PATIENT INFORMATION LEAFLET

Escitalopram Kern Pharma 20 mg / ml oral solution in EFG

Escitalopram

Read this leaflet carefully before you start taking this 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 for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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.

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).

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 a birth or have experienced an episode of heart rhythm alteration (verified by an electrocardiogram, a test to evaluate the heart's function).
• If you are taking medicines for heart rhythm problems or that can affect heart rhythm (see section 2 “Taking other medicines”).

Be especially 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 for the first time or if you observe an increase in seizure frequency (see also section 4 “Possible side effects”),
• If you have liver or kidney insufficiency. Your doctor may need to adjust your dose,
• If you have diabetes. Treatment with Escitalopram Kern Pharma may alter blood glucose control. You may need to adjust your insulin and/or oral hypoglycaemic dose,
• If you have a low sodium level in your blood,
• If you are prone to bleeding or bruising easily, or if you are pregnant (see “Pregnancy”)
• If you are receiving electroconvulsive therapy,
• If you have coronary disease,
• If you have or have had heart problems or have recently had a heart attack
• If your resting heart rate is slow and/or you know that you may have a low sodium level due to intense and prolonged vomiting and diarrhoea (due to illness) or the use of diuretics (tablets to dissolve in water)
• If you experience rapid or irregular heartbeats, dizziness, fainting, or dizziness when standing up, which may indicate abnormal heart rhythm.

Please note

Some patients with manic-depressive illness may enter a manic phase. This is characterised 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 weeks of treatment. Inform your doctor immediately if you experience these symptoms.

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.

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 taking your own life. These may increase when you first start taking antidepressants, as all these medicines take time to start working, usually around two weeks, although in some cases it may take longer.Youmay be more likely to have these thoughts:

• If you have previously had thoughts of harming yourself or taking your own life.
• If you are ayoung adult. Clinical trial information has shown an increased risk of suicidal behaviour in adults under 25 years with psychiatric illnesses who were treated with an antidepressant.

If you ever have thoughts of harming yourself or taking your own life, contact your doctor or go directly to a hospital.

It may be helpful to tell a family member 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. Also, be aware that in patients under 18 years there is a higher risk of adverse effects such as suicidal thoughts, suicidal ideation, and hostility (mainly aggression, confrontational behaviour, and irritability) when taking this type of medicine. However, your doctor may prescribe Escitalopram Kern Pharma to patients under 18 years if they decide it is the best option for the patient. If the doctor who prescribed Escitalopram Kern Pharma to you is under 18 years and wants to discuss this decision, please return to your doctor.

Please inform your doctor if any of the symptoms described above worsen 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 behavioural development of Escitalopram Kern Pharma in this age group have not yet been demonstrated.

Taking other medicines

Please inform your doctor or pharmacist if you are using, or have recently used, other medicines, including 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 ingredients. If you have taken any of these medicines, you will need to wait 14 days before starting to take Escitalopram Kern Pharma. After stopping Escitalopram Kern Pharma, 7 days must pass before taking any of these medicines.
• "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 adverse effects.
• The antibiotic linezolid.
• Lithium (used in the treatment of manic-depressive illness) and tryptophan.
• Imipramine and desipramine (both used for the treatment of depression).
• Sumatriptan and similar medicines (used for the treatment of migraine) and tramadol (used for severe pain). These increase the risk of adverse effects.
• Cimetidine, lansoprazole, and omeprazole (used for the treatment of stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These may cause an increase in escitalopram blood levels.
• St. John's Wort (Hypericum perforatum) – a medicinal plant used for depression.
• Acetylsalicylic acid (aspirin) and non-steroidal anti-inflammatory drugs (medicines used to relieve pain or to reduce the risk of thrombosis, also called anticoagulants). These may increase the risk of bleeding.
• 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 start 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), 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 Pharma if you are taking medicines for heart rhythm problems or that can affect heart rhythm, e.g. antiarrhythmic Class IA and III, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacine, moxifloxacine, erythromycin IV, pentamidine, malaria treatment, in particular, halofantrine), certain antihistamines (astemizol, mizolastine). Consult your doctor if you are unsure.

Taking Escitalopram Kern Pharma with food and drink

Escitalopram Kern Pharma can be taken with or without food (see section 3 “How to take escitalopram”). As with many medicines, it is not recommended to combine Escitalopram Kern Pharma with alcohol, although it is not expected to interact with alcohol.

Pregnancy and breastfeeding

Studies in animals treated with citalopram, a medicine like escitalopram, have shown that it reduces the quality of sperm. Theoretically, this could affect fertility, but no adverse effects on human fertility have been observed so far.

Please inform your doctor if you are pregnant or plan to become pregnant. Do not take Escitalopram Kern Pharma unless you and your doctor have weighed the risks and benefits.If you take Escitalopram Kern Pharma 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 so they can advise you.

Escitalopram Kern Pharma may be excreted in breast milk. Therefore, 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 baby: difficulty breathing, blue skin, convulsions, 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.

Please ensure that your midwife and/or doctor know that you are being treated with Escitalopram Kern Pharma. During pregnancy, particularly in the last three months, medicines like Escitalopram Kern Pharma 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 start within the first 24 hours after birth. If they occur in your baby, you should contact your midwife and/or doctor immediately.

If Escitalopram Kern Pharma is used during pregnancy, it should not be stopped abruptly.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

It is recommended that you do not drive or operate machinery until you know how Escitalopram Kern Pharma affects you.

Important information about some of the ingredients of Escitalopram Kern Pharma

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

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

Count the necessary number of drops in your drink (water, orange or apple juice), shake it 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 for the first week before increasing the dose to 10 mg (10 drops) per day. Your doctor may increase it further 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.

Older adults (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.

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 the treatment too soon, symptoms may reappear. It is recommended that the 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 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

Do it even if 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 forgot to take Escitalopram Kern Pharma:

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

If you interrupt the treatment with Escitalopram Kern Pharma:

Do not interrupt the treatment with Escitalopram Kern Pharma until your doctor tells you to. When you have finished your treatment course, it is usually recommended that the Escitalopram Kern Pharma dose be gradually reduced 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 may 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 the drops again and taper them off 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 (intense dreams, nightmares, inability to sleep), feeling of restlessness, headache, feeling of nausea (dizziness), sweating (including night sweats), feeling of anxiety or agitation, tremor (unsteadiness), 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 medication, ask your doctor or pharmacist.

Like all medicines, Escitalopram Kern Pharma may cause side effects, although not everyone will experience them.

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 improve as you start to feel better.

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

Uncommon side effects(may affect between 1 and 10 in every 1,000 patients):

• Unusual bleeding, including gastrointestinal bleeding.

Rare side effects(may affect between 1 and 10 in every 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 (convulsions), see also the section "Be especially careful with Escitalopram Kern Pharma."
• Yellowing of the skin and whitening of the eyes, which are signs of liver dysfunction/hepatitis.
• If you experience rapid or irregular heart palpitations, dizziness, which could be symptoms of a life-threatening condition known as Torsade de Pointes.

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

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

• Feeling dizzy (nausea).

Common side effects(may affect between 1 and 10 in every 100 patients):

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

Uncommon side effects(may affect between 1 and 10 in every 1,000 patients):

• Hives, skin rash, itching (pruritus).
• Teeth chattering, agitation, nervousness, anxiety attack, state of 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 side effects(may affect between 1 and 10 in every 10,000 patients):

• 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).
• Abnormal 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 skin and mucous membrane swelling (angioedema).
• Inadequate ADH secretion, resulting in increased urine production.
• Milk leakage in women who are not breastfeeding.
• Mania.
• An increased risk of bone fractures has been observed in patients treated with this type of medication.
• Alteration of heart rhythm (called "prolongation of the QT interval," confirmed by electrocardiogram, heart electrical activity).
• Heavy vaginal bleeding shortly after delivery (postpartum hemorrhage), see“Pregnancy” in thesection 2 for more information.

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

• Motor restlessness (akathisia)
• Anorexia

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use (Website: https://www.notificaram.es).

By reporting side effects, you can contribute to providing more information on the safety of this medication.

• 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 packaging after CAD. The expiration date is the last day of the month indicated.
• Once the packaging 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 an upright position.
• This medication does not require special storage conditions if it is closed.

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

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 medicine contains 4.7% ethanol (alcohol), which corresponds to 4.7 mg of ethanol per drop.

Appearance of the product and contents of the package

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

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Kern Pharma, S.L.

Pol. Ind. Colón II, C/ Venus 72

08228 Terrassa (Barcelona)

Spain

Responsible for manufacturing

Chanelle Medical Unlimited Company

Loughrea, Co.Galway

Ireland

This medicine is authorized in the Member States of the EEA under the following denominations:

Approval date of this leaflet: February 2021

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