Paroxetine EG

Package leaflet: Information for the user

PAROXETINE EG 20 mg film-coated tablets

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

Contents of this leaflet

1. What Paroxetine EG 20 mg film-coated tablets are and what they are used for
2. What you need to know before taking Paroxetine EG 20 mg film-coated tablets
3. How to take Paroxetine EG 20 mg film-coated tablets
4. Possible side effects
5. How to store Paroxetine EG 20 mg film-coated tablets
6. Contents of the pack and other information

1. What Paroxetina EG 20 mg film-coated tablets is and what it is used for

Paroxetina EG is used to treat depression and/or anxiety disorders in adults.
The anxiety disorders treated with Paroxetina EG are: obsessive-compulsive disorder (repetitive, obsessive thoughts with uncontrollable behaviour), panic disorder (panic attacks, including those caused by agoraphobia, i.e. fear of open spaces), social anxiety disorder (fear or tendency to avoid social situations), post-traumatic stress disorder (anxiety caused by a traumatic event), and generalized anxiety disorder (feeling generally very anxious or nervous).
Paroxetina EG belongs to a group of medicines known as SSRIs (selective serotonin reuptake inhibitors). The brain naturally contains a substance called serotonin. In people who are depressed or anxious, serotonin levels are lower than in others. The way Paroxetina EG and other SSRIs work is not fully understood, but they may help by increasing serotonin levels in the brain. It is important to treat depression or anxiety appropriately to help you feel better.

2. What you should know before taking Paroxetina EG 20 mg film-coated tablets

Do not take Paroxetina EG 20 mg film-coated tablets

• If you are taking other medicines called monoamine oxidase inhibitors (MAO inhibitors, including moclobemide and linezolid, methylene blue chloride (methylene blue)) or have taken them at any time within the previous two weeks. Your doctor will advise you on how to start taking Paroxetina EG after stopping the MAO inhibitor.

• If you are taking an antipsychotic called thioridazine or an antipsychotic called pimozide.

• If you are allergic to paroxetine, peanuts, or soya, or to any of the other ingredients of this medicine (listed in section 6).

If any of the above situations apply to you, inform your doctor before taking
Paroxetina EG.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Paroxetina EG and ask yourself the following questions:

• Are you taking other medicines? (See section Other medicines and Paroxetina EG)
• Do you have kidney, liver, or heart problems?
• Do you suffer from epilepsy or have a history of epileptic seizures or convulsions?
• Have you ever experienced episodes of mania (excessively active behaviour or thoughts)?
• Are you undergoing electroconvulsive therapy (ECT)?
• Do you have a history of bleeding disorders or are you taking medicines that may increase the risk of bleeding? (These include blood-thinning medicines such as warfarin, antipsychotics such as perphenazine or clozapine, tricyclic antidepressants, medicines used to treat pain and inflammation called non-steroidal anti-inflammatory drugs or NSAIDs, such as acetylsalicylic acid, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam)?
• Do you have diabetes?
• Are you on a low-sodium diet?
• Do you have glaucoma (increased intraocular pressure)?
• Are you pregnant or planning to become pregnant? (See section Pregnancy, breastfeeding and fertility)
• Are you under 18 years of age? (See Children and adolescents under 18 years)

If you answer YES to any of these questions, and have not yet discussed this with your doctor,
return to your doctor and ask what you should do regarding Paroxetina EG.
Suicidal thoughts and worsening of depression or anxiety symptoms
If you are depressed and/or anxious, you may at times have thoughts of self-harm or suicide. These effects may worsen when starting antidepressants, as all medicines of this type require time to take effect, usually about two weeks but sometimes longer.
You may be more likely to experience such thoughts if:

• You have previously had suicidal or self-harming thoughts.
• 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 being treated with antidepressants.

If you have thoughts of self-harm or suicide at any time, contact your doctor or go to hospital as soon as possible.
It may be helpful to inform a relative or close friend that you are depressed or suffering from anxiety and ask them to read this leaflet. You may wish to ask them whether they notice your depression or anxiety worsening or any changes in your behaviour.
Children and adolescents under 18 years of age
Paroxetina EG must not be used to treat children and adolescents under 18 years of age. Patients under 18 years of age have an increased risk of adverse effects such as suicide attempts, suicidal ideation, and hostility (mainly aggression, oppositional behaviour, and anger) when taking Paroxetina EG. If your doctor has prescribed Paroxetina EG for you (or your child) and you would like more information, please consult 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 EG. In addition, the long-term safety effects of paroxetine on growth, maturation, and cognitive and behavioural development in this patient group have not been established.
In clinical trials of paroxetine in patients under 18 years of age, the following adverse effects occurred in less than 1 in 10 children/adolescents: increased suicidal thoughts and suicide attempts, deliberate self-harm, hostility, aggression or hostility, loss of appetite, chills, abnormal sweating, hyperactivity (excess energy), agitation, and mood swings (with crying and mood changes). These studies also showed that the same symptoms occurred in children and adolescents treated with sugar pills (placebo) instead of paroxetine, although less frequently.
Some patients in these trials involving patients under 18 years of age experienced withdrawal symptoms when they stopped taking paroxetine. These symptoms were mostly similar to those observed in adults after discontinuation of paroxetine treatment (see section 3, How to take Paroxetina EG, in this leaflet). In addition, patients under 18 years of age frequently (in less than 1 in 10 cases) experienced stomach ache, nervousness, and mood swings (with crying, mood changes, self-harming behaviour, suicidal thoughts, and suicide attempts).
Important adverse effects observed with Paroxetina EG
Some patients taking Paroxetina EG develop a condition called akathisia, in which they feel restless and unable to sit still or remain calm. Other patients develop a condition called serotonin syndrome, which causes some or all of the following symptoms: confusion, restlessness, sweating, unsteadiness, chills, hallucinations (strange visions or sounds), sudden muscle contractions, or rapid heartbeat. If you notice any of these symptoms, contact your doctor. For further information about these or other adverse effects of Paroxetina EG, see section 4, Possible side effects, in this leaflet.
Other medicines and Paroxetina EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may affect how Paroxetina EG works or make side effects more likely. Paroxetina EG may also affect how other medicines work. These include:

• Medicines called monoamine oxidase inhibitors (MAO inhibitors, including moclobemide and methylene blue chloride (methylene blue)) – see section Do not take Paroxetina EG, in this leaflet.
• Thioridazine or pimozide, which are antipsychotics – see Do not take Paroxetina EG, in this leaflet.
• Linezolid, an antibiotic – see Do not take Paroxetina EG, in this leaflet.
• Acetylsalicylic acid, ibuprofen, and other medicines called NSAIDs (non-steroidal anti-inflammatory drugs) such as celecoxib, etodolac, diclofenac, and meloxicam, used to treat pain and inflammation.
• Tramadol, pethidine (painkillers).
• Fentanyl (used in general anaesthesia or for chronic pain treatment).
• 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.
• Medicines such as lithium, risperidone, perphenazine, clozapine (also called antipsychotics) used to treat certain psychiatric conditions.
• A combination of fosamprenavir and ritonavir, used to treat HIV infection (Human Immunodeficiency Virus).
• St. John’s wort, a herbal preparation 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.
• Rifampicin, used to treat tuberculosis (TB) and leprosy.
• Tamoxifen (used to treat breast cancer)

If you are taking or have recently taken any of the medicines listed above, and have not yet discussed this with your doctor, return to your doctor and ask what you should do. Your dosage may need to be adjusted or you may be prescribed a different medicine.
Paroxetina EG with food, drinks, and alcohol
Do not drink alcohol during treatment with Paroxetina EG. Alcohol may worsen your symptoms or side effects. Taking Paroxetina EG in the morning with food may reduce feelings of nausea.
Pregnancy, breastfeeding, and fertility
If you are already taking Paroxetina EG and have just found out you are pregnant, contact your doctor immediately. You should also consult your doctor if you are planning a pregnancy. This is because some studies have shown an increased risk of heart defects in babies whose mothers took paroxetine during the first months of pregnancy. In these studies, fewer than 2 out of 100 babies (2%) whose mothers took paroxetine during early pregnancy had heart problems, compared to the normal rate of 1 baby out of 100 (1%) in the general population. When considering all congenital malformations, there is no difference in the number of babies born with birth defects after maternal use of paroxetine during pregnancy compared to the overall rate of congenital malformations in the general population. You and your doctor may decide to switch to another treatment or gradually discontinue Paroxetina EG during pregnancy. However, depending on individual circumstances, your doctor may advise you to continue taking Paroxetina EG.
Ensure your midwife and/or doctor know you are taking Paroxetina EG. Medicines like Paroxetina EG, if taken during pregnancy, particularly during the last three months, 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 in your baby, contact your midwife and/or doctor immediately.
If you are taking Paroxetina EG during the last three months of pregnancy, inform your midwife, as your baby may experience certain symptoms at birth. These symptoms usually occur within the first 24 hours after birth and may include difficulty sleeping or feeding, breathing problems, bluish skin, high or low body temperature, nausea, excessive crying, stiff or floppy muscles, lethargy, trembling, extreme agitation, or seizures. If your baby shows any of these symptoms at birth and you are concerned, contact your doctor or midwife immediately for advice.
Paroxetina EG may pass into breast milk in very small amounts. If you are taking Paroxetina EG, consult your doctor before starting to breastfeed your baby.
In animal studies, paroxetine 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 EG include dizziness, confusion, drowsiness, or blurred vision. If you experience these side effects, do not drive or operate machinery.
Paroxetina EG contains soya lecithin
If you are allergic to peanuts or soya, do not use this medicine.

3. How to take Paroxetine EG 20 mg film-coated tablets

Take Paroxetine EG exactly as directed by your doctor. If you
have any doubts, consult your doctor or pharmacist.
You may sometimes need to

do not take more than one tablet or half a tablet. This table will indicate how many tablets you should take.
The usual doses for different conditions are shown in the table below.

Your doctor will advise you on the dose to take the first time you use Paroxetina EG.
Most people begin to feel better after a couple of weeks. If you do not notice any improvement after this time, contact your doctor, who will advise you. Your doctor may decide to gradually increase your dose by 10 mg at a time until reaching the maximum daily dose.
Take your tablets in the morning with food.
Swallow them with a glass of water.
Do not chew them.
Your doctor will tell you how long you should continue taking the tablets. This may be for months or even longer.

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

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

If you take more Paroxetina EG 20 mg film-coated tablets than you should
Never take more tablets than prescribed by your doctor. If you take too many Paroxetina EG tablets (or someone else does), contact your doctor or go to hospital immediately. Show them the tablet packaging.
People who have taken an excessive dose of Paroxetina EG may experience one of the symptoms listed in section 4, Possible side effects, or one of the following symptoms: feeling unwell, dilated pupils, fever, headache, uncontrollable muscle stiffness.

If you forget to take Paroxetina EG 20 mg film-coated tablets
Take your medicine every day at the same time.
If you forget a dose and remember before going to bed, take it immediately. The next day, continue treatment as usual.
If you only remember during the night or the following day, skip the missed dose. You may experience withdrawal symptoms, but these should disappear when you take the next dose at the usual time.

What to do if you do not notice any improvement
Paroxetina EG 20 mg will not provide immediate relief of your symptoms – All antidepressants require time to work. Some people start to feel better within a couple of weeks, but others may need more time. Some people taking antidepressants may feel worse before they start to feel better. If you do not notice any improvement after a couple of weeks, contact your doctor, who will advise you. Your doctor should ask you to come back for a check-up a couple of weeks after starting treatment for the first time. Inform your doctor if you do not notice any improvement.

If you stop taking Paroxetina EG 20 mg film-coated tablets
Do not stop taking Paroxetina EG without your doctor’s approval.
When stopping Paroxetina EG, your doctor will help you gradually reduce the dose over several weeks or months—this reduces the likelihood of withdrawal symptoms. One method of gradually reducing the dose of Paroxetina EG is to decrease it by 10 mg per week. Most patients find that withdrawal symptoms are mild and disappear spontaneously within two weeks. For others, these symptoms may be more severe or last longer.

If withdrawal symptoms occur during the dose reduction phase, your doctor may decide on a more gradual reduction. If you experience severe withdrawal symptoms when stopping Paroxetina EG, contact your doctor. Your doctor may ask you to restart taking the tablets and then stop more slowly.
Even if withdrawal symptoms occur, you always have the option to discontinue Paroxetina EG.

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

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

• Dizziness, unsteadiness, and loss of balance
• Pins and needles sensations, burning sensations, (less commonly) electric shock-like sensations, even in the head, and ringing, buzzing, hissing, or other persistent noises in the ears (tinnitus)
• Sleep disturbances (vivid dreams, nightmares, insomnia)
• 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 (shakiness)
• Feeling confused or disoriented
• Diarrhea (loose stools)
• Emotional disturbances or irritability
• Vision changes
• Fast or pounding heartbeat (palpitations)

Consult your doctor if you have concerns about withdrawal symptoms
when stopping treatment with Paroxetina EG.
If you have any questions about the use of this medicine, speak to your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects are more likely to occur during the first weeks of taking Paroxetina EG.
Contact your doctor if any of the following side effects occur during treatment.
You may need to contact your doctor or go to hospital immediately.

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

• If you develop unusual bruising or bleeding, including blood in your vomit or stools, contact your doctor immediately or go to hospital.
• If you feel unable to pass urine, contact your doctor or go immediately to hospital.

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

• If you experience epileptic fits (seizures), contact your doctor or go immediately to hospital.
• If you feel restless and feel unable to sit or stay still, you may have a condition called akathisia. These feelings may worsen if the dose of Paroxetina EG is increased. If you feel this way, contact your doctor.
• If you feel tired, weak or confused and your muscles are painful, stiff or uncoordinated, you may have low sodium levels in your blood. If you experience these symptoms, contact your doctor.

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

• Allergic reactions to Paroxetina EG which may be severe. If you develop a skin rash with red spots and lumps, swelling of the eyelids, face, lips, mouth or tongue, itching, or have difficulty breathing (shortness of breath) or swallowing, feel weak, or experience dizziness leading to collapse or loss of consciousness, contact your doctor or go immediately to hospital.
• If you experience some or all of the following symptoms, you may have a condition called serotonin syndrome. Symptoms include: confusion, restlessness, sweating, unsteadiness, shivering, hallucinations (strange sounds or visions), sudden muscle contractions, or rapid heartbeat. If you feel this way, contact your doctor.
• Acute glaucoma. If you have eye pain and blurred vision, contact your doctor.
• Severe skin reactions (erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis), which may be life-threatening and require immediate medical attention. These initially appear as circular patches, often with blisters in the center, usually on arms and hands or legs and feet. More severe rashes may include swelling of the chest and back. Severe forms of skin rash may progress to widespread skin peeling and may be life-threatening. If you develop a skin rash or these skin symptoms, stop taking Paroxetina EG and contact your doctor immediately.

Side effects with unknown frequency (frequency cannot be estimated from the available data):

• If you have had suicidal thoughts or self-harming thoughts (see section 2: Warnings and precautions).
• Aggression.

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

• Feeling unwell (nausea). You may reduce the likelihood of this by taking the medicine in the morning with food.
• 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:

• Loss of appetite.
• Trouble sleeping well (insomnia) or drowsiness.
• Abnormal dreams (including nightmares).
• Feeling dizzy or unsteady (tremor).
• Headache.
• Feeling agitated.
• Unusual weakness.
• Blurred vision.
• Yawning, dry mouth.
• Diarrhoea or constipation.
• Vomiting.
• Weight gain.
• Sweating.
• Increased cholesterol levels.

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

• Slight increase or decrease in blood pressure, faster than normal heartbeat.
• Lack of movement, stiffness, unsteadiness, or abnormal movements of the mouth and tongue.
• Skin rashes.
• Confusion.
• Drop in blood pressure when standing up, causing dizziness, feeling faint, or fainting.
• Hallucinations (strange visions or sounds).
• Excessive dilation of the pupil (mydriasis).
• Inability to pass urine (urinary retention) or involuntary and uncontrollable loss of urine (urinary incontinence).
• If you are a diabetic patient, you may notice poor control of your blood sugar levels while taking Paroxetina EG. Talk to your doctor about adjusting your insulin dose or diabetes treatment.

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

• Abnormal production of milk in men and women.
• Slowed heartbeat.
• Liver effects shown by blood tests assessing liver function.
• Panic attacks.
• Hyperactive behaviour or thoughts (mania).
• Feeling detached from yourself (depersonalisation).
• Feeling anxious.
• Joint or muscle pain.
• Urge to move your legs (or other body parts) to relieve an unpleasant sensation (restless legs syndrome).

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.
• Fluid or water retention, which may cause swelling of arms or legs.
• Sensitivity to sunlight.
• Painful and prolonged erection of the penis.
• Low platelet count in the blood.

Other possible side effects
An increased risk of bone fractures has been observed in patients taking this type of medicine.
Some patients have developed ringing, buzzing, hissing, or other persistent noises in the ears (tinnitus) during treatment with Paroxetina EG.
If you have any doubts about Paroxetina EG while taking it, discuss them with your doctor or pharmacist, who can advise you.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Paroxetine EG 20 mg film-coated tablets

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the blister pack, bottle, or outer packaging. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• If you are taking half a tablet, make sure to keep it safely in the original packaging.
• 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 EG 20 mg film-coated tablets contain

• The active substance is paroxetine (20 mg).
• The other components are:
  • Core: Magnesium stearate, Sodium carboxymethyl starch (type A), mannitol, microcrystalline cellulose.
  • Coating: Basic butyl methacrylate copolymer, polyvinyl alcohol, talc, soybean lecithin, xanthan gum, titanium dioxide (E171).

Description of the appearance of Paroxetina EG 20 mg film-coated tablets and contents of the pack
Paroxetina EG 20 mg film-coated tablets are film-coated, biconvex, round tablets, white to off-white in colour, with a score line on both sides. The tablets are marked with “P” on one side and “20” on the other. The tablets have a break line on both sides.
Each pack of Paroxetina EG 20 mg contains blisters (Al/Al) with 12, 14, 20, 28, 30, 50, 56, 60 and 100 tablets. Also available: 5 x 20 and 10 x 20 tablets or tablet containers (in polypropylene with LDPE caps) with desiccant, containing 100, 200, 250 and 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 - 20136 Milan, Italy

Manufacturer
Cosmo S.p.A., Via C. Colombo, 1 - 20020 Lainate, Milan, Italy
Balkanpharma – Dupnitsa AD, 3 Samokovsko Shosse Str., Dupnitsa 2600 (Bulgaria)
STADA Arzneimittel AG, Stadastrasse 2-18, D-61118 Bad Vilbel (Germany)

This medicinal product is authorized in the European Economic Area countries under the following names:
Austria Parocetan 20 mg – Filmtabletten
Denmark Paroxetin PCD
Italy Paroxetina EG 20 mg compresse rivestite con film
Netherlands Paroxetine CF 20 mg filmomhuldetabletten
Sweden Parocetan 20 mg filmdragerade tabletter

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