Patient Information Leaflet

HYDROXYZINUM POLFARMEX, 10 mg, coated tablets
HYDROXYZINUM POLFARMEX, 25 mg, coated tablets
Hydroxyzini hydrochloridum
Please read the entire leaflet carefully before using this medicine, as it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents:

What is Hydroxyzinum Polfarmex and what is it used for
Important information before taking Hydroxyzinum Polfarmex
How to take Hydroxyzinum Polfarmex
Possible side effects
How to store Hydroxyzinum Polfarmex
Contents of the pack and other information

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

Hydroxyzinum Polfarmex is an antipruritic, sedative, and anxiolytic medicine.
Hydroxyzinum Polfarmex is indicated for:

symptomatic treatment of anxiety in adults;
symptomatic treatment of pruritus (itching);
premedication – preparation of patients for surgical procedures.

2. Information before using Hydroxyzinum Polfarmex

When not to use Hydroxyzinum Polfarmex:

if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
if the patient has an allergy (hypersensitivity) to cetirizine, other piperazine derivatives, aminophylline or ethylenediamine;
if the patient has porphyria;
if the patient's ECG (electrocardiogram) shows heart rhythm disturbances known as QT interval prolongation;
if the patient has or has had cardiovascular disease or if the heart rate is very low;
if the patient has low levels of electrolytes (e.g. low potassium or magnesium levels);
if the patient is taking certain medicines used to treat heart rhythm disorders or medicines that may affect heart rhythm (see "Hydroxyzinum Polfarmex with other medicines");
if someone in the patient's family has died suddenly due to heart disease;
during pregnancy and while breastfeeding.

Warnings and precautions
Before starting treatment with Hydroxyzinum Polfarmex, discuss this with your doctor or
pharmacist:

if the patient has an increased tendency to seizures (especially in children);
if the patient has glaucoma, difficulty in urination from the bladder, weakened gastrointestinal motility, muscle weakness - myasthenia gravis (a disease characterized by muscle weakness and fatigue of skeletal muscles after repeated exertion; initial symptoms include drooping eyelids, double vision, nasal voice, difficulty chewing and swallowing; difficulty in raising upper limbs, walking, and rarely, respiratory muscle weakness) or dementia;
if Hydroxyzinum Polfarmex is used concomitantly with other medicines that depress the central nervous system or with medicines having anticholinergic properties (in such patients dose adjustment may be necessary).

Use of Hydroxyzinum Polfarmex may be associated with an increased risk of heart rhythm disturbances, which may be life-threatening. Therefore, inform your doctor about any heart disorders and about any other medicines you are taking, including those available without a prescription.
If, during treatment with Hydroxyzinum Polfarmex, symptoms related to the heart occur, such as rapid heartbeat (palpitations), difficulty breathing, or loss of consciousness, seek immediate medical advice. Treatment with hydroxyzine should also be discontinued.
Treatment should be discontinued at least 5 days before undergoing allergy tests or methacholine bronchial provocation tests to avoid interference with test results.

Hydroxyzinum Polfarmex with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines you plan to take.
This includes the following medicines:

medicines that depress the central nervous system (such as sedatives, anxiolytics, antidepressants, anticonvulsants, hypnotics) or medicines with anticholinergic effects (a group of medicines used, among others, in gastrointestinal disorders and respiratory diseases);
alcohol and alcohol dehydrogenase inhibitors;
betahistine (a medicine used in Ménière's disease) and cholinesterase inhibitors (a group of medicines used, among others, in the treatment of myasthenia gravis, Alzheimer's disease, and glaucoma);
monoamine oxidase inhibitors (medicines used, among others, in depression);
adrenaline (a medicine used, among others, in severe allergic reactions);
medicines that may cause heart rhythm disturbances – concomitant use with hydroxyzine may increase the risk of ECG changes, such as QT interval prolongation or occurrence of torsade de pointes type arrhythmias.

Caution is advised when using Hydroxyzinum Polfarmex concomitantly with medicines causing bradycardia and hypokalemia.
Do not take Hydroxyzinum Polfarmex if the patient is taking medicines used to treat:

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

Hydroxyzinum Polfarmex and alcohol
Avoid concomitant use of Hydroxyzinum Polfarmex and alcohol.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Hydroxyzinum Polfarmex must not be used during pregnancy or while breastfeeding.
Breastfeeding must be discontinued if treatment with Hydroxyzinum Polfarmex is necessary.
Driving and operating machinery
While taking Hydroxyzinum Polfarmex, do not drive, operate machinery, or use tools, as this medicine may impair the ability to react and concentrate.
Hydroxyzinum Polfarmex contains lactose
If the patient has previously been diagnosed with an intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Hydroxyzinum Polfarmex 10 mg contains 32.24 mg of lactose in each coated tablet.
Hydroxyzinum Polfarmex 25 mg contains 79.71 mg of lactose in each coated tablet.
Hydroxyzinum Polfarmex 10 mg contains sodium (from quinoline yellow).
Hydroxyzinum Polfarmex 10 mg contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to use Hydroxyzinum Polfarmex

This medicine should always be used as directed by the physician. In case of doubts, consult a
physician or pharmacist.
Hydroxyzinum Polfarmex should be used at the lowest effective dose. The duration of treatment
should be as short as possible.
In adults and children with body weight above 40 kg, the maximum daily dose is 100 mg.
The following are the usual recommended doses of Hydroxyzinum Polfarmex.
Adults
For symptomatic treatment of anxiety:
50 mg per day in 2 or 3 divided doses.
In severe cases, oral doses up to 100 mg per day may be used.
For symptomatic treatment of pruritus (itching):
Begin treatment with 25 mg at bedtime; continue therapy, increasing the dose if necessary to
25 mg 3 to 4 times daily.
For premedication before surgical procedures:
50 mg given in two doses or 100 mg as a single oral dose.
Use in children and adolescents
In children and adolescents with body weight up to 40 kg, the maximum daily dose is 2 mg/kg body weight.
In children and adolescents with body weight above 40 kg, the maximum daily dose is 100 mg.
Children from 12 months of age
For symptomatic treatment of pruritus:
1 mg/kg body weight per day up to 2 mg/kg body weight per day in divided doses;
For premedication before surgical procedures:
0.6 mg/kg body weight orally as a single dose.
The total daily dose should not exceed 2 mg/kg body weight per day.
Dose adjustment
Dosage should be individually adjusted within the recommended dose range, depending on
the patient's response to treatment.
Elderly patients
In elderly patients, treatment should be initiated at half the recommended dose.
In elderly patients, the maximum daily dose is 50 mg.
Patients with moderate or severe renal impairment
In patients with moderate or severe renal impairment, the administered doses should be reduced.
Patients with hepatic impairment
In patients with hepatic impairment, the daily dose should be reduced by 33%.
Use of a higher than recommended dose of Hydroxyzinum Polfarmex
If a patient has taken or used more than the recommended dose of Hydroxyzinum Polfarmex,
contact emergency services immediately, especially if this involves a child.
In case of overdose, symptomatic treatment may be applied. ECG monitoring is recommended
due to the possibility of cardiac rhythm disturbances such as QT interval prolongation or
t orsade de pointes.
Symptoms of Hydroxyzinum Polfarmex overdose include: nausea, vomiting, tachycardia
(increased heart rate), fever, drowsiness, disturbances of pupillary reflex, tremor, confusion or
hallucinations, followed by decreased level of consciousness, respiratory depression, seizures,
hypotension or cardiac arrhythmias, and progressively deepening coma with circulatory and
respiratory collapse.
There is no specific antidote.
Missed dose of Hydroxyzinum Polfarmex
Do not use a double dose to make up for a missed dose.
Discontinuation of Hydroxyzinum Polfarmex
If you have any further questions about the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Treatment should be discontinued and a doctor should be consulted immediately if the patient experiences
heart rhythm disturbances such as rapid heartbeat (palpitations), difficulty breathing, or loss of
consciousness.
The frequency of occurrence of the adverse reactions 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, sedation (calming effect)
Uncommon (may affect up to 1 in 100 people): nausea, malaise, fever, restlessness, confusion
Rare (may affect up to 1 in 1,000 people): tachycardia (increased heart rate), accommodation disorders, blurred vision, constipation, vomiting, hypersensitivity reactions, abnormal liver function test results, convulsions, dyskinesia (involuntary, uncoordinated movements of limbs and other body parts), disorientation, hallucinations, urinary retention, itching, erythematous rash, maculopapular rash, urticaria, dermatitis, hypotension
Very rare (may affect up to 1 in 10,000 people): anaphylactic shock, which in severe cases may be life-threatening (caused by a severe systemic allergic reaction; symptoms include: shortness of breath, laryngeal and throat swelling, skin itching and redness, headache, sensation of "tightness", dizziness, profound weakness, and even loss of consciousness); bronchospasm, angioedema (skin eruptions in the form of irregular patches, blisters and swellings), increased sweating, persistent drug eruption, acute generalized exanthematous pustulosis (pustular rash on red skin, which may be accompanied by swelling and general symptoms such as fever), erythema multiforme (skin rash which may cause blisters and resemble small bullseyes (a dark center surrounded by a lighter area and a dark ring around it)), Stevens-Johnson syndrome (widespread rash with blisters and skin peeling, mainly affecting the area around the mouth, eyes, nose, and genital organs)
Frequency not known (frequency cannot be estimated from available data): QT interval prolongation in electrocardiogram, cardiac arrhythmias of the torsade de pointes type, hepatitis

Additionally, the following adverse reactions associated with cetirizine, the main metabolite of hydroxyzine, have been observed and may also occur after administration of hydroxyzine: decreased platelet count, aggressive behavior, depression, tics, involuntary movements, tingling, compulsive eye rolling with ocular rotation, diarrhea, difficulty in urination, involuntary urination, asthenia (fatigue, weakness), edema, weight gain.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: 22 49-21-301
Fax: 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 Hydroxyzinum Polfarmex

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack
following: "EXP". The expiry date refers to the last day of the specified month.
Store below 30°C.
Keep in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Hydroxyzinum Polfarmex contains
Coated tablets, 10 mg:
The active substance is hydroxyzine hydrochloride. Each coated tablet contains 10 mg of
hydroxyzine hydrochloride.
The other ingredients are: microcrystalline cellulose, lactose, magnesium stearate, anhydrous colloidal silicon dioxide.
Composition of the coating: monohydrate lactose, hypromellose 6 cP, titanium dioxide (E 171), macrogol 6000, quinoline yellow (E 104).

Coated tablets, 25 mg:
The active substance is hydroxyzine hydrochloride. Each coated tablet contains 25 mg of
hydroxyzine hydrochloride.
The other ingredients are: microcrystalline cellulose, lactose, magnesium stearate, anhydrous colloidal silicon dioxide.
Composition of the coating: monohydrate lactose, hypromellose 6 cP, titanium dioxide (E 171), macrogol 6000.

What Hydroxyzinum Polfarmex looks like and contents of the pack
Hydroxyzinum Polfarmex 10 mg coated tablets are yellow, round, biconvex tablets, without spots or damage.
Hydroxyzinum Polfarmex 25 mg coated tablets are white to light cream, oblong, biconvex tablets with a division line on one side, without spots or damage.
The division line on the tablet is not intended for breaking the tablet.
The pack contains 30 coated tablets.

Marketing Authorisation Holder and Manufacturer
Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland
Tel.: 24 357 44 44
Fax: 24 357 45 45
e-mail: [email protected]