Paroxetine Cinfa 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

paroxetina cinfa 20 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.

Leaflet contents

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

1. What paroxetina cinfa is and what it is used for

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

The anxiety disorders for which paroxetine is indicated are:

• obsessive-compulsive disorder (obsessive, repetitive thoughts with uncontrollable behavior),
• panic disorder (panic attacks, including those caused by agoraphobia, which is fear of open spaces),
• social anxiety disorder (fear of or avoidance of social situations),
• post-traumatic stress disorder (anxiety caused by a traumatic event), and
• generalized anxiety disorder (persistently feeling very anxious and nervous).

Paroxetine belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). All of us have a substance in the brain called serotonin. People who are depressed or have anxiety have lower levels of this substance. The precise mechanism of action of paroxetine and other SSRIs is not fully understood, but they work by increasing the level of serotonin in the brain. Proper treatment of depression or anxiety disorder is important to help you feel better.

2. What you need to know before taking paroxetine cinfa

Do not take paroxetine cinfa

• If you are allergic to paroxetine or to any of the other ingredients of this medicine (listed in section 6).
• This medicine contains soya oil. It should not be used if you are allergic to peanuts or soya.
• If you are being treated with medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylene blue chloride), or if you have been treated with any of these medicines within the last two weeks. Your doctor will advise you on how to start taking paroxetine after stopping the MAOI.
• If you are taking an antipsychotic medicine called thioridazine or the antipsychotic called pimozide.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take paroxetine cinfa:

• if you are taking other medicines (see section “Other medicines and paroxetine cinfa”)

• 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 that you take another antidepressant

• if you have any kidney, liver, or heart problems

• if you have epilepsy or experience seizures or epileptic fits

• if you have had manic episodes (excessively active thoughts or behaviors)

• if you are receiving electroconvulsive therapy (ECT)

• if you are prone to bleeding or bruising, or are taking any medicine that may increase the risk of bleeding (including medicines such as warfarin (acenocoumarol), antipsychotics such as perphenazine or clozapine, tricyclic antidepressants, medicines for pain and inflammation called non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid, 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 (high eye pressure)

• if you are pregnant or planning to become pregnant (see “Pregnancy, breastfeeding and fertility”)

• if you are under 18 years of age (see “Children and adolescents under 18 years of age”)

If you are in any of these situations and have not yet consulted your doctor, ask your doctor about how to take paroxetine.

Some medicines in the same class as paroxetine cinfa (called SSRIs/SNRIs) can cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Children and adolescents under 18 years of age

Paroxetine should not be used to treat children and adolescents under 18 years of age. You should also be aware that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking paroxetine. Nevertheless, your doctor may prescribe paroxetine to patients under 18 years of age if they decide it is the most appropriate treatment for the patient. If your doctor has prescribed paroxetine to you or to your child under 18 years of age and you wish to discuss this decision, consult your doctor. You must inform your doctor if any of the symptoms listed above appear or worsen while you or your child under 18 years of age are taking paroxetine. The long-term effects of paroxetine on safety regarding growth, maturation, and cognitive and behavioral development in this age group have not yet been established.

In clinical studies with paroxetine in patients under 18 years of age, common adverse effects, which may affect up to 1 in 10 children or adolescents, included: increased thoughts and attempts of suicide, self-harm attempts, hostile behaviors, aggressive or unfriendly behaviors, loss of appetite, tremors, abnormal sweating, hyperactivity (excessive energy), agitation, emotional instability (including crying and mood swings), and occurrence of unexplained bruising or bleeding (such as nosebleeds). These effects were also observed in patients in these studies who did not take paroxetine, although less frequently.

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

Suicidal thoughts and worsening of depression or anxiety disorder

If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming yourself or of suicide. These may increase at the beginning of treatment with antidepressants, as all these medicines take time to work—usually about two weeks, but sometimes longer.

You are more likely to experience this

• If you have previously had thoughts of suicide or self-harm.
• If you are a young adult. Clinical trial data show an increased risk of suicidal behavior in psychiatric patients under 25 years of age being treated with antidepressants.

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

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

Important adverse effects observed with paroxetine

Some patients taking paroxetine develop a condition called akathisia and feel restless and unable to sit still or remain motionless. Other patients develop a condition called serotonin syndrome or neuroleptic malignant syndrome, and may experience one or more of the following symptoms: feeling very agitated or irritable, confusion, restlessness, feeling hot, sweating, tremor, chills, hallucinations (strange visions or sounds), muscle stiffness, sudden jerky movements, or increased heart rate. The condition may worsen and lead to loss of consciousness.

Contact your doctor if you experience any of these symptoms. For more information on this or other adverse effects of paroxetine, see section 4, “Possible side effects”, in this leaflet.

Other medicines and paroxetine cinfa

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

Some medicines may alter the effect of paroxetine or make it more likely that certain adverse effects occur. Paroxetine may also alter the effect of some medicines. For example:

• Medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylene blue chloride). See section “Do not take paroxetine cinfa”.
• Medicines called thioridazine or pimozide, which are antipsychotics. See section “Do not take paroxetine cinfa”.
• 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 and pethidine, analgesics.
• 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 supplement called tryptophan.
• Mivacurium and suxamethonium (used in anesthesia).
• Medicines such as lithium, risperidone, perphenazine, clozapine (antipsychotics) used to treat certain psychiatric disorders.
• Fentanyl, used in anesthesia or 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 used to treat depression.
• Phenobarbital, phenytoin, sodium valproate, or carbamazepine, used to treat seizures or 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 cardiac rhythm disorders.
• Metoprolol, a beta-blocker used to treat high blood pressure and heart conditions.
• 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, inform your doctor and ask what you should do. Your doctor may decide to change your dose or prescribe a different medicine.

Taking paroxetine cinfa with food, drinks, and alcohol

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

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Some studies have shown an increased risk of birth defects, particularly those affecting the heart, 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 defect. This rate increased to 2 in 100 newborns in mothers who took paroxetine. Your doctor, in consultation with you, may switch you to another treatment or gradually discontinue paroxetine during pregnancy. However, depending on your circumstances, your doctor may recommend continuing paroxetine.

Ensure your doctor or midwife knows that you are taking paroxetine. Medicines like paroxetine may increase the risk of a serious condition called persistent pulmonary hypertension of the newborn (PPHN) when taken during pregnancy, especially in the later stages. The pressure in the blood vessels between the heart and lungs is very high in newborns with persistent pulmonary hypertension (PPHN).

If you take paroxetine in late pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should be aware that you are taking paroxetine so they can advise you.

If you are taking paroxetine during the third trimester of pregnancy, your newborn may also experience other symptoms, usually beginning within the first 24 hours after birth. These symptoms include:

• Difficulty breathing.
• Bluish skin or appearance of being too hot or too cold.
• Bluish lips.
• Vomiting or feeding difficulties.
• Extreme tiredness, difficulty sleeping, or frequent crying.
• Muscle stiffness or floppiness.
• Tremors, localized tremors, or seizures.
• Exaggerated reflexes.

If your baby shows 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 paroxetine before starting breastfeeding. Your doctor, in consultation with you, may advise continuing breastfeeding while taking paroxetine.

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

Driving and using machines

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

paroxetine cinfa contains sodium

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

3. How to take paroxetine cinfa

Follow exactly the dosage instructions for this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

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

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

Take the tablets in the morning with food. The tablets must be swallowed whole with water. Do not chew the tablets.

Your doctor will determine how long your treatment should last. This period may extend for several months or even longer.

Elderly patients

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

Patients with kidney or liver problems

If you have severe hepatic or renal insufficiency, your doctor may advise you to take lower doses of paroxetine than usual.

If you take more paroxetine cinfa than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 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 experience some of the symptoms listed in section 4, “Possible side effects”, or any of the following symptoms: fever, involuntary muscle contractions.

If you forget to take paroxetine cinfa

Take your medication at the same time every day.

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

If you remember during the night or the following day, skip the missed dose. You may experience withdrawal symptoms, but they should disappear after taking your next dose at the usual time. Do not take a double dose to make up for a missed dose.

What to do if you do not feel better

Paroxetine will not improve your symptoms immediately; all antidepressants take time to work. Some people begin to feel better after a couple of weeks, but others may require more time. Some people taking antidepressants feel worse before they begin to feel better. If you do not start to feel better after a couple of weeks, inform your doctor, who will advise you on what to do. Your doctor may have scheduled a follow-up appointment 2 weeks after starting your treatment.

If you stop treatment with paroxetine cinfa

Do not stop treatment unless your doctor tells you to do so.

When stopping treatment with paroxetine, your doctor will instruct you on how to gradually reduce the dose over a period of several weeks or months, which will help reduce the risk of experiencing withdrawal symptoms. One way to do this is to gradually reduce your paroxetine dose by 10 mg each week. Most people find that any withdrawal symptoms they experience are mild and disappear on their own within two weeks. For others, these symptoms may be more severe or last longer.

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

Even if you experience withdrawal effects, you may still be able to discontinue your treatment with paroxetine.

Possible withdrawal effects when stopping treatment

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

Frequent adverse effects (may affect up to 1 in 10 patients):

• Feeling dizzy, unsteady, or having balance disturbances.
• Tingling, burning sensations, and less frequently, electric shock-like sensations, even in the head; tinnitus (ringing, buzzing, hissing, whistling, or other persistent noises in the ears).
• Sleep disturbances (very vivid dreams, nightmares, inability to sleep).
• Anxiety.
• Headaches.

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

• Vomiting (nausea).
• Sweating (including night sweats).
• Restlessness or agitation.
• Tremor.
• Confusion or disorientation.
• Diarrhea (loose stools).
• Feeling overly sensitive or irritable.
• Visual disturbances.
• Rapid or very strong heartbeats (palpitations).

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

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. Adverse effects are more likely to occur during the first weeks of treatment with paroxetine.

Inform your doctor if you experience any of the adverse effects listed below while taking paroxetine.

It may be necessary for you to consult your doctor or go to hospital immediately.

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

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

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

• If you experience seizures (epileptic fits), contact your doctor or go to hospital immediately.
• Feeling restless, unable to sit still or remain still, known as akathisia. Increasing the dose of paroxetine may worsen your symptoms. If you feel this way, consult your doctor.
• Tiredness, 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 adverse effects (may affect up to 1 in 10,000 patients):

• Allergic reactions to paroxetine which may be serious.

If you develop a rash with redness and lumps, swelling of the face, eyelids, lips, mouth or tongue, itching, or difficulty breathing (shortness of breath) or swallowing, and a feeling of weakness or dizziness that may lead to collapse or loss of consciousness, contact your doctor or go to hospital immediately.

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

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

• Some people have experienced thoughts of harming themselves or suicide while taking paroxetine or shortly after stopping treatment (see section 2 "What you need to know before taking paroxetine cinfa").
• Aggressiveness.
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see “Pregnancy, breastfeeding and fertility” in section 2 for more information.

Other possible adverse effects during treatment:

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

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

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

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

Uncommon adverse 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.
• Faster than normal heartbeat.
• 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 urinary incontinence (involuntary and uncontrolled urination).
• If you are a diabetic patient, you may notice loss of control of blood sugar levels while taking paroxetine. Consult your doctor about adjusting your insulin or diabetes medication dosage.
• Decreased white blood cell count.

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

• Abnormal breast milk secretion in men and women.
• Decreased heart rate.
• Liver effects seen in laboratory tests indicating liver function.
• Panic attacks.
• Very active behaviour or thoughts (mania).
• Feeling detached from oneself (depersonalisation).
• Anxiety.
• Irresistible urge to move the legs (Restless Legs Syndrome).
• Joint or muscle pain.
• Increased blood levels of a hormone called prolactin.
• Menstrual cycle disturbances (including heavy or irregular periods, bleeding between periods, and absence or delay of periods).

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

• Skin rash in which blisters appear resembling small targets (dark central spots surrounded by a pale area, with a dark ring around it), known as erythema multiforme.
• Widespread blistering rash with skin peeling, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome).
• Widespread rash affecting a large body surface area with blisters and skin peeling (toxic epidermal necrolysis).
• Liver disturbances causing yellowing of the skin or whites of the eyes.
• Syndrome of inappropriate antidiuretic hormone secretion (SIADH), a condition in which the body retains excess water and has reduced sodium (salt) concentration due to inappropriate chemical signals. Patients with SIADH may feel severely ill or may have no symptoms.
• Water or fluid retention (causing swelling of arms or legs).
• Sensitivity to sunlight.
• Painful and prolonged penile erection.
• Decreased platelet count in blood.

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

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

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

It has been observed that people taking medicines like paroxetine have an increased risk of bone fractures.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of paroxetine cinfa

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of paroxetine cinfa

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

The other components are:

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

Appearance of the product and contents of the pack

paroxetine cinfa are film-coated tablets, white or greyish-white in colour, cylindrical, biconvex, scored on one side and marked "P20" on the other.

They are presented in aluminium/aluminium blisters. Each pack contains 14, 28, 56 or 500 tablets (hospital pack).

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the most recent review of this leaflet: November 2023

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package 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

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