FROSINOR 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Frosinor 20 mg Film-Coated Tablets

paroxetine (as hydrochloride hemihydrate)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Frosinor and what is it used for

Frosinor is used for the treatment of depression and/or anxiety disorders in adults.The anxiety disorders for which Frosinor is indicated are: obsessive-compulsive disorder (obsessive thoughts, repetitive behavior), panic disorder (panic attacks, including those caused by agoraphobia, which is the fear of open spaces), social anxiety disorder (fear or avoidance of social contact), post-traumatic stress disorder (anxiety caused by a traumatic event), and generalized anxiety disorder (feeling normally very anxious and nervous).

Frosinor belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). The mechanism of action of Frosinor and other SSRIs is not fully understood, but they work by increasing the level of serotonin in the brain. Properly treating depression or anxiety disorder is important to help you feel better.

2. What you need to know before you take Frosinor

Do not take Frosinor

• if you are being treated with medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylthioninium chloride (methylene 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 Frosinor once you have stopped taking the MAOI.
• if you are taking an antipsychotic medicine called thioridazine or the antipsychotic called pimozide
• if you are allergicto paroxetine or any of the other ingredients of this medicine (listed in section 6).

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Frosinor

• if you are taking other medicines(see the section Other medicines and Frosinor)
• if you are taking tamoxifen for the treatment of breast cancer(or fertility problems). Frosinor may make tamoxifen less effective, so your doctor should recommend taking another antidepressant
• if you have kidney, liver, or heart problems
• if you have a heart condition known as prolongation of the QT intervalafter an electrocardiogram (ECG)
• if you have a family history of prolongation of the QT interval, heart disease such as heart failure, low heart rate, or low levels of potassium or magnesium
• if you have epilepsy or have had 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 easily, or are being treated with a medicine that may increase the risk of bleeding(including medicines such as warfarin (acenocoumarol), antipsychotics like perphenazine or clozapine, tricyclic antidepressants, medicines for pain and inflammation called non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam)

• 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, breastfeeding, and fertility)
• if you are under 18 years of age(see the section Children and adolescents under 18 years of age).

If you are in any of these situationsand have not yet talked to your doctor, ask your doctor how to take Frosinor.

Children and adolescents under 18 years of age

Frosinor 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 adverse effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritation) when taking Frosinor. Nevertheless, your doctor may prescribe Frosinor to patients under 18 years of age when they decide it is the most convenient for the patient. If your doctor has prescribed Frosinor to you or your child under 18 years of age and you wish to discuss this decision, talk to your doctor. You should inform your doctor if any of the symptoms mentioned above appear or worsen when you or your child under 18 years of age are taking Frosinor. The long-term effects of Frosinor on safety, related to growth, maturity, and cognitive and behavioral development in this age group, have not yet been demonstrated.

In studies conducted with Frosinor in patients under 18 years of age, the frequent adverse effects, which affected less than 1 in 10 children or adolescents, were: an increase in suicidal thoughts and attempts, self-harm behaviors, hostile, aggressive, or unfriendly behaviors, loss of appetite, tremors, abnormal sweating, hyperactivity (having too much energy), agitation, unstable emotions (including crying and mood swings), 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 Frosinor, although with less frequency.

When stopping treatment with Frosinor, in these studies, some of the patients under 18 years of age reported having withdrawal effects. These effects were very similar to those observed in adults who stopped treatment with Frosinor (see section 3). Additionally, patients under 18 years of age frequently experienced (affecting less than 1 in 10) stomach pain, nervousness, and unstable emotions (including crying, mood swings, self-harm behaviors, 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 may increase at the beginning of treatment with antidepressants, as all these medicines take time to work, which is usually a few weeks but sometimes may be longer.

This is more likely to happen

• If you have previously had thoughts of suicide or self-harm.
• If you are a young adult.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 an antidepressant.

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

It may be helpful for you to tell a relative 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 worried about changes in your behavior.

Important side effects seen with Frosinor

Some patients who take Frosinor develop a disorder called akathisia, and feel restless and unable to sit or stay still. Other patients develop a condition called serotonin syndrome or neuroleptic malignant syndrome, and may have some or all of the following symptoms: feeling very agitated or irritable, confusion, restlessness, feeling hot, sweating, trembling, chills, hallucinations (strange visions or sounds), muscle stiffness, sudden jerky movements, or increased heart rate. The severity can increase and lead to loss of consciousness. Talk to your doctorif you have any of these symptoms. For more information on this or other side effects of Frosinor, see section 4.

Some medicines in the same group as Frosinor (called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Other medicines and Frosinor

Some medicines may change the effect of Frosinor or make some side effects more likely. Frosinor may also change 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 Frosinor.
• Medicines known to increase the risk of changes in heart activity (e.g., antipsychotics thioridazine or pimozide). See the section Do not take Frosinor.
• 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, buprenorphine, and pethidine, painkillers.
• Buprenorphine combined with naloxone, substitution treatment for opioid addiction.
• 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.
• Mivacurium and suxamethonium (used in anesthesia).
• 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.
• 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, tell your doctor and ask what you should do. Your doctor may decide to change the dose or prescribe another medicine.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, even those bought without a prescription.

Taking Frosinor with food, drinks, and alcohol

Do not drink alcohol while taking Frosinor. Alcohol may worsen your symptoms or side effects.

Taking Frosinor 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, talk to your doctor or pharmacist before using this medicine.

In some studies, an increased risk of malformations, particularly those affecting the heart, has been observed in newborns whose mothers took Frosinor 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 Frosinor. Your doctor, in agreement with you, may change your treatment to another medicine or gradually stop Frosinor while you are pregnant. However, depending on your circumstances, your doctor may recommend continuing to take Frosinor.

Make sure your doctor or midwife knows you are taking Frosinor. If you take Frosinor in the final stage 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 Frosinor to advise you. Medicines like Frosinor may increase the risk of a serious condition called persistent pulmonary hypertension of the newborn (PPHN) when taken during pregnancy, particularly at the end of it. The pressure in the blood vessels between the heart and lungs is very high in newborns with PPHN.

If you are taking Frosinor 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
• blue-tinged skin or looking too hot or cold
• blue lips
• vomiting or difficulty feeding
• feeling very tired, difficulty sleeping, or frequent crying

stiffness or floppiness of the muscles

• tremors, localized tremors, or seizures
• exaggerated reflexes.

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.

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

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

Driving and using machines

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

Frosinor contains sodium

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

3. How to Take Frosinor

Follow your doctor's or pharmacist's administration instructions for this medication exactly.If you are unsure, consult your doctor or pharmacist again.

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

Normal doses for different indications are detailed in the following table:

Your doctor will indicate what dose you should take when starting treatment with Frosinor.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 indicate 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 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 Patients

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

Patients with Kidney or Liver Problems

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

If You Take More Frosinor Than You Should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 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 Frosinor may experience some of the symptoms that appear in section 4, Possible Adverse Effects,or some of the following symptoms: fever, involuntary muscle contraction.

If You Forget to Take Frosinor

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, skip the missed dose. You may suffer 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

Frosinorwill 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 starting to notice improvement. If you do not start to feel better after a couple of weeks, tell your doctor, who will indicate what to do. It is possible that your doctor has scheduled a follow-up appointment after 2 weeks of starting your treatment.

If You Interrupt Treatment withFrosinor

Do not interrupt treatment until your doctor indicates it.

When You Interrupt Treatment withFrosinor, your doctor will indicate how to gradually reduce the doses over a period of several weeks or months, which will help reduce the risk of suffering from withdrawal symptoms. One way to do this is to gradually reduce the dose of Frosinor you are taking by 10 mg each week. Most people consider that the possible symptoms that occur when treatment with Frosinor is interrupted are mild and disappear on their own within two weeks. For others, these symptoms can be more severe or last longer.

If You Suffer from Withdrawal Effectswhile interrupting your treatment, your doctor may decide to interrupt it more slowly. If you experience severe withdrawal symptoms, please consult your doctor. Your doctor may advise you to start treatment again and then interrupt it more slowly.

Although You May Suffer from Withdrawal Effects, You Will Be Able to Interrupt Your Treatment withFrosinor.

Possible Withdrawal Effects When Treatment is Interrupted

Studies have shown that 3 out of 10 patients experience one or more symptoms when they interrupt their treatment with Frosinor. Some of these effects occur more frequently than others.

Common Adverse Effects

May affect up to 1 in 10 people

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

Uncommon Adverse Effects

May affect up to 1 in 100 people

• 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 ofFrosinor.

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

4. Possible Adverse Effects

Like all medications, this medication can cause 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 Frosinor.

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

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

Uncommon Adverse Effects

May affect up to 1 in 100 people

• If you have bruises 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

May affect up to 1 in 1,000 people

• 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 Frosinor may worsen your symptoms. If you feel this way, consult your doctor.
• Fatigue, 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

• Severe allergic reactions to Frosinor.

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

• If you notice any or all of the following symptoms, you may be suffering from serotonin syndrome or neuroleptic malignant syndrome.The symptoms include: feeling very agitated or irritable, confusion, restlessness, feeling hot, sweating, trembling, chills, hallucinations (strange sounds or visions), muscle stiffness, sudden jerky movements, or rapid heartbeats. The severity can increase and lead to loss of consciousness. If you feel this way, consult your doctor.
• Acute glaucoma.

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

Frequency Not Known

The frequency cannot be estimatedfrom the available data

• Some people have experienced thoughts of self-harm or suicide while taking Frosinor or shortly after stopping treatment (see Suicidal Thoughts and Worsening of Your Depression or Anxiety Disorderin section 2).
• Some people have experienced aggression while taking Frosinor.
• Excessive vaginal bleeding shortly after childbirth (postpartum hemorrhage), see Pregnancy, Breastfeeding, and Fertilityin section 2 for more information.

If you experience these adverse effects, contact your doctor.

Other Possible Adverse Effects During Treatment:

Very Common Adverse Effects

May affect more than 1 in 10 people

• Feeling sick (nausea). 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

May affect up to 1 in 10 people

• 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

May affect up to 1 in 100 people

• 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.
• Skin 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 Frosinor. Consult your doctor about how to adjust your insulin or diabetes medication dose.
• Decreased white blood cell count.

Rare Adverse Effects

May affect up to 1 in 1,000 people

• 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.
• Increased levels of a hormone called prolactin in the blood.
• Menstrual disorders (including heavy or irregular periods, bleeding between periods, and absence or delay of period).

Very Rare Adverse Effects

May affect up to 1 in 10,000 people

• Skin rash, which can appear with blisters that have a target-like appearance (dark centers surrounded by a pale area, with a dark ring around) 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 over a large area of the body with blisters and peeling of the skin (toxic epidermal necrolysis).
• Liver disorders that turn the skin or the whites of the eyes yellow.
• Syndrome of inappropriate antidiuretic hormone secretion (SIADH), which is a condition in which the body develops an excess of water and a decrease in sodium (salt) concentration as a result of inappropriate chemical signals. Patients with SIADH may feel severely ill or may have no symptoms.
• Water or fluid retention (causing swelling of arms or legs).
• Sensitivity to sunlight.
• Painful and prolonged erection of the penis.
• Decreased platelet count in the blood.

Frequency Not Known

The frequency cannot be estimatedfrom the available data

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

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

It has been observed that people taking medications like Frosinor have a higher risk of bone fractures.

Reporting Adverse Effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects that do not appear in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Frosinor

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date (CAD) that appears on the packaging. 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 packaging.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofFrosinor

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 Package Contents

Frosinor 20 mg film-coated tablets are presented in the form of white, oval tablets, marked with “20” on one face and a break line on the other face. Each package of Frosinor contains child-resistant blisters of 4, 10, 14, 20, 28, 30, 50, 56, 60, 98, 100, 250, or 500 tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder:

GlaxoSmithKline, S.A.

P.T.M. C/ Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Tel: +34 900 202 700

es-ci@gsk.com

Manufacturer:

Delpharm Poznan Spólka Akcyjna ul. Grunwaldzka 189 60-322 Poznan Poland

This medication is authorized in the Member States of the European Economic Area with the following names:

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

Date of the Last Revision of this Leaflet:December 2023.

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