ATARAX 25 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
3. Atarax
4. 25 mg, coated tablets
   1. It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
5. What is Atarax and what is it used for
6. Important information before taking Atarax
   1. When not to take Atarax
   2. Warnings and precautions
   3. Atarax and other medications
   4. Taking Atarax with alcohol
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and operating machinery
   7. Atarax contains lactose monohydrate
7. How to take Atarax
   1. Use in children (from 12 months) and adolescents
   2. Taking a higher dose of Atarax than recommended
   3. Missing a dose of Atarax
   4. Stopping treatment with Atarax
8. Possible side effects
   1. Reporting side effects
9. How to store Atarax
10. Package contents and other information
    1. What Atarax contains
    2. What Atarax looks like and what the package contains
    3. Marketing authorization holder in Spain, the country of export:
    4. Manufacturer:
    5. Parallel importer:
    6. Repackaged by:
    7. Date of leaflet approval: 01.04.2025

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Atarax

25 mg, coated tablets

Hydroxyzine hydrochloride

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness 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 disturbances called "QT interval prolongation",
• if the patient has a 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 medications used to treat heart rhythm disorders or medications that may affect heart rhythm (see "Atarax and other medications"),
• if someone in the patient's family 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, and rarely, respiratory muscle weakness) or dementia,
• if Atarax is used concomitantly with other medications that have a sedative effect on the central nervous system or with medications that have anticholinergic properties (in these patients, dose adjustment may be necessary).

Treatment with 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 medications, 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 medications

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

• medications that have a sedative effect on the central nervous system or medications with anticholinergic effects,
• alcohol and alcohol dehydrogenase inhibitors,
• betahistamine and cholinesterase inhibitors,
• monoamine oxidase inhibitors (medications used, among other things, in depression),
• adrenaline,
• medications that may cause heart rhythm disturbances.

The patient should not take Atarax if they are taking medications 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 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: trembling, stiffness, and/or muscle weakness, breathing problems, and urinary retention.
Women of childbearing age must 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 the ability to react and concentrate.

Atarax contains lactose monohydrate

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

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 their doctor or pharmacist.
Atarax should be taken in the smallest effective dose. The treatment period 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 the 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 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
50 mg in two administrations or 100 mg in a single dose orally.

Use in children (from 12 months) and adolescents

In children and adolescents with a body weight up to 40 kg, the maximum daily dose is 2 mg/kg body weight per day.
In children and adolescents with a body weight over 40 kg, the maximum daily dose is 100 mg.
In the symptomatic treatment of itching
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.
The cumulative daily dose should not exceed 2 mg/kg body weight per day.
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 drug'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%.

Taking a higher dose of Atarax than recommended

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, trembling, confusion or hallucinations, and then decreased consciousness, respiratory depression, seizures, hypotension, or heart rhythm disturbances, as well as deepening coma and cardiopulmonary collapse.
There is no specific antidote.

Missing a dose of Atarax

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

Stopping treatment with Atarax

In case of any further doubts about the use of 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, trembling
• 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, 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 (dark spot surrounded by a lighter area and a dark ring around)), Stevens-Johnson syndrome (widespread rash with blisters and peeling skin, occurring mainly in the mouth, eyes, nose, and genital areas) 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 mouth, eyes, nose, and genital areas), pemphigoid (an autoimmune skin disease characterized by well-tensioned blisters, located in the area of reddened and swollen skin and in apparently unchanged skin)]
• weight gain

The patient should stop taking the medicine and immediately consult their 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 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, 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 or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Office for Registration of Medicinal 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Atarax

There are no special recommendations for storage temperature.
Store in the original packaging to protect from light.
The medicine should be stored 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 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 (hydroxyzine dichloride).
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, magnesium stearate, anhydrous colloidal silica. The coating contains: titanium dioxide (E 171), hypromellose 2910 5cP, macrogol 400.

What Atarax looks like and what the package contains

Atarax, coated tablets, 25 mg are white, oblong, tablets with a dividing line in the middle.
The package contains 25 coated tablets.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Spain, the country of export:

UCB Pharma, S.A.
Plaza de Manuel Gómez Moreno, s/n, Edificio Bronce, Planta 5, 28020 Madrid, Spain

Manufacturer:

UCB S.A. Pharma Sector
Chemin du Foriest, B-1420 Braine l´Alleud, Belgium

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warsaw
Marketing authorization number in Spain, the country of export:757427.9

• 713032.1 Parallel import authorization number:128/20

Date of leaflet approval: 01.04.2025