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Neozep

Neozep

Manufacturer:

UNILAB, Inc

Distributor:

UNILAB, Inc
Full Prescribing Info
Contents
Syr: Phenylephrine hydrochloride, chlorphenamine maleate, paracetamol.
Oral drops: Phenylephrine hydrochloride, chlorphenamine maleate.
Description
Syr: Phenylephrine HCl + Chlorphenamine maleate + Paracetamol (Neozep) Syrup is a dark pink, clear syrup with fruity strawberry odor and candy strawberry taste.
Each 5 mL (1 teaspoonful) syrup contains: Phenylephrine HCl 2.5 mg, Chlorphenamine maleate 0.5 mg, Paracetamol 125 mg.
Oral drops: Phenylephrine HCl + Chlorphenamine maleate (Neozep) Syrup (Oral Drops) is a red, clear syrup with fruity strawberry odor, and candy strawberry taste.
Each mL syrup (oral drops) contains: Phenylephrine HCl 1 mg, Chlorphenamine maleate 0.8 mg.
Action
Phenylephrine HCl, a nasal decongestant, clears obstructed air passages and nasal sinuses due to congestion making breathing easier. It also reduces postnasal drip.
Chlorphenamine maleate, an anti-allergy, relieves symptoms such as runny nose, sneezing, and itchy, watery eyes.
Syr: This medicine contains phenylephrine HCl, chlorphenamine maleate, and paracetamol.
Paracetamol is an effective fever reducer and pain reliever.
Phenylephrine HCl + chlorphenamine maleate + paracetamol, in an in vitro study (outside the living organism), was shown to maintain respiratory cell viability (ability to retain healthy cells) during viral infection which may aid in the recovery from viral infection/illness.
Oral drops: This medicine contains Phenylephrine HCl and Chlorphenamine maleate.
Indications/Uses
Syr: This medicine is used for the relief of clogged nose, runny nose, postnasal drip, itchy and watery eyes, sneezing, headache, body aches, and fever associated with the common cold, allergic rhinitis, sinusitis, flu, and other minor respiratory tract infections. It also helps decongest sinus openings and passages and protect respiratory cells against common cold and flu viruses.
Oral drops: This medicine is used for the relief of clogged nose, runny nose, postnasal drip, itchy and watery eyes, and sneezing associated with the common cold, allergic rhinitis, sinusitis, and other minor respiratory tract infections. It also helps decongest sinus openings and passages.
Dosage/Direction for Use
Syr: This medicine should be taken orally (by mouth). (See Table 1.)

Click on icon to see table/diagram/image

Oral drops: This medicine should be taken orally (by mouth) every 6 to 8 hours or, as recommended by a doctor. (See Table 2.)

Click on icon to see table/diagram/image

Missed dose: If the patient/child misses a dose, just give the next dose if still needed for the condition being treated, and the subsequent doses at the recommended time or schedule (i.e., every 6 hours).
Do not double the dose.
Overdosage
Phenylephrine HCl: Increased blood pressure, palpitation, vomiting, headache, paresthesia (sensation of tingling, pricking or numbness of the skin), cerebral hemorrhage (bleeding from a ruptured blood vessel in the brain), seizures.
Chlorphenamine maleate: Extreme sleepiness or prolonged drowsiness, agitation, weakness, irritability, hallucination, tachycardia, convulsion, coma.
Syr: Paracetamol: Overdosage of paracetamol usually involves 4 phases with the following signs and symptoms: Eating disorder, nausea, vomiting, malaise, and excessive sweating.
Right upper abdominal pain or tenderness, liver enlargement which may be characterized by abdominal discomfort of "feeling full", elevated bilirubin and liver enzyme concentrations, prolongation of prothrombin time, and occasionally decreased urine output.
Eating disorder, nausea, vomiting, and malaise recur and signs of liver (e.g., jaundice) and possibly kidney failure.
Recovery or progression to fatal complete liver failure.
When the patient has taken more than the recommended dosage: If the patient/child has taken more than the recommended dosage, consult a doctor or contact a poison control center right away, even if the patient seems well because of the risk of delayed, serious liver damage. Quick medical attention is important for adults as well as for children even if the patient does not notice any signs or symptoms.
Oral drops: If the child has taken more than the recommended dosage, consult a doctor.
Contraindications
Do not give this medicine if the patient/child: Is allergic to any ingredients in the product; Has high blood pressure or severe heart disease unless recommended by a doctor.
Syr: If the patient has anemia, kidney or liver disease unless recommended by a doctor; is pregnant or breastfeeding.
Special Precautions
May cause drowsiness.
Syr: Liver warning: This product contains paracetamol. Severe liver damage may occur if: An adult takes more than 4 g of paracetamol in 24 hours, which is the maximum daily amount;
A child takes more than 5 doses in 24 hours, which is the maximum daily amount of paracetamol;
Taken with other medicines containing paracetamol (or acetaminophen);
An adult has 3 or more alcoholic drinks everyday while using this product.
Allergy Alert: Paracetamol may cause severe skin reactions. Symptoms may include: Skin reddening; Blisters; Rash.
If a skin reaction occurs, stop use and seek medical help right away.
Do not use with any other medicine containing phenylephrine, chlorphenamine or paracetamol (prescription or nonprescription).
If the patient is not sure whether a medicine contains these three active ingredients, ask a doctor.
Ask a doctor before use if the patient has liver or kidney disease.
Ask a doctor before use if the patient is taking warfarin, a blood thinning medicine.
Patients should observe caution while driving or performing other tasks requiring alertness.
Do not take more than the recommended dose.
Consult a doctor: Syr: Before taking this medication, tell the doctor if the patient has: High blood pressure or any type of heart problems; Liver or kidney disease; Glaucoma; An enlarged prostate, bladder problems or difficulty urinating; Thyroid problems; Diabetes.
Stop use and ask a doctor if: Fever gets worse or lasts more than 3 days;
New symptoms occur.
Oral drops: Before giving this medication, tell the doctor if the child has: High blood pressure or any type of heart problems; Glaucoma; Thyroid problems; Diabetes; Bladder problems or difficulty urinating.
If symptoms do not improve or new symptoms appear.
Adverse Reactions
Syr: Phenylephrine HCl: Psychiatric disorders: Anxiety, insomnia/sleeplessness, nervousness.
Nervous system disorders: Dizziness, restlessness, tremor (muscle shaking).
Cardiac disorders: Arrhythmia (irregular heart beat), palpitation.
Vascular disorders: Increased blood pressure, pallor.
Respiratory, thoracic and mediastinal disorders: Respiratory distress (noisy, congested breathing).
General disorders and administration site conditions: Weakness.
Chlorphenamine maleate: Chlorphenamine maleate may cause sleepiness and drowsiness.
Psychiatric disorders: Insomnia/sleeplessness, nervousness.
Nervous system disorders: Facial dyskinesia (involuntary repetitive movements of the mouth and face), faintness, headache, paresthesia (sensation of tingling, pricking or numbness of the skin), tremor (muscle shaking).
Eye disorders: Blurred vision, diplopia (double vision), visual disturbance.
Ear and labyrinth disorders: Acute labyrinthitis (inflammation of the labyrinth), tinnitus (ringing in the ears), vertigo.
Cardiac disorders: Chest tightness.
Vascular disorders: Increased or decreased blood pressure.
Respiratory, thoracic and mediastinal disorders: Thickening of bronchial secretions, nasal stuffiness, wheezing (high-pitched whistling sound during breathing).
