Leaflet: information for the user

Atarax 2mg/ml syrup

hydroxyzine, dihydrochloride

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

- Keep this leaflet, as you may need to read it again.

- If you have any questions, consult your doctor or pharmacist.

- This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, consult your doctor or pharmacist even if they are not listed in this leaflet. See section 4.

1. What Atarax syrup is and what it is used for

2. What you need to know before you start taking Atarax syrup

3. How to take Atarax syrup

4. Possible side effects

5. Storage of Atarax syrup

6. Contents of the pack and additional information

Atarax is an anxiolytic medication that belongs to a class of compounds called diphenylmethanes.

Atarax is used for:

• symptomatic treatment of anxiety in adults aged 18 years and older;
• symptomatic treatment of pruritus in adults, adolescents, and children aged 12 months and older.

Do not take Atarax

• If you are allergic (hypersensitive) to hydroxyzine dihydrochloride or to any of the other components of Atarax, to cetirizine, to other piperazine derivatives, to aminophylline, or to ethylenediamine.
• If you have porphyria (a group of inherited blood disorders).
• 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 your heart rate is very low.
• If you have low levels of salts in your body (e.g. low potassium or magnesium levels).
• If you are taking certain medications for heart rhythm problems or medications that may affect heart rhythm (see “Use of Atarax with other medications”).
• If a close relative has died suddenly from heart problems.
• During pregnancy or breastfeeding.

Warnings and precautions

• If you have a high risk of seizures.
• If you have liver insufficiency and if you have moderate or severe renal insufficiency. In these cases, the dose of Atarax should be reduced.
• If you suffer from glaucoma, urinary tract obstruction, decreased gastrointestinal motility, myasthenia gravis, or dementia.
• Atarax may be associated with an increased risk of life-threatening heart rhythm problems. Therefore, inform your doctor if you have any heart problems or if you are taking any other medications, including those obtained without a prescription.

Seek immediate medical attention if, while you are being treated with Atarax, you experience heart problems such as palpitations, difficulty breathing, or loss of consciousness. Treatment with hydroxyzine should be discontinued.

Other medications and Atarax

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. This includes any medication obtained without a prescription. Atarax may affect or be affected by other medications.

Atarax may potentiate the central nervous system depressant effects if used concurrently with other medications with depressant or anticholinergic properties. In these cases, the dose should be adjusted for each patient.

Atarax antagonizes the effects of betahistamine and anticholinesterase medications.

You should discontinue treatment with Atarax at least 5 days before undergoing an allergy test or a metacholine bronchial provocation test to avoid effects on the results.

Concurrent administration of Atarax with monoamine oxidase inhibitors should be avoided.

Atarax counteracts the pressor effects of adrenaline.

Concurrent administration with medications that may cause arrhythmias may increase the risk of QT prolongation and Torsades de Pointes (alterations in electrocardiogram measurements).

Do not take Atarax if you are taking medications to treat:

• Bacterial infections (e.g. erythromycin, moxifloxacino, levofloxacino)
• Fungal infections (e.g. pentamidina)
• Cardiovascular problems or high blood pressure (e.g. amiodarona, quinidina, disopiramida, sotalol)

• Psychosis (e.g. haloperidol)
• Depression (e.g. citalopram, escitalopram)
• Gastrointestinal problems (e.g.prucaloprida)
• Allergy
• Malaria (e.g. mefloquina e hidroxicloroquina)
• Cancer (e.g.toremifeno, vandetanib)
• Abuse of medications or intense pain (metadona)

Until now, no more interactions with other medications have been detected.

Atarax with food, drinks, and alcohol

You should not consume alcohol while being treated with this medication. Concurrent administration of hydroxyzine and alcohol may produce effects on the central nervous system.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking any medication. Atarax should not be taken during pregnancy.

Atarax should not be taken during breastfeeding. If treatment with Atarax is necessary, breastfeeding should be discontinued.

The following reactions may appear in newborn babies of mothers who have taken Atarax during the last stage of pregnancy and/or during delivery, which were observed immediately or a few hours after birth: tremors, rigidity, and/or muscle weakness, difficulty breathing, and urinary retention (urine retention).

Driving and operating machinery

Atarax may alter your ability to drive or operate machinery, as it may cause drowsiness, decrease your attention, or decrease your reaction time. The appearance of these effects is more likely at the beginning of treatment or when the dose is increased. Do not drive or operate machinery if you experience any of these effects.

Older patients

This medication should not be used in older patients, as the effect of the medication may be prolonged and may increase the risk of adverse effects. If it is necessary to use this medication in older patients, it is recommended to start treatment with half the recommended dose.

Atarax contains benzoate of sodium, saccharose, and ethanol

This medication contains less than 1 mmol of sodium (23 mg) per 5 ml; it is essentially “sodium-free”.

This medication contains 1.5 mg of benzoate of sodium per 5 ml, equivalent to 0.3 mg/ml.

This medication contains saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication. Saccharose may harm teeth. At doses greater than 6.5 ml of syrup, the saccharose content should be taken into account in patients with diabetes mellitus.

This medication contains 4.75 mg of alcohol (ethanol) per 5 ml, which is equivalent to 0.95 mg/ml (0.095% p/v). The amount in 5 ml of this medication is equivalent to less than 2 ml of beer or 1 ml of wine. The small amount of alcohol contained in this medication does not produce any perceptible effect.

Follow exactly the administration instructions of this medication as indicated by your doctor.In case of doubt, consult your doctor or pharmacist again.

The lowest effective dose of Atarax should be administered for the shortest possible time.

Adults aged 18 years and older:

• For symptomatic treatment of anxiety: 50 mg (25 ml) per day, divided into 3 doses. It is recommended to administer 12.5 mg (6.25 ml) in the morning, 12.5 mg (6.25 ml) at noon, and 25 mg (12.5 ml) at night. Your doctor will indicate if you need to take a higher dose at night. In more severe cases, up to 100 mg (50 ml) per day may be used. The maximum daily dose is 100 mg (50 ml) per day.

• For symptomatic treatment of pruritus: It is recommended to start with a dose of 25 mg (12.5 ml) one hour before bedtime, and if necessary, administer doses of up to 25 mg (12.5 ml) 3 to 4 times a day. The maximum daily dose is 100 mg (50 ml) per day.

Adolescents and children aged 12 months and older:

• For symptomatic treatment of pruritus: 1 to 2 mg (0.5 to 1 ml) per kg per day, divided into several doses. In children weighing up to 40 kg, the maximum daily dose is 2 mg (1 ml) per kg per day. In children weighing more than 40 kg, the maximum daily dose is 100 mg (50 ml) per day.

This medication is not recommended for elderly patients (see section 2). If it is necessary to use it, it is recommended to start treatment with half the recommended dose. Your doctor will prescribe the lowest possible dose. The maximum daily dose in these patients is 50 mg (25 ml) per day.

If you have kidney problems or liver problems, your doctor may indicate that you take a lower dose (see “Warnings and precautions”).

The dose will be adjusted within the recommended dose range according to the patient's response to treatment.

If you believe that the effect of Atarax is too strong or too weak, consult your doctor or pharmacist.

The amount of syrup is measured with a 10 ml syringe for oral administration, graduated every 0.25 ml. Each ml contains 2 mg of hydroxyzine dihydrochloride. Insert the syringe included in the package into the inside of the bottle and extract the corresponding ml.

The syrup should be taken before meals, either alone or diluted in water or fruit juice.

If you take more Atarax than you should

If you have taken too much Atarax, consultimmediatelyyour doctor or pharmacist or call the Toxicological Information Service, phone 915 620 420, especially if a child has taken too much. In case of overdose, symptomatic treatment may be initiated. Electrocardiogram monitoring may be performed due to the possibility of cardiac rhythm problems, such as QT interval prolongation or Torsade de Pointes.

A significant overdose may causenausea, vomiting, tachycardia, fever, drowsiness, altered pupillary reflex, tremor, confusion, hallucination, decreased level of consciousness, respiratory depression, convulsions, decreased blood pressure, and cardiac arrhythmia, including bradycardia, which may lead to deep coma and cardiorespiratory collapse.

If you forget to take Atarax

Remember to take your medication always.

Do not take a double dose to compensate for the missed doses. Continue taking your regular dose when it is due.

If you interrupt treatment with Atarax

Your doctor will indicate the duration of your treatment with Atarax. Do not discontinue treatment before.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The following side effects have been reported in clinical trials:

- drowsiness, headache, fatigue, dry mouth.

The frequent side effect (that affects at least 1 in 100 patients) is sedation.

The less frequent side effects (that affect at least 1 in 1,000 patients) are: nausea, discomfort, fever, dizziness, insomnia, tremor, agitation, and confusion.

The rare side effects (that affect at least 1 in 10,000 patients) are: tachycardia, alterations in accommodation or ability to see at different distances, blurred vision, constipation, vomiting, hypersensitivity, abnormal liver function tests, seizures, involuntary abnormal movements (dyskinesia), disorientation, hallucinations, urinary retention, erythematous rash, maculopapular rash, dermatitis, pruritus, and hypotension.

The very rare side effects (that affect fewer than 1 in 10,000 patients) are: anaphylactic shock, bronchospasm (narrowing of the bronchi that causes difficulty breathing), angioneuritic edema (inflammation of the skin and mucous membranes), increased sweating, drug-induced rash, acute generalized exanthematous pustulosis (a type of allergic reaction that appears in response to a medication, infection, or disease), erythema multiforme, Stevens-Johnson syndrome (these two are skin disorders due to an allergic reaction or infection).

The side effects of unknown frequency (that cannot be estimated from the available data) are: QT prolongation on the electrocardiogram, Torsades de Pointes (electrocardiogram alteration associated with tachycardias), hepatitis, loss of consciousness (syncope), blistering diseases (e.g. toxic epidermal necrolysis, pemphigus), and weight gain.

Stop taking this medicine and seek immediate medical attention if you experience any cardiac rhythm problems such as palpitations, difficulty breathing, or loss of consciousness.

The following side effects have been observed with cetirizine, the main metabolite of hydroxyzine: thrombocytopenia (decrease in platelet count), aggression, depression, tic, dystonia (muscle contractions), paresthesia (tingling sensation), ocular crisis (positioning of the eyes in a fixed position), diarrhea, dysuria (difficulty urinating), enuresis (urinary incontinence), asthenia, edema, and weight gain.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Atarax should be stored in its cardboard box because the active ingredient hydroxyzine dihydrochloride is sensitive to light.

No special storage temperature is required.

Do not use Atarax syrup after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of the packaging and medicines you no longer need.

By doing so, you will help protect the environment.

Composition of Atarax syrup

• The active ingredient is hydroxyzine dihydrochloride. Each ml contains 2 mg of hydroxyzine dihydrochloride.
• The other components are: sucrose, sodium benzoate, almond flavor, levomenthol, ethanol, purified water.

Appearance of the product and contents of the packaging

Atarax syrup is presented in a topaz glass bottle with a child-resistant cap and a oral administration syringe (Polyethylene/Polyester) of 10 ml, graduated every 0.25 ml.Each package contains 150 ml of syrup.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

UCB Pharma, S.A.

Plaza de Manuel Gómez Moreno, s/n,

Edificio Bronce, 5th floor,

28020 Madrid

Spain

Responsible for manufacturing:

NEXTPHARMA, SAS

17, Route de Meulan (Limay)

78250 - France

Last review date of this leaflet:January 2023

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/