Zyx

Patient Information Leaflet

ZYX
0.5 mg/ml, oral solution
Levocetirizini dihydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

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

Levocetirizine dihydrochloride is the active substance in Zyx.
Zyx is an antiallergic medicine.
Zyx is used in adults, adolescents and children aged 2 years and older 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, 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 function impairment (severe renal failure with creatinine clearance less than 10 ml/min).

Warnings and precautions
Before starting treatment with Zyx, consult a doctor if the patient may have
difficulties emptying the bladder (in conditions such as: spinal cord injury or benign prostatic hyperplasia).
Children
Zyx is not recommended for infants and young children under 2 years of age.
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, including those available without a prescription.
Zyx, food, drink and alcohol
Exercise caution when taking Zyx together with alcohol.
In sensitive patients, concomitant administration of cetirizine or levocetirizine with alcohol or other agents affecting brain function may impair attention and concentration.
Zyx can be taken with or between meals.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Driving and operating machinery
Some patients treated with Zyx may experience drowsiness, fatigue, or exhaustion.
Exercise caution when driving or operating machinery until the patient's response to the medicine is known. Specific tests conducted in healthy individuals taking levocetirizine at the recommended dose did not show any effect of the medicine on attention, reaction ability, or driving skills.
Zyx contains methyl parahydroxybenzoate (E218) and ethyl parahydroxybenzoate (E214),
which may cause allergic reactions (including delayed-type reactions), such as headache, stomach upset, and diarrhoea.
Zyx contains sorbitol (E420)
The medicine contains 500 mg of sorbitol in each millilitre of solution. Patients with rare hereditary fructose intolerance should not take this product.
Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance—a rare genetic disorder in which the body cannot break down fructose—the patient should consult a doctor before taking the medicine or giving it to a child.
If the dose of sorbitol ingested 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 millilitre of solution.
If the dose of propylene glycol ingested with Zyx exceeds 50 mg/kg body weight per day, consult a doctor or pharmacist before administering the medicine to a child under 5 years of age, especially if the child is taking other medicines containing propylene glycol or alcohol.
Pregnant or breastfeeding women should not take this medicine without medical advice. The doctor may decide to perform additional tests in such patients.
Patients with impaired liver or kidney function should not take this medicine without medical advice. The doctor may decide to perform additional tests in such patients.
Zyx contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium in 10 ml of solution, meaning the medicine is considered "sodium-free".

3. How to use Zyx

This medicine should always be used as directed by the physician. If in doubt, consult a doctor or pharmacist.

Dosage:

The usual dose of the medicine is:

• Adults, adolescents, and children above 6 years of age: 10 ml of solution once daily.
• Children from 2 to 6 years of age: 2.5 ml of solution twice daily.

Zyx is not recommended for infants and young children under 2 years of age.

Dosage recommendations for special patient groups:

In patients with renal function impairment, dose reduction may be necessary depending on the severity of kidney disease. In children, the dose should also be adjusted according to body weight; the physician will determine the appropriate dose.

Zyx must not be used in patients with severe renal function impairment.

Patients with liver function impairment only should usually receive the recommended dose.

In patients with both hepatic and renal function impairment, a lower dose may be required depending on the severity of kidney disease. In children, the dose should also be adjusted according to body weight; the physician will determine the appropriate dose.

Dose adjustment is not necessary in elderly patients if renal function is normal.

How and when to take Zyx:

Zyx is for oral use only.

A measuring cup with graduated markings is provided in the package for accurate dosing. The solution may be taken undiluted or diluted in a glass of water.

Zyx may be taken during or between meals.

Instructions for using the measuring cup:

Fill the measuring cup to the mark corresponding to the prescribed dose in millilitres (ml). For children under 6 years of age, the daily dose of 5 ml given in two divided doses should be measured as 2.5 ml of solution twice daily (the dose must be accurately measured to the appropriate mark on the scale).

The oral solution should be taken immediately after pouring into the measuring cup or after dilution in a glass of water.

After each use, the measuring cup should be rinsed with water.

How long should Zyx be taken?

The duration of treatment depends on the type, duration, and severity of the disease symptoms and will be determined by the physician.

Overdose of Zyx:

In adults, taking a higher than recommended dose of Zyx may cause drowsiness. In children, initial symptoms may include restlessness and hyperactivity, followed by drowsiness.

If an overdose of Zyx is suspected, seek medical advice immediately. The doctor will decide what actions should be taken.

Missed dose of Zyx:

If a dose of Zyx is missed or a lower than recommended dose is taken, do not take a double dose to make up for the missed dose. Instead, take the next dose at the usual time.

Stopping Zyx:

Discontinuation of Zyx should not cause harmful effects. Disease symptoms may return, but their severity should not exceed that observed before starting treatment with Zyx.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If the first symptoms of hypersensitivity (allergic reaction) occur, treatment with Zyx must be discontinued and the doctor must be informed.
Symptoms of hypersensitivity may include:

• swelling of the lips, tongue, face and (or) throat (frequency unknown - cannot be estimated based on available data)
• difficulty breathing or swallowing (chest tightness or wheezing), urticaria (frequency unknown - cannot be estimated based on available data),
• sudden drop in blood pressure leading to collapse or shock, which may lead to death (frequency unknown - cannot be estimated based on available data).

Common (may affect more than 1 in 100 people, but less than 1 in 10 people) adverse reactions reported are generally mild or moderate in severity, such as:

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

Uncommon (may affect more than 1 in 1,000 people, but less than 1 in 100 people) adverse reactions observed include:

• exhaustion,
• abdominal pain.

Frequency unknown (frequency cannot be estimated from available data):

• rotary eye movements (involuntary circular eye movements).

Other adverse reactions have also been reported, such as:
palpitations, increased heart rate, seizures, tingling, dizziness, fainting, tremor, taste disturbances (altered sense of taste), sensation of spinning or swaying, visual 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, agitation and aggressive behaviour, hallucinations, depression, insomnia, recurrent suicidal thoughts, hepatitis, abnormal liver function tests, vomiting and nausea, increased appetite, diarrhoea.

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 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 this medicine.

5. How to store the medicine Zyx

Keep the medicine out of the sight and reach of children.
Store below 30°C.
Do not use this medicine after the expiry date stated on the outer carton and
bottle. The expiry date refers to the last day of the stated month.
Do not use more than 3 months after the date the bottle was first opened.
The date of opening the bottle should be recorded.
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 contains

• The active substance is levocetirizine dihydrochloride. One ml of oral solution contains 0.5 mg of levocetirizine dihydrochloride. 10 ml of oral solution contains 5 mg of levocetirizine dihydrochloride.
• Other components are: sorbitol liquid, non-crystallizing (E420), glycerol, propylene glycol, sodium citrate, sodium saccharin, pineapple flavour, methyl p-hydroxybenzoate (E218), ethyl p-hydroxybenzoate (E214), purified water.

What Zyx looks like and contents of the pack
Zyx 0.5 mg/ml oral solution is a clear, colourless, sweet oral solution with a pineapple flavour.
The pineapple flavour is obtained by adding a small amount of flavouring substance.
The solution is contained in a brown glass bottle (Type III) with a white polypropylene child-resistant cap, with an insert and a polyethylene tamper-evident ring.
The bottle with the solution is placed in a cardboard box containing a polypropylene (PP) measuring spoon graduated every 2.5 mL (for dose measurement) and a patient leaflet.
Pack size: 200 ml of oral solution

Marketing Authorisation Holder and Manufacturer
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
tel.: +48 61 66 51 500
fax: +48 61 66 51 505
e-mail: [email protected]
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