Paroxetine Doc Generici

Patient Information Leaflet

PAROXETINA DOC Generici 20 mg Film-coated Tablets

Generic Medicine
Please read this leaflet carefully before taking this medicine as 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, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:
1 What PAROXETINA DOC Generici 20 mg Film-coated Tablets are and what they are used for
2 What you need to know before taking PAROXETINA DOC Generici 20 mg Film-coated Tablets
3 How to take PAROXETINA DOC Generici 20 mg Film-coated Tablets
4 Possible side effects
5 How to store PAROXETINA DOC Generici 20 mg Film-coated Tablets
6 Contents of the pack and other information

1 WHAT PAROXETINA DOC Generici 20 mg Film-coated Tablets ARE AND WHAT THEY ARE USED FOR
This medicine belongs to a group of drugs called selective serotonin reuptake inhibitors (SSRIs). Everyone has a substance in their body called serotonin. Low levels of serotonin are thought to be a cause of depression and related disorders. Paroxetine works by restoring serotonin levels to normal.
Paroxetine is used to treat:

• Major Depressive Episode
• Obsessive Compulsive Disorder (OCD)
• Panic attacks with or without agoraphobia
• Social anxiety disorder / social phobia
• Generalized Anxiety Disorder
• Post-Traumatic Stress Disorder

Paroxetine hydrochloride contained in this medicine is authorized for the treatment of other conditions not mentioned in this patient leaflet. Ask your doctor, pharmacist, or other healthcare professional for further information and always follow their instructions.
It is important that you continue taking your tablets even when you start to feel better. Do not stop taking these tablets unless your doctor tells you to.
For information on the use of paroxetine in children and adolescents under 18 years of age, see section 2.

2 WHAT YOU NEED TO KNOW BEFORE TAKING PAROXETINA DOC Generici 20 mg Film-coated Tablets
Do not take PAROXETINA DOC Generici 20 mg Film-coated Tablets:

• If you are allergic (hypersensitive) to paroxetine hydrochloride or to any of the other ingredients of this medicine
• If you are taking or have taken at any time within the last 2 weeks any medicines known as monoamine oxidase inhibitors (called MAOIs), including moclobemide, generally prescribed for the treatment of depression
• If you are taking thioridazine (a major tranquilizer) or pimozide (an antipsychotic) used to treat mental illness

Warnings and precautions
If you answer YES to any of the following questions and have not already discussed them with your doctor, go back to your doctor and ask what to do:

• Are you breastfeeding, pregnant, or planning a pregnancy? (See the section “Pregnancy and breastfeeding” in this leaflet)
• Do you have eye, kidney, liver, or heart problems?
• Do you have epilepsy or have you had seizures in the past?
• Have you suffered or have you ever suffered from manic episodes (overactive behavior or thoughts)?
• Are you undergoing electroconvulsive therapy (ECT)?
• Have you had bleeding problems?
• Are you taking tamoxifen for the treatment of breast cancer or fertility problems? Since paroxetine may reduce the effect of tamoxifen, your doctor may prescribe you another antidepressant.
• Do you have diabetes?
• Are you on a low-sodium diet?
• Do you have glaucoma (high eye pressure)?
• Are you pregnant or planning a pregnancy? (See the section “Pregnancy and breastfeeding” in this leaflet)

Suicidal thoughts and worsening of your depression or anxiety disorder
If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming yourself or of suicide. These thoughts may increase at the beginning of antidepressant therapy, because these medicines take time to work, usually two weeks but sometimes longer.
The likelihood that you will have these thoughts increases:

• If you have previously had thoughts of suicide or self-harm.
• If you are a young adult. Clinical studies have shown an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders being treated with antidepressants. If at any time you have thoughts of harming yourself or of suicide, contact your doctor immediately or go immediately to the nearest hospital. It may help to tell a relative or close friend that you are depressed or have 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 behavior.

Some patient groups are more likely to have these thoughts:

• If you are a young adult, for example aged between 18 and 29 years.
• If you have previously had thoughts of suicide or self-harm.
• Contact your doctor or go immediately to the nearest hospital if you ever have these thoughts.

Children and adolescents
Paroxetine must not be used in children and adolescents under 18 years of age because it has not been shown to be an effective medicine in this age group.
Furthermore, patients under 18 years have a higher risk of side effects such as suicidal thoughts and self-harm when taking this medicine. If your doctor has prescribed this medicine for you (or your child) and you wish to discuss it, go back to your doctor.
In clinical studies on this medicine conducted in patients under 18 years of age, the common side effects affecting fewer than 1 in 10 children/adolescents were: increased suicidal thoughts and suicide attempts, deliberate self-harm, hostile, aggressive or resentful attitudes, loss of appetite, tremor, abnormal sweating, hyperactivity (excess energy), agitation, emotional lability (including crying, mood changes). These studies also showed that the same symptoms occurred in children and adolescents taking sugar pills (placebo) instead of this medicine, although less frequently.
In these studies, some patients under 18 years of age experienced withdrawal symptoms after stopping treatment.
These effects were mostly similar to those observed in adults after discontinuation of the medicine (see section 3 “If you stop taking PAROXETINA DOC Generici 20 mg Film-coated Tablets”). In addition, in patients under 18 years of age, the following commonly occurred (in fewer than 1 in 10): stomach ache, nervousness, and emotional lability (including crying, mood changes, attempts of self-harm, suicidal thoughts and suicide attempts).

Other medicines and PAROXETINA DOC Generici 20 mg Film-coated Tablets
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. If you are taking any of the medicines listed below and have not yet discussed this with your doctor, go back to your doctor and ask what to do. Your dose may need to be changed or you may need to switch to another medicine:

• Aspirin, ibuprofen, or other medicines called NSAIDs (non-steroidal anti-inflammatory drugs) such as celecoxib, etodolac, meloxicam, and refecoxib, used for pain and inflammation
• Tramadol and pethidine, painkillers
• Medicines called triptans, such as sumatriptan, used to treat migraine
• Other antidepressants, including other SSRIs, tryptophan, and tricyclic antidepressants such as clomipramine, nortriptyline, and desipramine
• Medicines such as lithium, risperidone, perphenazine (called antipsychotics) used to treat certain psychiatric disorders
• Fentanyl, used in anesthesia or for the treatment of chronic pain
• A combination of fosamprenavir and ritonavir, used to treat human immunodeficiency virus (HIV) infection
• 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, used to reduce tremor, especially in Parkinson’s disease
• Warfarin or other medicines (called anticoagulants) used to thin the blood
• Propafenone, flecainide, and medicines for the treatment of irregular heartbeat
• Metoprolol, a beta-blocker used to treat high blood pressure and heart problems
• Pravastatin, used to treat high cholesterol
• Rifampicin, used to treat tuberculosis and leprosy
• Linezolid, an antibiotic
• Tamoxifen, for the treatment of breast cancer or fertility problems

If you are taking any other medicine not listed here, ask your doctor or pharmacist before taking this medicine. They will know whether it is safe for you to take it.

PAROXETINA DOC Generici 20 mg Film-coated Tablets with food, drinks, and alcohol
You should avoid alcohol while taking this medicine.
You should take your medicine with food and swallow the tablet with a glass of water.

Pregnancy and breastfeeding

• If you are already taking this medicine and find out you are pregnant, you must speak to your doctor immediately. If you are planning a pregnancy, you must also speak to your doctor. This is because some studies have suggested an increased risk of heart defects in newborns whose mothers took the medicine during the first months of pregnancy. These studies found that fewer than 2 out of 100 newborns (2%) whose mothers took paroxetine during early pregnancy had heart defects, compared to the usual rate of 1 out of 100 newborns (1%) in the general population. You and your doctor may decide it is better for you to gradually discontinue paroxetine during pregnancy. However, depending on the circumstances, your doctor may advise you that it is better for you to continue taking the medicine.
• If you are taking this medicine during the last trimester of pregnancy, inform your midwife that your newborn may experience certain symptoms after birth. These symptoms usually appear within the first 24 hours after birth. They include inability to sleep or feed properly, breathing problems, bluish or abnormally hot or cold skin, malaise, excessive crying, stiff or floppy muscles, lethargy, tremors, jaundice, or seizures. If your newborn shows any of these symptoms after birth and you are concerned, contact your doctor or midwife, who will be able to advise you.
• Make sure your midwife and/or doctor know that you are taking PAROXETINA DOC Generici 20 mg Film-coated Tablets. Medicines like PAROXETINA DOC Generici 20 mg Film-coated Tablets, if taken during pregnancy, particularly during the last 3 months, may increase the risk of a serious condition in newborns called persistent pulmonary hypertension (PPHN), which presents with increased breathing rate and bluish skin. These symptoms usually appear within the first 24 hours after birth. Inform your midwife and/or doctor immediately if your baby shows these symptoms.
• This medicine may pass into breast milk in very small amounts. If you are taking this medicine, talk to your doctor before starting breastfeeding.

Ask your doctor for advice before taking any medicine.

Fertility
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
Dizziness, confusion, or vision disturbances are possible side effects of paroxetine. If you experience these side effects, your coordination, judgment, and concentration may be affected to such an extent that it may be dangerous for you to perform certain activities. If you experience these effects, do not drive and do not operate machinery.

PAROXETINA DOC Generici 20 mg Film-coated Tablets contain lactose.
This product contains lactose, a sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3 HOW TO TAKE PAROXETINA DOC Generici 20 mg Film-coated Tablets
Take this medicine exactly as prescribed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist. Sometimes you may need to take more than one tablet or to split a tablet in half to achieve the prescribed dose. The table below will help you decide how many tablets to take:

Take your tablets in the morning, with food. Swallow them with a glass of water without chewing.
Your doctor will advise you on the dose to take when you start using the medicine for the first time.
Many people begin to feel better after a couple of weeks. If you do not feel better after this time, speak with your doctor, who will be able to advise you. Your doctor may decide to gradually increase your dose by 10 mg at a time, up to the maximum daily dose.
The recommended doses for each condition are shown in the table below.

Please remember that your doctor will advise you on the dose to take.
Your doctor will tell you how long you should continue taking the tablets. This may be for many
months or even longer.

Elderly population
The maximum dose for patients over 65 years of age is 40 mg per day.

Patients with liver or kidney problems
If you have kidney or liver problems, your doctor may decide that you should take a lower dose
than usual. If you have severe liver or kidney problems, the maximum daily dose is 20 mg.

If you take more PAROXETINA DOC Generici 20 mg film-coated tablets than you should
Never take more tablets than your doctor has advised. If you have taken too many tablets (or
someone else has), inform your doctor immediately or go straight to hospital. Show them the
packaging of the tablets.

If you forget to take PAROXETINA DOC Generici 20 mg film-coated tablets
If you forget to take your medicine
Take your medicine at the same time each day.

• If you forget to take a dose and remember before going to bed, take it immediately and continue as normal the next day.
• If you forget to take a dose and remember during the night or the following day, do not take the missed dose. Withdrawal symptoms may occur, which should disappear when you take the next dose at the usual time.

If you stop taking PAROXETINA DOC Generici 20 mg film-coated tablets
Do not stop taking your medicine until your doctor tells you to do so.
When you stop taking the medicine, your doctor will help you gradually reduce the dose over a
period of weeks or months – this will help reduce the risk of withdrawal symptoms. One way to
do this is to gradually reduce your dose by 10 mg per week. Many people experience mild
withdrawal symptoms that disappear on their own within two weeks. For some people, these
symptoms may be more severe or last longer.
If you experience withdrawal symptoms during dose reduction, your doctor may decide to
reduce the dose more slowly. If you experience severe withdrawal symptoms when stopping the
medicine, see your doctor. Your doctor may ask you to restart the tablets and then stop them very
gradually.
Even if you experience withdrawal symptoms, you will still be able to stop the medicine.

Possible withdrawal symptoms when stopping treatment
Studies have reported that 3 out of 10 patients experienced one or more withdrawal symptoms
when stopping the medicine. Some withdrawal effects are more common than others.

May affect up to 1 in 10 patients:

• Dizziness, unsteadiness or loss of balance
• Tingling, burning sensations and, less commonly, electric shock sensations (also in the head)
• Sleep disturbances (vivid dreams, nightmares, inability to sleep)
• Feeling of anxiety
• Headache
• Difficulty concentrating

May affect up to 1 in 100 patients:

• Feeling unwell (nausea)
• Sweating (including night sweats)
• Feeling restless or agitated
• Tremor
• Feeling confused or disoriented
• Diarrhoea (loose stools)
• Feeling emotional or irritable
• Visual disturbances
• Palpitations

Please consult your doctor if withdrawal symptoms concern you.
The medicine will not relieve your symptoms immediately – all antidepressants take some
time to work.
Some patients begin to feel better within a couple of weeks, but for others it may take longer.
Before feeling better, some patients taking antidepressants may initially feel worse. If you do not
start to feel better within a few weeks, return to your doctor, who will be able to advise you.
Your doctor will ask to see you again after a couple of weeks from the start of treatment. Talk to
your doctor if you do not start to feel better.

4 POSSIBLE ADVERSE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Consult your doctor if you experience any of the following side effects during treatment.
You may need to contact your doctor or go to hospital immediately.

Uncommon (occur in less than 1 in 100 people):

• If you experience unusual bruising or bleeding, including vomiting blood or finding blood in your stools, contact your doctor or go to hospital immediately.
• If you notice you are unable to urinate, contact your doctor or go to hospital immediately.

Rare (occur in less than 1 in 1,000 people):

• If you have seizures, contact your doctor or go to hospital immediately.
• If you feel agitated and find it difficult to sit still or remain still, you may have a condition called akathisia. Increasing the dose of your medicine could worsen this condition. If this happens, contact your doctor.
• If you feel tired, weak or confused and have muscle pain, stiffness or lack of coordination, this could be due to low sodium levels in the blood. If you have these symptoms, contact your doctor.

Very rare (occur in less than 1 in 10,000 people):

• Allergic reaction to your medicine which may be severe. If you develop a red, swollen rash, swelling of the eyelids, face, lips, mouth or tongue, itching, breathing difficulties (shortness of breath), difficulty swallowing, or feel weak or lightheaded leading to collapse or loss of consciousness, contact your doctor or go to hospital immediately.
• If you experience some or all of the following symptoms, you may have a condition called serotonin syndrome. Symptoms include: confusion, agitation, sweating, tremor, chills, hallucinations (strange visions or sounds), sudden muscle spasms or rapid heartbeat. If you feel this way, contact your doctor.
• Acute glaucoma. If you experience eye pain and blurred vision, contact your doctor.

Frequency not known:

• Some people have had self-harming or suicidal thoughts while taking paroxetine or shortly after stopping treatment (see section 2)
• Aggression
• Teeth grinding

Other possible side effects that may occur during treatment

Very common (affects more than 1 in 10 people):

• Nausea (feeling unwell). Taking the medicine in the morning after food reduces the likelihood of this occurring.
• Changes in sexual desire or performance. For example, lack of orgasm and, in men, abnormal erections and ejaculation.

Common (affects less than 1 in 10 people):

• Increased blood cholesterol levels
• Loss of appetite
• Insomnia or drowsiness
• Abnormal dreams (including nightmares)
• Feeling confused or tremulous
• Headache
• Feeling agitated
• Blurred vision
• Yawning, dry mouth
• Diarrhoea or constipation
• Vomiting
• Weight gain
• Feeling weak
• Sweating

Uncommon (affects less than 1 in 100 people):

• Increased or decreased blood pressure, which may cause dizziness or fainting when standing up quickly, increased heart rate
• Movement difficulties, stiffness, tremors or abnormal movements of the mouth or tongue
• Dilated pupils
• Skin rashes
• Feeling confused
• Hallucinations (strange visions or sounds)
• Inability to urinate (urinary retention) or involuntary and uncontrollable loss of urine (urinary incontinence)
• If you are a diabetic patient, you may notice a loss of control over your blood sugar levels while taking PAROXETINA DOC Generici 20 mg film-coated tablets. Ask your doctor to adjust the dose of insulin or antidiabetic medicines.

Rare (affects less than 1 in 1,000 people):

• Abnormal milk production from the breasts in men and women
• Slow heartbeat
• Liver effects detected in liver function tests
• Panic attacks
• Hyperactive behaviour or thoughts (mania)
• Feeling detached from yourself (depersonalisation)
• Feeling anxious
• Irresistible urge to move the legs (Restless Legs Syndrome)
• Joint or muscle pain

Very rare (affects less than 1 in 10,000 people):

• Liver problems causing yellowing of the skin or whites of the eyes
• Fluid or water retention causing swelling of the arms or legs
• Sensitivity to sunlight
• Painful and persistent penile erection
• Unusual bleeding, e.g. bleeding from gums, blood in urine or vomit, or unexpected bruising or blood vessel rupture (venous rupture)
• Some patients have experienced ringing, buzzing, whistling, chirping or other persistent noises in the ears (tinnitus) while taking paroxetine.

An increased risk of bone fractures has been observed in patients taking this type of medicine.
If you have any concerns while taking your medicine, discuss them with your doctor or
pharmacist, who can advise you.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, contact your doctor
or pharmacist. You can also report adverse effects directly via the national reporting system at:
www.agenziafarmaco.gov.it/it/responsabili.
By reporting adverse effects, you can help provide more information on the safety of this
medicine.

5 HOW TO STORE PAROXETINA DOC Generici 20 mg film-coated tablets

• Keep this medicine out of the sight and reach of children.
• Store the tablets in the original packaging.
• If you use half a tablet, take care to return the other half to the packaging.

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.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6 CONTENTS OF THE PACK AND OTHER INFORMATION
What PAROXETINA DOC Generici 20 mg film-coated tablets contain
The active substance is paroxetine hydrochloride. Each tablet contains 22.2 mg of paroxetine
hydrochloride, equivalent to 20 mg of paroxetine.
The other ingredients are: magnesium stearate, sodium starch glycolate (type A), anhydrous
lactose; the tablet coating contains: hypromellose (type LF), hypromellose 2910, macrogol 8000
and the colourant titanium dioxide (E 171).

Description of the appearance of PAROXETINA DOC Generici 20 mg film-coated tablets and
contents of the pack
PAROXETINA DOC Generici 20 mg film-coated tablets are white, oval-shaped tablets with the
marking “20” and a break line on one side. The tablet can be divided into two equal halves.
Tablets are available in packs of 4, 12, 14, 20, 28, 30, 50, 56, 60, 100 tablets.

Marketing Authorisation Holder
DOC Generici S.r.l. - Via Turati 40 – 20121 Milan – Italy.

Manufacturer responsible for batch release

• Chanelle Medical Ltd, IDA Industrial Estate, Loughrea, Co. Galway, Ireland.
• Apotex Nederland B.V., Bio Science Park, Archimedesweg 2, 2333 CN Leiden, Netherlands.
• S.I.I.T. S.r.l., Via Ariosto 50/60, 20090 Trezzano sul Naviglio (Milan), Italy.
• Lamp San Prospero S.p.A., Via della Pace 25/A, 41030 San Prospero S/S (Modena), Italy.
• Lachifarma S.r.l. Laboratorio Chimico Salentino, S.S. 16 Zona Industriale, 73010 Zollino (Lecce), Italy.

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