ZYRTEC 10 mg/ml ORAL SOLUTION DROPS

Introduction

Package Leaflet: Information for the Patient

Zyrtec 10mg/ml Oral Drops 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 10 mg/ml oral drops solution is indicated in adults and pediatric patients from 2 years:

• for the relief of nasal and ocular symptoms of 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 to 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 starting to take 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, 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.

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

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

This medicine contains 350 mg of propylene glycol (E 1520) in each 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 again.

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

When counting the drops, the bottle should be held vertically (upside down). If it does not drip, if the required number of drops has not been released, turn the bottle upside down, hold it again upside down, and continue counting the drops.

Adults and adolescents from 12 years:

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

Use in children between 6 and 12 years:

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

Use in children between 2 and 6 years:

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

Patient with renal insufficiency:

It is recommended that patients with moderate renal insufficiency take 5 mg as 10 drops 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, malaise, pupil dilation, paresthesia, irritation, sedation, somnolence, stupor, abnormal tachycardia, 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 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 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, 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), eruption
• 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 (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 eruption
• 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 (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 Pharmacovigilance System for Human Use Medicines: 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 out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the bottle after EXP. The expiry date is the last day of the month shown.

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

This medicine does not require any special storage conditions.

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.

6. Contents of the pack and other information

Composition of Zyrtec

• The active substance is cetirizine dihydrochloride. One ml (equivalent to 20 drops) contains 10 mg of cetirizine dihydrochloride. One drop contains 0.5 mg of cetirizine dihydrochloride.
• The other ingredients 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 and packaging

Zyrtec is supplied as a clear, colorless liquid.

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

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 under 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 oldatos cseppek

Ireland: Zirtek oral drops 10 mg/ml

Italy: Zirtec 10 mg/ml gocce orali soluzione

Latvia: Zyrtec

Lithuania: Zyrtec

Luxembourg: Zyrtec

Norway: Zyrtec

Poland: Zyrtec

Romania: Zyrtec

Slovakia: Zyrtec

Spain: Zyrtec 10 mg/ml oral drops 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 Health Products (AEMPS) http://www.aemps.gob.es