Hidroxizinum Espefa

Package Leaflet: Information for the Patient

HYDROXYZINUM ESPEFA 10 mg, 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 any not listed in this leaflet, tell 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

Hydroxyzinum Espefa is a medicine with antipruritic, sedative and anxiolytic effects.
It contains the active substance hydroxyzine.

Indications for use

Hydroxyzinum Espefa is used for:

• symptomatic treatment of anxiety in adults;
• 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 has been diagnosed with hypersensitivity to the active substance or any of the other ingredients of this medicine (listed in section 6);
• if the patient has been diagnosed with hypersensitivity to cetirizine, other piperazine derivatives, aminophylline or ethylenediamine;
• if the patient has been diagnosed with porphyria (a disease involving abnormal heme production);
• if the patient is pregnant or breastfeeding;
• if the patient's ECG (electrocardiogram) shows heart rhythm disturbances 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 medicines used to treat heart rhythm disorders or medicines that may affect heart rhythm (see "Hydroxyzinum Espefa and other medicines");
• if someone in the patient's family has died suddenly from heart disease.

Warnings and precautions

Tell your doctor immediately:

• if the patient has an increased tendency to seizures;
• if the patient has glaucoma (eye disease);
• if the patient has been diagnosed with difficulty urinating from the bladder;
• if the patient has weakened peristalsis of the digestive tract (weakened or absent bowel movements);
• if the patient has been diagnosed with myasthenia gravis (a disease characterized by excessive muscle weakness);
• if the patient has been diagnosed with dementia (reduced mental fitness);
• if the patient has known factors predisposing to cardiac arrhythmias or is being treated with a medicine that may cause cardiac arrhythmias;
• if the patient's ECG shows QT interval prolongation, the doctor will consider alternative treatments;
• if the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact their doctor before taking the medicine;
• if the patient is taking medicines that depress the central nervous system or have anticholinergic properties (see "Hydroxyzinum Espefa and other medicines").

The use of Hydroxyzinum Espefa may be associated with an increased risk of cardiac arrhythmias, which can be life-threatening. Therefore, tell your doctor about any heart problems and about taking any other medicines, including those available without a prescription.
If cardiac symptoms occur during the use of Hydroxyzinum Espefa, such as rapid heartbeat (palpitations), difficulty breathing, loss of consciousness, seek medical attention immediately.
Also, stop taking hydroxyzine.

Children and adolescents

Young children are more likely to experience adverse effects on the central nervous system - see section 4 "Possible side effects". Seizures have been reported more frequently in children than in adults.

Elderly patients

In elderly patients (over 65 years), it is recommended to start treatment with half the recommended dose.
The medicine may affect the results of allergy tests or methacholine inhalation test, so do not take the medicine at least 5 days before performing these tests.
Avoid taking Hydroxyzinum Espefa with alcohol (see "Hydroxyzinum Espefa with food and drink").

Hydroxyzinum Espefa and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any 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.
In particular, inform about taking:

• medicines that depress the central nervous system(sedatives, anxiolytics, antidepressants, anticonvulsants, sleep aids);
• anticholinergic medicines(medicines used, among others, in gastrointestinal disorders and respiratory diseases);
• betahistine(a medicine used in Meniere's disease);
• cholinesterase inhibitors(medicines used, among others, in the treatment of myasthenia, Alzheimer's disease, and glaucoma);
• monoamine oxidase inhibitors (MAOIs)(medicines used mainly in the treatment of depression);
• adrenaline(a medicine used, among others, in severe allergic reactions);
• phenytoin(a medicine used in the treatment of epilepsy);
• cimetidine(a medicine used in gastrointestinal diseases, including the treatment of gastric and duodenal ulcers);
• medicines metabolized by one of the liver enzymes called CYP2D6(these include beta-blockers used, for example, in hypertension, selective serotonin reuptake inhibitors used, for example, in depression, anxiety, and obsessive-compulsive disorder);
• medicines that inhibit the action of enzymes, such as alcohol dehydrogenaseand CYP3A4/5(these include medicines used in the treatment of fungal infections, calcium channel blockers used in the treatment of cardiac arrhythmias).

Do not take Hydroxyzinum Espefa if you are taking medicines 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).

Alcoholenhances the effect of Hydroxyzinum Espefa.
Taking Hydroxyzinum Espefa with medicines that cause cardiac arrhythmiasmay increase the risk of QT interval prolongation or cardiac arrhythmias of the torsade de pointestype.

Hydroxyzinum Espefa with food and drink

The medicine can be taken regardless of meals.
Do not drink alcohol while taking this medicine, as it enhances the effect of the medicine.

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 medicine.
Do not use the medicine during pregnancy. Hydroxyzine should not be given during childbirth.
Do not use the medicine during breastfeeding, as hydroxyzine is likely to pass into breast milk.

Driving and using machines

Hydroxyzinum Espefa may cause drowsiness and affect concentration and reaction speed, so do not drive vehicles or operate machines.

Hydroxyzinum Espefa contains lactose

If you have previously been diagnosed with intolerance to certain sugars, consult 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.
Hydroxyzinum Espefa should be used in the lowest effective dose. The treatment duration should be as short as possible.
The medicine is taken orally.

Recommended dose

Adults

• In the treatment of anxiety: 50 mg per day in 2-3 divided doses.
• In the symptomatic treatment of itching: treatment should be started with a dose of 25 mg before bedtime. If necessary, the doctor may increase the dose, giving 25 mg 3 to 4 times a day.
• In preparation for surgical procedures: 50 mg to 100 mg in a single dose.

Children

• 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 preparation for surgical procedures: 0.6 mg/kg body weight in a single dose.

In adults and children over 40 kg, the maximum daily dose for all indications is 100 mg.
In children under 40 kg, the maximum daily dose is 2 mg/kg body weight per day.
In elderly patients (over 65 years), it is recommended to start treatment with half the recommended dose.
In elderly patients, the maximum daily dose is 50 mg.
In patients with liver and/or kidney function disorders, treatment should be started with half the recommended dose and continued with smaller doses than usual.

Use in children

It is not recommended to use tablets (10 mg) in 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 hazard.

Taking a higher dose of Hydroxyzinum Espefa than recommended

If you have taken a higher dose of Hydroxyzinum Espefa than recommended, contact your doctor or pharmacist immediately, especially if it concerns a child. In case of overdose, symptomatic treatment can be used. Monitor the ECG due to the possible occurrence of cardiac arrhythmias, such as QT interval prolongation or torsade de pointes. Bring the package of the medicine with you, which will facilitate its identification.
The most common symptom of hydroxyzine overdose is excessive sedation.
Other observed symptoms include: nausea, vomiting, rapid heartbeat, fever, drowsiness, weakened pupillary reflex, tremors, confusion or hallucinations, and then decreased level of consciousness, respiratory disorders, seizures, hypotension (low blood pressure) or cardiac arrhythmias, deepening coma, cardiopulmonary arrest.

Missing a dose of Hydroxyzinum Espefa

Continue taking the medicine, without increasing the next dose.
Do not take a double dose to make up for a missed dose.

Stopping the use of Hydroxyzinum Espefa

Hydroxyzinum Espefa should be used in accordance with the doctor's recommendations.
If you have any further doubts about the use of the medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Contact your doctor immediately if you experience:

• anaphylactic shock(the first symptoms may be: 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; in severe cases, it can be life-threatening).

Very common side effects(in more than 1 in 10 people):

• drowsiness.

Common side effects(in 1 to 10 in 100 people):

• dry mouth;
• fatigue, headache, excessive sedation.

Uncommon side effects(in 1 to 10 in 1,000 people):

• nausea;
• malaise, fever;
• dizziness, insomnia;
• tremors, excitement, confusion (disorders of consciousness, disorientation in time, place, situation, or own person).

Rare side effects(in 1 to 10 in 10,000 people):

• tachycardia (rapid, irregular heartbeat);
• accommodation disorders (manifested by blurred vision), blurred vision;
• constipation, vomiting;
• hypersensitivity reactions from the immune system;
• abnormal liver function test results;
• seizures, dyskinesia (uncoordinated and involuntary movements of limbs or the whole body);
• disorientation, hallucinations (perception of non-existent objects, people);
• urinary retention;
• itching, rash, urticaria, skin inflammation;
• hypotension (low blood pressure).

Very rare side effects(in less than 1 in 10,000 people, including single cases):

• anaphylactic shock;
• bronchospasm (wheezing, shortness of breath);
• angioedema (sudden swelling of the face, limbs, or joints without itching and pain);
• increased sweating;
• fixed drug eruption;
• acute generalized exanthematous pustulosis;
• erythema multiforme (red-purple spots on the skin and/or mucous membranes, sometimes with blisters, fever, and joint pain);
• Stevens-Johnson syndrome (blisters on the skin and/or mucous membranes that burst and turn into painful ulcers, often accompanied by fever, muscle and joint pain).

Unknown(frequency cannot be estimated from available data):

• cardiac arrhythmias of the torsade de pointestype (ventricular tachycardia);
• QT interval prolongation;
• weight gain.

Stop taking the medicine and seek medical attention immediately if you experience cardiac arrhythmias, such as rapid heartbeat (palpitations), difficulty breathing, loss of consciousness.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to:
Department for Monitoring of Adverse Reactions to 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Hydroxyzinum Espefa

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Store in the original package to protect from moisture.
Do not use the medicine after the expiry date stated on the carton and blister after the words "Expiry date".
The expiry date refers to the last day of the month.
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. One coated tablet contains 10 mg of hydroxyzine hydrochloride.
• Other ingredients are: tablet core: microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, magnesium stearate, talc. coating: partially hydrolyzed polyvinyl alcohol, macrogol 3350, titanium dioxide (E 171), talc, quinoline yellow, lake (E 104), iron oxide yellow (E172).

What Hydroxyzinum Espefa looks like and what the pack contains

The medicine is in the form of coated tablets, round, slightly convex on both sides, yellow in color.
The pack contains 25, 30, or 60 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,
tel. (12) 639 27 27
Information for the blind and visually impaired:800-007-777
To obtain more detailed information, contact the marketing authorization holder.

Date of last revision of the leaflet:

• 04.10.2021