Package Leaflet: Information for the User

Escitalopram Combix 10 mg Film-Coated Tablets

Escitalopram

Read this 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. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If you think you have suffered a side effect, you can help us by reporting it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Escitalopram Combix belongs to a group of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). These medications act on the serotonin system in the brain by increasing the level of serotonin. Alterations in the serotonin system are considered an important factor in the development of depression and related disorders.

Escitalopram 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).

No take Escitalopram Combix

• If you are allergic (hypersensitive) to the active ingredient escitalopram or to any of the other components of Escitalopram Combix (see section 6 “Additional information”).
• If you are taking other medications that belong to the group called monoamine oxidase inhibitors (MAOIs), including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic).

• If you have a heart rhythm disorder from birth or have ever had an episode of this type (this is observed with an electrocardiogram, a test that evaluates how the heart works).
• If you are taking medications for heart rhythm disorders or that can affect heart rhythm (see section 2 “Use of other medications”).

Be careful with Escitalopram Combix

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

• If you have epilepsy. Treatment with Escitalopram Combix should be interrupted if seizures occur for the first time or if you observe an increase in seizure frequency (see also section 4 “Possible side effects”).
• If you have liver or kidney insufficiency. Your doctor may need to adjust your dose.
• If you have diabetes. Treatment with Escitalopram Combix may alter blood sugar control.

You may need to adjust your insulin and/or oral hypoglycemic medication dose.

• If you have low sodium levels in your blood.
• If you are prone to bleeding or bruising easily, or if you are pregnant (see “Pregnancy and breastfeeding”).
• If you are receiving electroconvulsive therapy.
• If you have or have had any heart problems or have recently had a heart attack.
• If, when at rest, your heart beats slowly (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 taken diuretics (medications to urinate).
• If you have noticed that your heartbeats are rapid or irregular or have had fainting or dizziness when getting up from a sitting or lying position. This could indicate that you have a heart rhythm disorder.

Please note:

Some patients with manic-depressive illness may enter a manic phase. This is characterized by unusual and rapid changes in ideas, excessive 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 weeks of treatment. Inform your doctor immediately if you experience these symptoms.

Thoughts of suicide and worsening of depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may occasionally have thoughts of harming yourself or committing suicide. These may increase when taking antidepressants for the first time, as all these medications require time to start working, usually around two weeks, although in some cases it may take longer.Youmay be more prone to having these thoughts:

• If you have previously had thoughts of harming yourself or committing suicide.
• If you are ayoung adult. Information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years old with psychiatric illnesses treated with an antidepressant.

If you ever have thoughts of harming yourself or committing suicide, contact your doctor or go directly to a hospital.

It may be helpful for you to tell a family member 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.

A study has shown an increased risk of bone fractures in patients treated with this type of medication.

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

Use in pediatric population (under 18 years)

Escitalopram Combix should not be used normally in the treatment of the pediatric population (under 18 years). Also, be aware that in patients under 18 years, there is a higher risk of adverse effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medication. However, your doctor may prescribe Escitalopram Combix to patients under 18 years if they decide it is the best option for the patient. If the doctor who prescribed Escitalopram Combix to you is under 18 years and wants to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms described above progress or if you experience complications when patients under 18 years are taking Escitalopram Combix. At the same time, the long-term effects on safety and related to growth, maturity, and cognitive and behavioral development of Escitalopram Combix in this age group have not yet been demonstrated.

Use of other medications

Please inform your doctor or pharmacist if you are using, or have recently used, any other medication, including those purchased without a prescription.

Please inform your doctor if you are taking any of the following medications:

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

After stopping Escitalopram Combix, you should wait 7 days before taking any of these medications.

• “Reversible 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.
• The antibiotic linezolid.
• Lithium (used to treat manic-depressive illness) and tryptophan.
• Imipramine and desipramine (both used to treat depression).
• Sumatriptan and similar medications (used to treat migraines) and tramadol (used to treat severe pain). These increase the risk of side effects.
• Cimetidine 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 an increase in Escitalopram Combix blood levels.
• St. John's Wort (Hypericum perforatum) – a medicinal plant used to treat depression.
• Aspirin and non-steroidal anti-inflammatory drugs (medications used to relieve pain or reduce the risk of thrombosis, also called anticoagulants).

These may increase the risk of bleeding.

• Warfarin, dipiridamol, and phenprocoumon (medications used to reduce the risk of thrombosis, also called anticoagulants). Your doctor will probably monitor your blood clotting time at the start and end of treatment with Escitalopram Combix to check that the anticoagulant dose is still adequate.
• 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 (medications used to treat 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). You may need to adjust your Escitalopram Combix dose.

Do not take Escitalopram Combixif you are taking medications for any heart rhythm disorder or if you are taking medications that can affect heart rhythm, for example, antiarrhythmic class IA and III, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobials (sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, medications against malaria, particularly halofantrine), certain antihistamines (astemizole, mizolastine). If you are unsure 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 medications, it is not recommended to combine Escitalopram Combix and alcohol, although it is not expected to interact with alcohol.

Pregnancy and breastfeeding

Please inform 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: difficulty breathing, blue skin, seizures, changes in body temperature, difficulty feeding, vomiting, low blood sugar, muscle stiffness or weakness, intense reflexes, tremors, restlessness, irritability, drowsiness, and difficulty falling asleep.

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

If you take Escitalopram Combix in the final stages of pregnancy, there may be a higher risk of excessive 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 to be able to 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, medications like Escitalopram Combix may increase the risk of a serious condition in newborns, called persistent pulmonary hypertension of the newborn (PPHN), in which the baby breathes rapidly and turns blue. These symptoms usually start within the first 24 hours after birth. If they appear in your baby, contact your midwife and/or doctor immediately.

Do not stop taking Escitalopram Combix abruptly during pregnancy.

Citalopram, a medication like escitalopram, has been shown in animal studies to reduce sperm quality. Theoretically, this could affect fertility, but the impact on human fertility has not been observed so far.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

Important information about some components of Escitalopram Combix

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

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

Consult your doctor or pharmacist if you have any doubts.

Adults

Depression

The usual 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 for the first week before increasing the dose to 10 mg per day. Your doctor may increase it further up to a maximum of 20 mg per day.

Social anxiety disorder

The usually 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 usually 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 usually 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.

Patients over 65 years old

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 old)

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 break the tablets by placing the tablet on a flat surface with the notch facing upwards. The tablets can be broken by pressing down on each end of the tablet with your two index fingers.

Treatment duration

You may feel better in a couple of weeks. Continue taking Escitalopram Combix even if you start feeling better before the expected time.

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

Continue taking Escitalopram Combix for the recommended time by your doctor. If you interrupt the treatment too soon, symptoms may reappear. It is recommended that the treatment continue 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 Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount ingested.

Do it even if you do not observe any discomfort or signs of intoxication. Some signs of overdose may include dizziness, tremor, agitation, convulsion, coma, nausea, vomiting, changes in heart rate, decreased blood pressure, and changes in the body's electrolyte balance.

Bring the Escitalopram Combix packaging with you to the doctor or hospital.

If you forget to take Escitalopram Combix

Do not take a double dose to compensate for the missed doses. If you forget to take a dose and remember before going to bed, take it immediately. The next day, follow your usual schedule. If you remember during the night or the next day, leave the missed dose and follow your usual schedule.

If you interrupt the treatment with Escitalopram Combix

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

When you stop taking Escitalopram Combix, especially if it is done abruptly, you may experience withdrawal symptoms. These are common when treatment with Escitalopram Combix is suspended. The risk is higher when Escitalopram Combix 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 in two weeks. However, in some patients, they can be intense or prolonged (2-3 months or more). If you experience severe withdrawal symptoms when stopping Escitalopram Combix, please contact your doctor. They may ask you to take your tablets again and taper off them more slowly.

Withdrawal symptoms include:

Dizziness (unstable or loss of balance), tingling sensation, prickling sensation, and (less frequently) electric shock, even in the head, sleep disturbances (intense dreams, nightmares, inability to sleep), feeling of restlessness, headache, dizziness (nausea), sweating (including nocturnal sweating), feeling of anxiety or agitation, tremor (inability to stand still), feeling of confusion or disorientation, feelings of emotion or irritability, diarrhea (loose stools), visual disturbances, rapid heartbeat or palpitations.

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

Like all medicines, Escitalopram Combix may cause side effects, although not everyone will experience them.

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

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

Rare (may affect between 1 and 10 in every 10,000 patients)

• Unusual bleeding, including gastrointestinal bleeding

Very rare (may affect between 1 and 10 in every 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 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 side effects, consult your doctor or go to the hospital immediately:

• Difficulty urinating.
• Seizures (convulsions), see also the section “Be especially careful with Escitalopram Combix”.
• Yellowish skin and whitening of the eyes, which are signs of liver function impairment/hepatitis.
• Fast and irregular heartbeats or a feeling of fainting, as they may be symptoms of a serious heart condition called torsade de pointes.

In addition to what is mentioned above, the following side effects have been reported:

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

• Feeling dizzy (nausea)

Common (may affect between 1 and 10 in every 100 patients):

• Blockage or nasal 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 (arthralgia and myalgia)
• Sexual dysfunction (delayed ejaculation, erection problems, decreased sexual behavior, and women may experience difficulty reaching orgasm)
• Fatigue, fever
• Weight gain

Rare (may affect between 1 and 10 in every 1,000 patients):

• Hives, skin rash, itching (pruritus)
• Teeth chattering, agitation, nervousness, anxiety attack, state of confusion
• Sleep disturbances, taste disturbances, fainting (syncope)
• Pupil dilation (mydriasis), visual disturbances, ringing in the ears (tinnitus)
• Hair loss
• Vaginal bleeding
• Weight loss
• Fast heart rate
• Swelling of arms and legs
• Nasal bleeding

Very rare (may affect between 1 and 10 in every 10,000 patients):

• Aggression, depersonalization, hallucinations
• Low heart rate

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

• Thoughts of self-harm or suicidal thoughts, see also the section “Be especially careful with Escitalopram Combix”
• Decreased sodium levels in the blood (symptoms are feeling dizzy and experiencing muscle weakness or confusion)
• Dizziness when standing 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)
• Blood clotting 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 ADH secretion)
• Milk leakage in women who are not breastfeeding
• Mania
• A higher risk of bone fractures has been observed in patients treated with this type of medication
• Alteration of the heart rhythm (called prolonged QT interval, observed through electrocardiogram)
• Heavy vaginal bleeding shortly after delivery (postpartum hemorrhage), see “Pregnancy and breastfeeding” in section 2 for more information.

Other side effects have been reported with medications that work similarly to escitalopram (the active ingredient in Escitalopram Combix). These are:

• Motor restlessness (akathisia)
• Anorexia

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information about the safety of this medication.

Keep out of reach and sight of children.

No special storage conditions are required.

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

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Escitalopram Combix

• The active ingredient is escitalopram. Each tablet contains 10 mg of escitalopram (as oxalate).
• The other components are:
• • Tablet core: Microcrystalline cellulose-E460i-, sodium croscarmellose, anhydrous colloidal silica, micronized talc-E553b-, magnesium stearate, sucrose esters of fatty acids-E473-(containing saccharose)
  • Tablet coating: Instacoat Universal IC-U-6502 White (hypromellose-E464-, macrogol 400, titanium dioxide-E171).

Appearance of the product and contents of the package

Escitalopram Combix 10 mg film-coated tablets are presented in packages containing 28 or 56 film-coated tablets, oval, biconvex, white, scored on one face and with the engraving “I” on one side of the score and smooth on the other.

The tablet can be divided into two equal halves.

Escitalopram Combix is also available in 15 mg and 20 mg film-coated tablets, in packages of 28 or 56 tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible 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 Medical Devices (AEMPS)http://www.aemps.gob.es/