Cetirizine Hydrochloride Syrup IP (Cetrilin) 5mg/5ml Taj Pharma

Overview

INTRODUCTION OF CETRILIN SYRUP

Cetrilin 5mg Syrup belongs to a group of medicines called antihistamines. It is used to treat various allergic conditions such as hay fever, conjunctivitis and some skin reactions, and reactions to bites and stings. It relieves watery eyes, runny nose, sneezing, and itching.

Cetrilin 5mg Syrup can be taken with or without food. The dose required for you may vary depending on what you are taking it for. This medicine is usually taken in the evening but follow the advice of your doctor on how to take it. You may need this medicine only on days you have symptoms, but if you are taking it to prevent symptoms you should take it regularly. If you miss doses or stop taking it earlier than advised, your symptoms may come back.

This medicine is generally very safe. The most common side effects include feeling sleepy or dizzy. These are usually mild and go away after a couple of days as your body adjusts. Consult your doctor if any of the side effects persist or worry you. You should avoid alcohol while taking this medicine.

Before taking it, tell your doctor if you have any kidney problems or epilepsy. Your dose may need to be modified or this medicine may not be suitable. Some other medicines can interact with this medicine so let your healthcare team know what else you are taking. You should also talk to your doctor before using this medicine if you are pregnant or breastfeeding, although it is not thought to be harmful.

USES OF CETRILIN SYRUP

• Allergic conditions

CETRILIN SYRUP SIDE EFFECTS

Common

• Sleepiness

HOW TO USE CETRILIN SYRUP

Take this medicine in the dose and duration as advised by your doctor. Check the label for directions before use. Measure it with a measuring cup and take it by mouth. Shake well before use. Cetrilin 5mg Syrup may be taken with or without food, but it is better to take it at a fixed time.

HOW CETRILIN SYRUP WORKS

Cetrilin 5mg Syrup is an antihistaminic medication. It treats allergy symptoms such as itching, swelling, and rashes by blocking the effects of a chemical messenger (histamine) in the body.

CETRILIN SYRUP RELATED WARNINGS

Alcohol

UNSAFE

Cetrilin 5mg Syrup may cause excessive drowsiness with alcohol

Pregnancy

SAFE IF PRESCRIBED

Cetrilin 5mg Syrup is generally considered safe to use during pregnancy. Animal studies have shown low or no adverse effects on the developing baby; however, there are limited human studies.

Lactation

SAFE IF PRESCRIBED

Cetrilin 5mg Syrup is probably safe to use during breastfeeding. Limited human data suggests that the drug does not represent any significant risk to the baby.
Larger doses or prolonged use of Cetrilin 5mg Syrup may cause sleepiness and other effects in the baby

Driving

SAFE

Cetrilin 5mg Syrup does not usually affect your ability to drive.

Kidney

CAUTION

Cetrilin 5mg Syrup should be used with caution in patients with kidney disease. Dose adjustment of Cetrilin 5mg Syrup may be needed. Please consult your doctor.
Not recommended in patients with severe kidney disease. May cause excessive sleepiness in patients with end-stage kidney disease.

Liver

SAFE IF PRESCRIBED

Cetrilin 5mg Syrup is probably safe to use in patients with liver disease. Limited data available suggests that dose adjustment of Cetrilin 5mg Syrup may not be needed in these patients. Please consult your doctor.

Cetirizine Hydrochloride 5mg/5ml Oral Solution (Cetrilin) Taj Pharma

1. Name of the medicinal product

Cetirizine Hydrochloride 5mg/5ml Oral Solution

2. Qualitative and quantitative composition

Each ml of solution contains 1 mg cetirizine hydrochloride

Excipients with known effect:

– one mL of solution contains 500 mg sorbitol (solution at 70 %, non crystallizing)

– one mL of solution contains 2 mg methyl parahydroxybenzoate

– one mL of solution contains 0.20 mg propyl parahydroxybenzoate

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Oral Solution.

Clear, colourless, flavoured solution.

4. Clinical particulars

4.1 Therapeutic indications

In adults and paediatric patients 2 years and above:

– Cetirizine is indicated for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.

– Cetirizine is indicated for the relief of symptoms of chronic idiopathic urticaria.

4.2 Posology and method of administration

Posology

Children aged from 2 to 6 years

2.5 mg twice daily (2.5 mL oral solution twice daily).

Children aged from 6 to 12 years

5 mg twice daily (5 mL oral solution twice daily).

Adults and adolescents over 12 years of age

10 mg once daily (10 mL oral solution).

Elderly

Data do not suggest that the dose needs to be reduced in elderly subjects provided that the renal function is normal.

Patients with moderate to severe renal impairment

There are no data to document the efficacy/safety ratio in patients with renal impairment. Since cetirizine is mainly eliminated via renal route (see section 5.2), in cases no alternative treatment can be used, the dosing intervals must be individualized according to renal function. Refer to the following table and adjust the dose as indicated. To use this dosing table, an estimate of the patient’s creatinine clearance (CL_cr) in mL/min is needed. The CL_cr (mL/min) may be estimated from serum creatinine (mg/dl) determination using the following formula:

Dosing adjustments for adult patients with impaired renal function

In paediatric patients suffering from renal impairment, the dose will have to be adjusted on an individual basis taking into account the renal clearance of the patient, his age and his body weight.

Hepatic impairment

No dose adjustment is needed in patients with solely hepatic impairment.

Hepatic impairment and renal impairment

Dose adjustment is recommended (see Patients with moderate to severe renal impairment above).

Method of administration:

The solution can be swallowed as such.

4.3 Contraindications

Hypersensitivity to the active substance, or to any of the excipients listed in section 6.1, or to hydroxyzine or to any piperazine derivatives.

Patients with severe renal impairment at less than 10 ml/min creatinine clearance

4.4 Special warnings and precautions for use

At therapeutic doses, no clinically significant interactions have been demonstrated with alcohol (for a blood alcohol level of 0.5 g/l). Nevertheless, precaution is 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.

Response to 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.

Paediatric population

Due to the amount of some excipients in the formulation, the use of the product is not recommended in children aged less than 2 years.

Sorbitol

The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.

The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly.

Methyl and propyl parahydroxybenzoate

Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) may cause allergic reactions (possibly delayed).

Sodium

This medicine contains less than 1 mmol sodium (23 mg) per mL, that is to say essentially ‘sodium-free’.

The elimination of cetirizine may be impaired in patients with impaired hepatic and renal function. Caution should be exercised when administering cetirizine to these patients (see section 4.2 Posology, section 4.3 Contraindications)

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.

4.5 Interaction with other medicinal products and other forms of interaction

Due to the pharmacokinetic, pharmacodynamic and tolerance profile of cetirizine, no interactions are expected with this antihistamine. Actually, neither pharmacodynamic nor significant pharmacokinetic interaction was reported in drug-drug interactions studies performed, notably with pseudoephedrine or theophylline (400 mg/day).

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).

4.6 Fertility, pregnancy and lactation

Pregnancy

For cetirizine prospectively collected data on pregnancy outcomes do not suggest potential for maternal or foetal/embryonic toxicity above background rates.

Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development. Caution should be exercised when prescribing to pregnant women.

Breast-feeding

Cetirizine is excreted in human milk at concentrations representing 25% to 90% of those measured in plasma, depending on sampling time after administration. Therefore, caution should be exercised when prescribing cetirizine to lactating women.

Fertility

Limited data is available on human fertility but no safety concern has been identified.

Animal data show no safety concern for human reproduction.

4.7 Effects on ability to drive and 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.

However, patients who experience somnolence should refrain from driving, engaging in potentially hazardous activities or operating machinery. They should not exceed the recommended dose and should take their response to the medicinal product into account.

4.8 Undesirable effects

Clinical studies

Overview

Clinical studies have shown that cetirizine at the recommended dosage has minor undesirable effects on the CNS, including somnolence, fatigue, dizziness and headache. In some cases, paradoxical CNS stimulation has been reported.

Although cetirizine is a selective antagonist of peripheral H₁-receptors and is relatively free of anticholinergic activity, isolated cases of micturition difficulty, eye accommodation disorders and dry mouth have been reported.

Instances of abnormal hepatic function with elevated hepatic enzymes accompanied by elevated bilirubin have been reported. Mostly this resolves upon discontinuation of the treatment with cetirizine dihydrochloride.

Listing of ADRs

Double blind controlled clinical trials comparing cetirizine to placebo or other antihistamines at the recommended dosage (10 mg daily for cetirizine), of which quantified safety data are available, included more than 3200 subjects exposed to cetirizine.

From this pooling, the following adverse reactions were reported for cetirizine 10 mg in the placebo-controlled trials at rates of 1.0 % or greater:

Although statistically more common than under placebo, somnolence was mild to moderate in the majority of cases. Objective tests as demonstrated by other studies have demonstrated that usual daily activities are unaffected at the recommended daily dose in healthy young volunteers.

Paediatric population

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

Post-marketing experience

In addition to the adverse reactions reported during clinical studies and listed above, the following undesirable effects have been reported in post-marketing experience.

Undesirable effects are described according to MedDRA System Organ Class and by estimated frequency based on post-marketing experience.

Frequencies are defined as follows: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data):

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, hallucination, 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

Ear and labyrinth disorders

Not known: vertigo

Cardiac disorders

Rare: tachycardia

Gastro-intestinal disorders

Uncommon: diarrhoea,

Hepatobiliary disorders

Rare: abnormal hepatic function (increased transaminases, alkaline phosphatase, γ-GT and bilirubin)

Not known: hepatitis

Skin and subcutaneous tissue disorders

Uncommon: rash, pruritus

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

General disorders and administration site conditions

Uncommon: asthenia, malaise

Rare: oedema,

Investigations

Rare: weight increased

Description of selected adverse reactions

After discontinuation of cetirizine, pruritus (intense itching) and/or urticaria have been reported.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

4.9 Overdose

Symptoms

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 an intake of at least 5 times the recommended daily dose are: confusion, diarrhoea, dizziness, fatigue, headache, malaise, mydriasis, pruritus, restlessness, sedation, somnolence, stupor, tachycardia, tremor, and urinary retention.

Management

Should overdose occur, symptomatic or supportive measures are recommended. Gastric lavage should be considered following ingestion of a short occurrence.

There is no known specific antidote to cetirizine.

Cetirizine is not effectively removed by haemodialysis.

5. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antihistamines for systemic use, piperazine derivatives

Mechanism of action

Cetirizine, a human metabolite of hydroxyzine, is a potent and a selective antagonist of peripheral H₁-receptors. In vitro receptor binding studies have shown no measurable affinity for other than H₁-receptors.

The histamine-mediated ‘early’ phase of the allergic reaction is inhibited by cetirizine, which also reduces the migration of inflammatory cells and the release of mediators associated with the ‘late’ allergic responses. Effects on other receptors are negligible and consequently cetirizine is unlikely to cause undesirable anti-cholinergic and anti-serotonin effects. At the recommended therapeutic dose of 10 mg daily, impairment of CNS function has not been found to be greater than with the placebo.

Pharmacodynamic effects

In addition to its anti-H₁ effect, cetirizine was shown to display anti-allergic activities: at a dose of 10 mg once or twice daily, it inhibits the late phase recruitment of eosinophils, in the skin and conjunctiva of atopic subjects submitted to allergen challenge.

Clinical efficacy and safety

Studies in healthy volunteers show that cetirizine, at doses of 5 mg and 10 mg strongly inhibits the wheal and flare reactions induced by very high concentrations of histamine into the skin, but the correlation with efficacy is not established.

In a six-week, placebo-controlled study of 186 patients with allergic rhinitis and concomitant mild to moderate asthma, cetirizine 10 mg once daily improved rhinitis symptoms and did not alter pulmonary function. This study supports the safety of administering cetirizine to allergic patients with mild to moderate asthma.

In a placebo-controlled study, cetirizine given at the high daily dose of 60 mg for seven days did not cause statistically significant prolongation of the QT interval.

At the recommended dosage, cetirizine has demonstrated that it improves the quality of life of patients with perennial and seasonal allergic rhinitis.

Paediatric population

In a 35-day study in children aged 5 to 12, no tolerance to the antihistaminic effect (suppression of the wheal and flare) of cetirizine was found. When a treatment with cetirizine is stopped after repeated administration, the skin recovers its normal reactivity to histamine within 3 days.

5.2 Pharmacokinetic properties

Absorption

The steady – state peak plasma concentrations is approximately 300 ng/ml and is achieved within 1.0 ± 0.5 h. The distribution of pharmacokinetic parameters such as peak plasma concentration (C_max) and area under curve (AUC) is unimodal.

The extent of absorption of cetirizine is not reduced with food, although the rate of absorption is decreased. The extent of bioavailability is similar when cetirizine is given as solutions, capsules or tablets.

Distribution

The apparent volume of distribution is 0.50 l/kg. Plasma protein binding of cetirizine is 93 ± 0.3 %. Cetirizine does not modify the protein binding of warfarin.

Biotransformation

Cetirizine does not undergo extensive first pass metabolism.

Elimination

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

Linearity/non-linearity

Cetirizine exhibits linear kinetics over the range of 5 to 60 mg.

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 was 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 (see section 4.2).

Hepatic impairment

Patients with chronic liver diseases (hepatocellular, cholestatic, and biliary cirrhosis) given 10 or 20 mg 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.

5.3 Preclinical safety data

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.

6. Pharmaceutical particulars

6.1 List of excipients

Methyl parahydroxybenzoate, Propyl parahydroxybenzoate, Sorbitol solution (70%), Glycerol, Sodium citrate, Citric acid, Propylene glycol, Monoammonium glycyrrhizinate, Purified water.
Flavours; Pineapple singapore flavour (flavouring agent and propylene glycol), Sweet orange No. 1 (flavouring agent and propylene glycol).

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

Unopened:

3 years

After opening:

6 months

6.4 Special precautions for storage

No special precautions for storage.

6.5 Nature and contents of container

Pack size:

200 ml bottle.

Packaging:

Type III amber glass bottle with Tamper proof polypropylene closure and Polyethylene Terepthalate (PET) amber bottle with Tamper proof polypropylene closure.

6.6 Special precautions for disposal and other handling

No special requirements for disposal.

7. MANUFACTURED IN INDIA BY:
   TAJ PHARMACEUTICALS LTD;
   Plot No. 220, Mahagujarat Industrial Estate,
   Moraiyya, Tal-Sanand, Dist-Ahmedabad, Gujarat.

Package leaflet: Information for the user
Cetirizine Hydrochloride 5 mg/ 5 ml Oral Solution (Cetrilin) Taj Pharma
Cetirizine hydrochloride

The name of this medicine is Cetirizine Hydrochloride 5mg/5ml Oral Solution, which will be referred to as Cetirizine Solution throughout this leaflet.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

What is in this leaflet

1. What Cetirizine Solution is and what it is used for
2. What you need to know before you take Cetirizine Solution
3. How to take Cetirizine Solution
4. Possible side effects
5. How to store Cetirizine Solution
6. Contents of the pack and other information1. What Cetirizine Solution is and what it is used for

Cetirizine, the active ingredient of the solution is an antihistamine. It blocks the effects of a substance called histamine which occurs naturally in the body. Histamine is involved in allergic reactions.

Cetirizine dihydrochloride oral solution is used to treat adults and paediatric patients aged 2 years and over who have hay fever (seasonal allergic rhinitis), year round allergies such as dust or pet allergies (perennial allergic rhinitis) and urticaria (swelling, redness and itchiness of the skin).

Antihistamines like cetirizine dihydrochloride oral solution relieve the unpleasant symptoms and discomfort associated with these conditions, such as sneezing, irritated, runny and blocked up nose, itchy, red and watering eyes and skin rashes.

2. What you need to know before you take Cetirizine Solution Do not take Cetirizine Solution if you:

are allergic to cetirizine or any of the other ingredients of this medicine (listed in  section 6) or to hydroxyzine or to any piperazine derivatives (closely related active ingredients of other medicines).

• have a severe kidney failure (severe renal failure with creatinine clearance less than 10 ml/min).

Warnings and precautions

Talk to your doctor or pharmacist before taking Cetirizine Solution.

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 per mille (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 Solution with alcohol.

Allergy testing

If you are due to have an allergy test, ask your doctor if you should stop taking Cetirizine Solution for several days before testing. This medicine may affect your allergy test results.

Children

Do not give this medicine to children below 2 years of age.

Other medicines and Cetirizine Solution

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Due to the profile of cetirizine, no interactions with other drugs are expected.

Cetirizine Solution with food and alcohol

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

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 or pharmacist for advice before taking this medicine.

Cetirizine Solution should be avoided in pregnant women. Accidental use of the drug by a pregnant woman should not produce any harmful effects on the foetus. Nevertheless, the medicine should only be administered if necessary and after medical advice.

Cetirizine passes into breast milk. Therefore, you should not take Cetirizine Solution during breast- feeding unless you have contacted a doctor.

Driving and using machines

Clinical studies have produced no evidence of impaired attention, alertness and driving capabilities after taking cetirizine at the recommended dose.

You should closely observe your response to the drug after you have taken Cetirizine Solution if you are intending to drive, engage in  potentially  hazardous activities or operate machinery. You should not exceed the recommended dose.

Cetirizine Solution contains sorbitol, sodium, methyl parahydroxybenzoate and propyl parahydroxybenzoate.

• This medicine contains 0.0005 mg sorbitol in each mL of solution which is equivalent to 0.0005 mg/ml.
• The oral solution contains the preservatives methyl parahydroxybenzoate, propyl parahydroxybenzoate that may cause allergic reactions (possibly delayed).
• This medicine contains less than 1 mmol sodium (23 mg) per mL, that is to say essentially ‘sodium-free’.

3. How to take Cetirizine Solution

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

Remember the solution can be swallowed as such. Do not take more than 10 mL each day. If you do not feel better within a few days, consult your doctor.

The recommended dose is:

Children aged 2 to 6 years:

2.5 mg twice daily as 2.5 mL oral solution twice daily.

Children aged 6 to 12 years:

5 mg twice daily as 5 mL oral solution twice daily.

Adults and adolescents over 12 years of age:

10 mg once daily as 10 mL oral solution.

Use in children

Cetirizine Solution is not suitable for children under 2 years of age.

Renal impairment

Patients with moderate renal impairment are recommended to take 5 mg once daily.

If you suffer from severe kidney disease, please contact your doctor or pharmacist who may adjust the dose accordingly.

If your child suffers from kidney disease, please contact your doctor or pharmacist who may adjust the dose according to your child’s needs.

If you feel that the effect of Cetirizine Solution is too weak or too strong, please consult your doctor.

Method of administration

For oral use.

Duration of treatment

The duration of treatment depends on the type, duration and course of your complaints. Please ask your doctor or pharmacist for advice

If you take more Cetirizine Solution than you should

If you have accidentally taken more than the recommended/prescribed dose, contact your nearest hospital casualty department or tell your doctor or pharmacist immediately.

Your doctor will then decide what measures, if any, should be taken. Remember to take any packaging with you.

After an overdose, the side effects described in section 4 below may occur with increased intensity.

The following side effects have been reported:

• confusion
• diarrhoea
• dizziness
• tiredness
• headache
• a vague feeling of discomfort
• dilating of pupils of the eyes
• itching
• restlessness
• sedation
• sleepiness
• stunned state in which it is difficult to get a response
• abnormal rapid heart rate
• tremors
• urinary retention

If you forget to take Cetirizine Solution

Do not take double dose to make up for a forgotten dose.

If you have forgotten to take your medicine, take it as soon as you remember and then wait 24 hours before taking your next dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

If you stop taking Cetirizine Solution

Rarely, pruritus (intense itching) and/or urticaria may return if you stop taking Cetirizine Solution. If you have any further questions on the use of this medicine, ask your doctor or pharmacist

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking the tablets 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
• inflammation of liver (hepatitis)
• fits
• fixed drug eruption (appearance of red or blistered skin in the same place after taking this medicine
• suicidal ideation
• acute generalized exanthematous pustulosis (a red, scaly rash with bumps under the skin and blisters)

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 side effects (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.

Uncommon side effects (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)
• abdominal pain
• agitation
• itching, rash

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

• heart beating too fast
• oedema (swelling of the feet or ankles)
• changes in liver function tests, indicating the possibility of damage to the liver.
• weight increase
• aggression, confusion, depression, hallucination, insomnia
• hives

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

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

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

• increased appetite

forgetfulness, memory impairment

• vertigo (sensation of rotation or movement)
• urinary retention (inability to completely empty the urinary bladder)
• nightmare
• joint pain

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

5. How to store Cetirizine Solution

Keep this medicine out of sight and reach of children.

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.

This medicinal product does not require any special storage conditions. Use within 6 months of opening.

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 to protect the environment.

6. Contents of the pack and other information What Cetirizine Solution contains:

The active ingredient is cetirizine hydrochloride. Each 1ml of solution contains 1mg of cetirizine hydrochloride.

The other ingredients are: methyl parahydroxybenzoate, propyl parahydroxybenzoate, sorbitol solution (70%), glycerol, sodium citrate, citric acid, propylene glycol, monoammonium glycyrrhizinate, purified water, pineapple singapore flavour, sweet orange no.1.

What Cetirizine Solution looks like and the contents of the pack: Cetirizine Solution is a clear, colourless, flavoured solution.

Cetirizine Solution is available in a 200ml amber glass and polyethylene Terepthalate (PET) bottle.

7. MANUFACTURED IN INDIA BY:
   TAJ PHARMACEUTICALS LTD;
   Plot No. 220, Mahagujarat Industrial Estate,
   Moraiyya, Tal-Sanand, Dist-Ahmedabad, Gujarat.