Neozep Forte/Neozep Non-Drowsy

Neozep Forte/Neozep Non-Drowsy

Manufacturer:

UNILAB, Inc

Distributor:

UNILAB, Inc
Full Prescribing Info
Contents
Neozep Forte: Phenylephrine HCl, chlorphenamine maleate, paracetamol.
Neozep Non-Drowsy: Phenylephrine HCl, paracetamol.
Description
Neozep Forte: Each tablet contains: Phenylephrine HCl 10 mg, Chlorphenamine Maleate 2 mg, Paracetamol 500 mg.
Neozep Non-Drowsy: Each tablet contains: Phenylephrine HCl 10 mg, Paracetamol 500 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.
Paracetamol is an effective fever reducer and pain reliever.
Neozep Forte: These medicines contain Phenylephrine HCl, Chlorphenamine Maleate and Paracetamol.
Chlorphenamine Maleate, an anti-allergy, relieves symptoms such as runny nose, sneezing, and itchy, watery eyes.
Neozep Non-Drowsy: This medicine contains Phenylephrine HCl and Paracetamol.
Indications/Uses
Neozep Forte: These 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 decongest sinus openings and passages.
Neozep Non-Drowsy: This medicine is used for the relief of clogged nose, postnasal drip, headache, body aches, and fever associated with the common cold, sinusitis, flu, and other minor respiratory tract infections. It also helps decongest sinus openings and passages.
Dosage/Direction for Use
Neozep Forte: These medicines should be taken orally (by mouth).
Dose of Phenylephrine HCl + Chlorphenamine Maleate + Paracetamol every 6 hours: Adults and Children 12 years and older: 1 tablet.
Or, as recommended by a doctor.
Neozep Non-Drowsy: Adults and Children 12 years and older: Orally, 1 tablet every 6 hours, or, as recommended by a doctor.
Missed dose: If the patient missed a dose, just take 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
Signs and Symptoms of 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.
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 liver damage. Quick medical attention is important for adults as well as for children even if they do not notice any signs or symptoms.
Neozep Forte: Chlorphenamine Maleate: Extreme sleepiness or prolonged drowsiness; Agitation; Weakness; Irritability; Hallucination; Tachycardia; Convulsion; Coma.
Contraindications
If the patient is allergic to any ingredient in the product.
If the patient has high blood pressure or severe heart disease unless recommended by a doctor.
If the patient has anemia, kidney or liver disease unless recommended by a doctor.
If the patient is pregnant or breastfeeding.
Special Precautions
Liver Warning: These products contain 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 a medicine contains Paracetamol, ask a doctor.
Ask a doctor before use if the patient has liver disease 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 the 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; Liver or kidney disease; An enlarged prostate, bladder problems or difficulty urinating.
Stop use and ask a doctor if: Fever gets worse or lasts more than 3 days; New symptoms occur.
Neozep Forte: May cause drowsiness; patients should observe caution while driving or performing other tasks requiring alertness.
Use In Pregnancy & Lactation
Contraindicated if the patient is pregnant or breastfeeding.
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.
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.
Neozep Forte: 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.
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.
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.
Tell the doctor about other medicines the patient is taking, especially other medicines for cough, cold, allergy, pain, or fever.
Neozep Forte: The absorption of Paracetamol may be accelerated by metoclopramide or domperidone and absorption reduced by cholestyramine.
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.
Presentation/Packing
Neozep Forte: Tab (green and white, elliptical-convex, 0.662" x 0.300" in diameter, two-layer tablet, debossed with "NEOZEP" on the green layer, and plain on the white layer) 4's, 500's.
Neozep Non-Drowsy: Tab (green, 0.662" x 0.300" elliptical-shaped plain tablet, debossed with "NEOZEP" on one side and plain on the other side) 4's, 100's.
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