TRYPTIZOL 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Tryptizol 50 mg Film-Coated Tablets

amitriptyline, hydrochloride

Read this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Tryptizol and what is it 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
• Nocturnal enuresis in children aged 6 years and older, only when other organic causes, such as spina bifida and related disorders, have been excluded and no response has been achieved with other non-pharmacological or pharmacological treatments, including muscle relaxants and desmopressin. This medicine should only be prescribed by doctors with experience in the treatment of patients with persistent urinary incontinence.

2. What you need to know before you take Tryptizol

Do not take Tryptizol:

• if you are allergic to amitriptyline or 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 had heart problems such as irregular heartbeat (arrhythmias) detected on an electrocardiogram (ECG), heart block, or coronary heart disease
• if you are taking medicines known as monoamine oxidase inhibitors (MAOIs)
• if you have taken MAOIs in the last 14 days
• if you have taken moclobemide the day before
• 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 must not be used in children under 6 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Tryptizol.

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

Taking buprenorphine or buprenorphine/naloxone with Tryptizol may cause serotonin syndrome, a potentially life-threatening condition (see "Taking Tryptizol with other medicines").

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

QT interval prolongation

A heart problem called "QT interval prolongation" (which appears on an electrocardiogram [ECG]) and heart rhythm disorders (fast or irregular heartbeat) have been reported with Tryptizol. Tell your doctor if:

• you have a slow heart rate
• you have or have had a problem where the heart cannot pump blood to the body as it should (a condition called heart failure)
• you are taking any other medicine that may cause heart problems, or
• you have a problem that causes low potassium or magnesium or high potassium levels in the blood
• you are scheduled to have surgery, as it may be necessary to stop treatment with amitriptyline before you are given anesthetics. In case of emergency surgery, the anesthesiologist should be informed about the treatment with amitriptyline
• you have an overactive thyroid gland or are taking thyroid medication

Suicidal thoughts and worsening of depression

If you are depressed, you may sometimes think about harming or killing yourself. This type of thought 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 thoughts:

• If you have had thoughts of killing or harming yourself in the past.
• If you are a young adult. Clinical trial data have shown an increased risk of suicidal behavior in young adults (less than 25 years old) with psychiatric disorders who were treated with an antidepressant.

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

It may be helpful to tell a relative 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 worried about changes in your behavior.

Manic episodes

Some patients with manic-depressive illness may enter a manic phase, characterized by rapidly changing ideas, excessive joy, and excessive physical activity. In these cases, it is essential that you contact your doctor, who will probably change your medication.

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

• narrow-angle glaucoma (vision loss 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) and paralytic ileus (blockage of the intestine)

• diabetes, as it may be necessary to adjust your antidiabetic medication

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

Elderly 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").

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 have not been established for this age group.

Nocturnal enuresis

• An ECG should be performed before starting therapy with amitriptyline to rule out long QT syndrome
• These medicines should not be taken at the same time as an anticholinergic drug (see also section 2 "Taking Tryptizol with other medicines")
• During the early stages of treatment with antidepressants for disorders other than depression, suicidal thoughts and behaviors 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 may affect the way other medicines work, and this can sometimes cause serious side effects.

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

• monoamine oxidase inhibitors (MAOIs) such as, e.g., phenelzine, iproniazide, isocarboxazide, 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, e.g., 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, hyoscine)

• 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 muscle contractions, including muscles that control eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, 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 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 tell 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, e.g., furosemide)

If you are going to have surgery and receive general or local anesthetics, you must tell your doctor that you are taking this medicine.

Also, tell your dentist that you are taking this medicine if you are going to receive a local anesthetic.

Taking Tryptizol with alcohol

It is not recommended to drink alcohol during treatment with this medicine, 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 have a baby, ask your doctor for advice before taking this medicine.

Amitriptyline is not recommended during pregnancy unless your doctor considers it clearly necessary and only after careful consideration of the benefits and risks. If you have taken this medicine during the last part of your pregnancy, the newborn may experience withdrawal symptoms such as irritability, increased muscle tone, tremor, irregular breathing, poor sucking, loud crying, urinary retention, and constipation.

Driving and using machines

This medicine may cause drowsiness and dizziness, especially at the start of treatment. Do not drive or work with tools or machinery if you feel affected.

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

3. How to take Tryptizol

Follow your doctor's administration instructions for this medication exactly. If in doubt, consult your doctor again.

Not all dosage guidelines can be achieved with all pharmaceutical forms/concentrations. The appropriate pharmaceutical form/concentration should be selected for initial doses and for any subsequent dose increases.

Depression

Adults

The recommended initial dose is 25 mg twice a day.

Depending on the response to the medication, your doctor may gradually increase the dose to 150 mg per day, divided into two doses.

Elderly patients (over 65 years) and patients with cardiovascular disease

The recommended initial dose is 10-25 mg per day.

Depending on your response to the medication, 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 perform more frequent follow-ups.

Use in children and adolescents

This medication should not be administered to children or adolescents for the treatment of depression. For more information, see section 2.

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

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

Adults

The recommended initial dose is 10 mg - 25 mg at night.

The recommended daily dose is 25 mg - 75 mg.

Depending on your response to the medication, your doctor may gradually increase the dose. If you are administered a dose greater than 100 mg per day, your doctor may need to perform more frequent follow-up visits. Your doctor will indicate whether you should take the dose once a day or divide it into two doses.

Elderly patients (over 65 years) and patients with cardiovascular disease

The recommended initial dose is 10 mg - 25 mg at night.

Depending on your response to the medication, your doctor may gradually increase the dose. If you receive doses greater than 75 mg per day, your doctor may need to perform more frequent follow-ups.

Use in children and adolescents

This medication should not be administered to children or adolescents for the treatment of neuropathic pain, prevention of chronic tension-type headache, or migraine prophylaxis. For more information, see section 2.

Nocturnal urinary incontinence

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 suitable pharmaceutical form should be used.
• 11 years or older: 25 mg - 50 mg.

The dose should be gradually increased.

Take this medication 1 hour to 1 hour and a half before bedtime.

Before starting treatment, your doctor will perform an ECG to check for any unusual heart rhythms.

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

Do not interrupt treatment without consulting your doctor first.

Patients with special risks

Patients with liver disease or those with a "deficient metabolism" usually receive lower doses.

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

How and when to take Tryptizol

This medication can 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 the medication or interrupt treatment without consulting your doctor first.

Depression

As with other medications for the treatment of depression, it may take a few weeks to notice an improvement.

In depression, the duration of treatment is individual and usually lasts a minimum of 6 months. Your doctor will decide the duration of treatment.

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

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

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

It may take a few weeks to notice an improvement in pain.

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

Nocturnal urinary incontinence

Your doctor will evaluate whether to continue treatment after 3 months.

If you take more Tryptizol than you should

Contact your doctor or the emergency department of the nearest hospital immediately. Do this even if you do not have any symptoms of discomfort or poisoning. Bring the packaging of this medication with you if you go to the doctor or hospital.

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.

Among the symptoms of overdose are:

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

Overdose of amitriptilina in children can have serious consequences. Children are especially prone to coma, cardiac symptoms, difficulty breathing, convulsions, low sodium levels in the blood, lethargy, drowsiness, nausea, vomiting, and high blood sugar levels.

If you forget to take Tryptizol

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

If you interrupt treatment with Tryptizol

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

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

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not everyone will experience them.

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

• Intermittent blurred vision, rainbow vision, and eye pain.

You should have an eye examination immediately before being able to continue treatment with this medication. These symptoms can be a sign of acute glaucoma. Very rare adverse effect, may affect up to 1 in 10,000 people.

• A heart problem "prolonged QT interval" (which can be seen on your electrocardiogram). Frequent 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 and the white part of the eyes (jaundice).

It is possible that your liver is affected. Rare adverse effect, may affect up to 1 in 1,000 people.

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

These symptoms can be the first signs of a possible effect on the blood or bone marrow.

Blood effects can be 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 behaviors. Rare adverse effects, may affect up to 1 in 1,000 people.

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

Very frequent: may affect more than 1 in 10 people

• drowsiness/somnolence
• tremors of the hands or other parts of the body
• dizziness
• headache
• irregular, strong, or rapid heartbeat
• dizziness when standing up due to low blood pressure (orthostatic hypotension)
• dry mouth
• constipation
• nausea
• excessive sweating
• weight gain
• stuttering or slow speech
• aggression
• nasal congestion

Frequent: may affect up to 1 in 10 people

• confusion
• sexual disorders (decreased sexual desire, erection problems)
• attention disorders
• changes in taste
• numbness or tingling in the arms or legs
• coordination disorders
• dilated pupils
• heart block
• fatigue
• low sodium levels in the blood
• agitation
• urinary disorders
• feeling of thirst

Uncommon: may affect up to 1 in 100 people

• excitement, anxiety, difficulty sleeping, nightmares
• seizures
• tinnitus
• increased blood pressure
• diarrhea, vomiting
• skin rash, 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
• worsening of heart failure
• worsening of liver function (e.g., cholestatic liver disease)
• increased pressure in the eyeball, intermittent blurred vision, rainbow vision, 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 pattern, swelling of the salivary glands
• hair loss
• increased sensitivity to sunlight
• enlargement of the breasts in men
• fever
• weight loss
• abnormal liver function test results

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

• heart muscle disease
• feeling of restlessness and need to be in constant motion
• peripheral nerve disorders
• acute increase in eye pressure
• particular forms of abnormal heart rhythm (also called torsades de pointes)
• allergic inflammation of the lung tissue and pulmonary tissue

Frequency not known (cannot be estimated from available data)

• loss of appetite
• increased or decreased blood sugar levels
• paranoia
• movement disorders (involuntary or decreased movements)
• hypersensitivity inflammation of the heart muscle
• hepatitis
• flushing
• Dry eyes
• Stop using Tryptizol and seek medical attention immediately if you notice any of the following symptoms: Widespread rash, elevated body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

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

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Tryptizol

Keep this medication out of sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

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

Medications should not be thrown away through the sewers or in the trash. Deposit the packaging and medications you no longer need in the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Tryptizol

• The active ingredient is amitriptilina.
• The other components are hydrated lactose, calcium phosphate dibasic, powdered cellulose, cornstarch, colloidal silicon dioxide, stearic acid, magnesium stearate, hydroxypropyl methylcellulose (E464), hydroxypropyl cellulose (E463), titanium dioxide (E171), talc, yellow aluminum lacquer (E104), brown medium Kohnstamm 3329 powder, and carnauba wax.

Appearance of the product and package contents

Tryptizol is presented in packages of 30 coated tablets. The tablets are round and beige in color.

Marketing authorization holder and manufacturer

Marketing authorization 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 last revision of this prospectus:January 2025

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