Quetiapine Doc Generici

Italy
Brand name Quetiapine Doc Generici
Form tablets, prolonged-release
Active substance / Dosage
QUETIAPINE FUMARATE
Prescription type Prescription only
ATC code
N05AH04
Registration number 043695
Manufacturer DOC GENERICI SRL
Quetiapine Doc Generici tablets, prolonged-release

Table of Contents

Package Leaflet: Information for the User

QUETIAPINE DOC

50 mg, 150 mg, 200 mg, 300 mg, 400 mg, 600 mg prolonged-release tablets
Please read all of this leaflet carefully before you start taking this medicine, as 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
  • If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

  1. What QUETIAPINE DOC is and what it is used for
  2. What you need to know before taking QUETIAPINE DOC
  3. How to take QUETIAPINE DOC
  4. Possible side effects
  5. How to store QUETIAPINE DOC
  6. Contents of the pack and other information

1. What QUETIAPINA DOC is and what it is used for

QUETIAPINA DOC contains a substance called quetiapine. This substance belongs to a group of medicines known as antipsychotics. QUETIAPINA DOC can be used to treat several conditions, such as the following:

  • Bipolar depression and major depressive episodes associated with major depressive disorder: you may feel sad. You might notice that you feel depressed, guilty, lack energy, have loss of appetite, or have difficulty sleeping.
  • Mania: you may feel very excited, euphoric, agitated, enthusiastic, or hyperactive, or have poor judgment, including aggressive or destructive behavior.
  • Schizophrenia: you may have the sensation of hearing or perceiving things that are not actually present, may believe things that are not true, or may feel unusually suspicious, anxious, confused, guilty, tense, or depressed.

When QUETIAPINA DOC is taken for the treatment of major depressive episodes associated with major depressive disorder, it will be given in addition to another medicine used to treat this condition.
Your doctor may continue to prescribe QUETIAPINA DOC even if you feel better.

2. What you should know before taking QUETIAPINE DOC

Do not take QUETIAPINE DOC:
if you are allergic to quetiapine or to any of the other ingredients of this medicine
(listed in section 6)
if you are taking any of the following medicines:
• certain medicines for HIV virus
• azole drugs (for fungal infections)
• erythromycin or clarithromycin (for infections)
• nefazodone (for depression)
If you have any doubts, consult your doctor or pharmacist before taking QUETIAPINE DOC.

Warnings and precautions
Talk to your doctor or pharmacist before taking QUETIAPINE DOC if:
you suffer from depression or other conditions treated with antidepressants. The use of these medicines
together with QUETIAPINE DOC may lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and QUETIAPINE DOC”)
you or someone in your family has or has previously had heart problems, such as irregular heartbeat, weakened heart muscle, or heart inflammation, or if you are taking medicines that may affect heart rhythm
you have low blood pressure
you have had a stroke, especially if you are elderly
you suffer from liver problems
you have experienced seizures (epileptic fits)
you have diabetes or are at risk of developing diabetes. In this case, your doctor may monitor your blood sugar levels while you are taking QUETIAPINE DOC
you know you have previously had low levels of white blood cells in your blood (whether caused by medicines or not)
you are an elderly person with dementia (loss of some brain functions). In this case, you should not take QUETIAPINE DOC, as this class of medicines, to which QUETIAPINE DOC belongs, may increase the risk of stroke or, in some cases, the risk of death in elderly patients with dementia
you are an elderly person with Parkinson’s disease/parkinsonism.
you or someone in your family has a history of blood clots, as medicines of this type may increase the risk of blood clot formation
you suffer from or have suffered from a condition causing brief interruptions in breathing during normal sleep (called “sleep apnoea”) and are simultaneously taking medicines that slow down normal brain activity (“central nervous system depressants”)
you suffer from or have suffered from a condition that prevents complete emptying of the bladder (urinary retention), have an enlarged prostate, suffer from intestinal obstruction, or have increased intraocular pressure. In some cases, these conditions are caused by medicines (called “anticholinergics”) that affect nerve cell function to treat certain diseases
you suffer from or have suffered from alcohol or drug abuse.

Contact your doctor immediately if you experience any of the following symptoms after taking QUETIAPINE DOC:
fever associated with severe muscle stiffness, sweating, or decreased level of consciousness
(a condition called “neuroleptic malignant syndrome”). Immediate medical treatment may be required;
uncontrolled movements, mainly of the face or tongue;
dizziness or intense drowsiness. This may increase the risk of accidental injuries (falls) in elderly patients;
seizures (epileptic fits);
persistent and painful erection (Priapism);
rapid or irregular heartbeat, even at rest, palpitations, breathing difficulties, chest pain, or unexplained fatigue. Your doctor should check your heart and, if necessary, refer you immediately to a cardiologist.

The following conditions may be caused by this type of medicine.
Inform your doctor as soon as possible if you experience:
Fever, flu-like symptoms, sore throat, or any other infection, as these could be signs of a very low white blood cell count, which may require discontinuation of QUETIAPINE DOC and/or administration of treatment.
Constipation together with persistent abdominal pain or constipation that has not responded to treatment, as these may lead to a more serious intestinal obstruction.

Suicidal thoughts and worsening of depression
If you are depressed, you may sometimes feel the need to harm yourself or to commit suicide. These feelings may be stronger at the beginning of treatment, as these medicines require time to take effect, usually about two weeks but sometimes longer.
These thoughts may also intensify if you suddenly stop taking the medicine. You are more likely to experience such feelings if you are a young adult.
Clinical trial data have shown an increased risk of suicidal thoughts and/or suicidal behaviour in young adults with depression under the age of 25.
If at any time you notice that you are having thoughts of self-harm or suicide, contact your doctor or go to the hospital immediately.
You may find it helpful to inform a relative or close friend that you are depressed and ask them to read this leaflet. You may wish to ask them to alert you if they think your depression is worsening or if they are concerned about changes in your behaviour.

Severe cutaneous adverse reactions (SCARs)
Severe cutaneous adverse reactions (SCARs), which may be potentially life-threatening or fatal, have been very rarely reported during treatment with this medicine. These commonly include:

  • Stevens-Johnson Syndrome (SJS), a widespread skin rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals
  • Toxic Epidermal Necrolysis (TEN), a more severe form causing extensive skin peeling
  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), characterised by flu-like symptoms with rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and elevated liver enzymes)
  • Acute Generalized Exanthematous Pustulosis (AGEP), small pustules filled with pus
  • Erythema Multiforme (EM), skin rash with irregular, red, itchy patches

Stop using QUETIAPINE DOC and contact your doctor or seek immediate medical attention if you develop any of these symptoms.

Weight gain
Weight gain has been reported in patients treated with quetiapine. Your body weight should be monitored regularly by both you and your doctor.

Children and adolescents
QUETIAPINE DOC must not be used in children and adolescents under 18 years of age.

Other medicines and QUETIAPINE DOC
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Do not take QUETIAPINE DOC if you are taking any of the following medicines:
• certain medicines for HIV virus
• azole drugs (for fungal infections)
• erythromycin or clarithromycin (for infections)
• nefazodone (for depression)

Inform your doctor if you are taking any of the following medicines:
• antidepressants. These medicines may interact with QUETIAPINE DOC and may cause symptoms such as involuntary rhythmic muscle contractions, including those controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, body temperature above 38°C (serotonin syndrome). Consult your doctor if these symptoms occur;
• medicines for epilepsy (such as phenytoin or carbamazepine);
• medicines for high blood pressure;
• barbiturates (for sleep disorders);
• thioridazine or lithium (other antipsychotic medicines);
• medicines that affect heart rhythm, for example medicines that may cause electrolyte imbalance (low potassium or magnesium levels) such as diuretics (pills that increase urine production) or certain antibiotics (medicines for treating infections);
• medicines that may cause constipation;
• medicines (called “anticholinergics”) that affect nerve cell function to treat certain diseases.

Do not stop taking any medicine without first discussing it with your doctor.

QUETIAPINE DOC with food, drinks and alcohol
The effect of QUETIAPINE DOC may be influenced by food; therefore, you should take the tablets at least one hour before a meal or before going to sleep.
Be cautious about the amount of alcohol you consume. This is important because the combined effect of QUETIAPINE DOC and alcohol may increase drowsiness.
Do not drink grapefruit juice while taking QUETIAPINE DOC, as it may affect the medicine’s action.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
You should not take QUETIAPINE DOC during pregnancy without first discussing it with your doctor. QUETIAPINE DOC should not be taken during breastfeeding.
The following symptoms, which may represent withdrawal, have been observed in newborns of mothers who took quetiapine during the third trimester (the last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby shows any of these symptoms, contact your doctor.

Driving and using machines
The tablets may cause drowsiness. Do not drive or operate tools or machinery until you know how the tablets affect you.

Effect on urine screening tests
If you need to undergo a urine screening test, taking QUETIAPINE DOC may result in false positive results for methadone or certain antidepressant drugs known as tricyclic antidepressants (TCA), when certain testing methods are used, even if you are not taking methadone or TCAs. In such cases, more specific tests should be performed.

QUETIAPINE DOC contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take QUETIAPINE DOC

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your
doctor or pharmacist.
Your doctor will decide the most appropriate starting dose for you. The maintenance dose (daily
dose) will depend on the type of illness and individual needs, but is usually between 150 mg and 800 mg.
You should take the tablets once daily.
Do not divide, chew or crush the tablets.
Swallow the tablets whole with a glass of water.
Take the tablets away from meals (at least one hour before a meal or at bedtime, as directed by your
doctor).
Do not drink grapefruit juice during treatment with QUETIAPINE DOC, as it may affect the
medicine's action.
Do not stop taking the tablets even if you feel better, unless your doctor tells you to do so.
Liver problems
If you have liver problems, your doctor may adjust the dose.
Elderly
If you are elderly, your doctor may adjust the dose.
Use in children and adolescents
QUETIAPINE DOC must not be used in children and adolescents under 18 years of age.
If you take more QUETIAPINE DOC than you should
If you take more QUETIAPINE DOC than prescribed by your doctor, you may feel drowsy, dizzy, or
experience an abnormal heartbeat. Contact your doctor or the nearest hospital immediately. Take the
QUETIAPINE DOC packaging with you.
If you forget to take QUETIAPINE DOC
If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose,
wait and take the next dose at the scheduled time. Do not take a double dose to make up for a missed
tablet.
If you stop taking QUETIAPINE DOC
If you stop treatment with QUETIAPINE DOC suddenly, you may have difficulty sleeping (insomnia),
feel unwell (nausea), or experience headache, diarrhoea, feeling unwell (vomiting), dizziness or
irritability.
Your doctor may advise you to gradually reduce the dose before stopping treatment.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. 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.
  • Drowsiness (which diminishes over time with continued treatment with QUETIAPINE DOC) (may lead to falls).
  • Withdrawal symptoms (symptoms that occur when you stop taking QUETIAPINE DOC), including inability to sleep (insomnia), nausea, headache, diarrhoea, vomiting, dizziness, and irritability. Gradual discontinuation of the medicine over a period of at least 1 or 2 weeks is recommended.
  • Increase in body weight.
  • Abnormal muscle movements, including difficulty initiating muscle movement, tremor, feeling of restlessness, or muscle stiffness without pain.
  • Changes in levels of certain blood lipids (triglycerides and total cholesterol).

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

  • Fast heartbeat.
  • Awareness of heartbeat (palpitations), feeling that the heart is racing, pounding, or irregular.
  • Constipation, stomach discomfort (indigestion).
  • Feeling weak.
  • Swelling of arms or legs.
  • Low blood pressure when standing up. This may cause dizziness or fainting (which may lead to falls).
  • Increased blood sugar levels.
  • Blurred vision.
  • Abnormal dreams and nightmares.
  • Increased appetite.
  • Irritability.
  • Speech and language disturbances.
  • Suicidal thoughts and worsening of depression.
  • Shortness of breath.
  • Vomiting (especially in elderly people).
  • Fever.
  • Changes in thyroid hormone levels in blood.
  • Reduction in the number of certain types of blood cells.
  • Increase in liver enzyme levels in blood.
  • Increase in prolactin hormone levels in blood. Elevated prolactin levels may rarely lead to the following:
    o Men and women may experience breast enlargement and unexpected production of breast milk.
    o Women may experience absent or irregular menstrual cycles.

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

  • Seizures or epileptic fits.
  • Allergic reactions including swellings (hives), skin swelling, and swelling around the mouth.
  • Unpleasant sensation in legs (also known as restless legs syndrome).
  • Difficulty swallowing.
  • Uncontrollable movements, mainly of the face or tongue.
  • Sexual dysfunction.
  • Diabetes.
  • Changes in the heart's electrical activity seen on ECG (prolongation of QT interval).
  • Slowing of the normal heart rate, which may occur when starting treatment and may be associated with low blood pressure and fainting.
  • Difficulty urinating.
  • Fainting (may lead to falls).
  • Nasal congestion.
  • Reduction in the number of red blood cells in blood.
  • Reduction in sodium levels in blood.
  • Worsening of pre-existing diabetes.
  • Confusion.

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

  • High body temperature (fever) associated with sweating, muscle stiffness, pronounced drowsiness or fainting (a condition called "neuroleptic malignant syndrome").
  • Yellowing of the skin and eyes (jaundice).
  • Inflammation of the liver (hepatitis).
  • Prolonged and painful erection (priapism).
  • Breast enlargement and unexpected milk production from mammary gland (galactorrhoea).
  • Menstrual disorders.
  • Blood clots in veins, especially in the legs (symptoms include swelling, pain, and redness in the legs), which may travel through blood vessels to the lungs, causing chest pain and breathing difficulties. If you notice any of these symptoms, contact your doctor immediately.
  • Walking, talking, eating, or other activities during sleep.
  • Decrease in body temperature (hypothermia).
  • Inflammation of the pancreas.
  • A condition (called "metabolic syndrome") in which you may have a combination of 3 or more of the following symptoms: increased abdominal fat, decreased "good cholesterol" (HDL-C), increased levels of a type of blood fat called triglycerides, high blood pressure, and increased blood sugar levels.
  • Combination of fever, flu-like symptoms, sore throat, or any other infection with a very low white blood cell count, a condition called agranulocytosis.
  • Intestinal obstruction.
  • Increased blood levels of creatine phosphokinase (a substance from muscles).

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

  • Severe skin rash, blisters, or red patches on the skin.
  • Severe allergic reaction (called anaphylaxis), which may cause difficulty breathing or shock.
  • Rapid swelling of the skin, usually around the eyes, lips, and throat (angioedema).
  • Severe condition characterized by blister formation on the skin, in the mouth, eyes, and genitals (Stevens-Johnson syndrome). See section 2.
  • Inappropriate secretion of the hormone controlling urine volume (syndrome of inappropriate antidiuretic hormone secretion, SIADH).
  • Damage to muscle fibres and muscle pain (rhabdomyolysis).

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

  • Skin rash associated with appearance of irregular red patches (erythema multiforme). See section 2.
  • Rapid appearance of red skin areas with small pustules (small blisters filled with white/yellow fluid called Acute Generalized Exanthematous Pustulosis (AGEP)). See section 2.
  • Sudden, severe allergic reaction with symptoms such as fever, blistering of the skin, and skin peeling (toxic epidermal necrolysis). See section 2.
  • Drug rash with Eosinophilia and Systemic Symptoms (DRESS), consisting of flu-like symptoms with skin rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and increased liver enzymes). See section 2.
  • Withdrawal symptoms may occur in newborns of mothers who used quetiapine during pregnancy.
  • Stroke.
  • Heart muscle disorder (cardiomyopathy).
  • Inflammation of the heart muscle (myocarditis).
  • Inflammation of blood vessels (vasculitis), often with a skin rash showing small red or purple bumps.

The class of medicines to which QUETIAPINE DOC belongs may cause problems with heart rhythm, which can be serious and, in some cases, fatal.
Some side effects can only be detected through blood tests. These include changes in levels of certain blood lipids (triglycerides and total cholesterol) or blood sugar, changes in blood levels of thyroid hormones, increased liver enzymes, reduced number of certain types of blood cells, reduced number of red blood cells, increased serum creatine phosphokinase (a substance from muscles), reduced sodium levels in blood, and increased levels of prolactin hormone in blood. Elevated prolactin levels may, in rare cases, lead to the following consequences:
o Men and women may experience breast enlargement and unexpected production of breast milk.
o Women may experience absent or irregular menstrual cycles.
Therefore, your doctor may prescribe periodic blood tests.

