Hidroxizinum Espefa

Package Leaflet: Information for the Patient

HYDROXYZINUM ESPEFA, 10 mg/5 ml, Syrup

Hydroxyzine Hydrochloride

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a 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 inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

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

Description of the drug:
Hydroxyzinum Espefa contains hydroxyzine hydrochloride as the active substance.
It has antihistamine (reducing allergic symptoms), sedative and anxiolytic effects.
Its action is believed to be related to the influence on histamine, dopamine, and acetylcholine neurotransmission.
Indications:

• treatment of anxiety;
• symptomatic treatment of itching;
• preparation of patients for surgical procedures.

2. Important information before taking Hydroxyzinum Espefa

When not to take Hydroxyzinum Espefa:

• if the patient is allergic (hypersensitive) to the active substance, cetirizine, other piperazine derivatives, aminophylline, or ethylenediamine, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has porphyria;
• in pregnant and breastfeeding women;
• if the patient's ECG (electrocardiogram) shows heart rhythm disorders called QT interval prolongation;
• if the patient has or has had cardiovascular disease or if the heart rate is very low;
• if the patient has low electrolyte levels (e.g., low potassium or magnesium levels);
• if the patient is taking certain medications used to treat heart rhythm disorders or medications that may affect heart rhythm (see "Hydroxyzinum Espefa and other medicines");
• if someone in the patient's family has died suddenly due to heart disease.

Warnings and precautions

Before starting treatment with Hydroxyzinum Espefa, the patient should discuss it with their doctor:

• if the patient has an increased tendency to seizures;
• if the patient has glaucoma;
• if the patient has difficulty urinating from the bladder;
• if the patient has weakened gastrointestinal motility;
• if the patient has muscle weakness or dementia;
• if the patient has known factors predisposing to cardiac arrhythmias;
• if the patient is taking other medications - see "Hydroxyzinum Espefa and other medicines".

Taking Hydroxyzinum Espefa may be associated with an increased risk of heart rhythm disorders, which can be life-threatening. Therefore, the patient should inform their doctor about any heart problems and the use of any other medications, including those available without a prescription.
If cardiac symptoms occur during treatment with Hydroxyzinum Espefa, such as rapid heartbeat (palpitations), difficulty breathing, loss of consciousness, the patient should immediately consult a doctor. The treatment with hydroxyzine should also be discontinued.
The patient should avoid taking Hydroxyzinum Espefa with alcohol or sedatives, as hydroxyzine enhances their effects.
To avoid affecting the results of allergy tests or methacholine bronchial provocation tests, the patient should stop taking the medicine at least 5 days before the tests.

Children and adolescents

Young children are more susceptible to experiencing side effects from the central nervous system (see section 4 "Possible side effects").

Patients with renal and/or hepatic impairment

In patients with moderate or severe renal impairment, due to reduced excretion of the drug's metabolite, cetirizine, the doses used should be reduced.
The dosage in patients with hepatic impairment should be decided by the doctor.

Elderly patients

In elderly patients, it is recommended to start treatment with half the dose used in adults.

Hydroxyzinum Espefa and other medicines

The patient should inform their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take. This includes medications available without a prescription. Hydroxyzinum Espefa may affect the action of other medications. Other medications may affect the action of Hydroxyzinum Espefa.
Particularly, the patient should inform about the use of: painkillers, sleeping pills and sedatives, antidepressants from the imipramine group, antispasmodics, anti-Parkinson's disease medications, disopyramide (an antiarrhythmic medication), medications used in psychiatric disorders from the phenothiazine group, in hypotension, peptic ulcer disease (cimetidine changes the metabolism of the drug), flecainide (an antiarrhythmic medication), thioridazine (a medication used, among others, in schizophrenia).
The patient should not take Hydroxyzinum Espefa if they are taking medications 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).

The patient should avoid taking hydroxyzine and medications from the group of cholinesterase inhibitors (medications used, among others, in Alzheimer's disease) and monoamine oxidase inhibitors (MAOIs) - medications used, among others, in depression.
Hydroxyzine weakens the blood pressure-increasing effect of adrenaline and the anticonvulsant effect of phenytoin.
The patient should avoid taking Hydroxyzinum Espefa with alcohol or other sedatives, as the drug enhances their effects.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
The medicine should not be taken during pregnancy and during childbirth.
The medicine should not be taken during breastfeeding, as it is likely to pass into breast milk.

Driving and operating machinery

Hydroxyzinum Espefa may impair the patient's reaction and concentration abilities. Therefore, during treatment, the patient should not drive vehicles or perform tasks that require full mental and physical fitness.

Hydroxyzinum Espefa contains sucrose

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 Espefa

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Hydroxyzinum Espefa should be taken in the smallest effective dose. The treatment duration should be as short as possible.
The medicine is taken orally.
The recommended dose is:

Adults

In the treatment of anxiety: 50 mg per day in 2 or 3 divided doses.
In the symptomatic treatment of itching:
Treatment should start with a dose of 25 mg before bedtime. If necessary, the dose can be increased to 25 mg, 3 or 4 times a day.
In premedication before surgical procedures: 50 mg to 100 mg once.

Use in children and adolescents

In the symptomatic treatment of itching:
From 12 months: 1 mg/kg body weight per day to 2 mg/kg body weight per day in divided doses.
In premedication before surgical procedures: 0.6 mg/kg body weight once.
In adults and children over 40 kg body weight, the maximum daily dose in all indications is 100 mg.
In elderly patients, the maximum daily dose is 50 mg.
In children under 40 kg body weight, the maximum daily dose is 2 mg/kg body weight per day.
Dose adjustment
The dosage should be adjusted individually, within the recommended dose range, depending on the patient's response to treatment.

Taking a higher dose of Hydroxyzinum Espefa than recommended

In case of taking a higher dose of Hydroxyzinum Espefa than recommended, the patient should immediately consult their doctor or pharmacist, 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 torsades de pointes.
The most common symptom of hydroxyzine overdose is excessive sedation. Other observed symptoms include: nausea, vomiting, tachycardia, fever, drowsiness, weakened pupillary reflex, tremors, confusion or hallucinations, and then decreased consciousness, respiratory depression, seizures, hypotension, or cardiac arrhythmia, and deepening coma and cardio-respiratory arrest.

Missing a dose of Hydroxyzinum Espefa

The patient should not take a double dose to make up for a missed dose.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Hydroxyzinum Espefa 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), difficulty breathing, or loss of consciousness.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist, or nurse.

Anaphylactic shock requires immediate medical attention.

Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C,
02-222 Warsaw, Poland
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 medicine.

5. How to store Hydroxyzinum Espefa

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 month.
Store at a temperature below 25°C.
Store in the original packaging to protect from light.
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 pack and other information

What Hydroxyzinum Espefa contains

• The active substance of the medicine is hydroxyzine hydrochloride. 5 ml of syrup (a spoon) contains 10 mg of hydroxyzine hydrochloride.
• The other ingredients (excipients) are: sucrose, povidone, sodium benzoate, propylene glycol, orange flavor, menthol, purified water.

What Hydroxyzinum Espefa looks like and what the pack contains

A 250 ml bottle contains 250 g of syrup.
A 125 ml bottle contains 150 g of syrup.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Chemiczno - Farmaceutyczna Spółdzielnia Pracy ESPEFA
ul. J. Lea 208
30-133 Kraków, Poland
phone: 12 639 27 27

Information for the blind and visually impaired: 800-007-777

Date of last revision of the leaflet: