Paroxetine Normon 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

PAROXETINE NORMON 20 mg film-coated tablets EFG

Paroxetine (as hydrochloride hemihydrate)

Read the entire leaflet carefully before you start taking this medicine.

• 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 and you should not give it to other people, even if they have the same symptoms, as it may harm them.
• If you think any of the side effects you experience is serious or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What PAROXETINE NORMON is and what it is used for
2. Before you take PAROXETINE NORMON
3. How to take PAROXETINE NORMON
4. Possible side effects
5. How to store PAROXETINE NORMON
6. Further 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 uncontrolled behaviour), 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).

PAROXETINA NORMON belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). Serotonin is a substance naturally present in the brain. People who are depressed or have anxiety 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 levels of serotonin in the brain.

Properly treating depression or anxiety disorder is important to help you feel better.

2. Before taking PAROXETINE NORMON

Do not take PAROXETINE NORMON

• if you are being treated with medicines called monoamine oxidase enzyme inhibitors (MAOIs, including moclobemide and methylene blue 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 NORMON after stopping the MAOI.
• if you are taking an antipsychotic medicine called thioridazine or the antipsychotic called pimozide.
• if you are allergic (hypersensitive) to paroxetine or to any of the other components of PAROXETINE NORMON (see section “Additional information”).

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

Take special care with PAROXETINE NORMON

Consult your doctor

• if you are taking other medicines (see section “Use of other medicines”).
• if you are taking tamoxifen for the treatment of breast cancer (or fertility problems). PAROXETINE NORMON 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 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 being treated with 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 and breastfeeding”).
• 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 section “Pregnancy and breastfeeding”).
• if you are under 18 years of age (see section “Children and adolescents under 18 years of age”).

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

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

Children and adolescents under 18 years of age:

PAROXETINE NORMON 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 an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking PAROXETINE NORMON. Nevertheless, your doctor may prescribe PAROXETINE NORMON to patients under 18 years of age if they decide it is most appropriate for the patient. If your doctor has prescribed PAROXETINE NORMON to you or 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 begin while you or your child under 18 years of age are taking PAROXETINE NORMON. The long-term effects of PAROXETINE NORMON on safety regarding growth, maturation, and cognitive and behavioral development in this age group have not yet been established.

In studies conducted with PAROXETINE NORMON in patients under 18 years of age, the frequent adverse effects, affecting fewer than 1 in 10 children or adolescents, were: increased suicidal thoughts and attempts, self-harm attempts, hostile, aggressive, or uncooperative behaviors, loss of appetite, tremors, abnormal sweating, hyperactivity (excessive energy), agitation, emotional instability (including crying and mood changes), and occurrence of unexplained bruises or bleeding (such as nosebleeds). These effects were also observed, although less frequently, in patients included in these studies who did not take PAROXETINE NORMON.

When discontinuing treatment with PAROXETINE NORMON, in these studies some patients under 18 years of age reported adverse effects. These effects were very similar to those observed in adults who discontinued treatment with PAROXETINE NORMON (see section “How to take PAROXETINE NORMON”). In addition, patients under 18 years of age frequently experienced (affecting fewer than 1 in 10) stomach pain, nervousness, and emotional instability (including crying, mood changes, self-harm attempts, and 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 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 treated with antidepressants.

If at any time you have thoughts of harming yourself or of suicide, 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 NORMON:

Some patients taking PAROXETINE NORMON develop a condition called akathisia, and feel restless and unable to sit still or remain still. Other patients develop a condition called “serotonin syndrome”, and may experience one or more of the following symptoms: confusion, restlessness, sweating, tremor, chills, hallucinations (strange visions or sounds), sudden jerking movements, or increased heart rate. Consult your doctor if you experience any of these symptoms. For more information on this or other adverse effects of PAROXETINE NORMON, see section 4, “Possible adverse effects”, in this leaflet.

Use of other medicines

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

• Medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylene blue chloride (methylene blue)). See section “Do not take PAROXETINE NORMON”.
• Medicines called thioridazine or pimozide, which are antipsychotics. See section “Do not take PAROXETINE 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 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.
• 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 medicines used to treat cardiac rhythm disorders.
• Metoprolol, a beta-blocker used to treat high blood pressure and heart disorders.
• 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 consult what you should do. Your doctor may decide to change the dose or prescribe another medicine.

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Taking PAROXETINE NORMON with food and drinks

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

Taking PAROXETINE NORMON in the morning with food may reduce the likelihood of nausea occurring.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking any medication.

If you take PAROXETINE NORMON in the late stages of pregnancy, there may be an increased risk of severe 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 NORMON so they can advise you appropriately.

Inform your doctor immediately if you are pregnant, think you may be pregnant, or are planning to become pregnant. In some studies, an increased risk of birth defects—particularly those affecting the heart—has been observed in newborns whose mothers took PAROXETINE NORMON during the first months of pregnancy. In the general population, approximately 1 out of every 100 newborns is born with a heart defect. This rate increased to 2 out of every 100 newborns in mothers who took PAROXETINE NORMON. Your doctor, in agreement with you, may decide to switch you to another treatment or gradually discontinue treatment with PAROXETINE NORMON during pregnancy. However, depending on your individual circumstances, your doctor may recommend continuing PAROXETINE NORMON.

Ensure that your doctor or midwife knows you are taking PAROXETINE NORMON. Medicines such as PAROXETINE NORMON may increase the risk of a serious condition called persistent pulmonary hypertension in newborns (PPHN) when taken during pregnancy, particularly in the later stages. In newborns with persistent pulmonary hypertension (PPHN), the pressure in the blood vessels connecting the heart and lungs is very high.

If you are taking PAROXETINE NORMON during the third trimester of pregnancy, your newborn may also experience other symptoms, which typically begin within the first 24 hours after birth. These symptoms may include:

• Difficulty breathing.
• Bluish skin or appearance of being too hot or too cold.
• Blue lips.
• Vomiting or difficulty feeding.
• Extreme tiredness, trouble sleeping, or frequent crying.
• Muscle stiffness or floppiness.
• Tremors, irritability, or seizures.

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 NORMON passes into breast milk in very small amounts. Consult your doctor if you are taking PAROXETINE NORMON before starting breastfeeding. Your doctor, in agreement with you, may advise continuing breastfeeding while taking PAROXETINE NORMON.

Animal studies have shown that paroxetine may reduce sperm quality. Theoretically, this could affect fertility, but no impact on human fertility has been observed to date.

Driving and use of machines

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

PAROXETINE NORMON 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 NORMON

Follow exactly the instructions for administering PAROXETINE NORMON given by your doctor.

Consult your doctor or pharmacist if you have any doubts.

Sometimes you may need 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 NORMON. 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 the 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.

The tablets must not be chewed.

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 disease:

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

If you take more PAROXETINE NORMON than you should

Never take more tablets than your doctor has prescribed. If you or someone else takes more PAROXETINE NORMON than recommended, 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 taken.

A person who has taken an overdose of PAROXETINE NORMON may experience some of the symptoms listed in section 4, “POSSIBLE ADVERSE REACTIONS,” or any of the following symptoms: pupil dilation, fever, involuntary muscle contractions.

If you forget to take PAROXETINE 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 the 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 the 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 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 may feel worse before they start 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 two weeks after you started treatment.

If you stop treatment with PAROXETINE NORMON

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

When stopping treatment with PAROXETINE NORMON, your doctor will instruct you on 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 NORMON you are taking by 10 mg each week. Most people find that the possible symptoms occurring when stopping PAROXETINE NORMON 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 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 symptoms, you may still be able to discontinue treatment with PAROXETINE NORMON.

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 NORMON. Some of these effects occur more frequently than others.

Frequent adverse effects, which may affect up to 1 in 10 patients:

• Dizziness, unsteadiness, or balance disturbances

• Tingling, burning sensations, and less frequently, electric shock-like sensations, even in the head; tinnitus (ringing, buzzing, whistling, or other persistent noises in the ears)

• Sleep disturbances (vivid dreams, nightmares, inability to sleep)

• Anxiety

• Headaches

Uncommon adverse effects, which may affect up to 1 in 100 patients:

• Nausea (vomiting)
• Sweating (including night sweats)
• Restlessness or agitation
• Tremor
• Confusion or disorientation
• Diarrhea (loose stools)
• Increased sensitivity or irritability
• Visual disturbances
• Rapid or very strong heart palpitations.

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

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

4. Possible adverse effects

Like all medicines, PAROXETINE NORMON may have adverse effects, although not everyone will experience them. Adverse effects are more likely to occur during the first weeks of treatment with PAROXETINE NORMON.

Inform your doctor if you experience any of the adverse effects listed below during treatment with PAROXETINE NORMON.

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

Uncommon adverse effects, which 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, which may affect up to 1 in 1,000 patients:

• 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, known as akathisia. Increasing the dose of PAROXETINE NORMON 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, which may affect up to 1 in 10,000 patients:

• Allergic reactions to PAROXETINE NORMON.
• If you develop a skin rash with redness and lumps, swelling of the face, eyelids, lips, mouth or tongue, itching, or difficulty breathing or swallowing, 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

• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage), see “Pregnancy and breastfeeding” in section 2 for more information.
• Some people have experienced thoughts of harming themselves or suicide while taking PAROXETINE NORMON or shortly after stopping treatment (see section 2, before taking PAROXETINE NORMON).

Other possible adverse effects during treatment:

Very common adverse effects, which may affect more than 1 in 10 patients:

• Vomiting (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, which may affect up to 1 in 10 patients:

• 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, which may affect up to 1 in 100 patients:

• Transient increases in blood pressure, or transient decreases in blood pressure which 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.
• Dilation of the pupils.
• Skin rash.
• Confusion.
• Hallucinations (strange sounds or visions).
• Inability to urinate (urinary retention) or urinary incontinence (uncontrolled and involuntary urination).
• Decreased white blood cell count.

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

• Abnormal milk secretion in men and women.
• Slowing of the heartbeat.
• Effects on the liver seen in laboratory tests indicating liver function.
• Panic attacks.
• Very active behaviour or thoughts (mania).
• Feeling detached from oneself (depersonalisation).
• Anxiety.
• Irresistible need to move the legs (restless legs syndrome).
• Joint or muscle pain.

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

• 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), called erythema multiforme.
• Widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome).
• Widespread rash affecting a large area of the body with blisters and peeling of the skin (toxic epidermal necrolysis).
• Liver problems causing yellowing of the skin or whites of the eyes.
• Water or fluid retention causing swelling of arms or legs.
• Sensitivity to sunlight.
• Painful and prolonged erection of the penis.
• Decreased number of platelets in the blood.

Adverse effects with unknown frequency (cannot be estimated from available data):

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

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

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

If you have any doubts while taking PAROXETINE NORMON, consult your doctor or pharmacist.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of PAROXETINE NORMON

Keep out of the reach and sight of children.

Do not use PAROXETINE NORMON after the expiry date stated on the label and carton. The expiry date refers to the last day of the month indicated.

Do not store above 30°C. Keep in the original packaging to protect from light.

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

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

6. Additional information

Composition of PAROXETINA NORMON

The active substance is paroxetine (20 mg) as hydrochloride, hemihydrate.

The other components are:

• In the tablet core: calcium hydrogen phosphate dihydrate (E341), magnesium stearate (E470b), and sodium carboxymethyl starch (type A) from potato.
• In the tablet coating: hypromellose (E464), titanium dioxide (E171), macrogol 400, and polysorbate 80 (E433).

Appearance of the product and contents of the pack

PAROXETINA NORMON 20 mg film-coated tablets are white, oval-shaped tablets, marked on one side and with a score line on the other. They are available in packs of 14, 28 or 56 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.

This leaflet was last reviewed in: December 2023

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