Amitriptyline Mylan

Package leaflet: Information for the patient

Amitriptilina Mylan 40 mg/ml oral drops, solution

Equivalent medicine
Please read this leaflet carefully before you start 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, as it may be harmful.
• If you experience any side effects, including 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 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

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

Amitriptilina Mylan 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
• 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 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 Mylan

Do not use Amitriptyline Mylan:

• if you are allergic to the active substance (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 Mylan, 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 Mylan.
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.
Pay special attention to Amitriptyline Mylan:
severe skin reactions have been reported with treatment with Amitriptyline Mylan, including
drug reaction with eosinophilia and systemic symptoms (Drug Reaction with Eosinophilia and
Systemic Symptoms, DRESS). Discontinue use of Amitriptyline Mylan and contact a doctor immediately
if you notice any of the symptoms related to these severe skin reactions described in
section 4.
Prolongation of the QT interval
With Amitriptyline Mylan, a heart problem called "prolonged QT interval" (which appears on the electrocardiogram, ECG) and cardiac rhythm disturbances (rapid or irregular heartbeat) have been reported. Inform your doctor if:

• you have a slow heartbeat;
• you have or have had a condition in which the heart is unable to pump blood properly through the body (a condition called heart failure);
• you are taking any other medicine that may cause heart problems, or if you have 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 discontinue treatment with amitriptyline before administration of anaesthetics. In case of emergency surgery, the anaesthetist must be informed about your treatment with amitriptyline;
• you have an overactive thyroid or are taking medicines for thyroid conditions.

Serotonin syndrome
The use of this medicine together with buprenorphine may lead to serotonin syndrome, a condition that can be fatal.
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 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. Available data from clinical trials have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric conditions treated with an antidepressant. If at any time your symptoms worsen or if you have thoughts of 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 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 modify your treatment.
Inform your doctor if you have or have previously had any medical condition, particularly:

• 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 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 Mylan and section 3 How to take Amitriptyline Mylan).
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 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

• Before starting therapy with amitriptyline, an ECG should be performed to rule out long QT syndrome.
• This medicine must not be taken concurrently with an anticholinergic (see also section 2 Other medicines and Amitriptyline Mylan).
• Suicidal thoughts and behaviours may occur at the beginning of treatment with antidepressants, 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 Mylan
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 medicine.
In particular, inform your doctor if you are taking or have recently taken any of the following medicines:
Monoamine oxidase inhibitors (MAOIs). Amitriptyline Mylan must not be taken together with medicines called monoamine oxidase inhibitors (medicines used for depression) such as phenelzine, iproniazid, isocarboxazid, nialamide or tranylcypromine (used to treat depression), or selegiline (used to treat Parkinson's disease), due to the risk of serious adverse effects. If you need to switch from treatment with an MAOI to Amitriptyline Mylan, you must wait at least two weeks after stopping the first treatment before starting Amitriptyline Mylan. These medicines must not be taken simultaneously (see section 2 Do not take Amitriptyline Mylan).
Adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine and phenylpropanolamine (may be present in cough or cold medicines and in some anaesthetics).
Medicines containing buprenorphine. These medicines may interact with Amitriptyline Mylan and may cause symptoms such as involuntary rhythmic muscle contractions, including muscles controlling eye movements, 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 high blood pressure, such as calcium antagonists (e.g. diltiazem and verapamil), guanethidine, betanidine, clonidine, reserpine and methyldopa.
Sympathomimetic drugs. The combination of Amitriptyline 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, may cause low blood pressure (hypotension) and heart problems (cardiac arrhythmias).
Anticholinergic drugs. Caution is required when using medicines called antimuscarinics, such as certain medicines used to treat Parkinson's disease and gastrointestinal disorders (e.g. atropine, hyoscyamine).
Thioridazine (used to treat schizophrenia).
Tramadol (analgesic).
Medicines for fungal infections (e.g. fluconazole, terbinafine, ketoconazole and itraconazole).
Sedatives (e.g. barbiturates).
Valproic acid.
Antidepressant medicines (e.g. SSRIs (fluoxetine, paroxetine, fluvoxamine), duloxetine, and bupropion).
Medicines for certain heart conditions (e.g. beta-blockers and antiarrhythmics).
Cimetidine (used to treat stomach ulcers).
Methylphenidate (used to treat ADHD).
Ritonavir (used to treat HIV).
Oral contraceptives.
Rifampicin (used to treat infections).
Phenytoin and carbamazepine (used to treat epilepsy).
St. John's wort (Hypericum perforatum), a herbal remedy used for depression.
Thyroid medicines.
Inform your doctor also if you are taking or have recently taken medicines that may alter 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 undergoing surgery and receiving 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 Mylan and alcohol
Do not consume alcoholic beverages while taking this medicine, as this may increase the sedative effect.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor 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 show 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 the 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 Amitriptyline Mylan

Take this medicine exactly as instructed by 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 Amitriptyline Mylan twice daily.
Depending 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.
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 the treatment according to your 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 night-time urine loss)

Use in children and adolescents
Recommended doses for children:

• Under 6 years of age: see section 2. Do not take Amitriptyline Mylan.
• 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 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 re-evaluate the treatment after 3 months and, if necessary, perform an ECG.
Do not stop treatment without first consulting your doctor.

Patients with particular risks
Patients with liver disease or those who are "slow metabolisers" usually 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 Amitriptyline Mylan
This medicine can be taken with or without food.

Duration of treatment
Do not change the dose of this medicine or stop treatment without first 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 return.

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 night-time urine loss)
After 3 months, your doctor will decide whether to continue treatment.

If you take more Amitriptyline Mylan than you should
If you take/ingest too much Amitriptyline Mylan, contact your doctor immediately or go to the nearest hospital, even if you do not have any symptoms or signs of poisoning. If you go to see a doctor or to hospital, take the medicine container with you.
Symptoms of overdose include:
o dilated pupils
o rapid or irregular heartbeat
o difficulty urinating
o dry mouth and tongue
o intestinal obstruction
o seizures
o fever
o agitation
o confusion
o hallucinations
o uncontrolled movements
o low blood pressure, weak pulse, pallor
o breathing difficulties
o bluish discoloration of the skin
o reduced heart rate
o stupor
o loss of consciousness
o coma
o various heart-related symptoms such as heart block, heart failure, hypotension, cardiogenic shock, metabolic acidosis, hypokalaemia.

Overdose with amitriptyline in children may have serious consequences. Children are particularly susceptible to coma, cardiac symptoms, breathing difficulties, seizures, low sodium levels in the blood, lethargy, drowsiness, nausea, vomiting and high blood sugar levels.

If you forget to take Amitriptyline Mylan
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 Amitriptyline Mylan
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 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 everyone gets them.
Contact your doctor immediately if you experience any of the following symptoms:

• Episodes of intermittent blurred vision, seeing rainbow-like halos, 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 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 in 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 taking Amitriptilina Mylan and contact your doctor immediately if you notice any of the
following symptoms:

• Widespread skin rash, high body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).

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

• drowsiness/stupor
• tremor in 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 dysfunction (reduced sexual desire, erectile dysfunction)
• attention disorders
• taste disturbances
• numbness or tingling in arms or legs
• coordination disorders
• dilated pupils
• heart block
• fatigue
• low sodium levels in the blood
• 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, hives, 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-like 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 torsades de pointes)
• allergic inflammation of the lung alveoli and lung tissue

Not known: frequency cannot be estimated from available data

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

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

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Shelf life after first opening the bottle: 3 months.
Do not use this medicine after the expiry date stated on the carton and on the bottle after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of medicines 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 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 components 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 colour), with a dropper and child-resistant screw cap.
The bottle is contained in a cardboard carton, together with the leaflet.

Marketing Authorization Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan

Manufacturer
ABC Farmaceutici S.p.A.
Via Cantone Moretti, 29 (località San Bernardo)
10015 - Ivrea (TO)