Hidroxizinum Amara

Leaflet accompanying the packaging: patient information

HYDROXYZINUM AMARA

Hydroxyzine hydrochloride
2 mg/1 ml, syrup

Table of contents of the leaflet:

• 1. What is Hydroxyzinum Amara and what is it used for
• 2. Important information before taking Hydroxyzinum Amara
• 3. How to take Hydroxyzinum Amara
• 4. Possible side effects
• 5. How to store Hydroxyzinum Amara
• 6. Package contents and other information

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

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Hydroxyzinum Amara is a medicine with antihistamine, sedative, and anxiolytic effects.
Hydroxyzinum Amara is indicated for:

• symptomatic treatment of anxiety,
• symptomatic treatment of 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 any of the other ingredients of this medicine listed in section 6;
• if the patient has been diagnosed with an allergy (hypersensitivity) to cetirizine, other piperazine derivatives, aminophylline, or ethylenediamine;
• if the patient has porphyria (inherited or acquired disorders of enzyme function related to heme synthesis, so-called porphyrin pathway);
• if the patient's ECG (electrocardiogram) shows heart rhythm disorders called "QT interval prolongation";
• if the patient has or has had cardiovascular disease or if their heart rate is very low;
• if the patient has low electrolyte levels in the blood (e.g., low potassium or magnesium levels);
• if the patient is taking certain medications used to treat heart rhythm disorders or medications that may affect heart rhythm (see "Hydroxyzinum Amara and 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 to take Hydroxyzinum Amara, you should discuss it with your doctor:

• if the patient has an increased tendency to seizures (seizures have been reported more frequently in children than in adults),
• if the patient has glaucoma, difficulty urinating, weakened gastrointestinal peristalsis, myasthenia gravis(a disease characterized by muscle weakness and fatigue after repeated exertion, the first symptoms are: drooping eyelids, double vision, nasal voice, difficulty chewing and swallowing, difficulty lifting upper limbs, walking, rarely occurring muscle weakness of the respiratory muscles) or dementia,
• if Hydroxyzinum Amara is taken simultaneously with other medications that have a sedative effect on the central nervous system or with medications that have anticholinergic properties, i.e., affecting the autonomic nervous system (in these patients, it may be necessary to adjust the dose).

Taking Hydroxyzinum Amara may be associated with an increased risk of heart rhythm disorders, 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 heart symptoms occur during treatment with Hydroxyzinum Amara, such as rapid heartbeat (palpitations), breathing problems, loss of consciousness, you should immediately consult a doctor. You should also stop the treatment with hydroxyzine.
Treatment should be stopped at least 5 days before performing allergy tests or a methacholine bronchial challenge test to avoid affecting the results of these tests.
You should avoid taking Hydroxyzinum Amara and alcohol at the same time, as the product contains less than 100 mg of alcohol per dose.

Hydroxyzinum Amara and other medicines

You should tell your doctor, pharmacist, or nurse about all the medicines you are taking or have recently taken, as well as any medicines you plan to take. This also applies to 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 have a sedative effect on the central nervous system or anticholinergic properties,
• 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 disorders.

You should not take Hydroxyzinum Amara 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)

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
Hydroxyzinum Amara should not be taken during pregnancy or breastfeeding.
Breastfeeding should be stopped if it is necessary to take Hydroxyzinum Amara.

Driving and using machines

While taking Hydroxyzinum Amara, you should not drive vehicles or operate any mechanical equipment, as the medicine may impair your reaction ability and weaken your concentration.

Hydroxyzinum Amara contains ethanol (alcohol)

The medicine contains small amounts (0.1%) of ethanol (alcohol). The alcohol concentration after taking a dose of 100 ml of syrup (corresponding to 200 mg of hydroxyzine) is up to 100 mg, which is equivalent to 2 ml of beer or 1 ml of wine.
The medicine contains sorbitol. If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Hydroxyzinum Amara

Hydroxyzinum Amara should always be taken according to the doctor's or pharmacist's recommendations.
If you have any doubts, you should consult a doctor or pharmacist. The following are the usual doses of Hydroxyzinum Amara.
Hydroxyzinum Amara should be taken in the smallest effective dose. The treatment duration should be as short as possible.
In adults and children with a body weight over 40 kg, the maximum daily dose for all indications is 100 mg.

Adults

In the symptomatic treatment of anxiety:
50 mg/day in 2 to 3 divided doses.
In severe cases, oral doses of up to 100 mg/day can be taken.
In the symptomatic treatment of itching:
Treatment should be started with a dose of 25 mg before bedtime, and therapy should be continued, increasing the dose if necessary, administering 25 mg 3 to 4 times a day.
In premedication before surgical procedures (preparation of the patient for surgery using medications):
50 to 100 mg in a single oral dose.

Children

In children with a body weight up to 40 kg, the maximum daily dose is 2 mg/kg body weight per day.
In children with a body weight over 40 kg, the maximum daily dose is 100 mg.
In the symptomatic treatment of itching:

• from 12 months of age: 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.
A calibrated measuring cup is included in the syrup packaging to facilitate dosing.
Dose adjustment:
Dosing should be adjusted individually, within the recommended dose range, depending on the patient's response to treatment.
Elderly patients:
In elderly patients, treatment should be started with 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 excretion of the medicine's metabolite, cetirizine, the administered dose should be reduced.
Patients with liver impairment:
In patients with liver impairment, the daily dose should be reduced by 33%.

Taking a higher dose of Hydroxyzinum Amara than recommended:

In case of taking a higher dose of the medicine than recommended (overdose), you should immediately consult a doctor or pharmacist.
If you have taken too much Hydroxyzinum Amara, you should contact your doctor 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 heart rhythm disorders, such as QT interval prolongation or torsade de pointes.
Symptoms of Hydroxyzinum Amara overdose are: nausea, vomiting, tachycardia (rapid heart rate), fever, drowsiness, disturbances of pupillary reflex, tremors, confusion or hallucinations, and then decreased level of consciousness, respiratory depression, seizures, hypotension or heart rhythm disorders, and deepening coma and cardiopulmonary collapse. There is no specific antidote.

Missing a dose of Hydroxyzinum Amara:

You should not take a double dose to make up for a missed dose.

Stopping treatment with Hydroxyzinum Amara:

If you have any doubts about the use of the medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Hydroxyzinum Amara can cause side effects, although not everybody gets them.
The frequency of side effects listed below is defined as follows:
very common (occurring in more than 1 in 10 patients)
common (occurring in 1 to 10 in 100 patients)
uncommon (occurring in 1 to 10 in 1000 patients)
rare (occurring in 1 to 10 in 10,000 patients)
very rare (occurring in 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 (calmness).
Uncommon: nausea, malaise, fever, dizziness, insomnia, tremors, agitation, confusion.
Rare: tachycardia (rapid 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, rash, urticaria, skin inflammation, hypotension.
Very rare: anaphylactic shock (caused by a severe systemic allergic reaction, its symptoms include: shortness of breath, swelling of the throat and larynx, itching of the skin and its redness, headache, feeling of "pressure", dizziness, significant weakness, up to loss of consciousness; in severe cases, it can be life-threatening), bronchospasm, angioedema (skin lesions in the form of irregular spots, blisters, and swelling), increased sweating, fixed drug eruption, acute generalized exanthematous pustulosis (pustular rash on reddened skin, which may be accompanied by swelling and general symptoms, e.g., fever), erythema multiforme (skin rash that can cause blisters and looks like small targets, a dark spot surrounded by a lighter area and a dark circle around it), Stevens-Johnson syndrome (widespread rash with blisters and peeling skin, occurring mainly in the mouth, eyes, nose, and genital areas).
Unknown: QT interval prolongation in the electrocardiogram, heart rhythm disorders of the torsade de pointestype, liver inflammation.
You should stop taking the medicine and immediately consult a doctor if you experience heart rhythm disorders, such as rapid heartbeat (palpitations), breathing problems, or loss of consciousness.
Additionally, the following side effects have been observed with cetirizine, the main metabolite of hydroxyzine, which may also occur after administration of hydroxyzine: decreased platelet count, aggression, depression, tics, involuntary movements, paresthesia, compulsive eye movements with rotation of the eyeballs, diarrhea, difficulty urinating, involuntary urination, asthenia (fatigue, weakness), edema, weight gain.
Reporting suspected side effects
If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone number 22 49 21 301, fax 22 49 21 309, e-mail: ndl@urpl.gov.pl
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Hydroxyzinum Amara

Store in a temperature below 25°C. Store in the original packaging to protect from light.
Store in a place inaccessible and invisible to 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 given month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What does Hydroxyzinum Amara contain:

• the active substance of the medicine is hydroxyzine hydrochloride
• the other ingredients of the medicine are: ethanol 96%, sodium benzoate (E 211), levomenthol, fruit flavor (propylene glycol, water, tracetin, pulegone, flavoring substances, natural flavoring substances), non-crystallizing liquid sorbitol (E 420)

What Hydroxyzinum Amara looks like and what the package contains:
Hydroxyzinum Amara, syrup 2 mg/1 ml is a clear, colorless or slightly yellowish solution.
Immediate packaging: a brown glass bottle with a polyethylene (PE) or aluminum cap, containing 125 ml, 150 ml, 200 ml, 250 ml, 500 ml of syrup.
A measuring cup for administering the medicine.
Outer packaging: a cardboard box.
Responsible entity and manufacturer:
Zakład Farmaceutyczny "Amara" Sp. z o.o.
ul. Stacyjna 5
30-851 Kraków
Phone: 12 657 40 40
Fax: 12 657 40 40 ext. 34
e-mail: amara@amara.pl

Date of the last update of the leaflet: