Rexetin

Package Leaflet: Information for the User

Rexetin, 20 mg, Coated Tablets

Paroxetine

Read all of this leaflet carefully before taking this medicine.

• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack and Other Information

• 1. What Rexetin is and what it is used for
• 2. Before you take 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.

Anxiety disorders for which Rexetin is used include:

• obsessive-compulsive disorder (recurring, intrusive thoughts with uncontrollable behavior);
• panic disorder (panic attacks, including those caused by agoraphobia, or fear of open spaces);
• social phobia (fear or avoidance of social situations);
• post-traumatic stress disorder (anxiety caused by a traumatic event);
• generalized anxiety disorder (generalized feeling of anxiety or unease).

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

2. Before you take Rexetin

Do not take Rexetin:

• if you are allergic to paroxetine or any of the other ingredients of this medicine (listed in section 6);
• if you are taking medicines called monoamine oxidase inhibitors (MAOIs), including moclobemide and methylene blue (see section 2 "Taking other medicines");
• if you are taking antipsychotic medicines, such as thioridazine or pimozide (used to treat psychotic disorders).

If any of the above apply to you, do not take Rexetin. Talk to your doctor.

Warnings and precautions

Before taking Rexetin, tell your doctor or pharmacist:

• if you are under 18 years old (see section 2 "Children and adolescents under 18 years old");
• if you have ever had episodes of mania (excessive, uncontrolled behavior or racing thoughts);
• if you have kidney, liver, or heart disease;
• if you have diabetes (or are at risk of diabetes);
• if you have epilepsy or have had seizures in the past;
• if you have glaucoma (increased pressure in the eye);
• if you have had bleeding or are taking other medicines that may increase the risk of bleeding (including warfarin, antipsychotic medicines such as perphenazine or clozapine, tricyclic antidepressants, or non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen, celecoxib, etodolac, diclofenac, or meloxicam);
• if you are pregnant or planning to become pregnant (see "Pregnancy, breastfeeding, and fertility");
• if you are taking other antipsychotic medicines;
• if you have been diagnosed with schizophrenia and are taking medicines for it;
• if you are taking tamoxifen for breast cancer treatment (or for fertility problems);
• if you are undergoing electroconvulsive therapy (ECT);
• if you need to take opioid medicines, such as tramadol, pethidine, or buprenorphine (or its combination with naloxone). Taking these medicines with Rexetin may lead to serotonin syndrome, a potentially life-threatening condition (see "Rexetin and other medicines").
• if you have a family history of QT prolongation, heart disease such as heart failure, low heart rate, or decreased potassium or magnesium levels.

If you are taking any of these medicines, tell your doctor. Your dose may need to be changed or you may need to take a different medicine.

Children and adolescents under 18 years old

Rexetin should not be used in children and adolescents under 18 years old. Patients under 18 years old are at increased risk of side effects, such as suicidal thoughts, suicidal attempts, and hostility (especially aggression, rebelliousness, and anger) when taking Rexetin. If your doctor has prescribed Rexetin for you and you are under 18 years old, and you have concerns, talk to your doctor. If you experience any of these symptoms while taking Rexetin, tell your doctor.

Suicidal thoughts and worsening of depression or anxiety disorder

Patients with depression and/or anxiety disorders may sometimes have thoughts of harming themselves or suicide. These thoughts may be more frequent at the start of treatment with antidepressant medicines, as it may take a few weeks before they start to work, and sometimes even longer.

• if you have had thoughts of harming yourself or suicide before;
• if you are a young adult. Clinical studies have shown an increased risk of suicidal behavior in adults under 25 years old with psychiatric disorders who were treated with antidepressant medicines.

If you experience any thoughts of harming yourself or suicide, contact your doctor or the nearest hospital emergency department immediately.

Important side effects that may occur when taking Rexetin

Some patients taking Rexetin may develop a condition called akathisia, characterized by feelings of restlessness and an inability to sit or stand still. Other patients may develop serotonin syndrome, which can be life-threatening. Symptoms include:

• feeling extremely agitated or irritated;
• feeling confused or disoriented;
• feeling anxious or restless;
• feeling hot or sweating;
• shaking or trembling;
• having hallucinations (unusual images or sounds);
• having stiff muscles or sudden muscle contractions;
• having a fast heart rate.

If you experience any of these symptoms, contact your doctor immediately.

Rexetin and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.

