Escitalopram Aurobindo

Package leaflet: Information for the user

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

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, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet,
talk to your doctor or pharmacist.
Contents of this leaflet:

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

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

Escitalopram Aurobindo belongs to a group of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). These medicines act on the serotonin system in the brain, increasing serotonin levels. Disturbances in the serotonin system are considered an important factor in the development of depression and related disorders.
Escitalopram Aurobindo contains escitalopram and is used to treat depression (major depressive episodes) and anxiety disorders (such as panic disorder with or without agoraphobia, social anxiety disorder, generalized anxiety disorder, and obsessive-compulsive disorder).

2. What you need to know before taking Escitalopram Aurobindo

Do not take Escitalopram Aurobindo:
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 in the treatment of Parkinson's disease),
moclobemide (used in the treatment of depression), and linezolid (an antibiotic).
if you have been born with or have experienced an episode of abnormal heart rhythm (visible via
electrocardiogram (ECG): an examination to assess heart function).
if you are taking medicines for heart rhythm problems or medicines that may affect your heart rhythm
(see section 2 “Other medicines and Escitalopram Aurobindo”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Escitalopram Aurobindo.
Inform your doctor if you suffer from any other condition or illness, as your doctor may need to take this into account. In particular, inform your doctor:
if you suffer from epilepsy. Treatment with Escitalopram Aurobindo must be discontinued if you experience seizures for the first time or if the frequency of epileptic seizures increases
(see also section 4 “Possible side effects”).
if you have impaired liver or kidney function. Your doctor may need to adjust your dosage.
if you have diabetes. Treatment with Escitalopram Aurobindo may alter blood glucose control. It may be necessary to adjust the dose of insulin and/or oral hypoglycaemic agents.
if you have low sodium levels in your blood.
if you have a tendency to bleed easily or develop bruises.
if you are undergoing electroconvulsive therapy.
if you have coronary artery disease.
if you have heart problems or have previously had a heart attack.
if you have a low resting heart rate and/or if you think your body may have undergone significant salt loss due to prolonged and severe diarrhoea and vomiting or use of diuretics
(urination 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 have closed-angle glaucoma or have previously suffered from glaucoma.

Caution:
Some patients with bipolar disorder may enter a manic phase characterised by unusual and rapid changes in thinking, unjustified happiness, and excessive physical activity. If you experience this, contact your doctor.
During the first weeks of treatment, symptoms such as restlessness or difficulty sitting still may also occur. Inform your doctor immediately if these symptoms appear.

Suicidal thoughts and worsening of depression or anxiety disorder
If you are depressed and/or suffer from anxiety disorders, you may occasionally have thoughts of harming yourself or 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 such thoughts:
if you have previously experienced thoughts of suicide or self-harm.
if 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 straight to hospital.
You may find it helpful to inform a family member or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You could 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.

Children and adolescents
Use in children and adolescents under 18 years of age
Escitalopram Aurobindo 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 a higher 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 Aurobindo to patients under 18 years of age if they consider it to be in their best interest. If your doctor has prescribed Escitalopram Aurobindo to a patient under 18 years of age and you wish to discuss this, 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 Aurobindo. Furthermore, the long-term safety of Escitalopram Aurobindo regarding growth, maturation, and cognitive and behavioural development in this age group has not yet been established.

