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
Each 5 mL (1 teaspoonful) syrup contains: phenylpropanolamine HCl 2.5 mg, chlorphenamine maleate 0.5 mg and paracetamol 125 mg.
Each mL syrup (oral drops) contains: phenylephrine HCl 1 mg and chlorphenamine maleate 0.8 mg.
Action
Nasal decongestant; antihistamine.
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.
Paracetamol is an effective fever reducer and pain reliever.
Indications/Uses
This medicines are 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. They also help decongestant sinus openings and passages.
Dosage/Direction for Use
This medicine should be taken orally (by mouth) every 6 to 8 hours, or, as recommended by a doctor.
Syrup: see Table 1.

Click on icon to see table/diagram/image

Drops: see Table 2.

Click on icon to see table/diagram/image

Missed dose: If the 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).
Chlorphenamine maleate: Extreme sleepiness or prolonged drowsiness, agitation, weakness, irritability, hallucination, tachycardia, convulsion, coma.
Syrup: Paracetamol: Overdosage of paracetamol usually involves 4 phases with the following signs and symptoms: I. Eating disorder, nausea, vomiting, malaise, and excessive sweating.
II. 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.
III. Eating disorder, nausea, vomiting, and malaise recur and signs of liver (e.g., jaundice) and possibly kidney failure.
IV. Recovery or progression to fatal complete liver failure.
If the patient 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 damage. Quick medical attention is important for adults as well as for children even if the patient does not notice any signs or symptoms.
Contraindications
Do not give this medicine if the patient: Is allergic to any ingredients in the product; Has high blood pressure or severe heart disease unless recommended by a doctor.
Syrup: If the patient has anemia, kidney or liver disease unless recommended by a doctor; If the patient is pregnant or breastfeeding.
Special Precautions
May cause drowsiness. Patients should observe caution while driving or performing other tasks requiring alertness.
Syrup: Liver warning: This product contains Paracetamol. Severe liver damage may occur if: A child takes more than 5 doses in 24 hours, which is the maximum daily amount of Paracetamol; an adult takes more than 4 g of Paracetamol in 24 hours, which is the maximum daily amount; taken with other medicines containing Paracetamol (or Acetaminophen); an adult has 3 or more alcoholic drinks everyday while using these products.
Do not use with any other medicine containing Paracetamol (prescription or nonprescription). If the patient is not sure whether medicine contains Paracetamol, 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.
Do not take more than the recommended dose.
Consult a doctor: Before taking this medication, tell the doctor if the patient has: High blood pressure or any type of heart problems, glaucoma, thyroid problems, diabetes, bladder problems or difficulty urinating. Syrup: Liver or kidney disease, an enlarged prostate.
Stop use and ask a doctor if: Fever gets worse or lasts more than 3 days, new symptoms occur.
Adverse Reactions
Phenylephrine HCl may cause tremor (muscle shaking), restlessness, anxiety (feeling of uneasiness), insomnia/sleeplessness, nervousness, dizziness, increased blood pressure, palpitation, arrhythmia (irregular heart beat), 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.
Syrup: Paracetamol, when taken within the recommended dose and duration of treatment, has low incidence of side effects. Skin rashes, hypersensitivity reactions, changes in the number of white blood cells and platelets, and minor stomach and intestinal disturbances have been reported.
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.
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.
Syrup: The absorption of Paracetamol may be accelerated by metoclopramide or domperidone and absorption reduced by cholestyramine. Medicines which stimulate the enzymes responsible for the metabolic activation of Paracetamol such as medicines for convulsion (e.g., Phenobarbital, etc.) may increase susceptibility to the harmful effects to the liver.
Warfarin, a blood thinning medicine; an increase in the International Normalized Ratio (INR), which may serve as a sign of increased risk for bleeding, may be observed when using Paracetamol and warfarin at the same time. Paracetamol increases the anticoagulation effect of Warfarin.
Storage
Store at temperatures not exceeding 30°C.
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
Syr (dark pink, clear with fruity strawberry odor and candy strawberry taste) 60 mL. Oral drops (red, clear syrup with fruity strawberry odor and candy strawberry taste) 10 mL.
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in