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‫החמרה (( מידע‬
‫על החמרה‬
‫הודעה על‬
‫הודעה‬
May 14, 2012 :‫תאריך‬
NUSSIDEX Tablets, Syrup
:‫שם תכשיר באנגלית‬
Tablet: 006286218.11200,Syrup 00128121.81.200 :‫מספר רישום‬
Teva Pharmaceutical Industries Ltd., Petach Tikva 3190 :‫שם בעל הרישום‬
‫השינויים בעלון מסומנים על רקע צהוב‬
‫רופא‬
‫בעלון ללרופא‬
‫בעלון‬
‫ים‬/‫ים המבוקש‬/‫פרטים על השינוי‬
‫טקסט חדש‬
‫טקסט נוכחי‬
Use in the Elderly1
The elderly may experience paradoxical excitation with
dexchlorpheniramine maleate. In patients over 60 years of age,
antihistamines may cause dizziness, sedation and hypotension.
Also they are more likely to have central nervous system
(CNS) depressive side effects, including confusion.
Nussidex should be administered with caution to patients
with a history of bronchial asthma, increased intraocular
pressure, hyperthyroidism, cardiovascular disease,
hypertension seizures1 and diabetes mellitus.
Adverser Reactions attributed to the antihistamine component
(dexchlorpheniramine maleate)
Cardiovascular
Palpitations;
tachycardia;
extrasystoles;
hypotension,
hypertension1.
Central Nervous System
Drowsiness; headache; sedation; dizziness; vertigo; disturbed
coordination; fatigue; confusion; restlessness; excitation;
nervousness; tremor; irritability; insomnia; euphoria;
paresthesia; hysteria; neuritis; convulsions, depression1,
inability to concentrate1, hyperreflexia1, hyporeflexia1, facial
dyskinesia and seizures1.
Dermatologic
Urticaria; drug rash.
Eye, Ear and Nose
Tinnitus; acute labyrinthitis; blurred vision; diplopia1, dilated
pupils1, nasal stuffiness.
Gastrointestinal
Dryness of mouth (xerostomia) 1 , nose, and throat; epigastric
distress; anorexia; nausea; vomiting; diarrhea; appetite
stimulation1, constipation
Adverser Reactions attributed to pseudoepehdrine component
‫פרק בעלון‬
Warnings
Nussidex should be administered with
caution to patients with a history of
bronchial asthma, increased intraocular
pressure, hyperthyroidism,
cardiovascular disease, hypertension
seizures1 and diabetes mellitus.
Adverser Reactions attributed to the
antihistamine
component
(dexchlorpheniramine maleate)
Cardiovascular
Palpitations; tachycardia; extrasystoles;
hypotension,
Central Nervous System
Drowsiness;
headache;
sedation;
dizziness;
vertigo;
disturbed
coordination;
fatigue;
confusion;
restlessness; excitation; nervousness;
tremor; irritability; insomnia; euphoria;
paresthesia;
hysteria;
neuritis;
convulsions
Dermatologic
Urticaria; drug rash.
Eye, Ear and Nose
Tinnitus; acute labyrinthitis; blurred
vision;, nasal stuffiness.
Gastrointestinal
Dryness of mouth, nose, and throat;
epigastric distress; anorexia; nausea;
Precautions
Adverse Events
Cardiovascular stimulation – elevated blood pressure,
tachycardia or arrhythmias.
Central nervous system (CNS) stimulation – restlessness,
insomnia, anxiety, irritability2, excitability2, tremors and
(rarely) hallucinations, skin rashes and urinary retention, crosssensitivity with other sympathomimetics2.
Other
Convulsions, hallucinations and paranoid delusion2, shortness
of breath or troubled breathing , nervousness, dizziness or
lightheadedness , headache, increased sweating, nausea or
vomiting unusual paleness, weakness,
vomiting; diarrhea;, constipatio
Adverser Reactions attributed to
pseudoepehdrine component
Cardiovascular stimulation – elevated
blood
pressure,
tachycardia
or
arrhythmias.
Central
nervous
system
(CNS)
stimulation – restlessness, insomnia,
anxiety, , tremors and (rarely)
hallucinations, skin rashes and urinary
retention,
Because of the antihistamine component, Nussidex is
contraindicated in acute attacks of asthma, narrow-angle
glaucoma (closed-angle glaucoma) 2, stenosing peptic ulcer,
symptomatic prostatic hypertrophy, bladder neck obstruction,
pyloroduodenal obstruction, and concomitant use with
monoamine oxidase (MAO) inhibitor therapy, or within 14
days of stoping MAO inhibitor treatment2 (also due to the
pseudoepehdrine component), concomitant use with
sympathomimetic decongestants2, beta blockers2 .
Because of the pseudoephedrine component, Nussidex is
contraindicated in severe hypertension and severe coronary
artery disease, phaeochromocytoma2, hyperthyroidism2,
diabetes mellitus2, severe renal impairment2.
Other
Convulsions, hallucinations, shortness
of breath or troubled breathing ,
nervousness,
dizziness
or
lightheadedness , headache, increased
sweating, nausea or vomiting unusual
paleness, weakness.
Because of the antihistamine
component, Nussidex is contraindicated
in acute attacks of asthma, narrow-angle
glaucoma stenosing peptic ulcer,
symptomatic prostatic hypertrophy,
bladder neck obstruction,
pyloroduodenal obstruction, and
concomitant use with monoamine
oxidase (MAO) inhibitor therapy,
Because of the pseudoephedrine
component, Nussidex is contraindicated
in severe hypertension and severe
coronary artery disease.
Dexchlorpheniramine/Alcohol/CNS
Depressants/Sedatives/Hypnotics1/Opioid
Analgesics/Tricyclic Antidepressants:
Concurrent use may potentiate the effects of either these
medications or antihistamines.
Concomitant administration with tricyclic antidepressants
may result in additive antimuscarinic activity1
Nussidex/MAO Inhibitors: Concurrent use may prolong and
intensify the anticholinergic effects of antihistamines and the
effects of sympathomimetics. Severe hypertensive reactions
may occur when sympathomimetics are administered to
patients receiving MAO inhibitors, or within 14 days of
stoping MAO inhibitor treatment2. Concomitant use is
therefore contraindicated (see Contraindications). ,
Pseudoephedrine/Moclobemide2: Risk of hypertensive crisis.
Pseudoephedrine/Ergot
Alkaloids
(Ergotamine
and
Methysergide) 2: Increaed risk of ergotism.
Pseudoephedrine/Oxytocin2:: Risk of hypertension.
Dexchlorpheniramine/Alcohol/CNS
Depressants/Opioid
Analgesics/Tricyclic Antidepressants:
Concurrent use may potentiate the
effects of either these medications or
antihistamines.
Nussidex/MAO Inhibitors: Concurrent
use may prolong and intensify the
anticholinergic effects of antihistamines
and the effects of sympathomimetics.
Severe hypertensive reactions may
occur when sympathomimetics are
administered to patients receiving MAO
inhibitors,. Concomitant use is therefore
contraindicated (see Contraindications).
Contraindications
Drug Interactions