Package Leaflet: Information for the User
Escitalopram Durban 20 mg Film-Coated Tablets EFG

Escitalopram

Read this leaflet carefully before you start taking this medicine because it contains important information for you

• Keep this leaflet, as 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 pass it on to others even if their symptoms are the same as yours. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Escitalopram Durban.

3. How to take Escitalopram Durban.

4. Possible side effects.

5. Storage of Escitalopram Durban.

6. Contents of the pack and additional information.

Escitalopram Durban contains the active ingredient escitalopram.

Escitalopram belongs to a group of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). These medications act on the serotonin system in the brain by increasing the level of serotonin.

Escitalopram 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).

You may notice an improvement in a couple of weeks. Continue taking escitalopram even if it takes time to notice some improvement.

You should consult a doctor if you get worse or do not improve.

Do not take Escitalopram Durban

• If you are allergic to escitalopram or any of the other components of this medication (listed in section 6).
• If you are taking other medications that belong to the group of monoamine oxidase inhibitors, including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic).
• If you have a history of or have experienced an episode of arrhythmia (detected on an ECG, a test that evaluates the heart's function).
• If you are taking medications for heart rhythm disorders or that can affect heart rhythm (see section 2 "Taking Escitalopram Durban with other medications").

Warnings and precautions

Consult your doctor or pharmacist before starting to take Escitalopram Durban.

Please inform your doctor if you have any other condition or disease, as your doctor may need to take it into account. In particular, inform your doctor:

• If you have epilepsy. Treatment with escitalopram should be interrupted if seizures occur simultaneously or if you observe an increase in seizure frequency (see also section 4 "Possible side effects").
• If you have liver or kidney insufficiency. Your doctor may need to adjust your dose.
• If you have diabetes. Treatment with escitalopram may alter blood sugar control. You may need to adjust your insulin and/or oral hypoglycemic medication dose.
• If you have low sodium levels in your blood.
• If you are prone to bleeding or bruising easily.
• If you are receiving electroconvulsive therapy.
• If you have coronary artery disease.
• If you have or have had heart problems or have recently had a heart attack.
• If your resting heart rate is slow and/or you know you may have low sodium levels due to severe and prolonged diarrhea and vomiting (being ill) or diuretic use.
• If you experience rapid or irregular heartbeats, dizziness, fainting, or lightheadedness when standing up, which may indicate abnormal heart rhythm.
• If you have or have had eye problems, such as certain types of glaucoma (increased eye pressure).
• If you have depression or other conditions treated with antidepressants.
• If you use these medications with buprenorphine; buprenorphine, naloxone, which may cause serotonin syndrome, a potentially life-threatening condition (see "Taking Escitalopram Durban with other medications").

Please note:

Some patients with manic-depressive illness may enter a manic phase. This is characterized by unusual and rapid changes in ideas, excessive joy, and excessive physical activity. If you experience this, contact your doctor.

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

Medicines like Escitalopram (also called ISRS/IRSN) may cause sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Thoughts of suicide and worsening of depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may occasionally have thoughts of harming yourself or committing suicide. These may increase when you first start taking antidepressants, as all these medications take time to start working, usually around two weeks, although in some cases it may take longer.

Youmay be more likely to have these thoughts:

• If you have previously had thoughts of harming yourself or committing suicide.

• If you are ayoung adult. Information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years old with psychiatric illnesses who were treated with an antidepressant.

If you ever have thoughts of harming yourself or committing suicide,contact your doctor or go directly to a hospital.

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

Children and adolescents

Escitalopram Durban should not be used for the treatment of children and adolescents under 18 years old. Also, be aware that in patients under 18 years old, there is a higher risk of adverse effects such as suicidal behavior, suicidal thoughts, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this type of medication. However, your doctor may prescribe escitalopram to patients under 18 years old if they decide it is the best option for the patient. If the doctor who prescribed escitalopram to you wants to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms described above progress or if you experience complications when patients under 18 years old are taking escitalopram. Additionally, the long-term effects of escitalopram on safety, growth, maturity, and cognitive and behavioral development in this age group have not yet been demonstrated.

Taking Escitalopram Durban with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use, any other medication.

Inform your doctor if you are taking any of the following medications:

• "Non-selective monoamine oxidase inhibitors (IMAOs)", containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active ingredients. If you have taken any of these medications, you will need to wait 14 days before starting escitalopram. After stopping escitalopram, you should wait 7 days before taking any of these medications.
• "Selective reversible MAO-A inhibitors", containing moclobemide (used to treat depression).
• "Irreversible MAO-B inhibitors", containing selegiline (used to treat Parkinson's disease). These increase the risk of side effects.
• The antibiotic linezolid.
• Lithium (used to treat manic-depressive disorder) and tryptophan.
• Imipramine and desipramine (both used to treat depression).
• Sumatriptan and similar medications (used to treat migraines) and tramadol or similar medications (opioids, used for severe pain). These increase the risk of side effects.
• Cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (antidepressant), and ticlopidine (used to reduce the risk of stroke). These may cause an increase in escitalopram blood levels.
• St. John's Wort (Hypericum perforatum) - a medicinal plant used to treat depression.
• Aspirin and non-steroidal anti-inflammatory drugs (medications used to relieve pain or reduce the risk of thrombosis, also called anticoagulants). These may increase the risk of bleeding.
• Warfarin, dipiridamol, and phenprocoumon (medications used to reduce the risk of thrombosis, also called anticoagulants). Your doctor will probably monitor your blood clotting time at the start and end of treatment with escitalopram to ensure that your anticoagulant dose is still adequate.
• Mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used to treat severe pain) due to the possible risk of lowering the seizure threshold.
• Neuroleptics (medications used to treat schizophrenia, psychosis)and antidepressants (tricyclic antidepressants and ISRSs)due to the possible risk of lowering the seizure threshold.
• Flecainide, propafenone, and metoprolol (used in cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). You may need to adjust your escitalopram dose.
• Medications that lower potassium or magnesium levels in the blood, as this increases the risk of a life-threatening heart rhythm disorder.
• Antidepressants such as moclobemide, tranilcipromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepin, or trimipramine. These medications may interact with buprenorphine; buprenorphine, naloxone, and you may experience symptoms such as involuntary muscle contractions, including those that control eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, temperature above 38°C. Contact your doctor if you experience these symptoms.

Do not take escitalopram if you are taking medications for heart rhythm disorders or that can affect heart rhythm, such as Class IA and III, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antimicrobials (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, particular antimalarial treatment halofantrine), some antihistamines (astemizol, hydroxyzine, mizolastine).

If you have any other questions about this, contact your doctor.

Taking Escitalopram Durban with food, drinks, and alcohol.

Escitalopram can be taken with or without food (see section 3 "Taking Escitalopram Durban").

As with many medications, it is not recommended to combine escitalopram with alcohol, although it is not expected to interact with alcohol.

Pregnancy, breastfeeding, and fertility.

Inform your doctor if you are pregnant or breastfeeding or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy 1

If you take Escitalopram Durban in the final stages of pregnancy, there may be an increased risk of excessive vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking Escitalopram Durban to be able to advise you.

If you take escitalopram during the last 3 months of your pregnancy, be aware that the following effects may be observed in the newborn: difficulty breathing, blue skin, seizures, changes in body temperature, difficulty feeding, vomiting, low blood sugar, muscle stiffness or weakness, intense reflexes, tremors, restlessness, irritability, drowsiness, and difficulty falling asleep. If your newborn has any of these symptoms, please contact your doctor immediately.

Ensure that your midwife and/or doctor know that you are being treated with escitalopram. During pregnancy, particularly in the last 3 months, medications like escitalopram may increase the risk of a serious condition in newborns, called persistent pulmonary hypertension of the newborn (PPHN), in which the baby breathes rapidly and turns blue. These symptoms usually start within the first 24 hours after birth. If they appear in your baby, contact your midwife and/or doctor immediately.

If escitalopram is used during pregnancy, it should never be stopped abruptly.

It is expected that escitalopram will be excreted through breast milk.

Citalopram, a medication similar to escitalopram, has been shown to reduce sperm quality in animal models. Theoretically, this effect could affect fertility, but to date, it has not been observed in human fertility.

Driving and using machines

It is recommended that you do not drive or use machinery until you know how escitalopram may affect you.

This medication contains lactose.

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions for escitalopram as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Adults

Depression

The usual recommended dose of escitalopram is 10 mg taken as a single dose per day. Your doctor may increase it up to a maximum of 20 mg per day.

Anxiety Disorder

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

Social Anxiety Disorder

The usually recommended dose of escitalopram is 10 mg taken as a single dose per day. Your doctor may decrease 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 usually recommended dose of escitalopram is 10 mg taken as a single dose per day. The dose may be increased by your doctor up to a maximum of 20 mg per day.

Obsessive-Compulsive Disorder

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

Patients with advanced age (over 65 years)

The recommended initial dose of escitalopram is 5 mg taken as a single dose per day. The dose may be increased by your doctor up to 10 mg per day.

Children and adolescents

Escitalopram Durban should not normally be administered to children and adolescents. For additional information, please see the section 2 "Warnings and precautions".

Reduced renal function

Caution is recommended in patients with severely reduced renal function. Take as prescribed by your doctor.

Reduced liver function

Patients with liver problems should not receive more than 10 mg per day. Take as prescribed by your doctor.

Patients considered to be slow metabolizers of the CYP2C19 enzyme

Patients with this known genotype should not receive more than 10 mg per day. Take as prescribed by your doctor.

How to take the tablets:

You can take escitalopram with or without food. Swallow the tablets with water. Do not chew them, as they have a bitter taste.

If necessary, you can break the tablets by placing the tablet on a flat surface with the notch facing up. The tablets can be broken by pressing down on each end of the tablet with your two index fingers, as shown in the figure.

Treatment duration

You may feel better in a couple of weeks. Continue taking escitalopram even if you start feeling better before the expected time.

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

Continue taking escitalopram for the recommended time by your doctor. If you interrupt the treatment too soon, symptoms may reappear. It is recommended that treatment continue for at least 6 months after feeling well again.

If you take more Escitalopram Durban than you should

If you take more doses of escitalopram than prescribed, contact your doctor immediately, go to the nearest hospital emergency room, or consult the Toxicology Information Service, phone 915.620.420. Do it even if you do not observe discomfort or signs of intoxication.

Some signs of overdose may be dizziness, tremor, agitation, convulsion, coma, nausea, vomiting, changes in heart rhythm, decreased blood pressure, and changes in the body's electrolyte balance. Bring the escitalopram packaging if you go to the doctor or hospital.

If you forgot to take Escitalopram Durban

Do not take a double dose to compensate for the missed doses. If you forgot to take a dose and remember before going to bed, take it immediately. The next day, follow your usual schedule. If you remember during the night or the next day, leave the missed dose and follow your usual schedule.

If you interrupt the treatment with Escitalopram Durban

Do not interrupt the treatment with escitalopram until your doctor tells you to. When you have finished your treatment course, it is usually recommended that the escitalopram dose be gradually reduced over several weeks.

When you stop taking escitalopram, especially if it is done abruptly, you may experience withdrawal symptoms. These are common when escitalopram treatment is suspended. The risk is higher when escitalopram 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 disappear on their own in two weeks. However, in some patients, they can be intense or prolonged (2-3 months or more). If you have severe withdrawal symptoms when stopping escitalopram, please contact your doctor. They may ask you to take your tablets again and taper off them more slowly.

Withdrawal symptoms include: feeling of dizziness (unstable or loss of balance), feeling of tingling, feeling of prickling, and (less frequently) electric shock, even in the head, sleep disturbances (too intense dreams, nightmares, inability to sleep), feeling of restlessness, headache, feeling of nausea (dizziness), sweating (including night sweats), feeling of anxiety or agitation, tremor (unsteadiness), feeling of confusion or disorientation, feelings of emotion or irritability, diarrhea (loose stools), visual disturbances, rapid heartbeat or palpitations.

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

Like all medicines, escitalopram may have side effects, although not everyone will experience them.

Side effects usually disappear after a few weeks of treatment. Please be aware that many of the side effects may be symptoms of your illness and will improve as you start to feel better.

If you have any of the following symptoms, contact your doctor or go to the hospital immediately:

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

• Unusual bleeding, including gastrointestinal bleeding.

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

• Swelling of the skin, tongue, lips, face, or throat, urticaria, or difficulty breathing or swallowing (allergic reaction).
• High fever, agitation, confusion, tremors, and sudden muscle contractions, which may be signs of a rare condition called serotonin syndrome.

Unknown (cannot be determined from available data):

• Difficulty urinating.
• Seizures (convulsions), see also the section “Warnings and Precautions”.
• Yellow skin and white eyes, which are signs of liver dysfunction/hepatitis.
• Fast or irregular heartbeat or dizziness, symptoms that may indicate a life-threatening condition called Torsade de Pointes.
• Thoughts of self-harm or suicidal thoughts, see also the section “Warnings and Precautions”.
• Sudden swelling of the skin or mucous membranes (angioedema).

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

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

• Feeling dizzy (nausea).
• Headache

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

• Blockage or nasal mucus (sinusitis).
• Decreased or increased appetite.
• Anxiety, agitation, abnormal dreams, difficulty falling asleep, feeling drowsy, dizziness, yawning, tremors, skin itching.
• Diarrhea, constipation, vomiting, dry mouth.
• Increased sweating.
• Muscle and joint pain (arthralgia and myalgia).
• Sexual dysfunction (delayed ejaculation, erectile dysfunction, decreased sexual behavior, and women may experience difficulty reaching orgasm).
• Fatigue, fever.
• Weight gain.

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

• Urticaria, skin rash, itching (pruritus).
• Teeth chattering, agitation, nervousness, anxiety attacks, confusion.
• Sleep disturbances, taste disturbances, fainting (syncope).
• Pupil dilation (mydriasis), visual disturbances, ringing in the ears (tinnitus).
• Hair loss.
• Excessive menstrual bleeding
• Irregular menstrual period.
• Weight loss.
• Fast heart rate.
• Swelling of arms and legs.
• Nasal bleeding.

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

• Aggression, depersonalization, hallucinations.
• Slow heart rate.

Unknown (cannot be determined from available data):

• Decreased sodium levels in the blood (symptoms are feeling dizzy and muscle weakness or confusion).
• Dizziness when standing due to low blood pressure (orthostatic hypotension).
• Altered liver function tests (elevated liver enzymes in the blood).
• Movement disorders (involuntary muscle movements).
• Painful erections (priapism).
• Symptoms of abnormal bleeding, for example, from the skin or mucous membranes (ecchymosis) Increased secretion of the hormone called ADH, causing water retention in the body and dilution of the blood, reducing the amount of sodium (inadequate ADH secretion).
• Milk flow in menandin women who are not breastfeeding.
• Mania.
• An increased risk of bone fractures has been observed in patients treated with this type of medication.
• Heavy vaginal bleeding shortly after delivery (postpartum hemorrhage), see “Pregnancy” 1 in section 2 for more information.
• Alteration of heart rhythm (called “prolongation of the QT interval”, observed on the ECG, heart electrical activity).

• Heavy vaginal bleeding shortly after delivery (postpartum hemorrhage), see “Pregnancy” 1 in section 2 for more information.

Other side effects that have been reported with medications that work similarly to escitalopram (the active ingredient in escitalopram) are:

• Motor restlessness (akathisia).
• Lossofappetite.

Reporting of side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Escitalopram Durban

The active ingredient is escitalopram. Each tablet contains 20 mg of escitalopram (as oxalate).

The other components are:

Core: lactose monohydrate, colloidal anhydrous silica, sodium croscarmellose, sodium carboxymethyl cellulose,propyl gallate, talc, and magnesium stearate.

Coating: HPMC (hydroxypropylmethyl cellulose) 2910/hypromellose 6cP, titanium dioxide (E-171), and macrogol 400.

Appearance of the product and contents of the package

Escitalopram Durban 20 mg is presented in the form of film-coated tablets.

The tablets are round, biconvex, white or off-white, film-coated, and engraved with “ML 61” on one face and with a notch on the other face with grooves at each end of the notch (approximate size 9.5 mm).

Escitalopram Durban 20 mg is presented in blister packs (cold form of 25 µ OPA / 45µ aluminum / 60 µ PVC – aluminum foil :

Package sizes: 20, 28, 50, 56, 98, and 100 tablets.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Francisco Durbán, S.A.

Polígono Ind. La Redonda, c/ IX, nº 2

04710 El Ejido (Almería)

Responsible for manufacturing

Macleods Pharma UK Limited

Wynyard Park House,

Wynyard Avenue, Wynyard,

Billingham, TS22 5TB

United Kingdom

IDIFARMA DESARROLLO FARMACÉUTICO S.L.

Polígono Mocholi, Calle CEIN nº 1

31110 Noain, Navarra,

Spain

Synoptis Industrial Sp. z o.o

ul. Rabowicka 15, Swarzedz,

62-020, Poland

This medicine is authorized in the Member States of the EEA with the following names:

United Kingdom:Escitalopram 20 mg film-coated tablets

Germany:Escitalopram Macleods 20 mg filmtabletten

Spain:Escitalopram Durban 20 mg film-coated tablets EFG

Italy:Amasci 20 mg film-coated tablets

Last review date of this leaflet: October 2023

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/