ZYRTEC 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Zyrtec 10mg Film-Coated Tablets

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 and other information:

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

• relief of symptoms of seasonal and perennial allergic rhinitis and;
• 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 piperazine derivatives (closely related active substances of other medicines).

Warnings and precautions

Consult your doctor or pharmacist before taking Zyrtec.

If you have kidney failure, consult your doctor; if necessary, a lower dose will be taken. 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, 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 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.

Zyrtec film-coated tablets contain lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

Children

Do not give this medicine to children under 6 years of age, as this formulation does not allow for the necessary dose adjustment.

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 for advice before taking this medicine.

The use of Zyrtec should be avoided in pregnant women. Accidental use of the medicine in pregnant women should 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. A risk of adverse reactions in breastfed infants cannot be excluded. 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 produces alterations in attention, reduction of reactivity, 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 medicine.

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 tablets should be swallowed with a glass of liquid.

The tablets can be divided into 2 equal doses.

Adults and adolescents over 12 years:

The recommended dose is 10 mg once daily as 1 tablet.

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

Use in children between 6 and 12 years:

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

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

Patient with renal impairment:

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

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, malaise, pupil dilation, paresthesia, irritation, sedation, somnolence, stupor, abnormal heart rate, tremor, and urinary retention 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

Rarely, pruritus (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 must 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 may 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 or 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
• Pruritus (itching), rash
• Asthenia (extreme fatigue), malaise

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

• Allergic reactions, some severe (very rare)
• Depression, hallucination, aggression, confusion, insomnia
• Seizures
• Tachycardia (rapid heart rate)
• 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 the blood)
• Tics (muscle spasms)
• Syncope (fainting), dyskinesia (involuntary movements), dystonia (prolonged and abnormal muscle contraction), tremor, dysgeusia (taste disorder)
• Blurred vision, accommodation disorders (difficulty focusing), oculogyric crisis (uncontrolled eye movement)
• Angioedema (severe allergic reaction that causes swelling of the face or throat), drug rash
• Difficulty or inability to urinate (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 (feeling of spinning or movement)
• Urinary retention (inability to empty the bladder completely)
• Pruritus (intense itching) and/or urticaria after stopping treatment
• Arthralgia (joint pain), myalgia (muscle pain)
• Acute generalized exanthematous pustulosis (rash with pus-filled blisters)
• 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 this medicine after the expiry date which is stated on the carton and blister 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.

No special storage conditions are required.

6. Contents of the pack and other information

Composition of Zyrtec

• The active substance is cetirizine dihydrochloride. One film-coated tablet contains 10 mg of cetirizine dihydrochloride.
• The other ingredients are microcrystalline cellulose, lactose monohydrate, anhydrous colloidal silica, magnesium stearate, Opadry Y-1-7000 (hypromellose (E 464), titanium dioxide (E 171), macrogol 400).

Appearance and packaging

Film-coated tablets, white, oblong, scored, and with the logo Y-Y.

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

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

Manufacturers

Aesica Pharmaceuticals S.r.l.,

Via Praglia 15, I-10044

Pianezza (TO) – Italy

Poland>

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under 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 10 mg compresse rivestite con film

Latvia: Zyrtec

Lithuania: Zyrtec

Luxembourg: Zyrtec

Malta: Zyrtec

Netherlands: Zyrtec

Norway: Zyrtec

Poland: Zyrtec

Portugal: Zyrtec

Slovakia: Zyrtec

Slovenia: Zyrtec 10 mg filmsko oblozone tablete

Spain: Zyrtec 10 mg comprimidos recubiertos con película

United Kingdom (Northern Ireland): Zirtek allergy tablets

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