Hydroxyzine Bluefish 25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Hidroxizina Bluefish 25 mg film-coated tablets EFG

hydroxyzine hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

2. What you need to know before taking Hidroxizina Bluefish.

3. How to take Hidroxizina Bluefish.

4. Possible adverse effects.

5. How to store Hidroxizina Bluefish.

6. Contents of the pack and other information.

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

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

Hidroxizina Bluefish is used to treat:

• Anxiety in adults.
• Itching (pruritus) in adolescents and children aged 6 years and older.

For anxiety, the effect is noticeable within about 30–45 minutes.

For itching, the effect is achieved after approximately 1 hour.

2. What you need to know before taking Hidroxizina Bluefish

Do not take Hidroxizina Bluefish

• if you are allergic to hydroxyzine hydrochloride or to 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 substances in 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 “QT interval prolongation”
• if you have or have had 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 medicines for heart rhythm problems or medicines that may affect heart rhythm (see “Other medicines and Hidroxizina Bluefish”)
• if a close family member has suddenly died due to heart problems.

Warnings and precautions

Talk to your doctor or pharmacist before taking Hidroxizina Bluefish:

• if you have kidney or liver impairment or if you are elderly. You may require a lower dose
• if you have a high risk of seizures (fits)
• if you have any risk factors for stroke
• if you have increased pressure inside the eye (glaucoma)
• if you have difficulty urinating
• if you have constipation (slow bowel function)
• if you have severe muscle weakness (myasthenia gravis)
• if you have mental disorders (dementia)

Hidroxizina Bluefish may be associated with an increased risk of a life-threatening heart rhythm disorder. Therefore, inform your doctor if you have any heart problems or are taking other medicines, including those obtained without a prescription.

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

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

If you are undergoing allergy testing, treatment with Hidroxizina Bluefish must be stopped 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 in 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 central nervous system-related adverse effects, such as seizures.

Other medicines and Hidroxizina Bluefish

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

Do not take Hidroxizina 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)
• allergy
• 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 Ménière’s disease (balance and hearing problems)
• phenytoin used to treat seizures (fits)
• adrenaline used to treat severe allergic reactions
• medicines used to treat anxiety or help you sleep
• anticholinergic medicines used to treat, for example, irritable bowel syndrome (digestive 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). These may increase the risk of irregular heart rhythm.

Taking Hidroxizina Bluefish with food, drinks, and alcohol

Alcohol should be avoided while being treated with Hidroxizina Bluefish, as the combination may enhance the effects of Hidroxizina Bluefish and thereby increase the risk of adverse effects.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Hidroxizina Bluefish must not be used during pregnancy.

Hydroxyzine, the active substance in Hidroxizina 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 Hidroxizina Bluefish during the last stage of pregnancy and/or during delivery; observed immediately or only a few hours after birth: tremors, muscle stiffness and/or weakness, breathing difficulties, and urinary retention.

Hidroxizina Bluefish must not be used during breastfeeding.

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

Driving and using machines

Hidroxizina Bluefish may impair your ability to drive or operate machinery, as it may cause drowsiness, reduce your attention, or slow your reaction time. These effects are 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 informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Hidroxizina Bluefish coated tablets contain sodium

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

3. How to take Hidroxizina Bluefish

Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

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

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

Recommended dose:

For itching:

Adults:

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

Children aged 6 years and older:

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

In children weighing more than 40 kg, the maximum daily dose is 100 mg per day.

In children weighing 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 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 per day.

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

Elderly patients

In elderly individuals, 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 impairment

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

Patients with hepatic impairment

In patients with reduced liver function, the daily dose should be reduced.

Use in children and adolescents

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

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

Method of administration

The tablets should be swallowed with sufficient water. The tablets may be taken with or without food.

If you take more Hidroxizina Bluefish than you should

If you have taken too much Hidroxizina Bluefish, contact your doctor immediately or call the Toxicology Information Service at 915 620 420, especially if a child has taken an overdose. In case of overdose, symptomatic treatment may be initiated. Electrocardiographic (ECG) monitoring may be performed due to the possibility of cardiac rhythm disturbances, such as QT interval prolongation or Torsade de Pointes.

If you forget to take Hidroxizina Bluefish

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

• any problems with your heart rhythm such as palpitations, difficulty breathing, or loss of consciousness (frequency unknown, cannot be estimated from available data)
• swelling of the face, lips, tongue, and/or throat, sometimes with difficulty breathing or swallowing (angioedema) (very rare adverse effects which may affect up to 1 in 10,000 people)
• widespread blistering rashes (acute generalized exanthematous pustulosis), ring-shaped rashes, red and often blistering—commonly affecting the hands and feet (erythema multiforme), inflammation of the mucous membranes and skin, sometimes accompanied by high fever (Stevens-Johnson syndrome) (very rare adverse effects which may affect up to 1 in 10,000 people)
• severe peeling and shedding of the skin (toxic epidermal necrolysis) (frequency unknown, cannot be estimated from available data).

Other possible side effects:

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

• somnolence.

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

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

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

• restlessness,
• confusion,
• dizziness,
• insomnia,
• tremors,
• sensation of dizziness (nausea),
• fever.

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

• allergic reactions (hypersensitivity),
• disorientation, hallucinations (seeing things that are not real),
• seizures (convulsions), movement disorder (dyskinesia),
• eye accommodation disorders (difficulty focusing), blurred vision,
• low blood pressure,
• constipation,
• vomiting,
• changes in liver enzyme values (transaminases, alkaline phosphatase, bilirubin, and gamma-glutamyl transferase),
• itching, skin rashes with redness, spots or blemishes, skin inflammation,
• urinary retention,
• cardiac arrest, effects on heart rhythm, irregular heartbeat.

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

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

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

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Hydroxyzine Bluefish

Keep out of sight and reach of children.

Blister pack:

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 stated on the carton, blister, and bottle, following "EXP". The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials should be handed over to the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Hidroxizina Bluefish

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

Appearance of the product and contents of the pack

Film-coated tablets, biconvex, capsule-shaped, white to off-white, 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.

Bottle with child-resistant cap:

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

Bottle with polypropylene cap:

250 tablets.

The 250-tablet pack is intended for dose dispensing.

Only certain pack sizes may be commercially available.

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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Bluefish Pharma S.L.U.,
P.O. Box 36007
28320 Madrid, Branch 36
Spain

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

Date of the most recent review of this leaflet: October 2024

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