ESCITALOPRAM KERN PHARMA 10 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Escitalopram KERN PHARMA 10 mg film-coated tablets EFG

Escitalopram

Contents of the pack:

1. What Escitalopram KERN PHARMA 10 mg film-coated tablets are and what they are used for
2. Before you take Escitalopram KERN PHARMA 10 mg film-coated tablets
3. How to take Escitalopram KERN PHARMA 10 mg film-coated tablets
4. Possible side effects
5. Storage of Escitalopram KERN PHARMA 10 mg film-coated tablets
6. Further information

1. What is Escitalopram Kern Pharma 10 mg film-coated tablets and what is it used for

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 called selective serotonin reuptake inhibitors (SSRIs). These medications work on the serotonin system in the brain by increasing the level of serotonin. Alterations of the serotonin system are considered an important factor in the development of depression and related diseases.

2. Before taking Escitalopram Kern Pharma 10 mg film-coated tablets

Do not take Escitalopram Kern Pharma

• if you are allergic (hypersensitive) to escitalopram or any of the other ingredients of Escitalopram Kern Pharma (see section 6 "Further information"),
• if you are taking other medications that belong to the group called monoamine oxidase inhibitors (MAOIs), including selegiline (used for the treatment of Parkinson's disease), moclobemide (used for the treatment of depression), and linezolid (an antibiotic).
• If you have been born with any type of heart rhythm disorder or have ever suffered from any episode of this type (this is observed with an electrocardiogram, a test that serves to evaluate how the heart works).
• If you are taking medications for heart rhythm disorders or that may affect the heart rhythm (see section 2 "Use of other medications").

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 discontinued if seizures occur 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 Kern Pharma may alter glucose control. It may be necessary to adjust the dose of insulin and/or oral hypoglycemic agent,
• if you have a decreased level of sodium in the blood,
• if you tend to develop bleeding or bruising easily or if you are pregnant (see section "Pregnancy and lactation"),
• if you are receiving electroconvulsive therapy,
• if you have coronary heart disease.
• if you have or have had any heart problems or have recently suffered a heart attack,
• if your heart beats slowly when you are at rest (this is known as bradycardia) and/or 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 (medications to urinate),
• if you have noticed that your heart beats fast or irregularly 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.

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

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.

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 in which you harm or kill yourself. These may increase when you start 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 be longer. Youwould be more likely to have this type of thought:

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

If at any time you have thoughts in which you harm or kill yourself, contact your doctor or go directly to a hospital.

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

Use in children and adolescents under 18 years:

Escitalopram Kern Pharma should not normally be used in the treatment of children and adolescents under 18 years. Also, be aware that in patients under 18 years, there is a greater risk of adverse effects such as suicidal attempts, suicidal ideas, and hostility (predominantly aggression, confrontational behavior, and irritation) when taking this class of medications. Nevertheless, your doctor may prescribe Escitalopram Kern Pharma to patients under 18 years when they decide it is most convenient for the patient. If the doctor who corresponds to you has prescribed Escitalopram Kern Pharma to a patient under 18 years and you want to discuss this decision, please go back 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 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 medications

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

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

• "Non-selective monoamine oxidase inhibitors (IMAOs)" 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 Kern Pharma. After finishing with Escitalopram Kern Pharma, 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.
• Lithium (used in the treatment of manic-depressive disorder) and tryptophan.
• Imipramine and desipramine (both used for the treatment of depression).
• Sumatriptan and similar medications (used for the treatment of migraines) and tramadol (used against 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 blood levels of Escitalopram Kern Pharma.
• St. John's Wort (Hypericum perforatum) - a medicinal plant used for depression.
• Aspirin and non-steroidal anti-inflammatory drugs (medications used to relieve pain or reduce the risk of thrombosis, also called anticoagulants).
• Warfarin, dipyridamole, and fenprocoumon (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 Kern Pharma to check 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 the treatment of intense pain) due to the possible risk of lowering the seizure threshold.
• Neuroleptics (medications 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). It may be necessary to adjust the dose of Escitalopram Kern Pharma.

Do not take Escitalopram Kern Pharmaif you are taking medications for any heart rhythm disorder or if you are taking medications that may affect the heart rhythm, such as antiarrhythmic class IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, medications against malaria, particularly halofantrine), certain antihistamines (astemizole, mizolastine).

If you have 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 medications, it is not recommended to combine Escitalopram Kern Pharma and alcohol, although it is not expected that Escitalopram Kern Pharma will interact with alcohol.

Pregnancy and lactation

Tell 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 stage of pregnancy, there may be a greater risk of abundant 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 medication 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: 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, and difficulty sleeping. If your newborn has any of these symptoms, please contact your doctor immediately.

If Escitalopram Kern Pharma is used during pregnancy, it should never be discontinued abruptly.

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

Consult your doctor or pharmacist before using any medication.

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.

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

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

Adults

Depression

The normally 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.

Panic disorder

The initial dose of Escitalopram Kern Pharma is 5 mg as a single dose per day during 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 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 normally 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 normally 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 further information, please see 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 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.

Duration of treatment

It may take a couple of weeks before you start to feel better. Continue taking Escitalopram Kern Pharma 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 Kern Pharma for the time recommended by your doctor. If you interrupt treatment too soon, symptoms may reappear. It is recommended that treatment continue for at least 6 months after you feel better 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 emergency department of the nearest hospital, or consult the Toxicology Information Service, phone 91 562 04 20. Do this even if you do not observe discomfort or signs of intoxication. Some signs of overdose may be dizziness, tremors, agitation, seizures, coma, nausea, vomiting, changes in heart rhythm, decreased blood pressure, and changes in body fluid balance. Bring the package of Escitalopram Kern Pharma if you go to the doctor or hospital.

If you forget to take Escitalopram Kern Pharma

Do not take a double dose to make up for forgotten doses. If you forget to take a dose and remember before going to bed, take it immediately. The next day, follow the usual routine.

If you stop taking Escitalopram Kern Pharma

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

When you stop taking Escitalopram Kern Pharma, especially if it is sudden, you may feel withdrawal symptoms. These are common when treatment with Escitalopram Kern Pharma is discontinued. The risk is greater when Escitalopram Kern Pharma 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 have severe withdrawal symptoms when you stop taking Escitalopram Kern Pharma, please contact your doctor. He or she may ask you to start taking your tablets again and stop them more slowly.

Withdrawal symptoms include: feeling of dizziness (unstable or without balance), feeling of tingling, feeling of prickling, and (less frequently) electric shock, even in the head, sleep disturbances (intense dreams, nightmares, inability to sleep), feeling of restlessness, headache, feeling of nausea (nausea), sweating (including night sweats), feeling of restlessness or agitation, tremors (instability), feeling of confusion or disorientation, feelings of emotion or irritation, diarrhea (loose stools), 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 medicines, Escitalopram Kern Pharma can cause adverse effects, although not all people suffer from 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 therefore improve when you start to feel better.

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

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

• Unusual bleeding, including gastrointestinal bleeding.

Rare (at least 1 person in 10,000 and less than 1 person 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, these 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 adverse effects, consult your doctor or go to the hospital immediately:

• Difficulty urinating.
• Seizures (attacks), see the section "Be especially careful with Escitalopram Kern Pharma".
• Yellowish skin and whitening of the eyes, which are signs of altered liver function/hepatitis.
• Fast and irregular heartbeats or a feeling of fainting, as these could be symptoms of a serious heart problem known as torsades de pointes.

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

Very common (at least 1 person in 10):

• Feeling dizzy (nausea).

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

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

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

• Hives, skin rash, itching (pruritus).
• Teeth grinding, agitation, nervousness, panic attacks, confusion.
• Sleep disorders, taste disorders, fainting (syncope).
• Pupil dilation (mydriasis), visual disturbance, ringing in the ears (tinnitus).
• Hair loss.
• Vaginal bleeding.
• Weight loss.
• Fast heart rate.
• Swelling of arms and legs.
• Nosebleeds.

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

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

Some patients have reported (frequency not known):

• Thoughts of harming oneself or thoughts of killing oneself, see also the section "Be especially careful with Escitalopram Kern Pharma".
• Decreased sodium levels in the blood (symptoms are dizziness and discomfort with muscle weakness or confusion).
• Dizziness when standing up due to low blood pressure (orthostatic hypotension).
• Altered liver function tests (increased liver enzymes in blood).
• Movement disorders (involuntary muscle movements).
• Painful erections (priapism).
• Coagulation disorders including skin and mucous membrane bleeding (ecchymosis) and low platelet count in blood (thrombocytopenia).
• Sudden swelling of the skin and mucous membranes (angioedema).
• Increased urine production (inadequate secretion of ADH).
• Milk flow in non-lactating women.
• Mania.
• Alteration of heart rhythm (called QT interval prolongation, observed by electrocardiogram).
• Abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy and lactation" in section 2 for more information.

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

• Motor restlessness (akathisia).
• Anorexia.

If you consider that any of the adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

5. Conservation of Escitalopram Kern Pharma 10 mg tablets

Keep out of the reach and sight of children.

Do not store above 25°C.

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

Medicines should not be thrown away via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Additional Information

Composition of Escitalopram Kern Pharma 10 mg tablets

The active ingredient is escitalopram. Each Escitalopram Kern Pharma tablet contains 10 mg of escitalopram.

The other ingredients 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 packaging content

Escitalopram Kern Pharma 10 mg is presented in the form of film-coated tablets.

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

Escitalopram Kern Pharma 10 mg is presented in packs of 28 and 56 tablets, packaged in blisters.

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

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

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es