Pinexet 200 mg

Package leaflet: Information for the patient

Pinexet, 25 mg, film-coated tablets
Pinexet, 100 mg, film-coated tablets
Pinexet, 200 mg, film-coated tablets
Pinexet, 300 mg, film-coated tablets
Quetiapinum
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 further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Pinexet is and what it is 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 Pinexet is and what it is used for

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

• depressive episodes in bipolar affective disorder, when the patient feels sadness, depression, lack of energy, loss of appetite, and has difficulty sleeping;
• mania, when the patient is highly excited, agitated, overactive, full of enthusiasm or excessively active, has impaired judgment, and may be aggressive or troublesome;
• schizophrenia, when the patient hears or sees unreal voices and images, believes in things that are not real, is excessively suspicious, anxious, confused, feels guilt, and is tense or depressed.

Your doctor may continue prescribing Pinexet even after your condition has improved.

2. Information before using Pinexet

When not to use 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 concurrently taking:
  • certain medicines used in HIV infection,
  • azole antifungals (used in fungal infections),
  • erythromycin or clarithromycin (used in infections),
  • nefazodone (used in the treatment of depression).

If any of the above situations apply, Pinexet must not be used.
If in doubt, consult a doctor or pharmacist before taking Pinexet.

Warnings and precautions
Before starting treatment with Pinexet, discuss with your doctor or pharmacist if:

• the patient or a family member has or has had any heart problems, such as heart rhythm disorders, weakened heart muscle, or myocarditis, or if the patient is taking or has taken any medicines that could affect heart function;
• the patient has low blood pressure;
• the patient has had a stroke, especially if elderly;
• the patient has liver problems;
• the patient has ever had seizures (epilepsy);
• the patient has diabetes or is at risk of developing diabetes. In such cases, the doctor may monitor blood sugar levels during treatment with Pinexet;
• the patient has previously had a low white blood cell count (which may have been caused by other medicines);
• the patient is an elderly person with dementia (impaired brain function). In such cases, Pinexet should not be used, as medicines of this class may increase the risk of stroke and sometimes death in such patients;
• the patient or a family member has had blood clots; use of medicines such as this one may increase the risk of thrombosis;
• the patient has had or has had brief periods of stopped breathing during sleep (sleep apnoea syndrome) and is taking medicines that slow down brain activity (antidepressants, psychotropic drugs);
• the patient has or has had problems completely emptying the bladder (urinary retention), enlarged prostate gland, intestinal obstruction, or increased intraocular pressure;
• the patient has abused alcohol or drugs;
• the patient has depression or other conditions treated with antidepressants. Using these medicines together with Pinexet may lead to serotonin syndrome, a potentially life-threatening condition (see “Pinexet and other medicines”).

Immediately inform the doctor if the patient experiences any of the following after taking Pinexet:

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

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

Immediately inform the doctor if the patient experiences:

• fever, flu-like symptoms, sore throat, or any infections, as this may be due to a very low white blood cell count, which may require discontinuation of Pinexet and/or initiation of appropriate treatment;
• constipation together with persistent abdominal pain or persistent constipation despite treatment, as this may lead to a more serious intestinal blockage.

Suicidal thoughts or worsening depression
Patients with depression may sometimes have thoughts of self-harm or suicide. These symptoms or behaviours may worsen during the initial phase of treatment, as all antidepressants take time to work, usually after two weeks or sometimes later. These thoughts may worsen after abrupt discontinuation of the medicine. Young adults are more likely to experience such thoughts. Clinical trial data indicate an increased risk of suicidal thoughts and/or suicidal behaviour in people under 25 years of age with depression.
If the patient ever experiences suicidal thoughts or thoughts of self-harm, contact a doctor immediately or go to hospital. It may be helpful to inform family members or friends about the depression and ask them to read this leaflet. You may also ask these people to inform the patient if they notice worsening of depressive symptoms or other worrying changes in behaviour.

Weight gain
Weight gain has been observed in patients taking Pinexet. Therefore, the patient's body weight should be monitored regularly.

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

Pinexet and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Do not take Pinexet if the patient is taking any of the following medicines:

• certain medicines used to treat HIV;
• azole antifungals (used in fungal infections);
• erythromycin or clarithromycin (used in infections);
• nefazodone (used in the treatment of depression).

Tell the doctor if the patient is taking:

• antiepileptic medicines (such as phenytoin or carbamazepine);
• antidepressants. These medicines may interact with Pinexet and cause symptoms such as involuntary, rhythmic muscle contractions, including those affecting eye movements, agitation, hallucinations, coma, excessive sweating, tremor, increased reflexes, increased muscle tension, body temperature above 38°C (serotonin syndrome). If such symptoms occur, consult a doctor;
• antihypertensive medicines;
• barbiturates (medicines used for sleep disorders);
• thioridazine or lithium salts (other antipsychotic medicines);
• medicines affecting heart rhythm, for example, those that may disturb electrolyte balance (reduced potassium and magnesium levels), such as diuretics (causing increased urine output) or certain antibiotics (used in infections);
• medicines that may cause constipation;
• anticholinergic medicines.

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

Pinexet with food, drink and alcohol

• Be cautious with alcohol consumption. Taking Pinexet together with alcohol may cause drowsiness.
• Do not drink grapefruit juice during treatment with Pinexet. Grapefruit juice may affect how the medicine works.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.
The patient should not take Pinexet during pregnancy without first discussing it with her doctor.
Pinexet should not be taken during breastfeeding.
The following symptoms, which may indicate withdrawal syndrome, may occur in newborns whose mothers took Pinexet during the third trimester of pregnancy (last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding difficulties. If the patient's baby shows any of these symptoms, it may be necessary to contact a doctor.

Driving and using machines
Pinexet may cause drowsiness. Do not drive or operate machinery until you know how this medicine affects you.

Effect on urine drug screening tests
Taking quetiapine may cause a false-positive result in urine drug tests for methadone and certain antidepressants, specifically tricyclic antidepressants (TCA), even if the patient has not taken these drugs. In such cases, further testing by other methods should be performed to confirm the results.

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

3. How to take Pinexet

This medicine should always be taken as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Your doctor will determine the initial dose. The maintenance dose (daily dose) will depend on the severity of the disease and the individual patient's needs, but usually ranges from 150 mg to 800 mg.

• Take the medicine once daily, before bedtime, or twice daily, depending on the condition being treated.
• Swallow the tablets whole with water.
• The tablets may be taken with or without food.
• During treatment with Pinexet, grapefruit juice must not be consumed. It may affect how the medicine works.
• Do not stop taking the tablets even if you feel better, unless otherwise decided by your doctor.

Patients with liver impairment
Your doctor may adjust the dosing regimen for patients with hepatic impairment.

Elderly patients
Your doctor may adjust the dosing regimen for elderly patients.

Use in children and adolescents
Pinexet must not be used in patients under 18 years of age.

Taking more Pinexet than prescribed
If you take more Pinexet than prescribed by your doctor, symptoms such as drowsiness, dizziness, or irregular heartbeat may occur. Seek immediate medical advice from a doctor or go to the nearest hospital. Take the medicine pack with you.

Missed dose of Pinexet
If you miss a dose, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

Stopping Pinexet
If treatment with Pinexet is stopped abruptly, difficulty sleeping (insomnia), nausea, headache, diarrhoea, vomiting, dizziness, or irritability may occur. Your doctor may recommend gradually reducing the dose before stopping treatment.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Very common adverse effects (in more than 1 out of 10 patients):

• dizziness (may lead to falls), headache, dry mouth
• somnolence (may diminish during treatment with Pinexet); may lead to falls
• withdrawal symptoms (symptoms occurring after discontinuation of Pinexet), i.e. difficulty falling asleep (insomnia), nausea, headaches, diarrhoea, vomiting, dizziness or irritability. Gradual discontinuation of the medicine over a period of at least 1–2 weeks is recommended.
• weight gain
• abnormal muscle contractions; this may include difficulty initiating movement, tremor, motor restlessness or painless muscle stiffness
• changes in blood levels of certain lipids (triglycerides and total cholesterol)
• decreased haemoglobin levels.

Common adverse effects (in up to 1 out of 10 patients):

• increased heart rate
• sensation of heart pounding, rapid heartbeat or irregular heartbeat (palpitations)
• constipation, stomach irritation (dyspepsia)
• fatigue
• swelling of hands or feet
• low blood pressure upon standing; this may cause dizziness or fainting (may lead to falls)
• increased blood glucose levels
• blurred vision
• unusual dreams and nightmares
• increased appetite
• feeling of irritability
• speech and language disorders
• suicidal thoughts and worsening of depression
• shortness of breath
• vomiting (mainly in elderly patients)
• fever
• changes in blood levels of thyroid hormones
• decreased number of certain types of blood cells
• increased levels of liver enzymes in blood
• increased blood levels of one of the hormones (prolactin).

Uncommon adverse effects (in up to 1 out of 100 patients):

• seizures
• allergic reactions, such as skin blisters (vesicles), 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 facial muscles or tongue
• sexual dysfunction
• diabetes mellitus or worsening of pre-existing diabetes
• changes in the electrical activity of the heart seen on ECG (prolongation of QT interval)
• slower than normal heart rate, which may occur at the beginning of treatment and may be associated with low blood pressure and fainting
• urinary retention
• fainting (may lead to falls)
• nasal congestion
• decreased number of platelets (thrombocytopenia)
• decreased number of red blood cells in blood
• decreased sodium levels in blood.

Rare adverse effects (in up to 1 out of 1,000 patients):

• occurrence of high body temperature (fever), sweating, muscle stiffness, drowsiness or near-fainting (a condition known as neuroleptic malignant syndrome)
• yellowing of the skin and whites of the eyes (jaundice)
• hepatitis
• prolonged and painful penile erection (priapism)
• breast enlargement and unexpected milk production (galactorrhoea)
• menstrual cycle disturbances
• formation of blood clots in veins, particularly in the lower limbs (symptoms include swelling, pain and redness of the limb); a fragment of the clot may travel with the bloodstream to the lungs, causing chest pain and breathing difficulties; if any of these symptoms occur, the patient should immediately seek medical attention at a doctor’s office or hospital
• walking, talking, eating or performing other activities during sleep
• decreased body temperature (hypothermia)
• pancreatitis
• a condition (known as metabolic syndrome) involving a combination of 3 or more of the following: increased abdominal fat, decreased "good cholesterol" (HDL-C), increased blood levels of lipids (triglycerides), high blood pressure, and increased blood glucose levels
• intestinal obstruction
• increased blood levels of creatine kinase (a substance derived from muscles).

Very rare adverse effects (in up to 1 out of 10,000 patients):

• severe rash, blisters or red spots on the skin
• severe hypersensitivity reactions (anaphylactic reaction) manifesting as breathing difficulties or shock
• rapidly developing swelling of the skin, usually around the eyes, mouth and throat (angioedema)
• severe disorder with blister formation on the skin, mouth, eyes and genital organs (Stevens-Johnson syndrome)
• inappropriate secretion of the hormone regulating urine volume (syndrome of inappropriate antidiuretic hormone secretion, SIADH)
• breakdown of muscle fibres and muscle pain (rhabdomyolysis).

Unknown frequency (cannot be estimated from available data):

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

Medicines from the class to which Pinexet belongs may cause disturbances in heart rhythm, which can be dangerous and, in severe cases, may lead to death.

Some adverse effects can only be detected through laboratory blood tests. These include changes in blood levels of certain lipids (triglycerides and total cholesterol) or glucose, changes in blood levels of thyroid hormones, increased liver enzyme levels in blood, decreased number of certain types of blood cells, decreased number of red blood cells, increased blood levels of creatine kinase (a substance derived from muscles), decreased sodium levels in blood, and increased blood levels of one of the hormones – prolactin. Increased levels of this hormone may lead to:

• breast enlargement in both men and women, and unexpected milk production (galactorrhoea)
• absence or irregular menstruation in women.

Your doctor may recommend periodic monitoring tests.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
Widespread rash, high fever, elevated liver enzyme activity, blood abnormalities (eosinophilia), swollen lymph nodes and involvement of other organs (this condition is also known as DRESS or drug hypersensitivity syndrome). If any of these symptoms occur, Pinexet should be discontinued immediately and the patient should contact their doctor or seek medical help without delay.

Adverse effects in children and adolescents
The same adverse effects observed in adult patients may occur in children and adolescents.

The following adverse effects have been observed more frequently or exclusively in children and adolescents:

Very common adverse effects (in up to 1 out of 10 patients):

• increased blood levels of one of the hormones – prolactin. In rare cases, this may lead to:
  • breast enlargement and unexpected milk production in boys and girls
  • in girls, cessation or irregular menstruation
• increased appetite
• vomiting
• abnormal muscle contractions, including difficulty initiating intended movement, tremors, restlessness or muscle stiffness without concomitant pain
• increased blood pressure.

Common adverse effects (in up to 1 out of 10 patients):

• feeling of weakness, fainting (may lead to falls)
• nasal congestion
• feeling of irritability.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to: Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.

Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Pinexet

No special storage instructions are required.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
The marking on the packaging following "EXP" indicates the expiry date, and following "Lot/LOT" indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Pinexet contains

• The active substance is quetiapine. Each tablet contains 25 mg, 100 mg, 200 mg, or 300 mg of quetiapine in the form of fumarate, respectively.
• Other components of the medicine are:
  Tablet core: povidone K30, microcrystalline cellulose, calcium hydrogen phosphate dihydrate, sodium carboxymethyl starch (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: film-coated tablets, pink, round, biconvex.
Pinexet 100 mg: film-coated tablets, yellow, round, biconvex.
Pinexet 200 mg: film-coated tablets, white, round, biconvex.
Pinexet 300 mg: film-coated tablets, white, elongated, with a score line on one side. The tablet can be divided into equal doses.

Pack sizes:
Pinexet 25 mg: 30 film-coated tablets.
Pinexet 100 mg: 60 or 90 film-coated tablets.
Pinexet 200 mg: 60 or 90 film-coated tablets.
Pinexet 300 mg: 60 or 90 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01