Package leaflet: Information for the user

Escitalopram Mylan Generics 20 mg/ml oral drops, solution

Escitalopram
Generic medicine
Read this entire 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, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet,
contact your doctor or pharmacist.
Contents of this leaflet:

What Escitalopram Mylan Generics is and what it is used for
What you need to know before taking Escitalopram Mylan Generics
How to take Escitalopram Mylan Generics
Possible side effects
How to store Escitalopram Mylan Generics
Contents of the pack and other information

1. What is Escitalopram Mylan Generics and what is it used for

Escitalopram Mylan Generics belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs). These medicines act on the serotonin system in the brain, increasing the level of serotonin. Imbalances in the serotonin system are considered an important factor in the development of depression and related disorders.
Escitalopram Mylan Generics contains escitalopram, which is used to treat:

depression (major depressive episodes)
anxiety disorders (such as panic disorder with and without agoraphobia (fear of crowds/bridges/open spaces))
social anxiety disorder
generalized anxiety disorder
obsessive-compulsive disorder.

2. What you need to know before taking Escitalopram Mylan Generics

Do not take Escitalopram Mylan Generics

if you are allergic to escitalopram or to any of the excipients of this medicine (listed in section 6)
if you are taking other medicines belonging to a group called monoamine oxidase inhibitors (MAO inhibitors), including selegiline (used to treat Parkinson’s disease), moclobemide (used to treat depression), or linezolid (an antibiotic)
if you have been born with or have had an episode of abnormal heart rhythm (visible on electrocardiogram (ECG), a test to assess how the heart is working)
if you are taking medicines for heart rhythm problems or medicines that may affect heart rhythm (see section 2 “Other medicines and Escitalopram Mylan Generics”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Escitalopram Mylan Generics. Inform your
doctor if you have ever had any of the following conditions or illnesses, as your
doctor may need to take them into account:

if you suffer from epilepsy. Treatment with Escitalopram Mylan Generics must be stopped if you experience seizures for the first time or if the frequency of epileptic seizures increases (also see section 4 “Possible side effects”)
if you have thoughts of suicide or of harming yourself. See subsection “Suicidal thoughts and worsening of depression or anxiety disorder”
if you have impaired liver or kidney function. Your doctor may need to adjust your dose
if you have diabetes. Treatment with Escitalopram Mylan Generics may alter blood glucose control. It may be necessary to adjust the dose of insulin and/or oral antidiabetic medicines
if your blood sodium level is low
if you are under 18 years of age
if you have previously suffered from mania or manic depression
if you have a tendency to bleeding or easy bruising
if you are taking any other medicine, including herbal medicines. See subsection “Other medicines and Escitalopram Mylan Generics”
if you are undergoing electroconvulsive therapy (ECT)
if you have closed-angle glaucoma or have previously suffered from glaucoma
if you have coronary heart disease
if you are pregnant or breastfeeding
if you suffer or have suffered from heart problems or have recently had a heart attack
if you have a low resting heart rate and/or if you think your body may have experienced a significant loss of salt due to prolonged and severe diarrhoea and vomiting or use of diuretics (water tablets)
if you experience a fast or irregular heartbeat, fainting, collapse, or dizziness when standing up, which may indicate an irregular heart rhythm.

If you suffer from bipolar disorder (manic-depressive illness), you may enter a manic phase, characterised by
unusual and rapid changes of mind, unjustified happiness, and excessive physical activity. If you develop
such symptoms, contact your doctor.
Symptoms such as restlessness or difficulty sitting or standing still (akathisia) may also
occur during the first weeks of treatment. Inform your doctor immediately if you experience
such symptoms.
If you suffer from panic disorder, you may experience an increase in anxiety symptoms at the beginning of
treatment. Inform your doctor immediately if you experience these symptoms.
Suicidal thoughts and worsening of depression or anxiety disorder
If you are depressed and/or suffer from anxiety disorders, you may sometimes have thoughts of harming yourself or even of
suicide. These thoughts may increase at the beginning of treatment with antidepressants, as
these medicines take time to work, usually about two weeks but sometimes longer. You may be more likely to have these thoughts if:

you have previously had thoughts of suicide or self-harm
you are a young adult. Data from clinical trials have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders treated with an antidepressant.

If at any time you have thoughts of harming yourself or of suicide, contact your doctor immediately or go to the nearest hospital emergency department.
You may find it helpful to inform a close family member or friend about your depression or
anxiety disorder and ask them to read this leaflet. You may wish to ask them to inform you if they believe your depression or anxiety is worsening, or if they are concerned about any changes in your behaviour.
Medicines such as Escitalopram Mylan Generics (so-called selective serotonin reuptake inhibitors (SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs)) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have been observed to persist after
discontinuation of treatment.
Children and adolescents
Escitalopram Mylan Generics should not normally be used in children and adolescents under
18 years of age. In addition, you should know that patients under 18 years of age have an increased
risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility
(mainly aggression, oppositional behaviour, and anger) when taking this class of medicines. However, your doctor may still prescribe Escitalopram Mylan Generics
to patients under 18 years of age if they consider it to be in their best interest. If your doctor has prescribed
Escitalopram Mylan Generics to a patient under 18 years of age and you wish to discuss this, please speak to your doctor again. You must inform your doctor if any of the symptoms described above appear or worsen while the patient under 18 years of age is taking Escitalopram Mylan
Generics. Furthermore, the long-term safety of Escitalopram Mylan Generics with regard to growth, maturation, and cognitive and behavioural development in this age group has not yet been established.
Other medicines and Escitalopram Mylan Generics
Inform your doctor if you are taking, have recently taken, or might take any other
medicine. Inform your doctor if you are taking any of the following medicines:

Non-selective monoamine oxidase inhibitors (MAOIs), containing phenelzine, iproniazid, isocarboxazide, nialamide, or tranilcypramine as active ingredients. If you have taken any of these medicines, you must wait 14 days before starting Escitalopram Mylan Generics. After stopping Escitalopram Mylan Generics, you must wait 7 days before taking any of these medicines.
Reversible selective MAO-A inhibitors, containing moclobemide (used to treat depression).
Irreversible MAO-B inhibitors, containing selegiline (used to treat Parkinson’s disease). These medicines increase the risk of adverse effects.
The antibiotic linezolid.
Lithium (used to treat bipolar disorder) and tryptophan (an amino acid).
Other medicines used to treat depression, such as tricyclic antidepressants or other selective serotonin reuptake inhibitors (SSRIs) such as imipramine, desipramine, and fluvoxamine.
Sumatriptan and similar medicines (used to treat migraine) and tramadol (used for severe pain). These medicines increase the risk of adverse effects.
Cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcers or dyspepsia (indigestion)), fluconazole (used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These medicines may cause an increase in the levels of Escitalopram Mylan Generics in the blood.
St John’s wort (Hypericum perforatum), a herbal preparation used for depression.
Aspirin and non-steroidal anti-inflammatory drugs (medicines used to relieve pain or to thin the blood, so-called anticoagulants). Warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood, so-called anticoagulants). Your doctor will likely monitor your blood clotting time at the beginning and end of treatment with Escitalopram Mylan Generics to ensure your anticoagulant dose remains appropriate.
Mefloquine (used to treat malaria), tricyclic antidepressants or selective serotonin reuptake inhibitors (SSRIs), bupropion (used to treat depression), tramadol (used for severe pain), and neuroleptics (medicines to treat schizophrenia, psychosis), due to the possible risk of lowering the seizure threshold.
Flecainide, propafenone, and metoprolol (used for cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). Dose adjustment of Escitalopram Mylan Generics may be necessary.
Medicines that reduce potassium or magnesium levels in the blood, as these conditions increase the risk of life-threatening heart rhythm disturbances. DO NOT TAKE Escitalopram Mylan Generics if you are taking medicines for heart rhythm problems or medicines that may affect heart rhythm, such as, for example, class IA and III antiarrhythmics, antipsychotics (such as phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (such as sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarial treatments, particularly halofantrine), or certain antihistamines (astemizole, mizolastine). If you have any further doubts, contact your doctor.

Escitalopram Mylan Generics with food and drink and alcohol
Escitalopram Mylan Generics can be taken regardless of meals (see section 3
“How to take Escitalopram Mylan Generics”).
As with many medicines, it is not recommended to combine Escitalopram Mylan Generics with alcohol,
although no interactions between Escitalopram Mylan Generics and alcohol are expected.
Pregnancy, breastfeeding and fertility
Inform your doctor if you are pregnant or planning a pregnancy. Do not take Escitalopram
Mylan Generics if you are pregnant or breastfeeding, unless you have already discussed the associated risks
and benefits with your doctor. If you take Escitalopram Mylan Generics during the last 3 months of
pregnancy, you should be aware that the newborn may experience the following effects: breathing difficulties, bluish skin colour, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar levels, muscle stiffness or floppiness, overactive reflexes, tremor, nervousness, irritability, lethargy, constant crying, drowsiness, and difficulty sleeping. If your baby shows any of these symptoms, contact your doctor
immediately.
Ensure that your midwife and/or doctor know that you are being treated with Escitalopram Mylan
Generics. When taken during pregnancy, particularly in the last trimester, medicines such as Escitalopram Mylan Generics may increase the risk of a serious condition in the baby called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster than normal and have a bluish skin colour. These symptoms usually appear within the first 24 hours after the baby’s birth. If this occurs in your baby, contact your midwife and/or doctor immediately.
If used during pregnancy, Escitalopram Mylan Generics must never be stopped abruptly.
Animal studies have shown that citalopram, a medicine similar to escitalopram, reduces sperm quality. This could theoretically affect fertility, but no impact on fertility in men has been observed to date.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding with breast milk, consult your doctor before taking this medicine.
Driving and using machines
It is recommended not to drive or operate machinery until you know how Escitalopram Mylan Generics
affects you.
Escitalopram Mylan Generics contains ethanol
This medicine contains a small amount of ethanol (alcohol), less than 100 mg per 20 drops.
Each drop contains 4.8 mg of ethanol (alcohol).
3 How to take Escitalopram Mylan Generics
Always take Escitalopram Mylan Generics exactly as prescribed by your doctor. If you have
any doubts, consult your doctor or pharmacist.
Count the required number of drops into your drink (water, orange juice, or apple juice), mix briefly, and then drink it all.
Do not mix Escitalopram Mylan Generics with liquids other than water, orange juice, or apple juice, and do not mix it with other medicines.
Adults
Depression
The recommended dose of Escitalopram Mylan Generics is 10 mg (10 drops) as a single
daily dose. Your doctor may increase the dose to a maximum of 20 mg (20 drops) per day.
Panic disorder
The initial dose of Escitalopram Mylan Generics is 5 mg (5 drops) per day for the first week,
before increasing to 10 mg (10 drops) per day. Your doctor may further increase the dose up to a maximum of 20 mg (20 drops) per day.
Social anxiety disorder
The usual recommended dose of Escitalopram Mylan Generics is 10 mg (10 drops) as a single
daily dose. Your doctor may reduce the dose to 5 mg (5 drops) per day or increase it up to a maximum of 20 mg (20 drops) per day, depending on your response to the medicine.
Generalised anxiety disorder
The recommended dose of Escitalopram Mylan Generics is 10 mg (10 drops) as a single
daily dose. Your doctor may increase the dose up to a maximum of 20 mg (20 drops) per
day.
Obsessive-compulsive disorder
The recommended dose of Escitalopram Mylan Generics is 10 mg (10 drops) as a single
daily dose. Your doctor may increase the dose up to a maximum of 20 mg (20 drops) per
day.
Elderly patients (over 65 years of age)
The recommended starting dose of Escitalopram Mylan Generics is 5 mg (5 drops) as a single
daily dose. Your doctor may increase the dose to 10 mg (10 drops) per day.
Use in children and adolescents
Escitalopram Mylan Generics must not be used in children and adolescents. For further
information, see section 2 “What you need to know before taking Escitalopram Mylan Generics”.
Duration of treatment
It may take a few weeks before you start to feel better. Continue taking
Escitalopram Mylan Generics even if you need to wait some time before noticing an improvement
in your condition.
Do not change the dose of your medicine without first discussing it with your doctor.
Continue taking Escitalopram Mylan Generics for as long as your doctor has
recommended. If you stop treatment too early, your symptoms may return. It is recommended to continue treatment for at least 6 months after recovery.
If you take more Escitalopram Mylan Generics than you should
If you have taken more Escitalopram Mylan Generics than prescribed, contact
your doctor or the nearest hospital emergency department immediately, even if you do not feel any
symptoms or discomfort. Some signs of overdose may include dizziness, tremor, agitation,
seizures, coma, nausea, vomiting, changes in heart rate, low blood pressure, and disturbances in fluid and electrolyte balance. Take the box/container of
Escitalopram Mylan Generics with you when you go to the doctor or hospital.
If you forget to take Escitalopram Mylan Generics
Do not take a double dose to make up for the missed dose.
If you forget to take a dose and remember before going to bed, take the dose immediately and continue as usual the next day. If you only remember during the night or the next day, skip the missed dose and continue with your usual schedule.
If you stop taking Escitalopram Mylan Generics
Do not stop taking Escitalopram Mylan Generics unless your doctor tells you to. Once the treatment course is completed, it is generally recommended to gradually reduce
the dose of Escitalopram Mylan Generics over several weeks.
When stopping Escitalopram Mylan Generics, especially if abruptly, you may
experience the following symptoms:

dizziness (unstable balance), tingling sensations, burning sensations, and (less commonly) electric shock-like sensations (also in the head), sleep disturbances (vivid dreams, nightmares, inability to sleep), feeling anxious, headache, malaise (nausea), sweating (including night sweats), restlessness or agitation, tremor, feeling confused or disoriented, emotional or irritable feelings, diarrhoea (loose stools), visual disturbances, pounding or palpitating heartbeat (palpitations). These symptoms are common when stopping treatment with Escitalopram Mylan Generics. The risk is higher if Escitalopram Mylan Generics has been used for a long time, at high doses, or if the dose is reduced too quickly.

Most people find these symptoms mild and they resolve on their own within
two weeks. However, in some patients, symptoms may be severe or prolonged (2-3 months or more). If you experience severe withdrawal symptoms when stopping Escitalopram Mylan Generics, contact your doctor. Your doctor may advise you to restart the drops and then stop treatment more gradually.
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.
The side effects generally disappear after a few weeks of treatment. However, consider that many of these side effects may also be symptoms of your illness, which will therefore improve as you start feeling better.
If you experience any of the following side effects, you must contact your doctor immediately or go to hospital:

difficulty urinating
epileptic seizures (convulsions), see also section “Warnings and precautions”
yellowing of the skin and whites of the eyes, which may be signs of impaired liver function/hepatitis
rapid or irregular heartbeat, feeling faint, which may be symptoms of a life-threatening condition known as torsade de pointes.

Uncommon (may affect up to 1 in 100 people):

Unusual bleeding, including gastrointestinal and rectal bleeding.

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

If you notice swelling of the skin, tongue, lips or face, or have difficulty breathing or swallowing (allergic reaction).
If you experience high fever, agitation, confusion, tremor and sudden muscle contractions, these may be signs of a condition called serotonin syndrome.

The following side effects have been reported in addition to those mentioned above:

Very common (may affect more than 1 in 10 people):

Feeling unwell (nausea)
Headache.

Common (may affect up to 1 in 10 people):

Stuffy or runny nose (sinusitis)
Altered appetite, weight gain
Anxiety, restlessness, abnormal dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremor, tingling sensation on the skin
Diarrhoea, constipation, vomiting, dry mouth
Increased sweating
Muscle and joint pain (arthralgia and myalgia)
Sexual disorders (delayed ejaculation, erection problems, decreased sexual desire; women may have difficulty achieving orgasm)
Fatigue, fever.

Uncommon (may affect up to 1 in 100 people):

Hives, skin rash, itching
Teeth grinding, agitation, nervousness, panic attack, confusion
Disturbed sleep, altered taste, fainting (syncope)
Enlarged pupils (mydriasis), visual disturbances, ringing in the ears (tinnitus)
Hair loss
Vaginal bleeding
Weight loss
Fast heartbeat (tachycardia)
Swelling of the arms or legs
Nosebleeds.

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

Aggressiveness, depersonalization, seeing or hearing things that are not real (hallucinations)
Slow heartbeat (bradycardia).

Frequency not known (frequency cannot be estimated from the available data):

Thoughts of harming yourself or of suicide; see also section “Warnings and precautions”.
Reduced sodium levels in the blood (symptoms include feeling unwell, muscle weakness or confusion).
Dizziness when standing up due to low blood pressure (orthostatic hypotension).
Abnormal liver function tests (increased liver enzyme levels in the blood) and ECG (electrocardiogram) abnormalities.
Movement disorders (involuntary muscle movements).
Painful erection (priapism).
Bleeding disorders, including bleeding of the skin and mucous membranes (ecchymosis) and low platelet count (thrombocytopenia).
Sudden swelling of the skin and mucous membranes (angioedema).
Increased urine output (inappropriate ADH secretion).
Milk discharge in women who are not breastfeeding.
Mania.

An increased risk of bone fractures has been observed in patients taking this type of medicine.
Alteration of heart rhythm (known as “prolongation of the QT interval”, visible on ECG, the heart's electrical activity).

In addition, there are side effects that occur with medicines acting similarly to escitalopram (the active substance in Escitalopram Mylan Generics), such as:

Motor restlessness, urgency or need to move to relieve an unpleasant sensation (akathisia).
Loss of appetite (anorexia).

If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist.

5. How to store Escitalopram Mylan Generics

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 label and carton after
EXP. The expiry date refers to the last day of that month.
After first opening, the drops must be used within 8 weeks and should not be stored at
temperatures above 25 °C.
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 Escitalopram Mylan Generics contains
The active substance is escitalopram. Each ml of Escitalopram Mylan Generics contains 20 mg of
escitalopram (as 25.55 mg of escitalopram oxalate).
1 drop contains 1 mg of escitalopram.
The other components are: propyl gallate; anhydrous citric acid; ethanol 96%; sodium hydroxide; purified water.
Description of the appearance of Escitalopram Mylan Generics and the contents of the pack
Escitalopram Mylan Generics oral drops, solution is a clear, almost colourless to slightly yellowish solution supplied in a dark glass bottle containing 15 ml, with a dropper.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan S.p.A.
Via Vittor Pisani 20
20124 Milan
Italy
Manufacturer responsible for batch release
Doppel Farmaceutici S.r.l.
Via Martiri delle Foibe, 1
29016 Cortemaggiore (PC)
Italy