HYDROXYZINE TARBIS 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Hydroxyzine Tarbis 25 mg Film-Coated Tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the Package Leaflet

1. What is Hydroxyzine Tarbis and what is it used for
2. What you need to know before taking Hydroxyzine Tarbis
3. How to take Hydroxyzine Tarbis
4. Possible side effects
5. Storage of Hydroxyzine Tarbis
6. Package Contents and Additional Information

1. What is Hydroxyzine Tarbis and what is it used for

Hydroxyzine Tarbis blocks histamine, a substance found in body tissues. It is effective against anxiety, itching, and hives.

Hydroxyzine Tarbis is used to treat:

• Anxiety in adults.
• Itching (pruritus) associated with skin rash (urticaria) in adults, adolescents, and children 5 years of age and older.

2. What you need to know before taking Hydroxyzine Tarbis

Do not take Hydroxyzine Tarbis

• if you are allergic to hydroxyzine hydrochloride or any of the other components of this medication (listed in section 6),
• if you are allergic (hypersensitive) to cetirizine, aminophylline, ethylenediamine, or piperazine derivatives (active ingredients of other closely related medications)
• 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 "Using Hydroxyzine Tarbis with other medications").
• if a close relative has died suddenly from heart problems.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Hydroxyzine Tarbis:

• 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 seizures.
• if you have a high risk of having attacks (seizures)
• if you have a risk factor for suffering a stroke.
• if you have heart disease
• if you have increased pressure inside the eye (glaucoma).
• if you have problems urinating
• if you have a salt imbalance in the body
• if you have low potassium or magnesium levels
• if you have constipation (slow intestinal function)
• if you have severe muscle weakness (myasthenia gravis).
• if you have mental disorders (dementia)

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

Seek immediate medical attention if, while being treated with Hydroxyzine Tarbis, 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 Tarbis. Therefore, it is essential to have good oral hygiene during treatment with Hydroxyzine Tarbis.

If you undergo allergy tests, you should discontinue treatment with Hydroxyzine Tarbis 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 Tarbis should not be used in children under 5 years of age.

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

Taking Hydroxyzine Tarbis with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. This includes any medication purchased without a prescription. Hydroxyzine Tarbis may affect or be affected by other medications.

Do not take Hydroxyzine Tarbis 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)
• 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.
• medications used to treat anxiety or help you sleep.
• anticholinergic medications 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 Tarbis 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 Tarbis with food, drinks, and alcohol

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

Pregnancy and Breastfeeding

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

Hydroxyzine Tarbis should not be used during pregnancy.

Hydroxyzine, the active substance of Hydroxyzine Tarbis, passes to the fetus. There is a risk that the fetus may be affected.

Hydroxyzine Tarbis should not be used during breastfeeding.

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

Driving and Using Machines

Hydroxyzine Tarbis 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 Tarbis contains lactose

The tablets of Hydroxyzine Tarbis contain lactose. If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medication.

3. How to take Hydroxyzine Tarbis

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

The lowest effective dose of Hydroxyzine Tarbis should be administered and for the shortest possible duration.

The recommended dose is:

For itching and hives:

Adults and adolescents (12 years and older): Initial dose of 1-2 tablets of 25 mg at night, or as indicated by your doctor. In adults and children over 40 kg in weight, the maximum daily dose is 100 mg per day.

Children 5-11 years: 1 tablet of 10 mg or 1 tablet of 25 mg at night, or as indicated by the doctor. In children up to 40 kg, the maximum daily dose is 2 mg/kg/day.

For anxiety:

Adults: 10 mg-50 mg per day (1-5 tablets of 10 mg or 1-2 tablets of 25 mg), divided into 2-3 daily doses. The maximum daily dose is 10 tablets of 10 mg or 4 tablets of 25 mg (100 mg per day).

For a dose below 25 mg, other concentrations and forms of dosage that contain hydroxyzine should be used.

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 persons, 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 Tarbis is only for the treatment of hives and itching in adolescents and children 5 years of age or older.

Method of Administration

The tablets should be swallowed with a sufficient amount of water. The tablets can be taken with or without food. The 25 mg tablets cannot be divided into equal doses and therefore, when necessary, other concentrations and forms of dosage that contain hydroxyzine should be used.

If you take more Hydroxyzine Tarbis than you should

If you have taken too much Hydroxyzine Tarbis, 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) can 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 Tarbis

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Stop taking this medication 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 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)

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),
• eye accommodation disorders (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 available data):

• reduction in platelet count (thrombocytopenia),
• aggression,
• depression,
• recurring involuntary muscle contractions (tics),
• prolonged abnormal muscle contractions (dystonia),
• tingling, numbness, or tingling sensation (paresthesia),
• uncontrolled circular movements of the eyes (ocular gyration),
• diarrhea,
• bedwetting or difficulty urinating (abnormal urination),
• extreme weakness (asthenia),
• swelling of tissues due to fluid retention (edema),
• weight gain.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Hydroxyzine Tarbis

Keep out of sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date stated on the carton, blister, and bottle, after "EXP". The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications at the Sigre Collection Point in the pharmacy. Ask your pharmacist how to dispose of medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Hydroxyzine Tarbis

The active ingredient is hydroxyzine hydrochloride.

Each film-coated tablet contains 25 mg of hydroxyzine hydrochloride.

The excipients are:

Core of the tablet:Lactose, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate.

Coating of the tablet: Hypromellose, titanium dioxide (E171), macrogol.

Appearance of the Product and Package Contents

White to off-white, oblong film-coated tablets (dimensions: Length - 10.10 ± 0.20 mm, width - 4.00 ± 0.20 mm, thickness - 2.90 ± 0.30 mm) with a score line on both sides.

The score line is only for breaking and facilitating swallowing, but not for dividing into equal doses.

The film-coated tablets are packaged in PVC/aluminum and PVC/PVDC/aluminum blisters with 25 and 50 film-coated tablets.

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

Date of the Last Revision of this Package Leaflet: February 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/