To be sold by retail on the prescription of a Registered Medical Practitioner Only’

Generic name

Cetirizine Dihydrochloride, Phenylephrine Hydrochloride and Paracetamol Tablets

Brand Name
ALERID COLD Tablet

Qualitative and Quantitative Composition

Alerid Cold Tablets

Each Uncoated tablet contains:

Cetirizine Dihydrochloride IP.................5 mg

Phenylephrine Hydrochloride IP...........10 mg

Paracetamol IP......................................325 mg

Excipients………………………………...q.s

Dosage Form(S) and Strength(S)

Oral tablet

Clinical Particular

Therapeutic Composition

ALERID COLD Tablets are indicated for the symptomatic treatment of allergic rhinitis, fever and nasal congestion.

Posology & Method of Administration

Adults and Children (12 years and above)

One tablet twice daily or as recommended by the physician.

The recommended dosage should not be exceeded.

Contraindication

ALERID COLD Tablets are contraindicated in the following:

• Patients with a known hypersensitivity to them or any of their ingredients or hydroxyzine or piperazine.
• Patients with severe renal impairment at less than 10 mL/min creatinine clearance
• Patients with cardiovascular disease, high blood pressure, diabetes mellitus, closed-angle glaucoma, hyperthyroidism, prostatic enlargement, hepatic impairment and phaeochromocytoma.
• Patients being treated with monoamine oxidase inhibitors or within 14 days of ceasing such treatment.
• Concomitant use of other sympathomimetic decongestants.

Special Warnings & Precaution for Use

Cetirizine

At therapeutic doses, no clinically significant interactions have been demonstrated with alcohol (for a blood alcohol level of 0.5 g/L). Nevertheless, precautions are recommended if alcohol is taken concomitantly.

Caution should be taken in patients with predisposition factors of urinary retention (e.g. spinal cord lesion, prostatic hyperplasia) as cetirizine may increase the risk of urinary retention.

Caution in epileptic patients and patients at risk of convulsions is recommended.

Allergy skin tests are inhibited by antihistamines and a wash-out period (of 3 days) is required before performing them.

Pruritus and/or urticaria may occur when cetirizine is stopped, even if those symptoms were not present before treatment initiation. In some cases, the symptoms may be intense and may require treatment to be restarted. the symptoms should resolve when the treatment is restarted.

In some patients, long-term treatment with cetirizine may lead to an increased risk of caries due to mouth dryness. The patients should therefore be informed about the importance of oral hygiene.

Due to the amount of some excipients in the formulation, the oral solution is not recommended in children less than 2 years.

Phenylephrine

This medicine should be used with caution in patients with occlusive vascular disease, including Raynaud's phenomenon. Do not take for longer than 7 days, unless your doctor agrees. If symptoms do not go away talk to your doctor. Keep all medicines out of the reach of children.

Paracetamol

Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease. Do not exceed the stated dose. Do not take with any other paracetamol-containing products. If symptoms persist for more than 3 days or get worse consult the doctor.

Drugs interactions

Cetirizine

No clinically significant drug interactions have been found with theophylline at a low dose, azithromycin, pseudoephedrine, ketoconazole, or erythromycin. There was a small decrease in the clearance of cetirizine caused by a 400 mg dose of theophylline; it is possible that larger theophylline doses could have a greater effect.

The extent of absorption of cetirizine is not reduced with food, although the rate of absorption is decreased.

In sensitive patients, the concurrent use of alcohol or other CNS depressants may cause additional reductions in alertness and impairment of performance although cetirizine does not potentiate the effect of alcohol (0.5 g/l blood levels).

Renal Impairment

At impaired function and renal functions, the elimination of cetirizine may be impaired. Caution should be exercised when administering cetirizine to these patients.

Patients with end-stage renal disease may have increased response to phenylephrine, hence, reduced dosages may be required in patients with end-stage renal disease.

Hepatic Impairment

In 16 patients with chronic liver diseases (hepatocellular, cholestatic, and biliary cirrhosis), given 10 or 20 mg of cetirizine as a single oral dose, there was a 50% increase in half-life along with a corresponding 40% decrease in clearance compared to 16 healthy subjects. Dosing adjustment may be necessary in patients with hepatic impairment.

Patients with hepatic cirrhosis may have reduced response to phenylephrine, hence, higher dosages may be required.

Phenylephrine

Phenylephrine should be used with caution in combination with the following drugs as interactions have been reported.

Monoamine oxidase inhibitors (including moclobemide)	Hypertensive interactions occur between sympathomimetic amines such as phenylephrine and monoamine oxidase inhibitors (see contraindications). Should not be given to patients being treated with monoamine oxidase inhibitors or within 14 days of stopping such treatment
Sympathomimetic amines	Concomitant use of phenylephrine with other sympathomimetic amines can increase the risk of cardiovascular side effects.
Beta-blockers and other antihypertensives (including debrisoquine, guanethidine, reserpine, methyldopa)	Phenylephrine may reduce the efficacy of beta-blocking drugs and antihypertensive drugs. The risk of hypertension and other cardiovascular side effects may be increased.
Tricyclic antidepressants (e.g. amitriptyline)	May increase the risk of cardiovascular side effects with phenylephrine.
Ergot alkaloids	(ergotamine and methylsergide) increased risk of ergotism
Digoxin and cardiac glycosides	Increase the risk of irregular heartbeat or heart attack

Paracetamol

Cholestyramine: The speed of absorption of paracetamol is reduced by cholestyramine. Therefore, cholestyramine should not be taken within 1 hour if maximal analgesia is required.

Metoclopramide and Domperidone: The absorption of paracetamol is increased by metoclopramide and domperidone. However, concurrent use need not be avoided.

Warfarin: The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

Use in Special Populations

Pregnant Women

ALERID COLD Tablets should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.

Lactating Women

Alerid Cold Tablets are not recommended for use by nursing mothers.

Paediatric Patients

Alerid Cold Tablets are not recommended for use in children below the age of 12 years.

Effects on Ability to Drive & Use Machines

Objective measurements of driving ability, sleep latency and assembly line performance have not demonstrated any clinically relevant effects at the recommended dose of 10 mg. Cetirizine may have minor or moderate influence on the patient's ability to react. This should be considered when extra alertness is required e.g. when driving. Patients intending to drive, engaging in potentially hazardous activities or operating machinery should not exceed the recommended dose and should take their response to the medicinal product into account.

In these sensitive patients, concurrent use with alcohol or other CNS depressants may cause additional reductions in alertness and impairment of performance.  

Paracetamol has no influence on the ability to drive and use machines.

Thus, patients taking ALERID COLD Tablet who experience somnolence or dizziness should be advised not to drive or operate machinery if affected by dizziness.

Undesirable Effects

Cetirizine

The more commonly observed untoward reactions reported during cetirizine administration and not associated with an equivalent incidence among placebo-treated patients are somnolence, dry mouth and fatigue. The table below shows adverse events occurring with an incidence of greater than 1% after intake of cetirizine 5 to 20 mg cetirizine a day. It pools data obtained from American and European clinical studies (including open studies with access to rescue drug) in urticaria, perennial and seasonal rhinitis. The incidence of somnolence associated with Cetirizine was 14.3% (7.6% under placebo) and was predominantly mild to moderate in severity. After pooling the same studies in the three registered indications, sedation is reported more in the patients suffering from seasonal allergic rhinitis than in the patients suffering from perennial allergic rhinitis and urticaria.

Adverse experience by WHO grouping	Number of Patients (%)
	Cetirizine (n = 2,487)	Placebo (n = 1,577)
Somnolence	356 (14.3%)	120 (7.6%)
Headache	272 (10.2%)	177 (11.2%)
Dry mouth	122 (5.0%)	29 (1.8%)
Fatigue	85 (3.4%)	26 (1.6%)
Nausea	51 (2.1%)	48 (3.0%)
Dizziness	49 (2.0%)	26 (1.6%)
Pharyngitis	34 (1.4%)	15 (1.8%)
Insomnia	29 (1.2%)	17 (1.1%)
Dyspepsia	21 (0.8%)	23 (1.5%)
Pruritus	5 (0.2%)	16 (1.0%)

Assessment of severity of sedation in clinical trials indicates the mild nature of sedation associated with cetirizine.

The following events were observed infrequently (less than 1/100), but more than once, in 2,487 patients who received cetirizine in all US and European trials, a causal relationship with cetirizine administration has not been established. Events are listed in order of decreasing frequency within a given body system.

Autonomic nervous system. Increased appetite, anorexia, flushing, increased sweating.

Cardiovascular. Palpitations/tachycardia.

ENT: Earache, epistaxis, altered sense of taste, tinnitus, tongue disorder.

