Norfenazin 10 mg tablets

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

Norfenazin 10 mg Tablets

Nortriptyline hydrochloride

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Norfenazin is and what it is used for

2. What you need to know before taking Norfenazin

3. How to take Norfenazin

4. Possible side effects

5. How to store Norfenazin

6. Contents of the pack and other information

1. What Norfenazin is and what it is used for

Norfenazin contains the active substance nortriptyline.

Nortriptyline belongs to a group of medicines called tricyclic antidepressants, used for the treatment of major depressive episode in adults.

2. What you need to know before taking Norfenazin

Do not take Norfenazin

• if you are allergic to nortriptyline or any of the other ingredients of this medicine (listed in section 6),

• if you have recently suffered a myocardial infarction (heart attack) or have arrhythmias detected on electrocardiogram (ECG) or any other cardiovascular problem,

• if you have bipolar disorder,

• if you are taking medicines called monoamine oxidase inhibitors (MAOIs)—other medicines used for depression—or selegiline (used to treat Parkinson’s disease), or have taken them within 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

Talk to your doctor or pharmacist before taking this medicine.

Suicidal thoughts and worsening of depression

If you are depressed and/or have anxiety disorders, you may sometimes think about harming yourself or ending your life. These types of thoughts may increase 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 of 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 you have thoughts about harming yourself or ending 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 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.

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

• • if you have epilepsy, a history of seizures or epileptic fits
  • if you are agitated, hyperactive or suffer from 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 (loss of vision due to abnormally high pressure in the eye)
  • if you are being treated for diabetes, as your antidiabetic medication may need to be adjusted when starting treatment with nortriptyline.
  • if you have a mental illness (psychiatric disorder) other than depression.
  • if you are due 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 within the first 10 weeks.
  • if you have pyloric stenosis (narrowing of the gastric outlet) or 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). Using these medicines together with nortriptyline may cause serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Norfenazin”).

Some patients with manic-depressive disorders may experience a manic phase. This is characterised by unusual and rapidly changing thoughts, exaggerated happiness, and excessive physical activity. In such cases, it is important to consult your doctor.

Prolonged QT interval

A heart problem called “prolonged QT interval” (seen on electrocardiogram [ECG]) and cardiac rhythm disorders (fast or irregular heartbeat) have been reported with nortriptyline. Inform your doctor if:

• you have a slow heart rate
• you have or have had a condition in which the heart cannot pump blood properly (a condition called heart failure)
• you are taking any other medication that could cause heart problems, or
• you have a condition causing low levels of potassium or magnesium or a high level of potassium in the blood.

If you are scheduled for surgery, treatment with nortriptyline may need to be stopped before administration of anaesthetics. In case of emergency surgery, the anaesthetist must be informed about 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 using antidepressants such as selective serotonin reuptake inhibitors (SSRIs), your doctor may consider adjusting your dose (see also section 2 “Taking Norfenazin with other medicines” and section 3).

Children and adolescents

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

Elderly people

Dosage should be reduced in elderly patients. Older people are more likely to experience certain adverse effects such as dizziness upon standing due to low blood pressure (see also section 4 “Possible side effects”).

Other medicines and Norfenazin

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Some medicines can affect how other medicines work, and this may sometimes cause serious adverse effects.

You should be especially 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 must not be taken at the same time as nortriptyline (see section 2 “Do not take Norfenazin”).

• Certain antihypertensive drugs such as clonidine and methyldopa. Medicines like nortriptyline may counteract the antihypertensive effect.
• thioridazine (used to treat schizophrenia)
• tramadol (for pain relief)
• opioids (e.g., buprenorphine) may interact with nortriptyline and you may experience symptoms such as involuntary rhythmic muscle contractions, including muscles controlling eye movements, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, 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 and cold medicines and in some anaesthetics)
• anticholinergic drugs such as certain medicines for Parkinson’s disease and gastrointestinal disorders (e.g., atropine)
• medicines for high blood pressure such as calcium channel blockers (e.g., diltiazem, verapamil)
• medicines for 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)
• methylphenidate (used to treat ADHD)
• rifampicin (for treating infections)
• phenytoin and carbamazepine (used to treat epilepsy)
• thyroid medicines
• valproic acid (a medicine used for the treatment of 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 recently taken medicines that may affect heart rhythm, such as medicines used to treat 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 sertindole)
• cisapride (used to treat certain types of indigestion)
• halofantrine (used to treat malaria)
• methadone (used to treat pain and for detoxification)
• diuretics (“water tablets” such as furosemide)

Taking Norfenazin with alcohol

Drinking alcohol during treatment with this medicine is not recommended, as it may increase its sedative effect.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 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 tone, tremor, irregular breathing, poor sucking, loud crying, urinary retention, and constipation.

Your doctor will advise you whether to start/continue/stop breastfeeding or discontinue use of this medicine, taking into account the benefit of breastfeeding for the child and the benefit of treatment for you.

Driving and using machines

This medicine may cause drowsiness and dizziness, especially at the beginning of treatment. Do not drive or operate tools or machinery until you know how 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; this is essentially “sodium-free.”

3. How to take Norfenazin

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Adults

The daily dose in adults is 25 mg, 3 or 4 times a day, starting therapy at a low level and adjusting the dose as needed. It may be administered once daily, usually at night, or 3 or 4 times daily. It may take between 2 and 4 weeks to achieve a response. Doses exceeding 150 mg daily are not recommended.

Elderly patients

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 daily) and increased as necessary up to a maximum dose of 50 mg.

If increasing the dose in an elderly patient is considered necessary, an ECG should be checked and plasma levels of nortriptyline monitored.

Paediatric population

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

Hepatic and renal impairment

A reduced dose is recommended in cases of hepatic or renal impairment, since nortriptyline is extensively metabolized in the liver and primarily eliminated via the renal route.

Duration of treatment

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

The underlying condition may persist for a long time. If treatment is stopped too early, symptoms may recur.

It is advisable to continue treatment for at least 6 months after you start feeling better.

If you take more Norfenazin than you should

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you have accidentally taken an extra tablet of nortriptyline, side effects such as drowsiness, dry mouth, dizziness, or nausea may appear or worsen.

Symptoms of overdose may include:

• drowsiness or excitement
• agitation and hallucinations
• loss of consciousness
• difficulty breathing, bluish skin colouration
• dilated pupils
• epileptic seizures/convulsions
• cardiac disorders, including cardiac arrhythmias (observed on an ECG, an investigation to assess heart function)
• hypotension, weak pulse, pallor
• metabolic disturbances
• dry mouth and tongue
• pulmonary oedema
• fever
• coma
• urinary retention in the bladder due to disturbances in bladder emptying (urinary retention)
• reduced intestinal movements (which may lead to obstruction (constipation))
• confusion

Treatment of overdose should involve general supportive measures, gastric lavage, and assisted respiration.

If you forget to take Norfenazin

Take the next dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Norfenazin

Your doctor will decide when and how to stop treatment to avoid any unpleasant symptoms that might occur if treatment is stopped abruptly (e.g., headache, malaise, insomnia, and irritability).

Therefore, treatment with nortriptyline should not be stopped suddenly. The dose should be gradually reduced over a period of one week or longer.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone gets them.

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

Rare adverse effects (may affect up to 1 in 1,000 people):

• Yellowing of the skin and whites 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 possible blood or bone marrow problems. Blood-related effects may include a decrease in the number of red blood cells (which carry oxygen around the body), white blood cells (which help fight infections), and platelets (which help blood to clot).

• Suicidal thoughts or behaviour.

• A heart problem called “prolonged QT interval” (which can be seen on your electrocardiogram).

Frequent adverse effect (may affect up to 1 in 10 people):

• Involuntary and rhythmic muscle contractions, including muscles controlling 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).
• Severe constipation, stomach swelling, fever, and vomiting. These symptoms may be due to paralysis of parts of the intestine.

Very rare adverse effect (may affect up to 1 in 10,000 people):

• Intermittent blurred vision attacks, rainbow-coloured vision, and eye pain.

An eye examination must be performed immediately before continuing treatment with this medicine. These symptoms may be a sign of acute glaucoma (very rare adverse effect, may affect up to 1 in 10,000 people).

The following adverse effects have been reported with the following frequencies:

Very common: may affect more than 1 in 10 people

• Numbness/drowsiness
• Tremor, dizziness, headache
• Irregular, strong, or rapid heartbeat (palpitations)
• Dry mouth
• Constipation
• Nausea
• Excessive sweating
• Weight gain
• Aggression
• Nasal congestion
• Eye accommodation disorders (difficulty adjusting to see distant objects clearly, leading to blurred vision)

Common: may affect up to 1 in 10 people

• Confusion
• Sexual disturbances (decreased sex drive, erectile problems)
• Attention disturbances
• Changes in taste sensation
• Numbness or tingling in arms or legs
• Coordination disturbances
• Dilated pupils (mydriasis)
• Heart block
• Dizziness upon standing due to low blood pressure (orthostatic hypotension)
• Fatigue
• Low blood sodium concentration
• Agitation
• Urinary disorders
• Feeling of thirst

Uncommon: may affect up to 1 in 100 people

• Excitement, anxiety, difficulty sleeping, nightmares

• Seizures

• Ringing in the ears (tinnitus)

• Increased blood pressure

• Diarrhoea, vomiting

• Skin rash, rash with hives (urticaria), swelling of the face and tongue

• Difficulty urinating

  • Increased milk production during breastfeeding or milk secretion without breastfeeding.

• Increased pressure inside the eye

• Collapse episodes

• Worsening of heart failure

• Worsening of liver function (e.g. cholestatic liver disease)

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

• Decreased appetite
• Delirium (especially in elderly patients), hallucinations
• Abnormal heart rate or heart rhythm
• Swelling of the salivary glands
• Hair loss
• Increased sensitivity to sunlight
• Breast enlargement in males
• Fever
• Weight loss
• Abnormal liver function test results
• Decreased 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
• Specific types of abnormal heart rhythm (also called torsades de pointes)
• Allergic inflammation of the lung alveoli and lung tissue

Frequency not known (cannot be estimated from available data)

• Loss of appetite sensation
• Increase or decrease in blood sugar levels
• Feeling of restlessness and need to keep moving (akathisia)
• Paranoia
• Suicidal thoughts or behaviour
• Movement disorders (involuntary movements or reduced movements)
• Hypersensitivity inflammation of the heart muscle
• High body temperature
• Hepatitis
• Brugada syndrome (unmasking) (symptoms may include rapid heartbeat, dizziness, fainting, seizures). Inform your doctor immediately if you experience these symptoms.
• Low blood sodium concentration

An increased risk of bone fractures has been observed in patients treated with this type of medicine.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Norfenazin

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be handed over to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Norfenazin

• The active substance is nortriptyline hydrochloride.

Each tablet contains 10 mg of nortriptyline hydrochloride.

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

Appearance of the medicinal product and contents of the pack

Norfenazin 10 mg tablets are white, round, and scored on one side.

The tablets are supplied in PVC/aluminum blister packs containing 30 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

BIOWISE PHARMACEUTICALS, S.L.

C/Teixidors 22, Pol. Can Rubiol

07141 Marratxí - Illes Balears

Spain

Manufacturer:

TOLL MANUFACTURING SERVICES, S.L.

Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

Date of the most recent revision of this leaflet: July 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)