Lirra Gem

Package Leaflet: Information for the User

Lirra Gem, 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 the patient.

This medicine should always be taken exactly as described in this package leaflet or as directed by your doctor or pharmacist.

• You should keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, please inform 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 Package Leaflet

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

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

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

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

If after 3 days there is no improvement or you feel worse, you should contact your doctor.

2. Important information before taking Lirra Gem

When not to take Lirra Gem:

• if you are allergicto 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 Gem, you should discuss it with your doctor or pharmacist.
If you have difficulty emptying your bladder (in conditions such as spinal cord injury or prostate enlargement), you should consult your doctor.
Lirra Gem may increase the frequency of seizures, so you should consult your doctor if you have epilepsy or are at risk of seizures.
If you are scheduled to undergo allergy testing, you should ask your doctor if you should stop taking Lirra Gem a few days before the test. Lirra Gem may affect the results of allergy tests.

Children

Lirra Gem 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 form of the medicine.

Lirra Gem and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take, including those available without a prescription.

Lirra Gem with food, drink, and alcohol

You should be cautious when taking Lirra Gem with alcohol or other substances that affect brain function.
In susceptible patients, taking Lirra Gem with alcohol or other substances that affect brain function may cause additional decreased alertness and reaction ability.
Lirra Gem can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Some patients taking Lirra Gem may experience drowsiness, lethargy, fatigue, and exhaustion. You should be cautious when driving or operating machinery until you know how you react to the medicine. However, special tests conducted with healthy individuals after taking levocetirizine at the recommended dose did not show an effect on attention, reaction, or driving ability.

Lirra Gem contains lactose monohydrate

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

3. How to take Lirra Gem

This medicine should always be taken exactly as described in this package leaflet or as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
Do not take the medicine for more than 10 days without consulting your doctor.
The recommended dose of Lirra Gem for adults and children from 6 years of age is one tablet per day.

Dosing in special patient groups:

Renal and hepatic impairment
In patients with renal impairment, it may be necessary to reduce the dose of the medicine depending on the severity of the kidney disease. In children, the dose should also be adjusted according to body weight, and the dose of the medicine will be determined by the doctor.
In patients with severe kidney disease requiring dialysis, do not takeLirra Gem.
Patients with only hepatic impairment should take the usual recommended dose of the medicine.
In patients with both hepatic and renal impairment, it may be necessary to use a smaller dose depending on the severity of the kidney disease, and in children, the dose should also be adjusted according to body weight, and the dose of the medicine will be determined by the doctor.
Elderly patients (65 years and older)
In elderly patients, there is no need to adjust the dose if kidney function is normal.

Use in children

In children from 6 years of age, the dose of the medicine should also be adjusted according to body weight, and the dose of the medicine will be determined by the doctor. Lirra Gem is not recommended for children under 6 years of age (see section 2 Warnings and precautions). For children under 6 years of age, another form of levocetirizine is available. You should consult your doctor or pharmacist.

How and when to take Lirra Gem

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

How long to take Lirra Gem

Do not take Lirra Gem for more than 10 days without consulting your doctor.

Taking a higher dose of Lirra Gem than recommended

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

Missing a dose of Lirra Gem

If you miss a dose of Lirra Gem or take a lower dose than recommended, do not take a double dose to make up for the missed dose.
In this case, you should take the next dose at the usual time.

Stopping treatment with Lirra Gem

Stopping treatment with Lirra Gem should not cause any harmful effects. However, in rare cases, itching (intense itching) may occur after stopping treatment with Lirra Gem, 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 it may be necessary to resume treatment. These symptoms should resolve after resuming treatment.
If you have any further questions about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Lirra Gem 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/lethargy

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

• feeling of exhaustion
• abdominal pain

Frequency not known: 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 fully empty the bladder, swelling, itching, rash, urticaria (swelling, redness, and itching of the skin), skin eruptions, shortness of breath, weight gain, muscle pain, joint pain, restlessness and aggressive behavior, hallucinations, depression, insomnia, recurrent suicidal thoughts or interest in suicide, nightmares, hepatitis, abnormal liver function, vomiting, increased appetite, nausea, and diarrhea.
Itching (intense itching) after stopping treatment with Lirra Gem.
If you experience any symptoms of an allergic reaction, you should stop taking Lirra Gem and inform your doctor. Symptoms of an allergic 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 fatal.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, you should 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
Jerozolimskie Avenue 181C, 02-222 Warsaw; phone: +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 Lirra Gem

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 after: EXP and on the blister after: EXP. The expiry date refers to the last day of the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Lirra Gem 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, colloidal anhydrous silica, magnesium stearate, hypromellose (E 464), titanium dioxide (E 171), and macrogol
• 400.

What Lirra Gem looks like and contents of the pack

The 5 mg film-coated tablets are white, oval, and biconvex with two letters "G" engraved on one side, separated by a score line, and the other side is smooth.
The tablets are packaged in aluminum/aluminum blisters or PVC/PVDC/aluminum blisters in a carton.
Available pack sizes
7 or 10 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.
Fibichova 143
566 17 Vysoké Mýto
Czech Republic

For further information about this medicine, you should contact your local representative of the marketing authorization holder:

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

Date of last revision of the package leaflet: