Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the outer packaging in a foreign language.
Zyrtec, 10 mg/ml, oral drops, solution
Cetirizini dihydrochloridum
Please read the entire leaflet carefully before using this medicine, as it contains important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

What Zyrtec is and what it is used for
Important information before taking Zyrtec
How to take Zyrtec
Possible side effects
How to store Zyrtec
Contents of the pack and other information

1. What Zyrtec is and what it is used for

The active substance in Zyrtec is cetirizine dihydrochloride.
Zyrtec is an antiallergic medicine.
Zyrtec 10 mg/ml oral drops, solution is indicated in adults and children aged 2 years and older:

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

2. Important information before using Zyrtec

When not to use Zyrtec

if the patient has end-stage renal failure (severe kidney failure requiring dialysis),
if the patient is allergic to cetyriazine dihydrochloride or any of the other components of this medicine (listed in section 6), hydroxyzine, or piperazine derivatives (active substances with similar structure contained in other medicines).

Warnings and precautions
Before starting treatment with Zyrtec, discuss this with your doctor or pharmacist.
If the patient has kidney failure, consult a doctor before using the medicine;
a lower dose may be required. The doctor will determine the appropriate dose.
If the patient has problems with urination (e.g. due to spinal cord, prostate, or bladder issues), consult a doctor.
If the patient has epilepsy or is at risk of seizures, consult a doctor.
No clinically significant interactions have been observed between alcohol (at a blood concentration of 0.5 per mille (g/l), corresponding to the level after drinking one glass of wine) and ceterizine administered at recommended doses. However, there are no safety data available regarding concomitant use of higher doses of ceterizine and alcohol. Therefore, as with other antihistamine medicines, it is recommended to avoid taking Zyrtec together with alcohol.
If the patient has planned allergy testing, ask the doctor whether the patient should stop taking Zyrtec a few days before the test. Zyrtec may affect the results of allergy tests.

Zyrtec and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.

Taking Zyrtec with food and drink
Food does not affect the absorption of Zyrtec.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.
The use of Zyrtec in pregnant women should be avoided. Accidental intake of the medicine by a pregnant woman is not expected to have harmful effects on the fetus. However, the medicine may be used only if necessary and after consultation with a doctor.
Cetirizine passes into breast milk. Adverse effects in breastfed infants cannot be excluded. Therefore, Zyrtec should not be used during breastfeeding unless otherwise decided by a doctor.

Driving and operating machinery
Clinical studies have not shown impairment of reaction ability, concentration, or driving skills after administration of Zyrtec at the recommended dose.
If the patient plans to drive, perform potentially hazardous activities, or operate machinery after taking Zyrtec, the patient should carefully observe their body's reaction to the medicine. Do not exceed the recommended dose.

Zyrtec oral drops solution contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216), which may cause allergic reactions (delayed-type reactions possible).
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, meaning the medicine is considered "sodium-free".

3. How to use Zyrtec

This medicine should always be used as directed by a physician or pharmacist. If in doubt,
consult a physician or pharmacist.
The drops should be poured onto a spoon or diluted in water and taken orally. When diluting,
take into account that the volume of water to which the drops are added must be adjusted to
the volume that the patient, especially a child, is able to drink. The diluted solution should be
taken immediately after preparation.
When counting drops, hold the bottle vertically (upside down). If the required dose has not been
measured and the drops stop flowing, turn the bottle over, then turn it back upside down and
continue counting the drops.
Adults and adolescents over 12 years of age:
The recommended dose is 10 mg once daily, equivalent to 20 drops once daily.
Use in children aged 6 to 12 years:
The recommended dose is 5 mg twice daily, equivalent to 10 drops twice daily.
Use in children aged 2 to 6 years:
The recommended dose is 2.5 mg twice daily, equivalent to 5 drops twice daily.
Patients with renal impairment
For patients with moderate renal impairment, a dose of 5 mg (10 drops) once daily is recommended.
If a patient has severe kidney disease, consult a physician who will adjust the dose accordingly.
If a child has kidney disease, consult a physician 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 a physician.
Duration of treatment
The duration of treatment depends on the type, duration, and course of symptoms and is determined by
the physician.
Taking more than the recommended dose of Zyrtec
If more than the recommended dose of Zyrtec is taken, consult a physician. The physician
will decide whether and what measures should be taken.
After an overdose, the adverse reactions listed below may occur with increased intensity. The following adverse reactions have been reported: disorientation, diarrhoea, dizziness, fatigue, headache, malaise, mydriasis, pruritus, psychomotor agitation, sedation, somnolence, stupor, tachycardia, tremor, and urinary retention (difficulty completely emptying the bladder).
Missed dose of Zyrtec
Do not take a double dose to make up for a missed dose.
Stopping Zyrtec treatment
In rare cases, pruritus (intense itching) and/or urticaria may recur after discontinuation of Zyrtec.
If you have any further questions about the use of this medicine, consult a physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions occur rarely or very rarely; however, you should stop taking the medicine and immediately inform your doctor if any of the following occur:

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

Common adverse reactions (may occur in no more than 1 in 10 patients)

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

Uncommon adverse reactions (may occur in no more than 1 in 100 patients)

restlessness
paraesthesia (sensory disturbances)
abdominal pain
itching, rash
asthenia (extreme tiredness), malaise

Rare adverse reactions (may occur in no more than 1 in 1000 patients)

allergic reactions, sometimes severe (very rare)
depression, hallucinations, aggressive behaviour, disorientation, insomnia
seizures
tachycardia (rapid heartbeat)
abnormal liver function
urticaria
oedema
weight gain

Very rare adverse reactions (may occur in no more than 1 in 10,000 patients)

thrombocytopenia (low number of blood platelets)
tics (habitual spasms)
fainting, dyskinesia (involuntary movements), dystonia (abnormal, prolonged muscle contractions), tremor, taste disturbances
blurred vision, accommodation disorders (visual focusing problems), nystagmus (uncontrolled, circular eye movements)
angioedema (severe allergic reaction causing swelling of the face or throat), drug eruption (skin allergic reaction to a medicine)
urinary disorders (nocturnal enuresis, pain and/or difficulty in passing urine)

Adverse reactions with unknown frequency (frequency cannot be estimated from available data)

increased appetite
suicidal behaviour (recurring suicidal thoughts or interest in suicide), nightmares
amnesia (memory loss), memory impairment
dizziness (sensation of spinning or loss of balance)
urinary retention (inability to completely empty the bladder)
itching (intense pruritus) and/or urticaria after discontinuation of the medicine
joint pain, muscle pain
acute generalized exanthematous pustulosis (rash with pustules containing purulent discharge)
hepatitis

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Zyrtec medicine

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Do not use the medicine more than 3 months after first opening the bottle.
No special storage instructions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Zyrtec contains

The active substance in Zyrtec is cetirizine dihydrochloride. One ml (corresponding 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 contents of the pack
Zyrtec is a clear, colourless liquid.
The pack contains a bottle with 20 ml of solution.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Romania, 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 authorisation number in Romania, country of export: 5076/2012/03
Parallel import authorisation number: 324/18
This medicinal product is authorised in the European Economic Area countries 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