Hidroxizinum Bluefish

Leaflet accompanying the packaging: information for the user

Hydroxyzinum Bluefish, 10 mg, coated tablets

Hydroxyzinum Bluefish, 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 your doctor or pharmacist.
• 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 as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Hydroxyzinum Bluefish belongs to a group of medicines called sedating antihistamines. It inhibits certain brain activities without causing addiction. It also blocks histamine, a substance found in body tissues. It is effective in anxiety states and itching.

Hydroxyzinum Bluefish is used to treat:

• anxiety in adults;
• itching in adults, adolescents, and children over 6 years of age.

2. Important information before taking Hydroxyzinum Bluefish

When not to take Hydroxyzinum Bluefish

Warnings and precautions

Before starting treatment with Hydroxyzinum Bluefish, the patient should discuss it with their doctor or pharmacist:

Taking Hydroxyzinum Bluefish may be associated with an increased risk of heart rhythm disturbances, which can be life-threatening. Therefore, the patient should inform their doctor about any heart problems and about taking any other medicines, including those available without a prescription.

If the patient experiences any heart symptoms, such as rapid heartbeat (palpitations), breathing difficulties, or loss of consciousness, while taking Hydroxyzinum Bluefish, they should immediately consult their doctor. The patient should stop taking hydroxyzine.

A possible side effect of Hydroxyzinum Bluefish is dry mouth. Therefore, it is essential to maintain good oral hygiene while taking Hydroxyzinum Bluefish.

If the patient is undergoing allergy tests, they should stop taking Hydroxyzinum Bluefish at least 5 days before the tests. The patient should consult their doctor for advice.

Care should be taken when treating elderly patients. The 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 central nervous system side effects, such as seizures.

Hydroxyzinum Bluefish and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan 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.

The patient should not take Hydroxyzinum Bluefish 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),
• psychoses (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 (methadone).

The patient should also inform their doctor if they are taking:

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

Hydroxyzinum Bluefish with food, drink, and alcohol

The patient should avoid taking Hydroxyzinum Bluefish with alcohol, as this combination may enhance the effect of Hydroxyzinum Bluefish and increase the risk of side effects.

Pregnancy and breastfeeding

Pregnancy

Hydroxyzinum Bluefish should not be taken if the patient is pregnant or thinks they may be pregnant. If the patient plans to have a child, they should consult their doctor.

Hydroxyzine, the active substance of Hydroxyzinum Bluefish, passes into the fetus. There is a risk of an effect on the fetus.

In newborns of mothers who took Hydroxyzinum Bluefish in late pregnancy and/or during delivery, the following symptoms may occur immediately or a few hours after birth: trembling, muscle stiffness, and/or weakness, breathing difficulties, and urinary retention (urinary hesitation).

Breastfeeding

Hydroxyzinum Bluefish should not be taken during breastfeeding.

If treatment with Hydroxyzinum Bluefish is necessary, breastfeeding should be stopped.

The patient should consult their doctor. Hydroxyzine passes into breast milk.

Driving and using machines

Hydroxyzinum Bluefish may impair the ability to drive and use machines.

The medicine may cause drowsiness, decreased attention, and reduced reaction ability. The patient should not drive or operate machines if they experience any of these symptoms.

Hydroxyzinum Bluefish contains lactose

The tablets of Hydroxyzinum Bluefish contain lactose. If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

Coated tablets Hydroxyzinum Bluefish contain 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 Bluefish

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

The dose is determined by the doctor, who adjusts it individually for the patient.

Hydroxyzinum Bluefish should be taken in the smallest effective dose, and the treatment duration should be as short as possible.

The 25 mg tablet can be divided into two equal doses.

The recommended dose is:

Itching

Adults:

The initial dose is 25 mg in the evening, about an hour before bedtime.

If necessary, up to 25 mg can be taken 3 to 4 times a day. The maximum daily dose for adults is 100 mg.

Children over 6 years of age

1-2 mg/kg body weight per day, divided into several doses.

In children with a body weight over 40 kg, the maximum daily dose is 100 mg.

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

Anxiety

Adults:

50 mg per day, divided into 3 doses: half a tablet (12.5 mg), half a tablet (12.5 mg), and 1 tablet (25 mg).

In severe cases, doses up to 100 mg per day can be taken. The maximum daily dose for adults is 100 mg.

In the treatment of anxiety, this medicine should only be used as supplementary treatment. The dose should not be changed without prior consultation with the doctor.

Elderly patients

Due to the prolonged action, it is recommended to start treatment with 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 reduced liver function, the daily dose should be reduced.

Use in children and adolescents

In adolescents and children over 6 years of age, Hydroxyzinum Bluefish is intended only for the treatment of itching.

If the child has difficulty swallowing tablets, other hydroxyzine-containing medicines may be more suitable. The patient should consult their doctor.

Method of administration

The tablets should be swallowed with a sufficient amount of water. The tablets can be taken with or without food.

Overdose of Hydroxyzinum Bluefish

If the patient has taken more than the recommended dose of Hydroxyzinum Bluefish, they should immediately contact their doctor, especially if it concerns a child. In case of overdose, symptomatic treatment can be applied. The patient's ECG should be monitored due to the possibility of heart rhythm disturbances, such as QT interval prolongation or torsades de pointes.

Missed dose of Hydroxyzinum Bluefish

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

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 Bluefish can cause side effects, although not everybody gets them.

The patient should stop taking this medicine and seek medical help immediately if they experience:

• any heart rhythm disturbances, such as rapid heartbeat (palpitations), breathing difficulties, or loss of consciousness (frequency not known, cannot be estimated from the available data)
• swelling of the face, lips, tongue, and/or throat, sometimes causing difficulty 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)
• intensive peeling and separation of the skin (toxic epidermal necrolysis) (frequency not known, cannot be estimated from the available data)

Other possible side effects:

Very common side effects (may affect more than 1 in 10 people):

• drowsiness

Common side effects (may affect up to 1 in 10 people):

• headache
• calmness
• dry mouth
• fatigue

Uncommon side effects (may affect up to 1 in 100 people):

• agitation
• confusion
• dizziness
• insomnia
• tremors
• nausea
• malaise
• fever

Rare side effects (may affect up to 1 in 1,000 people):

• allergic reactions (hypersensitivity)
• disorientation, hallucinations (seeing things that do not exist)
• seizures (epilepsy), movement disorders (dyskinesias)
• accommodation disorders of the eyes (difficulty focusing), 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 blisters, hives, skin inflammation
• urination problems
• cardiac arrest, effect on heart rhythm, irregular heart rhythm

Very rare side effects (may affect less than 1 in 10,000 people):

• anaphylactic shock (severe allergic reaction)
• bronchospasm (bronchial constriction)
• excessive sweating

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

• reduced platelet count (thrombocytopenia)
• aggression
• depression
• repeated, involuntary muscle contractions (tics)
• abnormal, prolonged muscle contractions (dystonia)
• tingling, numbness, or prickling sensation (paresthesia)
• uncontrolled, circular eye movements (oculogyric crisis)
• diarrhea
• hepatitis (inflammation of the liver)
• bedwetting or urination problems (urinary disorders)
• extreme weakness (asthenia)
• tissue swelling due to fluid retention (edema)
• weight gain
• fainting
• blisters on the hands, feet, abdomen, and mucous membranes (pemphigoid)

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of 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

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Hydroxyzinum Bluefish

The medicine should be stored out of sight and reach of children.

Blister:

No special precautions for storage temperature are required.

Bottle:

No special precautions for storage temperature are required.

The bottle should be kept tightly closed to protect it 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 month stated.

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. Contents of the packaging and other information

What Hydroxyzinum Bluefish contains

• The active substance of Hydroxyzinum Bluefish 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, lactose monohydrate, sodium croscarmellose, colloidal anhydrous silica, 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, oval, capsule-shaped, 10.0 mm x 4.0 mm, biconvex, coated tablets with a dividing line on both sides. The tablet can be divided into two equal doses.

10 mg tablets:

Blister, in a cardboard box:

10, 20, 25, 30, 50, 60, 84, 90, 100, and 250 tablets.

Bottle with a child-resistant cap, in a cardboard box:

25, 30, 84, and 100 tablets. Also contains silica gel to control moisture.

Bottle with a cap, in a cardboard box:

250 tablets. Also contains silica gel to control moisture.

Packaging for dispensing by medical personnel.

25 mg tablets:

Blister, in a cardboard box:

10, 20, 25, 28, 30, 50, 60, 90, 100, and 250 tablets.

Bottle with a child-resistant cap, in a cardboard box:

20, 25, 28, 30, 50, 60, and 100 tablets. Also contains silica gel to control moisture.

Bottle with a cap, in a cardboard box:

250 tablets. Also contains silica gel to control moisture.

Packaging for dispensing by medical personnel.

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:

Date of last revision of the leaflet:06/2024