Escitalopram Combix 10 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Escitalopram Combix 10 mg film-coated tablets EFG

Escitalopram

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 must not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you think any of the side effects you experience are serious, 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 Combix is and what it is used for
2. Before you take Escitalopram Combix
3. How to take Escitalopram Combix
4. Possible side effects
5. How to store Escitalopram Combix
6. Further information

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

Escitalopram Combix 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 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).

2. Before taking 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 belonging to the group known as 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 a congenital heart rhythm disorder or have ever experienced an episode of this type (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”).

Take special care with Escitalopram Combix

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 Combix should be discontinued if you experience seizures for the first time or notice an increase in seizure frequency (see also section 4 “Possible side effects”).
• If you have liver or kidney impairment. Your doctor may need to adjust your dose.
• If you have diabetes. Treatment with Escitalopram Combix may alter glycaemic control.
  A dose adjustment of insulin and/or oral hypoglycaemic agents may be necessary.
• If you have low sodium levels in the blood.
• If you are prone to bleeding or bruising easily, or if you are pregnant (see “Pregnancy and breastfeeding”).
• If you are receiving electroconvulsive therapy.
• If you have or have had heart problems or 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 for increasing urine output).
• If you have noticed rapid or irregular heartbeats, or have experienced fainting or dizziness when standing up from a sitting or lying position. These symptoms may indicate a heart rhythm disorder.

Please note:

Some patients with bipolar disorder may enter a manic phase. This is characterized by unusually rapid and frequent shifts in thoughts, 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 of harming or killing yourself. These thoughts 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 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 if they are concerned about changes in your behaviour.

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

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

Use in paediatric population (under 18 years of age)

Escitalopram Combix should not normally be used in the treatment of paediatric patients (under 18 years of age). Also, 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, confrontation behaviour, and irritability) when taking this class of medicines. Nevertheless, your doctor may prescribe Escitalopram Combix to patients under 18 years of age if they consider it appropriate. If your doctor has prescribed Escitalopram Combix to a patient under 18 years of age and you wish to discuss this decision, please consult your doctor again. Inform your doctor if any of the previously described symptoms worsen or become complicated while a patient under 18 years of age is taking Escitalopram Combix. Furthermore, the long-term effects on safety, growth, maturation, and cognitive and behavioural development of Escitalopram Combix in this age group have not yet been fully established.

Use with other medicines

Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

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

• “Non-selective monoamine oxidase inhibitors (MAOIs)” containing phenelzine, iproniazid, isocarboxazid, nialamide, or tranylcypromine as active substances. If you have taken any of these medicines, you must wait 14 days before starting Escitalopram Combix.
  After stopping Escitalopram Combix, 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 for the treatment of depression).
• Sumatriptan and similar medicines (used for the treatment of migraine) and tramadol (used for 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 (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These may increase blood levels of Escitalopram Combix.
• 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 Combix to ensure the anticoagulant dose remains appropriate.
• Mefloquine (used for the treatment of malaria), bupropion (used for the treatment of depression), and tramadol (used for the treatment of severe pain), due to a possible risk of lowering the seizure threshold.
• Neuroleptics (medicines used for the treatment of schizophrenia, psychosis), due to a possible risk of lowering the seizure threshold, and antidepressants.
• Flecainide, propafenone, and metoprolol (used for cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). The dose of Escitalopram Combix may need to be adjusted.

Do not take Escitalopram Combix 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), and certain antihistamines (astemizole, mizolastine). If you have any doubts about this, consult your doctor.

Taking Escitalopram Combix with food and drink

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

As with many medicines, combining Escitalopram Combix with alcohol is not recommended, although no interaction between Escitalopram Combix and alcohol is expected.

Pregnancy and breastfeeding

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

If you take Escitalopram Combix during the last three months of pregnancy, the newborn baby may experience the following effects: breathing difficulties, bluish skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or floppiness, exaggerated reflexes, tremors, restlessness, irritability, lethargy, constant crying, drowsiness, and sleep disturbances.

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

If you take Escitalopram Combix in late 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 Combix so they can provide appropriate advice.

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

During pregnancy, particularly in the last three months, medicines 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 appears blue. These symptoms usually begin within the first 24 hours after birth. If they occur in your baby, contact your midwife and/or doctor immediately.

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

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 to date.

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 machinery until you know how escitalopram affects you.

Important information about some ingredients 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 exactly the instructions for using Escitalopram Combix provided by your doctor.

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 daily dose. Your doctor may increase it up to a maximum of 20 mg per day.

Panic disorder

The initial dose of Escitalopram Combix 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 Combix is 10 mg taken as a single daily dose. Your doctor may reduce your dose to 5 mg per day or increase it up to a maximum of 20 mg per day, depending on your response to the medication.

Generalized anxiety disorder

The normally recommended dose of Escitalopram Combix 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 Combix 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 (> 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 daily.

Paediatric population (under 18 years)

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

You may take Escitalopram Combix with or without food. Swallow the tablets with water. Do not chew them, as their taste is bitter.

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 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 Combix even if you start to feel better earlier than expected.

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

Continue taking Escitalopram Combix 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 have recovered.

If you take more Escitalopram Combix than you should

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

Do this even if you do not notice any discomfort or signs of poisoning. Some signs of overdose may include dizziness, tremor, agitation, seizures, coma, nausea, vomiting, changes in heart rhythm, decreased blood pressure, and disturbances in the body's fluid and electrolyte balance.

Take the Escitalopram Combix packaging 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 a missed dose. If you forget to take a dose and remember before going to bed, take it immediately. The next day, continue as usual. If you remember during the night or the following day, skip the missed dose and continue as usual.

If you stop taking Escitalopram Combix

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

When you stop taking Escitalopram Combix, especially if abruptly, you may experience withdrawal symptoms. These are common when treatment with Escitalopram Combix is discontinued. The risk is greater 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 resolve 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 Combix, please contact your doctor. They may ask you to resume taking your tablets and taper them more slowly.

Withdrawal symptoms include:

Dizziness (feeling unsteady or off balance), tingling sensations, burning sensations, and (less frequently) electric shock-like sensations, even in the head; sleep disturbances (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 pulse or palpitations.

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

4. Possible adverse effects

Like all medicines, Escitalopram Combix may have adverse effects, although not everyone experiences them.

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

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

Uncommon (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 swelling of the skin, tongue, lips, or face, or have difficulty breathing or swallowing (allergic reaction), contact your doctor or go to hospital immediately.
• If you 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, consult your doctor or go to hospital immediately:

• Difficulty urinating.
• Seizures (fits), see also section “Take special care with Escitalopram Combix”.
• Yellowing of the skin and whites of the eyes, signs of liver function disturbance /hepatitis.
• Rapid 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 (may affect more than 1 in 10 patients):

• Feeling dizzy (nausea)

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

• Nasal congestion or mucus (sinusitis)
• Decreased or increased appetite
• Anxiety, restlessness, abnormal dreams, difficulty falling asleep, feeling drowsy, yawning, tremors, skin itching
• Diarrhea, constipation, vomiting, dry mouth
• Increased sweating
• Muscle and joint pain (arthralgia and myalgia)
• Sexual disturbances (delayed ejaculation, erection problems, reduced sexual interest, and women may experience difficulty achieving orgasm)
• Fatigue, fever
• Weight gain

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

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

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

• Aggression, depersonalization, hallucinations
• Slow heart rate

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

• Thoughts of harming yourself or thoughts of suicide; see also section “Take special care with Escitalopram Combix”
• 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 blood)
• Movement disorders (involuntary muscle movements)
• Painful erections (priapism)
• Bleeding disorders including skin and mucosal bleeding (ecchymosis) and low platelet levels in blood (thrombocytopenia)
• Sudden swelling of skin or mucous membranes (angioedema)
• Increased urine output (inappropriate ADH secretion)
• Milk discharge in women who are not breastfeeding
• Mania
• An increased risk of bone fractures has been observed in patients treated with this type of medication
• Changes in heart rhythm (known as QT interval prolongation, observed on electrocardiogram)
• Excessive vaginal bleeding shortly after childbirth (postpartum haemorrhage); see “Pregnancy and breastfeeding” 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 Combix). These include:

• Motor restlessness (akathisia)
• Anorexia

Reporting of adverse effects

If you experience any 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 Combix

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Escitalopram Combix 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 must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Additional Information

Composition of Escitalopram Combix

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

Appearance of the product and contents of the container

Escitalopram Combix 10 mg film-coated tablets are available in packs containing 28 or 56 film-coated tablets, oval-shaped, biconvex, white in colour, with a score line on one side and engraved with the letter “I” on one side of the score line, smooth on the other side.

The tablet can be divided into two equal parts.

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

Only certain pack 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 patient information leaflet was last reviewed in January 2021

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/