Adazio is an atypical antipsychotic indicated for the treatment of ①Schizophrenia ②Bipolar disorder, manic episodes ③Bipolar disorder, depressive episodes. Adazio is Quetiapine tablets for oral use produced by Riyahd Pharma- KSA. 

Black Box WARNING

INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA RELATED PSYCHOSIS: Elderly patients with dementia_related psychosis treated with antipsychotic drugs are at an increased risk of death. Adazio is not approved for elderly patients with dementia.

SUICIDAL THOUGHTS AND BEHAVIORS:Increased risk of suicidal thoughts and behavior in children, adolescents and young adults taking antidepressants. Patients should be monitored for worsening and emergence of suicidal thoughts and behaviors.

What is Adazio? And what is it used for?

Adazio Tablets contain a substance called Quetiapine. This belongs to a group of medicines called atypical antipsychotics. Adazio Tablets can be used to treat several illnesses, such as:

Schizophrenia: Where you may hear or feel things that are not there, believe things that are not true or feel unusually suspicious, anxious, confused, guilty, tense or depressed.

Mania: where you may feel very excited, elated, agitated, enthusiastic or hyperactive or have poor judgment including being aggressive or disruptive.

Bipolar depression: where you feel sad. You may find that you feel depressed, feel guilty,lack energy, lose your appetite or can’t sleep.

Adazio is Quetiapine generic by RIYADH PHARMA- KSA

Your doctor may continue to prescribe Adazio tablets even when you are feeling better.

Adazio is local alternative for Seroquel

How to take Adazio Tablets?

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will decide on your starting dose. The maintenance dose (daily dose) will depend on your illness and needs but will usually be between 150 mg and 800 mg.

You will take your tablets once a day, at bedtime or twice a day, depending on your illness.

Swallow your tablets whole with a drink of water.

You can take your tablets with or without food.

Do not drink grapefruit juice while you are taking Adazio tablets.It can affect the way the medicine works.

Do not stop taking your tablets even if you feel better, unless your doctor tells you.

Dosage and administration

Indication Initial Dose Recommended Dose Maximum Dose Schizophrenia Adults

Initial dose: 25 mg twice daily.

Recommended dose: 150-750 mg/day.

Maximum dose: 750 mg/day.

Schizophrenia Adolescents (13-17 years)

Initial dose: 25 mg twice daily.

Recommended dose: 400-800 mg/day.

Maximum dose: 800 mg/day .

Bipolar Mania Adults Monotherapy or as an adjunct to lithium or divalproex 

Initial dose: 50 mg twice daily.

Recommended dose: 400— 800 mg/day.

Maximum dose: 800 mg/day.

Bipolar Mania Children and Adolescents (10 to 17 years), Monotherapy 

Initial dose: 25 mg twice daily.

Recommended dose: 400-600 mg/day.

Maximum dose:  600 mg/day.

Bipolar Depression Adults

Initial dose: 50 mg once daily at bedtime.

Recommended dose: 300 mg/day.

Maximum dose: 300 mg/day.

Warnings and Precautions

Cerebrovascular Adverse Reactions: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack) has been seen in elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs.

Neuroleptic Malignant Syndrome (NMS): Manage with immediate discontinuation and close monitoring.

Metabolic Changes: Atypical antipsychotics have been associated with metabolic changes. These metabolic changes include hyperglycemia, dyslipidemia, and weight gain.

Hyperglycemia and Diabetes Mellitus: Monitor patients for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Monitor glucose regularly in patients with diabetes or at risk for diabetes.

Dyslipidemia: Undesirable alterations have been observed in patients treated with atypical antipsychotics. Appropriate clinical monitoring is recommended. including fasting blood lipid testing at the beginning of, and periodically, during treatment .

Weight Gain: Gain in body weight has been observed; clinical monitoring of weight is recommended.

Tardive Dyskinesia: Discontinue if clinically appropriate.

Hypotension: Use with caution in patients with known cardiovascular or cerebrovascular disease.

Increased Blood Pressure in Children and Adolescents: Monitor blood pressure at the beginning of, and periodically during treatment in children and adolescents.

Leukopenia, Neutropenia and Agranulocytosis: Monitor complete blood count frequently during the first few months of treatment in patients with a pre-existing low white cell count or a history of leukopenia/neutropenia and discontinue Adazio at the first sign of a decline in WBC in absence of other causative factors.

Cataracts: Lens changes have been observed in patients during long-term quetiapine treatment. Lens examination is recommended when starting treatment and at 6-month intervals during chronic treatment .

Anticholinergic (antimuscarinic) Effects: Use with caution with other anticholinergic drugs and in patients with urinary retention, prostatic hypertrophy, constipation, and increased intraocular pressure.

Possible Side effects

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

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

Dizziness (may lead to falls).

Headache.

dry mouth.

Feeling sleepy (this may go away with time, as you keep taking Adazio Tablets) (may lead to falls).

Putting on weight. 

Abnormal muscle movements. These include difficulty starting muscle movements, shaking, feeling restless or muscle stiffness without pain. 

Changes in the amount of certain fats (triglycerides and total cholesterol).

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

Rapid heartbeat  Feeling like your heart is pounding, racing or has skipped beats.

Constipation, upset stomach (indigestion).

Feeling weak.

Swelling of arms or legs.

Low blood pressure when standing up. This may make you feel dizzy or faint (may lead to falls).

Increased levels of sugar in the blood.

Blurred vision.

Abnormal dreams and nightmares.

Feeling more hungry.

Feeling irritated.

Disturbance in speech and language.

 Thoughts of suicide and worsening of your depression.

Shortness of breath. 

Vomiting (mainly in the elderly). 

Fever.

Changes in the amount of thyroid hormones in your blood. 

Decreases in the number of certain types of blood cells.

Increases in the amount of liver enzymes measured in the blood.

Increases in the amount of the hormone prolactin in the blood-Increases in the hormone prolactin could in rare cases lead to the following: Men and women to have swelling breasts and unexpectedly produce breast milk. Women to have no monthly periods or irregular periods. 

Discontinuation symptoms

Discontinuation symptoms (symptoms which occur when you stop taking Adazio) include:

not being able to sleep (insomnia).

feeling sick (nausea).

Headache.

Diarrhoea.

being sick (vomiting).

dizziness and irritability.

Gradually withdrawal over a period of at least 1 to 2 weeks is advisable.

ادازيو… معلومات لغة عربية، أنقر هنا

Adazio- FAQ

Is Adazio a good sleep aid? Adazio is not approved as sleeping pills. Quetiapine, the active ingredient, has been officially approved in Canada for schizophrenia, bipolar disorder and major depression only. Quetiapine is sedating and makes people drowsy.

Is Adazio good for anxiety? Studies suggested that the antipsychotic drug Adazio may help battle major depression and generalized anxiety disorder. Adazio is already approved to treat schizophrenia and bipolar disorder (formerly called manic-depressive illness).

Does Adazio work immediately? Sedative effects happen almost immediately; however, it may take up to two to three weeks to see some improvement in other symptoms and up to six weeks for the full effects to be seen.

Is Adazio a mood stabilizer? Adazio is effective mood stabilizers, clinically used to treat mania and depression, while preventing recurrence and improving quality of life.

Is Adazio physically addictive? Quetiapine(Adazio) is an atypical or second-generation antipsychotic agent and has been a subject of a series of case reports and suggested to have the potential for misuse or abuse. However, it is not a controlled substance and is not generally considered addictive.

Marketing Authorisation Holder and Manufacturer

Medical and Cosmetic Products Company Ltd. (Riyadh Pharma)

P.O.Box 442, Riyadh 11411.

Fax: +966 11 265 0505 .

Email: [email protected].

For any information about this medicinal product, please contact the local representative of marketing authorisation holder: Saudi Arabia Marketing department

Riyadh Tel: +96611 265 0111.

Email: [email protected].

—

Agent in UAE: GULF DRUG LLC.

Agent in Oman: Bahwan Healthcare Centre LLC.

Agent in Bahrain: WAEL PHARMACY.

To report any side effect(s) in KSA:

The National Pharmacovigilance and Drug Safety Centre (NPC).

Fax: +966-11-205-7662.

Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.

Toll free phone: 8002490000.

E-mail: [email protected].

Website: www.sfda.gov.sa/npc.

To report any side effect(s) in UAE:

Click one of the PDF form: Adverse Reaction Reporting (AR) Form, Fill out all the required information, then Send a copy of the completed form either to:

Email: [email protected] .

Fax: +971-2-419-3668.

Adazio- Information Leaflet 

N05AH04 quetiapine  GULF DRUG LLC / UAE RIYADH PHARMA / KSA

أدازيو…علاج الاضطرابات العقلية/المزاجية:الفصام، الاضطراب ثنائي القطب

Adazio ↔ Seroquel

Adazio is a local alternative to Seroquel, it is a good idea to read the patient information leaflet for Seroquel as it will provide you with useful information.

Seroquel® Immediate release- Information Leaflet Seroquel® Extended release- Information Leafletسيروكويل أقراص فورية الإطلاق نشرة المعلوماتنشرة سيروكويل أقراص ممتدة المفعول ذات تحرير مطول

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