ATARAX 2 mg /Ml Syrup

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Atarax, 2 mg/ml, syrup
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Atarax and what is it used for
4. Important information before taking Atarax
   1. When not to take Atarax
   2. Warnings and precautions
   3. Atarax and other medicines
   4. Taking Atarax with alcohol
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Atarax contains sucrose and ethanol (alcohol)
5. How to take Atarax
   1. Use in children (from 12 months) and adolescents
   2. Overdose of Atarax
   3. Missed dose of Atarax
   4. Discontinuation of Atarax
6. Possible side effects
   1. Reporting side effects
7. How to store Atarax
8. Contents of the pack and other information
   1. What Atarax contains
   2. What Atarax looks like and contents of the pack
   3. Marketing authorization holder and manufacturer

Leaflet attached to the packaging: patient information

Atarax, 2 mg/ml, syrup

Hydroxyzine hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor or pharmacist.
• 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 or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Atarax and what is it used for
• 2. Important information before taking Atarax
• 3. How to take Atarax
• 4. Possible side effects
• 5. How to store Atarax
• 6. Contents of the pack and other information

1. What is Atarax and what is it used for

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

• symptomatic treatment of anxiety in adults,
• symptomatic treatment of itching,
• premedication before surgical procedures.

2. Important information before taking Atarax

When not to take Atarax

• if the patient is allergic to the active substance or any of the other ingredients of Atarax,
• if the patient is allergic to cetirizine, other piperazine derivatives, aminophylline, or ethylenediamine,
• if the patient has porphyria,
• if the patient's ECG (electrocardiogram) shows heart rhythm disturbances called "QT interval prolongation",
• if the patient has cardiovascular disease or if the heart rate is very low,
• if the patient has low levels of electrolytes (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 "Atarax and other medicines"),
• if a family member of the patient has died suddenly due to heart disease,
• during pregnancy and breastfeeding.

Warnings and precautions

Before starting treatment with Atarax, the patient should discuss it with their 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 occurs weakness of respiratory muscles) or dementia,
• if Atarax is used concomitantly with other medicines that have a sedative effect on the central nervous system or with anticholinergic properties (in these patients, dose adjustment may be necessary).

Taking Atarax may be associated with an increased risk of heart rhythm disturbances, which can be life-threatening. Therefore, the patient should tell their doctor about any heart problems and about taking any other medicines, including those available without a prescription.
If cardiac symptoms occur during treatment with Atarax, such as rapid heartbeat (palpitations), breathing problems, loss of consciousness, the patient should immediately consult a doctor.
Treatment should also be discontinued.
Treatment should be discontinued at least 5 days before performing allergy tests or methacholine bronchial provocation tests to avoid affecting the results of these tests.

Atarax and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as about medicines they plan to take. Atarax may affect the action of other medicines. Other medicines may affect the action of Atarax.
This applies to the following medicines:

• medicines with a sedative effect on the central nervous system or with 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 disturbances.

The patient should not take Atarax if they 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, hydroxychloroquine),
• cancer (e.g., toremifene, vandetanib),
• drug addiction or severe pain (methadone).

Taking Atarax with alcohol

The patient should avoid taking Atarax and alcohol concomitantly.

Pregnancy, breastfeeding, and fertility

Atarax should not be taken during pregnancy or breastfeeding. Breastfeeding should be discontinued if it is necessary to use Atarax.
In newborns whose mothers received hydroxyzine during late pregnancy and/or during delivery, directly or a few hours after birth, the following symptoms may occur: tremors, stiffness, and/or muscle weakness, breathing problems, and urinary retention.
Women of childbearing age should use appropriate contraception to prevent pregnancy during treatment with hydroxyzine.
Animal studies have not shown a negative effect on fertility. Data on the effect on human fertility are not available.

Driving and using machines

While taking Atarax, the patient should not drive vehicles, operate machines, or use tools, as Atarax may impair the ability to react and concentrate.

Atarax contains sucrose and ethanol (alcohol)

Atarax syrup 2 mg/ml contains 0.75 g of sucrose per 1 ml. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine. Sucrose is harmful to teeth.
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.

3. How to take Atarax

This medicine should always be taken according to the doctor's recommendations. In case of doubts, the patient should consult a doctor or pharmacist.
Atarax 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 is 100 mg.
The following are the usual doses of Atarax.
Adults
In symptomatic treatment of anxiety
50 mg/day in 2-3 divided doses.
In severe cases, oral doses of up to 100 mg/day can be used.
In 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
50 mg in two administrations or 100 mg in a single dose orally.

Use in children (from 12 months) and adolescents

In symptomatic treatment of itching
1 mg/kg/day to 2 mg/kg/day in divided doses.
In premedication before surgical procedures
0.6 mg/kg orally in a single dose.
The cumulative daily dose should not exceed 2 mg/kg/day.
In children and adolescents with a body weight up to 40 kg, the maximum daily dose is 2 mg/kg/day.
In children and adolescents with a body weight over 40 kg, the maximum daily dose is 100 mg.
A calibrated measuring device 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
The use of hydroxyzine in elderly patients is not recommended. If treatment is decided, it is recommended to start with half the recommended dose.
In elderly patients, the maximum daily dose is 50 mg.
Patients with renal impairment
In patients with moderate or severe renal impairment, due to reduced excretion of the medicine's metabolite, cetirizine, the doses used should be reduced.
Patients with hepatic impairment
In patients with hepatic impairment, it is recommended to reduce the daily dose by 33%.

Overdose of Atarax

If the patient has taken or used too much Atarax, they should immediately contact the emergency services, especially if it concerns a child. In case of overdose, symptomatic treatment can be used. The patient's ECG should be monitored due to the possibility of heart rhythm disturbances [including bradycardia (very slow heart rate)], such as QT interval prolongation or torsade de pointes.
Symptoms of Atarax 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 disturbances, as well as deepening coma and cardiopulmonary collapse.
There is no specific antidote.

Missed dose of Atarax

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

Discontinuation of Atarax

If the patient has any further doubts about taking this medicine, they should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Atarax can cause side effects, although not everybody gets them.
Very common: may affect more than 1 in 10 people

• drowsiness

Common: may affect up to 1 in 10 people

• dry mouth
• fatigue
• headache
• sedation (calmness) Uncommon: may affect up to 1 in 100 people
• nausea
• malaise, fever
• dizziness, insomnia, tremors
• agitation, confusion

Rare: may affect up to 1 in 1,000 people

• 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: may affect up to 1 in 10,000 people

• anaphylactic shock (caused by a severe, systemic allergic reaction, its symptoms are: 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 (rash on the skin 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 (rash on the skin that can cause the formation of blisters and looks like small targets, a dark spot surrounded by a lighter area and a dark circle around), Stevens-Johnson syndrome (widespread rash with blisters and peeling skin, occurring mainly in the area of the mouth, eyes, nose, and genitals) Frequency not known: frequency cannot be estimated from the available data
• QT interval prolongation in the electrocardiogram, heart rhythm disturbances of the torsade de pointestype
• hepatitis
• loss of consciousness (fainting)
• bullous changes [e.g., toxic epidermal necrolysis (widespread rash with blisters and peeling skin, occurring mainly in the area of the mouth, eyes, nose, and genitals), pemphigoid (an autoimmune skin disease characterized by well-tensioned blisters, located in the area of erythematous-edematous lesions and in apparently unchanged skin)]
• weight gain

The patient should stop taking the medicine and immediately consult a doctor if they experience heart rhythm disturbances, 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, episodes of forced gaze with eye rotation, diarrhea, difficulty urinating, involuntary urination, asthenia (fatigue, weakness), edema, weight gain.
In some people, during treatment with Atarax, other side effects may occur.
If any of the side effects worsen or if any side effects not listed in the leaflet occur, the patient should tell their doctor, pharmacist, or nurse.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor, pharmacist, or nurse. 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 181 C, 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 Atarax

Store in a temperature below 25°C.
Store in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after "Expiry date" and (or) "EXP". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Atarax contains

• The active substance of Atarax is hydroxyzine hydrochloride.
• The other ingredients are: ethanol, sodium benzoate, sucrose, menthol, walnut flavor, purified water.

What Atarax looks like and contents of the pack

Atarax syrup 2 mg/ml is a clear, colorless solution.
The packaging contains a brown glass bottle, closed with a child-resistant plastic cap, containing 200 ml of syrup, and a calibrated measuring device for oral administration.

Marketing authorization holder and manufacturer

Marketing authorization holder:
UCB Pharma SA
Allée de la Recherche 60
B-1070 Brussels
Belgium
Manufacturer:
NextPharma SAS
Route de Meulan 17
78520 Limay
France
To obtain more detailed information, the patient should contact the local representative of the marketing authorization holder:
UCB Pharma Sp. z o.o.
ul. Kruczkowskiego 8
00-380 Warsaw
Tel. + 48 22 696 99 20
Date of last revision of the leaflet: