Amitriptilinum Vp

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 medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist. This medicine 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 tell 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 medicines known as tricyclic antidepressants.
This medicine 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 drugs and vasopressin and related products. Amitriptylinum VP can 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 medicine (listed in section 6)
• if the patient has recently had a heart attack
• if the patient has heart problems, such as arrhythmias detected in the electrocardiogram (ECG), heart block, or coronary heart disease
• if the patient is taking monoamine oxidase inhibitor (MAOI) medicines
• 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 this medicine and wait 14 days before starting treatment with an MAOI. This medicine should not be used in children under 6 years of age.

Warnings and precautions

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 disturbances and low blood pressure may occur.
This can also happen after normally used doses in patients with pre-existing heart disease.
Long QT syndrome
During treatment with Amitriptylinum VP, a heart problem known as long QT syndrome (visible in the electrocardiogram, ECG) and heart rhythm disturbances (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,
• the heart is not pumping blood in the body as well as it should (a condition called heart failure),
• taking medicines that may cause heart rhythm disturbances or
• having 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 operation, it is necessary to inform the anesthesiologist about the treatment with amitriptyline,
• having hyperthyroidism or taking thyroid medicines.

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 medicines, as it may take a few weeks, usually two weeks or sometimes longer, for the medicines to start working.
These thoughts are more likely:

• if the patient has had suicidal thoughts or self-harm before,
• 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 medicines.

If the patient experiences thoughts of self-harm or suicide, they should contact their doctor or go directly to the hospital immediately.
It may be helpful to inform a relative or close friend about the depressive condition and ask them to read this patient information leaflet. The patient may ask them to tell 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 a doctor, who will probably change the patient's medicine.
The patient should tell 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 fits 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 medicine.

If the patient is taking antidepressant medicines, such as SSRIs, the doctor may consider changing the dose of the medicine (see also section 2: Amitriptylinum VP and other medicines and section 3).
During treatment with Amitriptylinum VP, severe skin reactions, including drug rash with eosinophilia and systemic symptoms (DRESS), have been reported. The patient should stop taking Amitriptylinum VP and go to the doctor immediately if they experience any symptoms related to severe skin reactions described in section 4.
In elderly patients, it is more likely that certain side effects will occur, 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 medicine 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 medicines (see also section 2: Amitriptylinum VP and other medicines).
• Suicidal thoughts and behaviors may also occur at the beginning of treatment with antidepressant medicines for other conditions than 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 medicines

Some medicines may affect the way other medicines work, which can lead to serious side effects.
The patient should tell their doctor or pharmacist about all medicines 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 medicines 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 medicines and some anesthetics)
• medicines for high blood pressure, such as calcium channel blockers (e.g., diltiazem and verapamil), guanethidine, betanidine, clonidine, reserpine, and methyldopa
• anticholinergic medicines, such as some medicines for Parkinson's disease and gastrointestinal disorders (e.g., atropine, hyoscine)
• thioridazine (used to treat schizophrenia)
• tramadol (a pain reliever)
• medicines used to treat fungal infections (e.g., fluconazole, terbinafine, ketoconazole, and itraconazole)
• sedatives (e.g., barbiturates)
• antidepressant medicines [e.g., SSRIs (fluoxetine, paroxetine, fluvoxamine), duloxetine, and bupropion]
• medicines for certain heart conditions (e.g., beta blockers and anti-arrhythmic medicines)
• 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 medicine used to treat depression
• medicines used to treat thyroid disorders
• valproic acid.

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

• medicines for irregular heartbeat (e.g., quinidine and sotalol)
• astemizole and terfenadine (used to treat allergies and hay fever)
• medicines 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 tell their doctor about taking this medicine.
Similarly, the patient should tell their dentist about taking this medicine if they are to receive a local anesthetic.

Amitriptylinum VP and alcohol

It is not recommended to drink alcohol while taking this medicine, 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 baby, they should consult their doctor before taking this medicine.
Amitriptyline is not recommended during pregnancy, unless the doctor considers it necessary and only after careful consideration of the risk-benefit ratio. If the patient took this medicine 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 medicine, considering the benefits of breastfeeding for the baby and the benefits of treatment for the patient.

Driving and using machines

This medicine may 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

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to take Amitriptylinum VP

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor.
Not all dosage schemes can be achieved using each formulation or strength of the product. The patient should choose the appropriate formulation or dose of the medicine 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 medicine, 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 medicine, 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 medicine should not be given to children or adolescents for the treatment of depression. For further information, see section 2.
Neuropathic pain, prevention of chronic tension headaches, and migraines
The doctor will adjust the medicine 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 medicine, 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 medicine 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 medicine, 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 medicine should not be given to children or adolescents for the treatment of neuropathic pain, prevention of chronic tension headaches, and prevention of migraines. For further information, see section 2.
Nocturnal enuresis
Use in children and adolescents
Recommended doses for children:

• under 6 years: see section 2: When not to take Amitriptylinum VP
• between 6 and 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.
This medicine 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, if necessary, perform a new ECG.
The patient should not stop taking this medicine without first consulting their doctor.
Patients at special risk
Patients with liver disease or those known to be poor 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 medicine 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 medicine or stop taking it without first consulting their doctor.
Depression
As with other medicines used to treat depression, it may take a few 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 medicine for the time recommended by their doctor.
The underlying disease may persist for a long time. If the patient stops treatment too early, the symptoms may return.
Neuropathic pain, prevention of chronic tension headaches, and migraines
It may take a few weeks before the patient feels a reduction in pain.
The patient should talk to their doctor about the duration of treatment and continue taking this medicine for as long as the doctor recommends.
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 contact their doctor or the emergency department of the nearest hospital immediately. They should do this even if they do not feel unwell or experience discomfort or poisoning. When going to the doctor, they should take the medicine 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 symptoms, such as heart block, heart failure, hypotension, cardiogenic shock, metabolic acidosis, hypokalemia.

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

Missing a dose of Amitriptylinum VP

The patient should take the next dose at the usual time. They 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 medicine (e.g., headache, malaise, insomnia, and irritability).
If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If the patient experiences any of the following side effects, they should go to their doctor immediately:

• Episodes of blurred vision, colored vision, and eye pain. It is necessary to have an eye examination immediately before continuing treatment with this medicine. This condition may be a sign of acute glaucoma. Rare side effect, may affect up to 1 in 1,000 people.
• A heart problem known as long QT syndrome (visible in the electrocardiogram, ECG). Frequent side effect, may affect up to 1 in 10 people.
• Constipation, bloated stomach, fever, and vomiting. These symptoms may be caused by paralysis of a part of the intestine. Rare side effect, may affect up to 1 in 1,000 people.
• Yellowing of the skin or eyes (jaundice). The medicine 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 go to their doctor immediately:

• Widespread rash, high fever, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome). Frequency not known.

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

Uncommon: may affect up to 1 in 100 people:

• anxiety, anxiety attacks, sleep disturbances, nightmares,
• seizures,
• ringing in the ears,
• high blood pressure,
• diarrhea, vomiting,
• increased milk production or milk secretion without breastfeeding,
• increased pressure in the eye,
• worsening of the patient's clinical condition,
• worsening of heart failure,
• liver function disturbances (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 disturbances or changes in heart rate pattern,
• 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 alveoli. Not known (frequency cannot be estimated from the available data):
• loss of appetite,
• fluctuations in blood sugar levels,
• paranoia,
• movement disorders (uncontrolled movements or decreased mobility),
• myocarditis,
• hepatitis,
• heat strokes,
• dry eye.

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

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell 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 medicine.

5. How to store Amitriptylinum VP

The medicine should be stored out of sight and reach of children.
This medicine should not be used after the expiry date stated on the packaging after the expiry date (EXP). The expiry date refers to the last day of the month.
Store at a temperature below 25°C.
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines 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 medicine is amitriptyline.
Other ingredients:

10 mg coated tablets:
microcrystalline cellulose, maize 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, maize 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: