Hydroxyzine vp

Package leaflet: information for the patient

Hydroxyzinum VP, 10 mg, coated tablets
Hydroxyzinum VP, 25 mg, coated tablets
Hydroxyzini hydrochloridum
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

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

• symptomatic treatment of anxiety in adults,
• symptomatic treatment of pruritus (itching),
• premedication prior to surgical procedures.

2. Important information before using Hydroxyzinum VP

When not to use 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 known as QT interval prolongation;
• if the patient has or has had cardiovascular disease or if the heart rate is very low;
• if the patient has low levels of electrolytes (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, discuss with the doctor:

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

Treatment with Hydroxyzinum VP may be associated with an increased risk of life-threatening heart rhythm disturbances. Therefore, inform the doctor about any heart disorders and about any other medicines the patient is taking, including those available without a prescription.
If symptoms related to the heart occur during treatment with Hydroxyzinum VP, such as rapid heartbeat (palpitations), breathing difficulties or loss of consciousness, seek immediate medical advice. The patient should also discontinue treatment with hydroxyzine.
Hydroxyzinum VP may affect the results of allergy tests and bronchial provocation tests with methacholine – the medicine should not be used for at least 5 days before such tests.
Alcohol consumption should be avoided during treatment with Hydroxyzinum VP.

Children and adolescents
Young children are more susceptible to adverse effects affecting the central nervous system (see section "4. Possible side effects").

Hydroxyzinum VP and other medicines
Inform the doctor about all medicines currently taken or recently taken, as well as any medicines the patient plans to take. This includes medicines available without a prescription. Hydroxyzinum VP may affect the action of other medicines, and other medicines may affect the action of Hydroxyzinum VP.
This is particularly important when the patient is taking the following medicines:

• anticholinergic medicines – a group of medicines used, among others, for gastrointestinal motility disorders and respiratory diseases;
• medicines with central nervous system depressant effects – such as sedatives, anxiolytics, antidepressants, anticonvulsants, hypnotics;
• betahistine – a medicine used in Meniere's disease;
• cholinesterase inhibitors – a group of medicines used, among others, in the treatment of myasthenia gravis, 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 disorders, including heartburn;
• monoamine oxidase inhibitors (MAO inhibitors) – a group of medicines mainly used in the treatment of depression;
• medicines metabolized by a liver enzyme called CYP2D6 – including beta-blockers used, for example, in hypertension, and selective serotonin reuptake inhibitors used, for example, in the treatment of depression, anxiety, and obsessive-compulsive disorder;
• medicines inhibiting the activity of certain enzymes (alcohol dehydrogenase and CYP3A4/5) – including disulfiram, used in alcohol dependence, and fluconazole and ketoconazole, used in the treatment of fungal infections.

Do not take Hydroxyzinum VP if the patient is 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 disorders (e.g. prucalopride);
• allergies;
• malaria (e.g. mefloquine);
• cancer (e.g. toremifene, vandetanib); drug dependence or severe pain (methadone).

Hydroxyzinum VP with food, drink and alcohol
The medicine should be taken after meals and with water.
Alcohol enhances the effect of Hydroxyzinum VP (see section "Warnings and precautions").

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Hydroxyzinum VP must not be used during pregnancy or breastfeeding. Breastfeeding should be discontinued if treatment with Hydroxyzinum VP is necessary.

Driving and using machines
Hydroxyzinum VP may impair reaction times and concentration ability – if this occurs, the patient should not drive or operate machinery.

Hydroxyzinum VP contains monohydrate lactose
If the patient has previously been diagnosed with an intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Hydroxyzinum VP contains carmine red
The medicine may cause allergic reactions.

3. How to use Hydroxyzinum VP

This medicine should always be used exactly as directed by the physician. If in doubt, consult
your doctor or pharmacist.
Hydroxyzinum VP should be used at the lowest effective dose. The duration of treatment should
be as short as possible.
In adults and children with body weight above 40 kg, the maximum daily dose in 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, oral doses up to 100 mg/day may be used.
Symptomatic treatment of pruritus (itching):
Begin treatment with a dose of 25 mg at bedtime. Later, if necessary, the dose may be increased
to 25 mg 3 or 4 times daily.
Premedication before surgical procedures:
50 mg in two doses or 100 mg as a single oral dose.
Children and adolescents
In children with body weight up to 40 kg, the maximum daily dose is 2 mg/kg body weight/day.
In children with body weight above 40 kg, the maximum daily dose in all indications
is 100 mg.
Children from 12 months of age
Symptomatic treatment of pruritus (itching):
1 mg/kg to 2 mg/kg body weight per day, in divided doses.
Premedication before surgical procedures:
0.6 mg/kg body weight orally, as a single dose.
The total daily dose should not exceed 2 mg/kg body weight per day.
The exact dosage should be determined by the physician.
For children aged from 12 months to 6 years, it is recommended to use a medicinal product
containing hydroxyzine in the form of oral syrup, which ensures appropriate dosing and avoids
the risk of choking.
Elderly patients:
Treatment should be initiated using half the dose recommended for adults.
In elderly patients, the maximum daily dose is 50 mg.
Patients with hepatic impairment:
Lower doses of Hydroxyzinum VP (approximately 1/3 lower) are usually used in treatment.
Patients with renal impairment:
The physician may consider it necessary to use lower doses of Hydroxyzinum VP.
Method of administration
Hydroxyzinum VP is administered orally.
Tablets should be taken after meals with water. Do not chew them.
Use of a higher than recommended dose of Hydroxyzinum VP
Never take more than the recommended dose.
If a patient has taken or used an excessive dose of Hydroxyzinum VP, contact a doctor or
hospital emergency department immediately, especially if this concerns a child. In case of overdose,
symptomatic treatment may be applied. ECG monitoring is required due to the possible occurrence
of cardiac arrhythmias such as QT interval prolongation or torsade de pointes.
Symptoms of overdose with Hydroxyzinum VP include nausea, vomiting, tachycardia (increased
heart rate), fever, drowsiness, disturbances of pupillary reflex, tremor, confusion or hallucinations,
followed by decreased level of consciousness, respiratory depression, seizures, hypotension,
cardiac arrhythmias, and progressively deepening coma and circulatory-respiratory collapse.
If an excessive dose of Hydroxyzinum VP has been taken together with any other medicines or
substances (e.g. alcohol), inform the doctor or pharmacist.
Missed dose of Hydroxyzinum VP
If a dose of the medicine is missed at the scheduled time, take it as soon as possible. However,
if the next dose is due soon, skip the missed dose. Do not take a double dose to make up for
a missed dose.
Discontinuation of Hydroxyzinum VP
Hydroxyzinum VP should always be taken exactly as prescribed by the doctor.
Discontinuing treatment without prior consultation with the doctor may lead to recurrence
or worsening of symptoms for which the medicine was prescribed (anxiety or pruritus).
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
In clinical trials, the most commonly observed adverse reactions in patients taking hydroxyzine were
drowsiness (in nearly 14%) and headache, fatigue, and dry mouth (in less than 2%
of patients).
After the medicine was placed on the market, the following adverse reactions have been observed:
Common (affects more than 1 in 100 but less than 1 in 10 patients):

• pronounced sedation,
• fatigue.

Uncommon (affects more than 1 in 1,000 but less than 1 in 100 patients):

• nausea,
• malaise,
• fever,
• dizziness,
• insomnia,
• tremor,
• restlessness, confusion.

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

• rapid heartbeat,
• accommodation disorders (difficulty focusing the eyes on objects at varying distances),
• blurred vision,
• constipation,
• vomiting,
• hypersensitivity reactions,
• abnormal liver function test results,
• seizures,
• uncoordinated and involuntary movements,
• disorientation,
• hallucinations,
• urinary retention,
• itching,
• skin rash,
• urticaria,
• dermatitis,
• hypotension.

Very rare (affects 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,
• persistent drug eruption, acute generalized exanthematous pustulosis, erythema multiforme, Stevens-Johnson syndrome.

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

• hepatitis,
• drowsiness, headache,
• dryness of the oral mucous membranes,
• QT interval prolongation on electrocardiogram,
• torsade de pointes type cardiac arrhythmias.

Treatment should be discontinued and medical advice should be sought immediately if the patient experiences
cardiac arrhythmias such as rapid heartbeat (palpitations), difficulty breathing, or loss of consciousness.
Additionally, the following adverse reactions associated with cetirizine, the main
metabolite of hydroxyzine, have been observed and may also occur after administration of hydroxyzine: thrombocytopenia, aggression, depression, tics, involuntary movements, paresthesia, compulsive upward gaze with eye rotation, diarrhea, urinary hesitancy, urinary incontinence, asthenia (fatigue, weakness), edema, weight gain.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported directly to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Hydroxyzinum VP

Keep this medicine 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 stated month.
Store below 30°C. Keep in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Hydroxyzinum VP contains

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

What Hydroxyzinum VP looks like and contents of the pack
10 mg: pink, round, biconvex film-coated tablet.
25 mg: dark pink, round, biconvex film-coated tablet.
Each cardboard box contains 30 film-coated tablets or 60 film-coated tablets.
Not all pack sizes may be marketed.

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

Manufacturer
ICN Polfa Rzeszów S.A.
Przemysłowa 2 Street
35-959 Rzeszów
Poland