Atarax

Package leaflet: Information for the patient

Warning! Keep the leaflet – the information on the immediate packaging is in a foreign language!
Atarax
25 mg, coated tablets
Hydroxyzini hydrochloridum
Please read the entire leaflet carefully before using 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 or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your 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 an antihistamine medicine with sedative and anxiolytic properties.
Atarax is indicated for:

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

2. Important information before using Atarax

When not to use Atarax

• if the patient is allergic to the active substance or to 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 a heart rhythm disorder known as "QT prolongation",
• if the patient has or has had heart 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 with other medicines"),
• if any family member has died suddenly due to heart disease,
• during pregnancy and while breastfeeding.

Warnings and precautions
Before starting treatment with Atarax, discuss 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 in passing urine 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, weakness of respiratory muscles) or dementia,
• if Atarax is used concomitantly with other medicines that depress the central nervous system or with medicines having anticholinergic properties (in these patients, dose adjustment may be necessary).

Treatment with Atarax may be associated with an increased risk of life-threatening heart rhythm disturbances. Therefore, inform your doctor about any heart-related problems and about any other medicines you are taking, including those available without a prescription.
If heart-related symptoms such as rapid heartbeat (palpitations), breathing difficulties, or loss of consciousness occur during treatment with Atarax, seek medical advice immediately.
Treatment with hydroxyzine should also be discontinued.
Treatment should be discontinued for at least 5 days before undergoing allergy tests or methacholine bronchial provocation tests to avoid influencing test results.

Atarax with other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines you plan to take. Atarax may affect the action of other medicines, and other medicines may affect the action of Atarax.
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 Atarax 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, hydroxychloroquine),
• cancer (e.g. toremifene, vandetanib),
• drug dependence or severe pain (methadone).

Use of Atarax with alcohol
Concomitant use of Atarax and alcohol should be avoided.

Pregnancy, breastfeeding and effects on fertility
Atarax must not be used during pregnancy or while breastfeeding. Breastfeeding should be discontinued if treatment with Atarax is necessary.
In newborns whose mothers received hydroxyzine in late pregnancy and (or) during delivery, the following symptoms may occur shortly after or several hours after birth: tremor, stiffness and (or) muscle weakness, breathing difficulties and urinary retention.
Women of childbearing potential must use an appropriate method of contraception to prevent pregnancy during treatment with hydroxyzine.
Animal studies have not shown any adverse effects on fertility. Data on effects on human fertility are not available.

Driving and operating machinery
While taking Atarax, patients should not drive, operate machinery or use tools, as Atarax may impair reaction ability and concentration.

Atarax contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to take Atarax

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, consult
your doctor or pharmacist.
Atarax should be used at the lowest effective dose. The duration of treatment should be as short
as possible.
In adults and children weighing over 40 kg, the maximum daily dose is 100 mg.
The usual recommended doses of Atarax are given below.
Atarax is available in the following strengths: 10 mg, 25 mg.
Adults
For symptomatic treatment of anxiety
50 mg/day in 2–3 divided doses.
In severe cases, oral doses up to 100 mg/day may be used.
For symptomatic treatment of pruritus (itching)
Treatment should be initiated with 25 mg at bedtime, and continued with dose increases if necessary, administering 25 mg 3 to 4 times daily.
For premedication before surgical procedures
50 mg given in two doses or 100 mg as a single oral dose.
Use in children (from 12 months of age) and adolescents
In children and adolescents weighing up to 40 kg, the maximum daily dose is 2 mg/kg body weight per day.
In children and adolescents weighing over 40 kg, the maximum daily dose is 100 mg.
For symptomatic treatment of pruritus
1 mg/kg body weight per day up to 2 mg/kg body weight per day in divided doses.
For premedication before surgical procedures
0.6 mg/kg body weight as a single oral dose.
The total daily dose should not exceed 2 mg/kg body weight per day.
Dosage adjustment
Dosage should be individually adjusted 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 initiated, 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 administered doses should be reduced.
Patients with hepatic impairment
In patients with hepatic impairment, a 33% reduction in the daily dose is recommended.
Taking more Atarax than recommended
If a patient has taken or used more Atarax than prescribed, contact emergency services immediately, especially if this involves a child. In case of overdose, symptomatic treatment may be administered. ECG monitoring is required due to the risk of cardiac arrhythmias [including bradycardia (very slow heartbeat)], such as QT interval prolongation or torsade de pointes.
Symptoms of Atarax overdose include: nausea, vomiting, tachycardia (increased heart rate), fever, drowsiness, disturbances in pupillary reflex, tremor, confusion or hallucinations, followed by decreased level of consciousness, respiratory depression, seizures, hypotension or cardiac arrhythmias, and progressively deepening coma with circulatory-respiratory collapse.
There is no specific antidote.
If you miss a dose of Atarax
Do not take a double dose to make up for a missed dose.
Stopping Atarax
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Very common: may occur in more than 1 in 10 people

