AMITRIPTYLINE HYDROCHLORIDE NEURAXPHARM 25 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Amitriptyline Hydrochloride Neuraxpharm 25 mg Film-Coated Tablets EFG

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

• Keep this leaflet, 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 signs of illness are the same as yours.
• If you get 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 Amitriptyline Hydrochloride Neuraxpharm is and what it is used for
2. What you need to know before you take Amitriptyline Hydrochloride Neuraxpharm
3. How to take Amitriptyline Hydrochloride Neuraxpharm
4. Possible side effects
5. Storage of Amitriptyline Hydrochloride Neuraxpharm
6. Contents of the pack and other information

1. What Amitriptyline Hydrochloride Neuraxpharm is and what it is used for

Amitriptyline 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 above, only when other organic causes such as spina bifida and related disorders have been excluded and a response has not 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 Amitriptyline Hydrochloride Neuraxpharm

Do not take Amitriptyline Hydrochloride Neuraxpharm:

• 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 heart problems such as irregular heart rhythm 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 amitriptyline, 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

Consult your doctor or pharmacist before starting treatment with Amitriptyline Hydrochloride Neuraxpharm.

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

Prolonged QT interval

A heart problem called "prolonged QT interval" (which appears on the electrocardiogram [ECG]) and heart rhythm disorders (fast or irregular heartbeat) have been reported with this medicine. 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 for 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 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 yourself or taking your own life. This type of thought may increase when you first start taking antidepressants, as all these medicines take time to work, usually around two weeks, but sometimes longer.

You are 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. Clinical trial data have shown an increased risk of suicidal behavior in young adults (under 25 years) with psychiatric disorders who were treated 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 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 rapid, profuse ideas, excessive joy, and excessive physical activity. In these cases, it is essential to contact your doctor, who will likely 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 (intestinal blockage)

• 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 medication (see also section 2 "Other medicines and Amitriptyline Hydrochloride Neuraxpharm" and section 3).

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

Elderly people are more likely to suffer from 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 studies have not been conducted in 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 "Other medicines and Amitriptyline Hydrochloride Neuraxpharm").
• 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.

Other medicines and Amitriptyline Hydrochloride Neuraxpharm

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 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 Amitriptyline Hydrochloride Neuraxpharm (see section 2 "Do not take Amitriptyline Hydrochloride Neuraxpharm")
• adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine, and phenylpropanolamine (which may be present in cough and cold medicines and some anesthetics)

• medicines to treat 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, hyoscine)

• thioridazine (used to treat schizophrenia)
• tramadol (for pain relief)
• medicines to treat fungal infections (e.g., fluconazole, terbinafine, ketoconazole, and itraconazole)
• sedatives (e.g., barbiturates)
• antidepressants (e.g., SSRIs [fluoxetine, paroxetine, fluvoxamine] and bupropion)
• medicines for certain heart conditions (e.g., beta-blockers and anti-arrhythmics)
• 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 your heart rhythm, such as:

• medicines to treat irregular heartbeats (e.g., quinidine and sotalol)
• astemizole and terfenadine (used to treat allergies and hay fever)
• 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 going to have surgery and will be given 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 have a local anesthetic.

Taking Amitriptyline Hydrochloride Neuraxpharm 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 have 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 stop using 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 start of treatment. Do not drive or work with tools or machinery if you are affected.

Amitriptyline Hydrochloride Neuraxpharm contains lactose.

If your doctor has told you that you have an intolerance to some sugars, consult your doctor 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 Amitriptilina hidrocloruro Neuraxpharm

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 (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-ups. Your doctor will indicate whether you should take the dose once a day or divide it into two doses.

Elderly (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 Amitriptilina hidrocloruro Neuraxpharm"
• 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 signs of unusual 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 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 Amitriptilina hidrocloruro Neuraxpharm

This medication should be taken orally.

The tablets 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 Amitriptilina hidrocloruro Neuraxpharm than you should

Contact your doctor or the emergency department of the nearest hospital immediately. Do this even if you do not have any signs 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 heartbeat
• 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

If you forget to take Amitriptilina hidrocloruro Neuraxpharm

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 Amitriptilina hidrocloruro Neuraxpharm

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 doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

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

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

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

An eye examination should be performed immediately before continuing treatment with this medication. These symptoms can be a sign of acute glaucoma. Very rare side effect, may affect up to 1 in 10,000 people.

• A heart problem "prolonged QT interval" (which can be seen on your electrocardiogram). Frequent side 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 side effect, may affect up to 1 in 1,000 people.

• Any degree of yellowish discoloration of the skin and the white part of the eyes (jaundice).

It is possible that your liver is affected. Rare side 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 through the body), white blood cells (which help fight infections), and platelets (which help with blood clotting). Rare side effect, may affect up to 1 in 1,000 people.

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

Stop using Amitriptilina hidrocloruro Neuraxpharm and seek medical attention immediately if you notice any of the following symptoms:

• Widespread rash, elevated body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome). Frequency not known.

The following side 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)

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
• sudden increase in eye pressure
• particular forms 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
• increased or decreased blood sugar levels
• paranoia
• movement disorders (involuntary or decreased movements)
• hypersensitivity inflammation of the heart muscle
• hepatitis
• hot flashes
• dry eyes

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

Reporting side effects

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

By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Amitriptilina hidrocloruro Neuraxpharm

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

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.

This medication does not require any special storage temperature.

Store in the original packaging to protect it from light.

Medications should not be thrown away through the sewage system 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 Amitriptilina hidrocloruro Neuraxpharm

The active substance is amitriptilina.

• Each tablet contains 25 mg of amitriptilina hidrocloruro (equivalent to 22.10 mg of amitriptilina).
• The other components are:

Core of the tablet: lactose monohydrate, pregelatinized corn starch, povidone K25, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate

Coating of the tablet: polyvinyl alcohol, titanium dioxide (E171), macrogol 4000, talc, yellow iron oxide (E172).

Appearance of the product and package contents

Amitriptilina hidrocloruro Neuraxpharm 25 mg are film-coated, round, biconvex tablets, yellow in color.

The tablets are packaged in blisters and cardboard boxes containing 20, 24, 50, 60, or 100 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Neuraxpharm, Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí – Barcelona

Spain

Manufacturer

Neuraxpharm Arzneimittel GmbH

Elisabeth-Selbert-Str. 23, 40764 Langenfeld

Germany

or

Dragenopharm Apotheker Pueschl GmbH

Goellstr. 1, 84529 Tittmoning

Germany

Date of the last revision of this leaflet: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/.