AMITRIPTILINA 40 mg /Ml Oral Drops, Solution

Содержание инструкции

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

Amitriptilina Mylan 40 mg/ml oral drops, solution

Generic medicine

Read this leaflet carefully before taking this medicine as 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 Mylan is and what it is used for
• 2. What you need to know before you take Amitriptilina Mylan
• 3. How to take Amitriptilina Mylan
• 4. Possible side effects
• 5. How to store Amitriptilina Mylan
• 6. Contents of the pack and other information

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

Amitriptilina Mylan 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 Amitriptilina Mylan

Do not use Amitriptilina Mylan:

• if you are allergic to the active ingredient (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 heart rhythm disturbances 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 Amitriptilina Mylan, 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 Amitriptilina Mylan.
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.
Take particular care with Amitriptilina Mylan:
Severe skin reactions have been reported associated with treatment with Amitriptilina Mylan, including
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Stop using Amitriptilina Mylan and contact your
doctor immediately if you notice any of the symptoms related to these severe skin reactions described in
section 4.
Prolongation of the QT interval
A heart problem called “prolonged QT interval” (which is shown on an electrocardiogram, ECG) and heart rhythm disturbances (fast or irregular heartbeat) have been reported with Amitriptilina Mylan. Tell your doctor if:

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

Serotonin syndrome
The use of this medicine together with buprenorphine may lead to serotonin syndrome, a
condition that can be life-threatening.

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 more.
You are more likely to have these kinds of thoughts:

• if you have previously thought about suicide or harming yourself;
• if you are a young adult. Available information from clinical studies has shown an increased risk of suicidal behavior in adults under 25 years of age with psychiatric conditions treated with an antidepressant. If at any time you experience a worsening of your symptoms or think about harming yourself or committing suicide, contact your doctor immediately. If you are depressed, it may be helpful to inform a family member or friend and ask them to read this

worsening or if they are concerned 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 the doctor, who will probably
modify the treatment.
Tell your doctor if you have or have had in the past any medical problem, in particular:

• narrow-angle glaucoma (loss of vision due to abnormally high 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) and paralytic ileus (intestinal blockage)
• diabetes, because it may be necessary to adjust the treatment with antidiabetic medicines.

If you use antidepressants such as selective serotonin reuptake inhibitors (SSRIs), the doctor may
assess whether it is appropriate to adjust the dose of the medicine (see also section 2 Other medicines
and Amitriptilina Mylan and section 3 How to take Amitriptilina Mylan).
Elderly people are more likely to experience certain undesirable effects, such as dizziness
when getting 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 diseases as the safety and efficacy over the long term 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 Amitriptilina Mylan)
• 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 taken in the treatment of patients with enuresis.

Other medicines and Amitriptilina Mylan
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
may take any other medicine.
In particular, tell your doctor if you are taking or have recently taken any of the following
medicines:

Monoamine oxidase inhibitors (MAOIs).Amitriptilina Mylan should not be taken together with
medicines called monoamine oxidase inhibitors (medicines used for depression) such as
phenelzine, iproniazide, isocarboxazide, nialamide or tranylcypromine (used for the treatment of
depression), or selegiline (used for the treatment of Parkinson's disease), due to the possibility of
serious side effects. If you need to switch from treatment with an MAOI to Amitriptilina Mylan, you must
allow an interval of at least two weeks from stopping the first treatment
before starting to take Amitriptilina Mylan. These medicines should not be taken
at the same time (see section 2 Do not take Amitriptilina Mylan).

Adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine and phenylpropanolamine(may
be present in cough or cold medicines and in some anesthetics).

Medicines containing buprenorphine. These medicines may interact with Amitriptilina
Mylan and symptoms such as involuntary and rhythmic muscle contractions may occur,
including the muscles that control eye movement, agitation, hallucinations, coma,
excessive sweating, tremor, exaggerated reflexes, increased muscle contraction, fever
above 38°C. Contact your doctor if you experience such symptoms.

Medicines for the treatment of high blood pressure, such as calcium antagonists (e.g.
diltiazem and verapamil), guanethidine, betanidine, clonidine, reserpine and methyldopa.

Sympathomimetic drugs. The combination of Amitriptilina Mylan with medicines called
sympathomimetics such as L-dopa (used to treat Parkinson's disease),
nasal decongestants and medicines used to treat asthma and allergies, can cause a
decrease in blood pressure (hypotension) and heart problems (cardiac arrhythmias).

