Cipralex 20 mg / ml oral drops, solution
active ingredient: 1 Escitalopram
What is Cipralex and what is it used?
contains Cipralex escitalopram and is used to treat depression (Episodes of major depression) and anxiety disorders (such as panic disorder with or without agoraphobia, social anxiety disorder, generalized anxiety disorder and obsessive compulsive disorder). called
Escitalopram belongs to a class of antidepressants, selective serotonin reuptake inhibitors (SSRIs). These drugs act on the serotonin system in the brain by increasing serotonin levels. Disturbances in the serotonin system may be regarded as an important factor in the emergence of depression and related disorders.
second What to consider before taking Cipralex?
Cipralex should not be taken, if you
- hypersensitive (allergic) to escitalopram or any of the other ingredients of Cipralex (see section 6 "Further information").
- if you are taking other medicines out of the group known as MAO inhibitors, including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depressive disorders) and linezolid (an antibiotic).
Tell your doctor if you suffer from other ailments or diseases that your doctor must take this into account if necessary. In particular, tell your doctor
- if you suffer from epilepsy. Treatment with Cipralex should be discontinued if seizures occur or if the frequency increases the seizure (see also section 4 Possible side effects are possible? ").
- if you have impaired liver or kidney function. Your doctor may then adjust your dose.
- if you have diabetes. Treatment with Cipralex can change your blood sugar levels. It is possible that the insulin dose and / or the dose of oral hypoglycaemic agents should be adjusted.
- when the sodium concentration in your blood is reduced.
- if you have an increased tendency to bleeding or bruising exists.
- if you have a Elektrokrampftheraphie is carried out.
- if you suffer from coronary heart disease. can
Some patients with manic-depressive illness fall into a manic phase. This is characterized by unusual and rapidly changing ideas, exaggerated gaiety and excessive physical activity strong. If you notice these symptoms, consult your doctor.
symptoms such as restlessness or difficulty to sit or stand quietly, may also occur during the first weeks of treatment. Tell your doctor immediately know if you experience such symptoms.
suicidal ideation and worsening of your depression / anxiety disorder
If you are depressed or have anxiety disorders you can sometimes have thoughts of hurting themselves or committing suicide. These may be increased by antidepressants in the initial application, since these medicines all take time to work, usually about two weeks, sometimes longer.
You may be more likely to think
- if you already have ever had the thought of taking their own lives or have thought about harming themselves,
- if you are a young adult. Results from clinical studies have shown an increased risk of suicidal behavior in young adults aged under 25 who suffered from a psychiatric disorder and were treated with an antidepressant.
It may be helpful to tell a friend or relative, that you are depressed or have an anxiety disorder. Ask them to read this leaflet. Call They tell you if they have the impression that aggravate your depression or anxiety, or if they are worried about changes in your behavior.
use in children and adolescents under 18 years Cipralex should not normally be used in children and adolescents under 18 years. You should also know that patients under 18 years when they take this class of drugs is an increased risk of side effects, such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behavior and anger), having. Nevertheless, your doctor may prescribe Cipralex patients under 18 years if he / she decides that this is in their best interest of the patient. If your doctor to a patient under 18 years has prescribed Cipralex, and you wish to discuss this, please go back to your doctor. You should inform your doctor if a patient under 18 years of Cipralex occupies one of the above symptoms occur or worsen. Also, the long-term safety effects of Cipralex in terms of growth, maturation and cognitive and behavioral development in this age group have not yet been demonstrated.
Taking Cipralex
other medicines Tell your doctor if you taking other medicines, or have recently taken any medicines, even if it is not prescribed.
Tell your doctor if you are taking one or more of the following medicines:
• "Non-selective monoamine oxidase inhibitors (MAOIs), the phenelzine, iproniazid, isocarboxazid, nialamide and tranylcypromine as active ingredients. If you take any of these medicines, you must wait 14 days before you start taking Cipralex. After the completion of treatment with Cipralex, you have to wait for at least 7 days before a der o. g. Arzneimittel einnehmen.
• „Reversible, selektive MAO-A-Hemmer“, die Moclobemid enthalten (Arzneimittel zur Behandlung von depressiven Erkrankungen).
• „Irreversible MAO-B-Hemmer“, die Selegilin enthalten (Arzneimittel zur Behandlung der Parkinson-Krankheit). Diese erhöhen das Risiko von Nebenwirkungen.
• Linezolid (Antibiotikum).
• Lithium (Arzneimittel zur Behandlung von manisch-depressiven Störungen) und Tryptophan.
• Imipramine and desipramine (both used to treat depressive disorders).
• Sumatriptan and similar medicines (used to treat migraine) and tramadol (a strong pain killer). These increase the risk of side effects.
• cimetidine and omeprazole (medicines to treat stomach ulcers), fluvoxamine (an antidepressant) and ticlopidine (used to reduce the stroke risk). This can lead to an increase in blood levels of Cipralex.
• St. John's wort (Hypericum perforatum) - a herbal remedy that is used in depressive disorders.
