Package leaflet: Information for the patient

HYDROXYZINUM AMARA
Hydroxyzini hydrochloridum
2 mg/1 ml, syrup
Please read carefully the entire leaflet before taking the medicine, as it contains
important information for the patient.

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

Table of contents of the leaflet:

What Hydroxyzinum Amara is and what it is used for
Important information before taking Hydroxyzinum Amara
How to take Hydroxyzinum Amara
Possible adverse reactions
How to store Hydroxyzinum Amara
Contents of the pack and other information

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

Hydroxyzinum Amara is an antihistaminic, sedative and anxiolytic medicine.
Hydroxyzinum Amara is indicated for:

symptomatic treatment of anxiety,
symptomatic treatment of pruritus (itching),
premedication before surgical procedures (preparation of the patient for surgery using medications).

2. Important information before taking Hydroxyzinum Amara

When not to take Hydroxyzinum Amara:

if the patient is allergic to the active substance (hydroxyzine hydrochloride) or to any of the other ingredients of this medicine listed in section 6;
if the patient has had an allergic reaction (hypersensitivity) to cetirizine, other piperazine derivatives, aminophylline, or ethylenediamine;
if the patient has porphyria (inherited or acquired disorders affecting enzymes involved in heme synthesis, known as the porphyrin pathway);
if the patient's ECG (electrocardiogram) shows heart rhythm disturbances known as "prolonged QT interval";
if the patient currently has or has had heart disease or if the heart rate is very low;
if the patient has low levels of electrolytes in the blood (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 Amara with other medicines");
if someone in the patient's family has died suddenly due to heart disease;
during pregnancy and breastfeeding.

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

if the patient has an increased tendency for seizures (seizures have been reported more frequently in children than in adults);
if the patient has glaucoma, difficulty in urination from the bladder, reduced gastrointestinal motility, myasthenia gravis (a disease characterized by muscle weakness and fatigue of skeletal muscles after repeated effort, with initial symptoms including drooping eyelids, double vision, nasal voice, difficulty chewing and swallowing, difficulty raising upper limbs, walking, and rarely, respiratory muscle weakness), or dementia;
if Hydroxyzinum Amara is taken together with other medicines that depress the central nervous system or with medicines having anticholinergic properties, i.e. affecting the autonomic nervous system (in such patients, dose adjustment may be necessary).

Taking Hydroxyzinum Amara may be associated with an increased risk of life-threatening heart rhythm disturbances. Therefore, inform your doctor about any heart-related problems and about taking any other medicines, including those available without a prescription.
If symptoms affecting the heart occur during treatment with Hydroxyzinum Amara, such as rapid heartbeat (palpitations), breathing difficulties, or loss of consciousness, contact your doctor immediately. Treatment with hydroxyzine should also be discontinued.
Treatment should be discontinued at least 5 days before undergoing allergy tests or bronchial provocation tests with methacholine to avoid interference with test results.
Avoid concomitant use of Hydroxyzinum Amara and alcohol; the product contains less than 100 mg of alcohol per dosage unit.

Hydroxyzinum Amara with other medicines:
Inform your doctor, pharmacist, or nurse about all medicines currently used or recently used, as well as any medicines the patient plans to take. This includes medicines available without a prescription. Hydroxyzinum Amara may affect the action of other medicines. Other medicines may affect the action of Hydroxyzinum Amara.
This applies to the following medicines:

medicines that depress the central nervous system or medicines with anticholinergic effects;
alcohol and alcohol dehydrogenase inhibitors;
betahistine and cholinesterase inhibitors;
monoamine oxidase inhibitors (medicines used, among others, in depression);
adrenaline;
medicines that may cause heart rhythm disturbances.

Do not take Hydroxyzinum Amara 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);
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).

Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before taking this medicine.
Hydroxyzinum Amara must not be taken during pregnancy or while breastfeeding.
Breastfeeding must be discontinued if treatment with Hydroxyzinum Amara is necessary.

Driving and operating machinery:
While taking Hydroxyzinum Amara, patients should not drive motor vehicles or operate any machinery, as Hydroxyzinum Amara may impair reaction ability and reduce concentration.

Hydroxyzinum Amara contains ethanol (alcohol)
This medicine contains small amounts (0.1%) of ethanol (alcohol). The alcohol concentration after taking a 100 ml dose of syrup (corresponding to 200 mg hydroxyzine) is up to 100 mg, equivalent to 2 ml of beer or 1 ml of wine.
This medicine contains sorbitol. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to take Hydroxyzinum Amara

Hydroxyzinum Amara should always be taken according to the doctor's or pharmacist's instructions.
If in doubt, consult a doctor or pharmacist. The following are the usual recommended doses of Hydroxyzinum Amara.
Hydroxyzinum Amara should be taken at the lowest effective dose. The duration of treatment should be as short as possible.
In adults and children with body weight above 40 kg, the maximum daily dose in all indications is 100 mg.

Adults
For symptomatic treatment of anxiety:
50 mg/day in 2 to 3 divided doses.
In severe cases, oral doses up to 100 mg/day may be taken.

For symptomatic treatment of pruritus (itching):
Begin treatment with 25 mg at bedtime. Continue therapy, increasing the dose if necessary, by administering 25 mg 3 to 4 times daily.

For premedication before surgical procedures (preparation of the patient for surgery with medication):
50 to 100 mg as a single oral dose.

Children
In children with body weight up to 40 kg, the maximum daily dose is 2 mg/kg body weight.
In children with body weight above 40 kg, the maximum daily dose is 100 mg.

For symptomatic treatment of pruritus:

From the age of 12 months: 1 mg/kg body weight/day up to 2 mg/kg body weight/day in divided doses.

For premedication before surgical procedures:
0.6 mg/kg body weight orally as a single dose.
The syrup packaging contains a calibrated measuring device to facilitate dosing.

Dosage adjustment:
Dosage should be individually adjusted within the recommended dose range, depending on the patient's response to treatment.

Elderly patients:
In elderly patients, treatment should be initiated at half the recommended dose.
In elderly patients, the maximum daily dose is 50 mg.

Patients with moderate or severe renal impairment:
In patients with moderate or severe renal impairment, due to reduced elimination of the drug's metabolite, cetirizine, the administered dose should be reduced.

Patients with hepatic impairment:
In patients with hepatic impairment, a 33% reduction of the daily dose is recommended.

Taking more than the recommended dose of Hydroxyzinum Amara:
If more than the recommended dose of Hydroxyzinum Amara has been taken (overdose), seek immediate medical advice from a doctor or pharmacist.
If a patient has taken too high a dose of Hydroxyzinum Amara, contact a doctor immediately, especially if this concerns a child. In case of overdose, symptomatic treatment may be applied. ECG monitoring is required due to the possibility of cardiac arrhythmias such as QT interval prolongation or torsade de pointes.
Symptoms of Hydroxyzinum Amara overdose include: nausea, vomiting, tachycardia (accelerated heart rate), fever, drowsiness, disturbances in pupillary reflex, tremor, confusion or hallucinations, followed by decreased level of consciousness, respiratory depression, seizures, hypotension, cardiac arrhythmias, progressing to deepening coma and circulatory-respiratory collapse. There is no specific antidote.

Missed dose of Hydroxyzinum Amara:
Do not take a double dose to make up for a missed dose.

Stopping Hydroxyzinum Amara:
If in doubt regarding the use of the medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, Hydroxyzinum Amara may cause adverse reactions, although they do not occur in
everyone.
The frequency of occurrence of the adverse reactions listed below is defined as follows:
very common (affecting more than 1 in 10 patients)
common (affecting 1 to 10 in 100 patients)
uncommon (affecting 1 to 10 in 1,000 patients)
rare (affecting 1 to 10 in 10,000 patients)
very rare (affecting less than 1 in 10,000 patients)
unknown (frequency cannot be estimated from the available data)
Very common: drowsiness.
Common: dry mouth, fatigue, headache, sedation.
Uncommon: nausea, malaise, fever, dizziness, insomnia, tremor, restlessness, confusion.
Rare: tachycardia (accelerated heart rate), accommodation disorders, blurred vision, constipation,
vomiting, hypersensitivity reactions, abnormal liver function test results, seizures, dyskinesia (involuntary, uncoordinated movements of limbs and other body parts), disorientation, hallucinations, urinary retention, itching, erythematous rash, maculopapular rash, urticaria, dermatitis, hypotension.
Very rare: anaphylactic shock (caused by a severe systemic allergic reaction; symptoms include: shortness of breath, laryngeal and pharyngeal swelling, skin itching and redness, headache, sensation of "pressure", dizziness, profound weakness, up to loss of consciousness; in severe cases, it may be life-threatening), bronchospasm, angioedema (skin manifestations in the form of irregular patches, blisters and swelling), increased sweating, persistent drug eruption, acute generalized exanthematous pustulosis (pustular rash on reddened skin, which may be accompanied by swelling and general symptoms such as fever), erythema multiforme (skin rash that may lead to blister formation and resemble small target lesions (a dark center surrounded by a lighter area and a dark ring around it)), Stevens-Johnson syndrome (widespread rash with blisters and skin peeling, primarily affecting areas around the mouth, eyes, nose, and genital organs).
Frequency unknown: QT interval prolongation on electrocardiogram, torsade de pointes type cardiac arrhythmias, hepatitis.
Treatment should be discontinued and immediate medical advice sought if the patient experiences cardiac arrhythmias such as rapid heartbeat (palpitations), breathing difficulties, or loss of consciousness.
Additionally, the following adverse reactions have been observed with cetirizine, the main metabolite of hydroxyzine, and may also occur after administration of hydroxyzine: thrombocytopenia (reduced platelet count), aggression, depression, tics, involuntary movements, tingling, compulsive eye movements with rotation of the eyeballs, diarrhea, difficulty in urination, urinary incontinence, asthenia (weakness, fatigue), edema, weight gain.
Reporting suspected adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone number: 22 49 21 301, fax number: 22 49 21 309, e-mail: [email protected]
Reporting of adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Hydroxyzinum Amara

Store below 25°C. Keep in the original packaging to protect from light.
Store in a place inaccessible and out of sight of children.
Do not use Hydroxyzinum Amara after the expiry date stated on the carton and bottle. The expiry date refers to the last day of the specified month.
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 packaging and other information

What Hydroxyzinum Amara contains:

The active substance is hydroxyzine hydrochloride.
The other ingredients are: ethanol 96%, sodium benzoate (E 211), levomenthol, forest fruit flavour (propylene glycol, water, trithiazine, pulegone, flavouring substances, natural flavouring substances), non-crystallizing liquid sorbitol (E 420).

What Hydroxyzinum Amara looks like and contents of the pack:
Hydroxyzinum Amara, syrup 2 mg/1 ml, is a clear, colourless or slightly yellow solution.
Immediate packaging: amber glass bottle of class III with a polyethylene (PE) or aluminium cap, containing 125 ml, 150 ml, 200 ml, 250 ml, 500 ml of syrup.
Medicine measure.
Outer packaging: cardboard box.

Marketing Authorisation Holder and Manufacturer:
Zakład Farmaceutyczny „Amara” Sp. z o.o.
Stacyjna 5 Street
30-851 Kraków
Tel.: 12 657 40 40
Fax: 12 657 40 40 ext. 34
e-mail: [email protected]