Parogen

Leaflet accompanying the packaging: information for the user

Parogen, 20 mg, coated tablets

Paroxetine

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• 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 side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

1. What is Parogen and what is it used for

Parogen is used to treat adults with depression (major depressive episode) and/or

anxiety disorders.The anxiety disorders for which Parogen is used are: obsessive-compulsive disorder (recurring, obsessive thoughts and uncontrollable behavior), panic disorder (panic attacks, including those caused by agoraphobia, i.e., fear of open spaces), social anxiety disorder (fear or avoidance of social situations), post-traumatic stress disorder (anxiety caused by a traumatic event), and generalized anxiety disorder (feeling of general, intense anxiety and nervousness).
Parogen belongs to a group of medicines called SSRIs (selective serotonin reuptake inhibitors). Each person has a substance called serotonin in their brain. In people with depression or anxiety, the level of serotonin is lower than in others. It is not fully understood how Parogen and other SSRIs work, but they may work by increasing the level of serotonin in the brain. Proper treatment of depression or depressive disorders is important for improving health and well-being.

2. Important information before taking Parogen

When not to take Parogen:

• 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 medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide, linezolid, or methylthioninium chloride (methylene blue)) or if they have taken these medicines in the last 2 weeks. The doctor will explain how to start taking paroxetine after stopping MAOI treatment;
• if the patient is taking other antipsychotic medicines - thioridazine or pimozide.

In any of the above situations, the patient should tell their doctor before taking Parogen.

Warnings and precautions

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

• if the patient has kidney or liver disease or heart problems;
• if the patient has epilepsy or has had seizures or convulsions in the past;
• if the patient has had episodes of mania (excessive activity or racing thoughts);
• if the patient has undergone electroconvulsive therapy for severe depression;
• if the patient has diabetes;
• if the patient has abnormal heart rhythm on an electrocardiogram (ECG) known as QT interval prolongation;
• if the patient has a family history of QT interval prolongation, heart disease such as heart failure, low heart rate, or decreased potassium or magnesium levels;
• if the patient has low sodium levels in the blood;
• if the patient has glaucoma (high pressure in the eye);
• if the patient is taking tamoxifen for breast cancer or fertility problems. Parogen may reduce the effectiveness of tamoxifen, and the doctor may recommend a different antidepressant;
• if the patient has had bleeding or is taking other medicines that may increase the risk of bleeding (including anticoagulants such as warfarin, antipsychotics such as perphenazine or clozapine, tricyclic antidepressants such as clomipramine, or non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen, celecoxib, etodolac, diclofenac, or meloxicam) or if the patient is pregnant (see "Pregnancy, breastfeeding, and fertility");
• if the patient is under 18 years old (see "Children and adolescents under 18 years old").

If any of the above situations apply to the patient, or if they have any doubts, they should consult their doctor.

Children and adolescents under 18 years old.

Parogen 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 (mainly aggression, oppositional behavior, and anger) when taking this medicine. However, the doctor may prescribe Parogen to a patient under 18 years old if they consider it to be in the patient's best interest. If the doctor has prescribed Parogen to the patient (or their child) and the patient wants to discuss this, they should consult their doctor again. The patient should inform their doctor if they (or their child) experience any of the above symptoms while taking Parogen. Additionally, the long-term safety of Parogen in this age group, in terms of its effects on growth, maturation, intellectual and behavioral development, has not been established.
In studies in patients under 18 years old, some patients experienced withdrawal symptoms when stopping paroxetine. These symptoms were very similar to those seen in adults when stopping paroxetine (see section 3 "How to take Parogen").

Suicidal thoughts and worsening of depression or anxiety

During depression and/or anxiety, patients may sometimes experience thoughts of self-harm or suicide. These thoughts may worsen at the start of the first treatment with antidepressants, as the effect of these medicines may not be seen immediately, usually after a few weeks or longer.

The risk of such thoughts is higher:

• in people who have previously thought about suicide or self-harm;
• in young adults. Information from clinical trials shows an increased risk of suicidal behavior in adults under 25 years old with mental health conditions treated with antidepressants.

If such thoughts occur at any time, the patient should contact their doctor or go to the hospital immediately.
Talking to a friend or family member about their depression or anxietyand asking them to read this leaflet may be helpful. They can be asked to tell the doctor if they think the patient's depression or anxiety is getting worse or if they notice any changes in the patient's behavior.
If the patient has any concerns, they should discuss them with their doctor.

Important side effects seen with Parogen

In some patients taking paroxetine, a condition called akathisia may develop, in which the patient feels restless and cannot sit or stand still.
In other patients, a condition called serotonin syndrome may develop, with symptoms such as confusion, restlessness, sweating, shaking, shivering, hallucinations (strange visions or sounds), sudden muscle contractions, or rapid heartbeat. If the patient experiences any of these symptoms, they should contact their doctor immediately. More information about these and other side effects of Parogen can be found in section 4 "Possible side effects".
Medicines like Parogen (SSRIs or SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms have persisted after stopping treatment.

Parogen with other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take.
Some medicines may affect the way Parogen works or increase the risk of side effects. Parogen may also affect the way other medicines work. These medicines include:

• medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide used to treat depression and methylthioninium chloride (methylene blue)) - see section "When not to take Parogen";
• medicines known to affect the heart's electrical activity (e.g., antipsychotic medicines thioridazine or pimozide) - see section "When not to take Parogen";
• aspirin (acetylsalicylic acid), ibuprofen, or other non-steroidal anti-inflammatory drugs (NSAIDs) such as celecoxib or rofecoxib, etodolac, diclofenac, and meloxicam (used to treat pain and inflammation);
• medicines used to prevent blood clots (antiplatelet agents) such as clopidogrel;
• painkillers, such as buprenorphine, tramadol, or pethidine. These medicines may interact with Parogen and cause serotonin syndrome (see section 2 "Important side effects seen with Parogen");
• medicines called triptans, such as sumatriptan (used to treat migraines);
• other antidepressants, including other SSRIs and tricyclic antidepressants such as clomipramine, nortriptyline, and desipramine;
• a dietary supplement called tryptophan;
• medicines such as lithium, risperidone, perphenazine, clozapine (called antipsychotics);
• fentanyl, a medicine used for anesthesia and chronic pain treatment;
• the combination of fosamprenavir and ritonavir (used to treat HIV infections);
• St. John's Wort (used as a herbal remedy for depression);
• phenobarbital, phenytoin, 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 medicines (called anticoagulants) used to thin the blood;
• medicines used to treat irregular heartbeat, such as propafenone and flecainide;
• metoprolol, a beta-blocker (used to treat high blood pressure and heart problems);
• pravastatin (used to treat high cholesterol levels);
• rifampicin (used to treat tuberculosis);
• linezolid (an antibiotic used to treat infections);
• tamoxifen, which is used to treat breast cancer or fertility problems;
• mivacurium or suxamethonium (used to relax muscles).

The patient should tell their doctor or pharmacist if they are taking, have recently taken, or might take any other medicines.

Parogen with food, drink, and alcohol

The patient should not drink alcohol while taking Parogen. Alcohol may increase the risk of side effects. Taking Parogen in the morning, with food, may reduce the risk 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.
Paroxetine should not be used during pregnancy, as it may harm the baby. The patient and their doctor can decide whether to change the medicine or stop taking Parogen during pregnancy. However, depending on the circumstances, the doctor may consider it better for the patient to continue taking Parogen.
The patient should inform their midwife and/or doctor that they are taking Parogen.Medicines like Parogen taken during pregnancy, especially in the last 3 months, may increase the risk of a serious condition called persistent pulmonary hypertension in the newborn (PPHN), which causes rapid breathing and bluish skin in the baby. These symptoms may occur in the first 24 hours after birth. If they occur in the baby, the patient should contact their midwife and/or doctor immediately.
Symptoms include:

• difficulty breathing,
• bluish skin or unstable body temperature,
• bluish lips,
• vomiting or difficulty feeding,
• fatigue, difficulty sleeping, or increased crying,
• stiff or floppy muscles,
• tremors, shakiness, or seizures,
• increased reflexes.

If the baby experiences any of these symptoms after birth, or if the patient has concerns about their baby's health, they should contact their doctor or midwife for advice.
Taking Parogen at the end of pregnancy may increase the risk of serious bleeding from the vagina, which occurs shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient is taking Parogen, they should inform their doctor or midwife so that they can provide appropriate advice.
Parogen may pass into breast milk in very small amounts. If the patient is breastfeeding, they should consult their doctor before starting to breastfeed.
In animal studies, paroxetine has been shown to reduce sperm quality. This could theoretically affect fertility, but no effect on fertility has been seen in humans so far.

Driving and using machines

Parogen may cause side effects such as dizziness, confusion, drowsiness, and blurred vision. If these symptoms occur, the patient should not drive or operate machinery.

Parogen contains sodium

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

3. How to take Parogen

The patient should always take this medicine exactly as their doctor or pharmacist has told them. If they are unsure, they should ask their doctor or pharmacist.
The recommended doses for the various disorders are listed in the table below.

Initial dose

Recommended daily dose

Maximum daily dose

Depression
20 mg
20 mg
50 mg
Obsessive-compulsive disorder
20 mg
40 mg
60 mg
Panic disorder
10 mg
40 mg
60 mg
Social anxiety disorder
20 mg
20 mg
50 mg
Post-traumatic stress disorder
20 mg
20 mg
50 mg
Generalized anxiety disorder
20 mg
20 mg
50 mg

The doctor will determine the dose when Parogen tablets are prescribed for the first time.

Most people start to feel better after a few weeks of treatment.If there is no improvement after this time, the patient should talk to their doctor, who will give them further advice.
The doctor may recommend gradually increasing the dose, by 10 mg at a time, up to the maximum daily dose.
The tablets should be taken in the morning, with food. The tablets should be swallowed whole, without chewing, with a glass of water.
The score line is to help break the tablet to make it easier to swallow, not to divide it into two equal doses.
The doctor will tell the patient how long they need to take the tablets. The treatment may last for several months or even longer.

Use in elderly patients

If the patient is elderly (over 65 years old), the maximum daily dose is 40 mg per day.

Use in children and adolescents

Children and adolescents under 18 years oldshould not normally take Parogen, unless their doctor considers it to be in their best interest.

Patients with liver or kidney disease

In cases of liver disease or severe kidney disease, the doctor may decide to prescribe a lower dose of Parogen than usual.

Taking more Parogen than prescribed

The patient should never take more tablets than their doctor has prescribed. If they have taken more Parogen tablets than prescribed (either intentionally or unintentionally), they should contact their doctor or go to the hospital immediately.
The patient should show the doctor the packaging of the tablets.
A person who has taken an overdose of Parogen may experience side effects listed in section 4 "Possible side effects" or symptoms such as vomiting, dilated pupils, fever, headache, uncontrollable muscle contractions, and rapid heartbeat.

Missing a dose of Parogen

The medicine should be taken every day at the same time.
If a dose is missed and the patient realizes it before going to bed, they should take the missed dose immediately. The next day, they should take the medicine as usual. If the patient realizes they have missed a dose in the night or the next day, they should skip the missed dose.
Withdrawal symptoms may occur, but they should go away after taking the next dose at the usual time. The patient should not take a double dose of Parogen to make up for a missed dose.

What to do if there is no improvement

Parogen does not relieve symptoms immediately - all antidepressants take time to work. Some people may start to feel better after a few weeks, but for others, it may take longer. Some people taking antidepressants may feel worse before they start to feel better. The doctor should recommend a follow-up visit after a few weeks of starting treatment. If there is no improvement, the patient should tell their doctor.

Stopping Parogen

The patient should not stop taking Parogen unless their doctor tells them to.
When stopping treatment with Parogen, the doctor will advise gradual reduction of the dose over a few weeks or months - this should help reduce the risk of withdrawal symptoms. One way to do this is to gradually reduce the dose of Parogen by 10 mg per week. Most people find that the withdrawal symptoms from Parogen are mild and go away by themselves within 2 weeks. In some people, these symptoms may be more severe or may last longer.
If withdrawal symptoms occurwhen stopping Parogen, the doctor may decide to reduce the dose more slowly. If the patient experiences severe withdrawal symptoms after stopping Parogen, they should contact their doctor. The doctor may recommend starting to take the tablets again and then stopping them more slowly. Even if withdrawal symptoms occur, it is still possible to stop taking Parogen.

Possible withdrawal symptoms when stopping Parogen

Studies have shown that 3 out of 10 patients experience one or more withdrawal symptoms when stopping Parogen. Some withdrawal symptoms are more common than others.

Common (may affect up to 1 in 10 people)

• dizziness, unsteadiness, or difficulty keeping balance;
• feeling of tingling, burning, or electric shock, including in the head, as well as buzzing, hissing, whistling, or other persistent sounds in the ears (tinnitus);
• sleep disturbances (vivid dreams, nightmares, insomnia);
• feeling of restlessness;
• headache.

Uncommon (may affect up to 1 in 100 people)

• nausea (feeling sick);
• sweating (including night sweats);
• restlessness or agitation;
• tremor;
• feeling of confusion or disorientation;
• diarrhea (loose stools);
• strong emotions or irritability;
• vision disturbances;
• rapid or irregular heartbeat (palpitations).

If the patient is concerned about withdrawal symptoms when stopping Parogen, they should contact their doctor.
If the patient has any doubts about taking Parogen, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Parogen can cause side effects, although not everybody gets them.
The risk of side effects is higher in the first few weeks of taking Parogen.

If the patient experiences any of the following side effects, they should contact their doctor or go to the hospital immediately:

Uncommon (may affect up to 1 in 100 people)

• unusual bruising or bleeding, including vomiting blood or blood in the stool.
• difficulty urinating.

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

• seizure (convulsions).
• restlessness or feeling unable to sit or stand still, which may be a sign of a serious condition called akathisia. Increasing the dose of Parogen may worsen these feelings.
• fatigue, weakness, or confusion, pain, stiffness, or lack of coordination of the muscles. This may be due to low sodium levels in the blood.

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

• allergic reactions to Parogen, including severe allergic reactions. If the patient experiences a red, lumpy rash, swelling of the eyelids, face, lips, mouth, or tongue, itching, or difficulty breathing (dyspnea) or swallowing, or feeling weak or fainting;
• a skin rash that may blister, with a central dark spot surrounded by a paler area and a dark ring around the edge, called erythema multiforme.
• a widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).
• a widespread rash with blisters and peeling of a large area of skin (toxic epidermal necrolysis).
• syndrome of inappropriate antidiuretic hormone secretion (SIADH), a condition in which the body produces too much water and lowers the level of sodium (salt) in the blood, due to incorrect chemical signals. Patients with SIADH may be seriously ill or have no symptoms.
• if the patient experiences any of the following symptoms, they may have a condition called serotonin syndrome: confusion, restlessness, sweating, shaking, shivering, hallucinations (strange visions or sounds), sudden muscle contractions, or rapid heartbeat.
• eye pain and vision disturbances, which may be symptoms of glaucoma.
• yellowing of the skin and whites of the eyes, which may indicate liver problems.

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

• thoughts of self-harm or suicide. Suicidal behavior has been reported in patients taking Parogen or shortly after stopping treatment.

Other possible side effects that may occur during treatment:

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

• feeling sick (nausea). The risk of this side effect can be reduced by taking Parogen in the morning, with food.
• changes in sex drive or sexual function. For example, lack of orgasm and - in men - erectile dysfunction and ejaculation disorder.

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

• reduced appetite.
• insomnia or feeling drowsy.
• unusual dreams (including nightmares).
• feeling dizzy or shaky.
• headache.
• feeling agitated.
• feeling unusually weak.
• yawning, dry mouth.
• diarrhea or constipation.
• weight gain.
• sweating.
• increased cholesterol levels.
• vomiting.
• concentration disturbances.

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

• rapid heartbeat.
• temporary increase in blood pressure or temporary decrease in blood pressure, which may cause dizziness or fainting when standing up quickly.
• involuntary movements, stiffness, or shaking, or abnormal movements of the mouth and tongue.
• dilated pupils.
• involuntary urination (incontinence).
• if the patient has diabetes, they may experience loss of control of blood sugar levels while taking Parogen. They should talk to their doctor about adjusting their insulin or diabetes medication.
• reduced white blood cell count.

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

• abnormal production of milk in men and women.
• slow heartbeat.
• increased liver enzyme activity, seen in blood tests
• panic attacks.
• excessive activity or thoughts (mania).
• feeling detached from oneself (depersonalization).
• feeling anxious.
• joint or muscle pain.
• involuntary movement of the legs (restless legs syndrome).
• increased levels of a hormone called prolactin in the blood.
• menstrual disturbances (including heavy or irregular bleeding, intermenstrual bleeding, and absence or delay of menstruation).

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

• fluid retention or water retention, which may cause swelling of the hands or feet.
• sensitivity to light.
• painful, prolonged erection of the penis.
• unexplained or unusual bleeding or bruising. This may be a sign of a low platelet count.

Unknown (frequency cannot be estimated from the available data):

• grinding of the teeth
• aggression
• buzzing, hissing, whistling, or other persistent sounds in the ears (tinnitus)
• inflammation of the colon (causing diarrhea)
• severe bleeding from the vagina, occurring shortly after delivery (postpartum hemorrhage), see additional information in subsection "Pregnancy, breastfeeding, and fertility" in section 2

Patient studies have shown an increased risk of fractures in patients taking this type of medicine.
In paroxetine studies in patients under 18 years old, common side effects (occurring in less than 1 in 10 patients) included increased thoughts of suicide and attempted suicide, self-harm, hostility, and aggression or oppositional behavior. These studies also showed that these symptoms occurred, although less frequently, in children and adolescents taking placebo (sugar pills) instead of paroxetine.
Additionally, in patients under 18 years old, common side effects (occurring in less than 1 in 10 patients) included abdominal pain, feeling irritable, and mood swings (including tearfulness and mood changes, self-harm, suicidal thoughts, and attempted suicide).

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, 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 will help to gather more information on the safety of this medicine.

5. How to store Parogen

The medicine should be stored out of the sight and reach of children.
The patient should not use this medicine after the expiry date (EXP) stated on the bottle, blister, or carton. The expiry date refers to the last day of that month.
The medicine should not be stored above 25°C.
The medicine should be stored in its original packaging to protect it from light.
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 Parogen tablets contain

The active substance is paroxetine.
Each coated tablet contains 20 mg of paroxetine in the form of anhydrous hydrochloride.
The other ingredients are:
tablet core: calcium hydrogen phosphate anhydrous, sodium carboxymethylcellulose (type A), colloidal silicon dioxide anhydrous, magnesium stearate. See section 2 "Parogen contains sodium".
tablet coating: talc, titanium dioxide (E171), Eudragit E100: butyl methacrylate, (2-dimethylaminoethyl) methacrylate, and methyl methacrylate copolymer (1:2:1).

What Parogen tablets look like and what the packaging contains

Parogen 20 mg coated tablets are white tablets, with the inscription "P2" on one side and the inscription "G" on the other side, with a diameter of approximately 8 mm. The tablets have a score line on one side.
Parogen is available in polyethylene bottles and blisters containing 10, 12, 14, 20, 28, 30, 50, 56, 58, 60, 98, 100, 200, 250, or 500 tablets. The bottles contain a desiccant. The patient should not take the desiccant.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN
Ireland
Manufacturer
McDermott Laboratories Ltd.
Trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate
Dublin 13
Ireland
Mylan Hungary Kft.
H-2900 Komárom
Mylan utca 1.
Hungary
To learn more about their condition, the patient can contact a patient support group or organization. The doctor can provide more information on this.
For more information about Parogen, the patient should contact the representative of the marketing authorization holder:

Viatris Healthcare Sp. z o.o.

Tel: +48 22 54 66 400
Date of last revision of the leaflet:December 2024