Leaflet: information for the user

Hidroxizina Qualigen 25 mg film-coated tablets

Hidroxizina, hydrochloride

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 is Hidroxizina Qualigen and what it is used for

2. What you need to know before starting to take Hidroxizina Qualigen

3. How to take Hidroxizina Qualigen

4. Possible side effects

5. Storage of Hidroxizina Qualigen

6. Contents of the pack and additional information

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

Hydroxyzine Qualigenis used for:

• Treatment of symptomatic anxiety in adults.
• Treatment of symptomatic pruritus and urticaria.
• Pre-medication before anesthesia.

Do not take Hidroxizina Qualigen

• If you are allergic to hidroxizina, hidrocloruro, or any of the other components of this medication (listed in section 6), to cetirizina, to other piperazina derivatives, to aminofilina, or to etilendiamina.
• If you have porfiria (a group of hereditary blood disorders).
• If your ECG (electrocardiogram) shows a heart rhythm problem called “prolongación del intervalo QT”.
• 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 Hidroxizina Qualigen with other medications”).
• If a close relative has suddenly died 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 Hidroxizina Qualigen should be reduced.
• If you suffer from glaucoma (increased intraocular pressure), urinary tract obstruction, decreased gastrointestinal motility, myasthenia gravis (muscle weakness), or dementia.
• Hidroxizina Qualigen may be associated with an increased risk of life-threatening heart rhythm disorders. 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 takingHidroxizina Qualigen, you experience heart problems such as palpitations, difficulty breathing, or loss of consciousness. Treatment with hidroxizina should be interrupted.

Use of Hidroxizina Qualigen with other medications

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

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

Hidroxizina Qualigen antagonizes the effects of betahistina and anticholinesterase medications.

Treatment with Hidroxizina Qualigen should be suspended at least 5 days before undergoing an allergy test or a bronchial provocation test with metacolina, to avoid effects on the results.

The simultaneous administration of Hidroxizina Qualigen with monoamine oxidase inhibitors should be avoided.

Hidroxizina Qualigen counteracts the pressor effect of adrenaline.

The concomitant 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 Hidroxizina Qualigen if you are taking medications to treat:

• Bacterial infections (e.g. eritromicina, 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 disorders (e.g.prucaloprida)
• Allergy
• Malaria (e.g. mefloquina)
• Cancer (e.g.toremifeno, vandetanib)
• Abuse of medications or intense pain (metadona)

No interactions with other medications have been detected to date.

Taking Hidroxizina Qualigen with food, drinks, and alcohol

You should not consume alcohol while taking this medication. The simultaneous administration of hidroxizina and alcohol may produce effects on the central nervous system.

Pregnancy and breastfeeding

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

Hidroxizina Qualigen should not be taken during breastfeeding. If treatment with Hidroxizina Qualigen is necessary, breastfeeding should be suspended.

Driving and operating machinery

Hidroxizina Qualigen may impair 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

In older patients, the recommended dose should be halved due to the prolonged action of the medication.

Hidroxizina Qualigen tablets contain lactose

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

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 Hidroxizina Qualigen should be administered for the shortest duration possible.

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

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

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

In adults and children over 40 kg of 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 monthss

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 up to 40 kg of 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 the operation, which may be preceded by 0.6 mg/kg the night before the anesthesia.

The 24-hour accumulated dose should not exceed 2 mg/kg/day.

Tablets are not suitable for administration of doses less than 12.5 mg. Other presentations of hydroxyzine hydrochloride are available that are more suitable for pediatric dosing.

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 believe 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 muchHidroxizina Qualigen, 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 (ECG) may be performed due to the possibility of a cardiac rhythm problem, 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, seizures, decreased blood pressure, and cardiac arrhythmia, which may lead to deep coma and cardiorespiratory collapse.

If you forget to take Hidroxizina Qualigen

Remember to always take your medication.

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 Hidroxizina Qualigen

Your doctor will indicate the duration of your treatment with Hidroxizina Qualigen. Do not discontinue treatment before. If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

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

The common side effect (may affect up to 1 in 10 people) is drowsiness.

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 1000 people) 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 (may affect up to 1 in 10,000 people) 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 (cannot be estimated from the available data) are: QT prolongation on the electrocardiogram, Torsades de Pointes (electrocardiogram alteration associated with tachycardias) 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 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), 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 prospectus. 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.

No special storage temperature is required.

Do not use Hydroxyzine Qualigen 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.Deposit the packaging and unused medications at the SIGRE collection pointof the pharmacy. In case of doubtask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Hidroxizina Qualigen tablet

- The active ingredient 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)], anhydrous colloidal silica.

Appearance of the product and content of the packaging

Hidroxizina Qualigen 25 mg is presented in the form of oblong, biconvex tablets with a notch on both faces, and of white or almost white color.

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the authorization

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Responsible for the manufacturing

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

Last review date of this leaflet: May 2021

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