Vision: Eye abnormality, periorbital oedema, abnormal vision, eye pain, conjunctivitis.

Gastrointestinal: Abdominal pain, diarrhoea, vomiting, constipation, flatulence.

Genitourinary: Polyuria, urinary retention, urinary tract infection.

Musculoskeletal: Back pain, myalgia, arthralgia, bone disorder (fracture), leg cramps.

Neurologic. Nervousness, impaired concentration, confusion, paraesthesia, asthenia, hypertonia, tremor.

Respiratory System: Respiratory disorder, coughing, bronchospasm, upper respiratory tract infection, dyspnoea.

Miscellaneous: Weight increase (see comment below), fever, oedema, chest pain, pain, rigors, dysmenorrhoea, thirst, decreased libido.

Weight gain was reported as an adverse effect in 0.4% of cetirizine patients in placebo-controlled trials. In an open study of six months’ duration, the mean gain in weight was 2.8% after 20 weeks, with no further increase at 26 weeks. This effect has been reported for other antihistamines.

Occasional instances of reversible liver function test (transaminase) elevations have occurred during cetirizine therapy, without evidence of jaundice, hepatitis or other clinical findings.

Adverse events at rates of 1 % or greater in children aged from 6 months to 12 years, included in placebo-controlled trials are:

Adverse events (WHO-ART)	Cetirizine (n=1656)	Placebo (n =1294)
Gastro-intestinal system disorders Diarrhoea	1.0 %	0.6 %
Psychiatric disorders Somnolence	1.8 %	1.4 %
Respiratory system disorders Rhinitis	1.4 %	1.1 %
Body as a whole – general disorders Fatigue	1.0 %	0.3 %

Post Marketing Data

Adverse drug reactions (ADRs) identified during Post-marketing experience with cetirizine are included in the following table. 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)

Adverse Drug Reactions Identified During Post-Marketing Experience with Cetirizine

by Frequency Category Estimated from Clinical Trials or Epidemiology Studies

Frequency Category	Adverse Event Preferred Term
Blood and lymphatic disorders:	Very rare: thrombocytopenia
Immune system disorders:	Rare: hypersensitivity Very rare: anaphylactic shock
Metabolism and nutrition disorders:	Not known: increased appetite
Psychiatric disorders:	Uncommon: agitation Rare: aggression, confusion, depression, hallucinations, insomnia Very rare: tics Not known: suicidal ideation, nightmare
Nervous system disorders:	Uncommon: paraesthesia Rare: convulsions Very rare: dysgeusia, syncope, tremor, dystonia, dyskinesia Not known: amnesia, memory impairment
Eye disorders:	Very rare: accommodation disorder, blurred vision, oculogyration
Respiratory, Thoracic and Mediastinal Disorders	Uncommon: Cough
Ear and labyrinth disorders:	Not known: vertigo
Cardiac disorders:	Rare: tachycardia
Gastro-intestinal disorders:	Common: nausea Uncommon: diarrhoea
Hepatobiliary disorders:	Rare: hepatic function abnormal (increased transaminases, alkaline phosphatises, γ-GT and bilirubin) Not known: hepatitis
Skin and subcutaneous tissue disorders:	Uncommon: pruritis, rash Rare: urticaria Very rare: angioneurotic oedema, fixed drug eruption Not known: acute generalized exanthematous pustulosis
Musculoskeletal and connective tissue disorders	Not known: arthralgia
Renal and urinary disorders:	Very rare: dysuria, enuresis Not known: urinary retention
Reproductive System and Breast Disorders	Not known: Erectile dysfunction
General disorders and administration site conditions:	Uncommon: asthenia, malaise Rare: oedema
Investigations:	Rare: weight increased

The following clinically significant adverse events have been reported: cholestasis, glomerulonephritis, haemolytic anaemia, hepatitis, severe hypotension and stillbirth. Data are insufficient to support an estimate of their incidence in the population to be treated.

Phenylephrine

The following adverse events have been observed in clinical trials with phenylephrine and may therefore represent the most commonly occurring adverse events.

Body System	Undesirable effect
Psychiatric disorders	Nervousness, irritability, restlessness, and excitability
Nervous system disorders	Headache, dizziness, insomnia
Cardiac disorders	Increased blood pressure
Gastrointestinal disorders	Nausea, Vomiting.

Adverse reactions identified during post-marketing use are listed below. The frequency of these reactions is unknown but likely to be rare.

Eye disorders	Mydriasis, acute angle closure glaucoma, most likely to occur in those with closed angle glaucoma
Cardiac disorders	Tachycardia, palpitations
Skin and subcutaneous disorders	Allergic reactions (e.g. rash, urticaria, allergic dermatitis). Hypersensitivity reactions – including that cross-sensitivity may occur with other sympathomimetics
Renal and urinary disorders	Dysuria, urinary retention. This is most likely to occur in those with bladder outlet obstruction, such as prostatic hypertrophy.

Paracetamol

Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system class. Due to limited clinical trial data, the frequency of these adverse events is not known (cannot be estimated from available data), but post-marketing experience indicates that adverse reactions to paracetamol are rare and serious reactions are very rare.

Body System	Undesirable effect
Blood and lymphatic system disorders	Thrombocytopenia, agranulocytosis. These are not necessarily causally related to paracetamol
Immune system disorders	Anaphylaxis, Cutaneous hypersensitivity reactions, including skin rashes, angioedema and Stevens Johnson syndrome / toxic epidermal necrolysis Very rare cases of serious skin reactions have been reported.
Respiratory, thoracic and mediastinal disorders	Bronchospasm*
Hepatobiliary disorders	Hepatic dysfunction
Skin	Fixed Drug Eruption

* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.

Reporting of Suspected Adverse Reactions

For Adverse Events / Complaints: call on Cipla Toll free number (for India)18002677779 or email to drugsafety@cipla.com.

By reporting side effects, you can help provide more information on the safety of this product.

Overdose

Cetirizine

Symptoms observed after an overdose of cetirizine are mainly associated with CNS effects or with effects that could suggest an anticholinergic effect. Adverse events reported after intake of at least five times the recommended daily dose are: confusion, diarrhoea, dizziness, fatigue, headache, malaise, mydriasis, pruritus, restlessness, sedation, somnolence, stupor, tachycardia, tremor and urinary retention.

Management

There is no known specific antidote to cetirizine. Should overdose occur symptomatic or supportive treatment is recommended. Gastric lavage should be considered following ingestion of a short occurrence. Alternatively consider activated charcoal.

Cetirizine is not effectively removed by dialysis.

Phenylephrine

Phenylephrine overdosage is likely to result in effects similar to those listed under adverse reactions. Additional symptoms may include hypertension and possibly reflux bradycardia. In severe cases confusion, hallucinations, seizures and arrythmias may occur. However, the amount required to produce serious phenylephrine toxicity would be greater than required to cause paracetamol-related toxicity.

Treatment should be as clinically appropriate. Severe hypertension may need to be treated with an alpha blocking drug such as phentolamine.

Paracetamol

Liver damage is possible in adults who have taken 10 g or more of paracetamol. Ingestion of 5 g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).

Risk Factors

If the patient

1. a) is on long-term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's wort or other drugs that induce liver enzymes;

or

1. b) regularly consumes ethanol in excess of recommended amounts;

or

1. c) is likely to be glutathione-deplete, e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines.

Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable).  Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol; however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required, the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital.

Pharmacological Properties

Pharmacodynamic properties

Cetirizine

a human metabolite of hydroxyzine, is an antiallergic compound; its principal effects are mediated via competitive occupancy of peripheral H1-receptors.

Phenylephrine

Phenylephrine is a sympathomimetic agent with mainly direct effects on adrenergic receptors. It has predominantly alpha-adrenergic activity and is without stimulating effects on the central nervous system (CNS). The sympathomimetic effect of phenylephrine produces vasoconstriction, which, in turn, relieves nasal congestion.

Paracetamol

Analgesic: The mechanism of analgesic action has not been fully determined. Paracetamol may act predominantly by inhibiting prostaglandin synthesis in the CNS and, to a lesser extent, through a peripheral action by blocking pain-impulse generation.

The peripheral action may also be due to inhibition of prostaglandin synthesis or to inhibition of the synthesis or actions of other substances that sensitize pain receptors to mechanical or chemical stimulation.

Antipyretic: Paracetamol probably produces antipyresis by acting centrally on the hypothalamic heat-regulation centre to produce peripheral vasodilation resulting in increased blood flow through the skin, sweating and heat loss. The central action probably involves inhibition of prostaglandin synthesis in the hypothalamus.

