Package Leaflet: Information for the User

Paroxetine hydrochloride hemihydrate 20 mg film-coated tablets

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 pass it on to others even if their symptoms are the same as yours. It may harm them.

-If you experience any side effects, talk to your doctor or pharmacist. See section 4.

Paroxetine is used for the treatment of depression and/or anxiety disorders in adults.

Anxiety disorders for which paroxetine 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).

Paroxetine belongs to a group of medications called selective serotonin reuptake inhibitors (SSRIs). We all have a substance called serotonin in the brain. People who are depressed or have anxiety have lower levels of this substance. The exact mechanism of action of paroxetine 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 cinfa

• Si is allergicto paroxetina or to any of the other components of this medication (listed in section 6).
• This medication contains soy oil. It should not be used in case of an allergy to peanuts or soy.
• If you are being treated with medications called monoamine oxidase inhibitors(MAOIs, including moclobemida and cloruro de metiltionina (azul de metileno)), or if you have been under treatment with any of these medications in the last two weeks. Your doctor will advise you how to start taking paroxetina once you have stopped taking the MAOI.
• If you are taking an antipsychotic medicationcalled tioridazina or the antipsychotic medication called pimozida.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take paroxetina cinfa:

• if you are taking other medications (see the section“Other medicationsand paroxetina cinfa”)
• if you are taking tamoxifeno for the treatment of breast cancer (or fertility problems). Paroxetina may make tamoxifeno less effective, so your doctor should recommend you take another antidepressant
• if you have any kidney, liver, or heart problems
• if you have epilepsy or if you have seizures or convulsions
• if you have had manic episodes (excessively active thoughts or behaviors)
• if you are being treated with electro-convulsive therapy (ECT)
• if you have a tendency to bleed or to develop hematomas, or if you are being treated with any medication that may increase the risk of hemorrhage (including medications such as warfarina (acenocumarol), antipsychotics like perphenazine or clozapine, antidepressants like tricyclic antidepressants, medications for pain and inflammation called nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam) or if you are pregnant (see“Pregnancy, breastfeeding, and fertility”)
• if you have diabetes
• if you are on a low-sodium diet
• if you have glaucoma (elevated 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 you are in any of these situationsand have not yet consulted your doctor,ask your doctor about how to take paroxetina.

Some medications in the group to which paroxetina cinfa belongs (called ISRS/IRSN) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Childrenand adolescentsunder 18 years of age

Paroxetina should not be used in the treatment of children and adolescents under 18 years of age.Furthermore, you should know that in patients under 18 years of age, there is a higher risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking paroxetina. Despite this, your doctor may prescribe paroxetina to patients under 18 years of age when they decide what is best for the patient. If your doctor has prescribed paroxetina to you or to your child under 18 years of age and you want to discuss this decision, consult your doctor. You should inform your doctor if any of the symptoms mentioned above appear orget worsewhen you or your child under 18 years of age are taking paroxetina. The long-term effects of paroxetina on safety, related to growth, maturity, 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, which may affect up to 1 in 10 children or adolescents, were: an increase in thoughts and suicide attempts, self-harm attempts, 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 patients included in these studies who did not take paroxetina, although less frequently.

When stopping treatment with paroxetina, some of the patients under 18 years of age in these studies reported having withdrawal effects.These effects were very similar to those observed in adults who stopped taking paroxetina (see the section“How to take paroxetina cinfa”). In addition, patients under 18 years of age frequently (may affect up to 1 in 10) experienced stomach pain, nervousness, and unstable emotions (including crying, mood changes, self-harm attempts, thoughts and suicide attempts).

Suicidal thoughtsand worsening of your depression or anxiety

Ifyou aredepressed and/orhaveanxiety disorders,you may have thoughts ofharming yourselforsuiciding. These may increaseat the beginning of treatment withantidepressants, as all these medications take timeto take effect,which is usuallyabout two weeksbut sometimes may be longer.

This is more likely to happen

• ifyou have already had previously thoughts ofsuiciding orharming yourself.
• if you are anadult young person. There is information from clinical trialsthat shows there isa higher risk of suicidal behaviors in adults under 25 years of age with psychiatric illnesses thatare beingtreated withsomeantidepressant.

If you have thoughts ofharming yourselforsuiciding at any time,consult your doctor or go to the hospital immediately.

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

Important side effects observed with paroxetina

Some patients who take paroxetina develop a disorder called akathisia, andfeel restless and cannot sit or stay still.Other patients develop the so-calledserotonin syndromeor malignant neuroleptic syndrome, and may have one or more of the following symptoms:feeling very agitated or irritable,confusion, restlessness,sensation of heat,sweating, tremors, chills, hallucinations (strange visions or sounds),muscle rigidity,brusque sudden movements or increased heart rate.The severity may increase and lead to loss of consciousness.

Consult your doctorif you have any of these symptoms. For more information about this or other side effects of paroxetina, see section 4,“Possible side effects”, in this leaflet.

Other medications and paroxetina cinfa

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

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

• Medications calledmonoamine oxidase inhibitors(MAOIs, including moclobemida and cloruro de metiltionina (azul de metileno)). See the section“Do not take paroxetina cinfa”.
• The medications called tioridazina or pimozida, which areantipsychotics. See the section“Do not take paroxetina cinfa”.
• Aspirin, ibuprofen, and other medications called nonsteroidal anti-inflammatory drugs (NSAIDs) such as celecoxib, etodolac, diclofenac, and meloxicam, used to treatpain and inflammation.
• Tramadol and petidina,analgesics.
• 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 illnesses.
• 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 treatseizuresorepilepsy.
• Atomoxetine, a medication used to treatattention deficit hyperactivity disorder (ADHD).
• Procyclidine, used to alleviate tremor, especially inParkinson's disease.
• Warfarin and other medications (called anticoagulants) used tothin the blood.
• Propafenone, flecainide, and medications used to treatheart rhythm disorders.
• Metoprolol, a beta-blocker used to treathigh blood pressureand heart disorders.
• Pravastatin, used to treathigh cholesterol.
• Rifampicin, used to treattuberculosis (TB)and leprosy.
• Linezolid, anantibiotic.
• Tamoxifen, used totreat breast cancer(orfertility problems).

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

Paroxetina cinfa with food, drinks, and alcohol

Do not consume alcohol while taking paroxetina. Alcohol may worsen your symptoms or side effects.

Take paroxetina in the morning with food, which 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, there has been an increase in the risk of malformations,particularly those affecting the heart,in newborns whose mothers took paroxetina during the first months of pregnancy.About 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 stop taking paroxetina while pregnant. However, depending on your circumstances, your doctor may recommend continuing to take paroxetina.

Make sure your doctor or midwife knows that you are taking paroxetina. 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 towards the end of it.The pressure in the blood vessels between the heart and lungs is very high in newborns with persistent pulmonary hypertension (PPHN).

If you take paroxetina towards the end of pregnancy, there may be a higher risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking paroxetina to be able to advise you.

If you are taking paroxetina 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 too hot or cold.
• Blue lips.
• Vomiting or difficulty feeding.
• Feeling very tired, difficulty sleeping, or frequent crying.
• Muscle stiffness or flaccidity.
• Tremors,localized tremorsor convulsions.
• Exaggerated reflexes.

If your baby has any of these symptoms at birth,or if you are concerned about your newborn'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 paroxetina before starting to breastfeed. Your doctor, in consultation with you, may advise you to continue breastfeeding while taking paroxetina.

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

Driving and operating machinery

During treatment with paroxetina, you may feel drowsy or dizzy. Do not drive or operate tools or machinery until you know how paroxetina affects you.

Paroxetina cinfa contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. 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 normal doses for different indications are detailed in the following table:

Your doctor will tell you what dose to take when starting 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 whole with water. The tablets should not be chewed.

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

Patients over 65 years old

The maximum dose for people over 65 years old 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

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.

Never take more tablets than your doctor has recommended.

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 contractions.

If you forget to take paroxetine

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 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. Ifyoudon'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 you after two weeks of starting treatment.

If you stop taking paroxetine

Do not stop treatment until your doctor tells you to.

When stopping paroxetine treatment, your doctor will tell you how to gradually reduce the dose over a period of several weeks or months, which 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 withdrawal symptoms that occur when stopping paroxetine treatment 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 slowly. If you experience severe withdrawal symptoms, please consult your doctor. Your doctor may advise you to start treatment again and then stop it more slowly.

Although you may experience withdrawal symptoms, you may still be able to stop taking paroxetine.

Withdrawal symptoms when stopping treatment

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

Common side effects (may affect up to 1 in 10 patients):

• Feeling dizzy, unstable, or experiencing balance problems.
• Tickling, burning sensations, and, less frequently, a feeling of electric discharge, even in the head, buzzing, ringing, 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 patients):

• Nausea (vomiting).
• Sweating (including night sweats).
• Restlessness or agitation.
• Tremors.
• Confusion or disorientation.
• Diarrhea (soft stools).
• Feeling extremely 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 weeks of treatment with paroxetine.

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

You may need to consult your doctor or go to the hospital immediately.

