Atarax 2 mg/ml syrup
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Atarax 2 mg/ml syrup
hydroxyzine, dihydrochloride
Read the entire 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, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Atarax syrup is and what it is used for
- What you need to know before taking Atarax syrup
- How to take Atarax syrup
- Possible adverse effects
- How to store Atarax syrup
- Contents of the pack and other information
1. What Atarax syrup is and what it is used for
Atarax is an anxiolytic medicine that belongs to a class of compounds known as diphenylmethanes.
Atarax is used for:
- symptomatic treatment of anxiety in adults over 18 years of age;
- symptomatic treatment of pruritus in adults, adolescents, and children from 12 months of age.
2. What you need to know before starting Atarax syrup
Do not take Atarax
- If you are allergic (hypersensitive) to hydroxyzine dihydrochloride or to any of the other components of Atarax, cetirizine, other piperazine derivatives, aminophylline, or ethylenediamine.
- If you have porphyria (a group of inherited disorders affecting the blood).
- If your ECG (electrocardiogram) shows a heart rhythm problem called "QT interval prolongation".
- If you have or have had 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 disorders or medications that may affect heart rhythm (see "Use of Atarax with other medicines").
- If a close relative has died suddenly due to heart problems.
- During pregnancy or breastfeeding.
Warnings and precautions
- If you have a high risk of seizures.
- If you have hepatic impairment or moderate to severe renal impairment. In these cases, the dose of Atarax should be reduced.
- If you suffer from glaucoma, urinary bladder outflow obstruction, decreased gastrointestinal motility, myasthenia gravis, or dementia.
- Atarax may be associated with an increased risk of potentially life-threatening cardiac arrhythmias. Therefore, inform your doctor if you have any heart problems or if you are taking any other medicines, including those obtained without a prescription.
Seek immediate medical attention if, while being treated with Atarax, you experience heart problems such as palpitations, difficulty breathing, or loss of consciousness. Treatment with hydroxyzine should be discontinued.
Other medicines and Atarax
Inform your doctor or pharmacist if you are currently using, have recently used, or may need to use any other medicines. This includes any medicines purchased without a prescription. Atarax may affect or be affected by other medicines.
Atarax may enhance the central nervous system depressant effects when used concomitantly with other drugs having depressant or anticholinergic properties. In such cases, the dose should be adjusted individually.
Atarax antagonizes the effects of betahistine and anticholinesterase drugs.
Treatment with Atarax should be discontinued at least 5 days before undergoing allergy testing or a bronchial provocation test with methacholine to avoid interference with test results.
Concomitant administration of Atarax with monoamine oxidase inhibitors (MAOIs) should be avoided.
Atarax counteracts the pressor action of adrenaline.
Concomitant use with drugs that may cause arrhythmias may increase the risk of QT prolongation and Torsades de Pointes (abnormalities in certain measurements on the electrocardiogram).
Do not take Atarax if you are taking medications to treat:
- bacterial infections (e.g., the antibiotics erythromycin, moxifloxacin, levofloxacin)
- fungal infections (e.g., pentamidine)
- heart problems or high blood pressure (e.g., amiodarone, quinidine, disopyramide, sotalol)
- psychosis (e.g., haloperidol)
- depression (e.g., citalopram, escitalopram)
- gastrointestinal disorders (e.g., prucalopride)
- allergy
- malaria (e.g., mefloquine and hydroxychloroquine)
- cancer (e.g., toremifene, vandetanib)
- drug abuse or severe pain (methadone)
No further drug interactions have been identified to date.
Taking Atarax with food, drinks, and alcohol
You should not drink alcohol while taking this medicine. Concomitant administration of hydroxyzine and alcohol may produce effects on the central nervous system.
Pregnancy and breastfeeding
Consult your doctor or pharmacist before taking any medicine. Atarax should not be taken during pregnancy.
Atarax should not be taken during breastfeeding. If treatment with Atarax is necessary, breastfeeding must be discontinued.
The following reactions may occur in newborns whose mothers took Atarax during the last stage of pregnancy and/or during delivery, observed immediately or within a few hours after birth: tremors, muscle rigidity and/or weakness, difficulty breathing, and urinary retention.
Driving and using machines
Atarax may impair your ability to drive or operate machinery, as it may cause drowsiness, reduce attention, or slow reaction times. These effects are 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.
Elderly patients
This medicine is not recommended for use in elderly patients, as the effect of the medicine may be prolonged and the risk of adverse effects may increase. If use in elderly patients is necessary, treatment should be initiated with half the recommended dose.
Atarax contains sodium benzoate, sucrose, and ethanol
This medicine contains less than 1 mmol of sodium (23 mg) per 5 ml, i.e., essentially "sodium-free".
This medicine contains 1.5 mg of sodium benzoate in each 5 ml, equivalent to 0.3 mg/ml.
This medicine contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine. Sucrose may harm the teeth. At doses exceeding 6.5 ml of syrup, the sucrose content should be considered in patients with diabetes mellitus.
