Zix

Leaflet attached to the packaging: information for the user

ZYX

0.5 mg/ml, oral solution

Levocetirizine dihydrochloride

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their 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 packaging and other information

1. What is Zyx and what is it used for

Levocetirizine dihydrochloride is the active substance of Zyx.
Zyx is an antiallergic medicine.
Zyx is used in adults, adolescents, and children from 2 years of age to treat symptoms associated with:

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

2. Important information before taking Zyx

When not to take Zyx

• if the patient is allergicto levocetirizine dihydrochloride, other piperazine derivatives (e.g., cetirizine, hydroxyzine), or any of the other ingredients of this medicine (listed in section 6),
• if the patient has severe kidney impairment(severe renal failure with creatinine clearance less than 10 ml/min).

Warnings and precautions

Before starting treatment with Zyx, you should discuss it with your doctor,if you have
difficulty emptying your bladder (in conditions such as spinal cord injury or prostate enlargement).

Children

Zyx should not be given to infants and young children under 2 years of age.

Zyx and other medicines

You should tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take, including those available without a prescription.

Zyx with food, drink, and alcohol

You should be cautious when taking Zyx with alcohol.
In sensitive patients, concomitant administration of cetirizine or levocetirizine with alcohol or other substances affecting brain function may affect attention.
Zyx can be taken during or between meals.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

In some patients treated with Zyx, drowsiness, fatigue, and exhaustion may occur.
You should be cautious when driving or operating machinery until you know your reaction to the medicine. Special tests conducted with healthy individuals after taking levocetirizine at the recommended dose did not show any effect on attention, reaction, or driving ability.
Zyx contains methyl parahydroxybenzoate (E218) and ethyl parahydroxybenzoate (E214), which may cause allergic reactions (possible late reactions), such as headache, stomach upset, and diarrhea.

Zyx contains sorbitol

The medicine contains 500 mg of sorbitol in each milliliter of solution. Patients with rare hereditary fructose intolerance should not take this product.
Sorbitol is a source of fructose. If you or your child have been diagnosed with intolerance to some sugars or have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which the body does not break down fructose, you should consult your doctor before taking the medicine or giving it to your child.
If the dose of sorbitol taken with Zyx exceeds 140 mg/kg body weight per day, sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.

Zyx contains propylene glycol

The medicine contains 100 mg of propylene glycol in each milliliter of solution.
If the dose of propylene glycol taken with Zyx exceeds 50 mg/kg body weight per day, before administering the medicine to a child under 5 years of age, you should consult your doctor or pharmacist, especially if the child is taking other medicines containing propylene glycol or alcohol. Pregnant or breastfeeding women should not take this medicine without consulting their doctor. The doctor may decide to perform additional tests on such patients.
Patient with liver or kidney impairment should not take this medicine without consulting their doctor. The doctor may decide to perform additional tests on such patients.

Zyx contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium in 10 ml of solution, which means the medicine is considered "sodium-free".

3. How to take Zyx

This medicine should always be taken as directed by your doctor. If you have any doubts, you should consult your doctor or pharmacist.

Dosage:

The usual dose of the medicine is:

• adults, adolescents, and children over 6 years: 10 ml of solution once a day.
• children from 2 to 6 years: 2.5 ml of solution twice a day.

Zyx should not be given to infants and young children under 2 years of age.

Recommendations for use in special patient groups

In patients with kidney impairment, it may be necessary to reduce the dose of the medicine depending on the severity of the kidney disease; in children, the dose should also be adjusted according to body weight; the dose of the medicine will be determined by the doctor.
Patient with severe kidney impairment should nottake Zyx.
Patient with liver impairment only should take the usual recommended dose of the medicine.
In patients with both liver and kidney impairment, it may be necessary to use a smaller dose depending on the severity of the kidney disease; in children, the dose should also be adjusted according to body weight; the dose of the medicine will be determined by the doctor.
In elderly patients, there is no need to adjust the dose if kidney function is normal.

How and when to take Zyx?

The medicine is for oral use only.
A measuring cup with a scale is included with the packaging to measure the dose. The solution can be taken undiluted or diluted in a glass of water.
Zyx can be taken during or between meals.
How to use the measuring cup
You should fill the measuring cup to the mark on the scale corresponding to the dose prescribed by your doctor in milliliters (ml). For children under 6 years, the daily dose of 5 ml, given in two divided doses, should be measured by pouring 2.5 ml of solution into the measuring cup twice a day (the dose should be measured exactly to the corresponding mark on the scale).
The oral solution should be taken immediately after pouring into the measuring cup or after diluting in a glass of water.
After each use, the measuring cup should be rinsed with water.

How long to take Zyx?

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

Taking a higher dose of Zyx than recommended

In adults, if a higher dose of Zyx than recommended is taken, drowsiness may occur. In children, initial excitement and restlessness, especially motor, may occur, followed by drowsiness.
If you suspect that you have taken a higher dose of Zyx than recommended, you should immediately consult your doctor, who will decide what actions should be taken.

Missing a dose of Zyx

If a dose of Zyx is missed or a dose lower than recommended by the doctor is taken, you should not take a double dose to make up for the missed dose. In such a case, you should take the next dose at the usual time.

Stopping treatment with Zyx

Stopping treatment with Zyx should not cause any harmful effects. The symptoms of the disease may return, but their severity should not be greater than before starting treatment with Zyx.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

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

In case of the first symptoms of hypersensitivity (allergic reaction), you should stop taking Zyx and inform your doctor.

The symptoms of hypersensitivity may include:

• swelling of the mouth, tongue, face, and (or) throat (frequency not known - cannot be estimated from the available data)
• difficulty breathing or swallowing (chest tightness or wheezing), urticaria (frequency not known - cannot be estimated from the available data),
• sudden drop in blood pressure leading to fainting or shock, which can be fatal (frequency not known - cannot be estimated from the available data).

Common(may affect up to 1 in 10 people) side effects include:

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

Uncommon(may affect up to 1 in 100 people) side effects include:

• exhaustion,
• abdominal pain.

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

• rotatory eye movements (uncontrolled circular eye movement).

Other side effects have also been reported, such as:

palpitations, increased heart rate, seizures, tingling, dizziness, fainting, tremors, taste disturbances (altered taste perception), feeling of spinning or swaying, vision disturbances, blurred vision, painful or difficult urination, inability to completely empty the bladder, swelling, itching, rash, urticaria (swelling, redness, and itching of the skin), skin eruptions, shortness of breath, weight gain, muscle pain, joint pain, excitement and aggressive behavior, hallucinations, depression, insomnia, recurring suicidal thoughts, hepatitis, abnormal liver test results, vomiting and nausea, increased appetite, diarrhea.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should inform 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:
Aleje 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 Zyx

The medicine should be stored out of sight and reach of children.
Store in a temperature below 30°C.
Do not use this medicine after the expiry date stated on the carton and bottle. The expiry date refers to the last day of the month.

Do not use after 3 months from the date of first opening the bottle.

You should note the date of opening the bottle.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Zyx contains

• The active substance of Zyx is levocetirizine dihydrochloride. One milliliter of oral solution contains 0.5 mg of levocetirizine dihydrochloride. 10 milliliters of oral solution contain 5 mg of levocetirizine dihydrochloride.
• The other ingredients of the medicine are: liquid sorbitol, non-crystallizing (E420), glycerol, propylene glycol, sodium citrate, sodium saccharin, ananas flavor, methyl parahydroxybenzoate (E218), ethyl parahydroxybenzoate (E214), purified water.

What Zyx looks like and contents of the packaging

Zyx, 0.5 mg/ml, oral solution is a clear, colorless, sweet oral solution with an ananas flavor.
The ananas flavor has been achieved by adding a small amount of flavoring substance.
The solution is packaged in a brown glass bottle (class III) with a white polypropylene screw cap, child-resistant, with a plug and a guarantee ring made of polyethylene.
The bottle with the solution is placed in a cardboard box, which also contains a polypropylene (PP) measuring cup with a scale and a patient leaflet.
Pack size: 200 ml oral solution

Marketing authorization holder and manufacturer

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
phone: +48 61 66 51 500
fax: +48 61 66 51 505
e-mail: biofarm@biofarm.pl

Date of last revision of the leaflet:

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