Hydroxyzine polfarmex

Patient Information Leaflet: Read this leaflet carefully before using the medicine, as it contains important information for you.

HYDROXYZINUM POLFARMEX, 2 mg/ml, syrup
Hydroxyzini hydrochloridum
Read this leaflet carefully before taking the medicine, because it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, 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 not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

1. What Hydroxyzinum Polfarmex is and what it is used for
2. Important information before taking Hydroxyzinum Polfarmex
3. How to take Hydroxyzinum Polfarmex
4. Possible side effects
5. How to store Hydroxyzinum Polfarmex
6. Contents of the pack and other information

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

Hydroxyzinum Polfarmex is an antihistamine medicine with sedative and anxiolytic properties.
This medicine is indicated:

• for symptomatic treatment of anxiety in adults;
• for symptomatic treatment of pruritus (itching);
• for premedication before surgical procedures.

2. Important information before using Hydroxyzinum Polfarmex

When not to use Hydroxyzinum Polfarmex:

• 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 has porphyria;
• if the patient has a history of QT interval prolongation in electrocardiogram (ECG);
• during pregnancy and breastfeeding;
• if the patient has a hereditary intolerance to certain sugars;
• if the patient's ECG shows heart rhythm disturbances known as QT interval 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 (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 Polfarmex with other medicines");
• if someone in the patient's family has died suddenly due to heart disease.

Warnings and precautions
Before starting treatment with Hydroxyzinum Polfarmex, discuss this with your doctor
or pharmacist:

• if the patient has an increased tendency to seizures (seizures have been reported more frequently in children than in adults);
• if the patient has glaucoma, difficulty in urinary outflow from the bladder, weakened gastrointestinal peristalsis, dementia or myasthenia gravis (a disease characterized by muscle weakness and fatigue of skeletal muscles after repeated effort; initial symptoms include drooping eyelids, double vision, nasal voice, difficulty chewing and swallowing, difficulty raising upper limbs and walking; rarely, respiratory muscle weakness may occur);
• if Hydroxyzinum Polfarmex is used concomitantly with other medicines that depress the central nervous system or with medicines having anticholinergic properties (in these patients, dose adjustment may be necessary);
• if the patient has been identified as being at risk of heart rhythm disturbances, including electrolyte imbalance (low blood potassium, low blood magnesium), or if the patient is taking concomitant medicines that may cause heart rhythm disturbances. In such cases, the doctor will consider alternative treatment options.

Use of Hydroxyzinum Polfarmex may be associated with an increased risk of
life-threatening heart rhythm disturbances. Therefore, inform your doctor
about any heart conditions and about any other medicines you are taking, including
those available without a prescription.
If heart-related symptoms occur during treatment with Hydroxyzinum Polfarmex,
such as rapid heartbeat (palpitations), difficulty breathing, or loss of consciousness,
seek immediate medical attention. You should also stop treatment with hydroxyzine.
Treatment should be discontinued at least 5 days before undergoing allergy tests or methacholine bronchial provocation tests to avoid interference of the drug with test results.
Alcohol must not be consumed during treatment with Hydroxyzinum Polfarmex.

Hydroxyzinum Polfarmex with other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take. This includes medicines available without a prescription. Hydroxyzinum Polfarmex may affect the action of other medicines, and other medicines may affect the action of Hydroxyzinum Polfarmex.
Taking certain medicines or substances together with Hydroxyzinum Polfarmex may cause adverse effects.
This applies to the following substances:

• medicines that depress the central nervous system or medicines with anticholinergic effects;
• alcohol and alcohol dehydrogenase inhibitors;
• betahistine and cholinesterase inhibitors;
• monoamine oxidase inhibitors (medicines used, among others, in depression);
• adrenaline;
• medicines that may cause heart rhythm disturbances – concomitant use with hydroxyzine may increase the risk of ECG changes such as QT interval prolongation or occurrence of torsade de pointes type arrhythmias.

Caution is advised when using Hydroxyzinum Polfarmex concomitantly with medicines causing bradycardia and hypokalemia.
Do not take Hydroxyzinum Polfarmex if the patient is using medicines for treating:

• 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);
• psychosis (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).

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 her doctor or pharmacist before using this medicine.
Hydroxyzinum Polfarmex must not be used during pregnancy or while breastfeeding.
Breastfeeding must be discontinued if treatment with Hydroxyzinum Polfarmex is necessary.

Driving and operating machinery
Do not drive or operate machinery while taking Hydroxyzinum Polfarmex, as this medicine may impair reaction ability and concentration.

Hydroxyzinum Polfarmex contains sodium, sodium benzoate (E 211), sucrose, alcohol (ethanol),
geraniol and citral (components of orange flavour)

Sodium
The medicine contains less than 1 mmol (23 mg) of sodium per 1 ml of syrup, meaning the medicine is considered "sodium-free".

Sodium benzoate (E 211)
The medicine contains 0.3 mg of sodium benzoate (E 211) per 1 ml of syrup. Sodium benzoate (E 211) may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of age); however, this medicinal product is indicated from 12 months of age.
The maximum single dose (contained in 50 ml of syrup) amounts to 15 mg of sodium benzoate.

Sucrose
The medicine contains 770 mg of sucrose per 1 ml of syrup. This should be taken into account in patients with diabetes.
If a patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicine.

Alcohol (ethanol)
The medicine contains 1.386 mg of ethanol (alcohol) per 1 ml of syrup, equivalent to less than 1 ml of beer or 1 ml of wine.
The maximum single dose (contained in 50 ml of syrup) amounts to 69.3 mg of ethanol, equivalent to 2 ml of beer or 1 ml of wine.
The small amount of alcohol in this medicine will not cause noticeable effects.

Geraniol and citral
The orange flavour, a component of the medicine, contains orange oil, which includes geraniol and citral.

3. How to use Hydroxyzinum Polfarmex

This medicine should always be used as directed by the physician. If in doubt, consult a doctor or pharmacist.
Hydroxyzinum Polfarmex 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 body weight/day.

Oral administration
Recommended doses
Adults
For symptomatic treatment of anxiety:
50 mg/day in 2 or 3 divided doses.
In severe cases, doses up to 100 mg/day may be used.

For symptomatic treatment of pruritus (itching):
Begin treatment with 25 mg at bedtime; continue therapy, increasing the dose if necessary to 25 mg, 3 to 4 times daily.

For premedication before surgical procedures:
50 to 100 mg as a single dose. The maximum dose in adults should not exceed 100 mg.

Use in children and adolescents
Children from 12 months of age
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 is 100 mg.

For symptomatic treatment of pruritus:
1 mg/kg body weight/day to 2 mg/kg body weight/day in divided doses.

For premedication before surgical procedures:
0.6 mg/kg body weight orally as a single dose.

The syrup packaging contains a dosing device with graduations to facilitate accurate dosing.

Dosage adjustment
Dosage should be individually adjusted within the recommended dose range, depending on the patient's response to treatment.

Elderly patients
In elderly patients, treatment should be initiated at half the dose recommended for adults. The maximum daily dose in elderly patients is 50 mg.

Patients with moderate or severe renal impairment
In patients with moderate or severe renal impairment, due to reduced elimination of the drug metabolite cetirizine, the administered doses should be reduced.

Patients with hepatic impairment
In patients with hepatic impairment, a 33% reduction of the daily dose is recommended.

Use of a higher than recommended dose of Hydroxyzinum Polfarmex
If a patient has taken or used more than the recommended dose of Hydroxyzinum Polfarmex, contact a physician immediately, especially if this involves a child. In case of overdose, symptomatic treatment may be administered. ECG monitoring is advised due to the potential risk of cardiac rhythm disturbances such as QT interval prolongation or torsade de pointes.

Symptoms of Hydroxyzinum Polfarmex overdose include: nausea, vomiting, tachycardia (accelerated heart rate), fever, drowsiness, disturbances of pupillary reflex, tremor, confusion or hallucinations, followed by decreased level of consciousness, respiratory depression, seizures, hypotension, cardiac arrhythmias, progressing to deepening coma and circulatory-respiratory collapse.
There is no specific antidote.

Missed dose of Hydroxyzinum Polfarmex
Do not take a double dose to make up for a missed dose.

Discontinuation of Hydroxyzinum Polfarmex
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 they do not occur in everyone.
The frequency of occurrence of the adverse reactions listed below is defined as follows:
Very common: may affect more than 1 in 10 people: drowsiness
Common: may affect up to 1 in 10 people: dry mouth, fatigue, headache, sedation (calming effect)
Uncommon: may affect up to 1 in 100 people: nausea, malaise, fever, dizziness, insomnia, tremor, restlessness, confusion
Rare: may affect up to 1 in 1,000 people: tachycardia (increased heart rate), accommodation disorders, blurred vision, constipation, vomiting, hypersensitivity reactions, abnormal liver function test results, convulsions, dyskinesia (involuntary, uncoordinated movements of limbs and other body parts), disorientation, hallucinations, urinary retention, itching, erythematous rash, maculopapular rash, urticaria, dermatitis, hypotension
Very rare: may affect up to 1 in 10,000 people: anaphylactic shock (caused by a severe systemic allergic reaction; symptoms include: shortness of breath, laryngeal and pharyngeal swelling, skin itching and redness, headache, sensation of "pressure", dizziness, profound weakness, up to loss of consciousness; in severe cases, it may be life-threatening), bronchospasm, angioedema (skin lesions appearing as irregular patches, blisters and swellings), increased sweating, persistent drug eruption, acute generalized exanthematous pustulosis (pustular rash on red skin, which may be accompanied by swelling and general symptoms such as fever), erythema multiforme (skin rash which may lead to blister formation and resemble target lesions - a dark center surrounded by a lighter area and a dark ring around it), Stevens-Johnson syndrome (widespread rash with blisters and skin peeling, mainly affecting the area around the mouth, eyes, nose and genital organs)
Frequency not known: cannot be estimated from available data: QT interval prolongation in electrocardiogram, torsade de pointes type cardiac arrhythmias

If the patient experiences any cardiac rhythm disturbances such as rapid heartbeat (palpitations), difficulty breathing, or loss of consciousness, the medicine should be discontinued immediately and medical advice should be sought without delay.

Additionally, the following adverse reactions associated with cetirizine, the main metabolite of hydroxyzine, have been observed and may also occur after administration of hydroxyzine: reduced platelet count, aggression, depression, tics, involuntary movements, tingling, compulsive gaze with eye rolling, diarrhoea, difficulty in urination, involuntary urination, asthenia (weakness, fatigue), oedema, weight gain.

Other adverse reactions may occur in some individuals during treatment with Hydroxyzinum Polfarmex.

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
Faks: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Hydroxyzinum Polfarmex

Store below 25°C.
Keep in the original packaging to protect from light.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle
after: "EXP". The expiry date refers to the last day of the stated month.
Medicines should 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 packaging and other information

What Hydroxyzinum Polfarmex contains

• The active substance is hydroxyzine hydrochloride. 1 ml of syrup contains 2 mg of hydroxyzine hydrochloride.
• Other components are: sodium benzoate (E 211), sucrose, orange flavour (containing, among others, ethanol, geraniol and citral), purified water.

What Hydroxyzinum Polfarmex looks like and contents of the pack
Hydroxyzinum Polfarmex is a colourless to straw-coloured liquid with a characteristic orange taste and odour.
The packaging consists of a brown glass bottle closed with an aluminium cap with a polyethylene seal, placed in a cardboard box, containing 200 ml of syrup and a polypropylene dosing cup with graduations to facilitate dosing.

Marketing Authorisation Holder and Manufacturer
Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland
Tel.: 24 357 44 44
Fax: 24 357 45 45
e-mail: [email protected]