Lirra

Package Leaflet: Information for the User

Lirra, 5 mg, Film-Coated Tablets

Levocetirizine Dihydrochloride
For adults and children from 6 years of age

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• Keep this package 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, 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 Package Leaflet

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

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

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

2. Important information before taking Lirra

When not to take Lirra

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

Warnings and precautions

Before taking Lirra, discuss it with your doctor or pharmacist.

If you may have difficulty urinating (in conditions such as spinal cord injury or prostate enlargement), consult your doctor.
Lirra may increase the risk of seizures, so consult your doctor if you have epilepsy or are at risk of seizures.
If you are scheduled to undergo allergy testing, ask your doctor if you should stop taking Lirra a few days before the test. Lirra may affect the results of allergy tests.
Children
Lirra film-coated tablets are not recommended for children under 6 years of age, as it is not possible to adjust the dose appropriately for this formulation.

Lirra and other medicines

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

Lirra with food, drink, and alcohol

Be cautious when taking Lirra with alcohol or other substances that affect brain function.
In sensitive patients, taking Lirra with alcohol or other substances that affect brain function may cause additional drowsiness and impaired reaction.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Some patients taking Lirra may experience drowsiness or sedation, fatigue, and exhaustion. Be cautious when driving or operating machinery until you know how the medicine affects you. However, special tests conducted with healthy volunteers did not show an effect on attention, reaction, or driving ability after taking levocetirizine at the recommended dose.

Lirra contains lactose

The tablets contain lactose. If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

3. How to take Lirra

Always take this medicine exactly as described in this package leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
The recommended dose for adults and children from 6 years of age is 1 tablet per day.

Dosing in special patient groups:

Kidney and liver impairment
For patients with kidney impairment, the dose may need to be reduced depending on the severity of the kidney disease, and for children, the dose should also be adjusted according to body weight; the dose will be determined by the doctor.
For patients with severe kidney impairment requiring dialysis, Lirra must not be taken.
Patients with liver impairment only should take the usual recommended dose.
For patients with both liver and kidney impairment, the dose may need to be reduced depending on the severity of the kidney disease, and for children, the dose should also be adjusted according to body weight; the dose will be determined by the doctor.
Elderly patients (65 years and over)
No dose adjustment is necessary for elderly patients with normal kidney function.

Use in children

Lirra is not recommended for children under 6 years of age.

How and when to take Lirra

This medicine is for oral use only.
The tablets should be swallowed whole with water. Lirra can be taken with or without food.

How long to take Lirra

The duration of treatment depends on the type, duration, and severity of the disease and is determined by the doctor.

Overdose of Lirra

In adults, if a higher dose than recommended is taken, drowsiness may occur. In children, initial excitement and restlessness, especially motor restlessness, may occur, followed by drowsiness.
If you think you have taken a higher dose of Lirra than recommended, consult your doctor immediately, who will decide what actions to take.

Missed dose of Lirra

If you miss a dose of Lirra or take a lower dose than recommended by your doctor, do not take a double dose to make up for the missed dose. Instead, take the next dose at the usual time.

Stopping Lirra treatment

Stopping treatment with Lirra should not cause any harm. However, in rare cases, itching (intense itching) may occur after stopping Lirra treatment, even if these symptoms did not occur before starting treatment. These symptoms may resolve on their own. In some cases, these symptoms may be intense and may require restarting treatment. These symptoms should resolve after restarting treatment.
If you have any further questions about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Lirra can cause side effects, although not everybody gets them.
Common side effects (may affect up to 1 in 10 people)

• dry mouth
• headache
• fatigue
• drowsiness or sedation

Uncommon side effects (may affect up to 1 in 100 people)

• feeling of exhaustion
• abdominal pain

Frequency not knownfrequency cannot be estimated from the available data
Other side effects have also been reported, such as palpitations, increased heart rate, seizures, tingling, dizziness, fainting, tremors, taste disturbances (altered taste), feeling of spinning or swaying, vision disturbances, blurred vision, rotational eye movements (uncontrolled circular eye movement), painful or difficult urination, inability to empty the bladder completely, swelling, itching, rash, urticaria (swelling, redness, and itching of the skin), skin eruptions, shortness of breath, weight gain, muscle pain, joint pain, excitement and aggressive behavior, hallucinations, depression, insomnia, recurring suicidal thoughts or interest in suicide, nightmares, hepatitis, abnormal liver function, increased appetite, nausea, and diarrhea.
Itching (intense itching) after stopping Lirra treatment.
If you notice any symptoms of a hypersensitivity reaction, stop taking Lirra and inform your doctor. Symptoms of a hypersensitivity reaction may include: swelling of the mouth, tongue, face, and (or) throat, difficulty breathing or swallowing (tightness in the chest or wheezing), urticaria, sudden drop in blood pressure leading to fainting or shock, which can be life-threatening.

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 Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Lirra

Keep this medicine out of the sight and reach of children.
Do not take Lirra after the expiry date stated on the carton after EXP and on the blister after EXP. The expiry date refers to the last day of that month.
There are no special storage precautions.
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 Lirra contains

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

What Lirra looks like and contents of the pack

The 5 mg film-coated tablets are white, oval, biconvex, with two letters "G" engraved on one side, separated by a score line, and the other side is smooth. The score line on the tablet is only to facilitate breaking and not to divide into equal doses.
The tablets are packaged in Aluminum/Aluminum blisters or PVC/PVDC/Aluminum blisters and a cardboard box.
Available pack sizes
28, 56, 84, and 90 film-coated tablets
Not all pack sizes may be marketed.

Marketing authorization 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 medicine, please contact the local representative of the marketing authorization holder:

Glenmark Pharmaceuticals Sp. z o.o.
ul. Dziekońskiego 3
00-728 Warsaw
Email: [email protected]

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the package leaflet: