Leaflet: information for the user

Paroxetina Almus20 mg film-coated tablets EFG

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, consult 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.

Paroxetina Almus is used for the treatment of depression and/or anxiety disorders in adults.

The anxiety disorders for which Paroxetina Almus is indicated are:

• obsessive-compulsive disorders (repetitive obsessive thoughts with uncontrolled behavior),
• panic disorder (including panic attacks caused by agoraphobia, which is the fear of open spaces)
• social phobia disorder (fear or avoidance of social contact situations)
• post-traumatic stress disorder (anxiety caused by a traumatic event)
• generalized anxiety disorder (feeling excessively anxious or nervous).

Paroxetina Almus belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). We all have a substance called serotonin in our brain.

People who are depressed or have anxiety have lower levels of serotonin than other people. The exact mechanism of action of Paroxetina Almus and other SSRIs is not precisely known, but they exert their action by increasing the level of serotonin in the brain. Treating depression or anxiety disorders properly is important to help you feel better.

Do not take Paroxetina Almus

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Paroxetina Almus.

- if you are taking other medications (see the sectionUse of other medications and Paroxetina Almus)

- if you are taking tamoxifen for the treatment of breast cancer (or fertility problems). Paroxetina Almus may make tamoxifen less effective, so your doctor should recommend another antidepressant.

- if you have any kidney, liver or heart problems

- if you have epilepsy or if you 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 are being treated with a medication that may increase the risk of bleeding (including medications such as warfarin (acenocoumarol), antipsychotics such as perphenazine or clozapine, antidepressants such as tricyclic antidepressants, medications for pain and inflammation called nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam) or if you are pregnant (see “Pregnancy, breastfeeding and fertility”)

- if you have diabetes

- if you are on a low-sodium diet

- if you have glaucoma (elevated eye pressure)

- if you are pregnant or 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 take Paroxetina Almus.

Children and adolescents under 18 years of age

Paroxetina Almus should 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 (predominantly aggression, confrontational behavior and irritability) when taking Paroxetina Almus. Despite this, your doctor may prescribe Paroxetina Almus to patients under 18 years of age when they decide it is the best option for the patient. If your doctor has prescribed Paroxetina Almus to your child under 18 years of age and you wish 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 taking Paroxetina Almus.The long-term effects of Paroxetina Almus 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 in patients under 18 years of age, the frequent adverse effects, affecting 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 (excessive energy), agitation, unstable emotions (including crying and mood changes)and the appearance of fortuitous cardinals or bleeding (such as nasal bleeding). These effects were also observed in patients included in these studies who did not take paroxetine, although less frequently.

When discontinuing paroxetine treatment in these studies, some of the patients under 18 years of agereported experiencing withdrawal effects. These effects were very similar to those observed in adults who discontinued paroxetine treatment (see section 3 “How to take Paroxetina Almus”). In addition, patients under 18 years of age frequently (affecting 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

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

• This is more likely to happenifyou have previously hadthoughts of suicide orself-harm.
• if you are anadult young person. 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 friendwho is depressed or has 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 Paroxetina Almus

Some patients taking Paroxetina Almus develop a disorder 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 some 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 of Paroxetina Almus, see section 4Possible adverse effects,in this leaflet.

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

Other medications and Paroxetina Almus

Some medications may modify the effect of Paroxetina Almus or make it more likely for adverse effects to occur. Paroxetina Almus may also modify the effect of some medications. For example:

• Medications calledmonoamine oxidase inhibitors(MAOIs, including moclobemide and cloruro de metiltionina (methylen blue)). See the section “Do not take Paroxetina Almus”.
• Medications called thioridazine or pimozide, which areantipsychotics. See the section “Do not take Paroxetina Almus”.
• Aspirin, ibuprofen and other medications called nonsteroidal anti-inflammatory drugs (NSAIDs), such as celecoxib, etodolac, diclofenac and meloxicam, used to treatpain and inflammation.
• Tramadol and petidina,analgesics.
• Medications called triptans, such as sumatriptan, used formigraine.
• 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 treathuman immunodeficiency virus (HIV) infection.
• St. John's Wort, a medicinal plant 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 tremor, 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 pressureandheart disorders.
• Pravastatin, used to treathigh cholesterol.
• Rifampicin, used to treattuberculosis (TB)andleprosy.
• Linezolid, anantibiotic.
• Tamoxifen, used to treatbreast cancer (or fertility problems).

If you are taking or have taken recently 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 acquired without a prescription.

Taking Paroxetina Almus with food, drinks and alcohol

Do not consume alcohol while taking Paroxetina Almus. Alcohol may worsen your symptoms or adverse effects.

Taking Paroxetina Almus in the morning with food may reduce the likelihood of nausea.

Pregnancy, breastfeeding and fertility

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

In some studies, an increased risk of malformations, particularly those affecting the heart, was observed in newborns whose mothers took Paroxetina Almus during the first months of pregnancy. In the general population, approximately 1 in 100 newborns are born with a heart malformation. This proportion increased to 2 in 100 newborns in mothers who took Paroxetina Almus. Your doctor, in consultation with you, may change you to another treatment or discontinue Paroxetina Almus gradually while you are pregnant. However, depending on your circumstances, your doctor may recommend continuing to take Paroxetina Almus.

If you take Paroxetina Almus 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 Paroxetina Almus to be able to advise you.

Ensure that your doctor or midwife knows that you are taking Paroxetina Almus. Medications like Paroxetina Almus may increase the risk of a serious condition called persistent pulmonary hypertension of the newborn (PPHN) when taken during pregnancy and particularly in the final stages. The pressure in the blood vessels between the heart and lungs is very high in newborns with PPHN.

If you are taking Paroxetina Almus 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 very 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 baby's health,contact your doctor or midwife, who will advise you.

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

Studies in animals have shown that paroxetine reduces the quality of sperm. Theoretically, this may affect fertility, but this has not yet been observed in humans.

Driving and operating machinery

Some of the adverse effects that Paroxetina Almus may cause are dizziness, confusion, feeling of drowsiness or blurred vision. If you experience any of these effects, do not drive a vehicle or operate machinery.

Paroxetina Almus 20 mg tablets contain soy.

If you are allergic to peanuts or soy, do not take this medication.

Paroxetina Almus 20 mg tablets contain sodium.

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

Follow exactly the administration instructions of this medication indicated 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 to take:

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

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

Take the tablets in the morning, with food.The tablets should be swallowed with water.

Do not chew the tablets.

The tablet can be divided into equal doses.

Your doctor will tell you the duration of treatment. This period may be extended 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 Paroxetina Almus than usual.

If you take more Paroxetina Almus than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

A person who has taken an overdose of Paroxetina Almus may have some of the symptoms listed in section 4, Possible side effects, or some of the following symptoms: fever, involuntary muscle contractions.

If you forget to take Paroxetina Almus

Take your medication at the same time every day.

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

If you remember during the night or the next day, omit the missed dose. You may experience withdrawal symptoms, but 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

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

If you interrupt treatment with Paroxetina Almus

Do not interrupt treatment until your doctor tells you to.

When interrupting treatment with Paroxetina Almus, your doctor will tell you 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 of Paroxetina Almus you are taking by 10 mg each week. Most people consider the possible symptoms that occur when treatment with Paroxetina Almus is interrupted to be mild and disappear on their own in two weeks. For other people, 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 can still interrupt treatment with Paroxetina Almus.

Withdrawal symptoms when interrupting treatment

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

Frequent side effects

May affect up 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 sounds.
• Persistent in the ears (tinnitus).
• Sleep disturbances (vivid dreams, nightmares, inability to sleep).
• Anxiety.
• Headaches.

Less frequent side effects

May affect up to 1 in 100 people

• Nausea (vomiting).
• Sweating (including nocturnal sweating).
• Restlessness or agitation.
• Tremors.
• Confusion or disorientation.
• Diarrhea (soft stools).
• Feeling very sensitive or irritable.
• Visual disturbances.
• Palpitations.

Consult your doctor if you are concerned about withdrawal symptoms from Paroxetina Almus.

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 weeks of treatment with Paroxetina Almus.

Inform your doctor if you experience any of the side effects described during treatment with Paroxetina Almus:

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

Uncommon side effects

May affect up 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 experience difficulty urinating, contact your doctor or go to the hospital immediately.

Rare side 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 have a feeling of restlessness, inability to sit or stay still,known as akathisia. Increasing the dose of Paroxetina Almus may worsen your symptoms. If you feel this way,consult your doctor.
• Feeling tired, 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 side effects

May affect up to 1 in 10,000 people:

• Severe allergic reactions to Paroxetina Almus

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

• You may be experiencing a serotonin syndrome or neuroleptic malignant syndrome. 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 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 Paroxetina Almus or shortly after stopping treatment (see section 2What you need to know before starting to take Paroxetina Almus).
• Aggression.
• Heavy vaginal bleeding shortly after delivery (postpartum hemorrhage), see «Pregnancy» in section 2 for more information.

Other possible side effects during treatment

Very common side effects

May affect more than 1 in 10 people:

• Sensation of illness (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 side 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.
• Restlessness.
• Unusual weakness.
• Blurred vision.
• Yawning, dry mouth.
• Diarrhea or constipation.
• Vomiting.
• Weight gain.
• Sweating.

Uncommon side 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.
• Abnormal heart rhythms.
• Lack of movement, stiffness, tremor, or abnormal movements of the mouth and tongue.
• Pupil dilation.
• Skin rash.
• Itching.
• Confusion.
• Hallucinations (strange sounds or visions).
• Inability to urinate (urinary retention) or incontinence (uncontrolled and involuntary urination).
• If you are a diabetic patient, you may notice a loss of control over your blood sugar levels while taking Paroxetina Almus. Consult your doctor about how to adjust your insulin or diabetes medication dose.
• Decreased white blood cell count.

Rare side effects

May affect up 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 behaviors or thoughts (mania).
• Feeling disconnected from oneself (derealization).
• Anxiety.
• Irresistible need to move the legs (Restless Legs Syndrome).
• Muscle or joint pain.
• Increased levels of a hormone called prolactin.
• Changes in menstrual period (including heavy or irregular periods, bleeding between periods, and absence or delay of period).

Very rare side effects

May affect up to 1 in 10,000 people:

• Changes in the liver that turn the skin or the white of the eyes yellow.
• Decreased platelet count in the blood.
• 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 noises in the ears (tinnitus) while taking Paroxetina Almus.

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a 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. Website: 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 that appears on the blister pack, tablet container, or outer packaging. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Paroxetina Almus 20 mg tablets

The active ingredient is hydrochloride of paroxetine. Each film-coated tablet contains anhydrous paroxetine hydrochloride equivalent to 20 mg of paroxetine.

Tablet core: magnesium stearate, sodium starch glycolate (Type A) from potato,mannitol, microcrystalline cellulose.

Tablet coating:copolymer of methacrylic acid-methacrylate methyl ester (Eudragit E100), partially hydrolyzed polyvinyl alcohol, titanium dioxide (E-171), talc, soy lecithin (E-322), xanthan gum (E-415).

Appearance of the product and contents of the packaging

Paroxetina Almus 20 mg: film-coated tablets, round and biconvex, white to off-white, 10 mm in diameter, scored on the beveled edges and on both faces, and marked with P20 on one face.

The tablet can be divided into equal doses.

Packaging sizes:

Blister: 10, 12, 14, 28, 30, and 56 film-coated tablets.

Cylindrical white tablet container with white cap with desiccant (silica gel) containing: 20, 30, 60, and 100 film-coated tablets.

Only some packaging sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80Email: [email protected]

Responsible manufacturer

Actavis Ltd.

BLB 015-016, Bulebel Industrial Estate

ZTN 3000 Zejtun

Malta

Balkanpharma – Dupnitsa AD

3 Samokovsko Shosse Str.

Dupnitsa 2600

Bulgaria

This medicine is authorized in the member states of the European Economic Area with the following names:

Italy: Paroxetina Almus 20 mg compresse rivestite con film

Last review date of this leaflet:January 2024