Paroxetine Doc Generici

Package leaflet: Information for the user

Paroxetina Doc 10 mg/ml, oral drops, solution

Equivalent 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 they have the same symptoms as you, because it could 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 Doc is and what it is used for
2. What you need to know before taking Paroxetina Doc
3. How to take Paroxetina Doc
4. Possible side effects
5. How to store Paroxetina Doc
6. Contents of the pack and other information

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

Paroxetina Doc contains the active substance paroxetine, an antidepressant which 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 Doc and other SSRIs work, but they may help by increasing the level 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 Doc 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 need to know before taking Paroxetina Doc

Do not take Paroxetina Doc

• If you are currently 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 Paroxetina Doc after stopping the MAOI.
• 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).

If any of these apply to you, speak with your doctor before taking Paroxetina Doc.
Warnings and precautions
Talk to your doctor or pharmacist before taking Paroxetina Doc
If you are taking other medicines (see “Other medicines and Paroxetina Doc”). If you have eye, kidney, liver, or heart problems.
If you are taking tamoxifen for the treatment of breast cancer or fertility issues, Paroxetina Doc may make tamoxifen less effective; therefore, your doctor might recommend taking another antidepressant.
If you have epilepsy or have had seizures or convulsions.
If you have episodes of mania (manic behaviors or thoughts).
If you are undergoing 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 within this leaflet Pregnancy, breastfeeding and fertility).
If you are under 18 years of age.

Medicines like Paroxetina Doc (so-called SSRIs/SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms may persist after discontinuation of treatment.
If you answer YES to any of these questions, and have not already discussed them with your doctor,
contact your doctor and ask what to do about taking Paroxetina Doc.
Suicidal thoughts and worsening of depression or anxiety disorder
If you are depressed and/or have anxiety disorders, you may occasionally have self-harming or suicidal thoughts.
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 such thoughts:
If you have previously had suicidal or self-harming thoughts.
If you are a young adult. Adults under 25 years of age with psychiatric disorders treated with an antidepressant have shown an increased risk of suicidal behavior. If at any time you experience suicidal or self-harming thoughts, contact your doctor or go immediately to hospital.
You may find it helpful to talk to a friend or relative about your depression or anxiety disorder and ask them to read this leaflet. You may ask them to inform you if they believe your depression or anxiety is worsening or if they are concerned about changes in your behavior.
If you experience restlessness, agitation, or inability to sit or stand still, usually associated with subjective 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 elevated body temperature, muscle rigidity, sudden muscle contractions (myoclonus), fluctuation of vital signs, changes in mental status including confusion, irritability, extreme restlessness progressing to delirium and coma. These syndromes may lead to potentially life-threatening conditions; if these events occur, paroxetine must be discontinued and symptomatic supportive treatment should be initiated.
If you develop manic behavior. In this case, you must stop treatment.
If you have liver or kidney problems, your doctor may need to adjust the dosage.
If you have diabetes.
If you suffer from or have ever suffered from high eye pressure (glaucoma).
If you are elderly, taking other medicines, or have liver problems, as these may reduce sodium levels in the blood (hyponatremia).
If you have an increased tendency to bleed. Caution is advised if you are concurrently 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).
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 PAROXETINA DOC”).
If any of these apply to you, speak with your doctor.
Children and adolescents
Paroxetina Doc 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 behaviors (suicide attempts and suicidal ideation) and hostility (mainly aggression, oppositional behavior, and anger). If, based on medical necessity, a decision is made to prescribe treatment, the patient must be closely monitored for the emergence of suicidal symptoms.
Other medicines and Paroxetina Doc
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Other medicines may affect the action of Paroxetina Doc or make side effects more likely. Paroxetina Doc may also interfere with the action of other medicines.
These include:
Medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide).
See section “Do not take Paroxetina Doc”.
Thioridazine or pimozide, which are antipsychotic medicines. See section “Do not take Paroxetina Doc” 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 anesthesia).
Medicines such as lithium, risperidone, perphenazine, pimozide (called antipsychotics or neuroleptics) used to treat certain psychiatric disorders.
Fentanyl, used in anesthesia 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 tremors, 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, contact your doctor and ask what to do. It may be necessary to adjust the dosage or change the medicine.
Paroxetina Doc with food and drink
Do not drink alcohol while taking Paroxetina Doc. Alcohol may worsen your symptoms or side effects.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
In newborns whose mothers took Paroxetina Doc 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 best for you to gradually discontinue Paroxetina Doc during pregnancy. However, based on your clinical condition, your doctor may advise you that it is better to continue taking Paroxetina Doc.
Ensure that your midwife or doctor knows that you are taking Paroxetina Doc. When medicines like Paroxetina Doc are taken during pregnancy, especially during the last three months, 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 Paroxetina Doc 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 or abnormally hot or 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 Paroxetina Doc 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 Paroxetina Doc so they can advise you on what to do.
Breastfeeding
Paroxetina Doc may pass into breast milk in very small amounts. If you are taking Paroxetina Doc, consult your doctor before starting breastfeeding. You and your doctor can decide whether you can breastfeed while taking Paroxetina Doc.
Fertility
Paroxetine has been shown to reduce sperm quality. Although the impact on fertility is unknown, fertility may be impaired in some men while taking Paroxetina Doc.
Driving and using machines
Possible side effects of Paroxetina Doc include dizziness, confusion, or blurred vision. If you experience these side effects, do not drive and do not operate machinery.
Paroxetina Doc contains benzoic acid
Benzoic acid may increase jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

3. How to take Paroxetine Doc

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Take Paroxetine Doc oral drops, diluted in water, in the morning with breakfast.
Mix the drops with 0.35 oz (100 ml) of plain water and then rinse the glass with another 0.35 oz (100 ml) of plain water and
drink it within one minute.
Your doctor will tell you which dose to take when you first start taking
Paroxetine Doc.
Most people begin 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 allowed daily dose.
The recommended doses for different indications are listed below:

Your doctor will advise you on 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 Doc must not be used in children and adolescents under 18 years of age because it has not been shown to be effective 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-harming behaviour when taking Paroxetina Doc. If your doctor has prescribed Paroxetina Doc for you (or your child) and you wish to discuss this, please consult your doctor again.

Elderly
The maximum recommended dose for people aged over 65 years 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 Doc from the usual dose.

If you take more Paroxetina Doc than you should
Do not take more Paroxetina Doc than your doctor has recommended.
If you take more Paroxetina Doc than you should, you may experience the symptoms listed in Section 4, Possible side effects, or develop one of the following symptoms: vomiting, dilated pupils, fever, changes in blood pressure, headache, involuntary muscle contractions, agitation, anxiety, and abnormally rapid heartbeat.
If you take more Paroxetina Doc than you should (or someone else does), inform your doctor or go to hospital immediately, and take the medicine bottle with you.

If you stop taking Paroxetina Doc
Do not stop treatment with Paroxetina Doc unless your doctor tells you to.
When stopping treatment with Paroxetina Doc, 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 by gradually reducing your dose of Paroxetina Doc by 10 mg per week.

Most people find that withdrawal symptoms from Paroxetina Doc are mild and disappear spontaneously within two weeks. For some people, these symptoms may be more severe or last longer.

If you experience withdrawal symptoms when stopping the drops, your doctor may decide to stop the medicine more slowly. If you experience severe withdrawal symptoms when stopping Paroxetina Doc, contact your doctor. Your doctor may advise you to restart the medicine and then stop treatment more gradually.

Despite withdrawal symptoms, you will still be able to discontinue Painnox. For a 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 sensations, 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
Tremor
Confusion or disorientation
Diarrhoea (loose stools)
Emotional lability or irritability
Vision disturbances
Rapid heartbeat (palpitations)

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

What to do if you do not feel better
Paroxetina Doc will not improve your symptoms immediately—like all antidepressants, it takes time to work.
Some people begin to feel better within a couple of weeks, while others may need more time. Some people taking antidepressants may feel worse before they start to improve. If you do not feel better after a couple of weeks, see your doctor, who will advise you accordingly.

Your doctor should review you a few 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 will experience them.
Side effects are more likely to occur during the first weeks of treatment with Paroxetina Doc.
Contact your doctor if you experience any of the following side effects during treatment:
You may need to contact your doctor or go to hospital immediately.

Allergic reactions to Paroxetina Doc, which may be severe.
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, start 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 people)
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 people)
If you have seizures (epileptic fits), contact your doctor or go to hospital immediately.
If you feel restless or unable to sit still, you may be experiencing a condition called akathisia. Increasing your dose of Paroxetina Doc could worsen these symptoms. If you feel this way, contact your doctor.
If you feel tired, weak or confused and have muscle pain, stiffness or incoordination, this could be due to a rare effect of Paroxetina Doc 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 people)
Allergic reactions to Paroxetina Doc, which may be severe. If you develop skin rashes with redness and lumps, swelling of the eyelids, face, lips, mouth or tongue, start 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 serotonin syndrome or neuroleptic malignant syndrome. Symptoms include: confusion, restlessness, sweating, tremors, chills, hallucinations (strange visions or sounds), muscle rigidity, 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 (tremors)
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
Impaired control of blood sugar levels 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)

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 menorrhagia, metrorrhagia, amenorrhoea, delayed menstruation, and irregular periods)
Slower heartbeat
Panic attacks
Hyperactive behaviour or thoughts (mania)
Liver effects indicated by specific blood tests for liver function
Feeling detached from oneself (depersonalization)
Feeling anxious
Increased blood levels 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 centres 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 too much water and sodium levels (salt) decrease due to improper chemical signals. Patients with SIADH may become seriously ill or may have no symptoms
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 broken blood vessels (rupture of veins)

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) while taking Paroxetina Doc.
An increased risk of bone fractures has been observed in patients taking this type of medicine.

If you have any concerns while taking Paroxetina Doc, speak with your doctor and/or pharmacist, who can 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 (having too much energy)
Agitation
Emotional changes (including crying and mood changes)
Unusual bruising or bleeding (such as nosebleeds)
Withdrawal symptoms similar to those observed in adults after stopping treatment with Paroxetina Doc
Stomach ache
Feeling nervous and emotional changes (including crying and mood changes, attempts of self-harm, suicidal thoughts and suicide 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 Doc

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and outer carton following
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.
Period of validity 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 in use. This will help protect the environment.

6. Package contents and other information

What Paroxetina Doc 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 Doc and the contents of the pack
Paroxetina Doc 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 Authorization Holder
Doc Generici S.r.l.
Via Filippo Turati, 40
20121 Milan
Italy

Manufacturer
Doppel Farmaceutici S.r.l.
Via Volturno, 48
20089 Quinto de’ Stampi – Rozzano
(Milan) – Italy
Doppel Farmaceutici S.r.l.
Via Martiri delle Foibe, 1
29016 Cortemaggiore (PC)
Italy

This medicinal product is authorized in the European Economic Area countries under the following names:
Malta: Paroxetina DOC 10 mg/ml oral drops, solution
Italy: Paroxetina Doc