Other medicines and Escitalopram Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor if you are taking any of the following medicines:
Non-selective monoamine oxidase inhibitors (MAOIs), containing phenelzine, iproniazid,
isocarboxazid, nialamide, and tranylcypromine as active substances. If you have taken any of
these medicines, you must wait 14 days before starting Escitalopram Aurobindo.
After stopping Escitalopram Aurobindo, you must wait 7 days before taking any of these medicines.
Reversible selective MAO-A inhibitors, containing moclobemide (used for the treatment of 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 for the treatment of bipolar disorder) and tryptophan.
Imipramine and desipramine (both used for the treatment of depression).
Sumatriptan and similar medicines (used to treat migraine) and tramadol (used for severe pain). These medicines increase the risk of adverse effects.
Cimetidine and omeprazole (used to treat stomach ulcers), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These medicines may cause an increase in Escitalopram Aurobindo levels in the blood.
St John's Wort (Hypericum perforatum), a herbal preparation used for depression.
Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medicines used to relieve pain or as blood thinners, so-called anticoagulants), which may increase the tendency to bleed.
Warfarin, dipyridamole, and phenprocoumon (medicines used as blood thinners, so-called anticoagulants). Your doctor will likely monitor your blood clotting time at the start and end of treatment with Escitalopram Aurobindo to ensure your anticoagulant dose remains appropriate.
Mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used for severe pain) due to a possible risk of lowered seizure threshold.
Neuroleptics (medicines for the treatment of schizophrenia, psychosis), due to a possible risk of lowered seizure threshold and antidepressants.
Flecainide, propafenone, and metoprolol (used in cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). Dose adjustment of Escitalopram Aurobindo may be necessary.
Medicines that reduce potassium or magnesium levels in the blood, as these conditions increase the risk of life-threatening heart rhythm disorders.
Do not take Escitalopram Aurobindo if you are taking medicines for heart rhythm disorders 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), certain antihistamines (astemizole, mizolastine). If you have further doubts, contact your doctor.

Escitalopram Aurobindo with food, drinks, and alcohol
Escitalopram Aurobindo can be taken with or without food (see section 3 “How to take Escitalopram Aurobindo”).
As with many medicines, it is not advisable to combine Escitalopram Aurobindo with alcohol, although no interactions between Escitalopram Aurobindo and alcohol are expected.

Pregnancy, breastfeeding, and fertility
Inform your doctor if you are pregnant or planning a pregnancy. Do not take Escitalopram Aurobindo if you are pregnant or breastfeeding, unless you have already discussed the associated risks and benefits with your doctor.
If you take Escitalopram Aurobindo 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, rigid or floppy muscles, overactive reflexes, tremors, nervousness, irritability, lethargy, constant crying, drowsiness, and sleep difficulties. 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 Aurobindo.
When taken during pregnancy, particularly in the last trimester, medicines such as Escitalopram Aurobindo 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 Aurobindo must never be stopped abruptly.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor for advice before taking this medicine.
Animal studies have shown that citalopram, a medicine similar to escitalopram, reduces sperm quality. This could theoretically affect fertility, but to date no impact on fertility has been observed in men.

Driving and using machines
It is advisable not to drive or operate machinery until you know how Escitalopram Aurobindo affects you.

3 How to take Escitalopram Aurobindo
Take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you. If you have any doubts, consult your doctor or pharmacist.

Adults
Depression
The recommended dose of Escitalopram Aurobindo is 10 mg as a single daily dose. Your doctor may increase the dose to a maximum of 20 mg per day.

Panic disorder
The initial dose of Escitalopram Aurobindo is 5 mg per day for the first week, before increasing to 10 mg per day. The dose may be further increased by your doctor up to a maximum of 20 mg per day.

Social anxiety disorder
The usual recommended dose of Escitalopram Aurobindo is 10 mg as a single daily dose. Your doctor may reduce the dose to 5 mg per day or increase it up to a maximum of 20 mg per day, depending on your response to the medicine.

Generalised anxiety disorder
The usual recommended dose of Escitalopram Aurobindo is 10 mg as a single daily dose. The dose may be increased by your doctor up to a maximum of 20 mg per day.

Obsessive-compulsive disorder
The recommended dose of Escitalopram Aurobindo is 10 mg as a single daily dose. The dose may be increased by your doctor up to a maximum of 20 mg per day.

Elderly patients (over 65 years of age)
The recommended starting dose of Escitalopram Aurobindo is 5 mg as a single daily dose. The dose may be increased by your doctor to 10 mg per day.

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

You may take Escitalopram Aurobindo with or without food. Swallow the tablet with some water. Do not chew it, as it has a bitter taste.

Escitalopram Aurobindo 10 mg and 20 mg film-coated tablets: if necessary, you may divide the tablets by first placing the tablet on a flat surface with the score line facing upwards. The tablets can then be broken by pressing on each end of the tablet using both index fingers as shown in the figure.

Duration of treatment
It may take a few weeks before you start to feel better. Continue taking Escitalopram Aurobindo even if you need to wait some time before noticing improvement in your condition.
Do not change the dose of your medicine without first discussing it with your doctor.
Continue taking Escitalopram Aurobindo for the entire duration recommended by your doctor. 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 Aurobindo than you should
If you take a dose of Escitalopram Aurobindo higher 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, decreased blood pressure, and disturbances in fluid and electrolyte balance. Take the box of Escitalopram Aurobindo with you when you go to the doctor or hospital.

If you forget to take Escitalopram Aurobindo
Do not take a double dose to make up for the forgotten dose. If you forget to take a dose and remember before going to bed, take it 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 regular schedule.

If you stop taking Escitalopram Aurobindo
Do not stop taking Escitalopram Aurobindo until your doctor tells you to do so.
Once the treatment course is completed, it is generally recommended to gradually reduce the dose of Escitalopram Aurobindo over several weeks.
When stopping Escitalopram Aurobindo, especially abruptly, you may experience withdrawal symptoms. These symptoms are common when stopping treatment with Escitalopram Aurobindo. The risk is higher if Escitalopram Aurobindo has been used for a long time, at high doses, or if the dose is reduced too quickly. Most people find that symptoms are mild and disappear 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 Aurobindo, contact your doctor. Your doctor may advise you to restart the tablets and then stop treatment more gradually.
Withdrawal symptoms include: dizziness (unstable or unsteady balance), tingling sensations, burning sensations, and (less commonly) electric shock-like sensations, including in the head, sleep disturbances (vivid dreams, nightmares, inability to sleep), anxiety, headache, malaise (nausea), sweating (including night sweats), restlessness or agitation, tremor, confusion or disorientation, emotional lability or irritability, diarrhoea (loose stools), visual disturbances, and palpitations (pounding or racing heartbeat).

If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Side effects generally disappear after a few weeks of treatment. However, please note that many of these side effects may also be symptoms of your underlying illness, which will therefore improve as you start feeling better.
Contact your doctor if you experience any of the following side effects during treatment:
Uncommon (affects 1 to 10 users in 1,000):
Unusual bleeding, including gastrointestinal bleeding

Rare (affects 1 to 10 users in 10,000):
If you notice swelling of the skin, tongue, lips, or face, or have difficulty breathing or swallowing (allergic reaction), contact your doctor immediately or go to hospital.
If you have high fever, agitation, confusion, tremor, and sudden muscle contractions, these may be signs of a condition known as serotonin syndrome. If you feel this way, contact your doctor.

If you experience any of the following side effects, contact your doctor immediately or go to hospital:
Difficulty urinating
Seizures (convulsions); see also section “Warnings and precautions”
Yellowing of the skin and whites of the eyes, which are signs of impaired liver function/hepatitis
Rapid or irregular heartbeat, feeling faint—these may be symptoms of a life-threatening condition known as Torsades de Pointes

The following side effects have also been reported in addition to those listed above:
Very common (affects more than 1 user in 10):
Feeling unwell (nausea)
Headache

Common (affects 1 to 10 users in 100):
Stuffed or runny nose (sinusitis)
Increased or decreased appetite
Anxiety, restlessness, abnormal dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremor, tingling sensations on the skin
Diarrhoea, constipation, vomiting, dry mouth
Increased sweating
Pain in muscles and joints (arthralgia and myalgia)
Sexual disorders (delayed ejaculation, erection problems, decreased sexual desire; women may experience difficulty achieving orgasm)
Fatigue, fever
Weight gain

