Zirtec Ucb

Leaflet attached to the packaging: patient information

Zyrtec UCB, 10 mg, film-coated tablets

Cetirizine dihydrochloride

Read the leaflet carefully before taking the medicine, as it contains

important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or
  pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, you should contact your doctor.

Table of contents of the leaflet:

• 1. What is Zyrtec UCB and what is it used for
• 2. Important information 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 is Zyrtec UCB and what is it used for

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

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

2. Important information before taking Zyrtec UCB

When not to take Zyrtec UCB

• if you have severe kidney failure (requiring dialysis),
• if you are allergic to cetirizine dihydrochloride or any of the other ingredients of this medicine (listed in
  section 6), to hydroxyzine or to piperazine derivatives (active substances with a similar structure,
  contained in other medicines).

Warnings and precautions

Before taking Zyrtec UCB, you should discuss it with your doctor or pharmacist.
If you have kidney problems, you should 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), you
should consult your doctor.
If you have epilepsy or are at risk of seizures, you should consult your doctor.
No significant clinically relevant interactions have been observed between alcohol (at a concentration of
0.5 per mille (g/l) in the blood, corresponding to the concentration after drinking one glass of wine) and
cetirizine used 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 UCB with alcohol.
If you are scheduled to undergo allergy testing, you should ask your doctor whether you should stop taking
Zyrtec UCB a few days before the test. Zyrtec UCB may affect the results of allergy tests.

Children

This medicine should not be given to children under 6 years of age, as the tablet formulation does not
allow for appropriate dose adjustment.

Zyrtec UCB and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as
well as about medicines you plan to take.

Zyrtec UCB with food and drink

Food does not affect the absorption of Zyrtec UCB.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, you
should consult your doctor before taking this medicine.
Zyrtec UCB 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 UCB should not be taken during breastfeeding, unless your doctor recommends
otherwise.

Driving and using machines

Clinical studies have not shown any impairment of reaction time, attention, or ability to drive vehicles after
taking Zyrtec UCB at the recommended dose.
If you plan to drive vehicles, perform potentially hazardous activities, or operate machinery after taking
Zyrtec UCB, you should carefully observe your body's reaction to the medicine. You should not take a
higher dose than recommended.
Zyrtec UCB film-coated tablets contain lactose;if you have previously been diagnosed with an intolerance to
some sugars, you should contact your doctor before taking the medicine.

3. How to take Zyrtec UCB

This medicine should always be taken exactly as described in this patient leaflet or as directed by your
doctor or pharmacist. If you are unsure, you should ask your doctor or pharmacist.
The tablets should be swallowed with a glass of liquid.
The tablet can be divided into 2 equal doses.

Adults and adolescents over 12 years of age

The recommended dose is 10 mg (1 tablet) once daily.

Children from 6 to 12 years of age

The recommended dose is 5 mg twice daily (half a tablet twice daily).
Other forms of this medicine may be more suitable for children. You should consult your doctor or
pharmacist.

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, you should consult your doctor, who will adjust the dose accordingly.
If your child has kidney disease, you should consult your doctor, who will adjust the dose according to your
child's needs.
If you feel that the effect of Zyrtec UCB is too strong or too weak, you should consult your doctor.

Duration of treatment

The duration of treatment depends on the type, duration, and course of symptoms. You should consult your
doctor or pharmacist.
Treatment with cetirizine without a doctor's recommendation should not last longer than 10 days.

Taking a higher dose of Zyrtec UCB than recommended

If you have taken a higher dose of Zyrtec UCB than recommended, you should consult your doctor.
Your doctor will decide what measures should be taken.
After an overdose, the following side effects may occur with increased intensity: disorientation, diarrhea,
dizziness, fatigue, headache, malaise, dilated pupils, itching, restlessness, sedation, sleepiness, stupor,
increased heart rate, and urinary retention (difficulty emptying the bladder).

Missing a dose of Zyrtec UCB

You should not take a double dose to make up for a missed dose.

Stopping treatment with Zyrtec UCB

In rare cases, itching (intense itching) and/or urticaria may recur after stopping treatment with Zyrtec UCB.
If you have any further doubts about taking this medicine, you should consult 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 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 may
  occur 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
• pruritus, 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 (habitual contractions)
• syncope, 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 of 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)
• pruritus (intense itching) and/or urticaria after stopping treatment with the medicine
• arthralgia, myalgia
• acute generalized exanthematous pustulosis (rash with pustules containing pus)
• hepatitis

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or
pharmacist. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions
to Medicinal Products, Medical Devices, and Biocides of the Office for Registration 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 UCB

The medicine should be stored out of 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 month.
There are no special precautions for storage of the medicine.

6. Contents of the pack and other information

What Zyrtec UCB contains

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

What Zyrtec UCB looks like and contents of the pack

White, elongated film-coated tablets with a dividing line and Y-Y logo.
The pack contains 7 or 10 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
VEDIM Sp. z o.o.
ul. Kruczkowskiego 8
00-380 Warsaw
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

Date of last revision of the leaflet: