Product Information for the Patient

Zyrtec 10mg/ml Oral Solution Drops

Cetirizine Dihydrochloride

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

Keep this product information, as you may need to read 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 product information. 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.

Zyrtec10 mg/ml oral drops in solutionisindicated in adults and pediatric patients aged 2 years and older:

• forthe relief of nasal and ocular symptoms of 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 piperazine derivatives (closely related active principles of other medications).

Warnings and precautions

Consult with 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 difficulty urinating (such as spinal cord problems 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 0.5per 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 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 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 recently, or may need 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 should not cause any harm to the fetus. However, the medication should only be administered if necessary and after consulting with the doctor.

Cetirizine passes into breast milk. A risk of adverse reactions in infants cannot be ruled out. 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 driving ability impairment at the recommended dose.

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

Zyrtec 10 mg/ml oral drops in solutioncontains methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216),propylene glycol (E 1520) and sodium

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

This medication contains 350 mg of propylene glycol (E 1520) per ml.

This medication contains less than 1 mmol of sodium (23 mg) per dose; it is essentially “sodium-free”.

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

The drops should be poured into a spoon or diluted in water, and taken orally. If used diluted, the volume of water in which the drops are added should be considered, especially for administration in children, to adapt to the amount of water the patient can ingest. The diluted solution should be taken immediately.

When counting the drops, the bottle should be held vertically (mouth down). If it does not drip, if the desired amount of drops has not been released, the bottle should be turned upside down, held again mouth down, and the drop count continued.

Adults and adolescents 12 years and older:

The recommended dose is 10mg once a day, as 20drops.

Use in children 6 to 12 years:

The recommended dose is 5mg twice a day, as 10drops twice a day.

Use in children 2 to 6 years:

The recommended dose is 2.5mg twice a day, administered as 5drops twice a day.

Patients with renal insufficiency:

Patients with moderate renal insufficiency are recommended to take 5mg as 10drops once a day.

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

If your child has 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 adverse effects described below 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 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, itching (intense itching) and/or urticaria (hives) may recur 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 can 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 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:

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

-Drowsiness (drowsiness)

-Dizziness, headache

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

-Diarrhea, nausea, dry mouth

-Fatigue

Infrequent side effects(may affect up to 1 in 100 patients)

-Agitation

-Paresthesia (abnormal skin sensation)

-Abdominal pain

-Pruritus (itching on the 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

-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 crises (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 prospectus. 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 out of sight and reach of children.

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

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

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines that you do not need in the SIGRE collection pointat the pharmacy. Please ask your pharmacist how to dispose of the packaging and medicines that you do not need. This will help protect the environment.

Composition of Zyrtec

-The active ingredient is cetirizine dihydrochloride. One milliliter (equivalent to 20 drops) contains 10 mg of cetirizine dihydrochloride. One drop contains 0.5 mg of cetirizine dihydrochloride.

• The other components are glycerol (E 422), propylene glycol (E 1520), sodium saccharin, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), sodium acetate, glacial acetic acid, purified water.

Appearance of the product and contents of the packaging

Zyrtec is supplied as a transparent and colorless liquid.

Original packaging with a 10, 15, or 20 ml bottle.

Not all packaging sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

UCB Pharma, S.A.

Plaza de Manuel Gómez Moreno, s/n,

Edificio Bronce, 5th floor,

28020 Madrid

Spain

Responsible for manufacturing

Aesica Pharmaceuticals S.r.l.

Via Praglia 15

I-10044 Pianezza (TO) – Italy

17 Route de Meulan, 78520Limay, France.

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

6413 Kunfehértó, IV. district 6., Hungary.>

This medicine is authorized in the Member States of the European Economic Area, with the following names:

Austria: Zyrtec 10 mg/ml – Tropfen

Belgium: Zyrtec

Bulgaria: Zyrtec

Czech Republic: Zyrtec

Denmark: Zyrtec

Estonia: Zyrtec

Finland: Zyrtec

France: Zyrtec

Greece: Ziptek

Hungary: Zyrtec 10 mg/ml oral drops

Ireland: Zirtek oral drops 10 mg/ml

Italy: Zirtec 10 mg/ml oral drops solution

Latvia: Zyrtec

Lithuania: Zyrtec

Luxembourg: Zyrtec

Norway: Zyrtec

Poland: Zyrtec

Romania: Zyrtec

Slovakia: Zyrtec

Spain: Zyrtec 10 mg/ml oral drops in solution

Last review date of this leaflet: 09/2023

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