ATARAX 10 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Atarax, 10 mg, coated tablets
3. Atarax, 25 mg, coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Atarax and what is it used for
5. 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 operating machinery
   7. Atarax contains lactose
6. 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
7. Possible side effects
   1. Reporting side effects
8. How to store Atarax
9. Package contents and other information
   1. What Atarax contains
   2. What Atarax looks like and what the package contains
   3. Marketing authorization holder and manufacturer

Leaflet attached to the packaging: patient information

Atarax, 10 mg, coated tablets

Atarax, 25 mg, coated tablets

Hydroxyzine hydrochloride

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

• Keep this leaflet, you may need to read it again.
• In case of 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. Package contents and other information

1. What is Atarax and what is it used for

Atarax is a medicine with antihistamine, sedative, and anti-anxiety 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 disorders called "QT interval prolongation",
• if the patient has a cardiovascular disease or if the heart rate is very low,
• if the patient has a low level 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 someone in the patient's family has died suddenly due to heart disease,
• during pregnancy and breastfeeding.

Warnings and precautions

Before starting 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, impaired gastrointestinal motility, 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 act on the central nervous system or have anticholinergic properties (in these patients, dose adjustment may be necessary).

Taking Atarax may be associated with an increased risk of heart rhythm disorders, 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 Atarax treatment, 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 any 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 that act on the central nervous system or have anticholinergic properties,
• alcohol and alcohol dehydrogenase inhibitors,
• betahistidine and cholinesterase inhibitors,
• monoamine oxidase inhibitors (medicines used, among others, in depression),
• adrenaline,
• medicines that may cause heart rhythm disorders.

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 diseases 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 or severe pain addiction (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 Atarax is necessary.
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: trembling, stiffness, and/or muscle weakness, breathing problems, and urinary retention.
Women of childbearing age should use appropriate contraception to prevent pregnancy during hydroxyzine treatment.
Animal studies have not shown a negative effect on fertility. Data on the effect on human fertility are not available.

Driving and operating machinery

While taking Atarax, the patient should not drive vehicles, operate machinery, or use tools, as Atarax may impair reaction and concentration abilities.

Atarax contains lactose

Atarax in tablet form contains lactose. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Atarax

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their 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 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, doses up to 100 mg/day can be taken orally.
In symptomatic treatment of itching
Treatment should be started with a dose of 25 mg before bedtime, continuing therapy by 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 oral dose.

Use in children (from 12 months) and adolescents

In children and adolescents up to 40 kg, the maximum daily dose is 2 mg/kg/day.
In children and adolescents over 40 kg, the maximum daily dose is 100 mg.
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.
Dose adjustment
Dosing should be adjusted individually, within the recommended dose range, depending on the patient's response to treatment.
Elderly patients
Hydroxyzine is not recommended for elderly patients. 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. ECG monitoring is necessary due to the possibility of heart rhythm disorders [including bradycardia (very slow heart rate)], such as QT interval prolongation or torsade de pointes.
Symptoms of Atarax overdose are: nausea, vomiting, tachycardia (accelerated heart rate), fever, drowsiness, disturbances of pupillary reflex, tremors, confusion or hallucinations, and then decreased consciousness, respiratory depression, seizures, hypotension, or heart rhythm disorders, as well as deepening coma and cardiopulmonary collapse.
There is no specific antidote.

Missed dose of Atarax

A double dose should not be taken to make up for a missed dose.

Discontinuation of Atarax

In case of further doubts about taking this medicine, the patient should consult their 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 (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
• pruritus, 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, laryngeal and throat edema, skin itching and 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 blistering and looks like small targets)

Frequency not known: frequency cannot be estimated from the available data

• QT interval prolongation in the electrocardiogram, heart rhythm disorders of the torsade de pointestype
• hepatitis
• loss of consciousness (syncope)
• bullous changes [e.g., toxic epidermal necrolysis (widespread rash with blisters and peeling skin, occurring mainly in the mouth, eyes, nose, and genital areas), 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 their doctor if they 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 hydroxyzine administration: 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, other side effects may occur during Atarax treatment.
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 Adverse Reaction Monitoring 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 gather more information on the safety of the medicine.

5. How to store Atarax

Store in a temperature below 25°C.
Store in the outer packaging.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after: "Expiry date and (or) EXP". The expiry date refers to the last day of the given 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. Package contents and other information

What Atarax contains

• The active substance of Atarax is hydroxyzine hydrochloride.
• The other ingredients are: o 10 mg coated tablets:lactose monohydrate, cornstarch, talc (E553b), calcium stearate, povidone K 30. Coating composition: methacrylic acid butyl ester copolymer, sodium lauryl sulfate, silicon dioxide (E551), stearic acid (E570), and talc (E553b). o 25 mg coated tablets:lactose monohydrate, microcrystalline cellulose, magnesium stearate, colloidal anhydrous silica. Coating composition: Opadry Y-1-7000 (titanium dioxide, hypromellose, macrogol 400).

What Atarax looks like and what the package contains

Atarax, 10 mg coated tablets, are white, round tablets.
Atarax, 25 mg coated tablets, are white, oval tablets with a dividing line.
The package contains 25 coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:
UCB Pharma SA
Allée de la Recherche 60
B-1070 Brussels
Belgium
Manufacturer:
Atarax 10 mg coated tablets
UCB Pharma SA, Chemin du Foriest, B-1420 Braine l’Alleud, Belgium
Aesica Pharmaceuticals GmbH, Alfred-Nobel-Str. 10, 40789 Monheim am Rhein, Germany
Atarax 25 mg coated tablets
UCB Pharma SA, Chemin du Foriest, B-1420 Braine l’Alleud, Belgium
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:December 2024