Escitalopram Teva 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Escitalopram Teva 10 mg film-coated tablets EFG

Escitalopram

Read the entire 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Escitalopram Teva 10 mg film-coated tablets are and what they are used for

2. What you need to know before taking Escitalopram Teva 10 mg film-coated tablets

3. How to take Escitalopram Teva 10 mg film-coated tablets

4. Possible adverse effects

5. How to store Escitalopram Teva 10 mg film-coated tablets

6. Contents of the pack and other information

1. What Escitalopram Teva 10 mg film-coated tablets are and what they are used for

Escitalopram Teva contains escitalopram and is indicated for the treatment of 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).

Escitalopram belongs to a group of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). These medicines act on the serotonin system in the brain by increasing the level of serotonin. Disturbances in the serotonin system are considered an important factor in the development of depression and related conditions.

2. What you need to know before starting to take Escitalopram Teva 10 mg film-coated tablets

Do not take Escitalopram Teva if:

• you are allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6);
• you are taking or have taken within the last 14 days a medicine called a monoamine oxidase inhibitor (MAOI), such as phenelzine, isocarboxazid, or selegiline;
• you are taking pimozide (a medicine used to treat certain mental/mood disorders).

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

• you have ever had an allergic reaction to any medicine;
• you have or have had epilepsy or seizures;
• you have or have had liver or kidney problems;
• you have or have had heart problems;
• you have low sodium levels in your blood;
• you have or have had bleeding disorders or are taking medicines that increase the risk of bleeding (e.g. acetylsalicylic acid, NSAIDs, warfarin);
• you have or have had mania or hypomania (periods of abnormally high mood);
• you have or have had suicidal thoughts or actions, or if you have a history of depression;
• you are being treated with other antidepressants or medicines that may affect the brain (e.g. triptans, tramadol, tryptophan, St. John’s wort);
• you have diabetes;
• you have glaucoma (increased pressure in the eye);
• you are elderly (over 65 years old), as you may be more sensitive to side effects, especially low sodium levels;
• you are under 18 years of age, as Escitalopram Teva is not recommended for children and adolescents under 18.

Children and adolescents under 18 years of age Escitalopram should not be given to children and adolescents under 18 years of age. Its use in this age group is not recommended because of an increased risk of side effects such as suicidal behavior, hostility (mainly aggression, oppositional behavior, and anger), and emotional instability.

Other medicines and Escitalopram Teva Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, tell your doctor if you are taking:

• medicines for depression (e.g. SSRIs, SNRIs, tricyclic antidepressants, MAOIs);
• medicines for psychosis or mania (e.g. antipsychotics, lithium, valproate);
• medicines that affect heart rhythm (e.g. QT-prolonging drugs such as antiarrhythmics, antipsychotics, certain antibiotics);
• NSAIDs (non-steroidal anti-inflammatory drugs) or acetylsalicylic acid (aspirin), which may increase the risk of bleeding;
• cimetidine, which may increase escitalopram levels in the blood;
• omeprazole, which may increase escitalopram levels;
• medicines metabolized by the liver enzyme CYP2C19 or CYP3A4;
• St. John’s wort (Hypericum perforatum), which may increase side effects;
• triptans used for migraine;
• tramadol or other opioids;
• tryptophan;
• alcohol.

Alcohol Avoid drinking alcohol while taking Escitalopram Teva, as it may increase the sedative effects of the medicine.

Pregnancy, breastfeeding and fertility If you are pregnant, think you may be pregnant, or are planning to become pregnant, talk to your doctor before taking this medicine. Escitalopram may affect pregnancy and the newborn. If you take escitalopram during the last trimester (last 3 months of pregnancy), the baby may have symptoms such as tremors, breathing problems, blue skin, seizures, irritability, difficulty feeding, vomiting, low blood sugar, or muscle stiffness. These symptoms may be due to either toxicity or withdrawal.

Tell your doctor if you are breastfeeding. Escitalopram passes into breast milk and may affect the breastfed infant.

Driving and using machines Escitalopram may affect your ability to drive or operate machinery. You may feel drowsy, dizzy, or have blurred vision. Do not drive or operate machinery until you know how this medicine affects you.

Do not take Escitalopram Teva 10 mg tablets:

-If you are allergic (hypersensitive) to escitalopram or to any of the other components of this medicine (listed in section 6).

-If you are taking other medicines belonging to the group known as MAO inhibitors, including selegiline (used for the treatment of Parkinson's disease), moclobemide (used for the treatment of depression), and linezolid (an antibiotic)

• If you have a congenital heart rhythm disorder or have ever experienced an episode of this type (this can be detected by an electrocardiogram, a test used to assess heart function).
• If you are taking medications for heart rhythm disorders or medicines that may affect heart rhythm (see section 2 “Other medicines and Escitalopram Teva”)

Warnings and precautions

Consult your doctor or pharmacist before starting to take Escitalopram Teva. Specifically, inform your doctor:

• If you have epilepsy. Your doctor may need to adjust your dose. Treatment with Escitalopram Teva should be discontinued if seizures occur or if you notice an increase in seizure frequency (see also section 4 “Possible side effects”).
• If you have hepatic or renal impairment. Your doctor may need to adjust your dose.
• If you have diabetes. Treatment with Escitalopram Teva may alter glycaemic control. A dose adjustment of insulin and/or oral hypoglycaemic agents may be necessary.
• If you have low sodium levels in the blood.
• If you tend to bleed easily or develop bruises, or if you are pregnant (see “Pregnancy, breastfeeding and fertility”).
• If you are receiving electroconvulsive therapy.
• If you have coronary artery disease.
• If you have or have had heart problems or have recently suffered a heart attack.
• If your heart beats slowly at rest (known as bradycardia) and/or if you think your body may be losing salts, for example due to severe diarrhoea and vomiting over several days or due to the use of diuretics (medicines to increase urine production).
• If you have noticed rapid or irregular heartbeats, or have experienced fainting or dizziness when standing up from a sitting or lying position. This could indicate a heart rhythm disorder.

Please note:

Some patients with bipolar disorder may enter a manic phase. This is characterized by unusually rapid and frequent changes of thought, excessive happiness, and excessive physical activity. If you experience this, contact your doctor.

Symptoms such as restlessness or difficulty sitting or standing still may also occur during the first weeks of treatment. Inform your doctor immediately if you experience these symptoms.

Some medicines in the same group as Escitalopram Teva (called SSRIs/SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

Suicidal thoughts and worsening of depression or anxiety disorder

If you are depressed and/or suffer from an anxiety disorder, you may occasionally have thoughts of harming or killing yourself. These thoughts may increase when starting antidepressants, as all such medicines require time to take effect, usually about two weeks, although in some cases it may take longer. You are more likely to have such thoughts:

• If you have previously had thoughts of killing or harming yourself.
• If you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in psychiatric patients under 25 years of age treated with an antidepressant.

If at any time you have thoughts of harming or killing yourself, contact your doctor or go directly to a hospital.

It may be helpful for you to tell a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You may ask them whether they think your depression or anxiety disorder has worsened, or if they are concerned about changes in your behaviour.

Children and adolescents

Escitalopram should not normally be used in the treatment of children and adolescents under 18 years of age. Also, you should know that in patients under 18 years of age there is an increased risk of adverse effects such as suicide attempts, suicidal ideation, and hostility (mainly aggression, confrontational behaviour, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe escitalopram to patients under 18 years of age if they decide it is the most appropriate treatment. If your doctor has prescribed escitalopram to a patient under 18 years of age and you wish to discuss this decision, please return to your doctor. You must inform your doctor if any of the previously described symptoms worsen or complications arise while patients under 18 years of age are taking escitalopram. In addition, the long-term effects on safety and on growth, maturation, and cognitive and behavioural development of escitalopram in this age group have not yet been established.

An increased risk of bone fractures has been observed in patients treated with this type of medicine.

Closed-angle glaucoma

SSRIs, including escitalopram, may affect pupil size, causing mydriasis (pupil dilation). This mydriatic effect may narrow the eye angle, potentially increasing intraocular pressure and leading to closed-angle glaucoma, especially in predisposed patients. Therefore, escitalopram should be used with caution in patients with closed-angle glaucoma or a history of glaucoma.

