Hidroxizinum Hasco

Package Leaflet: Information for the Patient

Hydroxyzinum Hasco, 25 mg, Film-Coated Tablets

Hydroxyzine Hydrochloride

Read the Leaflet Carefully Before Taking the Medication, 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 medication has been prescribed specifically for you. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, 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
• Pre-medication before surgical procedures

2. Important Information Before Taking Hydroxyzinum Hasco

When Not to Take Hydroxyzinum Hasco

• ;
• during breastfeeding and pregnancy.

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Warnings and Precautions

Before starting Hydroxyzinum Hasco, discuss it with your doctor or pharmacist.
Be particularly cautious when taking Hydroxyzinum Hasco:

myasthenia gravis(a disease characterized by muscle weakness and fatigue after repeated exertion; initial symptoms include: drooping eyelids, double vision, nasal voice, difficulty chewing and swallowing, difficulty lifting upper limbs and walking; rarely, respiratory muscle weakness occurs); or dementia;

Discontinue Hydroxyzinum Hasco tablets 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 disorders, which can be life-threatening. Therefore, tell your doctor about any heart disorders and the use of any other medications, including those available without a prescription.
If you experience heart symptoms such as rapid heartbeat (palpitations), breathing difficulties, or loss of consciousness while taking Hydroxyzinum Hasco, seek medical attention immediately. 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 any 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 response.
Hydroxyzine acts antagonistically to betahistine and cholinesterase inhibitors.
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 the blood and decreases the concentration of its metabolite, cetirizine.
Since hydroxyzine is metabolized by alcohol dehydrogenase and CYP3A4/5, concomitant use of medications that inhibit the action of these enzymes may lead to increased hydroxyzine concentrations in the blood.
Concomitant administration of hydroxyzine and medications that may cause heart rhythm disorders may increase the risk of changes in the ECG recording - QT interval prolongation or heart rhythm disorders of the torsade de pointestype.
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Be cautious when concomitantly using medications that cause bradycardia and hypokalemia.
Do not take Hydroxyzinum Hasco if you are receiving 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 disorders (e.g., prucalopride);
• allergies;
• malaria (e.g., mefloquine);
• cancer (e.g., toremifene, vandetanib);
• drug addiction or severe pain (methadone).

Hydroxyzinum Hasco with Alcohol

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

Pregnancy, Breastfeeding, and Fertility

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.
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.
Animal studies have shown a toxic effect of hydroxyzine on reproduction.

Driving and Operating Machines

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

Hydroxyzinum Hasco Contains Lactose Monohydrate

One Hydroxyzinum Hasco tablet contains 43.60 mg of lactose monohydrate. If you have previously been diagnosed with intolerance to some sugars, consult your doctor before taking the medication.

Hydroxyzinum Hasco Contains Sodium

The medication contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to Take Hydroxyzinum Hasco

Always take this medication exactly as your doctor or pharmacist has told you. If you are unsure, consult 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.
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In children under 40 kg, the maximum daily dose is 2 mg/kg body weight per day.
Oral administration.
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 may be used.
Symptomatic treatment of itching:
treatment should be started with a dose of 25 mg before bedtime, and if necessary, the dose can be increased to 25 mg 3 or 4 times a day.
Pre-medication 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 medication.

Administration 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/kg body weight per day to 2 mg/kg body weight per day in divided doses.
Pre-medication before surgical procedures:
0.6 mg hydroxyzine per kg body weight as a single dose.

Dose Adjustment

Your doctor will adjust the dose individually within the recommended dose range, depending on your response to treatment.

Elderly Patients

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

Patients with Liver Impairment

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

Patients with Moderate or Severe Renal Impairment

In patients with moderate or severe renal impairment, due to reduced excretion of the medication's metabolite, cetirizine, the doses used 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. Monitor ECG due to the possibility of heart rhythm disorders, such as QT interval prolongation or torsade de pointes.
Symptoms of Hydroxyzinum Hasco overdose include: nausea, vomiting, rapid heartbeat (tachycardia), fever, drowsiness, pupillary reflex disorders, 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.

Missed Dose of Hydroxyzinum Hasco

Do not take a double dose to make up for a missed dose.

Discontinuation of Hydroxyzinum Hasco

If you have any further doubts about taking this medication, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Hydroxyzinum Hasco can cause side effects, although not everybody gets them.
Stop taking the medication and seek medical attention immediately if you experience heart rhythm disorders, such as rapid heartbeat (palpitations), breathing difficulties, loss of consciousness, or symptoms of anaphylactic shock (a severe, systemic allergic reaction): shortness of breath, throat and throat swelling, 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(affects more than 1 in 10 people):
drowsiness.
Common(affects no more than 1 in 10 people):
dry mouth,
fatigue, headache,
sedation.
Uncommon(affects no more than 1 in 100 people):
nausea,
malaise,
fever,
dizziness,
insomnia,
trembling,
excitement,
confusion.
Rare(affects no more than 1 in 1000 people):
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(affects less than 1 in 10,000 people):
bronchospasm,
angioedema (skin rash 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 mouth, eyes, nose, and genital areas).
Frequency Not Known(frequency cannot be estimated from the available data):
changes in the ECG recording (QT interval prolongation or heart rhythm disorders of the torsade de pointestype), weight gain.
Additionally, the following side effects have been observed with cetirizine, the main metabolite of hydroxyzine, which may also occur after hydroxyzine administration:
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.
Some people may experience other side effects while taking Hydroxyzinum Hasco.

Reporting Side Effects

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

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 sight and reach of children.
Do not use this medication after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

6. Contents of the Pack and Other Information

What Hydroxyzinum Hasco Contains

• The active substance of Hydroxyzinum Hasco is hydroxyzine hydrochloride. 6/7

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

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

One film-coated tablet contains 43.60 mg of lactose monohydrate.

What Hydroxyzinum Hasco Looks Like and Contents of the Pack

White, oval, biconvex, smooth film-coated tablets with a score line on both sides. The tablet can be divided into equal doses.
One pack of Hydroxyzinum Hasco contains 30 film-coated tablets.

Marketing Authorization Holder and Manufacturer

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

Medication Information

phone: 22 742 00 22
e-mail: [email protected]

Date of Last Revision of the Leaflet:

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