Hydroxyzine pph

Package leaflet: information for the patient

Hydroxyzinum PPH, 10 mg, film-coated tablets
Hydroxyzinum PPH, 25 mg, film-coated tablets
Hydroxyzini hydrochloridum
Read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• 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 adverse reactions not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

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

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

Hydroxyzinum PPH is an antihistamine medicine with sedative and anxiolytic properties.
Hydroxyzinum PPH is indicated for:

• symptomatic treatment of anxiety in adults,
• symptomatic treatment of pruritus (itching),
• premedication prior to surgical procedures.

2. Important information before using Hydroxyzinum PPH

When not to use Hydroxyzinum PPH:

• 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 (a disease characterized by abnormal production of heme – a component of hemoglobin),
• if the patient's ECG (electrocardiogram) shows heart rhythm disturbances called "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 PPH with other medicines"),
• if someone in the patient's family has died suddenly due to heart disease,
• during pregnancy and breastfeeding.

Warnings and precautions
Before starting treatment with Hydroxyzinum PPH, discuss with the doctor:

• 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, urinary retention, reduced gastrointestinal motility, muscle weakness – myasthenia gravis (a disease characterized by skeletal muscle weakness and fatigue after repeated effort; initial symptoms include drooping eyelids, double vision, nasal speech, difficulty chewing and swallowing, difficulty raising upper limbs and walking; rarely, respiratory muscle weakness occurs) or dementia.

The use of Hydroxyzinum PPH together with other medicines that depress the central nervous system or with medicines having anticholinergic properties may require dose adjustment.

Treatment with Hydroxyzinum PPH may be associated with an increased risk of life-threatening heart rhythm disturbances. Therefore, inform the doctor about any heart problems and about all other medicines the patient is currently taking, including those available without a prescription.
If cardiac symptoms such as rapid heartbeat (palpitations), breathing difficulties, or loss of consciousness occur during treatment with Hydroxyzinum PPH, seek medical advice immediately. Treatment with hydroxyzine should also be discontinued.
Treatment should be discontinued at least 5 days before undergoing allergy tests or bronchial provocation tests with methacholine to avoid interference with test results.

Hydroxyzinum PPH and other medicines
Inform the doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take. Hydroxyzinum PPH may affect the action of other medicines, and other medicines may affect the action of Hydroxyzinum PPH. This applies to the following medicines:

• medicines that depress the central nervous system or medicines with anticholinergic effects (medicines used, among others, in gastrointestinal disorders and respiratory diseases),
• alcohol and alcohol dehydrogenase inhibitors,
• betahistine (medicines used in Meniere's disease) and cholinesterase inhibitors (medicines used, among others, in myasthenia gravis, Alzheimer's disease, and glaucoma),
• monoamine oxidase inhibitors (medicines used, among others, in depression),
• adrenaline,
• medicines that may cause heart rhythm disturbances.

Do not take Hydroxyzinum PPH 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),
• psychosis (e.g. haloperidol),
• depression (e.g. citalopram, escitalopram),
• gastrointestinal disorders (e.g. prucalopride),
• allergies,
• malaria (e.g. mefloquine, hydroxychloroquine),
• cancer (e.g. toremifene, vandetanib),
• drug addiction or severe pain (e.g. methadone).

Hydroxyzinum PPH and alcohol
Avoid concomitant use of Hydroxyzinum PPH and alcohol.
Pregnancy, breastfeeding and effects on fertility
Hydroxyzinum PPH must not be used during pregnancy or breastfeeding.
Breastfeeding must be discontinued if treatment with Hydroxyzinum PPH is necessary.
Women of childbearing potential must use an appropriate method of contraception to prevent pregnancy during treatment with hydroxyzine.
In newborns whose mothers used hydroxyzine in late pregnancy and/or during delivery, the following symptoms have been observed immediately or several hours after birth: tremor, muscle stiffness and/or weakness, breathing difficulties, and urinary retention (difficulty or inability to urinate).
Therefore, hydroxyzine is contraindicated during pregnancy.
Animal studies have not shown any negative effects on fertility. Data on effects on human fertility are not available.
Driving and operating machinery
Do not drive, operate machinery, or use tools while taking Hydroxyzinum PPH, as this medicine may impair reaction ability and concentration.
Hydroxyzinum PPH contains lactose monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Hydroxyzinum PPH contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Hydroxyzinum PPH

This medicine should always be used according to the instructions given by your doctor. If in doubt, consult your doctor or pharmacist.
Hydroxyzinum PPH should be used at the lowest effective dose. The duration of treatment should be as short as possible.
For children under 6 years of age and older children who cannot swallow tablets, check the availability of hydroxyzine in syrup form – a formulation suitable for this age group.
In adults and children with body weight above 40 kg, the maximum daily dose is 100 mg. The following are the usual doses of Hydroxyzinum PPH.

Adults
For symptomatic treatment of anxiety:
50 mg per day in 2–3 divided doses.
In severe cases, oral doses up to 100 mg per day may be used.

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

For premedication before surgical procedures:
50 mg given in two doses or 100 mg as a single oral dose.

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

Elderly patients
The use of hydroxyzine in elderly patients is not recommended. If treatment is initiated, it is recommended to start with half the recommended dose.
In elderly patients, the maximum daily dose is 50 mg.

Patients with hepatic impairment
In patients with liver impairment, the daily dose should be reduced by 33%.

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

Use in children (from 12 months) and adolescents
In children with body weight up to 40 kg, the maximum daily dose is 2 mg/kg body weight.
In children with body weight above 40 kg, the maximum daily dose is 100 mg.

For symptomatic treatment of pruritus:

• from 12 months: 1 mg/kg body weight per day up to 2 mg/kg body weight per day in divided doses.

For premedication before surgical procedures:
0.6 mg/kg body weight as a single oral dose.
The total daily dose should not exceed 2 mg/kg body weight per day.

Use of a higher than recommended dose of Hydroxyzinum PPH
If a patient has taken or used more than the recommended dose of Hydroxyzinum PPH, contact emergency services immediately, especially if this concerns a child. In case of overdose, symptomatic treatment may be applied. ECG monitoring is recommended due to the risk of cardiac rhythm disturbances [including bradycardia (very slow heart rate)], such as QT interval prolongation or torsade de pointes.

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

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

Stopping Hydroxyzinum PPH
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 may occur with the following frequency:
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 (low blood pressure).
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, swelling of the larynx and throat, skin itching and redness, headache, sensation of "tightness", dizziness, significant weakness, up to and including loss of consciousness; in severe cases may be life-threatening), bronchospasm, angioedema (skin lesions in the form of irregular patches, blisters and swelling), increased sweating, persistent 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 (a skin rash which may cause blister formation and resemble small target-like 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, occurring mainly around the mouth, eyes, nose, and genital organs).
Frequency not known (frequency cannot be determined from available data):
prolongation of the QT interval in electrocardiogram, cardiac arrhythmias of the torsade de pointes type, hepatitis, loss of consciousness (fainting), vesicular skin changes [e.g.: toxic epidermal necrolysis (extensive rash with blisters and skin peeling, occurring mainly around the mouth, eyes, nose, and genital organs), pemphigoid (an autoimmune skin disease characterized by tense blisters occurring within erythematous-edematous lesions or on apparently normal skin)], weight gain.
The medicine should be discontinued and medical advice should be sought immediately if the patient experiences cardiac arrhythmias such as rapid heartbeat (palpitations), breathing difficulties, or loss of consciousness.
Additionally, the following adverse reactions associated with cetirizine, the main metabolite of hydroxyzine, have been observed and may also occur following hydroxyzine administration: decreased platelet count, aggression, depression, tics, involuntary movements, tingling, episodes of compulsive upward gaze with eye rotation, diarrhea, difficulty in urination, involuntary urination, asthenia (fatigue, weakness), edema, weight gain.
Other adverse reactions may occur in some individuals during treatment with Hydroxyzinum PPH. If any of the adverse effects worsen or if any adverse effects not listed in this leaflet occur, inform your doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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 can 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 PPH

No special storage temperature requirements.
Store in the original packaging to protect from moisture.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following:
"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 in use. This will help protect the environment.

6. Contents of the pack and other information

What Hydroxyzinum PPH contains

• The active substance is hydroxyzine hydrochloride.
• The other components are:
• Core: monohydrate lactose, calcium phosphate, pregelatinized corn starch, sodium lauryl sulfate, magnesium stearate, colloidal anhydrous silica.
• Coating: Opadry white Y-1-7000 (titanium dioxide (E171), hypromellose, polyethylene glycol 400).

What Hydroxyzinum PPH looks like and contents of the pack
Hydroxyzinum PPH, 10 mg, film-coated tablets are white or almost white, round tablets with a diameter of approximately 5.6 mm, biconvex, film-coated and smooth on both sides.
Hydroxyzinum PPH, 25 mg, film-coated tablets are white or almost white, round tablets with a diameter of approximately 8.1 mm, biconvex, film-coated with a division line on one side and smooth on the other side.
The division line on the tablet is intended only to facilitate breaking the tablet for easier swallowing, and does not ensure equal dose division.
Film-coated tablets are available in PVDC/PVC/Aluminum blisters containing 30 tablets, packed in a cardboard box.

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01

Importer
Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz