Amitriptyline Doc Generici

Italy
Brand name Amitriptyline Doc Generici
Form drops, oral solution
Active substance / Dosage
AMITRIPTYLINE HYDROCHLORIDE
Prescription type Prescription only
ATC code
N06AA09
Registration number 045218
Manufacturer DOC GENERICI SRL

Table of Contents

Package leaflet: Information for the patient

AMITRIPTILINA DOC 40 mg/ml oral drops, solution

Equivalent medicine
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it may be harmful.
  • If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

  1. What AMITRIPTILINA DOC is and what it is used for
  2. What you need to know before taking AMITRIPTILINA DOC
  3. How to take AMITRIPTILINA DOC
  4. Possible side effects
  5. How to store AMITRIPTILINA DOC
  6. Contents of the pack and other information

1. What AMITRIPTILINA DOC is and what it is used for

AMITRIPTILINA DOC belongs to a group of medicines known as tricyclic antidepressants.
This medicine is used for the treatment of:

  • depression in adults (major depressive episodes)
  • neuropathic pain in adults
  • prophylaxis of chronic tension-type headache in adults
  • prophylaxis of migraine in adults
  • nocturnal enuresis (involuntary loss of urine during the night) in children aged 6 years and older, only when organic causes such as spina bifida and related disorders have been excluded and when there has been no response to all other non-pharmacological and pharmacological treatments, including muscle relaxants and desmopressin. This medicine must be prescribed exclusively by a healthcare professional experienced in the treatment of persistent enuresis.

2. What you should know before taking AMITRIPTYLINE DOC

Do not use AMITRIPTYLINE DOC

  • if you are allergic to amitriptyline or to 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 evident cardiac rhythm disturbances on electrocardiogram (ECG), heart block, or coronary artery disease;
  • if you are taking medicines known as monoamine oxidase inhibitors (MAOIs);
  • if you have taken MAOIs within the last 14 days;
  • if you have taken moclobemide the previous day;
  • if you have severe liver disease.

If you are being treated with AMITRIPTYLINE DOC, you must stop taking 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
Talk to your doctor or pharmacist before taking AMITRIPTYLINE DOC.
If you receive a high dose of amitriptyline, disturbances in heart rhythm and hypotension may occur.
These may also occur with usual doses in patients with pre-existing heart disease.
QT interval prolongation
With AMITRIPTYLINE DOC, a heart problem known as "QT interval prolongation" (evident on electrocardiogram, ECG) and cardiac arrhythmias (rapid or irregular heartbeat) have been reported. Inform your doctor if:

  • you have a slow heartbeat;
  • you have or have had heart failure (a condition in which the heart cannot pump blood properly throughout the body);
  • you are taking any other medicine that may cause heart problems;
  • you have low levels of potassium or magnesium, or high levels of potassium in the blood;
  • you are scheduled for surgery, as it may be necessary to discontinue amitriptyline treatment before administration of anaesthetics. In case of emergency surgery, the anaesthetist must be informed about your amitriptyline treatment;
  • you have hyperthyroidism or are receiving thyroid medications.

Suicidal thoughts and worsening of depression
If you are depressed, you may sometimes have thoughts of harming yourself or committing suicide.
These thoughts may increase at the beginning of antidepressant treatment, as the effect of these
medicines does not appear immediately, but only after two weeks or even longer.
You are more likely to have such thoughts if:

  • you have previously had thoughts of suicide or self-harm;
  • you are a young adult. Clinical study data have shown an increased risk of suicidal behaviour in young adults (under 25 years) with psychiatric disorders who were frequently treated with antidepressants.

If at any time you think about harming yourself or committing suicide, contact your doctor immediately or go to
hospital.
If you are depressed, it may be helpful to inform a family member or friend and ask them to read this leaflet.
You may also ask them to inform you if they believe your depression or anxiety is
worsening, or if they are concerned about changes in your behaviour.
Manic episodes
Some patients with bipolar disorder may enter a manic phase. This is
characterized by rapidly changing thoughts, exaggerated euphoria, and excessive
physical activity. In such cases, it is important to contact your doctor, who will likely adjust your treatment.
The use of medicines containing buprenorphine used to treat pain and opioid dependence
(buprenorphine with or without naloxone) together with amitriptyline may lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and AMITRIPTYLINE DOC”).
Inform your doctor if you have or have previously had any medical condition, especially:

  • narrow-angle glaucoma (loss of vision due to abnormally increased pressure inside the eye);
  • epilepsy, history of seizures, or convulsions;
  • difficulty urinating;
  • enlarged prostate;
  • thyroid disease;
  • bipolar disorder;
  • schizophrenia;
  • severe liver disease;
  • severe heart disease;
  • pyloric stenosis (narrowing of the stomach outlet valve) and paralytic ileus (intestinal blockage);
  • diabetes, as treatment with antidiabetic medicines may need to be adjusted.

If you are taking antidepressants such as serotonin reuptake inhibitors (SSRIs), your doctor may
consider adjusting the dose of the medicine (see also section 2 Other medicines and
AMITRIPTYLINE DOC and section 3).
Elderly patients are 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, chronic tension headache and migraine prophylaxis
Do not give this medicine to children and adolescents under 18 years of age for the treatment of these
conditions, as long-term safety and efficacy have not been established in this age group.
Nocturnal enuresis (involuntary loss of urine during sleep)

  • An ECG should be performed before starting amitriptyline therapy to rule out long QT syndrome.
  • This medicine must not be taken concurrently with an anticholinergic (see also section 2 Other medicines and AMITRIPTYLINE DOC).
  • Suicidal thoughts and behaviours may occur at the beginning of antidepressant treatment, even in patients suffering from disorders other than depression; therefore, the same precautions used in treating patients with depression should be adopted when treating patients with enuresis.

Other medicines and AMITRIPTYLINE DOC
Some medicines may alter the effect of other medicines, and this may sometimes cause serious
side effects.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicine, 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 DOC (see section 2 Do not take AMITRIPTYLINE DOC).
  • Adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine and phenylpropanolamine (may be present in cough and cold medicines and in some anaesthetics).
  • Medicines for high blood pressure, such as calcium antagonists (e.g. diltiazem and verapamil), guanethidine, betanidine, clonidine, reserpine and methyldopa.
  • Anticholinergics, such as certain medicines used to treat Parkinson's disease and gastrointestinal disorders (e.g. atropine, hyoscyamine).
  • Thioridazine (used to treat schizophrenia).
  • Tramadol (a painkiller).
  • Medicines for fungal infections (e.g. fluconazole, terbinafine, ketoconazole and itraconazole).
  • Sedatives (e.g. barbiturates).
  • Antidepressants (e.g. SSRIs (fluoxetine, paroxetine, fluvoxamine), duloxetine and bupropion).
  • Buprenorphine (used for opioid dependence and pain treatment); may interact with amitriptyline and cause symptoms such as involuntary rhythmic muscle contractions, including muscles controlling eye movements, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle contraction, and body temperature above 38°C. Contact your doctor if you experience such symptoms.
  • 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 (for treatment of infections).
  • Phenytoin and carbamazepine (used to treat epilepsy).
  • St. John's wort (Hypericum perforatum), a herbal product used for depression.
  • Thyroid medicines.
  • Valproic acid. Inform your doctor also if you are 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 illnesses (e.g. pimozide and sertindole);
  • cisapride (used to treat certain digestive disorders);
  • halofantrine (used to treat malaria);
  • methadone (used to treat pain and detoxification);
  • diuretics (medicines that increase urine production, e.g. furosemide). If you are scheduled for surgery and will receive general or local anaesthetics, inform your doctor that you are taking this medicine.

Similarly, inform your dentist that you are taking this medicine if you are to receive a local anaesthetic.
AMITRIPTYLINE DOC and alcohol
It is not advisable to consume alcoholic beverages during treatment with this medicine, as it may increase the sedative effect.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Amitriptyline is not recommended during pregnancy, unless your doctor considers it clearly necessary, and only after careful evaluation of benefit versus risk.
If you have taken this medicine during the last months of pregnancy, the newborn may experience withdrawal symptoms such as irritability, increased muscle tone, tremor, irregular breathing, feeding difficulties, loud crying, urinary retention and constipation.
Your doctor will advise you whether to start/continue/stop breastfeeding or discontinue use of 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 beginning of treatment. Do not drive and
do not operate tools or machinery if you experience these symptoms.

3. How to take AMITRIPTILINA DOC

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor.

If it is not possible to achieve the prescribed dose with AMITRIPTILINA DOC, other amitriptyline-containing medicines should be used to administer the required dose.

One drop of AMITRIPTILINA DOC contains 2 mg of amitriptyline.

Depression

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

Elderly (over 65 years of age) and patients with cardiovascular disease
The recommended starting dose is 10 mg – 25 mg per day.
Depending on your response to the medicine, your doctor may gradually increase the dose up to a total daily dose of 100 mg, divided into two doses. If you are receiving doses of 100 mg – 150 mg, your doctor may carry out more frequent checks.

Use in children and adolescents
This medicine must not be given to children or adolescents for the treatment of depression. For further information, see section 2.

Neuropathic pain, chronic tension-type headache and migraine prophylaxis

Your doctor will adjust treatment according to symptoms and response to therapy.

Adults
The recommended starting dose is 10 mg – 25 mg at bedtime.
The recommended daily dose is 25 mg – 75 mg.
Depending on your response to the medicine, your doctor may gradually increase the dose.
If you receive doses exceeding 100 mg per day, your doctor may carry out more frequent checks. Your doctor will advise whether you should take the dose once daily or divided into two doses.

Elderly (over 65 years of age) and patients with cardiovascular disease
The recommended starting dose is 10 mg – 25 mg at bedtime.
Depending on your response to the medicine, your doctor may gradually increase the dose.
If you receive doses exceeding 75 mg per day, your doctor may carry out more frequent checks.

Use in children and adolescents
This medicine must not be given to children or adolescents for the treatment of neuropathic pain, chronic tension-type headache prophylaxis or migraine prophylaxis. For further information, see section 2.

Nocturnal enuresis (involuntary loss of urine during the night)

Use in children and adolescents
Recommended doses for children:

  • Under 6 years of age: see section 2. Do not take AMITRIPTILINA DOC.
  • 6 to 10 years of age: 10 mg – 20 mg per day. A more suitable dosage form should be used for this patient group.
  • 11 years of age and older: 25 mg – 50 mg. Increase the dose gradually. Take this medicine 1 to 1.5 hours before bedtime. Before starting treatment, your doctor will perform an ECG to check for any signs of abnormal heart rhythm. Your doctor will reassess the treatment after 3 months and, if necessary, perform another ECG. Do not stop treatment without consulting your doctor.

Patients with special risks
Patients with liver disease or individuals who are "slow metabolizers" generally receive lower doses.
Your doctor may take blood samples to determine the level of amitriptyline in your blood (see also section 2).

How and when to take AMITRIPTILINA DOC
This medicine can be taken with or without food.

Duration of treatment
Do not change the dose or stop treatment without consulting your doctor.

Depression
As with other medicines used to treat depression, it may take several weeks before improvement is noticed.
The duration of treatment for depression varies individually and is generally at least 6 months. Your doctor will determine the duration of treatment.
Continue taking this medicine for the entire time recommended by your doctor.
The underlying condition may persist for a long time. If you stop treatment too early, symptoms may recur.

Neuropathic pain, chronic tension-type headache and migraine prophylaxis
It may take several weeks before improvement in pain is noticed.
Consult your doctor regarding the duration of treatment and continue taking this medicine for the entire time recommended by your doctor.

Nocturnal enuresis
After 3 months, your doctor will decide whether to continue treatment.

If you take more AMITRIPTILINA DOC than you should
Contact your doctor or the nearest hospital emergency department immediately, even if there are no symptoms or signs of poisoning. If you go to a doctor or hospital, bring the medicine container with you.

Symptoms of overdose include:

  • dilated pupils,
  • rapid or irregular heartbeat,
  • difficulty urinating,
  • dry mouth and tongue,
  • intestinal obstruction,
  • seizures,
  • fever,
  • agitation,
  • confusion,
  • hallucinations,
  • uncontrolled movements,
  • low blood pressure, weak pulse, pallor,
  • breathing difficulties,
  • bluish discoloration of the skin,
  • reduced heart rate,
  • lethargy,
  • loss of consciousness,
  • coma,
  • various heart-related symptoms such as cardiac block, heart failure, hypotension, cardiogenic shock, metabolic acidosis, hypokalemia.
    Overdose with amitriptyline in children may have serious consequences. Children are particularly susceptible to coma, cardiac symptoms, breathing difficulties, epileptic seizures, low sodium levels in the blood, lethargy, drowsiness, nausea, vomiting and high blood sugar levels.

If you forget to take AMITRIPTILINA DOC
Take the next dose at your usual time. Do not take a double dose to make up for the forgotten dose.

If you stop taking AMITRIPTILINA DOC
Your doctor will decide when and how to stop treatment to avoid unpleasant symptoms that may occur if treatment is stopped abruptly (e.g. headache, malaise, insomnia and irritability).

If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Contact your doctor immediately if you notice any of the following symptoms:

  • Episodes of intermittent blurred vision, seeing rainbows, and eye pain. Seek immediate examination by an ophthalmologist before continuing treatment with this medicine. These symptoms may be signs of acute glaucoma. Very rare side effect, may affect up to 1 in 10,000 people.
  • A heart problem called "QT interval prolongation" (visible on electrocardiogram, ECG). Common side effect, may affect up to 1 in 10 people.
  • Severe constipation, stomach bloating, 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.
  • Yellowing of the skin and whites of the eyes (jaundice).
  • You may have liver problems. Rare side effect, may affect up to 1 in 1,000 people.
  • Bruising, bleeding, paleness, or persistent sore throat and fever. These symptoms may be early signs of blood or bone marrow disorders. Blood-related effects include a reduced number of red blood cells (which carry oxygen throughout the body), white blood cells (which help fight infections), and platelets (which help blood to clot). Rare side effect, may affect up to 1 in 1,000 people.
  • Suicidal behaviour or thoughts. Rare side effect, may affect up to 1 in 1,000 people. (See section Warnings and precautions – Suicide/Suicidal thoughts).

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

  • drowsiness/stupor
  • tremor in hands or other parts of the body
  • 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 slowed speech
  • aggression
  • nasal congestion

Common: may affect up to 1 in 10 people

  • confusion
  • sexual dysfunction (reduced sexual desire, erectile dysfunction)
  • attention disorder
  • taste disturbances
  • numbness or tingling in arms or legs
  • coordination disorder
  • dilated pupils
  • heart block
  • fatigue
  • low blood sodium levels
  • 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
  • diarrhoea, vomiting
  • skin rash, hives, swelling of the face and tongue
  • difficulty urinating
  • increased milk production or milk leakage from the breast in people who are not breastfeeding
  • increased pressure inside the eye
  • collapse conditions
  • worsening of heart failure
  • worsening of liver function (e.g. cholestatic hepatopathy)

Rare: may affect up to 1 in 1,000 people

  • decreased appetite
  • delirium (particularly in elderly patients), hallucinations
  • abnormalities in heart rhythm or heartbeat sequence
  • swelling of the salivary glands
  • hair loss
  • increased sensitivity to sunlight
  • breast enlargement in males
  • fever
  • weight loss
  • changes in liver function test results

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

  • heart muscle disease
  • feeling of inner restlessness and an urgent need to keep moving
  • peripheral nerve disorders
  • acute increase in eye pressure
  • specific types of abnormal heart rhythm (called torsade de pointes)
  • allergic inflammation of the lung alveoli and lung tissue

Not known: frequency cannot be estimated from available data

  • feeling of absent appetite
  • increased or decreased blood sugar levels
  • paranoia
  • movement disorders (involuntary movements or reduced movements)
  • hypersensitivity myocarditis (inflammation of the heart muscle)
  • hepatitis
  • hot flushes
  • dry eyes

In patients taking medicines of this type, an increased risk of bone fractures has been observed.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store AMITRIPTYLINE DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after “Expiry”. The expiry date refers to the last day of that month.
Shelf life after first opening of the bottle: 36 months, or not beyond the expiry date indicated on the pack, whichever comes first.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What AMITRIPTILINA DOC contains

  • The active substance is amitriptyline hydrochloride. One ml of solution contains 40 mg of amitriptyline.
  • The other components are: purified water, hydrochloric acid.

Description of the appearance of AMITRIPTILINA DOC and contents of the pack
This medicine is packaged in a 20 ml amber glass bottle with a polyethylene dropper and a child-resistant polyethylene screw cap.
Marketing Authorization Holder
DOC Generici S.r.l. – Via Turati 40 – 20121 Milan – Italy.
Manufacturer
Special Product’s Line S.p.A. – Via Fratta Rotonda Vado Largo, 1 – 03012 Anagni (Frosinone) – Italy.