AMITRIPTYLINUM 25 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Amitriptylinum VP, 10 mg, Coated Tablets
3. Amitriptylinum VP, 25 mg, Coated Tablets
   1. Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Leaflet:
4. What is Amitriptylinum VP and what is it used for
5. Important information before taking Amitriptylinum VP
   1. When not to take Amitriptylinum VP
   2. Warnings and precautions
   3. Children and adolescents
   4. Amitriptylinum VP and other medications
   5. Amitriptylinum VP and alcohol
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Amitriptylinum VP contains sodium
6. How to take Amitriptylinum VP
   1. How and when to take Amitriptylinum VP
   2. Duration of treatment
   3. Taking a higher dose of Amitriptylinum VP than recommended
   4. Missing a dose of Amitriptylinum VP
   5. Stopping treatment with Amitriptylinum VP
7. Possible side effects
   1. Reporting side effects
8. How to store Amitriptylinum VP
9. Contents of the pack and other information
   1. What Amitriptylinum VP contains
   2. What Amitriptylinum VP looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet:

Package Leaflet: Information for the Patient

Amitriptylinum VP, 10 mg, Coated Tablets

Amitriptylinum VP, 25 mg, Coated Tablets

Amitriptyline Hydrochloride

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist. This medication has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Amitriptylinum VP and what is it used for
• 2. Important information before taking Amitriptylinum VP
• 3. How to take Amitriptylinum VP
• 4. Possible side effects
• 5. How to store Amitriptylinum VP
• 6. Contents of the pack and other information

1. What is Amitriptylinum VP and what is it used for

Amitriptylinum VP belongs to a group of medications known as tricyclic antidepressants.
This medication is used:

• to treat depression in adults (major depressive disorders)
• to treat neuropathic pain in adults
• to prevent chronic tension headaches in adults
• to prevent migraines in adults
• to treat nocturnal enuresis in children aged 6 and above, only when organic causes such as spina bifida and related diseases have been excluded, and when there is no response to other non-pharmacological and pharmacological therapies, including antispasmodic medications and vasopressin and related products. Amitriptylinum VP may only be prescribed by a specialist doctor for the treatment of persistent nocturnal enuresis.

2. Important information before taking Amitriptylinum VP

When not to take Amitriptylinum VP

• if the patient is allergic to amitriptyline or any of the other ingredients of this medication (listed in section 6)
• if the patient has recently had a heart attack
• if the patient has heart problems, such as rhythm disorders detected in an electrocardiogram (ECG), heart block, or coronary heart disease
• if the patient is taking medications called monoamine oxidase inhibitors (MAOIs)
• if the patient has taken MAOIs in the last 14 days
• if the patient took moclobemide the day before
• if the patient has severe liver disease. If the patient is being treated with Amitriptylinum VP, it is necessary to stop taking the medication and wait 14 days before starting treatment with an MAOI. This medication should not be used in children under 6 years of age.

Warnings and precautions

Before starting to take Amitriptylinum VP, the patient should discuss it with their doctor or pharmacist.
After taking a large dose of amitriptyline, heart rhythm disorders and low blood pressure may occur.
This can also happen after usual doses in patients with pre-existing heart disease.
Long QT syndrome
During treatment with Amitriptylinum VP, a heart problem called long QT syndrome (visible in an electrocardiogram, ECG) and heart rhythm disorders (fast or irregular heartbeat) have been reported. The patient should tell their doctor if they have any of the following conditions or situations:

• slow heart rate,
• current or past heart failure (a condition where the heart is not pumping blood in the body as it should),
• taking medications that can cause heart rhythm disorders or
• having disorders that cause low potassium or magnesium levels in the blood or high potassium levels,
• having a planned surgical procedure, as it may be necessary to stop treatment with amitriptyline before administering anesthetics. In case of an emergency surgery, it is necessary to inform the anesthesiologist about the treatment with amitriptyline,
• having hyperthyroidism or taking thyroid medications.

Suicidal thoughts or worsening depression
Patients with depression may sometimes have thoughts of self-harm or suicide. These thoughts may worsen after starting to take antidepressant medications, as it may take some time, usually two weeks or sometimes longer, for the medications to start working.
These thoughts are more likely:

• if the patient has had suicidal thoughts or self-harm in the past,
• if the patient is a young adult. Clinical trial data have shown an increased risk of suicidal behavior in young adults (under 25 years of age) with mental disorders treated with antidepressant medications.

In case of suicidal thoughts or self-harm, the patient should immediately contact their doctor or go directly to the hospital.
It may be helpful to inform a family member or close friend about the depressive condition and ask them to read this patient information leaflet. The patient may ask them to inform them if they notice that the depression or anxiety has worsened or if there are any worrying changes in behavior.
Manic episodes
Some patients with bipolar affective disorder may enter a manic phase.
This is characterized by a rush of rapidly changing ideas, excessive cheerfulness, and increased physical activity. In such cases, it is essential to contact the doctor, who will likely change the patient's medication.
The patient should inform their doctor if they have or have had any health problems, especially

• angle-closure glaucoma (vision loss due to abnormally high pressure in the eye)
• epilepsy, seizures, or convulsions in their medical history
• difficulty urinating
• enlarged prostate
• thyroid disease
• bipolar affective disorder
• schizophrenia
• severe liver disease
• severe heart disease
• pyloric stenosis (narrowing of the stomach outlet) and paralytic ileus (blocked intestines)
• diabetes, as the patient may need to adjust their antidiabetic medication.

If the patient is taking antidepressant medications, such as SSRIs, the doctor may consider changing the dose of the medication (see also section 2: Amitriptylinum VP and other medications and section 3).
Severe skin reactions, including drug rash with eosinophilia and systemic symptoms (DRESS), have been reported during treatment with Amitriptylinum VP. The patient should stop taking Amitriptylinum VP and immediately consult their doctor if they experience any symptoms related to severe skin reactions described in section 4.
In elderly patients, it is 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 headaches, and migraines
This medication should not be given to children or adolescents under 18 years of age for the treatment of these conditions, as safety and efficacy have not been established in this age group.
Nocturnal enuresis

• Before starting treatment with amitriptyline, an ECG should be performed to exclude the presence of long QT syndrome.
• Amitriptyline should not be taken with anticholinergic medications (see also section 2: Amitriptylinum VP and other medications).
• Suicidal thoughts and behaviors may also occur at the beginning of treatment with antidepressant medications for other disorders, not just depression. Therefore, during the treatment of patients with nocturnal enuresis, the same precautions should be taken as during the treatment of patients with depression.

Amitriptylinum VP and other medications

Certain medications can affect the action of other medications, resulting in serious side effects.
The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, 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 medications should not be taken at the same time as Amitriptylinum VP (see section 2: When not to take Amitriptylinum VP)
• adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine, and phenylpropanolamine (may be present in cough and cold medications and some anesthetics)
• medications for high blood pressure, such as calcium channel blockers (e.g., diltiazem and verapamil), guanethidine, betanidine, clonidine, reserpine, and methyldopa
• anticholinergic medications, such as those used to treat Parkinson's disease and gastrointestinal disorders (e.g., atropine, hyoscine)
• thioridazine (used to treat schizophrenia)
• tramadol (a pain medication)
• medications used to treat fungal infections (e.g., fluconazole, terbinafine, ketoconazole, and itraconazole)
• sedatives (e.g., barbiturates)
• antidepressant medications [e.g., SSRIs (fluoxetine, paroxetine, fluvoxamine), duloxetine, and bupropion]
• medications for certain heart conditions (e.g., beta blockers and antiarrhythmic medications)
• cimetidine (used to treat stomach ulcers)
• methylphenidate (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 herbal remedy used to treat depression
• medications used to treat thyroid disorders
• valproic acid.

The patient should also tell their doctor if they are currently taking or have recently taken medications that can affect heart rhythm, such as:

• medications for irregular heartbeat (e.g., quinidine and sotalol)
• astemizole and terfenadine (used to treat allergies and hay fever)
• medications used to treat certain mental disorders (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 (which increase the amount of urine produced, e.g., furosemide)

If the patient is scheduled to have surgery under general or local anesthesia, they should inform their doctor about taking this medication.
Similarly, the patient should inform their dentist about taking this medication if they are to receive a local anesthetic.

Amitriptylinum VP and alcohol

It is not recommended to drink alcohol while taking this medication, as it may enhance the sedative effect.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medication.
Amitriptyline is not recommended during pregnancy, unless the doctor considers it necessary and only after careful consideration of the risk-to-benefit ratio. If the patient took this medication during the last phase of pregnancy, the newborn may experience withdrawal symptoms, such as irritability, increased muscle tone, tremors, irregular breathing, poor feeding, loud crying, urinary retention, and constipation.
The doctor will advise whether to start/continue/stop breastfeeding or stop taking this medication, considering the benefits of breastfeeding for the child and the benefits of treatment for the patient.

Driving and using machines

This medication can cause drowsiness and dizziness, especially at the beginning of treatment. If these symptoms occur, the patient should not drive or operate machinery.

Amitriptylinum VP contains sodium

The medication contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Amitriptylinum VP

This medication should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor.
Not all dosing schedules can be achieved using each formulation or strength of the product. The patient should choose the appropriate formulation or dose of the medication for the initial dose and each subsequent dose increase.
Depression
Adults
The recommended initial dose is 25 mg twice a day.
Depending on the response to the medication, the doctor may gradually increase the dose up 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 in the evening.
Depending on the response to the medication, the doctor may gradually increase the dose up to a total daily dose of 100 mg, divided into two doses. If the patient is receiving doses between 100-150 mg, more frequent medical check-ups may be necessary.
Use in children and adolescents
This medication should not be given to children or adolescents for the treatment of depression. See section 2 for further information.
Neuropathic pain, prevention of chronic tension headaches, and migraines
The doctor will adjust the medication according to the patient's symptoms and response to treatment.
Adults
The recommended initial dose is 10-25 mg in the evening.
The recommended daily dose is 25-75 mg.
Depending on the response to the medication, the doctor may gradually increase the dose. If the patient is taking more than 100 mg of amitriptyline per day, the doctor may recommend more frequent check-ups.
The doctor will inform the patient whether to take the medication once a day or divided into two doses.
Elderly patients (over 65 years) and patients with cardiovascular disease
The recommended initial dose is 10-25 mg in the evening.
Depending on the response to the medication, the doctor may gradually increase the dose up to 100 mg. If the patient is receiving doses above 75 mg per day, more frequent medical check-ups may be necessary.
Use in children and adolescents
This medication should not be given to children or adolescents for the treatment of neuropathic pain, prevention of chronic tension headaches, and prevention of migraines. See section 2 for further information.
Nocturnal enuresis
Use in children and adolescents
The recommended doses for children are:

• under 6 years: see section 2: When not to take Amitriptylinum VP
• 6-10 years: 10-20 mg. The most suitable dosage form should be used for this age group.
• 11 years and older: 25-50 mg

The dose should be increased gradually.
The medication should be taken 1-1.5 hours before bedtime.
Before starting treatment, the doctor will perform an ECG to check for any abnormal heart rhythms.
The doctor will reassess the treatment after 3 months and may perform another ECG if necessary.
The patient should not stop taking the medication without consulting their doctor first.
Patients at special risk
Patients with liver disease or those known to be slow metabolizers usually receive lower doses.
The doctor may take blood samples to determine the level of amitriptyline in the blood (see also section 2).

How and when to take Amitriptylinum VP

This medication can be taken with or without food.
The tablets should be swallowed with water. They should not be chewed.

Duration of treatment

The patient should not change the dose of the medication or stop taking it without consulting their doctor first.
Depression
As with other medications used to treat depression, it may take several weeks before the patient feels an improvement.
The duration of treatment for depression is individual and usually lasts at least 6 months. The decision on the duration of treatment is made by the doctor.
The patient should continue taking this medication for the time recommended by their doctor.
The underlying disease may persist for a long time. If the patient stops treatment too soon, the symptoms may return.
Neuropathic pain, prevention of chronic tension headaches, and migraines
It may take several weeks before the patient feels a reduction in pain.
The patient should discuss the duration of treatment with their doctor and continue taking this medication for as long as recommended by the doctor.
Nocturnal enuresis
The doctor will assess whether to continue treatment after 3 months.

Taking a higher dose of Amitriptylinum VP than recommended

The patient should immediately contact their doctor or the emergency department of the nearest hospital. They should do this even if they do not feel unwell or experience any discomfort or poisoning. When going to the doctor, they should take the medication packaging with them.
Symptoms of overdose include:

• dilated pupils
• fast or irregular heartbeat
• difficulty urinating
• dry mouth and tongue
• intestinal obstruction
• seizures
• fever
• restlessness
• confusion
• hallucinations
• uncontrolled movements
• low blood pressure, weak pulse, paleness
• breathing difficulties
• cyanosis
• slow heart rate
• drowsiness
• loss of consciousness
• coma
• various heart problems, such as heart block, heart failure, low blood pressure, cardiogenic shock, metabolic acidosis, hypokalemia.

Overdose of amitriptyline in children can lead to serious consequences. Children are particularly susceptible to experiencing coma, cardiac problems, breathing difficulties, seizures, low sodium levels in the blood, lethargy, drowsiness, nausea, vomiting, and increased blood sugar levels.

Missing a dose of Amitriptylinum VP

The next dose should be taken at the usual time. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Amitriptylinum VP

The doctor will decide when and how to stop treatment to avoid unpleasant symptoms that may occur after sudden withdrawal of the medication (e.g., headache, malaise, insomnia, and irritability).
In case of any further doubts about the use of this medication, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medications, Amitriptylinum VP can cause side effects, although not everybody gets them.
If the patient experiences any of the following side effects, they should immediately consult their doctor:

• Episodes of blurred vision, rainbow-colored vision, and eye pain. It is necessary to have an eye examination immediately before continuing treatment with this medication. This condition may be a sign of acute glaucoma. Rare side effect, may affect up to 1 in 1,000 people.
• A heart problem called long QT syndrome (visible in an electrocardiogram, ECG). Frequent side effect, may affect up to 1 in 10 people.
• Constipation, bloating, fever, and vomiting. These symptoms may be caused by intestinal obstruction. Rare side effect, may affect up to 1 in 1,000 people.
• Yellowing of the skin or eyes (jaundice). The medication may affect the liver. Rare side effect, may 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 a blood disorder. Rare side effect, may affect up to 1 in 1,000 people.
• Suicidal thoughts or behaviors. Rare side effect, may affect up to 1 in 1,000 people.

If the patient experiences any of the following symptoms, they should stop taking Amitriptylinum VP and immediately consult their doctor:

• Widespread rash, high fever, and swollen lymph nodes (DRESS or hypersensitivity syndrome). Frequency of the side effect: unknown.

The following side effects have been reported with the following frequencies:
Very common: may affect more than 1 in 10 people:

• drowsiness/dizziness,
• tremors of the hands or other parts of the body,
• dizziness,
• headache,
• irregular, strong, or fast heartbeats,
• dizziness when standing up due to low blood pressure (orthostatic hypotension),
• dry mouth,
• constipation,
• nausea,
• excessive sweating,
• weight gain,
• slurred or slow speech,
• aggression,
• stuffy nose.

Common: may affect up to 1 in 10 people:

• confusion,
• sexual disorders (decreased libido, erectile dysfunction),
• attention disorders,
• changes in taste,
• numbness or tingling in the hands or feet,
• coordination disorders,
• slurred or slow speech,
• dilated pupils,
• heart block,
• fatigue,
• low sodium levels in the blood,
• restlessness,
• urinary disorders,
• thirst.

Uncommon: may affect up to 1 in 100 people:

• anxiety, anxiety disorders, insomnia, nightmares,
• seizures,
• ringing in the ears,
• high blood pressure,
• diarrhea, vomiting,
• increased milk production or milk secretion without breastfeeding,
• increased eye pressure,
• worsening of the patient's clinical condition,
• worsening of heart failure,
• liver function disorders (e.g., cholestatic liver disease). Rare: may affect up to 1 in 1,000 people:
• bone marrow suppression, blood changes (which may include bruising, bleeding, paleness, or persistent sore throat and fever),
• decreased appetite,
• delirium (especially in elderly patients), hallucinations,
• suicidal thoughts or behaviors,
• heart rhythm disorders or changes in heart rhythm,
• salivary gland swelling,
• small intestine obstruction causing constipation,
• yellowing of the skin or eyes (jaundice),
• hair loss,
• increased sensitivity to sunlight,
• breast enlargement in men,
• fever,
• weight loss,
• abnormal liver function test results.

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

• heart muscle disease,
• a feeling of inner restlessness with a need for constant movement,
• peripheral nerve disorders,
• sudden increase in eye pressure,
• a specific type of irregular heartbeat (called torsades de pointes),
• allergic inflammation of the lung tissue and air sacs. Unknown (frequency cannot be estimated from the available data):
• loss of appetite,
• fluctuations in blood sugar levels,
• paranoia,
• movement disorders (uncontrolled movements or decreased mobility),
• heart muscle inflammation,
• liver inflammation,
• heat strokes,
• dry eye.

Patient groups treated with this type of medication have been observed to have a higher risk of fractures.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medication.

5. How to store Amitriptylinum VP

The medication should be stored out of sight and reach of children.
Do not use this medication after the expiry date stated on the packaging after the "EXP" date. The expiry date refers to the last day of the month.
Store in a temperature below 25°C.
Store in the original packaging to protect from moisture.
Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Amitriptylinum VP contains

The active substance of the medication is amitriptyline.
Other ingredients:

10 mg coated tablets:
microcrystalline cellulose, corn starch, povidone, disodium edetate, talc, magnesium stearate.
Coating composition:
butyl methacrylate copolymer, citric acid monohydrate, triethyl citrate, polysorbate 80, macrogol 6000, talc, titanium dioxide (E 171), yellow iron oxide (E 172), simethicone emulsion.
25 mg coated tablets:
microcrystalline cellulose, corn starch, povidone, disodium edetate, talc, magnesium stearate.
Coating composition:
butyl methacrylate copolymer, citric acid monohydrate, triethyl citrate, polysorbate 80, macrogol 6000, talc, titanium dioxide (E 171), red iron oxide (E 172), simethicone emulsion.

What Amitriptylinum VP looks like and contents of the pack

10 mg coated tablets:yellow-brown, round, biconvex.
25 mg coated tablets:brown-red, round, biconvex.
Pack size: 60 coated tablets (2 blisters of 30 tablets each) in a cardboard box.

Marketing authorization holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Tel: +48 17 865 51 00

Manufacturer

Bausch Health Poland sp. z o.o.
Przemysłowa 2
35-959 Rzeszów
ICN Polfa Rzeszów S.A.
Przemysłowa 2
35-959 Rzeszów

Date of last revision of the leaflet: