Paroxetine PensA: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

PAROXETINE PENSA 20 mg film-coated tablets

Generic medicine
Please 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, inform your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. WHAT PAROXETINE PENSA IS AND WHAT IT IS USED FOR

PAROXETINE PENSA is used for the treatment of depression (major depressive episodes) and/or anxiety disorders in adults. The anxiety disorders treated with PAROXETINE PENSA 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),
generalized anxiety disorder (feeling generally very anxious or nervous).

PAROXETINE PENSA belongs to a group of medicines called SSRIs (selective serotonin reuptake inhibitors). The brain of every person contains a substance called serotonin. In people who are depressed or anxious, serotonin levels are lower than in others. It is not completely understood how PAROXETINE PENSA and other SSRIs work, but their effectiveness may be related to increasing serotonin levels in the brain. It is important to properly treat depression or anxiety in order to achieve improvement.

2. WHAT YOU SHOULD KNOW BEFORE TAKING PAROXETINE PENSA

Do not use PAROXETINE PENSA

If you are allergic to PAROXETINE, peanuts, soy, or any of the excipients of this medicine (listed in section 6).
If you are currently taking, or have taken within the last two weeks, other medicines known as monoamine oxidase inhibitors (MAO inhibitors, including moclobemide and methylene blue chloride (methylene blue)). Your doctor will advise you on how to start taking PAROXETINE PENSA after stopping the MAO inhibitor. Treatment with MAO inhibitors may only be started one week after discontinuation of PAROXETINE PENSA.
If you are taking an antipsychotic called thioridazine or an antipsychotic called pimozide.

If any of the above situations apply to you, inform your doctor before taking
PAROXETINE PENSA.
Warnings and Precautions
Talk to your doctor or pharmacist before taking PAROXETINE PENSA.
Use in children and adolescents under 18 years of age
PAROXETINE PENSA should generally not be used to treat children and adolescents under
18 years of age. You should be aware that patients under 18 years of age taking this class of medicines have an increased risk of side effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, oppositional behavior, and anger).
Nevertheless, your doctor may prescribe PAROXETINE PENSA to patients under 18 years of age if deemed strictly necessary. If your doctor has prescribed PAROXETINE PENSA to a patient under 18 years of age and you wish to obtain further information, please consult your doctor again. You should inform the doctor if any of the above symptoms appear or worsen during treatment with PAROXETINE PENSA in a patient under 18 years of age. In addition, the long-term effects of PAROXETINE PENSA on growth, maturation, and cognitive and behavioral development in this patient group have not yet been established.
In clinical studies with PAROXETINE in patients under 18 years of age, the following common side effects (occurring in 1 to 10 users out of 100) were observed: increased suicidal thoughts and suicide attempts, deliberate self-harm, hostility, aggression or animosity, loss of appetite, difficulty in coordinating movements, abnormal sweating, hyperactivity (excessive energy), restlessness, and mood swings (with crying and mood changes). These studies also showed that the same symptoms occurred in children and adolescents treated with sugar tablets (placebo) instead of PAROXETINE PENSA, although less frequently.
Some patients under 18 years of age involved in these studies experienced withdrawal symptoms when they stopped taking PAROXETINE PENSA. These effects were mostly similar to those observed in adults after discontinuation of PAROXETINE PENSA (see section 3, How to take PAROXETINE PENSA, within this leaflet). In addition, patients under 18 years of age commonly (1–10 patients out of 100) reported stomach pain, nervousness, and mood swings (with crying, mood changes, self-harm attempts, suicidal thoughts, and suicide attempts).
Self-harming thoughts and worsening of condition
Depressed and/or anxious individuals may sometimes experience self-harming or suicidal thoughts. These effects may worsen when starting antidepressants, as all medicines of this type require time to take effect.
Certain patient groups may be more prone to such thoughts:

If you have previously had suicidal or self-harming thoughts.
If you are a young adult. Clinical trial data have shown an increased risk of suicidal behavior in young adults (under 25 years) with psychiatric disorders who were previously treated with an antidepressant.

If you experience self-harming or suicidal thoughts at any time, seek immediate medical help
or go to hospital.
It may be helpful to inform a friend or relative that you are depressed or suffer from anxiety and ask them to read this leaflet. You may ask them whether they notice any worsening of your depression or anxiety or if they observe concerning changes in your behavior.
Inform your doctor if:

You develop symptoms such as restlessness (akathisia). These symptoms may occur during the first weeks of treatment. A dosage adjustment may be necessary.
You develop a condition called serotonin syndrome, characterized by one or more of the following symptoms: confusion, restlessness, sweating, tremors, chills, hallucinations (strange sounds or visions), sudden muscle contractions, or rapid heartbeat. If you notice any of these symptoms, contact your doctor immediately.
You have had or currently suffer from mania (hyperactive behavior or thoughts).
You have reduced kidney or liver function.
You have diabetes.
You have epilepsy or a history of epileptic seizures or convulsions.
You are undergoing electroconvulsive therapy (ECT).
You have glaucoma (increased eye pressure).
You have heart disease.
Your blood sodium levels are too low.
You have a history of bleeding disorders (e.g., bruising or gastrointestinal bleeding) or if you are pregnant (see section “Pregnancy, breastfeeding, and fertility”).
You are taking medicines that may increase the risk of bleeding (including blood thinners such as warfarin, antipsychotics such as perphenazine or clozapine, tricyclic antidepressants, or non-steroidal anti-inflammatory drugs (NSAIDs) used for pain and inflammation, such as acetylsalicylic acid, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam).
You are taking a medicine called tamoxifen.

During treatment with PAROXETINE PENSA, there is an increased risk of bone fractures, particularly during the first months of therapy.
Medicines such as PAROXETINE PENSA (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 may persist after discontinuation of treatment.
Taking PAROXETINE PENSA with other medicines
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those without a prescription.
Some medicines may affect how PAROXETINE PENSA works or increase the likelihood of side effects. PAROXETINE PENSA may also affect how certain other medicines work. These include:

Medicines called monoamine oxidase inhibitors (MAO inhibitors, including moclobemide), used to treat conditions such as depression or Parkinson’s disease – see “Do not use PAROXETINE PENSA” within this leaflet.
Thioridazine or pimozide, which are antipsychotics – see “Do not use PAROXETINE PENSA” within 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 and pethidine, analgesics (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.
St. John’s wort (hypericum), a herbal antidepressant preparation.
Fentanyl, an analgesic and anesthetic.
A dietary supplement called tryptophan.
Medicines such as lithium, risperidone, perphenazine, clozapine (also known as antipsychotics) used to treat certain psychiatric conditions.
A combination of fosamprenavir and ritonavir, used to treat HIV infection.
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 (anticoagulants) used to thin the blood.
Propafenone, flecainide, and other 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, a medicine used to treat breast cancer and female infertility.

PAROXETINE PENSA with food, drinks, and alcohol
PAROXETINE PENSA should be taken with food, preferably in the morning.
Do not drink alcohol during treatment with PAROXETINE PENSA. Alcohol may worsen your symptoms or the side effects of the medicine.
Pregnancy, breastfeeding, and fertility
Consult your doctor or pharmacist before taking any medicine.
Pregnancy
Due to a small increased risk of congenital malformations (cardiovascular malformations) associated with taking PAROXETINE PENSA during the first three months of pregnancy, it is important that you inform your doctor if you are planning to become pregnant or if you are already pregnant. Your doctor will decide whether treatment with PAROXETINE PENSA is absolutely necessary or whether switching to an alternative treatment is possible.
Treatment with PAROXETINE PENSA must not be stopped abruptly.
Ensure that your midwife and/or doctor know that you are taking PAROXETINE PENSA. Medicines such as PAROXETINE PENSA, 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 PAROXETINE PENSA during the last three months of pregnancy, inform your doctor, 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, abnormally high or low body temperature, feeling unwell, excessive crying, stiff or floppy muscles, lethargy, trembling, low blood sugar, extreme agitation, or seizures, and exaggerated reflexes. If your baby shows any of these symptoms at birth, contact your doctor or a healthcare professional immediately.
If you take PAROXETINE PENSA near the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have bleeding disorders (tendency to bleed easily). Inform your doctor or midwife that you are taking PAROXETINE PENSA so they can advise you on appropriate measures.
Breastfeeding
PAROXETINE may pass into breast milk in small amounts. If you are taking PAROXETINE, consult your doctor before starting breastfeeding.
Fertility
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 to date.
Driving and operating machinery
This medicine may cause side effects (dizziness, drowsiness, or confusion) that may impair your ability to concentrate and react quickly. If you experience these side effects, do not drive, operate machinery, or engage in any activity requiring alertness and concentration.
PAROXETINE PENSA contains soy and sodium
PAROXETINE PENSA contains soy lecithin. If you are allergic to peanuts or soy, do not take this medicine.
PAROXETINE PENSA contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially ‘sodium-free’.

3. HOW TO TAKE PAROXETINE PENSA

Always take PAROXETINE PENSA exactly as prescribed by your doctor. If you have any
doubts, consult your doctor or pharmacist.
It is recommended to take PAROXETINE PENSA once daily in the morning with food.
The tablets must not be chewed.
The tablet may be divided into two equal halves.
Recommended doses:
Adults
Depression:
The recommended dose is 20 mg daily.
Improvement usually occurs within 1–2 weeks after starting treatment.
The dosage may be increased only on medical prescription. Your doctor may decide to gradually increase
the dose by 10 mg at a time, up to a maximum daily dose of 50 mg.
Duration of treatment: at least 6 months to ensure symptoms disappear.
Obsessive-compulsive disorder:
Treatment is started at a daily dose of 20 mg, which may be gradually increased by 10 mg at a time, up to
the recommended daily dose of 40 mg. The maximum daily dose is 60 mg.
Dosage adjustments may be made only on medical prescription.
Duration of treatment: several months or longer.
Panic disorders:
Treatment is started at a daily dose of 10 mg, which may be gradually increased according to effect and on medical prescription, by 10 mg at a time, up to the recommended daily dose of 40 mg. The maximum daily dose is 60 mg. Dosage adjustments may be made only on medical prescription.
Duration of treatment: several months or longer.
Social anxiety disorder/social phobia, generalized anxiety disorder, and post-traumatic stress disorder:
The recommended dose is 20 mg daily. The maximum daily dose is 50 mg.
Dosage adjustments may be made only on medical prescription.
Duration of treatment: in case of long-term treatment, your doctor will regularly assess the need for continued therapy.
Elderly patients:
Start with the same dose as used in adults. However, the dose should not exceed 40 mg daily.
Children and adolescents under 18 years of age:
PAROXETINE PENSA must not be used in children and adolescents under 18 years of age (see section: “Special warnings with PAROXETINE PENSA”).
Reduced kidney or liver function:
Dose adjustment may be necessary. Follow your doctor’s instructions.
Treatment with PAROXETINE PENSA must not be stopped abruptly. This must be done only on the advice of your doctor (see section “If you stop taking PAROXETINE PENSA”).
If you take more PAROXETINE PENSA than you should
Contact your doctor, emergency services, or pharmacist if you have taken more PAROXETINE PENSA than indicated in this leaflet or prescribed by your doctor.
The most common symptoms of overdose are vomiting, dilated pupils, fever, changes in blood pressure, headache, involuntary muscle contractions, restlessness, anxiety, and rapid heartbeat.
If you forget to take PAROXETINE PENSA
Do not take a double dose to make up for the missed dose. Take the next dose at your usual time.
If you stop taking PAROXETINE PENSA
Do not stop treatment with PAROXETINE PENSA without consulting your doctor, even if you feel well.
Suddenly stopping PAROXETINE PENSA after a period of treatment may lead to the following symptoms:
Common side effects, affecting less than 1 in 10 patients:

Dizziness, unsteadiness, and loss of balance.
Pin-and-needle sensations, burning sensations, (less commonly) electric shock-like sensations, even in the head, and ringing, buzzing, whistling, or other persistent noises in the ears (tinnitus).
Sleep disturbances (vivid dreams, nightmares, inability to sleep).
Feelings of anxiety.
Headache.

Uncommon side effects, affecting less than 1 in 100 patients:

Malaise (nausea)
Sweating (including night sweats)
Feelings of restlessness or agitation
Tremor (shakiness)
Feelings of confusion or disorientation
Diarrhea (loose stools)
Emotional disturbances or irritability
Visual disturbances
Rapid or pounding heartbeat (palpitations)

When stopping PAROXETINE PENSA, your doctor will help you gradually reduce the dose over weeks or months—this reduces the likelihood of withdrawal symptoms. One method of gradually reducing the dose of PAROXETINE PENSA is to decrease it by 10 mg per week. Most patients experience mild withdrawal symptoms that resolve 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 slower tapering schedule. If severe withdrawal symptoms occur after stopping PAROXETINE PENSA, contact your doctor. They may advise you to restart the tablets and then discontinue them more gradually.
If you have any doubts about how to use PAROXETINE PENSA, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, PAROXETINE PENSA may cause adverse reactions, although not everyone experiences
them.
Contact your doctor if any of the following adverse reactions occur during treatment:
You may need to contact your general practitioner or go to hospital immediately.

Uncommon adverse reactions (affect fewer than 1 in 100 patients):

If you experience unusual bruising or bleeding, including blood in vomit or stools, contact your doctor immediately or go to hospital.
If you feel unable to urinate, contact your doctor immediately or go to hospital.

Rare adverse reactions (affect fewer than 1 in 1,000 patients):

If you experience epileptic seizures (fits), contact your doctor immediately or go to hospital.
If you feel restless and find you cannot sit still or stand still, you may be suffering from a condition called akathisia. These sensations may worsen with increasing doses of PAROXETINE PENSA. 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 adverse reactions (affect fewer than 1 in 10,000 patients):

Allergic reactions to PAROXETINE PENSA, 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, difficulty breathing (shortness of breath), difficulty swallowing, or feel weak or dizzy leading to collapse or loss of consciousness, contact your doctor immediately or go to hospital.
Bleeding in the stomach or intestines. If you notice blood in your vomit or stools, contact your doctor or go immediately to hospital.
If you experience some or all of the following symptoms, you may be suffering from a condition called serotonin syndrome. Symptoms include: confusion, restlessness, sweating, tremors, chills, hallucinations (strange sounds or visions), sudden muscle contractions or rapid heartbeat. If you feel this way, contact your doctor.
Acute glaucoma: If you experience eye pain and blurred vision, contact your doctor.

Adverse reactions with unknown frequency (frequency cannot be determined from available data):

If you have suicidal or self-harming thoughts at any time, contact your doctor or go immediately to hospital.
Aggression
Inflammation of the colon (causing diarrhoea)
Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage). See section 2 “Pregnancy, breastfeeding and fertility” for further information.

Other possible adverse reactions during treatment
Very common adverse reactions (affect more than 1 in 10 patients):
Nausea, changes in sexual interest or sexual performance (e.g. inability to achieve orgasm and, in men, abnormal erection and ejaculation).
Common adverse reactions (affect fewer than 1 in 10 patients):
Decreased appetite, increased blood cholesterol levels, difficulty sleeping or insomnia, abnormal dreams (including nightmares), difficulty concentrating, dizziness, tremors, agitation, blurred vision, yawning, dry mouth, constipation, diarrhoea, sweating, fatigue, weight gain, vomiting, headache.
Uncommon adverse reactions (affect fewer than 1 in 100 patients):
Confusion, hallucinations, slow or uncontrolled movements affecting the mouth and tongue, muscle stiffness, rapid pulse, temporary increase or decrease in blood pressure, skin rash, itching, involuntary urination (urinary incontinence), abnormal dilation of the pupil, reduced number of white blood cells. Inability to urinate (urinary retention) or uncontrolled and involuntary loss of urine (urinary incontin游戏副本

5. HOW TO STORE PAROXETINE PENSA

Keep this medicine out of the sight and reach of children.
Do not use PAROXETINE PENSA after the expiry date stated on the blister, tablet container, or carton. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. OTHER INFORMATION

What PAROXETINA PENSA contains
The active substance is PAROXETINE:
20 mg: Each tablet of PAROXETINA PENSA contains 22.2 mg of anhydrous paroxetine hydrochloride,
equivalent to 20 mg of paroxetine.
The excipients are:
Tablet core: Magnesium stearate, sodium starch glycolate (type A), mannitol, microcrystalline cellulose.
Tablet coating: Methacrylic acid-methyl methacrylate copolymer (Eudragit E100), polyvinyl alcohol (partially hydrolyzed), titanium dioxide (E171), talc, soybean lecithin (E322), xanthan gum (E415).

Description of the appearance of PAROXETINA PENSA and packaging contents
Film-coated tablets, white to cream in colour, round, biconvex, 10 mm in diameter, with a bevelled edge and a score line on both sides, and the imprint "P20" embossed on one side.
The tablet can be divided into two equal parts.

Pack sizes:
The blister pack contains 10, 12, 14, 28, 30 and 56 film-coated tablets.
White cylindrical tablet containers with a white cap and containing a desiccant powder (silica gel) hold: 20, 30, 60, 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Towa Pharmaceutical S.p.A.
Via Enrico Tazzoli, 6
20154 Milan
Italy

Manufacturer
Actavis Ltd.
BLB016, Bulebel Industrial Estate,
Zejtun ZTN 3000
Malta
Actavis hf.
Reykjavikurvegur 78, P.O. Box 420,
220 Hafnarfjörður,
Iceland
Balkanpharma – Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: PAROXETINA PENSA 20 mg film-coated tablets

This leaflet was last approved on: