Zyrtec ucb

Patient Information Leaflet

Zyrtec UCB, 10 mg, film-coated tablets
Cetirizini dihydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if you feel worse, contact your doctor.

Table of contents:

1. What Zyrtec UCB is and what it is used for
2. What you need to know before taking Zyrtec UCB
3. How to take Zyrtec UCB
4. Possible side effects
5. How to store Zyrtec UCB
6. Contents of the pack and other information

1. What Zyrtec UCB is and what it is used for

The active substance in Zyrtec UCB is cetirizine dihydrochloride.
Zyrtec UCB is an antiallergy medicine.
Zyrtec UCB 10 mg film-coated tablets are indicated in adults and children aged 6 years and older:

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

2. Important information before using Zyrtec UCB

When not to use Zyrtec UCB

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

Warnings and precautions
Before starting treatment with Zyrtec UCB, consult your doctor or pharmacist.
If the patient has kidney impairment, consult a doctor before using this medicine;
a lower dose may be required. The dose will be determined by the doctor.
If the patient has difficulty urinating (e.g. due to spinal cord disorders, prostate problems,
or bladder disorders), consult a doctor.
If the patient has epilepsy or a 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 concentration after drinking one glass of wine) and ceterizine administered at recommended doses. However, there is 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 UCB together with alcohol.
If the patient has planned allergy testing, ask the doctor whether the patient should stop taking Zyrtec UCB several days before the test. Zyrtec UCB 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 appropriate dose adjustment.
Zyrtec UCB with other medicines
Tell 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.
Zyrtec UCB with food and drink
Food does not affect the absorption of Zyrtec UCB.
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.
Avoid using Zyrtec UCB during pregnancy. Accidental intake by a pregnant woman is not expected to have harmful effects on the fetus. However, the medicine should only be used if clearly necessary and after consultation with a doctor.
Cetirizine passes into breast milk. Adverse effects in breastfed infants cannot be excluded. Therefore, Zyrtec UCB should not be used during breastfeeding unless otherwise advised by a doctor.
Driving and operating machinery
Clinical studies have not shown any impairment of reaction time, concentration, or ability to drive vehicles after administration of Zyrtec UCB at the recommended dose.
If the patient intends to drive, perform potentially hazardous activities, or operate machinery after taking Zyrtec UCB, the patient should carefully monitor their body's response to the medicine. Do not exceed the recommended dose.
Zyrtec UCB coated tablets contain lactose; if the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to take Zyrtec UCB

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The tablets should be swallowed with a glass of liquid.
The tablet may be divided into two equal doses.

Adults and adolescents aged over 12 years
The recommended dose is 10 mg (1 tablet) once daily.

Children aged 6 to 12 years
The recommended dose is 5 mg twice daily (half a tablet twice daily).
Other formulations of this medicine may be more suitable for children. Consult your doctor or pharmacist.

Patients with impaired kidney function
For patients with moderate kidney impairment, a dose of 5 mg once daily is recommended.
If a patient has severe kidney disease, consult a doctor, who will adjust the dose accordingly.
If a child has kidney disease, consult a doctor, who will adjust the dose according to the child's needs.

If you feel that the effect of Zyrtec UCB 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. Consult your doctor or pharmacist.
Treatment with cetirizine without medical advice should not last longer than 10 days.

Taking more Zyrtec UCB than recommended
If you take more Zyrtec UCB than recommended, consult your doctor.
The doctor will decide whether and what measures should be taken.
The following adverse effects may occur with increased intensity after overdose: disorientation, diarrhoea, dizziness, fatigue, headache, malaise, pupil dilation, itching, psychomotor agitation, sedation, somnolence, stupor, tachycardia, tremor, and urinary retention (difficulty completely emptying the bladder).

Missing a dose of Zyrtec UCB
Do not take a double dose to make up for a missed dose.

Stopping Zyrtec UCB
In rare cases, itching (intense pruritus) and/or urticaria may recur after discontinuation of Zyrtec UCB.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
The following adverse reactions are rare or very rare, but you must stop taking the medicine and contact your doctor immediately 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 or may occur later.

Adverse reactions that are common (may affect up to 1 in 10 people)

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

Adverse reactions that are uncommon (may affect up to 1 in 100 people)

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

Adverse reactions that are rare (may affect up to 1 in 1,000 people)

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

Adverse reactions that are very rare (may affect up to 1 in 10,000 people)

• thrombocytopenia (low platelet count)
• tics (habitual spasms)
• fainting, dyskinesia (involuntary movements), dystonia (abnormal, prolonged muscle contractions), tremor, taste disturbances
• blurred vision, accommodation disorders (visual focusing problems), ocular rotation (uncontrolled, circular eye movements)
• angioedema (severe allergic reaction causing swelling of the face or throat), drug rash (skin allergic reaction to medicine)
• urinary disorders (bedwetting, pain and/or difficulty passing urine)

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

• increased appetite
• suicidal behaviour (recurrent suicidal thoughts or interest in suicide), nightmares
• amnesia (memory loss), memory disorders
• vertigo (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 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 .
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Zyrtec UCB

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 blister. The expiry date refers to the last day of the stated month.
No special storage conditions apply for this medicine.

6. Contents of the pack and other information

What Zyrtec UCB contains

• The active substance in Zyrtec UCB is cetirizine dihydrochloride. One coated tablet contains 10 mg of cetirizine dihydrochloride.
• The other ingredients are: microcrystalline cellulose, monohydrate lactose, colloidal anhydrous silica, magnesium stearate, Opadry Y-1-7000 (hypromellose (E 464), titanium dioxide (E 171), polyethylene glycol 400).

What Zyrtec UCB looks like and contents of the pack
White, elongated, film-coated tablets with a dividing score and the logo Y-Y.
The pack contains 7, 10 or 20 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
VEDIM Sp. z o.o.
ul. Kruczkowskiego 8
00-380 Warszawa
Tel.: +48 22 696 99 20

Manufacturer:
Aesica Pharmaceuticals S.r.l.
Via Praglia 15
I-10044 Pianezza (TO), Italy

Importer:
PHOENIX Pharma Polska Sp. z o.o.
ul. Rajdowa 9, Konotopa
05-850 Ożarów Mazowiecki