• drowsiness

Common: may occur in up to 1 in 0 people

• dry mouth
• fatigue
• headache
• sedation

Uncommon: may occur in up to 1 in 100 people

• nausea
• malaise, fever
• dizziness, insomnia, tremor
• restlessness, confusion

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

• tachycardia (increased 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: may occur in up to 1 in 10,000 people

• anaphylactic shock (caused by severe systemic allergic reaction; symptoms include: shortness of breath, swelling of the larynx and throat, skin itching and redness, headache, sensation of "tightness", dizziness, profound weakness, up to loss of consciousness); in severe cases may be life-threatening
• bronchospasm
• angioedema (skin lesions in the form of irregular patches, blisters and swellings), 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 which may lead to blister formation and resemble 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, mainly affecting the area around the mouth, eyes, nose and genital organs)

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

• QT interval prolongation on electrocardiogram, cardiac arrhythmias such as torsade de pointes, hepatitis
• loss of consciousness (fainting)
• bullous skin reactions [e.g.: toxic epidermal necrolysis (widespread rash with blisters and skin peeling, mainly affecting the area around the mouth, eyes, nose and genital organs), pemphigoid (autoimmune skin disease characterized by tense blisters on erythematous-edematous lesions or on apparently normal skin)]
• weight gain

Treatment should be discontinued and medical advice sought immediately if the patient develops cardiac arrhythmias such as rapid heartbeat (palpitations), breathing difficulties, or loss of consciousness.

Additionally, the following adverse effects associated with cetirizine, the main metabolite of hydroxyzine, have been observed and may also occur following hydroxyzine administration: decreased platelet count, aggression, depression, tics, involuntary movements, tingling, compulsive upward gaze with eye rotation, diarrhoea, difficulty in urination, involuntary urination, asthenia (weakness, fatigue), oedema, weight gain.

Other adverse effects may occur in some individuals during treatment with Atarax.

If any of the adverse effects worsen or if any adverse effects not listed in this leaflet occur, inform your doctor, pharmacist or nurse.

Reporting of adverse effects

If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal 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 adverse effects helps to provide more information on the safety of the medicine.

5. How to store Atarax

No special storage temperature requirements.
Store in the original packaging to protect from light.
Keep the medicine out of the 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Atarax contains

• The active substance is hydroxyzine dihydrochloride (hydroxyzine hydrochloride).
• The other ingredients are: monohydrate lactose, microcrystalline cellulose, magnesium stearate, colloidal anhydrous silica. Coating ingredients: titanium dioxide (E 171), hypromellose 2910 5cP, macrogol 400.

What Atarax looks like and contents of the packaging
Atarax is a white, elongated tablet with a score line on one side.
The pack contains 25 film-coated tablets.
For more detailed information, please contact the marketing authorization holder or parallel importer.
Marketing authorization holder in Spain, the export country:
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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Spain, the export country: 713032.1
757427.9
Parallel import authorization number: 44/21