PAROXETINE TEVA-RATIO 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Paroxetina Teva-ratio 10 mg film-coated tablets EFG

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Paroxetine is used for the treatment of depression and/or anxiety disorders in adults.The anxiety disorders for which this medicine is indicated are: obsessive-compulsive disorder (obsessive thoughts, repetitive, uncontrolled behavior), panic disorder (panic attacks, 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 very anxious and nervous).

Paroxetine belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). The mechanism of action of this medicine and other SSRIs is not known precisely, but they work by increasing the level of serotonin in the brain. Properly treating depression or anxiety disorder is important to help you feel better.

2. What you need to know before you take Paroxetina Teva-ratio

Do not take Paroxetina Teva-ratio

• If you are being treated with medicines called monoamine oxidase inhibitors (MAOIs),including moclobemide and methylene blue (methylthioninium chloride), or if you have been under treatment with any of these medicines in the last two weeks. Your doctor will advise you how to start taking paroxetine once you have stopped taking the MAOI.
• If you are taking an antipsychotic medicinecalled thioridazine or the antipsychotic called pimozide.
• If you are allergicto paroxetine or any of the other ingredients of this medicine (listed in section 6)

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

Warnings and precautions

Consult your doctor or pharmacist before starting to takeparoxetine

• If you are taking other medicines (see the section Other medicines and Paroxetina Teva-ratio),
• If you are taking tamoxifen for the treatment of breast cancer (or fertility problems). Paroxetine may make tamoxifen less effective, so your doctor should recommend taking another antidepressant
• If you have any kidney, liver, or heart problems
• If you have an abnormality in your heart tracing after an electrocardiogram (ECG) known as QT interval prolongation
• If you have a family history of QT interval prolongation, heart diseases such as heart failure, low heart rate, or low potassium or low magnesium levels
• If you have epilepsy or if you have seizures or epileptic fits
• If you have had manic episodes (excessively active thoughts or behavior)
• If you are being treated with electro-convulsive therapy (ECT)
• If you have a tendency to bleed or bruise, or are being treated with any medicine that may increase the risk of bleeding (including medicines such as warfarin (acenocoumarol), antipsychotics like perphenazine or clozapine, tricyclic antidepressants, medicines to treat pain and inflammation called non-steroidal anti-inflammatory drugs (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 (high eye pressure)
• If you are pregnant or think you may be pregnant (see the section Pregnancy, breast-feeding, 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 them how to take paroxetine.

Childrenand adolescentsunder 18 years of age

Paroxetine 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 greater risk of adverse effects such as suicidal attempts, suicidal thoughts, and hostility (predominantly aggression, confrontational behavior, and irritation) when taking paroxetine. If your doctor has prescribed paroxetine to you (or your child) and you want to discuss this decision, consult your doctor. You must inform your doctor if any of the symptoms detailed above appear or worsen when you (or your child) are taking this medicine. The long-term effects on safety, related to growth, maturity, and cognitive and behavioral development in this age group, have not yet been demonstrated.

In studies conducted with paroxetine in patients under 18 years of age, the frequent adverse effects, which affected less than 1 in 10 children/adolescents, were: an increase in suicidal thoughts and attempts, self-harm behaviors, 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 bruises or bleeding (such as nosebleeds). These effects were also observed in children/adolescents included in these studies who were taking placebo, instead of paroxetine, although with lower frequency.

When stopping treatment with paroxetine, in these studies, some of the patients under 18 years of age reported having withdrawal effects. These effects were very similar to those observed in adults who stopped treatment with paroxetine (see section 3). Additionally, patients under 18 years of age frequently experienced (affecting less than 1 in 10) stomach pain, nervousness, and unstable emotions (including crying, mood changes, self-harm attempts, suicidal thoughts, and attempts).

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 suicide. These can increase at the beginning of treatment with antidepressants, as all these medicines take time to work, which is usually a few weeks but can sometimes be longer.

This is more likely to happen:

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

If you have thoughts of self-harm or suicide at any time, consult your doctor or go to the hospital immediately.

It may be useful for you to tell 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 side effects seen with Paroxetina Teva-ratio

Some patients taking paroxetine develop a disorder called akathisia, and feel restless and unable to sit or stay still. Other patients develop the so-called serotonin syndrome or neuroleptic malignant syndrome, and may have some or all of the following symptoms: feeling very agitated or irritable, confusion, restlessness, feeling hot, sweating, trembling, chills, hallucinations (strange visions or sounds), muscle stiffness, sudden jerky 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 side effects of paroxetine, see section 4.

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

Other medicines and Paroxetina Teva-ratio

Some medicines may change the effect of paroxetine or make it more likely that some side effects will appear. Paroxetine may also change the effect of some medicines. For example:

• Medicines called monoamine oxidase inhibitors(MAOIs, including moclobemide and methylene blue (methylthioninium chloride)). See the section Do not take Paroxetina Teva-ratio.
• Medicines known to increase the risk of changes in heart electrical activity (e.g., antipsychoticsthioridazine or pimozide). See the section Do not take Paroxetina Teva-ratio.
• Acetylsalicylic acid, ibuprofen, and other medicines called non-steroidal anti-inflammatory drugs (NSAIDs) such as celecoxib, etodolac, diclofenac, and meloxicam, used to treat pain and inflammation.
• Tramadol, buprenorphine, and pethidine, analgesics.
• Buprenorphine combined with naloxone, substitution treatment for opioid addiction.
• Medicines called triptans, such as sumatriptan, used to treat migraine.
• Other antidepressants, including other selective serotonin reuptake inhibitors and tricyclic antidepressants such as clomipramine, nortriptyline, and desipramine.
• A dietary supplementcalled tryptophan.
• Mivacurium and suxamethonium (used in anesthesia).
• Medicines such as lithium, risperidone, perphenazine, clozapine (antipsychotics) used to treat some psychiatric illnesses.
• Fentanyl, used in anesthesiaor to treat chronic pain.
• A combination of fosamprenavir and ritonavir, used to treat human immunodeficiency virus (HIV) infection.
• St. John's Wort, a herbal remedy for treating depression.
• Phenobarbital, phenytoin, sodium valproate, or carbamazepine, used to treat seizuresor epilepsy.
• Atomoxetine, a medicine used to treat attention deficit hyperactivity disorder (ADHD).
• Procyclidine, used to relieve tremors, especially in Parkinson's disease.
• Warfarin and other medicines (called anticoagulants) used to thin the blood.
• Propafenone, flecainide, and medicines used to treat heart rhythm disorders.
• Metoprolol, a beta-blocker used to treat high blood pressure andheart disorders.
• Pravastatin, used to treat high cholesterol.
• Rifampicin, used to treat tuberculosis (TB)and leprosy.
• Linezolid, an antibiotic.
• Tamoxifen, used to treat breast cancer(or fertility problems).

If you are taking or have recently taken any of these medicines, tell your doctor and ask what you should do.Your doctor may decide to change the dose or prescribe another medicine.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines,even those bought without a prescription.

Taking Paroxetina Teva-ratio with food, drinks, and alcohol

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

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

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

Make sure your doctor or midwife knows you are taking paroxetina. If you take this medicine in the final stages of pregnancy, there may be a greater 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 this medicine to advise you. Medicines like paroxetine may increase the risk of a serious disease called persistent pulmonary hypertension of the newborn (PPHN), when taken during pregnancy, particularly at the end of it. The pressure in the blood vessels that go between the heart and lungs is very high in newborns with persistent pulmonary hypertension (PPHN). If you are taking this medicine in the last trimester of pregnancy, your newborn may also have other symptoms that usually start during the first 24 hours after birth. These symptoms include:

• Difficulty breathing
• Blue-tinged skin or looking too hot or cold
• Blue lips
• Vomiting or difficulty feeding
• Feeling very tired, difficulty sleeping, or frequent crying
• Stiffness or floppiness of the muscles
• Tremors, localized tremors, or seizures
• 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.

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

Animal studies have shown that paroxetine reduces sperm quality. Theoretically, this could affect fertility in humans, but this impact has not yet been observed in people.

Driving and using machines

Some of the side effects that this medicine can cause are dizziness, confusion, drowsiness, or blurred vision. If you experience any of these effects, do not drive vehicles or use machines.

Paroxetina Teva-ratio contains sodium

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

3. How to take Paroxetina Teva-ratio

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

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

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

Your doctor will indicate what dose you should take when starting treatment with paroxetine.Most people start to feel better after a couple of weeks. If after this time you do not start to feel better, consult your doctor who will indicate how to proceed. 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 score line should not be used to break the tablet.

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

Elderly patients

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 more paroxetine than you should

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 package 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 experience some of the symptoms that appear in section 4, Possible side effects,or some of the following symptoms: fever, involuntary muscle contraction.

If you forget to take Paroxetina Teva-ratio

Take your medication at the same time every day.

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

If you remember during the night or the next day, skip 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 make up for missed doses.

What to do if you do not 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 require more time. Some people who take antidepressants feel worse before starting to notice improvement. If you do not start to feel better after a couple of weeks, tell your doctor, who will indicate what to do. It is possible that your doctor has scheduled a follow-up appointment after two weeks of starting your treatment. Consult your doctor if you have not started to feel better.

If you stop treatment with paroxetine

Do not stop treatment until your doctor indicates it.

When you stop treatment with paroxetine, your doctor will indicate how to gradually reduce the dose over a period of several weeks or months. This will help reduce the risk of experiencing 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 that the possible symptoms that occur when stopping treatment with this medication are mild and disappear on their own within two weeks. For others, these symptoms can be more severe or last longer.

If you experience withdrawal effectswhile stopping your treatment, your doctor may decide to stop it 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 some withdrawal effect, you will be able to stop your treatment with paroxetine.

Possible withdrawal effects when stopping treatment

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

Common side effects

May affect up to 1 in 10 people

• Feeling dizzy, unsteady, or having balance problems.
• Numbness, tingling, and, less frequently, electric shock sensations, even in the head, buzzing, whistling, ringing, or other persistent noises 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

• Vomiting (nausea).
• Sweating (including night sweats).
• Restlessness or agitation.
• Tremors.
• Confusion or disorientation.
• Diarrhea (soft stools).
• Feeling very sensitive or irritable.
• Visual disturbances.
• Fast or very strong heartbeats.

Consult your doctor if you are concerned about the withdrawal effects of paroxetine.

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

4. Possible side effects

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

Tell your doctor if you experience any of the following side effects during treatment

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

Uncommon side effects

May affect up to 1 in 100 people

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

Rare side effects

May affect up to 1 in 1,000 people

• If you experience seizures(epileptic fits), contact your doctor or go to the hospital immediately.
• If you feel restless, unable to sit still or stay still,called akathisia. Increasing the dose of this medication may worsen your symptoms. If you feel this way, consult your doctor.
• Weakness, confusion, 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 people

• Severe allergic reactions to paroxetine.

If you develop a skin rash with redness and bumps, swelling of the face, eyelids, lips, mouth, or tongue, itching, or difficulty breathing (difficulty breathing) or swallowing, and feeling weak or having a fainting spell that can cause 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 serotonin syndrome or neuroleptic malignant syndrome.The symptoms include: feeling very agitated or irritable, confusion, restlessness, feeling hot, sweating, trembling, chills, hallucinations (strange sounds or visions), muscle stiffness, sudden jerky movements, or rapid heartbeats. The severity can 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

The frequency cannot be estimatedfrom the available data

• Some people have experienced thoughts of harming themselves or suicidal thoughts while taking this medication or shortly after stopping treatment (see Suicidal thoughts and worsening of your depression or anxiety disorderin section 2).
• Some people have experienced aggression while taking this medication.
• Excessive vaginal bleeding shortly after childbirth (postpartum hemorrhage), see Pregnancy, breastfeeding, and fertilityin section 2 for more information.

If you experience these side effects, contact your doctor.

Other possible side effects during treatment:

Very common side effects

May affect more than 1 in 10 people

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

Common side effects

May affect up to 1 in 10 people

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

Uncommon side effects

May affect up to 1 in 100 people

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

Rare side effects

May affect up to 1 in 1,000 people

• Abnormal milk secretion in men and women.
• Decreased heart rate.
• Liver effects that appear in laboratory tests that indicate liver function.
• Panic attacks.
• Very active behavior or thoughts (mania).
• Feeling detached from oneself (depersonalization).
• Anxiety.
• Irresistible need to move the legs (Restless Legs Syndrome).
• Pain in joints or muscles.
• Increased levels of a hormone called prolactin in the blood.
• Menstrual disorders (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 people

• Skin rash, in which blisters appear with a target-like appearance (dark central spots surrounded by a pale area, with a dark ring around) called erythema multiforme.
• Widespread rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).
• Widespread rash over a large body surface with blisters and skin peeling (toxic epidermal necrolysis).
• Liver disorders that turn the skin or the whites 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 (salt) concentration due to inappropriate chemical signals. Patients with SIADH may feel severely ill or may have no symptoms.
• Fluid retention or swelling (causing swelling of arms or legs).
• Sensitivity to sunlight.
• Painful and prolonged erection of the penis.
• Decreased platelet count in the blood.

Frequency not known

The frequency cannot be estimatedfrom the available data

• Inflammation of the colon (causing diarrhea).
• Teeth grinding.

Some patients have experienced ringing, whistling, buzzing, or other persistent noises 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 side effects

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

5. Storage of Paroxetina Teva-ratio

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack or bottle and 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 thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Paroxetina Teva-ratio

• The active ingredient is paroxetine.

Each 10 mg tablet contains 10 mg of paroxetine (as paroxetine hydrochloride).

• The other ingredients are mannitol, microcrystalline cellulose, sodium carboxymethyl starch Type A (potato), magnesium stearate.

• The coating contains:

Basic butyl methacrylate copolymer, partially hydrolyzed polyvinyl alcohol (E1203), macrogol (E1521), titanium dioxide (E-171), talc (E553b), yellow iron oxide (E172).

Appearance of the Product and Container Contents

The tablets are yellow, round, coated, biconvex, 8 mm in diameter, scored on one side and printed on the other with P10.

The score line is not intended for breaking the tablet.

It is available in blister packs of 28, 30 or 100 film-coated tablets and in precut unit-dose blister packs of 28x1, 30x1 or 100x1 film-coated tablets and in bottles of 100 or 105 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Teva B.V.,

Swensweg 5,

2031GA Haarlem,

Netherlands

Local Representative

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta,

Alcobendas, 28108 - Madrid

Spain

Manufacturer:

Teva Pharma, S.L.U.

Polígono Malpica C/ C, 4.

50016 Zaragoza

Spain

Date of Last Revision of this Leaflet:February 2024

Other Sources of Information

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information about this medicinal product by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/89501/P_89501.html

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