Pharmacokinetics properties

Cetirizine

Absorption    

Cetirizine is rapidly absorbed after oral administration. In adults, peak plasma levels after a 10 mg dose are approximately 300 ng/mL and occur at about one hour. Co-administration with food decreases the rate of absorption by 1.7 hour (lower C_max and greater T_max) but does not affect bioavailability as measured by the AUC. Plasma protein binding is 93%. The bioavailability of cetirizine hydrochloride is similar from the different dosage forms. The mean time taken to reach the peak serum cetirizine concentration (T_max) was 0.67 hour after a single 10 mg dose of the film coated tablets.

Distribution    

The mean plasma protein binding of cetirizine was 93%. The apparent volume of distribution is 0.45 L/kg, suggestive of significant extravascular distribution. The plasma elimination half-life in adults is approximately 8 hours and does not change with multiple dosing. Plasma levels are proportional to the dose administered over the range of 5 to 20mg.

Metabolism   

Cetirizine does not undergo extensive first pass metabolism.

Elimination    

The terminal half-life is approximately 10 hours, and no accumulation is observed for cetirizine following daily doses of 10mg for 10 days. About two thirds of the dose are excreted unchanged in urine.

Interaction Studies

Pharmacokinetic interaction studies with cetirizine in adults were conducted with pseudoephedrine, antipyrine, ketoconazole, erythromycin and azithromycin. No interactions were observed. In a multiple dose study of theophylline (400 mg once daily for 3 days) and cetirizine (20 mg once daily for 3 days), a 16% decrease in the clearance of cetirizine was observed. The disposition of theophylline was not altered by concomitant cetirizine administration.

Special Populations

Elderly: Following a single 10 mg oral dose, half-life increased by about 50% and clearance decreased by 40% in 16 elderly subjects compared to the normal subjects. The decrease in cetirizine clearance in these elderly volunteers appeared to be related to their decreased renal function.

Paediatric population: The half-life of cetirizine was about 6 hours in children of 6 – 12 years and 5 hours in children 2–6 years. In infants and toddlers aged 6 to 24 months, it is reduced to 3.1 hours.

Renal impairment: The pharmacokinetics of the drug were similar in patients with mild impairment (creatinine clearance higher than 40 ml/min) and healthy volunteers. Patients with moderate renal impairment had a 3-fold increase in half-life and 70% decrease in clearance compared to healthy volunteers.

Patients on hemodialysis (creatinine clearance less than 7 ml/min) given a single oral 10 mg dose of cetirizine had a 3-fold increase in half-life and a 70% decrease in clearance compared to normals. Cetirizine was poorly cleared by haemodialysis. Dosing adjustment is necessary in patients with moderate or severe renal impairment.

Hepatic impairment: Patients with chronic liver disease (hepatocellular, cholestatic, and biliary cirrhosis) given 10 or 20mg of cetirizine as a single dose had a 50 % increase in half-life along with a 40 % decrease in clearance compared to healthy subjects.

Dosing adjustment is only necessary in hepatically impaired patients if concomitant renal impairment is present.

Phenylephrine

Phenylephrine is absorbed from the gastrointestinal tract but has reduced bioavailability by the oral route due to first-pass metabolism. It retains activity as a nasal decongestant when given orally, the drug distributing through the systemic circulation to the vascular bed of nasal mucosa. When taken by mouth as a nasal decongestant phenylephrine is usually given at intervals of 4-6 hours.

Paracetamol

Paracetamol is absorbed rapidly and completely mainly from the small intestine producing peak plasma levels after 15-20 minutes following oral dosing. The systemic availability is subject to first-pass metabolism and varies with dose between 70% and 90%. The drug is rapidly and widely distributed throughout the body and is eliminated from plasma with a T½ of approximately 2 hours. The major metabolites are glucuronide and sulphate conjugates (>80%) which are excreted in urine.

Non-Clinical Properties

Animal Toxicology or Pharmacology

Cetirizine

Carcinogenicity studies over 24 months showed increased incidences of benign liver tumours in male mice (at the maximum dose of 16 mg/kg/day), but not in female mice or in rats. These benign tumours in mice are commonly found with compounds which cause liver enzyme induction. Since cetirizine does not induce liver enzymes in non-rodents and humans, this may be considered to be a species-specific phenomenon. Cetirizine was devoid of mutagenic activity in a series of in vitro and in vivo assays.

Allergy skin tests are inhibited by antihistamines. Wash-out periods vary in individuals due to different rates of metabolism and different antihistamines. For cetirizine, a wash-out period of at least four days is generally recommended before performing the allergy skin tests.

