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LASYNAC 200MG/30MG FILM COATED TABLETS

Active substance(s): IBUPROFEN / PSEUDOEPHEDRINE HYDROCHLORIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Lasynac 200mg/30mg film coated tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each white film coated tablet contains 200 mg ibuprofen and 30 mg
pseudoephedrine hydrochloride.
Excipient(s) with known effect
Contains 84 mg lactose monohydrate.
For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Film coated tablet.
White, round film coated tablets of 11mm in diameter.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Symptomatic relief of nasal/sinus congestion with headache, fever, and pain
associated with the common cold.
Lasynac is indicated in adults and adolescents aged 15 and above .

4.2

Posology and method of administration
Posology
Adults and adolescents aged 15 and above:
1 tablet (equivalent to 200 mg ibuprofen and 30 mg pseudoephedrine
hydrochloride) every 6 hours if necessary.
For more severe symptoms, 2 tablets (equivalent to 400 mg ibuprofen and 60
mg pseudoephedrine hydrochloride) every 6 hours if necessary, to a maximum

total daily dose of 6 tablets (equivalent to 1200 mg ibuprofen and 180 mg
pseudoephedrine hydrochloride).
The maximum total daily dose of 6 tablets (equivalent to 1200 mg ibuprofen
and 180 mg pseudoephedrine hydrochloride) must not be exceeded.
Treatment should not be continued for more than 5 days.
Undesirable effects may be minimised by using the lowest effective dose for the
shortest duration necessary to control symptoms (see section 4.4).

This combination product should be used where both, the decongestant action
of pseudoephedrine hydrochloride and the analgesic and/or anti-inflammatory
action of ibuprofen are required. If one symptom (either nasal congestion or
headache and/or fever) predominates, single-agent therapy is preferable.
Paediatric population
Lasynac is contraindicated in paediatric patients below 15 years of age (see
section 4.3).
If in adolescents this medicinal product is required for more than 3 days, or if
symptoms worsen a physician should be consulted.
Method of administration
For oral use.
The tablets should be swallowed without chewing with a large glass of water,
preferably during meals.
4.3

Contraindications
















Known hypersensitivity to ibuprofen, pseudoephedrine hydrochloride or
to any of the excipients listed in section 6.1;
Patients aged under 15 years;
Pregnancy and Lactation (see section 4.6);
History of allergy or asthma precipitated by ibuprofen or substances with
similar activity such as other non-steroidal anti-inflammatory drugs
(NSAIDs) or acetylsalicylic acid;
History of gastrointestinal bleeding or perforation related to previous
anti-inflammatory therapy;
Active peptic ulcer or history of recurrent ulcer/haemorrhage (two or
more distinct episodes of proven ulceration or bleeding);
Cerebrovascular or other bleeding;
Unexplained haematopoietic abnormalities;
Severe hepatocellular insufficiency;
Severe renal failure;
Severe heart failure (NYHA Class IV);
Severe or poorly controlled hypertension;
History of stroke or presence of risk factors for stroke (because of the αsympathomimetic activity of pseudoephedrine hydrochloride);
Severe coronary insufficiency;
Risk of closed-angle glaucoma;









4.4

Risk of urinary retention related to urethroprostatic disorders;
History of myocardial infarction;
History of seizures;
Disseminated lupus erythematosus;
Concomitant use of other vasoconstrictor agents used as nasal
decongestants, whether administered orally or nasally (e.g.
phenylpropanolamine, phenylephrine and ephedrine), and
methylphenidate (see section 4.5);
Concomitant use of non-selective monoamine oxidase inhibitors
(MAOIs) (iproniazid) (see section 4.5) or use of monoamine oxidase
inhibitors within the last two weeks.

