Atarax 25 mg film-coated tablets
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Atarax 25mg film-coated tablets
hydroxyzine dihydrochloride
Read the entire leaflet carefully before you start 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 questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet Contents
- What Atarax tablets are and what they are used for
- What you need to know before taking Atarax tablets
- How to take Atarax tablets
- Possible adverse effects
- How to store Atarax tablets
- Contents of the pack and other information
1. What Atarax tablets are and what they are used for
Atarax is an anxiolytic medicine belonging to a class of compounds known as diphenylmethanes.
Atarax is used for:
- the symptomatic treatment of anxiety in adults over 18 years of age;
- the symptomatic treatment of pruritus in adults, adolescents, and children from 12 months of age.
2. What you need to know before taking Atarax tablets
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 electrolytes 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 family member 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 cardiac symptoms such as palpitations, difficulty breathing, or loss of consciousness. Treatment with hydroxyzine should be discontinued.
Other medicines and Atarax
Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines. This includes any medicines obtained 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 CNS depressant or anticholinergic properties. In such cases, the dose should be adjusted according to each individual patient.
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 methacholine bronchial provocation test, 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 medicines 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 interactions with other medicines have been identified to date.
Taking Atarax with food, drinks and alcohol
You should not drink alcohol while being treated with 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 must not be taken during pregnancy.
Atarax must not be taken during breastfeeding. If treatment with Atarax is necessary, breastfeeding must be discontinued.
The following reactions may occur in newborn infants whose mothers have taken Atarax during the last stage of pregnancy and/or during delivery, and which are observed immediately or 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 impair reaction ability. 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 be increased due to reduced elimination rate. If use in elderly patients is necessary, it is recommended to start treatment with half of the recommended dose.
Atarax tablets contain lactose
If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
3. How to take Atarax tablets
Follow exactly the instructions for use of 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:
-
For symptomatic treatment of anxiety: 2 tablets (50 mg) per day, divided into 3 doses. It is recommended to take half a tablet in the morning, half a tablet at midday, and one tablet at night. Your doctor will advise you if you need to take a higher dose at night. In more severe cases, up to 4 tablets (100 mg) per day may be used. The maximum daily dose is 4 tablets (100 mg) per day.
-
For symptomatic treatment of pruritus: It is recommended to start with a dose of one tablet (25 mg) one hour before bedtime. If necessary, your doctor may increase your dose up to one tablet (25 mg) 3 to 4 times per day. The maximum daily dose is 4 tablets (100 mg) per day.
Adolescents and children from 12 months of age:
Atarax film-coated tablets are not recommended for children under 6 years of age, as they may be unable to swallow the tablets.
Other pharmaceutical forms, such as Atarax syrup, may be more suitable for children from 12 months of age or for patients who cannot swallow tablets.
- For symptomatic treatment of pruritus: 1 to 2 mg per kg per day, divided into several doses. In children weighing up to 40 kg, the maximum daily dose is 2 mg per kg per day. In children weighing more than 40 kg, the maximum daily dose is 100 mg per day.
This medicine is not recommended for elderly patients (see section 2). If use is necessary, treatment should be initiated at half the recommended dose. Your doctor will prescribe the lowest possible dose. The maximum daily dose in these patients is 50 mg 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 should 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 tablets should be swallowed whole with liquid and may be taken either on an empty stomach or with food.
The tablet may be divided into equal doses.
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 (ECG) monitoring 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 scheduled time.
If you stop taking Atarax tablets
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 experiences 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 focusing 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 (swelling of skin and mucous membranes), increased sweating, drug rash, generalized exanthematous pustulosis (a type of allergic reaction occurring in response to a drug, infection, or disease), erythema multiforme, and Stevens-Johnson syndrome (the last two being skin disorders due to an allergic reaction or infection).
Adverse effects with unknown frequency (cannot be estimated from available data) are: QT prolongation on electrocardiogram, Torsades de Pointes (an ECG abnormality associated with tachycardia), hepatitis, loss of consciousness (syncope), bullous skin 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 (decreased platelet count), 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 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 Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Atarax tablets
Keep this medicine out of the 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 after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in the pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This helps protect the environment.
6. Contents of the pack and other information
Composition of Atarax tablets
- The active substance is hydroxyzine dihydrochloride. Each tablet contains 25 mg of hydroxyzine dihydrochloride.
- The excipients are: monohydrate lactose, microcrystalline cellulose, magnesium stearate, anhydrous colloidal silica, titanium dioxide (E171), HPMC 2910 5cP, polyethylene glycol 400, purified water.
Appearance of the product and contents of the pack
Atarax tablets are film-coated tablets, available in packs containing 25 or 50 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
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
Date of the most recent revision of this leaflet: January 2023
Detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/