Hydroxyzine teva

Package leaflet: Information for the user

Hydroxyzinum Teva, 50 mg/ml, solution for injection
Hydroxyzini hydrochloridum
Please read all of this leaflet carefully before using this medicine because it contains
important information for you.

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

Contents of the leaflet

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

Hydroxyzine is a medicine with anxiolytic, sedative and hypnotic properties. It is effective
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 H1 histamine receptors, producing an antiallergic effect.
Indications:

• States of anxiety, restlessness and psychomotor agitation;
• As adjunctive therapy in premedication before surgical procedures and in the postoperative period;

The injectable form of the medicine is used in acute, severe cases and when oral administration
is difficult or not feasible.

2. Important information before using Hydroxyzinum Teva

When not to use Hydroxyzinum Teva

• if the patient is allergic to the active substance or to 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's ECG (electrocardiogram) shows heart rhythm disturbances known as QT prolongation;
• if the patient has or has had cardiovascular disease or if heart rate is very low;
• if the patient has low levels of electrolytes in blood serum (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 Teva with other medicines");
• if someone in the patient's family has died suddenly due to heart disease;
• during pregnancy;
• during lactation;
• 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 used for subcutaneous, intravenous or intra-arterial injections.
Caution is advised in patients with an increased risk of seizures.
Children are more susceptible to adverse effects on the central nervous system. Seizures have occurred more frequently in children than in adult patients.
Due to its anticholinergic action, caution is required when administering to patients with narrow-angle glaucoma, urinary retention, reduced gastrointestinal motility, myasthenia (muscle weakness and fatigue of unknown cause) or dementia.
Hydroxyzine enhances the depressant effects on the central nervous system of substances such as narcotics, barbiturates and alcohol. If these medicines are used concomitantly with hydroxyzine, their dosage should be appropriately adjusted (reduced). Alcohol consumption should be avoided during treatment with hydroxyzine.
Dosage adjustment is also required when anticholinergic medicines are used concomitantly.
Caution is advised when using Hydroxyzinum Teva in patients with asthma.
Use of Hydroxyzinum Teva may be associated with an increased risk of life-threatening heart rhythm disturbances. Therefore, inform your doctor about any heart problems and about all medicines you are taking, 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, consult a doctor immediately. Treatment with hydroxyzine should be discontinued.
Dosage should be reduced in elderly patients due to prolonged drug action.
Patients with hepatic impairment or moderate to severe renal impairment require a reduced dose.
Treatment with hydroxyzine should be discontinued at least 5 days before undergoing allergy tests or methacholine bronchial provocation tests, as the drug may interfere with test results.

Use of Hydroxyzinum Teva in patients with renal and/or hepatic impairment
In patients with hepatic or renal impairment, a reduced dose of the medicine may be necessary.

Use of Hydroxyzinum Teva in elderly patients
Dosage should be reduced in elderly patients due to prolonged drug action.
Elderly patients may be more sensitive to the drug, and careful monitoring for adverse effects is recommended.

Pregnancy and breastfeeding
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.
Due to lack of data on safety during pregnancy, use of hydroxyzine is not recommended in this period.
In newborns of mothers who used Hydroxyzinum Teva in late pregnancy and/or during delivery, the following symptoms have been observed immediately after birth or within a few hours of delivery: tremors, muscle stiffness and/or weakness, breathing difficulties or urinary retention.
It is not known whether the drug passes into breast milk; therefore, use of hydroxyzine is not recommended during breastfeeding.

Driving and operating machinery
Hydroxyzine impairs psychomotor performance. Patients should not drive or operate machinery while taking this medicine.

Hydroxyzinum Teva with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future use. This includes medicines available without a prescription. Hydroxyzinum Teva may affect the action of other medicines, and other medicines may affect the action of Hydroxyzinum Teva.
Do not take Hydroxyzinum Teva 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 addiction or severe pain (methadone).

Hydroxyzine enhances the central nervous system depressant effects of barbiturates, other CNS depressants, alcohol, and drugs with anticholinergic properties (which cause, among others, pupil dilation, bronchodilation, slowed intestinal peristalsis, inhibition of exocrine gland secretion resulting in, among others, dry mouth, central nervous system stimulation causing hallucinations, psychomotor agitation, increased body temperature, and relaxation of smooth muscles).
Hydroxyzine counteracts the effect of betahistine (a medicine used in disorders characterized by vertigo and tinnitus) and acetylcholinesterase inhibitors (medicines used in cognitive disorders and dementia).
The medicine may enhance the anticholinergic effects of antihistamines and anticoagulants of the coumarin group.
Hydroxyzine reduces the blood pressure-raising effect of adrenaline.
Cimetidine (a medicine that reduces gastric acidity), administered at a dose of 600 mg twice daily, increased plasma hydroxyzine concentration by 36% and decreased the maximum concentration of its metabolite, cetirizine, by 20%.
Hydroxyzine inhibits the activity of the hepatic isoenzyme CYP2D6 of cytochrome P450 and, in high doses, may interact with substances metabolized by this isoenzyme.
The medicine is metabolized in the liver, and when administered concomitantly with other medicines that strongly inhibit liver enzyme activity, increased blood concentrations of hydroxyzine may be expected.

Hydroxyzinum Teva contains sodium
Hydroxyzinum Teva contains less than 1 mmol (23 mg) of sodium per ampoule, meaning the medicine is considered "sodium-free".

3. How to use Hydroxyzinum Teva

This medicine should always be used exactly as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
Hydroxyzinum Teva 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.
In elderly patients, the maximum daily dose is 50 mg.
In children with body weight up to 40 kg, the maximum daily dose is 2 mg/kg b.w./day.
This medicine is intended for intramuscular administration only.
Anxiolytic effect:
adults: maximum daily dose is 100 mg.
Sedative effect:
adults: 50 mg as a single dose.
children: 0.6 mg/kg b.w.
Adjunctive treatment in pre- and postoperative periods:
adults: 25 mg to 100 mg,
children: 1 mg/kg b.w.
The dose should be adjusted according to the patient's response.
Elderly patients:
At the beginning of treatment, a lower dose is recommended.
Patients with renal and/or hepatic impairment:
The dose should be adjusted according to the patient's response.
Use of a higher than recommended dose of Hydroxyzinum Teva
Overdose of hydroxyzine may cause nausea, vomiting, tachycardia, fever, excessive sedation,
drowsiness, headache, dry mouth, impaired motor coordination, involuntary movements, tremor,
disorientation or hallucinations. In severe overdose, the following may occur: disturbances of
consciousness, respiratory disturbances, seizures, hypotension, arrhythmia, coma and circulatory
collapse.
If a patient has taken or received an excessive dose of Hydroxyzinum Teva, seek immediate
medical advice, especially if this concerns a child. In case of overdose, symptomatic treatment
may be applied. ECG monitoring is recommended due to the possibility of cardiac rhythm
disturbances such as QT interval prolongation or torsade de pointes.
The benefit of hemodialysis is questionable.
In case of overdose, concomitant use of other drugs should be considered.
In case of psychiatric disturbances caused by simultaneous intake of other drugs or alcohol,
administration of oxygen, naloxone, glucose and thiamine is recommended, if necessary.
Adrenaline should not be used.
Literature data suggest that in case of severe, life-threatening anticholinergic symptoms unresponsive
to other treatments, 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
lead to seizures and cardiac arrest. Physostigmine should not be used in patients with cardiac
conduction disorders.
Missed dose of Hydroxyzinum Teva
Do not use a double dose to make up for a missed dose.
Stopping Hydroxyzinum Teva
If you have any further questions about 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 everyone will experience them.
Adverse reactions of hydroxyzine are related to central nervous system depression, sometimes paradoxical central nervous system stimulation, anticholinergic effects, and hypersensitivity reactions.
The following are possible adverse reactions of hydroxyzine, listed according to frequency of occurrence and classified by MedDRA system organ classes.
Frequency categories are defined as follows:
very common (affects more than 1 in 10 people);
common (affects more than 1 in 100 but less than 1 in 10 people);
uncommon (affects more than 1 in 1,000 but less than 1 in 100 people);
rare (affects more than 1 in 10,000 but less than 1 in 1,000 people);
very rare (affects less than 1 in 10,000 people);
frequency not known (cannot be estimated from the available data).

Cardiac disorders:
Frequency not known: rapid heartbeat.
The medicine should be discontinued and medical advice sought immediately if the patient experiences
heart rhythm disturbances 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 oral mucous membranes, nausea, vomiting.

General disorders and administration site conditions:
Frequency not known: fatigue, malaise, fever.

Immune system disorders:
Frequency not known: anaphylactic shock, hypersensitivity reactions.

Investigations:
Frequency not known: abnormal liver enzyme activity, weight gain.

Nervous system disorders:
Frequency not known: seizures, dizziness, dyskinesia, headache, insomnia, sedation, somnolence, tremor.

Psychiatric disorders:
Frequency not known: restlessness, 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, dermatitis, itching, rash, erythematous rash, maculopapular rash, excessive sweating, urticaria, acute generalized exanthematous pustulosis.

Vascular disorders:
Frequency not known: low blood pressure.

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 of 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 may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Hydroxyzinum Teva

Store below 25°C and protect from light.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
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 Teva contains

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

What Hydroxyzinum Teva looks like and contents of the pack
1 ml of injectable solution contains 50 mg of hydroxyzine hydrochloride.
Colourless glass ampoules packed in a cardboard box.
The pack contains 5 ampoules of 2 ml each.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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