HYDROXYZINE QUALIGEN 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Hydroxyzine Qualigen 25 mg Film-Coated Tablets EFG

Hydroxyzine, hydrochloride

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

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

Hydroxyzine Qualigen is a psycholeptic and anxiolytic agent that belongs to a class of compounds called diphenylmethanes.

Hydroxyzine Qualigen is used for:

• Symptomatic treatment of anxiety in adults.
• Symptomatic treatment of pruritus and urticaria.
• Pre-medication before anesthesia.

2. What you need to know before you take Hydroxyzine Qualigen

Do not take Hydroxyzine Qualigen

• If you are allergic to hydroxyzine, hydrochloride or any of the other ingredients of this medicine (listed in section 6), to cetirizine, to other piperazine derivatives, to aminophylline or to ethylenediamine.
• If you have porphyria (a group of inherited disorders that affect the blood).
• If your ECG (electrocardiogram) shows a heart rhythm problem called "prolonged 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 medicines for heart rhythm problems or medicines that may affect the heart rhythm (see "Using Hydroxyzine Qualigen with other medicines").
• If a close relative has died suddenly from heart problems.
• In case of pregnancy or breastfeeding.

Warnings and precautions

• If you have a high risk of seizures.
• If you have liver failure and if you have moderate or severe kidney failure. In these cases, the dose of Hydroxyzine 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.
• Hydroxyzine Qualigen may be associated with an increased risk of heart rhythm disorders that can be life-threatening. Therefore, inform your doctor if you have any heart problems or if you are taking any other medicine, including those purchased without a prescription.

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

Using Hydroxyzine Qualigen with other medicines

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. This includes any medicines bought without a prescription. Hydroxyzine Qualigen may affect or be affected by other medicines.

Hydroxyzine Qualigen may enhance the depressant effect on the central nervous system if used in conjunction with other drugs with depressant or anticholinergic properties. In these cases, the dose should be adjusted for each patient.

Hydroxyzine Qualigen antagonizes the effects of betahistine and anticholinesterase drugs.

Treatment with Hydroxyzine Qualigen should be discontinued at least 5 days before performing an allergy test or a bronchial provocation test with methacholine, to avoid effects on the results.

Concomitant administration of Hydroxyzine Qualigen with monoamine oxidase inhibitors should be avoided.

Hydroxyzine Qualigen counteracts the pressor effect of adrenaline.

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

Do not take Hydroxyzine Qualigen 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)
• cancer (e.g. toremifene, vandetanib)
• drug abuse or severe pain (methadone)

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

Taking Hydroxyzine Qualigen 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

Ask your doctor or pharmacist for advice before taking any medicine. Hydroxyzine Qualigen should not be taken during pregnancy.

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

Driving and using machines

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

Elderly patients

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

Hydroxyzine Qualigen tablets contain lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Hydroxyzine Qualigen

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

The smallest dose of Hydroxyzine Qualigen that is effective should be administered and for the shortest possible duration.

• For the treatment of anxiety: 2 to 4 tablets (50-100 mg) per day divided into 3 doses. It is recommended to administer 1/2-1 tablet in the morning, 1/2-1 tablet at noon 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 of up to 1 tablet (25 mg) 3 times a day.

• For pre-medication before anesthesia: 2 tablets (50 mg) per day in 2 doses (1 dose 1 hour before surgery preceded by 1 dose the night before anesthesia), or 4 tablets (100 mg) per day in 1 single dose. The cumulative dose in 24 hours should not exceed 100 mg.

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

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

Children from 12 months

For the symptomatic treatment of pruritus and urticaria:

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

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

For pre-medication 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 in 24 hours should not exceed 2 mg/kg/day.

The tablets are not suitable for the administration of doses less than 12.5 mg. Other presentations of hydroxyzine hydrochloride are available, more suitable for dosing in the pediatric population.

The tablets should be swallowed whole with the help of liquids and can be taken both on an empty stomach and with food.

The scored tablet allows for easy division into 2 parts, for the best adjustment of the necessary dose in each patient.

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

If you take more Hydroxyzine Qualigen than you should

If you have taken too much Hydroxyzine Qualigen, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 915 620 420, especially if it is a child who has taken too much. In case of overdose, symptomatic treatment can be established. Electrocardiographic monitoring (ECG) can be performed, due to the possibility of a heart rhythm problem, such as QT interval prolongation or Torsades de Pointes.

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

If you forget to take Hydroxyzine Qualigen

Remember to always take your medicine.

Do not take a double dose to make up for forgotten doses. Continue taking your normal dose when it is due.

If you stop taking Hydroxyzine Qualigen

Your doctor will indicate the duration of your treatment with Hydroxyzine Qualigen. Do not stop treatment before. If you have any other 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.

The frequent side effect (may affect up to 1 in 10 people) is sedation.

The uncommon side effects (may affect up to 1 in 100 people) are: nausea, discomfort, fever, dizziness, insomnia, tremor, agitation, and confusion.

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

The very rare side effects (may affect up to 1 in 10,000 people) are: anaphylactic shock, bronchospasm (narrowing of the bronchi that causes difficulty breathing), angioneurotic edema (inflammation of the skin and mucous membranes), increased sweating, drug rash, acute generalized exanthematous pustulosis (a type of allergic reaction that appears in response to a medicine, 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 (cannot be estimated from the available data) are: QT prolongation in the electrocardiogram, Torsades de Pointes (alteration of the electrocardiogram associated with tachycardias), and hepatitis.

Stop taking this medicine and seek medical attention immediately if you experience any heart 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 the number of platelets), aggression, depression, tic, dystonia (muscle contractions), paresthesia (tingling sensation), oculogyric crisis (fixation 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 side effects, talk to your doctor or pharmacist, even if it is possible side effects that are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency's website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Hydroxyzine Qualigen

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

No special storage temperature is required.

Do not use Hydroxyzine Qualigen after the expiry date stated on the carton after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to a pharmacy. If you are unsure, ask your pharmacist how to dispose of the containers and any unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Hydroxyzine Qualigen tablet

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

Appearance of the product and contents of the pack

Hydroxyzine Qualigen 25 mg is presented in the form of oblong, biconvex tablets with a score line on both sides, and white or almost white in color.

Packs of 25 or 50 tablets, in PVC/aluminum blister packs and Al/PVC-PVDC.

Marketing authorization holder and manufacturer

Marketing authorization

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 last revision of this leaflet:May 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/