Atarax

Patient Information Leaflet

Atarax, 2 mg/ml, syrup
Hydroxyzini hydrochloridum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

1. What Atarax is and what it is 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 Atarax is and what it is 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 prior to surgical procedures.

2. Important information before using Atarax

When not to use 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 a heart rhythm disorder called "QT prolongation",
• if the patient has or has had cardiovascular disease or if 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 someone in the patient's family has died suddenly due to heart disease,
• during pregnancy and while breastfeeding.

Warnings and precautions
Before starting 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 urination 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, respiratory muscle weakness) or dementia,
• if Atarax is used concomitantly with other medicines that depress the central nervous system or with medicines having anticholinergic properties (in such patients, dose adjustment may be necessary).

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

Taking Atarax with alcohol
Avoid taking Atarax together with alcohol.
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 birth or within several hours: tremor, muscle stiffness and (or) 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 negative effects on fertility. Data on effects on fertility in humans are not available.
Driving and operating machinery
Do not drive, operate machinery, or use tools while taking Atarax, as this medicine may impair reaction ability and concentration.
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 certain sugars, the patient should consult a doctor before taking the medicine. Sucrose is harmful to teeth.
The medicine contains a small amount (0.1%) of ethanol (alcohol). The alcohol concentration after taking a 100 ml dose of syrup (equivalent to 200 mg hydroxyzine) is up to 100 mg, which corresponds to 2 ml of beer or 1 ml of wine.

3. How to use Atarax

This medicine should always be used exactly as directed by the physician. If in doubt, consult a doctor or pharmacist.
Atarax should be used at the lowest effective dose. The duration of treatment should be as short as possible.
For adults and children with body weight above 40 kg, the maximum daily dose is 100 mg.
The following are the usual doses of Atarax.

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):
Begin treatment with 25 mg at bedtime. Continue therapy, increasing the dose if necessary to 25 mg, 3 to 4 times daily.

For premedication prior to 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
For symptomatic treatment of pruritus:
1 mg/kg body weight/day up to 2 mg/kg body weight/day in divided doses.

For premedication prior to surgical procedures:
0.6 mg/kg body weight orally as a single dose.
The total daily dose should not exceed 2 mg/kg body weight/day.
In children and adolescents with body weight up to 40 kg, the maximum daily dose is 2 mg/kg body weight/day.
In children and adolescents with body weight above 40 kg, the maximum daily dose is 100 mg.
The package of syrup contains a calibrated measuring device to facilitate dosing.

Dose adjustment
Dosage should be individually adjusted within the recommended dose range depending on the patient's response to treatment.

Elderly patients
Use of hydroxyzine in elderly patients is not recommended. If treatment is initiated, it is recommended to start at half the usual 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 elimination 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.

Use of a higher than recommended dose of Atarax
If a patient has taken or used more than the recommended dose of Atarax, contact emergency services immediately, especially if this involves a child. In case of overdose, symptomatic treatment may be applied. ECG monitoring is required due to the risk of cardiac rhythm disturbances [including bradycardia (very slow heart rate)], such as QT interval prolongation or torsade de pointes.
Symptoms of Atarax overdose include: nausea, vomiting, tachycardia (increased heart rate), fever, drowsiness, pupillary reflex disturbances, tremor, confusion or hallucinations, followed by decreased level of consciousness, respiratory depression, seizures, hypotension or cardiac arrhythmias, and progressing to deepening coma and circulatory-respiratory collapse.
There is no specific antidote.

Missed dose of Atarax
Do not take a double dose to make up for a missed dose.

Discontinuation of Atarax
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.

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

• drowsiness

Common: may occur in up to 1 in 10 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 a 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 swelling), increased sweating, fixed drug eruption, acute generalized exanthematous pustulosis (pustular rash on red 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 bullseyes (a dark center surrounded by a lighter area and a dark ring around it)), Stevens-Johnson syndrome (widespread rash with blisters and skin peeling, occurring mainly around the mouth, eyes, nose and genital organs)

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

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

If any of the following symptoms occur, stop taking the medicine and contact a doctor immediately:
cardiac arrhythmias such as rapid heartbeat (palpitations), breathing difficulties, loss of consciousness.

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

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

If any adverse reaction worsens or if any adverse reactions not listed in this leaflet occur, inform your doctor, pharmacist, or nurse.

Reporting of adverse reactions

If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl .

Adverse reactions can also be reported to the marketing authorization holder.

Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Atarax

Store below 25°C.
Keep out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle under
"Expiry date and (or) EXP". The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the package and other information

What Atarax contains

• The active substance is hydroxyzine hydrochloride.
• The other ingredients are: ethanol, sodium benzoate, sucrose, menthol, nut flavour, purified water.

What Atarax looks like and contents of the pack

Atarax, syrup 2 mg/ml is a clear, colourless solution.
The pack contains an amber glass bottle closed with a child-resistant plastic cap, containing 200 ml of syrup, and an oral dosing syringe graduated in 0.25 ml increments.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
UCB Pharma SA
Allée de la Recherche 60
B-1070 Brussels
Belgium

Manufacturer:
NextPharma SAS
Route de Meulan 17
78520 Limay
France

For further information, please contact the local representative of the Marketing Authorisation Holder:
UCB Pharma Sp. z o.o.
ul. Kruczkowskiego 8
00-380 Warsaw
Tel. + 48 22 696 99 20