Xetanor 20 mg

Patient Information Leaflet: Information for the User

Xetanor 20 mg, coated tablets
Paroxetinum hydrochloridum
Please read the entire leaflet carefully before taking this medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

1. What Xetanor is and what it is 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 pack and other information

1. What Xetanor is and what it is used for

Xetanor is used to treat adults with depression and (or) anxiety disorders.
Anxiety disorders treated with Xetanor include: obsessive-compulsive disorder (recurring, obsessive thoughts with uncontrollable behaviour), panic disorder with or without agoraphobia (panic attacks, including those caused by agoraphobia, which is fear of open spaces), social phobia (fear of or avoidance of social situations), post-traumatic stress disorder (anxiety caused by a traumatic event), and generalized anxiety disorder (generalized feelings of anxiety or nervousness).
Xetanor belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). The exact mechanism of action of Xetanor and other SSRIs is not fully understood, but they may increase the levels of serotonin in the brain. Proper treatment of depression and anxiety disorders is important to help the patient feel better.

2. Important information before taking Xetanor

When not to take Xetanor:

• if the patient is allergic to paroxetine hydrochloride, peanuts, soya, 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 Xetanor after stopping MAO inhibitors.
• if the patient is taking antipsychotic medicines, such as thioridazine or pimozide.

If any of the above situations apply to the patient, contact the doctor
in charge and do not take Xetanor.
Warnings and precautions
Before starting treatment with Xetanor, discuss this with your doctor or pharmacist if:

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

If the answer is YES to any of the above questions and the patient has not yet contacted
their doctor, go to the treating doctor and ask how to take Xetanor.
Children and adolescents under 18 years of age
Xetanor should not be used in children and adolescents under 18 years of age. Patients under
18 years of age are at increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (especially aggression, defiant behaviors, and anger) while taking Xetanor.
If the doctor has prescribed Xetanor to the patient (or the patient's child) and doubts arise,
contact the treating doctor. If the listed symptoms appear or worsen during treatment with Xetanor, inform the doctor. In addition, there are currently no data on the long-term safety of Xetanor or its effects on growth, maturation, cognitive development, and behavioral development in this age group.
In clinical trials of paroxetine in patients under 18 years of age, common adverse events occurring in less than 1 in 10 patients were: increased frequency of suicidal thoughts and suicide attempts, deliberate self-harm, hostility, aggressive or hostile behaviors, loss of appetite, tremor, abnormal sweating, hyperactivity (excessive energy), agitation, emotional lability (including tearfulness and mood swings), and unusual bruising or bleeding (such as nosebleeds).
These trials also showed that such symptoms occurred, although less frequently, in children and adolescents receiving placebo (sugar pills) instead of paroxetine.
Some patients under 18 years of age in these trials experienced withdrawal symptoms after stopping the medicine. These symptoms were very similar to those observed in adults after discontinuing Xetanor (see section 3). In addition, in patients under 18 years of age, abdominal pain, feeling nervous, and emotional lability (including tearfulness, mood swings, 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 disorder symptoms
Patients with depression and (or) anxiety disorders may sometimes experience thoughts of self-harm or suicidal thoughts. These may worsen at the beginning of treatment with antidepressants, as it may take some time—usually about 2 weeks, sometimes longer—before these medicines start to work.
Such thoughts may occur more frequently in the patient if:

• the patient previously had suicidal or self-harming thoughts.
• the patient is a young adult. Clinical trial data have shown an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders who were treated with antidepressants.
• if the patient ever experiences thoughts of self-harm or suicide, contact the doctor immediately or go to the hospital. It may be helpful for the patient to inform a relative or friend that they have depression or an anxiety disorder and ask them to read this leaflet. The patient may ask them to inform them if they notice worsening of depression or anxiety or concerning changes in behavior.

