Paroxetine Teva

Package leaflet: Information for the user

Paroxetina Teva 10 mg/ml, oral drops, solution

Generic medicine
Please read all of this leaflet carefully before you start 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, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Paroxetina Teva contains the active substance paroxetine, an antidepressant that belongs to a group of medicines called “selective serotonin reuptake inhibitors” (SSRIs). Everyone has a substance in the brain called serotonin. People who are depressed or anxious have lower levels of serotonin than others. It is not fully understood how Paroxetina Teva and other SSRIs work, but they may help increase the levels of serotonin in the brain.

Other medicines and psychotherapy can also treat depression and anxiety. Appropriate treatment of depression and anxiety disorders is important to help you feel better. If left untreated, your condition may not improve and could become more severe and harder to treat. You may find it helpful to talk to a friend or relative about your depression or anxiety disorder, and you may ask them to read this leaflet. You could ask them to tell you if they think your depression or anxiety is getting worse, or if they are concerned about changes in your behaviour.

Paroxetina Teva is used in adults for the treatment of:

• Depression (major depressive episode);
• Obsessive-compulsive disorder;
• Panic disorder with or without agoraphobia;
• Social anxiety disorder/social phobia (intense fear of any everyday social situation);
• Generalised anxiety disorder;
• Post-traumatic stress disorder.

Talk to your doctor if you do not feel better or if you feel worse.

2. What you should know before taking Paroxetine Teva

Do not take Paroxetine Teva

• If you are allergic to paroxetine or any of the other ingredients of this medicine (listed in section 6).
• If you are taking other medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide), or have taken them within the last two weeks. Your doctor will advise you on how to start taking Paroxetine Teva after stopping the MAOI.
• If you are taking an antipsychotic medicine called thioridazine or an antipsychotic called pimozide.

If any of these apply to you, speak with your doctor before taking Paroxetine Teva.
Warnings and precautions
Talk to your doctor or pharmacist before taking Paroxetine Teva.
If you are taking other medicines (see “Other medicines and Paroxetine Teva”).
If you have eye, kidney, liver, or heart problems.
If you have had an abnormality in your electrocardiogram (ECG) known as prolonged QT interval.
If you have a family history of prolonged QT interval, heart disease such as heart failure, slow heart rate, or low levels of potassium or magnesium.
If you are taking tamoxifen for the treatment of breast cancer or fertility problems, Paroxetine Teva may reduce the effectiveness of tamoxifen, so your doctor may recommend you take another antidepressant.
If you have epilepsy or have had seizures or convulsions.
If you have episodes of mania (manic behaviour or thoughts).
If you are receiving electroconvulsive therapy (ECT).
If you have previously experienced bleeding 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, medicines used for pain and inflammation 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 glaucoma (increased eye pressure).
If you are pregnant or planning to become pregnant (see “Pregnancy, breastfeeding and fertility” below).
If you are under 18 years of age.
Medicines such as Paroxetine Teva (so-called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may persist after discontinuation of treatment.
If any of these apply to you, and you have not already discussed them with your doctor, go back to your doctor and ask what to do about taking Paroxetine Teva.
Suicidal thoughts and worsening of depression or anxiety disorder:
If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of self-harm or suicide.
These may increase when you first start taking antidepressants, as these medicines take time to work, usually about two weeks but sometimes longer.
You may be more prone to these thoughts:
If you have previously had suicidal or self-harming thoughts.
If you are a young adult. Young adults under 25 years of age with psychiatric disorders treated with an antidepressant have shown an increased risk of suicidal behaviour. If at any time you have suicidal or self-harming thoughts, contact your doctor or go to hospital immediately.
You may find it helpful to talk to a friend or relative about your depression or anxiety disorder, and you may ask them to read this leaflet. You could ask them to tell you if they think your depression or anxiety is getting worse or if they are concerned about changes in your behaviour.
If you develop restlessness, agitation, or inability to sit or stand still, usually associated with inner discomfort. This is more likely to occur during the first few weeks of treatment. If you develop these symptoms, increasing the dose may be harmful.
If you develop a specific syndrome called serotonin syndrome/neuroleptic malignant syndrome, which presents as a combination of symptoms such as increased body temperature, muscle rigidity, sudden muscle contractions (myoclonus), fluctuation in vital signs, changes in mental status including confusion, irritability, extreme restlessness progressing to delirium and coma. These syndromes may involve potentially life-threatening conditions; if such events occur, paroxetine must be discontinued and symptomatic and supportive treatment initiated.
If you develop manic behaviour. In this case, you must stop treatment.
If you have liver or kidney problems, your doctor may need to adjust your dose.
If you have diabetes.
If you suffer or have ever suffered from high pressure in the eye (glaucoma).
If you are elderly, taking other medicines, or have liver problems, as this may reduce sodium levels in the blood (hyponatraemia).
If you have an increased tendency to bleed. Caution is advised if you are taking oral anticoagulants, e.g., medicines known to affect platelet function, or other medicines that may increase the risk of bleeding (such as atypical antipsychotics like clozapine, phenothiazines, most tricyclic antidepressants, acetylsalicylic acid, non-steroidal anti-inflammatory drugs (NSAIDs), COX-2 inhibitors) and if you have a clinical history of bleeding disorders or conditions that may cause bleeding.
If you wish to stop treatment with paroxetine. You may experience withdrawal symptoms, especially if treatment is stopped abruptly (see section “If you stop taking Paroxetine Teva”).
If any of these apply to you, talk to your doctor.
Children and adolescents
Paroxetine Teva is not recommended in children and adolescents.
Paroxetine must not be used in children and adolescents under 18 years of age, as they are more likely to develop suicidal behaviour (suicide attempts and suicidal ideation) and hostility (mainly aggression, oppositional behaviour and anger). If, based on medical need, a decision is made to prescribe treatment anyway, the patient must be closely monitored for the emergence of suicidal symptoms.
Other medicines and Paroxetine Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Other medicines may affect the action of Paroxetine Teva or make side effects more likely. Paroxetine Teva may also interfere with the action of other medicines.
These include:
Medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide). See section “Do not take Paroxetine Teva”.
Medicines known to increase the risk of changes in the heart's electrical activity (e.g., the antipsychotics thioridazine or pimozide). See section “Do not take Paroxetine Teva” in this leaflet.
Acetylsalicylic acid, ibuprofen, and other medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) such as celecoxib, etodolac, diclofenac, meloxicam, and rofecoxib, used for pain and inflammation.
The painkillers tramadol and pethidine.
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 containing buprenorphine.
A dietary supplement called tryptophan.
Mivacurium and succinylcholine (used in anaesthesia).
Medicines such as lithium, risperidone, perphenazine, pimozide (called antipsychotics or neuroleptics) used to treat certain psychiatric disorders.
Fentanyl, used in anaesthesia or for treating 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, carbamazepine used to treat seizures or epilepsy.
Atomoxetine used to treat attention deficit hyperactivity disorder (ADHD).
Procyclidine used to relieve tremor, especially in Parkinson’s disease.
Warfarin or other medicines (called anticoagulants) used to thin the blood.
Propafenone, flecainide, and medicines used for irregular heartbeat.
Metoprolol, a beta-blocker used to treat high blood pressure and other heart problems.
Pravastatin, used to treat high cholesterol levels.
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 medicine from this list, and have not yet discussed it with your doctor, go back to your doctor and ask what to do. It may be necessary to adjust the dose or change the medicine.
Paroxetine Teva with food and drink
Do not drink alcohol while taking Paroxetine Teva. 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.
Pregnancy
In newborns whose mothers took Paroxetine Teva during the first months of pregnancy, there has been evidence of an increased risk of birth defects, particularly heart defects. You and your doctor will decide whether it is better for you to gradually discontinue Paroxetine Teva during pregnancy. However, depending on your clinical condition, your doctor may advise that it is better to continue taking Paroxetine Teva.
Make sure your midwife or doctor knows that you are taking Paroxetine Teva. When medicines such as Paroxetine Teva are taken during pregnancy, especially during the last three months of pregnancy, they may increase the risk of a serious condition in the baby called persistent pulmonary hypertension of the newborn (PPHN). In PPHN, the blood pressure in the blood vessels between the newborn’s heart and lungs is too high. If you take Paroxetine Teva during the last three months of pregnancy, your baby may also experience other symptoms, which usually appear within the first 24 hours after birth.
These symptoms include:
breathing difficulties;
bluish, too hot, or too cold skin;
blue lips;
vomiting or feeding difficulties;
lethargy, inability to sleep, or excessive crying;
stiff or floppy muscles;
tremors, nervousness, or seizures.
If your baby shows any of these symptoms at birth or if you are concerned about your baby’s health, contact your doctor or midwife who will advise you.
Pregnancy
If you take Paroxetine Teva near the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have bleeding disorders. Inform your doctor or midwife that you are taking Paroxetine Teva so they can advise you on what to do.
Breastfeeding
Paroxetine Teva may pass into breast milk in very small amounts. If you are taking Paroxetine Teva, go back to your doctor and talk to them before starting breastfeeding. You and your doctor can decide whether you can breastfeed while taking Paroxetine Teva.
Fertility
Paroxetine has been shown to reduce sperm quality. Although the impact on fertility is not known, fertility may be impaired in some men while taking Paroxetine Teva.
Driving and using machines
Possible side effects of Paroxetine Teva include dizziness, confusion, or blurred vision. If you experience these side effects, do not drive or operate machinery.
Paroxetine Teva contains benzoic acid
This medicine contains 2 mg of benzoic acid per 20 mg dose (28 drops). Benzoic acid may increase jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).
Paroxetine Teva contains alcohol (ethanol)
This medicine contains 4.69 mg of alcohol (ethanol) in each 20 mg dose (28 drops). The amount in 20 mg (28 drops) of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.

3. How to take Paroxetine Teva

Take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, consult your doctor or pharmacist.
Take Paroxetine Teva drops, diluted in water, in the morning with breakfast. Shake the bottle well
before use.
Mix the drops with 100 ml of plain water and then rinse the glass with another 100 ml of plain water and
drink it within one minute.
Your doctor will tell you the dose to take when you first start taking
Paroxetine Teva.
Most people start to feel better after a couple of weeks. If you do not start to feel better after this time,
inform your doctor, who may decide to gradually increase the dose, up to the maximum daily dose allowed.
The recommended doses for the different indications are:

Your doctor will inform you about the daily dose and how long you should take the medicine. This may be for several months or longer.

Use in children and adolescents
Paroxetina Teva must not be used in children and adolescents under 18 years of age because
its efficacy has not been demonstrated in these age groups. In addition, patients under 18 years of age have an increased risk of experiencing adverse effects such as suicidal thoughts and self-harm when taking Paroxetina Teva. If your doctor has prescribed Paroxetina Teva for you (or for your child) and you wish to discuss this, please consult your doctor again.

Elderly
The maximum recommended dose for people over 65 years of age is 4 ml per day.

Patients with liver or kidney disorders
If you have liver or kidney problems, your doctor may decide to adjust the dose of Paroxetina Teva compared to the usual dose.

If you take more Paroxetina Teva than you should
Do not take more Paroxetina Teva than recommended by your doctor.
If you take more Paroxetina Teva than prescribed, you may experience the symptoms listed in section 4 “Possible side effects” or develop one or more of the following symptoms: vomiting, dilated pupils, fever, changes in blood pressure, headache, involuntary muscle contractions, agitation, anxiety, and faster than normal heartbeat.
If you take more Paroxetina Teva than you should (or if someone else does), inform your doctor or go to hospital immediately, taking the medicine bottle with you.

If you stop taking Paroxetina Teva
Do not stop treatment with Paroxetina Teva unless your doctor tells you to do so.
When stopping treatment with Paroxetina Teva, your doctor will help you gradually reduce the dose over several weeks or months – this will help reduce the likelihood of withdrawal effects. One way to do this is to gradually reduce your dose of Paroxetina Teva by 10 mg per week.
Most people find that withdrawal symptoms from Paroxetina Teva are mild and disappear spontaneously within two weeks. For some people, these symptoms may be more severe or last longer.

If you experience withdrawal effects when stopping the drops, your doctor may decide to discontinue the medicine more slowly. If you experience severe withdrawal effects when stopping Paroxetina Teva, contact your doctor. Your doctor may advise you to restart the medicine and then stop treatment more gradually.
Despite withdrawal effects, you will still be able to discontinue Paroxetina Teva.
For the complete list of possible side effects during discontinuation of this medicine, see section 4 “Possible side effects”.

Possible withdrawal effects when stopping treatment
Common (may affect up to 1 in 10 people)
Dizziness, feeling unsteady or loss of balance.
Tingling, burning sensation and (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, difficulty falling asleep).
Anxiety.
Headache.

Uncommon (may affect up to 1 in 100 people)
Feeling unwell (nausea).
Sweating (including night sweats).
Restlessness or agitation.
Tremors.
Confusion or disorientation.
Diarrhoea (loose stools).
Emotional lability or irritability.
Visual disturbances.
Rapid heartbeat (palpitations).

Inform your doctor if you are concerned about these withdrawal effects when stopping treatment
with Paroxetina Teva.

What to do if you do not feel better
Paroxetina Teva will not improve your symptoms immediately – all antidepressants require time to take effect.
Some people start to feel better within a couple of weeks, while others may need more time. Some people taking antidepressants may feel worse before they begin to improve. If you do not feel better after a couple of weeks, consult your doctor, who will advise you accordingly.
Your doctor should review your condition a couple of weeks after you start treatment. Inform your doctor if you do not feel better.

If you have any 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 everybody gets them.
Side effects are more likely to occur during the first weeks of treatment with Paroxetina Teva.
Contact your doctor if you develop any of the following side effects during treatment.
You may need to contact your doctor or go to hospital immediately.

Allergic reactions to Paroxetina Teva, which can be serious.
Very rare (may affect up to 1 in 10,000 people)
If you develop skin rashes with redness and lumps, swelling of the eyelids, face, lips, mouth or tongue, sudden itching, or have difficulty breathing (shortness of breath) or swallowing, and if you feel weak or dizzy, leading to collapse or loss of consciousness, contact your doctor or go to hospital immediately.

Syndrome of inappropriate antidiuretic hormone secretion (SIADH).

Uncommon (may affect up to 1 in 100)
If you experience unusual bruising or bleeding, including blood in vomit or stools, contact your doctor or go to hospital immediately.
If you have difficulty urinating, contact your doctor or go to hospital immediately.

Rare (may affect up to 1 in 1,000)
If you have seizures (epileptic fits), contact your doctor or go to hospital immediately.
If you feel restless or unable to sit still or remain still, you may be experiencing a condition called akathisia. Increasing your dose of Paroxetina Teva could worsen these symptoms. If you feel this way, contact your doctor.
If you feel tired, weak or confused and have pain, stiffness or lack of coordination in your muscles, this could be due to a rare effect of Paroxetina Teva that may lead to low sodium levels in your blood. If you have these symptoms, contact your doctor.

Very rare (may affect up to 1 in 10,000)
Allergic reactions to Paroxetina Teva, which can be serious. If you develop skin rashes with redness and lumps, swelling of the eyelids, face, lips, mouth or tongue, sudden itching, or have difficulty breathing (shortness of breath) or swallowing, and if you feel weak or dizzy, leading to collapse or loss of consciousness, contact your doctor or go to hospital immediately.

If you have some or all of the following symptoms, you may be experiencing what is called serotonin syndrome or neuroleptic malignant syndrome. Symptoms include: confusion, restlessness, sweating, tremors, chills, hallucinations (strange visions or sounds), muscle stiffness, sudden muscle contractions, or rapid heartbeat.

Acute glaucoma.
If your eyes become painful and you experience blurred vision, contact your doctor.

Gastrointestinal bleeding.

Other possible side effects of lesser severity that may occur during treatment.

Very common (may affect more than 1 in 10 people)
Feeling unwell (nausea). Taking the medicine in the morning with breakfast will reduce the likelihood of these symptoms occurring.
Changes in sexual habits or sexual function. For example, lack of orgasm, and in men, abnormal erection and ejaculation.

Common (may affect up to 1 in 10 people)
Increased blood cholesterol levels.
Loss of appetite.
Sleep disturbances (insomnia) or drowsiness.
Abnormal dreams (including nightmares).
Dizziness or shaking (tremor).
Headache.
Difficulty concentrating.
Feeling agitated.
Feeling weak.
Blurred vision.
Yawning, dry mouth.
Diarrhoea or constipation.
Vomiting.
Weight gain.
Sweating.

Uncommon (may affect up to 1 in 100 people)
Transient increase or decrease in blood pressure, with dizziness or fainting when standing up suddenly.
Altered blood sugar control in diabetic patients.
Extrapyramidal disorders (movement disorders).
Faster than normal heartbeat.
Inability to move, stiffness, shaking, or abnormal movements of the mouth and tongue.
Pupil dilation.
Skin rashes, itching.
Feeling confused.
Hallucinations (strange visions and sounds).
Inability to urinate (urinary retention) or involuntary and uncontrollable loss of urine (urinary incontinence).
Reduced number of white blood cells.

Rare (may affect up to 1 in 1,000 people)
Abnormal milk production in the mammary glands of men and women.
Menstrual cycle disorders (including heavy menstrual flow, intermenstrual bleeding, amenorrhea, delayed menstruation, and irregular periods).
Slowed heartbeat.
Panic attacks.
Hyperactive behaviour or thoughts (mania).
Liver effects indicated by specific blood tests for liver function.
Feeling detached from oneself (depersonalization/derealization).
Feeling anxious.
Increased levels in the blood of a hormone called prolactin.
Irresistible urge to move the legs (Restless Legs Syndrome).
Joint or muscle pain.

Very rare (may affect up to 1 in 10,000 people)
Skin rash, which may present with blisters and resemble small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge), known as erythema multiforme.
Widespread skin rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome).
Widespread skin rash with blisters and peeling of the skin over a large part of the body (toxic epidermal necrolysis).
Severe skin reactions.
Syndrome of inappropriate antidiuretic hormone secretion (SIADH), a condition in which the body retains excess water and has reduced sodium (salt) concentration due to improper chemical signals. Patients with SIADH may become seriously ill or may have no symptoms at all.
Low platelet count in the blood.
Liver problems causing yellowing of the skin or whites of the eyes.
Fluid or water retention that may cause swelling of the arms or legs.
Liver effects indicated by specific blood tests for liver function.
Sensitivity to sunlight.
Prolonged and painful erection of the penis.
Unexpected bleeding, for example bleeding gums, blood in urine or vomit, or unexpected bruising or blood vessel rupture (vein rupture).

Frequency not known (frequency cannot be estimated from the available data)
Suicidal thoughts, suicidal behaviour and 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.
Teeth grinding.
Some patients have developed ringing, buzzing, hissing, whistling, or other persistent noises in the ear (tinnitus) when taking Paroxetina Teva.
An increased risk of bone fractures has been observed in patients taking this type of medicine.

If you have any concerns while taking Paroxetina Teva, speak with your doctor and/or pharmacist, who will be able to advise you.

Additional side effects in children and adolescents:
Common (may affect up to 1 in 10 people)
Increased suicidal thoughts and suicide attempts.
Deliberate self-harm.
Hostile, aggressive or detached behaviour.
Loss of appetite.
Tremor.
Abnormal sweating.
Hyperactivity (excessive energy).
Agitation.
Changes in emotions (including crying and mood changes).
Unusual bruising or bleeding (such as nosebleeds).
Withdrawal symptoms similar to those observed in adults after discontinuation of treatment with Paroxetina Teva.
Stomach ache.
Feeling nervous and changes in emotions (including crying and mood changes, self-harm attempts, suicidal thoughts and attempts).

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 https://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 Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle and the carton after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Store in the original packaging.
Shelf life after first opening of the bottle: 2 months.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Paroxetina Teva contains

• The active substance is paroxetine (10 mg/ml) as hemihydrate hydrochloride. Each ml of liquid (1 ml corresponds to 14 drops) contains 10 mg of paroxetine.
• The other components are povidone K30, benzoic acid E210, sucralose, curcumin 8% (E100), natural orange/lemon flavour, purified water.

Description of the appearance of Paroxetina Teva and contents of the pack
Paroxetina Teva 10 mg/ml is a clear yellow liquid.
It is available in a 60 ml amber glass bottle with a tamper-evident screw cap, child-resistant closure and dropper.
Marketing Authorisation Holder
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4
20123 Milan (MI)
Italy
Manufacturer
Doppel Farmaceutici S.r.l.
Via Volturno, 48
20089 Quinto de’ Stampi – Rozzano (MI)
Italy
Doppel Farmaceutici S.r.l.
Via Martiri delle Foibe, 1
29016 Cortemaggiore (PC)
Italy
Vamfarma S.r.l.
Via Kennedy, 5
26833 Comazzo (LO)
Italy