Hidroxizinum Vp

Package Leaflet: Information for the Patient

Hydroxyzinum VP, 10 mg, Film-Coated Tablets

Hydroxyzinum VP, 25 mg, Film-Coated Tablets

Hydroxyzine Hydrochloride

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this Package Leaflet, so you can Read it Again if Necessary.
• If you have any Further Questions, Ask your Doctor or Pharmacist.
• This Medication has been Prescribed for a Specific Person. Do not Pass it on to Others. The Medication may Harm Another Person, even if their Symptoms are the Same.
• If the Patient Experiences any Undesirable Effects, including those not Mentioned in this Package Leaflet, they should Inform their Doctor or Pharmacist. See Section 4.

Package Leaflet Contents:

• 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 Undesirable 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 Medication with Anti-Anxiety, Sedative, and Anti-Itch Effects.
Hydroxyzinum VP is Indicated for:

• Symptomatic Treatment of Anxiety in Adults,
• Symptomatic Treatment of Itching,
• Pre-Medication 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 Medication (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 History of Cardiovascular Disease or if their 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 Medications used to Treat Heart Rhythm Disorders or Medications that may Affect Heart Rhythm (see "Hydroxyzinum VP and other Medications");
• If a Family Member of the Patient has Died Suddenly due to a Heart Condition;
• If the Patient is Pregnant or Breastfeeding;
• If the Patient has a Hereditary Intolerance to certain Sugars.

Warnings and Precautions

Before Starting Hydroxyzinum VP, the Patient should Discuss the Following with their Doctor:

• If the Patient has an Increased Risk of Seizures (more Common in Children than in Adults) or Heart Rhythm Disorders (Arrhythmias);
• If the Patient is Taking other Medications (see "Hydroxyzinum VP and other Medications");
• If the Patient has Glaucoma, Myasthenia (Muscle Weakness and Fatigue), or Dementia;
• If the Patient has Difficulty Urinating or has 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 Inform their Doctor about any Heart Problems and the Use of any other Medications, including those available without a Prescription.
If the Patient Experiences any Heart-Related Symptoms, such as Rapid Heartbeat (Palpitations), Breathing Difficulties, Loss of Consciousness, they should Immediately Consult their Doctor and Discontinue 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 while Taking Hydroxyzinum VP.

Children and Adolescents

Young Children are more Prone to Central Nervous System-Related Undesirable Effects (see Section "4. Possible Undesirable Effects").

Hydroxyzinum VP and other Medications

The Patient should Inform their Doctor about all Medications they are Currently Taking or have Recently Taken, including those available without a Prescription. Hydroxyzinum VP may Interact with other Medications, and other Medications may Affect the Action of Hydroxyzinum VP.
This is especially Important when the Patient is Taking the Following Medications:

• Anticholinergic Medications - a Group of Medications used to Treat Gastrointestinal Disorders and Respiratory Diseases;
• Medications with a Depressant Effect on the Central Nervous System - such as Sedatives, Anxiolytics, Antidepressants, Anticonvulsants, and Sleep Aids;
• Betahistine - a Medication used to Treat Meniere's Disease;
• Cholinesterase Inhibitors - a Group of Medications used to Treat Myasthenia, Alzheimer's Disease, and Glaucoma;
• Adrenaline - a Medication used to Treat Severe Allergic Reactions;
• Phenytoin - a Medication used to Treat Epilepsy;
• Cimetidine - a Medication used to Treat Gastrointestinal Diseases, including Heartburn;
• Monoamine Oxidase Inhibitors (MAOIs) - a Group of Medications used to Treat Depression;
• Medications Metabolized by a Specific Liver Enzyme (CYP2D6) - including Beta-Blockers used to Treat High Blood Pressure, Selective Serotonin Reuptake Inhibitors (SSRIs) used to Treat Depression, Anxiety, and Obsessive-Compulsive Disorder;
• Medications that Inhibit the Action of Certain Enzymes (Alcohol Dehydrogenase and CYP3A4/5) - including Disulfiram used to Treat Alcoholism, and Fluconazole and Ketoconazole used to Treat Fungal Infections.

The Patient should not Take Hydroxyzinum VP if they are Taking Medications 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 Medication should be Taken after Meals and Swallowed with Water.
Alcohol Enhances the Effect of Hydroxyzinum VP (see "Warnings and Precautions").

Pregnancy, Breastfeeding, and Fertility

If the Patient is Pregnant, Breastfeeding, or Thinks they may be Pregnant, or is Planning to have a Child, they should Consult their Doctor or Pharmacist before Taking this Medication.
Hydroxyzinum VP should not be Used during Pregnancy and Breastfeeding. Breastfeeding should be Discontinued if Hydroxyzinum VP is Necessary.

Driving and Operating Machinery

Hydroxyzinum VP may Impair Reactions and Concentration - if this Occurs, the Patient should not Drive or Operate Machinery.

Hydroxyzinum VP contains Lactose Monohydrate

If the Patient has been Diagnosed with an Intolerance to certain Sugars, they should Consult their Doctor before Taking the Medication.

Hydroxyzinum VP contains Erythrosine

The Medication may Cause Allergic Reactions.

3. How to Take Hydroxyzinum VP

This Medication should Always be Taken as Directed by the Doctor. If the Patient has any Questions, 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 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, up to 100 mg per 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.
Pre-Medication 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.
Pre-Medication Before Surgical Procedures:
0.6 mg/kg Body Weight Orally, in a Single Dose.
The Total 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 Hydroxyzine-Containing Medication in the Form of an Oral Syrup, which Ensures Proper Dosage and Reduces the Risk of Choking.
Elderly Patients:
Treatment should be Started with Half the Recommended Dose for Adults.
In Elderly Patients, the Maximum Daily Dose is 50 mg.
Patients with Liver Impairment
Usually, Lower Doses of Hydroxyzinum VP are Used (about 1/3).
Patients with Renal Impairment
The Doctor may Decide to Use Lower Doses of Hydroxyzinum VP.

Method of Administration

Hydroxyzinum VP should be Taken Orally.
Tablets should be Taken after Meals and Swallowed with Water. They should not be Chewed.

Taking a Higher than Recommended Dose of Hydroxyzinum VP

Never Take more than the Recommended Dose.
If the Patient has Taken or Used more than the Recommended Dose of Hydroxyzinum VP, they should Immediately Consult their Doctor or the 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 Risk of Heart Rhythm Disorders, such as QT Interval Prolongation or Torsades de Pointes.
Overdose Symptoms of Hydroxyzinum VP include Nausea, Vomiting, Tachycardia (Rapid Heart Rate), Fever, Drowsiness, Pupillary Reflex Disorders, Tremors, Confusion, or Hallucinations, followed by Decreased Level of Consciousness, Respiratory Depression, Seizures, Hypotension, or Heart Rhythm Disorders, and Progressing to Coma and Cardio-Respiratory Arrest.
If the Patient has Taken an Overdose of Hydroxyzinum VP along with an Excessive Amount of other Medications or Substances (e.g., Alcohol), they should Inform their Doctor or Pharmacist.

Missing a Dose of Hydroxyzinum VP

If a Dose is Missed, it should be Taken as Soon as Possible. However, if the Next Dose is Due, the Missed Dose should be Omitted. A Double Dose should not be Taken to Make up for the Missed Dose.

Discontinuing Hydroxyzinum VP

Hydroxyzinum VP should Always be Taken Exactly as Directed by the Doctor.
If Treatment is Discontinued without Consulting the Doctor, the Symptoms for which the Medication was Prescribed (Anxiety or Itching) may Return or Worsen.
If the Patient has any Further Questions about Taking the Medication, they should Consult their Doctor or Pharmacist.

4. Possible Undesirable Effects

Like all Medications, Hydroxyzinum VP can Cause Undesirable Effects, although not Everybody will Experience them.
In Clinical Trials, the Most Commonly Observed Undesirable Effects in Patients Taking Hydroxyzine were Drowsiness (in almost 14%) and Headache, Fatigue, and Dry Mouth (in less than 2% of Patients).
After the Medication was Released onto the Market, the Following Undesirable Effects were Observed:

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

• Severe Sedation,
• Fatigue.

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

• Nausea,
• Malaise,
• Fever,
• Dizziness,
• Insomnia,
• Tremors,
• Agitation, Confusion.

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

• Rapid Heartbeat,
• Accommodation Disorders,
• Blurred Vision,
• Constipation,
• Vomiting,
• Hypersensitivity Reactions,
• Abnormal Liver Function Test Results,
• Seizures,
• Involuntary Movements,
• Disorientation,
• Hallucinations,
• Urinary Retention,
• Itching,
• 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 of the Face, Extremities, 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 (cannot be Estimated from the Available Data):

• Hepatitis,
• Drowsiness, Headache,
• Dry Mouth,
• QT Interval Prolongation in the Electrocardiogram,
• Heart Rhythm Disorders of the Torsades de PointesType.

The Patient should Discontinue the Medication and Immediately Consult their Doctor if they Experience Heart Rhythm Disorders, such as Rapid Heartbeat (Palpitations), Breathing Difficulties, or Loss of Consciousness.
Additionally, the Following Undesirable 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, Forced Gaze with Eye Rotation, Diarrhea, Urinary Retention, Involuntary Urination, Asthenia (Fatigue, Weakness), Edema, Weight Gain.

Reporting Undesirable Effects

If the Patient Experiences any Undesirable Effects, including those not Mentioned in the Package Leaflet, they should Inform their Doctor or Pharmacist. Undesirable Effects can be Reported Directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Phone: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Undesirable Effects can also be Reported to the Marketing Authorization Holder.
Reporting Undesirable Effects will Help to Gather more Information on the Safety of the Medication.

5. How to Store Hydroxyzinum VP

The Medication should be Stored in a Place that is Inaccessible to Children.
Do not Use this Medication after the Expiration Date Stated on the Carton [after: Expiration Date (EXP)]. The Expiration Date refers to the Last Day of the Specified Month.
Store in a Temperature below 30°C. Store in the Original Packaging to Protect from Moisture.
Medications should not be Disposed of via Wastewater or Household Waste. The Patient should Ask their Pharmacist how to Dispose of Medications they no Longer Use. This will Help Protect the Environment.

6. Package Contents and other Information

What Hydroxyzinum VP Contains

• The Active Substance of the Medication is Hydroxyzine in the Form of Hydrochloride.
• Other Ingredients: Lactose Monohydrate, Corn Starch, Microcrystalline Cellulose, Povidone K 25, Talc, Magnesium Stearate; Coating: Talc, Methacrylic Acid Copolymer, Citric Acid Monohydrate, Triethyl Citrate, Macrogol 6000, Titanium Dioxide (E 171), Simethicone, Erythrosine, 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 the Last Update of the Package Leaflet: