Tryptizol 50 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Tryptizol 50 mg Film-coated tablets

amitriptiline 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, consult 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 may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Tryptizol is and what it is used for

Tryptizol belongs to a group of medicines called tricyclic antidepressants.

This medicine is used to treat:

• Depression in adults (major depressive episodes)
• Neuropathic pain in adults
• Prevention of chronic tension-type headache in adults
• Prevention of migraine in adults
• Urinary incontinence in children aged 6 years and older, only when organic causes such as spina bifida and related disorders have been excluded and an adequate response has not been achieved with other non-pharmacological or pharmacological treatments, including muscle relaxants and desmopressin. This medicine should only be prescribed by physicians experienced in the treatment of patients with persistent urinary incontinence.

2. What you need to know before taking Tryptizol

Do not take Tryptizol:

• if you are allergic to amitriptyline or to any of the other ingredients of this medicine (listed in section 6).
• if you have recently had a heart attack (myocardial infarction)
• if you have heart problems such as cardiac rhythm disturbances shown on the electrocardiogram (ECG), heart block, or coronary artery disease
• if you are taking medicines known as monoamine oxidase inhibitors (MAOIs)
• if you have taken MAOIs within the last 14 days
• if you have taken moclobemide the previous day
• if you have severe liver disease
• If you are taking Tryptizol, you must stop treatment with this medicine and wait 14 days before starting treatment with an MAOI.
• This medicine should not be used in children under 6 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Tryptizol.

Cardiac rhythm disturbances and hypotension may occur if you receive a high dose of amitriptyline. This may also happen with usual doses if you already have pre-existing heart disease.

The use of Buprenorphine or Buprenorphine/naloxone together with Tryptizol may cause serotonin syndrome, a potentially life-threatening condition (see “Taking Tryptizol with other medicines”).

Serious skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with Tryptizol treatment. Stop using Tryptizol and seek immediate medical attention if you notice any of the symptoms related to these serious skin reactions described in section 4.

Prolonged QT interval

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

• you have a slow heart rate
• you have or have had a condition where the heart cannot pump blood properly (a condition called heart failure)
• you are taking any other medicines that may cause heart problems, or
• you have a condition causing low levels of potassium or magnesium or high levels of potassium in the blood
• you are scheduled for surgery, as it may be necessary to stop treatment with amitriptyline before administration of anesthetics. In case of emergency surgery, the anesthetist must be informed about your treatment with amitriptyline
• you have an overactive thyroid gland or are receiving thyroid medication

Suicidal thoughts and worsening depression

If you are depressed, you may sometimes think about harming yourself or ending your life. These 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 such thoughts:

• If you have previously had thoughts of taking your own life or of 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) with psychiatric disorders who were treated with an antidepressant.

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

It may be helpful to tell a close family member or 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 getting worse or if they are concerned about changes in your behaviour.

Manic episodes

Some patients with bipolar disorder may enter a manic phase, characterized by rapidly changing, excessive thoughts, exaggerated happiness, and excessive physical activity. In such cases, it is important to contact your doctor, who will likely change your medication.

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

• narrow-angle glaucoma (loss of vision due to abnormally high pressure in the eye)

• epilepsy, history of seizures or epileptic fits

• difficulty urinating

• enlarged prostate

• thyroid disease

• bipolar disorder

• schizophrenia

• severe liver disease

• severe heart disease

• pyloric stenosis (narrowing of the stomach outlet) or paralytic ileus (intestinal blockage)

• diabetes, as your antidiabetic medication may need adjustment

If you are taking antidepressants such as selective serotonin reuptake inhibitors (SSRIs), your doctor may consider changing your dose (see also section 2 “Taking Tryptizol with other medicines” and section 3).

Elderly 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”).

Children and adolescents

Depression, neuropathic pain, prevention of chronic tension-type headache, and prevention of migraine

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

Nighttime bedwetting (nocturnal enuresis)

• An ECG should be performed before starting amitriptyline therapy to rule out long QT syndrome.
• These medicines should not be taken at the same time as anticholinergic drugs (see also section 2 “Taking Tryptizol with other medicines”).
• During the early stages of antidepressant treatment for disorders other than depression, suicidal thoughts and behaviours may also occur; therefore, when treating patients with enuresis, the same precautions should be taken as when treating patients with depression.

Taking Tryptizol with other medicines

Some medicines can affect how other medicines work, and this may sometimes cause serious adverse effects.

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, such as:

• monoamine oxidase inhibitors (MAOIs), e.g., phenelzine, iproniazid, isocarboxazid, nialamide, or tranylcypromine (used to treat depression) or selegiline (used to treat Parkinson’s disease). These medicines must not be taken at the same time as Tryptizol (see section 2 “Do not take Tryptizol”)

• adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine, and phenylpropanolamine (which may be present in cough and cold medicines and in some anesthetics)

• medicines for high blood pressure such as calcium channel blockers (e.g., diltiazem and verapamil), guanethidine, betanidine, clonidine, reserpine, and methyldopa

• anticholinergic drugs such as certain medicines for Parkinson’s disease and gastrointestinal disorders (e.g., atropine, hyoscyamine)

• thioridazine (used to treat schizophrenia)

• tramadol (for pain relief)

• medicines for fungal infections (e.g., fluconazole, terbinafine, ketoconazole, and itraconazole)

• sedatives (e.g., barbiturates)

• Buprenorphine or Buprenorphine/naloxone. These medicines may interact with Tryptizol 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 tone, and body temperature above 38°C. Contact your doctor if you experience these symptoms.

