Israel - English - Ministry of Health
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" עעבקנהזןולעטמרופ " רשואוקדבנונכותותואירבהדרשמי ." רשואמןולע : 28.5.2013
“This leaflet format has been determined by the Ministryof Healthand thecontent thereof has been
checked and approved.” Dateof approval:28. 5. 2013
Each tablet or caplet contains:
Chlorpheniramine maleate 2 mg
Phenylephrine hydrochloride 10 mg
Paracetamol 300 mg
Caffeine 30 mg
Lactose content: 26.5 mg per tablet/caplet.
Sodium content: 0.47-0.7 mg per tablet/caplet.
Lactose monohydrate, povidone, sodiumstarch glycolate, hydroxypropyl
methylcellulose, titanium dioxide, polyethylene glycol, quinoline yellow aluminium
lake,ironoxideyellow,indigocarmine aluminium lake [FD&C blue no.2], colloidal
silicon dioxide, magnesium stearate, hydrogenated vegetable oil, Eurdragit E 100.
Coldexisacomprehensive cold preparation, producing rapid and long-lasting relief
from cold symptoms.
Chlorpheniraminecontrolsrhinorrhea, sneezing, and itchy and watery eyes
associated with elevated histamine levels.
Phenylephrine reduces nasal and sinus congestion.
Paracetamolreduces fever and relieves headache, muscle and joint aches and
Coldex also contains caffeine, to help counteractpossibledrowsinessfromthe
Symptomaticreliefof common cold, congestion associated with sinusitis, allergic
rhinitis accompanied by fever and pain.
Known hypersensitivity to antihistamines or to any of the components ofthe
Patients with severe hypertension, severe coronaryarterydisease,narrow-angle
glaucoma,Closedangle glaucoma, hepatic or severe renal impairment, stenosing
peptic ulcer, symptomatic prostatic hypertrophy, bladderneckobstruction,
pyloroduodenal ulceration, and the elderly and debilitated.
Concomitant use with monoamine oxidase(MAO)inhibitors,or within 14 days of
discontinuation of such therapy (see Drug Interactions).
Concomitant use of other sympathomimetic decongestants
Patients taking tricyclic antidepressants, or beta blocking drugs
Pregnancy - see also Warnings.
Hyperthyroidism, diabetes and heart disease
Do not take this medicine with other paracetamol-containing products
Do not take this medicine with otherantihistamine-containingproducts,including
products for relief of colds and coughs
Special Warnings and special precautions for use
Sincedrowsiness may occur, patients should be warned that their ability to perform
potentially-hazardous tasks requiringmentalalertness or physical coordination such
asdrivingavehicleor operating machinery, may be impaired. Children should be
warned not to participate in activities such as riding a bicycle or playing near traffic.
Aswithotherantihistamine-containing products, Coldex exerts an anticholinergic
(atropine-like) effects and should be used with caution in patients withepilepsysince
convulsionsmaybeprecipitated;it should also be used with caution in patients with
cardiovasculardisease, hypertension, bronchitis/bronchial asthma, bronchiectasis,
asthma,increased intraocular pressure, hyperthyroidism, hepatic impairment, and
diabetesmellitus.Childrenandtheelderly patients are more likely to experience the
neurological anticholinergic effects and paradoxicalexcitation(e.g.increasedenergy,
The effects of alcohol may be increased andthereforeshouldbeavoided.(seeDrug
The preparation contains paracetamol which may cause liver damage when:
Given at a higher than recommended dosage or for a prolonged time.
When drinking alcoholic beverages during the treatment period.
When taking other medicines that affect liver function.
The patient should be informed not to take other medicines to reduce fever
and relieve pain, or cold medicines, without consulting a doctor or pharmacist,
in order to prevent paracetamol overdose/toxicity.
Avoid taking a high dosage (within the recommended limits) of this medicine
Coldexshould not be used with other antihistamine containing products such as
antihistamine containing cough and cold medicines- see also Contraindications .
Duetotheantihistaminecontent, Coldex may cause epigastric distress, and
therefore should preferably be taken after meals to diminish gastric irritation.
Accidentalpoisoningcanoccurdueto the paracetamol content; this may take place
in toddlers and infants. Paracetamol-containing products should be kept well outof
reach of children.
Thisproductshouldbeadministeredwith care to patients with impaired kidney or
Potentially fatal hepatotoxicity can result from paracetamoloverdosage.However,in
rarecases,hepatotoxicityhas occurred in patients receiving high or excessive doses
within therapeutic doses. Certain patients may be more susceptible toparacetamol
hepatotoxicity,e.g.,chronicalcoholics, patients with liver disease, or those who are
malnourished or taking other drugs that induce hepatic enzymes.
Because of the risk of heptotoxicity, patientsshouldbecautionedagainstthe
inadvertent administration of excessive doses of paracetamol by using multiple
paracetamol-containing product at once, such as coughandcoldremedies,
analgesics or arthritic formulations, antipyretics or products for relief of menstrual
symptoms or muscle spasm. Administration of paracetamol to children may be
especially prone to error due to the many concentrations and strengthsofproducts
available. To avoid dosing errors, all product labels should be checked carefullyto
ensure calculation of the amount of paracetamol to be given.
Medical advice should be sought before using this product in patients with these
Occlusive vascular disease (e.g. Raynaud's phenomenon)
This product should not be used by patients taking other sympathomimetics (such as
decongestants, appetite suppressants and amphetamine-like psychostimulants)
The doctor should be consulted prior to performing any type of surgery .
Consumption of large quantities of products containing caffeine (like coffee and tea)
may reactivate preexisting duodenal ulcers. High caffeine intake can cause difficulty in
sleeping, shaking , and uncomfortable feeling in the chest .
This product contains lactose and may cause allergy in individuals who have
intolerance to some sugars)
Use in Pregnancy
Safety of use in pregnancy has not been established.
There are no adequate data for the use ofchlorphenamineinpregnantwomen,the
potential risk in humans is unknown. Use during the third trimester mayresultin
reactions in the newborn or premature neonates
This product is not recommended for use in pregnancyduetothephenylephrineand
caffeine content. There is a potential increased risk of lower birth weight and
spontaneous abortion associated with caffeine consumption during pregnancy.
Use in Breastfeeding
Chlorphenamine maleate and other antihistamines may inhibit lactation andmaybe
secreted into the breast milk
. Caffeine in breast milk may have a stimulating effect on breast-fed infants .
Phenylephrine may be excreted in breast milk
The elderly are more likely to exhibit adverse reactions.
Adverse reactions to Coldex are usually mild, and ingeneralareduetothe
antihistamine component. These may include drowsiness,nervousness,restlessness,
dizziness, lassitude, giddiness, epigastric distress, dryness ofmouth,blurredvision,
cardiacpalpitations,flushing,increased irritability or excitement (especially in
children).Otheradversereactions (related to caffeine) include: nausea, abdominal
pain, and diarrhea.
Adverse reactions According to Body System
Central Nervous System
Sedation, somnolence /insomnia, depression, extrapyramidal reactions, dizziness,
drowsiness,headache,disturbancein attention, disturbed coordination, confusion,
restlessness, excitation, nervousness,anxiety, tremor, irritability, insomnia,
paresthesias, neuritis, convulsions, euphoria, hallucinations, hysteria, faintness.
Acute labyrinthitis, blurred vision, diplopia, vertigo, tinnitus.
Epigastric distress/abdominal pain, dyspepsia, dryness of mouth,mouthulcers,
sudden weight loss, anorexia, nausea, vomiting, diarrhea, constipation, sore throat.
Hypotension, headache, palpitations, tachycardia, extrasystoles, arrhythmias.
Urinary frequency, difficult urination, urinary retention, early menses.
Papillaryrenalfailurehasbeenreported following consumption of large amounts of
paracetamol.Renaltubularnecrosis has been associated occasionally with hepatic
injury produced by paracetamol overdose.
Thickeningofbronchialsecretions, tightness of chest and wheezing, nasal
stuffiness, dryness of nose and throat.
Hemolytic anemia, neutropenia, thrombocytopeniapurpura,leukopenia,
Hepatitis including jaundice, hepatotoxicity , hepatic dysfunction .
Skin and subcutaneous disorders:
Exfoliative dermatitis, rash, urticaria, photosensitivity,
Musculoskeletal and connective tissue disorders
Muscular twitching, muscular tremor , muscle weakness.
Renal: nephropathy, including
Hypersensitivity/Allergic Reactions:reactions including skin eruptions, skin rashes,
urticaria,photosensitivity, angioedema and Stevens Johnson syndrome, toxic
epidermal necrolysis, laryngeal edema, bronchospasm, and/or anaphylaxishave
occurredrarely. Dose-dependent cross-sensitivity to paracetamol may occur in
aspirin-sensitive asthmatics. Low initial doses of paracetamol (less than 1000mg)are
recommendedinthese patients, with monitoring for about 3 hours following initial
Other hypersensitivity reactions include:
Difficultybreathing; closing of the throat; swelling of lips, tongue, or face; or hives,
seizures; unusual behavior or hallucinations; or an irregular or fast heartbeat.
Less serious side effects may bemorelikelytooccur:dizziness,lightheadedness,or
drowsiness; headache; insomnia; anxiety ; tremor(shaking)orrestlessness;
increased blood pressure, diarrhoea, nausea or vomiting; or sweating.
Miscellaneous adverse reactions
Fatigue, chills,, fever.
AdverseReactionsidentifiedduring post-marketing use for combination products
containing paracetamol, caffeine, and phenylephrine HCl are listed below.The
frequencyof these reactions is unknown
Mydriasis,acuteangleclosure glaucoma, most likely to occur in those with closed
Skin and subcutaneous disorders
Allergic reactions (e.g. rash, urticaria, allergic dermatitis).
Hypersensitivityreactions– including that cross-sensitivity may occur with other
Renal and urinary disorders
Dysuria,urinaryretention.Thisismostlikely to occur in those with bladder outlet
obstruction, such as prostatic hypertrophy.
Coldex/Alcohol/CNS Depressants (including Tricyclic Antidepressants):
Additive effects may take place when Coldex is used concurrentlywithalcoholor
otherCNSdepressants, e.g. hypnotics, sedatives, tranquilizers, antianxiety agents,
narcotic analgesics, anticonvulsants, general anesthetics, other antihistamines.
Coldex/Ototoxic Medications: Symptoms of ototoxicity may bemaskedifused
concurrently with ototoxic medications, particularly aminoglycosideantibioticssuchas
amikacin, dihydrostreptomycin, gentamicin, kanamycin, neomycin, streptomycin,
tobramycin, and viomycin.
Coldex/Anticholinergic Agents or OtherAgentsPossessingAnticholinergic Activity:
Concurrentusemayleadtoa potentiation of the anticholinergic effects (such as
atropine).Thereforecaution should be exercised and patients should be advised to
promptly report occurrence of gastrointestinal problems, since paralytic ileusmay
occur upon concurrent therapy of antihistamines and anticholinergic agents.
Coldexd/Phenytoin : Phenytoin metabolism is inhibited by the chlorphenamine
component and this can cause phenytoin toxicity
Coldex/Oral Anticoagulants :Regularadministrationof Coldex may enhance the
activityofcoumarinanticoagulants(due to the paracetamol content) when given
concurrently. Occasional doses have no significant effect.
Coldex/HepaticEnzyme-Inducing Agents (e.g., Barbiturates, Carbamazepine,
Phenytoin)/ Hepatotoxic Medications/Alcohol: Concurrent administration of enzyme
inducers may decrease the therapeutic effect ofparacetamolintheproduct,probably
because of increased metabolism resulting frominductionofhepaticmicrosomal
The risk of hepatotoxicity with single toxic doses or prolongeduseofhighdosesof
paracetamolmaybeincreasedin patients consuming alcoholic beverages or in
patients taking other hepatotoxic medications.
Coldex/Salicylates/Other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): Chronic
high-dose administration of paracetamol withsalicylatesand/orothernon-steroidal
anti-inflammatory drugs increases the risk of analgesic nephropathy.
Coldex/Zidovudine: Theparacetamolcomponent may competitively inhibit the hepatic
glucuronidation and decrease the clearance of zidovudine. Zidovudine may also
inhibitthehepatic glucuronidation of paracetamol. Concurrent use should be avoided,
because the toxicity of either or both medications may be potentiated.
Coldex/Lopinavir :Lopinavir may increase the plasma concentration of
Colex/Cholestyramine: Cholestyraminemayreduce the absorption of paracetamol.
Oral doses of cholestyramine and paracetamol should be given at least 1 hour apart.
Coldex/Metoclopramide/Domperidone: The speed of absorption of paracetamol may
be increased by metoclopramide or domperidone.
Coldex/MAO inhibitors: Concurrentusemay prolong and intensify the anticholinergic
effects of antihistamines and the effectsofsympathomimetics. Severe hypertensive
reactions may occur when sympathomimeticsare given to patients receiving MAO
inhibitors (see Contraindications).
Coldex/Adrenergic Bronchodilators/Caffeine-Containing Medications/Caffeine-
ContainingBeverages: Due to the caffeine content of thepreparation,concomitant
administration may result in additive CNS stimulation.
Coldex/Anticholinergic Agents or OtherAgents Possessing Anticholinergic Activity:
Because of the antihistamine component present in Coldex, concurrentusemaylead
to a potentiation of the anticholinergic effects. Therefore caution should beexercised
andpatientsshould be advised to promptly report occurrence of gastrointestinal
problems, since paralytic ileus may occur upon concurrenttherapyofantihistamines
and anticholinergic agents.
