Zirtec

Leaflet accompanying the packaging: patient information

Zyrtec, 10 mg, film-coated tablets

Cetirizine dihydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Zyrtec and what is it used for
• 2. Important information before taking Zyrtec
• 3. How to take Zyrtec
• 4. Possible side effects
• 5. How to store 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 for adults and children aged 6 years and above:

• for the relief of symptoms associated with seasonal and perennial allergic rhinitis,
  including nasal and eye symptoms,
• for the relief of symptoms of urticaria.

2. Important information before taking Zyrtec

When not to take Zyrtec

• if you have severe renal impairment (requiring dialysis),
• if you are allergic to cetirizine dihydrochloride or any of the other ingredients of this medicine (listed in section 6), hydroxyzine or piperazine derivatives (active substances with a similar structure, contained in other medicines).

Warnings and precautions

Before taking Zyrtec, discuss it with your doctor or pharmacist.
If you have renal impairment, consult your doctor before taking Zyrtec;
a lower dose may be necessary. The dose will be determined by your doctor.
If you have problems with urination (e.g., spinal cord or prostate problems,
or bladder problems), consult your doctor.
If you have epilepsy or a risk of seizures, consult your doctor.
No significant clinical interactions have been observed between alcohol (at a concentration of 0.5 per mille (g/l) in blood, corresponding to the concentration after drinking one glass of wine) and cetirizine at the recommended doses. However, there are no data on the safety of concomitant use of higher doses of cetirizine and alcohol. Therefore, as with other antihistamines, it is recommended to avoid taking Zyrtec with alcohol.
If you are scheduled to undergo allergy testing, ask your doctor if you should stop taking Zyrtec a few days before the test. Zyrtec may affect the results of allergy tests.

Children

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

Zyrtec and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.

Taking Zyrtec with food and drink

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.
Avoid taking Zyrtec during pregnancy. Accidental intake of Zyrtec by a pregnant woman should not have a harmful effect on the fetus. However, Zyrtec should only be used if necessary and after consulting a doctor.
Cetirizine passes into breast milk. In breastfed infants, it cannot be excluded that adverse effects may occur. Therefore, do not take Zyrtec during breastfeeding, unless your doctor decides otherwise.

Driving and using machines

Clinical studies have not shown any significant impairment of reaction time, and ability to drive or operate machinery after taking Zyrtec at the recommended dose.
If you plan to drive a vehicle, perform potentially hazardous activities, or operate machinery after taking Zyrtec, carefully observe your body's reaction to the medicine. Do not exceed the recommended dose.
Zyrtec film-coated tablets contain lactose;if you have been diagnosed with an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Zyrtec

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Swallow the tablets with a glass of liquid.
The tablet can be divided into two equal doses.

Adults and adolescents over 12 years:

The recommended dose is 10 mg (1 tablet) once daily.
Other forms of this medicine may be more suitable for children. Consult your doctor or pharmacist.

Use in children aged 6 to 12 years:

The recommended dose is 5 mg twice daily (half a tablet twice daily).
Other forms of this medicine may be more suitable for children. Consult your doctor or pharmacist.

Patients with renal impairment

In patients with moderate renal impairment, a dose of 5 mg once daily is recommended.
If you have severe kidney disease, consult your doctor, who will adjust the dose accordingly.
If your child has kidney disease, consult your doctor, who will adjust the dose according to your child's needs.
If you feel that the effect of Zyrtec is too strong or too weak, consult your doctor.

Duration of treatment

The duration of treatment depends on the type, duration, and course of symptoms and is determined by your doctor.

Overdose of Zyrtec

If you take more Zyrtec than you should, contact your doctor.
Your doctor will decide whether and what measures should be taken.
After an overdose, the following side effects may occur with increased intensity: disorientation, diarrhea, dizziness, fatigue, headache, malaise, dilated pupils, itching, restlessness, sedation, somnolence, stupor, increased heart rate, tremor, and urinary retention (difficulty emptying the bladder completely).

Missing a dose of Zyrtec

Do not take a double dose to make up for a forgotten dose.

Stopping treatment with Zyrtec

In rare cases, itching (intense itching) and/or urticaria may recur after stopping 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, Zyrtec 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 inform your doctor immediately if you experience:

• allergic reactions, including severe reactions and angioedema (a severe allergic reaction that causes swelling of the face and throat). These reactions may occur immediately after the first dose or may occur later.

Common side effects(may affect up to 1 in 10 people)

• drowsiness
• dizziness, headache
• pharyngitis (sore throat), rhinitis (nasal discharge, feeling of nasal congestion) (in children)
• diarrhea, nausea, dry mouth
• fatigue

Uncommon side effects(may affect up to 1 in 100 people)

• excitation
• paresthesia (sensory disturbances)
• abdominal pain
• itching, rash
• asthenia (extreme fatigue), malaise

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

• allergic reactions, sometimes severe (very rare)
• depression, hallucinations, aggressive behavior, disorientation, insomnia
• seizures
• tachycardia (rapid heart rate)
• abnormal liver function
• urticaria
• edema
• weight gain

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

• thrombocytopenia (low platelet count)
• tics (involuntary muscle contractions)
• syncope, dyskinesia (involuntary movements), dystonia (abnormal, prolonged muscle contractions), tremor, taste disturbances
• blurred vision, accommodation disorders (vision disorders), eye rotation (uncontrolled, circular eye movements)
• angioedema (severe allergic reaction causing swelling of the face or throat), drug rash (skin allergic reaction to the medicine)
• urinary disorders (nocturia, pain and/or difficulty urinating)

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

• increased appetite
• suicidal attempts (recurring suicidal thoughts or interest in suicide), nightmares
• amnesia (memory loss), memory disorders
• vertigo (feeling of spinning or loss of balance)
• urinary retention (inability to completely empty the bladder)
• itching (intense itching) and/or urticaria after stopping Zyrtec
• arthralgia, myalgia
• acute generalized exanthematous pustulosis (rash with pus-filled blisters)
• hepatitis

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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. The expiry date refers to the last day of that month.
There are no special precautions for storage.

6. Contents of the pack and other information

What Zyrtec contains

• 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).

What Zyrtec looks like and contents of the pack

White, elongated film-coated tablets with a dividing line and Y-Y logo.
The pack contains 20, 30, 60, or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
VEDIM Sp. z o.o.
ul. Kruczkowskiego 8
00-380 Warsaw
Tel.: + 48 22 696 99 20
Manufacturers:
Aesica Pharmaceuticals S.r.l., Via Praglia 15, I-10044 Pianezza (TO), Italy
UCB Pharma Limited, 208 Bath Road, Slough, Berkshire, SL1 3WE, United Kingdom
Importer:
PHOENIX Pharma Polska Sp z o.o., ul. Rajdowa 9, Konotopa, 05-850 Ożarów Mazowiecki
ExtractumPharma Co. Ltd., 6413 Kunfehértó, IV. körzet 6, Hungary
United Drug Distributors Ireland Limited, United Drug House, Magna Drive, Magna Business Park,
Citywest, Road, Dublin 24, Ireland
UCB Pharma B.V., Hoge Mosten 2 A1, 4822 NH, Breda, Netherlands
UCB Pharma AS, Haakon VIIs gate 6, NO-0161 Oslo, Norway
UCB Nordic A/S, Edvard Thomsens Vej 14, DK-2300 København S, Denmark
UCB Pharma SA, Chemin Du Foriest 1, Braine-L’alleud, 1420, Belgium

This medicine is authorized 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 10 mg 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 oblozene tablete
Spain
Zyrtec 10 mg comprimidos recubiertos con pelicula
United Kingdom (Northern Ireland)
Zirtek allergy tablets
Date of last revision of the leaflet:December 2023