• 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)

• ritonavir (used to treat HIV)

• oral contraceptives

• rifampicin (for treating infections)

• phenytoin and carbamazepine (used to treat epilepsy)

• St. John’s Wort (Hypericum perforatum), a herbal medicine used for depression

• thyroid medicines

• Valproic acid.

You should also inform your doctor if you are taking or have recently taken medicines that may affect heart rhythm, such as:

• medicines for 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)

If you are undergoing surgery and will receive general or local anesthetics, you must inform your doctor that you are taking this medicine.

You should also inform your dentist that you are taking this medicine if you are to receive a local anesthetic.

Drinking alcohol while taking Tryptizol

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 plan to become pregnant, consult your doctor before using this medicine.

Amitriptyline is not recommended during pregnancy unless your doctor considers it clearly necessary, and only after careful consideration of benefit versus 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, tremors, irregular breathing, poor sucking, loud crying, urinary retention, and constipation.

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 if you feel affected.

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

3. How to take Tryptizol

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor again.

Not all dosage regimens may be achievable with all pharmaceutical forms/concentrations. The appropriate pharmaceutical form/concentration should be selected for initial dosing and for any subsequent dose increases.

Depression

Adults

The recommended starting dose is 25 mg twice daily.

Depending on your response to the medicine, your doctor may gradually increase the dose to 150 mg daily, divided into two doses.

Elderly people (over 65 years of age) and patients with cardiovascular disease

The recommended starting dose is 10–25 mg per day.

Depending on your response to the medicine, your doctor may gradually increase the dose to a total daily dose of 100 mg, divided into two doses. If you receive doses of 100 mg–150 mg, your doctor may need to carry out more frequent follow-ups.

Use in children and adolescents

This medicine must not be given to children or adolescents for the treatment of depression. For further information, see section 2.

Neuropathic pain, chronic tension-type headache, and migraine prevention

Your doctor will adjust the medication according to your symptoms and response to treatment.

Adults

The recommended starting dose is 10 mg–25 mg at night.

The recommended daily dose is 25 mg–75 mg.

Depending on your response to the medicine, your doctor may gradually increase the dose. If you are given more than 100 mg daily, your doctor may need to carry out more frequent follow-up visits. Your doctor will advise you whether to take the dose once daily or divided into two doses.

Elderly people (over 65 years of age) and patients with cardiovascular disease

The recommended starting dose is 10 mg–25 mg at night.

Depending on your response to the medicine, your doctor may gradually increase the dose. If you receive doses exceeding 75 mg daily, your doctor may need to carry out more frequent follow-ups.

Use in children and adolescents

This medicine must not be given to children or adolescents for the treatment of neuropathic pain, prevention of chronic tension-type headache, or migraine prophylaxis. For further information, see section 2.

Nocturnal enuresis

Use in children and adolescents

Recommended doses for children:

• under 6 years: see section 2 “Do not take Tryptizol”
• 6 to 10 years: 10 mg–20 mg. For this age group, a more appropriate pharmaceutical form should be used.
• 11 years and older: 25 mg–50 mg.

The dose should be increased gradually.

Take this medicine 1 to 1.5 hours before going to bed.

Before starting treatment, your doctor will perform an ECG to check for signs of abnormal heartbeats.

Your doctor will re-evaluate your treatment after 3 months and, if necessary, perform another ECG.

Do not stop treatment without first consulting your doctor.

Patients with special risks

Patients with liver disease or those who have what is known as "poor metabolizer" status usually receive lower doses.

Your doctor may take blood samples to determine the level of amitriptyline in your blood (see also section 2).

How and when to take Tryptizol

This medicine may be taken with or without food.

Swallow the tablets with a glass of water. Do not chew them.

Duration of treatment

Do not change the dose of this medicine or stop treatment without first consulting your doctor.

Depression

As with other medicines used to treat depression, it may take several weeks before you notice an improvement.

In depression, the duration of treatment is individual and usually lasts at least 6 months. Your doctor will decide on the duration of treatment.

Continue taking this medicine for as long as your doctor recommends.

The underlying condition may persist for a long time. If you stop treatment too early, symptoms may return.

Neuropathic pain, prevention of chronic tension-type headache, and migraine prevention

It may take several weeks before you notice an improvement in pain.

Talk to your doctor about the duration of treatment and continue taking this medicine for as long as your doctor recommends.

Nocturnal enuresis

Your doctor will assess whether treatment should continue after 3 months.

If you take more Tryptizol than you should

Contact your doctor or the nearest hospital emergency department immediately. Do this even if you have no signs of discomfort or poisoning. Take the medicine package with you if you go to the doctor or hospital.

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.

Symptoms of overdose include:

• dilated pupils
• rapid or irregular heartbeat
• difficulty urinating
• dry mouth and tongue
• intestinal obstruction
• epileptic seizures
• fever
• agitation
• confusion
• hallucinations
• uncontrolled movements
• low blood pressure, weak pulse, pallor
• difficulty breathing
• bluish skin discoloration
• decreased heart rate
• drowsiness
• loss of consciousness
• coma
• various cardiac symptoms, such as heart block, heart failure, hypotension, cardiogenic shock, metabolic acidosis, hypokalaemia

Overdose of amitriptyline in children may have serious consequences. Children are particularly prone to coma, cardiac symptoms, difficulty breathing, seizures, low blood sodium levels, lethargy, drowsiness, nausea, vomiting, and elevated blood sugar levels.

If you forget to take Tryptizol

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

If you stop taking Tryptizol

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

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 will experience them.

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

• Episodes of intermittent blurred vision, rainbow-coloured halos around lights, and eye pain.

An immediate eye examination must be performed before continuing treatment with this medicine. These symptoms may be signs of acute glaucoma. Very rare adverse effect, may affect up to 1 in 10,000 people.

• A heart problem called “prolonged QT interval” (which can be seen on your electrocardiogram). Common adverse effect, may affect up to 1 in 10 people.

• Severe constipation, stomach swelling, fever, and vomiting.

These symptoms may be due to paralysis of parts of the intestine. Rare adverse effect, may affect up to 1 in 1,000 people.

• Any degree of yellowing of the skin or the whites of the eyes (jaundice).

Your liver may be affected. Rare adverse effect, may affect up to 1 in 1,000 people.

• Bruising, bleeding, paleness, or persistent sore throat and fever.

These symptoms may be early 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 throughout the body), white blood cells (which help fight infections), and platelets (which help with blood clotting). Rare adverse effect, may affect up to 1 in 1,000 people.

• Suicidal thoughts or behaviour. Rare adverse effects, may affect up to 1 in 1,000 people.

The following adverse effects have been reported at the frequencies listed below:

Very common: may affect more than 1 in 10 people

• Drowsiness/somnolence
• Tremor of the hands or other parts of the body
• Dizziness
• Headache
• Irregular, strong, or rapid heartbeat
• Dizziness upon standing due to low blood pressure (orthostatic hypotension)
• Dry mouth
• Constipation
• Nausea
• Excessive sweating
• Weight gain
• Stuttering or slow speech
• Aggression
• Nasal congestion

Common: may affect up to 1 in 10 people

• Confusion
• Sexual dysfunction (decreased sex drive, erectile problems)
• Attention disturbances
• Changes in taste sensation
• Numbness or tingling in arms or legs
• Coordination disturbances
• Dilated pupils
• Heart block
• Fatigue
• Low blood sodium concentration
• Agitation
• Urinary disorders
• Feeling thirsty

Uncommon: may affect up to 1 in 100 people

• Excitement, anxiety, difficulty sleeping, nightmares
• Seizures
• 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 in the eyeball
• Collapse episodes
• Worsening of heart failure
• Worsening of liver function (e.g. cholestatic liver disease)
• Increased pressure in the eyeball, episodes of intermittent blurred vision, rainbow-coloured halos around lights, and eye pain

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

• Decreased appetite
• Delirium (especially in elderly patients), hallucinations, abnormal heart rhythm or heartbeat pattern, swelling of the salivary glands
• Hair loss
• Increased sensitivity to sunlight
• Breast enlargement in males
• Fever
• Weight loss
• Abnormal liver function test results

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

• Diseases of the heart muscle
• Feeling restless and an urge to keep moving constantly
• Peripheral nerve disorders
• Acute increase in eye pressure
• Specific forms of abnormal heart rhythm (also known as 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
• Paranoia
• Movement disorders (involuntary movements or reduced movements)
• Hypersensitivity inflammation of the heart muscle
• Hepatitis
• Flushing
• Dry eyes

Stop using Tryptizol and seek immediate medical attention if you experience any of the following symptoms: widespread rash, high body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).

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 effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may 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 Tryptizol

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date is the last day of the month indicated.

Do not use this medicine if you notice signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tryptizol

• The active substance is amitriptyline.
• The other components are monohydrate lactose, dibasic calcium phosphate, powdered cellulose, corn starch, colloidal silica, stearic acid, magnesium stearate, hydroxypropylmethylcellulose (E464), hydroxypropylcellulose (E463), titanium dioxide (E171), talc, aluminium lake yellow colour (E104), brown-Powder medium Kohnstamm 3329, and carnauba wax.

Appearance of the medicine and contents of the pack

Tryptizol is available in packs of 30 coated tablets. The tablets are round and beige in colour.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

PAN QUÍMICA-FARMACÉUTICA, S.A.

Rufino González, 50

28037 Madrid

Spain

Manufacturer

ROVI Pharma Industrial Services, S.A.

Vía Complutense, 140

Alcalá de Henares 28805 – Madrid

(Spain)

Local representative

Laboratorios Farmacéuticos ROVI, S.A.

Julián Camarillo, 35

28037 Madrid

Spain

Date of the most recent revision of this leaflet: January 2025.

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