Parogen

Package leaflet: Information for the user

Parogen, 20 mg, coated tablets
Paroxetine
Please read the entire leaflet carefully before starting treatment, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

1. What Parogen is and what it is 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 Parogen is and what it is used for

Parogen is used to treat adults with depression (major depressive episode) and/or
anxiety disorders. The anxiety disorders treated with Parogen include: obsessive-compulsive disorder (recurring, intrusive thoughts and uncontrollable repetitive behaviors), panic disorder (panic attacks, including those associated with agoraphobia, i.e., fear of open spaces), social anxiety disorder (fear or avoidance of social situations), post-traumatic stress disorder (anxiety resulting from a traumatic event), and generalized anxiety disorder (a persistent feeling of intense anxiety and restlessness).
Parogen belongs to a group of medicines known as SSRIs (selective serotonin reuptake inhibitors). Serotonin is a substance naturally present in the brain. In people with depression or anxiety disorders, serotonin levels are lower than normal. The exact mechanism of action of Parogen and other SSRIs is not fully understood, but they may work by increasing the level of serotonin in the brain. Appropriate treatment of depression or depressive disorders is important for improving health and well-being.

2. Important information before using Parogen

When not to use 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 methylene blue chloride (methylene blue)), or if these medicines have been taken within the last 2 weeks. Your doctor will explain how to start taking paroxetine after stopping MAOI treatment;
• if the patient is taking other antipsychotic medicines – thioridazine or pimozide.

If any of the above situations apply, you must inform your doctor before using Parogen.
Warnings and precautions
Before starting treatment with Parogen, discuss this with your 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 ever experienced episodes of mania (excessive activity in behaviour or racing thoughts);
• if the patient has received electroconvulsive therapy for the treatment of severe depression;
• if the patient has diabetes;
• if the patient has abnormal heart conduction on electrocardiogram (ECG), known as QT prolongation;
• if the patient has a family history of QT prolongation, heart disease such as heart failure, slow heart rate, or low potassium or low 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 the treatment of breast cancer or fertility problems. Parogen may reduce the effectiveness of tamoxifen, and therefore the treating doctor may recommend that the patient use another antidepressant;
• if the patient has had bleeding episodes in the past, or if the patient 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 such as clomipramine, or nonsteroidal anti-inflammatory drugs (NSAIDs) such as acetylsalicylic acid, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam), or if the patient is pregnant (see "Pregnancy, breastfeeding and fertility");
• if the patient is under 18 years of age (see section "Children and adolescents under 18 years").

If any of the above situations apply to the patient, or if you have any doubts, contact your doctor.
Children and adolescents under 18 years.
Parogen should not be used in children and adolescents under 18 years of age. Patients under 18 are at increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, oppositional behaviour, and anger) while taking this medicine. However, your doctor may prescribe Parogen to a patient under 18 if they consider it to be in the patient's best interest. If your doctor has prescribed Parogen to you (or your child) and you wish to discuss this, please contact your doctor again. Inform your doctor if any of the above symptoms occur or worsen in the patient (or your child) taking Parogen. In addition, the long-term safety of using this medicine in this age group has not yet been established with regard to its effects on growth, puberty, intellectual and behavioural development.
In clinical studies in patients under 18 years of age, some patients experienced symptoms related to discontinuation of paroxetine. These symptoms were very similar to those observed in adults after stopping paroxetine (see section 3 "How to use Parogen").
Suicidal thoughts and worsening of depression or anxiety
During episodes of depression and/or anxiety disorders, thoughts about self-harm or suicide may sometimes occur. These may worsen at the beginning of initial treatment with antidepressants, as the effect of these medicines becomes noticeable only after some time, usually after two weeks or longer.
The likelihood of such thoughts is higher:

• in individuals who have previously thought about killing themselves or harming themselves;
• in young adults. Clinical trial data show an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders treated with an antidepressant.

If such thoughts occur at any time, contact your treating doctor or go directly to hospital.
It may be helpful to talk to a friend or family member about your depression or anxiety disorder and ask them to read this leaflet. You may ask them to inform you if they notice worsening of depression or anxiety or if they are concerned about changes in your behaviour.
If you have any concerns, discuss them with your doctor.
Important adverse effects observed during treatment with Parogen
Some patients taking paroxetine may develop a condition called akathisia, in which patients feel restless and are unable to sit or stand still. In other patients, a condition called serotonin syndrome may develop, which includes some or all of the following symptoms: confusion, restlessness, sweating, tremors, chills, hallucinations (strange visions or sounds), sudden muscle contractions, or rapid heartbeat. If any of these symptoms are noticed, contact your doctor immediately. More information about these and other adverse effects of Parogen can be found in section 4. "Possible side effects *".
Medicines such as Parogen (so-called SSRIs or SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.
Parogen and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Some medicines may affect the action of Parogen or increase the likelihood of adverse effects. Parogen may also affect the action of other medicines. These include:

