Hidroxizinum Pph

Leaflet attached to the packaging: patient information

Hydroxyzinum PPH, 10 mg, coated tablets

Hydroxyzinum PPH, 25 mg, coated tablets

Hydroxyzine hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Hydroxyzinum PPH and what is it 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. Package contents and other information

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

Hydroxyzinum PPH is a medicine with antihistamine, sedative, and anxiolytic effects.
Hydroxyzinum PPH is indicated for:

• symptomatic treatment of anxiety in adults,
• symptomatic treatment of itching,
• premedication before surgical procedures.

2. Important information before taking Hydroxyzinum PPH

When not to take Hydroxyzinum PPH:

• if the patient is allergic to the active substance or 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 involving abnormal heme production - 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 the heart rate is very low,
• if the patient has low electrolyte levels (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 and 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, the patient should discuss it with their 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, difficulty urinating, weakened gastrointestinal peristalsis, myasthenia gravis (a disease characterized by muscle weakness and fatigue after repeated exertion, its first symptoms are: drooping eyelid, double vision, nasal voice, difficulty chewing and swallowing, difficulty lifting upper limbs, walking, and rarely, respiratory muscle weakness) or dementia,
• if Hydroxyzinum PPH is used concomitantly with other medicines that have a sedative effect on the central nervous system or anticholinergic properties (in these patients, dose adjustment may be necessary).

Taking Hydroxyzinum PPH may be associated with an increased risk of heart rhythm disturbances, which can be life-threatening. Therefore, the patient should tell their doctor about any heart problems and the use of any other medicines, including those available without a prescription.
If the patient experiences heart symptoms such as rapid heartbeat (palpitations), breathing problems, loss of consciousness, they should immediately consult
their doctor. The treatment should also be discontinued. The 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 PPH and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Hydroxyzinum PPH may affect the action of other medicines. Other medicines may affect the action of Hydroxyzinum PPH. This applies to the following medicines:

• medicines with a sedative effect on the central nervous system or anticholinergic properties (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.

The patient should not take Hydroxyzinum PPH if they are taking medicines used to treat:

• bacterial infections (e.g., antibiotics such as erythromycin, moxifloxacin, levofloxacin),
• fungal infections (e.g., pentamidine),
• heart disease or high blood pressure (e.g., amiodarone, quinidine, disopyramide, sotalol),
• psychosis (e.g., haloperidol),
• depression (e.g., citalopram, escitalopram),
• gastrointestinal diseases (e.g., prucalopride),
• allergies,
• malaria (e.g., mefloquine, hydroxychloroquine),
• cancer (e.g., toremifene, vandetanib),
• drug addiction or severe pain (e.g., methadone).

Hydroxyzinum PPH with alcohol

The patient should avoid taking Hydroxyzinum PPH and alcohol concomitantly.

Pregnancy, breastfeeding, and fertility

Hydroxyzinum PPH should not be taken during pregnancy or breastfeeding.
Breastfeeding should be discontinued if it is necessary to use Hydroxyzinum PPH.
Women of childbearing age must use an appropriate method of contraception to prevent pregnancy during treatment with hydroxyzine.
In newborns whose mothers took hydroxyzine during late pregnancy and/or during delivery, the following symptoms have been observed immediately or a few hours after birth: tremors, stiffness, and/or muscle weakness, breathing problems, and urinary retention
(urinary retention).
Therefore, hydroxyzine is contraindicated during pregnancy.
Animal studies have not shown a negative effect on fertility. Data on the effect on human fertility are not available.

Driving and operating machines

While taking Hydroxyzinum PPH, the patient should not drive vehicles, operate machines, or use tools, as the medicine may impair the ability to react and concentrate.

Hydroxyzinum PPH contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Hydroxyzinum PPH contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Hydroxyzinum PPH

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.

Hydroxyzinum PPH should be taken in the smallest effective dose. The treatment duration

should be as short as possible.
For children under 6 years of age and older children who cannot swallow tablets, the availability of hydroxyzine in the form of a syrup should be checked – a form suitable for this age group.
In adults and children with a body weight over 40 kg, the maximum daily dose is 100 mg. The following doses of Hydroxyzinum PPH are usually used.

Adults

In the symptomatic treatment of anxiety
50 mg per day in 2-3 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, and therapy should be continued, 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.
Dose adjustment
The dose should be adjusted individually, within the recommended dose range, depending on the patient's response to treatment.

Elderly patients

Taking hydroxyzine in elderly patients is not recommended. If a decision is made to treat, it is recommended to start treatment with half the recommended dose.
In elderly patients, the maximum daily dose is 50 mg.

Patients with liver failure

In patients with liver failure, it is recommended to reduce the daily dose by 33%.

Patients with renal failure

In patients with moderate or severe renal failure, due to reduced excretion of the medicine's metabolite, cetirizine, the used doses should be reduced.

Use in children (from 12 months) and adolescents

In children with a body weight up to 40 kg, the maximum daily dose is 2 mg/kg body weight per day.
In children with a body weight over 40 kg, the maximum daily dose is 100 mg.
In the symptomatic treatment of itching

• from 12 months: 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 cumulative daily dose should not exceed 2 mg/kg body weight per day.

Taking a higher dose of Hydroxyzinum PPH than recommended

If the patient has taken or used a higher dose of Hydroxyzinum PPH than recommended, they should immediately contact the emergency services, especially if it concerns a child. In case of overdose, symptomatic treatment can be used. The patient's ECG should be monitored due to the possibility of heart rhythm disturbances [including bradycardia (very slow heart rate)], such as QT interval prolongation or torsade de pointes.
Symptoms of Hydroxyzinum PPH overdose are: nausea, vomiting, tachycardia (rapid heart rate), fever, drowsiness, pupillary reflex disorders, tremors, confusion or hallucinations, and then decreased consciousness, respiratory depression, seizures, hypotension, or heart rhythm disturbances, and deepening coma and cardiopulmonary collapse.
There is no specific antidote.

Missing a dose of Hydroxyzinum PPH

The patient should not take a double dose to make up for a missed dose.

Discontinuing Hydroxyzinum PPH

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Hydroxyzinum PPH can cause side effects, although not everybody gets them.
Side effects 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 (calmness).
Uncommon (may affect up to 1 in 100 people):nausea, malaise, fever, dizziness, insomnia, tremors, 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 test results, 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 (caused by a severe, systemic allergic reaction, its symptoms are: shortness of breath, swelling of the throat and larynx, skin itching and redness, headache, feeling of "pressure", dizziness, significant weakness, up to loss of consciousness; in severe cases, it can be life-threatening), bronchospasm, angioedema (skin rashes 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), erythema multiforme (skin rash that can cause blistering and looks like small targets – a 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 mouth, eyes, nose, and genital areas).

Frequency not known (frequency cannot be estimated from the available data):

QT interval prolongation in the electrocardiogram, heart rhythm disturbances of the torsade de pointestype, liver inflammation, loss of consciousness (fainting), blistering changes [e.g., toxic epidermal necrolysis (widespread rash with blisters and peeling skin, occurring mainly in the mouth, eyes, nose, and genital areas), pemphigoid (an autoimmune skin disease characterized by well-tensioned blisters, located in the area of reddened and swollen skin and apparently unchanged skin)], weight gain.
If the patient experiences heart rhythm disturbances, such as rapid heartbeat (palpitations), breathing problems, or loss of consciousness, they should discontinue the medicine and immediately consult their doctor.
Additionally, the following side effects have been observed with cetirizine, the main metabolite of hydroxyzine, which may also occur after taking hydroxyzine: decreased platelet count, aggression, depression, tics, involuntary movements, paresthesia, episodes of forced gaze with eye rotation, diarrhea, difficulty urinating, involuntary urination, asthenia (fatigue, weakness), edema, weight gain.
In some patients, other side effects may occur during treatment with Hydroxyzinum PPH. If any of the side effects worsen or if any side effects not listed in the leaflet occur, the patient should tell their doctor or pharmacist.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, 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, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Hydroxyzinum PPH

There are no special recommendations for the storage temperature of the medicine.
Store in the original packaging to protect from moisture.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after: "EXP". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Hydroxyzinum PPH contains

• The active substance is hydroxyzine hydrochloride.
• Other ingredients are:
• Core: lactose monohydrate, calcium phosphate, cornstarch, sodium lauryl sulfate, magnesium stearate, colloidal silicon dioxide.
• Coating: Opadry white Y-1-7000 (titanium dioxide (E171), hypromellose, macrogol 400).

What Hydroxyzinum PPH looks like and what the package contains

Hydroxyzinum PPH, 10 mg, coated tablets are white or almost white, round, approximately 5.6 mm in diameter, convex on both sides, coated tablets, and smooth on both sides.
Hydroxyzinum PPH, 25 mg, coated tablets are white or almost white, round, approximately 8.1 mm in diameter, convex on both sides, coated tablets with a dividing line on one side and smooth on the other side.
The dividing line on the tablet is only to facilitate breaking it, to make it easier to swallow, and not to divide it into equal doses.
The coated tablets are available in PVDC/PVC/Aluminum blisters containing 30 tablets, placed in a cardboard box.

Marketing authorization holder

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01

Importer

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

Date of the last update of the leaflet: