Hidroxizinum Hasco

Package Leaflet: Information for the Patient

Hydroxyzinum Hasco, 10 mg/5 ml, Syrup

Hydroxyzine Hydrochloride

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please tell your 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 pack 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
Premedication before surgical procedures

2. Important Information Before Taking Hydroxyzinum Hasco

When Not to Take Hydroxyzinum Hasco

if you are allergic to hydroxyzine, cetirizine, other piperazine derivatives, aminophylline, ethylenediamine, or any of the other ingredients of this medicine (listed in section 6); if you have porphyria (a disease characterized by abnormal heme production - a component of hemoglobin); if your ECG (electrocardiogram) shows heart rhythm disturbances called QT interval prolongation; if you have cardiovascular disease or if your heart rate is very low; if you have low electrolyte levels in your blood (e.g., low potassium or magnesium levels); if you are taking certain medications used to treat heart rhythm disorders or medications that may affect heart rhythm (see "Hydroxyzinum Hasco and other medications"); if someone in your family has died suddenly due to heart disease; during pregnancy and breastfeeding; if you have hereditary intolerance to certain sugars.

• Contraindications include: known hypersensitivity to the active substance or to any of the excipients, porphyria, QT interval prolongation, cardiovascular disease, low electrolyte levels, and concomitant use of certain medications.

Warnings and Precautions

Before starting treatment with Hydroxyzinum Hasco, discuss it with your doctor or pharmacist.
Be particularly cautious when taking Hydroxyzinum Hasco:
if you have an increased tendency to seizures (such cases have been reported more frequently in children than in adults);
if you have glaucoma, difficulty urinating, weakened gastrointestinal peristalsis, 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, walking; rarely, there is weakness of respiratory muscles) or dementia;
if you are taking other medications that depress the central nervous system or have anticholinergic properties (in these patients, a lower dose may be necessary, which should be adjusted individually according to the patient's reaction).
Treatment 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 medication on the results of these tests.
Taking Hydroxyzinum Hasco may be associated with an increased risk of heart rhythm disturbances, which can be life-threatening. Therefore, you should tell your doctor about any heart rhythm disturbances and about taking any other medications, including those available without a prescription.
If you experience heart symptoms such as rapid heartbeat (palpitations), difficulty breathing, or loss of consciousness while taking Hydroxyzinum Hasco, you should immediately consult a doctor. You should discontinue hydroxyzine treatment.

Hydroxyzinum Hasco and Other Medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as medications you plan to take.
This includes medications available without a prescription. Hydroxyzinum Hasco may affect the action of other medications. Other medications may affect the action of Hydroxyzinum Hasco.
Concomitant use of hydroxyzine with medications 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 betahistine and cholinesterase inhibitors.
Concomitant administration of hydroxyzine with monoamine oxidase inhibitors (MAOIs) should be avoided.
Hydroxyzine limits the increase in blood pressure caused by adrenaline and reduces the anticonvulsant effect of phenytoin.
Since hydroxyzine is metabolized with the participation of alcohol dehydrogenase and CYP3A4/5, concomitant use of medications that inhibit the action of these enzymes may lead to an increase in hydroxyzine levels in the blood.
Concomitant administration of hydroxyzine and medications that may cause heart rhythm disturbances may increase the risk of changes in the ECG recording - QT interval prolongation or the occurrence of heart rhythm disturbances of the torsade de pointes type.
You should not take Hydroxyzinum Hasco if you are taking medications used to treat:
bacterial infections (e.g., antibiotics such as erythromycin, moxifloxacin, levofloxacin);
fungal infections (e.g., pentamidine);
heart disease 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 and Alcohol

Do not drink alcohol while taking Hydroxyzinum Hasco, as it enhances the effect of this medication.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medication.
Taking Hydroxyzinum Hasco during pregnancy and breastfeeding is contraindicated.
If it is necessary to use Hydroxyzinum Hasco, breastfeeding should be discontinued.

Driving and Operating Machines

Do not drive vehicles or operate machines while taking Hydroxyzinum Hasco, as this medication may impair your reaction and concentration abilities.

Hydroxyzinum Hasco Contains Sucrose

If you have previously been diagnosed with intolerance to certain sugars, you should consult your doctor before taking this medication.
Hydroxyzinum Hasco syrup contains 0.685 g of sucrose per 1 ml (i.e., approximately 3.4 g per 5 ml).
In diabetic patients, due to the sucrose content in the medication, when taking Hydroxyzinum Hasco syrup in amounts greater than approximately 7 ml (which corresponds to approximately 4.8 g of sucrose), the sucrose content should be taken into account.

3. How to Take Hydroxyzinum Hasco

Always take this medication exactly as your doctor or pharmacist has told you. If you are not sure, ask your 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 over 40 kg, the maximum daily dose for all indications is 100 mg.
In the elderly, the maximum daily dose is 50 mg.
In children under 40 kg, the maximum daily dose is 2 mg/kg body weight per day.
The medication is taken orally.
Usual dosing is described 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 can be taken.
Symptomatic treatment of itching:
treatment should be started with a dose of 25 mg before bedtime; if necessary, the doctor may increase the dose to 25 mg 3 or 4 times a day.
Premedication before surgical procedures:
50 mg to 100 mg in a single dose.

Use in Children and Adolescents

Children from 12 Months

In children under 40 kg, the maximum daily dose is 2 mg/kg body weight per day.
In children 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.
Premedication before surgical procedures:
0.6 mg per kg body weight in a single dose.
The medication should be measured using the enclosed measuring cup.

Dose Adjustment

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

Use of Hydroxyzinum Hasco in the Elderly

In the elderly, it is recommended to start treatment with half the dose recommended for adults. In the elderly, the maximum daily dose is 50 mg.

Use of Hydroxyzinum Hasco in Patients with Liver Impairment

In patients with liver impairment, it is recommended to reduce the daily dose by 33%.

Use of Hydroxyzinum Hasco in Patients with Moderate or Severe Renal Impairment

In patients with moderate or severe renal impairment, due to reduced elimination of the medication's metabolite, cetirizine, the used doses should be reduced.

Overdose of Hydroxyzinum Hasco

If you have taken or used too much Hydroxyzinum Hasco, contact your doctor immediately, especially if it concerns a child. In case of overdose, symptomatic treatment can be used. ECG monitoring is recommended due to the possibility of heart rhythm disturbances, such as QT interval prolongation or torsade de pointes.
Symptoms of Hydroxyzinum Hasco overdose are: nausea, vomiting, rapid heart rate (tachycardia), fever, drowsiness, pupillary reflex disturbances, tremors, confusion or hallucinations, and then decreased consciousness, reduced breathing rate (respiratory depression), seizures, hypotension, or heart rhythm disturbances, as well as deepening coma and cardiopulmonary collapse.

Missed Dose of Hydroxyzinum Hasco

Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Hydroxyzinum Hasco can cause side effects, although not everybody gets them.
Very Common(affects more than 1 in 10 people):
drowsiness.
Common(affects 1 to 10 people in 100):
dry mouth,
fatigue, headache,
sedation.
Uncommon(affects 1 to 10 people in 1,000):
nausea,
malaise,
fever,
dizziness,
insomnia,
tremors,
excitement,
confusion.
Rare(affects 1 to 10 people in 10,000):
rapid heart rate (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(affects less than 1 in 10,000 people):
anaphylactic shock (a severe, life-threatening allergic reaction, symptoms include: shortness of breath, swelling of the throat and larynx, 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.
bronchospasm,
angioedema (skin lesions 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 it),
Stevens-Johnson syndrome (widespread rash with blisters and peeling skin, occurring mainly in the area of the mouth, eyes, nose, and genitals).
Frequency Not Known(frequency cannot be estimated from the available data):
changes in the ECG recording (QT interval prolongation or heart rhythm disturbances of the torsade de pointes type),

• weight gain.

If you experience heart rhythm disturbances, such as rapid heartbeat (palpitations), difficulty breathing, or loss of consciousness, you should stop taking the medication and immediately consult a doctor.
Additionally, the following side effects have been observed with cetirizine, the main metabolite of hydroxyzine, which may also occur with hydroxyzine:
decreased platelet count (thrombocytopenia), aggression, depression, tics, dystonia (involuntary movements of different body parts), paresthesia (feeling of numbness and tingling), forced gaze with eye rotation, diarrhea, difficulty urinating, involuntary urination, fatigue and weakness (asthenia), edema, weight gain.
In some individuals, other side effects may occur while taking Hydroxyzinum Hasco.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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 side effects will help gather more information on the safety of this medication.
Side effects can also be reported to the marketing authorization holder.

5. How to Store Hydroxyzinum Hasco

Store in a temperature below 25°C. Store in the original packaging to protect from light.
Keep the medication out of the sight and reach of children.
Shelf life after first opening: 12 months.
Do not use this medication after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

What Hydroxyzinum Hasco Contains

• The active substance is hydroxyzine hydrochloride. 1 ml contains 2 mg of hydroxyzine hydrochloride.
• The other ingredients (excipients) are: sucrose, sodium hydroxide r-r 30%, raspberry flavor AR 0320, purified water.

What Hydroxyzinum Hasco Looks Like and Contents of the Pack

Hydroxyzinum Hasco is a colorless or light brown syrup with a raspberry flavor.
One pack of the medication (a brown glass bottle) contains 200 ml of the solution.
The bottle with a measuring cup for administering the medication is placed in a cardboard box.

Marketing Authorization Holder and Manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medication Information
tel.: +48 (22) 742 00 22
e-mail: [email protected]
Date of Last Revision of the Leaflet:07/2022