The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.Source: electronic medicines compendium (emc), DatapharmActive substance: cetirizine dihydrochlorideOfficial document: view the original leaflet on emc →Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

← Back to all medicines

Zirtek allergy relief for children 1 mg/ml oral solution

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Cetirizine dihydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Cetirizine dihydrochloride

Equivalent medicines (same active substance, strength and form)

→ Benadryl Allergy Children's 1mg/ml Oral Solution brand

→ Benadryl Allergy Children's 6+ 1mg/ml Oral Solution brand

→ Piriteze Childrens Hayfever & Allergy 1mg/ml Syrup (GSL) brand

→ Zirtek Allergy Solution 1mg/ml oral solution brand

Source: electronic medicines compendium (emc)

Official leaflet: Read the PIL on emc

What it is and what it is used for

for Cetirizine dihydrochloride, 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. Zirtek Allergy Relief for Children is used to treat adults and children aged 6 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 Zirtek Allergy Relief for Children 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.

What you need to know before you take it

e Zirtek Allergy Relief for Children Do not take Zirtek Allergy Relief for Children

if you have an end-stage kidney disease (severe renal failure requiring dialysis);
if you are allergic to cetirizine dihydrochloride, to any of the other ingredients (listed in section 6), to hydroxyzine or to any piperazine derivatives (closely related active ingredients of other medicines). Warning and precautions Talk to your doctor or pharmacist before taking Zirtek Allergy Relief for Children. 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 Zirtek Allergy Relief for Children with alcohol. If you are scheduled for allergy testing, ask your doctor if you should stop taking Zirtek Allergy Relief for Children for several days before testing. This medicine may affect your allergy test results. Other medicines and Zirtek Oral solution Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Zirtek Allergy Relief for Children with food and drink Food does not affect absorption of Zirtek Allergy Relief for Children. 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. Zirtek Allergy Relief for Children 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. A risk of side effects in breastfed infants cannot be excluded. Therefore, you should not take Zirtek Allergy Relief for Children during breastfeeding 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 Zirtek Allergy Relief for Children at the recommended dose. You should closely observe your response to the drug after you have taken Zirtek Allergy Relief for Children if you are intending to drive, engage in potentially hazardous activities or operate machinery. You should not exceed the recommended dose.

Zirtek oral solution contains sorbitol. This medicine contains 2250 mg sorbitol in each 5 ml which is equivalent to 450 mg/ml. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine. Zirtek oral solution contains methylparahydroxybenzoate (E 218), propylparahydroxybenzoate (E 216) that may cause allergic reactions (possibly delayed). This medicine contains 250 mg propylene glycol in each 5 ml which is equivalent to 50 mg/ml. This medicine contains less than 1 mmol sodium (23 mg) per 5 ml, that is to say essentially 'sodium-free'.

How to take it

Zirtek Allergy Relief for Children Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The solution can be swallowed as such. Children aged 6 to 12 years: The recommended dose is 5 mg twice daily as 5 ml (one full measuring spoon) twice daily. Adults and adolescents over 12 years of age: The recommended dose is 10 mg once daily as 10 ml oral solution (2 full measuring spoons). Zirtek Allergy Relief for Children is not suitable for children under 6 years of age. Patients with 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 Zirtek Allergy Relief for Children is too weak or too strong, please consult your doctor. 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 Zirtek Allergy Relief for Children than you should If you think you have taken an overdose of Zirtek Allergy Solution please inform your doctor. Your doctor will then decide what measures, if any, should be taken. After an overdose, the side effects described below may occur with increased intensity. Adverse effects such as confusion, diarrhoea, dizziness, tiredness, headache, mailaise (feeling unwell), dilating of pupil, itching, restlessness, sedation, somnolence (sleepiness), stupor, abnormal rapid heart rate, tremors and urinary retention (difficulty in completely emptying the bladder) have been reported. If you forget to take Zirtek Allergy Relief for Children Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, you should take one as soon as you remember, but wait at least 24 hours before taking the next dose. If you stop taking Zirtek Allergy Relief for Children Rarely, pruritus (intense itching) and/or urticaria (hives) may return if you stop taking Zirtek Allergy Relief for Children. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines this medicine can cause side effects, although not everybody gets them. The following side effects are rare or very rare, but you must stop taking the medicine and speak to your doctor straight away if you notice them:

•

Allergic reactions, including severe reactions and angioedema (serious allergic reaction which causes swelling of the face or throat). These reactions may start soon after you first take the medicine, or it might start later.

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

Somnolence (sleepiness)
Dizziness, headache
Pharyngitis (sore throat), rhinitis (runny, stuffy nose) (in children)
Diarrhoea, nausea, dry mouth
Fatigue Uncommon side effects (may affect up to 1 in 100 patients)
Agitation
Paraesthesia (abnormal feelings of the skin)
Abdominal pain
Pruritus (itchy skin), rash
Asthenia (extreme fatigue), malaise (feeling unwell) Rare side effects (may affect up to 1 in 1,000 patients)
Allergic reactions, some severe (very rare)
Depression, hallucination, aggression, confusion, insomnia
Convulsions
Tachycardia (heart beating too fast)
Liver function abnormal
Urticaria (hives)
Oedema (swelling)
Weight increased Very rare side effects (may affect up to 1 in 10,000 patients)
Thrombocytopenia (low levels of blood platelets)
Tics (habit spasm)
Syncope (fainting), dyskinesia (involuntary movements), dystonia (abnormal prolonged muscular contractions), tremor, dysgeusia (altered taste)
Blurred vision, accommodation disorder (difficulty focusing), oculogyric crisis (eyes having uncontrolled circular movements)
Angioedema (serious allergic reaction which causes swelling of the face or throat), fixed drug eruption (drug allergy)
Abnormal elimination of urine (bed wetting, pain and/or difficulty passing water) Not known frequency of side effects (frequency cannot be estimated from the available data)
Increased appetite
Suicidal ideation (recurring thoughts of or preoccupation with suicide), nightmare
Amnesia (memory loss), memory impairment
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), myalgia (muscular pain)

• •

Acute generalized exanthematous pustulosis (rash with blisters containing pus) Hepatitis (inflammation of the liver)

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. 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.

How to store it

Zirtek Allergy Relief for Children 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 carton. The expiry date refers to the last day of that month. Do not use after 3 months of first opening the bottle. This medicine does not require any special storage conditions. 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.

Contents of the pack and other information

What Zirtek Allergy Relief for Children contains The active substance is cetirizine. 10 ml (equals to 2 measuring spoons) contain 10 mg of cetirizine dihydrochloride. The other ingredients are sorbitol (E 420), glycerol, propylene glycol, saccharin sodium, methylparahydroxybenzoate (E 218), propylparahydroxybenzoate (E216), banana flavour 54.330/A (Firmenich), sodium acetate, glacial acetic acid and purified water. 10 ml Zirtek Allergy Relief for Children (=2 measuring spoons) contain: 3.15 g glucose equivalents (sorbitol). What Zirtek Allergy Relief for Children looks like and contents of the pack It is a clear, colourless solution with slightly sweet taste and a banana flavour. It is supplied in amber glass bottle containing 70 ml and 200 ml. Marketing Authorisation Holder and Manufacturer UCB Pharma Ltd, 208 Bath Road, Slough, Berkshire, SL1 3WE, United Kingdom This leaflet was last revised March 2023. If this leaflet is difficult to see or read or you would like it in a different format, please contact UCB Pharma Ltd, UK

Frequently asked questions about Zirtek allergy relief for children 1 mg/ml oral solution

How do I take Zirtek allergy relief for children 1 mg/ml oral solution?

Zirtek allergy relief for children 1 mg/ml oral solution comes as oral solution containing 1mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Zirtek allergy relief for children 1 mg/ml oral solution?

The active substance in Zirtek allergy relief for children 1 mg/ml oral solution is cetirizine dihydrochloride.

Are there equivalent medicines to Zirtek allergy relief for children 1 mg/ml oral solution?

Medicines with the same active substance, strength and form include: Benadryl Allergy Children's 1mg/ml Oral Solution, Benadryl Allergy Children's 6+ 1mg/ml Oral Solution, Piriteze Childrens Hayfever & Allergy 1mg/ml Syrup (GSL). In total there are 4 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Zirtek allergy relief for children 1 mg/ml oral solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Zirtek allergy relief for children 1 mg/ml oral solution without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Source: electronic medicines compendium (emc), Datapharm
Active substance: cetirizine dihydrochloride
Official document: view the original leaflet on emc →

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Cetirizine dihydrochloride (11 medicines)

See every medicine containing this substance, or browse the full A–Z of active substances.

⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+

Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Cetirizine dihydrochloride 1 mg/ml oral solution is indicated in adults and children aged 6 years and above:

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

- for the relief of symptoms of urticaria.

4.2. Posology and method of administration

Posology

10 mg once daily (10 mL oral solution (2 full spoons)).

Special population

Elderly

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

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.

Dosing adjustments for adult patients with impaired renal function

Group

GFR (mL/min)

Dosage and frequency

Normal renal function

≥90

10 mg once daily

Mildly decreased renal function

60 – < 90

10 mg once daily

Moderately decreased renal function

30 – < 60

5 mg once daily

Severely decreased renal function

15 - <30 not requiring dialysis treatment

5 mg once every 2 days

End-stage renal disease

<15 requiring dialysis treatment

Contra-indicated

Hepatic impairment

No dose adjustment is needed in patients with solely hepatic impairment. In patients with hepatic impairment and renal impairment, adjustment of the dose is recommended (see Renal impairment above).

Paediatric Population

Children aged from 6 to 12 years:

5 mg twice daily (5 mL oral solution twice daily (a full spoon twice daily)).

Adolescents over 12 years of age:

10 mg once daily (10 mL oral solution (2 full spoons)).

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

Method of administration

The solution can be swallowed as such.

4.3. Contraindications

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

Patients with end-stage renal disease with GFR (Glomerular Filtration Rate) below 15 ml/min.

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

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

Patients with rare hereditary problems of fructose intolerance should not take cetirizine 1 mg/ml oral solution.

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 6 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).

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 nevertheless be exercised when prescribing to pregnant women.

Breast-feeding

Cetirizine passes into breast milk. A risk of side effects in breastfed infants cannot be excluded. 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 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:

Adverse reactions

(WHO-ART)

Cetirizine 10 mg

(n= 3260)

Placebo

(n = 3061)

General disorders and administration site conditionsFatigue

1.63 %

0.95 %

Nervous system disordersDizzinessHeadache

1.10 %

7.42 %

0.98 %

8.07 %

Gastro-intestinal disordersAbdominal painDry mouthNausea

0.98 %

2.09 %

1.07 %

1.08 %

0.82 %

1.14 %

Psychiatric disordersSomnolence

9.63 %

5.00 %

Respiratory thoracic and mediastinal disordersPharyngitis

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.

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:

Adverse reactions

(WHO-ART)

Cetirizine

(n=1656)

Placebo

(n =1294)

Gastro-intestinal disordersDiarrhoea

1.0 %

0.6 %

Psychiatric disordersSomnolence

1.8 %

1.4 %

Respiratory thoracic and mediastinaldisordersRhinitis

1.4 %

1.1 %

General disorders and administration site conditionsFatigue

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, 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, oculogyric crisis

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)

Not known: hepatitis

Skin and subcutaneous tissue disorders:

Uncommon: pruritus, rash

Rare: urticaria

Very rare: angioneurotic oedema, fixed drug eruption

Not known: acute generalized exanthematous pustulosis

Musculoskeletal and connective tissue disorders

Not known: arthralgia, myalgia

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. 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 may be considered shortly after ingestion of the drug.

Cetirizine is not effectively removed by haemodialysis.

💬 Ask about this leaflet

Ask anything about Zirtek allergy relief for children 1 mg/ml oral solution. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.

Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.

Pharmacy Guide