HYDROXYZINUM 2 mg /Ml Syrup

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. HYDROXYZINUM POLFARMEX, 2 mg/ml, Syrup
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
3. What is Hydroxyzinum Polfarmex and what is it used for
4. Important information before taking Hydroxyzinum Polfarmex
   1. When not to take Hydroxyzinum Polfarmex:
   2. Warnings and precautions
   3. Hydroxyzinum Polfarmex and other medicines
   4. Pregnancy and breastfeeding
   5. Driving and using machines
5. How to take Hydroxyzinum Polfarmex
   1. Oral administration
   2. Recommended doses
   3. Adults
   4. Use in children and adolescents
   5. Children from 12 months
   6. Overdose of Hydroxyzinum Polfarmex
   7. Missed dose of Hydroxyzinum Polfarmex
   8. Stopping treatment with Hydroxyzinum Polfarmex
6. Possible side effects
   1. Reporting side effects
7. How to store Hydroxyzinum Polfarmex
8. Contents of the pack and other information
   1. What Hydroxyzinum Polfarmex contains
   2. What Hydroxyzinum Polfarmex looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet:

Package Leaflet: Information for the Patient

HYDROXYZINUM POLFARMEX, 2 mg/ml, Syrup

Hydroxyzine Hydrochloride

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

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

Table of Contents of the Leaflet

• 1. What is Hydroxyzinum Polfarmex and what is it used for
• 2. Important information before taking Hydroxyzinum Polfarmex
• 3. How to take Hydroxyzinum Polfarmex
• 4. Possible side effects
• 5. How to store Hydroxyzinum Polfarmex
• 6. Contents of the pack and other information

1. What is Hydroxyzinum Polfarmex and what is it used for

Hydroxyzinum Polfarmex is a medicine with antihistamine, sedative, and anxiolytic properties.
This medicine is indicated:

• for the symptomatic treatment of anxiety in adults;
• for the symptomatic treatment of itching;
• for premedication before surgical procedures.

2. Important information before taking Hydroxyzinum Polfarmex

When not to take Hydroxyzinum Polfarmex:

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to cetirizine, other piperazine derivatives, aminophylline, or ethylenediamine;
• if you have porphyria;
• if you have a history of prolonged QT interval in the electrocardiogram;
• during pregnancy and breastfeeding;
• if you have a hereditary intolerance to certain sugars;
• if your ECG (electrocardiogram) shows heart rhythm disturbances, known as QT interval prolongation;
• if you have or have had cardiovascular disease or if your heart rate is very slow;
• if you have low levels of electrolytes (e.g., low potassium or magnesium levels);
• if you are taking certain medicines used to treat heart rhythm disorders or medicines that may affect heart rhythm (see "Hydroxyzinum Polfarmex and other medicines");
• if someone in your family has died suddenly due to heart disease.

Warnings and precautions

Before starting treatment with Hydroxyzinum Polfarmex, discuss it with your doctor or pharmacist:

• if you have an increased tendency to seizures (seizures have been reported more frequently in children than in adults);
• if you have glaucoma, difficulty urinating, impaired gastrointestinal motility, dementia, or myasthenia gravis(a disease characterized by muscle weakness and fatigue after repeated exertion, the first symptoms are: drooping eyelids, double vision, nasal voice, difficulty chewing and swallowing, difficulty lifting upper limbs and walking; rarely, it can cause respiratory muscle weakness);
• if Hydroxyzinum Polfarmex is used concomitantly with other medicines that act on the central nervous system or have anticholinergic properties (in these patients, dose adjustment may be necessary);
• if you have been diagnosed with a risk of heart rhythm disturbances, including electrolyte imbalance (low potassium levels in the blood, low magnesium levels in the blood) or if you are taking medicines that may cause heart rhythm disturbances. In these patients, the doctor will consider alternative treatment methods.

Taking Hydroxyzinum Polfarmex may be associated with an increased risk of heart rhythm disturbances, which can be life-threatening. Therefore, you should tell your doctor about any heart problems and about taking any other medicines, including those available without a prescription.
If you experience any heart symptoms while taking Hydroxyzinum Polfarmex, such as rapid heartbeat (palpitations), difficulty breathing, loss of consciousness, you should immediately consult a doctor. You should also stop taking the hydroxyzine treatment.
Treatment should be discontinued at least 5 days before performing allergy tests or methacholine bronchial provocation tests to avoid the influence of the medicine on the results of these tests.
During treatment with Hydroxyzinum Polfarmex, you should not drink alcohol.

