Paroxetine Mylan Generics

PACKAGE LEAFLET

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Paroxetine Mylan Generics 20 mg film-coated tablets

paroxetine
Generic medicine
Read this leaflet carefully before taking this medicine because it contains important information for you

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What Paroxetine Mylan Generics is and what it is used for
2. What you need to know before taking Paroxetine Mylan Generics
3. How to take Paroxetine Mylan Generics
4. Possible side effects
5. How to store Paroxetine Mylan Generics
6. Contents of the pack and other information

1. What Paroxetina Mylan Generics is and what it is used for

Paroxetina Mylan Generics is a treatment for adults with depression (major depressive episodes) and/or anxiety disorders.
The anxiety disorders treated with paroxetine are: obsessive-compulsive disorder (obsessive, repetitive thoughts with uncontrollable behaviours), panic disorder (panic attacks, including those caused by agoraphobia, which is a 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 (a general feeling of excessive anxiety or nervousness).
Paroxetine belongs to a group of medicines called SSRIs (selective serotonin reuptake inhibitors). Serotonin is a substance present in the brain. People who are depressed or anxious have lower levels of serotonin than others. The exact way in which paroxetine and other SSRIs work is not fully understood, but they may help increase serotonin levels in the brain. Proper treatment of depression or anxiety disorders is important to help you feel better.

2. What you need to know before taking Paroxetina Mylan Generics

Do not take Paroxetina Mylan Generics:

• If you are allergic to paroxetine or any of the other ingredients of this medicine (listed in section 6).
• If you are taking medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide, linezolid, and methylene blue chloride (methylene blue)) or have taken them at any time within the last two weeks. Your doctor will advise you on how to start treatment with paroxetine after stopping MAOIs.
• If you are taking antipsychotic medicines called thioridazine or pimozide.

If any of these cases apply to you, inform your doctor and do not take Paroxetina Mylan Generics.
Warnings and precautions
Tell your doctor, pharmacist, or nurse before taking paroxetine

• if you have kidney or liver problems, or if you have heart problems.
• if you suffer from epilepsy or have previously had seizures or epileptic fits.
• if you have ever experienced episodes of mania (hyperactive behaviour or thoughts).
• if you are receiving a treatment for severe depression called electroconvulsive therapy (ECT).
• if you are diabetic.
• If you have an abnormality in your heart's electrical activity on the electrocardiogram (ECG), known as prolonged QT interval.
• If you have a family history of QT prolongation, heart conditions such as heart failure, slow heart rate, or low levels of potassium or magnesium.
• if you have low levels of sodium in your blood.
• if you have glaucoma (increased pressure in the eye).
• if you are taking tamoxifen for the treatment of breast cancer or fertility problems. Paroxetine may reduce the effectiveness of tamoxifen, so your doctor may recommend taking another antidepressant. if you have previously had bleeding disorders or are pregnant (see Pregnancy, breast-feeding and fertility) or are taking other medicines that may increase the risk of bleeding (these include blood-thinning medicines such as warfarin, antipsychotics such as perphenazine or clozapine, tricyclic antidepressants such as clomipramine, medicines used for pain and inflammation called non-steroidal anti-inflammatory drugs or NSAIDs, such as acetylsalicylic acid, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam).
• if you are under 18 years of age (see Children and adolescents under 18 years of age). Check with your doctor if any of the above cases apply to you or if you are unsure.

Children and adolescents under 18 years of age
Paroxetina Mylan Generics film-coated tablets must not be taken by children and
adolescents under 18 years of age. When taking this class of medicines, patients under
18 years of age have an increased risk of adverse effects such as suicide attempts,
suicidal thoughts, and hostility (mainly aggression, oppositional behaviour, and anger). Despite
this, your doctor may prescribe paroxetine to patients under 18 years of age if they consider it to be in their best interest. If your doctor has prescribed paroxetine to you (or your child) and you wish to obtain further information, please contact your doctor. You must inform your doctor if any of the conditions listed above appear or worsen during treatment with paroxetine (in yourself or your child). In addition, the long-term safety effects on growth, maturation, and cognitive and behavioural development in this age group have not yet been established.
In studies involving children under 18 years of age, some patients experienced withdrawal symptoms when they stopped taking paroxetine. These effects were mostly similar to those observed in adults after discontinuation of paroxetine (see section 3 “How to take Paroxetina Mylan Generics”).
Suicidal thoughts and worsening of depression or anxiety disorders
If you are depressed and/or suffer from anxiety disorders, you may sometimes have self-harming or suicidal thoughts. These symptoms may increase when starting antidepressants, as all these medicines require time to take effect, usually about two weeks or sometimes longer.
You may be more prone to such thoughts:

• If you have previously had suicidal or self-harming thoughts.
• If you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric conditions treated with an antidepressant.

If you experience suicidal or self-harming thoughts at any time, contact your doctor or go immediately to hospital.
You may find it helpful to confide in close family members or friends that you are depressed or suffering from anxiety disorders and ask them to read this leaflet. You may ask them to inform you if they think your depression or anxiety is worsening, or if they are concerned about changes in your behaviour.
If you have any doubts, discuss these matters with your doctor.
Important side effects observed with Paroxetina Mylan Generics film-coated tablets
Some patients taking paroxetine develop akathisia, characterised by a feeling of restlessness and an inability to sit still. Other patients develop serotonin syndrome, presenting with some or all of the following symptoms: confusion, restlessness, sweating, tremors, chills, hallucinations (strange visions or sounds), repeated muscle spasms, rapid heartbeat. If you notice any of these symptoms, contact your doctor. For further information on these or other side effects of paroxetine, see section 4 “Possible side effects”.
Medicines such as Paroxetina Mylan Generics (so-called selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs)) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may persist after discontinuation of treatment.
Other medicines and Paroxetina Mylan Generics
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Some medicines may affect how paroxetine works, or may make it more likely for side effects to occur. Paroxetine may also affect how certain medicines work. These include:

• Medicines called monoamine oxidase inhibitors (MAOIs) (including moclobemide for treating depression and methylene blue chloride (methylene blue)) – see “Do not take Paroxetina Mylan Generics” in this section.
• Medicines known to increase the risk of changes in the heart's electrical activity (e.g., antipsychotics such as thioridazine or pimozide) – see ‘Do not take Paroxetina Mylan Generics’ in this leaflet.
• Aspirin (acetylsalicylic acid), ibuprofen, or other medicines called NSAIDs (non-steroidal anti-inflammatory drugs) 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 agents) such as clopidogrel.
• Painkillers, e.g., buprenorphine, tramadol, meperidine. These medicines may interact with Paroxetina Mylan Generics and you may experience symptoms of serotonin syndrome (see section 2 ‘Important side effects observed with Paroxetina Mylan Generics film-coated tablets’).
• Medicines called triptans such as sumatriptan (used to treat migraine).
• Other medicines used to treat depression, 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, used in general anaesthesia or for treating chronic pain.
• A combination of fosamprenavir and ritonavir (used to treat human immunodeficiency virus (HIV) infections).
• St. John’s wort (a herbal remedy for depression).
• Phenobarbital, phenytoin, or carbamazepine (used to treat seizures or epilepsy).
• Atomoxetine (for the treatment of attention deficit hyperactivity disorder (ADHD)).
• Procyclidine (to relieve 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.
• Rifampicin (used to treat tuberculosis (TB) and leprosy).
• Linezolid (an antibiotic used to treat infections).
• Tamoxifen, used to treat breast cancer or fertility problems.
• Mivacurium or suxamethonium (medicines used to relax muscles).

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Paroxetina Mylan Generics with food and alcohol
Do not drink alcohol during treatment with paroxetine. Alcohol may worsen your symptoms or side effects. Taking paroxetine in the morning with food will reduce the likelihood of feeling unwell (nausea).
Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breast-feeding, consult your doctor or pharmacist before taking this medicine.
Paroxetina Mylan Generics is not recommended during pregnancy and may pose risks to the unborn child. Your doctor may decide whether it is better for you to switch treatments or gradually discontinue Paroxetina Mylan Generics during pregnancy. However, depending on the circumstances, your doctor may advise continuing paroxetine treatment.
Ensure that your midwife and/or doctor is aware that you are taking paroxetine.
If taken during pregnancy, especially during the last three months, medicines such as paroxetine may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear bluish. These symptoms usually begin within the first 24 hours after birth. If this occurs, contact your midwife and/or doctor immediately.
Symptoms include:

• breathing difficulties
• bluish or unusually hot or cold skin
• blue lips
• vomiting and feeding difficulties
• extreme tiredness, difficulty sleeping, or excessive crying
• stiff or floppy muscles
• tremors, agitation, or seizures
• exaggerated reflexes

If your baby shows any of these symptoms at birth or if you are concerned about your baby’s health, contact your doctor or midwife, who will advise you on what to do.
If you take Paroxetina Mylan Generics near the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after childbirth, especially if you have bleeding disorders (a tendency to bleed easily). Inform your doctor or midwife that you are taking Paroxetina Mylan Generics so they can advise you accordingly.
It may pass into breast milk in very small amounts. If you are taking paroxetine, talk to your doctor before starting breastfeeding.
Animal studies have shown that paroxetine reduces sperm quality. In theory, this could affect fertility in some men, but the impact on male fertility has not yet been proven.
Driving and using machines
Possible side effects of paroxetine include: dizziness, confusion, drowsiness, or blurred vision. If you experience these side effects, do not drive or operate machinery.
Paroxetina Mylan Generics contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 20 mg tablet, i.e., essentially ‘sodium-free’.

3. How to take Paroxetina Mylan Generics

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended doses for different conditions are listed in this table:

Your doctor will advise you on the dose to take when starting treatment with Paroxetina Mylan Generics film-coated tablets.
Most people begin to feel better after a couple of weeks of treatment. If you do not start to feel better after this time, speak with your doctor, who will be able to advise you. He/she may decide to gradually increase your dose by 10 mg at a time, up to the maximum daily dose.
Take the tablets in the morning with food. Do not chew the tablets; swallow them whole with a glass of water.
The break line is intended only to facilitate tablet splitting for easier swallowing and not for dividing the tablet into two equal doses.
Your doctor will tell you how long you should take the tablets. This may be for several months or even longer.

Use in elderly patients
If you are elderly (over 65 years of age), the maximum dose you can take is 40 mg per day.

Use in children and adolescents
Children and adolescents under 18 years of age should not routinely take paroxetine unless your doctor has decided that taking this medicine is in their best interest.

Patients with hepatic or renal impairment
If you have liver problems or severe kidney disease, your doctor may decide that you should take a lower dose of paroxetine than usual.

If you take more Paroxetina Mylan Generics than you should
Never take more tablets than your doctor has recommended. If you take too many tablets (or someone else does), inform your doctor or go to hospital immediately. Show them the medicine packaging.
People who have taken an overdose of paroxetine may experience any of the symptoms listed in Section 4 “Possible side effects”, or the following symptoms: vomiting, dilated pupils, fever, headache, involuntary muscle contractions, and increased heart rate.

If you forget to take Paroxetina Mylan Generics
Take your medicine every day at the same time.
If you forget to take a dose and remember before going to bed, take it immediately and continue as usual the next day.
If you remember only during the night or the following day, skip the missed dose. You may experience withdrawal symptoms, but these will disappear once you take the next dose at the usual time. Do not take a double dose to make up for the missed one.

What to do if you do not feel better
Paroxetina Mylan Generics will not relieve your symptoms immediately – all antidepressants require time to take effect. Some people begin to feel better within a couple of weeks, but for others it may take longer. Some people being treated with antidepressants feel worse before they start to feel better. Your doctor will ask to see you again after a couple of weeks from starting treatment.
Inform your doctor if you have not started to feel better.

If you stop taking Paroxetina Mylan Generics
Do not stop treatment with paroxetine unless your doctor tells you to do so.
When stopping paroxetine, your doctor will help you gradually reduce the dose over weeks or months

• this will help reduce the risk of withdrawal effects. One way to do this is to gradually reduce your dose of paroxetine by 10 mg per week. Most people find that paroxetine withdrawal symptoms are mild and resolve on their own within a couple of weeks. For others, these symptoms may be more severe or last longer.

If you experience withdrawal effects when stopping treatment, your doctor may decide that you should stop more slowly. If you experience severe withdrawal effects when stopping paroxetine, inform your doctor. He/she may ask you to restart treatment and then stop more gradually.
Even if you experience withdrawal effects, you will still be able to stop taking paroxetine.

Possible withdrawal effects following discontinuation of treatment
Studies show that 3 out of 10 patients experience one or more of these symptoms when stopping paroxetine.
Some withdrawal effects occur more frequently than others.

Common (may affect up to 1 in 10 people)

• Dizziness, unsteadiness, or loss of balance
• Prickling or tingling sensations, burning sensations, (less commonly) electric shock-like sensations, including in the head, and ringing, buzzing, whistling, sound, or other persistent noises in the ear (tinnitus)
• Sleep disturbances (vivid dreams, nightmares, or inability to sleep)
• Feeling anxious
• Headache

Uncommon (may affect up to 1 in 100 people)

• Feeling unwell (nausea)
• Sweating (including night sweats)
• Restlessness or agitation
• Tremor (shakiness)
• Feeling confused or disoriented
• Diarrhoea (loose stools)
• Feeling emotional or irritable
• Visual disturbances
• Irregular or pounding heartbeat (palpitations)

If you are concerned about these withdrawal effects when stopping paroxetine, ask your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Side effects are more likely to occur during the first weeks of treatment with paroxetine.
If you experience any of the side effects listed below, contact your doctor immediately or go to the nearest emergency room:

Uncommon (may affect up to 1 in 100 people)

• Bruising or unusual bleeding, including blood in vomit or stools
• Inability to urinate.

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

• Seizures (epileptic fits)
• Restlessness and feeling unable to sit still or remain motionless – you may have a serious condition called akathisia. Increasing your dose of paroxetine may worsen these sensations.
• Tiredness or feeling weak or confused and having sore, stiff or uncoordinated muscles – this may be due to low sodium levels in your blood.

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

• Allergic reactions that may be severe. If you develop a red, blotchy rash, swelling of the eyelids, face, lips, mouth or tongue, start itching, or have difficulty breathing (shortness of breath) or swallowing, feel weak or dizzy, leading to collapse or loss of consciousness
• Skin rash with blistering, resembling small targets (a dark central spot surrounded by a paler area, with a dark ring around the edge), known as erythema multiforme
• Widespread blistering rash with peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)
• Widespread blistering rash with peeling skin over most of the body surface (toxic epidermal necrolysis)
• Syndrome of inappropriate antidiuretic hormone secretion (SIADH) – a condition in which the body retains too much water and sodium levels decrease as a result of improper chemical signals. Patients with SIADH may become seriously ill or have no symptoms at all
• If you have some or all of the following symptoms, you may have a serious condition called serotonin syndrome: confusion, restlessness, sweating, tremors, chills, hallucinations (strange visions or sounds), sudden muscle spasms or rapid heartbeat
• If your eyes become painful and you experience blurred vision – this may be a symptom of glaucoma
• Skin or whites of the eyes turn yellow – this may be a sign of liver problems

Not known (frequency cannot be determined from available data)

• Thoughts of self-harm or suicide. Suicidal behaviour has been reported during treatment with paroxetine or immediately after stopping treatment.

Other possible side effects during treatment
Very common (may affect more than 1 in 10 people)

• Feeling unwell (nausea). Taking the medicine in the morning with food will reduce the likelihood of this occurring.
• Changes in sexual desire or sexual dysfunction. For example, lack of orgasm, or in men, abnormal erection and ejaculation.

Common (may affect up to 1 in 10 people)

• Decreased appetite
• Poor sleep (insomnia) or drowsiness
• Abnormal dreams (including nightmares)
• Dizziness or feeling unsteady (tremor)
• Headache
• Feeling agitated
• Unusual weakness
• Yawning and dry mouth
• Diarrhoea or constipation
• Weight gain
• Sweating
• Increased cholesterol levels
• Feeling sick (nausea)
• Inability to concentrate properly.

Uncommon (may affect up to 1 in 100 people)

• Faster than normal heartbeat
• Brief increase or brief decrease in blood pressure, which may cause dizziness or fainting when standing up suddenly
• Lack of movement, stiffness, tremor or abnormal movements of the mouth and tongue
• Dilated pupils
• Uncontrolled and involuntary loss of urine (urinary incontinence)
• If you have diabetes, you may notice a loss of control over your blood sugar levels while taking paroxetine. Talk to your doctor about adjusting your insulin or antidiabetic medication dosage.
• Reduced number of white blood cells

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

• Abnormal milk production from the breasts in men and women
• Slow heartbeat
• Increased liver enzymes, which may be seen in blood tests
• Panic attacks
• Hyperactive behaviour and thoughts (mania)
• Feeling detached from yourself (depersonalisation)
• Feeling anxious
• Ligament and muscle pain
• Irresistible urge to move the legs (restless legs syndrome)
• Increased levels in the blood of a hormone called prolactin
• Menstrual cycle disorders (including heavy or irregular periods, bleeding between periods, or absence or delay of menstrual periods).

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

• Fluid or water retention, which may cause swelling of the arms and legs
• Sensitivity to sunlight
• Painful and prolonged erection of the penis
• Unexplained or unusual bleeding or bruising – these may be signs of low platelet count in the blood.

Not known (frequency cannot be established from available data)

• Teeth grinding
• Aggression
• Ringing, buzzing, hissing, or other persistent noises in the ears (tinnitus)
• Inflammation of the colon (causing diarrhoea)
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage) – see Section 2, “Pregnancy, breastfeeding and fertility”, for further information.

An increased risk of bone fractures has been observed in patients taking this type of medicine.
In studies of paroxetine in patients under 18 years of age, common side effects affecting fewer than 1 in 10 children/adolescents were: increased suicidal thoughts and suicide attempts, self-harm, hostile, aggressive or uncooperative behaviour, loss of appetite, tremor, abnormal sweating, hyperactivity, agitation, mood swings (including crying and mood changes).
These studies also showed that the same symptoms occurred in children and adolescents taking sugar pills (placebo) instead of paroxetine, although less frequently.
Additionally, patients under 18 years commonly experienced (in fewer than 1 in 10): stomach pain, feeling nervous, and mood swings (including crying, mood changes, self-harm behaviour, suicidal thoughts and suicide attempts).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. Side effects can also be reported directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Paroxetine Mylan Generics

Keep this medicine out of the 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 the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Paroxetina Mylan Generics film-coated tablets contain
The active substance is paroxetine.
Each film-coated tablet contains 20 mg of paroxetine as anhydrous hydrochloride.
The other components are:
In the tablet core: Dibasic calcium phosphate, anhydrous colloidal silica, sodium starch glycolate and
magnesium stearate. See section 2 “Paroxetina Mylan Generics contains sodium”.
In the tablet coating: Talc, titanium dioxide (E 171) and basic butyl methacrylate copolymer.

Description of the appearance of Paroxetina Mylan Generics and package contents
Paroxetina Mylan Generics film-coated tablets are white, film-coated tablets, marked with "P2" on one side and a "G" on the other, with a diameter of approximately 8 mm. The tablets have a break line on one side.
Paroxetina Mylan Generics is available in polyethylene bottles and in blisters containing 10, 12, 14, 20, 28,
30, 50, 56, 58, 60, 98, 100, 200, 250 or 500 tablets, or in unit-dose perforated blisters of 28 x 1 tablet.
The bottles contain a desiccant; do not ingest the desiccant.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan S.p.A. - Via Vittor Pisani, 20 – 20124 Milano, Italy

Responsible producer for batch release
Generics [UK] Ltd.
Station Close, Potters Bar, Hertfordshire EN6 1TL – United Kingdom
Mylan Hungary Kft.
H-2900
Komárom, Mylan utca 1 – Hungary

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Denmark Paroxetin Viatris
Belgium Paroxetine Viatris
Germany Paroxedura
Italy Paroxetina Mylan Generics
Luxembourg Paroxetine Viatris
Portugal Paroxetina Mylan
Spain Paroxetina Viatris
United Kingdom
(Northern Ireland) Paroxetine

You may find it helpful to contact a self-help group or patient organisations to learn more about your condition. Your doctor can provide you with further details.

This summary of product characteristics was last approved in 02/2026