Letizen

Package Leaflet: Information for the Patient

Letizen, 10 mg, Film-Coated Tablets

Cetirizine Dihydrochloride

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

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

Table of Contents of the Leaflet

• 1. What is Letizen and what is it 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 is Letizen and what is it used for

The active substance of Letizen is cetirizine dihydrochloride.
Letizen is an antiallergic medication.
Letizen, 10 mg, film-coated tablets are indicated for adults and children aged 6 years and above:

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

2. Important information before taking Letizen

When Not to Take Letizen

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

Warnings and Precautions

Before taking Letizen, discuss it with your doctor or pharmacist.
If you have renal impairment, consult your doctor before taking the medicine;
a lower dose may be necessary. The dose will be determined by your doctor.
If you have a history of epilepsy or are at risk of seizures, consult your doctor.
If you have difficulty urinating (e.g., spinal cord injury, prostate problems, or bladder problems), consult your doctor.
If you are scheduled to undergo allergy testing, ask your doctor whether you should stop taking Letizen a few days before the test. This medicine may affect the results of allergy tests.
No significant clinically relevant interactions have been observed between alcohol (at a concentration of 0.5 g/L in the blood, corresponding to the concentration after drinking one glass of wine) and cetirizine at the recommended dose. However, there are no data on the safety of concomitant use of higher doses of cetirizine and alcohol. Therefore, as with other antihistamine medications, it is recommended to avoid taking Letizen with alcohol.

Children

Do not give this medicine to children under 6 years of age, as the tablet formulation does not allow for appropriate dose adjustment.

Letizen and Other Medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.

Letizen with Food and Drink

Food does not affect the absorption of Letizen.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Avoid taking Letizen during pregnancy. 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, it cannot be excluded that adverse effects may occur. Therefore, do not take Letizen during breastfeeding, unless your doctor decides otherwise.

Driving and Using Machines

Clinical studies with cetirizine at the recommended dose have not shown any significant impairment of reaction time or alertness, or any effect on the ability to drive or operate machinery.
If you plan to drive a vehicle, perform potentially hazardous activities, or operate machinery after taking Letizen, carefully observe your body's reaction to the medicine. Do not exceed the recommended dose.

Letizen Contains Lactose Monohydrate

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to Take Letizen

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Swallow the tablets with a glass of liquid.

Adults and Adolescents 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 cetirizine may be more suitable for children. 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, consult your doctor, who will adjust the dose accordingly.
If your child has kidney disease, consult your doctor, who will adjust the dose according to your 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 disease and is determined by your doctor.

Overdose of Letizen

If you take more Letizen than you should, contact your doctor immediately.
Your doctor will decide what measures should be taken.
After taking a higher dose than recommended, the following side effects may occur with increased intensity: disorientation, diarrhea, dizziness, fatigue, headache, malaise, dilated pupils, itching, restlessness, especially motor, sedation, somnolence, stupor, accelerated heart rate, tremor, urinary retention (difficulty emptying the bladder completely).

Missed Dose of Letizen

Do not take a double dose to make up for a forgotten dose.

Stopping Letizen Treatment

In rare cases, itching (intense itching) and/or urticaria may recur after stopping Letizen treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Letizen 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 Inform Your Doctor Immediately 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, rhinitis (in children)
• dry mouth, nausea, diarrhea
• fatigue

Uncommon Side Effects(may affect up to 1 in 100 people):

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

Rare Side Effects(may affect up to 1 in 1,000 people):

• allergic reactions, sometimes severe (very rare)
• aggressive behavior, disorientation, depression, hallucinations, 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 muscle contractions)
• syncope, dyskinesia (involuntary movements), dystonia (abnormal, prolonged muscle contractions), tremor, taste disturbances
• accommodation disorders (vision disturbances), blurred vision, eye rotation (uncontrolled, circular eye movements)
• angioedema (severe allergic reaction causing swelling of the face or throat), drug rash (skin reaction to medication)
• 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
• memory loss, memory disturbances
• vertigo (feeling of spinning or loss of balance)
• urinary retention (inability to completely empty the bladder)
• itching (intense itching) and/or urticaria after stopping Letizen treatment, skin rash with pus-filled blisters
• arthralgia, myalgia
• hepatitis.

Reporting Side Effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring 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
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 Letizen

Keep this medicine out of the sight and reach of children.
Store in a temperature 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 month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

What Letizen Contains

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

What Letizen Looks Like and Contents of the Pack

Round, slightly biconvex, white film-coated tablets with a notch on one side.
The tablet can be divided into equal doses.
Pack sizes: 7 or 20 film-coated tablets in blisters in a cardboard box.

Marketing Authorization Holder and Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
To obtain more detailed information on this medicine, contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
tel. 22 57 37 500
Date of Last Revision of the Leaflet: