Lecix

Package Leaflet: Information for the User

LECIX, 5 mg, film-coated tablets

Levocetirizine dihydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist.

Table of Contents of the Package Leaflet

• 1. What is LECIX and what is it 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 is LECIX and what is it used for

The active substance of LECIX is levocetirizine dihydrochloride.
LECIX is an antiallergic medicine.
It is used to treat the symptoms of:

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

2. Important information before taking LECIX

When not to take LECIX:

• if you are allergic to levocetirizine dihydrochloride or other antihistamines or any of the other ingredients of this medicine (listed in section 6).
• if you have severe kidney problems (severe renal impairment with creatinine clearance less than 10 mL/min).

Warnings and precautions

Before taking LECIX, tell your doctor or pharmacist.
If you have difficulty emptying your bladder (due to conditions such as spinal cord injury or prostate enlargement), consult your doctor.

Children

LECIX is not recommendedfor children under 6 years of age, as it is not possible to adjust the dose using film-coated tablets.

Other medicines and LECIX

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, and about any medicines you plan to take.

LECIX with food, drink, and alcohol

Caution is advised when taking LECIX with alcohol.
In sensitive patients, concomitant use of cetirizine or levocetirizine and alcohol or other central nervous system depressants may have an additive effect on the central nervous system, although the racemic cetirizine did not show potentiation of alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Some patients taking levocetirizine may experience somnolence, fatigue, and tiredness.
If you plan to drive, perform potentially hazardous activities, or operate machinery, you should know how you react to the medicine. However, special studies conducted with healthy volunteers after taking levocetirizine at the recommended dose did not show an effect on attention, reaction, or driving ability.
LECIX contains lactose.If you have previously been diagnosed with an intolerance to some sugars, you should consult your doctor before taking the medicine.

3. How to take LECIX

Always take this medicine exactly as your doctor has told you.
If you are not sure, ask your doctor or pharmacist.
The recommended dose for adults and children over 6 years is 1 tablet per day.

Special dosage recommendations for specific patient groups

In patients with renal impairment, the dose of LECIX may be reduced depending on the severity of the kidney disease, and in children, the dose will be adjusted according to body weight. The dose will be determined by your doctor.
In patients with severe renal impairment, do not takeLECIX.
Patient with only hepatic impairment should take the usual recommended dose.
In patients with both hepatic and renal impairment, a lower dose may be necessary depending on the severity of the kidney disease. In children, the dose will be determined by your doctor based on body weight.

Children

LECIX is not recommendedfor children under 6 years of age.

Elderly patients

No dose adjustment is needed in elderly patients, provided that their renal function is normal.

How and when to take LECIX

Swallow the tablets whole with water. The medicine can be taken with or without food.

Overdose of LECIX

In case of significant overdose in adults, somnolence may occur. In children, initial excitement and restlessness, especially motor, may occur, followed by somnolence.
If you suspect that you have taken more than the recommended dose of LECIX, consult your doctor, who will decide what actions should be taken.

Missed dose of LECIX

If you miss a dose of LECIX or take a lower dose than recommended by your doctor, do not take a double dose to make up for the missed dose. Wait until it is time for your next dose and take the recommended dose.

Stopping treatment with LECIX

Stopping treatment with LECIX should not cause any harmful effects. The symptoms of the disease may return, but their severity will not be greater than before the start of treatment.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, LECIX can cause side effects, although not everybody gets them.

Stop taking LECIX and tell your doctor immediately if you experience any of the following symptoms of an allergic reaction

• swelling of the face, lips, tongue, and/or throat,
• difficulty breathing or swallowing (tightness in the chest or wheezing),
• urticaria,
• a sudden fall in blood pressure, which can lead to collapse or shock, which can be life-threatening.

The following side effects have also been reported:
Common (may affect up to 1 in 10 people)

• dry mouth, headache, fatigue, and somnolence and/or drowsiness.

Uncommon (may affect up to 1 in 100 people)

• feeling of exhaustion and abdominal pain.

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

• palpitations (irregular heartbeat), rapid heartbeat,
• seizures, feeling of tingling and numbness, dizziness, fainting, tremors,
• taste disturbances (taste disorders), feeling of spinning or movement,
• vision disturbances, blurred vision,
• rotatory movements of the eyeballs (uncontrolled circular movement of the eyeballs),
• painful or difficult urination, inability to completely empty the bladder,
• edema, itching (pruritus), rash, urticaria (swelling, redness, and itching of the skin), skin eruptions, dyspnea,
• weight gain,
• muscle pain,
• aggressive or excited behavior, hallucinations, depression, insomnia, recurrent thoughts or fascination with suicide,
• hepatitis, liver function disorders, vomiting, increased appetite, and nausea.

If you experience any side effects, please tell your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 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 LECIX

Keep this medicine out of the 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 that month.
There are no special precautions for storage.
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 film-coated tablet contains 5 mg of levocetirizine dihydrochloride.
• The other ingredients are: Tablet core: microcrystalline cellulose, lactose monohydrate, silica colloidal anhydrous, magnesium stearate, Film coating: hypromellose type 2910, titanium dioxide (E 171), talc, and macrogol 400 (PEG-400).

What LECIX looks like and contents of the pack

White or almost white, oval, film-coated tablets, approximately 8 mm x 4.5 mm in size, with the number ‘5’ embossed on one side and a smooth surface on the other.
LECIX, 5 mg, film-coated tablets, are available in blisters of PVDC/PVC/Aluminum, packaged in cardboard boxes.
Pack sizes: 28, 30, 60, or 90 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Ranbaxy (Poland) Sp. z o.o.
ul. Idzikowskiego 16
00-710 Warsaw
Phone: 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 authorized 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 Levocetirizină Terapia 5 mg comprimate filmate

Date of last revision of the package leaflet: