Escitalopram Pensa 10 mg film-coated tablets EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Escitalopram Pensa 10 mg Film-coated Tablets EFG

escitalopram oxalate

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• 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 you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet Contents

1. What Escitalopram Pensa is and what it is used for
2. What you need to know before taking Escitalopram Pensa
3. How to take Escitalopram Pensa
4. Possible adverse effects
5. How to store Escitalopram Pensa
6. Contents of the pack and other information

1. What Escitalopram Pensa is and what it is used for

Escitalopram Pensa 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.

It may take a couple of weeks before you start to feel better. Continue taking Escitalopram Pensa even if it takes some time to notice improvement.

You should consult a doctor if you worsen or do not improve.

2. What you need to know before taking Escitalopram Pensa

Do not take Escitalopram Pensa:

• If you are allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6).
• 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 episodes of such a condition (this is detected by electrocardiogram, a test used to evaluate 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”).

Warnings and precautions:

Talk to your doctor or pharmacist before starting to take Escitalopram Pensa.

Please inform your doctor if you have any other disorders or illnesses, as your doctor may need to take them into account. Specifically, inform your doctor:

• If you have epilepsy. Treatment with Escitalopram Pensa 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 impairment. Your doctor may need to adjust your dose.
• If you have diabetes. Treatment with Escitalopram Pensa 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 (history of bleeding disorders), or if you are pregnant (see “Pregnancy, breastfeeding and fertility”).
• 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 while at rest (known as bradycardia) and/or if 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 to increase urine production).
• If you have noticed rapid or irregular heartbeats, or have experienced fainting or dizziness when standing up from a sitting or lying position. These symptoms may indicate a heart rhythm disorder.
• If you have or have previously had eye problems, such as certain types of glaucoma (increased pressure in the eye).

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.

Some medicines in the same class as Escitalopram Pensa (called SSRIs/SNRIs) may cause sexual dysfunction symptoms (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 of self-harm or suicide. These may increase when starting antidepressants, as all such medicines require time to take effect—usually about two weeks, although in some cases it may take longer.

You are more likely to have such 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 young adults (under 25 years) with psychiatric disorders treated with an antidepressant.

If at any time you have thoughts of self-harm or suicide, contact your doctor or go directly to a hospital.

It may be helpful to tell a close family member 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.

Paediatric population and adolescents under 18 years

Escitalopram Pensa should not normally be used in the treatment of children and adolescents under 18 years of age. Also, 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 Pensa to patients under 18 years of age if they consider it to be in the patient’s best interest. If your doctor has prescribed Escitalopram Pensa to a patient under 18 years of age and you wish to discuss this decision, please consult your doctor again. Inform your doctor immediately if any of the symptoms described above worsen or develop complications while a patient under 18 years of age is taking Escitalopram Pensa. Furthermore, the long-term effects on safety, growth, maturation, and cognitive and behavioural development of Escitalopram Pensa in this age group have not yet been established.

Use of Escitalopram Pensa with other medicines:

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Tell 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 Pensa. After stopping Escitalopram Pensa, 7 days must pass before starting 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.

• The antibiotic linezolid.

• 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 cause increased blood levels of Escitalopram Pensa.

• St. John’s wort (Hypericum perforatum) – a herbal remedy used for depression.

• Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medicines used to relieve pain or reduce the risk of thrombosis, also known as anticoagulants). These may increase the tendency to bleed.

• Warfarin, dipyridamole, and phenprocoumon (medicines used to reduce the risk of thrombosis, also known as anticoagulants). Your doctor will likely monitor your blood clotting time at the beginning and end of treatment with Escitalopram Pensa 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) and antidepressants (tricyclic antidepressants and SSRIs), due to the possible risk of lowering the seizure threshold.

• Flecainide, propafenone, and metoprolol (used in cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). The dose of Escitalopram Pensa may need to be adjusted.

• Medicines that reduce blood potassium or magnesium levels, as this increases the risk of life-threatening heart rhythm disturbances.

Do not take Escitalopram Pensa:

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 Pensa with food, drinks and alcohol:

Escitalopram Pensa can be taken with or without food (see section 3 “How to take Escitalopram Pensa”).

As with many medicines, combining Escitalopram Pensa with alcohol is not recommended, although a direct interaction between Escitalopram Pensa and alcohol is not expected.

Pregnancy, breastfeeding and fertility:

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy:

Do not take Escitalopram Pensa if you are pregnant unless you and your doctor have carefully considered the risks and benefits.

If you take Escitalopram Pensa during the last 3 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 weakness, exaggerated reflexes, tremors, restlessness, irritability, lethargy, constant crying, drowsiness, and difficulty sleeping. If your newborn baby shows any of these symptoms, contact your doctor immediately.

If you take Escitalopram Pensa in late pregnancy, you may have 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 escitalopram so they can provide appropriate advice.

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

Ensure that your midwife and/or doctor knows you are taking Escitalopram Pensa. Medicines like Escitalopram Pensa, when taken during pregnancy—particularly during the last 3 months—may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and appear blue. These symptoms usually begin within the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.

Breastfeeding:

Do not take Escitalopram Pensa while breastfeeding unless you and your doctor have carefully considered the risks and benefits.

Escitalopram is expected to be excreted in breast milk.

Fertility:

Citalopram, a medicine similar to escitalopram, has been shown in animal studies to reduce sperm quality. Theoretically, this could affect fertility, but an effect on human fertility has not been observed so far.

Driving and using machines:

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

Important information about some of the ingredients of Escitalopram Pensa:

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Escitalopram Pensa

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist.

Adults

Depression

The normally recommended dose of Escitalopram Pensa 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 Pensa 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 Pensa is 10 mg taken as a single daily dose.

Your doctor may reduce your dose to 5 mg per day or increase the dose up to a maximum of 20 mg per day, depending on how you respond to the medication.

Generalized anxiety disorder

The normally recommended dose of Escitalopram Pensa 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 Pensa 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)

A starting dose of 5 mg of escitalopram per day is recommended. If necessary, your doctor may increase your dose up to a maximum of 10 mg per day.

Paediatric population and adolescents (under 18 years of age)

Escitalopram Pensa should normally not be administered to paediatric and adolescent populations. For further information, please see section 2 (“What you need to know before taking Escitalopram Pensa”).

Method of administration:

You may take Escitalopram Pensa 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 side facing upwards. The tablets can be broken by pressing downwards with both index fingers at each end of the tablet.

Duration of treatment

It may take a few weeks before you start to feel better. Continue taking Escitalopram Pensa even if you start to feel better before the expected time.

Do not alter the dose of the medicine without first speaking to your doctor.

Continue taking Escitalopram Pensa 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 Pensa than you should:

If you take more Escitalopram Pensa than prescribed, contact your doctor immediately, go to the nearest hospital emergency department, or contact the Toxicology Information Service (telephone: 91 562 04 20). Do this even if you do not notice any discomfort or signs of poisoning.

Some of the signs of overdose may include dizziness, tremor, agitation, seizures, coma, nausea, vomiting, changes in heart rhythm, decreased blood pressure, and disturbances in the body's fluid and electrolyte balance. Take the Escitalopram Pensa packaging with you if you go to see a doctor or to hospital.

If you forget to take Escitalopram Pensa:

Do not take a double dose to make up for forgotten doses. If you forget to take a dose and remember before going to bed, take it immediately. On the following day, continue as usual.

If you remember during the night or the next day, skip the missed dose and continue as usual.

If you stop taking Escitalopram Pensa:

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

When you stop taking Escitalopram Pensa, especially if abruptly, you may experience withdrawal symptoms. These are common when treatment with Escitalopram Pensa is discontinued. The risk is greater when Escitalopram Pensa 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 more). If you experience severe withdrawal symptoms when stopping Escitalopram Pensa, please contact your doctor. He or she may ask you to resume taking your tablets and then stop 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); feelings of restlessness; headache; dizziness (nausea); sweating (including night sweats); feelings of anxiety or agitation; tremor (shakiness); feelings of confusion or disorientation; feelings of emotional disturbance or irritability; diarrhoea (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, this medicine can cause adverse effects, although not everyone experiences them.

Adverse effects are generally mild and 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.

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

Uncommon (may affect up to 1 in 100 people):

• Unusual bleeding, including gastrointestinal bleeding.

Rare (may affect up to 1 in 1,000 people):

• If you notice swelling of the skin, tongue, lips, throat, or face, hives, 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.

Frequency not known (cannot be estimated from available data):

• Difficulty urinating.
• Seizures (fits), see also section “Take special care with Escitalopram Pensa”.
• Yellowing of the skin and whitening of the eyes, 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.
• Thoughts of harming yourself or thoughts of killing yourself, see also section “Warnings and precautions”.
• Sudden swelling of the skin or mucous membranes (angioedema).

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

Very common (may affect more than 1 in 10 people):

• Feeling dizzy (nausea).
• Headache.

Common (may affect up to 1 in 10 people):

• Nasal congestion or mucus (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, problems with erection, decreased sexual drive, and women may experience difficulty achieving orgasm).

• Fatigue, fever.

• Weight gain.

Uncommon (may affect up to 1 in 100 people):

• Hives, skin rash, itching (pruritus).
• Teeth grinding, restlessness, nervousness, panic attacks, confusion.
• Sleep disturbances, taste disturbances, fainting (syncope).
• Dilated pupils (mydriasis), visual disturbances, ringing in the ears (tinnitus).
• Hair loss.
• Excessive menstrual bleeding.
• Irregular menstrual periods.
• Weight loss.
• Fast heartbeat.
• Swelling of arms and legs.
• Nosebleeds.

Rare (may affect up to 1 in 1,000 people):

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

Frequency not known (cannot be estimated from available data):

• Decreased sodium levels 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 (elevated liver enzymes in the blood).
• Movement disorders (involuntary muscle movements).
• Painful erections (priapism).
• Signs of abnormal bleeding, e.g., from the skin or mucous membranes (bruising).
• Increased secretion of the hormone called ADH, causing water retention in the body and dilution of the blood, reducing sodium levels (inappropriate antidiuretic hormone secretion).
• Milk discharge in men and 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 (known as QT interval prolongation, observed on electrocardiogram).
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see “Pregnancy, breastfeeding and fertility” in section 2 for more information.

Other adverse effects are known to occur with drugs that act similarly to escitalopram (the active substance in Escitalopram Pensa). These include:

• Motor restlessness (akathisia).
• Loss of appetite.

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

Reporting of adverse effects:

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Escitalopram Pensa

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection 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. Contents of the pack and other information

Composition of Escitalopram Pensa:

The active substance is escitalopram. Each tablet contains 10 mg of escitalopram (as oxalate).

The other components are:

• Tablet core: colloidal anhydrous silica, lactose monohydrate, povidone, microcrystalline cellulose, sodium croscarmellose, talc, and magnesium stearate.
• Coating: hypromellose, titanium dioxide, and macrogol 400.

Appearance of the medicinal product and contents of the pack:

Escitalopram Pensa is presented as white, coated, cylindrical, biconvex, scored tablets, marked with the code "ES1".

Escitalopram Pensa is available in packs containing 28 or 56 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Laboratorios Cinfa, S.A.

Olaz-Chipi, 10 – Polígono Areta

31620 Huarte-Pamplona (Navarra)

Spain

This leaflet was last revised in September 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) http://www.aemps.gob.es/