Paroxetine Aurovitas

Leaflet accompanying the packaging: patient information

Paroxetine Aurovitas, 20 mg, coated tablets

Paroxetine

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

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for this person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Paroxetine Aurovitas and what is it used for

Paroxetine Aurovitas is used to treat adults with depression and/or anxiety disorders.

Anxiety disordersthat Paroxetine Aurovitas is used to treat include:
obsessive-compulsive disorder (recurring, obsessive thoughts with uncontrolled behavior), panic disorder (panic attacks, including those caused by agoraphobia, which is 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).
Paroxetine Aurovitas belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). It is not fully understood how Paroxetine Aurovitas 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 Paroxetine Aurovitas

When not to take Paroxetine Aurovitas:

• If the patient is allergicto paroxetine 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 (methylthioninium chloride), or if they have taken them within the last two weeks. The doctor will advise the patient on how to start taking Paroxetine Aurovitas after stopping MAOIs.
• If the patient is taking antipsychotic medicines, such as thioridazine or pimozide.
• If any of the above situations apply to the patient, they should contact their doctor before taking Paroxetine Aurovitas.

Warnings and precautions

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

• Is the patient taking any other medicines (see Paroxetine Aurovitas and other medicineslater in the leaflet)?
• Is the patient taking tamoxifen for breast cancer? Paroxetine Aurovitas may reduce the effectiveness of tamoxifen, and the doctor may recommend a different antidepressant.
• Does the patient have kidney, liver, or heart problems?
• Does the patient have abnormal heart rhythm (ECG) known as QT interval prolongation?
• Is there a family history of QT interval prolongation, heart disease such as heart failure, low heart rate, or decreased potassium or magnesium levels?
• Does the patient have epilepsy or a history of seizures?
• Has the patient ever had episodes of mania (excessive activity or racing thoughts)?
• Is the patient undergoing electroconvulsive therapy?
• Has the patient ever had bleeding or is the patient pregnant (see Pregnancy, breastfeeding, and fertilitylater in the leaflet) or is the patient taking other medicines that may increase the risk of bleeding (including anticoagulants such as warfarin, antipsychotics such as perphenazine or clozapine, tricyclic antidepressants, non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam)?
• Does the patient have diabetes?
• Is the patient on a low-sodium diet?
• Does the patient have glaucoma (increased pressure in the eye)?
• Is the patient pregnant or planning to become pregnant (see Pregnancy, breastfeeding, and fertilitylater in the leaflet)?
• Is the patient under 18 years old (see Children and adolescentslater in the leaflet)?
• Is the patient taking buprenorphine-containing medicines? Taking these medicines with Paroxetine Aurovitas may lead to serotonin syndrome, a potentially life-threatening condition (see Paroxetine Aurovitas and other medicines).

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

Children and adolescents

Paroxetine Aurovitas should not be used in children and adolescents under 18 years old.

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 signs of anger). If the doctor has prescribed Paroxetine Aurovitas to a patient under 18 years old and there are concerns, the patient should consult their doctor. If these symptoms occur or worsen while taking Paroxetine Aurovitas, the patient should inform their doctor. Additionally, there is currently no data on the long-term safety of Paroxetine Aurovitas regarding growth, maturation, and cognitive and behavioral development in this age group.
In studies of Paroxetine Aurovitas 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, self-harm, hostility, aggressive behavior, or unfriendly behavior, loss of appetite, tremors, abnormal sweating, excessive activity (excess energy), restlessness, 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 Aurovitas.
In some patients under 18 years old in these studies, withdrawal symptoms from Paroxetine Aurovitas occurred. These symptoms were very similar to those observed in adults after stopping Paroxetine Aurovitas (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, 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 may sometimes occur. They may be more frequent at the start of antidepressant treatment, as it may take some time for the medicines to start working, usually around two weeks, and sometimes even longer.

The patient is more likely to have such thoughts:

• if they have had suicidal thoughts or self-harm before.
• if they are a young adult. Clinical studies 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 has ever had thoughts of self-harm or suicide, they should contact their doctor or the nearest emergency department immediately.It may be helpful to inform a relative or friend about their depression or anxiety disorder and ask them to read this leaflet. The patient may ask them to tell them if they notice that their depression or anxiety disorder has worsened or if there are any worrying changes in their behavior.

Important side effects seen with Paroxetine Aurovitas

In some patients taking Paroxetine Aurovitas, a condition called akathisia may develop. They may feel anxious and unable to sit or stand still. In other patients, a condition called serotonin syndrome or neuroleptic malignant syndrome may develop, in which patients have some or all of the following symptoms: feeling highly agitated or irritated, feeling confused, feeling anxious, feeling hot, sweating, shaking, chills, hallucinations (seeing or hearing strange things), muscle stiffness, sudden muscle contractions, or rapid heartbeat. These 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 Paroxetine Aurovitas can be found in section 4.
Medicines like Paroxetine Aurovitas (SSRIs/SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms may persist after stopping treatment.

Paroxetine Aurovitas and other medicines

Some medicines may affect the action of Paroxetine Aurovitas or increase the risk of side effects. Paroxetine Aurovitas may also affect the action of other medicines. These medicines include:

• monoamine oxidase inhibitors (MAOIs), including moclobemide and methylene blue (methylthioninium chloride) - see section When not to take Paroxetine Aurovitas;
• medicines known to increase the risk of changes in heart electrical activity (e.g., antipsychotic medicinessuch as thioridazine or pimozide) - see section When not to take Paroxetine Aurovitas;
• aspirin, ibuprofen, or other non-steroidal anti-inflammatory drugs (NSAIDs) such as celecoxib, diclofenac, etodolac, and meloxicam, used to treat pain and inflammation;
• tramadol, buprenorphine, and pethidine, pain relief medicines;
• buprenorphine in combination with naloxone, used for opioid substitution treatment;
• triptans, such as sumatriptan, used to treat migraines;
• other antidepressants, called SSRIs and tricyclic antidepressants, such as clomipramine, nortriptyline, and desipramine;
• dietary supplementcalled tryptophan;
• mivacurium and suxamethonium (used for general anesthesia);
• medicines such as lithium, risperidone, perphenazine, clozapine (called antipsychotic medicines) used to treat certain mental disorders;
• fentanyl, a medicine used during anesthesiaand to treat chronic pain;
• the combination of fosamprenavir and ritonavir, used to treat HIV infections;
• St. John's Wort used as a complementary treatment for depression;
• phenobarbital, phenytoin, sodium valproate, or carbamazepine used to treat seizures or epilepsy;
• atomoxetine, which is used to treat attention deficit hyperactivity disorder (ADHD);
• procyclidine used to treat Parkinson's disease;
• warfarin or other medicines (called anticoagulants) used to thin the blood;
• propafenone, flecainide, and medicines used to treat irregular heartbeat;
• metoprolol, a beta-blocker used to treat high blood pressure and heart problems;
• pravastatin used to treat high cholesterol;
• rifampicin used to treat tuberculosis;
• linezolid - an antibiotic;
• tamoxifen, which is used to treat breast canceror fertility problems;
• some medicines may increase the side effects of Paroxetine Aurovitas, and sometimes cause very serious reactions. While taking Paroxetine Aurovitas, the patient should not take any other medicines without first consulting their doctor, especially:
  ­ buprenorphine-containing medicines. These medicines may interact with Paroxetine Aurovitas and cause symptoms such as involuntary, rhythmic muscle contractions, including those affecting eye movements, restlessness, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle tension, and body temperature above 38°C. If the patient experiences such symptoms, they should contact their doctor.

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

Tell the doctor or pharmacist about all medicines being taken or planned to be taken

, including those that are available without a prescription.

Paroxetine Aurovitas with food, drink, and alcohol

While taking Paroxetine Aurovitas, the patient should not drink alcohol. Alcohol may increase the symptoms of the illness or side effects. Taking Paroxetine Aurovitas in the morning, with food, 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 baby, they should consult their doctor or pharmacist before taking this medicine.
There are reports that children whose mothers took Paroxetine Aurovitas during the first few months of pregnancy had congenital defects, 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 Paroxetine Aurovitas. 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 Paroxetine Aurovitas during pregnancy. In some cases, the doctor may also suggest that it is better for the patient to continue taking Paroxetine Aurovitas.

The patient should ensure that the midwife or doctor is informed that they are taking Paroxetine Aurovitas.

Taking Paroxetine Aurovitas late in pregnancy may increase the risk of severe bleeding from the vagina, occurring shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient is taking Paroxetine Aurovitas, they should inform their doctor or midwife so that they can provide appropriate advice. Medicines like Paroxetine Aurovitas taken during pregnancy, especially in the last trimester, may increase the risk of a condition called persistent pulmonary hypertension of 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 is taking Paroxetine Aurovitas during the last 3 months of pregnancy, the newborn may also experience other symptoms, usually within the first 24 hours after birth, including:

• breathing difficulties
• bluish discoloration of the skin or unstable 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
• increased reflexes.

If the baby experiences any of these symptoms after birth, the patient should contact their doctor or midwife for advice.
Paroxetine may pass into breast milk in very small amounts. If the patient is taking Paroxetine Aurovitas, they should consult their doctor before breastfeeding. The doctor and patient can decide together whether the patient should breastfeed while taking Paroxetine Aurovitas.
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 yet.

Driving and using machines

Paroxetine Aurovitas may cause side effects such as dizziness, disorientation, drowsiness, and vision disturbances. If the patient experiences such side effects, they should not drive or operate machinery.

Paroxetine Aurovitas contains lactose

Paroxetine Aurovitas contains a small amount of lactose. If the doctor has told the patient that they have an intolerance to some sugars, they should consult their doctor before taking this medicine.

Paroxetine Aurovitas 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 Paroxetine Aurovitas

This medicine should always be taken as directed by the doctor or pharmacist. If the patient is unsure, they should consult their doctor or pharmacist.
The following table shows how many tablets of Paroxetine Aurovitas correspond to a given dose.
The usual doses used for different conditions are listed below.

The doctor will advise the patient on what dose of Paroxetine Aurovitas to start with.

Most patients start to feel better after a few weeks. If the patient does not feel better after this time, they should consult their doctor. The doctor may decide to gradually increase the dose by 10 mg up to the maximum daily dose.

Tablets should be taken in the morning, with food.

Swallow the tablet with water.

Do not chew.

The doctor will discuss with the patient how long they need to 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

The doctor may recommend a lower dose of Paroxetine Aurovitas for patients with liver or severe kidney disease.

Taking more Paroxetine Aurovitas than prescribed

The patient should never take more tablets than prescribed by their doctor.If the patient (or someone else) has taken too many Paroxetine Aurovitas tablets, they should immediately inform their doctor or contact the nearest emergency department. They should show them the packaging of the tablets.

In case of overdose of Paroxetine Aurovitas, the patient may experience side effects listed in section 4: Possible side effectsor the following symptoms: fever, involuntary muscle contractions.

Missing a dose of Paroxetine Aurovitas

The medicine should be taken at the same time every day.
If a dose is missed and the patient 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

Paroxetine Aurovitas does not relieve symptoms immediately -all antidepressants take some time to start working. 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 a follow-up visit a few weeks after starting Paroxetine Aurovitas for the first time.
The patient should inform their doctor if they have not started to feel better.

Stopping Paroxetine Aurovitas

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

When stopping Paroxetine Aurovitas, the doctor will inform the patient how to gradually reduce the dose over a few weeks or months - this should limit the possibility of withdrawal symptoms. One way to do this is to gradually reduce the dose of Paroxetine Aurovitas 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 Paroxetine Aurovitas, the doctor may decide that the patient should stop taking the medicine more slowly. If the symptoms are severe during the withdrawal of Paroxetine Aurovitas, the patient 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 Paroxetine Aurovitas.

Possible withdrawal symptoms after stopping treatment

Studies show that 3 out of 10 patients notice one or more withdrawal symptoms when stopping Paroxetine Aurovitas. Some of these symptoms occur more frequently than others.

Common side effects (occurring in less than 1 in 10 people):

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

Uncommon side effects (occurring in less than 1 in 100 people):

• nausea;
• sweating (including night sweats);
• feeling restless or agitated;
• tremors;
• feeling disoriented;
• diarrhea (loose stools);
• emotional instability or irritability;
• vision disturbances;
• rapid or irregular heartbeat (palpitations).

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

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

Very rare side effects (occurring in less than 1 in 10,000 people):

• If the patient has a seizure (convulsions), they should contact their doctor or go to the hospital immediately.
• If the patient feels anxious or unable to sit or stand still, they may be experiencing a condition called akathisia. Increasing the dose of Paroxetine Aurovitas may worsen these feelings. If the patient experiences such symptoms, they should contact their doctor.
• If the patient feels tired, weak, painful, stiff, or has difficulty moving, or is disoriented, they may have low sodium levels in the blood. If the patient experiences such symptoms, they should contact their doctor.

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

• Some patients taking Paroxetine Aurovitas or shortly after stopping treatment have experienced suicidal thoughts or self-harm (see Suicidal thoughts and worsening of depression or anxiety disorderin section 2).
• Some patients taking Paroxetine Aurovitas have experienced aggression.
• Severe bleeding from the vagina, occurring shortly after delivery (postpartum hemorrhage), see additional information in subsection Pregnancy, breastfeeding, and fertilityin section 2. If the patient experiences such side effects, they should contact their doctor.

Other possible side effects that may occur during treatment

Very common: may affect more than 1 in 10 people

• nausea. Taking Paroxetine Aurovitas in the morning, with food, reduces the likelihood of nausea.
• change in sexual desire or sexual function. For example, lack of orgasm, or in men, erectile dysfunction and ejaculation disorders.

Common: may affect up to 1 in 10 people

• increased cholesterol levels in the blood;
• loss of appetite;
• sleep disturbances (insomnia) or feeling drowsy;
• abnormal dreams (including nightmares);
• dizziness or tremors;
• headache;
• difficulty concentrating;
• feeling restless;
• feeling excessively weak;
• vision disturbances;
• yawning, dry mouth;
• diarrhea or constipation;
• vomiting;
• weight gain;
• sweating.

Uncommon: may affect up to 1 in 100 people

• temporary increase or decrease 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;
• pupil dilation;
• rash;
• itching;
• feeling disoriented;
• hallucinations (seeing or hearing strange things);
• inability to urinate (urinary retention) or involuntary, uncontrollable urination (urinary incontinence);
• in patients with diabetes, Paroxetine Aurovitas may worsen blood sugar control. The patient should discuss with their doctor the adjustment of insulin or diabetes medication dosage;
• decreased white blood cell count.

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

• abnormal milk production in the breasts of men and women;
• slow heartbeat;
• liver function abnormalities shown in blood tests;
• panic attacks;
• excessive activity or racing thoughts (mania);
• feeling uncertain about one's own existence (depersonalization);
• feeling anxious;
• 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, and absence or delay of menstruation).

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

• a skin rash called erythema multiforme, which may be accompanied by blisters and look like small targets (a dark spot in the center surrounded by a lighter ring with a dark ring around the edge);
• a widespread skin rash with blisters and peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome);
• a widespread skin rash with blisters and peeling of large areas of skin (toxic epidermal necrolysis);
• liver function abnormalities that cause yellowing of the skin or whites of the eyes;
• a condition called syndrome of inappropriate antidiuretic hormone secretion (SIADH), in which the body retains too much water and the sodium levels in the blood become too low. Patients with this condition may have symptoms of severe illness or may not show any symptoms;
• fluid retention or water retention (which may cause swelling of the hands or feet);
• sensitivity to light;
• painful, persistent erection of the penis;
• decreased platelet count.

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

• inflammation of the colon (causing diarrhea);
• teeth grinding.

Some patients taking Paroxetine Aurovitas may experience ringing, buzzing, whistling, or other persistent noises in the ears (tinnitus) while taking the medicine.
Patients taking medicines like Paroxetine Aurovitas (SSRIs/SNRIs) have been shown to have an increased risk of fractures.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, 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 will help to gather more information on the safety of this medicine.

5. How to store Paroxetine Aurovitas

The medicine should be kept out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister after: EXP.
The expiry date refers to the last day of the month stated.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Paroxetine Aurovitas contains

The active substance of Paroxetine Aurovitas is paroxetine.
One coated tablet contains 20 mg of paroxetine (as paroxetine hydrochloride hemihydrate).
The other ingredients are:
Tablet core:calcium hydrogen phosphate dihydrate, calcium hydrogen phosphate, lactose monohydrate, sodium carboxymethylcellulose (type A), magnesium stearate.
Coating:titanium dioxide (E 171), hypromellose, macrogol 400, polysorbate 80.

What Paroxetine Aurovitas looks like and contents of the pack

Coated tablets.
Paroxetine Aurovitas, 20 mg, coated tablets are white or almost white, biconvex, coated tablets in the shape of a capsule with the number "56" embossed on one side and the letter "C" and a deep score line on the other side. The tablet can be divided into equal doses.
Paroxetine Aurovitas, 20 mg, coated tablets are available in packs of 7, 10, 14, 20, 28, 30, 50, 56, 60, 98, 100, and 250 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warszawa
e-mail: [email protected]

Manufacturer/Importer:

APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta

Date of last revision of the leaflet: 03/2024