Paroxetine Almus Pharma

Package leaflet: Information for the patient

Paroxetine Almus Pharma 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. Never give it to other people, even if their symptoms are the same as yours, because it could 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 Paroxetine Almus Pharma is and what it is used for
2. What you need to know before taking Paroxetine Almus Pharma
3. How to take Paroxetine Almus Pharma
4. Possible side effects
5. How to store Paroxetine Almus Pharma
6. Contents of the pack and other information

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

Paroxetina Almus Pharma is a medicine used to treat depression and/or anxiety disorders in adults.
The anxiety disorders treated with this medicine 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), and generalized anxiety disorder (a general feeling of intense anxiety or nervousness).
Paroxetina Almus Pharma belongs to a group of medicines called SSRIs (selective serotonin reuptake inhibitors). It is not fully understood how this medicine and other SSRIs work, but they can help increase 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 Paroxetina Almus Pharma

Do not take Paroxetina Almus Pharma

• If you are taking other medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylene blue chloride), or have taken them at any time within the last two weeks. Your doctor will advise you on how to start treatment with Paroxetina Almus Pharma after stopping MAOIs.
• If you are taking an antipsychotic called thioridazine or an antipsychotic called pimozide.
• If you are allergic to paroxetine, soya, peanuts, or any of the other ingredients of this medicine (listed in section 6). If any of these cases apply to you, inform your doctor and do not take this medicine.

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

• Are you taking any other medicines? (see Other medicines and Paroxetina Almus Pharma, in this leaflet)
• Are you taking tamoxifen for the treatment of breast cancer or fertility problems? Paroxetina Almus Pharma may make tamoxifen less effective, so your doctor may recommend taking another antidepressant.
• Do you have kidney, liver, or heart problems?
• Do you have an abnormality in your heart trace after an electrocardiogram (ECG), known as prolonged QT interval?
• Do you have a family history of prolonged QT interval, heart diseases such as heart failure, slow heart rate, or low levels of potassium or magnesium?
• Do you suffer from epilepsy or have you previously had seizures or convulsions?
• Have you ever experienced episodes of mania (hyperactive behaviour or thoughts)?
• Are you undergoing electroconvulsive therapy (ECT)?
• Have you previously had bleeding disorders, or are you taking other medicines that may increase the risk of bleeding (these include medicines used to thin the blood, such as warfarin, antipsychotics like perphenazine or clozapine, tricyclic antidepressants, medicines used for pain and inflammation called non-steroidal anti-inflammatory drugs or NSAIDs, such as acetylsalicylic acid, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam)?
• Do you have diabetes?
• Are you following a low-sodium diet?
• Do you have glaucoma (increased pressure in the eye)?
• Are you pregnant or planning to become pregnant? (see Pregnancy, breastfeeding and fertility, in this leaflet)
• Are you under 18 years of age? (see Children and adolescents under 18 years of age, in this leaflet)

If you answered YES to any of these questions, and have not already discussed this with your doctor,
return to your doctor and ask what you should do about taking Paroxetina Almus Pharma.
Children and adolescents under 18 years of age
Paroxetina Almus Pharma must not be used in children and adolescents under 18 years of age.
Furthermore, patients under 18 years of age have an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, oppositional behaviour, and anger) when taking paroxetine. If your doctor has prescribed this medicine for you (or your child) and you wish to discuss it, return to your doctor. You must inform your doctor if any of the symptoms listed above appear or worsen while you (or your child) are taking this medicine. In addition, the long-term safety effects of paroxetine on growth, maturation, and cognitive and behavioural development in this age group have not yet been established.
In clinical studies with paroxetine in patients under 18 years of age, the common adverse effects affecting fewer than 1 in 10 children/adolescents were: increased suicidal thoughts and suicide attempts, deliberate self-harm, hostile, aggressive or unfriendly attitude, loss of appetite, tremors, abnormal sweating, hyperactivity (excess energy), agitation, changes in emotions (including crying and mood changes), and unusual bruising or bleeding (such as nosebleeds). These studies also showed that the same symptoms occurred in children and adolescents taking sugar pills (placebo) instead of paroxetine, although less frequently.
In these studies conducted in patients under 18 years of age, some patients experienced withdrawal symptoms after stopping paroxetine. These symptoms were mostly similar to those observed in adults after discontinuation of paroxetine (see section 3).
Additionally, patients under 18 years of age also commonly (in fewer than 1 in 10 cases) experienced stomach ache, feeling nervous, and changes in emotions (including crying, mood changes, self-harm attempts, suicidal thoughts and suicide attempts).

Suicidal thoughts and worsening of depression or anxiety disorder
If you are depressed and/or suffer from anxiety disorders, you may sometimes have thoughts of harming yourself or ending your life. These thoughts may increase when you first start taking antidepressants, as 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 of ending your life or harming yourself.
• 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 treated with an antidepressant.

If at any time you think about harming yourself or ending your life, contact your doctor or go directly to hospital.
It may be helpful to tell a family member or close friend that you suffer from depression or an anxiety disorder and ask them to read this leaflet.
You may also ask them to inform you if they think your depression or anxiety disorder is worsening, or if they are concerned about changes in your behaviour.

Important adverse effects observed with Paroxetina Almus Pharma
Some patients taking this medicine develop a condition called akathisia, in which they feel restless and unable to sit still or remain motionless. Other patients develop what is called serotonin syndrome or neuroleptic malignant syndrome, in which they experience some or all of the following symptoms: intense agitation or irritability, confusion, restlessness, feeling hot, sweating, tremors, chills, hallucinations (strange visions or sounds), muscle stiffness, sudden muscle spasms, or rapid heartbeat. Severity may increase, leading to loss of consciousness. If you notice any of these symptoms, contact your doctor. For further information on these or other adverse effects of this medicine, see section 4.
Medicines such as Paroxetina Almus Pharma (so-called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after discontinuation of treatment.

Other medicines and Paroxetina Almus Pharma
Some medicines may affect the action of Paroxetina Almus Pharma or may increase the likelihood of adverse effects. Paroxetina Almus Pharma may also affect the action of other medicines. These include:

• Medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylene blue chloride). See Do not take Paroxetina Almus Pharma, in this leaflet.
• Medicines known to increase the risk of altering the electrical activity of the heart (e.g., antipsychotics thioridazine or pimozide). See Do not take Paroxetina Almus Pharma, in this leaflet.
• Acetylsalicylic acid, ibuprofen, or other medicines called NSAIDs (non-steroidal anti-inflammatory drugs) such as celecoxib, etodolac, diclofenac, and meloxicam, used to treat pain and inflammation.
• Tramadol, buprenorphine, and pethidine, painkillers.
• Buprenorphine in combination with naloxone, opioid dependence replacement therapy.
• 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 and suxamethonium (used in anaesthesia).
• Medicines such as lithium, risperidone, perphenazine, clozapine (called antipsychotics) used to treat certain psychiatric conditions.
• Fentanyl, used in anaesthesia or for the treatment of chronic pain.
• A combination of fosamprenavir and ritonavir, used to treat human immunodeficiency virus (HIV) infection.
• St. John’s wort, a herbal preparation 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 control tremors, 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 (TB) 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 on this list and have not yet discussed it with your doctor, return to your doctor and ask what to do. It may be necessary to adjust the dose or use another medicine.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.

Paroxetina Almus Pharma with food, drinks and alcohol
Do not drink alcohol while being treated with this medicine. Alcohol may worsen your symptoms or side effects.
Taking this medicine in the morning with food will 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 taking this medicine. In babies whose mothers took paroxetine during the first months of pregnancy, there have been some reports indicating an increased risk of birth defects, particularly heart defects. In the general population, about 1 in 100 babies is born with a heart defect. This risk increased to 2 in 100 in cases where mothers took paroxetine. You and your doctor may decide whether it is better for you to switch to another treatment or gradually discontinue this medicine during pregnancy.
However, depending on the circumstances, your doctor may advise that it is better for you to continue taking this medicine.
Ensure that your midwife or doctor knows that you are taking Paroxetina Almus Pharma. If you take this medicine close to the end of pregnancy, there may be an increased risk of severe vaginal bleeding immediately after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should be informed that you are taking this medicine so they can advise you on what to do. Medicines such as Paroxetina Almus Pharma, when taken during pregnancy, particularly in late pregnancy, may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN). In PPHN, the blood pressure in the blood vessels between the baby’s heart and lungs is too high. If you take this medicine during the last three months of pregnancy, your newborn may also experience other conditions, which usually appear within the first 24 hours after birth. Symptoms include:

• breathing difficulties;
• bluish skin colour or abnormally high or low body temperature;
• blue lips;
• vomiting or poor feeding;
• extreme tiredness, insomnia, or excessive crying;
• stiff or floppy muscles;
• tremors, agitation, or seizures;
• exaggerated reflexes.

If your baby develops any of these symptoms after birth, or if you are concerned about your baby’s health, contact your doctor or midwife for advice.
Paroxetina Almus Pharma can pass into breast milk in very small amounts. If you are taking this medicine, return to your doctor and discuss it before starting breastfeeding. You and your doctor may decide that you can breastfeed while taking this medicine.
In animal studies, paroxetine has been shown to reduce sperm quality. In theory, this could affect fertility, but the impact on human fertility has not yet been observed.

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

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

Paroxetina Almus Pharma contains soya lecithin
This medicine contains soya lecithin. If you are allergic to peanuts or soya, do not use this medicine.

3. How to take Paroxetine Almus Pharma

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

The usual doses for the various conditions are reported in the following table.

Your doctor will advise you on the dose to take at the beginning of treatment with Paroxetina Almus Pharma.
Most people start to feel better after a couple of weeks. If you do not start to feel better after this time, talk to your doctor, who will be able to 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 the tablets with a glass of water.
Do not chew the tablets.
The tablet may be divided into equal doses.
Your doctor will tell you how long you need to continue taking the tablets. Treatment may last for several months or longer.

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

Patients with liver or kidney disease
If you have liver problems or severe kidney disease, your doctor may decide to prescribe a lower than normal dose of this medicine.

If you take more Paroxetina Almus Pharma than you should
Never take more tablets than recommended by your doctor. If you (or someone else) take too much Paroxetina Almus Pharma, contact your doctor or go to a hospital immediately and show them the medicine pack.
Someone who has taken an overdose of Paroxetina Almus Pharma may experience any of the symptoms listed in Section 4, Possible side effects, or the following symptoms: fever, uncontrollable muscle rigidity.

If you forget to take Paroxetina Almus Pharma
Take the medicine at the same time every day.
If you forget to take a dose and remember before going to bed, take it immediately and continue as usual the next day.
If you remember during the night or the following day, skip the missed dose. You may experience withdrawal symptoms, which should disappear once you take the 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 Pharma will not relieve your symptoms immediately. All antidepressants require time to work. Some people start to feel better within a couple of weeks, but for others it may take slightly longer. Some people taking antidepressants feel worse before they start to feel better. If you do not start to feel better after a couple of weeks, return to your doctor for advice. Your doctor should arrange to see you again a couple of weeks after starting treatment. Inform your doctor that you have not started to feel better.

If you stop taking Paroxetina Almus Pharma
Do not stop treatment with Paroxetina Almus Pharma unless your doctor tells you to.
When stopping treatment with Paroxetina Almus Pharma, your doctor will help you gradually reduce the dose over several weeks or months. This should help reduce the likelihood of withdrawal symptoms. One way to do this is by gradually reducing the dose of this medicine by 10 mg per week. Most people find that withdrawal symptoms from this medicine 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 symptoms during the period when you are stopping treatment, your doctor may decide that you should stop more slowly. If you experience severe withdrawal symptoms when stopping this medicine, contact your doctor. They may ask you to start taking the tablets again and then stop more slowly.
If you experience withdrawal symptoms, you will still be able to stop treatment with Paroxetina Almus Pharma.

Possible withdrawal symptoms when stopping treatment
Studies show that 3 out of 10 patients experience one or more symptoms when stopping paroxetine.
Some withdrawal symptoms occur more frequently than others when stopping treatment.

Common side effects
These may affect up to 1 in 10 people

• Dizziness, unsteadiness, or loss of balance
• Pins and needles sensations, burning sensations, (less commonly) electric shock sensations, even in the head, and ringing, buzzing, hissing, or other persistent noise in the ear (tinnitus)
• Sleep disturbances (vivid dreams, nightmares, inability to sleep)
• Feeling anxious
• Headache

Uncommon side effects
These may affect up to 1 in 100 people

• Nausea
• Sweating (including night sweats)
• Feeling restless or agitated
• Tremor
• Feeling confused or disoriented
• Diarrhoea (loose stools)
• Feeling emotional or irritable
• Visual disturbances
• Rapid or pounding heartbeat (palpitations)

Contact your doctor if you are concerned about withdrawal symptoms when stopping Paroxetina Almus Pharma.
If you have any 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 few weeks of treatment with this medicine.
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
These may affect up to 1 in 100 people

• If you have unusual bruising or bleeding, including blood in your vomit or stools, contact your doctor immediately or go to hospital straight away.
• If you are unable to pass urine, contact your doctor immediately or go to hospital straight away.

Rare side effects
These may affect up to 1 in 1,000 people

• If you have seizures (epileptic fits), contact your doctor immediately or go to hospital straight away.
• If you feel restless and as though you cannot sit still or remain motionless, you may have a condition called akathisia. Increasing the dose of this medicine may worsen these feelings. If you feel like this, contact your doctor.
• If you feel tired, weak or confused and notice your muscles are painful, stiff or uncoordinated, this may be due to low levels of sodium in the blood. If you notice these symptoms, contact your doctor.

Very rare side effects
These may affect up to 1 in 10,000 people

• Allergic reactions, which may be severe, to Paroxetina Almus Pharma. If you develop a red, swollen skin rash, swelling of the eyelids, face, lips, mouth or tongue, start to feel itchy, or have difficulty breathing (shortness of breath) or swallowing, and feel weak or confused, leading to collapse or loss of consciousness, contact your doctor or go to hospital immediately.
• If you develop some or all of the symptoms listed below, you may have a condition called serotonin syndrome or neuroleptic malignant syndrome. Symptoms include: feeling very agitated or irritable, confusion, restlessness, feeling hot, sweating, tremor, chills, hallucinations (strange visions or sounds), muscle rigidity, sudden muscle contractions, or rapid heartbeat. The condition may worsen, leading to loss of consciousness. If you feel like this, contact your doctor.
• Acute glaucoma. If your eyes become painful and you develop 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 this medicine or immediately after stopping it (see Suicidal thoughts and worsening of depression or anxiety disorder in section 2).
• Some people have shown aggression while taking this medicine.
• Heavy vaginal bleeding soon after childbirth (postpartum haemorrhage); for further information see Pregnancy, breastfeeding and fertility in section 2. If you experience these side effects, contact your doctor.

Other possible side effects during treatment

Very common side effects
These may affect more than 1 in 10 people

• Nausea. Taking the medicine in the morning with food will reduce the likelihood of this occurring.
• Changes in sex drive or sexual function. For example, lack of orgasm and, in men, abnormal erection and ejaculation.

Common side effects
These may affect up to 1 in 10 people

• Increased level of cholesterol in the blood.
• Loss of appetite.
• Poor sleep (insomnia) or feeling drowsy.
• Abnormal dreams (including nightmares).
• Dizziness or tremors.
• Headache.
• Difficulty concentrating.
• Feeling agitated.
• Unusual feeling of weakness.
• Blurred vision.
• Yawning, dry mouth.
• Diarrhoea or constipation.
• Vomiting.
• Weight gain.
• Sweating.

Uncommon side effects
These may affect up to 1 in 100 people

• A 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 rashes.
• Itching.
• Feeling confused.
• Hallucinations (strange visions or sounds).
• Reduced number of white blood cells.
• 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 of your blood sugar levels while taking Paroxetina Almus Pharma. Talk to your doctor about adjusting your insulin or diabetes medication dosage.

Rare side effects
These may affect up to 1 in 1,000 people

• Abnormal production of milk from the breast in both men and women.
• Slower than normal heartbeat.
• Liver effects shown by blood tests for liver function.
• Panic attacks.
• Hyperactive behaviour and thoughts (mania).
• Feeling detached from yourself (depersonalisation).
• Feeling anxious.
• Irresistible urge to move the legs (restless legs syndrome).
• Joint or muscle pain.
• Increased levels in the blood of a hormone called prolactin.
• Menstrual cycle disturbances (including heavy or irregular periods, bleeding between periods, or absence or delay of periods).

Very rare side effects
These may affect up to 1 in 10,000 people

• Skin rash, possibly with blisters and resembling 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, particularly 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 the skin or the whites of the eyes to turn yellow.
• Syndrome of inappropriate antidiuretic hormone secretion (SIADH), a condition causing excessive water retention and reduced sodium (salt) concentration in the body due to inappropriate 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.
• Persistent painful erection.
• Low platelet count in the blood.

Not known
Frequency cannot be estimated from the available data.

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

Some patients have developed ringing, buzzing, hissing, whistling, or other persistent noise in the ear (tinnitus) while taking paroxetine.
An increased risk of bone fractures has been observed in patients treated with this type of medicine.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Paroxetina Almus Pharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the carton after "Exp.". The expiry date refers to the last day of that month.
If you use tablets that have been split in half, take care to store them safely in their packaging.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 Pharma contains

• The active substance is paroxetine. Each 20 mg film-coated tablet contains 20 mg of paroxetine (as paroxetine hydrochloride).
• The other components are mannitol, microcrystalline cellulose, sodium carboxymethyl starch (type A), magnesium stearate. The film coating contains butyl methacrylate copolymer (E 100), partially hydrolysed polyvinyl alcohol (E 1203), titanium dioxide (E 171), talc (E 553b), soybean lecithin (E 322) and xanthan gum (E 415).

Description of the appearance of Paroxetina Almus Pharma and contents of the pack
The tablets are white, round, coated, biconvex, with a diameter of 10 mm, with a score line on one side and "P20" engraved on the other.
The tablet can be divided into equal doses.
Paroxetina Almus Pharma is available in blister packs containing 14, 28 and 56 film-coated tablets and in unit-dose divisible blister packs containing 14x1, 28x1 and 56x1 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Almus S.r.l.
Via Cesarea, 11/10
16121 Genoa
Italy
[email protected]

Manufacturer
Teva Pharma S.L.U.
C/C, n° 4, Poligono Industrial Malpica
50016 Zaragoza
Spain

This medicinal product is authorised in the European Economic Area Member States under the following names:
Denmark: Zakkinter
Spain: Paroxetina Almus Pharma 20 mg, 30 mg comprimidos recubiertos con película EFG
France: Paroxetine Almus Pharma 20 mg, comprimé pelliculé sécable
Italy: Paroxetina Almus Pharma