Zyrtec 1 mg/ml oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Zyrtec 1 mg/ml oral solution

Cetirizine dihydrochloride

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Keep this leaflet as you may need to read it again. If you have any questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Zyrtec is and what it is used for
2. What you need to know before taking Zyrtec
3. How to take Zyrtec
4. Possible side effects
5. How to store Zyrtec
6. Contents of the pack and other information

1. What Zyrtec is and what it is used for

The active substance in Zyrtec is cetirizine dihydrochloride.

Zyrtec is an antiallergic medicinal product.

Zyrtec 1 mg/ml oral solution is indicated in adults and children from 2 years of age:

• for the relief of nasal and ocular symptoms associated with seasonal and perennial allergic rhinitis;
• for the relief of urticaria.

2. What you need to know before taking Zyrtec

Do not take Zyrtec

• if you have severe kidney disease (requiring dialysis);
• if you are allergic to cetirizine dihydrochloride, or to any of the other ingredients of this medicine (listed in section 6), to hydroxyzine, or to any piperazine derivative (active substances closely related to other drugs).

Warnings and precautions

Consult your doctor or pharmacist before taking Zyrtec

If you are a patient with renal impairment, consult your doctor; if necessary, you will be prescribed a lower dose. Your doctor will determine the new dose.

If you have problems urinating (such as spinal cord, prostate, or bladder problems), please consult your doctor.

If you are an epileptic patient or a patient at risk of seizures, consult your doctor.

No clinically significant interactions have been observed between alcohol (at a blood concentration of 0.5 per mille (g/l), equivalent to one glass of wine) and cetirizine at the recommended dose. However, safety data are not available when higher doses of cetirizine and alcohol are taken together. Therefore, as with all antihistamines, it is recommended to avoid taking Zyrtec with alcohol.

If you are scheduled for an allergy test, consult your doctor whether you should stop taking Zyrtec a few days before the test. This medicine may affect the results of your allergy tests.

Other medicines and Zyrtec

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Taking Zyrtec with food, drinks and alcohol

Food does not affect the absorption of Zyrtec.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

The use of Zyrtec should be avoided in pregnant women. Accidental use of the medicine in pregnant women does not cause any harmful effects on the fetus. However, the medicine should only be administered if necessary and after consultation with your doctor.

Cetirizine passes into breast milk. A risk of adverse reactions in breastfed infants cannot be excluded. Therefore, you should not take Zyrtec during breastfeeding unless advised by your doctor.

Driving and using machines

Clinical studies have not shown evidence that Zyrtec causes impairment of attention, reduced reaction ability, or impaired driving skills at the recommended dose.

If you intend to drive, perform potentially hazardous activities, or operate machinery, do not exceed the recommended dose. You should closely monitor your response to the medicine.

Zyrtec oral solution contains sorbitol (E 420), methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), propylene glycol (E 1520), and sodium

This medicine contains 1575 mg of sorbitol in each 5 ml, equivalent to 315 mg/ml. Sorbitol is a source of fructose. If your doctor has informed you (or your child) that you have an intolerance to certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot metabolize fructose, consult your doctor before taking this medicine. Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

This medicine contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216), which may cause allergic reactions (possibly delayed).

This medicine contains 250 mg of propylene glycol (E 1520) in each 5 ml, equivalent to 50 mg/ml.

This medicine contains less than 1 mmol of sodium (23 mg) per dose; hence, it is essentially "sodium-free".

3. How to take Zyrtec

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The solution can be taken as is.

Adults and adolescents aged 12 years and older:

The recommended dose is 10 mg once daily as 10 ml of oral solution (2 full measuring spoons).

Use in children between 6 and 12 years of age:

The recommended dose is 5 mg twice daily, as 5 ml (one full measuring spoon) twice daily.

Use in children between 2 and 6 years of age:

The recommended dose is 2.5 mg twice daily as 2.5 ml of oral solution (half a measuring spoon) twice daily.

Patients with renal impairment:

Patients with moderate renal impairment are advised to take 5 mg once daily.

If you have severe kidney disease, please contact your doctor, who may appropriately adjust the dose.

If your child has kidney disease, please contact your doctor, who will adjust the dose according to your child's needs.

If you notice that the effect of Zyrtec is too weak or too strong, consult your doctor.

Duration of treatment:

The duration of treatment depends on the type, duration, and course of your symptoms and will be determined by your doctor.

If you take more Zyrtec than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at phone number: 91 562 04 20, indicating the medicine and the amount ingested.

After an overdose, the adverse effects described below may occur with greater intensity. Adverse effects reported include confusion, diarrhea, dizziness, fatigue, headache, malaise (feeling unwell), pupillary dilation, tingling, irritation, sedation, somnolence (drowsiness), stupor, abnormally increased heart rate, tremor, and urinary retention (difficulty completely emptying the bladder).

If you forget to take Zyrtec

Do not take a double dose to make up for the missed dose.

If you stop taking Zyrtec

In rare cases, pruritus (intense itching) and/or urticaria (hives) may reappear if you stop taking Zyrtec.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following adverse effects are rare or very rare, but you must stop taking the medicine and tell your doctor immediately if you notice any of them:

• Allergic reactions, including severe reactions and angioedema (a severe allergic reaction causing swelling of the face or throat).