Other medicines and Escitalopram Teva

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to 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, isocarboxazid, nialamide, or tranylcypromine as active ingredients, used to treat depression. If you have taken any of these medicines, you must wait 14 days before starting escitalopram. After stopping escitalopram, 7 days must pass 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 in the treatment of Parkinson’s disease). These increase the risk of side effects.
• Tryptophan (a dietary supplement that is converted into serotonin during metabolism).
• Other antidepressants, including other SSRIs such as clomipramine, nortriptyline, desipramine, and imipramine.
• Medicines called triptans, such as sumatriptan (used for migraine) and tramadol (used for severe pain). These increase the risk of side effects.
• Medicines such as lithium, risperidone, thioridazine, or haloperidol used in the treatment of psychiatric disorders.
• Acetylsalicylic acid (aspirin), ibuprofen, or other medicines known as NSAIDs (non-steroidal anti-inflammatory drugs) used for pain and inflammation relief.
• Neuroleptics (medicines for the treatment of schizophrenia, psychosis) and other antidepressants, due to the possible risk of lowering the seizure threshold.
• Mefloquine (used for the treatment of malaria), bupropion (used to help quit smoking), due to the possible risk of lowering the seizure threshold.
• St. John’s wort (Hypericum perforatum) – a herbal remedy used for depression.
• Warfarin, dipyridamole, and phenprocoumon (medicines used to reduce the risk of thrombosis, also known as anticoagulants). Your doctor will likely monitor your blood clotting time at the beginning and end of treatment with Escitalopram Teva to ensure the anticoagulant dose remains appropriate.
• Cimetidine, omeprazole, and lansoprazole (used for the treatment of stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (an antidepressant), ticlopidine (used to reduce the risk of stroke). These may increase blood concentrations of Escitalopram Teva.
• Flecainide, propafenone, and medicines used to treat irregular heartbeat.
• Medicines that induce hypokalaemia / hypomagnesaemia.

Caution should be exercised when using concomitant products that may induce cardiac problems.

• Serotonergic medicines, such as buprenorphine, as they may increase the risk of serotonin syndrome.

Do not take Escitalopram Teva if you are taking medicines for 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 (sparfloxacin, moxifloxacin, IV erythromycin, pentamidine, antimalarials particularly halofantrine), or certain antihistamines (astemizole, mizolastine).

If you have any doubts about this, consult your doctor.

Taking Escitalopram Teva 10 mg tablets with food and drink

Escitalopram tablets can be taken with or without food.

As with many medicines, the combination of escitalopram and alcohol is not recommended, although an interaction between escitalopram and alcohol is not expected.

Pregnancy, breastfeeding and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take escitalopram if you are pregnant unless you and your doctor have discussed the risks and benefits involved.

If you take escitalopram during the last three months of pregnancy, the newborn baby may experience the following effects: breathing difficulties, bluish skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or floppiness, exaggerated reflexes, tremors, restlessness, irritability, lethargy, constant crying, drowsiness, and sleep difficulties. If your newborn baby shows any of these symptoms, please contact your doctor immediately.

If you take Escitalopram Teva in late pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should be aware that you are taking escitalopram so they can advise you appropriately.

If Escitalopram Teva is used during pregnancy, it must never be stopped abruptly.

Ensure that your midwife and/or doctor knows that you are taking Escitalopram Teva.

Medicines such as Escitalopram Teva, when taken during pregnancy, particularly during the last three months, may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear blue. These symptoms usually begin within the first 24 hours after birth. If this occurs in your baby, contact your midwife and/or doctor immediately.

Do not take Escitalopram Teva while breastfeeding unless you and your doctor have discussed the benefits and risks involved.

Citalopram, a medicine similar to escitalopram, has shown in animal studies to reduce sperm quality. This could theoretically affect fertility, but no impact on human fertility has been observed to date.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

It is advised not to drive or operate machinery until you know how escitalopram treatment affects you. This medicine may cause dizziness, fatigue, confusion, or hallucinations (strange visions or sounds). If you experience any of these side effects, you should not drive or operate machinery.

Escitalopram Teva contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Escitalopram Teva 10 mg film-coated tablets

Follow exactly the instructions for use of this medicine as given by your doctor. In case of doubt, consult your doctor or pharmacist again.

Adults

Depression

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

Panic disorder

The initial dose of Escitalopram Teva is 5 mg as a single daily dose for the first week before increasing the dose to 10 mg per day. Your doctor may subsequently increase it up to a maximum of 20 mg per day.

Social anxiety disorder

The normally recommended dose of Escitalopram Teva is 10 mg taken as a single daily dose. Your doctor may reduce your dose to 5 mg per day or increase the dose up to a maximum of 20 mg per day, depending on how you respond to the medication.

Generalized anxiety disorder

The normally recommended dose of Escitalopram Teva is 10 mg taken 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 normally recommended dose of Escitalopram Teva is 10 mg taken as a single daily dose. The dose may be increased by your doctor up to a maximum of 20 mg per day.

Elderly patients

It is recommended to start with a dose of Escitalopram Teva of 5 mg per day. If necessary, your doctor may increase this dose up to a maximum of 10 mg per day.

Use in children and adolescents

Escitalopram Teva must not be used in the treatment of children and adolescents under 18 years of age. For further information, see section 2 "Before taking Escitalopram Teva".

You may take Escitalopram Teva with or without food. Swallow the tablets with water. Do not chew them.

If necessary, you may split the tablets in half to help swallowing, by placing them on a flat surface with the score facing upwards. The tablets can be broken by pressing down on each end of the tablet with your index fingers.

Duration of treatment

It may take a few weeks before you start to feel better. Continue treatment even if you start to feel better before the expected time.

Do not change the dose of the medicine without first talking to your doctor.

If you take more Escitalopram Teva 10 mg tablets than you should

If you take more doses of Escitalopram Teva than prescribed, contact your doctor immediately, go to the nearest hospital emergency department, or contact the Toxicology Information Service at telephone number 91 562 04 20. Do this even if you do not observe any discomfort or signs of poisoning. Some of the signs of overdose may include dizziness, tremor, agitation, seizures, coma, nausea, vomiting, changes in heart rate, decreased blood pressure, and disturbances in the body's fluid and electrolyte balance. Take the Escitalopram Teva packaging with you if you go to the doctor or hospital.

If you forget to take Escitalopram Teva 10 mg tablets

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

If you stop taking Escitalopram Teva 10 mg tablets

Do not stop treatment with Escitalopram Teva until your doctor tells you to. When you have completed your course of treatment, it is generally recommended that the dose of Escitalopram Teva be gradually reduced over several weeks.

When you stop taking Escitalopram Teva, especially if abruptly, you may experience withdrawal symptoms. These are common when treatment with Escitalopram Teva is discontinued. The risk is higher when Escitalopram Teva has been used for a long time, at high doses, or when the dose is reduced too quickly. Most people find that these symptoms are mild and resolve on their own within two weeks. However, in some patients, they may be severe or prolonged (2-3 months or more). If you experience severe withdrawal symptoms when stopping escitalopram, contact your doctor. They may advise you to resume taking your tablets and taper off more slowly.

Withdrawal symptoms include: dizziness (feeling unsteady or off balance), tingling sensations, burning sensations, and (less frequently) electric shock-like sensations, even in the head; sleep disturbances (vivid dreams, nightmares, inability to sleep); restlessness; headache; dizziness (nausea); sweating (including night sweats); feelings of anxiety or agitation; tremor (shakiness); feelings of confusion or disorientation; feelings of emotional distress or irritability; diarrhea (loose stools); visual disturbances; rapid pulse or palpitations.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Escitalopram Teva 10 mg can cause adverse effects, although not everyone will experience them.

The adverse effects are generally mild and usually disappear after a few weeks of treatment. Please be aware that many of these effects may be symptoms of your illness and will therefore improve as you start to feel better.

Visit your doctor if you experience any of the following adverse effects during treatment:

Uncommon (affects at least 1 in 1,000 patients):

• Unusual bleeding, including gastrointestinal bleeding.

Rare (affects at least 1 in 10,000 patients):

• If you notice swelling of the skin, tongue, lips or face, or have difficulty breathing or swallowing (allergic reaction), contact your doctor or go to hospital immediately.
• If you develop high fever, agitation, confusion, tremors, and sudden muscle contractions, these may be signs of a rare condition called serotonin syndrome. If you feel like this, contact your doctor.

If you experience any of the following adverse effects, you must contact your doctor or go to hospital immediately:

• Difficulty urinating.
• Seizures (fits), see also section “Take special care with Escitalopram Teva 10 mg tablets”).
• Yellowing of the skin and whites of the eyes, signs of liver dysfunction/hepatitis.
• Rapid or irregular heartbeat or feeling faint, as these could be symptoms of a serious heart problem known as torsade de pointes.

In addition to the above, the following adverse effects have been reported:

Very common (affects at least 1 in 10 patients):

• Feeling dizzy (nausea)
• Headache

Common (affects at least 1 in 100 patients):

• Stuffy or runny nose (sinusitis).
• Decreased or increased appetite.
• Anxiety, restlessness, abnormal dreams, difficulty falling asleep, feeling sleepy, dizziness, yawning, tremors, skin itching.
• Diarrhea, constipation, vomiting, dry mouth.
• Increased sweating.
• Muscle and joint pain (arthralgia and myalgia).
• Sexual disturbances (in men, delayed ejaculation, problems with erection, decreased sexual activity; women may experience difficulty reaching orgasm).
• Fatigue, fever.
• Weight gain

Uncommon (affects at least 1 in 1,000 patients):

• Hives, skin rash, itching (pruritus).
• Teeth grinding, restlessness, nervousness, panic attacks, confusion, fainting (syncope).
• Sleep disturbances, taste disturbances, dizziness.
• Pupil dilation (mydriasis), visual disturbances, ringing in the ears (tinnitus).
• Hair loss
• Vaginal bleeding
• Weight loss
• Rapid heartbeat
• Swelling of arms and legs
• Nosebleeds

Rare (affects at least 1 in 10,000 patients):

• Aggression, depersonalization, hallucinations.
• Slow heart rate

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

• Thoughts of harming yourself or thoughts of killing yourself, see also section “Take special care with escitalopram”.
• Decreased sodium levels in the blood (symptoms include dizziness and feeling unwell with muscle weakness or confusion).
• Dizziness upon standing due to low blood pressure (orthostatic hypotension).
• Abnormal liver function tests (increased liver enzymes in the blood).
• Movement disorders (involuntary muscle movements).
• Painful erections (priapism).
• Bleeding disorders including skin and mucous membrane bleeding (ecchymosis) and low platelet levels in the blood (thrombocytopenia).
• Sudden swelling of skin or mucous membranes (angioedema).
• Increased amount of urine excreted (inappropriate ADH secretion).
• Milk flow in women who are not breastfeeding.
• Mania
• Changes in heart rhythm (called QT interval prolongation, observed on electrocardiogram).
• Heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage), see “Pregnancy and breastfeeding” in section 2 for more information.

Other adverse effects are known to occur with drugs that act similarly to escitalopram. These include:

• Motor restlessness (akathisia).
• Anorexia

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects:

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Escitalopram Teva 10 mg film-coated tablets

Keep out of the sight and reach of children.

Store below 30°C. Keep in the original packaging to protect from light and moisture.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of packaging and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Escitalopram Teva 10 mg film-coated tablets

• The active substance is escitalopram (as oxalate). Each tablet contains 12.78 mg of escitalopram (as oxalate).
• The other components are: microcrystalline cellulose, anhydrous colloidal silica, sodium croscarmellose, stearic acid, magnesium stearate, hypromellose (E464), titanium dioxide (E171) and macrogol 400.

Appearance of the product and contents of the container

Escitalopram Teva 10 mg are film-coated tablets, round, biconvex, white in colour, marked with a "10" on one side and scored on the other.

Escitalopram Teva 10 mg film-coated tablets are available in packs containing 28 and 56 tablets.

Marketing Authorisation Holder and Manufacturer

Holder:

Teva Pharma, S.L.U.

Anabel Segura 11. Edificio Albatros B.

28108 Alcobendas. Madrid

Spain

Manufacturer:

Teva Operations Poland Sp. z.o.o.

Ul. Mogilska 80

31-546 Kraków

Poland

Date of the most recent revision of this package leaflet: November 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/