Escitalopram Qualigen 15 mg film-coated tablets EFG

Package Leaflet: Information for the User

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Escitalopram Qualigen 15 mg film-coated tablets EFG

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 should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet Contents:

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

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

Escitalopram Qualigen 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, and obsessive-compulsive disorder).

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. Disturbances in the serotonin system are considered an important factor in the development of depression and related conditions.

2. What you need to know before taking Escitalopram Qualigen

Do not take Escitalopram Qualigen

• 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 used to treat depression or anxiety called “non-selective monoamine oxidase inhibitors (MAOIs)”. (See section “Other medicines and Escitalopram Qualigen”).
• If you have a congenital heart rhythm disorder or have ever experienced an episode of this type (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 “Other medicines and Escitalopram Qualigen”).

Warnings and precautions
Talk to your doctor or pharmacist before starting to take Escitalopram Qualigen. 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 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 (liver) or renal (kidney) impairment. Your doctor may need to adjust your dose.
• If you have diabetes. Treatment with escitalopram may alter glycaemic control, in which case adjustment of insulin and/or oral hypoglycaemic agent dosage may be necessary.
• If you have low sodium levels in your blood.
• If you tend to develop bleeding or bruising easily, or if you are pregnant (see “Pregnancy, breastfeeding and fertility”).
• If you are receiving electroconvulsive therapy.
• If you have or have had heart problems or have recently had 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 that 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 could indicate a heart rhythm disorder.

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

Please bear in mind

Some patients with bipolar disorder may enter a manic phase. This is characterised by unusually rapid and frequent changes of thought, disproportionate 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 about harming or killing yourself. 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 harming or killing 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 family member or close 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 whether they are concerned about changes in your behaviour.

Bone fractures

An increased risk of bone fractures has been observed in patients treated with this type of medicine.

Children and adolescents (under 18 years of age)

Escitalopram should not normally be used in the treatment of children and adolescents under 18 years of age.

Additionally, 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 (predominantly aggression, confrontational behaviour, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe escitalopram to patients under 18 years of age if they decide it is the most appropriate treatment. If your doctor has prescribed escitalopram to a patient under 18 years of age and you wish to discuss this decision, please return to your doctor. You must inform your doctor if any of the symptoms listed below worsen or become complicated while patients under 18 years of age are taking escitalopram. In addition, the long-term effects on safety, growth, maturation, and cognitive and behavioural development of escitalopram in this age group have not yet been fully established.

Other medicines and Escitalopram Qualigen
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 or pharmacist 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. After stopping escitalopram, you must wait 7 days before taking any of these medicines.
• “Reversible selective MAO-A inhibitors” containing moclobemide (used to treat depression).
• “Irreversible MAO-B inhibitors” containing selegiline (used to treat Parkinson’s disease). These increase the risk of side effects.
• Lithium (used to treat 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 escitalopram blood levels.
• 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 escitalopram treatment to ensure your anticoagulant dose remains appropriate.
• Mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used to treat severe pain), due to a possible risk of lowering the seizure threshold.
• Neuroleptics (medicines used to treat schizophrenia, psychosis), due to a possible risk of lowering the seizure threshold, and other antidepressants.
• Flecainide, propafenone, and metoprolol (used for cardiovascular diseases), desipramine, clomipramine, and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). The dose of escitalopram may need to be adjusted.

Do not take Escitalopram Qualigen 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 Qualigen with food, drinks, and alcohol

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

As with many medicines, combining escitalopram with alcohol is not recommended.

Pregnancy, breastfeeding and fertility

Consult your doctor or pharmacist before using any medicine.

Pregnancy

Inform your doctor if you are pregnant or plan to become pregnant. Do not take escitalopram during pregnancy unless you and your doctor have discussed the risks and benefits involved.

If you take Escitalopram Qualigen 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 Escitalopram Qualigen so they can advise you appropriately.

Ensure that your midwife and/or doctor knows you are taking Escitalopram Qualigen. Medicines such as Escitalopram Qualigen, when taken during pregnancy—particularly during the last three months—may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes 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.

If you take escitalopram during the last three months of pregnancy, the following effects may occur in the newborn baby: breathing difficulties, blue skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or floppiness, strong 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 escitalopram is used during pregnancy, it should never be stopped abruptly.

Breastfeeding

Do not take escitalopram while breastfeeding unless your doctor has evaluated the risks and benefits involved.

Fertility

Citalopram, a medicine similar to escitalopram, has been shown in animal studies to reduce sperm quality. Theoretically, this could affect fertility, but no impact on human fertility has been observed so far.

Driving and using machines:

During treatment with Escitalopram Qualigen, you may feel drowsy or dizzy. Do not drive or operate tools or machinery until you know how Escitalopram Qualigen affects you.

Escitalopram Qualigen contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; essentially “sodium-free”.

3. How to take Escitalopram Qualigen

Follow exactly the instructions for using Escitalopram Qualigen as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults

Depression

The normally recommended dose of escitalopram is 10 mg 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 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 recommended dose of escitalopram 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.

Obsessive-compulsive disorder

The recommended dose of escitalopram 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.

Patients aged 65 years and over

It is recommended to start with a dose of Escitalopram Qualigen of 5 mg per day. If necessary, your doctor may increase this dose up to a maximum of 10 mg daily.

Use in children and adolescents (under 18 years)

Escitalopram should normally not be given to children and adolescents. For further information, please see section 2 “What you need to know before taking Escitalopram Qualigen”.

You may take Escitalopram Qualigen with or without food. Swallow the tablets with water. Do not chew them. The tablet may be divided into equal doses. If necessary, you can split the tablets by placing the tablet on a flat surface with the score side facing upwards. The tablets can be broken by pressing down on each end of the tablet with your two index fingers.

Duration of treatment

It may take a few weeks before you start to feel better. Continue taking escitalopram even if you start to feel better before that time.

Do not change the dose of the medication without first talking to your doctor.

Continue taking escitalopram for as long as your doctor recommends. 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 Qualigen than you should

If you have taken more escitalopram tablets than you should, contact your doctor or pharmacist immediately, go to the nearest hospital or call the Toxicology Information Service at 915 620 420, stating the medication and the amount taken.

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 rate, decreased blood pressure, and disturbances in the body's fluid and electrolyte balance. Take the medicine packaging with you if you go to see a doctor or to the hospital.

If you forget to take Escitalopram Qualigen

Do not take a double dose to make up for missed doses. If you forget to take a dose, take it as soon as you can. However, if it is almost time for your next dose, wait until then and take your next dose at the usual time.

If you stop taking Escitalopram Qualigen

Do not stop treatment with escitalopram until your doctor tells you to. 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, especially if stopped abruptly, you may experience withdrawal symptoms. These are common when treatment with escitalopram is discontinued. The risk is higher when escitalopram 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, contact your doctor. Your doctor may advise you to restart taking your tablets and then taper off more slowly.

Withdrawal symptoms include: dizziness (feeling unsteady or off-balance), tingling sensations, prickling sensations, and (less frequently) electric shock-like sensations, even in the head; sleep disturbances (vivid dreams, nightmares, inability to sleep); restlessness; headache; dizziness (nausea); sweating (including night sweats); feelings of unease or agitation; tremor (shakiness); feelings of confusion or disorientation; emotional lability or irritability; diarrhoea (loose stools); visual disturbances; rapid heartbeat 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 will experience them. Inform your doctor if you experience any of the following adverse effects.

Adverse effects are generally mild and usually disappear after a few weeks of treatment. Bear in mind 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 patients):

• Unusual bleeding, including gastrointestinal bleeding.

Rare (affects at least 1 in 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 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 any of the following adverse effects, you must contact your doctor or go to the hospital immediately:

• Difficulty urinating.
• Seizures (fits); see also section “Warnings and precautions”.
• Yellowing of the skin and whites of the eyes, which are signs of impaired liver function (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 patients):

• Feeling nauseous.

Common (affects at least 1 in 100 patients):

• Nasal congestion or mucus (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 (myalgia and arthralgia).
• Sexual disturbances (delayed ejaculation, erection problems, reduced sexual interest, and women may experience difficulty achieving orgasm).
• Fatigue, fever.
• Weight gain.

Uncommon (affects at least 1 in 1,000 patients):

• Hives, skin rash, itching (pruritus).
• Teeth grinding, agitation, 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 patients):

• Aggression, depersonalization, hallucinations.
• Slow heartbeat.
• Events related to suicide; see also section “Use in children and adolescents (under 18 years)” for more information.

Frequency not known:

Some patients have reported:

• 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 (increased liver enzymes in the blood).
• Movement disorders (involuntary muscle movements).
• Painful erections (priapism).
• Bleeding disorders including skin and mucosal bleeding (ecchymosis) and low platelet counts in the blood (thrombocytopenia).
• Sudden swelling of the skin or mucous membranes (angioedema).
• Increased urine output (inappropriate antidiuretic hormone secretion).
• Milk discharge 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 “Pregnancy, breastfeeding and fertility” in section 2 for more information.

Other adverse effects are known to occur with drugs that work 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 effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through 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 Qualigen

• Keep this medicine out of the sight and reach of children. Storage:
  • PVC/PVDC-Al blister: Do not store above 25°C.
• Do not use Escitalopram Qualigen after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.
• Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Escitalopram Qualigen 15 mg tablets

The active substance is escitalopram. Each tablet contains 15 mg of escitalopram (as oxalate).

The other components are: microcrystalline cellulose (E460i), colloidal anhydrous silica, sodium croscarmellose, talc, magnesium stearate (E572), hypromellose (E464), titanium dioxide (E171), macrogol 6000.

Appearance of the product and pack contents

Escitalopram Qualigen 15 mg tablets are presented as white, oval, biconvex, film-coated tablets, scored on one side and marked with the letter "E-" on the other.

Each pack contains 28 or 56 tablets in a blister.

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Manufacturer

Actavis Limited

B16 Bulebel Industrial Estate

Zejtun ZTN 08

Malta

Date of the most recent revision of this leaflet: May 2021

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