Sinutab Cold/Sinutab Cold Plus

Sinutab Cold: Paracetamol 500 mg and Phenylephrine HCl 5 mg (Sinutab Cold) tablets are red-brown, film-coated, capsule-shaped tablets embossed with "85" on one side and plain on the other face.
Each tablet contains: Paracetamol, Ph. Eur. 500 mg, Phenylephrine HCl, BP 5 mg.
Sinutab Cold Plus: Paracetamol 500 mg, Phenylephrine HCl 5 mg and Chlorpheniramine maleate 2 mg (Sinutab Cold Plus) tablets are orange, film-coated, round tablets embossed with "N" on one face and plain on the other face.
Each tablet contains: Paracetamol, Ph. Eur. 500 mg, Phenylephrine HCl, BP 5 mg, Chlorpheniramine maleate, Ph. Eur. 2 mg.

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.
Sinutab Cold Plus: 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.

How much and how often should the patient use this Medicine: Unless otherwise required by local authorities, these products should be administered as follows: Sinutab Cold: 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 24-hour period.
Sinutab Cold Plus: 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 6 hours as needed. Do not exceed 8 tablets (16 mg chlorpheniramine, 4000 mg paracetamol, 40 mg phenylephrine) within a 24-hour period.
What should the patient do if they miss a dose: Continue medication based on dosage and/or consult the doctor.

Signs and Symptoms of Overdose: Sinutab Cold: 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 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 1 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. (See Table 1.)

Click on icon to see table/diagram/image

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 deficiency, 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.
Sinutab Cold Plus: No overdose-associated ADRs were identified for the combination of chlorpheniramine, paracetamol, and phenylephrine from review of post-marketing safety data.
The information presented as follows describes overdose with the single active ingredients.
Chlorpheniramine: Overdosage 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 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. (See Table 2.)

Click on icon to see table/diagram/image

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 haemorrhage, pancreatitis, acute kidney injury, and multiple organ dysfunction syndrome.
Blood and Lymphatic Disorders: Hemolytic anaemia (in patients with glucose-6-phosphate dehydrogenase [G6PD] deficiency): Hemolytic has been reported in patients with G6PD deficiency, 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.

Phenylephrine should not be used in patients taking monoamine oxidase inhibitors (MAOls), or for 2 weeks after stopping the MAOI drug. The concomitant use of these medications may cause a rise in blood pressure and hypertensive crisis.
Sinutab Cold: Hypersensitivity to paracetamol, phenylephrine or to any of the ingredients.
Sinutab Cold Plus: Hypersensitivity to chlorpheniramine, paracetamol, phenylephrine or to any of the ingredients.

Sinutab Cold: 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 they 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).
Patients with hepatic disease should consult a physician before use.
Serious skin reactions such as 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.
Effects on Ability to Drive or Use Machines: It is not known if the combination of paracetamol and phenylephrine has an effect on the ability to drive and use machines.
Sinutab Cold Plus: 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 they 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 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.
Effects on Ability to Drive or Use Machines: Use caution when driving a motor vehicle or operating machinery.

Pregnancy and Lactation: There are no adequate and well-controlled studies in pregnant or breastfeeding women for the combination of chlorpheniramine, 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 or breast-feeding 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 the patient is pregnant or breastfeeding.
Sinutab Cold Plus: Chlorpheniramine: There are no adequate or well-controlled studies of chlorpheniramine in pregnant or breastfeeding women. It is not known whether chlorpheniramine or its metabolites are excreted in breast milk.

Sinutab Cold: 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 3. 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 3, 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. (See Table 3.)

Click on icon to see table/diagram/image

Sinutab Cold Plus: 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 in 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 2 and 4. 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 4, 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 from sales data. (See Table 4.)

Click on icon to see table/diagram/image

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 healthcare provider before use if they are taking the antibiotic flucloxacillin.
Sinutab Cold Plus: CNS Depressants (Alcohol, Sedatives, Tranquilizers): Chlorpheniramine may enhance the sedative effects of central nervous system depressants, including alcohol, sedatives, and tranquilizers.

Store at temperatures not exceeding 30°C.

Cough & Cold Preparations

R01BA53 - phenylephrine, combinations ; Belongs to the class of systemic sympathomimetic preparations used as nasal decongestants.

Non-Rx