PROSPECTO: INFORMATION FOR THE USER

PAROXETINA NORMON 20 mgfilm-coated tablets

Paroxetine (as hydrochloride, hemihydrate)

Read this prospectus carefully before starting to take the medication.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

1. What is PAROXETINA NORMON and for what it is used

2. Before taking PAROXETINA NORMON

3. How to take PAROXETINA NORMON

4. Possible adverse effects

5. Storage of PAROXETINA NORMON

6. Additional information

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 (repetitive, obsessive thoughts with uncontrolled behavior), anxiety disorder (panic crises, including those caused by agoraphobia, which is the fear of open spaces), social anxiety disorder (fear or avoidance of social contact situations), post-traumatic stress disorder (anxiety caused by a traumatic event), and generalized anxiety disorder (feeling normally a lot of anxiety and nervousness).

PAROXETINA NORMON belongs to a group of medications called selective serotonin reuptake inhibitors (SSRIs). We all have a substance called serotonin in the brain. People who are depressed or have anxiety have lower levels of this substance. The exact mechanism of action of PAROXETINA NORMON and other SSRIs is not precisely known, but they exert their action by increasing the level of serotonin in the brain.

Treating depression or anxiety disorders properly is important to help you feel better.

Do not take PAROXETINA NORMON

• if you are being treated with medicines called monoamine oxidase inhibitors (MAOIs)(including moclobemide and methionine chloride (methylen blue)), or if you have been treated with any of these medicines in the last two weeks. Your doctor will advise you how to start taking PAROXETINA NORMON once you have stopped taking 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 PAROXETINA NORMON (see the section “Additional information”).

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

Be especially careful with PAROXETINA NORMON

Consult your doctor

• if you are taking other medicines (see the section “Use of other medicines”).
• if you are taking tamoxifen for the treatment of breast cancer (or fertility problems). PAROXETINA NORMON may make tamoxifen less effective, so your doctor should recommend another antidepressant.
• if you have any kidney, liver or heart problems.
• if you have epilepsy or if you have seizures or convulsions.
• if you have had manic episodes (excessively active thoughts or behaviour).
• if you are being treated with electroconvulsive therapy (ECT).
• if you have a tendency to bleed or bruise easily, or if you are being treated with a medicine that may increase the risk of bleeding (including medicines such as warfarin, acenocoumarol), antipsychotics such as perphenazine or clozapine, tricyclic antidepressants, pain and inflammation medicines called non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin, 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 if you think you may become pregnant (see the section “Pregnancy and breastfeeding”).
• if you are under 18 years of age (see the section “Children and adolescents under 18 years of age”).

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

If you are in any of these situationsand have not yet consulted your doctor, ask themabout how to take PAROXETINA NORMON.

Children and adolescents under 18 years of age:

PAROXETINA NORMON should not be used in the treatment of children and adolescents under 18 years.

Also, you should know that in patients under 18 years there is a higher risk of adverse effects such as suicidal thoughts, suicidal ideation and hostility (mainly aggression, confrontational behaviour and irritability) when taking PAROXETINA NORMON. Despite this, your doctor may prescribe PAROXETINA NORMON to patients under 18 years when they decide it is best for the patient. If your doctor has prescribed PAROXETINA NORMON to you or your child under 18 years and you wish to discuss this decision, consult your doctor. You should inform your doctor if any of the symptoms mentioned above appear or start when you or your child under 18 years are taking PAROXETINA NORMON. The long-term effects of PAROXETINA NORMON on safety, related to growth, maturity and cognitive and behavioural development in this age group have not yet been demonstrated.

In studies conducted with PAROXETINA NORMON in patients under 18 years, the most common adverse effects, which affected less than 1 in 10 children or adolescents, were: an increase in thoughts and attempts of suicide, self-harm, hostile, aggressive or unfriendly behaviour, loss of appetite, tremors, abnormal sweating, hyperactivity (having too much energy), agitation, unstable emotions (including crying and mood changes) and the appearance of fortuitous cardinals or bleeding (such as nasal bleeding). These effects were also observed in patients included in these studies who did not take PAROXETINA NORMON, although less frequently.

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

Suicidal thoughts and worsening of your depression or anxiety:

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

This is more likely to happen

• if you have previously had thoughts of suicide or self-harm.
• if you are ayoung adult. There is information from clinical trials that shows an increased risk of suicidal behaviour in young adults under 25 years with psychiatric illnesses being treated with some antidepressants.

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

It may be helpful for you to explain to a family member or a 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 behaviour.

Important adverse effects observed with PAROXETINA NORMON:

Some patients taking PAROXETINA NORMON develop a disorder called akathisia, andfeel restless and unable to sit or stay still. Other patients develop the so-called“serotonin syndrome”, and may have any or all of the following symptoms: confusion, restlessness, sweating, tremors, chills, hallucinations (strange visions or sounds), sudden, brief movements or increased heart rate. Consult your doctor if you have any of these symptoms. For more information on this or other adverse effects of PAROXETINA NORMON, see section 4. “Possible adverse effects”, in this leaflet.

Use of other medicines

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

• Medicines calledmonoamine oxidase inhibitors(MAOIs, including moclobemide and methionine chloride (methylen blue)). See the section “Do not take PAROXETINA NORMON”.
• Medicines called thioridazine or pimozide, which areantipsychotics. See the section “Do not take PAROXETINA NORMON”.
• Aspirin, ibuprofen and other medicines called non-steroidal anti-inflammatory drugs (NSAIDs), such as celecoxib, etodolac, diclofenac and meloxicam, used to treatpain and inflammation.
• Tramadol and petidina,analgesics.
• Medicines called triptans, such as sumatriptan, used to treatmigraine.
• Otherantidepressants, including other selective serotonin reuptake inhibitors and tricyclic antidepressants such as clomipramine, nortriptyline and desipramine.
• Adietary supplementcalled tryptophan.
• Medicines such as lithium, risperidone, perphenazine, clozapine (antipsychotics) used to treat somepsychiatric illnesses.
• Fentanil, used in anaesthesia or to treatchronic pain.
• A combination of fosamprenavir and ritonavir, used to treathuman immunodeficiency virus (HIV).
• St. John's Wort, a medicinal herb used to treatdepression.
• Phenobarbital, phenytoin, sodium valproate or carbamazepine, used to treatseizures or epilepsy.
• Atomoxetine, a medicine used to treatattention deficit hyperactivity disorder (ADHD).
• Procyclidine, used to relieve tremor, especially inparkinson's disease.
• Warfarin and other medicines (called anticoagulants) used tothin the blood.
• Propafenone, flecainide and medicines used to treatheart rhythm disorders.
• Metoprolol, a beta-blocker used to treathigh blood pressure and heart disorders.
• Rifampicin, used to treattuberculosis (TB)andleprosy.
• Linezolid, anantibiotic.
• Tamoxifen, used totreat breast cancer (orfertility problems).

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

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

Taking PAROXETINA NORMON with food and drinks

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

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

If you take PAROXETINA NORMON in the final stages of pregnancy, there may be an increased risk of heavy vaginal bleeding after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking PAROXETINA NORMON so they can advise you.

Inform your doctor immediately if you are pregnant, if you think you may be pregnant, or if you are planning to become pregnant.In some studies, there was an increased risk of malformations, particularly those affecting the heart, in newborns whose mothers took PAROXETINA NORMON during the first months of pregnancy. In the general population, approximately 1 in 100 newborns are born with a heart defect. This proportion increased to 2 in 100 newborns in mothers who took PAROXETINA NORMON. Your doctor, in consultation with you, may change your treatment or gradually stop taking PAROXETINA NORMON while you are pregnant. However, depending on your circumstances, your doctor may recommend continuing to take PAROXETINA NORMON.

Make sure your doctor or midwife knows that you are taking PAROXETINA NORMON. Medicines like PAROXETINA NORMON may increase the risk of a serious condition called persistent pulmonary hypertension of the newborn (PPHN) when taken during pregnancy and particularly towards the end of it. The pressure in the blood vessels between the heart and lungs is very high in newborns with persistent pulmonary hypertension (PPHN).

If you are taking PAROXETINA NORMON in the last trimester of pregnancy, your newborn may also present other symptoms that usually start within the first 24 hours after birth. These symptoms include:

• Difficulty breathing.
• Blue skin or appearance of being too hot or cold.
• Blue lips.
• Vomiting or difficulty feeding.
• Feeling very tired, difficulty sleeping or frequent crying.
• Muscle stiffness or flaccidity.
• Tremors, irritability or seizures.

If your baby has any of these symptoms at birth, or if you are concerned about your baby's health,contact your doctor or midwife,who will advise you.

PAROXETINA NORMONpasses into breast milk in very small amounts. Consult your doctor if you are taking PAROXETINA NORMON before starting to breastfeed. Your doctor, in consultation with you, may advise you to continue breastfeeding while taking PAROXETINA NORMON.

Paroxetine has been shown to reduce sperm quality in animal studies. Theoretically, this could affect fertility, but the impact on human fertility has not been observed so far.

Driving and operating machinery

Some of the adverse effects that PAROXETINA NORMON may cause are dizziness, confusion, feeling drowsy or blurred vision. If you experience any of these effects, do not drive vehicles or operate machinery.

PAROXETINA NORMON contains sodium

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

Follow exactly the administration instructions for PAROXETINA NORMON indicated by your doctor.

Consult your doctor or pharmacist if you have any doubts.

At times, you may need to take more than one tablet or half a tablet. The following table will show you how many tablets to take:

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

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

Take the tablets in the morning, with food..

The tablets should be swallowed whole with water..

The tablets should not be chewed.

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

Seniors:

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

Patients with kidney or liver disease:

If you have severe liver or kidney disease, your doctor may advise you to take smaller doses of PAROXETINA NORMON than usual.

If you take too much PAROXETINA NORMON

Never take more tablets than your doctor has recommended.If you or someone else has taken too much PAROXETINA NORMON, consult your doctor or pharmacist immediately, or the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

A person who has taken an overdose of PAROXETINA NORMON may have some of the symptoms listed in the "Possible Side Effects" section or some of the following symptoms: dilated pupils, 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 bedtime, take it immediately. Take the next dose at the usual time.

If you remember during the night or the next day, omit the missed dose. You may experience withdrawal symptoms, but these should disappear after taking the next dose at the usual time.

Do not take a double dose to compensate for the missed doses.

What to do if you don't feel better

PAROXETINA NORMON will not improve your symptoms immediately, all antidepressants take time to work. Some people start to feel better after a couple of weeks, but others may need more time. Some people who take antidepressants may feel worse before they start to notice an improvement. If you don't start to feel better after a couple of weeks, tell your doctor, who will tell you what to do. Your doctor may have scheduled a follow-up appointment after 2 weeks of starting treatment.

If you interrupt treatment with PAROXETINA NORMON

Do not stop treatment until your doctor tells you to.

When stopping treatment with PAROXETINA NORMON, your doctor will tell you how to gradually reduce the dose over several weeks or months, which will help reduce the risk of withdrawal symptoms. One way to do this is to gradually reduce the dose of PAROXETINA NORMON you are taking by 10 mg each week. Most people consider the possible symptoms that occur when stopping treatment with PAROXETINA NORMON to be mild and disappear on their own in 2 weeks. For some people, these symptoms may be more severe or last longer.

If you experience withdrawal symptoms while stopping treatment, your doctor may decide to stop treatment more gradually. If you experience severe withdrawal symptoms, please consult your doctor. Your doctor may advise you to start treatment again and then stop it more gradually.

Although you may experience some withdrawal symptoms, you can still be able to stop treatment with PAROXETINA NORMON.

Withdrawal symptoms when stopping treatment

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

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

• Feeling dizzy, unstable, or experiencing balance problems
• Tickling, burning sensations, and, less frequently, a feeling of electric shock, even in the head, buzzing, ringing, beeping, or other persistent sounds in the ears (tinnitus)
• Changes in sleep (vivid dreams, nightmares, inability to sleep)
• Anxiety
• Headaches

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

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

Consult your doctor if you are concerned about withdrawal symptoms from PAROXETINA NORMON.