This medicine contains 4.75 mg of alcohol (ethanol) in each 5 ml, equivalent to 0.95 mg/ml (0.095% w/v). The amount in 5 ml of this medicine is equivalent to less than 2 ml of beer or 1 ml of wine. The small amount of alcohol contained in this medicine does not produce any noticeable effect.
3. How to take Atarax syrup
Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
The lowest effective dose of Atarax should be used for the shortest possible duration.
Adults over 18 years of age:
-
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 midday, and 25 mg (12.5 ml) at night. Your doctor will indicate whether you need 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 from 12 months of age:
- 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 medicine is not recommended for elderly patients (see section 2). If its use is necessary, 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 or liver problems, your doctor may advise you to 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 think that the effect of Atarax is too strong or too weak, consult your doctor or pharmacist.
The amount of syrup should be measured using the 10 ml oral dosing syringe provided, graduated every 0.25 ml. Each ml contains 2 mg of hydroxyzine dihydrochloride. Insert the syringe supplied into the bottle and withdraw the required number of 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 915 620 420, especially if an overdose has occurred in a child. In case of overdose, symptomatic treatment may be initiated. Electrocardiographic monitoring (ECG) may be performed due to the possibility of cardiac rhythm disturbances, such as QT interval prolongation or Torsade de Pointes.
A significant overdose may cause nausea, vomiting, tachycardia, fever, drowsiness, altered pupillary reflex, tremor, confusion, hallucinations, decreased level of consciousness, respiratory depression, seizures, decreased blood pressure, and cardiac arrhythmia including bradycardia, potentially leading to deep coma and cardiorespiratory collapse.
If you forget to take Atarax
Remember to always take your medicine.
Do not take a double dose to make up for missed doses. Continue taking your normal dose at the next scheduled time.
If you stop taking Atarax
Your doctor will advise you on the duration of your treatment with Atarax. Do not stop treatment prematurely.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effects have been reported in clinical trials:
- drowsiness, headache, fatigue, dry mouth.
The common adverse effect (affecting at least 1 in 100 patients) is sedation.
The uncommon adverse effects (affecting at least 1 in 1,000 patients) are: nausea, malaise, fever, dizziness, insomnia, tremor, agitation, and confusion.
The rare adverse effects (affecting at least 1 in 10,000 patients) are: tachycardia, accommodation disorders or difficulty in seeing 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, itching, and hypotension.
The very rare adverse effects (affecting fewer than 1 in 10,000 patients) are: anaphylactic shock, bronchospasm (narrowing of the bronchi causing breathing difficulty), angioneurotic edema (inflammation of the skin and mucous membranes), increased sweating, drug rash, generalized acute exanthematous pustulosis (a type of allergic reaction occurring in response to a drug, infection, or illness), erythema multiforme, Stevens-Johnson syndrome (these last two are skin disorders due to an allergic reaction or infection).
Adverse effects with unknown frequency (cannot be estimated from the available data) are: prolonged QT interval on electrocardiogram, Torsades de Pointes (an ECG abnormality associated with tachycardia), hepatitis, loss of consciousness (syncope), bullous diseases (e.g. toxic epidermal necrolysis, pemphigus), and weight gain.
Stop taking this medicine and seek immediate medical attention if you experience any heart rhythm problems such as palpitations, difficulty breathing, or loss of consciousness.
The following adverse effects have been observed with cetirizine, the main metabolite of hydroxyzine: thrombocytopenia (decrease in the number of platelets), aggression, depression, tic, dystonia (muscle contractions), paresthesia (tingling sensation), oculogyric crisis (fixed abnormal eye position), diarrhea, dysuria (difficulty urinating), enuresis (urinary incontinence), asthenia, edema, and weight gain.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Atarax syrup
Keep this medicine out of sight and reach of children.
Atarax should be stored in its cardboard box because the active substance, hydroxyzine dihydrochloride, is sensitive to light.
No special storage temperature is required.
Do not use Atarax syrup after the expiry date indicated on the packaging after "EXP". The expiry date refers to the last day of the month stated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point in your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need.
This way, you will help protect the environment.
6. Contents of the pack and other information
Composition of Atarax syrup
- The active substance is hydroxyzine dihydrochloride. Each ml contains 2 mg of hydroxyzine dihydrochloride.
- The other components are: sucrose, sodium benzoate, hazelnut flavour, levomenthol, ethanol, purified water.
Nature of the product and contents of the container
Atarax syrup is supplied in a topaz glass bottle with a child-resistant cap and an oral dosing syringe (polyethylene/polystyrene) of 10 ml, graduated every 0.25 ml. Each pack contains 150 ml of syrup.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
UCB Pharma, S.A.
Plaza de Manuel Gómez Moreno, s/n,
Edificio Bronce, Planta 5,
28020 Madrid
Spain
Manufacturer:
NEXTPHARMA, SAS
17, Route de Meulan (Limay)
78250 - France
Date of the most recent revision of this leaflet: January 2023
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/