AMITRIPTILINA 40 mg /Ml Oral Drops, Solution

Зміст інструкції

1. Amitriptilina EG 40 mg/ml oral drops solution
   1. What is Amitriptilina EG and what is it used for
   2. What you need to know before taking Amitriptyline EG
   3. How to take Amitriptilina EG
   4. Possible side effects
   5. How to store Amitriptilina EG
   6. Contents of the pack and other information

Amitriptilina EG 40 mg/ml oral drops solution

Generic medicine

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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

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

• depression in adults (major depressive episodes);
• neuropathic pain in adults;
• prophylaxis of chronic tension headache in adults;
• prophylaxis of migraine in adults;
• involuntary loss of urine during the night in children aged 6 years and over only when organic causes, such as spina bifida and related disorders, have been excluded and no response has been obtained 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 need to know before taking Amitriptyline EG

Do not use Amitriptyline EG

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

If you are being treated with Amitriptyline EG, you must 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
Talk to your doctor or pharmacist before taking Amitriptyline EG.
If you receive a high dose of amitriptyline, heart rhythm disturbances and hypotension may occur.
These can also occur with the usual doses in patients with pre-existing heart disease.
QT interval prolongation
With Amitriptyline EG, a heart problem called “QT interval prolongation” (evident on an electrocardiogram, ECG) and heart rhythm disturbances (fast or
irregular heartbeat) have been reported.
Tell your doctor if:

• you have a slow heartbeat,
• you have or have had a problem with your heart being unable to pump blood around your body as it should (a condition called heart failure),
• you are taking any other medicine that can cause heart problems, or
• you have problems with low levels of potassium or magnesium, or high levels of potassium in your blood,
• you are scheduled for surgery, as it may be necessary to stop treatment with amitriptyline before you are given anesthetics. In case of emergency surgery, the anesthesiologist should be informed of the treatment with amitriptyline,
• you have an overactive thyroid or are receiving medicines for your thyroid.

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

• if you have thought about suicide or harming yourself before;
• if you are a young adult. Information obtained from clinical studies has highlighted an increased risk of suicidal behavior in young adults (under 25 years of age) with psychiatric illnesses who were 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 tell a family member or friend and ask them to read this leaflet. You can also ask them to inform you if they think your depression or anxiety is getting worse or if they are worried about changes in your behavior.

Manic episodes
Some patients with manic-depressive illness may enter a manic phase. This is
characterized by a variety of rapidly changing ideas, exaggerated cheerfulness and excessive
physical activity. In these cases it is important to contact your doctor, who will probably modify the treatment.
Tell your doctor if you have or have had any medical problem in the past, especially:

• narrow-angle glaucoma (loss of vision due to an abnormal increase in 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 outlet valve of the stomach) and paralytic ileus (intestinal blockage);
• diabetes, because it may be necessary to adjust the treatment with antidiabetic medicines.

If you are using antidepressants such as selective serotonin reuptake inhibitors (SSRIs), your doctor may
assess whether to adjust the dose of the medicine (see also section 2 Other medicines and Amitriptyline EG and section 3).
Serious skin reactions have been reported associated with treatment with Amitriptyline EG, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Stop using Amitriptyline EG and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
Elderly people are more likely to experience certain side effects, such as dizziness when getting up
from a sitting or lying position, 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
diseases as the 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 therapy with amitriptyline to rule out a long QT syndrome;
• This medicine should not be taken at the same time as an anticholinergic (see also section 2 Other medicines and Amitriptyline EG);
• Suicidal thoughts and behaviors may occur at the beginning of treatment with antidepressants even in patients suffering from disorders other than depression; the same precautions used in the treatment of patients with depression should therefore be adopted in the treatment of patients with enuresis.

Other medicines and Amitriptyline EG
Some medicines can alter the effect of other medicines and this can sometimes cause serious
side effects.
Tell 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, iproniazide, isocarboxazide, nialamide or tranylcypromine (used for the treatment of depression), or selegiline (used for the treatment of Parkinson's disease). These medicines should not be taken at the same time as Amitriptyline EG (see section 2 Do not take Amitriptyline EG).
• Adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine and phenylpropanolamine(may be present in cough or cold medicines and in some anesthetics).
• Medicines for the treatment of high blood pressure, such as calcium channel blockers (e.g. diltiazem and verapamil), guanethidine, betanidine, clonidine, reserpine and methyldopa.
• Anticholinergics,such as certain medicines for the treatment of Parkinson's disease and gastrointestinal disorders (e.g. atropine, hyoscyamine).
• Thioridazine(used for the treatment of schizophrenia).
• Tramadol(painkiller).
• Medicines for the treatment of 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 diseases(e.g. beta-blockers and antiarrhythmics).
• Cimetidine(used for the treatment of stomach ulcers).
• Methylphenidate(used for the treatment of ADHD).
• Ritonavir(used for the treatment of HIV).
• Oral contraceptives.
• Rifampicin(for the treatment of infections).
• Phenytoin and carbamazepine(used for the treatment of epilepsy).
• St John's Wort(Hypericum perforatum), a herbal remedy used for depression.
• Thyroid medicines.
• Valproic acid.

Also tell your doctor if you are taking or have recently taken medicines that can alter your heart
rhythm, such as:

• medicines for the treatment of irregular heartbeat (e.g. quinidine and sotalol);
• astemizole and terfenadine (used for the treatment of allergies and hay fever);
• medicines used for the treatment of some mental illnesses (e.g. pimozide and sertindole);
• cisapride (used for the treatment of certain digestive disorders);
• halofantrine (used for the treatment of malaria);
• methadone (used for the treatment of pain and detoxification);
• diuretics (medicines that increase urine production, e.g. furosemide).

If you are going to have surgery and receive general or local anesthetics, tell your doctor that you
are taking this medicine.
Similarly, tell your dentist that you are taking this medicine if you are going to receive a local anesthetic.

Amitriptyline EG with alcohol
It is not advisable to drink alcohol while being treated with this medicine because
it may increase the sedative effect.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor or
pharmacist for advice before taking this medicine.
Amitriptyline is not recommended during pregnancy unless your doctor considers it essential and only after a careful assessment of the benefit and risk. If you have taken this medicine
in the last months of pregnancy, the newborn may experience withdrawal symptoms such as irritability, increased
muscle tension, tremor, irregular breathing, feeding difficulties, loud crying,
urinary retention and constipation.
Your doctor will tell you whether to start/continue/stop breastfeeding or stop using this medicine
taking into account the benefit of breastfeeding for the baby and the benefit of therapy for you.

Driving and using machines
This medicine can cause drowsiness and dizziness, especially at the beginning of treatment. Do not drive
and do not use tools or machines if you experience these symptoms.

3. How to take Amitriptilina EG

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts consult your doctor or pharmacist.
One drop of solution contains 2 mg of amitriptyline.

• Depression

Adults
The recommended starting dose is 25 mg twice a day.
Based 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.
Based 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
perform more frequent checks.

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

• Neuropathic pain, chronic tension headache and migraine prophylaxisThe doctor will modify the treatment based on symptoms and response to therapy.

Adults
The recommended starting dose is 10 mg - 25 mg in the evening.
The recommended daily dose is 25 mg - 75 mg.
Based on your response to the medicine, your doctor may gradually increase the dose.
If you receive doses greater than 100 mg per day, your doctor may perform more frequent checks. Your doctor will
tell you whether to take the dose once a day 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 in the evening.
Based on your response to the medicine, your doctor may gradually increase the dose.
If you receive doses greater than 75 mg per day, your doctor may perform more frequent checks.

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

• Involuntary loss of urine during the night

Use in children and adolescents
Recommended doses for children:

• under 6 years of age: see paragraph 2 Do not take Amitriptilina EG;
• between 6 and 10 years of age: 10 mg - 20 mg per day. A more suitable dosage form should be used for this group of patients;
• 11 years of age or older: 25 mg - 50 mg.

Increase the dose gradually.
Take this medicine 1 - 1.5 hours before bedtime.
Before starting treatment, your doctor will perform an ECG of the heart to look for any signs of abnormal
heartbeat.
The doctor will re-evaluate the treatment after 3 months and, if necessary, perform an ECG.
Do not stop treatment without consulting your doctor.

Patients with particular risks
Patients with liver disease or people who are “slow metabolizers” generally receive lower doses.
The doctor may take blood samples to determine the level of amitriptyline in the blood (see
also paragraph 2).

How and when to take Amitriptilina EG
This medicine can be taken with or without food.

Duration of treatment
Do not change the dose of the medicine and do not stop treatment without consulting your doctor.

Depression
As with other medicines for the treatment of depression, it may take a few weeks
before you notice an improvement.
The duration of treatment for depression varies on an individual basis and is generally at least 6 months. The
doctor will determine the duration of treatment.
Continue taking this medicine for the entire time recommended by your doctor.
The underlying disease may persist for a long time. If you stop treatment too early, the symptoms may
recur.

Neuropathic pain, chronic tension headache and migraine prophylaxis
It may take a few weeks before you notice an improvement in pain.
Consult your doctor regarding the duration of treatment and continue taking this medicine for the entire
time recommended by your doctor.

Involuntary loss of urine during the night
After 3 months, the doctor will decide whether to continue treatment.

If you take more Amitriptilina EG than you should
Contact your doctor or the nearest hospital emergency room immediately, even if you have no symptoms
or signs of poisoning. If you go to the doctor or hospital, bring 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 blockage, seizures, fever, agitation,
confusion, hallucinations, uncontrolled movements, numbness, loss of consciousness, coma, various symptoms to the heart
such as heart block, heart failure, hypotension, cardiogenic shock, metabolic acidosis,
hypokalemia.
Amitriptyline overdose in children can have serious consequences. Children are particularly
susceptible to coma, cardiac symptoms, difficulty breathing, 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 the usual time. Do not take a double dose to make up for a missed dose.

If you stop taking Amitriptilina EG
The 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, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Seek immediate medical attention if you notice any of the following symptoms:

• Transient blurred vision, rainbow halos around lights and eye pain.
• See an ophthalmologist immediately before continuing treatment with this medicine. These disturbances may be signs of acute glaucoma. Very rare side effect, may affect up to 1 in 10,000 people.
• A heart problem called “prolonged QT interval” (evident on an electrocardiogram, ECG). Common side effect, may affect up to 1 in 10 people.
• Troublesome constipation, stomach bloating, fever and vomiting.
• These symptoms may be due to paralysis of part of the intestine. Rare side effect, may affect up to 1 in 1000 people.
• Yellowing of the skin and the whites of the eyes (jaundice).
• You may have problems with your liver. Rare side effect, may affect up to 1 in 1000 people.
• Bruising, bleeding, paleness or persistent sore throat and fever.
• These symptoms may be early signs of problems with the blood or bone marrow.
• Effects on the blood 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 help with blood clotting). Rare side effect, may affect up to 1 in
• 1000.
• Suicidal behaviour or thoughts. Rare side effect, may affect up to 1 in 1000 people.

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

• drowsiness/somnolence
• tremor of the hands or other parts of the body
• dizziness
• headache
• irregular, strong or rapid heartbeat
• dizziness when getting up, 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 (decreased sexual drive, erectile dysfunction)
• attention disorder
• altered taste
• numbness or tingling in the arms or legs
• lack of coordination
• dilated pupils
• heart block
• fatigue
• low sodium levels in the blood
• agitation
• urination disorders
• feeling of thirst.

Uncommon: may affect up to 1 in 100 people

• excitement, anxiety, difficulty sleeping, nightmares
• convulsions
• tinnitus
• increased blood pressure
• diarrhoea, vomiting
• skin rash, hives, swelling of the face and tongue
• difficulty urinating
• increased production of milk or breast milk flow 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

• loss of appetite
• delirium (especially in elderly patients), hallucinations
• abnormalities in heart rate or rhythm
• 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

• heart muscle disease
• feeling of inner restlessness and an urgent need to be constantly moving
• peripheral nerve disorders
• acute increase in pressure inside the eye
• particular forms of abnormal heart rhythm (called torsades de pointes)
• allergic inflammation of the alveoli of the lungs and lung tissue.

Not known: frequency cannot be estimated from available data

• feeling of absent appetite
• increase or decrease in blood sugar levels
• paranoia
• movement disorders (involuntary movements or decreased movements)
• hypersensitivity
• inflammation of the heart muscle
• hepatitis
• hot flashes
• dry eyes. Stop using Amitriptilina EG and contact your doctor immediately if you notice any of the following symptoms: widespread rash, high body temperature and swollen lymph nodes (DRESS or drug reaction with eosinophilia and systemic symptoms).

An increased risk of bone fractures has been observed in patients taking medicines of this type.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through 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 which is stated on the package and the bottle after Exp. The
expiry date refers to the last day of that month.
The validity after first opening of the bottle is 3 months.
Do not use this medicine if you notice visible signs of deterioration.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What contains Amitriptilina EG

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

Description of the appearance of Amitriptilina EG and contents of the pack
Oral drops solution in a glass bottle of 20 ml.

Marketing Authorisation Holder
EG S.p.A., Via Pavia 6, 20136 Milan

Manufacturer
ABC FARMACEUTICI S.p.A., Canton Moretti, 29 S. Bernardo d’Ivrea - TO - Italy