Cetirizine Tablet IP 5mg (Cetrilin) Taj Pharma

Overview

INTRODUCTION OF CETRILIN TABLET

Cetrilin 5 mg Tablet 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 5 mg Tablet 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 TABLET

• Allergic conditions

CETRILIN TABLET SIDE EFFECTS

Common

• Sleepiness

HOW TO USE CETRILIN TABLET

Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Cetrilin 5 mg Tablet may be taken with or without food, but it is better to take it at a fixed time.

HOW CETRILIN TABLET WORKS

Cetrilin 5 mg Tablet 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 TABLET RELATED WARNINGS

Alcohol

UNSAFE

Cetrilin 5 mg Tablet may cause excessive drowsiness with alcohol

Pregnancy

SAFE IF PRESCRIBED

Cetrilin 5 mg Tablet 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 5 mg Tablet 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 5 mg Tablet may cause sleepiness and other effects in the baby

Driving

SAFE

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

Kidney

CAUTION

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

Cetirizine Hydrochloride Tablets 5mg and 10mg (Cetrilin) Taj Pharma

1. Name of the medicinal product

Cetirizine Hydrochloride 5mg Tablets

Cetirizine Hydrochloride 10mg Tablets

2. Qualitative and quantitative composition

Each tablet contains Cetirizine hydrochloride 5mg.

Each tablet contains Cetirizine hydrochloride 10mg.

3. Pharmaceutical form

Film-coated tablet.

4. Clinical particulars

4.1 Therapeutic indications

In adults and paediatric patients 6 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

Children aged from 6 to 12 years: 5mg twice daily (a half tablet twice daily).

Adults and adolescents over 12 years of age: 10mg once daily (1 tablet)

The tablets need to be swallowed with a glass of liquid.

Elderly subjects: 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 patients with renal impairment. Since cetirizine is mainly excreted via renal route (see section 5.2), in cases where 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 the 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 adjustment 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, their age and body weight.

Patients with hepatic impairment: no dose adjustment is needed in patients with solely hepatic impairment.

Patients with hepatic impairment and renal impairment: dose adjustment is recommended (see Patients with moderate to severe renal impairment above).

4.3 Contraindications

Hypersensitivity to cetirizine hydrochloride, to any of the excipients listed in section 6.1, 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 or urinary retention (e.g. spinal cord lesion, prostatic hyperplasia) as cetirizine may increase the risk of urinary retention.

Caution in epileptic patients and patients who are 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.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

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

The use of the film-coated tablet formulation is not recommended in children aged less than 6 years since this formulation does not allow for appropriate dose adaptation. It is recommended to use a paediatric formulation of cetirizine.

4.5 Interaction with other medicinal products and other forms of interaction

Due to 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/foetal development, parturition or post natal development. Caution should be exercised when prescribing to pregnant women.

Breast-feeding

Cetirizine is excreted in human milk at concentrations representing 25% to 90% 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 hydrochloride.

• 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 events were reported for cetirizine 10mg 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 usually daily activities are unaffected at the recommended daily dose in healthy young volunteers.

Paediatric population

Adverse drug 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 effects 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, 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

Ear and labyrinth disorders:

Not known: vertigo

Cardiac disorders:

Rare: tachycardia

Gastro-intestinal disorders:

Uncommon: diarrhoea

Hepatobiliary disorders:

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

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

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

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.

5. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: antihistamine for systemic use, piperazine derivatives.

Mechanism of action

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

Pharmacodynamics 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 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 10mg 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 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 antihistamine effect (suppression of 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

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

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 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 (see section 4.2).

Hepatic impairment: Patients with chronic liver disease (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

Lactose Monohydrate, Microcrystalline Cellulose, Maize Starch, Colloidal Anhydrous Silica, Magnesium Stearate & Talc.

Film coat contains:

Hypromellose, Lactose monohydrate, Titanium Dioxide, Macrogol 4000 & Sodium Citrate.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

Three years.

6.4 Special precautions for storage

No special precautions for storage.

6.5 Nature and contents of container

PVC and aluminium foil blister strips.

Pack sizes: 7, 14, 21, 28, 30, 60 tablets

6.6 Special precautions for disposal and other handling

Not applicable.

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 5mg and 10mg Tablets (Cetrilin) Taj Pharma
Cetirizine Hydrochloride

Read all 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 has 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 your doctor if you do not feel better or if you feel worse after 3 days.

What is in this leaflet

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

The active ingredient (which makes this medicine work) is called cetirizine hydrochloride, which belongs to a family of medicines called antihistamines. Cetirizine Hydrochloride 10mg Tablets are used for the relief of symptoms of hayfever and other allergic conditions (e.g. sneezing, runny or itchy nose) or for skin rashes (chronic nettle rash, idiopathic urticaria) in adults and children over 6 years of age.

2. What you need to know before you take Cetirizine Hydrochloride Tablets

Do not take Cetirizine Hydrochloride Tablets

• if you are allergicto cetirizine hydrochloride, or any of the ingredients of this medicine (listed in section 6), to hydroxyzine or to any piperazine derivatives (closely related active substances of other medicines)
• if you have a severe kidney disease(severe renal failure with creatinine clearance below 10 ml/min).

Warnings and precautions

• If you have liveror kidney problems, 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 patientor a patient at risk of convulsions, you should ask your doctor for advice.
• If you are scheduled for allergy testing, ask your doctor if you should stop taking Cetirizine Hydrochloride Tablets for several days before testing. This medicine may affect your allergy test results.

Children and Cetirizine Hydrochloride Tablets

The use of this medicine is not recommended in children aged less than 6 years since this formulation does not allow for appropriate dose adaptation.

Other medicines and Cetirizine Hydrochloride Tablets

Please tell your doctor or a pharmacist if you are taking, have recently taken or might take any other medicines.

Cetirizine Hydrochloride Tablets with food and drink and alcohol

Food does not affect absorption of Cetirizine Hydrochloride Tablets.

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 Hydrochloride Tablets with alcohol.

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.

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

Cetirizine Hydrochloride Tablets contain lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking these tablets.

3. How to take Cetirizine Hydrochloride Tablets

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

The tablets should be swallowed with water.

Adults, elderly patients and children 12 years and over: 1 tablet daily.

Children aged 6 to 12 years: Half a tablet twice daily.

Children under 6 years: Not recommended.

Patients with renal impairment: Patients with moderate renal impairment are recommended to take 5 mg once daily. If you have severe kidney problems (or liver and kidney problems together) 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.

Duration of treatment

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

If you take more than you should

If you accidentally take too much medicine, contact your doctor or nearest casualty department at once.

If you forget to take Cetirizine Hydrochloride Tablets

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

If you stop taking Cetirizine Hydrochloride Tablets

Rarely, pruritus (intense itching) and/or urticaria may return if you stop taking Cetirizine Hydrochloride Tablets.

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.

The following side effects are very rare but you must stop taking the tablets and speak to your doctor immediately if you notice them:

• Allergic reactions including severe reactions and angioedema (serious allergic reaction which causes swelling of the face or throat)
• Convulsions (fits)
• Thoughts about committing suicide.

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

Common side effects (may affect up to 1 in 10 patients)

• Somnolence, ( sleepiness)
• Dizziness, headache
• Diarrhoea, nausea, dry mouth
• Fatigue
• Pharyngitis, cold-like symptoms of the nose (children only).

Uncommon side effects (may affect up to 1 in 100 patients)

• Feeling agitated
• Parestheisa (abnormal feelings of the skin)
• Abdominal pain
• Pruritus (itchy skin), rash
• Asthenia (extreme fatigue), malaise (feeling generally unwell).

Rare side effects (may affect up to 1 in 1000 patients)

• Depression, hallucination (hearing or seeing things), aggression, confusion, sleeplessness
• Tachycardia (heart beating too fast)
• Abnormal liver function test results (your doctor will know what to do)
• Urticaria (hives)
• Oedema (generalised swelling due to water retention)
• Weight increased.

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

• Low levels of blood platelets causing unusual bleeding or bruising
• Tics (habit spasm)
• Syncope, dyskinesia (involuntary movements), dystonia (abnormal prolonged muscular contractions), tremor, dysgeusia (altered taste)
• Blurred vision, accommodation disorder (difficulty focusing), oculogyration (eyes having uncontrolled circular movements)
• Fixed drug eruption
• Abnormal elimination of urine (bedwetting, pain and/or difficulty passing water).

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

• Increased appetite
• Memory loss and forgetfulness
• Vertigo (sensation of rotation or movement)
• Urinary retention (inability to completely empty the urinary bladder)
• Pruritus (intense itching) and/or urticaria upon discontinuation
• Arthralgia (joint pain)
• Acute generalised exanthematous pustulosis (rash with blisters containing pus).

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. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store,

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

5. How to store Cetirizine Hydrochloride Tablets

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date, which is stated on the blister and carton. 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 medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Cetirizine Hydrochloride Tablets contain

Each tablet contains 10mg of cetirizine hydrochloride (the active ingredient). They also contain: lactose, microcrystalline cellulose, maize starch, colloidal anhydrous silica, magnesium stearate, talc, hypromellose, titanium dioxide, macrogol 4000 and sodium citrate.

What Cetirizine Hydrochloride Tablets look like and contents of the pack

Available in cartons containing 7, 14, 21, 28, 30 and 60 tablets.

7. Manufactured in india by:
   TAJ PHARMACEUTICALS LTD;
   Plot No. 220, Mahagujarat Industrial Estate, Moraiyya,
   Tal-Sanand, Dist-Ahmedabad, Gujarat.