Package leaflet: Information for the patient

HYDROXYZINUM ESPEFA, 10 mg/5 ml, syrup
Hydroxyzini hydrochloridum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
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. The medicine may harm other people, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet

What is Hydroxyzinum Espefa and what is it used for
Important information before taking Hydroxyzinum Espefa
How to take Hydroxyzinum Espefa
Possible side effects
How to store Hydroxyzinum Espefa
Contents of the pack and other information

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

Mechanism of action:
Hydroxyzinum Espefa contains hydroxyzine hydrochloride as the active substance.
It acts as an antihistamine (reducing allergic symptoms), sedative, and anxiolytic.
Its action is believed to result from its influence on nerve transmission involving histamine, dopamine, and acetylcholine.
Indications:

treatment of anxiety;
symptomatic treatment of pruritus (itching);
premedication in surgical procedures.

2. Important information before using Hydroxyzinum Espefa

When not to use Hydroxyzinum Espefa:

if the patient is allergic (hypersensitive) to the active substance, hydroxyzine, other piperazine derivatives, aminophylline or ethylenediamine, or to any of the other ingredients of this medicine (listed in section 6);
if the patient has been diagnosed with porphyria;
in pregnant women and during 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 with other medicines");
if any family member has died suddenly due to heart disease.

Warnings and precautions
Before starting treatment with Hydroxyzinum Espefa, discuss with your doctor:

if the patient has an increased tendency to seizures;
if the patient has glaucoma;
if the patient has been diagnosed with difficulty in urinating (urinary retention);
if the patient has reduced gastrointestinal motility;
if the patient has been diagnosed with muscle weakness or mental confusion;
if the patient has known risk factors for developing heart rhythm disturbances;
if the patient is taking other medicines – see section "Hydroxyzinum Espefa with other medicines".

Treatment with Hydroxyzinum Espefa may be associated with an increased risk of potentially life-threatening heart rhythm disturbances. Therefore, inform your doctor about any heart problems and about all other medicines you are taking, including those available without a prescription.
If, during treatment with Hydroxyzinum Espefa, symptoms related to the heart occur, such as rapid heartbeat (palpitations), difficulty breathing, or loss of consciousness, seek immediate medical advice. Treatment with hydroxyzine should also be discontinued.
Avoid using Hydroxyzinum Espefa together with alcohol or sedative medicines, as hydroxyzine enhances their effects.
To avoid interference with allergy tests or methacholine bronchial provocation tests, discontinue treatment with this medicine at least 5 days before the test.

Children and adolescents
Young children are more susceptible to adverse effects on 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 elimination of the drug's metabolite, cetirizine, lower doses should be used.
Dosage in patients with liver impairment should be determined by a physician.

Elderly patients
In elderly patients, treatment should be initiated at half the adult dose.

Hydroxyzinum Espefa with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. 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.
Particular attention should be paid to concomitant use of: analgesics, sleeping pills and sedatives, tricyclic antidepressants such as imipramine, antispasmodic drugs, antiparkinsonian agents, disopyramide (antiarrhythmic), phenothiazine group drugs used for psychiatric disorders, antihypertensives, drugs for peptic ulcer disease (cimetidine alters drug metabolism), flecainide (antiarrhythmic), thioridazine (used e.g. in schizophrenia).

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 diseases 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).

Concomitant use of hydroxyzine with cholinesterase inhibitors (medicines used e.g. in Alzheimer's disease) and monoamine oxidase (MAO) inhibitors (medicines used e.g. in depression) should be avoided.
Hydroxyzine reduces the blood pressure-raising 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 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 before using this medicine.
Do not use this medicine during pregnancy or during delivery.
Do not use this medicine during lactation, as it is likely excreted in breast milk.

Driving and operating machinery
Hydroxyzinum Espefa may impair reaction ability and concentration. Therefore, during treatment, patients should not drive motor vehicles or operate machinery requiring full psycho-physical performance.

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

3. How to use Hydroxyzinum Espefa

This medicine should always be used as directed by the physician. In case of doubts, consult a 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 administered orally.
Recommended doses are:
Adults
For the treatment of anxiety: 50 mg per day in 2 or 3 divided doses.
For symptomatic treatment of pruritus:
Begin treatment with a dose of 25 mg at bedtime. If necessary, the dose may be increased to 25 mg, 3 or 4 times daily.
For premedication before surgical procedures: 50 mg to 100 mg as a single dose.
Use in children and adolescents
For symptomatic treatment of pruritus:
From 12 months of age: 1 mg/kg body weight per day up to 2 mg/kg body weight per day in divided doses.
For premedication before surgical procedures: 0.6 mg/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 elderly patients, the maximum daily dose is 50 mg.
In children with body weight up to 40 kg, the maximum daily dose is 2 mg/kg body weight/day.
Dose adjustment
Dosage should be individually adjusted within the recommended dose range, depending on the patient's response to treatment.
Use of a higher than recommended dose of Hydroxyzinum Espefa
If a higher than recommended dose of Hydroxyzinum Espefa has been taken, contact a doctor or pharmacist immediately, especially if this concerns a child. In case of overdose, symptomatic treatment may be applied. ECG should be monitored due to the possibility of cardiac rhythm disturbances 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, diminished pupillary reflex, tremor, confusion or hallucinations, followed by decreased level of consciousness, respiratory depression, seizures, hypotension or cardiac arrhythmia, and progressively deepening coma and cardiorespiratory collapse.
Missed dose of Hydroxyzinum Espefa
Do not use a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.

Frequency		Side effects
very common	affect more than 1 in 10 people	drowsiness
common	affect 1 to 10 in 100 people	dry mouth, fatigue, headache, excessive sedation
uncommon	affect 1 to 10 in 1,000 people	nausea, malaise, fever, dizziness, insomnia, tremor of head or body, restlessness, confusion
rare	affect 1 to 10 in 10,000 people	palpitations, accommodation disorders (manifested by blurred vision), blurred vision, constipation, vomiting, hypersensitivity reactions of the immune system, abnormal liver function tests, seizures, uncoordinated and involuntary movements of limbs or entire body, disorientation, hallucinations, urinary retention, itching, erythematous rash,
		maculopapular rash, urticaria, skin inflammation, hypotension
very rare	affect fewer than 1 in 10,000 people	anaphylactic shock (symptoms include: shortness of breath, swelling of larynx and throat, skin itching and redness, headache, feeling of "tightness", dizziness, marked weakness, up to loss of consciousness; in severe cases may be life-threatening), bronchospasm, angioedema, increased sweating, persistent drug eruption
not known	frequency cannot be estimated from available data	cardiac arrhythmias of the type torsade de pointes (ventricular tachycardia), QT interval prolongation, weight gain

The medication should be discontinued immediately and the patient should seek medical advice without delay if they experience cardiac rhythm disturbances, such as rapid heartbeat (palpitations), difficulty breathing, or loss of consciousness.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse.
Anaphylactic shock requires immediate medical attention.
Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables continuous monitoring of the benefit-risk balance of the medicinal product and helps to enhance patient safety.

5. How to store Hydroxyzinum Espefa

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

6. Contents of the package and other information

What Hydroxyzinum Espefa contains

The active substance is hydroxyzine hydrochloride. 5 ml of syrup (one teaspoon) contains 10 mg of hydroxyzine hydrochloride.
The other ingredients (excipients) are: sucrose, povidone, sodium benzoate, propylene glycol, orange flavour, menthol, purified water.

What Hydroxyzinum Espefa looks like and contents of the pack
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 Authorisation 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 partially sighted: 800-007-777