HYDROXYZINE ESPEFA

Package leaflet: information for the patient

HYDROXYZINUM ESPEFA 10 mg, coated tablets
(Hydroxyzini hydrochloridum)
Please read all of this leaflet carefully before taking this medicine, because it contains
information important for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

Hydroxyzinum Espefa is a medicine with antipruritic, sedative and anxiolytic properties.
It contains the active substance hydroxyzine.
Indications
Hydroxyzinum Espefa is used for:

• symptomatic treatment of anxiety in adults;
• symptomatic treatment of pruritus (itching);
• premedication of patients prior to surgical procedures.

2. Important information before taking Hydroxyzinum Espefa

When not to take Hydroxyzinum Espefa:

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to cetirizine, other piperazine derivatives, aminophylline, or ethylenediamine;
• if the patient has porphyria (a disorder involving abnormal production of heme – a component of haemoglobin);
• if the patient is pregnant or breastfeeding;
• if the patient's ECG (electrocardiogram) shows heart rhythm disturbances known as QT interval prolongation;
• if the patient has or has had cardiovascular disease or if 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 due to heart disease.

Warnings and precautions
Immediately inform the doctor:

• if the patient has an increased tendency to seizures;
• if the patient has glaucoma (an eye condition);
• if the patient has difficulty urinating (urinary retention);
• if the patient has reduced gastrointestinal motility (weakened or absent intestinal activity);
• if the patient has muscle weakness (myasthenia gravis – a condition characterized by excessive muscle weakness);
• if the patient has dementia (reduced mental function);
• if the patient has known risk factors for heart rhythm disturbances or is concurrently taking a medicine that may cause such disturbances;
• if QT interval prolongation is detected on ECG, the doctor will consider alternative treatments;
• if the patient has previously been diagnosed with intolerance to certain sugars – the patient should consult a doctor before taking this medicine;
• if the patient is taking medicines with central nervous system depressant effects or medicines with anticholinergic properties (see section "Hydroxyzinum Espefa and other medicines").

Treatment with Hydroxyzinum Espefa may be associated with an increased risk of potentially life-threatening heart rhythm disturbances. Therefore, it is essential to inform the doctor about any heart conditions and about all other medicines being taken, including those available without a prescription.
If, during treatment with Hydroxyzinum Espefa, symptoms affecting the heart occur, such as rapid heartbeat (palpitations), difficulty breathing, or loss of consciousness, seek immediate medical attention.
Treatment with hydroxyzine should also be discontinued immediately.

Children and adolescents
Young children are more susceptible to 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 of age), treatment should be initiated at half the recommended dose.
Hydroxyzinum Espefa may interfere with allergy tests or methacholine bronchial provocation tests; therefore, the medicine should not be taken at least 5 days before such tests.
Concomitant use of Hydroxyzinum Espefa with alcohol should be avoided (see section "Hydroxyzinum Espefa and food and drink").

Hydroxyzinum Espefa and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for use. This includes medicines available without a prescription. Hydroxyzinum Espefa may affect the action of other medicines, and other medicines may affect the action of Hydroxyzinum Espefa.

In particular, inform your doctor about the use of:

• medicines with central nervous system depressant effects (sedatives, anxiolytics, antidepressants, anticonvulsants, hypnotics);
• anticholinergic medicines (medicines used, among others, for gastrointestinal motility disorders and respiratory diseases);
• betahistine (a medicine used in Meniere's disease);
• cholinesterase inhibitors (medicines used, among others, in the treatment of myasthenia gravis, Alzheimer's disease, and glaucoma);
• monoamine oxidase inhibitors (MAO inhibitors) (medicines mainly used 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 disorders, including treatment of peptic ulcer disease);
• medicines metabolized by the liver enzyme CYP2D6 (including beta-blockers used, e.g., in hypertension, selective serotonin reuptake inhibitors used, e.g., in depression, anxiety, and obsessive-compulsive disorder);
• medicines that inhibit enzyme activity, such as alcohol dehydrogenase and CYP3A4/5 (including medicines used to treat fungal infections, calcium channel blockers used in heart rhythm disorders).

Do not take Hydroxyzinum Espefa if the patient is taking medicines used to treat:

• bacterial infections (e.g. antibiotics such as erythromycin, moxifloxacin, levofloxacin);
• fungal infections (e.g. pentamidine);
• heart conditions or high blood pressure (e.g. amiodarone, quinidine, disopyramide, sotalol);
• psychosis (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).

Alcohol intensifies the effect of Hydroxyzinum Espefa.
Concomitant use of Hydroxyzinum Espefa with medicines causing heart rhythm disturbances may increase the risk of QT interval prolongation or the occurrence of torsade de pointes arrhythmia.

Hydroxyzinum Espefa and food and drink
This medicine can be taken regardless of meals.
Alcohol must not be consumed during treatment with this medicine, as it enhances the medicine's effects.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
This medicine must not be used during pregnancy. Hydroxyzine should not be administered during childbirth.
This medicine must not be used during breastfeeding, as hydroxyzine is likely to pass into breast milk.

Driving and operating machinery
Hydroxyzinum Espefa may cause drowsiness and may affect concentration and reaction speed; therefore, driving vehicles or operating machinery should be avoided.

Hydroxyzinum Espefa contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to take Hydroxyzinum Espefa

This medicine should always be taken as directed by the physician. In case of doubt, consult your
doctor or pharmacist.
Hydroxyzinum Espefa should be used at the lowest effective dose. The duration of treatment should be
as short as possible.
This medicine is for oral use.
Recommended dose
Adults

• For the treatment of anxiety: 50 mg daily in 2–3 divided doses.
• For symptomatic treatment of pruritus (itching): treatment should be initiated with a dose of 25 mg at bedtime. If necessary, the doctor may increase the dose to 25 mg, 3 to 4 times daily.
• For premedication prior to surgical procedures: 50 mg to 100 mg as a single dose.

Children

• For symptomatic treatment of pruritus: From 12 months of age: 1 mg per kg body weight per day up to 2 mg per kg body weight per day in divided doses.
• For premedication prior to surgical procedures: 0.6 mg per kg body weight as a single dose.

In adults and children with body weight above 40 kg, the maximum daily dose in all indications
is 100 mg.
In children with body weight up to 40 kg, the maximum daily dose is 2 mg/kg body weight/day.
In elderly patients (over 65 years of age), treatment should be initiated at half the recommended dose.
In elderly individuals, the maximum daily dose is 50 mg.
In patients with hepatic and/or renal impairment, treatment should be initiated at half the recommended dose, and lower than usual doses should be continued.
Use in children
The use of tablets (10 mg) is not recommended in children under 6 years of age due to the risk of
choking. For children aged 12 months to 6 years, alternative medicinal products containing
hydroxyzine in the form of oral syrup are available, which allow accurate dosing and avoid the risk of
choking.
Taking more Hydroxyzinum Espefa than recommended
If more Hydroxyzinum Espefa has been taken than recommended, contact your doctor or pharmacist immediately, especially if this concerns a child. In case of overdose, symptomatic treatment may be applied. ECG monitoring is required due to the risk of cardiac arrhythmias such as QT interval prolongation or torsade de pointes. Bring the medicine packaging with you, as this will facilitate identification of the product.
The most common symptom of hydroxyzine overdose is excessive sedation.
Other observed symptoms include: nausea, vomiting, rapid heartbeat, fever, drowsiness, diminished pupillary reflex, tremor, confusion or hallucinations, followed by decreased level of consciousness, respiratory depression, seizures, hypotension (low blood pressure), or cardiac arrhythmias, progressing to deepening coma and cardiorespiratory collapse.
If you miss a dose of Hydroxyzinum Espefa
Continue taking the medicine as prescribed, without increasing the next dose.
Do not take a double dose to make up for a missed dose.
Stopping Hydroxyzinum Espefa
Hydroxyzinum Espefa should be taken as directed by the physician.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not everybody will experience them.
You should contact your doctor immediately if the following occurs:

• Anaphylactic shock (initial symptoms may include: shortness of breath, swelling of the larynx and throat, skin itching and redness, headache, feeling of "pressure", dizziness, significant weakness, up to and including loss of consciousness; in severe cases it may be life-threatening).

Very common adverse reactions (in more than 1 in 10 people):

• drowsiness.

Common adverse reactions (in 1 to 10 out of 100 people):

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

Uncommon adverse reactions (in 1 to 10 out of 1,000 people):

• nausea;
• malaise, fever;
• dizziness, insomnia;
• tremor, restlessness, confusion (disturbance of consciousness, disorientation in time, place, situation or self).

Rare adverse reactions (in 1 to 10 out of 10,000 people):

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

Very rare adverse reactions (in less than 1 in 10,000 people, including isolated cases):

• anaphylactic shock;
• bronchospasm (wheezing, shortness of breath);
• angioedema (sudden swelling of the face, limbs or joints without itching or pain);
• increased sweating;
• persistent 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 which rupture into painful erosions; often accompanied by fever, muscle and joint pain).

Unknown (frequency cannot be estimated from available data):

• torsade de pointes type cardiac arrhythmias (ventricular tachycardia);
• QT interval prolongation;
• weight gain.

Medication should be discontinued and medical attention sought immediately if the patient experiences
cardiac arrhythmias such as rapid heartbeat (palpitations), breathing difficulties, or loss of
consciousness.
Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to:
Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C,
02-222 Warsaw,
Phone: +48 22 49 21 301,
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Hydroxyzinum Espefa

Keep the medicine out of the reach and sight of children.
Store below 25°C.
Store in the original packaging 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Hydroxyzinum Espefa contains

• The active substance is hydroxyzine hydrochloride. One coated tablet contains 10 mg of hydroxyzine hydrochloride.
• Other ingredients are: Tablet core: microcrystalline cellulose, monohydrate lactose, colloidal anhydrous silica, magnesium stearate, talc. Coating: partially hydrolysed polyvinyl alcohol, macrogol 3350, titanium dioxide (E 171), talc, quinoline yellow, lac (E 104), yellow iron oxide (E172).

What Hydroxyzinum Espefa looks like and contents of the pack
Hydroxyzinum Espefa is in the form of yellow, round, biconvex coated tablets.
The pack contains 25, 30 or 60 coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Chemiczno-Farmaceutyczna Spółdzielnia Pracy ESPEFA
ul. J. Lea 208,
30-133 Kraków,
tel. (12) 639 27 27
Information for blind and partially sighted people: 800-007-777
For more detailed information, please contact the Marketing Authorisation Holder.
04.10.2021