Frosinor 20 mg film-coated tablets: detailed information

Patient Information Leaflet

Introduction

Patient Information Leaflet

Frosinor 20 mg film-coated tablets

paroxetine (as hemihydrochloride hydrate)

Read the entire 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; do not give it to others, even if they have the same symptoms as you, because it could harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

What Frosinor is and what it is used for
What you need to know before taking Frosinor
How to take Frosinor
Possible side effects
How to store Frosinor
Contents of the pack and other information

1. What Frosinor is and what it is 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, repetitive thoughts with uncontrollable behavior), panic disorder (panic attacks, including those caused by agoraphobia, which is the fear of open spaces), social anxiety disorder (fear of or avoidance of social interaction situations), post-traumatic stress disorder (anxiety caused by a traumatic event), and generalized anxiety disorder (chronically feeling excessive anxiety and nervousness).

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

2. What you need to know before taking Frosinor

Do not take Frosinor

if you are being treated with medicines called monoamine oxidase enzyme inhibitors (MAOIs, including moclobemide and methylene blue chloride), or if you have been treated with any of these medicines within the last two weeks. Your doctor will advise you on how to start taking Frosinor after stopping the MAOI.
if you are taking an antipsychotic medicine called thioridazine or the antipsychotic called pimozide.
if you are allergic to paroxetine or to any of the other ingredients of this medicine (listed in section 6).

If you are in any of these situations, inform 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 any kidney, liver, or heart problems
if you have an abnormality in your heart rhythm following an electrocardiogram (ECG) known as QT interval prolongation
if you have a family history of QT interval prolongation, heart conditions such as heart failure, slow heart rate, or low levels of potassium or magnesium
if you have epilepsy or experience seizures or epileptic fits
if you have had manic episodes (excessively active thoughts or behaviors)
if you are receiving electroconvulsive therapy (ECT)
if you are prone to bleeding or bruising, or are taking any medicine that may increase the risk of bleeding (including medicines such as warfarin (acenocoumarol), antipsychotics such as perphenazine or clozapine, tricyclic antidepressants, medicines for pain and inflammation called non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam)
if you have diabetes
if you are on a low-sodium diet
if you have glaucoma (increased eye pressure)
if you are pregnant or planning to become pregnant (see section Pregnancy, breastfeeding and fertility)
if you are under 18 years of age (see section Children and adolescents under 18 years of age).

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

Children and adolescents under 18 years of age

Frosinor should not be used to treat children and adolescents under 18 years of age. You should also be aware that in patients under 18 years of age, there is an increased risk of adverse effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking Frosinor. Nevertheless, your doctor may prescribe Frosinor to patients under 18 years of age if they consider it the most appropriate treatment. If your doctor has prescribed Frosinor for you or your child under 18 years of age and you wish to discuss this decision, speak to your doctor. You must inform your doctor if any of the symptoms listed above appear or worsen while you or your child under 18 years of age are taking Frosinor. The long-term effects of Frosinor on safety regarding growth, maturation, and cognitive and behavioral development in this age group have not yet been established.

In clinical studies of Frosinor in patients under 18 years of age, the common adverse effects, affecting less than 1 in 10 children or adolescents, included: increased suicidal thoughts and attempts, self-harm attempts, hostile, aggressive, or unfriendly behaviors, loss of appetite, tremors, abnormal sweating, hyperactivity (excessive energy), agitation, emotional instability (including crying and mood swings), and unexpected bruising or bleeding (such as nosebleeds). These effects were also observed, although less frequently, in patients in these studies who did not take Frosinor.

When stopping treatment with Frosinor, some patients under 18 years of age in these studies reported withdrawal-related adverse effects. These effects were very similar to those observed in adults who stopped taking Frosinor (see section 3). In addition, patients under 18 years of age frequently experienced (affecting less than 1 in 10) stomach pain, nervousness, and emotional instability (including crying, mood changes, self-harm attempts, suicidal thoughts, and suicide attempts).

Suicidal thoughts and worsening of your depression or anxiety disorder

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

You are more likely to experience this

If you have previously had thoughts of suicide or self-harm.
If you are a young adult. Clinical trial data show an increased risk of suicidal behavior in psychiatric patients under 25 years of age treated with antidepressants.

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

It may be helpful for you to explain to a family member or close friend that you are depressed or have anxiety disorders, and ask them to read this leaflet. You may also ask them to inform you if they think your depression or anxiety is worsening, or if they are concerned about changes in your behavior.

Important adverse effects observed with Frosinor

Some patients taking Frosinor develop a condition 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 experience one or more of the following symptoms: feeling very agitated or irritable, confusion, restlessness, feeling hot, sweating, tremor, chills, hallucinations (strange visions or sounds), muscle stiffness, sudden jerky movements, or increased heart rate. The condition may worsen and lead to loss of consciousness. Contact your doctor if you experience any of these symptoms. For more information about this or other adverse effects of Frosinor, see section 4.

Some medicines in the same class 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 alter the effect of Frosinor or make certain adverse effects more likely. Frosinor may also alter the effect of some medicines. For example:

Medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylene blue chloride). See section Do not take Frosinor.
Medicines known to increase the risk of changes in the electrical activity of the heart (e.g., the antipsychotics thioridazine or pimozide). See section Do not take Frosinor.
Acetylsalicylic acid, ibuprofen, and other medicines called non-steroidal anti-inflammatory drugs (NSAIDs) such as celecoxib, etodolac, diclofenac, and meloxicam, used to treat pain and inflammation.
Tramadol, buprenorphine, and pethidine, analgesics.
Buprenorphine combined with naloxone, a substitution treatment for opioid addiction.
Medicines called triptans, such as sumatriptan, used to treat migraine.
Other antidepressants, including other selective serotonin reuptake inhibitors and tricyclic antidepressants such as clomipramine, nortriptyline, and desipramine.
A dietary supplement called tryptophan.
Mivacurium and suxamethonium (used in anesthesia).
Medicines such as lithium, risperidone, perphenazine, clozapine (antipsychotics) used to treat certain psychiatric disorders.
Fentanyl, used in anesthesia or to treat chronic pain.
A combination of fosamprenavir and ritonavir, used to treat human immunodeficiency virus (HIV) infection.
St. John’s wort, a herbal remedy used to treat depression.
Phenobarbital, phenytoin, sodium valproate, or carbamazepine, used to treat seizures or epilepsy.
Atomoxetine, a medicine used to treat attention deficit hyperactivity disorder (ADHD).
Procyclidine, used to relieve tremors, especially in Parkinson’s disease.
Warfarin and other medicines (called anticoagulants) used to thin the blood.
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, inform your doctor and ask what you should do. Your doctor may decide to change your dose or prescribe a different medicine.

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Taking Frosinor with food, drinks, and alcohol

Do not consume alcohol while taking Frosinor. Alcohol may worsen your symptoms or adverse 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 are planning to become pregnant, consult 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 every 100 newborns is born with a heart malformation. This rate increased to 2 in every 100 newborns in mothers who took Frosinor. Your doctor, in agreement with you, may switch you to another treatment or gradually discontinue Frosinor during pregnancy. However, depending on your individual circumstances, your doctor may recommend continuing Frosinor.

Make sure your doctor or midwife knows that you are taking Frosinor. If you take Frosinor in the later stages of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife must be aware that you are taking Frosinor so they can provide appropriate advice. Medicines such as Frosinor may increase the risk of developing a serious condition called persistent pulmonary hypertension of the newborn (PPHN) when taken during pregnancy, particularly towards the end. In newborns with persistent pulmonary hypertension (PPHN), the pressure in the blood vessels between the heart and lungs is very high.

If you take Frosinor during the third trimester of pregnancy, your newborn may also experience other symptoms, which usually begin within the first 24 hours after birth. These symptoms may include:

difficulty breathing
bluish skin or appearance of being too hot or too cold
blue lips
vomiting or difficulty feeding
extreme tiredness, trouble sleeping, or frequent crying
muscle stiffness or floppiness
tremors, localized shaking, or seizures
exaggerated reflexes.

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

Frosinor passes into breast milk in very small amounts. Consult your doctor if you are taking Frosinor before starting breastfeeding. 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 effect has not yet been observed in people.

Driving and use of machines

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

Frosinor contains sodium

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

3. How to take Frosinor

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in 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 you should take:

Dosage	Number of tablets to take
10 mg	Half a tablet
20 mg	One tablet
30 mg	One and a half tablets
40 mg	Two tablets
50 mg	Two and a half tablets
60 mg	Three tablets

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

	Initial daily dose	Recommended daily dose	Maximum daily dose
Depression	20 mg	20 mg	50 mg
Obsessive-compulsive disorder	20 mg	40 mg	60 mg
Panic disorder	10 mg	40 mg	60 mg
Social anxiety disorder	20 mg	20 mg	50 mg
Post-traumatic stress disorder	20 mg	20 mg	50 mg
Generalized anxiety disorder	20 mg	20 mg	50 mg

Your doctor will tell you what dose to take when starting treatment with Frosinor. Most people begin to feel better after a couple of weeks. If you do not start to feel better after this time, consult your doctor, who will advise you on what to do. Your doctor may decide to gradually increase your 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 must not be chewed.

Your doctor will determine the duration of treatment. This period may extend for several months or even longer.

Elderly patients

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

Patients with kidney or liver problems

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

If you take more Frosinor than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount 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 listed in section 4, Possible side effects, or any of the following symptoms: fever, involuntary muscle contractions.

If you forget to take Frosinor

Take your medication at the same time every day.

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

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

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

What to do if you do not feel better

Frosinor will not improve your symptoms immediately; all antidepressants take time to work. Some people begin to feel better after a couple of weeks, but others may require more time. Some people taking antidepressants feel worse before they start to feel better. If you do not begin to feel better after a couple of weeks, inform your doctor, who will advise you on what to do. Your doctor may have scheduled a follow-up appointment two weeks after starting your treatment.

If you stop treatment with Frosinor

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

When stopping treatment with Frosinor, your doctor will advise you on how to gradually reduce the dose over a period of several weeks or months, which will help reduce the risk of experiencing withdrawal symptoms. One way to do this is to gradually reduce your current Frosinor dose by 10 mg each week. Most people find that any possible symptoms occurring when stopping Frosinor are mild and disappear on their own within two weeks. For others, these symptoms may be more severe or last longer.

If you experience withdrawal effects while stopping your treatment, your doctor may decide that you should stop more slowly. If you experience severe withdrawal symptoms, please consult your doctor. They may advise you to restart treatment and then stop again more gradually.

Even if you experience withdrawal effects, you may still be able to successfully stop treatment with Frosinor.

Possible withdrawal effects when stopping treatment

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

Frequent adverse effects

May affect up to 1 in 10 people

Dizziness, unsteadiness, or balance disturbances.
Tingling, burning sensations, and less frequently, electric shock-like sensations, even in the head; ringing, buzzing, hissing, or other persistent noises in the ears (tinnitus).
Sleep disturbances (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.
Tremor.
Confusion or disorientation.
Diarrhea (loose stools).
Feeling overly sensitive or irritable.
Visual disturbances.
Rapid or very strong palpitations.

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. Adverse effects are more likely to occur during the first weeks of treatment with Frosinor.

Inform your doctor if you experience any of the following adverse effects during treatment with Frosinor.

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

Uncommon adverse effects

May affect up to 1 in 100 people

If you have unusual bruising or bleeding, such as blood in vomit or stools, contact your doctor or go to hospital immediately.
If you are unable to urinate, contact your doctor or go to hospital immediately.

Rare adverse effects

May affect up to 1 in 1,000 people

If you experience seizures (epileptic fits), contact your doctor or go to hospital immediately.
If you feel restless or unable to sit still or remain still, known as akathisia. Increasing the dose of Frosinor may worsen your symptoms. If you feel this way, consult your doctor.
Tiredness, weakness, confusion, and muscle pain, stiffness, and lack of 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

Allergic reactions to Frosinor, which may be severe.

If you develop a rash with redness and lumps, swelling of the face, eyelids, lips, mouth or tongue, itching, or difficulty breathing (shortness of breath) or swallowing, and feel weak or faint, possibly leading to collapse or loss of consciousness, contact your doctor or go to hospital immediately.

If you notice any or all of the following symptoms, you may be experiencing serotonin syndrome or neuroleptic malignant syndrome. Symptoms include: feeling very agitated or irritable, confusion, restlessness, feeling hot, sweating, tremor, chills, hallucinations (strange sounds or visions), muscle rigidity, sudden jerky movements, or rapid heartbeat. Severity may increase and lead to loss of consciousness. If you feel this way, consult your doctor.
Acute glaucoma.

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

Frequency not known

Frequency cannot be estimated from the available data

Some people have experienced thoughts of harming themselves or suicide while taking Frosinor or shortly after stopping treatment (see Suicidal thoughts and worsening of depression or anxiety disorder in section 2).
Some people have experienced aggression while taking Frosinor.
Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage). See Pregnancy, breastfeeding and fertility in 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 unwell (nausea). This effect may be reduced 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 adverse effects

May affect up to 1 in 10 people

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

Uncommon adverse effects

May affect up 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.
Faster than normal heartbeat.
Lack of movement, stiffness, tremor, or abnormal movements of the mouth and tongue.
Dilatation of the 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 dosage.
Decreased white blood cell count.

Rare adverse effects

May affect up to 1 in 1,000 people

Abnormal production of breast milk in men and women.
Slowed heart rate.
Liver effects seen in laboratory tests indicating liver function abnormalities.
Panic attacks.
Excessively active behaviour or thoughts (mania).
Feeling detached from oneself (depersonalisation).
Anxiety.
Irresistible urge to move the legs (Restless Legs Syndrome).
Joint or muscle pain.
Increased blood levels of a hormone called prolactin.
Changes in menstrual periods (including heavy or irregular periods, bleeding between periods, or absence or delay of periods).

Very rare adverse effects

May affect up to 1 in 10,000 people

Skin rash, in which blisters resembling small targets (dark centres surrounded by a pale area, with a dark ring around) may appear, known as erythema multiforme.
Widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome).
Widespread rash affecting large areas of the body with blisters and skin peeling (toxic epidermal necrolysis).
Liver abnormalities causing yellowing of the skin or whites of the eyes.
Syndrome of inappropriate antidiuretic hormone secretion (SIADH), a condition in which the body retains excess water and sodium (salt) levels decrease due to inappropriate chemical signals. Patients with SIADH may feel severely unwell or may have no symptoms.
Water or fluid retention (causing swelling of arms or legs).
Sensitivity to sunlight.
Painful and prolonged penile erection.
Decreased platelet count in blood.

Frequency not known

Frequency cannot be estimated from the available data

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

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

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Frosinor

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date (EXP) stated on the packaging. The expiry date refers to the last day of the month indicated.

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

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

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

6. Contents of the pack and other information

Composition of Frosinor

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

The other components are:

In the tablet core: calcium hydrogen phosphate dihydrate (E341), magnesium stearate (E470b) and sodium carboxymethyl starch (type A) from potato.

In the tablet coating: hypromellose (E464), titanium dioxide (E171), macrogol 400 and polysorbate 80 (E433).

Appearance of the product and contents of the pack

Frosinor 20 mg film-coated tablets are white, oval-shaped tablets, marked with "20" on one side and a break line on the other. Each Frosinor pack contains child-resistant blisters of 4, 10, 14, 20, 28, 30, 50, 56, 60, 98, 100, 250 or 500 tablets.

Only certain pack 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

[email protected]

Manufacturer:

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

This medicinal product is authorized in the European Economic Area member states under the following names:

France	Paroxétine Biogaran
Hungary, Slovenia	Paroxat
Italy	Eutimil
Netherlands	Paroxetine GSK
Spain	Frosinor

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

Date of the most recent review of this leaflet: December 2023.

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