PATIENT INFORMATION LEAFLET

Escitalopram KERN PHARMA 15 mg Film-Coated Tablets

Escitalopram

Escitalopram Kern Pharma 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 medications act on the serotonin system in the brain by increasing the level of serotonin. Alterations in the serotonin system are considered an important factor in the development of depression and related conditions.

Do not take Escitalopram Kern Pharma

• if you are allergic (hypersensitive) to escitalopram or to any of the other components of Escitalopram Kern Pharma (see section 6 “Additional information”),
• if you are taking other medicines that belong to the group called monoamine oxidase 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 had any type of heart rhythm disorder since birth or have ever had an episode of this type (this is observed with an electrocardiogram, a test that serves to evaluate how the heart works).
• If you are taking medicines for heart rhythm disorders or that can affect heart rhythm, (see section 2 “Use of other medicines”).

Be careful with Escitalopram Kern Pharma

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 Kern Pharma should be interrupted if seizures occur or if you observe an increase in seizure frequency (see also section 4 “Possible side effects”),
• if you have liver failure or kidney failure. Your doctor may need to adjust your dose,
• if you have diabetes. Treatment with Escitalopram Kern Pharma may alter blood sugar control. You may need to adjust your insulin and/or oral hypoglycemic dose,
• if you have low sodium levels in your blood,
• if you are prone to bleeding or bruising easily or if you are pregnant (see section “Pregnancy and breastfeeding”),
• if you are receiving electroconvulsive therapy,
• if you have coronary disease.
• if you have or have had any heart problems or have recently had a heart attack,
• if, when at rest, your heart beats slowly (this is known as bradycardia) and/or if you think your body may be losing salt, for example because you have had intense diarrhea and vomiting for several days or because you have used diuretics (medicines to urinate),
• if you have noticed that your heartbeats are rapid or irregular or have fainted or felt dizzy when getting up from a sitting or lying position. This could indicate that you have some heart rhythm disorder.

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 few weeks of treatment. Inform your doctor immediately if you experience these symptoms.

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 taking antidepressants for the first time, as all these medicines require a time to start working, usually around two weeks, although in some cases it may take longer.Youwould be more prone to having these types of 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.

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

Some medicines in the group to which Escitalopram Kern Pharma belongs (called SSRIs/SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

Use in children and adolescents under 18 years:

Escitalopram Kern Pharma should not be used normally in 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 attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medication. However, your doctor may prescribe Escitalopram Kern Pharma to patients under 18 years old when they decide it is the most convenient for the patient. If the doctor who corresponds to you has prescribed Escitalopram Kern Pharma to a patient under 18 years old and 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 Kern Pharma. At the same time, the long-term effects on safety and related to growth, maturity, and cognitive and behavioral development of Escitalopram Kern Pharma in this age group have not yet been demonstrated.

Use of other medicines

Please inform your doctor or pharmacist if you are using, or have recently used, other medicines, even those purchased without a prescription.

Please inform your doctor if you are taking any of the following medicines:

• “Non-selective monoamine oxidase inhibitors (IMAOs)”, containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active principles. If you have taken any of these medicines, you will need to wait 14 days before starting to take Escitalopram Kern Pharma. After finishing Escitalopram Kern Pharma, 7 days must pass before taking any of these medicines.
• “Selective reversible MAO-A inhibitors”, containing moclobemide (used in 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.
• Lithium (used in the treatment of manic-depressive disorder) and tryptophan.
• Imipramine and desipramine (both used for the treatment of depression).
• Sumatriptan and similar medicines (used for the treatment of migraines) and tramadol (used for severe pain). These increase the risk of side effects.
• Cimetidine, lansoprazole, and omeprazole (used for 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 Escitalopram Kern Pharma blood levels.
• St. John's Wort (Hypericum perforatum) – medicinal plant used for depression.
• Aspirin and non-steroidal anti-inflammatory drugs (medicines used to relieve pain or to reduce the risk of thrombosis, also called anticoagulants).
• Warfarin, dipiridamol, and phenprocoumon (medicines used to reduce the risk of thrombosis, also called anticoagulants). Your doctor will probably check your blood clotting time at the beginning and end of treatment with Escitalopram Kern Pharma to ensure that the anticoagulant dose is still adequate.
• Mefloquine (used for the treatment of malaria), bupropion (used for the treatment of depression), and tramadol (used for severe pain) due to the possible risk of lowering the seizure threshold.
• Neuroleptics (medicines used for the treatment of schizophrenia, psychosis) due to the possible risk of lowering the seizure threshold and antidepressants.
• Flecainide, propafenone, and metoprolol (used in cardiovascular diseases) and desipramine, clomipramine, and nortriptyline (antidepressants) and risperidone, thioridazine, and haloperidol (antipsychotics). You may need to adjust your Escitalopram Kern Pharma dose.

Do not take Escitalopram Kern Pharmaif you are taking medicines for any heart rhythm disorder or if you are taking medicines that may affect heart rhythm, for example antiarrhythmic class IA and III, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobials (sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial drugs particularly halofantrine), certain antihistamines (astemizole, mizolastine).

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

Taking Escitalopram Kern Pharma with food and drinks

Escitalopram Kern Pharma can be taken with or without food (see section 3 “How to take Escitalopram Kern Pharma”).

As with many medicines, it is not recommended to combine Escitalopram Kern Pharma and alcohol, although it is not expected to interact with alcohol.

Pregnancy and breastfeeding

Please inform your doctor if you are pregnant or plan to become pregnant. Do not take Escitalopram Kern Pharma if you are pregnant unless you and your doctor have analyzed the risks and benefits involved.

If you take escitalopram in the final stages of pregnancy, there may be a higher 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 this medicine to be able to advise you.

If you take Escitalopram Kern Pharma 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 baby has any of these symptoms, please contact your doctor immediately.

Escitalopram Kern Pharma should not be interrupted abruptly if used during pregnancy.

Do not take Escitalopram Kern Pharma if you are breastfeeding unless you and your doctor have analyzed the risks and benefits involved.

Please consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Follow exactly the administration instructions of Escitalopram Kern Pharma indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Adults

Depression

The usual recommended dose of Escitalopram Kern Pharma 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 Kern Pharma 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 Kern Pharma 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 Kern Pharma 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 Kern Pharma 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)

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

Children and adolescents (under 18 years)

Escitalopram Kern Pharma should not normally be administered to children and adolescents. For additional information, please see the section 2 "Before taking Escitalopram Kern Pharma".

You can take Escitalopram Kern Pharma with or without food. Swallow the tablets with water. Do not chew them, as their taste is bitter.

If necessary, you can break the tablets by placing the tablet on a flat surface with the notch facing upwards. The tablets can be broken by pressing down on each end of the tablet.

Treatment duration

You may feel better in a couple of weeks. Continue taking Escitalopram Kern Pharma 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 Kern Pharma for the recommended time by your doctor. If you interrupt 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 Kern Pharma than you should

If you take more doses of Escitalopram Kern Pharma than prescribed, contact your doctor immediately, go to the nearest hospital emergency room, or consult the Toxicological Information Service, phone 91 562 04 20. Do it even when 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 Kern Pharma packaging if you go to the doctor or hospital.

If you forget to take Escitalopram Kern Pharma

Do not take a double dose to compensate for the missed doses. If you forget 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 treatment with Escitalopram Kern Pharma

Do not interrupt treatment with Escitalopram Kern Pharma until your doctor tells you to. When you have finished your treatment course, it is usually recommended to gradually reduce the Escitalopram dose over several weeks.

When you stop taking Escitalopram Kern Pharma, especially if it is done abruptly, you may experience withdrawal symptoms. These are common when treatment with Escitalopram Kern Pharma is suspended. The risk is higher when Escitalopram Kern Pharma 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 experience severe withdrawal symptoms when stopping Escitalopram Kern Pharma, please contact your doctor. They may ask you to take your tablets again and stop 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 nocturnal sweating), feeling of anxiety or agitation, tremor (instability), 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 Kern Pharma may cause side effects, although not everyone will experience them.

The 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 therefore improve as you start to feel better.

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

Uncommon (at least 1 in 1,000 and fewer than 1 in 100):

• Unusual bleeding, including gastrointestinal bleeding.

Rare (at least 1 in 10,000 and fewer than 1 in 1,000):

• 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 the hospital immediately.
• If you have a high fever, agitation, confusion, tremors, and sudden muscle contractions, they may be signs of a rare condition called serotonin syndrome. If you feel this way, contact your doctor.

If you experience any of the following side effects, consult your doctor or go to the hospital immediately:

• Difficulty urinating.
• Seizures (convulsions), see the section “Be especially careful with Escitalopram Kern Pharma”.
• Yellow skin and white eyes, which are signs of liver dysfunction/hepatitis.
• Fast and irregular heartbeats or a feeling of dizziness, as they may be symptoms of a serious heart condition called torsade de pointes.

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

Very common (at least 1 in 10):

• Feeling dizzy (nausea).

Common (at least 1 in 100 and fewer than 1 in 10):

• 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 problems (delayed ejaculation, erection problems, decreased sexual behavior, and women may experience difficulty reaching orgasm).
• Fatigue, fever.
• Weight gain.

Uncommon (at least 1 in 1,000 and fewer than 1 in 100):

• Hives, skin rash, itching (pruritus).
• Chattering teeth, agitation, nervousness, anxiety attacks, confusion.
• Sleep disturbances, taste alterations, fainting (syncope).
• Pupil dilation (mydriasis), visual disturbances, ringing in the ears (tinnitus).
• Hair loss.
• Vaginal bleeding.
• Weight loss.
• Rapid heart rate.
• Swelling of arms and legs.
• Nasal bleeding.

Rare (at least 1 in 10,000 and fewer than 1 in 1,000):

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

Some patients have reported (frequency unknown):

• Thoughts of self-harm or suicidal thoughts, see also the section “Be especially careful with Escitalopram Kern Pharma”.
• Decreased sodium levels in the blood (symptoms are feeling dizzy and muscle weakness or confusion).
• Dizziness when standing up 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).
• Blood clotting disorders, including skin and mucous membrane bleeding (ecchymosis) and low platelet count in the blood (thrombocytopenia).
• Sudden swelling of the skin and mucous membranes (angioedema).
• Inadequate ADH secretion, resulting in increased urine production.
• Milk flow in women who are not breastfeeding.
• Mania.
• Alteration of the heart rhythm (called QT interval prolongation, observed by electrocardiogram).
• Heavy vaginal bleeding shortly after delivery (postpartum hemorrhage), see “Pregnancy and breastfeeding” in section 2 for more information.

Other side effects have been reported with medications that work similarly to escitalopram. These are:

• Motor restlessness (akathisia).
• Anorexia.

If you consider any of the side effects you are experiencing to be severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not store at a temperature above 25°C.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Escitalopram Kern Pharma 15 mg Tablets

The active ingredient is escitalopram. Each Escitalopram Kern Pharma tablet contains 15 mg of escitalopram.

The other components are: microcrystalline cellulose (E-460i), anhydrous colloidal silica, talc, sodium croscarmellose, magnesium stearate (E-470b), hypromellose (E-464), macrogol 6000, and titanium dioxide (E-171).

Appearance of the Product and Contents of the Package

Escitalopram Kern Pharma 15 mg is presented in the form of film-coated tablets.

The tablets are oval, white, scored, coated, and marked with an “E” on one face, a score on the other face, and lateral scores.

Escitalopram Kern Pharma 15 mg is presented in packages of 28 and 56 tablets, conditioned in blisters.

Holder of the Marketing Authorization

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Responsible for Manufacturing

Actavis Limited.

BLB 015-016 Bulebel Industrial Estate

Zejtun – ZTN3000 – Malta

or

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

This leaflet was approved in: January 2021

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