Hidroxizinum Hasco

Leaflet attached to the packaging: patient information

Hydroxyzinum Hasco, 10 mg, coated tablets

Hydroxyzine hydrochloride

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

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

The active substance of Hydroxyzinum Hasco is hydroxyzine, which has antihistamine, sedative, and anxiolytic effects.

Indications for use

• Symptomatic treatment of anxiety in adults
• Symptomatic treatment of itching
• Pre-medication before surgical procedures

2. Important information before taking Hydroxyzinum Hasco

When not to take 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);
• 6);
• if the patient has porphyria (a disease characterized by abnormal heme production);
• if the patient's ECG (electrocardiogram) shows heart rhythm disturbances called QT interval prolongation;
• if the patient has a cardiovascular disease or if their heart rate is very low;
• if the patient has low electrolyte levels in their 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 "Hydroxyzinum Hasco and other medicines");
• if someone in the patient's family has died suddenly due to a heart disease;
• during breastfeeding and pregnancy.

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Warnings and precautions

Before starting treatment with Hydroxyzinum Hasco, the patient should discuss it with their doctor or pharmacist.
The patient should be particularly cautious when taking Hydroxyzinum Hasco:

• if they have an increased tendency to seizures (such cases have been reported more frequently in children than in adults);
• if they have glaucoma, difficulty urinating, decreased gastrointestinal motility, 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, there is weakness of the respiratory muscles) or dementia (reduced mental performance);
• if they are taking other medicines that depress the central nervous system or have anticholinergic properties (in these patients, a lower dose may be required, which should be adjusted individually according to the patient's reaction).

Administration of Hydroxyzinum Hasco tablets should be discontinued at least 5 days before performing allergy tests or the so-called methacholine bronchial provocation test to avoid the influence of the medicine on the results of these tests.
Taking Hydroxyzinum Hasco may be associated with an increased risk of heart rhythm disorders, which can be life-threatening. Therefore, the patient should tell their doctor about any heart disorders and the use of any other medicines, including those available without a prescription.
If the patient experiences heart symptoms such as rapid heartbeat (palpitations), breathing difficulties, or loss of consciousness while taking Hydroxyzinum Hasco, they should immediately consult their doctor. The treatment with hydroxyzine should be discontinued.

Hydroxyzinum Hasco and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they 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 have anticholinergic properties may require the use of a lower dose, which should be adjusted individually according to the patient's reaction.
Hydroxyzine acts antagonistically to betahistidine and cholinesterase inhibitors.
The patient should avoid concomitant administration of hydroxyzine with monoamine oxidase inhibitors (MAOIs).
Hydroxyzine limits the increase in blood pressure caused by adrenaline and reduces the anticonvulsant effect of phenytoin.
Cimetidine increases the concentration of hydroxyzine in blood plasma and decreases the concentration of its metabolite, cetirizine.
Since hydroxyzine is metabolized with the participation of alcohol dehydrogenase and CYP3A4/5, concomitant use of medicines that inhibit the action of these enzymes may lead to an increase in hydroxyzine concentration in blood plasma.
Concomitant administration of hydroxyzine and medicines that may cause heart rhythm disorders may increase the risk of changes in the ECG record - QT interval prolongation or heart rhythm disorders of the torsade de pointes type.
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The patient should be cautious when taking Hydroxyzinum Hasco with medicines that cause bradycardia and hypokalemia.
The patient should not take Hydroxyzinum Hasco if they are 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 diseases (e.g., prucalopride);
• allergies;
• malaria (e.g., mefloquine);
• cancer (e.g., toremifene, vandetanib);
• drug addiction or severe pain (methadone).

Hydroxyzinum Hasco with alcohol

While taking Hydroxyzinum Hasco, the patient should not drink alcohol, as it enhances the effect of the medicine.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Taking Hydroxyzinum Hasco during pregnancy and breastfeeding is contraindicated. If it is necessary to take Hydroxyzinum Hasco, breastfeeding should be discontinued.
In newborns whose mothers received hydroxyzine during late pregnancy and/or during delivery, the following symptoms have been observed directly or a few hours after birth: trembling, stiffness, and/or muscle weakness, breathing difficulties, and urinary retention.
Studies in animals have shown a toxic effect of hydroxyzine on reproduction.

Driving and operating machinery

While taking Hydroxyzinum Hasco, the patient should not drive vehicles or operate machinery, as the medicine may impair their reaction and concentration abilities.

Hydroxyzinum Hasco contains lactose monohydrate

One Hydroxyzinum Hasco tablet contains 49.08 mg of lactose monohydrate. If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Hydroxyzinum Hasco

This medicine should always be taken according to the doctor's or pharmacist's recommendations. If the patient has any doubts, they should consult their doctor or pharmacist.
Hydroxyzinum Hasco should be taken in the smallest effective dose. The treatment duration should be as short as possible.
In adults and children with a body weight over 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 a body weight up to 40 kg, the maximum daily dose is 2 mg/kg body weight per day.
Oral administration.
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The usual dosing is described below.

