ESCITALOPRAM MYLAN

Package leaflet: Information for the patient

Escitalopram Mylan 10 mg film-coated tablets, 20 mg film-coated tablets

Escitalopram
Generic medicine
Please read all of 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 effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Escitalopram belongs to a group of medicines known as Selective Serotonin Reuptake Inhibitors (SSRIs). These medicines act on the serotonin system in the brain by increasing serotonin levels. Disturbances in the serotonin system are considered an important factor in the development of depression and related disorders.
Escitalopram Mylan can be used to treat the following conditions:

• depression (major depressive episodes)
• panic disorder with or without agoraphobia (fear of open spaces)
• social anxiety disorder
• generalized anxiety disorder
• obsessive-compulsive disorder.

2. What you should know before taking Escitalopram Mylan

Do not take Escitalopram Mylan:

• if you are allergic to escitalopram or to any of the other ingredients of this medicine (listed in section 6).
• if you are taking other medicines belonging to the group called MAO inhibitors, including selegiline (used in the treatment of Parkinson's disease), moclobemide (used in the treatment of depression), or linezolid (an antibiotic).
• if you have congenital abnormalities of heart rhythm or have had an episode of abnormal heart rhythm (detected on ECG, a test to assess heart function).
• if you are taking medicines for heart rhythm disorders or medicines that may affect heart rhythm (see section 2 “Other medicines and Escitalopram Mylan”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Escitalopram Mylan:

• if you have impaired liver or kidney function. Your doctor may need to adjust your dose.
• if you are elderly.
• if you have epilepsy or a history of seizures. Discontinue treatment with Escitalopram Mylan if seizures occur for the first time or if there is an increased frequency of seizures (see also section 4 “Possible side effects”).
• if you are undergoing electroconvulsive therapy (ECT).
• if you have a tendency to bleeding or bruising, or if you are pregnant (see section “Pregnancy, breastfeeding and fertility”).
• if you have diabetes. Treatment with Escitalopram may alter glycaemic control (blood sugar level monitoring). Your insulin and/or antidiabetic medication dose may need adjustment.
• if you have low levels of sodium in the blood.
• if you have coronary heart disease.
• if you have heart problems or have had a recent heart attack.
• if you have a slow heart rate and/or you know you have low levels of salts in the blood due to prolonged diarrhoea and vomiting (malaise) or due to the use of diuretics (tablets that increase urine elimination).
• if you experience rapid or irregular heartbeat, fainting, collapse, or dizziness when standing up—signs indicating an abnormal heart rate.
• if you have glaucoma (increased pressure in the eye).

Note:
Some patients with bipolar disorder may enter a manic phase. Symptoms include unusual and rapid flow of thoughts, feelings of unusual and unjustified happiness, and excessive physical activity. If these symptoms occur, contact your doctor.
During the first few weeks of treatment, you may experience symptoms such as restlessness or difficulty sitting or standing still. Inform your doctor immediately if these symptoms occur.
Suicidal thoughts and worsening of depression or anxiety disorder
If you are depressed and/or have anxiety disorders, you may sometimes have self-harming or suicidal thoughts.
These thoughts may worsen at the beginning of treatment with antidepressants because all these medicines require time to take effect, usually about two weeks, but sometimes longer.
You may be more likely to develop these thoughts:

• if you have previously had suicidal or self-harming thoughts;
• if you are a young adult. Clinical studies have shown an increased risk of suicidal behaviour in adults under 25 years of age whose psychiatric conditions were being treated with an antidepressant.

If you have self-harming or suicidal thoughts at any time, contact your doctor or go immediately to a hospital.
It may be helpful to inform a relative or friend about your depression or anxiety disorder and ask them to read this leaflet. You may also ask them whether they notice your depression or anxiety worsening, or if they are concerned about changes in your behaviour.
Sexual dysfunction
Medicines such as escitalopram (so-called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may persist after discontinuation of treatment.
Children and adolescents under 18 years of age
Escitalopram Mylan should not normally be used in children and adolescents under 18 years of age. You should be aware that patients under 18 years of age who take this class of medicines have a higher risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, oppositional behaviour, and anger).
Nevertheless, your doctor may prescribe Escitalopram Mylan to patients under 18 years of age if they consider it to be in their best interest. If your doctor has prescribed Escitalopram Mylan to a patient under 18 years of age and you wish to discuss this, consult your doctor again.
You should report to your doctor any onset or worsening of the symptoms listed above in patients under 18 years of age taking Escitalopram. In addition, the long-term effects on safety regarding growth, maturation, and cognitive and behavioural development in this age group have not been established.
Other medicines and Escitalopram Mylan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is particularly important to inform your doctor if you are taking any of the following medicines:

• non-selective monoamine oxidase inhibitors (MAOIs) containing the active substances phenelzine, iproniazid, isocarboxazid, nialamide, or tranylcypromine (used in the treatment of depression). If you have taken any of these medicines, you must wait 14 days before starting treatment with Escitalopram. After stopping Escitalopram, you must wait 7 days before taking any of the medicines listed above.
• reversible selective MAO-A inhibitors containing moclobemide (used in the treatment of depression).
• linezolid (an antibiotic).
• irreversible MAO-B inhibitors containing selegiline (used in the treatment of Parkinson's disease). These medicines increase the risk of side effects.
• sumatriptan and similar medicines (used to treat migraine) or buprenorphine and tramadol (used to treat severe pain). These medicines may interact with Escitalopram Mylan and may cause symptoms such as involuntary rhythmic muscle contractions (including muscles controlling eye movement), agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle contraction, and fever above 38°C. Contact your doctor if you experience these symptoms.
• cimetidine, omeprazole, and lansoprazole (used to treat stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These medicines may increase blood levels of Escitalopram.
• St. John's wort (Hypericum perforatum) – a herbal remedy for depression.
• lithium or tryptophan (used for depression), as they may increase the effect of Escitalopram.
• acetylsalicylic acid (aspirin) (used to relieve pain or to thin the blood) and non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to relieve pain). These medicines may increase the tendency to bleeding.
• warfarin, dipyridamole, phenprocoumon, or other anticoagulants (medicines used to thin the blood). Your doctor will monitor your blood clotting time at the start and end of Escitalopram treatment to ensure that the anticoagulant dose remains appropriate.
• mefloquine (for the treatment of malaria), bupropion (used when trying to quit smoking or in the treatment of depression), and tramadol (used to treat severe pain), due to the possible risk of lowering the seizure threshold.
• neuroleptics (medicines used in the treatment of schizophrenia and psychosis) and antidepressants other than SSRIs, due to the possible risk of lowering the seizure threshold.
• flecainide, propafenone, and metoprolol (used to treat cardiovascular disorders), and imipramine, desipramine, clomipramine, and nortriptyline (used to treat depression), and risperidone, thioridazine, and haloperidol (antipsychotics). The dose of Escitalopram may need adjustment.
• medicines that cause low levels of potassium in the blood (hypokalaemia) or low levels of magnesium in the blood (hypomagnesaemia).

Do not take Escitalopram Mylan together with medicines used to treat heart rhythm disorders or medicines that may affect heart rhythm, such as Class IA and III antiarrhythmics, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g., sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarial treatments, especially halofantrine), and certain antihistamines (e.g., astemizole, hydroxyzine, mizolastine). If you have any doubts about using this medicine, consult your doctor.
Escitalopram Mylan with food, drinks and alcohol
Escitalopram may be taken with or without food (see section 3 “How to take Escitalopram”).
Avoid consuming alcohol during treatment with this medicine.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Inform your doctor if you are pregnant or planning a pregnancy. Do not take Escitalopram if you are pregnant unless you and your doctor have discussed the risks and benefits associated with this treatment. Do not stop taking Escitalopram abruptly.
Ensure that your midwife and/or doctor know that you are being treated with Escitalopram.
If taken during pregnancy, especially during the last three months, medicines like Escitalopram may increase the risk of a serious condition in the newborn called persistent pulmonary hypertension of the newborn (PPHN): the newborn breathes faster and develops a bluish skin colour. These symptoms usually begin within the first 24 hours after birth. If this occurs, inform your midwife and/or doctor immediately.
Other symptoms that may occur with the use of Escitalopram during the late stages of pregnancy include difficulty sleeping or feeding, interrupted breathing, body temperature too high or too low, malaise, continuous crying, low blood sugar levels, muscle stiffness or floppiness, exaggerated reflexes, irritability, lethargy, tremors, nervousness, or seizures. If your baby shows these symptoms at birth, contact your doctor immediately—they will be able to advise you.
If you take Escitalopram Mylan near the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have bleeding disorders (tendency to bleed easily). Inform your doctor or midwife that you are taking Escitalopram Mylan so they can advise you on what to do.
Breastfeeding
Inform your doctor if you are breastfeeding. Escitalopram is likely to pass into breast milk. Do not breastfeed while taking Escitalopram. Your doctor will decide whether you should continue breastfeeding or stop it, or whether you should continue or discontinue treatment with Escitalopram.
Fertility
Animal studies have shown that citalopram, a medicine similar to escitalopram, reduces sperm quality. In theory, this could affect fertility, but no effect on human fertility has been observed so far.
Driving and using machines
Do not drive or operate machinery until you know how Escitalopram affects you.
Escitalopram Mylan contains lactose and sodium
This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially “sodium-free”.

3. How to take Escitalopram Mylan

Take this medicine exactly as directed by your doctor or pharmacist.
If you are unsure, consult your doctor or pharmacist.
Remember that you will need to take Escitalopram tablets for 2 or more weeks before you start
to feel better.

Adults
Depression – The recommended dose is 10 mg of Escitalopram Mylan once daily. Your
doctor may increase the dose up to a maximum of 20 mg per day. It may take 2 to 4 weeks before
you start to feel better. Treatment should continue for at least 6 months after you begin to feel better.

Panic disorder – The recommended starting dose is 5 mg of Escitalopram Mylan daily. After
the first week, your doctor may increase the dose to 10 mg daily and, if necessary, up to a maximum
of 20 mg daily. Maximum effect is achieved after 3 months of treatment.

Social anxiety disorder – The recommended dose is 10 mg of Escitalopram Mylan daily.
It may take 2–4 weeks before you start to feel better. Afterwards, the dose may be reduced to 5 mg
daily or increased to 20 mg daily, depending on how the treatment is working. A treatment duration
of 12 weeks is normally recommended.

Generalised anxiety disorder – The recommended dose is 10 mg of Escitalopram Mylan daily.
Your doctor may increase this dose up to a maximum of 20 mg daily. Your doctor will regularly review
the dose.

Obsessive-compulsive disorder – The recommended dose is 10 mg of Escitalopram Mylan daily.
Your doctor may increase this dose up to a maximum of 20 mg daily. Your doctor will regularly review
the dose.

Elderly patients (over 65 years)
Your doctor will prescribe a lower dose than those listed above, as elderly patients may be more
sensitive to the effects of Escitalopram Mylan.
The recommended starting dose of Escitalopram Mylan is 5 mg as a single daily dose. Your doctor
may increase the dose up to 10 mg daily.

Use in children and adolescents (under 18 years of age)
Escitalopram Mylan should not normally be given to children and adolescents under 18 years of age.
For further information, see section 2 “What you need to know before taking Escitalopram Mylan”.

If you have severe liver or kidney problems, your doctor will prescribe a lower dose.
You may take Escitalopram Mylan with or without food. Swallow the tablet with a glass of water. Do
not chew the tablets as they have a bitter taste.

Continue taking the tablets for as long as your doctor prescribes, even if you start to feel better.
Treatment should continue for at least three to six months after you begin to feel better, in order to
prevent symptoms from returning.

Tablets of 10 mg, 15 mg and 20 mg may be divided into equal parts.

If you take more Escitalopram Mylan than you should
Contact your doctor or the nearest hospital emergency department immediately. Do this
even if you do not feel unwell. Symptoms of overdose include dizziness, tremor, agitation,
seizures, coma, feeling unwell, malaise, changes in heart rhythm (slowed or rapid heartbeat),
low blood pressure, and disturbances in electrolyte balance. Take the container and any
remaining tablets with you to the doctor or hospital.

If you forget to take Escitalopram Mylan
Do not take a double dose to make up for a forgotten dose. If you forget to take a dose and
remember before going to bed, take it immediately. Continue your treatment as usual the next day.
If you remember during the night or the following day, skip the missed dose and continue your
treatment as usual.

If you stop taking Escitalopram Mylan
Do not stop treatment with Escitalopram Mylan unless your doctor tells you to. After completing
treatment, it is generally recommended to gradually reduce the dose of Escitalopram Mylan over
several weeks.

When stopping treatment with Escitalopram Mylan, especially abruptly, you may experience
withdrawal symptoms. These are commonly observed when stopping escitalopram treatment.
The risk is greater if escitalopram has been used for a long time or at high doses, or if the dose is
reduced too quickly. Most patients find that symptoms are mild and resolve on their own within two
weeks. However, in some patients, these symptoms may be severe and last longer (2–3 months or more).
If you experience severe withdrawal symptoms when stopping escitalopram treatment, contact your
doctor, who may advise you to restart treatment and to taper off more slowly.

Withdrawal symptoms include: dizziness (unsteadiness or loss of balance), pins and needles sensation,
burning sensation (less commonly, electric shock-like sensations, including in the head), sleep disturbances
(vivid dreams, nightmares, inability to sleep), restlessness or agitation, tremor, confusion or disorientation,
emotional lability or irritability, diarrhoea (loose stools), visual disturbances, and rapid heartbeat (palpitations).

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects usually disappear after a few weeks of treatment. Many of these effects may also be symptoms of your illness and will improve as you start to feel better.
If you experience any of the following side effects, contact your doctor immediately or go to hospital straight away:
Uncommon (may affect up to 1 in 100 patients)

• Unusual bleeding, including gastrointestinal bleeding

Rare (may affect up to 1 in 1000 patients)

• Swelling of the skin, tongue, lips or face, or if you have difficulty breathing or swallowing (severe allergic reaction)
• High fever, agitation, confusion, tremor and involuntary muscle contractions, which may be signs of a rare condition called serotonin syndrome
• Not known (frequency cannot be estimated from the available data) difficulty passing urine
• seizures (fits), see also section 2 “Warnings and precautions”
• yellowing of the skin and whites of the eyes, which are signs of liver dysfunction/hepatitis
• fast and irregular heartbeat and fainting, which may be symptoms of a life-threatening condition called Torsades de Pointes
• suicidal or self-harming thoughts, see also section 2 “Warnings and precautions”

In addition, the following side effects have been reported:
Very common (may affect more than 1 in 10 people)

• headache
• feeling unwell (nausea)

Common (may affect up to 1 in 10 people)

• loss of appetite
• increased appetite
• weight gain
• feeling anxious or restless
• difficulty falling asleep
• drowsiness
• abnormal dreams
• tingling and numbness in hands and feet
• tremor
• dizziness
• yawning
• inflammation and swelling of the sinuses causing pain, fever and tenderness (a condition known as sinusitis)
• diarrhoea
• constipation
• vomiting
• dry mouth
• increased sweating
• fever
• muscle or joint pain
• unusual tiredness
• sexual problems (delayed ejaculation, erection problems, reduced sex drive and difficulty reaching orgasm in women)

Uncommon (may affect up to 1 in 100 people)

• weight loss
• confusion
• agitation
• nervousness
• teeth grinding during sleep
• panic attacks
• altered taste
• changes in sleep pattern
• fainting
• dilated pupils (mydriasis), visual disturbances
• ringing in the ears (tinnitus)
• fast heartbeat
• nosebleeds
• hair loss
• hives or wheals
• rash
• itchy skin
• heavy menstrual periods or bleeding between periods
• excessive fluid retention in the body

Rare (may affect up to 1 in 1000 people)

• feeling aggressive or detached from oneself
• hallucinations
• slow heartbeat

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

• thrombocytopenia (reduced platelet count leading to increased risk of bleeding and bruising)
• increased levels of a hormone (ADH) causing fluid or urine retention
• lower than normal sodium levels in the blood, causing weakness, confusion and discomfort
• mania (feelings of elation or over-excitement leading to unusual behaviour)
• abnormal muscle movements
• dizziness when standing up, due to low blood pressure (orthostatic hypotension)
• abnormal liver enzyme test results
• prolonged and painful erection
• abnormal breast milk production in men and women
• an increased risk of bone fractures has been observed in patients taking this type of medicine
• heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage), see section 2 “Pregnancy, breastfeeding and fertility” for further information

