Package Insert: Information for the Patient
Escitalopram Aurovitas Pharma 10 mg Bucodispersable Tablets EFG
Escitalopram Aurovitas Pharma 15 mg Bucodispersable Tablets EFG
Escitalopram Aurovitas Pharma 20 mg Bucodispersable Tablets EFG
Read this package insert carefully before starting to take this medication, as it contains important information for you
Contents of the package and additional information.
Escitalopram Aurovitas Pharma, contains escitalopram as the active substance. Escitalopram Aurovitas Pharmabelongs 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 diseases.
Escitalopram Aurovitas Pharma contains escitalopram and is indicated for the treatment of depression (major depressive episodes) and anxiety disorders (such as panic disorder with or without agoraphobia, social anxiety disorder, generalized anxiety disorder, and obsessive-compulsive disorder).
You may start feeling better in a couple of weeks. Continue taking Escitalopram Aurovitas Pharma, even if it takes some time before you notice any improvement. You should talk to your doctor if you do not feel better or if you feel worse.
Do not take Escitalopram Aurovitas Pharma:
Warnings and precautions
Consult your doctor or pharmacist before starting to take Escitalopram Aurovitas Pharma.
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:
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.
You may experience symptoms such as restlessness or difficulty sitting or staying still during the first few weeks of treatment. If you experience these symptoms, contact your doctor immediately.
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 you first start taking antidepressants, as all these medications take time to start working, usually around two weeks, although in some cases it may be longer.
Youmay be more likely to have these thoughts:
If you ever have thoughts of harming yourself or committing suicide, contact your doctor or go directly to a hospital.
It may be helpful 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 behavior.
Children and adolescents
Escitalopram Aurovitas Pharma should not be used normally in the treatment of children and adolescents under 18 years old. Also, be aware that in patients under 18 years old, there is a higher risk of side effects such as suicidal behavior, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medication. However, your doctor may prescribe Escitalopram Aurovitas Pharma to patients under 18 years old when they decide it is best for the patient. If the doctor who prescribed Escitalopram Aurovitas Pharma to you is under 18 years old and you want 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 old are taking Escitalopram Aurovitas Pharma. At the same time, the long-term effects on safety and related to growth, maturity, and cognitive and behavioral development of Escitalopram Aurovitas Pharma in this age group have not yet been demonstrated.
Other medications and Escitalopram Aurovitas Pharma
Inform your doctor or pharmacist that you are taking, have taken recently, or may need to take any other medication.
Inform your doctor if you are taking any of the following medications:
Some medications may increase the side effects of escitalopram and, in some cases, may cause severe reactions. Do not take any other medication while taking escitalopram without first consulting your doctor, especially:
Do not take Escitalopram Aurovitas Pharma if you are taking medications for heart rhythm problems or that may affect heart rhythm, such as antiarrhythmic Class IA and III, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antimicrobials (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial treatment, especially halofantrine) and some antihistamines (astemizol, mizolastine). If you are unsure, you should speak with your doctor.
Taking Escitalopram Aurovitas Pharma with food, drinks, and alcohol
Escitalopram Aurovitas Pharma can be taken with or without food (see section 3 “How to take Escitalopram Aurovitas Pharma”).
As with many medications, it is not recommended to combine Escitalopram Aurovitas Pharma and alcohol, although it is not expected to interact with alcohol.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication. Do not take Escitalopram Aurovitas Pharma if you are pregnant or breastfeeding unless you and your doctor have weighed the risks and benefits.
If you take Escitalopram Aurovitas Pharma during the last 3 months of your 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, twitching, irritability, drowsiness, and difficulty sleeping. If your newborn baby has any of these symptoms, contact your doctor immediately.
Make sure your midwife and/or doctor know that you are taking Escitalopram Aurovitas Pharma. When taken during pregnancy, especially in the last 3 months, medications like Escitalopram Aurovitas Pharma may increase the risk of a serious condition in the newborn, called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and appear blue. These symptoms usually start 24 hours after the baby's birth. If this happens to your baby, you should contact your midwife and/or doctor immediately.
Escitalopram Aurovitas Pharma should not be stopped abruptly during pregnancy. It is expected that Escitalopram Aurovitas Pharma will be excreted in breast milk.
If you take Escitalopram Aurovitas Pharma 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 Aurovitas Pharma to be able to advise you.
Citalopram, a medication similar to escitalopram, has shown reduced sperm quality in animal studies. In theory, this may affect fertility, but so far, there has been no observed impact on human fertility.
Driving and operating machinery
It is recommended that you do not drive or operate machinery until you know how Escitalopram Aurovitas Pharma may affect you.
Escitalopram Aurovitas Pharma contains lactose
If your doctor has warned you that you are intolerant to some sugars, contact your doctor before taking this medication.
Escitalopram Aurovitas Pharma contains sodium
This medication contains less than 1 mmol of sodium (23 mg) per buccal tablet; that is, it is essentially “sodium-free”.
Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.
Escitalopram Aurovitas Pharma buccal tablets are administered every day in a single daily dose. Escitalopram Aurovitas Pharma can be taken with or without food.
Escitalopram Aurovitas Pharma buccal tablets are easily broken, so the tablets should be handled with care. Do not handle the tablets with wet hands, as they may break.
Adults
Depression
The normally recommended dose of Escitalopram Aurovitas Pharma is 10 mg administered as a single daily dose. Your doctor may increase it to a maximum of 20 mg per day.
Anxiety disorder
The initial recommended dose is 5 mg of Escitalopram Aurovitas Pharma per day for the first week, to be increased to 10 mg per day and, if necessary, to a maximum of 20 mg per day.
Social anxiety disorder
The normally recommended dose of Escitalopram Aurovitas Pharma is 10 mg administered as a single daily dose. Your doctor may reduce your dose to 5 mg per day or increase the dose to a maximum of 20 mg per day, depending on your response to the medication.
Generalized anxiety disorder
The normally recommended dose of Escitalopram Aurovitas Pharma is 10 mg administered as a single daily dose. Your doctor may increase it to a maximum of 20 mg per day.
Obsessive-compulsive disorder
The normally recommended dose of Escitalopram Aurovitas Pharma is 10 mg administered as a single daily dose. Your doctor may increase it to a maximum of 20 mg per day.
Older adults (65 years of age or older)
The recommended dose of Escitalopram Aurovitas Pharma is 5 mg taken as a single daily dose. The dose may be increased by your doctor to 10 mg per day.
Children and adolescents (under 18 years)
Escitalopram Aurovitas Pharma should not normally be administered to children and adolescents. For additional information, see section 2 "Before taking Escitalopram Aurovitas Pharma".
Treatment duration
It may take a couple of weeks before you start feeling better. Continue taking Escitalopram Aurovitas Pharma even if you start feeling better before the expected time.
Do not change the medication dose without first talking to your doctor.
Continue taking Escitalopram Aurovitas Pharma for the recommended time by your doctor. If you interrupt treatment too soon, symptoms may reappear. It is recommended that treatment continue for at least 6 months after you feel better.
If you take more Escitalopram Aurovitas Pharma than you should
If you take more Escitalopram Aurovitas Pharma than prescribed, contact your doctor immediately, go to the nearest hospital emergency department, or consult the Toxicology Information Service, phone 915 620 420. Do it even when you do not observe discomfort or signs of intoxication. Some signs of overdose may be dizziness, tremor, agitation, convulsion, coma, nausea, vomiting, changes in heart rhythm, decreased blood pressure, and changes in the body's electrolyte balance. Bring the Escitalopram Aurovitas Pharma packaging if you visit your doctor or the hospital.
If you forget to take Escitalopram Aurovitas Pharma
Do not take a double dose to compensate for a missed dose. 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 treatment with Escitalopram Aurovitas Pharma
Do not interrupt treatment with Escitalopram Aurovitas Pharma until your doctor tells you to. When you have completed your treatment course, it is usually recommended that the Escitalopram Aurovitas Pharma dose be gradually reduced over several weeks.
When you stop taking Escitalopram Aurovitas Pharma, especially if it is done abruptly, you may experience withdrawal symptoms. These are common when treatment with Escitalopram Aurovitas Pharma is suspended. The risk is higher when Escitalopram Aurovitas Pharma 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 Aurovitas Pharma, please contact your doctor. They may ask you to take your tablets again and taper off them more slowly.
Withdrawal symptoms include: feeling of dizziness (unstable or loss of balance), feeling of tingling, feeling of prickling, and (less frequently) electric shock, even in the head, sleep disturbances (too intense dreams, nightmares, inability to sleep), feeling of restlessness, headache, feeling of nausea (dizziness), sweating (including nocturnal sweating), feeling of anxiety or agitation, tremor (instability), feeling of confusion or disorientation, feelings of emotion or irritability, diarrhea (loose stools), vision disturbances, palpitations.
If you have any other questions about the use of this medication, ask your doctor or pharmacist.
Like all medicines, this medicine may cause side effects, although not everyone will experience them.
Side effects usually disappear after a few weeks of treatment. Note that some of the side effects may also 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 the hospital directly:
Rare (may affect between 1 and 100 patients):
Uncommon (may affect between 1 and 1,000 patients):
Frequency not known (cannot be estimated from available data):
In addition to the above, the following side effects have been reported:
Very common (may affect more than 1 in 10 patients):
Common (may affect between 1 and 10 patients):
Rare (may affect between 1 and 100 patients):
Uncommon (may affect between 1 and 1,000 patients):
Not known (cannot be estimated from available data):
In addition, other side effects are known to appear with medications that act similarly to escitalopram (the active ingredient of Escitalopram Aurovitas Pharma. These are:
Reporting of side effects
Ifyou experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use, Website: www.notificaRAM.es
By reporting side effects, you can contribute to providing more information on the safety of this medicine.
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the box and the blister pack after CAD.
The expiration date is the last day of the month indicated.
This medication does not require a special storage temperature. Store in the original packaging to protect it from moisture and light.
Medications should not be disposed of through drains or in the trash. Deposit containers and medications you no longer need at the SIGRE point of the pharmacy.Ask your pharmacist how to dispose of containers and medications you no longer need if you are unsure. By doing so, you will help protect the environment.
Composition of Escitalopram Aurovitas Pharma
The active ingredient is escitalopram.
Escitalopram Aurovitas Pharma 10 mg: Each buccal dispersible tablet of Escitalopram Aurovitas Pharma contains 10 mg of escitalopram equivalent to 12.775 mg of escitalopram oxalate or
Escitalopram Aurovitas Pharma 15 mg: Each buccal dispersible tablet of Escitalopram Aurovitas Pharma contains 15 mg of escitalopram equivalent to 19.1625 mg of escitalopram oxalate or
Escitalopram Aurovitas Pharma 20 mg: Each buccal dispersible tablet of Escitalopram Aurovitas Pharma contains 20 mg of escitalopram equivalent to 25.55 mg of escitalopram oxalate.
Appearance of the product and contents of the package
Escitalopram Aurovitas Pharma 10 mg: White to off-white, circular, biplanar, beveled-edge tablets, 9 mm in diameter, with the inscription “10” on one side
Escitalopram Aurovitas Pharma 15 mg: White to off-white, circular, biplanar, beveled-edge tablets, 11 mm in diameter, with the inscription “15” on one side
Escitalopram Aurovitas Pharma 20 mg: White to off-white, circular, biplanar, beveled-edge tablets, 12 mm in diameter, with the inscription “20” on one side
Blister packs in packages of:12, 14, 20, 28, 50, 56, 60, 98, 100, and 200 buccal dispersible tablets.
Only some package sizes may be commercially available.
Marketing authorization holder and responsible manufacturer:
Marketing authorization holder
Aurovitas Spain, S.A.U.
Avda. de Burgos, 16-D.
28036 Madrid,
Spain
Responsible manufacturer
Genepharm S.A
18km Marathon Avenue,
15351 PalliniAttiki,
Greece
or
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park,
Paola PLA 3000, Malta
or
Rontis Hellas, S.A. Medical and Pharmaceutical Products Industrial Area of Larissa, P.O. Box 3012 Larisa Industrial Area, 41004, Greece or Pharmapath S.A. 28is Oktovriou 1, Agia Varvara, 123 51, Greece |
Last review date of this leaflet: December 2022
The 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/.
Have questions about this medication or your symptoms? Connect with a licensed doctor for guidance and personalized care.