Cetirizine Dihydrochloride Tablets Taj Pharma 10mg

1. Name Of The Medicinal Product

Cetirizine Dihydrochloride Tablets 10mg Taj Pharma

2. Qualitative and quantitative composition   

Each film-coated tablet contains:
Cetirizine dihydrochloride USP                               10mg
Excipients                                                              q.s.

3. Pharmaceutical form

Film-coated tablets.

White, oblong, film-coated tablet

4. Clinical particulars

4.1 Therapeutic indications

Cetirizine Dihydrochloride10mg Tablets are indicated in children aged 12 years and above, adolescents and adults:

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

– for the relief of symptoms of chronic idiopathic urticaria.

4.2 Posology and method of administration

Adults and adolescents over 12 years of age: 10 mg 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 in patients with renal impairment. Since cetirizine is mainly excreted 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 pediatric 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.

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 dihydrochloride, to hydroxyzine, to any piperazine derivatives, or to any of the excipients listed in section 6.1.

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.

Patients with kidney disease are instructed to consult a physician before use. The physician should determine if a different dose is needed (see section 4.2).

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.

Severe skin reactions such as acute generalised exanthematous pustulosis (AGEP) have been reported very rarely with cetirizine-containing products. This acute pustular eruption may occur within the first 2 days of treatment, with fever, and numerous, small, mostly non-follicular pustules arising on a widespread oedematous erythema and mainly localized on the skin folds, trunk, and upper extremities. Patients should be carefully monitored. If signs and symptoms such as pyrexia, erythema, or many small pustules are observed, administration of this medicine should be discontinued and appropriate measures taken if needed.

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.

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

Paediatric Population

The use of the film-coated tablet formulation is not recommended in children aged less than 12 years.

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).

In sensitive patients, concurrent use with alcohol or other CNS depressants may cause additional reductions in alertness and impairment of performance (see section 4.7).

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

4.6 Fertility, pregnancy and lactation

Pregnancy

For cetirizine very rare clinical data on exposed pregnancies are available. 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.

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.

In sensitive patients, concurrent use with alcohol or other CNS depressants may cause additional reductions in alertness and impairment of performance (see section 4.5).

4.8 Undesirable effects

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.

Clinical trials

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 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.

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 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

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

Not known: Eye pain

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 phosphatase, γ-GT and bilirubin)

Skin and subcutaneous tissue disorders:

Uncommon: pruritus, rash

Rare: urticaria

Very rare: angioneurotic oedema, fixed drug eruption

Not known: acute generalised exanthematous pustulosis (AGEP)

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

Not known: pruritus upon withdrawal

Investigations:

Rare: weight increased

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.

Cetirizine is not effectively removed by dialysis.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Piperazine derivatives,

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.

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.

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 35-day study in children aged 5 to 12, no tolerance to the antihistaminic 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.

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 QT interval.

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

5.2 Pharmacokinetic properties

The steady – state peak plasma concentrations is approximately 300 ng/ml and is achieved within 1.0 ± 0.5 h. No accumulation is observed for cetirizine following daily doses of 10 mg for 10 days. The distribution of pharmacokinetic parameters such as peak plasma concentration (C_max) and area under curve (AUC), is unimodal in human volunteers.

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.

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.

Cetirizine does not undergo extensive first pass metabolism. About two third of the dose are excreted unchanged in urine. The terminal half-life is approximately 10 hours.

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.

Children, infants and toddlers: 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

Renally impaired patients: 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).

Hepatically impaired patients: 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

Microcrystalline cellulose

Lactose, Colloidal anhydrous silica, Magnesium stearate, Opadry, Hydroxypropylmethylcellulose , Titanium dioxide,,  Macrogol.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

5 years

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

Thermoformed transparent, colorless, physiologically inert PVC blister strip thermosealed by an aluminium foil covered by suitable lac; in a carton box.

Boxes of 7, 14 or 30 tablets.

Not all the packs may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements for disposal

7. MANUFACTURED BY:

TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

Cetirizine Dihydrochloride Tablets 10mg Taj Pharma

PACKAGE LEAFLET INFORMATION FOR THE USER

Cetirizine Dihydrochloride

Read all this leaflet carefully before you start taking this medicine, referred to as CETIRIZINE DIHYDROCHLORIDE TABLETS 10MG TAJ PHARMA Tablets in this leaflet, 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 a doctor if you do not feel better or if you feel worse after a few days.

WHAT IS IN THIS LEAFLET:

1. What CETIRIZINE DIHYDROCHLORIDE TABLETS 10MG TAJ PHARMA Tablets are and what they are used for
2. What you need to know before you take CETIRIZINE DIHYDROCHLORIDE TABLETS 10MG TAJ PHARMA Tablets
3. How to take CETIRIZINE DIHYDROCHLORIDE TABLETS 10MG TAJ PHARMA Tablets
4. Possible side effects
5. How to store CETIRIZINE DIHYDROCHLORIDE TABLETS 10MG TAJ PHARMA Tablet
6. Contents of the pack and other information1. WHAT CETIRIZINE DIHYDROCHLORIDE TABLETS 10MG TAJ PHARMATABLETS 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 DIHYDROCHLORIDE TABLETS 10MG TAJ PHARMA Tablets are used to treat people 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 TABLETS 10MG TAJ PHARMA Tablets 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 DIHYDROCHLORIDE TABLETS 10MG TAJ PHARMA TABLETS

Do not take CETIRIZINE DIHYDROCHLORIDE TABLETS 10MG TAJ PHARMA Tablets if you;

• are allergicto cetirizine hydrochloride or to any of the ingredients listed in section 6, to hydroxyzine or to any piperazine derivatives (closely related active substances of other medicines)
• suffer from severe kidney failure(creatinine clearance less than 10ml/min)
• have problems of urinary retention
• you are breast-feeding

If any of the above applies to you talk to your pharmacist.

Warnings and precautions:

• If you have liveror kidney problems please ask your pharmacist for advice.
• If you have predisposition factors of urinary retention (eg: spinal cord lesion, prostatic hyperplasia) as cetirizine increases the risk of urinary retention.,
• If you suffer from epilepsy or are at risk of convulsions, you should ask your pharmacist for advice.

Children and CETIRIZINE DIHYDROCHLORIDE TABLETS 10MG TAJ PHARMA 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 DIHYDROCHLORIDE TABLETS 10MG TAJ PHARMA Tablets

Please tell your doctor or a pharmacist if you are taking or have recently taken any other medicines, including any bought without a prescription.

CETIRIZINE DIHYDROCHLORIDE TABLETS 10MG TAJ PHARMA Tablets with food and drink and alcohol

Food does not affect absorption of this medicine.

Avoid alcohol while you are taking this medicine.

Pregnancy and breastfeeding

If you are pregnant or trying to become pregnant ask your pharmacist for advice before taking CETIRIZINE DIHYDROCHLORIDE TABLETS 10MG TAJ PHARMA Tablets.

Do not take these tablets if you are breast-feeding.

Allergy Testing

If you are due to have an allergy test, ask your doctor if you should stop taking CETIRIZINE DIHYDROCHLORIDE TABLETS 10MG TAJ PHARMA Tablets for several days before testing. This medicine may affect your allergy test results.

Driving and using machines

Some people have reported that they feel drowsy or dizzy while they are taking CETIRIZINE DIHYDROCHLORIDE TABLETS 10MG TAJ PHARMA Tablets. If you are affected do not drive or use machines.

CETIRIZINE DIHYDROCHLORIDE TABLETS 10MG TAJ PHARMA Tablets contain lactose

This medicine contains 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 DIHYDROCHLORIDE TABLETS 10MG TAJ PHARMATABLETS

Remember. Take the tablet with a glass of water. Do not take more than one tablet each day. If you do not feel better within a few days, consult your doctor.

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

Adults and children aged 12 years and over: Take one tablet daily. If you have kidney problems (or liver and kidney problems together) please ask your doctor for advice: you may need to take a lower dose. The new dose will be determined by your doctor.

CETIRIZINE DIHYDROCHLORIDE TABLETS 10MG TAJ PHARMA Tablets are not suitable for children under 6.

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 a tablet

If you forget to take a tablet, you should take one as soon as you remember, but wait at least 24 hours before taking your next tablet.

4. POSSIBLE SIDE EFFECTS

Like all medicines Cetirizine Hydrochloride Tablets 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 straight away if you notice these symptoms:

• A severe allergic reaction including rash, itchiness and fever, swollen throat, face, eyelids or lips. This reaction may start soon after you first take the medicine or it might start later.
• Bruising or bleeding more easily than normal.
• Convulsions or fits.

The following side effects have also been reported.

Common side effects (affects less than 1 in 10 people)

• Tiredness, feeling sleepy
• Headache
• Dry mouth
• Nausea
• Diarrhoea (children only)
• Pain in the abdomen
• Dizziness
• Sore throat
• Cold like symptoms of the nose (children only)

Uncommon side effects (affects less than 1 in 100 people)

• Itching and rash
• Diarrhoea
• Feeling weak or generally unwell
• Tingling in the hands and feet
• Feeling agitated.

Rare side effects (affects less than 1 in 1000 people)

• Fast heart beat
• Oedema (generalised swelling due to water retention)
• Abnormal liver function test results (your doctor will know what to do)
• Increased weight
• Aggression, confusion, depression, hallucination (hearing or seeing things), sleepiness
• Urticaria (hives).

Very rare side effects (affects less than 1 in 10,000 people)

• Blurred vision, difficulty focussing
• Rotation of the eye
• Bad taste in the mouth
• Tremor, tics
• Involuntary movements and/or jerking of the limbs
• Muscle spasms in the neck and shoulders
• Swelling of the skin particularly around the face
• Fainting
• A recurring rash
• Bed wetting, pain and/or difficulty passing water.

Not known side effects

• Increased appetite
• Vertigo
• Urinary retention
• Memory loss and/or impairment,

In very rare cases people have thought about committing suicide and if you feel this way then stop taking the tablets and see your doctor.

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.

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

5. HOW TO STORE CETIRIZINE DIHYDROCHLORIDE TABLETS 10MG TAJ PHARMATABLETS

Keep this medicine out of the sight and reach of children. Do not take the tablets 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 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 DIHYDROCHLORIDE TABLETS 10MG TAJ PHARMA 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 (E171), macrogol 4000 and sodium citrate.

What CETIRIZINE DIHYDROCHLORIDE TABLETS 10MG TAJ PHARMA Tablets look like

The tablets are white circular bi-convex, film-coated tablets marked C on one side and a breakline on the other.

Available in cartons containing 14 and 30 tablets.

7. Manufactured in India by:

TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com