Hidroxizinum Bluefish

Package Leaflet: Information for the User

Hydroxyzinum Bluefish, 10 mg, coated tablets

Hydroxyzinum Bluefish, 25 mg, 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 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 pack 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 functions without causing addiction. It also blocks histamine, a substance found in body tissues. It is effective in anxiety and itching states.
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

• if you are allergic to hydroxyzine hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic (hypersensitive) to cetirizine, aminophylline, ethylenediamine, or piperazine derivatives (similar active substances of other medicines);
• if you have porphyria (a metabolic disorder);
• if you are pregnant or breastfeeding (see "Pregnancy and breastfeeding" below);
• if your ECG (electrocardiogram) shows heart rhythm disturbances called QT interval prolongation;
• if you have or have had 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 "Hydroxyzinum Bluefish with other medicines");
• if someone in your family has died suddenly due to heart disease.

Warnings and precautions

Before taking Hydroxyzinum Bluefish, discuss with your doctor or pharmacist:

• if you have kidney or liver disease, or if you are elderly. A lower dose may be necessary,
• if you have an increased risk of seizures (seizure disorders),
• if you have risk factors for stroke,
• if you have increased eye pressure (glaucoma),
• if you have difficulty urinating,
• if you have constipation (weakened intestinal peristalsis),
• if you have severe muscle weakness (myasthenia),
• if you have mental disorders (dementia).

Taking Hydroxyzinum Bluefish may be associated with an increased risk of heart rhythm disorders, which can be life-threatening. Therefore, you should tell your doctor about any heart problems and about taking any other medicines, including those available without a prescription.
If you experience heart symptoms such as rapid heartbeat (palpitations), breathing difficulties, loss of consciousness while taking Hydroxyzinum Bluefish, seek medical attention immediately. Hydroxyzine treatment should be discontinued.
A side effect of Hydroxyzinum Bluefish may be dry mouth. Therefore, it is essential to maintain good oral hygiene while taking Hydroxyzinum Bluefish.
If you are undergoing allergy tests, Hydroxyzinum Bluefish treatment should be discontinued at least 5 days before the tests. Consult your doctor for advice.
Caution should be exercised in 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 prone to central nervous system side effects, such as seizures.

Hydroxyzinum Bluefish with other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those available without a prescription. This includes:

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

You should also tell your doctor if you 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 disorders,
• anticholinergic medicines used to treat irritable bowel syndrome (gastrointestinal disorder) or asthma,
• cimetidine used to treat stomach disorders. It may increase the level of Hydroxyzinum Bluefish in your 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 disorders.

Hydroxyzinum Bluefish with food, drink, and alcohol

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
Do not take Hydroxyzinum Bluefish if you are pregnant or think you may be pregnant. If you plan to have a baby, ask your doctor for advice.
Hydroxyzine, the active substance of Hydroxyzinum Bluefish, passes into the fetus. There is a risk of fetal harm.
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:
tremors, muscle stiffness, and/or weakness, breathing difficulties, and urinary retention (urinary hesitation/incontinence).
Breastfeeding
Do not take Hydroxyzinum Bluefish during breastfeeding.
If treatment with Hydroxyzinum Bluefish is necessary, breastfeeding should be discontinued.
Consult your doctor. Hydroxyzine passes into breast milk.

Driving and using machines

Hydroxyzinum Bluefish may impair your ability to drive and use machines.
The medicine may cause drowsiness, decreased attention, and reduced reaction ability. Do not drive or operate machinery if you experience any of these symptoms.

Hydroxyzinum Bluefish contains lactose

The tablets of Hydroxyzinum Bluefish contain lactose. If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

Coated tablets of 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

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The dose is determined by your doctor, who will adjust it individually for you.
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.
Recommended dose:
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 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 anxiety treatment, this medicine should only be used as supplementary treatment. Do not change the dose without consulting your doctor.

Elderly patients

Due to the prolonged effect, 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 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 a sufficient amount of water. Tablets can be taken with or without food.

Overdose of Hydroxyzinum Bluefish

If you have taken more than the prescribed dose of Hydroxyzinum Bluefish, contact your doctor immediately, especially if it concerns a child. In case of overdose, symptomatic treatment can be applied. ECG monitoring is recommended due to the possibility of heart rhythm disorders, such as QT interval prolongation or torsades de pointes.

Missed dose of Hydroxyzinum Bluefish

Do not take a double dose to make up for a forgotten tablet.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Hydroxyzinum Bluefish can cause side effects, although not everybody gets them.

Stop taking this medicine and seek medical attention immediately if you experience:

• any heart rhythm disorders, such as rapid heartbeat (palpitations), breathing difficulties, loss of consciousness (frequency not known, cannot be estimated from 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 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):

• excitement
• 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)
• eye accommodation disorders (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)
• increased sweating

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

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

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Ministry of Health
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, you can help provide more information on the safety of this medicine.

5. How to store Hydroxyzinum Bluefish

Keep this medicine out of the sight and reach of children.
Blister:
No special precautions for storage temperature.
Bottle:
No special precautions for storage temperature.
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 month.
Medicines should 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 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, 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 child-resistant cap, 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 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 child-resistant cap, 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 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 package leaflet:06/2024