Xetanor 20 mg

Leaflet accompanying the packaging: patient information

Xetanor 20 mg, coated tablets

Paroxetine hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, 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 not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Xetanor and what is it used for

Xetanor is used to treat depression and/or anxiety disorders in adults.

Anxiety disorders for which Xetanor is used include: obsessive-compulsive disorder (recurring, obsessive thoughts with uncontrolled behavior), panic disorder with or without agoraphobia (panic attacks, including those caused by a 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 nervousness).
Xetanor belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). It is not fully understood how Xetanor and other SSRIs work, but they may increase the level of serotonin in the brain. Proper treatment of depression and anxiety disorders is important for the patient to feel better.

2. Important information before taking Xetanor

When not to take Xetanor:

• If the patient is allergicto paroxetine hydrochloride, peanuts, soy, or any of the other ingredients of this medicine (listed in section 6).
• If the patient is taking monoamine oxidase inhibitors (MAOIs), including moclobemide and methylene blue (methylene blue), or has taken them within the last two weeks. The doctor will advise the patient on how to start taking Xetanor after stopping MAOIs.
• If the patient is taking antipsychotic drugs, such as thioridazine or pimozide.

If any of the above situations apply to the patient, they should contact their doctor and not take Xetanor.

Warnings and precautions

Before starting Xetanor, the patient should discuss the following with their doctor or pharmacist:

• if the patient is taking any other medicines (see section Xetanor and other medicines, later in this leaflet)
• if the patient is taking tamoxifen for breast cancer or fertility problems. Xetanor may reduce the effectiveness of tamoxifen, and the doctor may recommend taking a different antidepressant.
• if the patient has kidney, liver, or heart problems, or has epilepsy or has had seizures in the past
• if the patient has had episodes of mania (excessive activity or racing thoughts)
• if the patient is undergoing electroconvulsive therapy
• if the patient has had bleeding or is taking other medicines that may increase the risk of bleeding (including blood thinners, such as warfarin, antipsychotic drugs, such as perphenazine or clozapine, tricyclic antidepressants, non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam)
• if the patient has diabetes
• if the patient is on a low-sodium diet
• if the patient has glaucoma (eye pressure)
• if the patient is pregnant or planning to become pregnant (see section Pregnancy, breastfeeding, and fertility, later in this leaflet)
• if the patient is under 18 years old (see section Children and adolescents under 18 years old, later in this leaflet)
• if the patient has acute or chronic pain or other conditions treated with buprenorphine. Taking this medicine with Xetanor may lead to serotonin syndrome, a life-threatening condition (see section Xetanor and other medicines).

If the answer is YES to any of the above questionsand the patient has not yet consulted a doctor, they should consult their doctor and ask how to take Xetanor.

Children and adolescents under 18 years old

Xetanor 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 attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and anger).
If a doctor has prescribed Xetanor to a patient (or their child), and there are concerns, they should consult their doctor. If the patient experiences any of these symptoms while taking Xetanor, they should inform their doctor. Additionally, there is currently no data on the safety of long-term use of Xetanor and its impact on growth, maturation, and cognitive and behavioral development in this age group.
In studies of paroxetine in patients under 18 years old, common side effects that occurred with a frequency of less than 1 in 10 were: increased suicidal thoughts and attempts, intentional self-harm, hostility, aggressive behavior, or unfriendly behavior, loss of appetite, tremors, abnormal sweating, excessive activity (excess energy), excitement, emotional instability (including tearfulness and mood changes), and unusual bruising or bleeding (such as nosebleeds).
These studies also showed that such symptoms occurred, although less frequently, in children and adolescents taking placebo (sugar pills) instead of paroxetine.
Some patients under 18 years old in these studies experienced withdrawal symptoms. These symptoms were very similar to those observed in adults after stopping Xetanor (see section 3). Additionally, in patients under 18 years old, the following also occurred frequently (with a frequency of less than 1 in 10): abdominal pain, feeling nervous, and emotional instability (including tearfulness, mood changes, self-harm attempts, suicidal thoughts, and suicidal attempts).

