Zyx

Package leaflet: Information for the user

Zyx, 5 mg, coated tablets
Levocetirizini dihydrochloridum
Please read carefully all the information in this leaflet before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Zyx is and what it is 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 Zyx is and what it is used for

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

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

2. Important information before using Zyx

When not to use Zyx

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

Warnings and precautions
Before starting to use Zyx, discuss this with your doctor or pharmacist.
If the patient may have difficulty emptying the bladder (in conditions such as spinal cord injury or prostate enlargement), medical advice should be sought.
Zyx 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 Zyx several days before the tests. 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 appropriate dose adjustment.

Elderly patients
If the patient has impaired kidney function, the doctor may decide to reduce the dose of Zyx.

Zyx 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 take.

Zyx with food, drink, and alcohol
No special precautions are required; however, the effect of the medicine may be delayed if taken with food.
It has not been shown that consuming alcohol together with Zyx increases the effect of either substance, but caution is advised when using Zyx and drinking alcohol simultaneously.
In sensitive patients, concomitant use of Zyx with alcohol or other substances affecting brain function may additionally reduce alertness and reaction ability.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
Some patients taking levocetirizine may experience drowsiness, sleepiness, fatigue, or exhaustion. If the patient plans to drive a car, perform potentially dangerous activities, or operate machinery, they should first assess their individual response to the medicine.
Specific tests have not shown impairment of mental performance, disturbances in reaction ability, or reduced ability to drive vehicles in healthy volunteers taking levocetirizine at recommended doses.

Zyx 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 Zyx

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
The usual dose of this medicine for adults and children aged 6 years and older is one tablet per day.

Dosing recommendations for specific patient groups:
Patients with impaired kidney function
A dose reduction may be necessary in patients with impaired kidney function, 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.
Zyx must not be used in patients with severe kidney impairment.

Patients with impaired liver function
The recommended dose of the medicine is usually administered to patients with impaired liver function.

Patients with impaired liver and kidney function
A dose reduction may be necessary in patients with impaired liver and kidney function, depending on the severity of kidney disease. In children, the dose is determined according to body weight. The treating physician will determine the dosing regimen.

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

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

How and when to take Zyx
For oral use only.
Tablets should be swallowed whole with water. Tablets may be taken during or independently of meals.

How long to take Zyx
The duration of treatment depends on the type, duration, and severity of disease symptoms and is determined by the doctor.

Taking more Zyx than recommended
If a patient suspects an overdose of Zyx, they should inform their doctor, who will decide on the necessary actions.
Taking more than the recommended dose of Zyx may cause drowsiness in adults.
In children, initial symptoms may include agitation and restlessness, especially motor restlessness, followed by drowsiness.

Missed dose of Zyx
Do not take a double dose to make up for a missed dose.
If a dose is missed or a lower-than-recommended dose is taken, wait until the next scheduled dose. Continue treatment according to the doctor's dosing instructions.

Stopping Zyx treatment
Stopping treatment with Zyx earlier than expected should not cause harmful effects; that is, disease symptoms will gradually reappear, and their severity should not exceed that observed before starting Zyx treatment.
However, in rare cases, itching (intense pruritus) may occur after discontinuation of Zyx, even if these symptoms were not present before starting treatment. These symptoms may resolve spontaneously. In some cases, symptoms may be severe and restarting treatment may be necessary. 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.

Common (affects less than 1 in 10 patients):

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

Uncommon (affects less than 1 in 100 patients):

• exhaustion,
• abdominal pain.

Frequency not known (cannot be estimated from available data):
palpitations, increased heart rate, convulsions, tingling, dizziness, fainting,
tremor, taste disturbances (altered sense of taste), sensation of spinning or swaying,
visual disturbances, blurred vision, nystagmus (uncontrolled circular eye movements),
painful or difficult urination, inability to completely empty the bladder, swelling, itching (pruritus),
rash, urticaria (skin swelling, redness, and itching), skin eruptions, shortness of breath, weight gain,
muscle pain, joint pain, aggressive behaviour and agitation, hallucinations, depression, insomnia,
recurrent suicidal thoughts or interest in suicide, nightmares, hepatitis, liver function abnormalities,
nausea, vomiting, increased appetite, diarrhoea.
Itching (intense pruritus) after discontinuation of the medicine.

Upon occurrence of first symptoms of hypersensitivity reactions, treatment with Zyx must be discontinued immediately and the prescribing physician should be contacted without delay. Hypersensitivity symptoms 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 result in death.

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 of Adverse Drug Reactions, 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 enables better assessment of the medicine's safety profile and helps to provide more information on the safe use of the medicine.

5. How to store the medicine Zyx

Keep the medicine out of the sight and reach of children.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the blister and on the carton.
The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Zyx contains

• The active substance is levocetirizine dihydrochloride. Each coated tablet contains 5 mg of levocetirizine dihydrochloride.
• 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 coated tablet.
The medicine is packed in aluminium/aluminium blisters or perforated aluminium/aluminium blisters or PVC/PVDC/aluminium blisters.
Pack contents:
7, 10, 14, 20, 28, 30, 40, 50, 56, 60, 84 or 100 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
BIOFARM Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
tel. +48 61 66 51 500

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