Zyx bio

Package leaflet: Information for the user

ZYX Bio
5 mg, coated tablets
Levocetirizini dihydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or as directed by
a doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse after 3 days, you should contact your doctor.

Contents of the leaflet

1. What ZYX Bio is and what it is 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. Contents of the pack and other information

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

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

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

2. Important information before using Zyx Bio

When not to use Zyx Bio:

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

Warnings and precautions
Before starting treatment with Zyx Bio, discuss with your doctor:

• if the patient has kidney disease. A lower dose may be required. The doctor will determine the appropriate dose;
• if the patient may have difficulty emptying the bladder (e.g. in conditions such as spinal cord injury or benign prostatic hyperplasia);
• if the patient has hereditary galactose intolerance, Lapp-type lactase deficiency, or glucose-galactose malabsorption syndrome, as Zyx Bio contains lactose.

Zyx Bio may affect the results of skin allergy tests. If the doctor orders such tests, Zyx Bio should be discontinued 3 days before testing.

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

Zyx Bio and other medicines
You must 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.
Some medicines may affect the action of Zyx Bio and vice versa.
These include:

• medicines with central nervous system depressant effects ( 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; however, the effect of the medicine may be delayed if taken with food.
There is no evidence that consuming alcohol together with this medicine increases the effect of either substance; however, caution is advised when using the medicine and drinking alcohol simultaneously.

Pregnancy, breastfeeding and fertility
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 this medicine may experience drowsiness, somnolence, fatigue or exhaustion.
If the patient plans to drive a car, perform potentially hazardous activities or operate machinery, they should first assess their individual response to the medicine.
Specific tests conducted in healthy volunteers taking levocetirizine at the recommended dose did not show any effect of the medicine on attention, reaction ability or driving performance.
In sensitive patients, concomitant use of this medicine with alcohol or other central nervous system depressants may impair reaction speed and concentration.

Zyx Bio 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 Bio

This medicine should always be taken exactly as described in the patient leaflet or as directed by a
physician or pharmacist. If in doubt, consult a physician or pharmacist.
Do not use the medicine for longer than 10 days without consulting a physician.
If there is no improvement after 3 days, or if the patient feels worse, consult a physician.
Method of administration
Tablets should be swallowed whole, with liquid (e.g. water). Tablets may be taken with food or
independently of meals.
Adults and children aged 6 years and older
The usual dose is 1 tablet once daily.
Children under 6 years of age
ZYX Bio tablets are not recommended for children under 6 years of age.
Patients with kidney disease
Consult a physician before using the medicine; a reduced dose may be necessary depending on the severity of kidney disease. The physician will determine the appropriate dose.
Patients with liver disease
Patients with liver function disorders alone should take the usual recommended dose of the medicine.
Patients with both kidney and liver disease
Consult a physician before using the medicine; a reduced dose may be necessary depending on the severity of kidney disease. The physician will determine the appropriate dose.
If you feel that the effect of ZYX Bio is too strong or too weak, consult your physician.
Taking more medicine than recommended
If you take more than the recommended dose, contact your physician immediately.
The physician will decide whether any measures are needed.
Taking more than the recommended dose may cause drowsiness in adults; in children, initial agitation and restlessness, especially motor restlessness, may occur, followed by 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 scheduled time.
Stopping treatment with ZYX Bio
Stopping treatment earlier than recommended should not cause harmful effects; symptoms of the disease will gradually reappear, and their severity should not be greater than before starting treatment.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
If first signs of hypersensitivity (allergic) reactions occur, discontinue use of Zyx Bio immediately and contact your doctor or the nearest hospital without delay.
The doctor will then assess the severity of the symptoms and decide whether further intervention is necessary.
Hypersensitivity symptoms may include:

• swelling of the lips, tongue, face and (or) throat, difficulty breathing and swallowing, accompanied by hives (angioedema), sudden drop in blood pressure leading to shock or collapse, which may be fatal. These reactions may occur immediately after the first dose of the medicine or may appear later.

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

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

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, tremor, taste disturbances (altered taste perception),
• sensation of spinning or swaying,
• visual disturbances, blurred vision,
• painful or difficult urination, inability to completely empty the bladder,
• swelling, itching (pruritus), rash, urticaria (skin swelling, redness, and itching), skin eruptions,
• dyspnea (difficulty breathing),
• weight gain,
• abnormal liver function test results, hepatitis,
• muscle pain,
• aggressive behavior or agitation, hallucinations, depression, insomnia, recurrent suicidal thoughts or suicidal ideation,
• nausea and vomiting,
• increased appetite,
• rotatory eye movements (involuntary circular eye movements).

Reporting of adverse reactions
If any adverse reactions occur, including any 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 of the 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 authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store ZYX Bio

Keep this medicine out of 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 the outer carton.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Zyx Bio contains

• The active substance is levocetirizine dihydrochloride. Each coated tablet contains 5 mg of levocetirizine dihydrochloride.
• Other ingredients are: monohydrate lactose, Prosolv SMCC 90 (microcrystalline cellulose with colloidal anhydrous 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.
Coated tablets are packed in aluminium/aluminium foil blisters or perforated aluminium/aluminium foil blisters divided into single doses, or in PVC/PVDC/aluminium foil with a heat-sealable coating, placed in a cardboard carton.
Pack contents: 7 or 10 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
e-mail: [email protected]