Paroxetine Almus

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

Paroxetina Almus 20 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Paroxetina Almus is and what it is used for

Paroxetina Almus is a treatment for adults with depression and/or anxiety disorders.
The anxiety disorders for which treatment with Paroxetina Almus is indicated are:

• obsessive-compulsive disorder (repetitive, obsessive thoughts with uncontrollable behaviour),
• panic disorder (panic attacks, including those caused by agoraphobia, i.e. fear of open spaces),
• social anxiety disorder (fear of or avoidance of social situations),
• post-traumatic stress disorder (anxiety caused by a traumatic event),
• generalized anxiety disorder (feeling generally very anxious or nervous). Paroxetina Almus belongs to a group of medicines called SSRIs (selective serotonin reuptake inhibitors). A substance called serotonin is commonly found in the brain. People who are depressed or anxious have lower levels of serotonin than others. It is not fully understood how Paroxetina Almus and other SSRIs work, but they may help increase the level of serotonin in the brain. Treating depression or anxiety disorders appropriately is important to help you feel better.

2. What you need to know before taking Paroxetina Almus

Do not take Paroxetina Almus

• If you are allergic to paroxetina, peanuts, soya, or any of the other ingredients of Paroxetina Almus (listed in section 6).
• If you are taking other medicines called monoamine oxidase inhibitors (MAO inhibitors, including moclobemide and methylene blue (methylthioninium chloride)), or have taken them at any time during the previous two weeks. Your doctor will advise you on when to start taking Paroxetina Almus after stopping the MAO inhibitor.
• If you are taking an antipsychotic medicine called thioridazine or an antipsychotic called pimozide. If any of these cases apply to you, speak to your doctor before taking Paroxetina Almus.

Warnings and precautions
Talk to your doctor or pharmacist before taking Paroxetina Almus if:

• You are taking any other medicine (see section Other medicines and Paroxetina Almus below)?
• You are taking tamoxifen for the treatment of breast cancer (or fertility problems)? Paroxetina Almus may make tamoxifen less effective, so your doctor may recommend that you take another antidepressant.
• You have kidney, liver, or heart problems?
• You suffer from epilepsy or have previously had seizures?
• You have ever experienced episodes of mania (hyperactive behaviour or thoughts)?
• You are receiving electroconvulsive therapy (ECT)?
• You have previously had bleeding episodes, or you are taking other medicines that may increase the risk of bleeding (including blood-thinning medicines such as warfarin, antipsychotics such as perphenazine or clozapine, tricyclic antidepressants, medicines used for pain and inflammation called non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam), or if you are pregnant (see section Pregnancy, breastfeeding and fertility below)?
• You have diabetes?
• You are on a low-sodium diet?
• You have glaucoma (high pressure in the eye)?
• You are pregnant or planning to become pregnant (see section Pregnancy, breastfeeding and fertility below)?
• You are under 18 years of age (see section Children and adolescents under 18 years below)? If you answered YES to any of these questions and have not already discussed this with your doctor, please consult your doctor again and ask what you should do about taking Paroxetina Almus.

Children and adolescents under 18 years
Paroxetina Almus must not be used in children and adolescents under 18 years of age. In addition, patients under 18 years of age have an increased risk of experiencing adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, oppositional behaviour, and anger) when taking Paroxetina Almus. If your doctor has prescribed Paroxetina Almus for you (or for your child) and you wish to discuss this, please consult your doctor. You must inform your doctor if any of the symptoms listed above appear or worsen while you (or your child) are taking Paroxetina Almus. Furthermore, in this age group, the long-term effects of Paroxetina Almus on growth, maturation, and cognitive and behavioural development have not yet been established.
In clinical studies with paroxetina in patients under 18 years of age, the following common adverse effects were observed in fewer than 1 in 10 children/adolescents: increased suicidal thoughts and suicide attempts, deliberate self-harm, hostile behaviour, aggressive or unfriendly behaviour, loss of appetite, tremors, abnormal sweating, hyperactivity (excessive energy), restlessness, emotional changes (including crying and mood changes), and unusual bruising or bleeding (such as nosebleeds). These studies showed that the same symptoms also occurred in children and adolescents taking sugar pills (placebo) instead of Paroxetina Almus, although less frequently.
In these studies conducted in patients under 18 years of age, some patients experienced withdrawal symptoms after stopping Paroxetina Almus. These symptoms were mostly similar to those observed in adults after discontinuation of Paroxetina Almus (see section 3, How to take Paroxetina Almus, below). In addition, patients under 18 years of age commonly (in fewer than 1 in 10 cases) also experienced stomach pain, nervousness, and emotional changes (including crying, mood changes, self-harm attempts, suicidal thoughts, and suicide attempts).

Suicidal thoughts and worsening of depression or anxiety disorders
If you are depressed and/or suffer from anxiety disorders, you may sometimes have thoughts about harming yourself or committing suicide. These thoughts may be more common when you first start taking antidepressants, as all these medicines take time to work—usually about two weeks, but sometimes longer.
You may be more likely to have these types of thoughts:

• If you have previously had thoughts about suicide or self-harm.
• If you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in young adults under 25 years of age with psychiatric disorders who were treated with an antidepressant. If at any time you have thoughts about harming yourself or committing suicide, contact your doctor or go immediately to hospital. You may find it helpful to tell a relative or friend that you suffer from depression or anxiety disorders and ask them to read this leaflet. You may ask them to inform you if they think your depression or anxiety is worsening, or if they are concerned about changes in your behaviour.

Important adverse effects observed with Paroxetina Almus
Some patients taking Paroxetina Almus experience a condition called akathisia, meaning they feel restless and unable to sit or stand still. Other patients may develop what is known as serotonin syndrome or neuroleptic malignant syndrome, which may include some or all of the following symptoms: feeling very agitated or irritable, confusion, restlessness, feeling hot, sweating, tremors, chills, hallucinations (strange visions or sounds), muscle stiffness, sudden muscle contractions, or rapid heartbeat. The condition may worsen and lead to loss of consciousness. If you experience any of these symptoms, contact your doctor. For more information on these or other side effects of Paroxetina Almus, see section 4, Possible side effects, below.
Medicines such as Paroxetina Almus (so-called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may persist after stopping treatment.

Other medicines and Paroxetina Almus
Some medicines may interfere with the action of Paroxetina Almus or increase the likelihood of side effects. Paroxetina Almus may also interfere with the action of other medicines. These include:

• Medicines called monoamine oxidase inhibitors (MAO inhibitors, including moclobemide and methylene blue (methylthioninium chloride)) – see section Do not take Paroxetina Almus above.
• Thioridazine or pimozide, which are antipsychotics – see section Do not take Paroxetina Almus above.
• Acetylsalicylic acid, ibuprofen, or other medicines called NSAIDs (non-steroidal anti-inflammatory drugs) such as celecoxib, etodolac, diclofenac, and meloxicam, used for pain and inflammation.
• Tramadol and meperidine, painkillers.
• Medicines called triptans, such as sumatriptan, used to treat migraine.
• Other antidepressants, including other SSRIs and tricyclic antidepressants such as clomipramine, nortriptyline, and desipramine.
• A dietary supplement called tryptophan.
• Mivacurium or succinylcholine (used in anaesthesia).
• Medicines such as lithium, risperidone, perphenazine, clozapine (called antipsychotics) used to treat certain psychiatric conditions.
• Fentanyl, used in anaesthesia or for treating chronic pain.
• A combination of fosamprenavir and ritonavir, used to treat HIV infection.
• St. John’s wort, a herbal remedy for depression.
• Phenobarbital, phenytoin, sodium valproate, or carbamazepine, used to treat seizures or epilepsy.
• Atomoxetine, used to treat attention deficit hyperactivity disorder (ADHD).
• Procyclidine, used to treat tremor, especially in Parkinson’s disease.
• Warfarin or other medicines (called anticoagulants) used to thin the blood.
• Propafenone, flecainide, and medicines used to treat irregular heartbeat.
• Metoprolol, a beta-blocker used to treat high blood pressure and heart problems.
• Pravastatin, used to treat high cholesterol.
• Rifampicin, used to treat tuberculosis and leprosy.
• Linezolid, an antibiotic.
• Tamoxifen, used for the treatment of breast cancer (or fertility problems).

If you are taking or have recently taken any of the medicines listed above and have not yet discussed this with your doctor, please consult your doctor and ask what you should do. It may be necessary to adjust your dose or you may need to take a different medicine.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

Paroxetina Almus with food, drinks, and alcohol
Do not drink alcohol while taking Paroxetina Almus. Alcohol may worsen your symptoms and side effects. Taking Paroxetina Almus in the morning with food will reduce the likelihood of feeling unwell (nausea).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
There have been some reports in children of mothers who took Paroxetina Almus during the first months of pregnancy showing an increased risk of birth defects, particularly heart defects. In the general population, about 1 in 100 children is born with a heart defect. This risk increases to 2 in 100 children in mothers taking Paroxetina Almus. You and your doctor may decide whether it is better for you to switch to another treatment or gradually discontinue Paroxetina Almus during pregnancy. However, depending on your circumstances, your doctor may advise you that it is better for you to continue taking Paroxetina Almus.
If you take Paroxetina Almus near the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after childbirth, especially if you have bleeding disorders (a tendency to bleed easily). Inform your doctor or midwife that you are taking Paroxetina Almus so they can advise you accordingly.
Make sure your midwife or doctor knows that you are taking Paroxetina Almus.
When medicines such as Paroxetina Almus are taken during pregnancy, particularly in late pregnancy, they may increase the risk of a serious condition in the newborn called persistent pulmonary hypertension of the newborn (PPHN). In PPHN, the pressure in the blood vessels between the baby’s heart and lungs is too high. If you take Paroxetina Almus during the last three months of pregnancy, your newborn may also experience other conditions, usually starting within the first 24 hours after birth. Symptoms include:

• breathing difficulties
• bluish skin colour, or being too hot or too cold
• blue lips
• vomiting or poor feeding
• being very tired, inability to sleep, or excessive crying
• stiff or floppy muscles
• tremors, restlessness, or seizures
• 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 be able to advise you.

Paroxetina Almus passes into breast milk in very small amounts. If you are taking Paroxetina Almus, please consult your doctor before starting breastfeeding. You and your doctor can decide whether you can breastfeed while taking Paroxetina Almus.
Paroxetina has been shown to reduce sperm quality in animal studies. This could theoretically affect fertility, but no impact on human fertility has been observed so far.

Driving and using machines
Possible side effects of Paroxetina Almus include dizziness, confusion, drowsiness, or blurred vision. If you experience any of these side effects, do not drive or operate machinery.

Paroxetina Almus 20 mg contains soya
If you are allergic to peanuts or soya, do not use this medicine.

Paroxetina Almus 20 mg contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially ‘sodium-free’.

3. How to take Paroxetine Almus

Take this medicine exactly as directed by your doctor or
pharmacist. If you have any doubts, consult your doctor or pharmacist.
Sometimes it may be necessary to take more than one tablet or half a tablet. This table will show you how many tablets to take.

The usual doses for the different conditions are reported in the table below.

Your doctor will tell you what dose to take when you start taking Paroxetina Almus.
Most people feel better after a couple of weeks. If you do not start to feel better after this time, talk to your doctor, who will advise you. Your doctor may decide to gradually increase your dose by 10 mg at a time, up to the maximum daily dose.
Take the tablets in the morning with food.
Swallow them with water.
Do not chew them.
The tablet may be divided into equal doses.
Your doctor will tell you how long you will need to take your tablets. This may be for several months or even longer.

Elderly patients
The maximum dose for patients over 65 years of age is 40 mg daily.

Patients with liver or kidney disease
If you have liver problems or severe kidney disease, your doctor may decide to reduce your dose of Paroxetina Almus compared to the usual dose.

If you take more Paroxetina Almus than you should
Do not take more tablets than your doctor has recommended. If you take more Paroxetina Almus tablets than you should (or if someone else does), contact your doctor or go immediately to hospital. Show them the tablet packaging.
People who have taken an overdose of Paroxetina Almus may experience one of the symptoms listed in section 4, Possible side effects, or one of the following symptoms: fever, uncontrollable muscle stiffness.

If you forget to take Paroxetina Almus
Take your medicine at the same time every day.
If you forget to take a dose and remember before going to bed, take it immediately. Continue as usual the next day.
If you only remember during the night, or the following day, do not take the missed dose. You may experience withdrawal effects, but these should disappear once you take your next dose at the usual time.
Do not take a double dose to make up for a forgotten dose.

What to do if you do not feel better
Paroxetina Almus does not improve your symptoms immediately – all antidepressants need time to work. Some people start to feel better within a couple of weeks, but for others it may take a little longer. Some people taking antidepressants feel worse before they feel better. If you do not start to feel better after a couple of weeks, go back to your doctor, who will advise you. Your doctor should ask to see you again a couple of weeks after starting treatment. Tell your doctor that you have not started to feel better.

If you stop taking Paroxetina Almus
Do not stop taking Paroxetina Almus unless your doctor tells you to do so.
When stopping Paroxetina Almus, your doctor will help you gradually reduce the dose over several weeks or months – this should help reduce the possibility of withdrawal effects. One way to do this is to gradually reduce your dose of Paroxetina Almus by 10 mg per week. Most people find that any withdrawal symptoms from Paroxetina Almus are mild and disappear on their own within two weeks. For some people, these symptoms may be more severe or last longer.
If you experience withdrawal effects while stopping the tablets, your doctor may decide to stop them more slowly. If you have severe withdrawal effects when stopping Paroxetina Almus, contact your doctor. They may ask you to start taking the tablets again and stop them more slowly.
If you experience withdrawal effects, you will still be able to stop Paroxetina Almus.

Possible withdrawal effects when stopping treatment
Studies show that 3 out of 10 patients notice one or more symptoms when stopping Paroxetina Almus. Some withdrawal effects occur more frequently than others when stopping treatment.

Common side effects
May affect up to 1 in 10 patients

• Dizziness, feeling unsteady or loss of balance
• Prickling or tingling sensations, burning sensations, and (less commonly) electric shock sensations, even in the head, and ringing, buzzing, hissing, or other persistent noises in the ears (tinnitus)
• Sleep disturbances (vivid dreams, nightmares, inability to sleep)
• Feeling anxious
• Headache

Uncommon side effects
May affect up to 1 in 100 patients

• Feeling unwell (nausea)
• Sweating (including night sweats)
• Feeling restless or agitated
• Tremors
• Feeling confused or disoriented
• Diarrhoea (loose stools)
• Feeling emotional or irritable
• Visual disturbances
• Increased or stronger heartbeat (palpitations)

Talk to your doctor if you are concerned about withdrawal effects when stopping Paroxetina Almus.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. Side effects are more likely to occur during the first weeks of treatment with Paroxetina Almus.
Contact your doctor if you experience any of the following side effects during treatment.
You may need to contact your doctor or go to hospital immediately.

Uncommon side effects
May affect up to 1 in 100 patients

• If you have bruises or unusual bleeding, including 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 side effects
May affect up to 1 in 1,000 patients

• If you have seizures (epileptic fits), contact your doctor or go to hospital immediately.
• If you feel restless and have an inability to sit or stand still, you may be experiencing a condition called akathisia. Increasing the dose of Paroxetina Almus may worsen these sensations. If you feel this way, contact your doctor.
• If you feel tired, weak, or confused and have painful, stiff, or uncoordinated muscles, this may be due to low sodium levels in the blood. If you experience these symptoms, contact your doctor.

Very rare side effects
May affect up to 1 in 10,000 patients

• Allergic reactions to Paroxetina Almus, which may be severe.
• If you develop a skin rash with red, raised areas, swelling of the eyelids, face, lips, mouth or tongue, onset of itching, or have difficulty breathing (shortness of breath) or swallowing, and feel weak or dizzy to the point of collapsing or losing consciousness, contact your doctor or go to hospital immediately.
• If you have some or all of the following symptoms, you may be experiencing serotonin syndrome or neuroleptic malignant syndrome. Symptoms include: feeling very restless or irritable, confusion, agitation, feeling hot, sweating, tremors, chills, hallucinations (strange visions or sounds), muscle rigidity, sudden muscle contractions, or rapid heartbeat. Severity may increase, leading to loss of consciousness. If you feel this way, contact your doctor.
• Acute glaucoma. If you begin to experience eye pain and blurred vision, contact your doctor.

Not known
Frequency cannot be estimated from the available data

• Some people have had thoughts of harming themselves or of suicide while taking Paroxetina Almus or immediately after stopping treatment (see section 2, What you need to know before taking Paroxetina Almus).
• Some people have shown aggression while taking Paroxetina Almus. If you experience these side effects, contact your doctor.
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see section 2, Pregnancy, breastfeeding and fertility, for further information.

Other possible side effects during treatment

Very common side effects
May affect more than 1 in 10 patients

• Feeling unwell (nausea). Taking the medicine in the morning with food will reduce the likelihood of this occurring.
• Changes in sexual behaviour or sexual function. For example, lack of orgasm, and in men, abnormalities of erection and ejaculation.

Common side effects
May affect up to 1 in 10 patients

• Increased blood cholesterol levels
• Loss of appetite
• Poor sleep (insomnia) or feeling drowsy
• Abnormal dreams (including nightmares)
• Dizziness or tremors
• Headache
• Difficulty concentrating
• Feeling restless
• Unusually weak feeling
• Blurred vision
• Yawning, dry mouth
• Diarrhoea or constipation
• Vomiting
• Weight gain
• Sweating

Uncommon side effects
May affect up to 1 in 100 patients

• Short-term increase or decrease in blood pressure, which may cause dizziness or fainting when standing up suddenly
• Faster than normal heartbeat
• Lack of movement, stiffness, tremor, or abnormal movements of the mouth and tongue
• Dilated pupils
• Skin rash
• Itching
• Feeling confused
• Hallucinations (strange visions or sounds)
• Inability to urinate (urinary retention) or involuntary and uncontrollable loss of urine (urinary incontinence)
• 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 for adjustment of insulin or diabetes medication dosage.

Rare side effects
May affect up to 1 in 1,000 patients

• Abnormal milk production from the breast in men and women
• Slowed heartbeat
• Liver problems detectable through blood liver function tests
• Panic attacks
• Hyperactive behaviour or thoughts (mania)
• Feeling detached from oneself (depersonalization)
• Feeling anxious
• Irresistible urge to move the legs (Restless Legs Syndrome)
• Joint or muscle pain
• Increased blood levels of a hormone called prolactin
• Menstrual cycle disorders (including heavy or irregular periods, bleeding between periods, or absence or delay of periods)

Very rare side effects
May affect up to 1 in 10,000 patients

• Skin rash, which may appear as blisters and resemble small targets (dark central spots surrounded by a paler area, with a dark ring around the edge), known as erythema multiforme
• Widespread skin rash with blisters and peeling of the skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)
• Widespread skin rash with blisters and peeling of the skin over most of the body surface (toxic epidermal necrolysis)
• Liver problems causing yellowing of the skin and whites of the eyes
• Syndrome of inappropriate antidiuretic hormone secretion (SIADH), a condition in which the body retains excess water and has reduced sodium concentration (a salt), as a result of improper chemical signals. Patients with SIADH may become seriously ill or may have no symptoms at all
• Fluid or water retention (which may cause swelling of the arms or legs)
• Sensitivity to sunlight
• Painful erection of the penis that does not stop
• Low platelet count

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, whistling, or other persistent noises in the ear (tinnitus) while taking Paroxetina Almus.
An increased risk of bone fractures has been observed in patients taking this type of medicine.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Paroxetina Almus

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, container of tablets or carton. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Paroxetina Almus contains
The active substance is paroxetine:
Each film-coated tablet contains anhydrous paroxetine hydrochloride equivalent to 20 mg of
paroxetine.
The excipients are:
Tablet core: Magnesium stearate, methacrylic acid-methyl methacrylate copolymer (Eudragit E100), sodium starch glycolate (type A), mannitol, microcrystalline cellulose.
Tablet coating: Polyvinyl alcohol (partially hydrolyzed), titanium dioxide (E171), talc, soy lecithin (E322), xanthan gum (E415).

Description of the appearance of Paroxetina Almus and package contents
Film-coated tablets, white to cream-colored, round, biconvex, 10 mm in diameter, with a bevelled edge and a score line on both sides, and the imprint "P20" embossed on one side.
The tablet can be divided into equal parts.

Pack sizes:
Blister packs containing 10, 12, 14, 28, 30 and 56 film-coated tablets.
Cylindrical containers with white cap containing a desiccant (silica gel) holding 20, 30, 60, 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Almus S.r.l.
Via Cesarea 11/10
16121 – Genoa
E-mail: [email protected]

Manufacturers

• Actavis Ltd. BLB 016 Bulebel Industrial Estate - Zejtun ZTN 3000 - Malta
• Actavis hf. - Reykjavikurvegur 78, P.O. Box 420, 220 Hafnarfjordur - Iceland
• Balkanpharma - Dupnitsa AD - 3 Samokovsko Shosse Str. - Dupnitsa 2600 - Bulgaria

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