ESCITALOPRAM KERN PHARMA 20 mg/ml ORAL SOLUTION DROPS

Introduction

PATIENT INFORMATION LEAFLET

Escitalopram Kern Pharma 20 mg / ml oral drops in solution EFG

Escitalopram

Read the entire leaflet carefully before starting to take the medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed 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 leaflet. See section 4.

Contents of the leaflet:

1. What is Escitalopram Kern Pharma and what is it used for
2. Before taking Escitalopram Kern Pharma
3. How to take Escitalopram Kern Pharma
4. Possible side effects
5. Storage of Escitalopram Kern Pharma
6. Additional information

1. What is Escitalopram Kern Pharma and what is it used for

Escitalopram belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). These medications work on the serotonin system in the brain, increasing the level of serotonin. Alterations in the serotonin system are considered an important factor in the development of depression and related disorders.

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).

2. Before taking Escitalopram Kern Pharma

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 "Additional information").
• If you are taking other medications that belong to the group called MAO inhibitors, 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 suffered from an episode of altered heart rate (confirmed by an electrocardiogram, a test to evaluate heart function)
• If you are taking medications for heart rhythm problems or that may affect heart rhythm (see section 2 "Taking 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 you experience seizures for the first time or 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 the 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 sodium level in the blood,
• if you tend to develop bleeding or bruising easily, or if you are pregnant (see "Pregnancy")
• if you are receiving electroconvulsive therapy,
• if you have coronary artery disease,
• if you have or have had heart problems or have recently suffered a heart attack
• if your resting heart rate is slow and/or you know you may have a decrease in salt as a result of intense and prolonged vomiting and diarrhea (due to illness) or the use of diuretics (water pills)
• if you experience rapid or irregular heartbeats, fainting, syncope, or dizziness when standing up, which may indicate abnormal heart function.

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.

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 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 sometimes 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 working, 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. Clinical trial data have 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 of harming or killing yourself, contact your doctor or go directly to a hospital.

It may be helpful for you to tell a relative orclose friendthat 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. Moreover, you should know that in patients under 18 years, there is a higher risk of side 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, growth, maturity, and cognitive and behavioral development of Escitalopram Kern Pharma in this age group have not yet been demonstrated.

Taking other medications

Tell your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription. Inform your doctor if you are taking any of the following medications:

• "Non-selective monoamine oxidase inhibitors (IMAOs)", which 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 Escitalopram Kern Pharma, 7 days must pass before taking any of these medications.
• "Reversible selective MAO-A inhibitors", which contain moclobemide (used in the treatment of depression).
• "Irreversible MAO-B inhibitors", which 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 migraine) and tramadol (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 concentrations of escitalopram.
• St. John's Wort (Hypericum perforatum) – a medicinal plant used for depression.
• Acetylsalicylic acid (aspirin) and non-steroidal anti-inflammatory drugs (medications used to relieve pain or reduce the risk of thrombosis, also called anticoagulants). These may increase the 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 Kern Pharma 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 in the treatment of schizophrenia, psychosis) due to the possible risk of decreasing the seizure threshold and antidepressants.
• 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 Kern Pharma.

Do not take Escitalopram Kern Pharma if you are taking medications for heart rhythm problems or that may affect heart rhythm, such as antiarrhythmics Class IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g., sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, treatment against malaria, particularly halofantrine), certain antihistamines (astemizole, mizolastine). Consult your doctor if you have doubts.

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"). As with many medications, it is not recommended to combine Escitalopram Kern Pharma with alcohol, although it is not expected that Escitalopram Kern Pharma will interact with alcohol.

Pregnancy and breastfeeding

Studies conducted in animals treated with citalopram, a medication like escitalopram, have shown that it decreases sperm quality. Theoretically, this could affect fertility, but so far, no effects on human fertility have been observed.

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 higher 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.

Escitalopram Kern Pharma may be excreted in human milk. Consequently, breastfeeding is not recommended during treatment.

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: respiratory difficulty, blue skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or weakness, intense reflexes, tremors, restlessness, irritability, lethargy, constant crying, and difficulty sleeping. If your newborn 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 Kern Pharma. During pregnancy, particularly in the last three months, medications like Escitalopram Kern Pharma 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 Kern Pharma is used during pregnancy, it should never be discontinued abruptly.

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.

Important information about some of the ingredients of Escitalopram Kern Pharma

This medication contains small amounts of ethanol (alcohol), less than 100 mg per dose. Each drop contains 4.7 mg of ethanol.

3. How to take Escitalopram Kern Pharma

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

Count the necessary number of drops in your drink (water, orange or apple juice), stir briefly, and drink it.

Do not mix Escitalopram Kern Pharma with other liquids or with other medications.

Adults:

Depression

The normally recommended dose of Escitalopram Kern Pharma is 10 mg (10 drops) 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 (5 drops) as a single dose per day during the first week before increasing the dose to 10 mg (10 drops) per day. Your doctor may increase it later up to a maximum of 20 mg (20 drops) per day.

Social Anxiety Disorder

The normally recommended dose of Escitalopram Kern Pharma is 10 mg (10 drops) taken as a single dose per day. Your doctor may decrease your dose to 5 mg (5 drops) per day or increase the dose up to a maximum of 20 mg (20 drops) per day, depending on how you respond to the medication.

Generalized Anxiety Disorder

The normally recommended dose of Escitalopram Kern Pharma is 10 mg (10 drops) taken as a single dose per day. The dose may be increased by your doctor up to a maximum of 20 mg (20 drops) per day.

Obsessive-Compulsive Disorder

The normally recommended dose of Escitalopram Kern Pharma is 10 mg (10 drops) taken as a single dose per day. The dose may be increased by your doctor up to a maximum of 20 mg (20 drops) per day.

Elderly patients (over 65 years):

The normally recommended initial dose of Escitalopram Kern Pharma is 5 mg (5 drops) taken as a single dose per day.

The dose may be increased by your doctor up to 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 section 2.

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 the treatment too early, the symptoms may reappear. It is recommended that the treatment continues for at least 6 months after you feel better.

If you take more Escitalopram Kern Pharma than you should

If you take more Escitalopram Kern Pharma than you should, inform your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

Do this even if you do not observe discomfort or signs of intoxication. Some signs of overdose may be dizziness, tremors, agitation, convulsions, coma, nausea, vomiting, changes in heart rate, decrease in blood pressure, and changes in body hydroelectrolytic 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 forgot to take a dose and remember before going to bed, take it immediately. The next day, follow the usual routine. If you remember during the night or the next day, skip the forgotten dose and follow the usual routine.

If you stop treatment with Escitalopram Kern Pharma

Do not stop treatment with Escitalopram Kern Pharma until your doctor tells you to. When you finish your treatment course, it is generally recommended that the dose of Escitalopram Kern Pharma 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 frequent when treatment with Escitalopram Kern Pharma is suspended. 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 the drops again and stop them more slowly.

The withdrawal symptoms include: feeling of dizziness (unstable or without balance), feeling of tingling, feeling of itching, 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 unease 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 medication, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medications, Escitalopram Kern Pharma can produce adverse effects, although not all people suffer from them.

The 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.

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

Uncommon adverse effects(may affect between 1 and 10 out of 1,000 patients):

• Unusual bleeding, including gastrointestinal bleeding.

Rare adverse effects(may affect between 1 and 10 out of 10,000 patients):

• 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 the following side effects, you should contact your doctor or go to the hospital immediately:

• Difficulty urinating.
• Seizures (attacks), see also the section "Be especially careful with Escitalopram Kern Pharma.
• Yellowish skin and whitening of the eyes, are signs of altered liver function/hepatitis.
• If you experience rapid or irregular heartbeats, fainting that could be symptoms of a life-threatening condition known as Torsade de Pointes.

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

Very common adverse effects(may affect more than 1 in 10 patients):

• Feeling nauseous (nausea).

Common adverse effects(may affectbetween 1 and 10 out of 100 patients):

• Nasal congestion or runny nose (sinusitis).
• Decreased or increased appetite.
• Anxiety, agitation, abnormal dreams, difficulty falling asleep, feeling drowsy, 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 adverse effects(may affectbetween 1 and 10 out of 1,000 patients):

• Hives, skin rash, itching (pruritus).
• Teeth grinding, agitation, nervousness, anxiety attacks, confused state.
• Sleep disturbances, taste disturbances, 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 adverse effects(may affectbetween 1 and 10 out of 10,000 patients):

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

Some patients have reported (frequency not known):

• Thoughts of harming oneself or thoughts of suicide, see also the section "Be especially careful with Escitalopram Kern Pharma.
• 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).
• Altered liver function tests (increased liver enzymes in the blood).
• Movement disorders (involuntary muscle movements).
• Painful erections (priapism).
• Bleeding disorders including skin and mucous membrane bleeding (ecchymosis) and low platelet counts in the blood (thrombocytopenia).
• Sudden swelling of the skin and mucous membranes (angioedema).
• Increased urine output (inadequate ADH secretion).
• Milk flow in non-lactating women.
• 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", checked in electrocardiograms, 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. These are:

• Motor restlessness (akathisia)
• Anorexia

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines (Website: 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 Kern Pharma

• Keep this medication out of the reach and sight of children.
• Do not use Escitalopram Kern Pharma after the expiration date that appears on the package after CAD. The expiration date is the last day of the month indicated.
• Once the package is opened, the drops can be used for 8 weeks and should be stored at a temperature below 25°C.
• Keep the bottle tightly closed and in a vertical position.
• This medication does not require special storage conditions if it is closed.

Medications should not be thrown away through the sewers or in the trash. Deposit the packages and medications you no longer need in the SIGRE point of the pharmacy. If in 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. Additional information

Composition of Escitalopram Kern Pharma

The active ingredient is escitalopram. Each ml of oral drops of Escitalopram Kern Pharma contains 20 mg of escitalopram (as escitalopram oxalate). 1 drop contains 1 mg of escitalopram.

The other components are: propyl gallate; anhydrous citric acid; 96% ethanol; sodium hydroxide and purified water.

This medication contains 4.7% ethanol (alcohol), which corresponds to an amount of 4.7 mg of ethanol per drop.

Appearance of the product and package contents

Escitalopram Kern Pharma oral drops in solution are presented in a 15ml amber glass bottle with a dropper and a child-resistant screw cap. It is a clear solution.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Kern Pharma, S.L.

Pol. Ind. Colón II, C/ Venus 72

08228 Terrassa (Barcelona)

Spain

Manufacturer

Chanelle Medical Unlimited Company

Loughrea, Co. Galway

Ireland

This medication is authorized in the EEA Member States under the following names:

Approval date of this prospectus: February 2021

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