ZYRTEC 1 mg/ml ORAL SOLUTION

Introduction

Patient Information Leaflet

Zyrtec 1mg/ml oral solution

Cetirizine dihydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

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.

Contents of the pack

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

1. What is Zyrtec and what is it used for

The active substance of Zyrtec is cetirizine dihydrochloride.

Zyrtec is an antiallergic medicine.

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

• 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 you take Zyrtec

Do not take Zyrtec

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

Warnings and precautions

Consult your doctor or pharmacist before taking Zyrtec

If you have kidney failure, consult your doctor; if necessary, you will take a lower dose. Your doctor will determine the new dose.

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

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

No clinically significant interactions have been observed between alcohol (with a blood level of 0.5 per thousand (g/l), corresponding to a glass of wine) and the use of cetirizine at the recommended dose. However, there are no safety data available when taking higher doses of cetirizine and alcohol together. Therefore, as with all antihistamines, it is recommended to avoid taking Zyrtec with alcohol.

If you are going to have an allergy test, consult your doctor if 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

Tell your doctor or pharmacist if you are taking, have recently taken or might 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Zyrtec should be avoided in pregnant women. Accidental use of the medicine in pregnant women does not produce any harmful effect on the fetus. However, the medicine should only be administered if necessary and after consulting a doctor.

Cetirizine passes into breast milk. It cannot be excluded that there is a risk of adverse reactions in breastfed infants. Therefore, you should not take Zyrtec during breastfeeding, unless you have consulted your doctor.

Driving and using machines

Clinical studies have not shown evidence that Zyrtec causes alterations in attention, decreased reaction capacity and ability to drive at the recommended dose.

If you intend to drive, perform potentially hazardous activities or use machinery, you should not exceed the recommended dose. You should closely observe 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 told you that you (or your child) have an intolerance to some sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder, in which the patient cannot break down fructose, consult your doctor before taking this medicine. Sorbitol may cause gastrointestinal upset 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; i.e., it is essentially “sodium-free”.

3. How to take Zyrtec

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The solution can be taken as is.

Adults and adolescents from 12 years:

The recommended dose is 10 mg once a day as 10 ml of oral solution (2 complete spoons).

Use in children between 6 and 12 years:

The recommended dose is 5 mg twice a day, as 5 ml (one complete spoon) twice a day.

Use in children between 2 and 6 years:

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

Patient with renal impairment:

It is recommended that patients with moderate renal impairment take 5 mg once a day.

If you suffer from severe kidney disease, please contact your doctor, who may adjust the dose accordingly.

If your child suffers from kidney disease, please contact your doctor, who may 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, Phone: 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 such as confusion, diarrhea, dizziness, fatigue, headache, discomfort (feeling unwell), pupil dilation, tingling, irritation, sedation, somnolence (drowsiness), stupor, abnormal increase in heart rate, tremor and urinary retention (difficulty emptying the bladder) have been reported.

If you forget to take Zyrtec

Do not take a double dose to make up for a forgotten dose.

If you stop taking Zyrtec

On rare occasions, itching (intense itching) and/or urticaria (hives) may reappear if you stop taking Zyrtec.

If you have any further questions on the use of this product, 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 should stop taking the medicine and tell your doctor immediately if you notice any of them:

• Allergic reactions, including serious and angioedema (severe allergic reaction that causes swelling of the face or throat).

These reactions can start soon after taking the medicine for the first time, or they can start later.

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

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

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

Uncommon side effects(may affect up to 1 in 100 people)

• Agitation
• Paresthesia (abnormal sensation of the skin)
• Abdominal pain
• Itching (itching of the skin), rash
• Asthenia (extreme fatigue), discomfort (feeling unwell)

Rare side effects(may affect up to 1 in 1,000 people)

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

Very rare side effects(may affect up to 1 in 10,000 people)

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

Side effects with frequency not known(frequency cannot be estimated from the available data)

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

Reporting of side effects

If you experience 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 Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es.

By reporting side 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 which is stated on the carton and bottle after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

Do not use 3 months after opening the bottle for the first time.

No special storage precautions are required.

6. Contents of the pack and other information

Composition of Zyrtec1mg/ml oral solution

• The active substance is cetirizine dihydrochloride. 10 ml (equal to 2 measuring spoons) contain 10 mg of cetirizine dihydrochloride.
• The other ingredients are sorbitol (E 420), glycerol (E 422), propylene glycol (E 1520), sodium saccharin, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), banana flavor 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).

Appearance and packaging

Clear and colorless liquid with a slightly sweet taste and banana flavor.

Original packaging with a bottle of 60, 75, 100, 150 or 200 ml of solution.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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

This medicine is authorized 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 oral solution

United Kingdom (Northern Ireland): Zirtek allergy solution

Date of last revision of this leaflet: 09/2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es