Hydroxyzine Qualigen 25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Hydroxyzine Qualigen 25 mg film-coated tablets EFG

Hydroxyzine hydrochloride

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 adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Hydroxyzine Qualigen is and what it is used for
2. What you need to know before taking Hydroxyzine Qualigen
3. How to take Hydroxyzine Qualigen
4. Possible adverse effects
5. How to store Hydroxyzine Qualigen
6. Contents of the pack and other information

1. What Hidroxizina Qualigen is and what it is used for

Hidroxizina Qualigen is a psycholeptic and anxiolytic agent belonging to a class of compounds known as diphenylmethanes.

Hidroxizina Qualigen is used for:

• Symptomatic treatment of anxiety in adults.
• Symptomatic treatment of pruritus and urticaria.
• Premedication prior to anesthesia.

2. What you need to know before taking Hidroxizina Qualigen

Do not take Hidroxizina Qualigen

• If you are allergic to hydroxyzine, hydrochloride, or any of the other ingredients of this medicine (listed in section 6), 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 medicines for heart rhythm problems or medicines that may affect heart rhythm (see "Use of Hidroxizina Qualigen with other medicines").
• If a close family member has died suddenly from heart problems.
• During pregnancy or breastfeeding.

Warnings and precautions

• If you have a high risk of seizures.
• If you have hepatic insufficiency or moderate to severe renal insufficiency. In these cases, the dose of Hidroxizina Qualigen should be reduced.
• If you suffer from glaucoma (increased intraocular pressure), urinary bladder outflow obstruction, decreased gastrointestinal motility, myasthenia gravis (muscle weakness), or dementia.
• Hidroxizina Qualigen may be associated with an increased risk of 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 Hidroxizina Qualigen, you experience heart problems such as palpitations, difficulty breathing, or loss of consciousness. Treatment with hydroxyzine should be discontinued.

Use of Hidroxizina Qualigen with other medicines

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. Hidroxizina Qualigen may affect or be affected by other medicines.

Hidroxizina Qualigen 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 patient.

Hidroxizina Qualigen antagonizes the effects of betahistine and anticholinesterase drugs.

Treatment with Hidroxizina Qualigen should be discontinued at least 5 days before undergoing an allergy test or a bronchial provocation test with methacholine to avoid interference with test results.

Concomitant administration of Hidroxizina Qualigen with monoamine oxidase inhibitors (MAOIs) should be avoided.

Hidroxizina Qualigen counteracts the pressor action of adrenaline.

Concomitant administration 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 Hidroxizina Qualigen if you are taking medicines to treat:

• Bacterial infections (e.g. antibiotics such as 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)
• Cancer (e.g. toremifene, vandetanib)
• Medication abuse or severe pain (methadone)

To date, no further interactions with other medicines have been identified.

Taking Hidroxizina Qualigen 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. Hidroxizina Qualigen must not be taken during pregnancy.

Hidroxizina Qualigen must not be taken during breastfeeding. If treatment with Hidroxizina Qualigen is necessary, breastfeeding must be discontinued.

Driving and using machines

Hidroxizina Qualigen may impair your ability to drive or operate machinery, as it may cause drowsiness, reduce attention, or impair reaction capacity. 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

In elderly patients, half the recommended dose should be administered due to the prolonged action of the drug.

Hidroxizina Qualigen tablets contain lactose

This medicine contains 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 Hidroxizina Qualigen

Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The lowest effective dose of Hidroxizina Qualigen should be used for the shortest possible duration.

• For the treatment of anxiety: 2 to 4 tablets (50–100 mg) daily, divided into 3 doses. It is recommended to administer 1/2–1 tablet in the morning, 1/2–1 tablet at midday, and 1–2 tablets at night.

• For the treatment of pruritus and urticaria: It is recommended to start with a dose of 1 tablet (25 mg) at night, and if necessary, administer doses up to 1 tablet (25 mg) 3 times daily.

• For premedication before anesthesia: 2 tablets (50 mg) daily in 2 doses (1 dose 1 hour before surgery preceded by 1 dose the night before anesthesia), or 4 tablets (100 mg) daily as a single dose. The cumulative dose within 24 hours must not exceed 100 mg.

In adults and children over 40 kg body weight, the maximum daily dose is 100 mg/day for all indications.

In elderly patients, the maximum daily dose is 50 mg/day.

Children from 12 months

For symptomatic treatment of pruritus and urticaria:

From 12 months: 1 mg/kg/day to 2 mg/kg/day, divided into several doses.

In children weighing up to 40 kg, the maximum daily dose is 2 mg/kg/day.

For premedication before anesthesia:

A single dose of 0.6 mg/kg 1 hour before surgery, which may be preceded by 0.6 mg/kg the night before anesthesia.

The cumulative dose within 24 hours must not exceed 2 mg/kg/day.

The tablets are not suitable for administering doses smaller than 12.5 mg. Other formulations of hydroxyzine hydrochloride are available that are more appropriate for dosing in the pediatric population.

The tablets should be swallowed whole with liquid and may be taken either on an empty stomach or with food.

The scored tablet allows for easy division into two parts, to better adjust the required dose for each patient.

Patients with kidney or liver problems should reduce the 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 Hidroxizina Qualigen is too strong or too weak, consult your doctor or pharmacist.

If you take more Hidroxizina Qualigen than you should

If you have taken too much Hidroxizina Qualigen, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 915 620 420, especially if a child has taken an excessive amount. 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, somnolence, altered pupillary reflex, tremor, confusion, hallucinations, decreased level of consciousness, respiratory depression, seizures, decreased blood pressure, and cardiac arrhythmia, potentially leading to deep coma and cardiorespiratory collapse.

If you forget to take Hidroxizina Qualigen

Remember to always take your medicine.

Do not take a double dose to make up for missed doses. Continue taking your next dose at the usual time.

If you stop taking Hidroxizina Qualigen

Your doctor will advise you on the duration of your treatment with Hidroxizina Qualigen. 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 common adverse effect (may affect up to 1 in 10 people) is sedation.

Uncommon adverse effects (may affect up to 1 in 100 people) are: nausea, malaise, fever, dizziness, insomnia, tremor, agitation, and confusion.

Rare adverse effects (may affect up to 1 in 1,000 people) are: tachycardia, accommodation disturbances 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.

Very rare adverse effects (may affect up to 1 in 10,000 people) are: anaphylactic shock, bronchospasm (narrowing of the airways causing breathing difficulty), angioneurotic edema (swelling of the skin and mucous membranes), increased sweating, drug-induced rash, generalized acute 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 the available data) are: prolonged QT interval on electrocardiogram, Torsades de Pointes (an ECG abnormality associated with tachycardia), and hepatitis.

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 can 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 Hidroxizina Qualigen

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

No special storage conditions are required.

Do not use Hidroxizina Qualigen 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 containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Hidroxizina Qualigen tablet

• The active substance is hydroxyzine hydrochloride. Each tablet contains 25 mg of hydroxyzine hydrochloride.
• The other components are: microcrystalline cellulose (E-460i), magnesium stearate (E-572), anhydrous lactose, Opadry White OY 58900 [hypromellose (E-464), titanium dioxide (E-171) and macrogol 400 (E-1521)], colloidal anhydrous silica.

Appearance of the product and contents of the pack

Hidroxizina Qualigen 25 mg is presented as white or almost white, oblong, biconvex tablets, scored on both sides.

Packs of 25 or 50 tablets in PVC/aluminum and Al/PVC-PVDC blisters.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Manufacturer

MEDREICH PLC

Warwick House, Plane Tree Crescent, Feltham, TW13 7HF,

United Kingdom

or

INPHARMASCI

ZI Nº2 de Prouvy – Rouvignies

1 rue de Nungesser

59121 Prouvy,

France

Date of the most recent revision of this leaflet: May 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/