Paroxetine Normon 30 mg film-coated tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Paroxetina Normon 30 mg film-coated tablets EFG

Read the entire leaflet carefully before starting to take this medicine, as 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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

What Paroxetina Normon is and what it is used for
What you need to know before taking Paroxetina Normon
How to take Paroxetina Normon
Possible side effects
How to store Paroxetina Normon
Contents of the pack and other information

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

Paroxetina Normon is used for the treatment of depression and/or anxiety disorders in adults. The anxiety disorders for which Paroxetina Normon 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 experiencing excessive anxiety and nervousness).

Paroxetina Normon belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). Serotonin is a substance naturally present in the brain. People who are depressed or have anxiety disorders have lower levels of this substance. The precise mechanism of action of Paroxetina Normon 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 disorders is important to help you feel better.

2. What you need to know before taking Paroxetina Normon

Do not take Paroxetina Normon

If you are being treated with medicines known as monoamine oxidase inhibitors (MAOIs, including moclobemide and methylthioninium chloride (methylene blue)), 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 allergic to paroxetine or to any of the other ingredients of this medicine (listed in section 6).

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

Warnings and precautions

Talk to your doctor or pharmacist before starting Paroxetina Normon

If you are taking other medicines (see the section Other medicines and Paroxetina Normon).
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 an abnormality in your heart rhythm seen on an electrocardiogram (ECG) known as QT interval prolongation.
If you have a family history of QT interval prolongation, heart diseases such as heart failure, slow heart rate, or low levels of potassium or magnesium.
If you have epilepsy or experience seizures or epileptic fits.
If you have had manic episodes (excessively active thoughts or behavior).
If you are receiving electroconvulsive therapy (ECT).
If you are prone to bleeding or bruising, or if you are taking any medicine that may increase the risk of bleeding (including medicines such as warfarin (acenocoumarol), antipsychotics like perphenazine or clozapine, tricyclic antidepressants, medicines used 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 (increased pressure in the eye).
If you have a history of bleeding disorders.
If you are pregnant or planning to become pregnant (see section Pregnancy, breastfeeding and fertility).
If you are under 18 years of age (see section Children and adolescents).

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

Children and adolescents

Paroxetina Normon 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 suicidal attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking paroxetine. Nevertheless, your doctor may prescribe paroxetine to patients under 18 years of age if they consider it to be the most appropriate treatment. If your doctor has prescribed paroxetine to you or your child under 18 years of age and you wish to discuss this decision, speak to 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, the common adverse effects, affecting less than 1 in 10 children or adolescents, were: increased suicidal thoughts and attempts, self-harm attempts, hostile, aggressive, or unfriendly behavior, loss of appetite, tremors, abnormal sweating, hyperactivity (excessive energy), agitation, emotional instability (including crying and mood swings), and occurrence of unexpected bruising or bleeding (such as nosebleeds). These effects were also observed, though less frequently, in patients included in these studies who did not take paroxetine.

When stopping treatment with paroxetine, some of the patients under 18 years of age in these studies reported withdrawal-related adverse effects. These effects were very similar to those observed in adults who stopped taking paroxetine (see section 3). In addition, patients under 18 years of age frequently experienced (affecting less than 1 in 10) stomach pain, nervousness, and emotional instability (including crying, mood swings, self-harm attempts, suicidal thoughts and 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 some time to work—usually about two weeks, but sometimes longer.

You are more likely to experience this

If you have previously had suicidal thoughts or thoughts of 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 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 Paroxetina Normon

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 known as 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.

Some medicines in the same class as Paroxetina Normon (known as SSRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

Other medicines and Paroxetina Normon

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 methylthioninium chloride (methylene blue)). See the section Do not take Paroxetina Normon.
Medicines called thioridazine or pimozide, which are antipsychotics. See the section Do not take Paroxetina Normon.
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, a replacement therapy 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 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 tremor, especially in Parkinson’s disease.
Warfarin and other medicines (called anticoagulants) used to thin the blood.
Propafenone, flecainide, and other medicines used to treat cardiac rhythm disorders.
Metoprolol, a beta-blocker used to treat high blood pressure and heart 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, inform your doctor and ask what you should do. Your doctor may decide to change your dose or prescribe another medicine.

Tell 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.

Taking Paroxetina Normon 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 may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

In some studies, an increased risk of birth defects, 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 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 individual circumstances, your doctor may recommend continuing paroxetine.

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

If you take paroxetine during the third trimester of pregnancy, your newborn may also experience other symptoms, which usually begin within the first 24 hours after birth.

These symptoms include:

Difficulty breathing.
Bluish skin or signs 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.

Paroxetina Normon 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 use of machines

Some of the adverse effects caused by paroxetine include dizziness, confusion, drowsiness, or blurred vision. If you experience any of these effects, do not drive or operate machinery.

Paroxetina Normon contains sodium

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

3. How to take Paroxetina Normon

Follow exactly the instructions for use of this medicine given 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:

Dosage	Number of tablets to take
30 mg	One tablet
60 mg	Two tablets

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

	Initial daily dose	Recommended daily dose	Maximum daily dose
Depression	20 mg	20 mg	50 mg
Obsessive compulsive disorder	20 mg	40 mg	60 mg
Panic disorder	10 mg	40 mg	60 mg
Social anxiety disorder	20 mg	20 mg	50 mg
Post-traumatic stress disorder	20 mg	20 mg	50 mg
Generalized anxiety disorder	20 mg	20 mg	50 mg

Your doctor will tell you what dose to take when you start 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 should be swallowed with water.

The tablets must not be chewed.

The tablet may be divided into equal doses.

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 impairment, your doctor may advise you to take lower doses of paroxetine than usual.

If you take more Paroxetina Normon 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 Paroxetina Normon

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 your usual time.

If you remember during the night or the following day, skip the missed dose. You may experience some 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 missed doses.

What to do if you do not feel better

Paroxetina Normon 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 start to feel better. If you do not begin 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 two weeks after you started treatment.

If you stop treatment with Paroxetina Normon

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

When stopping treatment with Paroxetina Normon, 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 possible symptoms that occur when stopping paroxetine are mild and resolve on their own within two weeks. For others, these symptoms may be more severe or last longer.

If you experience withdrawal-related effects while discontinuing your treatment, your doctor may decide that you should stop more slowly. If you experience severe withdrawal symptoms, please consult your doctor. Your doctor may advise you to restart treatment and then discontinue it more gradually.

Even if you experience withdrawal-related effects, you may still be able to stop your treatment with Paroxetina Normon.

Possible withdrawal effects when stopping treatment

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

Common adverse effects

May affect up to 1 in 10 people

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

Uncommon adverse effects

May affect up to 1 in 100 people

Nausea (vomiting).
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 Paroxetina Normon.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience 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 Paroxetina Normon.

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

Uncommon adverse effects

May affect up to 1 in 100 people

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 people

If you experience seizures (epileptic fits), contact your doctor or go to hospital immediately.
If you feel restless or unable to sit still or remain still, a condition 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 people

Allergic reactions to paroxetine that may be severe.

If you develop a rash with redness and lumps, swelling of the face, eyelids, lips, mouth or tongue, itching, 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 any or all of the following symptoms, you may be experiencing serotonin syndrome. Symptoms include: confusion, restlessness, sweating, tremor, chills, hallucinations (strange sounds or visions), sudden jerky movements or rapid heartbeat. If you feel this way, consult your doctor.
Acute glaucoma.

If you develop eye pain and blurred vision, consult your doctor.

Frequency not known

Frequency cannot be estimated from the available data

Some people have experienced thoughts of harming themselves or suicide while taking paroxetine or shortly after stopping treatment (see Suicidal thoughts and worsening of depression or anxiety disorder in section 2).
Some people have experienced aggressiveness while taking paroxetine.
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 people

Feeling unwell (nausea). This effect may be reduced by taking your medicine 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 people

Increased blood cholesterol levels.
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 people

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.
Rash.
Itching.
Confusion.
Hallucinations (strange sounds or visions).
Inability to urinate (urinary retention) or urinary incontinence (uncontrolled and involuntary urination).
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 dosage.
Decreased white blood cell count.

Rare adverse effects

May affect up to 1 in 1,000 people

Abnormal breast milk secretion in men and women.
Decreased heart rate.
Liver effects seen in laboratory tests indicating liver function.
Panic attacks.
Very active behaviours 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 people

Skin rash, in which blisters may appear with a target-like appearance (dark central spots surrounded by a pale area, with a dark ring around it), known as erythema multiforme.

Widespread rash with blisters and skin peeling, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome).
Widespread rash affecting a large area of the body with blisters and skin peeling (toxic epidermal necrolysis).
Liver problems 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 sodium (salt) concentration decreases, due to inappropriate chemical signals. Patients with SIADH may feel severely unwell or may have no symptoms at all.
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

Frequency cannot be estimated from the available data

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

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

5. Storage of Paroxetine Normon

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

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

Do not store above 30°C.

If you are taking half a tablet, take care to store it safely in its original container.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Paroxetina Normon

The active substance is paroxetine (30 mg), as hydrochloride, hemihydrate.

The other components are:

In the tablet core: calcium hydrogen phosphate dihydrate, sodium carboxymethyl starch Type A (from potato), and magnesium stearate.
In the tablet coating: hypromellose, macrogol, polysorbate 80, and titanium dioxide (E171).

Appearance of the product and contents of the pack

Paroxetina Normon 30 mg film-coated tablets are white, elliptical, and biconvex, with a diameter of 12.8 mm, marked with "30" on one side and a score line on the other. It is available in packs of 28 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

You can request further information about your condition by contacting a patient organization. Please consult your doctor.

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

Other sources of information

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