Hydroxyzinum Polfarmex and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, including those available without a prescription. Hydroxyzinum Polfarmex may affect the action of other medicines. Other medicines may affect the action of Hydroxyzinum Polfarmex.
Certain medicines and substances taken with Hydroxyzinum Polfarmex may cause side effects.
This applies to the following substances:

• medicines that act on the central nervous system or have anticholinergic properties;
• alcohol and alcohol dehydrogenase inhibitors;
• betahistine and cholinesterase inhibitors;
• monoamine oxidase inhibitors (medicines used, among others, in depression);
• adrenaline;
• medicines that may cause heart rhythm disturbances - their concomitant use with hydroxyzine may increase the risk of changes in the ECG recording - QT interval prolongation or the occurrence of heart rhythm disturbances of the torsade de pointestype.

Caution should be exercised when concomitantly using medicines that cause bradycardia and hypokalemia.
Do not take Hydroxyzinum Polfarmex if you are taking medicines used to treat:

• bacterial infections (e.g., antibiotics, such as erythromycin, moxifloxacin, levofloxacin);
• fungal infections (e.g., pentamidine);
• heart disease or high blood pressure (e.g., amiodarone, quinidine, disopyramide, sotalol);
• psychoses (e.g., haloperidol);
• depression (e.g., citalopram, escitalopram);
• gastrointestinal diseases (e.g., prucalopride);
• allergies;
• malaria (e.g., mefloquine);
• cancer (e.g., toremifene, vandetanib);
• drug or severe pain addiction (methadone).

Pregnancy and breastfeeding

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.
Hydroxyzinum Polfarmex should not be used during pregnancy or breastfeeding.
Breastfeeding should be discontinued if it is necessary to use Hydroxyzinum Polfarmex.

Driving and using machines

Do not drive vehicles or operate machines while taking Hydroxyzinum Polfarmex, as it may impair your reaction and concentration abilities.
Hydroxyzinum Polfarmex contains sodium, sodium benzoate (E 211), sucrose, alcohol (ethanol),
geraniol, and citral (components of orange flavor)
Sodium
The medicine contains less than 1 mmol (23 mg) of sodium per 1 ml of syrup, which means the medicine is considered "sodium-free".
Sodium benzoate (E 211)
The medicine contains 0.3 mg of sodium benzoate (E 211) per 1 ml of syrup. Sodium benzoate (E 211) may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of age), but this medicinal product is used from 12 months of age.
The maximum single dose (contained in 50 ml of syrup) is 15 mg of sodium benzoate.
Sucrose
The medicine contains 770 mg of sucrose per 1 ml of syrup. This should be taken into account in patients with diabetes.
If you have previously been diagnosed with intolerance to certain sugars, you should consult your doctor before taking the medicine.

3. How to take Hydroxyzinum Polfarmex

This medicine should always be taken as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
Hydroxyzinum Polfarmex should be taken in the smallest effective dose. The treatment duration should be as short as possible.
In adults and children over 40 kg, the maximum daily dose for all indications is 100 mg.
In elderly patients, the maximum daily dose is 50 mg.
In children under 40 kg, the maximum daily dose is 2 mg/kg body weight per day.

Oral administration

Recommended doses

Adults

For symptomatic treatment of anxiety
50 mg/day in 2 or 3 divided doses.
In severe cases, doses up to 100 mg/day can be used.
For symptomatic treatment of itching
Treatment should be started with a dose of 25 mg before bedtime, and therapy should be continued, increasing the dose if necessary, administering 25 mg 3 to 4 times a day.
For premedication before surgical procedures
50 to 100 mg in a single dose. The maximum dose in adults should not exceed 100 mg.

Use in children and adolescents

Children from 12 months

In children under 40 kg, the maximum daily dose is 2 mg/kg body weight per day.
In children over 40 kg, the maximum daily dose is 100 mg.
For symptomatic treatment of itching:

• 1 mg/kg body weight per day to 2 mg/kg body weight per day in divided doses.

For premedication before surgical procedures
0.6 mg/kg body weight orally in a single dose.
A measuring cup with a scale facilitating dosing is included in the syrup packaging.
Dose adjustment
Dosing should be adjusted individually, within the recommended dose range, depending on the patient's response to treatment.
Elderly patients
In elderly patients, treatment should be started with half the recommended dose for adults. In elderly patients, the maximum daily dose is 50 mg.
Patient with moderate or severe renal impairment
In patients with moderate or severe renal impairment, due to reduced excretion of the medicine's metabolite, cetirizine, the used doses should be reduced.
Patient with hepatic impairment
In patients with hepatic impairment, the daily dose should be reduced by 33%.

Overdose of Hydroxyzinum Polfarmex

If you have taken or used too much Hydroxyzinum Polfarmex, contact your doctor immediately, especially if it concerns a child. In case of overdose, symptomatic treatment can be used. ECG monitoring is recommended due to the possibility of heart rhythm disturbances, such as QT interval prolongation or torsade de pointes.
Symptoms of Hydroxyzinum Polfarmex overdose are: nausea, vomiting, tachycardia (rapid heart rate), fever, drowsiness, disturbances of pupillary reflex, tremors, confusion or hallucinations, and then decreased level of consciousness, respiratory depression, seizures, hypotension, or heart rhythm disturbances, as well as deepening coma and cardiopulmonary arrest.
There is no specific antidote.

Missed dose of Hydroxyzinum Polfarmex

Do not take a double dose to make up for a missed dose.

Stopping treatment with Hydroxyzinum Polfarmex

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of side effects listed below is defined as follows:
Very common:may affect more than 1 in 10 people: drowsiness
Common:may affect up to 1 in 10 people: dry mouth, fatigue, headache, sedation (calmness)
Uncommon:may affect up to 1 in 100 people: nausea, malaise, fever, dizziness, insomnia, tremors, agitation, confusion
Rare:may affect up to 1 in 1,000 people: tachycardia (rapid heart rate), accommodation disorders, blurred vision, constipation, vomiting, hypersensitivity reactions, abnormal liver function tests, seizures, dyskinesia (involuntary, uncoordinated movements of limbs and other body parts), disorientation, hallucinations, urinary retention, itching, rash, urticaria, skin inflammation, hypotension
Very rare:may affect up to 1 in 10,000 people: anaphylactic shock (caused by a severe, systemic allergic reaction, its symptoms are: shortness of breath, swelling of the throat and larynx, itching of the skin and its redness, headache, feeling of "pressure", dizziness, significant weakness, up to loss of consciousness; in severe cases, it can be life-threatening), bronchospasm, angioedema (rashes on the skin in the form of irregular spots, blisters, and swelling), increased sweating, fixed drug eruption, acute generalized exanthematous pustulosis (pustular rash on reddened skin, which may be accompanied by swelling and general symptoms, e.g., fever), polymorphic erythema (rash on the skin that can cause the formation of blisters and looks like small targets - a dark spot surrounded by a lighter area and a dark circle around), Stevens-Johnson syndrome (widespread rash with blisters and peeling skin, occurring mainly in the area of the mouth, eyes, nose, and genitals)
Frequency not known:cannot be estimated from the available data: QT interval prolongation in the electrocardiogram, heart rhythm disturbances of the torsade de pointestype
Stop taking the medicine and immediately consult a doctor if you experience heart rhythm disturbances, such as rapid heartbeat (palpitations), difficulty breathing, loss of consciousness.
Additionally, the following side effects have been observed with cetirizine, the main metabolite of hydroxyzine, which may also occur after hydroxyzine administration: decreased platelet count, aggression, depression, tics, involuntary movements, paresthesia, episodes of forced gaze with eye rotation, diarrhea, difficulty urinating, involuntary urination, asthenia (fatigue, weakness), edema, weight gain.
In some people, while taking Hydroxyzinum Polfarmex, other side effects may occur.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Hydroxyzinum Polfarmex

Store in a temperature below 25°C.
Store in the original packaging to protect from light.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after "EXP". 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 that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Hydroxyzinum Polfarmex contains

• The active substance of the medicine is hydroxyzine hydrochloride. 1 ml of syrup contains 2 mg of hydroxyzine hydrochloride.
• The other ingredients are: sodium benzoate (E 211), sucrose, orange flavor (contains, among others, ethanol, geraniol, and citral), purified water.

What Hydroxyzinum Polfarmex looks like and contents of the pack

Hydroxyzinum Polfarmex is a colorless to straw-colored liquid with a characteristic orange flavor and smell.
The packaging consists of a brown glass bottle with an aluminum cap and a PE seal, placed in a cardboard box, containing 200 ml of syrup and a measuring cup made of polypropylene with a scale facilitating dosing.

Marketing authorization holder and manufacturer

Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland (Poland)
Phone: 24 357 44 44
Fax: 24 357 45 45
e-mail: [email protected]

Date of last revision of the leaflet: