Escitalopram Meiji 20 mg orodispersible tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Escitalopram MEIJI 20 mg orodispersible tablets EFG
Escitalopram (as oxalate)
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
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Contents of the leaflet:
- What Escitalopram MEIJI is and what it is used for
- What you need to know before taking Escitalopram MEIJI
- How to take Escitalopram MEIJI
- Possible side effects
- Storage of Escitalopram MEIJI
- Contents of the pack and other information
1. What Escitalopram MEIJI is and what it is used for
Escitalopram MEIJI contains escitalopram. 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 disorders.
Escitalopram MEIJI 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).
It may take a couple of weeks before you start to feel better. Continue taking Escitalopram MEIJI even if it takes some time before you notice any improvement.
Consult a doctor if you worsen or do not improve.
2. What you need to know before taking Escitalopram MEIJI
Do not take Escitalopram MEIJI
- If you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).
- 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 were born with or have experienced an episode of heart rhythm disturbance (detected on an ECG, a test that evaluates heart function).
- If you are taking medicines for heart rhythm problems or that may affect heart rhythm (see section 2 “Other medicines and Escitalopram MEIJI”).
Warnings and precautions
Talk to your doctor or pharmacist before starting to take Escitalopram MEIJI.
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 MEIJI 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 hepatic or renal insufficiency. Your doctor may need to adjust your dose.
- If you have diabetes. Treatment with Escitalopram MEIJI may alter glycaemic control. Adjustment of insulin and/or oral hypoglycaemic agent dosage may be necessary.
- If you have low sodium levels in the blood.
- If you are prone to bleeding or bruising easily, or if you are pregnant (see “Pregnancy, breastfeeding and fertility”).
- If you are receiving electroconvulsive therapy.
- If you have coronary artery disease.
- If you have or have had heart problems or have recently suffered a heart attack.
- If your resting heart rate is slow and/or you know you may have low levels of salts due to severe and prolonged diarrhoea and vomiting (being unwell) or use of diuretics.
- If you experience rapid or irregular heartbeats, fainting, collapse, or dizziness upon standing, which may indicate abnormal heart rhythm.
- If you have or have previously had eye problems, such as certain types of glaucoma (increased pressure in the eye).
Some medicines in the same group as Escitalopram MEIJI (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after discontinuation of treatment.
Please note
Some patients with bipolar disorder may enter a manic phase. This is characterized 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 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 about harming or killing yourself. These may increase when starting antidepressants, as all such medicines require time to begin working—usually around two weeks, although in some cases it may take longer.
You would be more likely to have such thoughts:
- If you have previously had thoughts of killing or harming 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 help to inform a close family member or friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You may ask them whether they think your depression or anxiety disorder has worsened, or if they are concerned about changes in your behaviour.
Children and adolescents
Escitalopram MEIJI is not normally used to treat children and adolescents under 18 years of age. Also, be aware that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal ideation, and hostility (predominantly aggression, 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 in the patient’s best interest. If your doctor has prescribed Escitalopram MEIJI to a patient under 18 years of age and you wish to discuss this decision, please consult your doctor again. You should inform your doctor if any of the symptoms described above worsen or become complicated while patients under 18 years of age are taking escitalopram. In addition, the long-term effects on safety, as well as on growth, maturation, and cognitive and behavioural development of escitalopram in this age group, have not yet been established.
Other medicines and Escitalopram MEIJI
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
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 MEIJI. After stopping Escitalopram MEIJI, 7 days must pass before starting any of these medicines.
- “Reversible selective MAO-A inhibitors” containing moclobemide (used for 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 for 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, lansoprazole, 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 cause increased blood levels of escitalopram.
- 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 called anticoagulants). These may increase the tendency to bleed.
- 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 treatment with Escitalopram MEIJI 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 the possible risk of lowering the seizure threshold.
- Neuroleptics (medicines for the treatment of schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to the possible risk of lowering the seizure threshold.
- Flecainide, propafenone, and metoprolol (used in cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). The dose of escitalopram may need to be adjusted.
- Medicines that reduce blood levels of potassium or magnesium, as this increases the risk of life-threatening heart rhythm disturbances.
Do not take Escitalopram MEIJI if you are taking medicines for heart rhythm problems or that may affect heart rhythm, e.g. Class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, IV erythromycin, pentamidine, antimalarials particularly halofantrine), or certain antihistamines (astemizole, mizolastine).
Contact your doctor for any additional questions.
Taking Escitalopram MEIJI with food, drinks, and alcohol
Escitalopram MEIJI can be taken with or without food (see section 3 “How to take Escitalopram MEIJI”).
As with many medicines, combining escitalopram with alcohol is not recommended, although an interaction between escitalopram and alcohol is not expected.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Do not take escitalopram if you are pregnant or breastfeeding unless you and your doctor have discussed the risks and benefits involved.
If you take Escitalopram MEIJI during the last months of pregnancy, be aware that the following effects may occur in the newborn baby: breathing difficulties, bluish skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or floppiness, exaggerated reflexes, tremors, restlessness, irritability, lethargy, constant crying, drowsiness, and sleep difficulties. If your newborn baby shows any of these symptoms, please contact your doctor immediately.
Ensure that your midwife and/or doctor know that you are being treated with Escitalopram MEIJI. During pregnancy, particularly in the last months, medicines like Escitalopram MEIJI 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 begin within the first 24 hours after birth. If they occur in your baby, contact your midwife and/or doctor immediately.
If you take Escitalopram MEIJI 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 MEIJI so they can advise you.
If Escitalopram MEIJI is used during pregnancy, it should never be stopped abruptly.
Escitalopram is expected to be excreted in breast milk.
Citalopram, a medicine similar to escitalopram, has been shown to reduce sperm quality in animal models. Theoretically, this effect could affect fertility, but to date no impact on human fertility has been observed.
Driving and use of machines
You are advised not to drive or operate machinery until you know how Escitalopram MEIJI affects you.
Escitalopram MEIJI contains aspartame
This medicine contains 16 mg of aspartame per tablet. Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.
Escitalopram MEIJI contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.
3. How to take Escitalopram MEIJI
Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The orodispersible tablets should be taken once daily, with or without food.
The orodispersible tablet should be placed on the tongue, where it will begin to disintegrate with saliva and can be swallowed without water.
The orodispersible tablet is fragile and must be handled with care.
Adults
Depression
The normally recommended dose of Escitalopram MEIJI 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 recommended initial dose of Escitalopram MEIJI 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 MEIJI 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 medicine.
Generalized anxiety disorder
The normally recommended dose of Escitalopram MEIJI 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 MEIJI is 10 mg taken as a single daily dose. The dose may be increased by your doctor up to a maximum of 20 mg per day.
Elderly patients (over 65 years of age)
The recommended initial dose of Escitalopram MEIJI is 5 mg taken as a single daily dose. The dose may be increased by your doctor up to 10 mg per day.
Children and adolescents
Escitalopram MEIJI should not normally be given to children and adolescents. For further information, please see section 2 “Warnings and precautions”.
Duration of treatment
It may take a few weeks before you start to feel better. Continue taking Escitalopram MEIJI even if you start to feel better before the expected time.
Do not change the dose of the medicine without first speaking to your doctor.
Continue taking Escitalopram MEIJI for the length of time recommended by your doctor. If you stop treatment too early, symptoms may return. It is recommended that treatment continues for at least 6 months after you feel well again.
If you take more Escitalopram MEIJI 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 medicine and the amount ingested. Do this even if you do not observe 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. Bring the Escitalopram MEIJI packaging if you go to the doctor or hospital.
If you forget to take Escitalopram MEIJI
Do not take a double dose to make up for missed doses. 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 MEIJI
Do not stop treatment with Escitalopram MEIJI until your doctor tells you to do so. When you have completed your course of treatment, it is generally recommended that the dose of Escitalopram MEIJI be gradually reduced over several weeks.
When you stop taking Escitalopram MEIJI, especially if abruptly, you may experience withdrawal symptoms. These are common when treatment with Escitalopram MEIJI is discontinued. The risk is greater when Escitalopram MEIJI 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, please contact your doctor. He or she may ask you to restart taking your tablets and taper off 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 (overly 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 or irritable feelings, diarrhoea (loose stools), visual disturbances, rapid pulse or palpitations.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience 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.
If you experience any of the following symptoms, contact your doctor or go to hospital immediately:
Uncommon (may affect up to 1 in 100 people):
- Unusual bleeding, including gastrointestinal bleeding.
Rare (may affect up to 1 in 1,000 people):
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Swelling of the skin, tongue, lips, throat, or face, hives, or difficulty breathing or swallowing (allergic reaction).
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High fever, agitation, confusion, tremors, and sudden muscle contractions, which may be signs of a rare condition called serotonin syndrome.
Unknown frequency (cannot be estimated from available data):
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Difficulty urinating.
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Seizures (fits); see also section “Warnings and precautions”.
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Yellowing of the skin and whites of the eyes, signs of liver dysfunction/hepatitis.
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If you experience fast or irregular heartbeats or fainting, symptoms which may indicate a life-threatening condition known as Torsade de Pointes.
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Thoughts of harming yourself or thoughts of killing yourself; see also section “Warnings and precautions”.
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Sudden swelling of the skin or mucous membranes (angioedema).
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Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see section 2, “Pregnancy, breastfeeding and fertility”, for more information.
In addition to the above, the following adverse effects have been reported:
Very common (may affect more than 1 in 10 people):
??Feeling dizzy (nausea).
??Headache.
Common (may affect up to 1 in 10 people):
??Stuffy or runny nose (sinusitis).
??Decreased or increased appetite.
??Anxiety, restlessness, abnormal dreams, difficulty falling asleep, feeling drowsy, dizziness, yawning, tremors, skin itching.
- Diarrhoea, constipation, vomiting, dry mouth.
??Increased sweating.
??Muscle and joint pain (arthralgia and myalgia).
??Sexual disturbances (delayed ejaculation, problems with erection, decreased sexual drive; women may experience difficulty achieving orgasm).
??Fatigue, fever.
??Weight gain.
Uncommon (may affect up to 1 in 100 people):
??Hives, skin rash, itching (pruritus).
??Teeth grinding, restlessness, nervousness, panic attacks, confusion.
??Sleep disturbances, taste disturbances, fainting (syncope).
??Dilated pupils (mydriasis), visual disturbances, ringing in the ears (tinnitus).
??Hair loss.
??Excessive menstrual bleeding.
??Irregular menstrual periods.
??Weight loss.
??Fast heart rate.
??Swelling of arms and legs.
??Nosebleeds.
Rare (may affect up to 1 in 1,000 people):
??Aggression, depersonalisation, hallucinations.
??Slow heart rate.
Unknown frequency (cannot be estimated from available data):
??Decreased levels of sodium 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).
??Signs of abnormal bleeding, e.g., of the skin or mucous membranes (bruising).
??Increased secretion of the hormone called ADH, causing water retention in the body and dilution of the blood, reducing sodium levels (inappropriate ADH secretion).
??Milk discharge in men and in women who are not breastfeeding.
??Mania.
??An increased risk of bone fractures has been observed in patients treated with this type of medicine.
??Changes in heart rhythm (known as “prolongation of the QT interval”, seen on ECG, the electrical activity of the heart).
Other adverse effects are known to occur with medicines that act similarly to escitalopram, the active substance in Escitalopram MEIJI. 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 MEIJI
Keep this medicine out of the sight and reach of children.
Store below 30°C.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Escitalopram MEIJI 20 mg orodispersible tablets
- The active substance is escitalopram (as oxalate). Each orodispersible tablet contains 20 mg of escitalopram.
- The other components are: talc (E-553b), silicified microcrystalline cellulose (microcrystalline cellulose and colloidal anhydrous silica), sodium croscarmellose (E-468), magnesium stearate (E-572), mint flavour, aspartame (E-951), and colloidal anhydrous silica.
Appearance of the product and contents of the pack
Escitalopram MEIJI 20 mg are white, oblong orodispersible tablets, scored on one side.
The score line is not intended to divide the tablet into equal doses.
Escitalopram MEIJI 20 mg orodispersible tablets are available in pack sizes of 28, 56 and 500 tablets.
Other presentations
Escitalopram MEIJI 10 mg orodispersible tablets EFG 28, 56 and 500 tablets.
Escitalopram MEIJI 15 mg orodispersible tablets EFG 28, 56 and 500 tablets.
Only some pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Meiji Pharma Spain, S.A.
Avda. de Madrid, 94
28802 Alcalá de Henares, Madrid (Spain)
Date of the most recent revision of this leaflet: January 2021
Other sources of information:
Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/