Zix

Package Leaflet: Information for the User

Zyx, 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 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 inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Zyx and what is it used for

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

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

2. Important information before taking Zyx

When not to take Zyx

• if you are allergic to levocetirizine dihydrochloride, cetirizine, hydroxyzine, or any other substance with a similar chemical structure (piperazine derivatives), or any of the other ingredients of this medicine (listed in section 6);
• if you have severe kidney impairment (severe renal insufficiency with creatinine clearance less than 10 ml/min).

Warnings and precautions

Before taking Zyx, discuss it with your doctor or pharmacist.
If you may have difficulty emptying your bladder (in conditions such as spinal cord injury or prostate enlargement), consult your doctor.
Zyx may exacerbate seizure attacks, so consult your doctor if you have epilepsy or a risk of seizures.
If you are scheduled to undergo allergy testing, ask your doctor if you should stop taking Zyx a few days before the test. Zyx may affect the results of allergy tests.
Children
Zyx is not recommended for children under 6 years of age, as the available formulation (tablets) does not allow for appropriate dose adjustment.
Elderly patients
If you have kidney impairment, your doctor may decide to reduce the dose of Zyx.

Zyx and other medicines

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

Zyx with food, drink, and alcohol

No special precautions are required, but the action of the medicine may be delayed if taken with food.
It has not been shown that consuming alcohol and taking Zyx increases the effect of either substance, but caution is advised when taking Zyx and drinking alcohol at the same time.
In sensitive patients, taking Zyx with alcohol or other substances that affect brain function may cause additional decreased alertness and reaction ability.

Pregnancy and breastfeeding

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

Driving and using machines

Some patients taking levocetirizine may experience drowsiness, fatigue, and decreased reaction ability. If you plan to drive a vehicle, perform potentially hazardous activities, or operate machinery, you should first determine your reaction to the medicine.
Special tests have not shown impairment of mental performance, reaction ability, or driving ability in healthy volunteers taking levocetirizine at recommended doses.

Zyx contains lactose

If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking this medicine.

3. How to take Zyx

This medicine should always be taken exactly as advised by your doctor. If you are unsure, consult your doctor or pharmacist.
The usual dose of Zyx for adults and children over 6 years is onetabletper day.

Dosing recommendations for special patient groups:

Patient with kidney impairment
In patients with kidney impairment, a dose reduction may be necessary, depending on the severity of the kidney disease; in children, the dose should also be adjusted according to body weight; the dose of Zyx will be determined by your doctor.
Patient with severe kidney impairment should not take Zyx.
Patient with liver impairment
In patients with liver impairment, the usual recommended dose of Zyx should be taken.
Patient with liver and kidney impairment
In patients with liver and kidney impairment, a dose reduction may be necessary, depending on the severity of the kidney disease. In children, the dose is determined according to body weight. The dosing will be determined by your doctor.

Use in children

Zyx is not recommended for children under 6 years of age.

How and when to take Zyx?

Zyx is for oral use only.
Tablets should be swallowed whole with water. Tablets can be taken with or without food.

How long to take Zyx?

The duration of treatment depends on the type, duration, and severity of the disease symptoms and is determined by your doctor.

Taking more than the recommended dose of Zyx

If you think you have taken more than the recommended dose of Zyx, inform your doctor, who will decide what actions should be taken.
Taking more than the recommended dose of Zyx may cause drowsiness in adults.
In children, it may initially cause agitation and restlessness, especially motor restlessness, followed by drowsiness.

Missing a dose of Zyx

Do not take a double dose to make up for a forgotten dose.
If you miss a dose or take a lower dose than recommended by your doctor, wait until the next dose is due. Continue treatment, following the recommended dosing schedule.

Stopping treatment with Zyx

Stopping treatment with Zyx earlier than planned should not cause any harmful effects, i.e., the disease symptoms will reappear gradually, and their severity should not be greater than before starting treatment with Zyx.
However, in rare cases, itching (intense itching) may occur after stopping treatment with Zyx, even if these symptoms did not occur 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 the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Zyx can cause side effects, although not everybody gets them.
Common(occurring in less than 1 in 10 patients):

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

Uncommon(occurring in less than 1 in 100 patients):

• exhaustion,
• abdominal pain.

Frequency not known(cannot be estimated from the available data):
palpitations, increased heart rate, seizures, tingling, dizziness, fainting, tremors, taste disturbances (altered taste perception), feeling of spinning or swaying, vision disturbances, blurred vision, rotational eye movements (uncontrolled circular eye movement), painful or difficult urination, inability to fully empty the bladder, edema, itching (pruritus), rash, urticaria (hives, redness, and itching of the skin), skin eruptions, dyspnea, weight gain, muscle pain, joint pain, aggressive behavior and agitation, hallucinations, depression, insomnia, recurrent suicidal thoughts or interest in suicide, nightmares, hepatitis, liver function disorders, nausea, vomiting, increased appetite, diarrhea.
Itching (intense itching) after stopping Zyx.
After the first symptoms of a hypersensitivity reaction appear, stop taking Zyx and contact your doctor immediately. Hypersensitivity symptoms may 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 any not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products, 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 medicine.

5. How to store Zyx

Keep this medicine out of the sight and reach of children.
Store in the original package to protect from light.
Do not use this medicine after the expiry date stated on the blister and carton. The expiry date refers to the last day of that month.
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 Zyx contains

• The active substance is levocetirizine dihydrochloride. Each film-coated tablet contains 5 mg of levocetirizine dihydrochloride.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, hypromellose, titanium dioxide (E171), and macrogol 400.

What Zyx looks like and contents of the pack

Zyx is a white, round, biconvex film-coated tablet.
Zyx is packaged in Aluminum/Aluminum blisters or perforated Aluminum/Aluminum blisters or PVC/PVDC/Aluminum blisters.
The pack contains:
7, 10, 14, 20, 28, 30, 40, 50, 56, 60, 84, or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

BIOFARM Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
tel. +48 61 66 51 500

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Poland:
Zyx

Date of last revision of the leaflet: 12.02.2024