ATARAX 20 mg /10 Ml Syrop

Treść ulotki

1. ATARAX 25 mg film-coated tablets
   1. What is ATARAX and what is it used for
   2. What you need to know before you take ATARAX
   3. How to take ATARAX
   4. Possible side effects
   5. How to store ATARAX
   6. Package Contents and Other Information
2. ATARAX 2 mg /1 ml syrup
   1. What is ATARAX and what is it used for
   2. What you need to know before you take ATARAX
   3. How to take ATARAX
   4. Possible side effects
   5. How to store ATARAX
   6. Contents of the pack and other information

ATARAX 25 mg film-coated tablets

hydroxyzine dihydrochloride

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What ATARAX is and what it is used for
• 2. What you need to know before you take 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 contains the active ingredient hydroxyzine dihydrochloride and belongs to a group of
medicines called psycholeptics and anxiolytics.
ATARAX film-coated tablets are indicated for the treatment of anxiety symptoms in
adults aged 18 years and over and for the treatment of itching symptoms in adults, adolescents and
children aged 6 years and over.

2. What you need to know before you take ATARAX

Do not take ATARAX

• If you are allergic to hydroxyzine dihydrochloride, cetirizine, other piperazine derivatives, aminophylline, ethylenediamine or any of the other ingredients of this medicine (listed in section 6)
• If your ECG (electrocardiogram) shows a heart rhythm problem called “prolongation of the QT interval”
• If you have or have had a cardiovascular disease or if you have a very slow heart rate
• If you have low levels of salts in your body (for example low levels of potassium or magnesium)
• If you are taking certain medicines for heart rhythm problems or medicines that can affect the heart rhythm (see section “Other medicines and ATARAX”)
• If someone in your family has suddenly died from heart problems
• If you have a disease called porphyria
• If you are being treated with monoamine oxidase inhibitors (MAOIs) (see section “Other medicines and ATARAX”)
• If you are a pregnant woman
• If you are breastfeeding

Warnings and precautions
Talk to your doctor or pharmacist before taking ATARAX.
ATARAX may be associated with an increased risk of life-threatening heart rhythm disorders. Therefore, tell your doctor if you have heart problems or if you are taking
any other medicines, including over-the-counter medicines.
While you are taking ATARAX, immediately contact your doctor if you experience heart problems
such as palpitations, difficulty breathing, loss of consciousness. In these cases, treatment with
hydroxyzine must be stopped.
Before taking ATARAX, tell your doctor:

• If you have a predisposition to seizures. Small children are more prone to adverse effects on the central nervous system
• If you have an eye disease that increases intraocular pressure (glaucoma)
• If you have problems with urination (prostatic hypertrophy or urethral obstruction)
• If you have narrowing of the stomach valve (pyloric stenosis), the duodenum (duodenal stenosis) or other parts of the gastrointestinal or urogenital tract
• If you have gastrointestinal disorders (hypomotility)
• If you have high blood pressure (arterial hypertension)
• If you have a disease called myasthenia gravis that prevents the muscles from working properly
• If your thyroid is overactive (hyperthyroidism)
• If you have a disorder of intellectual functions (dementia)
• If you are taking anticoagulants. In this case, your doctor may prescribe you laboratory tests

Other medicines and ATARAX
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. This includes any medicine obtained without a prescription.
ATARAX can affect or be affected by other medicines.
Do not take ATARAX if you are taking medicines to treat:

• bacterial infections (for example, the antibiotics erythromycin, moxifloxacin and levofloxacin)
• fungal infections (for example, pentamidine)
• heart problems or high blood pressure (for example, amiodarone, quinidine, disopyramide, sotalol)
• psychosis (for example, haloperidol)
• depression (for example, citalopram, escitalopram, monoamine oxidase inhibitors (MAOIs))
• gastrointestinal disorders (for example, prucalopride)
• allergies
• malaria (for example, mefloquine and hydroxychloroquine)
• tumors (for example, toremifene, vandetanib)
• drug abuse or severe pain (methadone)

Tell your doctor if you are taking:

• medicines that slow down the heartbeat
• medicines that lower potassium levels
• substances with anticholinergic action
• medicines that depress the nervous system
• antihistamines
• betaistine
• anticholinesterases
• phenytoin (an antiepileptic)
• cimetidine (an anti-ulcer)

Tell your doctor that you are taking ATARAX if you need to undergo tests to assess the
presence of allergies and for the diagnosis of asthma. There may be effects on the test results.

ATARAX with food, beverages and alcohol
Alcohol can enhance the effect of hydroxyzine. Avoid drinking alcohol during treatment with
ATARAX.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take ATARAX if you are pregnant.
If you are a woman of childbearing potential, use effective contraceptive measures to prevent pregnancy
during treatment with ATARAX.
In newborns of mothers who have taken ATARAX in late pregnancy and/or during labor
the following symptoms may occur, which have been observed immediately or a few
hours after birth: tremors, muscle stiffness and/or weakness, breathing problems and urinary retention
(difficulty urinating/urinary retention).
Breastfeeding
Do not take ATARAX if you are breastfeeding.

Driving and operating machinery
ATARAX can impair reaction time and concentration when driving vehicles
and operating machinery as it can cause fatigue, dizziness and visual disturbances, especially
at higher doses and/or if you drink alcohol or take sedative medicines at the same time. Avoid
drinking alcohol or taking sedative medicines during treatment with ATARAX.
Do not drive and do not operate machinery until you have verified whether this medicine affects your
ability to perform these activities.

ATARAX contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him or her before taking
this medicine.

3. How to take ATARAX

Take this medicine always exactly as your doctor or pharmacist has told you.
If you have doubts, ask your doctor or pharmacist.
ATARAX must be used at the minimum effective dose and for the shortest possible time.

Adults

Treatment of anxiety symptoms
The recommended dose is 50 mg per day, to be divided into 3 administrations of 12.5 mg
(half a 25 mg tablet), 12.5 mg (half a 25 mg tablet), 25 mg (one 25 mg
tablet). Taking a higher dose in the evening is at the doctor's discretion. If necessary, the dose
may be increased up to 100 mg per day.

Treatment of itching symptoms
The initial dose is 25 mg up to 1 hour before bedtime, if necessary continue with doses of 25
mg up to 3 - 4 times a day.
The maximum daily dose in adults is 100 mg per day.

Special Populations
In some cases, your doctor may prescribe a different dose, but within the recommended dosage
range, in relation to your response to treatment.
Elderly
If you are 65 years of age or older, your doctor may prescribe a lower dose.
The doctor may start therapy by prescribing half the recommended dose. The doctor
will choose the lowest possible dose.
In the elderly, the maximum daily dose is 50 mg per day, equivalent to 2 tablets per
day.
Patients with liver problems
If you suffer from liver problems, your doctor will prescribe a lower dose.
Patients with kidney damage
If you suffer from moderate to severe kidney disease, your doctor will prescribe a lower dose
of the medicine, taking into account the degree of impairment of kidney function.

Use in children and adolescents
Atarax film-coated tablets are not recommended in children under 6 years of age
as they may not be able to swallow the tablet.
Other pharmaceutical forms of this medicine may be more appropriate for
administration in children, ask your doctor or pharmacist for advice.

For the treatment of itching symptoms in adolescents and children from 6 years of age
In adolescents and children aged 6 years and over: from 1 mg/kg per day up to 2
mg/kg per day in divided doses.
Children up to 40 kg in weight
The maximum daily dose is 2 mg/kg per day.
Children weighing over 40 kg
The maximum daily dose is 100 mg per day.
The tablets should be swallowed without chewing, with a sip of water. If desired
follow the intake of a small amount of food (biscuits, fruit, etc.) to avoid the
appearance of stomach discomfort.
The tablet can be divided into equal parts.

If you take more ATARAX than you should
If you have taken too much ATARAX, contact your doctor immediately or go to the nearest hospital,
especially if a child has taken too much. In case of overdose, symptomatic treatment may be
adopted. An ECG monitoring may be performed due to the possibility of heart rhythm problems
such as prolonged QT interval or torsades de pointes.
An overdose can cause the following symptoms: nausea, vomiting, rapid heartbeat
(tachycardia), fever, drowsiness, impaired pupillary light reflex, tremor,
confusion and hallucinations. These may be followed by impaired consciousness,
respiratory depression, seizures, low blood pressure (hypotension) or heart rhythm disturbances
(arrhythmias) including bradycardia (slowed heartbeat). Worsening of coma and cardiorespiratory
collapse may follow.

If you forget to take ATARAX
Do not take a double dose to make up for the forgotten tablet.

If you stop taking ATARAX
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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

Uncommon (may affect up to 1 in 1000 people)

• nausea
• weakness (asthenia)
• malaise
• fever
• dizziness
• insomnia
• tremor
• agitation
• confusion
• attention disorder
• vertigo

Rare (may affect up to 1 in 10,000 people)

• fast heartbeat (tachycardia)
• difficulty of the eye in focusing images (accommodation disorder)
• blurred vision
• constipation
• vomiting
• abnormal liver function tests
• allergic reactions (hypersensitivity)
• convulsions
• involuntary movements (dyskinesias)
• nervousness
• difficulty coordinating movements
• disorientation
• hallucinations
• difficulty urinating (urinary retention)
• itching, reddened skin rashes with possible spots and blisters (erythematous rash, maculopapular rash), urticaria, dermatitis
• low blood pressure (hypotension)

Very rare (may affect less than 1 in 10,000 people)

• sudden severe allergic reaction (anaphylactic shock)
• sudden narrowing of the airways causing difficulty breathing (bronchospasm)
• widespread skin rash with blisters and peeling of the skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)
• erythema multiforme
• acute generalized exanthematous pustulosis, a severe allergic reaction that causes swelling of the face or throat (angioedema)
• fixed drug eruption
• increased sweating

Not known (frequency cannot be estimated from available data)

• dry nose
• ringing in the ears
• hepatitis
• heart rhythm problems (electrocardiogram abnormalities such as prolonged QT interval, torsades de pointes). Stop taking the medicine and contact your doctor immediately if you experience any heart rhythm problems such as palpitations, difficulty breathing, loss of consciousness
• loss of consciousness (syncope)
• skin diseases that cause blisters and blistering lesions of the skin and/or mucous membranes (toxic epidermal necrolysis, pemphigoid)
• weight gain.

During treatment with ATARAX, a severe decrease in certain blood cells may occur exceptionally, for example, a type of white blood cells (agranulocytosis), platelets (thrombocytopenia) or red blood cells (hemolytic anemia).
Furthermore, during treatment with ATARAX, potentially undesirable effects such as aggression, depression, tics, alteration of muscle or nervous tone (dystonia), alteration of sensitivity (paresthesia), an eye disorder where the eyes assume a fixed position (oculogyric crisis), diarrhea, difficulty urinating (dysuria), involuntary urination (enuresis), swelling (edema), weight gain may potentially occur.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store ATARAX

Keep this medicine out of the sight and reach of children.
Keep the blisters in the outer packaging to protect the medicine from light.
Do not use this medicine after the expiry date which is stated on the pack after Exp.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What ATARAX contains

• The active ingredient is hydroxyzine dihydrochloride. One film-coated tablet contains 25 mg of hydroxyzine dihydrochloride.
• The other ingredients are:
• tablet core components: lactose monohydrate, microcrystalline cellulose, magnesium stearate, anhydrous colloidal silicon dioxide.
• film coating components: Opadry Y-1-7000 [titanium dioxide (E 171), hypromellose (E 464), macrogol 400].

Description of the appearance of ATARAX and package contents
ATARAX film-coated tablets are white, oblong-shaped, and divisible. One
pack contains 20 tablets in blisters.

Marketing Authorisation Holder
UCB Pharma S.p.A.
Via Varesina, 162
20156 Milan (Italy)

Manufacturer
UCB Pharma S.A.
Chemin du Foriest
1420 Braine l’Alleud (Belgium)

ATARAX 2 mg /1 ml syrup

hydroxyzine dihydrochloride

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What ATARAX is and what it is used for
• 2. What you need to know before you take 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 contains the active ingredient hydroxyzine dihydrochloride and belongs to a group of
medicines called psycholeptics and anxiolytics.
ATARAX syrup is indicated for the treatment of anxiety symptoms in adults aged 18 years and over and for the treatment of itching symptoms in adults, adolescents and children from 12 months of
age.

2. What you need to know before you take ATARAX

Do not take ATARAX

• If you are allergic to hydroxyzine dihydrochloride, cetirizine, other piperazine derivatives, aminophylline, ethylenediamine or any of the other ingredients of this medicine (listed in section 6)
• If your ECG (electrocardiogram) shows a heart rhythm problem called “QT interval prolongation”
• If you have or have had cardiovascular disease or if you have a very slow heart rate
• If you have low levels of salts in your body (for example low levels of potassium or magnesium)
• If you are taking certain medicines for heart rhythm problems or medicines that can affect heart rhythm (see section “Other medicines and ATARAX”)
• If someone in your family has died suddenly from heart problems
• If you have a condition called porphyria
• If you are being treated with monoamine oxidase inhibitors (MAOIs) (see section “Other medicines and ATARAX”)
• If you are a pregnant woman
• If you are breastfeeding

Warnings and precautions
Talk to your doctor or pharmacist before taking ATARAX.
ATARAX may be associated with an increased risk of life-threatening heart rhythm disorders. Therefore, tell your doctor if you have heart problems or if you are taking
any other medicines, including over-the-counter medicines.
While you are taking ATARAX, contact your doctor immediately if you experience heart problems
such as palpitations, difficulty breathing, loss of consciousness. In these cases, treatment with
hydroxyzine must be stopped.
Before taking ATARAX, tell your doctor:

• If you have a predisposition to seizures. Small children are more prone to adverse effects on the central nervous system
• If you have an eye disease that increases intraocular pressure (glaucoma)
• If you have problems with urination (prostatic hypertrophy or obstruction of the bladder neck)
• If you have narrowing of the stomach valve (pyloric stenosis), the duodenum (duodenal stenosis) or other parts of the gastrointestinal or urogenital tract
• If you have gastrointestinal disorders (hypomotility)
• If you have high blood pressure (arterial hypertension)
• If you have a condition called myasthenia gravis that prevents the muscles from working properly
• If your thyroid is overactive (hyperthyroidism)
• If you have a disorder of intellectual functions (dementia)
• If you are taking anticoagulants. In this case, your doctor may prescribe laboratory tests

Other medicines and ATARAX
Tell your doctor or pharmacist if you are taking, have recently taken or may take
any other medicines. This includes any medicine obtained without a prescription.
ATARAX can affect or be affected by other medicines.
Do not take ATARAX if you are taking medicines to treat:

• bacterial infections (for example, the antibiotics erythromycin, moxifloxacin and levofloxacin)
• fungal infections (for example, pentamidine)
• heart problems or high blood pressure (for example, amiodarone, quinidine, disopyramide, sotalol)
• psychosis (for example, haloperidol)
• depression (for example, citalopram, escitalopram, monoamine oxidase inhibitors MAOIs)
• gastrointestinal disorders (for example, prucalopride)
• allergy
• malaria (for example, mefloquine and hydroxychloroquine)
• tumors (for example, toremifene, vandetanib)
• drug abuse or severe pain (methadone)

Tell your doctor if you are taking:

• medicines that slow down the heartbeat
• medicines that lower potassium levels
• substances with anticholinergic action
• medicines that depress the nervous system
• antihistamines
• betaistine
• anticholinesterases
• phenytoin (an antiepileptic)
• cimetidine (an anti-ulcer)

Tell your doctor that you are taking ATARAX if you need to undergo tests to assess the
presence of allergy and for the diagnosis of asthma. There may be effects on test results.

ATARAX with food, drinks and alcohol
Alcohol can enhance the effect of hydroxyzine. Avoid drinking alcohol during treatment with
ATARAX.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take ATARAX if you are pregnant.
If you are a woman of childbearing age, use effective contraceptive measures to prevent pregnancy
during treatment with ATARAX.
In newborns of mothers who have taken ATARAX in late pregnancy and/or during labor
the following symptoms may occur, which have been observed immediately after or several
hours after birth: tremors, muscle stiffness and/or weakness, breathing problems and urinary retention (difficulty urinating/urine retention).
Breastfeeding
Do not take ATARAX if you are breastfeeding.

Driving and using machines
ATARAX can impair reaction time and concentration while driving
and operating machinery as it can cause fatigue, dizziness and visual disturbances, especially
at higher doses and/or if you drink alcohol or take sedative drugs at the same time. Avoid
drinking alcohol or taking sedative drugs during treatment with ATARAX.
Do not drive or operate machinery until you have checked if this medicine affects your
ability to perform these activities.

ATARAX contains ethanol, sucrose, sodium benzoate and sodium
This medicine contains 4.75 mg of alcohol (ethanol) in 5 ml, which is equivalent to 0.95 mg/ml
(0.095% w/v). The amount of this medicine in 5 ml is equivalent to less than 1 ml of beer or 1 ml of
wine.
The low amount of alcohol in this medicine has no noticeable effects.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking
this medicine. It may be harmful to your teeth
This medicine contains 0.75 g of sucrose per ml. This should be taken into account in people
with diabetes mellitus.
This medicine contains 0.3 mg of sodium benzoate per 1 ml, which is equivalent to 0.3 mg/ml.
This medicine contains less than 1 mmol of sodium (23 mg) per 5ml, i.e. essentially ‘sodium-free’

Anti-doping tests
For those who engage in sports, the use of medicines containing ethyl alcohol may result in
positive doping tests in relation to the concentration limits of alcohol indicated by some
sports federations.

3. How to take ATARAX

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.
ATARAX must be used at the minimum effective dose and for the shortest possible time.
When your doctor prescribes the syrup, the prescribed dose will be expressed in volume (ml).
The amount of syrup must be measured using an oral syringe, graduated every 0.25 ml.

Adults

Treatment of anxiety symptoms
The recommended dose is 25 ml per day, to be divided into 3 administrations of 6.25 ml – 6.25
ml – 12.5 ml. Taking a higher dose in the evening is at the doctor's discretion. If necessary
the dose may be increased up to 50 ml per day.

Treatment of itching symptoms
The initial dose is 12.5 ml up to 1 hour before bedtime, if necessary continue with doses of
12.5 ml up to 3 - 4 times a day.
The maximum daily dose in adults is 50 ml per day.

Special populations
In some cases, your doctor may prescribe a different dose, but within the range of
recommended dosage, in relation to your response to treatment.
Elderly
If you are 65 years of age or older, your doctor may prescribe a lower dose.
The doctor may start therapy by prescribing you half the recommended dose. The doctor
will choose the lowest possible dose.
In the elderly, the maximum daily dose is 25 ml per day.
Patients with liver problems
If you suffer from liver problems, your doctor will prescribe a lower dose.
Patients with kidney damage
If you suffer from moderate to severe kidney disease, your doctor will prescribe a lower dose of the
medicine, taking into consideration the degree of impairment of kidney function.

Use in children and adolescents

For the treatment of itching symptoms
In adolescents and children from 12 months of age: from 0.5 ml/kg per day up to 1 ml/kg per day in
separate doses.
Children weighing up to 40 kg
The maximum daily dose is 1 ml/kg per day.
Children weighing over 40 kg
The maximum daily dose is 50 ml per day
Take the syrup, pure or diluted, in a little water or fruit juice, immediately before
meals.

If you take more ATARAX than you should
If you have taken too much ATARAX, contact your doctor immediately or go to the nearest hospital,
especially if a child has taken too much. In case of overdose, symptomatic treatment may be
adopted. An ECG monitoring may be performed due to the possibility of heart rhythm problems such as QT prolongation
or torsades de pointes.
An overdose can cause the following symptoms: nausea, vomiting, rapid heartbeat
(tachycardia), fever, drowsiness, impairment of pupillary light reflexes, tremor,
confusion and hallucinations. These may be followed by impaired consciousness,
respiratory depression, seizures, low blood pressure (hypotension) or heart rhythm disturbances (arrhythmias) including bradycardia (slowed heartbeat). Worsening
of coma and cardiorespiratory collapse may follow.

If you forget to take ATARAX
Do not take a double dose to make up for a missed dose.

If you stop taking ATARAX
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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

Uncommon (may affect up to 1 in 1000 people)

• nausea
• weakness (asthenia)
• discomfort
• fever
• dizziness
• insomnia
• tremor
• agitation
• confusion
• attention disorder
• vertigo

Rare (may affect up to 1 in 10,000 people)

• fast heartbeat (tachycardia)
• difficulty of the eye in focusing images (accommodation disorder)
• blurred vision
• constipation
• vomiting
• abnormal liver function tests
• allergic reactions (hypersensitivity)
• convulsions
• involuntary movements (dyskinesias)
• nervousness
• difficulty coordinating movements
• disorientation
• hallucinations
• difficulty urinating (urinary retention)
• itching, reddened skin rashes with possible spots and blisters (erythematous rash, maculopapular rash), urticaria, dermatitis
• low blood pressure (hypotension)

Very rare (may affect less than 1 in 10,000 people)

• sudden severe allergic reaction (anaphylactic shock)
• sudden narrowing of the airways causing difficulty breathing (bronchospasm)
• widespread skin rash with blisters and peeling of the skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)
• erythema multiforme
• acute generalized exanthematous pustulosis, a severe allergic reaction causing swelling of the face or throat (angioedema)
• fixed drug eruption
• increased sweating

Not known (frequency cannot be estimated from the available data)

• dry nose
• ringing in the ears
• hepatitis
• heart rhythm problems (abnormal electrocardiogram with prolonged QT interval, torsades de pointes). Stop taking the medicine and contact your doctor immediately if you experience any heart rhythm problems such as palpitations, difficulty breathing, loss of consciousness
• loss of consciousness (syncope)
• skin diseases causing blisters and blistering lesions of the skin and/or mucous membranes (toxic epidermal necrolysis, pemphigoid)
• weight gain.

During treatment with ATARAX, a severe decrease in certain blood cells, for example a type of white blood cells (agranulocytosis), platelets (thrombocytopenia) or red blood cells (hemolytic anemia), may occur exceptionally.
Furthermore, during treatment with ATARAX, side effects such as aggression, depression, tics, alteration of muscle or nervous tone (dystonia), alteration of sensitivity (paresthesia), an eye disorder that assumes a fixed position (oculogyric crisis), diarrhea, difficulty urinating (dysuria), involuntary urination (enuresis), swelling (edema), weight gain could potentially occur.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store ATARAX

Keep this medicine out of sight and reach of children.
Keep the bottle in the outer packaging to protect the medicine from light.
Do not use this medicine after the expiry date which is stated on the pack after Exp.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ATARAX contains

• The active ingredient is hydroxyzine dihydrochloride. 1 ml of ATARAX syrup contains 2 mg of hydroxyzine dihydrochloride. 1 bottle contains 150 ml of ATARAX syrup, equivalent to 300 mg of hydroxyzine dihydrochloride.
• The other ingredients are: sucrose, sodiumbenzoate (E211), levomenthol, hazelnut flavour (containing propylene glycol, vanillin, ethyl vanillin, fenugreek seed extract, lovage oil), ethanol, purified water.

Description of the appearance of ATARAX and contents of the pack
ATARAX 2 mg/1 ml syrup is a clear and colourless solution. Each pack contains one
150 ml glass bottle with an oral administration syringe (polyethylene/polystyrene).

Marketing authorisation holder
UCB Pharma S.p.A.
Via Varesina, 162
20156 Milan (Italy)

Manufacturer
NextPharma S.A.S.
17 Route de Meulan
78520 Limay (France)