ESCITALOPRAM COMBIX 15 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Escitalopram Combix 15 mg film-coated tablets EFG

Escitalopram

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

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

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

Escitalopram Combix belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). These medicines act on the serotonin system in the brain, increasing the level of serotonin. Alterations of the serotonin system are considered an important factor in the development of depression and related diseases.

Escitalopram Combix 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 you take Escitalopram Combix

Do not take Escitalopram Combix

• If you are allergic (hypersensitive) to the active substance escitalopram or to any of the other ingredients of Escitalopram Combix (see section 6 "Further information").
• If you are taking other medicines that belong to the group called 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 any type of heart rhythm disorder or have ever suffered from any episode of this type (this is observed with an electrocardiogram, a test used to evaluate how the heart works).
• If you are taking medicines for heart rhythm disorders or that may affect the heart rhythm (see section 2 "Using other medicines").

Be especially careful with Escitalopram Combix

Please inform your doctor if you suffer from any other disorder or disease, as your doctor may need to take it into account. In particular, inform your doctor:

• If you suffer from epilepsy. Treatment with Escitalopram Combix should be discontinued if seizures occur for the first time or if you observe an increase in the frequency of seizures (see also section 4 "Possible side effects").
• If you suffer from liver or kidney failure. Your doctor may need to adjust your dose.
• If you suffer from diabetes. Treatment with Escitalopram Combix may alter glucose control.

A dose adjustment of insulin and/or oral hypoglycemic may be necessary.

• If you have a decreased sodium level in your blood.
• If you tend to develop bleeding or bruising easily, or if you are pregnant (see "Pregnancy and breastfeeding").
• If you are receiving electroconvulsive therapy.
• If you suffer from or have suffered from any heart problems or have recently had a heart attack.
• If your heart beats slowly when you are at rest (this is known as bradycardia) and/or you think your body may be losing salt, for example because you have had intense diarrhea and vomiting for several days or because you have used diuretics (medicines to urinate).
• If you have noticed that your heart beats quickly or irregularly or if you have fainted or felt dizzy when getting up from a sitting or lying position. This could indicate that you have some heart rhythm disorder.

Please note:

Some patients with manic-depressive illness may enter a manic phase. This is characterized by a change in ideas that is uncommon and rapid, disproportionate joy, and excessive physical activity. If you experience this, contact your doctor.

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

Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or suffer from an anxiety disorder, you may occasionally have thoughts of harming or killing yourself. These may increase when taking antidepressants for the first time, as all these medicines require time to start taking effect, usually around two weeks, although in some cases it may take longer. You would be more likely to have these thoughts:

• If you have previously had thoughts of killing yourself or harming yourself.
• If you are a young adult. Clinical trial data have shown an increased risk of suicidal behavior in adults under 25 with psychiatric disorders who were 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 relative or close friendthat you are depressed or have an anxiety disorder and ask them to read this leaflet. You can ask them if they think your depression or anxiety disorder has worsened, or if they are concerned about changes in your attitude.

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

Some medicines in the group to which Escitalopram Combix belongs (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after treatment is discontinued.

Use in pediatric population (under 18 years old)

Escitalopram Combix should not normally be used in the treatment of pediatric population (under 18 years old). Also, you should know that in patients under 18 years old, there is a higher risk of adverse effects such as suicidal attempts, suicidal ideas, and hostility (mainly aggression, confrontational behavior, and irritation) when taking this class of medicines. Nevertheless, your doctor may prescribe Escitalopram Combix to patients under 18 years old when they decide it is most convenient for the patient. If the doctor who corresponds to you has prescribed Escitalopram Combix to a patient under 18 years old and you want to discuss this decision, please go back to your doctor. You must inform your doctor if any of the symptoms described above progress or if you experience complications when patients under 18 years old are taking Escitalopram Combix. At the same time, the long-term effects on safety related to growth, maturity, and cognitive and behavioral development of Escitalopram Combix in this age group have not yet been demonstrated.

Using other medicines

Tell your doctor or pharmacist if you are using, or have recently used, any other medicines, even those bought without a prescription.

Tell your doctor if you are taking any of the following medicines:

• Non-selective monoamine oxidase inhibitors (MAOIs) that contain phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active ingredients. If you have taken any of these medicines, you will need to wait 14 days before starting to take Escitalopram Combix.

After finishing Escitalopram Combix, 7 days must pass before taking any of these medicines.

• Reversible MAO-A inhibitors that contain moclobemide (used in the treatment of depression).
• Irreversible MAO-B inhibitors that contain 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 manic-depressive 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 against severe pain). These increase the risk of side effects.
• Cimetidine and omeprazole (used for the treatment of stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (antidepressant), and ticlopidine (used to reduce the risk of stroke). These may cause an increase in blood levels of Escitalopram Combix.
• St. John's Wort (Hypericum perforatum) - a medicinal plant used for depression.
• Acetylsalicylic acid 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 bleeding.

• Warfarin, dipyridamole, and phenprocoumon (medicines used to reduce the risk of thrombosis, also called anticoagulants). Your doctor will probably check the blood coagulation time at the beginning and end of treatment with Escitalopram Combix to check that the dose of anticoagulant is still adequate.
• Mefloquine (used for the treatment of malaria), bupropion (used for the treatment of depression), and tramadol (used for the treatment of intense pain) due to the possible risk of lowering the seizure threshold.
• Neuroleptics (medicines used for the treatment of schizophrenia, psychosis) due to the possible risk of lowering the seizure threshold and antidepressants.
• Flecainide, propafenone, and metoprolol (used in cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). It may be that the dose of Escitalopram Combix needs to be adjusted.

Do not take Escitalopram Combixif you are taking medicines for heart rhythm disorders or if you are taking medicines that may affect the heart rhythm, such as antiarrhythmics class IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobials (sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, medicines against malaria, particularly halofantrine), certain antihistamines (astemizole, mizolastine). If you have doubts about this, consult your doctor.

Taking Escitalopram Combix with food and drinks

Escitalopram Combix can be taken with or without food (see section 3 "How to take Escitalopram Combix").

As with many medicines, it is not recommended to combine Escitalopram Combix and alcohol, although it is not expected that Escitalopram Combix will interact with alcohol.

Pregnancy and breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant. Do not take Escitalopram Combix if you are pregnant or breastfeeding, unless you and your doctor have analyzed the risks and benefits involved.

If you take Escitalopram Combix during the last 3 months of pregnancy, be aware that the following effects may be observed in the newborn: breathing difficulties, blue skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or floppiness, intense reflexes, tremors, restlessness, irritability, lethargy, constant crying, and difficulty sleeping.

If your newborn has any of these symptoms, please contact your doctor immediately.

If you take Escitalopram Combix in the final stage 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 know that you are taking Escitalopram Combix so they can advise you.

Make sure your midwife and/or doctor know that you are being treated with Escitalopram Combix.

During pregnancy, particularly in the last 3 months, medicines like Escitalopram Combix may increase the risk of a serious disease in newborns called persistent pulmonary hypertension (PPHN), in which the baby breathes quickly and turns blue. These symptoms usually start during the first 24 hours after birth. If they appear in your baby, you must contact your midwife and/or doctor immediately.

If Escitalopram Combix is used during pregnancy, it should never be stopped abruptly.

Citalopram, a medicine like escitalopram, has been shown in animal studies to reduce sperm quality. This could theoretically affect fertility, but the impact on human fertility has not been observed yet.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

During treatment with escitalopram, you may feel drowsy or dizzy. Do not drive or operate tools or machines until you know how the treatment with escitalopram affects you.

Important information about some components of Escitalopram Combix

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

3. How to Take Escitalopram Combix

Follow the administration instructions of Escitalopram Combix as indicated by your doctor exactly.

Consult your doctor or pharmacist if you have any doubts.

Adults

Depression

The normally recommended dose of Escitalopram Combix is 10 mg taken as a single dose per day. Your doctor may increase it up to a maximum of 20 mg per day.

Anxiety Disorder

The initial dose of Escitalopram Combix is 5 mg as a single dose per day during the first week before increasing the dose to 10 mg per day. Your doctor may increase it later up to a maximum of 20 mg per day.

Social Anxiety Disorder

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

Elderly Patients (> 65 years)

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

Pediatric Population (under 18 years)

Escitalopram Combix should not normally be administered to children and adolescents. For additional information, please see section 2 "Before taking Escitalopram Combix".

You can take Escitalopram Combix with or without food. Swallow the tablets with water. Do not chew them, as they have a bitter taste.

If necessary, you can split the tablets by placing the tablet on a flat surface with the score line facing up. The tablets can be broken by pressing down on each end of the tablet with your index fingers.

Duration of Treatment

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

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

Continue taking Escitalopram Combix for the time recommended by your doctor. If you interrupt the treatment too early, the symptoms may reappear. It is recommended that the treatment continues for at least 6 months after you feel better.

If You Take More Escitalopram Combix Than You Should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

Do this even if you do not observe discomfort or signs of intoxication. Some signs of overdose may be dizziness, tremors, agitation, convulsions, coma, nausea, vomiting, changes in heart rate, decrease in blood pressure, and changes in body hydroelectrolytic balance.

Take the Escitalopram Combix package with you if you go to the doctor or hospital.

If You Forget to Take Escitalopram Combix

Do not take a double dose to make up for forgotten doses. If you forgot to take a dose and remember before going to bed, take it immediately. The next day, follow your normal routine.

If You Interrupt Treatment with Escitalopram Combix

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

When you stop taking Escitalopram Combix, especially if it is sudden, you may feel withdrawal symptoms. These are common when treatment with Escitalopram Combix is suspended. The risk is greater when Escitalopram Combix has been used for a long time, in 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 can be intense or prolonged (2-3 months or more). If you experience severe withdrawal symptoms when you stop taking Escitalopram Combix, please contact your doctor. They may ask you to start taking your tablets again and stop them more slowly.

Withdrawal symptoms include:

Feeling of dizziness (unstable or without balance), feeling of tingling, feeling of itching, and (less frequently) electric shock, even in the head, sleep disturbances (intense dreams, nightmares, inability to sleep), feeling of restlessness, headache, feeling of nausea (nausea), sweating (including night sweats), feeling of unease or agitation, tremors (instability), feeling of confusion or disorientation, feelings of emotion or irritation, diarrhea (loose stools), visual disturbances, rapid or irregular heartbeat.

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

4. Possible Adverse Effects

Like all medications, Escitalopram Combix can have adverse effects, although not all people experience them.

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

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

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

• Unusual bleeding, including gastrointestinal bleeding

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

• If you notice skin swelling, tongue, lips, or face, or have difficulty breathing or swallowing (allergic reaction), contact your doctor or go to the hospital immediately.
• If you have a high fever, agitation, confusion, tremors, and sudden muscle contractions, they may be signs of a rare condition called serotonin syndrome. If you feel this way, contact your doctor.

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

• Difficulty urinating.
• Seizures (attacks), see also the section "Special precautions with Escitalopram Combix".
• Yellowish skin and whitening of the eyes, which are signs of altered liver function/hepatitis.
• Rapid and irregular heartbeats or feeling of fainting, as they could be symptoms of a serious heart problem known as torsades de pointes.

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

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

• Feeling nauseous (nausea)

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

• Nasal congestion or mucosity (sinusitis)
• Decreased or increased appetite
• Anxiety, agitation, abnormal dreams, difficulty falling asleep, feeling drowsy, dizziness, yawning, tremors, itching of the skin
• Diarrhea, constipation, vomiting, dry mouth
• Increased sweating
• Muscle and joint pain (arthralgia and myalgia)
• Sexual disturbances (delayed ejaculation, erection problems, decreased sexual behavior, and women may experience difficulty reaching orgasm)
• Fatigue, fever
• Weight gain

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

• Hives, skin rash, itching (pruritus)
• Teeth grinding, agitation, nervousness, anxiety attacks, confusion
• Sleep disturbances, taste disturbances, fainting (syncope)
• Pupil dilation (mydriasis), visual disturbance, ringing in the ears (tinnitus)
• Hair loss
• Vaginal bleeding
• Weight loss
• Rapid heartbeat
• Swelling of arms and legs
• Nasal bleeding

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

• Aggression, depersonalization, hallucinations
• Slow heartbeat

Some patients have experienced (the frequency cannot be estimated from the available data):

• Thoughts of self-harm or thoughts of suicide, see also the section "Special precautions with Escitalopram Combix".
• Decreased sodium levels in the blood (symptoms are feeling dizzy and discomfort with muscle weakness or confusion)
• Dizziness when standing up due to low blood pressure (orthostatic hypotension)
• Altered liver function tests (increased liver enzymes in the blood)
• Movement disorders (involuntary muscle movements)
• Painful erections (priapism)
• Coagulation disorders, including skin and mucous membrane bleeding (ecchymosis) and low platelet counts in the blood (thrombocytopenia)
• Sudden swelling of the skin or mucous membranes (angioedema)
• Increased urine production (inadequate secretion of ADH)
• Milk flow in non-lactating women
• Mania
• An increased risk of bone fractures has been observed in patients treated with this type of medication
• Alteration of heart rhythm (called QT interval prolongation, observed by electrocardiogram)
• Abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy and lactation" in section 2 for more information.

Other adverse effects are known to occur with drugs that work similarly to escitalopram (the active ingredient of Escitalopram Combix). These are:

• Motor restlessness (akathisia)
• Anorexia

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 that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Escitalopram Combix

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Escitalopram Combix after the expiration date that appears on the package after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown away through wastewater or household waste. Deposit the packages and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you will help protect the environment.

6. Additional Information

Composition of Escitalopram Combix

• The active ingredient is escitalopram. Each tablet contains 15 mg of escitalopram (as oxalate).
• The other components are:

• Tablet core: Microcrystalline cellulose-E460i-, sodium croscarmellose, anhydrous colloidal silica, talc-E553b-, magnesium stearate, sucrose esters of fatty acids-E473- (containing sucrose).
• Tablet coating: Instacoat Universal IC-U-6502 White (hypromellose-E464-, macrogol 400, titanium dioxide-E171-).

Appearance of the Product and Package Contents

Escitalopram Combix 15 mg film-coated tablets are presented in packages containing 28 or 56 film-coated tablets, oval, biconvex, white, scored on one side and smooth on the other.

The tablet can be divided into two equal halves.

Escitalopram Combix is also available in 10 mg and 20 mg film-coated tablets, in packages of 28 or 56 tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Combix, S.L.U

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

25, parc d’activités des Peupliers

92000 Nanterre

France

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

This leaflet was revised in January 2021

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/