Package Insert: Information for the Patient

Paxtibi 25 mg Coated Tablets

nortriptilina hidrocloruro

Read this entire package insert carefully before taking this medicine, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others who may 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 package insert. See section 4.

Paxtibi contains the active ingredient nortriptyline.

Nortriptyline belongs to a group of medications known as tricyclic antidepressants, used for the treatment of major depressive episode in adults.

Do not take Paxtibi

• if you are allergic to nortriptyline or any of the other ingredients of this medication (listed in section 6),
• if you have recently had a myocardial infarction (heart attack) or have arrhythmias detected on an electrocardiogram (ECG) or any other cardiovascular problem,
• if you have bipolar disorder,
• if you are taking medications called monoamine oxidase inhibitors (MAOIs)

(MAOIs - other medications used for depression or selegiline (used to treat Parkinson's disease) or have taken them in the last 14 days: if you have taken any of these medications, you must wait 14 days before starting to take this medication.

• if you have taken moclobemide (for the treatment of depression), you must wait one day before starting to take this medication

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

Thoughts of suicide and worsening of depression

If you are depressed and/or have anxiety disorders, it is possible that you may sometimes think about harming yourself or taking your life. These types of thoughts may increase when you first start taking antidepressants, as all these medications take time to work, usually two weeks, but sometimes longer.

You may be more likely to have these types of thoughts:

• if you have had thoughts of taking your life or harming yourself before.
• if you are a young adult. The information from clinical trials has shown an increased risk of suicidal behavior in young adults (under 25 years old) with psychiatric disorders who received treatment with an antidepressant.

If you have thoughts of harming yourself or taking your life, contact your doctor or go to a hospital immediately.

It may be helpful to tell a family member or close friend that you are depressed and ask them to read this leaflet. You can 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.

Inform your doctor if you have or have had any medical problems, especially

• • if you have epilepsy, a history of seizures or convulsions
  • if you are agitated, hyperactive or have schizophrenia
  • if you have difficulty urinating
  • if you have an enlarged prostate
  • if you have severe liver disease
  • if you have severe heart disease
  • if you have thyroid disease
  • if you have narrow-angle glaucoma (vision loss due to abnormally high pressure in the eye)
  • if you are being treated for diabetes, as you may need to adjust your diabetes medication when you start treatment with Paxtibi.
  • if you have a mental illness (psychiatric disorder) other than depression.
  • if you are undergoing surgery. Inform your doctor that you are taking this medication.
  • if you have low blood pressure.
  • if you have sore throat, fever and flu-like symptoms in the first 10 weeks.
  • if you have pyloric stenosis (narrowing of the stomach outlet) and paralytic ileus (intestinal obstruction)
  • if you have high fever (hyperpyrexia).
• if you have a heart condition called Brugada syndrome
• • if you are taking opioids (e.g. buprenorphine). The use of these medications with Paxtibi may cause the serotonin syndrome, a potentially fatal disease (see "Other medications and Paxtibi").

Some patients with manic-depressive disorders may go through a manic phase. It is characterized by unusual and rapidly changing thoughts, excessive joy and excessive physical activity. In these cases, it is essential to consult your doctor.

Interval QT prolongado

A heart problem called "interval QT prolongado" (which appears on an electrocardiogram [ECG]) and heart rhythm disorders (irregular heartbeat) have been reported with nortriptyline. Inform your doctor if:

• you have a slow heart rate
• you have or have had a problem in which the heart cannot pump blood to the body as it should (a situation called heart failure)
• you are taking any other medication that may cause heart problems, or
• you have a problem that causes low levels of potassium or magnesium or high levels of potassium in the blood.

If you are scheduled for surgery, as you may need to stop taking nortriptyline before being given anesthetics. In the case of emergency surgery, inform the anesthesiologist about the treatment with nortriptyline, as it may increase the risk of arrhythmias and hypotension.

• if you have an overactive thyroid gland or are receiving thyroid medication

If you are taking antidepressants such as selective serotonin reuptake inhibitors (SSRIs), your doctor may consider changing your medication dose (see also section 2 "Taking Paxtibi with other medications" and section 3).

Children and adolescents

Do not administer this medication to children and adolescents under 18 years old for these treatments as the safety and efficacy have not been established in this age group.

Older adults

The dosage should be reduced in the elderly. Older adults have a higher probability of experiencing certain adverse effects such as dizziness when standing due to low blood pressure (see also section 4 "Possible side effects").

Other medications and Paxtibi

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication. Some medications may affect the functioning of other medications and this can sometimes cause severe side effects.

You should be especially careful if you are taking any of the following medications: monoamine oxidase inhibitors (MAOIs) such as moclobemide (for the treatment of depression) or selegiline (used to treat Parkinson's disease). These medications should not be taken at the same time as nortriptyline (see section 2 "Do not take Paxtibi").

• Certain antihypertensive medications such as clonidine and methyldopa. Medications such as Paxtibi may counteract the anti-hypertensive effect.
• thioridazine (used to treat schizophrenia)
• tramadol (for pain relief)
• opioids (e.g. buprenorphine) may interact with Paxtibi and you may experience symptoms such as involuntary muscle contractions, including those that control eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, high body temperature. Contact your doctor if you experience these symptoms
• Substances with a stimulating effect on a certain part of the nervous system (sympathomimetics) such as adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine and phenylpropanolamine (which may be present in medications for coughs or colds and in some anesthetics)
• anticholinergic medications such as certain medications for Parkinson's disease and gastrointestinal disorders (e.g. atropine)
• medications for high blood pressure such as, for example, calcium channel blockers (e.g. diltiazem, verapamil),
• medications for fungal infections (e.g. fluconazole, terbinafine, ketoconazole and itraconazole)
• sedatives (e.g. barbiturates)
• antidepressants (e.g. SSRIs [fluoxetine, paroxetine, fluvoxamine], duloxetine and bupropion)
• medications for certain heart conditions (e.g. beta-blockers and anti-arrhythmics)
• cimetidine (used to treat stomach ulcers)
• methamphetamine (used to treat ADHD)
• rifampicin (for treating infections)
• phenytoin and carbamazepine (used to treat epilepsy)
• thyroid medications
• valproic acid (a medication used to treat epilepsy and bipolar disorder).
• anticoagulant medications derived from coumarin or indandione.
• St. John's Wort (Hypericum perforatum), a herbal medication used for depression

You should also inform your doctor if you are taking or have taken recently medications that may affect heart rhythm such as, for example.medications for irregular heartbeats (e.g. quinidine and sotalol)

• astemizol and terfenadine (used to treat allergies and seasonal rhinitis)
• medications used to treat certain mental disorders (e.g. pimozide and sertindol)
• cisapride (used to treat certain types of indigestion)
• halofantrine (used to treat malaria)
• methadone (used to treat pain and for detoxification)
• diuretics ("urine tablets" such as, for example, furosemide

Taking Paxtibi with alcohol

Do not drink alcohol during treatment with this medication, as it may increase its sedative effect.

Pregnancy and breastfeeding

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

Nortriptyline is not recommended during pregnancy unless your doctor considers it clearly necessary and only after careful consideration of the benefit and risk. If you have taken this medication during the last part of pregnancy, the newborn may experience withdrawal symptoms such as irritability, increased muscle tension, tremors, irregular breathing, poor sucking, loud crying, urinary retention and constipation.

Your doctor will advise you if you should start/continue/stop breastfeeding or interrupt the use of this medication, taking into account the benefit of breastfeeding for the baby and the benefit of treatment for you.

Driving and operating machinery

This medication may cause drowsiness and dizziness, especially at the beginning of treatment. Do not drive or work with tools or machinery until you know how the treatment with nortriptyline affects you.

Paxtibi contains lactose and sunset yellow S

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

This medication contains sunset yellow S (E110, azoic dye).This medication may cause allergic reactions.

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

Adults

The daily dose for adults is 25 mg, 3 or 4 times a day, starting with a low dose and adjusting the dose. It can be administered once a day, usually at night, or 3 or 4 times a day.

It may take between 2 and 4 weeks to achieve a response. Doses above 150 mg per day are not recommended.

Older adults

The dosage for elderly patients is 25 to 50 mg per day in divided doses.

Treatment should be initiated with a low dose (10-20 mg per day) and increased as needed to a maximum dose of 50 mg.

If it is necessary to increase the dose in an elderly patient, the ECG should be checked and plasma nortriptyline levels monitored.

Pediatric population

Do not administer this medication to children and adolescents under 18 years of age for these treatments, as the safety and efficacy have not been established in this age group.

Liver and kidney insufficiency

It is recommended to reduce the dose in cases of liver or kidney insufficiency, as nortriptyline is extensively metabolized in the liver and primarily eliminated through the kidneys.

How to take Paxtibi

The tablets should be taken with water.

Treatment duration

Do not change the medication dose or interrupt treatment without consulting your doctor first.Continue taking this medication for as long as your doctor recommends.

The underlying disease may persist for a long time. If you stop treatment too soon, symptoms may reappear.

It is recommended to continue treatment for at least 6 months after feeling better.

If you take more Paxtibi than you should

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

If you accidentally take an extra Paxtibi tablet, you may experience or worsen side effects such as drowsiness, dry mouth, dizziness, or nausea.

The symptoms of overdose may include:

• drowsiness or excitement
• agitation and hallucinations
• loss of consciousness
• difficulty breathing, blue discoloration of the skin
• enlarged pupils
• seizures/convulsions
• cardiac disturbances, including arrhythmias (observed on an ECG, an investigation to evaluate heart function)
• low blood pressure, weak pulse, paleness
• metabolic disturbances
• dry mouth and tongue
• pulmonary edema
• fever
• coma
• urinary retention due to alterations in bladder emptying (urinary retention).
• reduced bowel movements (which may cause obstruction (constipation)
• confusion

The treatment of overdose should be done with general measures, gastric lavage, and assisted respiration.

If you forget to take Paxtibi

Take the next dose at the usual time. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Paxtibi

Your doctor will decide when and how to interrupt treatment to avoid any unpleasant symptoms that may occur if treatment is stopped abruptly (e.g., headache, feeling of discomfort, insomnia, and irritability).

Therefore, nortriptyline treatment should not be stopped abruptly. The dose should be gradually reduced over a week or more.

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.

If you notice any of the following symptoms, you should see your doctor immediately:

Prolonged QT interval heart problem (which can be seen on your electrocardiogram).Common side effect, may affect up to 1 in 10 people

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

• Yellowing of the skin and the white part of the eyes (jaundice). It is possible that your liver is affected.
• bruising, bleeding, paleness or persistent sore throat and fever.

• These symptoms may be the first signs of possible blood or bone marrow damage. Blood effects may be a decrease in the number of red blood cells (which transport oxygen throughout the body), white blood cells (which help fight infections) and platelets (which help with clotting).
• Thoughts or suicidal behavior.
• .
• Involuntary and rhythmic muscle contractions, including muscles that control eye movements, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, body temperature above 38 °C. (signs of serotonin syndrome, a potentially fatal condition).
• Important constipation, bloating of the stomach, fever and vomiting. These symptoms may be due to paralysis of parts of the intestine.

Very rare side effect, may affect up to 1 in 10,000 people).

• Intermittent blurred vision, rainbow vision and eye pain.

You should have an eye examination immediately before you can continue treatment with this medicine. These symptoms may be a sign of acute glaucoma (Very rare side effect, may affect up to 1 in 10,000 people).

The following side effects have been reported in the following frequencies:

Very common: may affect more than 1 in 10 peoplepeople

• drowsiness/drowsiness
• shaking, dizziness, headache
• irregular, strong or fast heartbeat (palpitations)
• dry mouth
• constipation
• nausea
• excessive sweating
• weight gain
• aggression
• nasal congestion
• eye focusing disorder eye focusing disorder (disorder that makes objects appear blurry)

Common: may affect up to 1 in 10 peoplepeople

• confusion
• sexual dysfunction (decreased libido, erectile dysfunction)
• attention disorders
• changes in taste
• numbness or tingling in the arms or legs
• coordination disorders
• enlarged pupils (mydriasis)
• abnormal heart rhythms observed as changes in the electrocardiogram (ECG)
• dizziness when standing due to low blood pressure (orthostatic hypotension)
• fatigue
• low sodium levels in the blood
• urinary disorders
• feeling of thirst

Uncommon: may affect up to 1 in 100 peoplepeople

• excitement, anxiety, difficulty sleeping, nightmares
• seizures
• ringing in the ears (tinnitus)
• increased blood pressure
• diarrhea, vomiting
• skin rash, hives (urticaria), swelling of the face and tongue
• difficulty urinating

• increased milk production during lactation or milk secretion without lactation.

• increased pressure in the eyeball
• collapse situations
• worsening of heart failure
• worsening of liver function (e.g. cholestatic liver disease)

Rare: may affect up to 1 in 1,000 peoplepeople

• decreased appetite
• delirium (especially in elderly patients), hallucinations
• abnormal heart rhythm or heart pattern
• swelling of the salivary glands
• hair loss
• increased sensitivity to sunlight
• increased size of the breasts in men
• fever
• weight loss
• abnormal liver function test results
• decrease in blood cells, such as white blood cells, eosinophils and platelets

Very rare: may affect up to 1 in 10,000 people

• heart muscle diseases
• acute increase in eye pressure
• particular forms of abnormal heart rhythm (also called torsades de pointes)
• allergic inflammation of the alveoli and lung tissue

Frequency not known (cannot be estimated from available data)

• loss of appetite
• increase or decrease in blood sugar levels
• feeling of restlessness and need to be constantly in motion
• agitation
• thoughts or suicidal behavior
• movement disorders (involuntary movements or decreased movement)
• hypersensitivity myocarditis (inflammation of the heart muscle)
• elevated body temperature
• hepatitis
• orgasm disorder in women, increased libido
• Brugada syndrome (unmasking) (symptoms may include rapid heartbeats, dizziness, fainting, seizures). Inform your doctor immediately if you experience these symptoms.
• low sodium levels in the blood

A higher risk of bone fractures has been observed in patients treated with this type of medication.

Reporting of side effects

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

Keepthis medicationout of the sight and reach of children.

This medication does not require special storage conditions.

Do not usethis medicationafter the expiration date that appears onthe packagingafter CAD.

Do not dispose of medications through drains or trash. Dispose of packaging and medications you no longer need at the SIGREpoint at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Paxtibi

• The active ingredient is nortriptyline hydrochloride.

Each tablet contains 25 mg of nortriptyline hydrochloride.

• The other excipients are: lactose monohydrate, calcium phosphate dibasic, cornstarch, magnesium stearate,yellow orange S (E110), hydroxypropylmethylcellulose, ethylcellulose, and glycerin.

Appearance of the product and content of the container

Paxtibi 25 mg coated tablets are round, orange, convex, coated with transparent film.

The tablets are presented in aluminum/PVC blister packs of 25 coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Teva B.V.

Swensweg 5, 2031 GA Haarlem

Netherlands

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Biowise Pharmaceuticals

c/Teixidors nº 22, Polígono industrial Can Robiols

07141 Marratxi (Balearic Islands)

Spain

Responsible for manufacturing:

LILLY, S.A.

Avda. de la Industria, 30

Alcobendas (Madrid) 28108

Spain

or

TOLL MANUFACTURING SERVICES, S.L.

Aragoneses, 2

Alcobendas (Madrid) 28108

Spain

Last review date of this leaflet: August 2024

The detailed information about this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)