Package Insert: Information for the Patient

Zyrtec 1mg/ml Oral Solution

Cetirizine dihydrochloride

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

Keep this package insert, as you may need to refer to it again.
If you have any questions, consult your doctor or pharmacist.

This medication has been prescribed to you alone, and you should not give it to others who have the same symptoms as you, as it may harm them.

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

1. What is Zyrtec and how is it used

2. What you need to know before starting to take Zyrtec

3. How to take Zyrtec

4. Possible adverse effects

5. Storage of Zyrtec

6. Contents of the package and additional information

The active ingredient of Zyrtec is cetirizine dihydrochloride.

Zyrtec is an antihistamine medication.

Zyrtec1 mg/ml oral solutionisindicated in adults and children aged 2 years and above:

• forthe relief of nasal and ocular symptoms associated with seasonal and perennial allergic rhinitis;
• forthe relief ofurticaria.

Do not take Zyrtec

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Zyrtec

If you are a patient with renal insufficiency, 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 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 (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 available safety data when taking together higher doses of cetirizine and alcohol. Therefore, as with all antihistamines, it is recommended to avoid taking Zyrtec with alcohol.

If you are scheduled to undergo an allergy test, consult your doctor if you should interrupt taking Zyrtec a few days before the test. This medication may affect the results of your allergy tests.

Other medications and Zyrtec

Inform your doctor or pharmacist if you are taking, have taken or may have to take any other medication.

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 intend to become pregnant, consult your doctor or pharmacist before using this medication.

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

Cetirizine passes into breast milk. It cannot be ruled out that there is a risk of adverse reactions in infants. Therefore, do not take Zyrtec during breastfeeding, unless you consult your doctor.

Driving and operating machinery

Clinical studies have not shown evidence that Zyrtec produces attention alterations, reaction ability decrease and ability to drive at the recommended dose.

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

Zyrtec oral solution contains sorbitol (E 420), methylparahydroxybenzoate (E 218), propylparahydroxybenzoate (E 216), propylene glycol (E 1520) and sodium

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

This medication contains methylparahydroxybenzoate (E 218) and propylparahydroxybenzoate (E 216) that may cause allergic reactions (possibly delayed).

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

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

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

The solution can be taken as such.

Adults and adolescents 12 years and older:

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

Use in children between 6 and 12 years:

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

Use in children between 2 and 6 years:

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

Patients with renal insufficiency:

Patients with moderate renal insufficiency are recommended to take 5mg once a day.

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

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.

Treatment duration:

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 Toxicological Information Service, Phone: 91 562 04 20, indicating the medication and the amount ingested.

After an overdose, the following adverse effects may occur with greater intensity. Adverse effects such as confusion, diarrhea, dizziness, fatigue, headache, discomfort (feeling unwell), dilated pupils, tingling, irritation, sedation, drowsiness (drowsiness), stupor, abnormal increase in heart rate, tremor, and urinary retention (difficulty emptying the bladder) have been reported.

If you forgot to take Zyrtec

Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Zyrtec

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience 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 severe reactions and angioedema (a severe allergic reaction that causes swelling of the face or throat).

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

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

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

-Drowsiness (drowsiness)

-Vertigo, headache

-Pharyngitis (sore throat), rhinitis (runny nose, nasal congestion) (in children)

-Diarrhea, nausea, dry mouth

-Fatigue

Uncommon side 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 side effects(may affect up to 1 in 1,000 patients)

-Allergic reactions, some severe (very rare)

-Depression, hallucination, aggression, confusion, insomnia

-Seizures

-Tachycardia (heart beats too quickly)

-Abnormal liver function

-Urticaria (hives)

-Edema (swelling)

-Weight gain

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

-Thrombocytopenia (low platelet count in the blood)

-Tics (spasms)

-Syncope (fainting), dyskinesia (involuntary movements), dystonia (prolonged and abnormal muscle contraction), tremor, dysgeusia (taste disorder)

-Blurred vision, accommodation disorders (difficulty focusing), ocular crisis (eyes have an uncontrolled circular movement)

-Angioedema (severe allergic reaction that causes swelling of the face or throat), drug eruption (allergic reaction to the drug)

-Difficulty or inability to urinate (wetting the bed, pain, and/or difficulty urinating)

Side effects of unknown frequency (the frequency cannot be estimated from the available data)

-Increased appetite

-Suicidal thoughts (recurring thoughts or obsession with suicide), nightmares

-Amnesia (memory loss), memory deterioration

-Dizziness (sensation of rotation or movement)

-Urinary retention (inability to completely empty the urinary bladder)

-Pruritus (intense itching) and/or urticaria after stopping treatment

-Arthralgia (joint pain), myalgia (muscle pain)

-Generalized acute exanthematous pustulosis (eruption with blisters that have pus)

-Hepatitis (inflammation of the liver)

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use Zyrtec after the expiration date that appears on the packaging and bottle after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drains or in the trash.Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy.Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

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

No special storage conditions are required.

Composition of Zyrtec1mg/ml oral solution

• The active ingredient is cetirizine dihydrochloride. 10ml (equivalent to 2 teaspoons) contain 10mg of cetirizine dihydrochloride.
• The other components 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.
• 10ml of Zyrtec 1 mg/ml oral solution (= 2 teaspoons) contain 3.15g of glucose (sorbitol).

Appearance of the product and contents of the container

Transparent and colorless liquid with a slight sweet taste and banana flavor.

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

Not all container 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, 5th floor,

28020 Madrid

Spain

Manufacturer

Aesica Pharmaceuticals S.r.l.

Via Praglia 15

I-10044 Pianezza (TO) - Italy

<Phoenix Pharma Polska Sp. z o.o.,ul. Rajdowa 9, Konotopa, 05-850 Ozarów Mazowiecki,Poland>

TheNetherlands>

Chemin Du Foriest 1, Braine-L'alleud, 1420, Belgium>

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

Austria: Zyrtec 1mg/ml – oral solution

Belgium: Zyrtec

Cyprus: Zyrtec

Denmark: Zyrtec

Estonia: Zyrtec

Finland: Zyrtec

France: Zyrtec

Ireland: Zirtek oral solution 1mg/ml

Italy: Zirtek 1mg/ml oral solution

Latvia: Zyrtec

Lithuania: Zyrtec

Luxembourg: Zyrtec

Malta: Zyrtec

Netherlands:Zyrtec

Norway: Zyrtec

Poland: Zyrtec

Portugal: Zyrtec

Slovenia: Zyrtec 1mg/ml peroral solution

Spain: Zyrtec oral solution

United Kingdom (Northern Ireland): Zirtek allergy solution

Last review date of this leaflet: 09/2023

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