Package Insert: Information for the Patient

Zyrtec 10mg Film-Coated Tablets

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 only for you, and you should not give it to others, even if they 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.

Zyrtec 10 mg film-coated tablets are indicated in adults and children aged 6 years and above for:

• relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis;
• relief of urticaria.

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 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.

Zyrtec film-coated tablets contain lactose. If your doctor has indicated that you suffer from an intolerance to certain sugars, consult with him before taking this medication.

Children

Do not administer this medication to children under 6 years old, as this formulation does not allow for the necessary dose adjustment.

Other medications and Zyrtec

Inform your doctor or pharmacist if you are taking, have taken recently, 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, believe you may be pregnant, or intend to become pregnant, consult your doctor before using this medication.

Zyrtec should be avoided in pregnant women. Accidental use of the medication in pregnant women should not cause any harmful effects on 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 capacity 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.

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 tablets must be swallowed with a glass of liquid.

The tablets can be divided into 2 equal doses.

Adults and adolescents over 12 years old:

The recommended dose is 10mg once a day as 1 tablet.

Other forms of this medication may be more suitable for children: ask your doctor or pharmacist.

Use in children between 6 and 12 years old:

The recommended dose is 5mg twice a day, as half a tablet twice a day.

Other forms of this medication may be more suitable for children: ask your doctor or pharmacist.

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 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.

Treatment duration:

The treatment duration 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 reported include confusion, diarrhea, dizziness, fatigue, headache, discomfort (feeling unwell), dilated pupil, tingling, irritation, sedation, drowsiness (drowsiness), stupor, abnormal increase in heart rate, tremor, and urinary retention (difficulty emptying the bladder completely).

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 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 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 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)

-Vertigo, 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 treatment suspension

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

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

Medicines should not be disposed of through drains or in the trash.Deposit 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.

No special storage conditions are required.

Composition of Zyrtec

• The active ingredient is cetirizine dihydrochloride. A coated tablet contains 10mg of cetirizine dihydrochloride.
• The other components are microcrystalline cellulose, lactose monohydrate, anhydrous colloidal silica, magnesium stearate, Opadry Y-1-7000 (hydroxypropylmethylcellulose (E 464), titanium dioxide (E171), macrogol 400).

Appearance of the product and contents of the package

Coated tablets with a film coating, white, oval, scored, and the Y-Y logo.

Package with 1, 4, 5, 7, 10, 14, 15, 20, 21, 30, 40, 45, 50, 60, 90, 100, or 100 (10x10)tablets.

Not all package 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

UCB, Berkshire, SL1 3WE, United Kingdom

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

Poland

Extractum Pharma, 6413 Kunfehértó, IV. district 6., Hungary

UCB, Netherlands

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

Austria: Zyrtec 10 mg - Filmtabletten

Belgium: Zyrtec

Bulgaria: Zyrtec

Cyprus: Zyrtec

Czech Republic: Zyrtec

Denmark: Zyrtec

Estonia: Zyrtec

Finland: Zyrtec

France: Zyrtec

Germany: Zyrtec

Greece: Ziptek

Hungary: Zyrtec 10mg filmtabletta

Ireland: Zirtek tablets

Italy: Zirtec 10mg compresse rivestite con film

Latvia: Zyrtec

Lithuania: Zyrtec

Luxembourg: Zyrtec

Malta: Zyrtec

Netherlands: Zyrtec

Norway: Zyrtec

Poland: Zyrtec

Portugal: Zyrtec

Slovakia: Zyrtec

Slovenia: Zyrtec 10mg filmsko oblozone tablete

Spain: Zyrtec 10 mg comprimidos recubiertos con película

United Kingdom (Northern Ireland): Zirtek allergy tablets

Last review date of this leaflet:09/2023

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