Levalergedd

Package Leaflet: Information for the Patient

Levalergedd, 5 mg, Film-Coated Tablets

Levocetirizine Dihydrochloride
For adults and children from 6 years of age

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains

important information for the patient.
This medication should always be taken exactly as described in this package leaflet or as directed by your doctor, pharmacist, or nurse.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. 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 Levalergedd and what is it used for
• 2. Important information before taking Levalergedd
• 3. How to take Levalergedd
• 4. Possible side effects
• 5. How to store Levalergedd
• 6. Contents of the pack and other information

1.

What is Levalergedd and what is it used for

The active substance of Levalergedd is levocetirizine dihydrochloride. Levalergedd is an antiallergic medication.
Levalergedd is used to treat allergic symptoms associated with:

• allergic rhinitis (including chronic rhinitis)
• urticaria.

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

2. Important information before taking Levalergedd

When not to take Levalergedd

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

Warnings and precautions

Before taking Levalergedd, you should discuss it with your doctor or pharmacist.
If you have mild or moderate kidney impairment, you should contact your doctor before taking Levalergedd. Your doctor may adjust the dose of the medication depending on the severity of your kidney disease.
If you have difficulty emptying your bladder completely (e.g., due to spinal cord injury or prostate enlargement), you should consult your doctor.
If you have epilepsy or are prone to seizures, you should consult your doctor, as taking Levalergedd may worsen seizures.
If you are scheduled to undergo allergy testing, you should ask your doctor if you should stop taking Levalergedd a few days before the test. Levalergedd may affect the results of allergy tests.

Children

Levalergedd is not recommended for children under 6 years of age, as the film-coated tablets do not allow for appropriate dose adjustment.

Levalergedd and other medications

You should tell your doctor or pharmacistabout all medications you are currently taking or have recently taken, as well as any medications you plan to take.

Levalergedd with food, drink, and alcohol

You should be cautious when taking Levalergedd with alcohol or other substances that affect brain function. In sensitive patients, taking Levalergedd with alcohol or other substances that affect brain function may cause additional drowsiness and impaired reaction time.
Levalergedd can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medication.

Driving and operating machinery

Some patients taking Levalergedd may experience drowsiness, fatigue, and exhaustion.
You should be cautious when driving or operating machinery until you know how the medication affects you. However, special tests conducted with healthy volunteers after taking levocetirizine at the recommended dose did not show any effect on attention, reaction time, or driving ability.

Levalergedd contains lactose

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

3. How to take Levalergedd

This medication 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.
The recommended dose of Levalergedd for adults and children 6 years of age and older is 1 tablet per day.
Dosing in special patient groups:
Kidney and liver impairment
If you have mild or moderate kidney impairment, you should contact your doctor before taking Levalergedd. Your doctor may adjust the dose of the medication depending on the severity of your kidney disease.
Patients with severe kidney disease requiring dialysis should not take Levalergedd.
Patients with liver impairment only should take the usual recommended dose.
For patients with both liver and kidney impairment, a lower dose may be necessary depending on the severity of the kidney disease.
For children, the dose should also be adjusted according to body weight. The dose will be determined by your doctor.
Elderly patients (65 years and older)
For elderly patients, there is no need to adjust the dose if kidney function is normal.
Use in children
Levalergedd is not recommended for children under 6 years of age.
How and when to take Levalergedd?
The medication is intended for oral use only.
Levalergedd tablets should be swallowed whole with water. The medication can be taken with or without food.
How long to take Levalergedd?
If after 3 days there is no improvement or you feel worse, you should contact your doctor.
You should not take Levalergedd for more than 10 days without consulting your doctor.

Taking a higher dose of Levalergedd than recommended

If you take a higher dose than recommended, you may experience drowsiness. In children, you may initially experience restlessness and agitation, especially motor agitation, followed by drowsiness.
If you suspect an overdose of Levalergedd, you should contact your doctor, who will decide what actions to take.

Missing a dose of Levalergedd

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

Stopping Levalergedd

Stopping Levalergedd should not cause any harmful effects. However, in rare cases, you may experience itching (intense itching) after stopping Levalergedd, even if you did not experience these symptoms 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 the medication, you should consult your doctor or pharmacist.

4. Possible side effects

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

• dry mouth
• headache
• fatigue
• drowsiness

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

• exhaustion
• abdominal pain

Frequency not known(frequency cannot be estimated from the available data):

• palpitations
• rapid heartbeat
• seizures
• tingling
• dizziness
• fainting
• tremors
• taste disturbances
• feeling of spinning or swaying
• vision disturbances
• blurred vision
• rotatory eye movements (uncontrolled circular eye movement)
• painful or difficult urination
• inability to empty the bladder completely
• edema
• itching
• rash
• urticaria (hives, redness, and itching of the skin)
• skin eruptions
• shortness of breath
• weight gain
• muscle pain
• joint pain
• agitation or aggressive behavior
• hallucinations
• depression
• insomnia
• recurring suicidal thoughts or interest in suicide
• nightmares
• hepatitis
• liver function disorders
• vomiting
• increased appetite
• nausea
• diarrhea
• itching (intense itching) after stopping Levalergedd

If you experience the first symptoms of a hypersensitivity reaction, you should stop taking Levalergedd and consult your doctor immediately. Symptoms of a hypersensitivity reaction include: swelling of the mouth, tongue, face, and (or) throat, difficulty breathing or swallowing (chest tightness 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 leaflet, you should tell 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:
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 medication.

5. How to store Levalergedd

The medication should be stored out of sight and reach of children.
Do not use this medication after the expiration date stated on the blister pack and carton after "EXP". The first two digits indicate the month, and the last four digits indicate the year. The expiration date is the last day of the specified month.
Store in the original packaging to protect from moisture.
Medications should not be disposed of in wastewater or household waste. You should ask your pharmacist how to dispose of unused medications. This will help protect the environment.

6. Contents of the pack and other information

What Levalergedd contains

• The active substance of Levalergedd is levocetirizine. Levocetirizine is present in the form of levocetirizine dihydrochloride (5 mg), which corresponds to 4.2 mg of levocetirizine.
• The other ingredients of the medication are: microcrystalline cellulose, lactose monohydrate, magnesium stearate (tablet core) and hypromellose, titanium dioxide (E 171), and macrogol 400 (coating).

What Levalergedd looks like and contents of the pack

White or almost white, oval, biconvex film-coated tablets with "L9CZ" engraved on one side and "5" on the other side.
The pack contains 7 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
tel.: 22 32 16 240

Manufacturer:

Synthon BV
Microweg 22
6545 CM Nijmegen
Netherlands
Synthon Hispania S.L. Castello, 1
Poligono Las Salinas
08830 Sant Boi de Llobregat
Spain
Genericon Pharma GmbH
Hafnerstraße 211
8054 Graz
Austria

Date of last revision of the package leaflet: 03.2023