Escitalopram Teva

Patient Information Leaflet

Escitalopram Teva 5 mg film-coated tablets, 10 mg film-coated tablets, 15 mg film-coated tablets, 20 mg film-coated tablets

Generic medicine
Please read this 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 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What escitalopram Teva is and what it is used for

Escitalopram Teva contains the active substance escitalopram. Escitalopram Teva 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. Disorders of the
serotonin system are considered an important factor in the development of depression and related
conditions.
Escitalopram Teva 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).
It may take a couple of weeks before you start to feel better. Continue taking Escitalopram Teva even if it
takes some time before you notice an improvement in your condition.
Speak to your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Escitalopram Teva

Do not take Escitalopram Teva

• 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 a group called MAO inhibitors, including selegiline (used for the treatment of Parkinson’s disease), moclobemide (used for the treatment of depression), or linezolid (an antibiotic).
• If you were born with or have experienced an episode of abnormal heart rhythm (detectable via electrocardiogram (ECG), a test to assess heart function).
• If you are taking medicines for heart rhythm problems or that may affect heart rhythm (see section 2 “Other medicines and Escitalopram Teva”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Escitalopram Teva.
Inform your doctor if you have 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 Teva should be discontinued if seizures occur for the first time or if the frequency of epileptic seizures increases (see also section 4 “Possible side effects”);
• if your liver or kidney function is impaired. Your doctor may adjust the dosage of the medicine;
• if you have diabetes. Treatment with Escitalopram Teva may alter glycaemic control. It may be necessary to adjust the dose of insulin and/or oral hypoglycaemic agents;
• if your blood sodium level is low;
• if you have a tendency to bleed or bruise easily, or if you are pregnant (see section “Pregnancy, breastfeeding and fertility”);
• if you are undergoing electroconvulsive therapy;
• if you have coronary heart disease;
• if you suffer or have suffered from heart problems or have recently had a heart attack;
• if you have a slow resting heart rate and/or if you think your body may have experienced a significant loss of salt due to prolonged and severe episodes of diarrhoea and vomiting or due to the use of diuretics (water tablets);
• if you experience a fast or irregular heartbeat, fainting, collapse, or dizziness upon standing, which may indicate an irregular heart rhythm;
• if you suffer or have suffered from eye problems, such as certain types of glaucoma (increased eye pressure).

Warning
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 such symptoms, contact your doctor.
Symptoms such as restlessness or difficulty sitting still or standing still may also occur during the first weeks of treatment. Inform your doctor immediately if you notice these symptoms.
Medicines such as Escitalopram Teva (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 may persist after discontinuation of treatment.
Suicidal thoughts and worsening of depression or anxiety disorder
If you are depressed and/or suffer from anxiety disorders, you may occasionally feel the urge to harm yourself or even commit suicide. These thoughts may increase at the beginning of treatment with antidepressants, as these medicines require time to take effect, usually about two weeks but sometimes longer.
You may be more likely to have these thoughts if:

• you have previously expressed suicidal thoughts or intentions to harm yourself;
• you are a young adult. Data from clinical studies have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders treated with an antidepressant.

If you have thoughts of self-harm or suicide at any time, contact your doctor immediately or go straight to the nearest hospital.
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 ask them to alert you if they believe your depression or anxiety is worsening, or if they are concerned about any changes in your behaviour.
Children and adolescents
Escitalopram Teva should not normally be used in children and adolescents under 18 years of age. Furthermore, you should know that patients under 18 years of age have a higher risk of experiencing side effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggressive behaviour, oppositional behaviour, and anger) when taking this class of medicines. However, your doctor may still prescribe Escitalopram Teva to patients under 18 years of age if they consider it the best option in that particular case. If your doctor has prescribed Escitalopram Teva to a patient under 18 years of age and you wish to discuss this, please speak to your doctor again. You must inform the doctor if any of the above-mentioned symptoms appear or worsen while the patient under 18 years of age is taking Escitalopram Teva. In addition, the long-term safety of Escitalopram Teva with regard to growth, maturation, and cognitive and behavioural development in this age group has not yet been established.
Other medicines and Escitalopram Teva
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, or tranilcypramine as active ingredients. If you have taken any of these medicines, you must wait 14 days before starting Escitalopram Teva. After stopping Escitalopram Teva, 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 for the treatment of Parkinson’s disease). These medicines increase the risk of side effects.
• The antibiotic linezolid.
• Lithium (used for the treatment of bipolar disorder) and tryptophan.
• Imipramine and desipramine (both used to treat depression).
• Sumatriptan and similar medicines (used to treat migraine), tramadol, and buprenorphine (used for severe pain). These medicines increase the risk of side effects.
• Cimetidine, lansoprazole, omeprazole, and esomeprazole (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 cause an increase in escitalopram 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 thin the blood, so-called anticoagulants). These medicines may increase the tendency to bleed.
• Warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood, so-called anticoagulants). Your doctor will likely monitor your blood clotting time at the start and upon discontinuation of Escitalopram Teva treatment 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 the possible risk of lowering the seizure threshold.
• Neuroleptics (medicines for the treatment of schizophrenia, psychosis), and antidepressants (tricyclic antidepressants and SSRIs) due to the possible risk of lowering the seizure threshold.
• Flecainide, propafenone, and metoprolol (used in cardiovascular diseases), desipramine, clomipramine, and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). Adjustment of the Escitalopram Teva dosage may be necessary.
• Medicines that can reduce potassium or magnesium levels in the blood, as these conditions increase the risk – which can be life-threatening – of heart rhythm disturbances.

Do not take Escitalopram Teva if you are taking medicines for heart rhythm problems or 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 Teva with food, drinks, and alcohol
Escitalopram Teva can be taken regardless of meals (see section 3 “How to take Escitalopram Teva”).
As with many medicines, it is not recommended to combine Escitalopram Teva with alcohol, although no interactions between Escitalopram Teva and alcohol are expected.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. Do not take Escitalopram Teva if you are pregnant or breastfeeding, unless you have already discussed the associated risks and benefits with your doctor.
If you take Escitalopram Teva during the last three 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, stiff or floppy muscles, overactive reflexes, tremors, 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 Teva.
When taken during pregnancy, particularly in the last trimester, medicines such as Escitalopram Teva may increase the risk of a serious condition in the newborn 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 birth. If this occurs in your baby, contact your midwife and/or doctor immediately.
If used during pregnancy, Escitalopram Teva should never be stopped abruptly.
If you take Escitalopram Teva 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 Teva so they can advise you on what to do.
Escitalopram is expected to be excreted in breast milk.
Animal studies have shown that citalopram, a medicine similar to escitalopram, reduces sperm quality. This could theoretically affect fertility, but no impact on human fertility has been observed to date.
Driving and using machines
It is recommended not to drive or operate machinery until you know how Escitalopram Teva affects you.
Escitalopram Teva contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e., it is essentially “sodium-free”.

3. How to take Escitalopram Teva

Take this medicine exactly as prescribed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

Adults

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

Panic disorder
The starting dose of Escitalopram Teva is 5 mg taken as a single daily dose for the first week, then increased to 10 mg per day. Your doctor may further increase the dose up to a maximum of 20 mg per day.

Social anxiety disorder
The usual recommended dose of Escitalopram Teva is 10 mg taken 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 Teva is 10 mg taken as a single daily dose. Your doctor may increase the dose up to a maximum of 20 mg per day.

Obsessive-compulsive disorder
The usual recommended dose of Escitalopram Teva is 10 mg taken as a single daily dose. Your doctor may increase the dose up to a maximum of 20 mg per day.

Elderly (over 65 years of age)
The recommended starting dose of Escitalopram Teva is 5 mg taken as a single daily dose. Your doctor may increase the dose to 10 mg per day.

Use in children and adolescents
Escitalopram Teva should not normally be used in children and adolescents. For further information, see section 2 “What you need to know before taking Escitalopram Teva”.

Escitalopram Teva may be taken with or without food. Swallow the tablet with a glass of water. Do not chew the tablets, as they have a bitter taste.

Escitalopram Teva 10 mg + 20 mg film-coated tablets
If necessary, you may split the tablet by first placing it on a flat surface with the score line facing upwards. The tablet can then be broken by pressing downwards on both sides of the tablet using your index fingers, as shown in the illustration below.

Duration of treatment
It may take a few weeks before you start to feel better. Continue taking Escitalopram Teva even if you need to wait some time before noticing an improvement in your condition.
Do not change the dose of this medicine without first discussing it with your doctor.
Continue taking Escitalopram Teva 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 Teva than you should
If you have taken more Escitalopram Teva 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 the body's fluid and electrolyte balance. Take the pack/container of Escitalopram Teva with you when you go to the doctor or hospital.

If you forget to take Escitalopram Teva
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 the missed dose immediately and continue as usual the next day. If you only remember during the night or the following day, skip the missed dose and continue with your regular dosing schedule.

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

When you stop taking Escitalopram Teva, especially if abruptly, you may experience withdrawal symptoms. These symptoms are common when stopping treatment with Escitalopram Teva. The risk is greater if Escitalopram Teva has been taken for a long time or at high doses, or if the dose is reduced too quickly. Most people experience mild symptoms that resolve on their own within two weeks. However, in some patients, symptoms may be severe or prolonged (2–3 months or longer). If you experience severe withdrawal symptoms when stopping Escitalopram Teva, consult your doctor. Your doctor may advise you to restart the tablets and then discontinue treatment more gradually.

Withdrawal symptoms include: dizziness (a feeling of unsteadiness or instability), tingling sensations, burning sensations, and (less commonly) electric shock-like sensations, even in the head; sleep disturbances (vivid dreams, nightmares, inability to sleep); feeling anxious; headache; malaise (nausea) and/or vomiting; sweating (including night sweats); feeling restless or agitated; tremor; feeling confused or disoriented; emotional lability or irritability; diarrhoea (loose stools); visual disturbances; and palpitations (pounding or racing heartbeat).

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The side effects generally disappear after a few weeks of treatment. However, please consider that many of these side effects may also be symptoms of your illness, which will improve as the treatment takes effect and you start feeling better.
If you experience any of the following symptoms, contact your doctor or go to hospital immediately:
Uncommon (may affect up to 1 in 100 people)

• Unusual bleeding, including gastrointestinal bleeding.

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

• Swelling of the skin, tongue, lips, throat or face, hives or difficulty breathing or swallowing (severe allergic reaction).
• High fever, agitation, confusion, tremor and sudden muscle contractions, which could be symptoms of a rare condition known as serotonin syndrome.

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

• Difficulty urinating.
• Seizures (convulsions); see also section “Warnings and precautions”.
• Yellowing of the skin or whites of the eyes, which may be signs of impaired liver function/hepatitis.
• Fast and irregular heartbeat and fainting, which could be symptoms of a life-threatening condition known as Torsades de Pointes.
• Suicidal thoughts or self-harming thoughts; see also section “Warnings and precautions”.
• Sudden swelling of the skin or mucous membranes (angioedema).

The following side effects have also been reported in addition to those listed 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).
• Decreased or increased appetite.
• Anxiety, restlessness, abnormal dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremor, tingling sensations on the skin.
• Diarrhoea, constipation, vomiting, dry mouth.
• Increased sweating.
• Muscle and joint pain (arthralgia and myalgia).
• Sexual problems (delayed ejaculation, erection problems, decreased sexual desire; women may experience difficulty reaching orgasm).
• Fatigue, fever.
• Increase in body weight.

Uncommon (may affect up to 1 in 100 people)

• Hives, skin rash, itching.
• Teeth grinding, agitation, nervousness, panic attacks, confusion.
• Disturbed sleep, taste disturbances, fainting (syncope).
• Enlarged pupils (mydriasis), visual disturbances, ringing in the ears (tinnitus).
• Hair loss.
• Excessive menstrual bleeding.
• Irregular menstrual cycle.
• Decrease in body weight.
• Fast heartbeat.
• Swelling of arms or legs.
• Nosebleeds.

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

• Aggressive behaviour, depersonalisation, hallucinations.
• Slow heartbeat.

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

• Reduced levels of sodium in the blood (symptoms include feeling unwell, muscle weakness or confusion).
• Dizziness upon standing due to low blood pressure (orthostatic hypotension).
• Abnormalities in liver function tests (increased levels of liver enzymes in the blood).
• Movement disorders (involuntary muscle movements).
• Painful erection (priapism).
• Signs of abnormal bleeding, for example, under the skin or mucous membranes (bruising).
• Low platelet count (thrombocytopenia).
• Increased secretion of a hormone called ADH, which causes the body to retain water and dilute the blood, thereby reducing sodium levels (inappropriate ADH secretion).
• Milk production in men and women who are not breastfeeding.
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see section 2 “Pregnancy, breastfeeding and fertility” for further information.
• Mania.
• Changes in heart rhythm (known as “QT interval prolongation”, detectable on an ECG, a test that evaluates the heart's electrical activity).

In addition, there are side effects that occur with medicines that work in a similar way to escitalopram (the active substance in Escitalopram Teva), such as:

• Motor restlessness (akathisia).
• Loss of appetite.

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 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 Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, label, and carton after the abbreviation “Exp.”. The expiry date refers to the last day of that month.
Blister and bottle:
Do not store above 25°C.
Keep in the original packaging to protect the medicine from light and moisture.
Bottle:
After first opening, use within 100 days.
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 Teva contains
The active substance is escitalopram.
Each film-coated tablet contains 5 mg, 10 mg, 15 mg or 20 mg of escitalopram (as
oxalate).
The other components are:
Tablet core: microcrystalline cellulose, anhydrous colloidal silica, croscarmellose
sodium, stearic acid, magnesium stearate.
Tablet coating: hypromellose (E464), macrogol 400, titanium dioxide (E171).
Description of the appearance of Escitalopram Teva and pack contents
Escitalopram Teva 5 mg is a white, round, biconvex film-coated tablet, marked with "5" on one side and smooth on the other side.
Escitalopram Teva 10 mg is a white, round, biconvex film-coated tablet, marked with "10" on one side and a breakline on the other side. The tablet can be divided into equal doses.
Escitalopram Teva 15 mg is a white, round, biconvex film-coated tablet with a breakline on one side and an engraving of "S" on one side of the breakline and "C" on the other side. The opposite side of the tablet is engraved with "15".
The score line on the tablet is intended to facilitate breaking for easier swallowing and is not intended for dividing the tablet into equal doses.
Escitalopram Teva 20 mg is a white, round, biconvex film-coated tablet with a breakline on one side and an engraving of "9" on one side of the breakline and "3" on the other side. The opposite side of the tablet is engraved with "7463".
The tablet can be divided into equal doses.
Escitalopram Teva is available in packs containing blisters of 7, 10, 14, 20, 28, 30, 49, 50, 56, 60, 90, 98, 100, 112, 120, 200 and 500 film-coated tablets, and perforated unit dose blisters containing 49x1, 50x1, 100x1 and 500x1 film-coated tablets.
PVC/PVdC-Aluminium blisters are contained in cardboard packaging.
Escitalopram Teva is also available in plastic bottles containing 100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Italia S.r.l., Piazzale Luigi Cadorna, 4 - 20123 Milan, Italy
Manufacturers
TEVA Pharmaceutical Works Private Limited Company (TEVA Gyógyszergyár Zrt)
Pallagi út 13, 4042 Debrecen, Hungary
Pharmachemie B.V.
Swensweg 5, 2031 GA Haarlem, The Netherlands
Teva Operations Poland Sp.z.o.o.
ul. Mogilska 80, 31-546 Krakow, Poland
Merckle GmbH
Ludwig-Merckle-Strasse 3
89143 Blaubeuren, Germany
This medicinal product is authorised in the European Economic Area countries under the
following names: