Hydroxyzine bluefish

Patient Information Leaflet

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

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• 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 effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

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

Hydroxyzinum Bluefish belongs to a group of medicines called mild sedative antihistamines. It reduces certain brain activities without causing dependence. It also blocks histamine, a substance present in body tissues. It is effective in anxiety states and itching.
Hydroxyzinum Bluefish is used for the treatment of:

• anxiety in adults;
• itching in adults, adolescents and children aged 6 years and above.

2. Information before using Hydroxyzinum Bluefish

When not to use Hydroxyzinum Bluefish

• if the patient is allergic to hydroxyzine hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• if the patient has an allergy (hypersensitivity) to cetirizine, theophylline, ethylenediamine, or piperazine derivatives (similar active substances found in other medicines);
• if the patient has porphyria (a metabolic disorder);
• if the patient is pregnant or breastfeeding (see section "Pregnancy and breastfeeding" below);
• if the patient's ECG (electrocardiogram) shows a heart rhythm disorder known as QT prolongation;
• if the patient has or has had cardiovascular disease, or if the heart rate is very low;
• 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 "Hydroxyzinum Bluefish with other medicines");
• if someone in the patient's family has died suddenly due to heart disease.

Warnings and precautions
Before starting treatment with Hydroxyzinum Bluefish, discuss this with a doctor or
pharmacist:

• if the patient has kidney or liver disease, or is elderly. A lower dose may be necessary,
• if the patient has an increased tendency for seizures (convulsions),
• if the patient has risk factors for stroke,
• if the patient has increased eye pressure (glaucoma),
• if the patient has difficulty urinating,
• if the patient has constipation (reduced intestinal peristalsis),
• if the patient has severe muscle weakness (myasthenia gravis),
• if the patient has psychiatric disorders (dementia).

Treatment with Hydroxyzinum Bluefish may be associated with an increased risk of potentially life-threatening heart rhythm disturbances. Therefore, inform the doctor about any heart-related problems and about any other medicines being taken, including those available without a prescription.
If symptoms related to the heart occur during treatment with Hydroxyzinum Bluefish, such as rapid heartbeat (palpitations), difficulty breathing, or loss of consciousness, contact a doctor immediately. Treatment with hydroxyzine should be discontinued.
Dry mouth may occur as an adverse effect of Hydroxyzinum Bluefish. Therefore, maintaining proper oral hygiene during treatment with Hydroxyzinum Bluefish is important.
If allergy testing is to be performed, treatment with Hydroxyzinum Bluefish should be discontinued at least 5 days before the tests. Consult a doctor for advice.
Exercise caution in elderly patients. Treatment duration should be as short as possible.
Children
Hydroxyzinum Bluefish should not be used in children under 6 years of age, as they may have difficulty swallowing tablets.
This medicine should not be used in children under 12 months of age, as it has not been studied in this age group.
Younger children are more susceptible to adverse effects on the central nervous system, such as seizures.
Hydroxyzinum Bluefish with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This includes medicines available without a prescription. Hydroxyzinum Bluefish may affect the action of other medicines, and other medicines may affect the action of Hydroxyzinum Bluefish.
Do not use Hydroxyzinum Bluefish 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 conditions 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 dependence or severe pain (methadone).

Also inform the doctor if the patient is taking:

• betahistine used to treat Ménière'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, for example, in the treatment of irritable bowel syndrome (a gastrointestinal disorder) or asthma,
• cimetidine used to treat stomach disorders. Cimetidine may increase the blood concentration of Hydroxyzinum Bluefish,
• monoamine oxidase inhibitors used to treat depression and Parkinson's disease,
• thiazide diuretics (used, for example, in the treatment of high blood pressure). These may increase the risk of heart rhythm disturbances.

Hydroxyzinum Bluefish with food, drink and alcohol
Avoid taking Hydroxyzinum Bluefish together with alcohol, as this combination may intensify the effect of Hydroxyzinum Bluefish and increase the risk of adverse effects.
Pregnancy and breastfeeding
Pregnancy
Do not use Hydroxyzinum Bluefish AB if the patient is pregnant or suspects she may be pregnant. If the patient plans to become pregnant, she should consult a doctor.
Hydroxyzine, the active substance in Hydroxyzinum Bluefish, crosses into the fetal circulation. There is a risk of effects on the fetus.
In newborns of mothers who used Hydroxyzinum Bluefish in late pregnancy and/or during delivery, the following symptoms may occur immediately or several hours after birth: tremors, muscle stiffness and/or weakness, breathing difficulties, and urinary retention (inability to pass urine).
Breastfeeding
Do not use Hydroxyzinum Bluefish during breastfeeding.
If treatment with Hydroxyzinum Bluefish is necessary, breastfeeding should be discontinued. Consult a doctor. Hydroxyzine passes into breast milk.
Driving and operating machinery
Hydroxyzinum Bluefish may impair the ability to drive and operate machinery.
The medicine may cause drowsiness, reduced attention, and decreased reaction ability. Do not drive or operate machinery if any of these symptoms occur.
Hydroxyzinum Bluefish contains lactose
Hydroxyzinum Bluefish coated tablets contain lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Hydroxyzinum Bluefish coated tablets contain 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 Bluefish

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
The dose is determined by the doctor, who adjusts it individually for each patient.
Hydroxyzinum Bluefish should be used at the lowest effective dose, and the duration of treatment
should be as short as possible.
The 25 mg tablet may be divided into two equal doses.

Recommended dosage:
Itching
Adults:
Initial dose is 25 mg in the evening, about one hour before bedtime.
If necessary, up to 25 mg may be taken 3 to 4 times daily. In adults,
the maximum daily dose is 100 mg.

Children aged 6 years and above:
1–2 mg/kg body weight/day, divided into several doses.
In children with body weight above 40 kg, the maximum daily dose is 100 mg.
In children with body weight up to 40 kg, the maximum daily dose is 2 mg/kg body weight/day.

Anxiety
Adults:
50 mg/day, divided into 3 doses: half a tablet (12.5 mg), half a tablet (12.5 mg), and one tablet (25 mg).
In more severe cases, doses up to 100 mg/day may be used. The maximum daily dose for
adults is 100 mg.
For the treatment of anxiety, this medicine should only be used as an adjunctive therapy.
Do not change the dose without prior consultation with your doctor.

Elderly patients
Due to prolonged effects, it is recommended to start treatment at half the recommended dose 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.

Use in children and adolescents
In adolescents and children aged 6 years and above, Hydroxyzinum Bluefish is indicated
only for the treatment of itching.
If a child has difficulty swallowing tablets, other hydroxyzine-containing medicines may be more suitable.
Consult your doctor.

Method of administration
Tablets should be swallowed with an adequate amount of water. Tablets may be taken
with food or independently of meals.

Use of a higher than recommended dose of Hydroxyzinum Bluefish
If a patient has taken too high a dose of Hydroxyzinum Bluefish, contact a doctor 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, such as QT interval prolongation or torsade de pointes.

Missed dose of Hydroxyzinum Bluefish
Do not take a double dose to make up for a missed tablet.
If you have any further doubts concerning 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 everybody will get them.
Treatment with this medicine must be discontinued and immediate medical help sought if the
patient experiences:

• any heart rhythm disturbances, such as rapid heartbeat (palpitations), breathing difficulties, loss of consciousness (frequency unknown, cannot be estimated from 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 the hands and feet (erythema multiforme), mucous membrane and skin inflammation combined with high fever (Stevens-Johnson syndrome) (very rare adverse reactions, which may occur in no more than 1 in 10,000 people).
• extensive peeling and shedding of the skin (toxic epidermal necrolysis) (frequency unknown, cannot be estimated from available data).

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

• drowsiness.

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

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

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

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

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

• allergic reactions (hypersensitivity),
• disorientation, hallucinations (seeing things that do not exist),
• convulsions (seizures), movement disorders (dyskinesias),
• eye accommodation disorders (difficulty focusing the eye), blurred vision,
• low blood pressure,
• constipation,
• vomiting,
• changes in liver enzyme activity (can be observed in blood tests),
• itching, skin rash with redness, spots or pimples, urticaria, skin inflammation,
• problems with urination,
• cardiac arrest, effects on heart rhythm, irregular heartbeat.

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

• anaphylactic shock (severe allergic reaction),
• narrowing of the airways (bronchospasm),
• excessive sweating.

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

• decreased number of platelets (thrombocytopenia),
• aggression,
• depression,
• repetitive, involuntary muscle contractions (tics),
• abnormal, prolonged muscle contractions (dystonia),
• sensations of tingling, pricking or numbness (paresthesia),
• uncontrolled, circular eye movements (episodes of forced upward gaze with eye rotation),
• diarrhea,
• liver inflammation,
• nocturnal enuresis or difficulty in passing urine (urinary retention),
• extreme weakness (asthenia),
• tissue swelling due to fluid retention (edema),
• weight gain,
• fainting,
• blisters on the hands, feet, abdomen and mucous membranes (pemphigoid).

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, the patient should inform their doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 Bluefish
Keep the medicine out of sight and reach of children.
Blister:
No special temperature requirements for storage of the medicine.
Bottle:
No special temperature requirements for storage of the medicine.
Keep the bottle tightly closed to protect from moisture.
Do not use this medicine after the expiry date stated on the carton, blister, and bottle after: “EXP”. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Hydroxyzinum Bluefish 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: microcrystalline cellulose, monohydrate lactose, sodium croscarmellose, anhydrous colloidal silicon dioxide, talc, magnesium stearate; coating: hypromellose 5 cPs, macrogol 400, titanium dioxide (E 171).

What Hydroxyzinum Bluefish looks like and contents of the pack
10 mg tablets: White to almost white, 5.0 mm in diameter, round, biconvex, coated tablets.
25 mg tablets: White to almost white, capsule-shaped oval tablets measuring 10.0 mm x 4.0 mm, biconvex, coated tablets with a score line on both sides. The tablet can be divided into two equal doses.

10 mg tablets:
Blister pack in a cardboard box:
10, 20, 25, 30, 50, 60, 84, 90, 100 and 250 tablets.
Bottle with cap and child-resistant closure, in a cardboard box:
25, 30, 84 and 100 tablets. Also contains silica gel desiccant.
Bottle with cap, in a cardboard box:
250 tablets. Also contains silica gel desiccant.
Packaging intended for dosing by healthcare professionals.

25 mg tablets:
Blister pack in a cardboard box:
10, 20, 25, 28, 30, 50, 60, 90, 100 and 250 tablets.
Bottle with cap and child-resistant closure, in a cardboard box:
20, 25, 28, 30, 50, 60 and 100 tablets. Also contains silica gel desiccant.
Bottle with cap, in a cardboard box:
250 tablets. Also contains silica gel desiccant.
Packaging intended for dosing by healthcare professionals.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Bluefish Pharmaceuticals AB
P.O. Box 49013
100 28 Stockholm
Sweden
Tel. +46 8 51 91 16 00

Manufacturer
Bluefish Pharmaceuticals AB
Gävlegatan 22
113 30 Stockholm
Sweden

This medicinal product is authorized in the member states of the European Economic Area under the following names: