Package Insert: Information for the Patient

Norfenazin 10 mg Tablets

Nortriptilina hydrochloride

Read this entire package insert carefully before starting to take this medication, 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 medication has been prescribed only for you, 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1.What is Norfenazin and what is it used for

2.What you need to know before starting to take Norfenazin

3.How to take Norfenazin

4.Possible adverse effects

5Storage of Norfenazin

6.Contents of the package and additional information

Norfenazin 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 takeNorfenazin

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

(MAOIs - other medicines 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 medicines, you must wait 14 days before starting to take this medicine.

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

Warnings and precautions

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

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 own life. These types of thoughts may increase when you first start taking antidepressants, as all these medicines 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 own 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 illnesses who received treatment with an antidepressant.

If you have thoughts of harming yourself or taking your own 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 nortriptyline.
  • if you have a mental illness (psychiatric disorder) other than depression.
  • if you are to undergo surgery. Inform your doctor that you are taking this medicine.
  • 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 medicines with nortriptyline may cause the serotonin syndrome, a potentially fatal disease (see "Other medicines and Norfenazin").

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 prolongadoprolonged QT interval

A heart problem called "prolonged QT interval" (which appears on an electrocardiogram [ECG]) and arrhythmias (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 medicine 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 anesthetist 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 Norfenazin with other medicines" and section 3).

Children and adolescents

Do not administer this medicine 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 people

The dosage should be reduced in the elderly. Older people are more likely to experience certain side effects such as dizziness when standing up due to low blood pressure (see also section 4 "Possible side effects").

Other medicines and Norfenazin

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

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

• Certain antihypertensive medicines such as clonidine and methyldopa. Medicines such as nortriptyline may counteract the antihypertensive effect.
• thioridazine (used to treat schizophrenia)
• tramadol (for pain relief)
• opioids (e.g. buprenorphine) may interact with nortriptyline and 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 above 38°C. 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 cough medicines or cold remedies and in some anesthetics)
• anticholinergic medicines such as certain medicines for treating Parkinson's disease and gastrointestinal disorders (e.g. atropine)
• medicines for treating high blood pressure such as, for example, calcium channel blockers (e.g. diltiazem, verapamil),
• medicines for treating fungal infections (e.g. fluconazole, terbinafine, ketoconazole and itraconazole)
• sedatives (e.g. barbiturates)
• antidepressants (e.g. SSRIs [fluoxetine, paroxetine, fluvoxamine], duloxetine and bupropion)
• medicines for certain heart conditions (e.g. beta-blockers and antiarrhythmics)
• cimetidine (used to treat stomach ulcers)
• methamphetamine (used to treat ADHD)
• rifampicin (for treating infections)
• phenytoin and carbamazepine (used to treat epilepsy)
• thyroid medicines
• valproic acid (a medicine used to treat epilepsy and bipolar disorder).
• anticoagulant medicines derived from coumarin or indandione.
• St. John's Wort (Hypericum perforatum), a herbal medicine used for depression

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

• astemizole and terfenadine (used to treat allergies and seasonal rhinitis)
• medicines used to treat certain mental illnesses (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 Norfenazin with alcohol

Do not drink alcohol during treatment with this medicine, 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 medicine.

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 medicine 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 whether to start/continue/stop breastfeeding or interrupt the use of this medicine, taking into account the benefit of breastfeeding for the baby and the benefit of treatment for you.

Driving and operating machinery

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

Norfenazin contains lactose

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

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

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 in adults is 25 mg, 3 or 4 times a day, starting therapy 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 old 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 mainly eliminated by the kidneys.

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 moreNorfenazinthan 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 nortriptyline 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 forgot to takeNorfenazin

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

If you interrupt treatment withNorfenazin

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:

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

• Yellowing of the skin and the white part of the eyes (jaundice). Your liver may be affected.
• bruising, bleeding, paleness or persistent sore throat and fever.

• These symptoms may be the first signs of a possible blood or bone marrow disorder. Blood effects may include 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.
• A heart problem called "prolonged QT interval" (which can be seen on your electrocardiogram).Frequent side effect, which may affect up to 1 in 10 people.
• Uncontrollable 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 life-threatening condition). (signs of serotonin syndrome, a potentially life-threatening 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, which may affect up to 1 in 10,000 people).

• Intermittent blurred vision, rainbow vision and eye pain.

You must undergo 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, which may affect up to 1 in 10,000 people).

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

Very frequent: may affect more than 1 in 10 peoplepeople

• numbness/drowsiness
• tremor, 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 (eye focusing disorder that makes objects appear blurry)

Frequent: 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
• dilated pupils (mydriasis)
• heart block
• dizziness when standing due to low blood pressure (orthostatic hypotension)
• fatigue
• low sodium levels in the blood
• agitation
• urinary disorders
• feeling thirsty

Infrequent: 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
• • increase in milk production during lactation or milk secretion without lactation.
• increased pressure in the eyeball
• collapse situations
• heart failure worsening
• liver function worsening (e.g. cholestatic liver disease)

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

• loss of appetite
• delirium (especially in elderly patients), hallucinations
• abnormal heart rhythm or heart pattern
• salivary gland swelling
• hair loss
• sensitivity to sunlight
• breast enlargement 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 alveolar and lung tissue

Frequency not known (cannot be estimated from available data)

• loss of appetite sensation
• increase or decrease in blood sugar levels
• sensation of restlessness and need to be in constant movement
• paranoia
• thoughts or suicidal behavior
• movement disorders (involuntary movements or decreased movements)
• hypersensitivity myocarditis (inflammation of the heart muscle)
• high body temperature
• hepatitis
• 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 Medicines 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 conditions for conservation.

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

Medications should not be disposed of through drains or in the 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 ofNorfenazin

• The active ingredient is nortriptyline hydrochloride.

Each tablet contains 10mg of nortriptyline hydrochloride.

The other excipients are: Lactose, microcrystalline cellulose, sodium glycolate starch Type A (from potato), cornstarch, talc, and magnesium stearate.

Appearance of the product and content of the packaging

Norfenazin10mg tablets are white, round, and scored on one face.

The tablets are presented in a PVC/aluminum blister pack with 30 tablets

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

BIOWISE PHARMACEUTICALS, S.L.

C/Teixidors 22, Pol.Can Rubiol

07141 Marratxí - Illes Balears

Spain

Responsible for manufacturing:

TOLL MANUFACTURING SERVICES, S.L.

Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

Last review date of this leaflet: July 2024

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