Amitriptyline vp

Patient Information Leaflet

Amitriptylinum VP, 10 mg, coated tablets
Amitriptylinum VP, 25 mg, coated tablets
Amtriptyline hydrochloride
Please read this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist. This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Amitriptylinum VP is and what it is used for
2. What you need to know 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 Amitriptylinum VP is and what it is used for

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

• for the treatment of depression in adults (major depressive disorders)
• for the treatment of neuropathic pain in adults
• for the prevention of chronic tension-type headaches in adults
• for the prevention of migraine in adults
• for the treatment of nocturnal enuresis in children aged 6 years and older, only after exclusion of organic causes such as spina bifida and related disorders, and when there is no response to other non-pharmacological and pharmacological treatments, including antispasmodics, vasopressin and related products. Amitriptylinum VP may be prescribed only by a specialist physician for the maintenance treatment of persistent nocturnal enuresis.

2. Information to know 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 suffered a myocardial infarction (heart attack)
• if the patient has heart problems, such as cardiac arrhythmias identified on electrocardiogram (EKG), heart block, or coronary heart disease
• if the patient is taking medicines known as monoamine oxidase inhibitors (MAO inhibitors)
• if the patient has taken MAO inhibitors within the last 14 days
• if the patient took moclobemide the previous day
• if the patient has severe liver disease. If the patient is being treated with Amitriptylinum VP, treatment must be discontinued and 14 days must elapse before starting treatment with an MAO inhibitor. This medicine should not be used in children under 6 years of age.

Warnings and precautions
Before starting treatment with Amitriptylinum VP, discuss this with your doctor or
pharmacist.
After receiving a large dose of amitriptyline, cardiac arrhythmias and hypotension may occur.
This may also happen with normally used doses in patients with pre-existing heart disease.
Long QT syndrome
Use of Amitriptylinum VP has been associated with a heart problem known as long QT syndrome (visible on electrocardiogram, EKG) and cardiac arrhythmias (rapid or irregular heartbeat). Inform your doctor if any of the following conditions or situations apply to the patient:

• slowed heart rate,
• current (or past) heart failure (a condition in which the heart is unable to pump blood adequately),
• taking medicines that may cause heart function disturbances, or
• presence of conditions causing low blood potassium or magnesium levels, or high potassium levels,
• planned surgical procedure, as treatment with amitriptyline may need to be discontinued before administration of anesthetic agents. In case of emergency surgery, it is essential to inform the anesthesiologist that the patient is being treated with amitriptyline,
• hyperthyroidism or taking thyroid medications.

Suicidal thoughts or worsening depression
Patients with depression may sometimes experience thoughts of self-harm or suicide. These may worsen after starting antidepressant treatment, as it may take some time—usually two weeks or sometimes longer—for the medicine to take effect.
Such thoughts are more likely:

• if the patient previously experienced suicidal thoughts or self-harm,
• if the patient is a young adult. Clinical trial data have indicated an increased risk of suicidal behaviour in young adults (under 25 years of age) with psychiatric disorders treated with antidepressants.

If thoughts of self-harm or suicide occur, contact a doctor immediately or go directly to a hospital.
It may be helpful to inform a relative or close friend about the depressive condition and ask them to read this patient leaflet. The patient may ask them to inform him/her if they notice worsening depression or anxiety, or concerning changes in behaviour.
Manic episodes
Some patients with bipolar affective disorder may enter a manic phase. This is characterised by a flood of rapidly changing ideas, excessive euphoria, and increased physical activity. In such cases, it is important to contact the doctor, who may change the patient's medication.
Inform the doctor if the patient has or has previously had any health problems, especially:

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

If the patient is taking antidepressants such as SSRIs, the doctor may consider changing the dose (see also section 2: Amitriptylinum VP and other medicines and section 3).
Serious skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during treatment with Amitriptylinum VP. Treatment with Amitriptylinum VP should be discontinued and medical advice sought immediately if any symptoms of serious skin reactions described in section 4 occur.
In elderly patients, certain adverse effects are more likely, such as dizziness upon standing due to low blood pressure (see also section 4: Possible side effects).
Children and adolescents
Depression, neuropathic pain, prophylaxis of chronic tension-type headaches and migraine
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.
Night enuresis

• An EKG should be performed before starting amitriptyline treatment to rule out long QT syndrome.
• Amitriptyline should not be taken together with anticholinergic medicines (see also section 2: Amitriptylinum VP and other medicines).
• Suicidal thoughts and behaviours may also occur at the beginning of treatment with antidepressants for disorders other than depression. Therefore, the same precautions should be observed when treating patients with nocturnal enuresis as when treating patients with depression.

Amitriptylinum VP and other medicines
Some medicines may affect the action of other medicines, leading to serious adverse effects.
Inform your doctor or pharmacist about all medicines currently taken or recently taken by the patient, such as:

• monoamine oxidase inhibitors (MAO inhibitors), e.g. 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 or cold remedies and certain anesthetics)
• medicines for high blood pressure, e.g. calcium channel blockers (e.g. diltiazem and verapamil), guanethidine, betanidine, clonidine, reserpine, and methyldopa
• anticholinergic medicines, such as certain medicines for Parkinson's disease and gastrointestinal disorders (e.g. atropine, hyoscine)
• thioridazine (used to treat schizophrenia)
• tramadol (a painkiller)
• medicines used to treat fungal infections (e.g. fluconazole, terbinafine, ketoconazole, and itraconazole)
• sedatives (e.g. barbiturates)
• antidepressants [e.g. SSRIs (fluoxetine, paroxetine, fluvoxamine), duloxetine, and bupropion]
• medicines for certain heart conditions (e.g. beta-blockers and antiarrhythmics)
• cimetidine (used to treat stomach ulcers)
• methylphenidate (used to treat ADHD)
• ritonavir (used to treat HIV)
• oral contraceptives
• rifampicin (used to treat infections)
• phenytoin and carbamazepine (used to treat epilepsy)
• St John's wort (Hypericum perforatum) – a herbal remedy used for depression
• medicines used to treat thyroid disorders
• valproic acid.

Also inform the doctor if the patient is currently taking or has recently taken medicines affecting 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 psychiatric disorders (e.g. pimozide and sertindole)
• cisapride (used to treat certain types of indigestion)
• halofantrine (used to treat malaria)
• methadone (used for pain relief and detoxification)
• diuretics (increasing urine production, e.g. furosemide)

If the patient has a planned surgical procedure under general or local anesthesia, he/she should inform the doctor about taking this medicine.
Similarly, inform the dentist about taking this medicine if the patient is to receive a local anesthetic.

Amitriptylinum VP and alcohol
Drinking alcohol during treatment with this medicine is not recommended, as it may enhance the sedative effect.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using 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 stage of pregnancy, the newborn may experience withdrawal symptoms such as irritability, increased muscle tone, tremor, irregular breathing, poor feeding, loud crying, urinary retention, and constipation.
The doctor will advise whether breastfeeding should be started/continued/stopped or whether treatment with this medicine should be discontinued, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the patient.

Driving and operating machinery
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, meaning it is considered "sodium-free".

3. How to take Amitriptylinum VP

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor.
Not all dosing regimens can be achieved using each available form or strength of the product. An appropriate formulation or dosage should be selected for the initial dose and for each subsequent dose increase.

Depression
Adults
The recommended starting dose is 25 mg twice daily.
Depending on the response to treatment, your doctor may gradually increase the dose up to 150 mg per day, divided into two doses.

Elderly patients (over 65 years of age) and patients with cardiovascular disease
The recommended starting dose is 10–25 mg in the evening.
Depending on the response to treatment, your doctor may gradually increase the dose up to a total daily dose of 100 mg, divided into two doses. If a patient receives doses between 100–150 mg, more frequent medical monitoring may be required.

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-type headaches and migraine prophylaxis
Your doctor will adjust the dose according to symptoms and the patient's response to treatment.

Adults
The recommended starting dose is 10–25 mg at bedtime.
The recommended daily dose is 25–75 mg.
Depending on the response to treatment, your doctor may gradually increase the dose. If a patient receives more than 100 mg of amitriptyline per day, your doctor may recommend more frequent check-ups.
Your doctor will inform you whether the medicine should be taken once daily or divided into two doses.

Elderly patients (over 65 years of age) and patients with cardiovascular disease
The recommended starting dose is 10–25 mg at bedtime.
Depending on the response to treatment, your doctor may gradually increase the dose up to 100 mg. If a patient receives doses exceeding 75 mg per day, more frequent medical monitoring 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-type headaches, or migraine prophylaxis. For further information, see section 2.

Nocturnal enuresis (bedwetting)
Use in children and adolescents
Recommended doses for children:

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

The dose should be increased gradually.
This medicine should be taken 1–1½ hours before bedtime.
Before starting treatment, your doctor will perform an ECG to check for signs of abnormal heart rhythm.
Your doctor will reassess treatment after 3 months and, if necessary, perform a new ECG.
Do not stop treatment without first consulting your doctor.

Patients in special risk groups
Patients with liver disease or individuals known to be slow metabolizers usually receive lower doses.
Your doctor may take blood samples to measure the concentration of amitriptyline in the blood (see also section 2).

How and when to take Amitriptylinum VP
This medicine may be taken with or without food.
Tablets should be swallowed whole with water. Do not chew them.

Duration of treatment
Do not change the dose or stop taking this medicine without first consulting your doctor.

Depression
As with other medicines used in the treatment of depression, it may take several weeks before improvement is felt.
The duration of treatment for depression is individual and usually lasts at least 6 months. The decision on treatment duration is made by the doctor.
Continue taking this medicine for the duration recommended by your doctor.
The underlying condition may persist for a long time. If treatment is stopped too early, symptoms may return.

Neuropathic pain, prevention of chronic tension-type headaches and migraine prophylaxis
It may take several weeks before a reduction in pain is felt.
Discuss the duration of treatment with your doctor and continue taking this medicine for as long as directed.

Nocturnal enuresis
Your doctor will assess whether treatment should continue after 3 months.

Taking more Amitriptylinum VP than prescribed
Contact your doctor or the nearest hospital emergency department immediately. Do this even if no symptoms of discomfort or poisoning are present. When going to the doctor, bring the medicine packaging with you.
Symptoms of overdose include:

• dilated pupils
• rapid or irregular heartbeat
• difficulty urinating
• dryness of the mouth and tongue
• intestinal obstruction
• seizures
• fever
• restlessness
• confusion
• hallucinations
• uncontrolled movements
• low blood pressure, weak pulse, pallor
• breathing difficulties
• cyanosis (bluish skin)
• bradycardia (slow heart rate)
• drowsiness
• loss of consciousness
• coma
• various cardiac effects such as heart block, heart failure, hypotension, cardiogenic shock, metabolic acidosis, hypokalaemia.

Overdose with amitriptyline in children may lead to serious consequences. Children are particularly susceptible to coma, cardiac symptoms, breathing difficulties, seizures, hyponatraemia, lethargy, drowsiness, nausea, vomiting, and hyperglycaemia.

If you miss a dose of Amitriptylinum VP
Take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

Stopping Amitriptylinum VP
Your doctor will decide when and how to discontinue treatment to avoid unpleasant symptoms that may occur after abrupt withdrawal (e.g. headache, malaise, insomnia, and irritability).

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur, you should immediately
seek medical advice:

• Episodes of blurred vision, rainbow-colored vision, and eye pain. Immediate eye examination is necessary before continuing treatment with this medicine. This condition may be a sign of acute glaucoma. Rare adverse reaction, may affect up to 1 in 1,000 people.
• Heart problem known as long QT syndrome (visible on electrocardiogram, ECG). Common adverse reaction, may affect up to 1 in 10 people.
• Constipation, abdominal distension, fever, and vomiting. These symptoms may be due to intestinal paralysis. Rare adverse reaction, may affect up to 1 in 1,000 people.
• Yellowing of the skin or eyes (jaundice). The medicine may affect the liver. Rare adverse reaction, may affect up to 1 in 1,000 people.
• Bruising, bleeding, paleness, or persistent sore throat and fever. These symptoms may be the first signs of bone marrow and blood effects. Blood effects may include reduced numbers of red blood cells (which carry oxygen in the body), white blood cells (which help fight infections), and platelets (which help blood to clot). Rare adverse reaction, may affect up to 1 in 1,000 people.
• Suicidal thoughts or behaviour. Rare adverse reaction, may affect up to 1 in 1,000 people.

If any of the following symptoms occur, you must stop taking
Amitriptylinum VP and immediately seek medical advice:

• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). Frequency of the adverse reaction: unknown.

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

• drowsiness/sleepiness,
• tremor of hands or other body parts,
• dizziness,
• headache,
• irregular, strong, or rapid heartbeat,
• dizziness upon standing due to low blood pressure (orthostatic hypotension),
• dry mouth,
• constipation,
• nausea,
• excessive sweating,
• weight gain,
• slurred or slow speech,
• aggression,
• nasal congestion.

Common: may affect up to 1 in 10 people:

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

Uncommon: may affect up to 1 in 100 people:

• anxiety, restlessness, sleep difficulties, nightmares,
• seizures,
• tinnitus (ringing in the ears),
• high blood pressure,
• diarrhoea, vomiting,
• increased milk production or milk discharge without breastfeeding,
• increased intraocular pressure,
• worsening of the patient's clinical condition,
• exacerbation 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 (e.g. bruising, bleeding, paleness, persistent sore throat and fever),
• decreased appetite,
• delirium (especially in elderly patients), hallucinations,
• suicidal thoughts or behaviour,
• heart rhythm or pulse pattern disturbances,
• salivary gland swelling,
• obstruction of the small intestine causing constipation,
• yellowing of the skin or eyes (jaundice),
• hair loss,
• increased sensitivity to sunlight,
• breast enlargement in males,
• fever,
• weight loss,
• abnormal liver function test results.

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

• cardiomyopathy (heart muscle disease),
• inner restlessness with an urge to move constantly (akathisia),
• peripheral nerve disorders,
• sudden increase in eye pressure,
• a specific type of irregular heart rhythm (called torsades de pointes),
• allergic alveolitis and lung tissue inflammation.

Unknown (frequency cannot be estimated from available data):

• loss of appetite,
• fluctuations in blood sugar levels,
• paranoia,
• movement disorders (uncontrolled movements or reduced mobility),
• myocarditis (inflammation of the heart muscle),
• hepatitis (liver inflammation),
• hot flushes,
• dry eyes.

In patients taking this type of medicine, an increased risk of bone fractures has been observed.
Reporting of adverse reactions
If you experience any adverse reactions, including any not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions
of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website:
https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safe use of the medicine.

5. How to store Amitriptylinum VP

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following the label **Expiry date (EXP)**. The expiry date refers to the last day of that month.
Store below 25°C.
Keep in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Amitriptylinum VP contains
The active substance is amitriptyline.
Other components:
Film-coated tablets 10 mg:
microcrystalline cellulose, maize starch, povidone, disodium edetate, talc, magnesium stearate.
Coating composition:
basic butyl methacrylate copolymer, citric acid monohydrate, triethyl citrate, polysorbate 80, macrogol 6000, talc, titanium dioxide (E 171), yellow iron oxide (E 172), simeticone emulsion.
Film-coated tablets 25 mg:
microcrystalline cellulose, maize starch, povidone, disodium edetate, talc, magnesium stearate.
Coating composition:
basic butyl methacrylate copolymer, citric acid monohydrate, triethyl citrate, polysorbate 80, macrogol 6000, talc, titanium dioxide (E 171), red iron oxide (E 172), simeticone emulsion.

What Amitriptylinum VP looks like and contents of the pack
Film-coated tablets 10 mg: yellow-brown, round, biconvex tablets.
Film-coated tablets 25 mg: brown-red, round, biconvex tablets.
Pack size: 60 film-coated tablets (2 blisters of 30 tablets each) in a cardboard box.

Marketing Authorisation 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.
ul. Przemysłowa 2
35-959 Rzeszów
ICN Polfa Rzeszów S.A.
ul. Przemysłowa 2
35-959 Rzeszów