Paroxetine Aurobindo

Package leaflet: Information for the patient

Paroxetina Aurobindo 20 mg film-coated tablets

Paroxetine (as hydrochloride hemihydrate)
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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Paroxetina Aurobindo is and what it is used for

Paroxetina Aurobindo is a treatment for adults with depression and/or anxiety disorders. The anxiety
disorders treated with Paroxetina Aurobindo are: obsessive-compulsive disorder (obsessive, repetitive
thoughts with uncontrollable behaviour), panic disorder (panic attacks, including those caused by
agoraphobia, which is a fear of open spaces), social anxiety disorder (fear of, or avoidance of, social
situations), post-traumatic stress disorder (anxiety caused by a traumatic event), and generalized anxiety
disorder (a general feeling of being very anxious or nervous).
Paroxetina Aurobindo belongs to a group of medicines called SSRIs (selective serotonin reuptake inhibitors).
Serotonin is a substance present in everyone's brain. People who are depressed or anxious have lower levels
of serotonin than others. It is not fully understood how Paroxetina Aurobindo and other SSRIs work, but they
can help by increasing the level of serotonin in the brain.
Appropriately treating depression or anxiety disorders is important to help you feel better.

2. What you should know before taking Paroxetina Aurobindo

Do not take Paroxetina Aurobindo

• If you are taking medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide (an antidepressant), linezolid (an antibiotic), or methylthioninium chloride (methylene blue – a pre-surgical diagnostic agent), or if you have taken any of these medicines at any time within the last two weeks. Your doctor will advise you on how to start taking Paroxetina Aurobindo after stopping the MAOI.
• If you are taking an antipsychotic called thioridazine or an antipsychotic called pimozide.
• If you are allergic to paroxetine or to any of the other ingredients of this medicine (listed in section 6). If any of these conditions apply to you, inform your doctor and do not take Paroxetina Aurobindo.

Warnings and precautions
Talk to your doctor or pharmacist before taking Paroxetina Aurobindo.
Check with your doctor if:

• You are taking other medicines (see Other medicines and Paroxetina Aurobindo, within this leaflet)?
• You have kidney, liver, or heart problems?
• You suffer from epilepsy or have a history of seizures or convulsions?
• You have ever had episodes of mania (overactive behaviour or thoughts)?
• You are undergoing electroconvulsive therapy (ECT)?
• You have a history of bleeding disorders, or you are taking other medicines that may increase the risk of bleeding (including medicines used to improve blood fluidity, such as warfarin, antipsychotics such as perphenazine or clozapine, tricyclic antidepressants, medicines used for pain and inflammation called non-steroidal anti-inflammatory drugs or NSAIDs, such as acetylsalicylic acid, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam)?
• You are taking tamoxifen for the treatment of breast cancer or fertility problems? Paroxetina Aurobindo may reduce the effectiveness of tamoxifen, so your doctor may advise you to take another antidepressant.
• You have diabetes?
• You are on a low-sodium diet?
• You have glaucoma (increased eye pressure)?
• You are pregnant or planning a pregnancy (see Pregnancy, breastfeeding and Paroxetina Aurobindo, within this leaflet)?
• You are under 18 years of age (see Children and adolescents under 18 years, within this leaflet)? If you answered YES to any of these questions and have not yet discussed them with your doctor, go back to your doctor and ask what you should do about taking Paroxetina Aurobindo.

Children and adolescents under 18 years
Paroxetina Aurobindo must not be used in children and adolescents under 18 years of age. In addition,
patients under 18 years have a higher risk of side effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggressive behaviour, oppositional behaviour, and anger) when taking Paroxetina Aurobindo. If your doctor has prescribed Paroxetina Aurobindo for you (or your child) and you wish to discuss this, go back to your doctor. You must inform your doctor if any of the symptoms listed above appear or worsen while you (or your child) are taking Paroxetina Aurobindo. Furthermore, the long-term safety effects of paroxetine on growth, maturation, and cognitive and behavioural development in this age group have not yet been established.
In studies of paroxetine in patients under 18 years of age, the common adverse reactions affecting fewer than 1 in 10 children/adolescents were: increased suicidal thoughts and suicide attempts, deliberate self-harm, hostility, aggressiveness or unfriendliness, loss of appetite, tremors, abnormal sweating, hyperactivity (excessive energy), agitation, emotional changes (including crying and mood swings), and unusual bruising or bleeding (such as nosebleeds). These studies also showed that the same symptoms occurred in children and adolescents taking sugar pills (placebo) instead of paroxetine, although less frequently.
Some patients in these studies of adolescents under 18 years experienced a withdrawal syndrome when stopping paroxetine. These effects were largely similar to those observed in adults after discontinuation of paroxetine (see Section 3, How to take Paroxetina Aurobindo, within this patient information leaflet). In addition, patients under 18 years commonly experienced (affecting fewer than 1 in 10) stomach ache, nervousness, and emotional changes (including crying, mood swings, self-harm, suicidal thoughts, and attempted suicide).

Suicidal thoughts and worsening of depression or anxiety disorder
If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of self-harm or suicide. These may increase when you first start taking an antidepressant, as these medicines take time to become effective, usually about two weeks, but sometimes longer.
You may be more likely to have such thoughts:

• If you have previously had thoughts of suicide or self-harm.
• If you are a young adult. Data from clinical trials have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders who were treated with an antidepressant. If you have thoughts of self-harm or suicide at any time, contact your doctor or go immediately to hospital. It may help to inform a close relative or friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You may ask them to tell you if they think your depression or anxiety is worsening, or if they are concerned about changes in your behaviour.

Important side effects observed with Paroxetina Aurobindo
Some patients taking Paroxetina Aurobindo develop a condition called akathisia, in which they feel restless and unable to sit still. Other patients develop a condition called serotonin syndrome or neuroleptic malignant syndrome-like events, which may include some or all of the following symptoms: intense agitation or irritability, confusion, restlessness, feeling hot, sweating, chills, tremors, hallucinations (strange visions or sounds), sudden muscle jerks, or rapid heartbeat. If you experience any of these symptoms, contact your doctor. For more information on these or other side effects of Paroxetina Aurobindo, see Section 4, Possible side effects, within this leaflet.
Medicines such as Paroxetina Aurobindo (so-called selective serotonin reuptake inhibitors (SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs)) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after discontinuation of treatment.

Other medicines and Paroxetina Aurobindo
Some medicines may affect how Paroxetina Aurobindo works, or make it more likely that you will experience side effects. Paroxetina Aurobindo may also affect how some other medicines work. These include:

• Medicines called monoamine oxidase inhibitors (MAO inhibitors, including moclobemide (an antidepressant) and methylthioninium chloride (methylene blue – a pre-surgical diagnostic agent)) – see Do not take Paroxetina Aurobindo, within this leaflet.
• Thioridazine or pimozide, which are antipsychotics – see Do not take Paroxetina Aurobindo, within this leaflet.
• Acetylsalicylic acid, ibuprofen, or other medicines called NSAIDs (non-steroidal anti-inflammatory drugs) such as celecoxib, etodolac, diclofenac, and meloxicam, used for pain and inflammation.
• Tramadol and pethidine, painkillers.
• Medicines called triptans, such as sumatriptan, used to treat migraine.
• Other antidepressants, including other SSRIs and tricyclic antidepressants such as clomipramine, nortriptyline, and desipramine.
• A dietary supplement called tryptophan.
• Mivacurium and succinylcholine (used in anaesthesia).
• Medicines such as lithium, risperidone, perphenazine, clozapine (called antipsychotics) used to treat certain psychiatric conditions.
• Fentanyl, used in anaesthesia or to treat chronic pain.
• A combination of fosamprenavir and ritonavir, used to treat human immunodeficiency virus (HIV).
• St. John’s wort, a herbal remedy for depression.
• Phenobarbital, phenytoin, sodium valproate, or carbamazepine, used to treat seizures or epilepsy.
• Atomoxetine, used to treat attention deficit hyperactivity disorder (ADHD).
• Procyclidine, used to relieve tremors, especially in 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 levels.
• Rifampicin, used to treat tuberculosis (TB) and leprosy.
• Linezolid, an antibiotic.
• Tamoxifen, used to treat breast cancer or fertility problems.

If you are taking or have recently taken any of the medicines on this list, and have not already discussed this with your doctor, go back to your doctor and ask what you should do. It may be necessary to adjust your dose or to switch to another medicine.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine, including medicines obtained without a prescription.

Taking Paroxetina Aurobindo with food and drink and alcohol
Do not drink alcohol while taking Paroxetina Aurobindo. Alcohol may worsen your symptoms or side effects. Taking Paroxetina Aurobindo in the morning with food reduces the likelihood of feeling unwell (nausea).

Pregnancy and breastfeeding and Paroxetina Aurobindo
Talk to your doctor as soon as possible if you are pregnant, might be pregnant, or are planning a pregnancy. In newborns whose mothers took Paroxetina Aurobindo during the first months of pregnancy, there have been some reports indicating an increased risk of birth defects, particularly those affecting the heart. In the general population, about 1 in 100 babies are born with a heart defect. This risk increases to 2 in 100 babies in mothers who took Paroxetina Aurobindo. You and your doctor may decide it is better for you to switch to another treatment or gradually discontinue Paroxetina Aurobindo during pregnancy. However, depending on your circumstances, your doctor may advise that it is better for you to continue taking Paroxetina Aurobindo.
Make sure your midwife or doctor knows that you are taking Paroxetina Aurobindo. If taken during pregnancy, particularly in late pregnancy, medicines like Paroxetina Aurobindo may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN). In PPHN, the blood pressure in the blood vessels between the baby’s heart and lungs is too high. If you take Paroxetina Aurobindo during the last three months of pregnancy, the newborn may also experience other conditions, which usually begin within the first 24 hours after birth. Symptoms include:

• Breathing difficulties
• Bluish or abnormally hot or cold skin
• Blue lips
• Vomiting or poor feeding
• Being very tired, inability to sleep, or excessive crying
• Stiff or floppy muscles
• Tremors, nervousness, or seizures
• Exaggerated reflexes

If your baby has any of these symptoms at birth, or if you are concerned about your baby’s health, contact your doctor or midwife who will be able to advise you.
Paroxetina Aurobindo may pass into breast milk in very small amounts. If you are taking Paroxetina Aurobindo, go back and talk to your doctor before starting breastfeeding. You and your doctor may decide that you can breastfeed while taking Paroxetina Aurobindo.

Paroxetine, in animal studies, has been shown to reduce sperm quality. In theory, this could affect fertility, but the impact on human fertility has not yet been observed.

Driving and using machines
Possible side effects of Paroxetina Aurobindo include dizziness, confusion, drowsiness, or blurred vision. If you experience these side effects, do not drive or operate machinery.

Paroxetina Aurobindo contains lactose
Paroxetina Aurobindo contains small amounts of lactose. If your doctor has told you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Paroxetine Aurobindo

Always take this medicine exactly as your doctor has instructed. If you have any doubts, consult your doctor or pharmacist.
The recommended doses for different conditions are shown in the following table:
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
Generalized anxiety disorder 20 mg 20 mg 50 mg
Your doctor will advise you which dose to start taking the first time you use Paroxetine Aurobindo.
Most people begin to feel better after a couple of weeks. If you do not start to feel better by then, contact your doctor, who will advise you. He or she may decide to gradually increase your dose by 10 mg at a time, up to the maximum daily dose.
Take your tablets in the morning with food.
Swallow them with a glass of water.
Do not chew.
Your doctor will discuss with you how long you need to continue taking the tablets. This may be for many months or even longer.
Elderly patients
The maximum dose for people over 65 years of age is 40 mg per day.
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 than usual dose of Paroxetine Aurobindo.
If you take more Paroxetine Aurobindo than you should
Never take more tablets than your doctor has prescribed. If you take too many tablets of Paroxetine Aurobindo (or someone else does), inform your doctor or go to hospital immediately.
Show them the tablet pack.
Someone who has taken an overdose of Paroxetine Aurobindo may experience any of the symptoms listed in section 4 Possible side effects, or the following symptoms: fever, uncontrollable muscle rigidity.
If you forget to take Paroxetine Aurobindo
Take your medicine at the same time every day.
If you miss a dose but remember before going to bed, take it immediately. Continue as usual the next day.
If you only remember during the night or the following day, skip the missed dose. You may experience withdrawal symptoms, but these should resolve once you take the next dose at the usual time.
Do not take a double dose to make up for a forgotten dose.
What to do if you do not feel better
Paroxetine Aurobindo does not relieve symptoms immediately – all antidepressants take time to work. Some people start to feel better within a couple of weeks, but for others it may take longer. Some people taking antidepressants feel worse before they start to feel better. If you do not start to feel better after a couple of weeks, return to your doctor for advice. Your doctor will usually ask to see you again a couple of weeks after starting treatment. Inform your doctor if you have not started to feel better.
If you stop taking Paroxetine Aurobindo
Do not stop taking Paroxetine Aurobindo unless your doctor tells you to.
When stopping Paroxetine Aurobindo, your doctor will help you gradually reduce the dose over several weeks or months – this should help reduce the likelihood of withdrawal effects. One way to do this is by gradually reducing the dose of Paroxetine Aurobindo by 10 mg at weekly intervals. Most people report that any withdrawal symptoms are mild and resolve on their own within two weeks. For some, these symptoms may be more severe or last longer.
If you experience withdrawal effects, your doctor may decide that you should stop more slowly. If you experience severe withdrawal symptoms when stopping Paroxetine Aurobindo, consult your doctor. He or she may ask you to restart taking the tablets and then stop more gradually.
If you have further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. Side effects are more likely to occur during the first weeks of taking Paroxetina Aurobindo.
If you experience any of the following side effects during treatment, consult your doctor.
It may be necessary to consult your doctor or go immediately to hospital.

Uncommon side effects, may affect up to 1 in 100 people:

• If you have unusual bruising or bleeding, such as vomiting blood or passing blood in your stools, contact your doctor or go immediately to hospital.
• If you find you are unable to urinate, consult your doctor or go immediately to hospital.

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

• If you experience seizures (fits), consult your doctor or go immediately to hospital.
• If you feel restless and feel unable to sit still or remain motionless, you may have developed a condition called akathisia. Increasing the dose of Paroxetina Aurobindo may worsen these symptoms. If you feel this way, contact your doctor.
• If you feel tired, weak, or confused and have stiff, painful, or uncoordinated muscles, this may be due to low sodium levels in your blood. If you have these symptoms, contact your doctor.

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

• Allergic reactions to Paroxetina Aurobindo, which may be severe. If you develop a red, lumpy rash, swelling of the eyelids, face, lips, mouth, or tongue, start itching, or have difficulty breathing (shortness of breath), difficulty swallowing, feel weak or dizzy, and collapse or lose consciousness, consult your doctor or go immediately to hospital.
• If you have some or all of the following symptoms, you may have developed a condition called serotonin syndrome or neuroleptic malignant syndrome-like events. Symptoms include: feeling very agitated or irritable, confusion, restlessness, feeling hot, sweating, chills, tremors, hallucinations (strange visions or sounds), sudden muscle jerks, or rapid heartbeat. Severity may increase, leading to loss of consciousness. If you feel this way, contact your doctor.
• Acute glaucoma. If your eyes become painful and you have blurred vision, contact your doctor.

Frequency not known

• Aggression.
• While taking Paroxetina Aurobindo or shortly after stopping treatment, some people have had thoughts of harming themselves or of suicide (see section 2 What you need to know before taking Paroxetina Aurobindo).
• Teeth grinding. If you experience these side effects, contact your doctor.

Other possible side effects during treatment

Very common side effects, may affect more than 1 in 10 people:

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

Common side effects, may affect up to 1 in 10 people:

• Increased blood cholesterol levels
• Loss of appetite
• Poor sleep (insomnia) or feeling drowsy
• Abnormal dreams (including nightmares)
• Dizziness or unsteadiness (tremor)
• Headache
• Agitation
• Feeling unusually weak
• Blurred vision
• Yawning, dry mouth
• Diarrhoea or constipation
• Vomiting
• Weight gain
• Sweating.

