Quetiapine Doc Generici

PACKAGE LEAFLET: INFORMATION FOR THE USER

QUETIAPINA DOC Generici 25 mg film-coated tablets, 100 mg film-coated tablets, 200 mg film-coated tablets, 300 mg film-coated tablets

Generic medicinal product
Please read this leaflet carefully before 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. 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 effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

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

• Bipolar depression: you may feel sad, depressed, guilty, without energy, without appetite, or have difficulty sleeping.
• Mania: you may feel highly excited, euphoric, restless, enthusiastic or hyperactive, or have poor judgment, including states of aggression or agitation.
• Schizophrenia: you may experience hearing or sensing things that are not actually present, believe things that are not true, or feel unusually suspicious, anxious, confused, guilty, tense or depressed.

Your doctor may continue prescribing QUETIAPINA DOC Generici even if you feel better.

2. What you need to know before taking QUETIAPINA DOC Generici

Do not take QUETIAPINA DOC Generici:

• if you are allergic (hypersensitive) to quetiapine or to any of the other ingredients of QUETIAPINA DOC Generici (listed in section 6: Contents of the pack and other information)
• if you are taking any of the following medicines: certain antiviral medicines for HIV, antifungal azole medicines, erythromycin or clarithromycin (for infections), or nefazodone (for depression).

Do not take QUETIAPINA DOC Generici if you fall into any of the above categories. If you have any
doubts, consult your doctor or pharmacist before taking QUETIAPINA DOC Generici.
Warnings and precautions
Talk to your doctor or pharmacist before taking QUETIAPINA DOC Generici if:

• you or someone in your family has had or has heart problems, such as irregular heartbeat, weakened heart muscle, or inflammation of the heart, or if you are taking medicines that may affect your heartbeat.
• your blood pressure is low.
• you have had a stroke, especially if you are elderly.
• you have liver problems.
• you have had 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 QUETIAPINA DOC Generici.
• you know you have previously had low levels of white blood cells (either caused by medicines or not).
• you are an elderly person with dementia (loss of some brain functions). In this case, you should not take QUETIAPINA DOC Generici, as this class of medicines to which QUETIAPINA DOC Generici belongs may increase the risk of stroke, or in some cases the risk of death in elderly patients with dementia.
• you or someone in your family has a history of conditions related to blood clots, since this type of medicine may increase the risk of blood clot formation.
• you have or have had a condition causing brief interruptions in breathing during normal sleep (called “sleep apnea”) and at the same time are taking medicines that slow down normal brain activity (“central nervous system depressants”).
• you have or have had a condition that prevents complete emptying of the bladder (urinary retention), have an enlarged prostate, suffer from intestinal obstruction, or have high intraocular pressure. In some cases, these conditions are caused by medicines (called “anticholinergics”) that affect nerve cell function to treat certain diseases.

Inform your doctor immediately if you experience any of the following symptoms after taking QUETIAPINA
DOC Generici:

• Fever associated with severe muscle stiffness, sweating, or decreased level of consciousness (a condition called “neuroleptic malignant syndrome”). Immediate medical treatment may be required.
• Uncontrollable 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). The following conditions may be caused by the type of medicine you are taking. 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 QUETIAPINA DOC Generici and/or additional treatment.
• Constipation together with persistent abdominal pain or constipation that has not responded to treatment, as these may lead to a more serious intestinal blockage.

Suicidal thoughts and worsening of depression
If you are depressed, you may occasionally have thoughts of harming yourself or of suicide. These feelings
may be stronger at the beginning of treatment, since these medicines take time to work—usually about two weeks, but sometimes longer. These thoughts may also worsen if you suddenly stop taking the medicine. You are more likely to have such feelings if you are a young adult. Clinical studies 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 experience 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 suffer from depression 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 any changes in your behaviour.
Weight gain
Weight gain has been reported in patients treated with QUETIAPINA DOC Generici. It is important that your body weight is monitored regularly by both you and your doctor.
Children and adolescents
QUETIAPINA DOC Generici must not be used in children and adolescents under 18 years of age.
Other medicines and QUETIAPINA DOC Generici
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Do not take QUETIAPINA DOC Generici if you are taking any of the following medicines:

• Certain antiviral medicines for HIV.
• Azole antifungal medicines (for fungal infections).
• Erythromycin or clarithromycin (for infections).
• Nefazodone (for depression).

