Hidroxizinum Vp

Package Leaflet: Information for the Patient

Hydroxyzinum VP, 2 mg/ml, Syrup

Hydroxyzine Hydrochloride

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 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. Contents of the pack and other information

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

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

• for the symptomatic treatment of anxiety in adults,
• for the 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 disturbances 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 someone in the patient's family 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 or heart rhythm disorders (arrhythmias);
• if the patient is taking other medicines (see "Hydroxyzinum VP and other medicines");
• if the patient has glaucoma, myasthenia (muscle weakness and fatigue), or dementia;
• if the patient has difficulty urinating or 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 problems and about taking any other medicines, including those available without a prescription.
If the patient experiences heart symptoms such as rapid heartbeat (palpitations), difficulty breathing, loss of consciousness during treatment with Hydroxyzinum VP, they should immediately consult their doctor. The patient should also stop taking Hydroxyzinum VP.
Hydroxyzinum VP may affect the results of allergy tests and the methacholine bronchial provocation test - it should not be taken for at least 5 days before such tests.
The patient should avoid drinking alcohol while taking Hydroxyzinum VP.

Children and adolescents

Young children are more prone to experiencing adverse effects on the central nervous system (see section 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:

• anticholinergic medicines - a group of medicines used, among other things, in gastrointestinal disorders and respiratory diseases,
• medicines with a depressive effect on the central nervous system - such as sedatives, anxiolytics, antidepressants, anticonvulsants, sleep aids,
• betahistine - a medicine used in Meniere's disease,
• cholinesterase inhibitors - a group of medicines used, among other things, in the treatment of myasthenia, Alzheimer's disease, and glaucoma,
• adrenaline - a medicine used, among other things, 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 depression, anxiety, and 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, drinks, and alcohol

Taking food and drinks does not affect treatment with Hydroxyzinum VP.
Alcohol enhances the effect of Hydroxyzinum VP (see "Warnings and precautions").

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their 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 the ability to concentrate - if this happens, the patient should not drive vehicles or operate machinery.
Hydroxyzinum VP contains liquid maltitol
The medicine may have a mild laxative effect. The energy value is 2.3 kcal/g of liquid maltitol.
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking the medicine.
Hydroxyzinum VP contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per 50 ml (which corresponds to the maximum daily dose),
which means the medicine is considered "sodium-free".
Hydroxyzinum VP contains propylene glycol
The medicine contains 5.16 mg of propylene glycol per 1 ml of solution, which is equivalent to 258 mg/50 ml. Before administering the medicine to a child under 4 weeks of age, the patient should consult their doctor or pharmacist, especially if the child is taking other medicines containing propylene glycol or alcohol.
Hydroxyzinum VP contains sodium benzoate
The medicine contains 2 mg of sodium benzoate per 1 ml, which corresponds to 100 mg/50 ml.
Sodium benzoate may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of age).

3. How to take Hydroxyzinum VP

This medicine should always be taken exactly as prescribed by the doctor. If the patient has any doubts, they should consult their 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 with a body weight over 40 kg, the maximum daily dose for all indications is 100 mg.

Recommended dose Adults

Symptomatic treatment of anxiety:
50 mg/day in 2 to 3 divided doses.
In severe cases, doses of 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 doctor may increase the dose to 25 mg 3 to 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 with a body weight up to 40 kg, the maximum daily dose is 2 mg/kg body weight/day.
In children with a body weight 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.
Elderly patients
Treatment usually starts with half the dose recommended for younger 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 kidney failure
The doctor may consider it necessary to use smaller doses of Hydroxyzinum VP.

Method of administration

Hydroxyzinum VP is taken orally.

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 their doctor or hospital emergency department, especially if it concerns a child. The patient should take the medicine packaging with them, which will facilitate its identification.
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.
Overdose symptoms of Hydroxyzinum VP include: nausea, vomiting, tachycardia (rapid heart rate), fever, drowsiness, disturbances of pupillary reflex, tremors, confusion, or hallucinations, and then decreased 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 for the next dose, the patient 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 the 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 this medicine, they should consult their 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 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 were observed:

Very common (in more than 1 in 10 patients):

• drowsiness.

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

• dry mouth,
• fatigue,
• headache,
• strong sedation.

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 (difficulty adjusting the eye to look at 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,
• hives,
• skin inflammation,
• 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, polymorphic erythema, Stevens-Johnson syndrome.

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

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

The patient should stop taking the medicine and immediately consult their doctor if they experience heart rhythm disorders, such as rapid heartbeat (palpitations), difficulty breathing, or 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, compulsive eye movements 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 not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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 gather more information on the safety of the medicine.

5. How to store Hydroxyzinum VP

Store in a temperature below 25°C.
Store in the original packaging.
Shelf life after opening the bottle with a capacity of 120 ml: 48 days
Shelf life after opening the bottle with a capacity of 200 ml: 80 days
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle after EXP. The expiry date refers to the last day of the given month.
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. Contents of the pack and other information

What Hydroxyzinum VP contains

• The active substance of the medicine is hydroxyzine hydrochloride.
• The other ingredients are: liquid maltitol, sodium benzoate (E 211), propylene glycol, Tutti-Frutti flavor, purified water, concentrated hydrochloric acid.

What Hydroxyzinum VP looks like and what the pack contains

Brown glass bottle (type III) with a capacity of 125 ml or 200 ml, closed with a polypropylene cap with a child-resistant closure and a tamper-evident seal. A 15 ml polypropylene measuring cup is attached to the bottle. The outer packaging is a cardboard box.
Pack sizes: 120 ml or 200 ml.

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, Poland

Date of the last update of the leaflet: