Hidroxizinum Polfarmex

Package Leaflet: Information for the Patient

HYDROXYZINUM POLFARMEX, 10 mg, Film-Coated Tablets

HYDROXYZINUM POLFARMEX, 25 mg, Film-Coated Tablets

Hydroxyzine Hydrochloride

Read the Leaflet Carefully Before Taking the Medication, 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 medicine has been prescribed for you only. 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 those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

Hydroxyzinum Polfarmex is a medication with antihistamine, sedative, and anxiolytic effects.
Hydroxyzinum Polfarmex is indicated for:

• symptomatic treatment of anxiety in adults;
• symptomatic treatment of itching;
• premedication - preparation of the patient for surgical procedures.

2. Important information before taking Hydroxyzinum Polfarmex

When not to take Hydroxyzinum Polfarmex:

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic (hypersensitive) to cetirizine, other piperazine derivatives, aminophylline, or ethylenediamine;
• if you have porphyria;
• if your ECG (electrocardiogram) shows heart rhythm disturbances called QT interval prolongation;
• if you have a cardiovascular disease or if your heart rate is very slow;
• if you have low levels of electrolytes (e.g., low potassium or magnesium levels);
• if you are taking certain medications used to treat heart rhythm disorders or medications that may affect heart rhythm (see "Hydroxyzinum Polfarmex and other medications");
• if someone in your family has died suddenly due to heart disease;
• during pregnancy and breastfeeding.

Warnings and precautions

Before starting treatment with Hydroxyzinum Polfarmex, discuss it with your doctor or pharmacist:

• if you have an increased tendency to seizures (especially in children);
• if you have glaucoma, difficulty urinating, weakened gastrointestinal peristalsis, myasthenia gravis (a disease characterized by muscle weakness and fatigue after repeated exertion, the first symptoms are: drooping eyelids, double vision, nasal voice, difficulty chewing and swallowing; difficulty lifting upper limbs, walking, rarely occurs muscle weakness of the respiratory muscles) or dementia;
• if Hydroxyzinum Polfarmex is used concomitantly with other medications that have a sedative effect on the central nervous system or with medications that have anticholinergic properties (in these patients, dose adjustment may be necessary).

Taking Hydroxyzinum Polfarmex may be associated with an increased risk of heart rhythm disturbances, which can be life-threatening. Therefore, you should tell your doctor about any heart problems and about taking any other medications, including those available without a prescription.
If you experience heart symptoms such as rapid heartbeat (palpitations), difficulty breathing, loss of consciousness during treatment with Hydroxyzinum Polfarmex, you should immediately consult a doctor. You should also stop taking Hydroxyzinum Polfarmex.
Treatment should be discontinued at least 5 days before performing allergy tests or methacholine bronchial provocation tests to avoid affecting the results of these tests.

Hydroxyzinum Polfarmex and other medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as medications you plan to take.
This applies to the following medications:

• medications that have a sedative effect on the central nervous system (such as sedatives, anxiolytics, antidepressants, anticonvulsants, sleep aids) or medications with anticholinergic effects (a group of medications used, among other things, in gastrointestinal disorders and respiratory diseases);
• alcohol and alcohol dehydrogenase inhibitors;
• betahistine (a medication used in Meniere's disease) and cholinesterase inhibitors (a group of medications used, among other things, in the treatment of myasthenia, Alzheimer's disease, and glaucoma);
• monoamine oxidase inhibitors (medications used, among other things, in depression);
• adrenaline (a medication used, among other things, in severe allergic reactions);
• medications that may cause heart rhythm disturbances - their concomitant use with hydroxyzine may increase the risk of changes in the ECG record - QT interval prolongation or the occurrence of heart rhythm disturbances of the torsade de pointes type.

Caution should be exercised when using medications that cause bradycardia and hypokalemia concomitantly.
Do not take Hydroxyzinum Polfarmex if you 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 or severe pain addiction (methadone).

Hydroxyzinum Polfarmex with alcohol

Avoid concomitant use of Hydroxyzinum Polfarmex and alcohol.

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 before taking this medication.
Hydroxyzinum Polfarmex should not be used during pregnancy or breastfeeding.
Breastfeeding should be discontinued if it is necessary to use Hydroxyzinum Polfarmex.

Driving and operating machinery

Do not drive vehicles, operate machinery, or use tools while taking Hydroxyzinum Polfarmex, as it may impair your ability to react and concentrate.

Hydroxyzinum Polfarmex contains lactose

If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking the medication.
Hydroxyzinum Polfarmex, 10 mg contains 32.24 mg of lactose in each film-coated tablet.
Hydroxyzinum Polfarmex, 25 mg contains 79.71 mg of lactose in each film-coated tablet.

Hydroxyzinum Polfarmex, 10 mg contains sodium (from yellow quinoline)

Hydroxyzinum Polfarmex, 10 mg contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means the medication is considered "sodium-free".

3. How to take Hydroxyzinum Polfarmex

Always take this medication exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Hydroxyzinum Polfarmex should be used at the lowest effective dose. The treatment duration should be as short as possible.
In adults and children over 40 kg, the maximum daily dose is 100 mg.
The following are the usual doses of Hydroxyzinum Polfarmex.

Adults
In the symptomatic treatment of anxiety
50 mg per day in 2 or 3 divided doses.
In severe cases, doses up to 100 mg per day can be taken orally.
In the symptomatic treatment of itching
Treatment should be started with a dose of 25 mg before bedtime, continuing therapy by increasing the dose if necessary, administering 25 mg 3 to 4 times a day.
In premedication before surgical procedures
50 mg in two administrations or 100 mg in a single dose orally.

Use in children and adolescents

In children and adolescents up to 40 kg, the maximum daily dose is 2 mg/kg body weight per day.
In children and adolescents over 40 kg, the maximum daily dose is 100 mg.

Children from 12 months

In the symptomatic treatment of itching:
1 mg/kg body weight per day to 2 mg/kg body weight per day in divided doses;
In premedication 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.
Dose adjustment
Dosing should be adjusted individually, within the recommended dose range, depending on the patient's response to treatment.
Elderly patients
In elderly patients, it is recommended to start treatment with half the recommended dose.
In elderly patients, the maximum daily dose is 50 mg.
Patients with moderate or severe renal impairment
In patients with moderate or severe renal impairment, the doses used should be reduced.
Patients with liver impairment
In patients with liver impairment, it is recommended to reduce the daily dose by 33%.

Using a higher dose of Hydroxyzinum Polfarmex than recommended

If you have taken or used too much Hydroxyzinum Polfarmex, immediately contact the emergency services, 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 disturbances, such as QT interval prolongation or torsade de pointes.
Symptoms of Hydroxyzinum Polfarmex overdose are: nausea, vomiting, tachycardia (rapid heart rate), fever, drowsiness, disturbances of pupillary reflex, tremors, confusion or hallucinations, and then decreased consciousness, respiratory depression, seizures, hypotension, or heart rhythm disturbances, as well as deepening coma and cardiopulmonary collapse.
There is no specific antidote.

Missing a dose of Hydroxyzinum Polfarmex

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

Stopping treatment with Hydroxyzinum Polfarmex

If you have any further questions about taking this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Hydroxyzinum Polfarmex can cause side effects, although not everybody gets them.
Stop taking the medication and immediately consult a doctor if you experience heart rhythm disturbances, such as rapid heartbeat (palpitations), difficulty breathing, or loss of consciousness.
The frequency of side effects 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, sedation (calming)
Uncommon(may affect up to 1 in 100 people): nausea, malaise, fever, agitation, confusion
Rare(may affect up to 1 in 1,000 people): tachycardia (rapid heart rate), accommodation disorders, blurred vision, constipation, vomiting, hypersensitivity reactions, abnormal liver function tests, seizures, dyskinesia (involuntary, uncoordinated movements of limbs and other body parts), disorientation, hallucinations, urinary retention, itching, rash, urticaria, skin inflammation, hypotension
Very rare(may affect up to 1 in 10,000 people): anaphylactic shock, which can be life-threatening in severe cases (caused by a severe, systemic allergic reaction, its symptoms are: shortness of breath, swelling of the throat and larynx, itching and redness of the skin, headache, feeling of "pressure", dizziness, significant weakness, up to loss of consciousness); bronchospasm, angioedema (hives on the skin in the form of irregular spots, blisters, and swelling), increased sweating, fixed drug eruption, acute generalized exanthematous pustulosis (pustular rash on reddened skin, which may be accompanied by swelling and general symptoms, such as fever), erythema multiforme (rash on the skin that can cause the formation of blisters and looks like small targets (a dark spot surrounded by a lighter area and a dark circle around it), Stevens-Johnson syndrome (widespread rash with blisters and peeling skin, occurring mainly in the area of the mouth, eyes, nose, and genitals)
Frequency not known(frequency cannot be estimated from the available data): QT interval prolongation in the electrocardiogram, torsade de pointes-type heart rhythm disturbances, liver inflammation
Additionally, the following side effects have been observed with cetirizine, the main metabolite of hydroxyzine, which may also occur after hydroxyzine administration: decreased platelet count, aggressive behavior, depression, tics, involuntary movements, paresthesia, episodes of forced gaze with rotation of the eyeballs, diarrhea, difficulty urinating, involuntary urination, asthenia (fatigue, weakness), edema, weight gain.
Reporting side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: 22 49-21-301
Fax: 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 this medication.

5. How to store Hydroxyzinum Polfarmex

Keep the medication out of sight and reach of children.
Do not use this medication after the expiration date stated on the carton and blister after: "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. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Hydroxyzinum Polfarmex contains

Film-coated tablets, 10 mg:
The active substance is hydroxyzine hydrochloride. Each film-coated tablet contains 10 mg of hydroxyzine hydrochloride.
The other ingredients are: microcrystalline cellulose, lactose, magnesium stearate, colloidal anhydrous silica
Coating composition: lactose monohydrate, hypromellose 6cP, titanium dioxide (E 171), macrogol 6000, quinoline yellow (E 104)
Film-coated tablets, 25 mg:
The active substance is hydroxyzine hydrochloride. Each film-coated tablet contains 25 mg of hydroxyzine hydrochloride.
The other ingredients are: microcrystalline cellulose, lactose, magnesium stearate, colloidal anhydrous silica
Coating composition: lactose monohydrate, hypromellose 6 cP, titanium dioxide (E 171), macrogol 6000

What Hydroxyzinum Polfarmex looks like and contents of the pack

Hydroxyzinum Polfarmex, 10 mg, film-coated tablets are yellow, round, biconvex tablets, without spots and damage.
Hydroxyzinum Polfarmex, 25 mg, film-coated tablets are white to light cream, oblong, biconvex tablets, with a dividing line on one side, without spots and damage.
The dividing line on the tablet is not intended for breaking the tablet.
The pack contains 30 film-coated tablets.

Marketing authorization holder and manufacturer

Polfarmex S.A.
Józefów 9
99-300 Kutno
Poland (Poland)
Phone: 24 357 44 44
Fax: 24 357 45 45
e-mail: polfarmex@polfarmex.pl
Date of last revision of the leaflet:September 2021