Levalergedd

Package leaflet: Information for the patient

Levalergedd, 5 mg, film-coated tablets
Levocetirizini dihydrochloridum
For adults and children aged 6 years and older
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by a
physician, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your physician, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days or if you feel worse, contact your physician.

Leaflet contents

1. What Levalergedd is and what it is 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 Levalergedd is and what it is used for
The active substance in Levalergedd is levocetirizine dihydrochloride. Levalergedd is an antiallergic medicine.
Levalergedd is used to treat allergic symptoms associated with:

• allergic rhinitis (including perennial rhinitis)
• urticaria.

If there is no improvement after 3 days or if you feel worse, consult your physician.

2. Important information before taking Levalergedd

When not to take Levalergedd

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

Warnings and precautions
Before starting treatment with Levalergedd, discuss it with your physician or pharmacist.
If you have mild or moderate renal impairment, consult your physician before taking Levalergedd. Your physician may adjust the dose depending on the severity of kidney disease.
If you have difficulty completely emptying your bladder (e.g. due to spinal cord injury or benign prostatic hyperplasia), consult your physician.
If you have epilepsy or are prone to seizures, consult your physician, as treatment with Levalergedd may increase the risk of seizures.
If you have planned allergy testing, ask your physician whether you should discontinue 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 with other medicines
Tell your physician or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Levalergedd with food, drink and alcohol
Exercise caution when taking Levalergedd together with alcohol or other substances affecting brain function. In sensitive individuals, concomitant administration of Levalergedd with alcohol or other substances affecting brain function may additionally reduce alertness and reaction ability.
Levalergedd may be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a child, consult your physician or pharmacist before using this medicine.
Driving and operating machinery
Some patients taking Levalergedd may experience drowsiness, fatigue, or exhaustion. Exercise caution when driving or operating machinery until you know how you react to the medicine. However, specific tests conducted in healthy volunteers taking levocetirizine at the recommended dose did not show any effect on attention, reaction ability, or driving performance.
Levalergedd contains lactose
The tablets contain lactose. If you have previously been diagnosed with intolerance to certain sugars, you should consult your physician before taking this medicine.

3. How to use Levalergedd

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

The recommended dose of the medicine in adults and children aged 6 years and older is 1 tablet per day.

Dosing in special patient groups:

Renal and hepatic impairment

If the patient has mild or moderate renal impairment, contact a doctor before taking Levalergedd. The doctor may adjust the dose depending on the severity of kidney disease.

Levalergedd must not be used in patients with severe renal disease requiring dialysis.

Patients with hepatic impairment alone should usually receive the standard recommended dose.

In patients with both hepatic and renal impairment, a lower dose may be necessary depending on the severity of renal impairment.

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)

In elderly patients, dose adjustment is not necessary provided renal function is normal.

Use in children

Levalergedd tablets are not recommended for children under 6 years of age.

How and when to take Levalergedd

This medicine is for oral use only.

Levalergedd tablets should be swallowed whole with water. The medicine can be taken with or without food.

How long to take Levalergedd

If there is no improvement after 3 days, or if the patient feels worse, consult a doctor.

Do not use Levalergedd for longer than 10 days without consulting a doctor.

Taking more Levalergedd than recommended

If a higher than recommended dose is taken, drowsiness may occur in adults. In children, initial excitation and restlessness, especially motor restlessness, may occur, followed by drowsiness.

If overdose is suspected, consult a doctor, who will decide what actions should be taken.

If you miss a dose of Levalergedd

If a dose of Levalergedd 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 Levalergedd

Stopping treatment with Levalergedd should not cause harmful effects. However, in rare cases, itching (intense pruritus) may occur after discontinuation of Levalergedd, 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 upon resumption of 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 everybody will experience them.
Common (may occur in fewer than 1 in 10 people):

• dry mouth
• headache
• fatigue
• drowsiness

Uncommon (may occur in fewer than 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
• tremor
• taste disturbances
• sensation of spinning or swaying
• visual disturbances
• blurred vision
• rotatory eye movements (uncontrolled circular movements of the eyeballs)
• 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 or aggressive behaviour
• hallucinations
• depression
• insomnia
• recurring suicidal thoughts or interest in suicide
• nightmares
• hepatitis
• liver function disorders
• vomiting
• increased appetite
• nausea
• diarrhoea
• itching (intense pruritus) after discontinuation of the medicine

If the first symptoms of hypersensitivity reactions occur, treatment with Levalergedd should be stopped immediately and medical advice should be sought. Symptoms of hypersensitivity reactions include: swelling of the oral cavity, tongue, face and (or) throat, breathing or swallowing difficulties (chest tightness or wheezing), urticaria, sudden drop in blood pressure leading to collapse or shock, which may result in 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 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 authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Levalergedd

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton after: "Expiry date (EXP)". The first two digits indicate the month, and the last four digits indicate the year. The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from moisture.
Medicines must 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 Levalergedd contains

• The active substance is levocetirizine. Levocetirizine is present in the form of levocetirizine dihydrochloride (5 mg), corresponding to 4.2 mg of levocetirizine.
• The other ingredients 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 coated tablets, with the imprint
‘L9CZ’ on one side and ‘5’ on the other side.
The pack contains 7 coated tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warszawa
tel.: 22 32 16 240

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