These reactions may begin soon after first taking the medicine, or they may begin later.

The frequency of the possible adverse effects listed below is defined as follows:

Frequent adverse effects (may affect up to 1 in 10 patients)

• Somnolence (drowsiness)
• Dizziness, headache
• Pharyngitis (sore throat), rhinitis (runny nose, nasal congestion) (in children)
• Diarrhea, nausea, dry mouth
• Fatigue

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

• Agitation
• Paresthesia (abnormal skin sensation)
• Abdominal pain
• Pruritus (itching), rash
• Asthenia (extreme fatigue), malaise (feeling unwell)

Rare adverse effects (may affect up to 1 in 1,000 patients)

• Allergic reactions, some severe (very rare)
• Depression, hallucination, aggression, confusion, insomnia
• Seizures
• Tachycardia (heart beating too fast)
• Abnormal liver function
• Urticaria (hives)
• Edema (swelling)
• Weight gain

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

• Thrombocytopenia (low platelet levels in blood)
• Tics (spasms)
• Syncope (fainting), dyskinesia (involuntary movements), dystonia (prolonged and abnormal muscle contractions), tremor, dysgeusia (taste disturbance)
• Blurred vision, accommodation disorders (difficulty focusing eyes), oculogyric crisis (eyes have uncontrolled circular movements)
• Angioedema (severe allergic reaction causing swelling of the face or throat), drug rash (drug allergy)
• Difficulty or lack of control when urinating (bedwetting, pain and/or difficulty urinating)

Adverse effects with unknown frequency (frequency cannot be estimated from available data)

• Increased appetite
• Suicidal thoughts (recurring thoughts or obsession about suicide), nightmares
• Amnesia (memory loss), memory impairment
• Vertigo (sensation of spinning or movement)
• Urinary retention (inability to completely empty the urinary bladder)
• Pruritus (intense itching) and/or urticaria after discontinuation of treatment
• Arthralgia (joint pain), myalgia (muscle pain)
• Acute generalized exanthematous pustulosis (rash with pus-filled blisters)
• Hepatitis (inflammation of the liver)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es.

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

5. Storage of Zyrtec

Keep this medicine out of the sight and reach of children.

Do not use Zyrtec after the expiry date stated on the outer packaging and bottle after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

Do not use more than 3 months after first opening the container.

No special storage conditions are required.

6. Contents of the pack and other information

Composition of Zyrtec 1 mg/ml oral solution

• The active substance is cetirizine dihydrochloride. 10 ml (equivalent to 2 measuring spoons) contain 10 mg of cetirizine dihydrochloride.
• The other components are sorbitol (E 420), glycerol (E 422), propylene glycol (E 1520), sodium saccharin, methylparaben (E 218), propylparaben (E 216), banana flavour 54.330/A (Firmenich), sodium acetate, glacial acetic acid, purified water.
• 10 ml of Zyrtec 1 mg/ml oral solution (= 2 measuring spoons) contain 3.15 g of glucose (sorbitol).

Nature of the product and contents of the pack

Clear, colourless liquid with a slightly sweet taste and banana flavour.

Original pack containing a bottle of 60, 75, 100, 150 or 200 ml of solution.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

UCB Pharma, S.A.
Plaza de Manuel Gómez Moreno, s/n,
Edificio Bronce, Planta 5,
28020 Madrid
Spain

Manufacturer

Aesica Pharmaceuticals S.r.l.
Via Praglia 15
I-10044 Pianezza (TO) - Italy

<UCB Pharma Limited, 208 Bath Road, Slough, Berkshire, SL1 3WE, United Kingdom>
<Phoenix Pharma Polska Sp. z o.o., ul. Rajdowa 9, Konotopa, 05-850 Ozarów Mazowiecki, Poland>
<UCB Pharma B.V., Hoge Mosten 2 A1, 4822 NH, Breda, The Netherlands>
<UCB Pharma AS, Haakon VIIs gate 6, NO-0161 Oslo, Norway>
<UCB Nordic A/S, Edvard Thomsens Vej 14, DK-2300 København S, Denmark>
<UCB Pharma SA Chemin Du Foriest 1, Braine-L'alleud, 1420, Belgium>

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria: Zyrtec 1 mg/ml – orale Lösung
Belgium: Zyrtec
Cyprus: Zyrtec
Denmark: Zyrtec
Estonia: Zyrtec
Finland: Zyrtec
France: Zyrtec
Ireland: Zirtek oral solution 1 mg/ml
Italy: Zirtec 1 mg/ml soluzione orale
Latvia: Zyrtec
Lithuania: Zyrtec
Luxembourg: Zyrtec
Malta: Zyrtec
Netherlands: Zyrtec
Norway: Zyrtec
Poland: Zyrtec
Portugal: Zyrtec
Slovenia: Zyrtec 1 mg/ml peroralna raztopina
Spain: Zyrtec solución oral
United Kingdom (Northern Ireland): Zirtek allergy solution

Date of the most recent revision of this leaflet: 09/2023

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es