Package leaflet: Information for the patient

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

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse effects, including any possible adverse effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 3 days of treatment, or if your condition worsens, consult your doctor.

Table of contents of the leaflet:

What Levorex is and what it is used for
Important information before taking Levorex
How to take Levorex
Possible side effects
How to store Levorex
Contents of the pack and other information

1. What Levorex is and what it is used for

The active substance in Levorex is levocetirizine dihydrochloride.
Levorex is an antiallergic medicine.
Levorex is used to treat symptoms associated with:

allergic rhinitis (including perennial allergic rhinitis);
urticaria.

Levorex is indicated for use in adults, adolescents and children aged 6 years and older.
Do not use this medicine for longer than 10 days without consulting a doctor. If there is no improvement or if your condition worsens after 3 days of treatment, consult your doctor.

2. Important information before using Levorex

When not to use Levorex

if the patient is allergic to levocetirizine dihydrochloride, cetirizine, hydroxyzine, active substances with a chemical structure similar to piperazine, 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 to use Levorex, discuss it with your doctor or pharmacist.
If the patient has difficulty emptying the bladder (in conditions such as spinal cord injury or benign prostatic hyperplasia), consult a doctor.
Levorex 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 has planned allergy testing, ask the doctor whether the patient should stop taking Levorex a few days before the tests.
Levorex may affect the results of allergy tests.

Children
It is not recommended to administer Levorex coated tablets to children under 6 years of age, as appropriate dose adjustment is not possible with this formulation.

Levorex and other medicines
Tell your 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.

Taking Levorex with food, drink and alcohol
Exercise caution when taking Levorex together with alcohol or other substances affecting brain function.
In sensitive patients, concomitant use of Levorex with alcohol or other substances affecting brain function may additionally reduce alertness and reaction ability.
Levorex 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 child, she should consult her doctor or pharmacist before using this medicine.

Driving and operating machinery
Some patients treated with Levorex may experience drowsiness, somnolence, fatigue, or exhaustion. Exercise caution when driving or operating machinery until the patient's response to the medicine is known. However, specific tests conducted in healthy volunteers receiving levocetirizine at the recommended dose did not show any effect of the medicine on attention, reaction ability, or driving skills.

Levorex contains lactose
The tablets contain lactose; therefore, if the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before using this medicine.

3. How to take Levorex

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose for adults, adolescents, 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 kidney 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.
Levorex must not be used in patients with severe kidney disease requiring dialysis.
Patients with impaired liver function alone should usually receive the standard recommended dose.
In patients with both impaired liver function and impaired kidney function, a lower dose may be required 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.

Elderly patients (65 years and older)
Dose adjustment is not necessary in elderly patients provided kidney function is normal.

Use in children
Levorex tablets are not recommended for children under 6 years of age.

How and when to take Levorex
For oral use only.
Levorex tablets should be swallowed whole with water. The medicine may be taken during or between meals.

How long to take Levorex
The duration of treatment depends on the type, duration, and severity of the disease symptoms and should be determined by the doctor. Do not use this medicine for longer than 10 days without consulting a doctor. If there is no improvement after 3 days of treatment, or if symptoms worsen, the patient should consult a doctor.

Taking more Levorex than recommended
In adults, taking more than the recommended dose of Levorex may cause drowsiness. In children, initial symptoms may include restlessness and agitation, especially motor agitation, followed by drowsiness.
If an overdose of Levorex is suspected, consult a doctor immediately, who will decide on the necessary actions.

If you miss a dose of Levorex
If a dose of Levorex is missed or a lower than recommended dose has been taken, do not take a double dose to make up for the missed dose. Instead, take the next dose at the usual time.

Stopping Levorex
Stopping treatment with Levorex should not cause harmful effects. However, in rare cases, itching (intense pruritus) may occur after discontinuation, 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. These 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 any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
If the first symptoms of hypersensitivity reactions (frequency not known) occur, treatment with Levorex should be discontinued and a 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 collapse or shock, which may lead to death.

Common: may occur in less than 1 in 10 patients
Dry mouth, headache, fatigue, drowsiness or somnolence

Uncommon: may occur in less than 1 in 100 patients
Feeling of exhaustion, abdominal pain

Frequency not known: frequency cannot be determined from 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, oedema, itching, rash, urticaria (skin swelling, redness and itching), skin eruptions, dyspnoea, weight gain, muscle pain, joint pain, agitation and aggressive behaviour, hallucinations, depression, insomnia, recurrent suicidal thoughts or interest in suicide, nightmares, hepatitis, abnormal liver function, vomiting, increased appetite, nausea and diarrhoea.

Itching (intense pruritus) after discontinuation of the medicine.

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

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the stated month.
Store below 25°C.
Store in the original packaging.
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 Levorex contains

The active substance is levocetirizine dihydrochloride.

Each coated tablet contains 5 mg of levocetirizine dihydrochloride.

Other ingredients are: microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, magnesium stearate, hypromellose (E 464), titanium dioxide (E 171), talc, macrogol.

What Levorex looks like and contents of the pack
Levorex is a white or almost white, oval, biconvex coated tablet, with an embossed "5" on one side and smooth on the other side.
The pack contains 4, 8 or 10 coated tablets.
Marketing Authorisation Holder
MEDICOFARMA S.A.
Sokołowska Street 9, loc. U19
01-142 Warsaw
Phone number: +48 22 654 77 70
Importer
Medicofarma S.A.
Tarnobrzeska Street 13
26-613 Radom