Package Insert: Information for the Patient

Tryptizol 25 mg Film-Coated Tablets

amitriptilina, hydrochloride

Read this 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 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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 or older, only when other organic causes, such as spina bifida and related disorders, have been ruled out and other treatments, including non-pharmacological and pharmacological treatments, including muscle relaxants and desmopressin, have not been effective. This medicine should only be prescribed by experienced doctors in the treatment of patients with persistent urinary leakage.

Do not take Tryptizol:

• if you are allergic to amitriptyline or any of the other ingredients of this medication (listed in section 6)
• if you have recently had a heart attack (myocardial infarction)
• if you have heart problems such as arrhythmias detected on an electrocardiogram (ECG), heart block, or coronary disease
• if you are taking medications 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 interrupt treatment with this medication and wait 14 days before starting treatment with an MAOI.

This medication should not be used in children under 6 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tryptizol.

Abnormal heart rhythms and hypotension may occur if you receive a high dose of amitriptyline. This can also occur with regular doses if you have pre-existing heart disease.

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

Severe skin reactions, including drug reactions with eosinophilia and systemic symptoms (DRESS), have been reported in association with Tryptizol treatment. Stop using 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

QT interval prolongation (a heart problem that appears on an electrocardiogram [ECG]) and arrhythmias (rapid or irregular heartbeat) have been reported with Tryptizol. Inform 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 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
• you are scheduled for surgery, as you may need to stop taking amitriptyline before receiving anesthetics. In the case of emergency surgery, inform the anesthesiologist about your treatment with amitriptyline
• you have an overactive thyroid gland or are receiving thyroid medication

Thoughts of suicide and worsening of depression

If you are depressed, 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 medications take time to work, usually two weeks, but sometimes longer.

You may be more likely to have these thoughts:

• if you have had thoughts of taking your own life or harming yourself before
• if you are a young adult. 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

Inform your doctor or go to the hospital immediately if you have thoughts of harming yourself or taking your own life.

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.

Manic episodes

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

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

• angle-closure glaucoma (vision loss due to abnormally high eye pressure)
• epilepsy, history of seizures, or convulsions
• 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 (intestinal blockage)

• diabetes, as you may need to adjust your diabetes medication

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

Older adults are more likely to experience certain side effects such as dizziness when 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 administer this medication to children and adolescents under 18 years old for these treatments, as there have been no long-term safety and efficacy studies for this age group.

Nocturnal urinary incontinence

• Perform an ECG before starting treatment with amitriptyline to rule out long QT syndrome
• These medications should not be taken at the same time as an anticholinergic medication (see also section 2 “Taking Tryptizol with other medications”)
• During the early stages of treatment with antidepressants for conditions other than depression, thoughts and behaviors of suicide may occur; therefore, the same precautions should be taken when treating patients with enuresis as when treating patients with depression

Taking Tryptizol with other medications

Some medications may affect the functioning of other medications, and this can sometimes cause severe side effects.

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

• monoamine oxidase inhibitors (MAOIs) such as, for example, phenelzine, iproniazid, isocarboxazid, nialamide, or tranylcypromine (used to treat depression) or selegiline (used to treat Parkinson's disease). These medications should 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 cold and flu medications and some anesthetics)

• medications to treat high blood pressure such as, for example, calcium channel blockers (e.g., diltiazem and verapamil), guanethidine, betanidine, clonidine, reserpine, and methyldopa
• anticholinergic medications such as certain medications to treat Parkinson's disease and gastrointestinal disorders (e.g., atropine, hyoscyamine)

• thioridazine (used to treat schizophrenia)
• tramadol (to relieve pain)
• medications to treat fungal infections (e.g., fluconazole, terbinafine, ketoconazole, and itraconazole)
• sedatives (e.g., barbiturates)
• Buprenorphine or Buprenorphine/naloxone. These medications may interact with Tryptizol 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, temperature above 38°C. Inform your doctor if you experience these symptoms.
• antidepressants (e.g., SSRIs [fluoxetine, paroxetine, fluvoxamine], duloxetine, and bupropion)
• medications for certain heart conditions (e.g., beta-blockers and antiarrhythmics)
• cimetidine (used to treat stomach ulcers)
• methamphetamine (used to treat ADHD)
• ritonavir (used to treat HIV)
• oral contraceptives
• rifampicin (used to treat infections)
• phenytoin and carbamazepine (used to treat epilepsy)
• St. John's Wort (Hypericum perforatum), a plant-based medication used to treat depression
• thyroid medications
• valproic acid.

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

• medications to treat irregular heartbeats (e.g., quinidine and sotalol)
• astemizol and terfenadine (used to treat allergies and seasonal rhinitis)
• medications used to treat certain mental health conditions (e.g., pimozide and sertindol)
• cisapride (used to treat certain types of indigestion)
• halofantrine (used to treat malaria)
• methadone (used to treat pain and withdrawal)
• diuretics (”urine tablets” such as, for example, furosemide)

If you are to undergo surgery and receive general or local anesthetics, inform your doctor that you are taking this medication.

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

Taking Tryptizol with alcohol

It is not recommended to 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 before using this medication.

Amitriptyline 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 whether to start, continue, or 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 operate 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 medication.

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

Not all dosing guidelines can be achieved with all pharmaceutical forms/concentrations. The appropriate pharmaceutical form/concentration must 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.

Older adults (65 years and older) 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 100-150 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 10-25 mg at night.

The recommended daily dose is 25-75 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-ups. Your doctor will indicate whether you should take the dose once a day or divide it into two doses.

Older adults (65 years and older) and patients with cardiovascular disease

The recommended initial dose is 10-25 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 prevention. 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”
• 6-10 years: 10-20 mg.For this age group, a more appropriate pharmaceutical form should be used.
• 11 years or older: 25-50 mg.

The dose should be gradually increased.

Take this medication 1-1.5 hours before bedtime.

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

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 what is known as a "deficient metabolism" usually receive lower doses.

Your doctor may extract blood samples to determine the level of amitriptyline in the same (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.

Treatment duration

Do not change the medication dose or interrupt treatment without consulting your doctor first.

Depression

Like other depression medications, it may take several weeks to notice an improvement.

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

Continue taking this medication 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

You may take several weeks to notice an improvement in pain.

Discuss the duration of treatment with your doctor and continue taking this medication 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 nearest hospital emergency service immediately. Do this even if you do not have signs of discomfort or intoxication. Bring the packaging of this medication with you to the doctor or hospital.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological 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
• Alucinations
• Uncontrolled movements
• Low blood pressure, weak pulse, paleness
• Difficulty breathing
• Blue discoloration of the skin
• Decreased heart rate
• Somnolence
• Loss of consciousness
• Coma
• Various cardiac symptoms, such as cardiac arrest, heart failure, hypotension, cardiogenic shock, metabolic acidosis, hypokalemia

Amitriptyline overdose in children could have serious consequences. Children are especially prone to coma, cardiac symptoms, difficulty breathing, seizures, low sodium levels in the blood, lethargy, somnolence, 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 compensate for the missed 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 unwell, insomnia, irritability).

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:

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

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

• A heart problem called "prolonged QT interval" (which can be seen on your electrocardiogram).A frequent side effect that can affect up to 1 in 10 people.

• Important constipation, stomach bloating, fever, and vomiting.

These symptoms may be due to paralysis of parts of the intestine.A rare side effect that can 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.A rare side effect that can affect up to 1 in 1,000 people.

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

These symptoms may be the first signs of possible blood or bone marrow involvement.

The 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 clotting).A rare side effect that can affect up to 1 in 1,000 people.

• Thoughts or suicidal behavior.Rare side effects that can affect up to 1 in 1,000 people.

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

Very frequent: can affect more than 1 in 10 peoplepeople

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

Frequent: can affect up to 1 in 10 peoplepeople

• confusion
• sexual dysfunction (decreased libido, erectile dysfunction)
• attention disturbances
• changes in taste
• numbness or tingling in the arms or legs
• coordination disturbances
• dilated pupils
• cardiac arrest
• fatigue
• low sodium levels in the blood
• agitation
• urinary disturbances
• thirst sensation

Rare: can affect up to 1 in 100 peoplepeople

• excitement, anxiety, difficulty sleeping, nightmares
• seizures
• tinnitus
• increased blood pressure
• diarrhea, vomiting
• skin rash, urticaria, facial swelling, and tongue swelling
• urinary difficulties
• 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)
• increased pressure in the eyeball, intermittent blurred vision, rainbow vision, and eye pain

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

• decreased appetite
• delirium (especially in elderly patients), hallucinations
• abnormal heart rhythm or cardiac pattern
• salivary gland swelling
• hair loss
• increased sensitivity to sunlight
• increased breast size in men
• fever
• weight loss
• abnormal liver function test results

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

• heart muscle diseases
• sensation of restlessness and need to be constantly moving
• peripheral nerve damage
• acute increase in eye pressure
• particular forms of abnormal heart rhythm (also called torsades de pointes)
• allergic inflammation of the alveolar lung 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 disturbances (involuntary movements or decreased movements)
• hypersensitivity myocarditis
• hepatitis
• apathy
• Dry eyes
• Stop using Tryptizol and seek medical attention immediately if you notice any of the following symptoms: Generalized rash, elevated body temperature, and increased size of lymph nodes (DRESS or drug hypersensitivity syndrome).

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

Reporting of side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it ispossibleside effects that do not appear in this prospectus.You can also report them directly through the Spanish System for the Pharmacovigilance 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.

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

No special storage conditions are required.

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

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. In this way, you will help protect the environment.

Composition ofTryptizol

• The active ingredient isamitriptilina.
• The other components arelactose monohydrate, calcium phosphate dibasic, powdered cellulose, cornstarch, colloidal silicon dioxide, stearic acid, magnesium stearate, hydroxypropyl methylcellulose (E464), hydroxypropyl cellulose (E463), titanium dioxide (E171), talc, aluminium lake yellow (E104), yellow iron oxide (E172), and carnauba wax.

Appearance of the product and contents of the packaging

Tryptizol is presented in packaging of 24 and 60 coated tablets. The tablets are round, biconvex, and yellow in color.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

PAN QUÍMICA-FARMACÉUTICA, S.A.

Rufino González, 50

28037 Madrid

Spain

Responsible for manufacturing

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 review of this prospectus:January 2025.

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