Package leaflet: Information for the patient

Hydroxyzinum Hasco, 10 mg, coated tablets
Hydroxyzini hydrochloridum
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are similar.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

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

The active substance in Hydroxyzinum Hasco is hydroxyzine, which has antihistaminic, sedative, and anxiolytic properties.
Indications

Symptomatic treatment of anxiety in adults
Symptomatic treatment of pruritus (itching)
Premedication before surgical procedures

2. Information before using Hydroxyzinum Hasco

When not to use Hydroxyzinum Hasco

if the patient is allergic to hydroxyzine, cetirizine, other piperazine derivatives, aminophylline, ethylenediamine, or any of the other ingredients of this medicine (listed in section 6);
if the patient has porphyria (a disorder characterized by abnormal heme production – a component of hemoglobin);
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 in blood serum (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 section "Hydroxyzinum Hasco and other medicines");
if someone in the patient's family has died suddenly due to heart disease;
during breastfeeding and pregnancy.

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Warnings and precautions
Before starting treatment with Hydroxyzinum Hasco, discuss this with your doctor or pharmacist.
Exercise particular caution when using Hydroxyzinum Hasco:

if the patient has an increased tendency to seizures (such cases have been reported more frequently in children than in adults);
if the patient has glaucoma, difficulty in urination from the bladder, weakened gastrointestinal peristalsis, myasthenia gravis (a disease characterized by muscle weakness and fatigue of skeletal muscles after repeated effort; initial symptoms include drooping eyelids, double vision, nasal voice, difficulty chewing and swallowing, difficulty lifting upper limbs and walking; rarely, respiratory muscle weakness may occur), or dementia (reduced mental capacity);
if the patient is simultaneously taking other medicines that depress the central nervous system or medicines with anticholinergic properties (in such patients, dose adjustment may be necessary).

Administration of Hydroxyzinum Hasco tablets should be discontinued at least 5 days before undergoing allergy tests or so-called methacholine bronchial provocation tests to avoid interference of the medicine with test results.
Use of Hydroxyzinum Hasco may be associated with an increased risk of potentially life-threatening heart rhythm disturbances. Therefore, inform your doctor about any heart problems and about any other medicines you are taking, including those available without a prescription.
If, during treatment with Hydroxyzinum Hasco, 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 be discontinued.
Hydroxyzinum Hasco and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines you plan to take.
This also applies to medicines available without a prescription. Hydroxyzinum Hasco may affect the action of other medicines. Other medicines may affect the action of Hydroxyzinum Hasco.
Concomitant use of hydroxyzine with medicines that depress the central nervous system or with medicines exhibiting anticholinergic effects may require a lower dose, which should be individually adjusted according to the patient's response.
Hydroxyzine acts antagonistically to betahistine and cholinesterase inhibitors.
Concomitant administration of hydroxyzine with monoamine oxidase inhibitors (MAO inhibitors) should be avoided.
Hydroxyzine reduces the blood pressure increase caused by adrenaline and diminishes the anticonvulsant effect of phenytoin.
Cimetidine increases the plasma concentration of hydroxyzine and reduces the concentration of its metabolite – cetirizine.
Since hydroxyzine is metabolized via alcohol dehydrogenase and CYP3A4/5 enzymes, concomitant use of drugs that inhibit these enzymes may lead to increased plasma concentrations of hydroxyzine.
Concomitant administration of hydroxyzine and medicines that may cause heart rhythm disturbances may increase the risk of ECG changes – QT interval prolongation or occurrence of torsade de pointes-type arrhythmias.
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Caution is advised when using hydroxyzine concomitantly with medicines causing bradycardia and hypokalemia.
Do not take Hydroxyzinum Hasco if the patient is receiving 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);
cancer (e.g. toremifene, vandetanib);
drug addiction or severe pain (methadone).

Hydroxyzinum Hasco and alcohol
Do not drink alcohol while taking Hydroxyzinum Hasco, as alcohol intensifies the effect of this medicine.
Pregnancy, breastfeeding and effect on 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.
Use of Hydroxyzinum Hasco during pregnancy and breastfeeding is contraindicated. If treatment with Hydroxyzinum Hasco is necessary, breastfeeding must be discontinued.
In newborns whose mothers received hydroxyzine during late pregnancy and/or during delivery, the following symptoms have been observed immediately or several hours after birth: tremors, muscle stiffness and/or weakness, breathing difficulties, and urinary retention.
Animal studies have shown toxic effects of hydroxyzine on reproduction.
Driving and operating machinery
Do not drive or operate machinery while taking Hydroxyzinum Hasco, as this medicine may impair reaction ability and concentration.
Hydroxyzinum Hasco contains monohydrate lactose
One tablet of Hydroxyzinum Hasco contains 49.08 mg of monohydrate lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking the medicine.

3. How to use Hydroxyzinum Hasco

This medicine should always be used as directed by a physician or pharmacist. If in doubt,
consult a physician or pharmacist.
Hydroxyzinum Hasco 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 in all indications
is 100 mg.
In elderly patients, the maximum daily dose is 50 mg.
In children with body weight up to 40 kg, the maximum daily dose is 2 mg/kg body weight/day.
Oral administration.
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The usual dosage regimens are provided below.
Use in adults
Symptomatic treatment of anxiety:
50 mg per day, divided into 2 or 3 doses; in severe cases, up to 100 mg per day may be used.
Symptomatic treatment of pruritus (itching):
treatment should be initiated with a dose of 25 mg at bedtime; if necessary, the dose may be
increased to 25 mg 3 or 4 times daily.
Premedication prior to surgical procedures:
50 to 100 mg as a single dose.
For doses not achievable with tablets of this strength, the physician may prescribe another
available strength of this medicine.
Use in children and adolescents
Children from 12 months of age
In children with body weight up to 40 kg, the maximum daily dose is 2 mg/kg body weight/day.
In children with body weight above 40 kg, the maximum daily dose is 100 mg.
Symptomatic treatment of pruritus:
1 mg per kg body weight per day up to 2 mg per kg body weight per day, in divided doses.
Premedication prior to surgical procedures:
0.6 mg of hydroxyzine per kg body weight as a single dose.
Dosage adjustment
The physician will individually adjust the dosage within the recommended dose range according to
the patient's response to treatment.
Elderly patients
In elderly patients, treatment should be initiated with half the dose recommended for adults. In elderly
patients, the maximum daily dose is 50 mg.
Patients with hepatic impairment
In patients with hepatic impairment, a 33% reduction of the daily dose is recommended.
Patients with moderate or severe renal impairment
In patients with moderate or severe renal impairment, due to reduced elimination of the drug's
metabolite, cetirizine, the administered doses should be reduced.
Use of a higher than recommended dose of Hydroxyzinum Hasco
If a patient has taken or used an excessive dose of Hydroxyzinum Hasco, contact a physician
immediately, especially if it 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
torsade de pointes.
Symptoms of Hydroxyzinum Hasco overdose include: nausea, vomiting, rapid heartbeat
(tachycardia), fever, drowsiness, disturbances of pupillary reflex, tremor, confusion or hallucinations,
followed by decreased level of consciousness, reduced respiratory rate (respiratory depression),
seizures, hypotension or cardiac arrhythmias, and progressing to deepening coma and
cardiorespiratory collapse.
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Missed dose of Hydroxyzinum Hasco
Do not use a double dose to make up for a missed dose.
Discontinuation of Hydroxyzinum Hasco
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 not everybody will experience them.
Treatment must be discontinued and immediate medical advice sought if the patient develops
cardiac rhythm disturbances such as rapid heartbeat (palpitations), difficulty breathing, loss of
consciousness, or symptoms of anaphylactic shock (caused by a severe systemic allergic reaction):
shortness of breath, swelling of the larynx and throat, skin itching and redness, headache, feeling of
"tightness", dizziness, significant weakness, up to and including loss of consciousness. Anaphylactic
shock may be life-threatening in severe cases.
Very common (in more than 1 out of 10 patients):
drowsiness.
Common (in no more than 1 out of 10 patients):
dry mouth,
fatigue, headache,
sedation.
Uncommon (in no more than 1 out of 100 patients):
nausea,
malaise,
fever,
dizziness,
insomnia,
tremor,
agitation,
confusion.
Rare (in no more than 1 out of 1,000 patients):
increased heart rate (tachycardia),
accommodation disorders, blurred vision,
constipation,
vomiting,
hypersensitivity reactions,
abnormal liver function tests,
seizures,
involuntary, uncoordinated movements of limbs and other body parts (dyskinesia),
disorientation,
hallucinations,
urinary retention,
itching, erythematous rash, maculopapular rash, urticaria, dermatitis,
hypotension.
Very rare (occurring in fewer than 1 out of 10,000 patients):
bronchospasm,
angioedema (skin lesions presenting as irregular patches, blisters and swelling),
increased sweating,
persistent drug eruption,
acute generalized exanthematous pustulosis (pustular rash on erythematous skin, which may be
accompanied by swelling and systemic symptoms such as fever),
erythema multiforme (skin rash which may lead to blister formation and resemble target lesions:
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 the available data):
changes in electrocardiogram (ECG findings showing QT interval prolongation or cardiac rhythm
disturbances such as torsade de pointes), weight gain.
Additionally, the following adverse reactions related to cetirizine, the main metabolite of
hydroxyzine, have been observed and may also occur after administration of hydroxyzine:
decreased platelet count (thrombocytopenia), aggression, depression, tics, dystonia (involuntary
movements of various body parts), paresthesia (episodes of compulsive upward gaze with eye
rotation), diarrhea, difficulty in urination, involuntary urination, fatigue and weakness (asthenia),
edema, weight gain.
Other adverse reactions may occur in some individuals during treatment with Hydroxyzinum Hasco.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, patients
should inform their 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:
Aleje 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 Hydroxyzinum Hasco

Store below 25°C.
Keep in the original packaging to protect from light.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via sewage systems or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Hydroxyzinum Hasco contains

The active substance is hydroxyzine hydrochloride. One coated tablet of Hydroxyzinum Hasco contains 10 mg of hydroxyzine.
The other excipients are: monohydrate lactose, microcrystalline cellulose, anhydrous colloidal silicon dioxide, magnesium stearate and the coating (containing hypromellose, 6/7
polydextrose, titanium dioxide (E 171), talc, maltodextrin and medium-chain triglycerides).
One coated tablet contains 49.08 mg of monohydrate lactose.

What Hydroxyzinum Hasco looks like and contents of the pack
White, round, biconvex, smooth coated tablets.
One pack of Hydroxyzinum Hasco contains 30 coated tablets.

Marketing authorisation holder and manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E

Information on the medicinal product
tel.: 22 742 00 22
e-mail: [email protected]
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