Letizen

Package leaflet: information for the patient

Letizen, 10 mg, film-coated tablets
Cetirizini dihydrochloridum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Letizen is and what it is used for

The active substance in Letizen is cetirizine dihydrochloride.
Letizen is an antiallergy medicine.
Letizen 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 chronic idiopathic urticaria.

2. Important information before using Letizen

When not to use Letizen

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

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

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

Other medicines and Letizen
Tell your doctor or pharmacist about any medicines the patient is currently taking, has recently taken, or might take in the future.

Letizen with food and drink
Food does not affect the extent of absorption of Letizen.

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 her doctor before using this medicine.
The use of Letizen should be avoided in pregnant women. 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, Letizen should not be used during breastfeeding, unless otherwise decided by the doctor.

Driving and operating machinery
Clinical studies using cetirizine at the recommended dose have not shown impairment of reaction ability, concentration, or driving skills.
If the patient plans to drive, perform potentially hazardous activities, or operate machinery after taking Letizen, he or she should carefully observe how his or her body reacts to the medicine. Do not exceed the recommended dose.

Letizen contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, he or she should consult a doctor before taking this medicine.

3. How to use Letizen

This medicine should always be used according to the instructions given by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Tablets should be swallowed with a glass of liquid.
Adults and adolescents aged above 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 cetyryzine-containing medicines may be more suitable for children. Consult your
doctor or pharmacist.
Patients with renal function impairment
For patients with moderate renal 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 Letizen is too strong or too weak, consult your doctor.
Duration of treatment
The duration of treatment depends on the type, duration and course of the illness, and is determined by
the doctor.
Use of a higher than recommended dose of Letizen
If a higher than recommended dose of Letizen is taken, consult a doctor immediately.
The doctor will decide whether any measures are needed and what they should be.
After taking a dose higher than recommended, the adverse reactions listed below may occur with
increased intensity. The following adverse reactions have been reported: disorientation, diarrhoea,
dizziness, fatigue, headache, malaise, pupil dilation, itching, restlessness, particularly motor restlessness,
calming, drowsiness, stupor, rapid heartbeat, tremor, urinary retention (difficulty completely emptying the bladder).
Missed dose of Letizen
Do not take a double dose to make up for a missed dose.
Stopping Letizen treatment
In rare cases, itching (intense pruritus) and (or) urticaria may recur after stopping Letizen.
If you have any further doubts regarding 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 will experience them.
The following adverse reactions occur rarely or very rarely; however, you must stop taking the medicine and immediately inform your doctor if any of the following occur:

• allergic reactions, including severe reactions and angioedema (a serious 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.

Adverse reactions occurring frequently (may affect up to 1 in 10 patients):

• drowsiness
• dizziness, headache
• sore throat, nasal mucosal inflammation (in children)
• dry mouth, nausea, diarrhoea
• fatigue

Adverse reactions occurring not frequently (may affect up to 1 in 100 patients):

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

Adverse reactions occurring rarely (may affect up to 1 in 1,000 patients):

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

Adverse reactions occurring very rarely (may affect up to 1 in 10,000 patients):

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

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

• increased appetite
• suicidal behaviour (recurrent suicidal thoughts or interest in suicide), nightmares
• memory loss, memory disturbances
• 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, pustular skin rash
• joint pain, muscle pain
• hepatitis.

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

5. How to store Letizen medicine

Keep the medicine out of the sight and reach of children.
Store below 30°C.
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.
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 packaging and other information

What Letizen contains

• The active substance is cetirizine dihydrochloride. One coated tablet contains 10 mg of cetirizine dihydrochloride.
• Other components: monohydrate lactose, corn starch, povidone, magnesium stearate; film-coating composition (Opadry 33G28707): monohydrate lactose, hypromellose, titanium dioxide, macrogol, triacetin.

What Letizen looks like and contents of the pack
Round, slightly biconvex, white coated tablets with a break line on one side.
The tablet can be divided into equal doses.
Pack size: 7 or 20 coated tablets in blisters packed in a cardboard box.

Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw, Poland
Tel. 22 57 37 500