Zirtec

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Zyrtec, 10 mg/ml, oral drops, solution

Cetirizine dihydrochloride

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 packaging 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 the relief of symptoms related to the nose and eyes, associated with seasonal and perennial allergic rhinitis,
• for the relief of symptoms of urticaria.

2. Important information before taking Zyrtec

When not to take Zyrtec

• if the patient has terminal renal insufficiency (severe renal insufficiency requiring dialysis),
• if the patient is 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 starting to take Zyrtec, you should discuss it with your doctor or pharmacist.
If the patient has renal insufficiency, they should consult their doctor before taking the medicine;
it may be necessary to use a lower dose. The dose of the medicine will be determined by the doctor.
If the patient has problems with urination (e.g. problems with the spinal cord or prostate,
or problems with the bladder), they should consult their doctor.
If the patient has epilepsy or a risk of seizures, they should consult their 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 used
in 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 the patient is scheduled to undergo allergy tests, they should ask their doctor if they should stop taking Zyrtec a few days before the test. Zyrtec may affect the results of allergy tests.

Zyrtec and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.

Taking Zyrtec with food and drink

Food does not affect the absorption of Zyrtec.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant or are planning to have a child, they should consult their doctor 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 may 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 used during breastfeeding, unless the doctor has decided otherwise.

Driving and using machines

Clinical studies have not shown any impairment of reaction and concentration, as well as the ability to drive vehicles after taking Zyrtec in the recommended dose.
If the patient plans to drive vehicles, perform potentially hazardous activities or operate machines after taking Zyrtec, they should carefully observe their body's reaction to the medicine. They should 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

This medicine should always be taken according to the doctor's or pharmacist's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.
The drops should be poured onto a spoon or diluted in water and taken orally. When diluting, it should be taken into account that the volume of water to which the drops are added must be adjusted to the volume that the patient, in particular a child, is able to drink. The diluted solution should be taken immediately after preparation.
When counting the drops, the bottle should be held vertically (upside down). If the correct dose of the medicine has not been measured and the drops have stopped flowing, the bottle should be turned upside down and then turned right side up again and the counting of drops should be continued.

Adults and adolescents over 12 years of age:

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 the patient has severe kidney disease, they should consult their doctor, who will adjust the dose accordingly.
If the child has kidney disease, they should consult their doctor, who will adjust the dose according to the child's needs.
If the patient feels that the effect of Zyrtec is too strong or too weak, they should consult their doctor.

Duration of treatment

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

Taking a higher dose of Zyrtec than recommended

In case of taking a higher dose of Zyrtec than recommended, the patient should consult their 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, pupil dilation, itching, restlessness, sedation, sleepiness, stupor, accelerated heart rate, tremor and urinary retention (difficulty emptying the bladder).

Missing a dose of Zyrtec

A double dose should not be taken 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.
In case of any further doubts about the use of this medicine, the patient should consult their 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 the patient should stop taking the medicine and immediately inform their doctor if they occur:

• 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 intake of the medicine or may occur later.

Common side effects(may occur in up to 1 in 10 patients)

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

Uncommon side effects(may occur in up to 1 in 100 patients)

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

Rare side effects(may occur in up to 1 in 1,000 patients)

• 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 occur in up to 1 in 10,000 patients)

• thrombocytopenia (low platelet count)
• tics (habitual contractions)
• fainting, dyskinesia (involuntary movements), dystonia (abnormal, prolonged muscle contractions), tremor, taste disturbances
• blurred vision, accommodation disorders (vision acuity disorders), eye rotation (uncontrolled, circular movements of the eyeballs)
• 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 pustules containing pus)
• hepatitis

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl.
By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Zyrtec

The medicine should be stored in a place that is out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
The medicine should not be used after 3 months from the first opening of the bottle.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging 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 85%, propylene glycol, sodium saccharin, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), sodium acetate, glacial acetic acid, purified water.

What Zyrtec looks like and what the packaging contains

Zyrtec is a clear, colorless liquid.
The packaging contains a bottle with 20 ml of solution.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Romania, the country of export:

UCB Pharma GmbH
Alfred Nobel, Strasse 10
40789 Monheim
Germany

Manufacturer:

Aesica Pharmaceuticals S.r.l.
Via Praglia 15, I-10044 Pianezza, Torino
Italy
Nextpharma SAS
17 Route de Meulan, 78520 Limay
France

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Marketing authorization number in Romania, the country of export:5076/2012/03
Parallel import authorization number:324/18

This medicine is authorized in the Member States of the European Economic Area under the following names:

Contents of the packaging

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 oral solution drops
Ireland
Zirtek oral drops 10 mg/ml
Italy
Zirtec 10 mg/ml oral solution drops
Latvia
Zyrtec
Lithuania
Zyrtec
Luxembourg
Zyrtec
Norway
Zyrtec
Poland
Zyrtec
Romania
Zyrtec
Slovakia
Zyrtec
Spain
Zyrtec 10 mg/ml oral solution drops

Date of approval of the leaflet: 27.09.2023

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