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.

Description

ALERID COLD Tablets are a fixed-dose combination of cetirizine, phenylephrine and paracetamol. Cetirizine belongs to the class of antihistamines and phenylephrine belongs to the class of decongestants. Paracetamol is an effective analgesic and antipyretic agent with weak anti-inflammatory properties.

Pharmaceutical Particulars

Incompatibilities

None

Shelf life

As on pack

Packaging information

ALERID COLD Tablets: Blister pack of 10 tablets

Storage & Handling Instruction

Store in a cool dry and dark place

Keep out of reach of children.

Patient Counselling Information

What is the product ALERID COLD Tablet?

ALERID COLD Tablets are a fixed-dose combination of cetirizine, phenylephrine, and paracetamol. Cetirizine belongs to the class of antihistamines; it is used to relieve the symptoms of allergy. Paracetamol is an effective analgesic and antipyretic agent with weak anti-inflammatory properties. It also helps to reduce fever. Phenylephrine Hydrochloride is a decongestant which helps relieve a blocked nose.

Do not take ALERID COLD Tablet if you are

• Patients with hypersensitivity to cetirizine, or its parent compound hydroxyzine or piperazine, paracetamol or any of the other constituents.
• Patients with severe renal impairment at less than 10 mL/min creatinine clearance.
• Avoid in patients with cardiovascular disease, high blood pressure, diabetes mellitus, closed-angle glaucoma, hyperthyroidism, prostatic enlargement, hepatic impairment and phaeochromocytoma.
• Patients being treated with monoamine oxidase inhibitors or within 14 days of ceasing such treatment.
• Concomitant use of other sympathomimetic decongestants.
• If you are pregnant or breastfeeding, unless your doctor tells you to

This medicine may cause dizziness. You should not drive or use machines until you are sure you are not affected.

Do not drink alcohol (wine, beer, spirits) whilst taking this medicine.

Before you take the ALERID COLD Tablet.

Talk to your doctor before taking this medicine.

• If you are a patient with renal insufficiency, please ask your doctor for advice; if necessary, you will take a lower dose. The new dose will be determined by your doctor.
• If you have problems passing urine (like spinal cord problems or prostate or bladder problems), please ask your doctor for advice.
• If you are an epileptic patient or a patient at risk of convulsions, you should ask your doctor for advice.
• No clinically significant interactions have been observed between alcohol (at the blood level of 0.5 g/l corresponding to one glass of wine) and cetirizine used at the recommended doses. However, there are no data available on the safety when higher doses of cetirizine and alcohol are taken together. Therefore, as it is the case with all antihistamines, it is recommended to avoid taking cetirizine tablets with alcohol.
• If you are scheduled for allergy testing, ask your doctor if you should stop taking Cetirizine Tablets for several days before testing. This medicine may affect your allergy test results.
• Children Cetirizine Tablets are not recommended for use in children below 12 years of age because the tablet formulation does not allow the necessary dose adjustments.
• if you are taking, have recently taken or might take any other medicines such as, medication for anxiety or stress (CNS depressants)
• This medicine contains cetirizine, phenylephrine, and paracetamol.

Do not take with any other products containing any of these medicines

Before you take this tablet make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly the following:

• Domperidone or metoclopramide for feeling sick or being sick (may increase the pain relief effect of paracetamol)
• Colestyramine for reducing blood fat levels (may reduce the pain relief effect of paracetamol)
• Warfarin or other blood thinners – if you take warfarin you can take occasional amounts of this medicine but talk to your doctor first before you take it on a regular basis
• Anticonvulsants (for epilepsy)
• Contraceptive tablets
• Isoniazid (for bacterial infections)
• Diflunisal (for pain relief)
• Probenecid (for gout)
• Tricylic antidepressants
• Atropine (for muscle spasm in the stomach)
• Guanethidine (for emergency treatment of very high blood pressure)
• Ergot alkaloids (for migraine)
• Oxytocin (used to induce labour in pregnant women)
• Other decongestants
• Medicines to treat asthma.

If you are unsure about interactions with any other medicines, talk to your doctor.

includes medicines prescribed by your doctor and medicine you have bought for yourself,

including herbal and homeopathic remedies.

How should I take the ALERID COLD Tablet?

Always take this medicine exactly as described in this leaflet or as your doctor has told you. Check with your doctor if you are not sure.