Gastrointestinal disorders: Constipation, diarrhea, gastrointestinal discomfort, nausea, vomiting.
Musculoskeletal and connective tissue disorders: Muscle weakness.
Renal and urinary disorders: Difficulty urinating.
Reproductive system and breast disorders: Early menses, impotence.
General disorders and administration site conditions: Chills, dryness of the mouth, nose, and throat; irritability, sweating.
Paracetamol: Paracetamol, when taken within the recommended dose and duration of treatment, has low incidence of side effects.
Blood and lymphatic system disorders: Changes in the number of white blood cells and platelets such as agranulocytosis (decrease in the number of granulocytes), leukopenia (decrease in the number of leukocytes), neutropenia (decrease in the number of neutrophils), pancytopenia (deficiency of all cellular elements in the blood), thrombocytopenia (decrease in the number of platelets).
Immune system disorders: Allergic reactions which may cause difficulty in breathing, skin rash, angioedema (swelling of the face or throat).
Gastrointestinal disorders: Minor stomach and intestinal disturbances.
Skin and subcutaneous tissue disorders: Rare cases of serious skin reactions (i.e., Stevens-Johnson syndrome, toxic epidermal necrolysis and acute generalized exanthematous pustulosis) which may include symptoms such as reddening of the skin, rash, blisters and detachment of the upper surface of the skin have been reported with paracetamol.
Oral drops:
Phenylephrine HCl may cause tremor (muscle shaking), restlessness, anxiety (feeling of uneasiness), insomnia/sleeplessness, nervousness, dizziness, increased blood pressure, palpitation, arrhythmia (irregular heartbeat), weakness, respiratory distress (noisy, congested breathing), and pallor.
Chlorphenamine Maleate may cause sleepiness and drowsiness. Other undesirable effects include muscle weakness, gastrointestinal discomfort, nausea, vomiting, diarrhea or constipation, dryness of the mouth, nose, and throat, difficulty urinating, ringing in the ears, visual disturbance, blurred vision, insomnia/sleeplessness, tremor, nervousness, irritability, chest tightness, increased or decreased blood pressure, and headache.
Drug Interactions
Do not use this product together with sympathomimetic agents (e.g., Epinephrine, etc.) and general anesthetics (e.g., Halothane, etc.) because of the possibility for increased toxicity.
Syr: Concurrent administration with medicines for depression such as monoamine oxidase (MAO) inhibitors (e.g., selegiline, moclobemide) and tricyclic antidepressants (e.g., amitriptyline, imipramine) may result in hypertensive crisis (sudden, severe increase in blood pressure that can lead to stroke).
Taking an alpha-adrenergic blocking agent (e.g., phenothiazine drugs, phentolamine) before the administration of this product may decrease the effect of phenylephrine.
Concomitant use with beta-adrenergic blocking agents (e.g., propranolol) and methyldopa may cause an increase in blood pressure.
Medicines that cause sedation such as anxiolytics (e.g., alprazolam, diazepam) and hypnotics (e.g., zolpidem) may potentiate drowsiness.
Paracetamol, when used together with warfarin (a blood-thinning medicine), may cause an increase in the International Normalized Ratio (INR), which may serve as a sign of increased risk for bleeding. Paracetamol increases the anticoagulation effect of warfarin.
Medicines which stimulate the enzymes responsible for the metabolic activation of paracetamol such as medicines for convulsion (e.g., phenobarbital, phenytoin) may increase susceptibility to the harmful effects to the liver.
The absorption of paracetamol may be accelerated by metoclopramide or domperidone and reduced by cholestyramine.
Tell the doctor about other medicines the patient is taking (i.e., other medicines for cough, cold, allergy, pain, or fever, especially other paracetamol-containing products).
Oral drops:
Concurrent administration with medicines for depression (e.g., Amitriptyline, Imipramine, Sertraline, Moclobemide, etc.) may result in hypertensive crisis (sudden, severe increase in blood pressure that can lead to stroke).
Taking an adrenergic-blocking agent (e.g., Phenothiazine drugs, Phentolamine, Propranolol, etc.) before the administration of this product may decrease the effect of phenylephrine.
Tell the doctor about other medicines the child is taking, especially other medicines for cough, cold, or allergy.
Storage
Store at temperatures not exceeding 30°C.
MIMS Class
Cough & Cold Preparations
ATC Classification
N02BE51 - paracetamol, combinations excl. psycholeptics ; Belongs to the class of anilide preparations. Used to relieve pain and fever.
R01BA53 - phenylephrine, combinations ; Belongs to the class of systemic sympathomimetic preparations used as nasal decongestants.
Presentation/Packing
Form
Neozep oral drops
Packing/Price
10 mL x 1's (P106/bottle)
Form
Neozep syr
Packing/Price
60 mL x 1's (P106/bottle)
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