Lirra

Package leaflet: Information for the user

Lirra, 5 mg, film-coated tablets
Levocetirizini dihydrochloridum
For adults and children aged 6 years and older
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so 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 only. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are similar.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist immediately. See section 4.

Table of contents

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

1. What Lirra is and what it is used for

Lirra is an antihistamine medicine.
It is used to treat symptoms associated with:

• allergic rhinitis (including chronic allergic rhinitis),
• urticaria.

2. Important information before using Lirra

When not to use Lirra

• if the patient is allergic to levocetirizine dihydrochloride, cetirizine, hydroxyzine, or any of the other ingredients of this medicine (listed in section 6),
• if the patient has severe kidney disease requiring dialysis.

Warnings and precautions
Before starting treatment with Lirra, consult a doctor or pharmacist.
If the patient has difficulty passing urine (e.g. due to spinal cord injury or benign prostatic hyperplasia), medical advice should be sought.
Lirra may increase the frequency of epileptic seizures; therefore, consult a doctor if the patient has epilepsy or is at risk of seizures.
If the patient is scheduled for allergy testing, ask the doctor whether the patient should stop taking Lirra several days before the test. Lirra may affect the results of allergy tests.
Children
Lirra coated tablets are not recommended for children under 6 years of age, as appropriate dose adjustment is not possible with this formulation.
Lirra with other medicines
Inform the 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.
Lirra, food, drink and alcohol
Exercise caution when taking Lirra together with alcohol or other substances affecting brain function.
In sensitive patients, concomitant use of Lirra with alcohol or other substances affecting brain function may additionally reduce alertness and reaction ability.
Lirra may be taken during or between meals.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
Some patients may experience drowsiness or somnolence, fatigue and exhaustion while taking Lirra. Caution should be exercised when driving or operating machinery until the patient's response to the medicine is known. However, specific tests conducted in healthy volunteers did not show any effect on attention, reaction ability or driving skills after administration of levocetirizine at the recommended dose.
Lirra contains lactose
This medicine contains lactose. If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Lirra

This medicine should always be taken exactly as described in the patient information leaflet or as
advised by the doctor or pharmacist. If in doubt, consult your doctor or
pharmacist.
The recommended dose for adults and children aged 6 years and older is 1 tablet per day.
Dosing in special patient groups:
Renal and hepatic impairment
In patients with impaired renal function, a dose reduction may be necessary depending on the severity of kidney disease. In children, the dose should also be adjusted according to body weight; the doctor will determine the appropriate dose.
Lirra must not be used in patients with severe renal impairment requiring dialysis.
Patients with hepatic impairment alone should usually receive the recommended dose.
In patients with both hepatic and renal impairment, a dose reduction may be necessary depending on the severity of renal disease; in children, the dose should also be adjusted according to body weight; the doctor will determine the appropriate dose.
Elderly patients (65 years and older)
Dose adjustment is not necessary in elderly patients if renal function is normal.
Use in children
Lirra is not recommended for children under 6 years of age.
How and when to take Lirra
For oral use only.
Lirra tablets should be swallowed whole with water. The medicine can be taken during or between meals.
How long to take Lirra
The duration of treatment depends on the type, duration, and severity of the disease symptoms and is determined by the doctor.
Taking more Lirra than recommended
In adults, taking more than the recommended dose of Lirra may cause drowsiness. In children, initial excitation and restlessness, particularly motor restlessness, may occur, followed by drowsiness.
If a patient suspects that they have taken more than the recommended dose of Lirra, they should immediately contact a doctor, who will decide what actions should be taken.
Missing a dose of Lirra
If a dose of Lirra is missed or a lower than recommended dose is taken, do not take a double dose to make up for the missed dose. Instead, take the next dose at the usual time.
Stopping Lirra
Discontinuing treatment should not cause harmful effects. However, in rare cases, itching (intense pruritus) may occur after stopping Lirra, even if these symptoms were not present before starting treatment. These symptoms may resolve spontaneously. In some cases, symptoms may be severe and treatment may need to be restarted. Symptoms should resolve after resuming treatment.
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 everyone will experience them.

Common adverse reactions (may occur in less than 1 in 10 patients)

• Dry mouth
• Headache
• Fatigue
• Drowsiness or somnolence

Uncommon adverse reactions (may occur in less than 1 in 100 patients)

• Feeling of exhaustion
• Abdominal pain

Frequency unknown – frequency cannot be estimated from the available data
Other adverse reactions reported include palpitations, increased heart rate, convulsions, tingling, dizziness, fainting, tremor, taste disturbances (altered taste perception), sensation of spinning or swaying, visual disturbances, blurred vision, rotatory eye movements (uncontrolled circular eye movements), painful or difficult urination, inability to completely empty the bladder, swelling, itching, rash, urticaria (skin swelling, redness and itching), skin eruptions, shortness of breath, weight gain, muscle pain, joint pain, restlessness and aggressive behaviour, hallucinations, depression, insomnia, recurrent suicidal thoughts or suicidal ideation, nightmares, hepatitis, abnormal liver function, increased appetite, nausea and diarrhoea.
Itching (intense pruritus) after discontinuation of the medicine.

If the first signs of hypersensitivity reactions occur, treatment with Lirra should be discontinued and the doctor should be informed immediately. Symptoms of hypersensitivity reactions may include: swelling of the lips, tongue, face and (or) throat, difficulty breathing or swallowing (chest tightness or wheezing), urticaria, sudden drop in blood pressure leading to circulatory collapse or shock, which may lead to death.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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 can 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 Lirra

Keep this medicine out of sight and reach of children.
Do not use Lirra after the expiry date stated on the cardboard box after "Expiry date (EXP)" and on the blister after the abbreviation: EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Lirra contains

• The active substance is levocetirizine dihydrochloride. Each coated tablet contains 5 mg of levocetirizine dihydrochloride.
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, magnesium stearate, hypromellose, titanium dioxide (E 171) and polyethylene glycol 400.

What Lirra looks like and contents of the pack
The 5 mg coated tablets are biconvex, white, oval-shaped, with two letters "G" embossed on one side separated by a break line, and smooth on the other side. The break line on the tablet is intended only to facilitate breaking for easier swallowing, and does not ensure equal dose division.
The tablets are packed in aluminium/aluminium blisters or PVC/PVDC/aluminium blisters and placed in a cardboard box.
Pack sizes
28, 56, 84 and 90 coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b
140 78 Prague 4
Czech Republic
Manufacturer
Glenmark Pharmaceuticals s.r.o.
Fibíchova 143
566 17 Vysoké Mýto
Czech Republic
For further information about this medicinal product, please contact the local representative
of the Marketing Authorisation Holder:
Glenmark Pharmaceuticals Sp. z o.o.
ul. Dziekońskiego 3
00-728 Warsaw
Email: [email protected]
This medicinal product is authorised in the European Economic Area countries under the
following names: