Package Leaflet: Information for the User

Paroxetina Davurgama 20 mg Film-Coated Tablets EFG

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

• Keep this leaflet, as 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 others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4

Paroxetina is used for the treatment of depression and/or anxiety disorders in adults.The anxiety disorders for which this medication is indicated are: obsessive-compulsive disorder (repetitive, obsessive thoughts with uncontrolled behavior), anxiety disorder (panic crises, including those caused by agoraphobia, which is the fear of open spaces), social anxiety disorder (fear or avoidance of social contact situations), post-traumatic stress disorder (anxiety caused by a traumatic event), and generalized anxiety disorder (feeling normally a lot of anxiety and nervousness).

Paroxetina belongs to a group of medications called selective serotonin reuptake inhibitors (SSRIs). The exact mechanism of action of this medication and other SSRIs is not precisely known, but they exert their action by increasing the level of serotonin in the brain. Treating depression or anxiety disorders properly is important to help you feel better.

Do not take Paroxetina Davurgama

• If you are being treated with medications called monoamine oxidase inhibitors(MAOIs, including moclobemide and methionine chloride (methylen blue)), or if you have been treated with any of these medications in the last two weeks. Your doctor will advise you on how to start taking paroxetina once you have stopped taking the MAOI.
• If you are taking an antipsychotic medicationcalled thioridazine or the antipsychotic called pimozide.
• If you are allergicto paroxetina, soy or peanuts or to any of the other components of this medication (listed in section 6).

If you are in any of these situations,inform your doctor and do not take this medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to takeparoxetina

• If you are taking other medications (see the section Other Medications and Paroxetina Davurgama),
• If you are taking tamoxifen for breast cancer (or fertility problems). Paroxetina may make tamoxifen less effective, so your doctor should recommend another antidepressant
• If you have any kidney, liver or heart problems
• If you have a heart condition known as prolonged QT interval after an electrocardiogram (ECG)
• If you have a family history of prolonged QT interval, heart diseases such as heart failure, low heart rate or low levels of potassium or magnesium
• If you have epilepsy or if you experience seizures or convulsions
• If you have had manic episodes (excessively active thoughts or behaviors)
• If you are being treated with electroconvulsive therapy (ECT)
• If you have a tendency to bleed or bruise, or if you are being treated with any medication that may increase the risk of bleeding (including medications such as warfarin (acenocoumarol), antipsychotics such as perphenazine or clozapine, tricyclic antidepressants, pain and anti-inflammatory medications called nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam)
• If you have diabetes
• If you are on a low-sodium diet
• If you have glaucoma (high eye pressure)
• If you are pregnant or if you think you may become pregnant (see the section Pregnancy, breastfeeding and fertility)
• If you are under 18 years of age (see the section Children and adolescents under 18 years of age).

If your answer is YES to any of these situationsand you have not yet consulted your doctor, go to your doctor and ask about how to take paroxetina.

Childrenand adolescentsunder 18 years of age

Paroxetina should not be used in the treatment of children and adolescents under 18 years of age.

Also, you should know that in patients under 18 years of age, there is a higher risk of adverse effects such as suicidal thoughts, suicidal ideation and hostility (predominantly aggression, confrontational behavior and irritability) when taking paroxetina. If your doctor has prescribed paroxetina to you (or your child) and you want to discuss this decision, consult your doctor. You should inform your doctor if any of the symptoms listed above appear or worsen when you (or your child) are taking this medication. The long-term effects on safety, related to growth, maturation and cognitive and behavioral development in this age group have not yet been demonstrated.

In studies conducted with paroxetina in patients under 18 years of age, the frequent adverse effects, affecting less than 1 in 10 children/adolescents, were: an increase in thoughts and attempts of suicide, self-mutilation, hostile, aggressive or unfriendly behaviors, loss of appetite, tremors, abnormal sweating, hyperactivity (having too much energy), agitation, unstable emotions (including crying and mood changes) and the appearance of fortuitous cardinals or bleeding (such as nasal bleeding). These effects were also observed in children/adolescents included in these studies who were taking (placebo), instead of paroxetina, although with lower frequency.

When discontinuing paroxetina treatment in these studies, some of the patients under 18 years of age reported adverse effects of withdrawal. These effects were very similar to those observed in adults who discontinued paroxetina treatment (see section 3). In addition, patients under 18 years of age frequently (affecting less than 1 in 10) experienced stomach pain, nervousness and unstable emotions (including crying, mood changes, self-mutilation, thoughts and attempts of suicide).

Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming yourself or committing suicide. These may increase at the beginning of treatment with antidepressants, as all these medications take time to take effect, which is usually two weeks but can be longer.

This is more likely to happen:

• If you have previously had thoughts of suicide or self-harm.
• If you are anadult young person. There is information from clinical trials that shows an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders who were being treated with some antidepressant.

If you have thoughts of harming yourself or committing suicide at any time,consult your doctor or go to the hospital immediately.

It may be helpful for you to explain to a family member or close friendthat you are depressed or have anxiety disorders, and ask them to read this leaflet. You can also ask them to tell you if they think your depression or anxiety is getting worse, or if they are concerned about changes in your behavior.

Important adverse effects observed with paroxetina

Some patients taking paroxetina develop a condition called akathisia, and feelrestless and unable to sit or stay still. Other patients develop the so-calledserotonin syndrome or malignant neuroleptic syndrome, and may have any or all of the following symptoms: feeling very agitated or irritable, confusion, restlessness, sensation of heat, sweating, tremors, chills, hallucinations (strange visions or sounds), muscle rigidity, sudden, brief movements or increased heart rate. The severity can increase and lead to loss of consciousness.Consult your doctorif you have any of these symptoms. For more information on this or other adverse effects of paroxetina, see section 4.

Some medications in the group to which paroxetina belongs (called SSRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after discontinuing treatment.

Other medications and Paroxetina Davurgama

Some medications may modify the effect of paroxetina or make it more likely for some adverse effects to occur. Paroxetina may also modify the effect of some medications. For example:

• Medications calledmonoamine oxidase inhibitors(MAOIs, including moclobemide and methionine chloride (methylen blue)). See the sectionDo not take Paroxetina Davurgama
• Medications known to increase the risk of changes in heart electrical activity (e.g. theantipsychoticstioridazine or pimozide). See the sectionDo not takeParoxetina Davurgama.
• Aspirin, ibuprofen and other medications called nonsteroidal anti-inflammatory drugs (NSAIDs) such as celecoxib, etodolac, diclofenac and meloxicam, used to treatpain and inflammation
• Tramadol, buprenorphine and petidina,analgesics
• Buprenorphine combined with naloxone, treatment for opioid addiction
• Medications called triptans, such as sumatriptan, used to treatmigraine
• Otherantidepressants, including other selective serotonin reuptake inhibitors and tricyclic antidepressants such as clomipramine, nortriptyline and desipramine.
• Adietary supplementcalled tryptophan.
• Mivacurio and suxamethonium (used in anesthesia).
• Medications such as lithium, risperidone, perphenazine, clozapine (antipsychotics) used to treat somepsychiatric disorders
• Fentanyl, used inanesthesiaor to treatchronic pain
• A combination of fosamprenavir and ritonavir, used to treathuman immunodeficiency virus (HIV) infection
• St. John's Wort, a medicinal herb to treatdepression
• Phenobarbital, phenytoin, sodium valproate or carbamazepine, used to treatseizures or epilepsy
• Atomoxetine, medication used to treatattention deficit hyperactivity disorder (ADHD)
• Procyclidine, used to relieve tremor, especially inparkinson's disease
• Warfarin and other medications (called anticoagulants) used tothin the blood
• Propafenone, flecainide and medications used to treatcardiac arrhythmias
• Metoprolol, a beta-blocker used to treathigh blood pressure and cardiac disorders
• Pravastatin, used to treathigh cholesterol
• Rifampicin, used to treattuberculosis (TB) and leprosy
• Linezolid, anantibiotic
• Tamoxifen, used to treatbreast cancer(orfertility problems)

If you are taking or have taken recently any of these medications, inform your doctor and consult what to do.You may need to change the dose or have another medication prescribed.

