Zix Bio

Package Leaflet: Information for the User

ZYX Bio

5 mg, coated tablets

Levocetirizine dihydrochloride

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

This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, consult a doctor.

Table of Contents of the Leaflet

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

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

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

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

2. Important information before taking Zyx Bio

When not to take Zyx Bio:

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

Warnings and precautions

Before taking Zyx Bio, discuss with your doctor:

• if you have kidney disease. A lower dose may be necessary. The dose will be determined by your doctor;
• if you may have difficulty emptying your bladder (e.g., in conditions such as spinal cord injury or prostate enlargement);
• if you have hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption syndrome, as Zyx Bio contains lactose.

Zyx Bio may affect the results of skin allergy tests. If your doctor orders such tests, you should stop taking Zyx Bio 3 days before the tests.

Children and adolescents

Zyx Bio is not recommended for children under 6 years of age, as the available form of the medicine (coated tablets) does not allow for appropriate dose adjustment. It is recommended to use levocetirizine in forms intended for children, e.g., in the form of a solution or oral drops.
Levocetirizine is not recommended for use in infants and children under 2 years of age.

Zyx Bio and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Some other medicines may affect the action of Zyx Bio and vice versa.
These include:

• medicines with a central nervous system depressant effect (medicines that slow down normal brain function) - e.g., sedatives, hypnotics, antidepressants, anxiolytics or some painkillers.

Zyx Bio 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 the medicine increases the effect of either substance, but caution is advised when taking the medicine and drinking alcohol at the same time.

Pregnancy, breastfeeding, and fertility

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 the medicine may experience drowsiness, lethargy, fatigue, and exhaustion.
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 conducted with healthy volunteers after taking levocetirizine at the recommended dose did not show an effect on attention, reaction, or driving ability.
In sensitive patients, concomitant use of the medicine with alcohol or central nervous system depressants may affect reaction speed and attention.
Zyx Bio 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 Bio

This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Do not take the medicine for more than 10 days without consulting a doctor.
If after 3 days there is no improvement or you feel worse, consult a doctor.

Method of administration

Swallow the tablets whole with a liquid (e.g., water). The tablets can be taken with or without food.

Adults and children over 6 years

The usual dose is 1 tablet once a day.

Children under 6 years

Zyx Bio tablets are not recommended for children under 6 years of age.

Patients with kidney disease

Consult your doctor before taking the medicine; a lower dose may be necessary depending on the severity of kidney disease. The dose will be determined by your doctor.

Patients with liver disease

Patients with only liver function disorders should take the usual dose of the medicine.

Patients with kidney and liver disease

Consult your doctor before taking the medicine; a lower dose may be necessary depending on the severity of kidney disease. The dose will be determined by your doctor.
If you feel that the effect of Zyx Bio is too strong or too weak, consult your doctor.

Taking a higher dose of Zyx Bio than recommended

In case of taking a higher dose of the medicine than recommended, consult your doctor immediately.
Your doctor will decide what measures to take.
Taking a higher dose of the medicine than recommended may cause drowsiness in adults; in children, it may initially cause excitement and restlessness, especially motor restlessness, and then drowsiness.

Missing a dose of Zyx Bio

Do not take a double dose to make up for a missed dose.
Take the next dose at the usual time.

Stopping Zyx Bio treatment

Stopping the treatment earlier than recommended should not cause any harmful effects, i.e., the symptoms of the disease will reappear gradually, and their severity should not be greater than before starting the treatment.

4. Possible side effects

Like all medicines, Zyx Bio can cause side effects, although not everybody gets them.
In case of the first symptoms of an allergic reaction (hypersensitivity), stop taking Zyx Bio and consult your doctor or the nearest hospital immediately.
Your doctor will assess the severity of the symptoms and decide whether further action is necessary.
Signs of hypersensitivity may include:

• swelling of the mouth, tongue, face, and (or) throat, difficulty breathing and swallowing with urticaria (angioedema), a sudden drop in blood pressure leading to fainting or shock, which can be fatal. These reactions may occur immediately after the first dose of the medicine or may occur later.

During treatment with levocetirizine, the following side effects have also been observed: Common (in 1 to 10 out of 100 people):

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

Uncommon(in 1 to 10 out of 1,000 people):

• feeling of exhaustion,
• abdominal pain.

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

• hypersensitivity reactions (allergic), including anaphylaxis (severe, sudden allergic reaction).
• palpitations, increased heart rate,
• seizures, tingling, dizziness, fainting, tremors, taste disorders (altered taste perception),
• feeling of spinning or swaying,
• vision disturbances, blurred vision,
• painful or difficult urination, inability to empty the bladder completely,
• edema, itching (pruritus), rash, urticaria (swelling, redness, and itching of the skin), skin eruptions,
• dyspnea (breathing difficulties),
• weight gain,
• abnormal liver function test results, hepatitis,
• muscle pain,
• aggressive behavior or agitation, hallucinations, depression, insomnia, recurrent suicidal thoughts or interest in suicide,
• nausea and vomiting,
• increased appetite,
• rotatory eye movements (uncontrolled circular eye movement).

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Zyx Bio

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 pack and carton. The expiry date refers to the last day of the 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. Package contents and other information

What Zyx Bio contains

• The active substance of Zyx Bio is levocetirizine dihydrochloride. Each coated tablet contains 5 mg of levocetirizine dihydrochloride.
• The other ingredients are: lactose monohydrate, Prosolv SMCC 90 (microcrystalline cellulose with anhydrous colloidal silica), magnesium stearate, hypromellose, titanium dioxide (E 171), and macrogol 400.

What Zyx Bio looks like and contents of the pack

The medicine is in the form of white, round, biconvex coated tablets.
The coated tablets are packaged in aluminum/aluminum blisters or perforated aluminum/aluminum blisters divided into single doses or PVC/PVDC/aluminum foil with a heat-sealable coating on the surface, placed in a cardboard box.
The pack contains: 7 or 10 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
phone: +48 61 66 51 500
e-mail: [email protected]

Date of last revision of the leaflet: