Lecix

Package leaflet: Information for the user

LECIX, 5 mg, film-coated tablets
Levocetirizini dihydrochloridum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• Consult your doctor or pharmacist if you have any doubts.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet

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

1. What LECIX is and what it is used for

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

• allergic rhinitis (including perennial allergic rhinitis);
• urticaria.

2. Important information before using LECIX

When not to use LECIX:

• if the patient is allergic to levocetirizine dihydrochloride, antihistamines, or any of the other ingredients of this medicine (listed in section 6).
• if the patient has severe renal function impairment (severe renal failure with creatinine clearance less than 10 mL/min).

Warnings and precautions
Before starting treatment with LECIX, consult a doctor or pharmacist.
If the patient has difficulty emptying the bladder (due to conditions such as spinal cord injury or benign prostatic hyperplasia), medical advice should be sought.
Children
The use of LECIX is not recommended in children under 6 years of age, as appropriate dose adjustment using coated tablets is not possible.
Other medicines and LECIX
Inform your doctor or pharmacist about all medicines currently used, recently used, or which you plan to use.
LECIX with food, drink and alcohol
Caution is advised when taking LECIX together with alcohol.
In sensitive patients, concomitant use of cetirizine or levocetirizine and alcohol or other centrally acting medicines may affect the central nervous system, although the cetirizine racemate used in the medicine did not show potentiation of alcohol effects.
Pregnancy, breastfeeding and fertility
During pregnancy, breastfeeding, if pregnancy is suspected, or when planning pregnancy, consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
In some patients treated with levocetirizine, somnolence, drowsiness, fatigue, and exhaustion may occur. If the patient intends to drive, perform potentially hazardous activities, or operate machinery, the individual response to the medicine should be assessed first. However, specific tests conducted in healthy volunteers after administration of levocetirizine at the recommended dose did not show any effect of the medicine on attention, reaction ability, or driving capacity.
LECIX contains lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use LECIX

This medicine should always be taken as directed by the physician. If in doubt, consult a
doctor or pharmacist.
The recommended dose for adults and children aged 6 years and older is 1 tablet per day.
Special dosage recommendations for specific patient groups
In patients with renal impairment, the dose of the medicine may be reduced depending on the severity
of kidney disease, and in children the dose will be adjusted according to body weight. The dose will be determined by
the doctor.
LECIX must not be used in patients with severe renal impairment.
Patients with hepatic impairment only should usually receive the recommended dose of the medicine.
In patients with both hepatic and renal impairment, a lower dose may be necessary depending on the severity of
kidney disease. In children, the dose will be determined by the doctor based on body weight.
Children
The use of LECIX is not recommended in children under 6 years of age.
Elderly patients
There is no need to adjust the dose in elderly patients, provided their renal function is normal.
How and when to take LECIX
Tablets should be swallowed whole with water. The medicine can be taken with or without food.
Overdose of LECIX
In case of significant overdose in adults, drowsiness may occur. In children, initial excitation and restlessness,
especially motor restlessness, may occur, followed by drowsiness.
If an overdose of LECIX is suspected, consult a doctor, who will decide what actions should be taken.
Missed dose of LECIX
If a dose of LECIX is missed or a lower than recommended dose has been taken, do not take a double dose to
make up for the missed dose. Wait until the next scheduled dose and take the dose recommended by the doctor.
Discontinuation of LECIX
Discontinuation of LECIX should not cause harmful effects. Disease symptoms may return, but their severity will not be greater than before treatment initiation.
If you have any further questions concerning 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 everyone will experience them.
You must immediately stop taking LECIX and seek immediate medical attention
if you notice any of the following symptoms of hypersensitivity reactions

• 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 result in death.

The following adverse reactions have also been reported:
Common (occur in no more than 1 in 10 patients)

• dry mouth, headache, fatigue, drowsiness and (or) lethargy.

Uncommon (occur in no more than 1 in 100 patients)

• feeling of exhaustion and abdominal pain.

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

• palpitations (irregular heartbeat), rapid heartbeat,
• seizures, tingling and numbness, dizziness, fainting, tremor,
• taste disturbances (altered sense of taste), sensation of spinning or movement,
• visual disturbances, blurred vision,
• rotatory eye movements (uncontrolled circular eye movements),
• painful or difficult urination, inability to completely empty the bladder,
• swelling, itching (pruritus), rash, urticaria (swelling, redness, and itching of the skin), skin eruptions, shortness of breath,
• weight gain,
• muscle pain,
• aggressive or agitated behavior, hallucinations, depression, insomnia, recurring thoughts or fascination with suicide,
• hepatitis, liver function abnormalities, vomiting, increased appetite, and nausea.

If any adverse reactions occur, consult your doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this
leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Reactions of Medicinal Products
of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 4921 301
Fax: +48 22 4921 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store LECIX

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP".
The expiry date refers to the last day of the stated month.
No special storage precautions are required.
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 LECIX contains

• The active substance is levocetirizine dihydrochloride. Each coated tablet contains 5 mg of levocetirizine dihydrochloride.
• Other ingredients are:
  Tablet core: microcrystalline cellulose, monohydrate lactose, colloidal anhydrous silica, magnesium stearate.
  Coating: hypromellose type 2910, titanium dioxide (E 171), talc, macrogol 400 (PEG - 400).

What LECIX looks like and contents of the pack
White or almost white, oval coated tablets, approximately 8 mm x 4.5 mm, with the number '5' embossed on one side and smooth on the other.
LECIX 5 mg, coated tablets, is available in blisters made of PVDC/PVC/Aluminium, packed in cardboard boxes.
Pack sizes: 28, 30, 60 or 90 coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Ranbaxy (Poland) Sp. z o.o.
Idzikowskiego Street 16
00-710 Warsaw
Tel.: 22 642 07 75
Manufacturer/Importer
PharmaS d.o.o.
Industrijska cesta 5
44317 Potok, Popovača
Croatia
Terapia S.A.
124 Fabricii Street
400640 Cluj-Napoca
Romania
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Poland: LECIX
Portugal: Levocetirizina Ipca 5 mg Comprimidos revestidos por película
Romania: Levocetirizina Terapia 5 mg comprimate filmate