Atarax (hydroxyzine) 25 Mg 30 Tablets

• Excipients: lactose monohydrate, microcrystalline cellulose, magnesium stearate, colloidal anhydrous silica, titanium dioxide (E171), hydroxypropylmethyl cellulose 2910 5cp, macrogol 400 (polyethylene glycol 400),

this medicine You should read this INSTRUCTIONAL INSTRUCTION carefully before using it, because it contains important information for you.

• Keep these instructions for use. You can need to read again.

• If you have other questions, please talk your doctor or pharmacist.

• This medication has been prescribed to you personally and you should not give it to others.

• When using this medicine, tell your doctor if you go to a doctor or hospital.

• We sleep exactly as written in this instruction. Do not use high or low doses other than the recommended dose for the medication.

In this Instructions for Use: 1. What is ATARAX and what is it used for? 2. Things to consider before using A TARAX 3. How to use TARAX? 4. What are the possible side effects? 5. ATARAX 's Hiding

titles are included.

1. What is ATARAX and what is it used for?

ATARAX is in white colored, oblong, notched film coated tablets. There are 30 tablets in each box.

ATARAX is a medicine used in the treatment of pruritus, which relieves mental stress, uneasiness and anxiety.

atarax; - in the treatment of symptoms of anxiety (anxiety) disorders in adults, - in the treatment of an itch symptom, - in pre-treatment before surgery for surgical interventions.

If you have ATARAX in the following situations - you are allergic to ATARAX or any of the adjuncts, cetirizine, piperazine derivatives, aminophylline or ethylenediamine (hypersensitivity) - prolonged QT interval in your past (a disorder that occurs in the heart's electrical system)

Please consult your doctor if available. - If you are suffering from porphyria (a rare metabolic disorder), - Do not use this medicine if you are pregnant or breastfeeding. - If you have already been told by your doctor that you have intolerance to some sugars,

you should definitely take your medicine with you before taking this medicinal product.

Use ATARAX ATTENTION - If there is involuntary serial muscle spasm (convulsions), - Narrow angle glaucoma, benign prostate enlargement, asthma, chronic obstructive pulmonary disease, bladder outlet obstruction, myasthenia gravis (gastrointestinal (gestational) bowel movements have decreased if there is a marked reduction in the working power in the muscles and prominent neuromuscular disease-neuromuscular disease with rapid fatigue) or dementia (dementia), - Cardiac arrest in the past, including electrolyte imbalance rhythm loss) or if you are experiencing concurrent treatment with a medication that can lead to heart rhythm disturbance, please consult your doctor. - If you have an elderly or liver function disorder, or if you have moderate or severe renal insufficiency, your doctor will need to adjust your dose, and follow your doctor's instructions.

Please consult your doctor if these reminders apply to you, even at any time in the past.

Using ATARAX with food and drink Do not take ATARAX with alcohol. Alcohol may increase the effectiveness of this medicine. You can open ATARAX or take it on a full stomach.

Consult your doctor or pharmacist before using Pregnancy Pills.

If you are pregnant or you think you are pregnant, do not take ATARAX and please tell your doctor.

ATARAX should not be used during pregnancy. Various adverse effects (such as a drop in blood pressure) have been observed in the mothers receiving ATARAX during the late period of pregnancy and / or during birth, immediately or within a few hours after birth.

If you notice that you are pregnant during your treatment, consult your doctor immediately.

Breastfeeding Consult your doctor or pharmacist before using the medicine. As ATARAX has gone to the mother, the mothers who use ATARAX should drop their mother ATARAX who want to breastfeed.

Vehicle and machine use can affect your ATARAX ability to react and concentrate. For this reason, be careful when using your vehicle and machine.

Important information about some of the adjunct ingredients contained in ATARAX 's ingredient is lactose in the content of ATARAX. If your doctor has indicated that you are sensitive to some types of sugar, consult your doctor before using this medicine.

Use with other medications If you are using ATARAX simultaneously with medicines that are effective on the central nervous system (such as psychotropics, anesthetics, antiepileptics, epileptic seizures, sedatives, sleeping pills, or pain reliever medications) or anticholinergic medications, some of these medications or your doctor may need to adjust the dose as it may increase the effectiveness of all.

ATARAX reduces the effects of betahistine and anticholinesterase drugs.

Do not use ATARAX simultaneously with monoamine oxidase inhibitors (used in the treatment of depression), sedative (sedative) medications.

Simultaneous use with cimetidine, a drug used in the treatment of gastrointestinal (gastro-intestinal) ulcers, may increase the efficacy of ATARAX tablets.

If the ATARAX tablet is taken with phenytoin, a drug used for epileptic seizures, the effect of phenytoin is weak.

The active substance, hydroxyzine, inhibits certain enzymes (CYP2D6) in the liver (prints), causing high doses to interact with other drugs that are metabolized (degraded) by these enzymes.

Since the active substance is metabolized by hydroxyzine, alcohol dehydrogenase and CYP3A4 / 5 enzymes, an increase in the levels of hydroxyzine blood can be expected when used in combination with drugs that are inhibitors of these enzymes.

Treatment with ATARAX tablet should be discontinued as a precaution one week before any allergy skin test or bronchoprovocation test with methacholine.

Administration of ATARAX with a drug that can lead to cardiac arrhythmia may increase QT prolongation and Torsade de Pointes risk. If you are using or have recently used any medicine with or without a prescription, please tell your doctor or pharmacist about them.

3. How to use ATARAX?

• Instructions for proper use and dose / application frequency: Dosage and duration of use depends on the type of patient and the severity of the disease as well as the treatment of the patient.

Adults - Treatment of symptoms of anxiety (anxiety): General dose: 50mg / day (morning ^ tablet, lunch ^ tablet and evening 1 tablet). In heavier cases the dose can be increased up to a total of 300 mg per day.

- Treatment of pruritus symptoms: Before bed, treatment is started with 1 tablet. If necessary, treatment is continued with doses of 1 tablet 3-4 times a day.

- As a pre-treatment before surgery: 50 mg (2 tablets) applied 1 or 2 times - 200 mg

(8

tablets): An application is made one hour before the operation after anesthesia the previous night.

The maximum (highest) single dose in adults should not exceed 200 mg

(8

tablets) and the maximum daily dose should not exceed 300 mg (12 tablets).

Children (from 12 months of age) - Treatment of pruritus: From 12 months to

6

years: Dose is divided by 1-2.5 mg per kg of body weight per day.

6

Overyears oldeach kg of body weight,

1-2

, divided intomg dose.

- As a pre-treatment before surgery: After akg of body weight the previous night before anesthesia, aadministeredoperation

1

// kg of body weight ishour before the

11

single dose ofmgsingle dose ofmg.

• Application route and method: ATARAX tablet is for oral use. Suck the ATARAX tablet with enough liquid (eg a glass of water).

• Different age groups: Use in the elderly:

The dosage should be adjusted according to the patient's treatment. In the elderly it is suggested to start treatment with a dose half recommended for adults.

• Specific use cases:

Kidney / Liver failure: The dose should be reduced in patients with impaired liver function (dysfunction), moderate or severe renal insufficiency. If you have an impression that ATARAX 's effect is too strong or weak, talk to your doctor or pharmacist.

If you use more ATARAX than you need to use ATARAX, you should talk to a doctor or pharmacist immediately if you have used too much.

If you forget to use ATARAX, continue taking medication in accordance with the instructions your doctor gave you. Do not take double doses to compensate for forgotten doses.

Effects of termination of treatment with ATARAX The duration of treatment with ATARAX depends on the clinical indication and on the individual's disease.

4. What are the possible side effects? As with all medicines, there may be side effects in people susceptible to substances in the context of ATARAX.

- Anaphylactic shock, - Chills, - Unintentional muscle contractions (Convulsions), - Difficulty in moving voluntarily (Dyskinesia), - If you have any of the following, stop using ATARAX and report it to your IMD or contact your nearest hospital emergency department: (Bronchospasm), - Angioneurotic edema (including hands, feet, ankles, face, lips) - Congestive irregularity (Urinary retention) swelling or swelling, especially in the mouth

or throat, which will make swallowing or breathing difficult).

These are all very serious side effects. If one of these exists in you, then you have a serious allergy against ATARAX. You may need to be admitted to an emergency medical intervention or hospital.

All of these very serious side effects are very rare.

Tell your doctor if you notice any of the following: - The number of heartbeats (pulse) above normal (Tachycardia), - QT prolongation at ECG, Torsade de Pointes - Disorientation of the eye (Akomodation impairment), - Blurred vision, - Nausea, - Constipation, - Vomiting, - Abnormalities in liver function tests, - Hepatitis, - Fatigue, - Brokenness, - Fever, - Somnolence, - Headache, - Sedation, - Drowsiness, - Insomnia (erythematous) rash, - maculopapular rash, - rash (urticaria), - irritation of the upper layer of the skin (dermatitis), - perspiration increase, - irritability, - irritability, - confusion, - Fixed drug eruption, - Fever and bubbles in skin, mouth, eye and genital area, - Drop in blood pressure (Hypotension).

These are the minor side effects of ATARAX.

The frequency and intensity of side effects can be reduced by careful adjustment of individual daily doses. Elderly patients are more likely to have side effects.

If you encounter any side effects not mentioned in these instructions for use, please inform your doctor or pharmacist.

5. Hiding the ATARAXaccessed by

Store it in its place and on its packaging where it can not be seen orchildren.

Store at room temperatures below 25 ° C.

Keep it in your pills because it is sensitive to light.

Use in accordance with expiration dates.

Do not use ATARAX after the expiry date indicated on the packaging.