HYDROXYZINE BLUEFISH 25 mg FILM-COATED TABLETS

2. What you need to know before you take Hydroxyzine Bluefish

Do not take Hydroxyzine 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 (active ingredients of other closely related medicines)
• if you have porphyria (a metabolic disorder)
• if you are pregnant or breastfeeding (see section "Pregnancy, breastfeeding, and fertility" below)
• if your ECG (electrocardiogram) shows a heart rhythm problem called "prolonged 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 medicines and Hydroxyzine Bluefish")
• if a close relative has died suddenly from heart problems.

Warnings and Precautions

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

• if you have kidney or liver failure or if you are an elderly person. You may need a lower dose
• if you have a high risk of having seizures
• if you have any risk factor for having a stroke
• if you have increased pressure inside the eye (glaucoma)
• if you have problems urinating
• if you have constipation (slow bowel function)
• if you have severe muscle weakness (myasthenia gravis)
• if you have mental disorders (dementia)

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

Seek immediate medical attention if, while being treated with Hydroxyzine Bluefish, you experience heart problems such as palpitations, difficulty breathing, or loss of consciousness. Treatment with hydroxyzine should be discontinued.

Dry mouth may be a side effect of using Hydroxyzine Bluefish. Therefore, it is essential to have good oral hygiene during treatment with Hydroxyzine Bluefish.

If you are undergoing allergy tests, you should discontinue treatment with Hydroxyzine 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

Hydroxyzine Bluefish is not recommended for children under 6 years of age, as they may have difficulty swallowing the 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 related to the central nervous system, such as seizures.

Other medicines and Hydroxyzine Bluefish

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes any medicines bought without a prescription. Hydroxyzine Bluefish may affect or be affected by other medicines.

Do not take Hydroxyzine Bluefish if you are taking medicines 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)
• allergies
• malaria (e.g., mefloquine)
• cancer (e.g., toremifene, vandetanib)
• drug abuse or severe 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
• medicines used to treat anxiety or help you sleep
• anticholinergic medicines for the treatment of, for example, irritable bowel syndrome (digestive disorders) and asthma
• cimetidine used to treat stomach problems. This may increase the level of Hydroxyzine 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 Hydroxyzine Bluefish with food, drinks, and alcohol

It is recommended to avoid taking alcohol while being treated with Hydroxyzine Bluefish, as the combination may increase the effects of Hydroxyzine Bluefish and thus the risk of side effects.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Hydroxyzine Bluefish should not be used during pregnancy.

Hydroxyzine, the active substance of Hydroxyzine Bluefish, 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 Hydroxyzine Bluefish during the last stage of pregnancy and/or childbirth; they are observed immediately or only a few hours after birth: tremors, stiffness and/or muscle weakness, respiratory problems, and urinary retention (urinary retention).

Hydroxyzine Bluefish should not be used during breastfeeding.

If treatment with Hydroxyzine Bluefish is necessary during breastfeeding, breastfeeding should be discontinued, as hydroxyzine passes into breast milk.

Driving and using machines

Hydroxyzine Bluefish may alter your ability to drive or operate machinery, as it can cause drowsiness, reduce your attention, or reduce your reaction time. The occurrence of these effects is more likely at the start of treatment or when the dose is increased. Do not drive or use machines if you experience any of these effects.

Hydroxyzine Bluefish contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Hydroxyzine Bluefish film-coated tablets contain sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 25 mg tablet; this is essentially "sodium-free".

3. How to take Hydroxyzine Bluefish

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

The lowest effective dose of Hydroxyzine Bluefish should be used for the shortest possible duration.

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. Up to a total of 25 mg may be taken 3-4 times a day if necessary. In adults, the maximum daily dose is 100 mg per day.

Children over 6 years of age:

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

In children over 40 kg in weight, 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 a tablet (12.5 mg), half a 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.

Elderly patients

In elderly patients, it is recommended to start with half the recommended dose due to the 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 hepatic problems

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

Use in children and adolescents

Hydroxyzine Bluefish is only for the treatment of itching in adolescents and children over 6 years of age.

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

Method of administration

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

If you take more Hydroxyzine Bluefish than you should

If you have taken too much Hydroxyzine Bluefish, consult your doctor or pharmacist immediately, especially if it is a child who has taken too much. In case of overdose, symptomatic treatment can be initiated. Electrocardiographic monitoring (ECG) may be performed due to the possibility of a heart rhythm problem, such as prolonged QT interval or Torsade de Pointes.

If you forget to take Hydroxyzine Bluefish

Do not take a double dose to make up for forgotten doses.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• any heart rhythm problems such as palpitations, difficulty breathing, or loss of consciousness (frequency not known, cannot be estimated from the 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)
• widespread rashes with blisters (acute generalized exanthematous pustulosis), ring-shaped rashes, red and often with blisters - common on hands and feet (erythema multiforme), inflammation of the mucous membranes 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 skin peeling and rejection (toxic epidermal necrolysis) (frequency not known, cannot be estimated from the available data).

Other side effects that may occur:

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,
• lethargy,
• dry mouth,
• fatigue.

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

• agitation,
• confusion,
• dizziness,
• insomnia,
• tremors,
• feeling of dizziness (nausea),
• 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 (convulsions), movement disorder (dyskinesia),
• accommodation disorders of the eye (difficulty focusing), blurred vision,
• low blood pressure,
• constipation,
• vomiting,
• changes in liver enzyme values (transaminases, alkaline phosphatase, bilirubin, and glutamyl),
• itching, skin rashes 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),
• constrictions in the airway (bronchospasm),
• increased sweating,

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

• reduction in the number of platelets (thrombocytopenia),
• aggression,
• depression,
• involuntary recurrent muscle contractions (tics),
• prolonged abnormal muscle contractions (dystonia),
• tingling, numbness, or tingling sensation (paresthesia),
• fainting,
• uncontrolled circular movements of the eyes (ocular gyration),
• irregular heart rhythm and changes in the electrocardiogram related to this (prolonged QT interval, Torsade de Pointes),
• diarrhea,
• liver inflammation,
• pemphigus (blisters on arms, legs, stomach, and mucous membranes),
• bedwetting or difficulty urinating (abnormal urination),
• extreme weakness (asthenia),
• swelling of tissues due to fluid retention (edema),
• weight gain.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Hydroxyzine Bluefish

Keep out of the sight and reach of children.

Blister:

This medicine does not require any special storage temperature.

HDPE bottle:

This medicine does not require special storage conditions.

Store in the original packaging to protect from moisture.

Do not use this medicine after the expiry date which is stated on the carton, blister, and bottle, after "EXP". The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Content and Additional Information

Composition of Hydroxyzine Bluefish

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

Appearance of the Product and Container Content

Film-coated tablets, biconvex, capsule-shaped, white to off-white in color, with a score line 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 screw cap bottle:

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

Polypropylene screw cap bottle:

250 tablets.

The 250-tablet container is for dose dispensing.

Only some pack sizes may be marketed.

Marketing Authorization Holder:

Bluefish Pharmaceuticals AB

P.O. Box 49013

100 28 Stockholm

Sweden

Manufacturer:

Bluefish Pharmaceuticals AB

Gävlegatan 22

113 30

Stockholm

Sweden

Adamed Sp. z.o.o

Pienków 149

05-152, Czosnów

Poland

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Bluefish Pharma S.L.U.,

AP 36007

2832094 Madrid, Branch 36

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

Date of the Last Revision of this Leaflet:October 2024

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/