Administration 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 can be taken.
Symptomatic treatment of itching:
treatment should be started with a dose of 25 mg before bedtime, and the dose can be increased to 25 mg 3 or 4 times a day if necessary.
Pre-medication before surgical procedures:
50 to 100 mg in a single dose.
For doses that cannot be achieved with tablets of this strength, the doctor may prescribe another available strength of this medicine.

Administration in children and adolescents

Children from 12 months
In children with a body weight up to 40 kg, the maximum daily dose is 2 mg/kg body weight per day.
In children with a body weight over 40 kg, the maximum daily dose is 100 mg.
Symptomatic treatment of itching:
1 mg per kg body weight per day to 2 mg per kg body weight per day in divided doses.
Pre-medication before surgical procedures:
0.6 mg of hydroxyzine per kg body weight in a single dose.

Dose adjustment

The doctor will adjust the dose individually, within the recommended dose range, depending on the patient's reaction to the 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.

Patients with liver failure

In patients with liver failure, the daily dose of the medicine should be reduced by 33%.

Patients 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 doses used should be reduced.

Overdose of Hydroxyzinum Hasco

If the patient has taken or administered too much Hydroxyzinum Hasco, they should immediately contact their doctor, especially if it concerns a child.
In case of overdose, symptomatic treatment can be applied. The patient's ECG should be monitored due to the possibility of heart rhythm disorders, such as QT interval prolongation or torsade de pointes.
Symptoms of overdose of Hydroxyzinum Hasco include: nausea, vomiting, rapid heartbeat (tachycardia), fever, drowsiness, disturbances of pupillary reflex, trembling, confusion, or hallucinations, followed by decreased consciousness, reduced breathing frequency (respiratory depression), seizures, hypotension, or heart rhythm disorders, and deepening coma and cardiopulmonary collapse.
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Missed dose of Hydroxyzinum Hasco

The patient should not take a double dose to make up for a missed dose.

Discontinuation of Hydroxyzinum Hasco

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Hydroxyzinum Hasco can cause side effects, although not everybody gets them.
The patient should stop taking the medicine and immediately consult their doctor if they experience heart rhythm disorders, such as rapid heartbeat (palpitations), breathing difficulties, loss of consciousness, as well as if they experience symptoms of anaphylactic shock (caused by a severe systemic allergic reaction): shortness of breath, swelling of the throat and pharynx, skin itching and redness, headache, feeling of "pressure", dizziness, significant weakness, up to loss of consciousness. Anaphylactic shock can be life-threatening in severe cases.
Very common(in more than 1 in 10 patients):
drowsiness.
Common(in up to 1 in 10 patients):
dry mouth,
fatigue, headache,
sedation (sedation).
Uncommon(in up to 1 in 100 patients):
nausea,
malaise,
fever,
dizziness,
insomnia,
trembling,
excitement,
confusion.
Rare(in up to 1 in 1,000 patients):
rapid heartbeat (tachycardia),
accommodation disorders, blurred vision,
constipation,
vomiting,
allergic reactions,
abnormal liver function test results,
seizures,
involuntary, uncoordinated movements of limbs and other body parts (dyskinesia),
disorientation,
hallucinations,
urinary retention,
itching, rash, urticaria, skin inflammation,
hypotension.
Very rare(in less than 1 in 10,000 patients):
bronchospasm,
angioedema (skin rashes 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 such as fever),
erythema multiforme (skin rash that can cause blistering and looks like small targets: a dark spot surrounded by a lighter area and a dark ring around),
Stevens-Johnson syndrome (widespread rash with blisters and peeling skin, occurring mainly in the mouth, eyes, nose, and genital areas).
Frequency not known(frequency cannot be estimated from the available data):
changes in the ECG record (QT interval prolongation or heart rhythm disorders of the torsade de pointes type), weight gain.
Additionally, the following adverse reactions have been observed with cetirizine, which is the main metabolite of hydroxyzine, and may also occur after administration of hydroxyzine:
decreased platelet count (thrombocytopenia), aggression, depression, tics, dystonia (involuntary movements of different body parts), paresthesia (attacks of forced gaze with rotation of the eyeballs), diarrhea, difficulty urinating, involuntary urination, fatigue, and weakness (asthenia), edema, weight gain.
In some patients, other adverse reactions may occur while taking Hydroxyzinum Hasco.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw,
phone: +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 can help gather more information on the safety of the medicine.

5. How to store Hydroxyzinum Hasco

Store in a temperature below 25°C.
Store in the original packaging to protect from light.
The medicine should be stored out of 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 specified month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Hydroxyzinum Hasco contains

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

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 authorization holder and manufacturer

"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E

Medicine information

phone: 22 742 00 22
e-mail: informacjaoleku@hasco-lek.pl

Date of last revision of the leaflet:

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