Hidroxizinum Vp

Leaflet attached to the packaging: patient information

Hydroxyzinum VP, 10 mg, film-coated tablets

Hydroxyzinum VP, 25 mg, film-coated tablets

Hydroxyzine hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Hydroxyzinum VP and what is it used for
• 2. Important information before taking Hydroxyzinum VP
• 3. How to take Hydroxyzinum VP
• 4. Possible side effects
• 5. How to store Hydroxyzinum VP
• 6. Package contents and other information

1. What is Hydroxyzinum VP and what is it used for

Hydroxyzinum VP is a medicine with anxiolytic, sedative, and antipruritic action.
Hydroxyzinum VP is indicated:

• for symptomatic treatment of anxiety in adults,
• for symptomatic treatment of itching,
• for premedication before surgical procedures.

2. Important information before taking Hydroxyzinum VP

When not to take Hydroxyzinum VP

• if the patient is allergic to hydroxyzine hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to cetirizine, other piperazine derivatives, aminophylline, or ethylenediamine;
• if the patient has porphyria;
• if the patient's ECG (electrocardiogram) shows heart rhythm disorders called QT interval prolongation;
• if the patient has a cardiovascular disease or if the heart rate is very low;
• if the patient has low electrolyte levels (e.g., low potassium or magnesium levels);
• if the patient is taking certain medicines used to treat heart rhythm disorders or medicines that may affect heart rhythm (see "Hydroxyzinum VP and other medicines");
• if a family member of the patient has died suddenly due to heart disease;
• if the patient is pregnant or breastfeeding;
• if the patient has a hereditary intolerance to certain sugars.

Warnings and precautions

Before starting treatment with Hydroxyzinum VP, the patient should discuss it with their doctor:

• if the patient has an increased tendency to seizures (seizures have been reported more frequently in children than in adults) or heart rhythm disorders (arrhythmias);
• if the patient is taking other medicines (see "Hydroxyzinum VP and other medicines");
• if the patient has glaucoma, myasthenia (fatigue and muscle weakness) or dementia;
• if the patient has difficulty urinating or difficulty with impaired gastrointestinal motility.

Taking Hydroxyzinum VP may be associated with an increased risk of heart rhythm disorders, which can be life-threatening. Therefore, the patient should tell their doctor about any heart disorders and about taking any other medicines, including those available without a prescription.
If the patient experiences heart symptoms such as rapid heartbeat (palpitations), breathing problems, loss of consciousness during treatment with Hydroxyzinum VP, they should immediately consult a doctor. The patient should also stop taking Hydroxyzinum VP.
Hydroxyzinum VP may affect the results of allergy tests and methacholine bronchial provocation tests - it should not be taken for at least 5 days before such tests.
The patient should avoid drinking alcohol during treatment with Hydroxyzinum VP.

Children and adolescents

Young children are more likely to experience side effects related to the central nervous system (see "4. Possible side effects").

Hydroxyzinum VP and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This includes medicines available without a prescription. Hydroxyzinum VP may affect the action of other medicines. Other medicines may affect the action of Hydroxyzinum VP.
This is especially important if the patient is taking the following medicines:

• anticholinergic medicines - a group of medicines used, among others, in gastrointestinal disorders and respiratory diseases;
• medicines with a depressive effect on the central nervous system - such as sedatives, anxiolytics, antidepressants, anticonvulsants, sleeping pills;
• betahistine - a medicine used in Meniere's disease;
• cholinesterase inhibitors - a group of medicines used, among others, in the treatment of myasthenia, Alzheimer's disease, and glaucoma;
• adrenaline - a medicine used, among others, in severe allergic reactions;
• phenytoin - a medicine used in the treatment of epilepsy;
• cimetidine - a medicine used in gastrointestinal diseases, including the treatment of heartburn;
• monoamine oxidase inhibitors (MAOIs) - a group of medicines used mainly in the treatment of depression;
• medicines metabolized by one of the liver enzymes (called CYP2D6) - including beta-blockers used, for example, in hypertension, selective serotonin reuptake inhibitors used, for example, in the treatment of depression, anxiety, obsessive-compulsive disorder;
• medicines that inhibit the action of certain enzymes (alcohol dehydrogenase and CYP3A4/5) - including disulfiram, which is used in the treatment of alcoholism, and fluconazole and ketoconazole, which are used in the treatment of fungal infections.

The patient should not take Hydroxyzinum VP if they are taking medicines used to treat:

• bacterial infections (e.g., antibiotics such as erythromycin, moxifloxacin, levofloxacin);
• fungal infections (e.g., pentamidine);
• heart diseases or high blood pressure (e.g., amiodarone, quinidine, disopyramide, sotalol);
• psychoses (e.g., haloperidol);
• depression (e.g., citalopram, escitalopram);
• gastrointestinal diseases (e.g., prucalopride);
• allergies;
• malaria (e.g., mefloquine);
• cancer (e.g., toremifene, vandetanib);
• drug addiction or severe pain (methadone).

Hydroxyzinum VP with food, drink, and alcohol

The medicine should be taken after meals and washed down with water.
Alcohol enhances the effect of Hydroxyzinum VP (see "Warnings and precautions").

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
Hydroxyzinum VP should not be used during pregnancy and breastfeeding. Breastfeeding should be stopped if it is necessary to use Hydroxyzinum VP.

Driving and using machines

Hydroxyzinum VP may impair reactions and ability to concentrate - if this happens, the patient should not drive vehicles or operate machinery.

Hydroxyzinum VP contains lactose monohydrate

If the patient has been diagnosed with an intolerance to certain sugars, they should consult a doctor before taking the medicine.

Hydroxyzinum VP contains carmine

The medicine may cause allergic reactions.

3. How to take Hydroxyzinum VP

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult a doctor or pharmacist.
Hydroxyzinum VP should be taken in the smallest effective dose. The treatment duration should be as short as possible.
In adults and children over 40 kg, the maximum daily dose for all indications is 100 mg.

Recommended dose: Adults

Symptomatic treatment of anxiety:
50 mg per day in 2 or 3 divided doses.
In severe cases, doses up to 100 mg/day can be taken orally.
Symptomatic treatment of itching:
Treatment should be started with a dose of 25 mg before bedtime. Later, if necessary, the dose can be increased to 25 mg 3 or 4 times a day.
Premedication before surgical procedures:
50 mg in two doses or 100 mg in a single dose orally.
Children and adolescents
In children under 40 kg, the maximum daily dose is 2 mg/kg body weight per day.
In children over 40 kg, the maximum daily dose for all indications is 100 mg.
Children from 12 months
Symptomatic treatment of itching:
1 mg/kg body weight to 2 mg/kg body weight per day, in divided doses.
Premedication before surgical procedures:
0.6 mg/kg body weight orally, in a single dose.
The cumulative daily dose should not exceed 2 mg/kg body weight per day.
The exact dosage is determined by the doctor.
For children from 12 months to 6 years, it is recommended to use a medicinal product containing hydroxyzine in the form of an oral syrup, which ensures proper dosing and does not pose a risk of choking.
Elderly patients:
Treatment should be started with half the dose recommended for adults.
In elderly patients, the maximum daily dose is 50 mg.
Patients with liver failure
Smaller doses of Hydroxyzinum VP are usually used (about 1/3).
Patients with renal failure
The doctor may consider it necessary to use smaller doses of Hydroxyzinum VP.

Method of administration

Hydroxyzinum VP is taken orally.
The tablets should be taken after meals and washed down with water. They should not be chewed.

Taking a higher dose of Hydroxyzinum VP than recommended

Never take more than the recommended dose.
If the patient has taken or used too much Hydroxyzinum VP, they should immediately contact a doctor or hospital emergency department, especially if it concerns a child. In case of overdose, symptomatic treatment can be used. The patient's ECG should be monitored due to the possibility of heart rhythm disorders, such as QT interval prolongation or torsade de pointes.
Symptoms of overdose of Hydroxyzinum VP include nausea, vomiting, tachycardia (rapid heart rate), fever, drowsiness, disturbances of pupillary reflex, tremors, confusion or hallucinations, and then decreased level of consciousness, respiratory depression, seizures, hypotension, or heart rhythm disorders, as well as deepening coma and cardiopulmonary collapse.
If the patient has taken too much Hydroxyzinum VP along with an excessive amount of other medicines or substances (e.g., alcohol), they should inform their doctor or pharmacist about it.

Missing a dose of Hydroxyzinum VP

If the patient misses a dose of Hydroxyzinum VP at the scheduled time, they should take it as soon as possible. However, if it is close to the time of the next dose, they should skip the missed dose. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Hydroxyzinum VP

Hydroxyzinum VP should always be taken exactly as prescribed by the doctor.
If treatment is stopped without consulting a doctor, the symptoms for which the medicine was taken (anxiety or itching) may recur or worsen.
If the patient has any further doubts about taking the medicine, they should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Hydroxyzinum VP can cause side effects, although not everybody gets them.
In clinical trials, the most common side effects reported in patients taking hydroxyzine were drowsiness (in almost 14%) and headache, fatigue, and dry mouth (in less than 2% of patients).
After the medicine was placed on the market, the following side effects have been reported:

Common (in more than 1 in 100, but less than 1 in 10 patients):

• strong sedation,
• fatigue.

Uncommon (in more than 1 in 1000, but less than 1 in 100 patients):

• nausea,
• malaise,
• fever,
• dizziness,
• insomnia,
• tremors,
• agitation, confusion.

Rare (in more than 1 in 10,000, but less than 1 in 1000 patients):

• rapid heartbeat,
• disturbances of accommodation of the eye to viewing objects at different distances,
• blurred vision,
• constipation,
• vomiting,
• allergic reactions,
• abnormal liver function test results,
• seizures,
• involuntary and uncontrolled movements,
• disorientation,
• hallucinations,
• urinary retention,
• itching,
• skin rash,
• urticaria,
• dermatitis,
• hypotension.

Very rare (in less than 1 in 10,000 patients):

• anaphylactic shock (a type of severe, life-threatening allergic reaction),
• bronchospasm,
• angioedema (painless swelling, most commonly affecting the face, limbs, and joints, and sometimes the mucous membranes of the respiratory and gastrointestinal tracts),
• increased sweating,
• fixed drug eruption, acute generalized exanthematous pustulosis, erythema multiforme, Stevens-Johnson syndrome.

Frequency not known (frequency cannot be estimated from the available data):

• hepatitis,
• drowsiness, headache,
• dry mouth,
• QT interval prolongation in the electrocardiogram,
• heart rhythm disorders of the torsade de pointestype.

The patient should stop taking the medicine and immediately consult a doctor if they experience heart rhythm disorders, such as rapid heartbeat (palpitations), breathing problems, loss of consciousness.
Additionally, the following side effects have been observed with cetirizine, the main metabolite of hydroxyzine, which may also occur after administration of hydroxyzine: decreased platelet count, aggression, depression, tics, involuntary movements, paresthesia, episodes of forced eye movement with rotation of the eyeballs, diarrhea, difficulty urinating, involuntary urination, asthenia (fatigue, weakness), edema, weight gain.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Hydroxyzinum VP

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton [after: Expiry date(EXP)]. The expiry date refers to the last day of the month.
Store in a temperature below 30°C. Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Hydroxyzinum VP contains

• The active substance of the medicine is hydroxyzine in the form of hydrochloride.
• Other ingredients: lactose monohydrate, corn starch, microcrystalline cellulose, povidone K 25, talc, magnesium stearate; coating ingredients: talc, methacrylic acid butyl copolymer, citric acid monohydrate, triethyl citrate, macrogol 6000, titanium dioxide (E 171), simethicone, carmine, lake (E 124).

What Hydroxyzinum VP looks like and what the package contains

10 mg: pink, round, biconvex film-coated tablet.
25 mg: dark pink, round, biconvex film-coated tablet.
The carton contains 30 or 60 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer

ICN Polfa Rzeszów S.A.
Przemysłowa 2
35-959 Rzeszów

Date of last revision of the leaflet: