HYDROXYZINUM 10 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. HYDROXYZINUM POLFARMEX, 10 mg, coated tablets
3. HYDROXYZINUM POLFARMEX, 25 mg, coated tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet:
4. What is Hydroxyzinum Polfarmex and what is it used for
5. Important information before taking Hydroxyzinum Polfarmex
   1. When not to take Hydroxyzinum Polfarmex:
   2. Warnings and precautions
   3. Hydroxyzinum Polfarmex and other medicines
   4. Hydroxyzinum Polfarmex with alcohol
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Hydroxyzinum Polfarmex contains lactose
   8. Hydroxyzinum Polfarmex, 10 mg contains sodium (from quinoline yellow).
6. How to take Hydroxyzinum Polfarmex
   1. Use in children and adolescents
   2. Children from 12 months
   3. Overdose of Hydroxyzinum Polfarmex
   4. Missed dose of Hydroxyzinum Polfarmex
   5. Stopping treatment with Hydroxyzinum Polfarmex
7. Possible side effects
8. How to store Hydroxyzinum Polfarmex
9. Contents of the pack and other information
   1. What Hydroxyzinum Polfarmex contains
   2. What Hydroxyzinum Polfarmex looks like and contents of the pack
   3. Marketing authorization holder and manufacturer

Package Leaflet: Information for the Patient

HYDROXYZINUM POLFARMEX, 10 mg, coated tablets

HYDROXYZINUM POLFARMEX, 25 mg, coated tablets

Hydroxyzine hydrochloride

Read the package leaflet carefully before taking the medicine, 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 to you by a doctor. 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, 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 medicine 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 medicines used to treat heart rhythm disorders or medicines that may affect heart rhythm (see "Hydroxyzinum Polfarmex and other medicines");
• 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 weakness of respiratory muscles) or dementia;
• if Hydroxyzinum Polfarmex is used concomitantly with other medicines that act on the central nervous system or with anticholinergic properties (in these patients, dose adjustment may be necessary).

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

Hydroxyzinum Polfarmex and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
This includes:

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

Caution should be exercised when concomitantly using medicines that cause bradycardia and hypokalemia.
Do not take Hydroxyzinum Polfarmex if you are 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 diseases (e.g., prucalopride);
• allergies;
• malaria (e.g., mefloquine);
• cancer (e.g., toremifene, vandetanib);
• drug addiction or severe pain (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, ask your doctor or pharmacist for advice before taking this medicine.
Hydroxyzinum Polfarmex should not be used during pregnancy or breastfeeding.
Breastfeeding should be discontinued if it is necessary to use Hydroxyzinum Polfarmex.

Driving and using machines

Do not drive vehicles, operate machines, 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, contact your doctor before taking the medicine.
Hydroxyzinum Polfarmex, 10 mg contains 32.24 mg of lactose in each coated tablet.
Hydroxyzinum Polfarmex, 25 mg contains 79.71 mg of lactose in each coated tablet.

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

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

3. How to take Hydroxyzinum Polfarmex

Always take this medicine 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 duration of treatment 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, oral doses of up to 100 mg per day can be used.
In the symptomatic treatment of itching
Treatment should be started with a dose of 25 mg before bedtime, and therapy should be continued, increasing the dose if necessary, giving 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 used doses should be reduced.
Patients with liver impairment
In patients with liver impairment, it is recommended to reduce the daily dose by 33%.

Overdose of Hydroxyzinum Polfarmex

If you have taken or used too much Hydroxyzinum Polfarmex, contact the emergency services 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.

Missed dose of Hydroxyzinum Polfarmex

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

Stopping treatment with Hydroxyzinum Polfarmex

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking the medicine and seek medical attention immediately if you experience heart rhythm disorders, such as rapid heartbeat (palpitations), difficulty breathing, loss of consciousness.
The frequency of side effects 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 (calmness)
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 (rash 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, e.g., fever), polymorphic erythema (rash on the skin that can cause the formation of blisters and looks like small targets (dark spot surrounded by a lighter area and a dark circle around)), 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 disorders, 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 eye rotation, diarrhea, difficulty urinating, involuntary urination, asthenia (fatigue, weakness), edema, weight gain.
Reporting side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 medicine.

5. How to store Hydroxyzinum Polfarmex

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after "EXP". The expiry date refers to the last day of that month.
Store in a temperature below 30°C.
Store in the original package to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Hydroxyzinum Polfarmex contains

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

What Hydroxyzinum Polfarmex looks like and contents of the pack

Hydroxyzinum Polfarmex, 10 mg, coated tablets are yellow, round, biconvex tablets, without spots and damage.
Hydroxyzinum Polfarmex, 25 mg, coated tablets are white to light cream, oblong, biconvex tablets, with a score line on one side, without spots and damage.
The score line is not intended for tablet breaking.
The pack contains 30 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: [email protected]
Date of last revision of the leaflet:September 2021