Hidroxizinum Teva

Package Leaflet: Information for the User

Hydroxyzinum Teva, 50 mg/ml, Solution for Injection

Hydroxyzine Hydrochloride

Read the Package Leaflet Carefully Before Using the Medicinal Product, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicinal product has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Hydroxyzinum Teva and What is it Used For
• 2. Important Information Before Using Hydroxyzinum Teva
• 3. How to Use Hydroxyzinum Teva
• 4. Possible Side Effects
• 5. How to Store Hydroxyzinum Teva
• 6. Contents of the Pack and Other Information

1. What is Hydroxyzinum Teva and What is it Used For

Hydroxyzine is a medicinal product with anxiolytic, sedative, and hypnotic effects. It acts in cases of anxiety, increased emotional tension in adult patients with psychosomatic disorders, as well as in children with anxiety states and excessive excitement. Hydroxyzine blocks histamine receptors of type H1, causing an antihistaminic effect. Indications:

• states of anxiety, restlessness, and psychomotor agitation;
• as an adjunctive treatment in premedication before surgical procedures and in the postoperative period;

The medicinal product in the form of an injection is used in emergency, severe cases, and when oral administration is difficult.

2. Important Information Before Using Hydroxyzinum Teva

When Not to Use Hydroxyzinum Teva

• if the patient is allergic to the active substance or any of the other ingredients of this medicinal product (listed in section 6);
• if the patient is allergic to cetirizine, other piperazine derivatives, aminophylline, and ethylenediamine;
• 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 in the blood serum (e.g., low potassium or magnesium levels);
• if the patient is taking certain medicinal products used to treat heart rhythm disorders or medicinal products that may affect heart rhythm (see "Hydroxyzinum Teva and Other Medicinal Products");
• if someone in the patient's family has died suddenly due to heart disease;
• during pregnancy;
• during breastfeeding;
• if the patient has been diagnosed with porphyria;
• in newborns.

Warnings and Precautions

Hydroxyzinum Teva is intended only for intramuscular injection and must not be administered subcutaneously, intravenously, or intra-arterially. Caution should be exercised in patients with an increased risk of seizures. Children are more susceptible to central nervous system side effects. Seizures occurred more frequently in children than in adult patients. Due to its anticholinergic effect, caution should be exercised when using the medicinal product in patients with narrow-angle glaucoma, urinary retention, reduced gastrointestinal motility, muscle weakness (weakness and fatigue of muscles of unknown cause), and dementia (senile dementia). Hydroxyzine enhances the effect of centrally acting depressants, such as narcotics, barbiturates, and alcohol. If these medicinal products are used concomitantly with hydroxyzine, their dose should be adjusted (reduced). During treatment with hydroxyzine, alcohol should be avoided. The dosage of concomitantly used medicinal products with anticholinergic properties should also be adjusted. The medicinal product should be used with caution in patients with asthma. The use of Hydroxyzinum Teva may be associated with an increased risk of heart rhythm disorders, which can be life-threatening. Therefore, you should inform your doctor about any heart disorders and the use of any medicinal products, including those available without a prescription.If symptoms such as rapid heartbeat (palpitations), difficulty breathing, or loss of consciousness occur during treatment with Hydroxyzinum Teva, you should immediately consult a doctor. Treatment with hydroxyzine should be discontinued.In elderly patients, the dose should be reduced due to the prolonged effect of the medicinal product. Patients with liver or kidney impairment require a dose reduction. Treatment with hydroxyzine should be discontinued at least 5 days before performing allergy tests or a methacholine bronchial challenge test, as the medicinal product may affect the results.

Using Hydroxyzinum Teva in Patients with Renal and/or Hepatic Impairment

In patients with liver and kidney impairment, a dose reduction may be necessary.

Using Hydroxyzinum Teva in Elderly Patients

In elderly patients, the dose should be reduced due to the prolonged effect of the medicinal product. Elderly patients may exhibit increased sensitivity to the medicinal product, and therefore, close monitoring for the occurrence of side effects is recommended.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist. Due to the lack of data on the safety of use during pregnancy, hydroxyzine is not recommended during this period. In newborns of mothers who used Hydroxyzinum Teva in late pregnancy and/or during delivery, the following symptoms were observed immediately after birth or within a few hours after birth: trembling, muscle stiffness, and/or weakness, breathing difficulties, or urinary retention. It is not known whether the medicinal product passes into breast milk, and therefore, hydroxyzine is not recommended during breastfeeding.