Suicidal thoughts and worsening of depression or anxiety disorder

In patients with depression and/or anxiety disorders, suicidal thoughts or self-harm thoughts may sometimes occur. They may worsen at the start of antidepressant treatment, as it may take some time, usually about 2 weeks, or sometimes even longer, for the medicines to start working.

The patient is more likely to experience such thoughts:

• if the patient has had suicidal thoughts or self-harm thoughts before.
• if the patient is a young adult. Clinical trial data have shown an increased risk of suicidal behavior in adults under 25 years old with mental disorders who were treated with antidepressants.
• if the patient experiences suicidal thoughts or self-harm thoughts, they should contact their doctor or go to the hospital immediately. It may be helpful if the patient informs a relative or friend that they have depression or an anxiety disorder and asks them to read this leaflet. The patient may ask them to tell the doctor if they notice that the depression or anxiety disorder has worsened or if there are worrying changes in the patient's behavior.

Important side effects observed during Xetanor treatment

In some patients taking Xetanor, symptoms called akathisia may occur. They feel anxious and cannot sit or stand still. In other patients, a condition called serotonin syndrome or malignant neuroleptic syndromemay occur, in which patients have some or all of the following symptoms: feeling highly agitated or irritated, feeling confused (disoriented), anxious, hot, sweating, shaking, shivering, hallucinations (strange images 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 side effects of Xetanor can be found in section 4.
Medicines like Xetanor (SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after treatment was stopped.

Xetanor and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Some medicines may affect the action of Xetanor or increase the risk of side effects. Xetanor may also affect the action of other medicines. These medicines include:

• monoamine oxidase inhibitors (MAOIs, including moclobemide and methylene blue (methylene blue)) - see section When not to take Xetanor
• thioridazine or pimozide, which are antipsychotic drugs - see section When not to take Xetanor
• aspirin, ibuprofen, or other non-steroidal anti-inflammatory drugs (NSAIDs) used to treat pain and inflammation, such as celecoxib, etodolac, diclofenac, and meloxicam
• tramadol, pethidine, buprenorphine - opioid painkillers. These medicines may interact with Xetanor and cause symptoms such as involuntary, rhythmic muscle contractions, including those affecting eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle tension, or body temperature above 38°C. If the patient experiences such symptoms, they should contact their doctor.
• triptans, such as sumatriptan, used to treat migraines
• other antidepressants, including other SSRIs, tryptophan, and tricyclic antidepressants, such as clomipramine, nortriptyline, and desipramine
• tryptophan dietary supplement
• mivacurium and suxamethonium (used for general anesthesia)
• medicines such as lithium, risperidone, perphenazine, and clozapine (used to treat certain mental disorders)
• fentanyl, used during anesthesia and to treat chronic pain
• the combination of fosamprenavir and ritonavir, used to treat HIV infections
• St. John's Wort, a herbal remedy used to treat depression
• 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 tremors, especially in Parkinson's disease
• warfarin or other anticoagulant medicines 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
• linezolid, an antibiotic
• tamoxifen, used to treat breast cancer and fertility problems

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

Xetanor with food, drink, and alcohol

While taking Xetanor, the patient should not drink alcohol. Alcohol may worsen the symptoms of the disease or worsen the side effects. Taking Xetanor in the morning, during a meal, reduces the likelihood of nausea.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
There are reports that children whose mothers took paroxetine during the first few months of pregnancy had congenital malformations, particularly heart defects. In the general population, about 1 in 100 children is born with a heart defect. This number increases to 2 in 100 children if the mother takes a paroxetine-containing medicine. The doctor will decide together with the patient whether it is better for the patient to switch to a different medicine or gradually stop taking Xetanor during pregnancy. In some cases, the doctor may also suggest that it is better for the patient to continue taking Xetanor.
It is essential to inform the midwife or doctor that the patient is taking Xetanor. Taking Xetanor at the end of pregnancy may increase the risk of severe postpartum hemorrhage, especially if the patient has a history of bleeding disorders. If the patient is taking Xetanor, they should inform their doctor or midwife so that they can provide appropriate advice. Medicines like Xetanor taken during pregnancy, especially in the later stages, may increase the risk of a condition called persistent pulmonary hypertension in the newborn (PPHN). In PPHN, the blood pressure in the blood vessels between the heart and lungs of the baby is too high.
If the patient takes Xetanor during the last 3 months of pregnancy, the newborn may also experience other disorders, which usually occur within the first 24 hours after birth. These symptoms include: breathing difficulties, bluish discoloration of the skin or instability of body temperature, bluish discoloration of the lips, vomiting or difficulty feeding, fatigue, difficulty sleeping or increased crying, stiff or floppy muscles, tremors, jitteriness or seizures. If the baby experiences any of these symptoms or if there are concerns about the baby's health, the patient should contact their doctor or midwife for advice.
Breastfeeding
Paroxetine may pass into breast milk in very small amounts.If the patient is taking Xetanor, they should discuss this with their doctor before breastfeeding. The doctor and patient can decide together whether the patient should breastfeed while taking Xetanor.
Fertility
In animal studies, paroxetine has been shown to reduce sperm quality. This may theoretically affect fertility, but the impact on human fertility has not been determined.

Driving and using machines

Possible side effects of Xetanor include dizziness, disorientation, drowsiness, and vision disturbances. If the patient experiences any of these side effects, they should not drive or operate machinery.

Xetanor contains soy lecithin (E322), which may contain soy proteins.

The patient should not take this medicine if they are allergic to peanuts or soy.

Xetanor contains sodium

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

3. How to take Xetanor

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.
Usual doses for different indications are presented in the table below:

The doctor will advise the patient on what dose of Xetanor to start with.Most patients start to feel better after a few weeks. If there is no improvement after this time, the patient should consult their doctor. The doctor may decide to gradually increase the dose by 10 mg until the maximum daily dose is reached.

Tablets should be taken in the morning, during a meal. Tablets should be swallowed, washed down with water. Do not chew.

The doctor will discuss with the patient how long they should take the tablets. Treatment may last 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

The doctor may recommend a lower dose of Xetanor for patients with liver or kidney disease. For patients with severe liver or kidney disease, the maximum daily dose is 20 mg.

Taking more than the recommended dose of Xetanor

The patient should never take more tablets than recommended by their doctor.If the patient (or someone else) has taken too many Xetanor tablets, they should immediately inform their doctor or go to the nearest hospital emergency department (ER). They should show the packaging of the tablets.
As a result of overdosing on Xetanor, the patient may experience side effects described in section 4 Possible side effects or the following symptoms: fever, involuntary muscle contractions.

Missing a dose of Xetanor

The medicine should be taken at the same time every day.

If the patient misses a dose and remembers before going to bed,they should take it immediately. The next day, they should take the dose as usual.
If the patient remembers in the night or the next day that they missed a dose,they should not take the missed dose. The patient may experience withdrawal symptoms, but they should resolve quickly after taking the next dose at the usual time.
The patient should not take a double dose to make up for the missed dose.

What to do if there is no improvement

Xetanor does not relieve symptoms immediately –all antidepressants start working only after some time. Some patients start to feel better after a few weeks, and others later. Some patients taking antidepressants feel worse before they start to feel better. If the patient does not feel better after a few weeks of treatment, they should consult their doctor. The doctor should recommend that the patient have a follow-up visit a few weeks after starting to take the medicine for the first time. The patient should inform their doctor if they have not started to feel better.

Stopping Xetanor treatment

The patient should not stop taking Xetanor unless their doctor advises them to do so.

In the case of stopping Xetanor, the doctor will help the patient gradually reduce the dose over several weeks or months – this should reduce the risk of withdrawal symptoms. One way to do this is to gradually reduce the dose of Xetanor 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 may persist for longer.
If the patient experiences withdrawal symptomsafter stopping Xetanor, their doctor may decide that they should stop the medicine more slowly. If the patient experiences severe withdrawal symptoms while stopping Xetanor, they should contact their doctor. The doctor may recommend restarting the tablets and stopping them more slowly.

Even if the patient experiences withdrawal symptoms, it is still possible to stop taking Xetanor.

Possible withdrawal symptoms that may occur after stopping treatment

Studies have shown that 3 out of 10 patients experience one or more withdrawal symptoms when stopping Xetanor. Some of these symptoms occur more frequently than others.

Common side effects, which may occur in less than 1 in 10 patients:

• dizziness, unsteadiness, or difficulty maintaining balance • feeling of tingling, burning, and (less frequently) electric shock-like sensations, also in the head • in some patients taking paroxetine, tinnitus (ringing, buzzing, whistling, or other persistent noise in the ears) may occur • sleep disturbances (intensive dreams, nightmares, insomnia) • feeling of anxiety • headaches.

Uncommon side effects, which may occur in less than 1 in 100 patients:

• nausea (nausea) • sweating (including night sweats) • feeling of restlessness or agitation • tremors • feeling of disorientation • diarrhea (loose stools) • emotional instability or irritability • vision disturbances • palpitations or rapid heartbeat (palpitations).

If the patient is concerned about withdrawal symptoms after stopping Xetanor

they should contact their doctor.

In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Xetanor can cause side effects, although not everybody gets them.
Side effects are more likely to occur in the first few weeks of taking Xetanor.

The patient should contact their doctor if they experience any of the following side effects during treatment:

It may be necessary to contact the doctor or hospital emergency department (ER) immediately.
Uncommon side effects(occurring in less than 1 in 100 patients):

• If the patient experiences unusual bruising or bleeding, including vomiting blood or blood in the stool, they should contact their doctor or go to the hospital immediately.

If the patient experiences difficulty urinating, they should contact their doctor or go to the hospital immediately.

Rare side effects(occurring in less than 1 in 1,000 patients):

• If the patient experiences seizures (convulsions), they should contact their doctor or go to the hospital immediately;
• If the patient feels anxious or has difficulty sitting or standing still; these may be symptoms of akathisia. Increasing the dose of Xetanor may worsen these symptoms. If such symptoms occur, the patient should contact their doctor.

If the patient feels tired, weak, or disoriented and experiences pain, stiffness, or lack of muscle coordination

they may have low sodium levels in the blood. If such symptoms occur, the patient should contact their doctor.
Very rare side effects(occurring in less than 1 in 10,000 patients):

Severe allergic reactions to Xetanor.

If the patient experiences a red, lumpy rash on the skin, swelling of the eyelids, face, lips, mouth, or tongue, itching, or difficulty breathing (dyspnea) or swallowing, and weakness or dizziness leading to falls or fainting, they should contact their doctor or go to the hospital immediately.

If the patient experiences some or all of the following symptoms

they may have serotonin syndrome. Symptoms include: feeling disoriented, anxious, sweating, shaking, shivering, hallucinations (strange images or sounds), sudden muscle contractions, or rapid heartbeat. If these symptoms occur, the patient should contact their doctor.

• Acute glaucoma. If the patient experiences eye pain and vision disturbances, they should contact their doctor.

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

• Some patients taking Xetanor or shortly after stopping treatment have experienced suicidal thoughts or self-harm thoughts (see section 2).
• Some patients taking Xetanor have experienced aggression.
• Severe postpartum hemorrhage, occurring shortly after delivery (postpartum hemorrhage), see additional information in subsection Pregnancy, breastfeeding, and fertility in section 2.
• 2.

If the patient experiences any of these side effects, they should contact their doctor.

Other possible side effects that may occur during treatment

Very common side effects(occurring in more than 1 in 10 patients):
nausea (nausea). Taking Xetanor in the morning, during a meal, reduces the likelihood of nausea; changes in sexual desire or sexual function. For example, lack of orgasm, or in men, erectile dysfunction and ejaculation disorders.
Common side effects(occurring in less than 1 in 10 patients):
increased cholesterol levels in the blood; loss of appetite; sleep disturbances (insomnia) or drowsiness; abnormal dreams, including nightmares; dizziness or tremors (shivering); headaches; difficulty concentrating; feeling of agitation; feeling of excessive weakness; vision disturbances; yawning, dry mouth; diarrhea or constipation; vomiting; weight gain; sweating.
Uncommon side effects(occurring in less than 1 in 100 patients):
short-term increases or decreases in blood pressure, which may cause dizziness or fainting when changing position quickly; rapid heartbeat; difficulty moving, stiffness, tremors, or abnormal movements of the mouth and tongue; dilated pupils; rash; itching; feeling of disorientation; hallucinations (strange images or sounds); inability to urinate (urinary retention) or involuntary, uncontrollable urination (urinary incontinence); decreased white blood cell count; in patients with diabetes, Xetanor may worsen blood sugar control. The patient should contact their doctor to adjust the dose of insulin or oral hypoglycemic medicines.
Rare side effects(occurring in less than 1 in 1,000 patients):
abnormal milk production in the breasts of men and women; slow heartbeat; effects on the liver, which can be detected in blood tests of liver function; panic attacks; excessive activity or racing thoughts (mania); feeling of uncertainty about one's own existence (depersonalization); feeling of anxiety; irresistible urge to move the legs (restless legs syndrome); joint or muscle pain; increased levels of a hormone called prolactin in the blood; menstrual disorders (including heavy or irregular bleeding, intermenstrual bleeding, absence of menstruation, or prolonged menstrual cycle).
Very rare side effects(occurring in less than 1 in 10,000 patients):
a skin rash called erythema multiforme, which may be accompanied by blisters and looks like small targets (a dark spot in the center surrounded by a lighter border with a dark ring around the edge); a widespread rash on the skin with blisters and peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome); a widespread rash on the skin with blisters and peeling of a large area of skin (toxic epidermal necrolysis); liver function disorders, which cause yellowing of the skin or the whites of the eyes; a syndrome of inappropriate antidiuretic hormone secretion (SIADH), in which the body retains too much water and the sodium level (salt) is reduced. Patients may experience symptoms of a serious illness or no symptoms at all; fluid retention or water retention (which may lead to swelling of the hands or feet); sensitivity to light; painful, persistent erections; decreased platelet count.
Frequency not known(frequency cannot be estimated from the available data):
grinding of the teeth; inflammation of the colon (causing diarrhea).
Some patients taking Xetanor may experience ringing, buzzing, whistling, or other persistent noises in the ears (tinnitus) during treatment.
Patients taking medicines from this group have been observed to have an increased risk of fractures.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps to gather more information on the safety of the medicine.

5. How to store Xetanor

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton after "EXP" and "Expiry date". The expiry date refers to the last day of the month stated.
Blisters should be stored in the original outer packaging.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the packaging and other information

What Xetanor contains

• The active substance of Xetanor is paroxetine. Each tablet contains 22.2 mg of paroxetine hydrochloride anhydrous, equivalent to 20 mg of paroxetine.
• Other ingredients are: Tablet core: magnesium stearate, sodium carboxymethylcellulose (Type A), mannitol, microcrystalline cellulose,

Coating: Eudragit E100, Opadry ABM White: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), talc, soy lecithin (E322), xanthan gum.

What Xetanor looks like and contents of the pack

Xetanor: round, biconvex, white or almost white coated tablets, 10 mm in diameter, with a score line on both sides, with the letter "P" on one side and the number "20" on the other side.
Packaging: The tablets are packaged in blisters placed in a cardboard box containing 20, 30, 60, 100 coated tablets. Each blister contains 10 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert Str. 23
40764 Langenfeld
Germany

Manufacturer

GE Pharmaceuticals Ltd.
Industrial zone, "Chekanitza-South" area
2140 Botevgrad
Bulgaria
Balkanpharma – Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria

For more information, the patient should contact the representative of the marketing authorization holder:

Neuraxpharm Polska Sp. z o.o.
ul. Poleczki 35
02-822 Warsaw
Date of last revision of the leaflet:12/2023