Special warnings and precautions for use
Concomitant use of Lasynac with other NSAIDs containing cyclo-oxygenase
(COX)-2 inhibitors should be avoided.
Undesirable effects may be reduced by using the minimum effective dose for
the shortest duration necessary to control symptoms (see "Gastro-intestinal
effects" and "Cardiovascular and cerebrovascular effects" below).
Special warnings related to pseudoephedrine hydrochloride:
• The dosage, the recommended maximum duration of treatment (5
days) and the contraindications must be strictly adhered to (see section
4.8).
• Patients should be informed that treatment must be discontinued if they
develop hypertension, tachycardia, palpitations, cardiac arrhythmias,
nausea or any neurological signs such as onset or worsening of
headache.
Before using this product, patients should consult their physician in case of:
Hypertension, heart disease, hyperthyroidism, psychosis or diabetes.
Concomitant administration of antimigraine agents, especially ergot
alkaloid vasoconstrictors (because of the α-sympathomimetic activity
of pseudoephedrine).
• SLE and mixed connective tissue disease: Systemic lupus
erythematosus and mixed connective tissue disease – increased risk of
aseptic meningitis (see section 4.8).
Neurological symptoms such as seizures, hallucinations, behavioural
disturbances, agitation and insomnia. These have been described after
systemic administration of vasoconstrictors, especially during febrile
episodes or on overdose. These symptoms have been more commonly
reported in paediatric population.
As a result, it is advisable:
• to avoid administration of Lasynac either in combination with
medicines which can lower the epileptogenic threshold, such as terpene
derivatives, clobutinol, atropine-like substances and local anaesthetics,
or where there is a history of seizures;



to adhere strictly to the recommended dosage in all cases and to inform
the patients about the risks of overdose if Lasynac is taken
concomitantly with other medicines containing vasoconstrictors.

Patients with urethroprostatic disorders are more prone to develop symptoms
like dysuria and urinary retention.
Elderly patients may be more sensitive to the effects on the central nervous
system (CNS).
Precautions for use related to pseudoephedrine hydrochloride:
• In patients undergoing scheduled surgery in which volatile halogenated
anaesthetics are to be used, it is preferable to discontinue treatment with
Lasynac several days before surgery in view of the risk of acute
hypertension (see section 4.5).Athletes should be informed that treatment
with pseudoephedrine hydrochloride can lead to positive results in doping
tests.

Interference with serological testing
Pseudoephedrine has the potential to reduce iobenguane i-131 uptake in
neuroendocrine tumors, thus interfering with scintigraphy.
Special warnings related to ibuprofen:
Patients who have asthma associated with chronic rhinitis, chronic sinusitis
and/or nasal polyposis have a higher risk of allergic reactions when taking
acetylsalicylic acid and/or NSAIDs. Administration of Lasynac may
precipitate an acute asthma attack; particularly in some patients who are
allergic to acetylsalicylic acid or an NSAID (see section 4.3).
Gastro-intestinal effects:
Gastro-intestinal bleeding, ulceration or perforation, which can be fatal, has
been reported with all NSAIDs at any time during treatment, with or without
warning symptoms or a previous history of gastrointestinal events.
The risk of gastro-intestinal bleeding, ulceration or perforation, which can be
fatal, is higher with increasing NSAID doses, in patients with a history of ulcer
(particularly if complicated with bleeding or perforation (see section 4.3) and
in patients older than 60 years of age. These patients should commence
treatment on the lowest dose available. Combination therapy with protective
agents (e.g. misoprostol or proton pump inhibitors) should be considered for
these patients and also for patients taking concomitant low-dose acetylsalicylic
acid or other medicinal drug products likely to increase gastro-intestinal risk
(see below and section 4.5).
Patients with a history of gastrointestinal toxicity, especially elderly patients,
may present with unusual abdominal symptoms (especially gastrointestinal
bleeding) in the initial stages of treatment.
Particular caution is advised in patients receiving concomitant medications
which could increase the risk of ulceration or bleeding such as oral
corticosteroids, anticoagulants such as warfarin, SSRIs or antiplatelet agents
such as acetylsalicylic acid (see section 4.5).

Treatment with Lasynac should be discontinued immediately if gastrointestinal bleeding or ulceration occurs.
NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as their condition may be
exacerbated (see section 4.8).
Cardiovascular and cerebrovascular effects:
Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400
mg/day) may be associated with a small increased risk of arterial thrombotic
events (for example myocardial infarction or stroke). Overall, epidemiological
studies do not suggest that low-dose ibuprofen (e.g. ≤1200 mg/daily) is
associated with an increased risk of arterial thrombotic events.
Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III),
established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular
disease should only be treated with ibuprofen after careful consideration and high
doses (2400 mg/day) should be avoided.