Anticholinergic drugs. Caution is required when using medicines called parasympatholytics,
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(pain reliever).

Medicines for the treatment of fungal infections(e.g. fluconazole, terbinafine,
ketoconazole and itraconazole).

Sedatives(e.g. barbiturates).

Valproic acid.

Antidepressant drugs(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 product used for depression.

Thyroid medicines.
Also tell your doctor if you are taking or have recently taken medicines that can alter
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 certain 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 to receive a
local anesthetic.

Amitriptilina Mylan and alcohol
Do not drink alcohol if you are taking this medicine as 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 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 disorders, loud crying, urinary retention and constipation.
The 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 Mylan

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

Depression

Adults
The recommended starting dose is 25 mg of Amitriptilina Mylan twice a day.
Based on your response to the medicine, your doctor may gradually increase the dose up to a total daily dose of 150 mg, divided into two doses. If you receive doses of 100 mg - 150 mg, your doctor may
carry out more frequent checks.

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
carry out 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 section 2.

Neuropathic pain, chronic tension headache and migraine prophylaxis
The 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 carry out more frequent checks. The
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 carry out 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 section 2.

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 Mylan.
• 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, the 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 section 2).

How and when to take Amitriptilina Mylan
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 an improvement is noticed.
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 to take 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 return.

Neuropathic pain, chronic tension headache and migraine prophylaxis
It may take a few weeks before an improvement in pain is noticed.
Consult your doctor regarding the duration of treatment and continue to take 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 Mylan than you should
In case of ingestion/taking an overdose of Amitriptilina Mylan, immediately warn
your doctor or go to the nearest hospital even if you have no symptoms or signs of
poisoning. If you go to the doctor or hospital, bring the medicine container with you.
The symptoms of overdose include:
o dilated pupils
o rapid or irregular heartbeat
o difficulty urinating
o dry mouth and tongue
o intestinal blockage
o seizures
o fever
o agitation
o confusion
o hallucinations
o uncontrolled movements
o low blood pressure, weak pulse, paleness
o difficulty breathing
o bluish discoloration of the skin
o reduced heart rate
o drowsiness
o loss of consciousness
o coma
o various symptoms to the heart such as cardiac 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 Mylan
Take the next dose at the usual time. Do not take a double dose to make up for the
forgotten dose.

If you stop taking Amitriptilina Mylan
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 questions about the use of 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, seeing rainbows and eye pain. See an eye doctor 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 “QT prolongation” (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 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). 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 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 1,000 people.
• Suicidal behaviour or thoughts. Rare side effect, may affect up to 1 in 1,000 people.

Frequency not known:
Stop using Amitriptilina Mylan 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).

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

• drowsiness/sedation
• tremor of the hands or other parts of the body
• dizziness
• headache
• irregular, strong or fast heartbeat
• dizziness when getting up from a sitting or lying position, 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 desire, erectile dysfunction)
• attention disorder
• altered taste
• numbness or tingling in the arms or legs
• loss 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

• decreased appetite
• delirium (especially in elderly patients), hallucinations
• abnormal heart rhythm or sequence of heartbeat
• 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 torsade de pointes)
• allergic inflammation of the alveoli of the lungs and lung tissue.

Not known: frequency cannot be estimated based on 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

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the website:
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 Mylan

Keep this medicine out of the sight and reach of children.
This medicine does not require any particular storage conditions.
Shelf life after first opening of the bottle: 3 months.
Do not use this medicine after the expiry date which is stated on the pack and the bottle after
“Exp.”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in 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 Mylan contains

• The active substance is amitriptyline hydrochloride. One ml of Amitriptilina Mylan oral drops solution contains: amitriptyline hydrochloride 45.28 mg (equivalent to 40 mg amitriptyline base).
• The other ingredients are: purified water, hydrochloric acid.

Description of the appearance of Amitriptilina Mylan and contents of the pack
Amitriptilina Mylan oral drops solution is presented in a dark glass bottle (amber yellow color),
with dropper and child-resistant screw cap.

Marketing Authorisation Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milano

Manufacturer
ABC Farmaceutici S.p.A.
Via Cantone Moretti, 29 (località San Bernardo)

• 10015 - Ivrea (TO)