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication,including those acquired without a prescription.

Paroxetina Davurgama with food, drinks and alcohol

Do not consume alcohol while taking this medication. Alcohol may worsen your symptoms or adverse effects.

Taking this medication in the morning with food may reduce the likelihood of nausea.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or if you think you may become pregnant, consult your doctor or pharmacist before using this medication.

In some studies, an increased risk of malformations, particularly those affecting the heart, was observed in newborns whose mothers took paroxetina during the first months of pregnancy. In the general population, approximately 1 in 100 newborns are born with a heart malformation. This proportion increased to 2 in 100 newborns in mothers who took paroxetina. Your doctor, in consultation with you, may change your medication or gradually discontinue paroxetina treatment while pregnant. However, depending on your circumstances, your doctor may recommend continuing to take this medication.

Make sure your doctor or midwife knows that you are taking paroxetina. If you take this medication in the final stages of pregnancy, there may be an increased risk of excessive vaginal bleeding after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking this medication to advise you.

Medications like paroxetina may increase the risk of a serious condition called persistent pulmonary hypertension of the newborn (PPHN) when taken during pregnancy and particularly in the last stages of pregnancy. The pressure in the blood vessels between the heart and lungs is very high in newborns with PPHN. If you are taking this medication in the last trimester of pregnancy, your newborn may also experience other symptoms that usually begin within the first 24 hours after birth. These symptoms include:

• Difficulty breathing
• Blue skin or appearance of being very hot or cold
• Blue lips
• Vomiting or difficulty feeding
• Feeling very tired, difficulty sleeping or frequent crying
• Muscle stiffness or flaccidity
• Tremors, localized tremors or seizures
• Exaggerated reflexes.

If your baby has 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.

Paroxetina passes into breast milk in very small amounts.Consult your doctor if you are taking this medication before starting to breastfeed. Your doctor, in consultation with you, may advise you to continue breastfeeding while taking this medication.

Studies in animals have shown that paroxetina reduces sperm quality. Theoretically, this may affect human fertility, but this impact has not yet been observed in humans.

Driving and operating machinery

Some of the adverse effects that this medication may cause are dizziness, confusion, feeling drowsy or blurred vision. If you experience any of these effects, do not drive vehicles or operate machinery.

Paroxetina Davurgama contains sodium

This medication contains less than 1mmol of sodium (23 mg) per tablet; it is essentially "sodium-free"

Paroxetina Davurgama contains soy lecithin

This medication contains soy lecithin (derived from soy oil). Do not take this medication if you are allergic to peanuts or soy.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Sometimes you may need to take more than one tablet or half a tablet. The following table will show you how many tablets to take:

The usual doses for different indications are detailed in the following table:

Your doctor will tell you what dose to take when you start treatment with paroxetine.Most people start to feel better after a couple of weeks. If you don't start to feel better after this time, consult your doctor who will tell you what to do. Your doctor may decide to gradually increase the dose, in increments of 10 mg, up to the maximum daily dose.

Take the tablets in the morning, with food.

The tablets should be swallowed with water.

The tablets should not be chewed.

The groove serves to divide the tablet into equal doses.

Your doctor will tell you the duration of treatment. This period may be extended for several months or even longer.

Older patients

The maximum dose for people over 65 is 40 mg per day.

Patients with kidney or liver problems

If you have severe liver or kidney failure, your doctor may advise you to take smaller doses of paroxetine than usual.

If you take too much paroxetine

Never take more tablets than your doctor has recommended. If you take too many paroxetine tablets (or someone else does), consult your doctor or go to the hospital immediately. Show them the packaging of the tablets.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

A person who has taken an overdose of paroxetine may have some of the symptoms listed in section 4, Possible side effects, or some of the following symptoms: fever, involuntary muscle contraction.

If you forget to take Paroxetine Davurgama

Take your medication at the same time every day.

If you forget to take a dose and remember before bedtime, take it immediately. Take the next dose at the usual time.

If you remember during the night or the next day, omit the missed dose. You may experience some withdrawal symptoms, but they should disappear after taking the next dose at the usual time.

Do not take a double dose to compensate for the missed doses.

What to do if you don't feel better

Paroxetine will not improve your symptoms immediately. All antidepressants take time to work. Some people start to feel better after a couple of weeks, but others may need more time. Some people who take antidepressants feel worse before they start to notice improvement. If you don't start to feel better after a couple of weeks, tell your doctor, who will tell you what to do. Your doctor may have scheduled a follow-up appointment for two weeks after starting treatment. Consult your doctor if you haven't started to feel better.

Stopping treatment with paroxetine

Do not stop treatment until your doctor tells you to.

When stopping treatment with paroxetine, your doctor will tell you how to gradually reduce the dose over a period of several weeks or months. This will help reduce the risk of withdrawal symptoms. One way to do this is to gradually reduce the dose of paroxetine you are taking by 10 mg each week. Most people consider the possible symptoms that occur when stopping treatment with this medication to be mild and disappear on their own in two weeks. For some people, these symptoms may be more severe or last longer.

If you experience withdrawal symptoms while stopping treatment, your doctor may decide to stop treatment more gradually. If you experience severe withdrawal symptoms, please consult your doctor. They may advise you to start treatment again and then stop it more gradually.

Although you may experience some withdrawal symptoms, you can still stop treatment with paroxetine.

Possible withdrawal effects when stopping treatment

Studies have shown that 3 out of 10 patients experience one or more symptoms when they stop taking paroxetine. Some of these effects occur more frequently than others.

Common side effects

May affect up to 1 in 10 people

• Feeling dizzy, unstable, or experiencing balance problems.
• Tickling, burning sensations, and, less frequently, a feeling of electric discharge, even in the head, ringing, buzzing, beeping, or other persistent sounds in the ears (tinnitus).
• Sleep disturbances (vivid dreams, nightmares, inability to sleep).
• Anxiety.
• Headaches.

Uncommon side effects

May affect up to 1 in 100 people

• Nausea (vomiting).
• Sweating (including night sweats).
• Restlessness or agitation.
• Tremors.
• Confusion or disorientation.
• Diarrhea (soft stools).
• Feeling very sensitive or irritable.
• Visual disturbances.
• Palpitations (rapid or strong heartbeats).

Consult your doctor if you are concerned about withdrawal symptoms from paroxetine.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.It is more likely that side effects will occur during the first few weeks of treatment with this medicine.

Inform your doctor if you experience any of the side effects described below during treatment

You may need to see your doctor or go to the hospital immediately

Frequent side effects

May affectmore than 1 in 10 people

• If you have unusual bruising or bleeding, such as blood in your vomit or stools, contact your doctor or go to the hospital immediately.
• If you experience difficulty urinating, contact your doctor or go to the hospital immediately.

Common side effects

May affectup to 1 in 10 people

• Increased levels of cholesterol in the blood.
• Loss of appetite.
• Difficulty sleeping (insomnia) or drowsiness.
• Abnormal dreams (including nightmares).
• Dizziness, tremors.
• Headache.
• Difficulty concentrating.
• Restlessness.
• Unusual weakness.
• Blurred vision.
• Yawning, dry mouth.
• Diarrhea or constipation.
• Vomiting.
• Weight gain.
• Sweating.

Uncommon side effects

May affectup to 1 in 100 people

• Transient increases in blood pressure, or transient decreases in blood pressure that may cause dizziness or fainting when standing up quickly.
• Abnormal heart rhythms.
• Lack of movement, stiffness, tremors, or abnormal movements of the mouth and tongue.
• Pupil dilation.
• Skin rash.
• Itching.
• Confusion.
• Alucinations (strange sounds or visions).
• Decreased white blood cell count.
• Difficulty urinating (urinary retention) or incontinence (uncontrolled and involuntary urination).
• If you are a diabetic patient, you may notice a loss of control of blood sugar levels while taking this medicine. Consult your doctor about how to adjust your insulin or diabetes medication dose.

Rare side effects

May affectup to 1 in 1,000 people

• Abnormal secretion of breast milk in men and women.
• Decreased heart rate.
• Liver function abnormalities that are seen in laboratory tests that indicate liver function.
• Panic attacks.
• Very active or agitated behavior (mania).
• Feeling disconnected from oneself (derealization).
• Anxiety.
• Irresistible urge to move the legs (Restless Legs Syndrome).
• Muscle or joint pain.
• Increased levels of a hormone called prolactin in the blood.
• Changes in menstrual cycle (including heavy or irregular periods, bleeding between periods, and absence or delay of period).

Very rare side effects

May affectup to 1 in 10,000 people

• Skin rash, with small, round, red spots (erythema multiforme).
• Widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).
• Widespread rash with blisters and peeling of the skin (toxic epidermal necrolysis).
• Liver function abnormalities that turn the skin or the white of the eyes yellow.
• Syndrome of inappropriate antidiuretic hormone secretion (SIADH), which is a condition in which the body develops an excess of water and a decrease in sodium concentration due to inappropriate chemical signals. SIADH patients may feel severely ill or have no symptoms.
• Water retention or fluid accumulation (causing swelling of arms or legs).
• Sensitivity to sunlight.
• Prolonged and painful erection of the penis.
• Decreased platelet count in the blood.

Unknown frequency

The frequency cannot be estimatedfrom the available data

• Colitis (inflammation of the colon, causing diarrhea).
• Grinding of teeth.

Some patients have experienced persistent ringing, buzzing, beeping, or other sounds in the ears (tinnitus) when taking paroxetine.

It has been observed that people taking this type of medication have a higher risk of bone fractures.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister or bottle and on the packaging after CAD. The expiration date is the last day of the month indicated.

If you are taking a half tablet, be careful to store it safely in the packaging

This medication does not require special storage conditions.

Medications should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Paroxetina Davurgama

• The active ingredient is paroxetine.

Each 20 mg tablet contains 20 mg of paroxetine (as paroxetine hydrochloride).

• The other components are mannitol, microcrystalline cellulose, sodium carboxymethylcellulose Type A (from potato), magnesium stearate.
• The coating contains: basic copolymer of butyl methacrylate, partially hydrolyzed polyvinyl alcohol (E1203), titanium dioxide (E171), talc (E553b), soy lecithin (E322), and xanthan gum (E415)

Appearance of the product and contents of the package

The tablets are white, round, coated, biconvex, 10 mm in diameter, scored on one side and printed on the other with P20.

The score serves to divide the tablet into equal doses.

It is presented in blister packs of 10, 14, 20, 28, 30, 50, 56, 60, 98 or 100 coated tablets, and in pre-cut blister packs of 10x1, 14x1, 20x1, 28x1, 30x1, 50x1, 56x1, 60x1, 98x1 or 100x1 coated tablets, and in bottles of 28, 56, 100 or 250 coated tablets.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

Teva B.V.,

Swensweg 5,

2031GA Haarlem,

Netherlands

Local representative

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108 - Madrid

Spain

Responsible for manufacturing:

Teva Pharma, S.L.U.

Polígono Malpica C/ C, 4.

50016 Zaragoza

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Denmark: Paroxetin Teva B.V.

Spain: Paroxetina Davurgama 20 mg coated tablets EFG

Portugal: Paroxetina Refta

Last review date of this leaflet: February 2024

Other sources of information

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/