Coldex/Bronchodilators/Caffeine Containing Beverages : Due to the caffeine content
concomitant administration may result in additive CNS stimulation.Toomuchcaffeine
maycausenervousness, irritability, sleeplessness, and, occasionally, rapid heart
Coldex/ -Blockers: -Blockers increase the effects of sympathomimetics.
Coldex/ -Blockers:The vasopressor response to phenylephrine is decreased by prior
administration of an adrenergic blocking agent
Coldex/Oxytocic Drugs : When a vasopressor, e.g. phenylephrine,isusedin
conjunction with oxytocic drugs, the pressor effect is potentiated.
Coldex/Sympathomimetic Agents: Combination products containing phenylephrine and
a bronchodilator sympathomimetic agent should not be used concomitantly with
epinephrine or other sympathomimetic agents (such as decongestants, appetite
suppressants and amphetamine-like psychostimulants) because tachycardia or other
serious arrhythmias may occur.
Coldex/General Anesthetics: Rarely, administration of phenylephrine to patientswho
havereceivedcyclopropane or halogenated hydrocarbon general anesthetics that
increase cardiac irritability and seem to sensitize the myocardium tophenylephrine
mayresultinarrhythmias.Vasopressorsshould therefore be used only with extreme
caution or not at all with these general anesthetics.
Coldex/Monoamine Oxidase (MAO) Inhibitors : Thecardiacand pressor effects of
phenylephrine are potentiatedbyadministration of monoamine oxidase (MAO)
inhibitorsbecausemetabolism of phenylephrine is reduced. Oral administration of
phenylephrineto patients receiving a MAO inhibitor should be avoided. In addition,
concurrentadministrationmayprolong and intensify the anticholinergic (drying) effects
of the antihistaminic component. Therefore concurrent useofColdexwithmonoamine
oxidase (MAO) inhibitor therapy or within 14days of discontinuation of such therapyis
contraindicated (see Contraindications).
Coldex/Tricyclic Antidepressants : Tricyclic antidepressants may potentiate the
vasopressor effects of phenylephrine component.
Coldex/Atropine : Atropine sulfate may block the reflex tachycardia caused by
phenylephrine and enhances the pressor response to phenylephrine.
Coldex/Injectable Ergot Alkaloid :An excessive rise in blood pressure may occur if
phenylephrine-containing product is administered to patients receiving aparenteral
injection of an ergot alkaloid such as ergonovine maleate.
Coldex/Digitalis :Thepossibilitythat digitalis can sensitize the myocardium to the
effects of sympathomimetic drugs should be considered.
Coldex/ Furosemide or OtherDiuretics : Administration of furosemide or other diuretics
may decrease arterial responsiveness to vasopressors such as phenylephrine.
Duetothe antihistamine component, Coldex should be discontinued about 4 days
prior to skin testing procedures, since it maypreventotherwisepositivereactionsto
dermal reactivity indicators.
The paracetamol component in this product may produce false-negativetestresults
for urinary 5-hydroxy- indoleacetic acid.
Dosage and Administration
Adults:1 tablet or caplet every 4 hours, with meals.
Children 6-12 Years of Age: 1 tablet or caplet, 3 times daily.
Symptomsofparacetamoloverdosagein the first 24 hours are pallor, nausea,
vomiting,anorexia,and abdominal pain. Abnormalities of glucose metabolism and
metabolicacidosismay occur. In severe poisoning, hepatic failure may progress to
encephalopathy, coma and death. Acute renal failure with acutetubularnecrosismay
develop even in the absence of severe liver damage. Cardiac arrhythmiasand
pancreatitis have been reported.
In massive overdosage, paracetamol may cause hepatic toxicity. In adultsand
adolescents, hepatic toxicity has been rarely reported following ingestion ofacute
overdoseoflessthan7.5–10g. Fatalities are infrequent (less than 3-4% of untreated
cases)andhavebeenrarelyreported with overdoses of less than 15 g. Early
symptomsfollowingapotentiallyhepatotoxic overdose may include nausea, vomiting,
stomach pain, diaphoresis, and general malaise. Clinicalandlaboratoryevidenceof
hepatic toxicity may not be apparent until 48-72 hours post-ingestion.
Serious toxicity or fatalities are extremely infrequent in children, possibly due to
differencesinthewaythey metabolize paracetamol. An acute overdosage of less than
150 mg/kg bodyweight in children has not been associated with hepatic toxicity.
Adults and Adolescents
Regardless of the quantity of paracetamol reported orassumedtohavebeen
ingested, N-acetylcysteine should be administered immediately, if 24 hours or less
have elapsed from the time of ingestion.
An initial dose of 150 mg N-acetylcysteine/kg bodyweightisinfusedI.V.in200ml
of 5% Dextrose Injection over 15 minutes. This is followed by I.V infusion of 50 mg
N-acetylcysteine/kg body weight in 500 ml of 5% Dextrose Injectionoverthenext4
hours,and 100 mg N-acetylcysteine/kg body weight in 1 liter of 5% Dextrose Injection
over the next 16 hours (providing a total dose of 300mg/kgbodyweightofN-
acetylcysteine over 20 hours).
In addition to N-acetylcysteine administration, it is recommended that the stomach
be emptied promptly by lavage, or by induction of emesis with syrup of ipecac.
A serum paracetamol assay should be obtained as early as possible, but not less
than 4 hours following ingestion. If plasma level falls above the lower treatment lineon
the paracetamol overdose nomogram, acetylcysteine therapy should be continued.
Liver function tests should be performed initially, and repeated at 24-hour intervals.
Induce emesis using syrup of ipecac.
A serum paracetamol assay should be obtained as soon as possible, but not less
than 4 hours following ingestion.
Ifmorethan150mg/kg body weight or an unknown amount was ingested, plasma
paracetamol level should be obtained.
The plasma paracetamol level should be obtained as soonaspossible,butno
soonerthan4 hours following ingestion. If plasma level falls above the lower
treatment line on the paracetamol overdose nomogram, theacetylcysteinetherapy
should be initiated and continued for a full course of therapy. Ifaparacetamolassayis
not available and the paracetamol ingestion exceeds 150 mg/kg body weight,N-
acetylcysteine therapy should be initiated and continued for a full course.
Thedosageandadministration of N-acetylcysteine in children is the same as
recommended for adults and adolescents. However, thequantityofI.V.fluidusedin
children should be modified, taking into account both age and weight.
For Chlorpheniramine Maleate
Antihistamineoverdosagereactionsmay vary from central nervous system
depressiontostimulation,especiallyin children. Atropine-like signs and symptoms
suchasdrymouth,fixeddilated pupils and flushing, as well as gastrointestinal
symptoms, may occur.
There is no specific therapy for acute overdosage with antihistamines.General
symptomatic and supportive measures should be instituted promptlyandmaintained
for as long as necessary.
Vomiting should be induced even though it may haveoccurredspontaneously.Ifthe
patientisunabletovomit, gastric lavage is indicated. Isotonic saline is the lavage of
choice.Adequateprecautionsmust be taken to protect against aspiration, especially
in infants and children.
Charcoal slurry or another suitable agent should be instilled intothestomachafter
vomiting or lavage. Saline cathartics or milk of magnesia may be of additional benefit.
The airway should be secured with a cuffed endotracheal tube beforeattemptingto
evacuate the gastric contents. Intensive supportive and nursingcareareindicated,as
for any comatose patient.
Do not administer CNS stimulants.
Hypotension is an early sign of impending cardiovascular collapse. If a vasopressor
agentisneeded, noradrenaline, phenylephrine or dopamine is indicated. Use of
adrenaline should be avoided since it mayworsenhypertension.Incaseof
convulsions, diazepam may be used and repeated as necessary.
Whenlife-threateningCNSsigns and symptoms are present, intravenous
physostigmine salicylate may be considered.
Ice packs and cooling sponge baths, but not alcohol, can help in reducing the fever
commonly observed in children.
Hemoperfusion may be used in severe cases.
Overdose of caffeine may result in epigastric pain, vomiting, diuresis, tachycardia or
cardiac arrhythmia, CNS stimulation (insomnia, restlessness, excitement, agitation,
jitteriness, tremors and convulsions).
It must be noted that for clinically significant symptoms of caffeine overdose to occur
with this product, the amount ingested would be associated with serious paracetamol-
related liver toxicity.
No specific antidote is available, but supportive measures may be used.
Overdosage of phenylephrine may cause hypertension and possibly reflex
bradycardia, headache, seizures, cerebral hemorrhage, palpitations, paresthesia, or
vomiting. Headache may be a symptom of hypertension. In severe cases confusion,
hallucinations, seizures and arrhythymia may occur. However the amount required to
produce serious phenylephrine toxicity would be greater than that required to cause
paracetamol-related liver toxicity.
Hypertension may be relieved by administration of an -adrenergic blocking agent
Drug Registration No.:
Tablets: 069 84 28596 00
Caplets: 059 74 21484 00
Store in a dark place below 25 C.
Teva Pharmaceutical Industries Ltd
P.O.Box 3190, Petach Tikva.