Paroxinor

Leaflet accompanying the packaging: information for the user

Paroxinor, 20 mg, coated tablets

Paroxetine

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.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed specifically 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, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Paroxinor and what is it used for

Paroxinor belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs), which are antidepressants.
Paroxinor is used to treat:

• Depression (episodes of severe depression).
• Obsessive-compulsive disorder (obsessive neurosis).
• Anxiety disorder with panic attacks with or without agoraphobia (e.g. fear of leaving home, entering shops, or fear of public places).
• Social phobia (overwhelming fear of contact with people or avoidance of such situations).
• Generalized anxiety disorder (long-standing fear, in which chronic, nervous worrying dominates).
• Post-traumatic stress disorder (anxiety caused by a traumatic event).

2. Important information before taking Paroxinor

When not to take Paroxinor:

• 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 or has taken monoamine oxidase inhibitors (MAOIs) within the last two weeks. MAOIs are a group of medicines used, among other things, to treat depression and Parkinson's disease. Before taking Paroxinor, consult a doctor.
• if the patient intends to take MAOIs. At least one week should be allowed between stopping Paroxinor and starting MAOI treatment. Consult a doctor for advice.
• if the patient is being treated with thioridazine or pimozide (medicines used to treat psychosis).

Warnings and precautions

Before starting Paroxinor, discuss it with your doctor or pharmacist.

Use in children and adolescents under 18 years of age

Paroxinor should not be used in the treatment of children and adolescents under 18 years of age. It should be known that patients of this age group are at increased risk of experiencing side effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, rebellious behavior, and anger) when taking medicines from this group. Nevertheless, the doctor may prescribe Paroxinor to patients under 18 years of age if he considers it to be in their best interest. If Paroxinor has been prescribed to a patient under 18 years of age and you have any doubts, you should contact your doctor again. If any of the above symptoms appear or worsen in a patient under 18 years of age taking Paroxinor, you should inform the doctor. Additionally, the long-term effects of Paroxinor on safety, including effects on growth, maturation, and cognitive development, have not been demonstrated in this age group.

Suicidal thoughts and worsening of depression or anxiety disorders

People with depression or anxiety disorders may sometimes have thoughts of self-harm or suicide. Such symptoms or behavior may worsen at the beginning of treatment with antidepressants, as these medicines usually start working after about 2 weeks, sometimes later.
The above symptoms are more likely to occur in:

• patients who have had suicidal thoughts or attempts in the past;
• young adult patients. Clinical trial data indicate an increased risk of suicidal behavior in people under 25 with mental disorders treated with antidepressants.

If the patient experiences thoughts of self-harm or suicide, they should contact their doctor or go to the hospital immediately.
It may be helpful to inform relatives or friendsabout depression or anxiety disorders and ask them to read this leaflet. The patient may ask to be informed if they notice that depression or anxiety has worsened or if there are worrying changes in behavior.
The patient should consult a doctor if any of the following situations apply to them or have applied in the past:

• if the patient develops symptoms such as inner restlessness and psychomotor agitation, including inability to sit or stand still, usually associated with subjective discomfort (akathisia). This condition usually occurs within the first few weeks of treatment and may worsen with increasing doses of the medicine (see "Possible side effects").
• if the patient develops symptoms such as high fever, muscle spasms, confusion, and anxiety, as these symptoms may indicate the onset of serotonin syndrome.
• if the patient has had manic episodes (excessive activity or thoughts) in the past. Paroxinor should be discontinued in any patient entering a manic phase. Consult a doctor.
• if the patient has heart, liver, or kidney disease. A dose reduction is recommended in patients with severe renal impairment or liver impairment.
• if the patient has irregular heart rhythm abnormalities on the electrocardiogram (ECG), known as QT interval prolongation.
• if there is a family history of QT interval prolongation, heart disease, such as heart failure, slow heart rate, or low potassium or magnesium levels.
• if the patient has diabetes. Paroxinor may cause increased or decreased blood glucose levels. It may be necessary to adjust the dose of insulin or oral antidiabetic medication. Additionally, an increase in blood glucose levels may occur when Paroxinor is used in combination with pravastatin.
• if the patient has epilepsy.
• if the patient experiences seizures during treatment with Paroxinor. Paroxinor should be discontinued and the doctor consulted.
• if the patient is undergoing electroconvulsive therapy for depression.
• if the patient has glaucoma (increased pressure in the eyeballs).
• if the patient is at risk of decreased sodium levels in the blood (hyponatremia), e.g. due to concomitant use of other medicines and liver cirrhosis. Hyponatremia has been rarely reported during treatment with Paroxinor and mainly in elderly patients.
• if the patient is taking tamoxifen (for breast cancer treatment). Paroxinor may affect the efficacy of tamoxifen, so the doctor may recommend using a different antidepressant.
• if the patient has or has had blood disorders (e.g. abnormal bleeding into the skin or stomach) or if the patient is pregnant (see "Pregnancy, breastfeeding, and fertility").
• if the patient is taking medicines that increase the risk of bleeding (see "Paroxinor with other medicines").

Medicines like Paroxinor (SSRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms have persisted after discontinuation of treatment.

Paroxinor with other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Interaction means that medicines used at the same time may affect each other's effects and/or side effects. The following notes may also apply to medicines that you have taken at any time in the past or will take in the near future.
Interaction may occur when Paroxinor is used in combination with the following medicines:

• tricyclic antidepressants (used to treat depression), e.g. clomipramine, nortriptyline, and desipramine,
• SSRIs (selective serotonin reuptake inhibitors), e.g. citalopram and fluoxetine,
• L-tryptophan (used to treat sleep disorders),
• MAOIs (e.g. used to treat depression or Parkinson's disease) (see "When not to take Paroxinor"),
• lithium (used to treat mental disorders),
• buprenorphine,
• St. John's wort (Hypericum perforatum),
• triptans (used to treat migraines), e.g. sumatriptan,
• tramadol (a strong pain reliever),
• linezolid (an antibiotic),
• methylene blue (used as an antidote or antiseptic),
• pethidine (a strong pain reliever),
• fentanyl (used for general anesthesia or chronic pain).

Concomitant use of the above medicines may enhance the serotonergic effects of Paroxinor, leading to the onset of serotonin syndrome (see "Warnings and precautions").

• perphenazine, risperidone, atomoxetine, thioridazine, pimozide, and clozapine (antipsychotic medicines),
• propafenone and flecainide (used to treat irregular heart rhythm),
• metoprolol (used to treat heart failure),
• pravastatin (used to lower cholesterol).

Concomitant use of the above medicines may increase the frequency of their side effects, such as heart disorders, which can sometimes be severe (see "When not to take Paroxinor").

• phenobarbital, carbamazepine, and phenytoin (used to treat epilepsy),
• rifampicin (an antibiotic),
• the combination of fosamprenavir and ritonavir (used to treat HIV infections),
• medicines known to affect heart rhythm (e.g. antipsychotic medicines thioridazine or pimozide).

Concomitant use of the above medicines may reduce the effect of Paroxinor by increasing the metabolism of paroxetine.

• tamoxifen, which is used to treat breast cancer.

Concomitant use of tamoxifen with Paroxinor may reduce the efficacy of tamoxifen.

• NSAIDs (non-steroidal anti-inflammatory drugs, e.g. ibuprofen, diclofenac), cyclooxygenase-2 inhibitors, and acetylsalicylic acid (pain relievers),
• warfarin (used to prevent blood clotting).

Concomitant use of the above medicines may increase or prolong bleeding (see "Warnings and precautions").

• procyclidine (used to treat Parkinson's disease). An increase in the frequency of procyclidine's side effects may occur due to increased blood levels.
• mivacurium and suxamethonium (used for general anesthesia).

Note that the above medicines may be known to the patient under different names, often brand names. In this section of the leaflet, only the active substance or therapeutic group of the medicine is mentioned, not the brand name. The patient should always read the information on the packaging and in the leaflet accompanying the packaging of the medicines they are taking, where the active substance or therapeutic group of the medicine should be listed.

Paroxinor with food, drink, and alcohol

Food: The tablets should be taken in the morning during breakfast. This will reduce the risk of side effects.
Alcohol: Do not drink alcohol while taking Paroxinor. Alcohol may enhance the symptoms of the disease or side effects.

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
After using Paroxinor in the first three months of pregnancy, there may be a slight increase in the risk of congenital malformations (cardiovascular system) in the child. Therefore, women considering becoming pregnant or who are pregnant must inform their doctor. The doctor will decide whether the use of Paroxinor is absolutely necessary or whether there is a possibility of using other types of treatment for the patient.
Make sure that the midwife and/or doctor know that you are taking Paroxinor.
Similar medicines (SSRIs) used by pregnant women may increase the risk of a serious disease in the child, called persistent pulmonary hypertension of the newborn (PPHN), causing rapid breathing and bluish skin discoloration in the child. These symptoms usually occur within the first day of life. If this happens, you should contact the midwife and/or doctor immediately.
Do not stop treatment abruptly.
If you are taking Paroxinor in the last three months of pregnancy, you should tell your doctor, as the newborn may experience certain abnormal symptoms. These symptoms usually occur within the first 24 hours after birth and include: difficulty sleeping or feeding, difficulty breathing, bluish skin discoloration, high or low body temperature, vomiting, crying, muscle stiffness or floppiness, drowsiness, tremors, nervousness, or difficulty recognizing their surroundings (disorientation). If the child experiences any of these symptoms, you should contact the doctor, who will provide appropriate advice.
Taking Paroxinor at the end of pregnancy may increase the risk of severe postpartum hemorrhage, which occurs shortly after delivery, especially if there is a history of bleeding disorders in the patient. If you are taking Paroxinor, you should inform your doctor or midwife so that they can provide you with appropriate advice.

Breastfeeding

Paroxinor may pass into breast milk in small amounts. If you are taking Paroxinor, you should contact your doctor before breastfeeding.

Fertility

Animal studies have shown that paroxetine reduces sperm quality. This may theoretically affect fertility, although no effect on fertility has been observed in humans so far.

Driving and using machines

Paroxinor may cause side effects (such as dizziness, drowsiness, or confusion) that affect concentration and reaction speed. If you experience these side effects, do not drive a car, operate machinery, or do anything that requires special attention.

Paroxinor contains lactose.

This medicine contains 9.5 mg of lactose (monohydrate). If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine.

Other excipients

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Paroxinor

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Recommended dose:

Adults

Depression
The recommended dose is 20 mg per day. Depending on the patient's response to the medicine, the dose can be gradually increased by 10 mg to a dose of 50 mg per day.
Improvement usually starts in patients after one week of treatment, but may only be noticeable from the second week. Treatment should be continued for at least 6 months.
Obsessive-compulsive disorder (obsessive neurosis)
The initial dose is 20 mg per day. Depending on the patient's response to the medicine, the dose can be gradually increased by 10 mg to a dose of 40 mg per day. The recommended dose is 40 mg per day.
The maximum daily dose is 60 mg. Treatment should be continued for several months.
Anxiety disorder with panic attacks
The initial dose is 10 mg per day. Depending on the patient's response to the medicine, the dose can be gradually increased by 10 mg to a dose of 40 mg per day. The recommended dose is 40 mg per day.
The maximum daily dose is 60 mg. Treatment should be continued for several months.
Social phobia, generalized anxiety disorder, and post-traumatic stress disorder
The recommended dose is 20 mg per day. Depending on the patient's response to the medicine, the dose can be gradually increased by 10 mg to a dose of 50 mg per day. The maximum daily dose is 50 mg.

Use in children and adolescents

Paroxetine should not be used in children and adolescents under 18 years of age.

Use in the elderly

Depending on the patient's response to the medicine, the dose can be increased to 40 mg per day. The maximum daily dose is 40 mg.

