Benadryl Allergy One A Day 10mg tablets

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

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Active ingredient:
Cetirizine hydrochloride
Available from:
McNeil Products Ltd
ATC code:
R06AE07
INN (International Name):
Cetirizine hydrochloride
Dosage:
10mg
Pharmaceutical form:
Tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 03040100; GTIN: 3574661202662 3574661202655 3574661253848
Authorization number:
PL 15513/0118

Read the complete document

If anyone has too much

If anyone has too much contact a doctor or

your nearest Accident and Emergency

department (Casualty) taking this leaflet and

pack with you.

If you forget to take the medicine

If you forget to take a dose, take the next dose

when needed provided that you only take a

maximum of 1 tablet in 24 hours. Do not take

a double dose.

4 Possible side-effects

Like all medicines, this medicine can cause side

effects, although not everybody gets them.

If you experience any of the following,

stop taking this medicine and seek

immediate medical help:

Sudden onset of fever, reddening of the skin,

or many small pustules (possible symptoms

of Acute Generalised Exanthematous

Pustulosis - AGEP) may occur within the first

2 days of treatment with this medicine (See

section 2).

Sudden signs of allergy such as rash, itching

or hives on the skin, swelling of the face,

lips, tongue or other parts of the body,

shortness of breath, wheezing or trouble

breathing

Bruising or bleeding more easily than

normal

Convulsions (fits) or hallucinations

Loss of consciousness

This medicine is used to relieve the symptoms of

hay fever and other allergic conditions such as

pet or dust allergies and skin reactions.

This medicine is for use by adults and children

aged 12 years and over.

A doctor must be contacted if symptoms worsen

or do not improve after 3 days

Read the leaflet carefully before use. Keep this

leaflet, you might need it again.

1 What the medicine is for

Benadryl Allergy One a Day 10 mg Tablets is a

medicine which is used to relieve the symptoms of

hay fever and other allergic conditions such as pet

or dust allergies. The tablets contain 10 mg

cetirizine dihydrochloride which is an antihistamine

that helps relieve allergy symptoms such as

sneezing, runny nose and watery eyes.

It can also be used to treat allergic skin reactions.

These include urticaria, also known as hives, where

the skin looks blotchy, with white raised wheals

(bumps) surrounded by redness.

This medicine is for use in adults and children aged

12 years and over.

2 Before taking this medicine

This medicine is suitable for most adults and

children aged 12 years and over, but a few people

should not use it. If you are in any doubt, talk to

your doctor or pharmacist.

Do not take this medicine...

If you have ever had a bad reaction to

cetirizine dihydrochloride, to hydroxyzine

or piperazine derivatives or any other

ingredients of this medicine (See section 6).

If you have serious kidney problems.

Talk to your doctor or pharmacist

If you are an epileptic or at risk of

convulsions (fits).

If this applies to you, talk to a doctor or

pharmacist.

If you experience symptoms such as a sudden

onset of fever, reddening of the skin with blisters

containing pus, stop giving this medicine

immediately and talk to a doctor or pharmacist

(See section 4).

Warnings and precautions

If you are a patient with 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

difficulty passing urine, you should ask your

doctor for advice.

If you are pregnant or 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.

You should not take Benadryl Allergy One a

Day 10 mg Tablets during breast feeding

because cetirizine passes into breast milk.

Special warnings about this medicine

In most people this product does not cause

drowsiness. However, there are rare

exceptions and you should take care when

you use this product for the first time. If this

product makes you feel drowsy, do not drive

or operate machinery. This may be worsened

by alcohol, sedatives or tranquilisers (used to

treat anxiety or sleep disorders).

As with all antihistamines, it is advisable to

avoid alcohol consumption when taking this

medicine.

You should stop taking this product for 3 days

before undergoing a skin allergy test because

antihistamines can affect the results of the test.

This product contains lactose. If you have been

told by your doctor that you have an

intolerance to some sugars, contact your

doctor before taking this medicinal product.

3 How to take this medicine

For oral use only.

Swallow with a glass of water.

Do not take more than the stated dose shown in

the table.

Children under 12 years old

This medicine is not recommended for children

aged under 12 years old.

Adults and children aged 12 years

and above

Age

Dose

Adults and children

Take 1 tablet

aged 12 years and above once a day

Do not take more than 1 tablet in 24 hours.

If symptoms persist or worsen, stop use and

consult your doctor or pharmacist.

!

!

!

!

!

If you experience any of the following,

stop taking this medicine and talk to your

doctor:

Confusion

Abnormal liver function tests

Rapid heartbeat

Other effects which may occur include:

Common: affects 1 to 10 users in 100

Headache or dizziness

Drowsiness or tiredness

Restlessness

Dry mouth, sore throat

Upset stomach, abdominal pain, diarrhoea,

nausea

Runny nose

Uncommon: affects 1 to 10 users in 1,000

Agitation

Unusual weakness

Feeling of general discomfort or uneasiness

Pins & needles

Rarely: affects 1 to 10 users in 10,000

Aggression, depression

Weight gain

Movement disorders including tremor,

muscle spasm and tics

Sleeplessness

Very rarely: affects less than 1 user in 10,000

Taste disorder

Blurred vision, eye movement disorder

Difficult, painful or involuntary urination

Other effects which may occur but it is unknown

how often:

Vertigo, increased appetite

Amnesia, memory impairment

Inability to pass urine

Eye pain

Joint pain.

Pruritus (intense itching) when you stop

giving this medicine.

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.

Cases of impotence in adults have also been

reported.

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.

The following details are applicable for Malta: ADR

Reporting

www.medicinesauthority.gov.mt/adrportal

By reporting side effects you can help provide

more information on the safety of this medicine.

5 Storing this medicine

Keep this medicine out of the sight and reach of

children.

This medicine does not require any special storage

conditions. Do not use this medicine after the

expiry date stated on the carton and blister. 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 Further Information

What's in this medicine?

The active ingredient in Benadryl Allergy One a

Day 10 mg Tablets is: 10 mg Cetirizine

dihydrochloride in each tablet.

turn over

10 mg TABLETS

Cetirizine dihydrochloride

!

Other ingredients are: Microcrystalline cellulose,

lactose, colloidal anhydrous silica and magnesium

stearate.

The film coating contains

hydroxypropylmethylcellulose (E464), titanium

dioxide (E171) and macrogol 400.

What the medicine looks like and

contents of the pack

Benadryl Allergy One a Day 10 mg Tablets are

white oblong film-coated tablets, with a break-line

and Y-Y logo available in packs of 7, 14 and 30.

Not all pack sizes may be marketed.

Product licence holder and manufacturer:

McNeil Products Ltd, Maidenhead, Berkshire,

SL6 3UG, UK.

This leaflet was revised in February 2019.

Benadryl is a registered trade mark.

TYPE

BARCODES

NUMBER

LAETUS_PHARMA

1593

26.04.19

401349179_V2R1

CIA79546E

CIA79546D

1593

19-0127

TI006PIL-024-06

305 x 148 mm

HelveticaNeue

MetaPlusBold-Roman

MyriadPro-Regular

Optima

Optima-Bold

Optima-BoldItalic

ZapfDingbatsITC

PANTONE

287 C

PANTONE

167 C

Benadryl Allergy One a Day 10mg Tablets 7s 14s 30s

If anyone has too much

If anyone has too much contact a doctor or

your nearest Accident and Emergency

department (Casualty) taking this leaflet and

pack with you.

If you forget to take the medicine

If you forget to take a dose, take the next dose

when needed provided that you only take a

maximum of 1 tablet in 24 hours. Do not take

a double dose.

4 Possible side-effects

Like all medicines, this medicine can cause side

effects, although not everybody gets them.

If you experience any of the following,

stop taking this medicine and seek

immediate medical help:

Sudden onset of fever, reddening of the skin,

or many small pustules (possible symptoms

of Acute Generalised Exanthematous

Pustulosis - AGEP) may occur within the first

2 days of treatment with this medicine (See

section 2).

Sudden signs of allergy such as rash, itching

or hives on the skin, swelling of the face,

lips, tongue or other parts of the body,

shortness of breath, wheezing or trouble

breathing

Bruising or bleeding more easily than

normal

Convulsions (fits) or hallucinations

Loss of consciousness

2 Before taking this medicine

This medicine is suitable for most adults and

children aged 12 years and over, but a few people

should not use it. If you are in any doubt, talk to

your doctor or pharmacist.

Do not take this medicine...

If you have ever had a bad reaction to

cetirizine dihydrochloride, to hydroxyzine

or piperazine derivatives or any other

ingredients of this medicine (See section 6).

If you have serious kidney problems.

Talk to your doctor or pharmacist

If you are an epileptic or at risk of

convulsions (fits).

If this applies to you, talk to a doctor or

pharmacist.

If you experience symptoms such as a sudden

onset of fever, reddening of the skin with blisters

containing pus, stop giving this medicine

immediately and talk to a doctor or pharmacist

(See section 4).

Warnings and precautions

If you are a patient with 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

difficulty passing urine, you should ask your

doctor for advice.

If you are pregnant or 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.

You should not take Benadryl Allergy One a

Day 10 mg Tablets during breast feeding

because cetirizine passes into breast milk.

Special warnings about this medicine

In most people this product does not cause

drowsiness. However, there are rare

exceptions and you should take care when

you use this product for the first time. If this

product makes you feel drowsy, do not drive

or operate machinery. This may be worsened

by alcohol, sedatives or tranquilisers (used to

treat anxiety or sleep disorders).

As with all antihistamines, it is advisable to

avoid alcohol consumption when taking this

medicine.

You should stop taking this product for 3 days

before undergoing a skin allergy test because

antihistamines can affect the results of the test.

This product contains lactose. If you have been

told by your doctor that you have an

intolerance to some sugars, contact your

doctor before taking this medicinal product.

3 How to take this medicine

For oral use only.

Swallow with a glass of water.

Do not take more than the stated dose shown in

the table.

Children under 12 years old

This medicine is not recommended for children

aged under 12 years old.

Adults and children aged 12 years

and above

Age

Dose

Adults and children

Take 1 tablet

aged 12 years and above once a day

Do not take more than 1 tablet in 24 hours.

If symptoms persist or worsen, stop use and

consult your doctor or pharmacist.

If you experience any of the following,

stop taking this medicine and talk to your

doctor:

Confusion

Abnormal liver function tests

Rapid heartbeat

Other effects which may occur include:

Common: affects 1 to 10 users in 100

Headache or dizziness

Drowsiness or tiredness

Restlessness

Dry mouth, sore throat

Upset stomach, abdominal pain, diarrhoea,

nausea

Runny nose

Uncommon: affects 1 to 10 users in 1,000

Agitation

Unusual weakness

Feeling of general discomfort or uneasiness

Pins & needles

Rarely: affects 1 to 10 users in 10,000

Aggression, depression

Weight gain

Movement disorders including tremor,

muscle spasm and tics

Sleeplessness

Very rarely: affects less than 1 user in 10,000

Taste disorder

Blurred vision, eye movement disorder

Difficult, painful or involuntary urination

Other effects which may occur but it is unknown

how often:

Vertigo, increased appetite

Amnesia, memory impairment

Inability to pass urine

Eye pain

Joint pain.

Pruritus (intense itching) when you stop

giving this medicine.

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.

Cases of impotence in adults have also been

reported.

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.

The following details are applicable for Malta: ADR

Reporting

www.medicinesauthority.gov.mt/adrportal

By reporting side effects you can help provide

more information on the safety of this medicine.

5 Storing this medicine

Keep this medicine out of the sight and reach of

children.

This medicine does not require any special storage

conditions. Do not use this medicine after the

expiry date stated on the carton and blister. 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 Further Information

What's in this medicine?

The active ingredient in Benadryl Allergy One a

Day 10 mg Tablets is: 10 mg Cetirizine

dihydrochloride in each tablet.

Other ingredients are: Microcrystalline cellulose,

lactose, colloidal anhydrous silica and magnesium

stearate.

The film coating contains

hydroxypropylmethylcellulose (E464), titanium

dioxide (E171) and macrogol 400.

What the medicine looks like and

contents of the pack

Benadryl Allergy One a Day 10 mg Tablets are

white oblong film-coated tablets, with a break-line

and Y-Y logo available in packs of 7, 14 and 30.

Not all pack sizes may be marketed.

Product licence holder and manufacturer:

McNeil Products Ltd, Maidenhead, Berkshire,

SL6 3UG, UK.

This leaflet was revised in February 2019.

Benadryl is a registered trade mark.

19-0127

CIA79546E

TYPE

BARCODES

NUMBER

LAETUS_PHARMA

1593

26.04.19

401349179_V2R1

CIA79546E

CIA79546D

1593

19-0127

TI006PIL-024-06

305 x 148 mm

HelveticaNeue

MetaPlusBold-Roman

MyriadPro-Regular

Optima

Optima-Bold

Optima-BoldItalic

ZapfDingbatsITC

PANTONE

287 C

PANTONE

167 C

Benadryl Allergy One a Day 10mg Tablets 7s 14s 30s

Read the complete document

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

Benadryl One A Day Relief

Benadryl Allergy One A Day 10mg Tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

One film-coated tablet contains 10 mg cetirizine dihydrochloride

Excipients: one film-coated tablet contains 66.40 mg lactose-monohydrate

For the full list of excipients, see section 6.1

3

PHARMACEUTICAL FORM

Film-coated tablets

White, oblong, film-coated tablet, with breakline and Y-Y logo

4

CLINICAL PARTICULARS

4.1

Therapeutic indications

Benadryl Allergy One a Day 10mg 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 impairement. 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

) in ml/min is needed. The CL

(ml/min) may be estimated from serum creatinine (mg/dl) determination using the

following formula:

Dosing adjustments for adult patients with impaired renal function

Group

Creatinine clearance

(ml/min)

Dosage and frequency

Normal

10 mg once daily

Mild

50 – 79

10 mg once daily

Moderate

30 – 49

5 mg once daily

Severe

< 30

5 mg once every 2 days

End-stage renal disease -

Patients undergoing dialysis

< 10

Contra-indicated

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.

women

for

x

dl

mg

creatinine

serum

x

kg

weight

x

years

age

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.

Interactions 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 H

-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:

Adverse event

(WHO-ART)

Cetirizine 10 mg

(n= 3260)

Placebo

(n = 3061)

Body as a whole – general disorders

Fatigue

1.63 %

0.95 %

Central and peripheral nervous system disorders

Dizziness

Headache

1.10 %

7.42 %

0.98 %

8.07 %

Gastro-intestinal system disorders

Abdominal pain

Dry mouth

Nausea

0.98 %

2.09 %

1.07 %

1.08 %

0.82 %

1.14 %

Psychiatric disorders

Somnolence

9.63 %

5.00 %

Respiratory system disorders

Pharyngitis

1.29 %

1.34 %

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:

Adverse drug reactions

(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 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,

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 (AEGP)

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. Healthcare professionals are asked to report any suspected adverse reactions

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.

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, ATC code: R06A E07

Cetirizine, a human metabolite of hydroxyzine, is a potent and selective antagonist of

peripheral H

-receptors. In vitro receptor binding studies have shown no measurable

affinity for other than H

-receptors.

In addition to its anti-H

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

) 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 Y-1-7000

- Hydroxypropylmethylcellulose (E 464)

- Titanium dioxide (E 171)

- Macrogol 400

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, colourless, 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

No special requirements for disposal.

7

MARKETING AUTHORISATION HOLDER

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire

SL6 3UG

8

MARKETING AUTHORISATION NUMBER(S)

PL 15513/0118

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

27/11/2008

10

DATE OF REVISION OF THE TEXT

11/07/2019

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