:
Alcohol

Corticosteroids:
Lithium:

Methotrexate:

Mifepristone:
Oral antidiabetics
Phenytoin
Potassium sparing
diuretics
Probenecid
Sulfinpyrazone
Quinolone
antibiotics
Selective serotonin
reuptake inhibitors
(SSRI’s)
Tacrolimus:
Zidovudine:

May increase the risk of adverse reactions, especially of the
gastrointestinal tract (see section 4.3)
May increase serum levels of lithium – adequate control and, if
necessary, dose adjustment is recommended
The administration of NSAIDs within 24 hours before or after
administration of methotrexate may lead to elevated
concentrations of methotrexate and an increase in its toxic
effect.
NSAIDs should not be used for 8 – 12 days after mifepristone
administration as NSAIDs can reduce the effect of
mifepristone.
Alteration of blood glucose levels reported (increased check
rate recommended)
May increase serum levels of phenytoin – adequate control
and, if necessary, dose adjustment is recommended
Concomitant use may cause hyperkalaemia
Medicinal products that contain probenecid or sulfinpyrazone
may delay the excretion of flurbiprofen.
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.
Increased risk of gastrointestinal ulceration or bleeding (see
section 4.4).
Possible increased risk of nephrotoxicity when NSAIDs are
given with tacrolimus.
Increased risk of haematological toxicity when NSAIDs are
given with zidovudine.

No studies so far have revealed any interactions between flurbiprofen and
tolbutamide or antacids.

4.6

Fertility, Pregnancy and lactation
Pregnancy
Inhibition of prostaglandin synthesis may adversely affect the pregnancy
and/or the embryo/foetal development. Data from epidemiological studies
suggest an increased risk of miscarriage and of cardiac malformation and
gastroschisis after use of a prostaglandin synthesis inhibitor in early
pregnancy. The absolute risk for cardiovascular malformation was increased
from less than 1%, up to approximately 1.5 %. The risk is believed to increase
with dose and duration of therapy. In animals, administration of a
prostaglandin synthesis inhibitor has been shown to result in increased preand post-implantation loss and embryo-foetal lethality. In addition, increased
incidences of various malformations, including cardiovascular, have been
reported in animals given a prostaglandin synthesis inhibitor during the
organogenetic period. During the first and second trimester of pregnancy,
flurbiprofen should not be given unless clearly necessary. If flurbiprofen is
used by a woman attempting to conceive, or during the first and second
trimester of pregnancy, the dose should be kept as low and duration of
treatment as short as possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors
may expose
• the fœtus to:
o cardiopulmonary toxicity (with premature closure of the ductus
arteriosus and pulmonary hypertension);
o renal dysfunction, which may progress to renal failure with
oligo-hydroamniosis;
• the mother and the neonate, at the end of pregnancy, to:
o possible prolongation of bleeding time, an anti-aggregating
effect which may occur even at very low doses.
o inhibition of uterine contractions resulting in delayed or
prolonged labour.
Consequently, flurbiprofen is contraindicated during the third trimester of
pregnancy.
Lactation
In limited studies, flurbiprofen appears in the breast milk in very low
concentration and is unlikely to affect the breast-fed infant adversely.
However, because of possible adverse effects of NSAIDs on breast-fed
infants, Strefen Honey & Lemon lozenges are not recommended for use in
nursing mothers.

Fertility
There is some evidence that drugs which inhibit cyclo-oxygenase/
prostaglandin synthesis may cause impairment of female fertility by an effect
on ovulation. This is reversible on withdrawal of treatment.
4.7

Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use of machines have been
performed.

4.8

Undesirable effects
Hypersensitivity reactions to NSAIDs 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)
Oedema, hypertension and cardiac failure have been reported in association
with NSAID treatment. Clinical trial and epidemiological data suggest that use
of some NSAIDs, (particularly at high doses 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). There is
insufficient data to exclude such a risk for flurbiprofen 8.75 mg lozenges
The following list of adverse effects relates to those experienced with
flurbiprofen at OTC doses for short-term use.
(Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1000 to
<1/100), Rare (≥1/10000 to <1/1000), Very rare (<1/10000), not known
(cannot be estimated from the available data))
Blood and lymphatic system disorders:
Not known: anaemia, thrombocytopenia.
Immune System disorders:
Rare: anaphylactic reaction
Psychiatric disorders:
Uncommon: insomnia
Cardiovascular and cerebrovascular disorders
Not known: Oedema, hypertension and cardiac failure

Nervous System disorders:
Common: dizziness, headache, parasthesia
Uncommon: somnolence
Respiratory, thoracic and mediastinal disorders:
Common: throat irritation
Uncommon: exacerbation of asthma and bronchospasm, dyspnoea, wheezing,
oropharyngeal blistering, pharyngeal hypoaesthesia.
Gastrointestinal disorders:
Common: diarrhoea, mouth ulceration, nausea, oral pain, paraesthesia oral,
oropharyngeal pain, oral discomfort (warm or burning feeling or tingling of
the mouth).
Uncommon: abdominal distension, abdominal pain, constipation, dry mouth,
dyspepsia, flatulence, glossodynia, dysgeusia, oral dysaesthesia, vomiting
Hepatobiliary disorders:
Not known: hepatitis
Skin and subcutaneous tissue disorders:
Uncommon: various skin rashes, pruritus.
Not known: severe forms of skin reaction such as bullous reactions, including
Stevens-Johnson syndrome and toxic epidermal necrolysis.
General disorders and administration site conditions:
Uncommon: pyrexia, pain
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal
product is important. It allows continued monitoring of the benefit/risk balance
of the medicinal product. Healthcare professionals are asked to report any
suspected adverse reactions via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
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 with NSAIDs, toxicity is seen in the central nervous
system, manifesting as drowsiness, occasionally excitation, blurred vision and
disorientation or coma. Occasionally patients develop convulsions. In serious
poisoning with NSAIDs 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 or gastric lavage and if
necessary correction of serum electrolytes and if the patient presents within 1 hour
of ingestion or a potentially toxic amount. If frequent or prolonged,
convulsions should be treated with intravenous diazepam or lorazepam. Give
bronchodilators for asthma. There is no specific antidote to flurbiprofen.

5.1

Pharmacodynamic properties
Pharmacotherapeutic Group: Throat preparations, other throat preparations.
ATC Code: R02AX01
Flurbiprofen is a propionic acid derivative NSAID which acts through
inhibition of prostaglandin synthesis. In humans flurbiprofen has potent
analgesic, antipyretic and anti-inflammatory properties and the 8.75mg dose
dissolved in artificial saliva has been shown to reduce prostaglandin synthesis
in cultured human respiratory cells. According to studies using the whole
blood assay, flurbiprofen is a mixed COX-1/COX-2 inhibitor with some
selectivity towards COX-1.
Pre-clinical studies suggest that the R (-) enantiomer of flurbiprofen and
related NSAIDs may act on the central nervous system; the suggested
mechanism is by inhibition of induced COX-2 at the level of the spinal cord.
A single dose of flurbiprofen 8.75mg delivered locally to the throat in a
lozenge has been demonstrated to relieve sore throat, including swollen and
inflamed sore throats through a significant reduction (LS Mean Difference) in
sore throat pain intensity from 22 minutes (-5.5mm), reaching a maximum at
70 minutes (-13.7mm) and remaining significant for up to 240 minutes (3.5mm) including patients with streptococcal and non-streptococcal infections,
reduction in difficulty swallowing from 20 minutes (-6.7mm), reaching a
maximum at 110 minutes (-13.9mm) and for up to 240 minutes (-3.5mm) and
reduction in the feeling of a swollen throat at 60 minutes (-9.9mm), reaching a
maximum at 120 minutes (-11.4mm) and for up to 210 minutes (-5.1mm).
Multiple dose efficacy measured using Sum of Pain Intensity Differences
(SPID) over 24 hours has demonstrated significant reduction in sore throat
pain intensity (-473.7mm*h to -529.1mm*h), difficulty swallowing (458.4mm*h to -575.0mm*h) and swollen throat (-482.4mm*h to 549.9mm*h) with statistically significant greater summed reduction in pain at
each hourly interval over 23 hours for all three measures and statistically
significantly greater sore throat relief each hour over the 6 hour assessment

time. Efficacy of multiple doses after 24 hours and over 3 days has also been
demonstrated.
For those patients taking antibiotics for streptococcal infection, there was
statistically significant greater relief of sore throat pain intensity for
flurbiprofen 8.75mg from 7 hours and onwards after antibiotics were taken.
The analgesic effect of flurbiprofen 8.75 mg was not reduced by the
administration of antibiotics to treat patients with streptococcal sore throat.
At 2 hours post first dose, flurbiprofen 8.75mg lozenges provided significant
resolution of some of the associated symptoms of sore throat present at
baseline including coughing (50% vs 4%), loss of appetite (84% vs 57%) and
feverishness (68% vs 29%). The lozenge format dissolves in the mouth over 5
- 12 minutes and provides a measurable soothing and coating effect at 2
minutes.
Paediatric Population
No specific studies in children have been undertaken. Efficacy and safety
studies on flurbiprofen 8.75mg lozenges have included children aged 12 – 17
years, although small sample size means that no statistical conclusions can be
drawn.

5.2

Pharmacokinetic properties
Absorption
Flurbiprofen 8.75mg lozenges dissolve over 5 – 12 minutes and the
flurbiprofen is readily absorbed, with detection in the blood at 5 minutes and
plasma concentrations peaking at 40 - 45 minutes after administration but
remaining at a mean low level of 1.4µg/mL which is approximately 4.4 times
lower than a 50mg tablet dose. Absorption of flurbiprofen can occur from the
buccal cavity by passive diffusion. Rate of absorption is dependent on
pharmaceutical form with peak concentrations achieved more rapidly than, but
of similar magnitude to, those achieved after an equivalent swallowed dose.
Distribution
Flurbiprofen is rapidly distributed throughout the body and is extensively
bound to plasma proteins.
Metabolism / Excretion
Flurbiprofen is mainly metabolised by hydroxylation and excreted via the
kidneys. It has an elimination half-life of 3 to 6 hours. Flurbiprofen is excreted
in very small amounts in human milk (less than 0.05 µg/ml). Approximately
20-25% of a flurbiprofen oral dose is excreted unchanged.
Special Groups
No difference in pharmacokinetic parameters between elderly and young adult
volunteers has been reported following oral administration of flurbiprofen
tablets. No pharmacokinetic data have been generated in children below 12
years of age following administration of Flurbiprofen 8.75 mg however
administration of both flurbiprofen syrup and suppository formulations

indicate no significant differences in pharmacokinetic parameters compared
with adults.
5.3

Preclinical safety data
There are no preclinical data of relevance additional to information already
included in other relevant sections.

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
Reckitt Benckiser Healthcare (UK) Ltd
103-105 Bath Road
Slough
Berkshire
SL1 3UH
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 00063/0714

9

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

10

DATE OF REVISION OF THE TEXT
22/07/2016

Expand Transcript

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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