Leaflet: information for the user

Frosinor 20 mg film-coated tablets

paroxetine (ashydrochloride hemihydrate)

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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 (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 excessively anxious and nervous).

Frosinorbelongs to a group of medications called selective serotonin reuptake inhibitors (SSRIs). The exact mechanism of action ofFrosinorand 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 Frosinor

• if you are being treated with medications called monoamine oxidase inhibitors(MAOIs, including moclobemide and methionine chloride (methylen blue)), or if you have been treated with any of these medications in the last two weeks. Your doctor will advise you how to start takingFrosinoronce you have stopped taking the MAOI
• if you are taking an antipsychotic medicationcalled thioridazine or the antipsychotic called pimozide
• if you are allergicto paroxetine or to any of the other components of this medication (included in section 6)

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

Warnings and precautions

Consult with your doctor or pharmacist before starting to take Frosinor

• if you are taking other medications (see the sectionOther medications 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 another antidepressant
• if you have any kidney, liver, or heart problems
• if you have a heart condition known as prolonged QT interval after an electrocardiogram (ECG)
• if you have a family history of prolonged QT interval, heart diseases such as heart failure, low heart rate, or low potassium or magnesium levels
• if you have epilepsy or if you experience seizures or convulsions
• if you have had manic episodes (excessively active thoughts or behaviors)
• 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 medication that may increase the risk of bleeding (including medications such as warfarin (acenocoumarol), antipsychotics such as perphenazine or clozapine, tricyclic antidepressants, pain and inflammation medications called nonsteroidal 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 if you think you may become pregnant (see the sectionPregnancy, breastfeeding, and fertility)
• if you are under 18 years of age (see the sectionChildren and adolescents under 18 years of age)

If you are in any of these situationsand have not yet consulted your doctor,ask your doctor how to takeFrosinor.

Children and adolescents under 18 years of age

Frosinorshould not be used in the treatment of children and adolescents under 18 years of age.Also, be aware that in patients under 18 years of age, there is a higher risk of adverse effects such as suicidal thoughts, suicidal ideation, and hostility (primarily aggression, confrontational behavior, and irritability) when takingFrosinor. Despite this, your doctor may prescribe Frosinor to patients under 18 years of age when they decide it is the best option for the patient. If your doctor has prescribed Frosinor to you or your child under 18 years of age and you want to discuss this decision, consult your doctor. Inform your doctor if any of the symptoms listed above appear or worsen when you or your child under 18 years of age are takingFrosinor. The long-term effects ofFrosinoron 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 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 behaviors, 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 takeFrosinor, although less frequently.

When discontinuing treatment withFrosinor, some patients under 18 years of age reported adverse effects of withdrawal. These effects were very similar to those observed in adults who discontinued treatment withFrosinor(see section3). In addition, patients under 18 years of age frequently (affecting less than 1 in 10) experienced stomach pain, nervousness, and unstable emotions (including crying, mood changes, self-harm, thoughts and attempts of suicide)

Suicidal thoughts and worsening of depression or anxiety disorder

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

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 behavior in adults under 25 years of age with psychiatric disorders who were being treated with some antidepressant.

If you have thoughts of harming yourself or committing 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 close friend that 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 adverse effects observed with Frosinor

Some patients takingFrosinordevelop a condition called akathisia, andfeel restless and unable to sit or stay still. Other patients develop the so-calledserotonin syndrome or malignant neuroleptic syndrome, and may have any or all of the following symptoms: feeling very agitated or irritable, confusion, restlessness, sensation of heat, sweating, tremors, chills, hallucinations (strange visions or sounds), muscle rigidity, sudden, rapid movements, or increased heart rate. The severity can increase and lead to loss of consciousness.Consult your doctorif you have any of these symptoms. For more information on this or other adverse effects ofFrosinor, see section4.

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

Other medications and Frosinor

Some medications may modify the effect ofFrosinoror make it more likely for some adverse effects to appear.Frosinormay also modify the effect of some medications. For example:

• Medications calledmonoamine oxidase inhibitors(MAOIs, including moclobemide and methionine chloride (methylen blue)). See the sectionDo not takeFrosinor.
• Medications known to increase the risk of changes in heart activity (e.g. theantipsychoticstioridazine or pimozide). See the sectionDo not takeFrosinor.
• Aspirin, ibuprofen, and other medications called nonsteroidal anti-inflammatory drugs (NSAIDs) such as celecoxib, etodolac, diclofenac, and meloxicam, used to treatpain and inflammation.
• Tramadol,buprenorphine, and petidina,analgesics.
• Buprenorphine combined with naloxone, treatment for opioid addiction.
• Medications 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.
• Mivacurio and suxamethonium (used in anesthesia).
• Medications such as lithium, risperidone, perphenazine, clozapine (antipsychotics) used to treat somepsychiatric disorders.
• Fentanyl, used inanesthesiaor to treatchronic pain.
• A combination of fosamprenavir and ritonavir, used to treatHIV infection.
• St. John's Wort, a medicinal herb to treatdepression.
• Phenobarbital, phenytoin, sodium valproate, or carbamazepine, used to treatseizuresorepilepsy.
• Atomoxetine, a medication used to treatattention deficit hyperactivity disorder (ADHD).
• Procyclidine, used to alleviate tremors, especially inParkinson's disease.
• Warfarin and other medications (called anticoagulants) used tothin the blood.
• Propafenone, flecainide, and medications used to treatheart rhythm disorders.
• Metoprolol, a beta-blocker used to treathigh blood pressure and heart disorders.
• Pravastatin, used to treathigh cholesterol.
• Rifampicin, used to treattuberculosis (TB)andleprosy.
• Linezolid, anantibiotic.
• Tamoxifen, used to treatbreast cancer(orfertility problems)

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

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

Taking Frosinor with food, drinks, and alcohol

Do not consume alcohol while takingFrosinor. Alcohol may worsen your symptoms or adverse effects.

TakingFrosinorin the morning with food may reduce the likelihood of nausea.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may become pregnant, consult your doctor or pharmacist before using this medication.

In some studies, there was an increased risk of malformations, particularly those affecting the heart, in newborns whose mothers took Frosinor 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 Frosinor. Your doctor, in consultation with you, may change your medication or gradually discontinue 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 that you are taking Frosinor.If you take Frosinor in the final stages of pregnancy, there may be an increased risk of excessive vaginal bleeding 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.Frosinor may increase the risk of a serious condition called persistent pulmonary hypertension of the newborn (PPHN) when taken during pregnancy and particularly at 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 Frosinor in the last trimester of pregnancy,your newborn may also experience other symptoms that usually begin within the first 24 hours after birth. These symptoms include:

- difficulty breathing

- blue-tinged 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, localized tremors, or convulsions

- 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.Consult your doctor if you are taking Frosinor before starting to breastfeed. Your doctor, in consultation with you, may advise you to continue breastfeeding while taking Frosinor.

Studies in animals have shown that paroxetine reduces sperm quality. Theoretically, this may affect human fertility, but this impact has not yet been observed in people.

Driving and operating machinery

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

Frosinor contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.

Sometimes 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 indicate what dose to 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 treatment. This period may be prolonged for several months or even longer.

Patients over 65 years old

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.

Do not take more tablets than your doctor has recommended..

A person who has taken an overdose ofFrosinormay have some of the symptoms listed in section 4,Adverse reactions,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 remember to take it before going to bed, take it immediately. Take the next dose at the usual time.

If you remember it during the night or the next day, omit 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 compensate for the missed doses.

What to do if you don't feel better

Frosinorwill not improve your symptoms immediately, all antidepressants take time to act. Somepeople 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 improvement. If you do not start to feel better after a couple of weeks, inform your doctor, who will indicate what to do. Your doctor may have scheduled a follow-up appointment after 2 weeks of starting treatment.

If you interrupt treatment withFrosinor

Do not interrupt treatment until your doctor tells you to.

When interrupting treatment withFrosinor, your doctor will indicate how to gradually reduce the dose over a period of several weeks or months, which will help reduce the risk of withdrawal symptoms. One way to do this is to gradually reduce the dose ofFrosinoryou are taking by 10 mg each week. Most people consider the possible symptoms that occur when treatment withFrosinoris interrupted to be mild and disappear on their own in two weeks. For others, these symptoms may be more severe or last longer.

If you experience withdrawal symptoms while interrupting treatment, your doctor may decide to interrupt treatment 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 experience withdrawal symptoms, you will be able to interrupt treatment withFrosinor.

Withdrawal symptoms when interrupting treatment

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

Common adverse effects

May affectup to 1 in 10 people

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

Less common adverse effects

May affectup to 1 in 100 people

• Nausea (vomiting).
• 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 fromFrosinor.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. It is more likely that side effects will occur during the first few weeks of treatment withFrosinor.

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

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

Uncommon side effects

May affectup to 1 in 100 people

• 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 are unable to urinate, contact your doctor or go to the hospital immediately.

Rare side effects

May affectup to 1 in 1,000 people

• If you experience seizures(epileptic fits),contact your doctor or go to the hospital immediately.
• If you have restlessness, inability to sit or stay still,known as akathisia. Increasing the dose of Frosinor may worsen your symptoms. If you feel this way,see your doctor.
• Feeling tired, weak, confused, and painful, stiff, and lack of muscle coordination.This may be due to low sodium levels in the blood. If you have these symptoms,see your doctor.

Very rare side effects

May affectup to 1 in 10,000 people

• Allergic reactions to Frosinor that can be severe.

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

• If you notice any of the following symptoms, you may be experiencing 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 rigidity, sudden, rapid movements, or rapid heartbeat. The severity may increase and lead to loss of consciousness. If you feel this way,see your doctor.
• Acute glaucoma.

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

Frequency not known

The frequency cannot be estimatedfrom the available data

• Some people have experienced thoughts of self-harm or suicide while takingFrosinoror shortly after stopping treatment (seeThoughts of suicide and worsening of depression or anxiety disorderinsection 2).
• Some people haveexperiencedaggression while taking Frosinor.
• Heavy vaginal bleeding shortly after delivery (postpartum hemorrhage), seePregnancy, lactation, and fertilityin section 2 for more information.

If you experience these side effects, contact your doctor.

Other possible side effects during treatment:

Very common side effects

May affectmore than 1 in 10 people

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

Common side effects

May affectup to 1 in 10 people

• 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

May affectup to 1 in 100 people

• Transient increases in blood pressure, or transient decreases in blood pressure that may cause dizziness or fainting when standing up quickly.
• Abnormal heartbeats.
• Lack of movement, stiffness, tremor, 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 involuntary urination (incontinence).
• If you are a diabetic patient, you may notice loss of control of blood sugar levels while taking Frosinor. See your doctor about adjusting your insulin or diabetes medication dose.
• Decreased white blood cell count.

Rare side effects

May affectup to 1 in 1,000 people

• Abnormal milk secretion in men and women.
• Decreased heart rate.
• Liver effects that are seen in laboratory tests that indicate liver function.
• Panic attacks.
• Very active thoughts or behaviors (mania).
• Feeling disconnected from oneself (dissociation).
• Anxiety.
• Irresistible need to move legs (Restless Legs Syndrome).
• Muscle or joint pain.
• Increased levels of a hormone called prolactin in the blood.
• Changes in menstrual period (including heavy or irregular periods, bleeding between periods, and absence or delay of period).

Very rare side effects

May affectup to 1 in 10,000 people

• Skin rash, in which small blisters with a central dark spot surrounded by a pale area, with a dark ring around it, called erythema multiforme may appear.
• 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 over a large body surface (toxic epidermal necrolysis).
• Liver changes that turn the skin or the white of the eyes yellow.
• Syndrome of inappropriate antidiuretic hormone secretion (SIADH) that is a state in which the body develops an excess of water and a decrease in sodium concentration as a result of inappropriate chemical signals. SIADH patients may feel severely ill or have no symptoms.
• Water or fluid retention (causing swelling of arms or legs).
• Sensitivity to sunlight.
• Prolonged and painful erection of the penis.
• Decreased platelet count in the blood.

Frequency not known

The frequency cannot be estimatedfrom the available data

• Colitis (inflammation of the colon that causes diarrhea).
• Grinding of teeth.

Some patients have experienced persistent ringing, buzzing, hissing, or other sounds in the ears (tinnitus) while takingFrosinor.

It has been observed that people taking medications likeFrosinorhave a higher risk of bone fractures.

Reporting of side effects

If you experience any type of side effect, see your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date (EXP) that appears on the packaging. The expiration date is the last day of the month indicated.

Do not store above 86°F (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.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines you no longer need at theSIGREcollection point at the pharmacy. If in doubtask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Frosinor Frosinor

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

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 polisorbate 80 (E433).

Appearance of the product and content of the container

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

Only some container sizes may be commercially available.

Marketing authorization holder:

GlaxoSmithKline, S.A.

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

28760 Tres Cantos (Madrid)

Tel: +34 900 202 700

[email protected]

Responsible for manufacturing:

Del pharm Poznan Spólka Akcyjna
ul. Grunwaldzka 189
60-322 Poznan
Poland

This medicine 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.

Last review date of this leaflet: 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/