• medicines called monoamine oxidase inhibitors (MAO inhibitors, including moclobemide used to treat depression and methylene blue chloride (methylene blue)) – see section "When not to use Parogen *";
• medicines known to increase the risk of changes in electrical activity of the heart (e.g. antipsychotic medicines thioridazine or pimozide) – see section "When not to use Parogen";
• aspirin (acetylsalicylic acid), ibuprofen, or other medicines called nonsteroidal anti-inflammatory drugs (NSAIDs), such as celecoxib or rofecoxib, etodolac, diclofenac, and meloxicam (used to treat pain and inflammation);
• medicines used to reduce the risk of blood clots (antiplatelet medicines) such as clopidogrel;
• painkillers such as buprenorphine, tramadol, pethidine. These medicines may interact with Parogen and cause symptoms of serotonin syndrome (see section 2 "Important adverse effects observed during treatment with Parogen");
• medicines called triptans, such as sumatriptan (used to treat migraine);
• other antidepressants, including other SSRIs (selective serotonin reuptake inhibitors) and tricyclic antidepressants such as clomipramine, nortriptyline, and desipramine;
• a dietary supplement called tryptophan;
• medicines such as lithium, risperidone, perphenazine, clozapine (called antipsychotic medicines);
• fentanyl, a medicine used during anaesthesia and for the treatment of chronic pain;
• the combination of fosamprenavir and ritonavir (used to treat human immunodeficiency virus (HIV) infections);
• St. John's wort (used as an adjunct in the treatment of 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 and acne);
• linezolid (an antibiotic used to treat infections);
• tamoxifen, used to treat breast cancer or fertility problems;
• mivacurium or suxamethonium (used to relax muscles).

Inform your doctor or pharmacist if you are taking, have recently taken, or might have taken any other medicines.
Parogen with food, drink and alcohol
Do not drink alcohol while taking Parogen. Alcohol may worsen symptoms and adverse effects. Taking Parogen in the morning with food reduces the likelihood of nausea.
Pregnancy, breastfeeding and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
Paroxetine is not recommended for use in pregnant women as it may be harmful to the unborn child. Together with your doctor, you may decide it is better to switch to another medicine or gradually discontinue Parogen during pregnancy. However, depending on the circumstances, your doctor may decide that continuing Parogen is more beneficial for you.
Inform your midwife and/or doctor that you are taking Parogen. Medicines such as Parogen taken during pregnancy, especially during the last three months, may increase the risk of serious complications in the newborn, known as persistent pulmonary hypertension of the newborn (PPHN), causing rapid breathing and bluish skin in the baby. These symptoms may occur within the first 24 hours after birth. If any of these symptoms occur in the baby, contact your midwife and/or doctor immediately.
Symptoms include:

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

If the baby develops any of these symptoms after birth or if you are concerned about the baby's health, contact your doctor or midwife for advice.
Taking Parogen towards the end of pregnancy may increase the risk of serious vaginal bleeding shortly after delivery, especially if the patient has a history of bleeding disorders. If you are taking Parogen, inform your doctor or midwife so they can provide appropriate advice.
Parogen may pass into breast milk in very small amounts. If you are taking Parogen, you should consult your doctor before starting breastfeeding.
Animal studies have shown that paroxetine reduces sperm quality. Theoretically, this may affect fertility, but no effect on human fertility has been observed to date.
Driving and operating machinery
Possible adverse effects of Parogen include dizziness, confusion, drowsiness, and blurred vision. If such symptoms occur, do not drive or operate machinery.
Parogen contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".

3. How to take Parogen

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.
The recommended doses for each condition are shown in the table below.

| Condition | Starting 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 | | Generalised anxiety disorder | 20 mg | 20 mg | 50 mg |

Your doctor will determine the appropriate dose when Parogen tablets are prescribed for the first time.
Most people begin to feel better after a few weeks of treatment. If there is no improvement after this time, you should speak with your doctor, who will provide further advice.
Your doctor may recommend gradually increasing the dose by 10 mg at a time until the maximum daily dose is reached.

The tablets should be taken in the morning with food. The tablets must not be chewed, but swallowed whole with water.

The breakline on the tablet is intended to facilitate breaking the tablet for easier swallowing, and not for dividing it into two equal doses.

Your doctor will advise how long you should continue taking the tablets. Treatment may last for several months or even longer.

Use in elderly patients
If the patient is elderly (over 65 years of age), the maximum daily dose is 40 mg.

Use in children and adolescents
Children and adolescents under 18 years of age should generally not take Parogen unless the doctor considers it to be in their best interest.

Patients with liver or kidney disease
In case of liver disease or severe kidney disease, your doctor may decide that a lower than usual dose of Parogen should be taken.

Taking more Parogen than prescribed
Never take more tablets than your doctor has prescribed. If you or someone else takes more Parogen tablets than prescribed, you should contact your doctor immediately or go directly to a hospital. You should bring the tablet packaging with you.
Symptoms in a person who has overdosed on Parogen may include those listed in section 4 "Possible side effects", or such symptoms as: vomiting, dilated pupils, fever, headache, uncontrolled muscle contractions, and rapid heartbeat.

If you miss a dose of Parogen
You should take this medicine every day at the same time.
If you miss a dose and remember before going to bed, take the missed dose immediately. The next day, continue taking the medicine as usual. If you only realize you missed a dose during the night or the following day, skip the missed dose.
Withdrawal symptoms may occur, but they should 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
Parogen does not relieve symptoms immediately – all antidepressant medicines require time to take effect. Some people start to feel better after a few weeks, but for others it may take longer. Some people taking antidepressants may initially feel worse before they begin to feel better. Your doctor should schedule a follow-up visit a few weeks after starting treatment. If there is no improvement, you should inform your doctor.

Stopping Parogen
Do not stop taking Parogen unless your doctor advises you to do so.
When discontinuing treatment with Parogen, your doctor will recommend gradually reducing the dose over several weeks or months – this should help reduce the likelihood of withdrawal symptoms. One method is to gradually reduce the dose of Parogen by 10 mg per week. Most people find that withdrawal symptoms are mild and resolve on their own within 2 weeks. In some individuals, symptoms may be more severe or last longer.

If withdrawal symptoms occur during dose reduction, your doctor may decide that the medicine should be tapered more slowly. If you experience severe withdrawal symptoms after stopping Parogen, you should contact your doctor. The doctor may recommend restarting the tablets and then tapering them more gradually.
Even if withdrawal symptoms occur, stopping Parogen treatment is still possible.

Possible withdrawal symptoms after stopping treatment
Studies show that 3 out of 10 patients experience one or more withdrawal symptoms after discontinuing Parogen. Some withdrawal symptoms occur more frequently than others.

Common (may affect 1 in 10 patients)

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

Uncommon (may affect 1 in 100 patients)

• nausea;
• sweating (including night sweats);
• inner restlessness or agitation;
• tremor;
• feeling confused or disoriented;
• diarrhoea (loose stools);
• intense emotions or irritability;
• visual disturbances;
• rapid or irregular heartbeat (palpitations).

If withdrawal symptoms after stopping Parogen are concerning, you should contact your doctor.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The likelihood of adverse effects is higher during the first weeks of taking Parogen.
If any of the following adverse effects occur, you should contact your doctor or go to the
accident and emergency department of your nearest hospital:
Uncommon (may affect up to 1 in 100 patients)

• Unusual bruising or bleeding, including vomiting blood or blood in the stool.
• Inability to pass urine.

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

• Seizure (fit).
• Agitation or a feeling of restlessness, inability to sit or stand still – this may indicate a serious condition called akathisia. Increasing the dose of Parogen may worsen these feelings.
• Tiredness, weakness, or confusion; muscle pain, stiffness, or lack of coordination. These may result from low blood sodium levels.

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

• Allergic reactions to Parogen, including severe allergic reactions. 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) or swallowing, or a feeling of weakness or dizziness leading to collapse or loss of consciousness.
• Skin rash which may involve blister formation, appearing as small targets (dark central spots surrounded by a paler area with a dark ring at the edge), known as erythema multiforme.
• Widespread skin rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).
• Widespread skin 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 excess water and lowers sodium (salt) levels in the blood due to improper chemical signals. Patients with SIADH may become seriously ill or may have no symptoms at all.
• If the patient has some or all of the symptoms listed below, they may be experiencing a condition called serotonin syndrome. These symptoms include: confusion, restlessness, sweating, tremor, shivering, hallucinations (strange visions or sounds), sudden muscle contractions, or rapid heartbeat.
• Eye pain and blurred vision. These may be symptoms of glaucoma.
• Yellowing of the skin and whites of the eyes, which may indicate liver problems.

Adverse effects with unknown frequency (frequency cannot be determined from available data):

• Thoughts of self-harm or suicide. Suicidal behaviour has been reported during treatment with Parogen or shortly after treatment has been stopped.

Other possible adverse effects occurring during treatment:
Very common (may affect more than 1 in 10 patients):

• Feeling nauseous. The likelihood of experiencing such discomfort may be reduced by taking the medicine in the morning with food.
• Changes in sexual desire or sexual function. For example, inability to reach orgasm and – in men – disturbances of erection and ejaculation.

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

• Decreased appetite.
• Insomnia or drowsiness.
• Unusual dreams (including nightmares).
• Dizziness or tremor.
• Headache.
• Feeling of restlessness.
• Feeling of unusual weakness.
• Yawning, dry mouth.
• Diarrhoea or constipation.
• Weight gain.
• Sweating.
• Increased cholesterol levels.
• Vomiting.
• Difficulty concentrating.

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

• Faster than normal heartbeat.
• Short-term increase in blood pressure or short-term drop in blood pressure, which may cause dizziness or fainting when standing up suddenly.
• Immobility, stiffness, tremor, or abnormal movements of the mouth and tongue.
• Dilated pupils.
• Uncontrolled, involuntary passing of urine (urinary incontinence).
• If the patient has diabetes, loss of blood sugar control may occur while taking Parogen. Talk to your doctor about adjusting the dose of insulin or antidiabetic medicines.
• Decreased white blood cell count.

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

• Abnormal milk production in men and women.
• Slow heartbeat.
• Increased liver enzyme activity, noticeable in blood tests.
• Panic attacks.
• Excessive activity in behaviour or thoughts (mania).
• Feeling detached from oneself (depersonalization).
• Feeling anxious.
• Joint or muscle pain.
• Uncontrollable urge to move the legs (Restless Legs Syndrome).
• Increased levels of a hormone called prolactin in the blood.
• Menstrual disorders (including heavy or irregular bleeding, bleeding between periods, and absence or delay of menstruation).

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

• Fluid retention or water retention, which may cause swelling of the hands or feet.
• Light sensitivity.
• Painful, prolonged erection of the penis (priapism).
• Unexplained or unusual bleeding or bruising. This may be a sign of low platelet count.

Unknown frequency (cannot be determined from available data):

• Teeth grinding (bruxism)
• Aggression
• Ringing, buzzing, whistling, or other persistent noise in the ears (tinnitus)
• Inflammation of the colon (causing diarrhoea)
• Severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage); see additional information in section “Pregnancy, breastfeeding and fertility” in section 2

An increased risk of bone fractures has been observed in patients taking this type of medicine.
In clinical trials of paroxetine in patients under 18 years of age, common adverse effects occurring at a frequency of less than 1 in 10 patients included: increased frequency of suicidal thoughts and suicide attempts, deliberate self-harm, hostility, aggressive or defiant behaviour, decreased appetite, tremor, abnormal sweating, excessive activity (exhibiting excess energy), restlessness, emotional lability (including tearfulness and mood swings).
These trials also showed that the same symptoms occurred, although less frequently, in children and adolescents taking placebo (sugar pills) instead of paroxetine.
Additionally, in patients under 18 years of age, abdominal pain, feeling agitated, 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).
Reporting of adverse effects
If any adverse effects occur, including any 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 authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Parogen

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the bottle, blister pack, or
carton. The expiry date refers to the last day of that month.
Do not store above 25°C.
Keep in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Parogen coated 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 carboxymethyl starch (type A),
colloidal anhydrous silica, magnesium stearate. See section 2, "Parogen contains sodium".
Tablet coating: talc, titanium dioxide (E171), Eudragit E100: copolymer of butyl methacrylate,
(2-dimethylaminoethyl)methacrylate and methyl methacrylate (1:2:1).

What Parogen coated tablets look like and contents of the pack
Parogen 20 mg coated tablets are white tablets, embossed with the code "P2" on one side and "G" on the other, approximately 8 mm in diameter. The tablets are scored on one side.
Parogen is available in polyethylene bottles and blister packs containing 10, 12, 14, 20, 28, 30, 50, 56, 58, 60, 98, 100, 200, 250 or 500 tablets. The bottles contain a desiccant to protect against moisture. Do not consume the desiccant.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN
Ireland

Manufacturers
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

For further information about your condition, patients may contact a patient support group or patient organisation. Your doctor can provide more details on this.
For more detailed information about the medicine, please contact the representative of the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
Tel: +48 22 54 66 400