Pinexet 200 mg

Leaflet attached to the packaging: patient information

Pinexet, 25 mg, coated tablets

Pinexet, 100 mg, coated tablets

Pinexet, 200 mg, coated tablets

Pinexet, 300 mg, coated tablets

Quetiapine

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Pinexet and what is it used for
• 2. Important information before taking Pinexet
• 3. How to take Pinexet
• 4. Possible side effects
• 5. How to store Pinexet
• 6. Contents of the pack and other information

1. What is Pinexet and what is it used for

Pinexet contains a substance called quetiapine. It belongs to a group of antipsychotic medicines.
Pinexet is used to treat several diseases, such as:

• depressive episodes in bipolar disorder, when the patient feels sad, depressed, lacks energy, loses appetite, cannot sleep;
• mania, when the patient is very excited, agitated, restless, full of enthusiasm or overly active, or has impaired critical judgment, is aggressive or troublesome;
• schizophrenia, when the patient hears and sees unreal voices and images, takes non-existent things for real, is overly suspicious, anxious, confused, feels guilty, is tense, depressed.

The doctor may recommend taking Pinexet even when the patient's condition has already improved.

2. Important information before taking Pinexet

When not to take Pinexet

• if the patient is allergic to quetiapine or any of the other ingredients of this medicine (listed in section 6);
• if the patient is taking certain HIV medicines,
• azoles (used to treat fungal infections),
• erythromycin or clarithromycin (used to treat infections),
• nefazodone (used to treat depression).

If any of the above situations apply to the patient, they should not take Pinexet.
In case of doubts, the patient should consult a doctor or pharmacist before taking Pinexet.

Warnings and precautions

Before starting to take Pinexet, the patient should discuss it with their doctor or pharmacist if:

• the patient or someone in their family has or has had any heart problems, such as arrhythmias, heart muscle weakness, or myocarditis, or if the patient is taking or has taken any medicines that may affect heart function
• the patient has low blood pressure
• the patient has had a stroke, especially if the patient is elderly
• the patient has liver problems
• the patient has ever had a seizure (epilepsy)
• the patient has diabetes or is at risk of developing diabetes. In such cases, the doctor may check the patient's blood sugar levels during treatment with Pinexet.
• the patient has had a decreased white blood cell count in the past (which may have been caused by the action of other medicines)
• the patient is an elderly person with dementia (impairment of brain function). In such a case, Pinexet should not be taken, as medicines in the same class as Pinexet may increase the risk of stroke and sometimes the risk of death in such patients.
• the patient or their family members have had blood clots; the use of medicines like this one is associated with the formation of blood clots
• the patient has or has had short pauses in breathing during sleep (sleep apnea) and is taking medicines that slow down brain activity (antidepressants, anti-anxiety medicines)
• the patient has or has had problems with complete emptying of the bladder (urinary retention), enlarged prostate, intestinal obstruction, or increased eye pressure
• the patient has abused alcohol or drugs
• the patient has depression or other conditions that are treated with antidepressant medicines. Taking these medicines with Pinexet may lead to the development of serotonin syndrome, a potentially life-threatening condition (see "Pinexet and other medicines").

The patient should immediately inform their doctor if they experience any of the following after taking Pinexet:

• combined: fever, muscle stiffness, excessive sweating, consciousness disorders (a condition called malignant neuroleptic syndrome); immediate treatment may be necessary
• involuntary movements, especially of the face or tongue
• dizziness or severe drowsiness; these changes may increase the risk of accidental injury (falls) in elderly patients
• seizures (epilepsy)
• rapid and irregular heartbeat, even at rest, palpitations, breathing difficulties, chest pain, or unexplained fatigue. The doctor will need to examine the heart and, if necessary, refer the patient to a cardiologist immediately
• prolonged painful erection (priapism).

All these symptoms may occur during treatment with medicines in this therapeutic class.

The patient should immediately inform their doctor if they experience:

• combined: fever, flu-like symptoms, sore throat, or any infections, as this may be a consequence of a very low white blood cell count in the blood, and it may be necessary to discontinue Pinexet and/or administer appropriate treatment
• constipation combined with persistent abdominal pain or persistent constipation despite treatment, as this may lead to a more serious bowel obstruction.

Suicidal thoughts or worsening depression

People with depression may sometimes have thoughts of self-harm or suicide. Such symptoms or behaviors may worsen during the initial phase of treatment, as all antidepressant medicines start working after some time, usually after two weeks, sometimes later. These thoughts may worsen after sudden discontinuation of the medicine. Young adults are more likely to have such thoughts. Clinical trial data indicate an increased risk of suicidal thoughts and/or suicidal behaviors in people under 25 years of age with depression.
If the patient has ever had suicidal thoughts or thoughts of self-harm, they should immediately contact their doctor or go to the hospital. It may be helpful to inform relatives or friends about the depression and ask them to read this leaflet.
It may also be helpful to ask these people to tell the patient if they notice any worsening of depressive symptoms or other worrying changes in behavior.

Weight gain

Patients taking Pinexet have been observed to gain weight. For this reason, the patient's weight should be checked regularly.

Children and adolescents

Pinexet is not intended for use in children and adolescents under 18 years of age.

Pinexet and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking, have recently taken, or plan to take.
The patient should not take Pinexet if they are taking any of the following medicines:

• certain HIV medicines,
• azoles (used to treat fungal infections),
• erythromycin or clarithromycin (used to treat infections),
• nefazodone (used to treat depression).

The patient should tell their doctor if they are taking:

• antiepileptic medicines (such as phenytoin or carbamazepine),
• antidepressant medicines. These medicines may interact with Pinexet and may cause symptoms such as involuntary, rhythmic muscle contractions, including eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle tension, body temperature above 38°C (serotonin syndrome). If such symptoms occur, the patient should consult their doctor.
• antihypertensive medicines,
• barbiturates (medicines used to treat sleep disorders),
• thioridazine or lithium salts (other antipsychotic medicines),
• medicines that affect heart rhythm, such as those that may disrupt electrolyte balance (reduced potassium and magnesium levels), such as diuretics (which increase urine production) or certain antibiotics (used to treat infections),
• medicines that may cause constipation,
• anticholinergic medicines.

Before stopping treatment with any medicine, the patient should tell their doctor.

Pinexet with food, drinks, and alcohol

• The patient should be careful with the amount of alcohol they consume. Taking Pinexet and alcohol at the same time may cause drowsiness.
• During treatment with Pinexet, the patient should not consume grapefruit juice. It may affect the way the medicine works.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
The patient should not take Pinexet during pregnancy without first discussing it with their doctor.
Pinexet should not be taken during breastfeeding.
The following symptoms, which may indicate withdrawal syndrome, may occur in newborns whose mothers took Pinexet in the last trimester of pregnancy (last three months of pregnancy):
tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding difficulties. If the patient's child experiences any of these symptoms, they may need to contact their doctor.

Driving and using machines

Pinexet may cause drowsiness. The patient should not drive or operate machinery until they know how the medicine affects them.

Effect on urine tests for drug presence

Taking quetiapine may result in a positive test result for methadone or certain antidepressant medicines (tricyclic antidepressants) in the urine, even if the patient has not taken them. In such a case, more detailed tests should be performed using other methods to confirm the results.

Pinexet contains lactose and sodium

If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking Pinexet.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Pinexet

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The initial dose will be determined by the doctor. The maintenance dose (daily dose) will depend on the severity of the disease and the patient's needs, but it usually ranges from 150 mg to 800 mg.

• The medicine should be taken once a day, before bedtime, or twice a day, depending on the disease the patient is suffering from.
• The tablets should be swallowed whole, with a glass of water.
• The tablets can be taken with or without food.
• During treatment with Pinexet, the patient should not consume grapefruit juice. It may affect the way the medicine works.
• The patient should not stop taking the tablets even if their condition improves, unless their doctor decides otherwise.

Patients with liver function disorders
The doctor may recommend changing the dosage regimen in patients with liver failure.

Elderly patients

The doctor may recommend changing the dosage regimen in elderly patients.

Use in children and adolescents

Pinexet should not be used in patients under 18 years of age.

Taking more than the recommended dose of Pinexet

If the patient takes more Pinexet than prescribed by their doctor, they may experience:
drowsiness, dizziness, abnormal heartbeat. The patient should immediately consult their doctor or go to the nearest hospital. They should take the Pinexet tablets with them.

Missing a dose of Pinexet

If the patient misses a dose, they should take it as soon as possible. If the time until the next dose is short, they should wait and take the dose at the usual time. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Pinexet

If the patient suddenly stops taking Pinexet, they may experience:
difficulty sleeping (insomnia) or nausea, headaches, diarrhea, vomiting, dizziness, or irritability. The doctor may recommend gradually reducing the dose before stopping treatment.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Pinexet can cause side effects, although not everybody gets them.
Very common side effects (affecting more than 1 in 10 people):

• dizziness (may lead to falls), headache, dry mouth
• drowsiness (may resolve during treatment with Pinexet); may lead to falls
• withdrawal symptoms (symptoms that occur after stopping Pinexet), i.e., difficulty sleeping (insomnia), nausea, headaches, diarrhea, vomiting, dizziness, or irritability. It is recommended to gradually stop taking the medicine over a period of at least 1-2 weeks.
• weight gain
• abnormal muscle contractions; may be difficulty starting a movement, tremors, restlessness, or muscle stiffness without pain
• changes in blood levels of certain fatty substances (triglycerides and total cholesterol)
• decreased hemoglobin levels.

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

• rapid heartbeat
• feeling that the heart is pounding, rapid heartbeat, or pauses in heart rhythm
• constipation, stomach upset (indigestion)
• weakness
• swelling of hands or feet
• low blood pressure when standing up; this may cause dizziness or fainting (may lead to falls)
• increased blood sugar levels
• blurred vision
• unusual dreams and nightmares
• increased appetite
• feeling irritable
• speech and language disorders
• suicidal thoughts and worsening depression
• shortness of breath
• vomiting (mainly in elderly people)
• fever
• changes in thyroid hormone levels in the blood
• decreased levels of certain types of blood cells
• increased liver enzyme levels in the blood
• increased levels of one hormone (prolactin) in the blood.

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

• seizures
• allergic reactions, such as blisters (bubbles), skin swelling, and swelling around the mouth
• unpleasant sensations in the lower limbs (also known as restless legs syndrome)
• difficulty swallowing
• involuntary movements, especially of the face or tongue
• sexual dysfunction
• diabetes, worsening of existing diabetes
• changes in the electrical activity of the heart visible on an ECG (prolonged QT interval)
• slower than normal heart rate, which may occur when starting treatment and may be associated with low blood pressure and fainting
• urinary retention
• fainting (may lead to falls)
• stuffy nose
• decreased platelet count
• decreased red blood cell count
• decreased sodium levels in the blood.

Rare side effects (affecting up to 1 in 1,000 people):

• combined: high body temperature (fever), sweating, muscle stiffness, drowsiness, or near-fainting (a condition called malignant neuroleptic syndrome)
• yellowing of the skin and whites of the eyes (jaundice)
• liver inflammation
• prolonged and painful erection (priapism)
• breast swelling and unexpected milk production (galactorrhea)
• menstrual disorders
• blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the limb); a fragment of the clot may move with the blood flow to the lungs, causing chest pain and breathing difficulties; if the patient notices any of these symptoms, they should immediately consult their doctor or go to the hospital
• walking, talking, eating, or performing other activities while asleep
• decreased body temperature (hypothermia)
• pancreatitis
• a condition (known as metabolic syndrome) in which there is a combination of three or more of the following features: increased abdominal fat, decreased "good" cholesterol (HDL-C), increased triglycerides, high blood pressure, and increased blood sugar levels
• intestinal obstruction
• increased creatine kinase levels in the blood (a substance derived from muscles).

Very rare side effects (affecting up to 1 in 10,000 people):

• severe rash, blisters, or red spots on the skin
• severe allergic reactions (anaphylactic reaction) with symptoms such as difficulty breathing or shock
• rapidly developing skin swelling, usually around the eyes and mouth, as well as throat (angioedema)
• severe skin disorder with blistering of the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome)
• inadequate secretion of the hormone that regulates urine volume
• muscle breakdown and muscle pain (rhabdomyolysis).

Unknown frequency (cannot be estimated from available data):

• skin rash with irregular red spots (erythema multiforme)
• severe, sudden allergic reaction with symptoms such as fever, blisters on the skin, and peeling of the skin (toxic epidermal necrolysis)
• withdrawal symptoms may occur in newborns whose mothers took Pinexet during pregnancy
• heart muscle disorders (cardiomyopathy)
• heart muscle inflammation
• blood vessel inflammation (vasculitis), often with a skin rash with small red or purple bumps.

Medicines in the same class as Pinexet may cause heart rhythm disorders, which can be dangerous and, in severe cases, may lead to death.
Some side effects can only be detected by blood tests in a laboratory. These include changes in levels of certain fatty substances (triglycerides and total cholesterol) or blood sugar, changes in thyroid hormone levels, increased liver enzyme levels, decreased levels of certain types of blood cells, decreased red blood cell count, increased creatine kinase levels, decreased sodium levels, and increased levels of one hormone (prolactin) in the blood. Increased levels of this hormone may lead to:

• breast swelling and unexpected milk production in both men and women
• absence or irregular menstruation in women.

The doctor may recommend regular check-ups.
Widespread rash with eosinophilia and systemic symptoms (DRESS)
Widespread rash, high body temperature, increased liver enzyme activity, blood disorders (eosinophilia), lymph node enlargement, and involvement of other organs (rash with eosinophilia and systemic symptoms is also known as DRESS or hypersensitivity syndrome). If the patient experiences these symptoms, they should stop taking Pinexet and immediately consult their doctor or seek medical attention.

Side effects in children and adolescents

The same side effects that occur in adults may also occur in children and adolescents.
The following side effect has been observed more frequently or exclusively in children and adolescents:
Very common side effects (affecting more than 1 in 10 people):

• increased levels of one hormone (prolactin) in the blood. This may rarely lead to:
• breast swelling and unexpected milk production in boys and girls
• in girls, absence or irregular menstruation
• increased appetite
• vomiting
• abnormal muscle contractions, including difficulty starting a movement, tremors, restlessness, or muscle stiffness without pain
• increased blood pressure.

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

• feeling weak, fainting (may lead to falls)
• stuffy nose
• feeling irritable.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the address: Department for Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Pinexet

There are no special precautions for storing the medicine.
The medicine should be stored out of sight and reach of children.
The medicine should not be taken after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Pinexet contains

• The active substance of the medicine is quetiapine. Each tablet contains 25 mg, 100 mg, 200 mg, or 300 mg of quetiapine in the form of fumarate.
• Other ingredients of the medicine are: Tablet core: povidone K30, microcrystalline cellulose, calcium hydrogen phosphate dihydrate, sodium carboxymethylcellulose (type C), colloidal anhydrous silica, magnesium stearate.

Coating:
Pinexet 25 mg
hypromellose (6 cP - E464), titanium dioxide (E171), lactose monohydrate, macrogol 3350, triacetin, iron oxide red (E172), iron oxide yellow (E172).
Pinexet 100 mg
hypromellose (6 cP - E464), titanium dioxide (E171), lactose monohydrate, macrogol 3350, triacetin, iron oxide yellow (E172).
Pinexet 200 mg and 300 mg
hypromellose (6 cP - E464), titanium dioxide (E171), lactose monohydrate, macrogol 3350, triacetin.

What Pinexet looks like and contents of the pack

Pinexet 25 mg: pink, round, biconvex coated tablets.
Pinexet 100 mg: yellow, round, biconvex coated tablets.
Pinexet 200 mg: white, round, biconvex coated tablets.
Pinexet 300 mg: white, oval, biconvex coated tablets with a score line on one side. The tablet can be divided into equal doses.
Pinexet 25 mg: 30 coated tablets.
Pinexet 100 mg: 60 or 90 coated tablets.
Pinexet 200 mg: 60 or 90 coated tablets.
Pinexet 300 mg: 60 or 90 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Polpharma S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01
Date of last revision of the leaflet: June 2024