Paroxetine Ratiopharm: detailed information

Package leaflet: Information for the patient

Paroxetina ratiopharm 20 mg film-coated tablets

Paroxetine
Generic medicine
Please read all of this leaflet carefully before you take 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 they have the same symptoms as you, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

What is in this leaflet:

What Paroxetina ratiopharm is and what it is used for
What you need to know before taking Paroxetina ratiopharm
How to take Paroxetina ratiopharm
Possible side effects
How to store Paroxetina ratiopharm
Contents of the pack and other information

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

Paroxetina ratiopharm is a medicine used to treat depression and/or anxiety disorders in adults.
The anxiety disorders treated with Paroxetina ratiopharm are the following:

obsessive-compulsive disorder (repetitive, obsessive thoughts with uncontrollable behaviour)
panic disorders (panic attacks, including those caused by agoraphobia, i.e. fear of open spaces)
social anxiety disorder (fear of or avoidance of social situations)
post-traumatic stress disorder (anxiety caused by a traumatic event)
generalized anxiety disorder (a general feeling of intense anxiety or nervousness)

Paroxetina ratiopharm belongs to a group of medicines called SSRIs (selective serotonin reuptake inhibitors).
Each of us has a substance in the brain called serotonin. People who are depressed or anxious have lower levels of serotonin than others.
The exact mechanism of action of Paroxetina ratiopharm and other SSRIs is not yet fully understood, but they may be helpful because they increase serotonin levels in the brain. It is important to properly treat your anxiety- or depression-related conditions to help you feel better.

2. What you need to know before taking Paroxetina ratiopharm

Do not take Paroxetina ratiopharm

if you are taking medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylene blue chloride), or have taken them at any time within the last two weeks. Your doctor will advise you on how to start treatment with Paroxetina ratiopharm after stopping MAOI therapy
if you are taking an antipsychotic medicine 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). Warnings and precautions Talk to your doctor or pharmacist before taking Paroxetina ratiopharm
If you are taking any other medicine (see “Other medicines and Paroxetina ratiopharm” in this leaflet)
If you are taking tamoxifen for the treatment of breast cancer or fertility problems, Paroxetina ratiopharm may make tamoxifen less effective; therefore, your doctor will likely recommend another antidepressant
If you have kidney, liver, or heart problems
If you suffer from epilepsy or have previously had seizures or epileptic fits
If you have experienced episodes of mania (overactive behaviour or thoughts)
If you are undergoing electroconvulsive therapy (ECT)
If you have a history of bleeding disorders, or are taking other medicines that may increase the risk of bleeding (these include medicines used to thin the blood, such as warfarin, antipsychotics such as perphenazine or clozapine, tricyclic antidepressants, pain and inflammation medicines called non-steroidal anti-inflammatory drugs or NSAIDs, such as acetylsalicylic acid, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam)
If you have diabetes
If you are on a low-sodium diet
If you have narrow-angle glaucoma or a history of glaucoma (increased pressure in the eye)
If you are pregnant or planning to become pregnant (see “Pregnancy, breastfeeding and fertility” in this leaflet)
If you are under 18 years of age (see “Children and adolescents under 18 years” below in this leaflet)

Medicines such as Paroxetina ratiopharm (so-called selective serotonin reuptake inhibitors (SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs)) can cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may persist after stopping treatment.

Children and adolescents under 18 years of age
Paroxetina ratiopharm must not be used in children and adolescents under 18 years of age. In addition, patients under 18 years of age have a higher risk of experiencing adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, oppositional behaviour, and anger) when taking Paroxetina ratiopharm.
If your doctor has prescribed Paroxetina ratiopharm (for you or your child) and you wish to discuss this, please speak to your doctor again. You must inform your doctor if any of the symptoms listed above appear or worsen while you (or your child) are taking Paroxetina ratiopharm.
Furthermore, the long-term safety effects of Paroxetina ratiopharm on growth, maturation, and cognitive and behavioural development in this age group have not yet been established.
In studies conducted with paroxetine in patients under 18 years of age, the common adverse effects, occurring in fewer than 1 in 10 children/adolescents, included: increased suicidal thoughts and suicide attempts, self-harm, hostility, aggression or oppositional behaviour, loss of appetite, tremor, abnormal sweating, hyperactivity (feeling overly energetic), restlessness, emotional instability (including crying and mood swings), and unusual bruising or bleeding (e.g. nosebleeds). These studies also showed that these same symptoms, although to a lesser extent, occurred in children and adolescents taking sugar pills (placebo) instead of paroxetine.
Within these studies, some patients under 18 years of age experienced withdrawal symptoms when stopping treatment with paroxetine. These effects were very similar to those observed in adults after discontinuation of paroxetine (see section 3 “How to take Paroxetina ratiopharm” in this leaflet). In addition, patients under 18 years of age also commonly experienced (may affect up to 1 in 10 people) stomach ache, nervousness, and emotional instability (including crying, mood swings, self-harm, suicidal thoughts, and suicide attempts).

Suicidal thoughts and worsening of depression or anxiety disorder
If you are depressed and/or suffer from anxiety disorders, you may sometimes have thoughts of self-harm or suicide. These thoughts may increase at the beginning of treatment with antidepressants, as these medicines take time to work, usually about two weeks but sometimes longer.
You are more likely to have these thoughts if:

you have previously thought about suicide or harming yourself
you are a young adult. Clinical study data have shown an increased risk of suicidal behaviour in young adults under 25 years of age with psychiatric disorders treated with antidepressants.

If at any time you have thoughts of self-harm or suicide, contact your doctor immediately or go to hospital straight away.
It may be helpful to inform a relative or close friend about your depression or anxiety disorder, and ask them to read this leaflet. You may ask them to let you know if they think your depression or anxiety is worsening, or if they are concerned about changes in your behaviour.

Important adverse effects observed with Paroxetina ratiopharm
Some patients taking Paroxetina ratiopharm develop a condition known as akathisia, where they feel restless and unable to sit still. Other patients may develop a condition known as serotonin syndrome or neuroleptic malignant syndrome, where they experience all of the following symptoms: feeling very agitated or irritable, confusion, restlessness, feeling hot, sweating, tremor, chills, hallucinations (strange visions or sounds), muscle stiffness, sudden muscle contractions, or rapid heartbeat. The condition may worsen, leading to loss of consciousness. If you experience any of the symptoms listed above, contact your doctor. For more information on these or other adverse effects related to the use of Paroxetina ratiopharm, see section 4 “Possible side effects” in this leaflet.

Other medicines and Paroxetina ratiopharm
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may affect how Paroxetina ratiopharm works, or make side effects more likely. Paroxetina ratiopharm may in turn affect how some other medicines work. These include:

Medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylene blue chloride) – see “Do not take Paroxetina ratiopharm” in this leaflet
Thioridazine or pimozide, both antipsychotic medicines – see “Do not take Paroxetina ratiopharm” in 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
Dietary supplements called tryptophan and oxitriptan (also known as 5-hydroxytryptophan)
Mivacurium and suxamethonium (used in anaesthesia)
Medicines such as lithium, risperidone, perphenazine, clozapine (called antipsychotics) used to treat certain psychiatric disorders
Fentanyl, used in anaesthesia or for the treatment of chronic pain
A combination of fosamprenavir and ritonavir, used to treat Human Immunodeficiency Virus (HIV)
St. John’s Wort, a herbal preparation used 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 control tremor, 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
Rifampicin, used to treat tuberculosis (TB) and leprosy
Linezolid, an antibiotic
Tamoxifen, used for the treatment of breast cancer or fertility problems

If you are taking or have recently taken any of the medicines on this list, and have not yet discussed this with your doctor, talk to your doctor and ask what you should do. It may be necessary to adjust your dose, prescribe a different medicine, or your doctor may need to monitor you more closely.

Paroxetina ratiopharm and alcohol
Do not drink alcohol while taking Paroxetina ratiopharm. Alcohol may worsen your symptoms or side effects.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
In babies whose mothers took Paroxetina ratiopharm during the first months of pregnancy, some studies have indicated an increased risk of congenital malformations, particularly heart defects. In the general population, about 1 in 100 babies had a heart defect. This rate increased to 2 in 100 babies in mothers who took Paroxetina ratiopharm.
Your doctor may decide together with you that it is better for you to switch to another medicine or gradually discontinue Paroxetina ratiopharm during pregnancy. However, depending on the circumstances, your doctor may decide it is better for you to continue treatment with Paroxetina ratiopharm.
Make sure your midwife and/or doctor know that you are taking Paroxetina ratiopharm. When taken during pregnancy, particularly during the last 3 months of gestation, medicines such as Paroxetina ratiopharm 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 ratiopharm during the last 3 months of pregnancy, your newborn may also experience other conditions, which usually appear within the first 24 hours after birth. Symptoms include:

breathing difficulties,
bluish skin colour or abnormally high or low body temperature,
blue lips,
vomiting or poor feeding,
extreme tiredness, insomnia, or excessive crying,
stiff or floppy muscles,
tremors, agitation, or seizures,
exaggerated reflexes.

If your baby develops one or more of these symptoms after birth, or if you are concerned about your baby’s health, contact your doctor or midwife immediately for advice.
Paroxetina may pass into breast milk in very small amounts. If you are taking Paroxetina ratiopharm, talk to your doctor before starting breastfeeding. Your doctor may decide together with you that breastfeeding is possible while taking Paroxetina ratiopharm.
Paroxetine, in animal studies, has been shown to reduce sperm quality. In theory, this could affect fertility, but no impact on human fertility has been observed so far.

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

Paroxetina ratiopharm contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially ‘sodium-free’.

3. How to take Paroxetina ratiopharm

Always take this medicine exactly as instructed by your doctor. If you have
any doubts, consult your doctor or pharmacist.
Sometimes you may need to take more than one or half a tablet. The table
below shows you how many 10 mg tablets to take.
Dose Number of tablets to take
10 mg Half a tablet
20 mg One tablet
30 mg One and a half tablets
40 mg Two tablets
50 mg Two and a half tablets
60 mg Three tablets

The recommended doses for different conditions are listed in the following table.
Recommended Initial Dose 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 with when beginning treatment with Paroxetina ratiopharm.
Most people start to feel better after a couple of weeks. If you do not start to feel better after this time, discuss it 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.

Take the tablets in the morning, with food. This will reduce the likelihood of feeling unwell (nausea).
Swallow the tablets with a glass of water.
Do not chew the tablets.

Your doctor will tell you how long you need to continue taking the tablets.
Treatment may last for many months or even longer.

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

Patients with liver or kidney disease
If you have liver problems or severe kidney disease, your doctor may decide to prescribe a lower-than-usual dose of Paroxetina ratiopharm.

If you take more Paroxetina ratiopharm than you should
Never take more tablets than recommended by your doctor. If you (or someone else) take too many tablets, contact your doctor or go to a hospital immediately, and show them the medicine pack.
After an overdose of Paroxetina ratiopharm, you may experience some of the symptoms described in section 4 “Possible side effects”, or the following symptoms: fever, uncontrollable muscle rigidity.

If you forget to take Paroxetina ratiopharm
Take the medicine at the same time every day.
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 only remember 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 your usual time.
Do not take a double dose to make up for a forgotten dose.

What to do if you do not feel better
Paroxetina ratiopharm will not relieve your symptoms immediately – all antidepressants require time to take effect. Some people start to feel better within a couple of weeks, but for others it may take a little longer. Some people taking antidepressants feel worse before they begin to improve. If you do not start to feel better after a couple of weeks, return to your doctor, who will be able to advise you. Your doctor should ask to see you again two weeks after starting treatment. Inform your doctor if you have not started to feel better.

If you stop taking Paroxetina ratiopharm
Do not stop treatment with Paroxetina ratiopharm unless your doctor tells you it is safe to do so.
When stopping treatment with Paroxetina ratiopharm, your doctor will help you gradually reduce the dose over several weeks or months – this will help reduce the likelihood of withdrawal symptoms. One way to achieve this gradual discontinuation is to reduce your dose of Paroxetina ratiopharm by 10 mg per week. Most people report that symptoms occurring after stopping Paroxetina ratiopharm are mild and disappear on their own within two weeks. For others, these symptoms may be more severe or persist for a longer period.

If you experience withdrawal symptoms during the period when stopping treatment, your doctor may decide that you should stop more slowly. If you experience severe withdrawal symptoms when stopping treatment with Paroxetina ratiopharm, contact your doctor. Your doctor may advise you to restart taking the tablets and then begin stopping treatment more gradually.
Even if you experience withdrawal effects, you will still be able to stop treatment with Paroxetina ratiopharm.

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

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

Dizziness, unsteadiness, or loss of balance
Tingling, burning sensations, and (less commonly) electric shock sensations, including in the head, and ringing, buzzing, hissing, or other persistent noises in the ear (tinnitus)
Sleep disturbances (vivid dreams, nightmares, difficulty falling asleep)
Feeling anxious
Headache

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

Feeling unwell, nausea
Sweating (including night sweats)
Restlessness and agitation
Tremor (shakiness)
Feeling confused or disoriented
Diarrhea (loose stools)
Feeling emotional or irritable
Visual disturbances
Palpitations (pounding or racing heartbeat)

Contact your doctor if you are concerned about withdrawal symptoms after stopping treatment with Paroxetina ratiopharm.
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 experiences them. Side effects are more likely to occur during the first few weeks of treatment with Paroxetina ratiopharm.
If you experience any of the following side effects, stop taking the medicine and contact your doctor or go to the nearest hospital emergency department immediately.

Uncommon (may occur in 1 out of 100 people):

Unusual bruising or bleeding, including vomiting blood or blood in the stools.
Inability to urinate.

Rare (may occur in 1 out of 1,000 people):

Seizures (convulsive fits).
If you feel restless and as if you cannot sit still or remain motionless, this may be a symptom called akathisia. Increasing the dose of Paroxetina ratiopharm may worsen this feeling.
If you experience symptoms such as fatigue, weakness, confusion, and feel your muscles aching, stiff, or uncoordinated, this may be due to low levels of sodium in the blood.

Very rare (may occur in 1 out of 10,000 people):

Allergic reactions, which may be severe, to Paroxetina ratiopharm. Symptoms include: skin rash with red blisters, swelling of the eyelids, face, lips, mouth or tongue, itching, difficulty breathing (shortness of breath) or swallowing, and feeling weak, dizzy, leading to collapse or loss of consciousness.
If some or all of the following symptoms occur, you may have a condition known as serotonin syndrome or neuroleptic malignant syndrome. These symptoms include: feeling very agitated or irritable, confusion, restlessness, feeling hot, sweating, trembling, chills, hallucinations (strange visions or sounds), muscle stiffness, sudden muscle contractions, or rapid heartbeat. This condition may worsen, leading to loss of consciousness.
Acute glaucoma (symptoms include: eye pain and blurred vision)
Liver failure
Skin rash with possible blisters, resembling small spots (dark central spots surrounded by a paler area, with a dark ring around the edge), called erythema multiforme
Widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)
Widespread rash with blisters and peeling of the skin over most of the body surface (toxic epidermal necrolysis)

Not known (frequency cannot be estimated from available data):

Some people have had thoughts of harming themselves or of suicide while taking Paroxetina ratiopharm or immediately after stopping treatment (see "Warnings and precautions").
Some people have shown aggression while taking Paroxetina ratiopharm.

Other possible side effects during treatment
Very common (may occur in more than 1 out of 10 people):

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

Common (may occur in 1 out of 10 people):

Increased levels of cholesterol in the blood
Loss of appetite
Disturbed sleep (insomnia) or feeling sleepy
Abnormal dreams (including nightmares)
Feeling dizzy or unsteady (tremor)
Headache
Difficulty concentrating
Feeling agitated
Unusual feeling of weakness
Blurred vision
Yawning, dry mouth
Diarrhea or constipation
Vomiting
Weight gain
Sweating

Uncommon (may occur in 1 out of 100 people):

Sudden increase or decrease in blood pressure, which may cause dizziness or fainting when standing up too quickly
Faster than normal heartbeat
Lack of movement, stiffness, tremor, or abnormal movements of the mouth or tongue
Dilated pupils
Skin rashes
Itching sensation
Feeling confused
Hallucinations (strange visions or sounds)
Uncontrollable, involuntary leakage of urine (urinary incontinence)
If you are a diabetic patient, you may notice loss of control over your blood sugar levels while taking Paroxetina ratiopharm. Please consult your doctor for adjustment of insulin or diabetic medication dosage.

Rare (may occur in 1 out of 1,000 people):

Abnormal milk production in men and women
Slower heartbeat
Liver-related effects, detected by liver function tests
Panic attacks
Hyperactive behaviour or thoughts (mania)
Feeling detached from oneself (depersonalization)
Feeling anxious
Irresistible urge to move the legs (Restless Legs Syndrome)
Joint or muscle pain
Increased levels in the blood of a hormone called prolactin
Menstrual cycle disturbances (including heavy or irregular periods, bleeding between periods, or absence or delay of periods)

Very rare (may occur in 1 out of 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 too much water and sodium levels decrease due to inappropriate chemical signals. Patients with SIADH may become seriously ill or may have no symptoms at all.
Fluid or water retention, which may cause swelling in the arms or legs
Sensitivity to sunlight
Persistent painful erection
Low platelet count (increases the risk of bleeding or bruising)

Not known (frequency cannot be estimated from available data):

Teeth grinding

Some people have developed a persistent ringing, buzzing, hissing, or other noise in the ear (tinnitus) while taking Paroxetina ratiopharm.
An increased risk of bone fractures has been observed in patients treated with this type of medicine.
Withdrawal symptoms may occur if treatment is stopped abruptly (see "If you stop taking Paroxetina ratiopharm").

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 ratiopharm

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 label.
The expiry date refers to the last day of the month indicated.
Tablet container made of white high-density polyethylene (HDPE)
Store in the original packaging to protect from moisture.
After first opening of the tablet container:
Validity after first opening: 6 months
Store in the original packaging to protect from moisture.
Store at a temperature not exceeding 25 °C.
PVC/Aluminum/OPA – Aluminum blisters
Store in the original packaging to protect from moisture.
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. Contents of the packaging and other information
What Paroxetina ratiopharm contains
The active substance is paroxetine.
Each film-coated tablet contains 20 mg of paroxetine (as hydrochloride).
The excipients are:
dibasic calcium phosphate, anhydrous colloidal silica, magnesium stearate, sodium starch glycolate (type A), talc, titanium dioxide (E 171), butyl methacrylate copolymer basic.

Description of the appearance of Paroxetina ratiopharm and contents of the packaging
White, round, biconvex film-coated tablets, marked with "P 2" and a break line on the other side.
Pack sizes of 10, 12, 14, 20, 21, 28, 30, 50, 56, 58, 60, 98, 100, 200, 250 or 500 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
ratiopharm GmbH, Graf-Arco Strasse 3, Ulm (Germany)
BATCH RELEASE
Merckle GmbH, Ludwig-Merckle-Strasse 3, 89143 Blaubeuren (Germany)

This medicine is authorised in the European Economic Area countries under the following names:
Denmark Paroxegen
Germany Paroxetin AbZ 20 mg Filmtabletten
Austria Paroxetin ratiopharm GmbH 20 mg-Filmtabletten
Belgium Paroxetine-ratiopharm 20 mg
Luxembourg Paroxetine-ratiopharm 20 mg
Norway Paroxetin ratiopharm 20 mg filmdrasjerte tabletter
Portugal Paroxetina-ratiopharm 20 mg, comprimidos revestidos
Spain Paroxetina ratiopharm 20 mg comprimidos recubiertos EFG
Sweden Paroxin 20 mg tablets
United Kingdom Paroxetine 20mg tablets
Italy Paroxetina ratiopharm 20 mg compresse rivestite con film