Additional side effects in children and adolescents
The same side effects observed in adults may also occur in children and adolescents.
The following side effects have been observed more frequently in children and adolescents, or were not reported in adults:

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

  • Increased blood levels of a hormone called prolactin. Elevated prolactin levels may rarely lead to the following:
    o Boys and girls may experience breast enlargement and unexpected production of breast milk.
    o Girls may experience absent or irregular menstrual cycles.
  • Increased appetite.
  • Vomiting.
  • Abnormal muscle movements, including difficulty initiating muscle movement, tremor, feeling of restlessness, or muscle stiffness without pain.
  • Increased blood pressure.

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

  • Weakness, fainting (may lead to falls).
  • Nasal congestion.
  • Irritability.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store QUETIAPINA DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after “Exp”. The expiry date refers to the last day of that month.
QUETIAPINA DOC does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What QUETIAPINA DOC contains

  • The active substance is quetiapine. QUETIAPINA DOC contains 50 mg, 150 mg, 200 mg, 300 mg, 400 mg, or 600 mg of quetiapine (as quetiapine fumarate).
  • The other components are: Core of the tablet: lactose, methacrylic acid-ethyl acrylate copolymer (1:1), type A, crystalline maltose, magnesium stearate and talc. Tablet coating: methacrylic acid-ethyl acrylate copolymer (1:1), type A, triethyl citrate.

Description of the appearance of QUETIAPINA DOC and contents of the pack
The 50 mg prolonged-release tablets are white to almost white, round, biconvex tablets, engraved with '50' on one side, 7.1 mm in diameter and 3.2 mm thick.
The 150 mg prolonged-release tablets are white to almost white, oblong, biconvex tablets, engraved with '150' on one side, 13.6 mm long, 6.6 mm wide and 4.2 mm thick.
The 200 mg prolonged-release tablets are white to almost white, oblong, biconvex tablets, engraved with '200' on one side, 15.2 mm long, 7.7 mm wide and 4.8 mm thick.
The 300 mg prolonged-release tablets are white to almost white, oblong, biconvex tablets, engraved with '300' on one side, 18.2 mm long, 8.2 mm wide and 5.4 mm thick.
The 400 mg prolonged-release tablets are white to almost white, oval, biconvex tablets, engraved with '400' on one side, 20.7 mm long, 10.2 mm wide and 6.3 mm thick.
The 600 mg prolonged-release tablets are white to almost white, oval, biconvex tablets, engraved with '600' on one side, 22.7 mm long, 10.2 mm wide and 8.1 mm thick.
QUETIAPINA DOC is available in PVC/PCTFE-aluminum blisters packed in cardboard boxes.
QUETIAPINA DOC 50 mg: 10, 20, 30, 50, 60 and 100 tablets.
QUETIAPINA DOC 150 mg: 10, 20, 30, 50, 60 and 100 tablets.
QUETIAPINA DOC 200 mg: 10, 20, 30, 50, 60 and 100 tablets.
QUETIAPINA DOC 300 mg: 10, 20, 30, 50, 60 and 100 tablets.
QUETIAPINA DOC 400 mg: 10, 20, 30, 50, 60 and 100 tablets.
QUETIAPINA DOC 600 mg: 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
DOC Generici S.r.l., Via Turati 40, 20121 Milan, Italy.
Manufacturers:
Pharmathen International S.A.
Industrial Park Sapes, Rodopi Prefecture, Block 5, 69300 Rodopi, Greece.
Pharmathen S.A.
6, Dervenakion str., Pallini, Attiki, 15351 Greece.

This medicinal product is authorized in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following trade names:
Austria Quetialan XR 50 mg, 150 mg, 200 mg, 300 mg, 400 mg Retardtabletten
Cyprus Queloran
Germany Quetiapin-Hormosan 50 mg, 150 mg, 200 mg, 300 mg, 400 mg Retardtabletten
Denmark Antoreq
Greece Megazon
Spain Quetiapina Aurovitas Pharma
Finland Queloran
Italy QUETIAPINA DOC
Portugal Quetiapina Bluepharma LP
Sweden Quetiapin 1A Farma
United Kingdom Zaluron XL
(Northern Ireland)