XETAMED 25 mg Tabletki Powlekane

Treść ulotki

1. Xetamed 25 mg film-coated tablets, 50 mg film-coated tablets, 100 mg film-coated tablets, 150 mg film-coated tablets
   1. What is Xetamed and what is it 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. Package Contents and Other Information

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

Xetamed 200 mg film-coated tablets
Xetamed 300 mg film-coated tablets
Xetamed 400 mg film-coated tablets
Quetiapine
Generic medicine

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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Xetamed and what is it used for

Xetamed contains a substance called quetiapine which belongs to a group of
medicines called antipsychotics. Xetamed can be used to treat several illnesses,
such as the following:

• Bipolar depression: you may feel sad, or depressed, with feelings of guilt, lacking energy, lacking appetite or having difficulty falling asleep.
• Mania: you may feel very excited, euphoric, agitated, enthusiastic or hyperactive or have poor judgement, including states of aggression or destructiveness.
• Schizophrenia: you may have the sensation of hearing or feeling things that are not actually present, you may become convinced of things that are not true or you may feel unusually suspicious, anxious, confused, with feelings of guilt, tense or depressed.

Your doctor may continue to prescribe Xetamed film-coated tablets even if you
feel better.

2. What you need to know before taking Xetamed

Do not take Xetamed

• If you are allergic (hypersensitive) to quetiapine or any of the other ingredients of this medicine (listed in section 6).
• If you are taking any of the following medicines: o some medicines for the HIV virus o azole medicines (for infections caused by fungi) o erythromycin or clarithromycin (for infections) o nefazodone (for depression).

If you have any doubts, ask 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 had heart problems in the past, for example, irregular heartbeat, weakening of the heart muscle or inflammation of the heart or if you are taking medicines that can affect your heartbeat.
• Your blood pressure is low.
• You have had a stroke, especially if you are elderly.
• You have liver problems.
• You have suffered from convulsions (seizures).
• You suffer from diabetes or are at risk of developing diabetes. In this case, your doctor may check your blood sugar levels while you are taking Xetamed.
• You are aware that you have had low levels of white blood cells in your blood in the past (whether or not caused by other medicines).
• You are an elderly person suffering from dementia (loss of some brain functions). In this case, you should not take Xetamed, because this class of medicines, to which Xetamed belongs, can increase the risk of stroke, or in some cases the risk of death in elderly patients with dementia.
• You are an elderly person suffering from Parkinson's disease/parkinsonism.
• You or someone in your family has a history of blood clot-related disorders, as this type of medicine can promote blood clot formation.
• You have or have had a condition (called “sleep apnea”) in which you stop breathing for short periods during normal nighttime sleep and are taking medicines that slow down normal brain activity (“depressants”).
• You have or have had a condition in which you cannot completely empty your bladder (urinary retention), have an enlarged prostate, a blockage of the intestine, or increased pressure inside the eye. These conditions are sometimes caused

by medicines (called “anticholinergics”), which affect how nerve cells
function and are used to treat certain medical conditions.

• If you have had problems with alcohol or drug abuse in the past.

Immediately inform your doctor if you experience the following symptoms after taking
Xetamed:

• Fever accompanied by severe muscle stiffness, sweating or decreased level of consciousness (a condition called “neuroleptic malignant syndrome”). You may need immediate medical attention.
• Uncontrollable movements, especially of the face or tongue.
• Dizziness or an intense feeling of drowsiness. This can increase the risk of accidental injuries (falls) in elderly patients.
• Convulsions (seizures).
• Persistent and painful erection (Priapism).

The following conditions may be caused by the type of medicine you are
taking.
Tell your doctor as soon as possible if you experience:

• Fever, flu-like symptoms, sore throat or any other infection, as these may be a consequence of a very low white blood cell count, which may require Xetamed to be stopped and/or treatment to be administered.
• Constipation associated with persistent abdominal pain or constipation that has not responded to treatment, as this may lead to a more serious intestinal blockage.
• Thoughts of suicide and worsening of depressionIf you are depressed, you may sometimes feel the need to harm yourself or kill yourself. These feelings may be more intense at the beginning of treatment, as these medicines take time to work, usually about two weeks but sometimes even longer. These thoughts may also intensify if you suddenly stop taking the medicine. You are more likely to have these feelings if you are a young adult. Information from clinical studies has shown an increased risk of suicidal thoughts and/or suicidal behavior in young adults under the age of 25 with depression.