Severe renal impairment

The doctor will prescribe the appropriate dose for the patient.

Liver impairment

The doctor will prescribe the appropriate dose for the patient.
The medicine is best taken in the morning during a meal, with a glass of water.
The tablet or half-tablet should be swallowed whole rather than chewed.

Overdose of Paroxinor

In case of overdose, contact a doctor, pharmacist, or the nearest hospital.
Symptoms of overdose include, for example, vomiting, dilated pupils, fever, changes in blood pressure, headache, involuntary muscle contractions, agitation, anxiety, and rapid heart rate.

Missed dose of Paroxinor

In case of a missed dose, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping Paroxinor treatment

Do not stop treatment with Paroxinor without consulting your doctor, even if you feel better.
In case of sudden cessation of long-term treatment, the patient may experience withdrawal symptoms: dizziness, sensory disturbances (numbness or tingling, known as paresthesia, electric shock sensation, and ringing in the ears), sleep disturbances (including intense dreams), nausea (nausea), diarrhea, headaches, rapid and irregular heart rhythm (palpitations), tremors, increased sweating, vision disturbances, or a feeling of agitation, anxiety, irritation, or difficulty recognizing their surroundings (disorientation). These symptoms are usually mild or moderate and resolve on their own within two weeks. However, in some patients, they may be more severe or longer-lasting. They usually occur within the first few days after stopping the medicine. See section 4 "Withdrawal symptoms after stopping paroxetine".
When stopping Paroxinor, the doctor will inform the patient how to gradually reduce the dose over several weeks or months. This should reduce the likelihood of withdrawal symptoms. One way to do this is to gradually reduce the dose of Paroxinor by 10 mg per week.
If the patient experiences withdrawal symptoms when gradually reducing the dose, the doctor may recommend a slower tapering schedule. If the patient experiences severe withdrawal symptoms after stopping Paroxinor, they should contact their doctor. The doctor may recommend returning to tablet treatment and tapering off more slowly.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Paroxinor can cause side effects, although not everybody gets them.
Consult a doctor immediately if you experience any of the following symptoms:

• -swelling of the face, tongue, and/or throat and/or difficulty swallowing or hives with accompanying breathing difficulties (angioedema)
• -high fever, muscle spasms, confusion, and anxiety, as these symptoms may indicate the onset of serotonin syndrome.

If you experience thoughts of self-harm or suicide while taking Paroxinor, especially within the first 2-4 weeks, you should contact your doctor immediately.

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

• nausea (nausea),
• sexual dysfunction.

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

• decreased appetite, increased cholesterol levels,
• drowsiness, insomnia, agitation, unusual dreams (including nightmares),
• headaches,
• dizziness, tremors (tremors),
• concentration disturbances,
• blurred vision,
• yawning,
• constipation, diarrhea, vomiting, dry mouth,
• sweating,
• weakness (asthenia), weight gain.

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

• abnormal bleeding, mainly in the skin and mucous membranes (including bruising and unexplained bleeding from the genital tract),
• confusion, hallucinations,
• slow and/or involuntary movements (extrapyramidal symptoms),
• rapid heart rate,
• transient increases or decreases in blood pressure, which may cause dizziness or fainting when standing up quickly. Paroxetine treatment has caused transient increases or decreases in blood pressure, usually in patients with pre-existing hypertension or anxiety.
• pupil dilation,
• skin rash, itching,
• urinary retention, involuntary urination (incontinence),
• if the patient has diabetes, they may notice a loss of control over blood sugar levels while taking Paroxinor. They should discuss adjusting the dose of insulin or oral antidiabetic medication with their doctor,
• decreased white blood cell count.

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

• decreased sodium levels in the blood (hyponatremia). Hyponatremia has been reported, mainly in elderly patients, and sometimes due to SIADH (syndrome of inappropriate antidiuretic hormone secretion).
• manic reactions, anxiety, feeling of detachment from oneself (depersonalization), panic attacks, restlessness, and a feeling of being unable to sit still (akathisia) (see section 2 "Warnings and precautions"). These symptoms may also be caused by the disease being treated.
• seizures, restless legs syndrome,
• slow heart rate,
• increased liver enzyme activity,
• joint pain, muscle pain,
• hyperprolactinemia (abnormally high prolactin levels in the blood), appearance of breast discharge,
• menstrual disturbances (including increased or irregular bleeding, intermenstrual bleeding, and absence or delay of menstruation).

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

• decreased platelet count,
• allergic reactions, which may be severe and related to Paroxinor, including hives and swelling of the eyelids, face, lips, tongue, or throat with difficulty breathing (angioedema) or swallowing (dysphagia),
• feeling of weakness or dizziness that may cause falls or loss of consciousness - contact a doctor or go to the hospital immediately,
• increased secretion of antidiuretic hormone (SIADH), leading to hyponatremia with symptoms such as headache, nausea, and vomiting,
• -serotonin syndrome (symptoms may include agitation, confusion, excessive sweating, hallucinations, increased muscle tone, muscle spasms, shivering, rapid heart rate, and tremors),
• acute glaucoma (eye disorder caused by damage to the optic nerve),
• gastrointestinal bleeding,
• liver disorders (such as hepatitis, sometimes associated with jaundice and/or liver failure). Increased liver enzyme activity has been reported. Since the marketing of paroxetine, liver disorders (including hepatitis, sometimes associated with jaundice and/or liver failure) have been reported very rarely.
• severe skin reactions (including polymorphic erythema, Stevens-Johnson syndrome, and toxic epidermal necrolysis), photosensitivity,
• prolonged erection of the penis (priapism),
• edema due to fluid retention.

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

• suicidal thoughts or behaviors. Suicidal thoughts or behaviors have been reported during paroxetine treatment or shortly after discontinuation (see section 2 "Warnings and precautions").
• some patients have reported a ringing, buzzing, whistling, or other persistent sound in the ears (tinnitus) when taking Paroxinor.
• aggression,
• teeth grinding,
• colitis (causing diarrhea),
• severe postpartum hemorrhage, which occurs shortly after delivery (see additional information in subsection "Pregnancy, breastfeeding, and fertility" in section 2).

Withdrawal symptoms after stopping paroxetine

Common:dizziness, sensory disturbances, ringing in the ears (tinnitus), sleep disturbances, anxiety, headaches.
Uncommon:agitation, nausea, tremors, confusion, sweating, emotional instability, vision disturbances, rapid heart rate, diarrhea, irritability.
See section 3: "Stopping Paroxinor treatment".
There is an increased risk of fractures in patients taking medicines like Paroxinor.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Paroxinor

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month.
There are no special precautions for storage.
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 pack and other information

What Paroxinor contains

• The active substance is paroxetine. Each coated tablet contains 20 mg of paroxetine (as paroxetine hydrochloride hemihydrate).
• The other ingredients in the tablet core are: calcium hydrogen phosphate dihydrate (Calipharm), calcium hydrogen phosphate dihydrate (Ditab), anhydrous calcium hydrogen phosphate, lactose monohydrate, sodium carboxymethylcellulose (Type A), and magnesium stearate.
• The other ingredients in the tablet coating are: titanium dioxide (E 171), hypromellose 3 cP, hypromellose 6 cP, macrogol 400, and polysorbate 80.

What Paroxinor looks like and contents of the pack

The tablets are white to off-white, modified capsule-shaped, biconvex, with the number "56" embossed on one side and a deep break line and the letter "C" on the other side. The tablet can be divided into equal doses.
Pack sizes: 20, 30, 60, and 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Orion Corporation
Orionintie 1
02200 Espoo
Finland

Manufacturer

Orion Corporation
Orion Pharma
Orionintie 1
02200 Espoo
Finland
To obtain more detailed information on this medicine, please contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o.o.
[email protected]

This medicinal product is authorized in the Member States of the EEA under the following names:

Date of last revision of the leaflet: 05.2025