Rexetin

Patient Information Leaflet

Rexetin, 20 mg, film-coated tablets
Paroxetinum
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, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not give it to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents:

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

1. What Rexetin is and what it is used for

Rexetin is used to treat adults with depression and (or) anxiety disorders.
The anxiety disorders treated with Rexetin include:

• Obsessive-compulsive disorder (recurring, obsessive thoughts with uncontrollable behaviour);
• Panic disorder (panic attacks), including those associated with agoraphobia (fear of open spaces);
• Social phobia (fear of, or avoidance of, social situations);
• Post-traumatic stress disorder (anxiety caused by a traumatic event);
• Generalised anxiety disorder (general feelings of anxiety or nervousness).

Rexetin belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). In the brain, there is a substance called serotonin. In people with depression or anxiety disorders, serotonin levels are lower than in healthy individuals. Rexetin and other SSRIs may increase serotonin levels in the brain.

2. Information before taking Rexetin

When not to take Rexetin:

• if the patient is allergic to paroxetine or any of the other ingredients of this medicine (listed in section 6);
• if the patient is taking medicines called monoamine oxidase inhibitors (MAO inhibitors, including moclobemide and methylene blue chloride) or has taken them within the last two weeks. The doctor will advise the patient on how to start taking Rexetin after stopping MAO inhibitors;
• if the patient is taking antipsychotic medicines such as thioridazine or pimozide (used to treat psychotic disorders).

If any of the above situations apply, the patient should contact their doctor before taking Rexetin.

Warnings and precautions

Before starting Rexetin, discuss the following with your doctor or pharmacist:

• if the patient is under 18 years of age (see below: Children and adolescents under 18 years of age);
• if the patient has ever experienced episodes of mania (excessively active behaviour or racing thoughts);
• if the patient has kidney, liver, or heart disease;
• if the patient has diabetes (or suffers from diabetes);
• if the patient has epilepsy or has had seizures in the past;
• if the patient has glaucoma (increased pressure in the eye);
• if the patient has had bleeding in the past or is taking other medicines that may increase the risk of bleeding (including medicines used to thin the blood), such as warfarin, antipsychotics such as perphenazine or clozapine, tricyclic antidepressants, or medicines used for pain and inflammation called non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam;
• if the patient is pregnant or planning to become pregnant (see "Pregnancy, breastfeeding and fertility");
• if the patient is taking any other antipsychotic medicines;
• if the patient has been diagnosed with schizophrenia and is taking medicines for this condition;
• if the patient is taking tamoxifen for breast cancer (or fertility problems);
• if the patient is undergoing electroconvulsive therapy (ECT);
• if the patient requires opioid treatment, e.g. tramadol, pethidine, buprenorphine (or its combination with naloxone). Taking these medicines together with Rexetin may lead to serotonin syndrome, a potentially life-threatening condition (see "Rexetin and other medicines");
• if the patient has a family history of QT interval prolongation, heart disease such as heart failure, slow heart rate, or low potassium or low magnesium levels.

After taking paroxetine in combination with certain antidepressants or opioids, or paroxetine alone, there is a small risk of serotonin syndrome. If the patient experiences any symptoms of this serious condition, they should seek immediate medical advice (see section 4).

Special caution is advised when treating patients over 65 years of age or patients with impaired liver function with Rexetin, as in rare cases Rexetin may cause a decrease in blood sodium levels (hyponatraemia). This condition may lead to fatigue and muscle weakness. This may occur more frequently in patients with liver cirrhosis and/or those taking other medicines that may contribute to hyponatraemia. If such symptoms occur, contact a doctor.

Medicines such as Rexetin (so-called SSRIs or SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Children and adolescents

Rexetin should not be used to treat children and adolescents under 18 years of age. Patients under 18 are at increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (especially aggression, defiant behaviour, and anger) while taking Rexetin. If a doctor has prescribed Rexetin to a patient under 18 and there are any concerns, contact the doctor. If the mentioned symptoms occur or worsen during treatment with Rexetin, inform the doctor. Additionally, there is currently no long-term safety data available regarding growth, maturation, cognitive development, and behavioural development in this age group.

In clinical studies of Rexetin in patients under 18 years of age, common adverse reactions occurring in less than 1 in 10 patients included: increased frequency of suicidal thoughts and suicide attempts, deliberate self-harm, hostility, aggressive or hostile behaviour, loss of appetite, tremor, abnormal sweating, excessive activity (exhibiting excess energy), restlessness, emotional lability (including tearfulness and mood swings), and unusual bruising or bleeding (such as nosebleeds). These studies also showed that the same symptoms occurred, although less frequently, in children and adolescents taking placebo (sugar pills) instead of Rexetin.

In these studies, some patients under 18 years of age experienced symptoms related to discontinuation of Rexetin. These symptoms were very similar to those observed in adults after stopping Rexetin (see section 3: "How to take Rexetin", later in this leaflet).

Additionally, in patients under 18 years of age, abdominal pain, feeling of restlessness, and emotional lability (including tearfulness, mood changes, self-harm attempts, suicidal thoughts, and suicide attempts) were also common (occurring in less than 1 in 10 patients).

Suicidal thoughts and worsening of depression or anxiety symptoms

Patients with depression and/or anxiety disorders may sometimes experience thoughts of self-harm or suicidal thoughts. These may be intensified at the beginning of treatment with antidepressants, as it may take some time, usually about two weeks, before the medicines start to work, and sometimes even longer.

The patient may be more likely to have such thoughts:

• if they have previously had suicidal thoughts or thoughts of self-harm;
• if they are a young adult. Clinical studies have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders who were treated with antidepressants.

If thoughts of self-harm or suicide ever occur, contact a doctor or the nearest hospital emergency department immediately.

It may be helpful to inform a relative or friend about your depression or anxiety disorder and ask them to read this leaflet. You may ask them to inform you if they notice that your depression or anxiety worsens or if there are any worrying changes in your behaviour.

Important adverse effects observed during treatment with Rexetin

In some patients taking Rexetin, symptoms called akathisia may develop. They may feel restless and unable to sit or stand still. In other patients, serotonin syndrome or neuroleptic malignant syndrome may develop – patients may experience some or all of the following symptoms: intense agitation or irritability, confusion, anxiety, feeling hot, sweating, tremor, chills, hallucinations (unusual sights or sounds), muscle stiffness, sudden muscle contractions, or rapid heartbeat. Symptoms may worsen, leading to loss of consciousness. If the patient notices any of these symptoms, they should contact their doctor. More information about these or other adverse effects of Rexetin is provided in section 4: Possible side effects.

Rexetin and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Some medicines may affect the action of Rexetin or increase the risk of adverse effects.

Rexetin may also affect the action of other medicines. These include:

• medicines called monoamine oxidase inhibitors (MAO inhibitors, including moclobemide and methylene blue chloride) – see section: "When not to take Rexetin";
• thioridazine or pimozide, which are antipsychotic medicines – see section: "When not to take Rexetin";
• acetylsalicylic acid, ibuprofen, or other medicines called non-steroidal anti-inflammatory drugs (NSAIDs), such as celecoxib, etodolac, diclofenac, and meloxicam, used to treat pain and inflammation;
• medicines called triptans, such as sumatriptan, used to treat migraine;
• other antidepressants, called SSRIs and tricyclic antidepressants, such as clomipramine, nortriptyline, and desipramine;
• a dietary supplement called tryptophan;
• medicines such as lithium, risperidone, perphenazine, clozapine (called antipsychotics) used to treat certain psychiatric disorders;
• fentanyl, a medicine used during anaesthesia and for chronic pain;
• opioids, e.g. tramadol and pethidine (painkillers), buprenorphine (used to treat severe pain or opioid addiction), or its combination with naloxone (used to treat opioid addiction). Rexetin may interact with opioids (e.g. tramadol, pethidine, buprenorphine (or its combination with naloxone)) and cause serotonin syndrome (see section 4). If the patient develops this syndrome, contact a doctor.
• the combination of fosamprenavir and ritonavir, used to treat human immunodeficiency virus (HIV) infection;
• St. John's wort, used as an adjunct in depression;
• mivacurium and suxamethonium (used for general anaesthesia);
• phenobarbital, phenytoin, sodium valproate, or carbamazepine used to treat seizures or epilepsy;
• atomoxetine, used to treat attention deficit hyperactivity disorder (ADHD);
• procyclidine used to treat tremor, especially in Parkinson's disease;
• warfarin or other medicines (called anticoagulants) used to thin the blood;
• propafenone, flecainide, and medicines used to treat irregular heartbeat;
• metoprolol, a beta-blocker used to treat high blood pressure and heart problems;
• pravastatin used to treat high cholesterol;
• rifampicin used to treat tuberculosis and acne;
• linezolid – an antibiotic;
• tamoxifen, used to treat breast cancer.

If the patient is currently taking or has recently taken any of the listed medicines and has not yet discussed this with their doctor, they should contact them again and ask how to proceed. The dose of the medicine may need to be changed or another medicine may need to be taken.

Rexetin with food, drink and alcohol

During treatment with Rexetin, alcohol should not be consumed. Alcohol may worsen symptoms of the illness or adverse effects. Taking Rexetin in the morning with food reduces the likelihood of nausea.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

There are some reports indicating that babies whose mothers took Rexetin during the first few months of pregnancy may have congenital developmental abnormalities, particularly heart defects. In the general population, about 1 in 100 babies is born with a heart defect. This number increases to 2 in 100 babies if the mother took Rexetin. The doctor, together with the patient, will decide whether it is better for the patient to switch to another medicine or gradually discontinue Rexetin during pregnancy. In certain circumstances, however, the doctor may suggest that it is more beneficial for the patient to continue taking Rexetin.

Ensure that the midwife or doctor is informed that the patient is taking Rexetin. Medicines such as Rexetin taken during pregnancy, especially in the later stages, may increase the risk of serious complications in the newborn, known as persistent pulmonary hypertension of the newborn (PPHN).

In animal studies, it has been shown that paroxetine reduces semen quality. This could theoretically affect fertility, although no effect on fertility has been observed in humans so far.
Driving and operating machinery
Possible adverse effects of Rexetin include dizziness, disorientation, feeling of drowsiness, and visual disturbances. If such adverse effects occur, driving and operating machinery should be avoided.
Rexetin contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, the medicine is considered "sodium-free".

3. How to take Rexetin

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Sometimes one tablet does not correspond to the entire recommended dose of the medicine.
The table below indicates how many Rexetin tablets should be taken for a given dose.
Dose Number of tablets to be taken
10 mg half a tablet
20 mg one tablet
30 mg one and a half tablets
40 mg two tablets
50 mg two and a half tablets
60 mg three tablets

The usual doses used for various conditions are given below.
Dose Recommended Maximum
initial dose daily dose daily dose
Depression 20 mg 20 mg 50 mg
Obsessive-compulsive disorder 20 mg 40 mg 60 mg
Panic disorder with or without agoraphobia 10 mg 40 mg 60 mg
Social phobia 20 mg 20 mg 50 mg
Post-traumatic stress disorder 20 mg 20 mg 50 mg
Generalized anxiety disorder 20 mg 20 mg 50 mg

Your doctor will advise you on the starting dose of Rexetin.
Most patients begin to feel better after a few weeks. If there is no improvement by then, consult your doctor. The doctor may decide to gradually increase the dose by 10 mg, up to the maximum daily dose.

The tablets should be taken in the morning, during a meal. Swallow them with water. Do not chew.

Your doctor will discuss with you how long you should continue taking the tablets. Treatment may last for several months or even longer.

Elderly patients
The maximum dose for patients over 65 years of age is 40 mg per day.

Patients with liver or kidney disease
If you have liver disease or severe kidney disease, your doctor may prescribe a lower dose of Rexetin than the usual dose.

Taking more Rexetin than prescribed
Never take more tablets than your doctor has prescribed. If you (or someone else) have taken too many Rexetin tablets, contact your doctor immediately or go to the nearest hospital emergency department. Take the tablet packaging with you.

Symptoms of Rexetin overdose may include those listed in section 4: Possible side effects, or the following symptoms: fever, involuntary muscle contractions.

If you forget to take Rexetin
Take the medicine at the same time each day.
If you forget a dose and remember before going to bed, take it immediately. Take the next dose as usual the following day.
If you remember during the night or the next day that you missed a dose, do not take the missed dose. You may experience withdrawal symptoms, but these should quickly subside after taking the next dose at the usual time.
Do not take a double dose to make up for a missed dose.

What to do if there is no improvement
Rexetin does not relieve symptoms of illness immediately – all antidepressants take some time to start working. Some patients feel better after a few weeks, while for others it may take longer. Moreover, some patients may initially feel worse before they start to feel better. If you do not feel better after a few weeks of treatment, consult your doctor. Your doctor should schedule a follow-up visit a few weeks after you first start taking the medicine. Inform your doctor if you have not started to feel better.

Stopping Rexetin treatment
Do not stop taking Rexetin unless your doctor tells you to.
When stopping Rexetin, your doctor will usually recommend gradually reducing the dose over several weeks or months – this should reduce the risk of withdrawal symptoms. One way is to gradually reduce the dose of Rexetin by 10 mg per week. In most patients, withdrawal symptoms are mild and resolve on their own within two weeks. In some patients, symptoms may be more severe or last longer.

If you experience withdrawal symptoms after stopping the tablets, your doctor may decide that you should taper off the medicine more slowly. If you experience severe withdrawal symptoms while stopping Rexetin, contact your doctor. The doctor may recommend restarting the tablets and tapering them more gradually.

Even if you experience withdrawal symptoms, it is still possible to stop taking Rexetin.

Withdrawal symptoms after stopping treatment
Studies show that 3 out of 10 patients notice one or more withdrawal symptoms when stopping treatment with Rexetin. Some of these symptoms occur more frequently than others.

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

• dizziness, unsteadiness or difficulty in maintaining balance;
• tingling sensations, burning sensations, and (less commonly) electric shock-like sensations, including in the head, and tinnitus (ringing, buzzing, whistling, or other persistent noise in the ears);
• sleep disturbances (vivid dreams, nightmares, insomnia);
• feeling of anxiety;
• headache.

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

• nausea;
• sweating (including night sweats);
• feeling restless or agitated;
• tremors;
• feeling disoriented;
• diarrhoea (loose stools);
• emotional lability or irritability;
• visual disturbances;
• palpitations or increased heart rate (pounding or racing heart).

If you are concerned about symptoms after stopping Rexetin, contact your doctor.

4. Possible side effects

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

difficulty breathing (shallow breathing) or swallowing, and feeling weak or lightheaded,
leading to collapse or loss of consciousness. Seek immediate medical attention
or go to a hospital.

• Serotonin syndrome, which may present with mental status changes (e.g. agitation, irritability, confusion, restlessness, hallucinations, coma) and other symptoms such as feeling hot, fever, sweating, shivering, chills, rapid heartbeat, unstable blood pressure, involuntary muscle contractions, muscle stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea) (see section 2 "Important information before taking Rexetin").
• Acute angle-closure glaucoma; the patient may experience eye pain and visual disturbances.

Adverse reactions with unknown frequency (frequency cannot be estimated from available data):

• In some patients, suicidal thoughts or self-harming behavior occurred during treatment with Rexetin or shortly after discontinuation of treatment (see section 2. Warnings and precautions),
• Aggression,
• Severe vaginal bleeding occurring shortly after childbirth (postpartum hemorrhage); see additional information in subsection "Pregnancy, breastfeeding and fertility" in section 2.

Other possible adverse reactions during treatment
Very common adverse reactions (may occur in more than 1 in 10 people):

• Nausea. Taking Rexetin in the morning with food reduces the likelihood of nausea;
• Changes in sexual desire or sexual function. For example, anorgasmia, and in men, disturbances in erection and ejaculation.

Common adverse reactions (may occur in no more than 1 in 10 people):

• Increased blood cholesterol levels;
• Loss of appetite;
• Sleep disturbances (insomnia) or drowsiness;
• Unusual dreams (nightmares);
• Dizziness or tremor;
• Headache;
• Difficulty concentrating;
• Feeling of restlessness;
• Feeling of unusual weakness;
• Visual disturbances;
• Yawning, dry mouth;
• Diarrhea or constipation;
• Vomiting;
• Weight gain;
• Feeling of unusual fatigue;
• Sweating.

Uncommon adverse reactions (may occur in no more than 1 in 100 people):

• Transient increase or transient decrease in blood pressure, which may cause dizziness or fainting upon sudden change to upright position;
• Faster than normal heartbeat;
• Difficulty moving, stiffness, tremor, or abnormal movements of the mouth and tongue;
• Pupil dilation;
• Rash;
• Itching;
• Feeling of disorientation;
• Hallucinations (unusual images or sounds);
• Inability to urinate (urinary retention) or uncontrolled, involuntary urination (urinary incontinence);
• If the patient has diabetes, they may experience difficulties controlling blood sugar levels while taking Rexetin. In such a case, consult a doctor about adjusting the dose of insulin or antidiabetic medications;
• Decreased white blood cell count.

Rare adverse reactions (may occur in no more than 1 in 1,000 people):

• Abnormal milk production in the breast glands in both men and women;
• Slow heartbeat;
• Liver effects indicated by blood tests assessing liver function;
• Panic attacks;
• Excessive activity or racing thoughts (mania);
• Feeling of unreality regarding one's self (depersonalization);
• Anxiety;
• Irresistible urge to move the legs (restless legs syndrome);
• Joint or muscle pain;
• Increased blood levels of prolactin hormone;
• Menstrual disturbances (including heavy or irregular periods, intermenstrual bleeding, absence or delay of menstruation).

Very rare adverse reactions (may occur in no more than 1 in 10,000 people):

• Skin rash called erythema multiforme, with blisters and appearing as small targets (dark center surrounded by a lighter ring with a dark edge);
• Widespread skin rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genital organs (Stevens-Johnson syndrome);
• Widespread skin rash with blisters and peeling of a large skin surface (toxic epidermal necrolysis);
• Liver function disorders causing yellowing of the skin or whites of the eyes;
• Fluid retention or water retention, which may lead to swelling of the hands or feet;
• Light sensitivity;
• Painful, persistent penile erection (priapism);
• Decreased platelet count.

Frequency not known (cannot be estimated from available data):
‐ Teeth grinding;
‐ In some patients, ringing, buzzing, whistling, or other persistent noise in the ears (tinnitus) may occur during treatment with Rexetin;
‐ Inflammation of the colon (causing diarrhea).

In patients taking this type of medication, an increased risk of bone fractures has been observed.

If you have any doubts during treatment with Rexetin, consult your doctor or pharmacist for advice.

Reporting of adverse reactions
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 4921 301
Fax: +48 22 4921 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Rexetin

Keep this medicine 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.
Store in the original packaging. Do not store above 30 ° C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Rexetin contains

• The active substance is 20 mg of paroxetine (as 22.76 mg paroxetine hydrochloride hemihydrate).
• Other ingredients are: Tablet core: calcium hydrogen phosphate dihydrate, sodium carboxymethyl starch, hypromellose, magnesium stearate; Coating: hypromellose, macrogol 400, macrogol 6000, polysorbate 80, titanium dioxide E 171.

What Rexetin looks like and contents of the pack
White or almost white, round, biconvex film-coated tablets with a division line on one side and
the imprint "X20" on the other.
The cardboard box contains 30 film-coated tablets packed in PVC/aluminum blisters.
Marketing Authorisation Holder and Manufacturer
Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest
Hungary
For further information about this medicinal product, please contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Tel. +48 (22)755 96 48
[email protected]