Patient leaflet - Zirtek Allergy Relief for children 1 mg/ml oral solution
1. What Zirtek Allergy Relief for Children is and what it is used for
Cetirizine dihydrochloride, the active ingredient of the solution is an antihistamine. It blocks the effects of a substance called histamine which occur
s 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 sn
eezing, irritated, runny and blocked up nose, itchy, red and watering eyes and skin rashes.
2. What you need to know before you take 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 derivative
s (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 determine
d 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) an
d 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. Ther
efore, 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. Th
is 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 medici
ne.
Zirtek Allergy Relief for Children should be avoided in pregnant women. Accidental use of the drug by a pregnant woman should not produce any h
armful 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 fo
r Children during breast-feeding unless you have contacted a doctor.
Driving and using machines
Clinical studies have produced no evidence of impaired attention, alertness and driving capabilities after taking Zirtek Allergy Relief for Children at th
e 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 pote
ntially 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 sour
ce 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 intolera
nce (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 (pos
sibly 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’.
3. How to take 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 y
ou 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 childr
en 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.
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Back
CIB73830B_MU1 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.
4. 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.
5. How to store 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.
6. 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 in 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
v
PC Description : CIB73830B_MU1
8 pt
8 pt
Designer :
Creation date :
PRG - MG
01.OCT.2025
Amended by :
Modific. date :
N/A
N/A
Page(s): 2 of 2
MOCK-UP
PROOF PC Code :
CMO PC Code :
CIB73830B_MU1 N/A
N/A
PRINT COLORS
TECH COLORS
TECHNICAL (do not print)
Additional comment: N/A