Important adverse effects observed during treatment with Xetanor
In some patients taking Xetanor, symptoms called akathisia may occur. They may feel restless and unable to sit or stand still. In other patients, a condition called serotonin syndrome or neuroleptic malignant syndrome may occur, in which patients may experience some or all of the following symptoms: intense agitation or irritability, confusion (disorientation), anxiety, fever, sweating, tremor, chills, 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 adverse effects of Xetanor can be found in section 4.
Medicines such as Xetanor (so-called SSRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms persisted after stopping treatment.
Xetanor and other medicines
Tell your doctor or pharmacist about all medicines currently or recently taken by the patient, as well as any medicines the patient plans to take.
Some medicines may affect the action of Xetanor or increase the risk of adverse effects. Xetanor 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 Xetanor"
• thioridazine or pimozide, which belong to antipsychotic medicines – see section "When not to take Xetanor"
• acetylsalicylic acid, ibuprofen, or other medicines called NSAIDs (non-steroidal anti-inflammatory drugs), such as celecoxib, etodolac, diclofenac, and meloxicam, used for treating pain and inflammatory conditions
• tramadol, pethidine, buprenorphine – opioid analgesics. These medicines may interact with Xetanor and cause symptoms such as involuntary, rhythmic muscle contractions, including muscles controlling eye movements, agitation, hallucinations, coma, excessive sweating, tremor, increased reflexes, increased muscle tone, body temperature above 38°C. If the patient experiences such symptoms, contact the doctor.
• medicines called triptans, such as sumatriptan, used for treating migraine
• other antidepressants, including other SSRIs, tryptophan, and tricyclic antidepressants such as clomipramine, nortriptyline, and desipramine
• a dietary supplement called tryptophan
• mivacurium and suxamethonium (used for general anesthesia)
• medicines such as lithium, risperidone, perphenazine, clozapine (called antipsychotics) used to treat certain mental disorders
• fentanyl, used during anesthesia and for treating chronic pain
• the combination of fosamprenavir and ritonavir, used for treating human immunodeficiency virus (HIV) infections
• St. John's wort, a herbal medicine used for depression
• phenobarbital, phenytoin, sodium valproate, or carbamazepine used for treating seizures or epilepsy
• atomoxetine, used for treating 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 for treating irregular heartbeat
• metoprolol, a beta-blocker used for treating high blood pressure and heart problems
• pravastatin, used for treating high cholesterol levels
• rifampicin, used for treating tuberculosis and acne
• linezolid, an antibiotic
• tamoxifen, used for treating breast cancer and fertility problems

If the patient is currently taking or has recently taken any of these medicines and has not yet discussed this with the doctor, they should contact the doctor again and ask what to do. The dose of the medicine may need to be changed, or another medicine may need to be taken.
Xetanor with food, drink, and alcohol
Do not consume alcohol while taking Xetanor. Alcohol may worsen symptoms of the illness or increase adverse effects. Taking Xetanor 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.
Pregnancy
There are some reports indicating that congenital developmental abnormalities, particularly heart defects, may occur in children whose mothers took a medicine containing paroxetine during the first few months of pregnancy. 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 medicine containing paroxetine. The doctor will decide together with the patient whether it is better during pregnancy to switch to another medicine or gradually discontinue Xetanor. In certain circumstances, the doctor may also suggest that it is better for the patient to continue taking Xetanor.
Ensure that the midwife or doctor is informed that the patient is taking Xetanor. Taking Xetanor towards the end of pregnancy may increase the risk of serious vaginal bleeding shortly after delivery, especially if the patient has a history of blood clotting disorders. If the patient is taking Xetanor, she should inform the doctor or midwife so they can provide appropriate advice. Medicines such as Xetanor taken during pregnancy, especially in the later stages, may increase the risk of serious complications in the newborn, called persistent pulmonary hypertension of the newborn (PPHN). In PPHN, 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 three months of pregnancy, other disturbances may also occur in the newborn, usually within the first 24 hours after birth. These symptoms include: breathing difficulties, skin discoloration (cyanosis), unstable body temperature, bluish lips, vomiting, or difficulty feeding properly, fatigue, difficulty falling asleep or increased crying, stiff or floppy muscles, tremors, jitteriness due to agitation, or seizures, and increased reflexes. If any of these symptoms occur in the baby after birth or if there are concerns about the baby's health, contact the doctor or midwife for advice.
Breastfeeding
Paroxetine may pass into breast milk in very small amounts. If the patient is taking Xetanor, she should discuss breastfeeding with the doctor before starting. The doctor and the patient may decide together whether the patient will breastfeed while taking Xetanor.
Fertility
Animal studies have shown that paroxetine reduces sperm quality. This could theoretically affect fertility; however, the effect on human fertility has not yet been established.
Driving and operating machinery
Possible adverse effects caused by Xetanor include dizziness, disorientation, drowsiness, and visual disturbances. If such adverse effects occur, do not drive or operate machinery.
Xetanor contains soya lecithin (E322), which may contain soya-derived proteins.
Do not take this medicine if the patient is allergic to peanuts or soya.
Xetanor contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Xetanor

This medicine should always be used as directed by the physician. If in doubt, consult a doctor or pharmacist.
The usual doses for various indications are shown in the table below:

The prescribing doctor will advise from which dose of Xetanor treatment should be started. Most
patients begin to feel better after a few weeks. If there is no improvement by then,
you should 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, with food. Swallow the tablets whole,
with water. Do not chew.
The prescribing doctor will discuss with the patient how long the tablets should be taken. 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
For patients with liver or kidney disease, the doctor may prescribe a lower dose of Xetanor than
normally used. For patients with severe liver or kidney disease, the maximum daily dose
is 20 mg.
Taking more than the recommended dose of Xetanor
Never take more tablets than prescribed by the doctor. If a patient (or another person)
has taken too many Xetanor tablets, contact a doctor immediately or go to
the nearest hospital emergency department (A&E). Show the tablet packaging.
Symptoms of Xetanor overdose may include those 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 each day.
If a dose is missed and remembered before going to bed, the dose should be taken immediately.
The next day, take the usual dose as scheduled.
If the patient remembers during the night or the next day that a dose was missed,
the missed dose should not be taken. Withdrawal symptoms may occur, but they should
quickly resolve 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
Xetanor does not relieve symptoms of illness immediately – all antidepressant medicines
begin to work only after some time. Some patients begin to feel better after a few
weeks, while others may take longer. Some patients taking antidepressants may
feel worse before they start to feel better. If the patient does not feel better after
a few weeks of treatment, they should consult the doctor for advice. The doctor should
schedule a follow-up visit a few weeks after starting the medicine for the first time.
Inform the prescribing doctor if the patient has not started to feel better.
Stopping treatment with Xetanor
Do not stop taking Xetanor unless advised by the doctor.
When discontinuing Xetanor, the prescribing doctor will help gradually reduce the dose over
several weeks or months – this should reduce the likelihood of withdrawal symptoms.
One way is to gradually reduce the patient's dose of Xetanor by 10 mg weekly.
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 the patient experiences withdrawal symptoms after stopping the tablets, the doctor may
decide that the patient should taper the medicine more slowly. If severe withdrawal symptoms
occur during discontinuation of Xetanor, contact the doctor. The doctor may recommend
resuming the tablets and tapering them more slowly.
Even if withdrawal symptoms occur, it is still possible to discontinue treatment with Xetanor.
Possible withdrawal symptoms occurring after stopping treatment
Studies show that 3 out of 10 patients experience one or more withdrawal symptoms when
stopping treatment with Xetanor. Some of these symptoms occur more frequently than others.
Common side effects, may occur in less than 1 in 10 patients:

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

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

• 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 (rapid heartbeat).

If the patient is concerned about withdrawal symptoms after stopping Xetanor,
they should contact their doctor.
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
Adverse effects may be more likely during the first weeks of treatment with Xetanor.
You should contact your doctor if any of the following adverse effects occur during treatment:
Immediate contact with a doctor or hospital emergency department may be necessary.

Uncommon adverse effects (occurring in less than 1 out of 100 patients):

• If the patient develops unusual bruising or bleeding, including vomiting blood or blood in the stool, seek immediate medical attention or go to the hospital.
• If the patient experiences difficulty urinating, seek immediate medical attention or go to the hospital.

Rare adverse effects (occurring in less than 1 out of 1,000 patients):

• If the patient experiences seizures (convulsions), seek immediate medical attention or go to the hospital.
• If the patient feels restless 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, contact your doctor.
• If the patient feels tired, weak, or disoriented, and experiences pain, stiffness, or lack of muscle coordination, this may indicate low blood sodium levels. If these symptoms occur, contact your doctor.

Very rare adverse effects (occurring in less than 1 out of 10,000 patients):

• Severe allergic reactions to Xetanor. If the patient develops a red, bumpy skin rash, swelling of the eyelids, face, lips, mouth, or tongue, itching, or difficulty breathing (shortness of breath), swallowing, or experiences weakness or dizziness leading to collapse or fainting, seek immediate medical attention or go to the hospital.
• If the patient experiences some or all of the symptoms listed below, they may be experiencing serotonin syndrome. Symptoms include: disorientation, restlessness, sweating, tremor, chills, hallucinations (strange images or sounds), sudden muscle contractions, or rapid heartbeat. If these symptoms occur, contact your doctor immediately.
• Acute glaucoma. If the patient experiences eye pain and develops visual disturbances, contact your doctor.

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

• In some patients, thoughts of self-harm or suicide occurred during treatment with Xetanor or shortly after stopping treatment (see section 2).
• In some patients, aggression occurred during treatment with Xetanor.
• Severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage); see additional information in subsection Pregnancy, breastfeeding and fertility in section 2.
  If any of these adverse effects occur, contact your treating physician.

Other possible adverse effects during treatment

Very common adverse effects (may occur in more than 1 out of 10 patients):
Nausea. Taking Xetanor in the morning with food reduces the likelihood of nausea; changes in sexual desire or sexual function, for example, anorgasmia, and in men, erectile or ejaculation disorders.

Common adverse effects (may occur in less than 1 out of 10 patients):
Increased blood cholesterol levels; loss of appetite; sleep disturbances (insomnia) or drowsiness; abnormal dreams, including nightmares; dizziness or tremors (chills); headache; difficulty concentrating; feeling of restlessness; feeling of excessive fatigue; blurred vision; yawning; dry mouth; diarrhoea or constipation; vomiting; weight gain; sweating.

Uncommon adverse effects (may occur in less than 1 out of 100 patients):
Short-term increase or decrease in blood pressure, which may cause dizziness or fainting upon sudden change to an upright position; faster than usual heartbeat; difficulty moving, stiffness, tremors, or involuntary movements of the mouth and tongue; pupil dilation; skin rash; itching; feeling of disorientation; hallucinations (strange images or sounds); inability to urinate (urinary retention) or uncontrolled, involuntary urination (urinary incontinence); decreased white blood cell count; in patients with diabetes, treatment with Xetanor may lead to worsening blood glucose control. Contact your doctor to adjust the dose of insulin or antidiabetic medication.

Rare adverse effects (may occur in less than 1 out of 1,000 patients):
Abnormal milk production in the breast glands in men and women; slow heartbeat; liver effects detectable in blood tests assessing liver function; panic attacks; excessive mental activity or racing thoughts (mania); feeling of uncertainty about one's own existence (depersonalization); anxiety; irresistible urge to move the legs (restless legs syndrome); joint or muscle pain; increased blood levels of the hormone called prolactin; menstrual disorders (including heavy or irregular bleeding, intermenstrual bleeding, absence of menstruation, or prolonged menstrual cycle).

Very rare adverse effects (may occur in less than 1 out of 10,000 patients):
Skin rash called erythema multiforme, which may present with blisters and appear as target-like lesions (dark spot in the center surrounded by a lighter ring with a dark edge); widespread skin rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genital organs (Stevens-Johnson syndrome); widespread skin rash with blisters and peeling of a large surface area of skin (toxic epidermal necrolysis); liver function disorders causing yellowing of the skin or whites of the eyes; syndrome of inappropriate antidiuretic hormone secretion (SIADH), where due to improper chemical signals in the body, excess water is retained and sodium (salt) levels are reduced. Patients may experience symptoms of serious illness or may have no symptoms; fluid or water retention (which may lead to swelling of the hands or feet); light sensitivity; painful, persistent penile erection; decreased platelet count.

Frequency not known (frequency cannot be determined from available data):
Teeth grinding; inflammation of the colon (causing diarrhoea).
Some patients may experience ringing, buzzing, whistling, or other persistent noise in the ears (tinnitus) while taking Xetanor.
Patients taking medicines in this class have shown an increased risk of bone fractures.

Reporting of adverse effects
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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, 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 authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Xetanor 20 mg

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister after "EXP" and on the
carton after: Expiry date (EXP). The expiry date refers to the last day of the stated month.
Store blisters in the original outer packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Xetanor contains

• The active substance is paroxetine. Each Xetanor tablet contains 22.2 mg of anhydrous paroxetine hydrochloride, equivalent to 20 mg of paroxetine.
• Other ingredients are:
  Tablet core: magnesium stearate, sodium carboxymethyl starch (Type A), mannitol, microcrystalline cellulose.
  Tablet coating: Eudragit E100, Opadry ABM White: partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), talc, soya 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 break line on both sides, marked with the letter "P" on one side and the number "20" on the other.

Available pack sizes:
Tablets are packed in blisters placed in cardboard boxes containing 20, 30, 60, or 100 coated tablets. Each blister contains 10 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 further information, contact the local representative of the Marketing Authorisation Holder:
Neuraxpharm Polska Sp. z o.o.
ul. Poleczki 35
02-822 Warsaw
Poland