Hidroxizine Orion

Package Leaflet: Information for the User

Hydroxyzine Orion, 10 mg, Film-Coated Tablets

Hydroxyzine Orion, 25 mg, Film-Coated Tablets

Hydroxyzine Hydrochloride

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

• Keep this package 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 package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Hydroxyzine Orion and what is it used for

Hydroxyzine Orion belongs to a group of medicines called sedating antihistamines. Hydroxyzine inhibits certain functions of the brain, without causing dependence. Hydroxyzine also blocks histamine, a substance found in body tissues. It is effective in treating anxiety, itching, and hives.

Hydroxyzine Orion is used to treat:

• anxiety in adults, when other treatments are not suitable;
• itching and hives due to allergic reactions.

In the case of anxiety, the effect of the medicine is noticeable after about 30-45 minutes after administration. In the case of itching and hives, the effect of the medicine is achieved after about 1 hour after administration and lasts for about 24 hours.

2. Important information before taking Hydroxyzine Orion

When not to take Hydroxyzine Orion:

• if you are allergic to hydroxyzine hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to cetirizine (a medicine used to treat allergies), aminophylline (a medicine used to treat asthma or other lung diseases), ethylenediamine (a component of aminophylline) or piperazine derivatives (similar active substances of other medicines);
• if you have a hereditary disease (porphyria), characterized by the accumulation of toxic substances (porphyrins) in the body;
• 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 in your blood (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 "Hydroxyzine Orion and other medicines");
• if someone in your family has died suddenly due to a heart disease;
• if you are pregnant or breastfeeding.

Warnings and precautions

Before starting treatment with Hydroxyzine Orion, discuss it with your doctor or pharmacist:

• if you have kidney or liver disease, a lower dose may be necessary;
• if you have an increased risk of seizures (seizure attacks);
• if you have risk factors for stroke, such as high blood pressure, smoking, or obesity;
• if you have increased eye pressure (glaucoma);
• if you have difficulty urinating;
• if you have slow bowel movements;
• if you have severe muscle weakness (myasthenia);
• if you have dementia.

Taking Hydroxyzine Orion may be associated with an increased risk of heart rhythm disorders, which can be life-threatening. Therefore, you should inform your doctor about any heart problems and about taking any other medicines, including those available without a prescription. If you experience any heart symptoms, such as rapid heartbeat (palpitations), difficulty breathing, loss of consciousness, you should immediately consult a doctor. You should also stop taking Hydroxyzine Orion. A side effect of Hydroxyzine Orion may be dry mouth. Therefore, it is essential to maintain good oral hygiene. If you are undergoing allergy tests, you should stop taking Hydroxyzine Orion at least 5 days before the tests. You should consult your doctor for advice.

Elderly patients

Caution should be exercised in elderly patients. The treatment duration should be as short as possible.

Hydroxyzine Orion and other medicines

Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as medicines you plan to take. This includes medicines available without a prescription. Hydroxyzine Orion may affect the action of other medicines, and other medicines may affect the action of Hydroxyzine Orion. You should not take Hydroxyzine Orion 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);
• stomach and intestine diseases (e.g. prucalopride);
• allergies;
• malaria (e.g. mefloquine, hydroxychloroquine);
• cancer (e.g. toremifene, vandetanib);
• drug addiction or severe pain (e.g. methadone).

You should also inform your doctor if you are taking:

• betahistine, used to treat Meniere's disease (a disorder of balance and hearing);
• phenytoin, used to treat seizure attacks (epilepsy);
• adrenaline, used to treat severe allergic reactions;
• medicines used to treat anxiety or sleeping pills;
• anticholinergic medicines, used e.g. to treat irritable bowel syndrome (a gastrointestinal disease) or asthma;
• cimetidine, used to treat stomach disorders. It may increase the level of Hydroxyzine Orion in your blood;
• monoamine oxidase inhibitors, used to treat depression and Parkinson's disease;
• thiazide diuretics (used e.g. to treat high blood pressure). They may increase the risk of heart rhythm disorders.

Hydroxyzine Orion with food, drink, and alcohol

The tablets can be taken with or without food. You should avoid taking Hydroxyzine Orion at the same time as alcohol, as this combination may enhance the effect of Hydroxyzine Orion and increase the risk of side effects.

Pregnancy, breastfeeding, and fertility

Pregnancy

You should not take Hydroxyzine Orion if you are pregnant or think you may be pregnant. You should consult your doctor if you plan to have a baby. Hydroxyzine, the active substance of Hydroxyzine Orion, passes into the fetus. There is a risk of fetal harm.

Breastfeeding

You should not take Hydroxyzine Orion during breastfeeding. If treatment with Hydroxyzine Orion is necessary, breastfeeding should be stopped. You should consult your doctor.

Driving and using machines

Hydroxyzine Orion may impair your ability to react and concentrate. You should be cautious when driving or operating machinery. You should assess your ability to perform tasks that require attention, such as driving and operating machinery.

Hydroxyzine Orion contains lactose

This medicine contains 53.3 mg and 133.2 mg of lactose (in the form of monohydrate) per tablet, respectively, in the 10 mg and 25 mg tablets. If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

Other excipients

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

3. How to take Hydroxyzine Orion

This medicine should always be taken exactly as directed by your doctor. If you are unsure, consult your doctor or pharmacist.

Important:your doctor will determine the correct dose for you. Do not change the dose without consulting your doctor. Hydroxyzine Orion should be taken in the smallest effective dose. The treatment duration should be as short as possible. The 25 mg tablet can be divided into equal doses.

Recommended dose:

Itching and hives:

• Adults and adolescents over 12 years:the initial dose is 1 or 2 tablets of 25 mg in the evening.

Children from 5 to 11 years:

• 1 tablet of 10 mg or 1 tablet of 25 mg in the evening. Your doctor will inform you about the correct dose.

See below "maximum daily dose in all indications". If you or your child need a dose lower than 10 mg or have difficulty swallowing tablets, other hydroxyzine-containing medicines may be more suitable. You should discuss this with your doctor.

Anxiety in adults:

Adults: the recommended dose is 1 to 5 tablets of 10 mg 2 to 3 times a day or 1 to 2 tablets of 25 mg 2 to 3 times a day. The maximum daily dose is 10 tablets of 10 mg or 4 tablets of 25 mg (100 mg per day). See below "maximum daily dose in all indications".

Maximum daily dose in all indications:

In adults and children over 40 kg, the maximum daily dose is 100 mg. In children under 40 kg, the maximum daily dose is 2 mg/kg/day.

In the case of anxiety, this medicine should only be used as supplementary treatment. The treatment should be started, conducted, and ended by the same doctor.

Special patient groups

Elderly patients

Due to the prolonged effect, it is recommended to start treatment with half of the recommended dose in elderly patients. In the treatment of elderly patients, the smallest possible dose should be used. In elderly patients, the maximum daily dose is 50 mg.

Patients with renal impairment

In patients with moderate or severe renal impairment, the dose should be reduced.

Patients with hepatic impairment

In patients with reduced liver function, the daily dose should be reduced.

Method of administration

The tablets should be swallowed with a sufficient amount of water. The tablets can be taken with or without food. The 25 mg tablets can be divided into two equal doses.

Taking a higher dose of Hydroxyzine Orion than recommended

If you have taken more than the recommended dose of Hydroxyzine Orion, you should immediatelycontact your doctor, especially if it concerns a child. In case of overdose, symptomatic treatment can be applied. You should monitor the ECG, due to the possibility of heart rhythm disorders, such as QT interval prolongation or torsade de pointes.

Missing a dose of Hydroxyzine Orion

You should not take a double dose to make up for a missed tablet. Whether you should take the missed dose or take the next dose at the usual time will depend on the prescribed dose. You should consult your doctor.

Stopping treatment with Hydroxyzine Orion

If you stop taking Hydroxyzine Orion, your disease may worsen. You should discuss this with your doctor before stopping treatment with Hydroxyzine Orion. If you have any further questions about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Hydroxyzine Orion can cause side effects, although not everybody gets them. You should stop taking the medicine and seek medical help immediately if you experience:

• any heart rhythm disorders, such as rapid heartbeat (palpitations), difficulty breathing, loss of consciousness (frequency not known, cannot be estimated from the available data),
• swelling of the face, lips, tongue, and/or throat, which may cause difficulty in breathing or swallowing (angioedema) (very rare side effects, which may occur in less than 1 in 10,000 people),
• generalized rash with blisters (acute generalized exanthematous pustulosis), red rash in a ring shape, often with blisters, mainly on the hands and feet (erythema multiforme), inflammation of the mucous membranes and skin, combined with high fever (Stevens-Johnson syndrome) (very rare side effects, which may occur in less than 1 in 10,000 people),
• severe skin peeling and detachment (toxic epidermal necrolysis) (frequency not known, cannot be estimated from the available data).

Other possible side effects:

Very common (may occur in more than 1 in 10 people):

• drowsiness.

Common (may occur in less than 1 in 10 people):

• headache,
• fatigue,
• dry mouth,
• sedation.

Uncommon (may occur in less than 1 in 100 people):

• agitation, confusion,
• dizziness, insomnia, tremors,
• nausea (feeling sick),
• malaise, fever.

Rare (may occur in less than 1 in 1,000 people):

• allergic reactions (hypersensitivity),
• disorientation, hallucinations (seeing/hearing things that do not exist),
• seizure attacks (convulsions), movement disorders,
• accommodation disorders (difficulty focusing the eyes), blurred vision,
• cardiac arrest, effect on heart rhythm, irregular heart rhythm,
• low blood pressure,
• constipation, vomiting,
• changes in liver enzyme values (visible in blood tests),
• itching, rash with redness, spots or blisters on the skin, skin inflammation,
• difficulty urinating.

Very rare (may occur in less than 1 in 10,000 people):

• anaphylaxis (a potentially life-threatening allergic reaction),
• bronchospasm (constriction of the airways).

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

• reduced platelet count (thrombocytopenia),
• hepatitis,
• aggression, depression, repeated, involuntary muscle contractions (tics),
• abnormal, prolonged muscle contractions (dystonia), feeling of tingling, numbness or prickling,
• irregular heart rhythm and related changes in the electrocardiogram (QT interval prolongation, torsade de pointes),
• uncontrolled, circular eye movements,
• diarrhea,
• nocturnal enuresis,
• extreme weakness (asthenia), swelling of tissues due to fluid retention (edema),
• weight gain,
• fainting,
• pemphigoid (blisters on hands, feet, abdomen, and mucous membranes).

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, you should inform your doctor or pharmacist. You can report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: + 48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl. You can also report side effects 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 Hydroxyzine Orion

Keep the medicine out of the 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. You should 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 Hydroxyzine Orion contains

• The active substance is hydroxyzine hydrochloride.
• 10 mg tablets:each film-coated tablet contains 10 mg of hydroxyzine hydrochloride.
• 25 mg tablets:each film-coated tablet contains 25 mg of hydroxyzine hydrochloride.
• Other ingredients are:
• Core:lactose monohydrate, calcium phosphate, maize starch, sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate.
• Coating:titanium dioxide (E 171), hypromellose, macrogol.

What Hydroxyzine Orion looks like and contents of the pack

10 mg tablets: white or almost white, round, biconvex film-coated tablets with a diameter of 5.5 mm, smooth on both sides.

25 mg tablets: white or almost white, biconvex, round film-coated tablets with a diameter of 8 mm, with a dividing line on one side. The 25 mg tablet can be divided into two equal doses.

Blisters:

10 mg: 30 tablets

25 mg: 30 tablets

Marketing authorization holder

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Manufacturer

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Orion Corporation Orion Pharma

Joensuunkatu 7

FI-24100 Salo

Finland

To obtain more detailed information on this medicine, you should contact the local representative of the marketing authorization holder:

Orion Pharma Poland Sp. z o.o.

kontakt@orionpharma.info.pl

Date of last revision of the package leaflet:01/10/2022