Driving and Using Machines

Hydroxyzine impairs psychophysical abilities. Do not drive vehicles or operate machines while using the medicinal product.

Hydroxyzinum Teva and Other Medicinal Products

Inform your doctor or pharmacist about all medicinal products you are currently taking or have recently taken, as well as about medicinal products you plan to take. This also applies to medicinal products available without a prescription. Hydroxyzinum Teva may affect the action of other medicinal products. Other medicinal products may affect the action of Hydroxyzinum Teva. Do not use Hydroxyzinum Teva if you are taking medicinal products 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).

Hydroxyzine enhances the effect of medicinal products that depress the central nervous system (barbiturates, other central nervous system depressants), alcohol, and medicinal products with anticholinergic properties (which can cause, among other things, pupil dilation, bronchodilation, slowed gastrointestinal motility, inhibition of external secretion, resulting in, among other things, dry mouth). Hydroxyzine counteracts the effect of betahistine (a medicinal product used to treat diseases characterized by dizziness, tinnitus) and acetylcholinesterase inhibitors (medicinal products used to treat cognitive and dementia disorders). The medicinal product may enhance the anticholinergic effect of antihistamine medicinal products and anticoagulant medicinal products from the coumarin group. Hydroxyzine reduces the effect of adrenaline, which increases blood pressure. Cimetidine (a medicinal product that reduces stomach acid) administered at a dose of 600 mg twice a day increased the hydroxyzine concentration in serum by 36% and reduced the maximum concentration of its metabolite, cetirizine, by 20%. Hydroxyzine inhibits the activity of the liver enzyme cytochrome P450 isoenzyme CYP 2D6 and may interact with substances metabolized by this isoenzyme in high doses. The medicinal product is metabolized in the liver, and when administered concomitantly with other medicinal products that strongly inhibit liver enzyme activity, an increase in hydroxyzine concentration in the blood can be expected.

Hydroxyzinum Teva Contains Sodium

Hydroxyzinum Teva contains less than 1 mmol (23 mg) of sodium per ampoule, which means the medicinal product is considered "sodium-free".

3. How to Use Hydroxyzinum Teva

This medicinal product should always be used as directed by your doctor. If you are unsure, consult your doctor or pharmacist. Hydroxyzinum Teva should be used 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 in all indications is 100 mg.In elderly patients, the maximum daily dose is 50 mg.In children with a body weight up to 40 kg, the maximum daily dose is 2 mg/kg body weight/day.The medicinal product is intended only for intramuscular injection. Anxiolytic:adults: the maximum daily dose is 100 mg. Sedative:adults: 50 mg, in a single dose. children: 0.6 mg/kg body weight. Adjunctive treatment in the pre- and postoperative period:adults: 25 mg to 100 mg, children: 1 mg/kg body weight. The dose of the medicinal product should be adjusted according to the patient's response. Elderly patients:At the beginning of treatment, a lower dose of the medicinal product is recommended. Patients with Renal and/or Hepatic Impairment:The dose of the medicinal product should be adjusted according to the patient's response.

Using a Higher Than Recommended Dose of Hydroxyzinum Teva

Overdose of hydroxyzine may cause nausea, vomiting, rapid heartbeat, fever, excessive sedation, drowsiness, headaches, dry mouth, impaired coordination, involuntary movements, tremors, disorientation, or hallucinations. Following severe overdose, the following may occur: impaired consciousness, respiratory disorders, seizures, hypotension, arrhythmia, coma, and circulatory collapse. If you have taken or used too much Hydroxyzinum Teva, contact your doctor immediately, especially if it concerns a child. In case of overdose, symptomatic treatment can be used. ECG monitoring is recommended due to the possibility of heart rhythm disorders, such as QT interval prolongation or torsade de pointes. The benefits of using hemodialysis are uncertain. In case of overdose, consider the possibility of taking other medicinal products. In case of mental disorders caused by the concomitant use of other medicinal products or alcohol, oxygen, naloxone, glucose, and thiamine administration is recommended if necessary. Adrenaline should not be used. Data from the literature indicate that in case of severe, life-threatening cholinergic symptoms that do not respond to other medicinal products, the administration of a therapeutic dose of physostigmine may be helpful. However, physostigmine should be avoided in patients who have taken tricyclic antidepressants, as it may cause seizures and cardiac arrest. Physostigmine should not be used in patients with conduction disorders.

Missing a Dose of Hydroxyzinum Teva

Do not use a double dose to make up for a missed dose.

Stopping Treatment with Hydroxyzinum Teva

If you have any further questions regarding the use of this medicinal product, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medicinal products, Hydroxyzinum Teva can cause side effects, although not everybody gets them. Hydroxyzine side effects are related to the inhibition of the central nervous system, sometimes with paradoxical stimulation of this system, anticholinergic effect, and hypersensitivity reactions. The following side effects of hydroxyzine are listed according to the frequency of occurrence, classified by system organ classes (MedDRA): Frequency is defined as follows: very common (occurring in more than 1 in 10 patients); common (occurring in more than 1 in 100 but less than 1 in 10 patients); uncommon (occurring in more than 1 in 1000 but less than 1 in 100 patients); rare (occurring in more than 1 in 10,000 but less than 1 in 1000 patients); very rare (occurring in less than 1 in 10,000 patients); frequency not known (frequency cannot be estimated from the available data). Cardiac disorders: Frequency not known: rapid heartbeat. You should stop taking the medicinal product and immediately consult a doctor if you experience heart rhythm disorders, such as rapid heartbeat (palpitations), difficulty breathing, or loss of consciousness.Eye disorders: Frequency not known: accommodation disorders, blurred vision. Gastrointestinal disorders: Frequency not known: constipation, dryness of the mucous membranes of the mouth, nausea, vomiting. General disorders and administration site conditions: Frequency not known: fatigue, malaise, fever. Immune system disorders: Frequency not known: anaphylactic shock, hypersensitivity reactions. Diagnostic tests: Frequency not known: abnormal liver enzyme activity, weight gain. Nervous system disorders: Frequency not known: seizures, dizziness, dyskinesia, headaches, insomnia, sedation, drowsiness, tremors. Psychiatric disorders: Frequency not known: excitement, confusion, disorientation, hallucinations. Renal and urinary disorders: Frequency not known: urinary retention. Respiratory, thoracic, and mediastinal disorders: Frequency not known: bronchospasm. Skin and subcutaneous tissue disorders: Frequency not known: angioedema, skin inflammation, itching, rash, erythematous rash, maculopapular rash, excessive sweating, urticaria, acute generalized exanthematous pustulosis. Vascular disorders: Frequency not known: hypotension.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, please inform your 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. By reporting side effects, you can help provide more information on the safety of the medicinal product.

5. How to Store Hydroxyzinum Teva

Store in a temperature below 25°C, protected from light. The medicinal product should be stored out of the sight and reach of children. Do not use this medicinal product after the expiry date stated on the carton after "Expiry Date" (EXP). The expiry date refers to the last day of the month stated. Medicinal products should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicinal products that are no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

What Hydroxyzinum Teva Contains

• The active substance of the medicinal product is hydroxyzine hydrochloride. 1 ml of the solution contains 50 mg of hydroxyzine hydrochloride. 1 ampoule (2 ml) contains 100 mg of hydroxyzine hydrochloride.
• The other ingredients are: sodium hydroxide, hydrochloric acid, water for injections.

What Hydroxyzinum Teva Looks Like and Contents of the Pack

1 ml of the solution for injection contains 50 mg of hydroxyzine hydrochloride. Colorless glass ampoules in a cardboard box. The pack contains 5 ampoules of 2 ml each.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel.: (022) 345 93 00

Manufacturer

Merckle GmbH, Ludwig-Merckle Str. 3, 89143 Blaubeuren, Germany

Date of Last Revision of the Package Leaflet: