Amitriptyline EG

Italy
Brand name Amitriptyline EG
Form drops, oral solution
Active substance / Dosage
AMITRIPTYLINE HYDROCHLORIDE
Prescription type Prescription only
ATC code
N06AA09
Registration number 044532
Manufacturer EG S.P.A.

Table of Contents

Patient Information Leaflet

Amitriptiline EG 40 mg/ml oral drops solution

Generic medicine
Please read 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 others, even if their symptoms are the same as yours, because it could be harmful.
  • If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Amitriptilina EG is and what it is used for

Amitriptilina EG belongs to a group of medicines known as tricyclic antidepressants.
This medicine is used to treat:

  • 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 in children aged 6 years and older, only when organic causes such as spina bifida and related disorders have been excluded and no response has been achieved with 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 need to know before taking Amitriptiline EG

Do not use Amitriptiline EG

  • 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 disorders 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 took moclobemide the previous day;
  • if you have severe liver disease.

If you are being treated with Amitriptiline EG, 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 Amitriptiline EG.
If you receive a high dose of amitriptyline, cardiac rhythm disorders and hypotension may occur.
These may also occur at usual doses in patients with pre-existing heart disease.
QT interval prolongation
Cases of a heart problem called "QT interval prolongation" (visible on electrocardiogram, ECG) and cardiac arrhythmias (fast or irregular heartbeat) have been reported with Amitriptiline EG.
Inform your doctor if:

  • you have a slow heartbeat,
  • you have or have had heart failure (a condition where the heart is unable to pump blood properly),
  • you are taking any other medicine that may cause heart problems, or
  • 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 stop treatment with amitriptyline before receiving anaesthetics. In case of emergency surgery, the anaesthetist must be informed about your treatment with amitriptyline,
  • you have an overactive thyroid or are taking thyroid medications.

Suicidal thoughts and worsening depression
If you are depressed, you may sometimes have thoughts of harming yourself or committing suicide.
These thoughts may increase at the beginning of treatment with antidepressants, 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 thought about suicide or self-harm;
  • if you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in young adults (under 25 years) with psychiatric disorders being treated with an antidepressant. 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 experience manic episodes. These are characterized by rapidly changing thoughts, excessive euphoria, and excessive physical activity. In such cases, it is important to contact your doctor, who will likely adjust your treatment.
Inform your doctor if you have or have had any medical conditions, especially:

  • narrow-angle glaucoma (loss of vision due to abnormally increased pressure inside the eye);
  • epilepsy, a 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 your antidiabetic treatment may need adjustment.

If you are taking antidepressants such as serotonin reuptake inhibitors (SSRIs), your doctor may consider adjusting the dose of your medicine (see also section 2 Other medicines and Amitriptiline EG and section 3).
Serious skin reactions associated with treatment with Amitriptiline EG have been reported, including drug reaction with eosinophilia and systemic symptoms (DRESS). Stop using Amitriptiline EG and contact a doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
Elderly patients are more likely to experience certain adverse effects, such as dizziness upon standing, due to low blood pressure (see also section 4 Possible side effects).
Children and adolescents
Depression, neuropathic pain, chronic tension-type 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.
Involuntary loss of urine during the night

  • 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 Amitriptiline EG);
  • Suicidal thoughts and behaviours may occur at the beginning of treatment with antidepressants, even in patients suffering from conditions other than depression; therefore, the same precautions applied in the treatment of patients with depression should be adopted when treating patients with enuresis.

Other medicines and Amitriptiline EG
Some medicines may alter the effect of other medicines, and this may sometimes cause serious adverse effects.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, such as:

  • Monoamine oxidase inhibitors (MAOIs) such as phenelzine, iproniazid, isocarboxazid, nialamide or tranylcypromine (used to treat depression), or selegiline (used to treat Parkinson's disease). These medicines must not be taken at the same time as Amitriptiline EG (see section 2 Do not take Amitriptiline EG).
  • Adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine, and phenylpropanolamine (may be present in cough or cold remedies 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).
  • 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 the treatment of infections).
  • Phenytoin and carbamazepine (used to treat epilepsy).
  • St. John's wort (Hypericum perforatum), a herbal remedy 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 for pain relief 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.
Amitriptiline EG and alcohol
It is not advisable to consume alcoholic beverages during treatment with this medicine, as it may increase the sedative effect.
Pregnancy, breastfeeding and fertility
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 assessment 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 or operate tools or machinery if you experience these symptoms.

3. How to take Amitriptilina EG

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
One drop of solution contains 2 mg of amitriptiline.

  • 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 receive 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 tell you whether to 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 EG;
  • aged 6 to 10 years: 10 mg – 20 mg per day. A more suitable dosage form should be used for this patient group;
  • aged 11 years and older: 25 mg – 50 mg per day.

Increase the dose gradually.
Take this medicine 1 hour – 1.5 hours before going to bed.
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 an ECG.
Do not stop treatment without consulting your doctor.
Patients at particular risk
Patients with liver disease or individuals who are "slow metabolizers" usually receive lower doses.
Your doctor may take blood samples to determine the level of amitriptiline in your blood (see also section 2).
How and when to take Amitriptilina EG
This medicine may be taken with or without food.
Duration of treatment
Do not change the dose of this medicine 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 (involuntary loss of urine during the night)
After 3 months, your doctor will decide whether to continue treatment.
If you take more Amitriptilina EG 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, take the medicine container with you.
Symptoms of overdose include: dry mouth and tongue, dilated pupils, rapid or irregular heartbeat, low blood pressure, weak pulse, pallor, difficulty breathing, bluish discoloration of the skin, reduced heart rate, difficulty urinating, intestinal obstruction, seizures, fever, agitation, confusion, hallucinations, uncontrolled movements, stupor, loss of consciousness, coma, various heart symptoms such as heart 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 EG
Take the next dose at your usual time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Amitriptilina EG
Your doctor will decide when and how to stop treatment to avoid unpleasant symptoms that may occur if treatment is stopped suddenly (e.g. headache, malaise, insomnia and irritability).
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 ophthalmological examination 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 problems.
  • Blood-related effects include a reduction in the number of red blood cells (which carry oxygen throughout the body), white blood cells (which help fight infections), and platelets (which aid blood clotting). Rare side effect, may affect up to 1 in 1,000 people.
  • Suicidal thoughts or behaviour. Rare side effect, may affect up to 1 in 1,000 people.

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

  • drowsiness/stupor
  • tremor of the 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 slowed speech
  • aggression
  • nasal congestion.

Common: may affect up to 1 in 10 people

  • confusion
  • sexual disorders (reduced sexual desire, erectile dysfunction)
  • attention disorders
  • taste disturbances
  • numbness or tingling in arms or legs
  • coordination disorders
  • dilated pupils
  • heart block
  • fatigue
  • low blood sodium levels
  • agitation
  • urinary disorders
  • sensation 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, urticaria, swelling of the face and tongue
  • difficulty urinating
  • increased milk production or milk discharge from the breast in people 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

  • reduced 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 men
  • fever
  • weight loss
  • changes in liver function test results.

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

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

Not known: frequency cannot be estimated from the available data

  • loss of appetite sensation
  • increased or decreased blood sugar levels
  • paranoia
  • movement disorders (involuntary movements or reduced movements)
  • hypersensitivity
  • myocarditis
  • hepatitis
  • hot flushes
  • dry eyes. Stop using Amitriptilina EG and contact a doctor immediately if you experience any of the following symptoms: widespread rash, high body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).

An increased risk of bone fractures has been observed in patients taking medicines of this type.
Reporting of side effects
If you experience any side effect, 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 Amitriptilina EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after Exp. The expiry date refers to the last day of that month.
The shelf life after first opening the bottle is 3 months.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Amitriptilina EG contains

  • The active substance is amitriptyline. One ml of solution contains 45.28 mg of amitriptyline hydrochloride (equivalent to 40 mg of amitriptyline base).
  • The other components are purified water and hydrochloric acid.

Description of the appearance of Amitriptilina EG and package contents
Oral drops solution in a 20 ml glass bottle.
Marketing Authorization Holder
EG S.p.A., Via Pavia 6, 20136 Milan
Manufacturer
ICE S.p.A., Via Cantone Moretti, 29, Località San Bernardo - 10015 Ivrea (TO) - Italy