Package leaflet: Information for the patient

Hydroxyzinum Hasco, 10 mg/5 ml, syrup
Hydroxyzini hydrochloridum
Please read the entire leaflet carefully before using the medicine, as it contains important information for the patient.

Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist immediately. See section 4.

Table of contents

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

1. What is Hydroxyzinum Hasco and what is it 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 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 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 with other medicines");
if someone in the patient's family has died suddenly due to heart disease;
during pregnancy and while breastfeeding;
if the patient has a hereditary intolerance to certain sugars.

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 exertion; initial symptoms include drooping eyelids, double vision, nasal speech, difficulty chewing and swallowing, difficulty raising upper limbs, walking; rarely, respiratory muscle weakness may occur), or dementia (reduced mental capacity);
if the patient is concurrently using other medicines that depress the central nervous system or medicines with anticholinergic properties (in such patients, dosage adjustment may be necessary).
Treatment should be discontinued at least 5 days before undergoing allergy tests or so-called bronchial provocation tests with methacholine 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 disturbances. Therefore, inform your doctor about any heart conditions and about taking any other medicines, including those available without 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 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 also includes 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 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.
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 heart rhythm disturbances such as torsade de pointes.
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 and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Use of Hydroxyzinum Hasco during pregnancy and while breastfeeding is contraindicated.
If use of Hydroxyzinum Hasco is necessary, breastfeeding must be discontinued.

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 sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Hydroxyzinum Hasco in syrup form contains 0.685 g of sucrose per 1 ml (i.e. approximately 3.4 g in 5 ml).
In diabetic patients, due to the sucrose content of the medicine, the amount of this ingredient should be taken into account when administering more than approximately 7 ml of Hydroxyzinum Hasco syrup (corresponding to about 4.8 g of sucrose).

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.
This medicine is taken orally.
The usual dosing recommendations are given below.
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 physician may
increase the dose to 25 mg 3 or 4 times daily.
Premedication before surgical procedures:
50 mg to 100 mg as a single dose.
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 per kg body weight as a single dose.
The medicine should be measured using the provided measuring device.
Dose adjustment
The physician will individually adjust the dose within the recommended dose range depending on the patient's response to treatment.
Use of Hydroxyzinum Hasco in 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.
Use of Hydroxyzinum Hasco in patients with hepatic impairment
In patients with liver impairment, a 33% reduction in the daily dose is recommended.
Use of Hydroxyzinum Hasco in patients with moderate or severe renal impairment
In patients with moderate or severe renal impairment, due to reduced excretion 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 more than the recommended dose of Hydroxyzinum Hasco, contact a physician immediately, especially if it concerns a child. In case of overdose, symptomatic treatment may be applied. ECG monitoring is recommended due to the risk 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 circulatory-respiratory collapse.
Missed dose of Hydroxyzinum Hasco
Do not take a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
Very common (in more than 1 patient out of 10):
drowsiness.
Common (in 1 to 10 patients out of 100):
dry mouth,
fatigue, headache,
sedation.
Uncommon (in 1 to 10 patients out of 1,000):
nausea,
malaise,
fever,
dizziness,
insomnia,
tremor,
nervousness,
confusion.
Rare (in 1 to 10 patients out of 10,000):
rapid heartbeat (tachycardia),
accommodation disorders, blurred vision,
constipation,
vomiting,
hypersensitivity reactions,
abnormal liver function tests,
seizures,
involuntary, uncoordinated movements of limbs and other body parts (so-called dyskinesia),
disorientation,
hallucinations,
urinary retention,
itching, erythematous rash, maculopapular rash, urticaria, dermatitis,
hypotension.
Very rare (occurring in less than 1 patient out of 10,000):
anaphylactic shock (caused by a severe systemic allergic reaction; symptoms include: shortness of breath, laryngeal and pharyngeal swelling, skin itching and redness, headache, sensation of "pressure", dizziness, profound weakness up to loss of consciousness).
Anaphylactic shock in severe cases may be life-threatening.
bronchospasm,
angioedema (skin manifestations in the form of irregular patches, blisters and swellings),
excessive 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 lead to blister formation and resemble small 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 based on available data):
changes in electrocardiogram (ECG) findings (prolongation of QT interval or cardiac arrhythmias of the torsade de pointes type),

weight gain.

The medicine should be discontinued and medical advice should be sought immediately if the patient experiences
cardiac arrhythmias such as rapid heartbeat (palpitations), difficulty breathing, or loss of consciousness.
Additionally, the following adverse reactions associated with cetirizine, the main metabolite of hydroxyzine, have been observed and may also occur during hydroxyzine treatment:
decreased platelet count (thrombocytopenia), aggression, depression, tics, dystonia (involuntary movements of various body parts), paresthesia (tingling and numbness sensations), 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 reactions occur, including any not listed in this leaflet, patients should inform their doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Aleje Jerozolimskie 181C, 02-222 Warsaw:
tel.: 22 49 21 301, fax: 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to gather more information on the safety of the medicine.
Adverse reactions can also be reported to the marketing authorization holder.

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.
Shelf life after first opening: 12 months.
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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Hydroxyzinum Hasco contains

The active substance is hydroxyzine hydrochloride. 1 ml contains 2 mg of hydroxyzine hydrochloride.
Other components (excipients): sucrose, sodium hydroxide 30% solution, raspberry flavour AR 0320, purified water.

What Hydroxyzinum Hasco looks like and contents of the pack
Hydroxyzinum Hasco is a colourless or light brown syrup with a raspberry odour.
One pack (a brown glass bottle) contains 200 ml of solution.
The bottle together with the dosing device is placed in a cardboard box.

Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Product information
tel.: +48 (22) 742 00 22
e-mail: [email protected]