Xetamed

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Xetamed 25 mg film-coated tablets, 50 mg film-coated tablets, 100 mg film-coated tablets, 150 mg film-coated tablets, 200 mg film-coated tablets, 300 mg film-coated tablets, 400 mg film-coated tablets

Quetiapine
Generic medicine
Please read all of 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 others, even if their symptoms are the same as yours, because it could 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 Xetamed is and what it is used for
2. What you need to know before taking Xetamed
3. How to take Xetamed
4. Possible side effects
5. How to store Xetamed
6. Contents of the pack and other information

1. What Xetamed is and what it is used for

Xetamed contains a substance called quetiapine which belongs to a group of
medicines known as antipsychotics. Xetamed can 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 aggressive or destructive behaviour.
• 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 to prescribe Xetamed film-coated tablets even if you
are feeling better.

2. What you should know before taking Xetamed

Do not take Xetamed

• If you are allergic (hypersensitive) 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 antiviral drugs for HIV, antifungal azole medications, erythromycin or clarithromycin (for infections), or nefazodone (for depression).

If you have any doubts, consult your doctor or pharmacist before taking Xetamed.

Warnings and precautions

Talk to your doctor or pharmacist before taking Xetamed film-coated tablets if:

• You or someone in your family has or has previously had 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 Xetamed.
• 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 certain brain functions). In this case, Xetamed should not be taken, as this class of medicines to which Xetamed 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 conditions related to blood clots, since medicines of this type may increase the risk of blood clot formation.
• You have or have previously had a condition (called "sleep apnoea") in which you stop breathing for short periods during normal sleep, and you are taking medicines that slow down normal brain activity ("depressants").
• You have or have previously had a condition in which you are unable to completely empty your bladder (urinary retention), have an enlarged prostate, intestinal obstruction, or increased pressure inside the eye. These conditions are sometimes caused by medicines (called "anticholinergics") that affect how nerve cells function and are used to treat certain medical conditions.
• You have previously had problems related to alcohol or drug abuse.

Contact your doctor immediately if you experience any of the following symptoms after taking Xetamed:

• Fever associated with severe muscle stiffness, sweating, or reduced 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 stopping Xetamed and/or starting appropriate treatment.
• Constipation associated with persistent abdominal pain or constipation that has not responded to treatment, as this could lead to a more serious intestinal blockage.
• Suicidal thoughts and worsening of depression If you are depressed, you may sometimes feel the need to harm yourself or to take your own life. These feelings may be stronger at the beginning of treatment, as 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 experience 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 under 25 years of age with depression.

If you notice persistent thoughts of self-harm or suicide, contact your doctor or go to the hospital immediately. It may be helpful to inform a close family member or friend that you suffer from depression and ask them to read this leaflet. You may also ask them to alert you if they think your depression is worsening or if they are concerned about changes in your behaviour.

• Drug rash with eosinophilia and systemic symptoms (DRESS). Widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and involvement of other organs (Drug rash with eosinophilia and systemic symptoms, also known by the English acronym DRESS, also referred to as drug hypersensitivity syndrome).
  Stop using Xetamed if you develop these symptoms and contact your doctor or seek immediate medical help.

Weight gain
Weight gain has been reported in patients treated with quetiapine. It is important that your body weight is regularly monitored by both you and your doctor.

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

Other medicines and Xetamed
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not take Xetamed if you are taking any of the following medicines:

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

Tell 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 ("water pills" that increase urine production) or certain antibiotics (medicines for treating infections).
• Medicines that may cause constipation.
• Medicines (called "anticholinergics") that affect how nerve cells function and are used to treat certain medical conditions.

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

Xetamed with food, drinks, and alcohol

• Xetamed can be taken regardless of meals.
• Be cautious about the amount of alcohol you consume. This is important because the combined effect of Xetamed and alcohol may increase drowsiness.
• Do not drink grapefruit juice while taking Xetamed, 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 must not take Xetamed during pregnancy without first discussing it with your doctor.
Xetamed must not be taken during breastfeeding.
The following symptoms, which may represent withdrawal, have been observed in newborns whose mothers took Xetamed 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 machinery until you know how the tablets affect you.

Xetamed contains lactose and sodium
Xetamed contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially "sodium-free".

Effect on urine screening tests
If you need to undergo a urine drug screening test, taking Xetamed may result in false-positive results for methadone or certain antidepressants called 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.

3. How to take Xetamed

Take this medicine exactly as your doctor has instructed. 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 will 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 Xetamed, 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
Xetamed must not be used in children and adolescents under 18 years of age.
50, 100, 200, 300, 400 mg: The tablets may be divided into equal doses.

If you take more Quetiapina FB Healt than you should
If you take more Xetamed than prescribed by your doctor, you may feel drowsy, dizzy, or experience an abnormal heartbeat. Contact your doctor or the nearest hospital immediately, and take the Xetamed packaging with you.

If you forget to take Xetamed
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 forgotten tablet.

If you stop taking Xetamed
If you stop treatment with Xetamed suddenly, you may experience difficulty sleeping (insomnia), feel unwell (nausea), or develop 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 questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not
everyone 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 diminishes over time with continued treatment with Xetamed) (which may lead to falls).
• Withdrawal symptoms (symptoms occurring when you stop taking Xetamed), including inability to sleep (insomnia), feeling unwell (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 fats (triglycerides and total cholesterol).

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

• Fast heartbeat.
• Sensation of rapid or pounding heartbeat, or sensation of missed heartbeats.
• Constipation, stomach discomfort (indigestion).
• Feeling of weakness.
• 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 feeling of hunger.
• Irritability.
• Difficulties with speech and language.
• Suicidal thoughts and worsening of depression.
• Shortness of breath.
• Vomiting (especially in elderly patients).
• Fever.
• Changes in levels of thyroid hormones in the blood.
• Reduction in the number of certain types of blood cells.
• Increase in liver enzyme levels measured in blood.
• Increase in blood levels of the hormone prolactin. Elevated prolactin levels may rarely lead to the following:
  o Breast enlargement and unexpected milk production in both men and women.
  o Women may experience absent or irregular menstrual cycles.

Uncommon side effects (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 the legs (also known as restless legs syndrome).
• Difficulty swallowing.
• Involuntary 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 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).
• Persistent and painful erection (priapism).
• Breast enlargement and unexpected milk production from the mammary gland (galactorrhea).
• 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.
• 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 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 known as agranulocytosis.
• Intestinal obstruction.
• Increased blood levels of creatine phosphokinase (a substance from muscles).

Very rare side effects (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 breathing difficulties 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 controlling urine volume.
• Muscle fiber damage and muscle pain (rhabdomyolysis).

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

• Skin rash associated with appearance of irregular red patches (erythema multiforme).
• Severe sudden 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 Xetamed during pregnancy.
• Stroke.
• Drug reaction with eosinophilia and systemic symptoms (DRESS). Widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes and involvement of other body organs (Drug reaction with eosinophilia and systemic symptoms, also known by the English acronym DRESS, also known as drug hypersensitivity syndrome). Stop using Xetamed if you develop these symptoms and contact your doctor or seek immediate medical help.
• The class of medicines to which Xetamed belongs can cause problems with heart rhythm, which may be serious and, in some cases, fatal.

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 numbers of
certain types of blood cells, reduced red blood cell count, increased serum creatine
phosphokinase (a substance from muscles), reduced sodium levels in the blood, and
increased blood levels of the hormone prolactin. 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 will 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. Elevated prolactin levels may, in rare cases, lead to the following consequences:
  o Breast enlargement and unexpected milk production from the mammary gland in both boys and girls.
  o Absence or irregularity of menstrual cycles in girls.
• Increased appetite.
• Vomiting.
• Abnormal muscle movements, including difficulty initiating muscle movement, tremor, feeling of restlessness, or muscle stiffness without pain.
• Increased blood pressure.

Common side effects (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 effect, including those not listed in this leaflet,
please inform your doctor or pharmacist. You may also report side effects
directly via the national reporting system at
www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects helps provide
more information on the safety of this medicine.

5. How to store Xetamed

• 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 the abbreviation EXP. The expiry date refers to the last day of the month indicated.
• No special storage precautions required.
• 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 Xetamed contains:

• The active substance is quetiapine. Xetamed tablets contain 25 mg, 50 mg, 100 mg, 150 mg, 200 mg, 300 mg or 400 mg of quetiapine (as quetiapine fumarate).

The other components are:
Tablet core: lactose monohydrate, microcrystalline cellulose, povidone (K=25),
sodium starch glycolate type A, glyceryl dibehenate, colloidal anhydrous silica, magnesium
stearate.
Tablet coating: lactose monohydrate, hypromellose, titanium dioxide (E171),
macrogol 4000 and red iron oxide (E172) (for Xetamed 25 mg) and yellow iron oxide
(E172) (for Xetamed 100 mg).

Description of the appearance of Xetamed and contents of the pack
Xetamed 25 mg film-coated tablets are pink, round and biconvex.
Diameter: 6 mm
Xetamed 50 mg film-coated tablets are white, round, biconvex, with a score on one side.
Diameter: 8 mm
Xetamed 100 mg film-coated tablets are yellow, round, biconvex, with a score on one side.
Diameter: 10 mm
Xetamed 150 mg film-coated tablets are white, round and biconvex.
Diameter: 11 mm
Xetamed 200 mg film-coated tablets are white, round, biconvex, with a score on one side.
Diameter: 12 mm
Xetamed 300 mg film-coated tablets are white, oblong-shaped, biconvex, with a score on one side.
Major diameter: 20 mm
Minor diameter: 8 mm
Xetamed 400 mg film-coated tablets are white, oblong-shaped, biconvex, with a score on both sides.
Major diameter: 21 mm
Minor diameter: 10 mm

Pack sizes available:
25 mg: 6, 20, 24, 30, 48, 60, 96 and 100 film-coated tablets
50 mg, 150 mg, 200 mg: 12, 48, 96 and 60 film-coated tablets
100 mg: 24, 48, 96 and 60 film-coated tablets
300 mg, 400 mg: 10, 50, 60 and 100 film-coated tablets
Not all pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Neuraxpharm Italy S.p.A.
Via Piceno Aprutina, 47
63100 – Ascoli Piceno (AP)
Italy

Manufacturer:
Laboratorios Lesvi S.L.
Av. Barcelona, 69
08970 – Sant Joan Despí
Barcelona
Spain

This medicinal product is authorized in the European Economic Area countries under the following names: