PAROXETINE NORMON 20 mg FILM-COATED TABLETS

2. Before taking PAROXETINE NORMON

Do not take PAROXETINE NORMON

• if you are being treated with medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylene blue), or if you have been under treatment with any of these medicines in the last two weeks.Your doctor will advise you on how to start taking PAROXETINE 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 any of the other ingredients of PAROXETINE NORMON (see the section "Further information").

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

Be careful with PAROXETINE NORMON

Consult your doctor

• if you are taking other medicines (see the section "Using 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 kidney, liver, or heart problems.
• if you have epilepsy or if you have seizures or epileptic fits.
• if you have had manic episodes (excessively active thoughts or behavior).
• if you are being treated with electroconvulsive therapy (ECT).
• if you have a tendency to bleed or bruise, or if you 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 treating pain and inflammation 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 think you may be 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 same group as Paroxetine Normon (called SSRIs) 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 your doctor 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.

Also, you should know that in patients under 18 years of age, there is a greater risk of side effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritation) when taking PAROXETINE NORMON. Nevertheless, your doctor may prescribe PAROXETINE NORMON to patients under 18 years of age when they decide it is most convenient 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 should inform your doctor if any of the symptoms mentioned above appear or begin when you or your child under 18 years of age are taking PAROXETINE NORMON. The long-term effects of PAROXETINE NORMON on safety, related to growth, maturity, and cognitive and behavioral development in this age group, have not yet been demonstrated.

In studies conducted with PAROXETINE NORMON in patients under 18 years of age, the frequent side effects, which affected less than 1 in 10 children or adolescents, were: an increase in suicidal thoughts and attempts, self-harm, hostile, aggressive, or unfriendly behavior, loss of appetite, tremors, abnormal sweating, hyperactivity (having too much energy), agitation, unstable emotions (including crying and mood changes), and the appearance of bruises or bleeding (such as nosebleeds). These effects were also observed in patients included in these studies who did not take PAROXETINE NORMON, although with less frequency.

When stopping treatment with PAROXETINE NORMON, in these studies, some of the patients under 18 years of age reported having side effects. These effects were very similar to those observed in adults who stopped treatment with PAROXETINE NORMON (see the section "How to take PAROXETINE NORMON"). Additionally, patients under 18 years of age frequently experienced (affecting less than 1 in 10) stomach pain, nervousness, and unstable emotions (including crying, mood changes, self-harm, 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 committing suicide.These can increase at the beginning of treatment with antidepressants, as all these medicines take time to work, which is usually a few weeks but can sometimes be longer.

This is more likely to happen

• There is information from clinical trials that shows an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders who were being treated with some antidepressant.

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

It may be useful for you to explain to a family member or close friendthat you are depressed or have anxiety disorders, and ask them to read this leaflet. You can also ask them to tell you if they think your depression or anxiety is getting worse, or if they are concerned about changes in your behavior.

Important side effects seen with PAROXETINE NORMON:

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

Using other medicines

Some medicines can change the effect of PAROXETINE NORMON or make some side effects more likely. PAROXETINE NORMON can also change the effect of some medicines. For example:

• Medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylene blue).See the section "Do not take PAROXETINE NORMON".
• Antipsychotic medicines called thioridazine or pimozide.See the section "Do not take PAROXETINE NORMON".
• Aspirin, 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, painkillers.
• Medicines called triptans, such as sumatriptan, used to treat migraines.
• 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 some 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 for 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 make the blood more fluid.
• Propafenone, flecainide, and medicines used to treat heart 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, tell your doctor and consult what to do. Your doctor may decide to change the dose or prescribe another medicine.

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

Taking PAROXETINE NORMON with food and drinks

Do not drink alcohol while taking PAROXETINE NORMON.Alcohol can worsen your symptoms or side effects.

Taking PAROXETINE 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 PAROXETINE NORMON in the final stages of pregnancy, there may be a greater risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders.Your doctor or midwife should know that you are taking PAROXETINE NORMON to advise you.

Tell 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 malformations, 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 in 100 newborns is born with a heart malformation. This proportion increased to 2 in 100 newborns in mothers who took PAROXETINE NORMON. Your doctor, in agreement with you, may change your treatment to another or gradually stop treatment with PAROXETINE NORMON while you are pregnant. However, depending on your circumstances, your doctor may recommend continuing to take PAROXETINE NORMON.

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

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

• Difficulty breathing.
• Bluish skin or looking too hot or cold.
• Bluish lips.
• Vomiting or difficulty feeding.
• Feeling very tired, difficulty sleeping, or frequent crying.
• Stiff or floppy muscles.
• Tremors, irritability, or seizures.

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

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

Driving and using machines

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

PAROXETINE NORMON contains sodium

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

3. How to take PAROXETINA NORMON

Follow your doctor's instructions for taking PAROXETINA NORMON exactly.

Consult your doctor or pharmacist if you have any doubts.

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

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

Your doctor will tell you what dose to take when you start treatment with PAROXETINA NORMON.Most people start to feel better after a couple of weeks. If after this time you do not start to feel better, consult your doctor who will 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 indicate the duration of the treatment. This period may be extended for several months or even longer.

Elderly:

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

Patients with kidney or liver disease:

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

If you take more PAROXETINA NORMON than you should

Never take more tablets than your doctor has recommended.If you or someone else takes more PAROXETINA NORMON than they should, consult your doctor or pharmacist or the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used.

A person who has taken an overdose of PAROXETINA NORMON may have some of the symptoms that appear in section 4, "Possible adverse effects" or some of the following symptoms: enlarged pupils, fever, involuntary muscle contraction.

If you forget to take PAROXETINA NORMON

Take your medication at the same time every day.

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

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

Do not take a double dose to make up for missed doses.

What to do if you do not feel better

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 require more time. Some people who take antidepressants feel worse before they start to notice an improvement. If you do not start to feel better after a couple of weeks, tell your doctor, who will tell you what to do. It is possible that your doctor has scheduled a follow-up appointment after 2 weeks of starting your treatment.

If you stop treatment with PAROXETINA NORMON

Do not stop treatment until your doctor tells you to.

When you stop treatment with PAROXETINA NORMON, your doctor will tell you 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 PAROXETINA NORMON you are taking by 10 mg each week. Most people consider that the possible symptoms that occur when stopping treatment with PAROXETINA NORMON are mild and disappear on their own within two weeks. For other people, these symptoms can be more severe or last longer.

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

Although you may experience some withdrawal effect, you will be able to stop your treatment with PAROXETINA NORMON.

Possible withdrawal effects 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, unsteady, or having balance problems
• Numbness, tingling, and, less frequently, electric shock sensations, even in the head, buzzing, whistling, ringing, or other persistent noises in the ears (tinnitus)
• Sleep disturbances (vivid dreams, nightmares, inability to sleep)
• Anxiety
• Headaches

Uncommon 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 very sensitive or irritable
• Visual disturbances
• Rapid or very strong heartbeats

Consult your doctor if you are concerned about the withdrawal effects of 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, PAROXETINA NORMON can have adverse effects, although not everyone will experience them. It is more likely that adverse effects will appear during the first few weeks of treatment with PAROXETINA NORMON.

Tell your doctor if you experience any of the adverse effects described below during treatment with PAROXETINA NORMON.

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

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

• If you have bruising or unusual bleeding, such as blood in your vomit or stools, contact your doctor or go to the hospital immediately.
• If you experience difficulty urinating, contact your doctor or go to the 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 the hospital immediately.
• If you feel restless, unable to sit still or stay still, called akathisia. Increasing the dose of PAROXETINA NORMON may worsen your symptoms. If you feel this way, consult your doctor.
• Feeling tired, weak, confused, and painful, stiff, and uncoordinated muscles. 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 PAROXETINA NORMON.
• If you develop a rash with redness and bumps, swelling of the face, eyelids, lips, mouth, or tongue, itching, or difficulty breathing or swallowing, contact your doctor or go to the hospital immediately.
• If you notice any 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 jerky 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.

Frequency not known

• Abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy and lactation" 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 adverse effects during treatment:

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

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

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

• Increased cholesterol levels in the blood.
• Decreased appetite.
• Difficulty sleeping (insomnia) or drowsiness.
• Abnormal dreams (including nightmares).
• Dizziness, tremors.
• Headache.
• Difficulty concentrating.
• Agitation.
• Unusual weakness.
• Blurred vision.
• Diarrhea 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 that can cause dizziness or fainting when standing up quickly.
• Faster than normal heartbeats.
• Lack of movement, stiffness, tremors, or abnormal movements of the mouth and tongue.
• Dilated pupils.
• Rash.
• Confusion.
• Hallucinations (strange sounds or visions).
• Inability to urinate (urinary retention) or uncontrolled urination (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.
• Decreased heart rate.
• Liver effects that appear in laboratory tests that indicate liver function.
• Panic attacks.
• Very active behavior or thoughts (mania).
• Feeling detached from oneself (depersonalization).
• Anxiety.
• Irresistible urge to move the legs (restless legs syndrome).
• Pain in joints or muscles.

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

• Rash with blisters that can appear with a target-like appearance (dark central spots surrounded by a pale area, with a dark ring around) called erythema multiforme.
• Widespread rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).
• Widespread rash over a large area of the body with blisters and skin peeling (toxic epidermal necrolysis).
• Liver disorders that turn the skin or the whites of the eyes yellow.
• Fluid retention or swelling that causes swelling of the arms or legs.
• Sensitivity to sunlight.
• Painful and prolonged erection of the penis.
• Decreased platelet count in the blood.

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

• Aggression.
• Teeth grinding
• Colon inflammation (causing diarrhea)

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

It has been observed that 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 that any of the adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of PAROXETINA NORMON

Keep out of the reach and sight of children.

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

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

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

Medicines should not be disposed of through wastewater or household waste. Deposit the containers and medicines you no longer need at the SIGRE collection point in 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.

6. Additional information

Composition of PAROXETINA NORMON

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

The other components are:

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

Appearance of the product and packaging content

PAROXETINA NORMON 20 mg film-coated tablets are white, oval, marked on one face and with a dividing 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 more information about your illness by contacting a patient organization. Consult your doctor.

This leaflet was revised in: December 2023

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