| Paracetamol + Phenylephrine HCl + Chlorpheniramine maleate |
Sinutab® Cold Plus
500 mg/5 mg/2mg Film-Coated Tablet
Analgesic/Antipyretic/Nasal Decongestant/Antihistamine
Product Description
Paracetamol 500mg, Phenylephrine HCI 5mg and Chlorpheniramine maleate 2mg (Sinutab Cold plus) tablets are orange, film-coated, round tablets embossed with “N” on one side and plain on the other face.
What is in the Medicine and Strength of the Medicine?
Each tablet contains:
Paracetamol, Ph, Eur……………….……….. 500 mg
Phenylephrine HCI, BP……………………….. 5 mg
Chlorpheniramine maleate, PH, Eur………… 2mg
What is the Medicine used for?
- Temporarily relieves nasal and sinus congestion, sinus pressure, sinus pain, headache, runny nose, sneezing, itching of the nose or throat, itchy, watery eyes and minor aches and pains due to the common cold, flu, hay fever (allergic rhinitis), sinusitis and other respiratory allergies.
- Promotes nasal and/or sinus drainage.
- Fever reduction.
How much and how often should you use this Medicine?
Unless otherwise required by local authorities, these products should be administered as follows:
Adults and children 12 years and over:
Take 1 to 2 tablets (each tablet contains 2 mg chlorpheniramine, 500 mg paracetamol, 5 mg phenylephrine) every six hours as needed. Do not exceed 8 tablets (16 mg chlorpheniramine, 4000 mg paracetamol, 40 mg phenylephrine) within a 24-hour period.
Why should you not take this Medicine?
- Hypersensitivity to chlorpheniramine, paracetamol, phenylephrine or to any of the ingredients.
- Phenylephrine should not be used in patients taking monoamine oxidase inhibitors (MAOIs), or for 2 weeks after stopping MAOI drug. The concomitant use of these medications may cause a rise in blood pressure and hypertensive crisis.
Care that should be taken when taking this Medicine
- Patients with a respiratory condition such as emphysema, chronic bronchitis, bronchial asthma, or where cough is accompanied by excessive secretions or glaucoma should be advised to consult a physician before using this product.
- Paracetamol overdose warning: Taking more than the recommended dose (overdose) may result in liver damage. In case of overdose, get medical help immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- Paracetamol Alcohol warning: Chronic alcohol users should ask their physician whether they should take paracetamol or other pain relievers or fever reducers.
- Patients with hepatic disease should consult a physician before use.
- Serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), have been reported very rarely in patients receiving paracetamol. Patients should be informed about the signs of serious skin reactions and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
- Do not use with any other product containing paracetamol.
- Patients with heart disease, high blood pressure, thyroid disease, diabetes, difficulty in urination and/or enlargement of the prostate should not take phenylephrine unless directed by a physician.
- May cause drowsiness.
- While taking this product, avoid alcoholic beverages and consult a healthcare professional prior to taking with central nervous system (CNS) depressants. Chlorpheniramine may enhance the sedative effects of central nervous system depressants including alcohol, sedatives, and tranquilizers.
- If symptoms persist or get worse, or if new symptoms occur, patients should stop use and consult a physician.
Pregnancy and Lactation
There are no adequate and well-controlled studies in pregnant or breastfeeding women for the combination of chlorpheniramine, paracetamol and phenylephrine.
Chlorpheniramine
There are no adequate and well-controlled studies of chlorpheniramine in pregnant or breastfeeding women. It is not known whether chlorpheniramine or its metabolites are excreted in breast milk.
Paracetamol
There are no adequate and well-controlled clinical studies in pregnant or breastfeeding women for paracetamol. When given to the mother in labeled doses, paracetamol crosses the placenta into fetal circulation as early as 30 minutes after ingestion and is effectively metabolized by fetal sulfate conjugation. When taken as directed, paracetamol does not adversely affect the pregnant mother or fetus.
Paracetamol is excreted in breast milk in low concentrations (0.1% to 1.85% of the ingested maternal dose). Maternal ingestion of paracetamol in labeled doses does not present a risk to the nursing infant.
Phenylephrine
There are no adequate and well-controlled studies in pregnant and breastfeeding women. It is not known if phenylephrine or its metabolites are excreted in human milk.
This product should not be used during pregnancy or lactation unless the potential benefit of treatment to the mother outweighs the possible risks to the developing fetus or breastfeeding infant. Ask a physician before use if you are pregnant or breastfeeding.
Effects on Ability to Drive or Use of Machines
Use caution when driving a motor vehicle or operating machinery.
Undesirable Effects of the Medicine
Clinical Trial Data
Placebo-controlled studies with sufficient adverse event data were not available for the combination of chlorpheniramine, paracetamol and phenylephrine.
The following adverse events were reported by > 1% of subjects randomized, placebo-controlled trials with single-ingredient chlorpheniramine and phenylephrine: dizziness, somnolence, dry mouth, dyspepsia, pharyngitis, feeling jittery, headache, nausea and nasal dryness. The adverse events related to chlorpheniramine were dizziness, somnolence, dry mouth, dyspepsia, pharyngitis and feeling jittery. The adverse events related to phenylephrine were headache, nausea, and nasal dryness.
Post Marketing Data
Adverse drug reactions (ADRs) identified during post-marketing experience with chlorpheniramine, paracetamol, phenylephrine are included in Table 1 and 2. In these tables, the frequencies are provided according to the following convention:
Very common >1/10
Common >1/100 and < 1/10
Uncommon >1/1,000 and < 1/100
Rare >1/10,000 and < 1/1,000
Very rare <1/10,000
Not known (cannot be estimated from the available data)
In Table 1, the ADRs are presented with ADR frequency categories estimated from spontaneous reporting rates where numerator represents total number of reported Company AEs under given preferred term (PT) or medical concept and denominator represents exposure data calculated form sales data.
Table 1. Adverse Drug Reactions Identified During Post-Marketing Experience with Chlorpheniramine, Paracetamol, Phenylephrine by Frequency Category Estimated from Spontaneous Reporting Rates
| System Organ Classification Frequency Category |
Adverse Event Preferred Term |
| Immune System Disorders Not known Not known |
Anaphylactic reaction Hypersensitivity |
| Psychiatric Disorders Not known |
Nervousness |
| Nervous System Disorders Not known |
Insomnia |
| Gastrointestinal Disorders Not known Not known Not known |
Abdominal pain+ Diarrhea Vomiting |
| Skin and Subcutaneous Tissue Disorder Not known Not known Not known Not known |
Fixed eruption Rash Rash pruritic Urticaria |
| Investigations Not known Not known |
Heart rate increased Transaminases increased++ |
+ The ADR Abdominal pain includes cases reporting the PT Abdominal discomfort, Abdominal pain, and Abdominal pain upper.
++ Low level transaminase elevations may occur in some patients taking labeled doses of paracetamol; these elevations are not accompanied with liver failure and usually resolve with continued therapy or discontinuation of paracetamol
What other Medicine or Food should be avoided while taking This Medicine?
CNS DEPRESSANTS (ALCOHOL, SEDATIVES, TRANQUILIZERS) Chlorpheniramine may enhance the sedative effects of central nervous system depressants, including alcohol, sedatives, and tranquilizers.
MONOAMINE OXIDASE INHIBITORS (MAOIS)
Phenylephrine exerts its vasoconstricting properties by stimulating adrenergic receptors and displacing norepinephrine from neuronal storage sites. Since MAOIs impede the metabolism of sympathomimetic amines and increase the store of releasable norepinephrine in adrenergic nervous tissue, MAOIs may potentiate the pressor effect of phenylephrine.
WARFARIN-LIKE COMPOUNDS
For most patients, occasional use of paracetamol generally has little or no effect on the INR in patients on chronic warfarin therapy; however there has been controversy regarding the possibility of paracetamol potentiating the anticoagulant effects of warfarin and other coumarin derivatives. Consumers should be instructed to ask a physician or pharmacist before use if they are taking the blood thinning drug warfarin or other coumarin derivatives.
FLUCLOXACILLIN
High anion gap metabolic acidosis from pyroglutamic acid (5-oxoprolinemia) has been reported with concomitant use of therapeutic doses of paracetamol and flucloxacillin. Patients reported to be most at risk are elderly females with underlying disease such as sepsis, renal function abnormality, and malnutrition. Most patients improve after stopping one or both of the drugs. Consumers should be instructed to ask their health care provider before use if they are taking the antibiotic flucloxacillin.
What should you do if you miss a dose?
Continue medication based on dosage and/or consult your doctor.
Signs and Symptoms of Overdose
No overdose-associated ADRS were identified for the combination of chlorpheniramine, paracetamol, and phenylephrine from review of post-marketing safety data.
The information presented below describes overdose with the single active ingredients.
Chlorpheniramine
Overdose of an H1 receptor antagonist may result in depressed level of consciousness, hyperthermia, anticholinergic syndrome (mydriasis, flushing, pyrexia, dry mouth, urinary retention, gastrointestinal sounds abnormal), tachycardia, hypotension, hypertension, nausea, vomiting, agitation, confusional state, hallucination, psychotic disorder, seizure, or arrhythmia.
Rhabdomyolysis and renal failure may rarely develop in patients with prolonged agitation, coma, or seizures.
Paracetamol
Hepatobiliary Disorders
If a paracetamol extended release product is involved or if the exact formulation is not known, it is recommended to obtain an additional plasma paracetamol level 4 to 6 hours following the initial paracetamol level as these levels will continue to rise with the extended release products and may alter treatment decisions.
In adults and adolescents (> 12 years of age), hepatic toxicity may occur following ingestion of greater than 7.5 to 10 g over a period of 8 hours or less. Fatalities are infrequent (less than 3-4% of untreated cases) and have rarely been reported with
| System Organ Class | Preferred Term |
| Metabolism and Nutrition Disorders | Decreased appetite |
| Gastrointestinal Disorders | Abdominal discomfort Nausea Vomiting |
| Hepatobiliary Disorders | Acute hepatic failure Hepatic necrosis Hepatomegaly Jaundice Liver tenderness |
| General Disorders and Administration Site Conditions | Hyperhidrosis Malaise Pallor |
| Investigations | Blood bilirubin increased Blood lactic acid increased Blood phosphorus increased Hepatic enzymes increased International normalised ratio increased Prothrombin time prolonged |
overdoses of less than 15 grams. In children (<12 years of age), an acute overdosage of less than 150 mg/kg has not been associated with hepatic toxicity. Early symptoms following a potentially hepatotoxic overdose may include: anorexia, nausea, vomiting, diaphoresis, pallor and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion. Serious toxicity or fatalities have been extremely infrequent following an acute paracetamol overdose in young children, possibly because of differences in the way they metabolize paracetamol.
Table 2 shows the clinical events associated with paracetamol overdose that if seen with overdose are considered expected, including fatal events due to fulminant hepatic failure or its sequelae.
Table 2. Adverse Drug Reactions Identified with Overdose of Paracetamol
The following clinical events are sequelae to acute hepatic failure and may be fatal. If these events occur in the setting of acute hepatic failure associated with paracetamol overdose (adults and adolescents: >12 years of age: >7.5g within 8 hours; children <12years of age: >150 mg/kg within 8 hours), they are considered expected.
Expected sequelae to acute hepatic failure associated with paracetamol overdose include the following: Bacterial infection, fungal infection, sepsis, coagulopathy, disseminated intravascular coagulation, thrombocytopenia, hypoglycemia, hypophosphatemia, lactic acidosis, metabolic acidosis, brain oedema, coma (with massive paracetamol overdose or multiple drug overdose), encephalopathy, cardiomyopathy, hypotension, respiratory failure, gastrointestinal haemorrhage, pancreatitis, acute kidney injury, and multiple organ dysfunction syndrome.
Blood and Lymphatic Disorders
Haemolytic anaemia (in patients with glucose-6-phosphate dehydrogenase [G6PD] deficiency): Haemolysis has been reported in patients with G6PD efficiency, with use of paracetamol in overdose.
Phenylephrine
Overdosage may result in vomiting, central nervous system stimulation (such as nervousness, anxiety, restlessness, dizziness and tremor), seizures, palpitations, hypertension, headache (a possible symptom of hypertension), cerebral hemorrhage and paresthesia.
Keep out of reach of children. In the event of overdose, get medical help or contact a Poison Control Center right away.
What to do when you have taken more than the recommended dosage?
Consult your doctor if you have taken more than the recommended dosage.
How should you keep this Medicine?
Store at temperatures not exceeding 30°C.
When should you consult your doctor?
If symptoms persist or worsen, or if new symptoms occur, stop use and consult your doctor.
Imported & Distributed by:
JNTL Consumer Health (Philippines), Inc.,
KM 14 Edison Road, Merville, Parañaque City, Philippines
Manufactured by:
Probiotec Pharma Pty Limited
83 Cherry Lane, LAVERTON NORTH VIC 3026, Australia
Patients must seek medical attention immediately at the first sign of any adverse drug reaction.For suspected adverse drug reaction, report to the FDA: www. fda.gov.ph
Registration No.: DR-XY47297
Date of First Authorization: 14 June 2021
Based on CCDS Version: 02 Aug 2021
Toll Free Except hand-phone
Philippines: 00 800 888-111-00