• monoamine oxidase inhibitors (MAOIs), including moclobemide and methylene blue;
• thioridazine or pimozide, which are antipsychotic medicines;
• aspirin, ibuprofen, or other non-steroidal anti-inflammatory drugs (NSAIDs) used to treat pain and inflammation;
• triptans, such as sumatriptan, used to treat migraines;
• other antidepressant medicines, such as SSRIs or tricyclic antidepressants;
• tryptophan, a dietary supplement;
• lithium, risperidone, perphenazine, or clozapine, which are antipsychotic medicines used to treat certain mental disorders;
• fentanyl, a medicine used for anesthesia or chronic pain treatment;
• opioids, such as tramadol, pethidine, or buprenorphine (or its combination with naloxone), which may lead to serotonin syndrome (see "Rexetin and other medicines");

If you are taking any of these medicines, tell your doctor. Your dose may need to be changed or you may need to take a different medicine.

Rexetin with food, drink, and alcohol

Do not drink alcohol while taking Rexetin. Alcohol may increase the side effects of your medicine or worsen your condition. Taking Rexetin in the morning with food may reduce the likelihood of nausea.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or planning to become pregnant, talk to your doctor or pharmacist before taking Rexetin.

There have been reports of congenital malformations in babies born to mothers who took Rexetin during the first few months of pregnancy, 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 takes Rexetin. Your doctor will discuss with you whether it is better for you to take a different medicine or to gradually stop taking Rexetin during pregnancy.

Tell your doctor or midwife that you are taking Rexetin. Taking Rexetin during pregnancy, especially in the last few months, may increase the risk of a condition called persistent pulmonary hypertension in newborns (PPHN).

If you are taking Rexetin and become pregnant, or are planning to become pregnant, talk to your doctor.

Paroxetine passes into breast milk in small amounts. If you are taking Rexetin and want to breastfeed, talk to your doctor.

In animal studies, paroxetine has been shown to decrease sperm quality. This may affect fertility, although this has not been observed in humans.

Driving and using machines

Rexetin may cause side effects such as dizziness, confusion, drowsiness, or blurred vision. If you experience any of these side effects, do not drive or operate machinery.

Rexetin contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially "sodium-free".

3. How to take Rexetin

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Sometimes, one tablet does not equal the recommended dose of Rexetin.

The following table shows how many tablets of Rexetin you should take for each dose.

Dose Number of tablets to take

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 for different conditions are listed below.

Initial dose

Recommended daily dose

Maximum daily dose

Depression 20 mg 20 mg 50 mg

Obsessive-compulsive disorder 20 mg 40 mg 60 mg

Panic disorder 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 tell you which dose to take when you start treatment.

Most patients start to feel better after a few weeks. If you do not feel better after this time, talk to your doctor. Your doctor may decide to gradually increase your dose by 10 mg until you reach the maximum daily dose.

Take the tablets in the morning with food. Swallow them with water. Do not chew.

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

Elderly patients

The maximum dose for patients over 65 years old is 40 mg per day.

Patients with liver or kidney disease

Your doctor may prescribe a lower dose of Rexetin if you have liver or kidney disease.

Taking too much Rexetin

Never take more tablets than your doctor has prescribed. If you (or someone else) have taken too many tablets, contact your doctor or the nearest hospital emergency department immediately. Take the packet and any remaining tablets with you.

Forgetting to take Rexetin

Take the tablets at the same time each day.

If you forget to take a dose and remember before going to bed, take it as soon as you remember. Take the next dose as usual the next day.

If you forget to take a dose and only remember the next day, do not take a double dose to make up for the forgotten dose. You may experience withdrawal symptoms, but they should disappear quickly once you take your next dose at the usual time.

What to do if you do not feel better

Rexetin does not relieve symptoms immediately - all antidepressant medicines take time to start working. Some patients may feel better after a few weeks, while others may take longer. Additionally, before feeling better, some patients may feel worse. If you do not feel better after a few weeks of treatment, talk to your doctor.

Stopping treatment with Rexetin

Do not stop taking Rexetin without talking to your doctor first.

When stopping treatment with Rexetin, your doctor will tell you to reduce the dose gradually over a few weeks or months to reduce the risk of withdrawal symptoms. One way to do this is to decrease the dose by 10 mg each week. In most patients, withdrawal symptoms are mild and disappear within two weeks. In some patients, symptoms may be more severe or may last longer.

If you experience withdrawal symptoms after stopping Rexetin, talk to your doctor.

Withdrawal symptoms when stopping treatment

Studies have shown that 3 in 10 patients experience one or more withdrawal symptoms when stopping treatment with Rexetin. Some of these symptoms are more common than others.

Common withdrawal symptoms(may affect up to 1 in 10 people):

• dizziness, unsteadiness, or difficulty walking;
• tingling sensations, such as pins and needles, or electric shock-like sensations, including in the head;
• sleep disturbances (vivid dreams, nightmares, insomnia);
• anxiety;
• headaches.

Uncommon withdrawal symptoms(may affect up to 1 in 100 people):

• nausea;
• sweating (including night sweats);
• feeling anxious or restless;
• tremors;
• feeling disoriented;
• diarrhea (loose stools);
• mood swings or irritability;
• blurred vision;
• palpitations (rapid or irregular heartbeats).

If you are concerned about withdrawal symptoms, talk to your doctor.

4. Possible side effects

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

Side effects with unknown frequency (cannot be estimated from the available data):

• suicidal thoughts or attempts;
• aggression;
• severe bleeding after childbirth (postpartum hemorrhage), see additional information in section 2 "Pregnancy, breastfeeding, and fertility";

Other possible side effects that may occur when taking Rexetin:

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

• nausea. Taking Rexetin in the morning with food may reduce the likelihood of nausea;
• changes in sexual desire or sexual function, such as difficulty achieving orgasm or erectile dysfunction.

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

• increased cholesterol levels;
• loss of appetite;
• sleep disturbances (insomnia) or drowsiness;
• unusual dreams (nightmares);
• dizziness or tremors;
• headaches;
• difficulty concentrating;
• feeling agitated;
• feeling unusually weak;
• blurred vision;
• yawning, dry mouth;
• diarrhea or constipation;
• vomiting;
• weight gain;
• feeling unusually weak;
• sweating.

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

• temporary increases in blood pressure or decreases in blood pressure, which may cause dizziness or fainting;
• rapid heart rate;
• difficulty moving, stiffness, tremors, or abnormal movements of the mouth and tongue;
• dilated pupils;
• rash;
• itching;
• feeling disoriented;
• hallucinations (unusual images or sounds);
• inability to urinate (urinary retention) or involuntary urination (incontinence);
• if you have diabetes, you may have difficulty controlling your blood sugar levels while taking Rexetin. Talk to your doctor about adjusting your insulin or diabetes medicine;
• decreased white blood cell count.

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

• abnormal milk production in the breasts of men and women;
• slow heart rate;
• liver problems, as shown by blood tests;
• panic attacks;
• mania (excessive, uncontrolled behavior or racing thoughts);
• feeling detached from reality (depersonalization);
• feeling anxious;
• restless legs syndrome (an irresistible urge to move your legs);
• joint or muscle pain;
• increased levels of the hormone prolactin in the blood;
• menstrual disorders (including heavy or irregular periods, bleeding between periods, or absence of periods).

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

• a skin rash with blisters and peeling skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome);
• a widespread skin rash with blisters and peeling skin (toxic epidermal necrolysis);
• liver problems, which may cause yellowing of the skin or eyes;
• fluid retention or swelling, which may cause swelling of the hands or feet;
• sensitivity to light;
• a painful, persistent erection of the penis;
• decreased platelet count.

Side effects with unknown frequency (cannot be estimated from the available data):

• grinding of the teeth;
• ringing, buzzing, whistling, or other persistent noises in the ears (tinnitus) while taking Rexetin;
• inflammation of the colon (causing diarrhea).

Patients taking medicines like Rexetin may have an increased risk of bone fractures.

If you experience any side effects, talk to your doctor or pharmacist.

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist. You can also report side effects directly to the national reporting system via the contact details listed below. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rexetin

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging.

Store in the original package. Do not store above 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Rexetin contains

• The active substance is paroxetine (as 22.76 mg of paroxetine hydrochloride hemihydrate).
• The other ingredients are: Core:calcium phosphate dibasic dihydrate, carboxymethylcellulose sodium, 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, coated tablets with a score line on one side and "X20" engraved on the other.

30 coated tablets are packed in a cardboard box containing 3 blisters of 10 tablets each, made of PVC/Aluminum foil.

Marketing authorization holder and manufacturer

Gedeon Richter Plc.

Gyömrői út 19-21

1103 Budapest

Hungary

For further information, 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]

Date of last revision of the leaflet: