Hydroxyzine orion

Package leaflet: Information for the user

Hydroxyzine Orion, 10 mg, film-coated tablets
Hydroxyzine Orion, 25 mg, film-coated tablets
Hydroxyzini hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• 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 personally. 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.

Contents of the leaflet

1. What Hydroxyzine Orion is and what it is used for
2. What you need to know before you take 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 Hydroxyzine Orion is and what it is used for

Hydroxyzine Orion belongs to a group of medicines called antihistamines with calming effects.
Hydroxyzine suppresses certain brain activities without causing dependence. Hydroxyzine also blocks histamine, a substance present in body tissues. It is effective in the treatment of anxiety, itching and hives.
Hydroxyzine Orion is used to treat:

• anxiety in adults, when other treatments are inappropriate;
• itching and hives due to allergic reactions.

In the case of anxiety, the effect of the medicine becomes noticeable approximately 30–45 minutes after administration.
In the case of itching and hives, the effect occurs about 1 hour after administration and lasts for approximately 24 hours.

2. Important information before using Hydroxyzine Orion

When not to use Hydroxyzine Orion:

• if the patient is allergic to hydroxyzine hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to cetirizine (a medicine used to treat allergies), theophylline (a medicine used to treat asthma or other lung diseases), ethylenediamine (a component of theophylline), or piperazine derivatives (similar active substances in other medicines);
• if the patient has a hereditary disease (porphyria), characterized by accumulation of toxic substances (porphyrins) in the body;
• if the patient's ECG (electrocardiogram) shows heart rhythm disturbances called QT interval prolongation;
• if the patient has or has had heart disease, or if the heart rate is very slow;
• if the patient has low levels of electrolytes in the blood (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 "Hydroxyzine Orion with other medicines");
• if someone in the patient's family has died suddenly due to heart disease;
• if the patient is pregnant or breastfeeding.

Warnings and precautions
Before starting treatment with Hydroxyzine Orion, discuss this with a doctor or
pharmacist:

• if the patient has kidney or liver disease, a lower dose may be required;
• if the patient has an increased tendency to seizures (convulsions);
• if the patient has risk factors for stroke, such as high blood pressure, smoking, or obesity;
• if the patient has increased eye pressure (glaucoma);
• if the patient has difficulty urinating;
• if the patient has slow intestinal function;
• if the patient has severe muscle weakness (myasthenia gravis);
• if the patient has dementia.

Treatment with Hydroxyzine Orion may be associated with an increased risk of life-threatening heart rhythm disturbances. Therefore, inform the doctor about any heart disorders and about taking any other medicines, including those available without a prescription.
If symptoms related to the heart occur during treatment with Hydroxyzine Orion, such as rapid heartbeat (palpitations), difficulty breathing, or loss of consciousness, seek immediate medical advice. Treatment with hydroxyzine should also be discontinued.
Dry mouth may occur as an undesirable effect of Hydroxyzine Orion. Therefore, maintaining proper oral hygiene is important.
If allergy testing is to be performed, treatment with Hydroxyzine Orion should be discontinued at least 5 days before the tests. Consult a doctor for advice.
Elderly patients
Exercise caution in elderly patients. The duration of treatment should be as short as possible.
Hydroxyzine Orion with other medicines
Inform the doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans 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.
Do not use Hydroxyzine Orion 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);
• psychoses (e.g. haloperidol);
• depression (e.g. citalopram, escitalopram);
• stomach and intestinal disorders (e.g. prucalopride);
• allergies;
• malaria (e.g. mefloquine, hydroxychloroquine);
• cancer (e.g. toremifene, vandetanib);
• drug addiction or severe pain (e.g. methadone).

Also inform the doctor if the patient is taking:

• betahistine, used to treat Meniere's disease (a disorder affecting balance and hearing);
• phenytoin, used to treat seizures (convulsions);
• adrenaline, used to treat severe allergic reactions;
• medicines used to treat anxiety or sleeping pills;
• anticholinergic medicines, used e.g. in irritable bowel syndrome (a gastrointestinal disorder) or asthma;
• cimetidine, used to treat stomach disorders. It may increase the concentration of Hydroxyzine Orion in the 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 disturbances.

Hydroxyzine Orion with food, drink and alcohol
Tablets can be taken with or without food.
Avoid taking Hydroxyzine Orion together with alcohol, as this combination may intensify the effect of Hydroxyzine Orion and increase the risk of adverse effects.
Pregnancy, breastfeeding and fertility
Pregnancy
Do not use Hydroxyzine Orion if the patient is pregnant or suspects she may be pregnant. Consult a doctor if the patient plans to become pregnant.
Hydroxyzine, the active substance in Hydroxyzine Orion, crosses the placenta into the fetal body. There is a risk of effects on the fetus.
Breastfeeding
Do not use Hydroxyzine Orion during breastfeeding.
If treatment with Hydroxyzine Orion is necessary, breastfeeding must be discontinued. Consult a doctor.
Driving and operating machinery
Hydroxyzine Orion may impair the ability to react and concentrate. Exercise caution when driving or operating machinery. The patient should personally assess whether they are able to perform tasks requiring alertness, such as driving or operating machinery.
Hydroxyzine Orion contains lactose
This medicine contains 53.3 mg and 133.2 mg of lactose (as monohydrate) per tablet, in the 10 mg and 25 mg tablets respectively. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Other excipients
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Hydroxyzine Orion

This medicine should always be used exactly as directed by the doctor. If in doubt, consult
your doctor or pharmacist.
Important: Your doctor will determine the appropriate dose for you. Do not change the dose without consulting
your doctor.
Hydroxyzine Orion should be used at the lowest effective dose. The duration of treatment should be
as short as possible.
25 mg tablet: The tablet may be divided into equal doses.
Recommended dose:
Urticaria and itching:
Adults and adolescents aged 12 years and above:

• Initial dose is 1 or 2 tablets of 25 mg in the evening.

Children aged 5 to 11 years:

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

See below for "maximum daily dose in all indications".
If the patient or the patient's child requires a dose lower than 10 mg or has difficulty
swallowing tablets, other hydroxyzine-containing medicines may be more suitable. Please
consult your doctor.
Anxiety in adults:
Adults: The recommended dose is 1 to 5 tablets of 10 mg, 2 to 3 times daily, or 1 to 2 tablets
of 25 mg, 2 to 3 times daily. The maximum daily dose is 10 tablets of 10 mg
or 4 tablets of 25 mg (100 mg per day). See below for "maximum daily dose in
all indications".
Maximum daily dose in all indications:
In adults and children with body weight of 40 kg and above, the maximum daily dose is 100 mg.
In children with body weight below 40 kg, the maximum daily dose is 2 mg/kg body weight/day.
When treating anxiety, this medicine should be used only as an adjunctive therapy. Treatment
should be initiated, supervised, and discontinued by the same physician.
Special patient groups
Elderly patients
Due to prolonged effects, treatment should be initiated at half the recommended dose in elderly patients.
The lowest possible dose should be used in elderly patients. 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 impaired liver function, the daily dose should be reduced.
Method of administration
Tablets should be swallowed with an adequate amount of water. Tablets may be taken
with food or independently of meals. 25 mg tablets may be divided into two equal
doses.
Use of a higher than recommended dose of Hydroxyzine Orion
If a patient has taken too much Hydroxyzine Orion, immediately contact a doctor, especially if this concerns a child.
In case of overdose, symptomatic treatment may be administered. ECG monitoring is recommended due to the risk of cardiac arrhythmias, such as QT interval prolongation or torsade de pointes.
Missed dose of Hydroxyzine Orion
Do not take a double dose to make up for a missed tablet. Whether a missed dose should be taken or the next dose taken at the usual time will depend on the prescribed dose. Consult your doctor.
Stopping Hydroxyzine Orion
If the patient stops taking this medicine, the condition may worsen. Talk to your doctor before stopping treatment with Hydroxyzine Orion.
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.
Treatment should be discontinued and immediate medical attention sought if the patient experiences:

• any disturbances in heart rhythm, such as rapid heartbeat (palpitations), difficulty breathing, loss of consciousness (frequency unknown, cannot be estimated based on available data),
• swelling of the face, lips, tongue, and (or) throat, sometimes causing difficulty in breathing or swallowing (angioedema) (Very rare adverse reactions, which may occur in no more than 1 in 10,000 people),
• generalized blistering rash (acute generalized exanthematous pustulosis), red ring-shaped rash, often with blisters, mainly on palms and soles (erythema multiforme), inflammation of mucous membranes and skin, associated with high fever (Stevens-Johnson syndrome) (Very rare adverse reactions, which may occur in no more than 1 in 10,000 people),
• severe peeling and shedding of the skin (toxic epidermal necrolysis) (frequency unknown, cannot be estimated based on available data).

Other possible adverse reactions:
Very common (may occur in more than 1 in 10 people):

• somnolence.

Common (may occur in no more than 1 in 10 people):

• headache,
• fatigue,
• dryness of the oral mucosa,
• sedation.

Uncommon (may occur in no more than 1 in 100 people):

• restlessness, confusion,
• dizziness, insomnia, tremor,
• nausea,
• malaise, fever.

Rare (may occur in no more than 1 in 1,000 people):

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

Very rare (may occur in no more than 1 in 10,000 people):

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

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

• decreased platelet count (thrombocytopenia),
• hepatitis,
• aggression, depression, repetitive involuntary muscle contractions (tics),
• abnormal, prolonged muscle contractions (dystonia), sensations of tingling, prickling, or numbness,
• irregular heart rhythm and associated changes in electrocardiogram (prolongation of QT interval, torsade de pointes),
• uncontrolled, circular eye movements,
• diarrhoea,
• nocturnal enuresis,
• extreme weakness (asthenia), tissue swelling due to fluid retention (oedema),
• weight gain,
• fainting,
• pemphigoid (blisters on hands, legs, abdomen, and mucous membranes).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. 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 181 C, 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 provide more information on the safety of the medicine.

5. How to store Hydroxyzine Orion

Keep this 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:
"Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Medicines must 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 Hydroxyzine Orion contains

• The active substance is hydroxyzine hydrochloride.
• 10 mg tablets: each coated tablet contains 10 mg of hydroxyzine hydrochloride.
• 25 mg tablets: each coated tablet contains 25 mg of hydroxyzine hydrochloride.
• Other ingredients are:
• Tablet core: lactose monohydrate, calcium hydrogen phosphate, maize starch gelatinised, 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 coated tablets with a diameter of 5.5 mm, smooth on both sides.
25 mg tablets: white or almost white, biconvex, round coated tablets with a diameter of 8 mm, with a score line on one side.
The 25 mg tablet can be divided into equal doses.
Blister packs:
10 mg: 30 tablets
25 mg: 30 tablets

Marketing Authorisation 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]