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

Like all medications, PAROXETINA NORMON may have side effects, although not everyone will experience them. It is more likely that side effects will occur during the first weeks of treatment with PAROXETINA NORMON.

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

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

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

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

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

• If you experience seizures (epileptic crises), contact your doctor or go to the hospital immediately.
• If you experience restlessness, inability to sit or remain still, known as akathisia. Increasing the dose of PAROXETINA NORMON may worsen your symptoms. If you feel this way, consult your doctor.
• Fatigue, weakness, confusion, and pain, stiffness, and muscle coordination loss. This may be due to low sodium levels in the blood. If you have these symptoms, consult your doctor.

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

• Allergic reactions to PAROXETINA NORMON.
• If you develop a skin rash with redness and blisters, facial, eyelid, lip, mouth, or tongue swelling, itching, or difficulty breathing or swallowing, contact your doctor or go to the hospital immediately.
• If you notice any or all of the following symptoms, you may be experiencing a serotonin syndrome. The symptoms are: confusion, restlessness, sweating, tremors, chills, hallucinations (strange sounds or visions), sudden, rapid movements, or rapid heartbeats. If you feel this way, consult your doctor.
• Acute glaucoma.
• If you experience eye pain and blurred vision, consult your doctor.

Unknown frequency

• Heavy vaginal bleeding shortly after delivery (postpartum hemorrhage), see "Pregnancy and breastfeeding" in section 2 for more information
• Some people have experienced thoughts of self-harm or suicide while taking PAROXETINA NORMON or shortly after stopping treatment (see section 2, before taking PAROXETINA NORMON).

Other possible side effects during treatment:

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

• Vomiting (nausea). This side effect may decrease 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 side effects, which may affect up to 1 in 10 patients:

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

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

• Transient increases in blood pressure, or transient decreases that may cause dizziness or fainting when standing up quickly.
• Abnormal heartbeats.
• Lack of movement, stiffness, tremors, or abnormal movements of the mouth and tongue.
• Pupil dilation.
• Skin rash.
• Confusion.
• Hallucinations (strange sounds or visions).
• Inability to urinate (urinary retention) or involuntary urination (incontinence).
• Decreased white blood cell count.

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

• Abnormal milk secretion in men and women.
• Decreased heart rate.
• Liver effects that are seen in laboratory tests indicating liver function.
• Panic attacks.
• Very active behaviors or thoughts (mania).
• Feeling disconnected from oneself (dissociation).
• Anxiety.
• Irresistible urge to move legs (restless legs syndrome).
• Muscle or joint pain.

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

• Skin rash with small, pinpoint spots (erythema multiforme).
• Widespread rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).
• Widespread rash with blisters and skin peeling (toxic epidermal necrolysis).
• Liver changes that turn the skin or the white of the eyes yellow.
• Water retention or fluid accumulation that causes swelling of the arms or legs.
• Sensitivity to sunlight.
• Prolonged and painful erection of the penis.
• Decreased platelet count in the blood.

Side effects of unknown frequency (cannot be estimated from available data):

• Aggression.
• Teeth grinding.
• Colitis (inflammation of the colon that causes diarrhea).

Some patients have experienced persistent ringing, buzzing, beeping, or other sounds in the ears (tinnitus) when taking PAROXETINA NORMON.

People taking medications like PAROXETINA NORMON have a higher risk of bone fractures.

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

If you consider any of the side effects you are experiencing to be severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Keep out of reach and sight of children.

Do not use PAROXETINA NORMON after the expiration date that appears on the label and the carton. The expiration date is the last day of the month indicated.

Do not store at a temperature above30°C. Store in the original packaging to protect from light.

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

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need.This will help protect the environment.

Composition ofPAROXETINA NORMON

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

The other components are:

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

Appearance of the product and contents of the package

PAROXETINA NORMON 20 mg film-coated tablets are white, oval-shaped tablets, marked on one face and a line of division on the other.They are available in packages of14, 28 or 56 tablets.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

You can request more information about your disease by contacting a patient organization. Consult your doctor.

This leaflet was revised in: December 2023

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es.