Inform your doctor if you are taking any of the following medicines:

• 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 levels of potassium or magnesium), 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.
QUETIAPINA DOC Generici with food, drinks and alcohol

• QUETIAPINA DOC Generici may be taken regardless of meals.
• Be cautious about the amount of alcohol you consume. This is important because the combined effect of QUETIAPINA DOC Generici and alcohol may increase drowsiness.
• Do not drink grapefruit juice while taking QUETIAPINA DOC Generici, as it may

affect the action of the medicine.
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 QUETIAPINA DOC Generici. You must not take
QUETIAPINA DOC Generici during pregnancy without first discussing it with your doctor.
QUETIAPINA DOC Generici must not be taken during breastfeeding.
The following symptoms, which may represent withdrawal, have been observed in newborns whose mothers took QUETIAPINA DOC Generici during the third trimester (the last three months of pregnancy):
tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and difficulty feeding. 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 any 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 QUETIAPINA DOC Generici may lead to false positive results for methadone or certain antidepressants called tricyclic antidepressants (TCA), depending on the testing method used, even if you are not taking methadone or TCAs. If this occurs, more specific tests should be performed.

3. How to take QUETIAPINA DOC Generici

Take QUETIAPINA DOC Generici exactly as prescribed by your doctor. 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.

• Take the tablets either once daily, in the evening before going to bed, or twice daily, depending on the condition being treated.
• Swallow the tablets whole with a glass of water.
• You may take the tablets regardless of meals.
• Do not drink grapefruit juice while taking QUETIAPINA DOC Generici, as it may affect the medicine's action.
• Do not stop taking the tablets even if you feel better, unless your doctor tells you otherwise.

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
QUETIAPINA DOC Generici must not be used in children and adolescents under 18 years of age.
If you take more QUETIAPINA DOC Generici than you should
If you take more QUETIAPINA DOC Generici than prescribed, you may feel drowsy, dizzy, or experience an abnormal heartbeat. Contact your doctor or the nearest hospital immediately, and bring the medicine pack with you.
If you forget to take QUETIAPINA DOC Generici
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 the missed tablet.
If you stop taking QUETIAPINA DOC Generici
If you stop treatment with QUETIAPINA DOC Generici abruptly, you may experience difficulty sleeping (insomnia), feel unwell (nausea), or develop headache, diarrhoea, malaise (vomiting), dizziness, or irritability. Your doctor may advise you to gradually reduce the dose before stopping treatment.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

• Dizziness (which may lead to falls), headache, dry mouth.
• Drowsiness (which disappears over time while continuing treatment with QUETIAPINE DOC Generics) (which may lead to falls).
• Withdrawal symptoms (symptoms that occur when you stop taking QUETIAPINE DOC Generics), 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 painless muscle stiffness.
• Changes in the levels of certain blood fats (triglycerides and total cholesterol).

Common side effects (may affect less than 1 in 10 people):

• Fast heartbeat.
• Sensation of rapid or forceful heartbeat, or awareness of missed heartbeats.
• Constipation, stomach discomfort (indigestion).
• Feeling of weakness.
• Swelling of the 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 feeling of hunger.
• Irritability.
• Speech and language disturbances.
• Suicidal thoughts and worsening of depression.
• Shortness of breath.
• Vomiting (especially in elderly patients).
• Fever.
• Changes in the levels of thyroid hormones in the blood.
• Reduction in the number of certain types of blood cells.
• Increase in the levels of liver enzymes measured in the blood.
• Increase in the level of prolactin hormone in the blood. Elevated prolactin levels may rarely lead to the following:
  • Breast enlargement and unexpected production of breast milk in both men and women.
  • In women, absence or irregularity of menstrual cycles.

Uncommon side effects (may affect less than 1 in 100 people):

• Seizures or epileptic fits.
• Allergic reactions including swellings (wheals), skin swelling, and swelling around the mouth.
• Unpleasant sensation in the 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 the QT interval).
• A slowing of the normal heart rate 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 the blood.
• Reduction in the amount of sodium in the blood.
• Worsening of pre-existing diabetes.

Rare side effects (may affect less than 1 in 1,000 people):

• High body temperature (fever) associated with sweating, muscle stiffness, marked 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 production of milk from the mammary gland (galactorrhoea).
• Menstrual disorders.
• Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the legs), which may travel through the bloodstream to the lungs, causing chest pain and breathing difficulties. If you experience any of these symptoms, contact your doctor immediately.
• Sleepwalking and other related events (such as talking during sleep and sleep-related eating disorders).
• 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 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 known as agranulocytosis.
• Intestinal obstruction.
• Increased blood levels of creatine phosphokinase (a substance from muscles).

Very rare side effects (may affect less than 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).
• Inappropriate secretion of the hormone that controls urine volume (syndrome of inappropriate antidiuretic hormone secretion, SIADH).
• Muscle fibre damage 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).
• Sudden, severe allergic reaction with symptoms such as fever, blistering of the skin, and skin peeling (toxic epidermal necrolysis).
• Withdrawal symptoms may occur in newborns of mothers who used QUETIAPINE DOC Generics during pregnancy. The class of medicines to which QUETIAPINE DOC Generics belongs may cause disturbances in heart rhythm, which can be serious and even fatal in some cases.

Some side effects are only detectable after a blood test. These include changes in levels of certain blood fats (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 the blood, and increased levels of prolactin hormone in the blood. Elevated prolactin levels may, in rare cases, lead to the following consequences:

• Breast enlargement and unexpected milk production from the mammary gland in both men and women.
• Absence or irregularity of menstrual cycles in women. Your doctor may therefore prescribe periodic blood tests.

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 reported more frequently in children and adolescents, or were not reported in adults:

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

• Increased blood levels of a hormone called prolactin. In rare cases, these increased prolactin levels may cause the following conditions:
  • Breast enlargement and unexpected milk production from the mammary gland in boys and girls.
  • Absence or irregularity of menstrual cycles in girls.
• Increased appetite.
• Vomiting.
• Abnormal muscle movements, including difficulty initiating muscle movement, tremor, feeling of restlessness, or painless muscle stiffness.
• Increased blood pressure.

Common side effects (may affect less than 1 in 10 people):

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

Reporting of side effects
If you experience any side effect, 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: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store QUETIAPINE DOC Generici

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

6. Package contents and other information

What QUETIAPINA DOC Generici contains
The active substance is quetiapine fumarate.
One tablet of QUETIAPINA DOC Generici 25 mg film-coated tablets contains 28.8 mg of
quetiapine fumarate, equivalent to 25 mg of quetiapine.
One tablet of QUETIAPINA DOC Generici 100 mg film-coated tablets contains 115.1 mg of
quetiapine fumarate, equivalent to 100 mg of quetiapine.
One tablet of QUETIAPINA DOC Generici 200 mg film-coated tablets contains 230.1 mg of
quetiapine fumarate, equivalent to 200 mg of quetiapine.
One tablet of QUETIAPINA DOC Generici 300 mg film-coated tablets contains 345.2 mg of
quetiapine fumarate, equivalent to 300 mg of quetiapine.
The other ingredients are: croscarmellose sodium, anhydrous colloidal silica, fumaric acid, ethylcellulose,
magnesium stearate, hypromellose, hydroxypropylcellulose, macrogol, titanium dioxide (E171). The 100 mg tablets also contain yellow iron oxide (E172). The 25 mg tablets also contain yellow iron oxide (E172) and red iron oxide (E172).
Description of the appearance of QUETIAPINA DOC Generici and package contents
QUETIAPINA DOC Generici 25 mg film-coated tablets are peach-colored, round, biconvex, film-coated tablets, marked with 'APO' on one side and 'QUE' above '25' on the other side.
QUETIAPINA DOC Generici 100 mg film-coated tablets are yellow-colored, round, biconvex, film-coated tablets, marked with 'APO' on one side and 'QUE' above '100' on the other side.
QUETIAPINA DOC Generici 200 mg film-coated tablets are white, round, biconvex, film-coated tablets, marked with 'APO' on one side and 'QUE' above '200' on the other side.
QUETIAPINA DOC Generici 300 mg film-coated tablets are white, capsule-shaped, film-coated tablets, marked with 'APO' on one side and 'QUE' above '300' on the other side.
The 25 mg strength is available in blisters of 6, 30, and 60 tablets. The 100 mg strength is available in blisters of 60 tablets. The 200 mg and 300 mg strengths are available in blisters of 60 and 100 tablets. The 25 mg, 100 mg, 200 mg, and 300 mg strengths are also available in HDPE bottles containing 30 and 100 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 Milano - Italy.
Manufacturer:
Apotex Nederland B.V. - Archimedesweg 2 - 2333 CN Leiden – The Netherlands.