If you realize you have persistent thoughts of self-harm or suicide,
contact your doctor or go to the hospital immediately. You may find it helpful to tell
a relative or close friend that you are suffering from depression, inviting them to read
depressive is getting worse or if they are concerned about changes in your
behavior.

• Drug rash with eosinophilia and systemic symptoms (DRESS).Widespread rash, high body temperature, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes and involvement of other body organs (Drug rash with eosinophilia and systemic symptoms also known as

with the English acronym DRESS and also known as drug hypersensitivity syndrome).
Stop using Xetamed if you develop these symptoms and contact your doctor or seek
immediate medical attention.

Weight gain
Weight gain has been reported in patients treated with quetiapine. It is necessary
that your body weight be checked regularly by you and your doctor.

Children and adolescents
Xetamed should 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:

• Some medicines for the HIV virus.
• Azole medicines (for infections caused by fungi).
• 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 your heartbeat, for example, medicines that can cause an electrolyte imbalance (low levels of potassium or magnesium) such as diuretics (pills that increase urine production) or some antibiotics (medicines for treating infections).
• Medicines that can cause constipation.
• Medicines (called “anticholinergics”) that affect how nerve cells function and are used to treat certain medical conditions.

Before stopping taking any medicine, talk to your doctor.

Xetamed with food, drinks and alcohol

• Xetamed can be taken independently of meals.
• Be careful about the amount of alcohol you consume. This is important because the combined effect of Xetamed and alcohol can promote drowsiness.
• Do not drink grapefruit juice while taking Xetamed, as it may affect the action of the drug.

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

Driving and using machines
The tablets can cause drowsiness. Do not drive or use any tools or 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
an intolerance to some sugars, contact them 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 screening test, taking Xetamed may generate
false positive results for methadone or some antidepressants, called tricyclic antidepressants (TCAs) when certain testing methods are used,
even if you are not taking methadone or TCAs. If this happens, more specific tests must be
performed.

3. How to take Xetamed

Take this medicine following exactly the instructions of your doctor. If you have
doubts, consult your doctor or pharmacist. The doctor will decide what the most
appropriate initial dose is for you. The maintenance dose (daily dose) will depend on the type of
disease and individual needs, but is usually between 150 mg and 800 mg.

• You will take the tablets either once a day, in the evening before going to bed, or twice a day, depending on the type of illness.
• You must swallow the tablets whole, with a sip of water.
• You can take the tablets independently of meals.
• Do not drink grapefruit juice while taking Xetamed, as it may affect the action of the medicine.
• Do not stop taking the tablets even if you feel better, unless your doctor tells you that you can.

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 can 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 sleepy, experience
dizziness and perceive an abnormal heartbeat. Contact your doctor or
the nearest hospital immediately, bringing the Xetamed package 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 to
take the next dose, wait until the scheduled time. Do not take a double dose to
make up for the missed tablet.

If you stop taking Xetamed
If you suddenly stop treatment with Xetamed, you may have difficulty
sleeping (insomnia), feel unwell (nausea), or experience headache,
diarrhea, feeling unwell (vomiting), dizziness or irritability. Your doctor may suggest that you gradually reduce
the dose before stopping treatment.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

• Dizziness (which can lead to falls), headache, dry mouth.
• Feeling sleepy (which disappears over time, continuing treatment with Xetamed) (which can lead to falls).
• Withdrawal symptoms (symptoms that appear when you stop taking Xetamed), which include inability to sleep (insomnia), feeling unwell (nausea), headache, diarrhea, vomiting, dizziness and irritability. Gradual discontinuation of the drug is recommended, over a period of at least 1 or 2 weeks.
• Weight gain.
• Abnormal muscle movements, including difficulty starting a muscle movement, tremor, feeling restless or muscle stiffness without pain.
• Changes in the amount of certain fats (triglycerides and total cholesterol).

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

• Rapid heartbeat.
• Feeling that the heart is racing, beating strongly or feeling skipped beats.
• Constipation, stomach discomfort (indigestion).
• Feeling of weakness.
• Swelling of the arms or legs.
• Low blood pressure when getting up from a sitting or lying position. This can cause dizziness or fainting (which can lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Increased feeling of hunger.
• Irritability.
• Speech and language disorders.
• Suicidal thoughts and worsening of depression.
• Shortness of breath.
• Vomiting (especially in elderly patients).
• Fever.
• Changes in the amount of thyroid hormones in the 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 which may in rare cases lead to the following: o Men and women may experience breast enlargement and unexpected milk production. o Women may experience absent or irregular menstrual cycles.

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

• Convulsions or seizures.
• Allergic reactions including welts (urticaria), swelling of the skin and around the mouth.
• Unpleasant sensation in the legs (also called restless legs syndrome).
• Difficulty swallowing.
• Involuntary movements, mainly of the face or tongue.
• Sexual dysfunction.
• Diabetes.
• Alteration of the electrical activity of the heart detected on an ECG (prolongation of the QT interval).
• A slowing of the normal heartbeat may occur when starting treatment and may be associated with low blood pressure and fainting.
• Difficulty urinating.
• Fainting (can cause falls).
• Nasal congestion.
• Reduction in the number of red blood cells.
• 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, accentuated feeling of stupor 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 the veins, especially in the legs (symptoms include swelling, pain and redness of the legs), which can move through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, contact your doctor immediately.
• Sleepwalking and other related events (such as talking in your sleep and sleep-related eating disorders).
• Decreased 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 type of fat in the blood called triglycerides, high blood pressure and increased blood sugar levels.
• Association of fever, flu-like symptoms, sore throat or any other infection with a very low white blood cell count, a condition defined as agranulocytosis.
• Intestinal obstruction.
• Increase in the blood of creatine phosphokinase (a substance from the 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 can cause difficulty breathing or shock.
• Rapid swelling of the skin, usually in the area around the eyes, lips and throat (angioedema).
• Severe condition characterized by blistering of the skin, in the mouth, eyes and genitals (Stevens-Johnson syndrome).
• Inappropriate secretion of the hormone that controls urine volume.
• Damage to muscle fibers and muscle pain (rhabdomyolysis).

Frequency not known (frequency cannot be estimated based on available data):

• Skin rash associated with the 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 appear in newborns of mothers who have used Xetamed during pregnancy.
• Stroke
• Drug reaction with eosinophilia and systemic symptoms (DRESS). Widespread rash, high temperature, increased 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 and also known as drug hypersensitivity syndrome). Stop using Xetamed if you develop these symptoms and contact your doctor or seek immediate medical attention.
• The class of medicines to which Xetamed belongs can cause problems with the heart rhythm, which can also be severe and fatal in some cases.

Some side effects are only visible after a blood test. These include changes in the amount of certain fats (triglycerides and total cholesterol) or sugars in the blood, changes in blood levels of thyroid hormones, increased liver enzymes, decreased number of certain types of blood cells, decreased amount of red blood cells, increased creatine phosphokinase serum (a substance present in muscles), decreased amount of sodium in the blood and increases in the amount of the hormone prolactin in the blood. Increases in prolactin levels may, in rare cases, have the following consequences:

• Enlargement of the breasts and unexpected milk production from the mammary gland in both men and women.
• Absence or irregularity of the menstrual cycle in women.

The doctor will therefore prescribe you blood tests from time to time.

Side effects in children and adolescents
The same side effects observed in adults can also occur in children and adolescents.
The following side effects have been reported more frequently in children and adolescents or have not been reported in adults:

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

• Increased levels in the blood of a hormone called prolactin. Increases in the hormone prolactin may, in rare cases, have the following consequences: o Enlargement of the breasts and unexpected milk production from the mammary gland in both boys and girls. o Absence or irregularity of the menstrual cycle in girls.
• Increased appetite.
• Vomiting.
• Abnormal muscle movements, including difficulty starting a muscle movement, tremor, feeling restless or muscle stiffness without pain.
• Increased blood pressure.

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

• Weakness, fainting (can cause falls).
• Nasal congestion.
• Irritability.

Reporting of side effects
If you get any side effect, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at
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 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 SCAD. The expiry date refers to the last day of the month indicated.
• No special storage precautions.
• Do not dispose of any medicine in 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 ingredient 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 ingredients are:
Tablet core: lactose monohydrate, microcrystalline cellulose, povidone (K= 25),
sodium starch glycolate type A, glycerin 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 Xetamed’s appearance and package contents
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
an inscription on one side. Diameter: 8 mm
Xetamed 100 mg film-coated tablets are yellow, round, biconvex, with
an inscription 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
an inscription on one side. Diameter: 12 mm
Xetamed 300 mg film-coated tablets are white, oblong,
biconvex, with an inscription on one side.
Major diameter: 20 mm
Minor diameter: 8 mm
Xetamed 400 mg film-coated tablets are white, oblong,
biconvex, with an inscription on both sides.
Major diameter: 21 mm
Minor diameter: 10 mm
The pack sizes are registered:
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 available on the market.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 Despì Barcelona Spain

This medicinal product is authorised in the Member States of the European Economic Area with the
following names: