Sinutab Cold Information Leaflet

Paracetamol
+ Phenylephrine HCl

Sinutab® Cold

500 mg/5 mg Film-Coated Tablet

Analgesic/Antipyretic/Nasal Decongestant

Product Description

Paracetamol 500mg and Phenylephrine HCI 5mg (Sinutab Cold) tablets are red-brown, film-coated, capsule-shaped tablets embossed with “85” 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

What is the Medicine used for?

• Temporarily relieves nasal and sinus congestion, sinus pressure, sinus pain, headache, and minor aches and pains due to the common cold, flu, hay fever, (allergic rhinitis), sinusitis and other upper 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:

Tablet (500 mg / 5 mg)

Adults and children 12 years and over:

Take 1 to 2 tablets (each tablet contains 500 mg paracetamol, 5 mg phenylephrine) every 6 hours as necessary. Do not exceed 8 tablets (4000 mg paracetamol, 40 mg phenylephrine) within a 24-hour period.

Why should you not take this Medicine?

• Hypersensitivity to 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

• 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.

• Alcohol Warning: Chronic alcohol users should ask their physician whether they should take paracetamol or other pain relievers or fever reducers (adult products).

• 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.  

• 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 paracetamol and phenylephrine.

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

It is not known if the combination of paracetamol and phenylephrine has an effect on the ability to drive and use machines.

Undesirable Effects of the Medicine

Clinical Trial Data

Placebo-controlled studies with sufficient adverse event data were not available for the combination of paracetamol and phenylephrine.

The following adverse events were reported by > 1% of subjects in randomized, placebo-controlled trials with single-ingredient phenylephrine were nausea, nasal dryness and headache.

Post Marketing Data

Adverse drug reactions (ADRs) identified during post-marketing experience with paracetamol, phenylephrine are included in Table 1 and 2. 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/,1000

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 adverse events (AEs) under given a preferred term (PT) or medical concept and denominator represents exposure data calculated from sales data.

Table 1. Adverse Drug Reactions Identified During Post-Marketing Experience with Paracetamol, Phenylephrine by Frequency Category Estimated from Spontaneous Reporting Rates  

+ 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?

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 International Normalized Ratio (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

Paracetamol

Hepatobiliary Disorders

If 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 continues 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 or 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 overdoses of less than 15 grams. In children (<12 years of age), an acute overdosage of less than 150 mg/kg gas 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: >7.5 g within 8 hours; children <12 years 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 hemorrhage, pancreatitis, acute kidney injury, and multiple organ dysfunction syndrome.

Blood and Lymphatic Disorders

Hemolytic anaemia (in patients with glucose-6-phosphate dehydrogenase [G6PD] deficiency): Hemolysis 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-XY47296

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