Decolgen Forte/No-Drowse Decolgen

Decolgen Forte/No-Drowse Decolgen

Manufacturer:

UNILAB, Inc

Distributor:

UNILAB, Inc
Full Prescribing Info
Contents
Decolgen Forte: Phenylpropanolamine HCl, chlorphenamine maleate, paracetamol.
No-Drowse Decolgen:
Phenylpropanolamine (as hydrochloride), paracetamol.
Description
Decolgen Forte: Each tablet contains: Phenylpropanolamine HCl 25 mg, Chlorphenamine Maleate 2 mg, Paracetamol 500 mg.
No-Drowse Decolgen: Each tablet contains: Phenylpropanolamine (as Hydrochloride) 25 mg, Paracetamol 500 mg.
Action
This medicine contains Paracetamol, Phenylpropanolamine HCl or with Chlorphenamine Maleate.
Paracetamol is an effective fever reducer and pain reliever.
Phenylpropanolamine HCl, a nasal decongestant, clears obstructed and congested air passages making breathing easier. It decongests stuffy nose and clogged nasal sinuses.
Chlorphenamine Maleate, an anti-allergy, relieves symptoms of allergy such as runny nose, sneering, and itchy, watery eyes.
Indications/Uses
Decolgen 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.
No-Drowse Decolgen: 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
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: 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 and cardiomyopathy (disorder of the heart muscle) may develop.
IV. Recovery or progression to fatal complete liver failure.
Phenylpropanolamine HCl: Fast heart rate (tachycardia); Irregular heart beat (arrhythmia); High blood pressure; Excitation; Seizures; Enlargement of the pupils; Cases of heart attack, stroke, intracranial bleeding/cerebral hemorrhage (bleeding from ruptured blood vessel in the brain), and death have also been reported.
Chlorphenamine Maleate: Extreme sleepiness or prolonged drowsiness; Weakness; Hallucination; Convulsion; Agitation; Irritability; Tachycardia; Coma.
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.
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
Use with caution in patients with high blood pressure, toxic goiter, benign prostatic hypertrophy, heart rate irregularity, glaucoma, and in those taking antidepressants.
Patients with heart disease and uncontrolled/untreated high blood pressure should consult a doctor prior to taking Phenylpropanolamine.
Liver Warning: This product contains Paracetamol. Severe liver damage may occur if the patient takes: An adult or child 12 years and older takes more than 4g of paracetamols 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.
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 or kidney disease.
Ask a doctor before use if the patient is taking warfarin, a blood thinning medicine.
May cause drowsiness; patients should observe caution while driving or performing other tasks requiring alertness.
Do not take more than the recommended dose.
Do not use after the expiry date on the label.
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.
Use In Pregnancy & Lactation
These medicines are contraindicated if the patient is pregnant or breastfeeding.
Adverse Reactions
Paracetamol, when taken within the recommended dose and duration of treatment, has low incidence of side effects. Skin rashes and minor stomach and intestinal disturbances have been reported.
Decolgen Forte: Phenylpropanolamine may cause sudden, persistent, severe headache, nervousness, restlessness, insomnia/sleeplessness, dizziness, anxiety, confusion, high blood pressure, palpitation, chest tightness, tremor, agitation, irritability, aggressiveness (particularly in young children), nausea, and blurred vision.
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. Paracetamol, when taken within the recommended dose and duration of treatment. has low incidence of side effects. Skin rashes and minor stomach and intestinal disturbances have been reported.
No-Drowse Decolgen: Phenylpropanolamine HCl: Psychiatric disorders: Aggressiveness (particularly in young children), anxiety (feeling of uneasiness), confusion, insomnia/sleep disturbance, nervousness.
Nervous system disorders: Agitation, dizziness, restlessness; sudden, persistent, severe headache, tremor (muscle shaking).
Eye disorders: Blurred vision.
Cardiac disorders: Chest tightness, palpitation.
Vascular disorders: High blood pressure.
Gastrointestinal disorders: Nausea.
General disorders and administration site conditions: Irritability.
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 skin reddening, blisters or rash.
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).
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.
Tell the doctor about other medicines the patient is taking, especially other medicines for cough, cold, allergy, pain, or fever.
Decolgen Forte: The absorption of Paracetamol may be accelerated by Metoclopramide or Domperidone and reduced by Cholestyramine.
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.
No-Drowse Decolgen: Combined use of phenylpropanolamine and caffeine may produce an additive increase in blood pressure. Severe, life threatening, and occasionally fatal hypertensive reactions have been reported.
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.
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
Decolgen Forte tab
Packing/Price
100's (P7.5/tab)
Form
No-Drowse Decolgen tab
Packing/Price
100's (P8.25/tab);5's (P8.25/tab)
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