Adults and Children (12 years and above)

One tablet twice daily or as recommended by the physician. The recommended dosage should not be exceeded.

If you have kidney problems, your dose should be adjusted as recommended by a doctor.

What are the possible side effects of the ALERID COLD Tablet?

Like all medicines, this medicine can cause side effects, although not everybody gets them.  Stop taking this medicine and speak to your doctor straight away if you notice these symptoms:

• serious allergic reaction which causes difficulty in breathing or dizziness, swelling of the face or throat 
• reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia)
• suicidal ideation (recurring thoughts of or preoccupation with suicide)
• fits
• fixed drug eruption, acute generalized exanthematous pustulosis (appearance of red or blistered skin in the same place after taking this medicine)

These reactions may start soon after you first take the medicine, or it might start later.

The following side effects have also been reported.

Common: (may affect up to 1 in 10 people)

• fatigue
• dry mouth, nausea, diarrhoea
• dizziness, headache
• sleepiness
• sore throat
• sneezing, a blocked, congested, or itchy nose (children only).

Uncommon: (may affect up to 1 in 100 people)

• paraesthesia (feeling of pins and needles)
• feelings of weakness and/or extreme tiredness (asthenia), feeling unwell (malaise)
• agitation
• itching, rash
• stomachache

Rare: (may affect up to 1 in 1,000 people)

• oedema (swelling of the feet or ankles)
• weight increase
• abnormal liver function test results (your doctor will know what to do), fast heartbeat (tachycardia), aggression, confusion, depression, seeing or hearing things (hallucination), difficulty in sleeping (insomnia)
• hives

Very rare: (may affect up to 1 in 10,000 people)

• difficulty with focusing the eyes, blurred vision, eyes having uncontrolled circular movements
• fainting, tremor, altered taste
• difficult, painful or involuntary urination
• tics
• loss of urinary control (enuresis)
• dyskinesia (involuntary movements)
• dystonia (abnormal prolonged muscular contractions)

Not known: (frequency cannot be estimated from the available data)

• forgetfulness, memory impairment
• urinary retention (inability to completely empty the urinary bladder)
• vertigo (sensation of rotation or movement)
• increased appetite
• inflammation of liver (hepatitis)
• nightmare
• pain in joint

If you get any of these serious side effects, stop taking this tablet. See a doctor at once.

• Difficulty in breathing, tight chest, wheezing, runny nose, swelling of the face, neck, tongue or throat (severe allergic reactions)
• These other effects are less serious. If they bother, you talk to a doctor:
• Other allergic reactions (e.g. skin rash)
• Being sick, headache, dizziness – do not drive or use machines if you feel dizzy.
• Fast heart rate, slow heart rate, raised blood pressure.
• Difficulty in passing urine and emptying the bladder.
• Unusual bruising, or infections such as sore throat – this may be due to very rare changes in the blood.

If you take this medicine every day for a long time you may also get kidney problems

If any side effect becomes severe, or you notice any side effect not listed here, please tell your doctor.

For Adverse Events / Complaints: call on Cipla Toll free number (for India)18002677779 or email to drugsafety@cipla.com.

By reporting side effects, you can help provide more information on the safety of this product.

How should I store ALERID COLD Tablet?

• Keep this medicine out of the sight and reach of children
• Keep the blister in the outer carton to protect it from light.
• Do not use this medicine after the expiry date which is stated on the carton after ‘EXP’. The expiry date refers to the last day of that month.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicine you no longer use. These measures will help protect the environment.

General information about safe & effective use of ALERID COLD Tablet.

• Avoid alcoholic drinks while you are taking this medicine.
• Food does not affect absorption of cetirizine hydrochloride.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

ALERID COLD Tablets should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.

ALERID COLD Tablets are not recommended for use by nursing mothers.

Patients taking ALERID COLD Tablet who experience somnolence should refrain from driving, engaging in potentially hazardous activities or operating machinery.

Details of Manufacturers

Mfd by:

M/S. HSN International,
Plot No 54 & 55, Sector – 6A, Sidcul,

Ranipur, Haridwar, Uttarakhand – 249403

Marketed by:

Cipla Ltd

Regd. Office: Cipla House, Peninsula Business Park,

Ganpatrao Kadam Marg, Lower Parel, Mumbai – 400 013, India

Details of Permission or Licence Number with Date

Licence No. 106/UA/2007

Date of Revision

02/03/2023