Neozep Z+ Forte/Neozep Z+ Non-Drowsy

Neozep Z+ Forte/Neozep Z+ Non-Drowsy

Manufacturer:

UNILAB, Inc

Distributor:

UNILAB, Inc
Full Prescribing Info
Contents
Neozep Z+ Forte: Phenylephrine hydrochloride, chlorphenamine maleate, paracetamol, zinc.
Neozep Z+ Non-Drowsy: Phenylephrine hydrochloride, paracetamol, zinc.
Description
Neozep Z+ Forte: Phenylephrine HCl + Chlorphenamine maleate + Paracetamol + Zinc (Neozep Z+ Forte) Tablet is a green and yellow with white speckle, elliptical-convex, 0.662" x 0.300" in diameter, two-layer tablet, debossed with "NEOZEP" on the green layer and plain on the yellow layer.
Each tablet contains: Phenylephrine HCl 10 mg, Chlorphenamine maleate 2 mg, Paracetamol 325 mg, Zinc 10 mg (equivalent to 27.446 mg Zinc Sulfate Monohydrate).
Neozep Z+ Non-Drowsy: Phenylephrine HCl + Paracetamol + Zinc (Neozep Z+ Non-Drowsy) Tablet is a green with white speckle, 0.662" x 0.300" elliptical-shaped plain tablet, debossed with "NEOZEP" on one side and plain on the other side.
Each tablet contains: Phenylephrine HCl 10 mg, Paracetamol 325 mg, Zinc 10 mg (equivalent to 27.446 mg Zinc Sulfate Monohydrate).
Action
Pharmacology: 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.
Zinc is an essential mineral required for the normal development and maintenance of the immune system. It helps regulate the activity of cells involved in immune function. Zinc may also help in alleviating symptoms reducing the severity and progression, leading to shorter duration of common cold.
Neozep Z+ Forte: This medicine contains phenylephrine HCl, chlorphenamine maleate, paracetamol and zinc.
Chlorphenamine maleate, an anti-allergy, relieves symptoms such as runny nose, sneezing, and itchy, watery eyes.
Phenylephrine HCl + chlorphenamine maleate + paracetamol + zinc, 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.
Phenylephrine HCl + chlorphenamine maleate + paracetamol + zinc is expected to start taking effect in as fast as 15 minutes.
Neozep Z+ Non-Drowsy: This medicine contains phenylephrine HCl, paracetamol and zinc.
Phenylephrine HCl + paracetamol + zinc, 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.
Phenylephrine HCl + paracetamol + zinc is expected to start taking effect in as fast as 15 minutes.
Indications/Uses
Neozep Z+ Forte: 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. It also provides zinc for treatment and prevention of mineral deficiency.
Neozep Z+ 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 and protect respiratory cells against common cold and flu viruses. It also provides zinc for treatment and prevention of mineral deficiency.
Dosage/Direction for Use
Adults: Orally, 1 tablet every 6 hours, or as recommended by a doctor.
Missed dose: If the patient misses a dose, 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
Phenylephrine HCl: Increased blood pressure; Headache; Seizures; Palpitation; Paresthesia (sensation of tingling, pricking, or numbness of the skin); Vomiting; Cerebral hemorrhage (bleeding from a ruptured blood vessel in the brain).
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 failure (e.g., jaundice) and possibly kidney failure and cardiomyopathy (disorder of the heart muscle) may develop.
Recovery or progression to fatal complete liver failure.
Zinc: Signs of acute zinc toxicity (doses >200 mg daily) include gastrointestinal pain/cramps, nausea, vomiting, and diarrhea, loss of appetite, headache, lethargy (sleepiness), muscle pains, and fever.
Prolonged zinc supplementation may cause impairment of copper and iron status, and anemia at doses >50 mg/day; immune deficiency, reduced blood high-density lipoprotein (HDL) levels, and gastric erosion at doses >150 mg daily.
Long-term (average 6.3 years) ingestion of supplemental zinc (80 mg/day) has also been linked to a significant increase in hospitalizations for urinary tract infections and kidney stones.
When the patient has taken more than the recommended dose: 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 seem 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.
Neozep Z+ Forte: Chlorphenamine maleate: Extreme sleepiness or prolonged drowsiness; Weakness; Hallucination; Convulsion; Agitation; Irritability; Tachycardia; Coma.
Contraindications
If the patient is allergic to any ingredient of 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.
Warnings
Liver Warning: This product contains paracetamol. Severe liver damage may occur if the patient takes: More than 4 g of paracetamol in 24 hours, which is the maximum daily amount.
With other medicines containing paracetamol (or acetaminophen).
3 or more alcoholic drinks everyday while using this product.
Special Precautions
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 active ingredients, ask a doctor.
This product provides the maximum daily intake of zinc when taken at the recommended dose of four times a day. To avoid excessive intake, refrain from using other supplements or medicines containing zinc. If the patient is not sure whether a medicine contains zinc, 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.
Do not use after the expiry date on the label.
When to 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 Z+ Forte: May cause drowsiness; patients should observe caution while driving or performing other tasks requiring alertness.
Adverse Reactions
Phenylephrine HCl: Psychiatric disorders: Anxiety, insomnia/sleeplessness, nervousness.
Nervous system disorder: Dizziness, restlessness, tremor (muscle shaking).
Cardiac disorders: Arrythmia (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.
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.
Zinc: Metabolism and nutrition disorders: Loss of appetite.
Psychiatric disorders: Drowsiness.
Nervous system disorders: Headache, metallic taste.
Gastrointestinal disorders: Abdominal pain/cramps, diarrhea, dyspepsia, gastritis, gastrointestinal discomfort/irritation, nausea, vomiting.
Neozep Z+ Forte: Chlorphenamine maleate: Chlorphenamine maleate may cause sleepiness and drowsiness.
Psychiatric disorders: Insomnia/sleepiness, 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.
Drug Interactions
Do not use this product together with sympathomimetic agents (e.g., epinephrine) and general anesthetics (e.g., halothane) because of the possibility for increased toxicity.
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.
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.
Zinc decreases the absorption of certain antibiotics such as quinolones (e.g., ciprofloxacin, levofloxacin, ofloxacin) and tetracyclines (e.g., doxycycline, tetracycline). Zinc salts should be given 2 hours after or 6 hours before antibiotics.
Concomitant intake of a bisphosphonate (e.g., alendronate, etidronate, risedronate) and zinc may decrease the absorption of both the bisphosphonate and zinc.
Zinc inhibits the absorption of copper and iron. Administer zinc and copper or iron as far apart as possible.
Additive effects are possible with concurrent administration of zinc and cholesterol medicines; use with caution.
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).
Neozep Z+ Forte: Medicines that cause sedation such as anxiolytics (e.g., alprazolam, diazepam) and hypnotics (e.g., zolpidem) may potentiate drowsiness.
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.
Presentation/Packing
Form
Neozep Z+ Forte tab
Packing/Price
10's (P7/tab);500's (P7/tab)
Form
Neozep Z+ Non-Drowsy tab
Packing/Price
100's (P7.75/tab)
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