Escitalopram Kern Pharma 20 mg/ml oral solution EFG

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Escitalopram Kern Pharma 20 mg / ml oral drops solution EFG

Escitalopram

Read the entire 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 and must not be given to others, even if they have the same symptoms as you, because it could be harmful to them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Escitalopram Kern Pharma is and what it is used for
2. Before you take Escitalopram Kern Pharma
3. How to take Escitalopram Kern Pharma
4. Possible side effects
5. How to store Escitalopram Kern Pharma
6. Further information

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

Escitalopram belongs to a group of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). These medicines act on the serotonin system in the brain by increasing the level of serotonin. 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 to any of the other components of Escitalopram Kern Pharma (see section 6 "Further information").
• If you are taking other medicines belonging to the group known as MAO 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 been born with or have experienced an episode of irregular heart rhythm (confirmed by an electrocardiogram, a test to assess heart function).
• If you are taking medicines for heart rhythm problems or that may affect your heart rhythm (see section 2 “Taking other medicines”).

Take special care with Escitalopram Kern Pharma:

Please inform your doctor if you have any other disorder or illness, as your doctor may need to consider this. Specifically, inform your doctor:

• if you have epilepsy. Treatment with Escitalopram Kern Pharma should be discontinued if you experience seizures for the first time or notice an increase in seizure frequency (see also section 4 “Possible side effects”),
• if you have hepatic or renal insufficiency. Your doctor may need to adjust your dose,
• if you have diabetes. Treatment with Escitalopram Kern Pharma may alter glycaemic control. A dose adjustment of insulin and/or oral hypoglycaemic agents may be necessary,
• if you have low sodium levels in the 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 artery disease,
• if you have or have had heart problems or recently suffered a heart attack,
• if your resting heart rate is slow and/or you know you may have low salt levels due to severe and prolonged vomiting and diarrhoea (due to illness) or use of diuretics (water tablets),
• if you experience rapid or irregular heartbeats, fainting, syncope, or dizziness upon standing, which may indicate abnormal heart rhythm.

Please note:

Some patients with bipolar disorder may enter a manic phase. This is characterised by unusually rapid and frequent shifts in thoughts, excessive happiness, and excessive physical activity. If you experience this, contact your doctor.

Symptoms such as restlessness or difficulty sitting or standing still may also occur during the first weeks of treatment. Inform your doctor immediately if you experience these symptoms.

Some medicines in the same class as Escitalopram Kern Pharma (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Suicidal thoughts and worsening of depression or anxiety disorder:

If you are depressed and/or suffer from an anxiety disorder, you may occasionally have thoughts about harming or killing yourself. These may increase when starting antidepressants, as all such medicines require time to begin working—usually about two weeks, although sometimes longer. You are more likely to have such thoughts:

• If you have previously had thoughts of killing or harming yourself.
• If you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in psychiatric patients under 25 years of age treated with an antidepressant.

If at any time you have thoughts of harming or killing yourself, contact your doctor or go directly to a hospital.

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

Use in children and adolescents under 18 years:

Escitalopram Kern Pharma should not normally be used to treat children and adolescents under 18 years of age. Also, you should know that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal ideation, and hostility (mainly aggression, confrontation behaviour, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe Escitalopram Kern Pharma to patients under 18 years of age if they decide it is most appropriate for the patient. If your doctor has prescribed Escitalopram Kern Pharma to a patient under 18 years of age and you wish to discuss this decision, please consult your doctor again.

Inform your doctor if any of the symptoms described above worsen or develop complications while patients under 18 years of age are taking Escitalopram Kern Pharma. In addition, the long-term effects on safety, growth, maturation, and cognitive and behavioural development of Escitalopram Kern Pharma in this age group have not yet been established.

Taking other medicines

Inform your doctor or pharmacist if you are using, or have recently used, any other medicines, including those obtained without a prescription. Inform your doctor if you are taking any of the following medicines:

• "Non-selective monoamine oxidase inhibitors (MAOIs)" containing phenelzine, iproniazid, isocarboxazid, nialamide, or tranylcypromine as active ingredients. If you have taken any of these medicines, you must wait 14 days before starting Escitalopram Kern Pharma. After stopping Escitalopram Kern Pharma, you must wait 7 days before taking any of these medicines.
• "Reversible selective MAO-A inhibitors" containing moclobemide (used for the treatment of depression).
• "Irreversible MAO-B inhibitors" containing selegiline (used for the treatment of Parkinson's disease). These increase the risk of side effects.
• The antibiotic linezolid.
• Lithium (used for the treatment of bipolar disorder) 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 side 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 increase blood levels of escitalopram.
• St. John's wort (Hypericum perforatum)—a herbal remedy used for depression.
• Acetylsalicylic acid (aspirin) and non-steroidal anti-inflammatory drugs (medicines used to relieve pain or reduce the risk of thrombosis, also called anticoagulants). These may increase the tendency to bleed.
• Warfarin, dipyridamole, and phenprocoumon (medicines used to reduce the risk of thrombosis, also called anticoagulants). Your doctor will likely monitor your blood clotting time at the beginning and end of treatment with Escitalopram Kern Pharma to ensure the anticoagulant dose is still appropriate.
• Mefloquine (used for the treatment of malaria), bupropion (used for the treatment of depression), and tramadol (used for the treatment of 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 for cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). The dose of Escitalopram Kern Pharma may need to be adjusted.

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

Taking Escitalopram Kern Pharma with food and drinks

Escitalopram Kern Pharma may be taken with or without food (see section 3 “How to take escitalopram”). As with many medicines, combining Escitalopram Kern Pharma with alcohol is not recommended, although no interaction between Escitalopram Kern Pharma and alcohol is expected.

Pregnancy and breastfeeding

Animal studies with citalopram, a drug similar to escitalopram, have shown reduced sperm quality. Theoretically, this could affect fertility, but to date, no effects on human fertility have been observed.

Inform your doctor if you are pregnant or plan to become pregnant. Do not take Escitalopram Kern Pharma during pregnancy unless you and your doctor have discussed the risks and benefits involved. If you take Escitalopram late in pregnancy, there is an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should be aware that you are taking this medicine so they can advise you.

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

If you take Escitalopram Kern Pharma during the last three months of pregnancy, the following effects may occur in the newborn baby: breathing difficulties, bluish skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or floppiness, exaggerated reflexes, tremors, restlessness, irritability, lethargy, constant crying, drowsiness, and sleep difficulties. If your newborn baby shows any of these symptoms, please contact your doctor immediately.

Ensure that your midwife and/or doctor know you are being treated with Escitalopram 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 begin within the first 24 hours after birth. If they occur in your baby, contact your midwife and/or doctor immediately.

If Escitalopram Kern Pharma is used during pregnancy, it must never be stopped abruptly.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

It is advisable not to 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.

3. How to take Escitalopram Kern Pharma

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

Count the required number of drops into your drink (water, orange or apple juice), stir briefly, and then 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 daily dose. Your doctor may increase this up to a maximum of 20 mg per day.

Panic disorder

The initial dose of Escitalopram Kern Pharma is 5 mg (5 drops) as a single daily dose for the first week before increasing the dose to 10 mg (10 drops) per day. Your doctor may subsequently increase the dose 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 daily dose. Your doctor may reduce your dose to 5 mg (5 drops) per day or increase it up to a maximum of 20 mg (20 drops) per day, depending on your response to the medication.

Generalized anxiety disorder

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

Elderly patients (over 65 years of age):

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

The dose may be increased by your doctor up to 10 mg per day.

Children and adolescents (under 18 years of age):

Escitalopram Kern Pharma should normally not be administered to children and adolescents. For further information, please see section 2.

Duration of treatment:

It may take a few 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 first speaking to your doctor.

Continue taking Escitalopram Kern Pharma for the length of time recommended by your doctor. If you stop treatment too early, symptoms may return. It is recommended that treatment continues for at least 6 months after you feel 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, contact your doctor, pharmacist, or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount ingested.

Do this even if you do not experience any discomfort or signs of poisoning. Some signs of overdose may include dizziness, tremor, agitation, seizures, coma, nausea, vomiting, changes in heart rate, decreased blood pressure, and disturbances in the body's fluid and electrolyte balance. Take the Escitalopram Kern Pharma container with you 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 missed doses. If you forget to take a dose and remember before going to bed, take it immediately. The next day, continue as usual. If you remember during the night or the following day, skip the missed dose and continue as usual.

If you stop taking Escitalopram Kern Pharma

Do not stop treatment with Escitalopram Kern Pharma until your doctor tells you to. When you have completed your course of treatment, 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 abruptly, you may experience withdrawal symptoms. These are common when treatment with Escitalopram Kern Pharma is discontinued. 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 resolve on their own within two weeks. However, in some patients, they may be severe or prolonged (2–3 months or longer). If you experience severe withdrawal symptoms when stopping Escitalopram Kern Pharma, please contact your doctor. He or she may advise you to restart taking the drops and to taper off more slowly.

Withdrawal symptoms include: dizziness (feeling unsteady or off balance), tingling sensations, burning sensations, and (less frequently) electric shock-like sensations, even in the head; sleep disturbances (vivid dreams, nightmares, inability to sleep); restlessness; headache; lightheadedness (nausea); sweating (including night sweats); feelings of uneasiness or agitation; tremor (shakiness); feelings of confusion or disorientation; emotional lability or irritability; diarrhea (loose stools); visual disturbances; rapid pulse or palpitations.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Escitalopram Kern Pharma can produce adverse effects, although not everyone will experience them.

Adverse effects usually disappear after a few weeks of treatment. Please be aware that many of these effects may be symptoms of your illness and will therefore improve as you start to feel better.

Visit your doctor if you experience 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 hospital immediately.
• If you have 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 the following side effects, you must contact your doctor or go to hospital immediately:

• Difficulty urinating.
• Seizures (fits), see also section "Take special care with Escitalopram Kern Pharma".
• Yellowing of the skin and whitening of the eyes, which are signs of liver function disturbances/hepatitis.
• If you experience rapid or irregular heartbeats, fainting, which 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 sick (nausea).

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

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

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

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

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

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

Some patients have reported (frequency not known):

• Thoughts of harming yourself or thoughts of killing yourself, see also section "Take special care with Escitalopram Kern Pharma".
• Decreased levels of sodium in the blood (symptoms include dizziness and malaise with muscle weakness or confusion).
• Dizziness upon standing due to low blood pressure (orthostatic hypotension).
• Abnormal liver function tests (increased liver enzymes in the blood).
• Movement disorders (involuntary muscle movements).
• Painful erections (priapism).
• Bleeding disorders including skin and mucosal bleeding (bruising) and low platelet levels in the blood (thrombocytopenia).
• Sudden swelling of the skin and mucous membranes (angioedema).
• Increased amount of urine excreted (inappropriate ADH secretion).
• Milk discharge in women who are not breastfeeding.
• Mania.
• An increased risk of bone fractures has been observed in patients treated with this type of medicine.
• Changes in heart rhythm (called "QT interval prolongation", detected on electrocardiograms, electrical activity of the heart).
• Heavy 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 act similarly to escitalopram. These include:

• Motor restlessness (akathisia)
• Anorexia

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines (Website: https://www.notificaram.es).

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Escitalopram Kern Pharma

• Keep this medicine out of the sight and reach of children.
• Do not use Escitalopram Kern Pharma after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
• After opening the container, the drops may 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 medicine does not require any special storage conditions when unopened.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Additional information

Composition of Escitalopram Kern Pharma

The active substance is escitalopram. Each ml of Escitalopram Kern Pharma oral drops solution 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), corresponding to 4.7 mg of ethanol per drop.

Appearance of the medicinal product and content of the container

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

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

Date of approval of this package leaflet: February 2021

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