ESCITALOPRAM DURBAN 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Escitalopram Durban 10 mg Film-Coated Tablets EFG

Escitalopram

Read the entire package leaflet carefully before starting to take the medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

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

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

Escitalopram Durban contains the active substance escitalopram. Escitalopram belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). These medications act on the serotonin system in the brain, 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).

It may take a couple of weeks before you start to feel better. Continue taking escitalopram even if it takes time to notice any improvement.

You should consult a doctor if your symptoms worsen or do not improve.

2. What you need to know before taking Escitalopram Durban

Do not take Escitalopram Durban

• If you are allergic to escitalopram or any of the other ingredients of this medication (listed in section 6).
• If you are taking other medications that belong to the group called monoamine oxidase inhibitors (MAOIs), including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic).
• If you have been born with or have had an episode of altered heart rate (detected on an ECG, a test that evaluates heart function).
• If you are taking medications for heart rhythm disorders or that may affect heart rhythm (see section 2 "Use of 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 disorder 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 discontinued if seizures occur at the same time or if you observe an increase in the frequency of seizures (see also section 4 "Possible side effects").
• If you have liver or kidney failure. Your doctor may need to adjust your dose.
• If you have diabetes. Treatment with escitalopram may alter blood sugar control. It may be necessary to adjust the dose of insulin and/or oral hypoglycemic medication.

• If you have a low level of sodium in the blood.
• If you tend to develop 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 a decrease in salt levels as a result of severe and prolonged diarrhea and vomiting (being sick) or use of diuretics.
• If you experience rapid or irregular heartbeats, fainting, collapse, or dizziness when standing up, which may indicate abnormal heart rhythm.
• If you have or have had eye problems, such as certain types of glaucoma (increased pressure in the eye).
• Depression or other diseases treated with antidepressants.
• The use of these medications with buprenorphine; buprenorphine, naloxone can cause serotonin syndrome, a potentially life-threatening disease (see "Use of Escitalopram Durban with other medications").

Please note:

Some patients with manic-depressive illness may enter a manic phase. This is characterized by a change in ideas that is uncommon and rapid, disproportionate 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 few weeks of treatment. Inform your doctor immediately if you experience these symptoms.

Medications like escitalopram (also called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after discontinuing treatment.

Suicidal thoughts and worsening of your 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 may increase when taking antidepressants for the first time, as all these medications require time to start taking effect, usually around two weeks, although in some cases it may take longer.

Youwould be more likely to have these thoughts:

• If you have previously had thoughts of killing yourself or harming yourself.
• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years of age with psychiatric diseases who were treated with an antidepressant.

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

It may be helpful for you to tell a relativeor close friendthat you are depressed or that you havean anxiety disorder and ask them to read this package leaflet. You can ask them if they think your depression or anxiety disorder has worsened. Or if they are concerned about changes in your attitude.

Children and adolescents

Escitalopram Durban 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 a greater risk of side effects such as suicidal attempts, suicidal ideas, and hostility (mainly aggression, confrontational behavior, and irritation) when taking this class of medications.

However, your doctor may prescribe escitalopram to patients under 18 years of age when they decide it is most convenient for the patient. If the doctor who corresponds to you has prescribed escitalopram to a patient under 18 years of age and you want 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 of age are taking escitalopram. Also, the long-term effects on safety and related to growth, maturity, and cognitive and behavioral development of escitalopram in this age group have not yet been demonstrated.

Use ofEscitalopram Durban withother medications

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

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

• "Non-selective monoamine oxidase inhibitors (MAOIs)" that contain 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 to take escitalopram. After finishing escitalopram, 7 days must pass before taking any of these medications.
• "Reversible selective MAO-A inhibitors" that contain moclobemide (used in the treatment of depression).
• "Irreversible MAO-B inhibitors" that contain selegiline (used in the treatment of Parkinson's disease). These increase the risk of side effects.
• The antibiotic linezolid.
• Lithium (used in the treatment of manic-depressive disorder) and tryptophan.
• Imipramine and desipramine (both used in the treatment of depression).
• Sumatriptan and similar medications (used in the treatment of migraines) and tramadol or similar medications (opioids, used against severe pain). These increase the risk of side effects.
• Cimetidine, lansoprazole, and omeprazole (used in the treatment of 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 blood levels of escitalopram.
• St. John's Wort (Hypericum perforatum) - a medicinal plant used for depression.
• Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medications used to relieve pain or reduce the risk of thrombosis, also called anticoagulants). These may increase the tendency to bleeding.
• Warfarin, dipyridamole, and phenprocoumon (medications used to reduce the risk of thrombosis, also called anticoagulants). Your doctor will probably check the blood coagulation time at the start and end of treatment with escitalopram to ensure that the dose of anticoagulant is still adequate.
• Mefloquine (used in the treatment of malaria), bupropion (used in the treatment of depression), and tramadol (used in the treatment of intense pain) due to the possible risk of decreasing the seizure threshold.
• Neuroleptics (medications used to treat schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to the possible risk of decreasing the seizure threshold.
• Flecainide, propafenone, and metoprolol (used in cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). It may be necessary to adjust the dose of escitalopram.
• Medications that decrease potassium or magnesium levels in the blood, as this increases the risk of a life-threatening heart rhythm disorder.
• Antidepressants such as moclobemide, tranylcypromine, 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 rhythmic muscle contractions, including the muscles that control eye movement, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor if you experience these symptoms.

Do not take Escitalopram if you are taking medications for heart rhythm problems or that may 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, antimalarial treatment, particularly halofantrine), some antihistamines (astemizole, hydroxyzine, mizolastine).

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

Taking Escitalopram Durban with food, drinks, andalcohol.

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

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

Pregnancy, breastfeeding, andfertility.

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

Pregnancy

If you take Escitalopram Durban in the final stages of 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 know that you are taking Escitalopram Durban to advise you.

If you take escitalopram during the last 3 months of your pregnancy, you should be aware that the following effects may be observed in the newborn baby: breathing difficulties, blue skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or floppiness, increased reflexes, tremors, restlessness, irritability, lethargy, constant crying, and sleep difficulties. If your newborn baby has any of these symptoms, please contact your doctor immediately.

Make sure 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 disease in newborns called persistent pulmonary hypertension (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, you should 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 in breast milk.

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

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.

3. How to Take Escitalopram Durban

Follow your doctor's instructions for taking escitalopram exactly as indicated.

Consult your doctor or pharmacist if you have any doubts.

Adults

Depression

The normally 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 later up to a maximum of 20 mg per day.

Social Anxiety Disorder

The normally 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 normally 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 normally 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.

Elderly Patients (over 65 years old)

The initial recommended 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 should not normally be administered to children and adolescents. For additional information, please see section 2 "Warnings and Precautions".

Reduced Renal Function

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

Reduced Hepatic 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 split the tablets by placing the tablet on a flat surface with the score line facing up. The tablets can be broken by pressing down on each end of the tablet with your index fingers, as shown in the figure.

Duration of Treatment

It may take a couple of weeks before you start to feel better. Continue taking escitalopram even if you start to feel better before the expected time.

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

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

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 emergency department of the nearest hospital, or consult the Toxicology Information Service, phone 915.620.420. Do this even if you do not observe discomfort or signs of intoxication.

Some signs of overdose may include dizziness, tremors, agitation, convulsions, coma, nausea, vomiting, changes in heart rhythm, decreased blood pressure, and changes in body fluid balance.

Bring the package of escitalopram if you go to the doctor or hospital.

If You Forget to Take Escitalopram Durban

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

If You Interrupt Treatment with Escitalopram Durban

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

When you stop taking escitalopram, especially if it is sudden, you may experience withdrawal symptoms. These are common when treatment with escitalopram is suspended. The risk is greater when escitalopram has been used for a long time, in high doses, or when the dose is reduced too quickly. Most people find that these symptoms are mild and disappear on their own within two weeks. However, in some patients, they can be intense or prolonged (2-3 months or more). If you experience severe withdrawal symptoms when stopping escitalopram, please contact your doctor. They may ask you to start taking your tablets again and stop them more slowly.

Withdrawal symptoms include: feeling dizzy (unstable or without balance), feeling tingling, feeling itchy, and (less frequently) electric shock, even in the head, sleep disturbances (intense dreams, nightmares, inability to sleep), feeling restless, headache, feeling nauseous, sweating (including night sweats), feeling anxious or agitated, trembling (instability), feeling confused or disoriented, feelings of emotion or irritation, diarrhea, visual disturbances, rapid or irregular heartbeat.

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

4. Possible Adverse Effects

Like all medications, this medication can have adverse effects, although not all people experience them.

Adverse effects usually disappear after a few weeks of treatment. Please be aware that many of the effects can be symptoms of your illness and will improve when you start to feel better.

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

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

• Unusual bleeding, including gastrointestinal bleeding.

Rare (may affect up to 1 in 1000 people):

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

Unknown (cannot be determined from available data):

• Difficulty urinating.
• Seizures (attacks), see also the section "Warnings and Precautions".
• Yellowing of the skin and eyes, are signs of liver function alteration / hepatitis.
• If you experience rapid or irregular heartbeats or fainting, symptoms that may indicate a life-threatening condition known as Torsade de Pointes.
• Thoughts of harming yourself or thoughts of suicide, see also the section "Warnings and Precautions".
• Sudden swelling of the skin or mucous membranes (angioedema).

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

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

• Feeling nauseous.
• Headache.

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

• Nasal congestion or runny nose (sinusitis).
• Decreased or increased appetite.
• Anxiety, agitation, abnormal dreams, difficulty sleeping, feeling sleepy, dizziness, yawning, tremors, itching of the skin.
• Diarrhea, constipation, vomiting, dry mouth.
• Increased sweating.
• Muscle and joint pain (arthralgia and myalgia).
• Sexual disturbances (delayed ejaculation, erection problems, decreased sexual behavior, and women may experience difficulty reaching orgasm).
• Fatigue, fever.
• Weight gain.

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

• Hives, skin rash, itching (pruritus).
• Teeth grinding, agitation, nervousness, panic 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.
• Rapid heartbeat.
• Swelling of arms and legs.
• Nosebleeds.

Rare (may affect up to 1 in 1000 people):

• Aggression, depersonalization, hallucinations.
• Slow heartbeat.

Unknown (cannot be determined from available data):

• Decrease in sodium levels in the blood (symptoms are feeling dizzy and discomfort with muscle weakness or confusion).
• Dizziness when standing up 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).
• Signs of abnormal bleeding, e.g., 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 men and in women who are not breastfeeding.
• Mania.
• An increased risk of bone fractures has been observed in patients treated with this type of medication.
• Alteration of heart rhythm (called "prolongation of the QT interval", observed in the ECG, heart electrical activity).
• Abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy" in section 2 for more information.

Other adverse effects are known to occur with drugs that work similarly to escitalopram (the active ingredient in escitalopram). These are:

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

Reporting of Adverse Effects:

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

5. Conservation of Escitalopram Durban

Keep out of sight and reach of children.

Do not use this medication after the expiration date shown on the package after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be thrown away in drains or trash. Deposit the packages and medications you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

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, anhydrous colloidal 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 Package Contents

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

The tablets are round, biconvex, white or almost white, film-coated, and engraved with "ML 61" on one side and with a score line on the other side with notches at each end of the score line (approximate size 9.5 mm).

Escitalopram Durban 20 mg is presented in blister packs (cold-form 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 marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Francisco Durbán, S.A.

Polígono Ind. La Redonda, c/ IX, nº 2

04710 El Ejido (Almería)

Manufacturer

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 medication is authorized in the EEA Member States with the following names:

United Kingdom: Escitalopram 20 mg film-coated tablets

Germany: Escitalopram Macleods 20 mg film tablets

Spain: Escitalopram Durban 20 mg film-coated tablets EFG

Italy: Amasci 20 mg film-coated tablets

Date of the Last Revision of this Leaflet: October 2023

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/