Package Insert: Information for the User

Hidroxizina Bluefish 25 mg Film-Coated Tablets

hydroxyzine hydrochloride

Read this package insert carefully before starting to take this medication, as it contains important information for you

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• Ifyou experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert.See section 4.

6. Contents of the pack and additional information.

Hydroxyzine Bluefish reduces certain activities in the brain without being addictive and blocks histamine, a substance found in the body tissues. It is effective against anxiety and itching.

Hydroxyzine Bluefish is used to treat:

• Adult anxiety.
• Itching (pruritus) in adolescents and children 6 years of age and older.

For anxiety, the effect is noticed after 30-45 minutes.

In the case of itching, the effect is achieved after approximately 1 hour.

Do not take Hidroxizina Bluefish

• if you are allergic to hidroxizina hydrochloride or any of the other ingredients of this medication (listed in section 6)
• if you are allergic (hypersensitive) to cetirizine, aminophylline, ethylenediamine or piperazine derivatives (active principles of other closely related medications)
• if you have porphyria (a metabolic disease)
• if you are pregnant or breastfeeding (see the section “Pregnancy, lactation and fertility” below)
• if your ECG (electrocardiogram) shows a heart rhythm problem called “prolongation of the QT interval”
• if you have or have had a cardiovascular disease or if your heart rate is very low.
• if you have low levels of salts in your body (e.g. low potassium or magnesium levels)
• if you are taking certain medications for heart rhythm problems or medications that may affect heart rhythm (see “Other medications and Hidroxizina Bluefish”)
• if a close relative has died suddenly from heart problems.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take this Hidroxizina Bluefish:

• if you have renal or hepatic insufficiency or if you are an elderly person. You may need a lower dose
• if you have a high risk of having seizures (convulsions)
• if you have any risk factor for suffering a stroke
• if you have increased pressure in the eye (glaucoma)
• if you have problems urinating
• if you have constipation (slow intestinal function)
• if you have severe muscle weakness (myasthenia gravis)
• if you have mental disorders (dementia)

Hidroxizina Bluefish may be associated with a higher risk of heart rhythm problems, which can be life-threatening. Therefore, inform your doctor if you have any heart problems or are taking other medications, even those obtained without a prescription.

Seek immediate medical attention if, while taking Hidroxizina Bluefish, you experience heart problems such as palpitations, difficulty breathing, loss of consciousness. Treatment with hidroxizine should be discontinued.

Dry mouth may be an adverse effect of using Hidroxizina Bluefish. Therefore, it is essential to maintain good oral hygiene during treatment with Hidroxizina Bluefish.

If you undergo allergy tests, discontinue treatment with Hidroxizina Bluefish at least 5 days before the test. Ask your doctor.

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

Children

Hidroxizina Bluefish is not recommended for children under 6 years old, as they may have difficulty swallowing the tablets.

This medication should not be used in children under 12 months, as it has not been studied in this age group.

Younger children are more susceptible to adverse effects related to the central nervous system, such as seizures.

Other medications and Hidroxizina Bluefish

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication. This includes any medication obtained without a prescription. Hidroxizina Bluefish may affect or be affected by other medications.

Do not take Hidroxizina Bluefish if you are taking medications to treat:

• bacterial infections (e.g. antibiotics such as erythromycin, moxifloxacin, levofloxacin)
• fungal infections (e.g. pentamidine)
• heart problems or high blood pressure (e.g. amiodarone, quinidine, disopyramide, sotalol)
• psychosis (e.g. haloperidol)
• depression (e.g. citalopram, escitalopram)
• gastrointestinal disorders (e.g. prucalopride)
• allergy
• malaria (e.g. mefloquine)
• cancer (e.g. toremifene, vandetanib)
• drug abuse or intense pain (methadone)

Also inform your doctor if you are taking:

• betahistine used to treat Meniere's disease (balance and hearing problems)
• phenytoin used to treat seizures (convulsions)
• adrenaline used to treat severe allergic reactions
• medications used to treat anxiety or help you sleep
• anticholinergic medications for the treatment of, for example, irritable bowel syndrome (gastrointestinal disorders) and asthma
• cimetidine used to treat stomach problems. This may increase the level of Hidroxizina Bluefish in the blood
• monoamine oxidase inhibitors used to treat depression and Parkinson's disease
• thiazide diuretics (used to treat, for example, high blood pressure). They may increase the risk of irregular heart rhythm.

Taking Hidroxizina Bluefish with food, drinks and alcohol

It is recommended to avoid taking alcohol while taking Hidroxizina Bluefish, as the combination may increase the effects of Hidroxizina Bluefish and thereby the risk of adverse effects.

Pregnancy, lactation and fertility

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Hidroxizina Bluefish should not be used during pregnancy.

The active substance of Hidroxizina Bluefish, hidroxizine, passes to the fetus. There is a risk that the fetus may be affected.

The following symptoms may occur in newborn babies of mothers who have used Hidroxizina Bluefish during the last stage of pregnancy and/or delivery; they were observed immediately or only a few hours after birth: tremors, stiffness and/or muscle weakness, respiratory problems and urinary retention (retention/urinary retention).

Hidroxizina Bluefish should not be used during breastfeeding.

If treatment with Hidroxizina Bluefish is necessary during breastfeeding, breastfeeding should be discontinued, as hidroxizine passes to the breast milk

Driving and operating machinery

Hidroxizina Bluefish may affect your ability to drive or operate machinery, as it may cause drowsiness, decrease your attention or decrease your reaction time. The appearance of these effects is more likely at the beginning of treatment or when the dose is increased. Do not drive or operate machinery if you experience any of these effects.

Hidroxizina Bluefish contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Hidroxizina Bluefish coated tablets contain sodium

This medication contains less than 1 mmol of sodium (23 mg) per 25 mg tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.

The dose is decided by your doctor, who adjusts it individually for you.

The smallest effective dose of Hidroxizina Bluefish should be administered and for the shortest possible time.

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

The recommended dose is:

For itching:

Adults:

The initial dose is 25 mg at night, approximately 1 hour before bedtime. It can be taken up to a total of 25 mg 3-4 times a day if necessary. In adults, the maximum daily dose is 100 mg per day.

Children 6 years and older:

1-2 mg/kg/day divided into several doses.

In children over 40 kg, the maximum daily dose is 100 mg per day.

In children up to 40 kg, the maximum daily dose is 2 mg/kg/day.

For anxiety:

Adults:

50 mg per day, divided into 3 doses: half tablet (12.5 mg), half tablet (12.5 mg), and 1 tablet (25 mg).In more severe cases, doses of up to 100 mg/day may be used. The maximum daily dose for adults is 100 mg per day.

In the treatment of anxiety, pharmacological treatment should only be used to support other forms of treatment. Do not change the dose without consulting your doctor first.

Geriatric patients

In elderly patients, it is recommended to start with half the recommended dose due to prolonged action. The maximum daily dose is 50 mg per day.

Patients with renal problems

The dose should be reduced in patients with moderate or severe renal problems.

Patients with liver problems

In patients with reduced liver activity, it is recommended to reduce the daily dose.

Use in children and adolescents

Hidroxizina Bluefish is only for the treatment of itching in adolescents and children 6 years and older.

If your child has difficulty swallowing the tablets, other medications containing hydroxyzine may be more appropriate. Consult your doctor.

Administration form

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

If you take more Hidroxizina Bluefish than you should

If you have taken too much Hidroxizina Bluefish, consultimmediatelyyour doctor or call the Toxicological Information Service, phone 915 620 420, especially if a child has taken too much. In case of overdose, symptomatic treatment may be initiated. Electrocardiogram (ECG) monitoring may be performed due to the possibility of cardiac rhythm problems, such as QT interval prolongation or Torsade de Pointes.

If you forgot to take Hidroxizina Bluefish

Do not take a double dose to compensate for the missed doses.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Stop taking this medicine and seek immediate medical attention if you experience

• any problem with your heart rhythm, such as palpitations, difficulty breathing, or loss of consciousness (unknown frequency, cannot be estimated from available data)
• swelling of the face, lips, tongue, and/or throat, sometimes with difficulty breathing or swallowing (angioedema) (very rare side effects that may affect up to 1 in 10,000 people)
• generalized eruptions with blisters (acute generalized pustular psoriasis), ring-shaped eruptions, red and often with blisters - common on the hands and feet (erythema multiforme), inflammation of the mucosa and skin in combination with high fever (Stevens-Johnson syndrome) (very rare side effects that may affect up to 1 in 10,000 people)
• severe peeling and rejection of the skin (toxic epidermal necrolysis) (unknown frequency, cannot be estimated from available data).

Other side effects that may occur:

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

• drowsiness.

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

• headache,
• lethargy,
• dry mouth,
• fatigue.

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

• agitation,
• confusion,
• dizziness,
• insomnia,
• tremors,
• nausea,
• fever.

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

• allergic reactions (hypersensitivity),
• disorientation, hallucinations,
• seizures, movement disorders (dyskinesia),
• eye focusing disorders (difficulty focusing), blurred vision,
• low blood pressure,
• constipation,
• vomiting,
• changes in liver enzyme values (transaminases, alkaline phosphatase, bilirubin, and glutamyl transferase),
• itching, skin eruptions with redness, spots, or imperfections, skin inflammation,
• urinary retention,
• cardiac arrest, effects on heart rhythm, irregular heart rhythm.

Very rare side effects(may affect up to 1 in 10,000 people):

• anaphylactic shock (severe allergic reaction),
• bronchospasm (constriction of the airway),
• increased sweating,

Unknown frequency(cannot be estimated from available data):

• reduction in the number of platelets (thrombocytopenia),
• aggression,
• depression,
• recurring involuntary muscle contractions (tics),
• prolonged abnormal muscle contractions (dystonia),
• tingling, numbness, or prickling (paresthesia),
• syncope,
• uncontrolled circular eye movements (oculogyric crisis),
• irregular heart rhythm and changes in its electrocardiogram related to this (prolongation of the QT interval, Torsade de Pointes),
• diarrhea,
• inflammation of the liver,
• pemphigus (blisters on the arms, legs, stomach, and mucous membranes),
• bedwetting or difficulty urinating (abnormal urine excretion),
• extreme weakness (asthenia),
• swelling of tissues due to fluid retention (edema),
• weight gain.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of the sight and reach of children.

Blister:

This medication does not require any special storage temperature.

HDPE Bottle:

This medication does not require special storage conditions.

Store in the original packaging to protect it from moisture.

Do not use this medication after the expiration date that appears on the box, blister, and bottle, after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of containers and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medications. By doing so, you will help protect the environment.

Composition of Hydroxyzine Bluefish

• The active ingredient is 25 mg of hydroxyzine hydrochloride.
• The other components are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, anhydrous colloidal silica, talc, magnesium stearate, hypromellose 5cPs, macrogol 400, and titanium dioxide (E171).

Appearance of the product and contents of the package

Film-coated, biconvex, capsule-shaped tablets, white to off-white in color, with a notch on both sides. The tablet can be divided into two equal doses.

PVC/PVdC-Alu blisters:

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

Child-resistant bottle:

20, 25, 28, 30, 50, 60, and 100 tablets.

Polypropylene cap bottle:

250 tablets.

The 250-tablet package is for dispensing doses.

Only some package sizes may be marketed.

Marketing Authorization Holder:

Bluefish Pharmaceuticals AB

P.O. Box 49013

100 28Stockholm

Sweden

Responsible for Manufacturing:

Bluefish Pharmaceuticals AB

Gävlegatan 22

113 30

Stockholm

Sweden

Adamed Sp. zo.o

Pienków 149

05-152, Czosnów

Poland

For more information about this medication, please contact the local representative of the marketing authorization holder:

Bluefish Pharma S.L.U.,

AP 36007

2832094 Madrid, Sucursal 36

This medication is authorized in the following Member States of the EEA and in the United Kingdom (Northern Ireland) under the following names:

Last reviewed date of this leaflet:October 2024

For detailed information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/