In addition, other side effects have been observed with medicines that have the same action as escitalopram:

• restlessness or difficulty remaining still (psychomotor agitation/acathisia)
• anorexia

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Escitalopram Mylan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container/blister and carton after EXP. The expiry date refers to the last day of that month.
Store below 25 °C.
Bottles: Keep the container tightly closed.
Blister packs: Store in the original packaging.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Escitalopram Mylan contains
The active substance is escitalopram.
Each tablet contains 10 mg or 20 mg of escitalopram (as oxalate).
The other components are:
microcrystalline cellulose, anhydrous colloidal silica, talc, sodium croscarmellose, magnesium stearate, monohydrate lactose, macrogol 4000, titanium dioxide (E171) and hypromellose. See section 2, "Escitalopram contains lactose and sodium".

Description of the appearance of Escitalopram Mylan and pack contents
Escitalopram Mylan is a film-coated tablet.
The 10 mg film-coated tablets are white, oval-shaped, with a score line and engraved "EC|10" on one side and "G" on the other. The tablet can be divided into two equal parts.
The 20 mg film-coated tablets are white, oval-shaped, with a score line and engraved "EC|20" on one side and "G" on the other. The tablet can be divided into two equal parts.
Escitalopram Mylan is available in tablet containers containing 28, 49, 100, 200, 250 and 500 film-coated tablets, in blisters containing 10, 14, 20, 28, 30, 49, 50, 56, 60, 90, 100, 180 and 200 film-coated tablets, and in perforated unit dose blisters containing 28 x 1 and 56 x 1 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Mylan S.p.A.
Via Vittor Pisani 20
20124 Milan (Italy)

Manufacturer:
McDermott Laboratories Limited t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road
Dublin 13
Ireland
Mylan Hungary Kft.,
Mylan utca 1, Komárom
2900, Hungary

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria: Escitalopram Arcana 10 mg Filmtabletten, Escitalopram Arcana 20 mg Filmtabletten.
Belgium: Escitalopram Mylan 5 mg filmomhulde tabletten, Escitalopram Mylan 10 mg filmomhulde tabletten, Escitalopram Mylan 15 mg filmomhulde tabletten, Escitalopram Mylan 20 mg filmomhulde tabletten.
Czech Republic: Escitalopram Mylan
Denmark: Escitalopram Mylan
France: Escitalopram Mylan 5 mg, comprimé pelliculé, Escitalopram Mylan 10 mg, comprimé pelliculé sécable, Escitalopram Mylan 15 mg, comprimé pelliculé sécable, Escitalopram Mylan 20 mg, comprimé pelliculé sécable.
Greece: Escitalopram Mylan Film-coated Tablets 10mg/TAB, Escitalopram Mylan Film-coated Tablets 20mg/TAB
Hungary: Escigen 10 mg filmtabletta.
Ireland: Escitalpro 5 mg film-coated tablets, Escitalpro 10 mg film-coated tablets, Escitalpro 15 mg film-coated tablets, Escitalpro 20 mg film-coated tablets
Italy: Escitalopram Mylan.
Luxembourg: Escitalopram Mylan 5 mg comprimés pelliculés, Escitalopram Mylan 10 mg comprimés pelliculés, Escitalopram Mylan 15 mg comprimés pelliculés, Escitalopram Mylan 20 mg comprimés pelliculés.
Norway: Escitalopram Mylan
Netherlands: Escitalopram Mylan 5 mg filmomhulde tabletten, Escitalopram Mylan 10 mg filmomhulde tabletten, Escitalopram Mylan 15 mg filmomhulde tabletten, Escitalopram Mylan 20 mg filmomhulde tabletten.
Portugal: Escitalopram Mylan
Slovakia: Escitalopram Mylan 10 mg
Spain: Escitalopram Mylan 10 mg comprimidos recubiertos con pelicula EFG, Escitalopram Mylan 15 mg comprimidos recubiertos con pelicula EFG, Escitalopram Mylan 20 mg comprimidos recubiertos con pelicula EFG.
Sweden: Escitalopram Mylan 5 mg, Escitalopram Mylan 10 mg, Escitalopram Mylan 15 mg, Escitalopram Mylan 20 mg.