Escitalopram Kern Pharma 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Escitalopram KERN PHARMA 20 mg film-coated tablets EFG

Escitalopram

Package leaflet contents:

1. What Escitalopram KERN PHARMA 20 mg tablets are and what they are used for
2. Before taking Escitalopram KERN PHARMA 20 mg tablets
3. How to take Escitalopram KERN PHARMA 20 mg tablets
4. Possible side effects
5. Storage of Escitalopram KERN PHARMA 20 mg tablets
6. Further information

1. What Escitalopram Kern Pharma 20 mg tablets are and what they are 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 known as selective serotonin reuptake inhibitors (SSRIs). These medicines act on the serotonergic system in the brain by increasing the level of serotonin. Alterations in the serotonergic system are considered an important factor in the development of depression and related conditions.

2. Before taking Escitalopram Kern Pharma 20 mg tablets

Do not take Escitalopram Kern Pharma

• if you are allergic (hypersensitive) to escitalopram or to any of the other ingredients of Escitalopram Kern Pharma (see section 6 “Further information”),
• if you are taking other medicines belonging 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 a congenital heart rhythm disorder or have ever experienced an episode of such a disorder (this is detected by electrocardiogram, a test used to assess heart function).
• If you are taking medicines for heart rhythm disorders or medicines that may affect heart rhythm (see section 2 “Use with 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 take this into account. Specifically, inform your doctor:

• if you have epilepsy. Treatment with Escitalopram Kern Pharma should be discontinued if seizures occur or if you 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. Adjustment of insulin and/or oral hypoglycaemic agent dosage 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 section “Pregnancy and breastfeeding”),

• 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 heart beats slowly at rest (known as bradycardia) and/or you suspect your body may be losing salts, for example due to severe diarrhoea and vomiting over several days or due to diuretic use (medicines for increasing urine output),

• if you have noticed rapid or irregular heartbeats or have experienced fainting or dizziness when standing up from a sitting or lying position. This could indicate a heart rhythm disorder.

Please note:

Some patients with bipolar disorder may enter a manic phase. This is characterized 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 few weeks of treatment. Inform your doctor immediately if you experience these symptoms.

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 of harming yourself or ending your life. These thoughts may increase when you first start taking antidepressants, as all such medicines require time to begin working—usually about two weeks, although in some cases it may take longer. You are more likely to have these thoughts:

• If you have previously had thoughts of self-harm or suicide.
• 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 inform 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.

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

Use in children and adolescents under 18 years of age:

Escitalopram Kern Pharma should not normally be used to treat children and adolescents under 18 years of age. Furthermore, you should be aware that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal ideation, and hostility (predominantly 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 the most appropriate treatment. 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. You should inform your doctor if any of the previously described symptoms worsen or develop complications while a patient under 18 years of age is taking Escitalopram Kern Pharma. In addition, the long-term effects on safety, as well as on growth, maturation, and cognitive and behavioural development of Escitalopram Kern Pharma in this age group have not yet been fully established.

Use with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take 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 in the treatment of depression).
• “Irreversible MAO-B inhibitors” containing selegiline (used in the treatment of Parkinson’s disease). These increase the risk of side effects.
• Lithium (used in the treatment of bipolar disorder) and tryptophan.
• Imipramine and desipramine (both used to treat depression).
• Sumatriptan and similar medicines (used to treat migraine) and tramadol (used for severe pain). These increase the risk of side effects.
• Cimetidine, lansoprazole, and omeprazole (used to treat 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 Kern Pharma.
• St. John’s wort (Hypericum perforatum) – a herbal remedy used for depression.
• Aspirin and non-steroidal anti-inflammatory drugs (medicines used to relieve pain or reduce the risk of thrombosis, also called anticoagulants).
• 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 remains appropriate.
• Mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used to treat severe pain) due to the possible risk of lowering the seizure threshold.
• Neuroleptics (medicines used to treat schizophrenia, psychosis) due to the possible risk of lowering the seizure threshold and antidepressants.
• Flecainide, propafenone, and metoprolol (used for cardiovascular diseases), and desipramine, 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 disorders or medicines that may affect heart rhythm, such as class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarials particularly halofantrine), or certain antihistamines (astemizole, mizolastine).

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

Taking Escitalopram Kern Pharma with food and drink

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

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

Inform your doctor if you are pregnant or planning 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 in the late stages of pregnancy, there may be 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 appropriately.

If you take Escitalopram Kern Pharma during the last 3 months of pregnancy, be aware that 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, sleepiness, and difficulty sleeping. If your newborn baby shows any of these symptoms, please contact your doctor immediately.

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

Do not take Escitalopram Kern Pharma while breastfeeding unless you and your doctor have discussed the risks and benefits involved.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

It is advised not to drive or operate machinery until you know how Escitalopram Kern Pharma affects you.

3. How to take Escitalopram Kern Pharma 20 mg tablets

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

Adults

Depression

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

Generalized anxiety disorder

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

Elderly patients (over 65 years of age)

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 of age)

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 may 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 may split the tablets by placing the tablet on a flat surface with the score facing upwards. The tablets can be broken by pressing down on each end of the tablet.

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 alter 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 prescribed, contact your doctor immediately, go to the nearest hospital emergency department, or contact the Toxicology Information Service at telephone number 91 562 04 20. Do so even if you do not notice 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 packaging 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 do so. When you have completed your course of treatment, it is generally recommended that the dose of Escitalopram 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 greater 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 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 ask you to resume taking your tablets and taper them 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 (excessively vivid dreams, nightmares, inability to sleep); restlessness, headache, dizziness (nausea), sweating (including night sweats), feelings of agitation or restlessness, tremor (shakiness), feelings of confusion or disorientation, emotional or irritable feelings, diarrhea (loose stools), visual disturbances, rapid pulse or palpitations.

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

4. Possible adverse effects

Like all medicines, Escitalopram Kern Pharma may cause adverse effects, although not everyone gets 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 (affects at least 1 in 1,000 and less than 1 in 100 people):

• Unusual bleeding, including gastrointestinal bleeding.

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

• 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 develop high fever, agitation, confusion, tremors, and sudden muscle contractions, these may be signs of a rare condition called serotonin syndrome. If you feel like this, contact your doctor.

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

• Difficulty urinating.
• Seizures (fits), see section “Special warnings and precautions for use”.
• Yellowing of the skin and whitening of the eyes, which are signs of liver dysfunction/hepatitis.
• Fast or irregular heartbeat or feeling faint, as these could be symptoms of a serious heart problem known as torsade de pointes.

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

Very common (affects at least 1 in 10 people):

• Feeling sick (nausea).

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

• Nasal congestion or runny nose (sinusitis).
• Decreased or increased appetite.
• Anxiety, restlessness, 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 disturbances (delayed ejaculation, problems with erection, reduced sexual drive, and women may experience difficulty achieving orgasm).
• Fatigue, fever.
• Weight gain.

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

• 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 heartbeat.
• Swelling of arms and legs.
• Nosebleeds.

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

• 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 “Special warnings and precautions for use”.
• Decreased sodium levels in the blood (symptoms include dizziness and feeling unwell with muscle weakness or confusion).
• Dizziness upon standing due to low blood pressure (orthostatic hypotension).
• Abnormal liver function tests (increased liver enzymes in blood).
• Movement disorders (involuntary muscle movements).
• Painful erections (priapism).
• Bleeding disorders including bleeding from skin and mucous membranes (bruising) and low platelet counts in blood (thrombocytopenia).
• Sudden swelling of skin and mucous membranes (angioedema).
• Increased urine output (inappropriate ADH secretion).
• Milk production in women who are not breastfeeding.
• Mania.
• Changes in heart rhythm (known as QT interval prolongation, observed on electrocardiogram).
• Heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage), see section 2 “Pregnancy and breastfeeding” for more information.

Other adverse effects are known to occur with medicines that act similarly to escitalopram. These include:

• Motor restlessness (akathisia).
• Anorexia.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of Escitalopram Kern Pharma 20 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Additional Information

Composition of Escitalopram Kern Pharma 20 mg tablets

The active substance is escitalopram. Each tablet of Escitalopram Kern Pharma contains 20 mg of escitalopram.

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

Appearance of the product and contents of the container

Escitalopram Kern Pharma 20 mg is presented as film-coated tablets.

The tablets are oval, white, biconvex, film-coated, marked with an "E" on one side, a central groove on the other side, and lateral grooves.

Escitalopram Kern Pharma 20 mg is available 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 up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) www.aemps.gob.es