Hidroxizinum Espefa

Package Leaflet: Information for the Patient

HYDROXYZINUM ESPEFA, 25 mg, Film-Coated Tablets

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.
• 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 inform your 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

1 film-coated tablet of Hydroxyzinum Espefa contains 25 mg of hydroxyzine hydrochloride.
Hydroxyzine acts as an antihistamine, sedative, and anxiolytic.
It is believed that this action is related to its effect on neurotransmission of acetylcholine, histamine, and dopamine.

Indications for Use

Symptomatic treatment of anxiety in adults, symptomatic treatment of itching, premedication before surgical procedures.

2. Important Information Before Taking Hydroxyzinum Espefa

When Not to Take Hydroxyzinum Espefa:

• in pregnant or breastfeeding women;

Warnings and Precautions

Before starting treatment with Hydroxyzinum Espefa, discuss it with your doctor:

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

Children and Adolescents

Young children are more prone to experiencing adverse reactions 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 administered doses should be reduced.
The dosage in patients with liver 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

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as about the medicines you plan to take. This also applies to medicines available without a prescription. Hydroxyzinum Espefa may affect the action of other medicines. Other medicines may affect the action of Hydroxyzinum Espefa.
Particularly, inform about taking: painkillers, sleeping pills and sedatives, antidepressants from the imipramine group, antispasmodics, anti-Parkinson's disease medications, dyzopiramid (antiarrhythmic medication), medications used in psychiatric disorders from the phenothiazine group, in hypotension, peptic ulcer disease (cimetidine changes the metabolism of the medicine), flecainide (antiarrhythmic medication), thioridazine (medication used, among others, in schizophrenia).
Do not take Hydroxyzinum Espefa if you 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, dyzopiramid, 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 or severe pain addiction (methadone).

Avoid concomitant administration of hydroxyzine and cholinesterase inhibitors (medicines used, among others, in Alzheimer's disease) and monoamine oxidase inhibitors (MAOIs) - medicines used, among others, in depression.
Hydroxyzine weakens the blood pressure-increasing effect of adrenaline and the anticonvulsant effect of phenytoin.
Avoid concomitant use of Hydroxyzinum Espefa with alcohol or other sedatives, as the medicine enhances their effect.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine.
Hydroxyzine should not be administered during pregnancy, as there are no adequate clinical studies that unequivocally confirm the safety of the medicine in pregnant women.
Hydroxyzine should not be administered during childbirth.
The medicine should not be used during lactation, as it is likely to pass into breast milk.

Driving and Operating Machines

Hydroxyzinum Espefa may cause drowsiness, and therefore, you should not drive vehicles or operate machinery during its use.

Hydroxyzinum Espefa Contains Lactose

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to Take Hydroxyzinum Espefa

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The medicine is for oral use.
Hydroxyzinum Espefa should be used in the lowest effective dose. The duration of treatment should be as short as possible.
The recommended dose is:

Adults

In the treatment of anxiety:
50 mg/day in 2 or 3 divided doses.
In the symptomatic treatment of itching:
Treatment should be started with a dose of 25 mg before bedtime, continuing therapy by increasing the dose as needed, administering 25 mg 3 or 4 times a day.
In premedication before surgical procedures:
50 mg to 100 mg in a single dose.

Use in Children and Adolescents

Tablets are not recommended for children under 6 years of age due to the risk of choking.
For children from 12 months to 6 years, other medicinal products containing hydroxyzine in the form of oral syrup are available, which provide proper dosing and do not pose a choking risk.
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 orally in a single dose.
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 up to 40 kg body weight, the maximum daily dose is 2 mg/kg body weight per day.
Dose adjustment should be individual, within the recommended dose range, depending on the patient's response to treatment.

Overdose of Hydroxyzinum Espefa

In case of overdose, contact your doctor or pharmacist 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 cardiac arrhythmias, such as QT interval prolongation or torsade 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 cardiorespiratory arrest.

Missed Dose of Hydroxyzinum Espefa

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience cardiac arrhythmias, such as rapid heartbeat (palpitations), difficulty breathing, loss of consciousness, you should stop taking the medicine and immediately consult a doctor.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist.

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 of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Hydroxyzinum Espefa

Keep the medicine out of the 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 in a temperature below 25°C.
Store in the original packaging to protect from moisture.
Medicines should 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 Pack and Other Information

What Hydroxyzinum Espefa Contains

• The active substance of the medicine is hydroxyzine hydrochloride. 1 film-coated tablet contains 25 mg of hydroxyzine hydrochloride.
• The other ingredients (excipients) are: potato starch, microcrystalline cellulose, lactose, sodium carboxymethyl cellulose, colloidal anhydrous silica, magnesium stearate, talc, and the Opadry II pink coating with the composition: macrogol 3350, polyvinyl alcohol, titanium dioxide (E171), talc, carmine (E120).

What Hydroxyzinum Espefa Looks Like and Contents of the Pack

The pack contains 25, 30, or 60 film-coated tablets.
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
tel. 12 639 27 27

Information for the Blind and Visually Impaired: 800-007-777

Date of Last Revision of the Leaflet:

• 04.10.2021