Careful consideration should also be exercised before initiating longer-term
treatment of patients with risk factors for cardiovascular events (e.g.
hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if
high doses of ibuprofen (2400 mg/day) are required.
Caution is required in patients with a history of hypertension and/or heart
failure as fluid retention, hypertension or oedema have been observed in
association with previous NSAID therapy; advice from a physician and/or
pharmacist must be sought prior to starting treatment under these
circumstances.
Skin reactions:
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 NSAIDs (see section 4.8). Patients
are 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. Lasynac should be discontinued at the first appearance of skin rash,
mucosal lesions, or any other sign of hypersensitivity.
Precautions for use related to ibuprofen:
• Elderly: The pharmacokinetics of ibuprofen is not modified by age, no dose
adjustments is necessary in the elderly. However, elderly patients should
be carefully monitored as they are more sensitive to NSAID-related
undesirable effects, particularly gastro-intestinal bleeding and perforation,
which can be fatal.
• Caution and special monitoring is required when administering ibuprofen to
patients with a history of gastro-intestinal disease (such as peptic ulcer,
hiatus hernia or gastrointestinal bleeding).
• In the initial stages of treatment, careful monitoring of urine output and renal
function is required in patients with heart failure, patients with chronically
impaired renal or hepatic function, patients taking diuretics, patients who
are hypovolaemic as a result of major surgery and, in particular, elderly
patients.

• If visual disturbances occur during the course of treatment, a full
ophthalmological examination should be carried out.

If symptoms persist or worsen, the patient should be advised to consult a
physician.
This product contains 504 mg lactose monohydrate per maximum
recommended daily dose. Patients with rare hereditary conditions of galactose
intolerance e.g. galactosaemia, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicine.
4.5

Interaction with other medicinal products and other forms of interaction
Combination of pseudoephedrine
with:
Non-selective MAOIs (iproniazid):

Other indirectly-acting, orally or
nasally administered
sympathomimetics or vasoconstrictor
agents, α-sympathomimetic drugs,
phenylpropanolamine, phenylephrine,
ephedrine, methylphenidate:
Reversible inhibitors of monoamine
oxidase A (RIMAs), linezolid,
dopaminergic ergot alkaloids,
vasoconstrictor ergot alkaloids:
Volatile halogenated anaesthetics:

Guanethidine, reserpine and
methyldopa:
Tricyclic antidepressants:
Digitalis, chinidine or tricyclic
antidepressants:
Concomitant use of ibuprofen with :
Other NSAIDs, including salicylates:

Possible Reaction
Paroxysmal hypertension and
hyperthermia, which can be fatal.
Because of the long duration of
action of MAOIs, this interaction
can occur up to 15 days after
discontinuation of the MAOI.
Risk of vasoconstriction and/or
hypertensive crises.

Risk of vasoconstriction and/or
hypertensive crises.

Perioperative acute hypertension.
In scheduled surgery, discontinue
treatment with Lasynac several
days before.
Effect of peudoephedrine may be
diminished.
Effect of peudoephedrine may be
diminished or enhanced.
Increased frequency of arrhythmia.

Possible Reaction
The concomitant administration of
several NSAIDs may increase the
risk of gastrointestinal ulcers and
bleeding due to a synergistic effect.
The concomitant use of ibuprofen

with other NSAIDs should
therefore be avoided (see
section 4.4).
Digoxin:

The concomitant use of Lasynac
with digoxin preparations may
increase serum levels of these
medicinal products. A check of
serum-digoxin is not as a rule
required on correct use (maximum
over 5 days).

Corticosteroids:

Corticosteriods as these may
increase the risk of adverse
reactions, especially of the
gastrointestinal tract
(gastrointestinal; ulceration or
bleeding) (see section 4.3).

Anti-platelet agents:

Increased risk of gastrointestinal
bleeding (see section 4.4).

Acetylsalicylic acid (low dose):

Concomitant administration of
ibuprofen and acetylsalicylic acid
is not generally recommended
because of the potential of
increased adverse effects.
Experimental data suggest that
ibuprofen may competitively
inhibit the effect of low dose
acetylsalicylic acid on platelet
aggregation when they are dosed
concomitantly. Although there are
uncertainties regarding
extrapolation of these data to the
clinical situation, the possibility
that regular, long-term use of
ibuprofen may reduce the
cardioprotective effect of low-dose
acetylsalicylic acid cannot be
excluded. No clinically relevant
effect is considered to be likely for
occasional ibuprofen use (see
section 5.1).

Anticoagulants:
(e.g.: warfarin, ticlopidine, clopidogrel,
tirofiban, eptifibatide, abciximab,
iloprost)

NSAIDs as ibuprofen may enhance
the effect of anti-coagulants (see
section 4.4).

Phenytoin:

The concomitant use of Lasynac
with phenytoin preparations may
increase serum levels of these

medicinal products. A check of
serum-phenytoin levels is not as a
rule required on correct use
(maximum over 5 days).
Selective serotonin reuptake inhibitors
(SSRIs):

Increased risk of gastrointestinal
bleeding (see section 4.4).

Lithium:

The concomitant use of Lasynac
with lithium preparations may
increase serum levels of these
medicinal products. A check of
serum-lithium is not as a rule
required on correct use (maximum
over 5 days).

Probenecid and sulfinpyrazone:

Medicinal products that contain
probenecid or sulfinpyrazone may
delay the excretion of ibuprofen.

Diuretics, ACE inhibitors,
betareceptor-blockers and angiotensinII antagonists:

NSAIDs may reduce the effect of
diuretics and other antihypertensive
medicinal products. In some
patients with compromised renal
function (e.g. dehydrated patients
or elderly patients with
compromised renal function) the
co-administration of an ACE
inhibitor, betareceptor-blockers or
angiotensin-II antagonists and
agents that inhibit cyclo-oxygenase
may result in further deterioration
of renal function, including
possible acute renal failure, which
is usually reversible. Therefore, the
combination should be
administered with caution,
especially in the elderly. Patients
should be adequately hydrated and
consideration should be given to
monitoring of renal function after
initiation of concomitant therapy,
and periodically thereafter.

Potassium sparing diuretics:

The concomitant administration of
Lasynac and potassium-sparing
diuretics may lead to
hyperkalaemia (check of serum
potassium is recommended).

Methotrexate:

The administration of Lasynac
within 24 hours before or after
administration of methotrexate may
lead to elevated concentrations of

methotrexate and an increase in its
toxic effect.

4.6

Ciclosporin:

The risk of a kidney-damaging
effect due to ciclosporin is
increased through the concomitant
administration of certain
nonsteroidal antiinflammatory
drugs. This effect also cannot be
ruled out for a combination of
ciclosporin with ibuprofen.

Tacrolimus:

The risk of nephrotoxicity is
increased if the two medicinal
products are administered
concomitantly.

Zidovudine:

There is evidence of an increased
risk of haemarthroses and
haematoma in HIV (+)
haemophiliacs receiving concurrent
treatment with zidovudine and
ibuprofen.

Sulphonylureas:

Clinical investigations have shown
interactions between nonsteroidal
anti-inflammatory drugs and
antidiabetics (sulphonylureas).
Although interactions between
ibuprofen and sulphonylureas have
not been described to date, a check
of blood-glucose values is
recommended as a precaution on
concomitant intake.

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.

Heparins; Gingko biloba:

Increased risk of bleeding.

Fertility, pregnancy and lactation
Pregnancy
Pseudoephedrine hydrochloride:
While no studies for reproductive toxicity, fertility and postnatal development
with pseudoephedrine hydrochloride are available and pseudoephedrine

hydrochloride has been in widespread use for many years without apparent ill
consequence, an increased risk concerning the use of pseudoephedrine
hydrochloride due to its vasoconstrictive effects in early pregnancy might
exist.
Ibuprofen:
During the 3rd trimester, ibuprofen 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.
In conclusion, Lasynac is contraindicated during pregnancy and not
recommended in women of childbearing potential not using contraception.
Breastfeeding
Pseudoephedrine hydrochloride passes into breast milk.
Ibuprofen and its metabolites are excreted into human breast milk in very low
concentrations and are unlikely to have an adverse effect on breast-fed infants.
In view of the potential cardiovascular and neurological effects of
vasoconstrictor agents, the use of Lasynac is contraindicated during lactation.
Fertility
There is limited evidence that drugs which inhibit cyclooxygenase/prostaglandin synthesis may cause impairment of female fertility
by an effect on ovulation. This is reversible upon withdrawal of treatment.
4.7

Effects on ability to drive and use machines
Lasynac has negligible influence on the ability to drive or use machines.
Patients should be warned about the potential occurrence of the ibuprofen
related side effects dizziness or visual disturbances.

4.8

Undesirable effects
The most commonly-oberved adverse events related to ibuprofen are
gastrointestinal in nature. In general, the risk of development of adverse events
(in particular the risk of development of serious gastrointestinal complications)
increases with increasing dose and with increasing duration of treatment
administration.
Hypersensitivity reactions have been reported following treatment with
ibuprofen. These may consist of:
(a) Non-specific allergic reaction and anaphylaxis
(b) Respiratory tract reactivity comprising of asthma, aggravated asthma,
bronchospasm or dyspnoea
(c) Assorted skin disorders, including rashes of various types, pruritis, urticaria,
purpura, angioedema and, more rarely, exfoliative and bullous dermatoses
(including epidermal necrolysis and erythema multiforme)

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.
Oedema, hypertension and cardiac failure have been reported in association
with NSAID treatment.
Clinical studies suggest that use of ibuprofen, particularly at a high dose
(2400mg/day) may be associated with a small increased risk of arterial
thrombotic events (for example myocardial infarction or stroke) (see section
4.4).
The following list of adverse effects relates to those experienced with
ibuprofen and pseudoephedrine hydrochloride at OTC doses, for short-term
use. In the treatment of chronic conditions, under long-term treatment,
additional adverse effects may occur.
Patients should be informed that they should stop taking Lasynac
200mg/30mg film coated tablets immediately and consult a physician if they
experience a serious adverse drug reaction.





from the available data)>
Infections and
infestations

Ibuprofen

Very rare

Exacerbation of
infectious
inflammations (e.g.
necrotizing fasciitis),
Aseptic meningitis
(stiffness of the neck,
headache, nausea,
vomiting, fever or
disorientation in
patients with preexistent autoimmune
diseases (SLE, mixed
connective tissue
disease)

Blood and
lymphatic system
disorders

Ibuprofen

Very rare

Haematopoietic
disorders (anaemia,
leucopenia,
thrombocytopenia,
pancytopenia,
agranulocytosis)

Immune system

Ibuprofen

Uncommo

Hypersensitivity

n

reactions with
urticaria, pruritus and
asthma attacks (with
drop in blood
pressure)

Ibuprofen and
pseudoephedrine
hydrochloride

Very rare

Severe generalised
hypersensitivity
reactions, signs may
be facial oedema,
angioedema,
dyspnoea, tachycardia,
drop in blood pressure,
anaphylactic shock

Ibuprofen

Very rare

Psychotic reactions,
depression

Pseudoephedrine
hydrochloride

Not
known

Agitation, hallucination,
anxiety, abnormal
behaviour, insomnia

Ibuprofen

Uncommo
n

Central nervous
disturbances such as
headache, dizziness,
sleeplessness,
agitation, irritability or
tiredness

Pseudoephedrine
hydrochloride

Not
known

Haemorhagic stroke,
ischemic stroke,
convulsion, headache

Ibuprofen

Uncommo
n

Visual disturbances

Ear and labyrinth Ibuprofen
disorders

Rare

Tinnitus

Cardiac disorders Ibuprofen

Very rare

Palpitations, heart
failure, myocardial
infarction

Pseudoephedrine
hydrochloride

Not
known

Palpitations,
tachycardia, chest
pain, arrythmia

Ibuprofen

Very rare

Arterial hypertension

Pseudoephedrine
hydrochloride

Not
known

Hypertension

Ibuprofen

Common

Dyspepsia, abdominal

disorders

Psychiatric
disorders

Nervous system
disorders

Eye disorders

Vascular
disorders

Gastrointestinal

pain, nausea,
vomiting, flatulence,
diarrhoea,
constipation, minor
gastrointestinal blood
loss in rare cases
leading to anaemia

disorders

Ibuprofen

Uncommo
n

Gastric ulcer with
bleeding and/or
perforation, gastritis,
ulcerous stomatitis,
exacerbation of colitis
and Crohn’s disease
(see section 4.4)

Ibuprofen

Very rare

Oesophagitis,
pancreatitis, intestinal
diaphragm-like
stricture

Pseudoephedrine
hydrochloride

Not
known

Dry mouth, thirst,
nausea, vomiting

Hepatobiliary
disorders

Ibuprofen

Very rare

Hepatic dysfunction,
hepatic damage,
particularly in longterm therapy, hepatic
failure, acute hepatitis

Skin and
subcutaneous
tissue disorders

Ibuprofen

Uncommo
n

Various skin rashes

Ibuprofen

Very rare

Bullous exanthema
such as StevensJohnson syndrome and
toxic epidermal
necrolysis (Lyell
syndrome), alopecia,
severe skin infections,
soft-tissue
complications in a
varicella infection

Pseudoephedrine
hydrochloride

Not
known

Rash, urticaria,
pruritus, hyperhidrosis

Rare

Kidney-tissue damage
(papillary necrosis)
and elevated uric acid
concentrations in the

Ibuprofen
Renal and
Urinary disorders

blood
Ibuprofen

Very rare

Oedemas (particularly
in patients with
arterial hypertension
or renal insufficiency),
nephrotic syndrome,
interstitial nephritis,
acute renal
insufficiency

Pseudoephedrine
hydrochloride

Not
known

Difficulty in
micturition

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
The clinical effects of overdose are more likely to be due to the pseudoephedrine
hydrochloride rather than ibuprofen in this product. The effects do not correlate well
with the dose taken due to inter-individual sensitivity to sympathomimetic properties.
Symptoms of sympathomimetic effect
CNS depression: e.g. sedation, apnea, cyanosis, coma
CNS stimulation (which is more likely in children): e.g. insomnia, hallucinations,
convulsions, tremor
Besides the symptoms already mentioned as undesirable effect, the following
symptom can occur: hypertensive crisis, cardiac arrhythmias, muscle weakness and
tenseness, euphoria, excitement, thirst, chest pain, dizziness, tinnitus, ataxia, blurred
vision, hypotension
Ibuprofen-related symptoms (in addition to the gastro-intestinal and neurological
symptoms already mentioned as undesirable effect)
Drowsiness, nystagmus; tinnitus, hypotension, metabolic acidosis, loss of
consciousness
Therapeutic measures
No specific antidote is available.
Activated charcoal is recommended if the patient presents with one hour of ingestion.
Gastric lavage can also be considered in severe cases.

Electrolytes should be checked and ECG performed. In case of cardiovascular
instability and/or symptomatic electrolyte imbalance, symptomatic treatment should
be initiated.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic group: Other cold combination preparations. ATC codes:
R05X
Pseudoephedrine hydrochloride is a sympathomimetic agent which, when
administered systemically, acts as a nasal decongestant.
Ibuprofen is an NSAID belonging to the propionic acid class of drugs. It is an
arylcarboxylic acid derivative which has analgesic, antipyretic and antiinflammatory properties as well as a short-acting inhibitory effect on platelet
function. All of these properties are related to its ability to inhibit
prostaglandin synthesis.
Lasynac is a combination of a vasoconstrictor (pseudoephedrine
hydrochloride) with an analgesic, antipyretic and anti-inflammatory dose of an
NSAID (ibuprofen).
Experimental data suggest that ibuprofen may competitively inhibit the effect
of low dose acetylsalicylic acid on platelet aggregation when they are dosed
concomitantly. Some pharmacodynamic studies show that when single doses
of ibuprofen 400mg were taken within 8 h before or within 30 min after
immediate release acetilsalicylic acid dosing (81mg), a decreased effect of
acetylsalicylic acid on the formation of thromboxane or platelet aggregation
occurred. Although there are uncertainties regarding extrapolation of these
data to the clinical situation , the possibility that regular, long-term use of
ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic
acid cannot be excluded. No clinically relevant effect is considered to be likely
for occasional ibuprofen use (see section 4.5).

5.2

Pharmacokinetic properties
Ibuprofen:
Absorption:
Peak plasma levels following oral administration are achieved within 90 min.
Following a single dose, peak plasma levels in healthy adults are proportional
to the dose administered (Cmax is 17 ± 3.5 µg/ml for a dose of 200 mg and 30.3
± 4.7 µg/ml for a dose of 400 mg). Absorption of ibuprofen is delayed by
food.
Distribution:

Ibuprofen is not associated with any accumulation phenomena. Plasma protein
binding is 99%.
In synovial fluid, stable levels of ibuprofen are found between 2 and 8 h after
administration; the synovial fluid Cmax is about one-third the Cmax in plasma.
The quantity of ibuprofen detected in the milk of breastfeeding women is less
than 1 mg/24 h following administration of 400 mg every 6 h.
Biotransformation:
Ibuprofen is not an enzyme inducer. About 90% of a dose is metabolised to
inactive metabolites.
Elimination:
Ibuprofen is principally eliminated in the urine, with 10% being in unchanged
form and 90% in the form of inactive metabolites, which are mainly formed by
glucuronide conjugation. Elimination is complete within 24 h.
The elimination half-life is about 2 h.
Age, renal impairment and hepatic impairment do not affect the
pharmacokinetic parameters to any major extent and the variations observed
are not sufficient to warrant any dosage adjustments.
Linearity/non-linearity:
The pharmacokinetics of ibuprofen is linear at therapeutic doses.
Pseudoephedrine hydrochloride:
Elimination:
Following oral administration, pseudoephedrine hydrochloride is largely
excreted unchanged (70 - 90%) in the urine.
The elimination half-life depends on urinary pH. Urinary alkalinisation leads
to an increase in tubular reabsorption and thus to an increase in the elimination
half-life.
5.3

Preclinical safety data
Only limited toxicity data are available with the drug combination ibuprofen and
pseudoephedrine hydrochloride.
Based on different mechanisms of action of ibuprofen (non-steroidal antiinflammatory) and pseudoephedrine hydrochloride (sympathomimetic), a compoundspecific toxicity profile related to the pharmacodynamic activity of the monocompounds was seen in non-clinical toxicity tests following overdosing
(pseudoephedrine human data). Accordingly, there were different toxicological target
organs, e.g. gastrointestinal lesions for ibuprofen and hemodynamic as well as CNSeffects for pseudoephedrine hydrochloride. Co-administration of ibuprofen and
pseudoephedrine hydrochloride did not result in any clinically significant interaction.
Therefore, no additive, synergistic and potentiating effects will be expected for the
fixed-dose combination (FDC) ibuprofen/pseudoephedrine hydrochloride (200 mg/30
mg) in animals and men at equipotent doses. This is also supported by the absence of

competitive metabolic pathways. There is no scientific evidence that the safety
margins for the individual drugs will be different for the drug combination.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Core
Lactose monohydrate
Cellulose microcrystalline
Sodium starch glycolate (type A)
Silica, colloidal anhydrous
Magnesium stearate
Coating
Polyvinyl alcohol
Titanium dioxide E 171
Macrogol/PEG 3350
Talc

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
3 years

6.4

Special precautions for storage
Do not store above 25ºC.
Store in the original package. Keep blister in the outer carton.

6.5

Nature and contents of container
PVC/PVDC/aluminium foil blister.

Pack sizes: 10, 20.
Not all pack sizes may be marketed.

6.6

Special precautions for disposal
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance
with local requirements.

7

MARKETING AUTHORISATION HOLDER
Boehringer Ingelheim International GmbH
Binger Strasse 173
55216 Ingelheim am Rhein, Germany

8

MARKETING AUTHORISATION NUMBER(S)
PL 14598/0091

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
22/08/2012

10

DATE OF REVISION OF THE TEXT
22/12/2015

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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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