Package leaflet: Information for the patient

Hydroxyzinum Hasco, 25 mg, film-coated tablets
Hydroxyzini hydrochloridum
Please read carefully the entire leaflet before taking 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 further 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 other people, even if their symptoms are the same.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

What Hydroxyzinum Hasco is and what it is used for
Important information before taking Hydroxyzinum Hasco
How to take Hydroxyzinum Hasco
Possible adverse reactions
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 prior to surgical procedures

2. Important 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 been diagnosed with porphyria (a disorder characterized by abnormal production of heme – 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 heart rate is very low;
if the patient has low serum electrolyte levels (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 with 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 special 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 due to urinary retention, 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 raising upper limbs and walking; rarely, respiratory muscle weakness occurs), or dementia (reduced mental capacity);
if the patient is concurrently 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 performing allergy tests or so-called methacholine bronchial provocation tests to avoid interference of the drug with test results.
Use of Hydroxyzinum Hasco may be associated with an increased risk of life-threatening heart rhythm disorders. Therefore, inform your doctor about any heart problems and about taking any other medicines, including those available without prescription. If symptoms related to the heart occur during treatment with Hydroxyzinum Hasco, such as rapid heartbeat (palpitations), difficulty breathing, or loss of consciousness, seek immediate medical attention. Treatment with hydroxyzine should be discontinued.
Hydroxyzinum Hasco with other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient plans to take.
This includes medicines available without a prescription. Hydroxyzinum Hasco may affect the action of other medicines, and 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 lower doses, 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 hydroxyzine's metabolite – cetirizine.
Since hydroxyzine is metabolized by 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 consume alcohol while taking Hydroxyzinum Hasco, as alcohol intensifies the effect of this medicine.
Pregnancy, breastfeeding and effects on fertility
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.
Use of Hydroxyzinum Hasco during pregnancy and breastfeeding is contraindicated. If treatment with Hydroxyzinum Hasco is necessary, breastfeeding should 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 lactose monohydrate
One tablet of Hydroxyzinum Hasco contains 43.60 mg of lactose monohydrate. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Hydroxyzinum Hasco contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Hydroxyzinum Hasco

This medicine should always be used according to the instructions given by your doctor or pharmacist. If in doubt,
consult your doctor 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.
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In children with body weight up to 40 kg, the maximum daily dose is 2 mg/kg body weight/day.
Oral administration.
The usual dosage regimens are provided below.
Use in adults
Symptomatic treatment of anxiety:
50 mg per day in 2 or 3 divided 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 before surgical procedures:
50 to 100 mg as a single dose.
For doses that cannot be achieved with tablets of this strength, your doctor 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 before surgical procedures:
0.6 mg of hydroxyzine per kg body weight as a single dose.
Dosage adjustment
Your doctor will individually adjust the dosage 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 dose recommended for adults. In elderly patients, the maximum daily dose is 50 mg.
Patients with hepatic impairment
In patients with liver impairment, a reduction of the daily dose by 33% is recommended.
Patients with moderate or severe renal impairment
In patients with moderate or severe renal impairment, due to reduced excretion of the drug 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 more than the recommended dose of Hydroxyzinum Hasco, contact a doctor immediately, especially if this concerns a child.
In case of overdose, symptomatic treatment may be applied. ECG monitoring is required due to the risk of cardiac arrhythmias 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; subsequently, decreased level of consciousness, reduced respiratory rate
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(respiratory depression), seizures, hypotension or cardiac arrhythmias, and worsening coma with circulatory and respiratory collapse may occur.
Missed dose of Hydroxyzinum Hasco
Do not take a double dose to make up for a missed dose.
Stopping treatment with Hydroxyzinum Hasco
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although they do not occur in everyone.
Treatment should be discontinued and medical advice should be sought immediately if the patient develops
cardiac rhythm disturbances such as rapid heartbeat (palpitations), breathing difficulties, loss of
consciousness, or symptoms of anaphylactic shock (caused by a severe systemic allergic reaction): shortness of breath, laryngeal and pharyngeal swelling, skin itching and redness, headache, sensation of "tightness", dizziness, significant weakness, up to and including loss of consciousness. Anaphylactic shock, in severe cases, may be life-threatening.
Very common (in more than 1 in 10 patients):
drowsiness.
Common (in no more than 1 in 10 patients):
dry mouth,
fatigue, headache,
sedation.
Uncommon (in no more than 1 in 100 patients):
nausea,
malaise,
fever,
dizziness,
insomnia,
tremor,
agitation,
confusion.
Rare (in no more than 1 in 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 in 10,000 patients):
bronchospasm,
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angioedema (skin lesions presenting as irregular patches, blisters and swellings),
excessive 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 cause blister formation and resemble 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 areas around the mouth, eyes, nose and genital organs).
Frequency not known (frequency cannot be estimated from available data):
changes in electrocardiogram (ECG findings showing QT interval prolongation or cardiac arrhythmias such as torsade de pointes), weight gain.
Additionally, the following adverse effects related to cetirizine, the main metabolite of hydroxyzine, have been observed and may also occur following 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), diarrhoea, difficulty in urination, involuntary urination, fatigue and weakness (asthenia), oedema, weight gain.
Other adverse effects may occur in some individuals during treatment with Hydroxyzinum Hasco.
Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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:
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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects 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 the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This helps protect the environment.

6. Contents of the pack and other information

What Hydroxyzinum Hasco contains

The active substance is hydroxyzine hydrochloride. 6/7

One coated tablet of Hydroxyzinum Hasco contains 25 mg of hydroxyzine.

The other ingredients are: monohydrate lactose, microcrystalline cellulose, sodium carboxymethyl starch (type A), colloidal anhydrous silica, magnesium stearate and the coating (containing hypromellose, polydextrose, titanium dioxide (E 171), talc, maltodextrin and medium-chain triglycerides).

Each coated tablet contains 43.60 mg of monohydrate lactose.
What Hydroxyzinum Hasco looks like and contents of the pack
White, oval, biconvex, smooth coated tablets with a score line on both sides. The tablet can be divided into equal doses.
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
Medicinal product information
tel.: 22 742 00 22
e-mail: [email protected]
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