Zirtec

Leaflet attached to the packaging: patient information

Zyrtec, 10 mg/ml, oral drops, solution

Cetirizine dihydrochloride

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• 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. Package contents 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 for adults and children aged 2 years and older:

• for relieving symptoms of the nose and eyes associated with seasonal and perennial allergic rhinitis,
• for relieving symptoms of urticaria.

2. Important information before taking Zyrtec

When not to take Zyrtec

• if you have end-stage renal failure (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 kidney problems, consult your doctor before taking the medicine;
it may be necessary to use a lower dose. 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, have recently taken, or 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 plan to have a child, consult your doctor before taking this medicine.
Avoid taking Zyrtec during pregnancy. 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, do not take Zyrtec during breastfeeding, unless your doctor decides otherwise.

Driving and using machines

Clinical studies have not shown any impairment of reaction time, attention, or ability to drive a vehicle 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 take a higher dose than recommended.

Zyrtec oral drops, solution contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate

(E 216), which may cause allergic reactions (possible late reactions).
This medicine contains 350 mg of propylene glycol in each ml (20 drops).
The medicine contains less than 1 mmol of sodium (23 mg) per ml, i.e., 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, consult your doctor or pharmacist.
Drops should be poured onto a spoon or diluted in water and taken orally. When diluting, consider that the volume of water to which the drops are added must be adjusted to the volume that the patient, especially a child, can drink. The diluted solution should be taken immediately after preparation.
When counting drops, hold the bottle vertically (upside down). If the correct dose of the medicine has not been measured and the drops have stopped flowing, turn the bottle upside down and then turn it back upright and continue counting the drops.

Adults and adolescents over 12 years:

The recommended dose is 10 mg once a day, which corresponds to 20 drops once a day.

Use in children aged 6 to 12 years:

The recommended dose is 5 mg twice a day, which corresponds to 10 drops twice a day.

Use in children aged 2 to 6 years:

The recommended dose is 2.5 mg twice a day, which corresponds to 5 drops twice a day.

Patients with renal impairment

In patients with moderate renal impairment, a dose of 5 mg (10 drops) once a day 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 the 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 have taken a higher dose of Zyrtec than recommended, consult your doctor. Your 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, pupil dilation, itching, restlessness, sedation, somnolence, stupor, accelerated 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 missed dose.

Stopping treatment with Zyrtec

In rare cases, itching (intensive itching) and/or urticaria may recur after stopping treatment with Zyrtec.
If you have any further doubts about taking this medicine, consult 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 immediately inform your doctor 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 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)
• 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 allergic reaction to the medicine)
• urinary disorders (nocturia, pain and/or difficulty urinating)

Side effects with 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 (intensive itching) and/or urticaria after stopping treatment with the medicine
• arthralgia (joint pain), myalgia (muscle pain)
• acute generalized exanthematous pustulosis (rash with pus-filled blisters)
• hepatitis

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocides, 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 the 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 storing the medicine.

6. Package contents and other information

What Zyrtec contains

• The active substance of Zyrtec is cetirizine dihydrochloride. One ml (which corresponds to 20 drops) contains 10 mg of cetirizine dihydrochloride. One drop contains 0.5 mg of cetirizine dihydrochloride.
• The other ingredients are: glycerol, propylene glycol, sodium saccharin, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), sodium acetate, glacial acetic acid, purified water.

What Zyrtec looks like and contents of the pack

Zyrtec is a clear, colorless liquid.
The pack contains a bottle with 10, 15, or 20 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
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
Nextpharma SAS, 17 Route de Meulan, 78520 Limay, France
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 AS, Haakon VIIs gate 6, NO-0161 Oslo, Norway
UCB Nordic A/S, Edvard Thomsens Vej 14, DK-2300 København S, Denmark

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 belsőleges 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 gotas orales en solución
Date of last revision of the leaflet:June 2022