Zirtec

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: patient information

Zyrtec, 1 mg/ml, oral solution

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 specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those 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, 1 mg/ml, oral solution is indicated for adults and children aged 2 years and above:

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

2. Important information before taking Zyrtec

When not to take Zyrtec

• if you have severe renal impairment (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, present 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 the medicine;
a lower dose may be necessary. The dose of the medicine 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 antihistamine medicines, it is recommended to avoid taking Zyrtec with alcohol.
If you are scheduled to undergo allergy tests, ask your doctor if you should stop taking Zyrtec a few days before the test.
Zyrtec may affect the results of allergy tests.

Zyrtec and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, 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.
Zyrtec should be avoided in pregnant women. Accidental intake of the medicine by a pregnant woman should not have a harmful effect on the fetus.
However, the medicine should only be used if necessary and after consulting a doctor.
Cetirizine passes into breast milk. In breastfed infants, the risk of side effects cannot be excluded.
Therefore, Zyrtec should not be taken during breastfeeding, unless the doctor decides otherwise.

Driving and using machines

Clinical studies have not shown any impairment of reaction time, attention, and ability to drive vehicles after taking Zyrtec at the recommended dose.
If you plan to drive vehicles, perform potentially hazardous activities, or operate machinery after taking Zyrtec, observe your body's reaction to the medicine carefully.
Do not take a higher dose than recommended.

Zyrtec oral solution contains sorbitol (E 420), methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), propylene glycol (E 1520), and sodium.

This medicine contains 1,575 mg of sorbitol (E 420) in each 5 ml, which corresponds to 315 mg/ml.
Sorbitol is a source of fructose. If you or your child have been diagnosed with intolerance to some sugars or have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which the body does not break down fructose, you should consult your doctor before taking the medicine or giving it to your child.
Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.
This medicine contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216), which may cause allergic reactions (possible late reactions).
This medicine contains 250 mg of propylene glycol (E 1520) in each 5 ml, which corresponds to 50 mg/ml.
The medicine contains less than 1 mmol of sodium (23 mg) per dose, which means that the medicine is considered "sodium-free".

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.
The solution can be taken orally without dilution.

Adults and adolescents over 12 years:

The recommended dose is 10 mg once daily, which corresponds to 10 ml of oral solution (2 full measuring spoons).

Use in children from 6 to 12 years:

The recommended dose is 5 mg twice daily, which corresponds to 5 ml of solution (1 full measuring spoon) twice daily.

Use in children from 2 to 6 years:

The recommended dose is 2.5 mg twice daily, which corresponds to 2.5 ml of oral solution (half a measuring spoon) twice daily.

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.

Taking a higher dose of Zyrtec than recommended

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

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 treatment with Zyrtec.
If you have any further questions about the use of this medicine, 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 inform your doctor immediately if you experience:

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

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

• drowsiness
• dizziness, headache
• pharyngitis (sore throat), rhinitis (runny nose, stuffy nose) (in children)
• diarrhea, nausea, dry mouth
• fatigue

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

• agitation
• 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)
• fainting, 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 reaction to the medicine)
• urinary disorders (nocturia, pain and/or difficulty urinating)

Side effects with unknown frequency(frequency cannot be estimated from 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 empty the bladder completely)
• itching (intense itching) and/or urticaria after stopping treatment with the medicine
• arthralgia (joint pain), myalgia (muscle pain)
• acute generalized exanthematous pustulosis (rash with pustules containing pus)
• hepatitis

Reporting side effects

If you experience any side effects, including those 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,
Jerozolimskie Avenue 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 stated on the carton and bottle. The expiry date refers to the last day of the month.
Do not use after 3 months from the first opening of the bottle.
There are no special precautions for storage.

6. Contents of the pack and other information

What Zyrtec contains

• The active substance is cetirizine dihydrochloride. 10 ml of solution (which corresponds to 2 full measuring spoons) contains 10 mg of cetirizine dihydrochloride.
• The other ingredients are: sorbitol (E 420), glycerol (E 422), propylene glycol (E 1520), sodium saccharin, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), banana flavor 54.330/A, sodium acetate, glacial acetic acid, purified water.
• 10 ml of Zyrtec oral solution (= 2 full measuring spoons) contains sorbitol in an amount equivalent to: 3.15 g of glucose.

What Zyrtec looks like and contents of the pack

Zyrtec is a clear, colorless liquid with a sweet taste and banana flavor.
The pack contains a bottle containing 75 or 200 ml of solution.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
VEDIM Sp. z o.o.
Kruczkowskiego 8
00-380 Warsaw
Phone: + 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., Rajdowa 9, Konotopa, 05-850 Ożarów Mazowiecki
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 1 mg/ml oral solution
Belgium
Zyrtec
Cyprus
Zyrtec
Denmark
Zyrtec
Estonia
Zyrtec
Finland
Zyrtec
France
Zyrtec
Ireland
Zirtek oral solution 1 mg/ml
Italy
Zirtec 1 mg/ml oral solution
Latvia
Zyrtec
Lithuania
Zyrtec
Luxembourg
Zyrtec
Malta
Zyrtec
Netherlands
Zyrtec
Norway
Zyrtec
Poland
Zyrtec
Portugal
Zyrtec
Slovenia
Zyrtec 1 mg/ml oral solution
Spain
Zyrtec 1 mg/ml oral solution
United Kingdom (Northern Ireland)
Zirtek allergy solution
Date of last revision of the leaflet:September 2023