Uncommon side effects, may affect up to 1 in 100 people:

• Brief increase in blood pressure, or brief decrease which may cause dizziness or fainting when standing up suddenly
• Faster than normal heartbeat
• Lack of movement, stiffness, tremors, or abnormal movements of the mouth and tongue
• Dilated pupils
• Skin rashes
• Itching
• Feeling confused
• Hallucinations (strange visions or sounds)
• Inability to urinate (urinary retention) or uncontrollable, involuntary loss of urine (urinary incontinence)
• If you are a diabetic patient, you may notice a loss of control of your blood sugar levels while taking Paroxetina Aurobindo. Talk to your doctor about a possible adjustment of your insulin or diabetes medication dose.
• Increase in the hormone called prolactin in the blood
• Menstrual cycle disorders (including heavy or irregular periods, bleeding between cycles, and absence or delay of menstruation)

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

• Abnormal production of breast milk in men and women
• Slow heartbeat
• Liver effects indicated by blood tests of liver function
• Panic attacks
• Hyperactive behaviour or thoughts (mania)
• Feeling detached from yourself (depersonalisation)
• Anxiety
• Strong urge to move the legs (Restless Legs Syndrome)
• Joint or muscle pain

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

• Liver problems causing yellowing of the skin or whites of the eyes
• Syndrome of inappropriate antidiuretic hormone secretion (SIADH), a condition in which the body retains excess water and sodium levels (salt) decrease, as a result of improper chemical signals. Patients with SIADH may become severely ill or may have no symptoms.
• Fluid retention or water retention which may cause swelling of the arms or legs
• Sensitivity to sunlight
• Persistent and painful erection of the penis
• Low platelet count in the blood
• Skin rash known as erythema multiforme, which may appear as blisters with a target-like appearance (dark central spots surrounded by a lighter area with a dark ring at the edges)
• Widespread rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)
• Widespread rash with blisters and skin peeling affecting most of the body surface (toxic epidermal necrolysis)

Frequency not known (cannot be estimated from available data)

• Inflammation of the colon (causing diarrhoea)

While taking Paroxetina Aurobindo, some patients have experienced ringing, buzzing, whistling, or other persistent noises in the ears (tinnitus).
An increased risk of bone fractures has been observed in patients taking this type of medicine.

Possible withdrawal effects when stopping treatment

Very common side effects, may affect more than 1 in 10 people:

• Dizziness, unsteadiness, or loss of balance
• Tingling, burning sensation, and (less commonly) electric shock sensations, even in the head
• While taking Paroxetina Aurobindo, some patients have experienced ringing, buzzing, whistling, or other persistent noises in the ears (tinnitus)
• Sleep disturbances (vivid dreams, nightmares, inability to sleep)
• Feeling anxious
• Headache

Uncommon side effects, may affect up to 1 in 100 people:

• Feeling unwell (nausea)
• Sweating (including night sweats)
• Feeling restless or agitated
• Tremor (shaking)
• Feeling confused or disoriented
• Diarrhoea (loose stools)
• Feeling sensitive or irritable
• Visual disturbances
• Fast or pounding heartbeat (palpitations)

Contact your doctor if withdrawal effects concern you when stopping treatment with Paroxetina Aurobindo.

Reporting of side effects

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

5. How to store Paroxetina Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 Aurobindo contains

• The active substance is Paroxetine. Each film-coated tablet contains 20 mg of paroxetine (as paroxetine hydrochloride hemihydrate).
• The other components are: Dibasic calcium phosphate dihydrate, anhydrous dibasic calcium phosphate, lactose monohydrate, sodium starch glycolate (Type A), magnesium stearate (E470b).
  Coating: Titanium dioxide (E171), hypromellose (E464), macrogol 400, polysorbate 80 (E433)

Description of the appearance of Paroxetina Aurobindo and package contents
Film-coated tablets
Paroxetina Aurobindo 20 mg film-coated tablets are white, capsule-shaped, biconvex tablets with ‘56’ imprinted on one side and ‘C’ with a deep score line on the other side. The tablet can be divided into two equal parts.
Paroxetina Aurobindo 20 mg film-coated tablets are available in packs of 12 and 28 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe 102
21047 Saronno (VA)
Italy

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

This medicinal product is authorized in the European Economic Area Member States under the following names:
Italy: Paroxetina Aurobindo