Escitalopram Durban 20 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet
Escitalopram Durban 20 mg Film-coated Tablets EFG

Escitalopram

Read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further 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. It could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if the side effect is not listed in this leaflet. See section 4.

Contents of this leaflet:

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

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

Escitalopram Durban contains the active substance escitalopram.

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.

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 some time to notice improvement.

Consult a doctor if you get worse or do not improve.

2. What you need to know before starting to take Escitalopram Durban

Do not take Escitalopram Durban

• 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 the group called monoamine oxidase inhibitors (MAOIs), including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), or linezolid (an antibiotic).
• If you have been born with or have had an episode of abnormal heart rhythm (detected on an ECG, a test that evaluates heart function).
• If you are taking medicines for heart rhythm disorders or medicines that may affect heart rhythm (see section 2 "Use of Escitalopram Durban with other medicines").

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 illness, as your doctor may need to take this into account. Specifically, tell your doctor:

• If you have epilepsy. Treatment with escitalopram should be discontinued if seizures occur or 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 may alter glycaemic control. Adjustment of insulin and/or oral hypoglycaemic agent dosage may be necessary.
• If you have low sodium levels in the 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 heart problems or have recently had a heart attack.
• If your resting heart rate is slow and/or you know you may have low levels of salts due to severe and prolonged diarrhoea and vomiting (being unwell) or use of diuretics.
• If you experience rapid or irregular heartbeats, fainting, collapse, or dizziness upon standing, which may indicate abnormal heart rhythm.
• If you have or have previously had eye problems, such as certain types of glaucoma (increased pressure in the eye).
• Depression or other conditions treated with antidepressants.
• The use of these medicines together with buprenorphine; buprenorphine, naloxone may cause serotonin syndrome, a potentially life-threatening condition (see "Use of Escitalopram Durban with other medicines").

Please note:

Some patients with bipolar disorder may enter a manic phase. This is characterised by unusual and rapid thought changes, 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 few weeks of treatment. Inform your doctor immediately if you experience these symptoms.

Medicines such as Escitalopram (also known as SSRIs/SNRIs) may cause symptoms of sexual dysfunction (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 yourself or taking your own life. These may increase when first starting antidepressants, as all these medicines require time to take effect, usually about two weeks, although in some cases it may take longer.

You are more likely to have these types of thoughts:

• If you have previously had thoughts of killing yourself 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 yourself or taking your own life, 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 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 an increased risk of adverse effects such as suicide attempts, suicidal ideation, and hostility (predominantly aggression, confrontation 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 for the patient. 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 symptoms described above 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 fully established.

Use of Escitalopram Durban with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Tell 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. If you have taken any of these medicines, you must wait 14 days before starting escitalopram. After stopping escitalopram, 7 days must pass before starting any of these medicines.
• "Reversible selective 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 bipolar disorder) and tryptophan.
• Imipramine and desipramine (both used to treat depression).
• Sumatriptan and similar medicines (used to treat migraine) and tramadol or similar medicines (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 (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These may increase blood levels of escitalopram.
• St. John's wort (Hypericum perforatum) – a herbal remedy used for depression.
• Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medicines used to relieve pain or reduce the risk of thrombosis, also called anticoagulants). These may increase the tendency to bleed.
• Warfarin, dipyridamole, and phenprocoumon (medicines used to reduce the risk of thrombosis, also called anticoagulants). Your doctor will likely monitor your blood clotting time at the start and end of escitalopram treatment to ensure your anticoagulant dose remains appropriate.
• 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 (medicines used to treat schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs), due to the possible risk of lowering the seizure threshold.
• Flecainide, propafenone, and metoprolol (used for cardiovascular conditions), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). The dose of escitalopram may need to be adjusted.
• Medicines that reduce 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 medicines may interact with buprenorphine; buprenorphine, naloxone, and you may experience symptoms such as involuntary rhythmic muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated 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 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 (e.g. sparfloxacin, moxifloxacin, IV erythromycin, pentamidine, antimalarial treatments particularly halofantrine), or certain antihistamines (astemizole, hydroxyzine, mizolastine).

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

Taking Escitalopram Durban with food, drinks, and alcohol

Escitalopram may be taken with or without food (see section 3 “How to take Escitalopram Durban”).

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

Pregnancy, breastfeeding, and fertility

Inform your doctor if you are pregnant, breastfeeding, or planning to become pregnant. Consult your doctor or pharmacist before using this medicine.

Pregnancy

If you take Escitalopram Durban in the late stages of pregnancy, there is 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 Durban so they can advise you appropriately.

If you take escitalopram during the last three months of pregnancy, be aware that the following effects may occur in the newborn baby: 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.

Ensure that your midwife and/or doctor know you are being treated with escitalopram. During pregnancy, particularly in the last three months, medicines 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 begin within the first 24 hours after birth. If they occur in your baby, contact your midwife and/or doctor immediately.

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

Escitalopram is expected to be excreted in breast milk.

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

Driving and use of machines

You are advised not to drive or operate machinery until you know how escitalopram affects you.

This medicine contains lactose.

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

3. How to take Escitalopram Durban

Follow exactly the dosing instructions for escitalopram given by your doctor. 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 daily dose. Your doctor may increase this up to a maximum of 20 mg per day.

Panic disorder

The initial dose of escitalopram 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 the dose 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 daily dose. Your doctor may reduce your dose to 5 mg per day or increase it up to a maximum of 20 mg per day, depending on your response to the medication.

Generalized anxiety disorder

The normally recommended dose of escitalopram 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 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 (over 65 years of age)

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

Children and adolescents

Escitalopram Durban should not normally be given to children and adolescents. For further information, please see 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 known 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 may take escitalopram with or without food. Swallow the tablets with water. Do not chew them, as they have a bitter taste.

If necessary, you may split the tablets by placing the tablet 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 two index fingers, as shown in the figure.

Duration of treatment

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

Do not alter the dose of the medication without first speaking to your doctor.

Continue taking escitalopram for the length of time recommended by your doctor. If you stop treatment too early, symptoms may return. It is recommended that treatment continues for at least 6 months after you have recovered.

If you take more Escitalopram Durban than you should

If you take more escitalopram than prescribed, contact your doctor immediately, go to the nearest hospital emergency department, or contact the Toxicology Information Service at telephone number 915.620.420. Do this even if you do not notice any discomfort or signs of poisoning.

Some 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 packaging with you 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 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 Durban

Do not stop treatment with escitalopram unless your doctor tells you to. When you have completed 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 abruptly, you may experience withdrawal symptoms. These are common when treatment with escitalopram is stopped. 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 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 longer). If you experience severe withdrawal symptoms when stopping escitalopram, please contact your doctor. He or she may advise you to resume taking your tablets and to taper them more slowly.

Withdrawal symptoms include: dizziness (feeling unsteady or off balance), tingling sensations, prickling sensations, and (less frequently) electric shock-like sensations, even in the head; sleep disturbances (overly vivid dreams, nightmares, inability to sleep); restlessness; headache; feeling of dizziness (nausea); sweating (including night sweats); feelings of uneasiness or agitation; tremor (shakiness); feelings of confusion or disorientation; emotional lability 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 can have adverse effects, although not everyone will experience them.

Adverse effects 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.

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 (allergic reaction).
• High fever, agitation, confusion, tremors, and sudden muscle contractions, which may be signs of a rare condition called serotonin syndrome.

Unknown frequency (cannot be estimated from available data):

• Difficulty urinating.
• Seizures (fits), see also section “Warnings and precautions”.
• Yellowing of the skin and whites of the eyes, signs of liver dysfunction/hepatitis.
• Fast or irregular heartbeat, or fainting, symptoms which may indicate a life-threatening condition known as Torsade de Pointes.
• Thoughts of harming yourself or thoughts of killing yourself, see also 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 (nausea).
• Headache.

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

• Nasal congestion or runny nose (sinusitis).
• Decreased or increased appetite.
• Anxiety, restlessness, abnormal dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremors, skin itching.
• Diarrhea, constipation, vomiting, dry mouth.
• Increased sweating.
• Muscle and joint pain (arthralgia and myalgia).
• Sexual disturbances (delayed ejaculation, erection problems, reduced sexual drive; women may experience difficulty achieving orgasm).
• Fatigue, fever.
• Weight gain.

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

• Hives, skin rash, itching (pruritus).
• Teeth grinding, restlessness, 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 periods.
• Weight loss.
• Fast heartbeat.
• Swelling of arms and legs.
• Nosebleeds.

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

• Aggression, depersonalization, hallucinations.
• Slow heartbeat.

Unknown frequency (cannot be estimated from available data):

• Decreased levels of sodium in the blood (symptoms include dizziness and malaise 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).

• 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 sodium levels (inappropriate ADH secretion).

• Milk production 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 medicine.

• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage), see «Pregnancy»1 in section 2 for more information.

• Changes in heart rhythm (known as “QT interval prolongation”, seen on ECG, electrical activity of the heart).

• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage), see «Pregnancy»1 in section 2 for more information.

Other adverse effects known to occur with drugs that act similarly to escitalopram (the active substance in escitalopram) include:

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

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, 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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Escitalopram Durban

Keep out of sight and reach of children.

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

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a pharmacy’s SIGRE collection point. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Escitalopram Durban

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

The other components are:

Core: monohydrate lactose, anhydrous colloidal silicon dioxide, sodium croscarmellose, sodium carboxymethylcellulose, propyl gallate, talc, and magnesium stearate.

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

Appearance of the product and contents of the container

Escitalopram Durban 20 mg is presented as film-coated tablets.

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

Escitalopram Durban 20 mg is available in blister packs (cold-formed, cold-forming foil: 25 µ OPA / 45 µ Aluminium / 60 µ PVC – aluminium foil):

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

Only certain pack 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)
Spain

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 medicinal product is authorized in EEA Member States under the following names:

United Kingdom: Escitalopram 20 mg film coated tablets
Germany: Escitalopram Macleods 20 mg filmtabletten
Spain: Escitalopram Durban 20 mg comprimidos recubiertos con película EFG
Italy: Amasci 20 mg compresse rivestite con film

Date of the most recent review of this leaflet: October 2023

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