Uncommon (affects 1 to 10 users in 1,000):
Hives, skin rash, itching
Teeth grinding, agitation, nervousness, panic attack, confusion
Sleep disturbances, altered taste, fainting (syncope)
Dilated pupils (mydriasis), visual disturbances, ringing in the ears (tinnitus)
Hair loss
Vaginal bleeding
Weight loss
Increased heart rate
Swelling of arms or legs
Nosebleeds

Rare (affects 1 to 10 users in 10,000):
Aggression, depersonalization, hallucinations
Slowed heart rate

Some patients have reported the following (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 blood)
Movement disorders (involuntary muscle movements)
Painful erection (priapism)
Bleeding disorders, including bleeding of the skin and mucous membranes (bruising) and low platelet count (thrombocytopenia)
Sudden swelling of the skin and mucous membranes (angioedema)
Increased urine output (inappropriate antidiuretic hormone 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.
Changes in heart rhythm (known as “QT interval prolongation,” detectable on an ECG, which records the heart's electrical activity)

Additionally, there are side effects associated with medicines that act similarly to escitalopram (the active substance in Escitalopram Aurobindo), such as:
Motor restlessness (akathisia)
Anorexia

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

5. How to store Escitalopram Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 Aurobindo contains
Each film-coated tablet contains 10 mg of escitalopram (as oxalate).
Each film-coated tablet contains 20 mg of escitalopram (as oxalate).
The excipients are:
Tablet core: Silicified microcrystalline cellulose, Butylhydroxytoluene (E321),
Butylhydroxyanisole (E320), Sodium croscarmellose, Microcrystalline cellulose, Anhydrous colloidal silica, Talc, Magnesium stearate.
Coating: Hypromellose, Macrogol 400, Titanium dioxide (E171).

Description of the appearance of Escitalopram Aurobindo and package contents
Escitalopram Aurobindo 10 mg film-coated tablets:
White to off-white, oval-shaped, film-coated, biconvex tablets, marked with 'F' on one side and '54' on the other side, with a deep score line between '5' and '4'. Size: 8.1 mm x 5.6 mm.
Escitalopram Aurobindo 20 mg film-coated tablets:
White to off-white, oval-shaped, film-coated, biconvex tablets, marked with 'F' on one side and '56' on the other side, with a deep score line between '5' and '6'. Size: 11.6 mm x 7.1 mm.
The 10 mg and 20 mg tablets can be divided into equal doses.

Pack sizes:
PVC/Aclar-aluminum blisters: 14, 20, 28, 50, 56, 100 and 500 tablets.
HDPE bottles: 30 and 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l.
Vicolo San Giovanni sul Muro, 9
20121 Milano
Italy

Responsible manufacturers for batch release
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000, Malta
Milpharm Limited
Ares Block, Odyssey Business Park, West End Road, South Ruislip HA46QD, United Kingdom

This medicinal product is authorized in the European Economic Area countries under the following names:
France ESCITALOPRAM AUROBINDO 5 mg comprimé pelliculé
ESCITALOPRAM AUROBINDO 10 mg/15 mg/20 mg, comprimé pelliculé sécable
Germany Escitalopram Aurobindo 10 mg/20 mg Filmtabletten
Italy Escitalopram Aurobindo
Malta Escitalopram 5 mg/10 mg/15 mg/20 mg film-coated tablets
Netherlands Escitalopram Aurobindo 10 mg/15 mg/20 mg, filmomhulde tabletten
Portugal Escitalopram Orua
Romania Escitalopram Aurobindo 10 mg comprimate filmate
Spain Escitalopram Aurobindo 10 mg/15 mg/20 mg comprimidos recubiertos con película EFG
United Kingdom Escitalopram 10 mg/20 mg film-coated tablets