Uncommon side effects (may affect up to 1 in 100 patients):

• 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.

Rare side effects (may affect up to 1 in 1,000 patients):

• If you experience seizures (epileptic fits), contact your doctor or go to the hospital immediately.
• If you have a feeling of restlessness, inability to sit or stay still, known as akathisia. Increasing the dose of paroxetine may worsen your symptoms. If you feel this way, consult your doctor.
• Feeling tired, weak, confused, and pain, stiffness, and lack of muscle coordination. This may be due to low sodium levels in the blood. If you have these symptoms, consult your doctor.

Very rare side effects (may affect up to 1 in 10,000 patients):

• Severe allergic reactions to paroxetine.

If you develop a skin rash with redness and blisters, swelling of the face, eyelids, lips, mouth, or tongue, itching, or difficulty breathing (difficult breathing) or swallowing, and feeling weak or having a dizziness that may cause a collapse or loss of consciousness, contact your doctor or go to the hospital immediately.

• If you notice any of the following symptoms, you may be experiencing a serotonin syndrome or malignant neuroleptic syndrome. Symptoms include: feeling very agitated or irritable, confusion, restlessness, feeling hot, sweating, tremors, chills, hallucinations (strange sounds or visions), muscle rigidity, sudden, rapid movements, or rapid heartbeat. The severity may increase and lead to loss of consciousness. If you feel this way, consult your doctor.
• Acute glaucoma.
• If you experience eye pain and blurred vision, consult your doctor.

Frequency not known (cannot be estimated from available data):

• Some people have experienced thoughts of self-harm or suicide while taking paroxetine or shortly after stopping treatment (see section 2 “What you need to know before starting to take paroxetine cinfa”).
• Aggression.
• Heavy vaginal bleeding shortly after delivery (postpartum hemorrhage), see “Pregnancy, breastfeeding, and fertility” in section 2 for more information.

Other possible side effects during treatment:

Very common side effects (may affect more than 1 in 10 patients):

• Feeling sick (nausea). This effect may be reduced by taking your medication in the morning after breakfast.
• Change in sex drive or sexual function, for example, lack of orgasm and, in men, abnormal erection and ejaculation.

Common side effects (may affect up to 1 in 10 patients):

• Increased levels of cholesterol in the blood.
• Decreased 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 affect up to 1 in 100 patients):

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

Rare side effects (may affect up to 1 in 1,000 patients):

• Abnormal secretion of breast milk in men and women.
• Decreased heart rate.
• Liver effects that are seen in laboratory tests indicating liver function.
• Panic attacks.
• Very active behaviors or thoughts (mania).
• Feeling disconnected from oneself (derealization).
• Anxiety.
• Irresistible need 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 affect up to 1 in 10,000 patients):

• Skin rash, in which small blisters with a central dark spot surrounded by a pale area, with a dark ring around it, called erythema multiforme may appear.
• Widespread rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).
• Widespread rash with blisters and skin peeling over a large body surface (toxic epidermal necrolysis).
• Liver changes 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 as a result of inappropriate chemical signals. Patients with SIADH may feel severely ill or have no symptoms.
• Water retention or fluid (which causes swelling of arms or legs).
• Sensitivity to sunlight.
• Prolonged and painful erection of the penis.
• Decreased platelet count in the blood.

Frequency not known (cannot be estimated from available data):

-Teeth grinding.

-Colitis (inflammation of the colon that causes diarrhea).

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

People taking medications like paroxetine 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 Pharmacovigilance 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 packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. In case of 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 ofparoxetina cinfa

The active ingredient is paroxetine in the form of hydrochloride. Each tablet contains 20 mg of paroxetine.

The other components are:

• Tablet core:magnesium stearate, carboxymethylcellulose sodium (type A) (from potato), mannitol (E-421) and microcrystalline cellulose (E-460).
• Tablet coating:polymethacrylate (E-100) and partially hydrolyzed polyvinyl alcohol, titanium dioxide (E-171), talc (E-553b), soy lecithin (E-322) and xanthan gum (E-415).

Appearance of the product and contents of the packaging

paroxetina cinfa are film-coated tablets, white or off-white, cylindrical, biconvex, scored on one face and with the mark “P20” on the other.

They are presented in Aluminio/Aluminio blisters. Each package contains 14, 28, 56 or 500 (clinical package) tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Park Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:November 2023

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

You can access detailed and updated information about this medication by scanning with your smartphone the QR code included in the leaflet and packaging. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/66932/P_66932.html

QR code to:https://cima.aemps.es/cima/dochtml/p/66932/P_66932.html