Quetiapine PensA: detailed information

Package leaflet: Information for the user

Quetiapine PENSA 25 mg, 100 mg, 150 mg, 200 mg, 300 mg film-coated tablets

Quetiapine
Generic medicine
Read this entire 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 adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See Section 4.

Contents of this leaflet:

What Quetiapine PENSA is and what it is used for
What you need to know before taking Quetiapine PENSA
How to take Quetiapine PENSA
Possible side effects
How to store Quetiapine PENSA
Contents of the pack and other information

1. What Quetiapina PENSA is and what it is used for

Quetiapina PENSA contains a substance called quetiapine. This substance belongs to a group of medicines known as antipsychotics. Quetiapina PENSA may be used to treat several conditions, such as:

Bipolar depression: you may feel sad, depressed, guilty, without energy, with loss of appetite or difficulty sleeping.
Mania: you may feel highly excited, euphoric, restless, enthusiastic or hyperactive, or have poor judgment, including aggressive or destructive behaviors.
Schizophrenia: you may experience sensations or hear 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 PENSA even if you are feeling better.

2. What you should know before taking Quetiapine PENSA

Do not take Quetiapine PENSA:

if you are allergic to quetiapine or to any of the other ingredients of Quetiapine PENSA (listed in Section 6: Further information)
if you are taking any of the following medicines:
- certain medicines for HIV virus
- azole antifungals (for fungal infections)
- erythromycin or clarithromycin (for infections)
- nefazodone (for depression).

If you have any doubts, consult your doctor or pharmacist before taking Quetiapine PENSA film-coated tablets.
Warnings and precautions
Talk to your doctor or pharmacist before taking Quetiapine PENSA 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 suffer from 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 Quetiapine PENSA film-coated tablets.
You know you have previously had low levels of white blood cells in your blood (whether caused by other medicines or not).
You are an elderly person with dementia (loss of some brain functions). In this case, Quetiapine PENSA film-coated tablets should not be taken, as this class of medicines to which Quetiapine PENSA 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, as medicines of this type may promote blood clot formation.
You have or have previously had a condition (called “sleep apnoea”) where you stop breathing briefly during normal night sleep and you are taking medicines that slow down normal brain activity (“depressants”).
You have or have previously had a condition where you cannot fully 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 a history of alcohol or drug abuse.

Inform your doctor immediately if you experience any of the following symptoms after taking Quetiapine PENSA
film-coated tablets:

Fast or irregular heartbeat, even at rest, palpitations, breathing difficulties, chest pain, or unexplained tiredness. Your doctor will need to check your heart and, if necessary, refer you immediately to a cardiologist.
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 a strong feeling of 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 Quetiapine PENSA and/or starting appropriate treatment.
Constipation together with persistent abdominal pain or constipation that has not responded to treatment, as these could lead to a more serious intestinal blockage.
Suicidal thoughts and worsening depression. If you are depressed, you may sometimes feel the need to harm yourself or to kill yourself. 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 intensify if you suddenly stop taking the medicine. You are more likely to have such feelings if you are a young adult. Data from clinical trials have shown an increased risk of suicidal thoughts and/or suicidal behaviour in young adults with depression under 25 years of age. If at any time you notice that you are having thoughts of self-harm or suicide, contact your doctor or go immediately to hospital. You may find it helpful to tell 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.
Severe cutaneous adverse reactions (SCARs)
Severe cutaneous adverse reactions (SCARs), which may be potentially life-threatening or fatal, have been reported very rarely during treatment with this medicine. These commonly include:

Stevens-Johnson syndrome (SJS), a widespread 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), a rash with irregular, red, itchy spots

Stop using Quetiapine PENSA if you develop any of these symptoms and contact your doctor or seek immediate medical assistance.
Weight gain
Weight gain has been reported in patients treated with Quetiapine PENSA film-coated tablets. It is important that your body weight is monitored regularly by both you and your doctor.
Children and adolescents
Quetiapine PENSA must not be used in children and adolescents under 18 years of age.
Other medicines and Quetiapine PENSA
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Do not take Quetiapine PENSA film-coated tablets if you are taking any of the following medicines:

Certain medicines for HIV virus.
Azole antifungals (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 heartbeat, 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 used to treat 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 talking to your doctor.
Quetiapine PENSA with food, drinks and alcohol

Quetiapine PENSA can be taken regardless of meals.
Be cautious about the amount of alcohol you consume. This is important because the combined effect of Quetiapine PENSA and alcohol may increase drowsiness.
Do not drink grapefruit juice while taking Quetiapine PENSA, 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 Quetiapine PENSA. You must not take Quetiapine PENSA during pregnancy without first discussing it with your doctor. Quetiapine PENSA must not be taken during breastfeeding.
The following symptoms, which may represent withdrawal, have been observed in newborns whose mothers took Quetiapine PENSA 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 any tools or machinery until you know how the tablets affect you.
Quetiapine PENSA contains lactose
Quetiapine PENSA contains lactose, a type of sugar. If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
Quetiapine PENSA contains sodium
Quetiapine PENSA contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.
Effect on urine drug screening tests
If you need to undergo a urine drug screening test, taking Quetiapine PENSA may lead to 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. If this occurs, more specific tests should be performed.

3. How to take Quetiapine PENSA

Take Quetiapine PENSA exactly as directed 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.

You will take the tablets either once daily, in the evening before going to bed, or twice daily, depending on the type of condition.
Swallow the tablets whole with a glass of water.
You may take the tablets regardless of meals.
Do not drink grapefruit juice while taking Quetiapine PENSA, 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 your dose.
Elderly
If you are elderly, your doctor may adjust your dose.
Use in children and adolescents
Quetiapine PENSA must not be used in children and adolescents under 18 years of age.
If you take more Quetiapine PENSA than you should
If you take more Quetiapine PENSA than prescribed, you may feel drowsy, dizzy, or experience an abnormal heartbeat. Contact your doctor or the nearest hospital immediately, taking the Quetiapine PENSA pack with you.
If you forget to take Quetiapine PENSA
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 Quetiapine PENSA
If you stop treatment with Quetiapine PENSA suddenly, 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 the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Quetiapina PENSA can cause side effects, although not everybody gets them.

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

Dizziness (which may lead to falls), headache, dry mouth.
Drowsiness (which fades over time as treatment with Quetiapina PENSA continues) (may lead to falls).
Withdrawal symptoms (symptoms that occur when you stop taking Quetiapina PENSA), 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 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 forceful heartbeat or awareness of irregular heartbeats.
Constipation, stomach discomfort (indigestion).
Feeling of weakness.
Swelling of arms or legs.
Low blood pressure upon standing (orthostatic hypotension). 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 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 in blood tests.
Increase in prolactin hormone levels in the blood.
Increased prolactin levels which may rarely lead to the following:
- Men and women may experience breast enlargement and unexpected production of breast milk.
- 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 sensations 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).
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.
Decrease in the number of red blood cells in the blood.
Decrease in sodium levels in the blood.
Worsening of pre-existing diabetes.
Confusion.

Rare side effects (may affect up to 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 (galactorrhea).
Menstrual disorders.
Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of 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 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). See section 2.
Inappropriate secretion of the hormone that controls urine volume (syndrome of inappropriate antidiuretic hormone secretion, SIADH).
Damage to muscle fibres and muscle pain (rhabdomyolysis).

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

Skin rash associated with appearance of irregular red patches (erythema multiforme). See section 2.
Rapid onset of areas of red skin covered 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 Reaction 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 Quetiapina PENSA 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 Quetiapina PENSA belongs can cause problems with heart rhythm, which may be serious and, in some cases, fatal.

Some side effects are only detectable through blood tests. 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 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. Increased levels of prolactin hormone may, in rare cases, lead to the following consequences:

Breast enlargement and unexpected production of milk from the mammary gland in both men and women.
Absence or irregularity of menstrual cycles in women.

Therefore, your doctor will periodically prescribe blood tests for you.

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 increases in 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 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, 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 Quetiapine PENSA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after Exp. The expiry date refers to the last day of that month.
This medicine 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 PENSA contains

The active substance is quetiapine. Quetiapina PENSA contains 25 mg, 100 mg, 150 mg, 200 mg or 300 mg of quetiapine (as quetiapine fumarate).
The other components are:

Tablet core: povidone, calcium hydrogen phosphate dihydrate, microcrystalline cellulose, sodium
starch glycolate, magnesium stearate, anhydrous colloidal silica.
Tablet coating: hypromellose, macrogol, titanium dioxide, triacetin, lactose monohydrate.
The 25 mg, 100 mg and 150 mg tablets also contain yellow iron oxide (E172), and the 25 mg tablets additionally contain red iron oxide (E172).

Description of the appearance of Quetiapina PENSA film-coated tablets and contents of the
pack
Quetiapina PENSA 25 mg film-coated tablets are pink, round, biconvex.
Quetiapina PENSA 100 mg film-coated tablets are yellow, round, biconvex.
Quetiapina PENSA 150 mg film-coated tablets are cream-coloured, round, biconvex.
Quetiapina PENSA 200 mg film-coated tablets are white, round, biconvex.
Quetiapina PENSA 300 mg film-coated tablets are white, oblong, with a score line on one side.
The score line is intended to facilitate breaking the tablet for easier swallowing and does not allow for division into equal doses.

Pack sizes registered for the 25 mg tablets are 6 and 30 tablets.
For the 100 mg, 150 mg, 200 mg and 300 mg tablets, packs of 60 tablets are registered.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Towa Pharmaceutical S.p.A.
Via Enrico Tazzoli, 6
20154 Milan - Italy

Manufacturer
Pharmaceutical Works Polpharma S.A. - 19, Pelplinska Str., Starogard Gdanski - POLAND

This leaflet was last approved on