• Aspirin and non-steroidal anti-inflammatory drugs (medicines for pain relief or to thin the blood, called anticoagulants).
• warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood, called anticoagulants). Your doctor will probably be the clotting time of your blood at the beginning and the end of treatment with Cipralex check to see if possibly the dose of your anti-clotting drugs angepasst werden muss.
• Mefloquin (Arzneimittel zur Behandlung von Malaria), Bupropion (ein Antidepressivum) und Tramadol (ein starkes Schmerzmittel) aufgrund des möglichen Risikos, dass die Krampfschwelle erniedrigt wird.
• Neuroleptika (Arzneimittel zur Behandlung von Schizophrenie, Psychosen) aufgrund des möglichen Risikos, dass die Krampfschwelle erniedrigt wird, sowie Antidepressiva.
• Flecainid, Propafenon und Metoprolol (werden bei Herz-Kreislauf-Erkrankungen eingesetzt), Clomipramin und Nortriptylin (Antidepressiva), außerdem Risperidon, Thioridazine and haloperidol (antipsychotics). The dose of Cipralex must then be adjusted.
Taking Cipralex with food and drinks
Cipralex can be taken with food (see Section 3, "How to take Cipralex?").
As with many drugs, the Cipralex with alcohol is not advisable, although interaction between Cipralex and alcohol are not expected.
pregnancy and lactation
Tell your doctor if you are pregnant or plan to become pregnant. Do not take escitalopram if you are pregnant are, unless you have discussed the risks and benefits with your doctor.
If you are taking Cipralex for the last three months of your pregnancy, you should know that your newborn may exhibit the following symptoms: difficulty breathing, bluish skin, seizures, changes in body temperature, difficulty in feeding, vomiting, low blood sugar level; stiff or floppy muscles, vivid reflexes, anxious / nervous tremors, irritability, lethargy, constant crying, sleepiness and difficulty sleeping. If your newborn shows any of these symptoms, contact your doctor immediately.
If you Cipralex during der Schwangerschaft einnehmen, sollten Sie die Behandlung niemals plötzlich abbrechen.
Nehmen Sie Cipralex nicht ein, wenn Sie stillen, es sei denn, Sie haben Nutzen und Risiken mit Ihrem Arzt besprochen.
Fragen Sie vor der Einnahme von allen Arzneimitteln Ihren Arzt oder Apotheker um Rat.
Verkehrstüchtigkeit und das Bedienen von Maschinen
Es ist ratsam, nicht Auto zu fahren und keine Maschinen zu bedienen, bis Sie wissen, wie Sie auf Cipralex reagieren.
Wichtige Informationen über bestimmte sonstige Bestandteile von Cipralex
Dieses Arzneimittel enthält einen geringen Alkoholanteil (weniger als 100 mg pro Einzelgabe). Ein Tropfen enthält 4,7 mg Ethanol (Alkohol).
3. Wie ist Cipralex einzunehmen?
Nehmen Sie Cipralex immer genau nach Anweisung des Arztes ein. Bitte fragen Sie bei Ihrem Arzt oder Apotheker nach, wenn Sie sich nicht ganz sicher sind.
Tropfen Sie die gewünschte Anzahl von Tropfen in Ihr Getränk (Wasser, Orangensaft oder Apfelsaft), rühren Sie kurz um und trinken es dann vollständig aus.
Cipralex Tropfen zum Einnehmen dürfen nicht anderen Flüssigkeiten beigemischt werden und Sie dürfen sie nicht mit anderen Arzneimitteln mischen.
Erwachsene
Depressive Erkrankungen Die üblicherweise empfohlene Dosis von Cipralex beträgt 10 mg (10 Tropfen) einmal täglich. Die Dosis kann von Ihrem Arzt auf maximal 20 mg (20 Tropfen) pro Tag gesteigert werden.
Panikstörung Die Anfangsdosis von Cipralex in der ersten Behandlungswoche beträgt 5 mg (5 Tropfen) einmal täglich, bevor sie auf 10 mg (10 Tropfen) pro Tag erhöht wird. Die Dosis kann von Ihrem Arzt auf maximal 20 mg (20 Tropfen) pro Tag weiter gesteigert werden.
Soziale Angststörung
Die üblicherweise empfohlene Dosis von Cipralex beträgt 10 mg (10 Tropfen) einmal täglich. Ihr Arzt kann die Dosis entweder auf 5 mg (5 drops) per day or lower, they increase to a maximum of 20 mg (20 drops) per day, depending on how you respond to the medicine.
Generalized anxiety disorder
is the usual recommended dose of Cipralex 10 mg (10 drops) once daily. The dose may be increased by your doctor to a maximum of 20 mg (20 drops) per day.
OCD
is the usual recommended dose of Cipralex 10 mg (10 drops) once daily. The dose may be increased by your doctor to a maximum of 20 mg (20 drops) per day.
Ältere Patienten (über 65 Jahren)
Die üblicherweise empfohlene Anfangsdosis von Cipralex beträgt 5 mg (5 Tropfen) einmal täglich.
Kinder und Jugendliche (unter 18 Jahren)
Cipralex sollte normalerweise Kindern und Jugendlichen nicht verordnet werden. Weitere Informationen siehe Abschnitt 2. „Was müssen Sie vor der Einnahme von Cipralex beachten?“.
Dauer der Behandlung
Es kann einige Wochen dauern, bevor Sie beginnen, sich besser zu fühlen. Setzen Sie die Einnahme von Cipralex fort, auch wenn es einige Zeit dauert, bis Sie eine Verbesserung Ihres Krankheitszustandes feststellen.
Verändern Sie nicht die Dosierung Ihres Arzneimittels, ohne vorher darüber mit Ihrem Arzt zu sprechen.
Setzen Sie die Einnahme von Cipralex solange fort, wie Ihr Arzt es Ihnen empfiehlt. Wenn Sie die Behandlung zu früh beenden, können Ihre Krankheitszeichen wiederkehren. Es wird empfohlen, dass die Behandlung noch mindestens 6 Monate fortgesetzt wird, nachdem Sie sich wieder gut fühlen.
Wenn Sie eine größere Menge von Cipralex eingenommen haben, als Sie sollten
Wenn Sie eine größere Menge als die verschriebene Dosis eingenommen haben, verständigen Sie bitte sofort Ihren Arzt oder suchen Sie die Notaufnahme des nächsten Krankenhauses auf. Tun Sie so even if you have no complaints. Signs of overdose can be dizziness, tremor, agitation, convulsions, coma, nausea, vomiting, heart rhythm disturbances, low blood pressure and changes in fluid / salt balance of the body. Take Cipralex pack with the doctor or hospital.
If you forget to take Cipralex
Do not take a double dose to make up the missed dose. If you miss a dose, and this notice before going to bed, take the dose immediately. Run the next day taking as usual. If You notice only during the night or the next day that you miss a dose, take only that dose not taken, then take Cipralex continues as normal.
If you stop taking Cipralex cancel
stop taking Cipralex not before your doctor recommends it. If your treatment is to be terminated, it is generally advisable that the dose of Cipralex is gradually reduced over several weeks.
If you stop taking Cipralex, especially if this happens abruptly, you may notice withdrawal symptoms. These often occur when treatment is finished with Cipralex. The risk of this is higher if Cipralex was taken over a longer period of time or in high doses or when the dose is reduced too quickly. For most patients, the symptoms are mild and disappear within two weeks of itself in some patients but may also occur with high intensity or for a longer period (2 to 3 months or longer). If you experience any serious withdrawal symptoms after the Cipralex-dose, inform your doctor. He or she may ask you, again taking Cipralex first and then to decrease the dose slowly.
Withdrawal symptoms may include: dizziness (feeling insecure or dizziness), Pinprick-like sensations, burning, or (less commonly) electric shock-like sensations (including in the head), sleep disturbances (vivid dreams, nightmares, inability to sleep), anxiety, headaches, feeling sick (nausea), sweating (including night sweats), feeling of restlessness or nervousness, tremors, feeling of confusion or disorientation, emotionality or irritability, diarrhea, blurred vision, restless, or pounding heartbeat.
If you have further questions on the use of this medicine, ask your doctor or pharmacist.
4th What side effects are possible?
Like all medicines, Cipralex can cause side effects, although not everybody gets them.
The side effects usually resolve after a few weeks of treatment. you should also know that many of these symptoms are also due to your illness and, thus, disappear when you start to feel better.
Please inform your doctor if you experience during treatment or you see more of the following side effects:
Uncommon (more than 1 in 1,000 patients and less than 1 in 100 patients):
- unusual bleeding, including gastrointestinal bleeding
- If you notice any swelling of the skin, tongue, lips or face, or if you have difficulty breathing or swallowing (allergic reaction), notify your doctor or look directly at a hospital.
- If you have a high fever, agitation, confusion, tremors, and sudden muscle contractions, can be signs of rare, so-called "serotonin syndrome" to be. If you notice this, tell your doctor.
- difficulty urinating
- convulsions (seizures), see the section "special care with Cipralex ® is required"
- Yellowish discoloration of the skin and the white area of the eyes are signs of liver failure / hepatitis.
Very common (more than 1 in 10 patients):
- feeling sick (nausea)
- stuffy or runny nose (sinusitis)
- Reduced or increased appetite
- anxiety, restlessness, abnormal dreams, difficulty sleeping, drowsiness, dizziness, yawning, trembling, tingling of the skin
- diarrhea, constipation, vomiting, dry mouth
- Sweating
- pain in muscles and joints (myalgia and arthralgia) Occasionally
- sexual dysfunction (delayed ejaculation, erectile dysfunction, loss of sexual interest and women orgasm disorders)
- fatigue, fever
- weight gain
- hives (Urticaria), rash, itching (pruritus)
- teeth grinding, agitation, nervousness, panic attacks, confused state
- sleep, taste disturbance, fainting (syncope)
- Dilated pupils (mydriasis), visual disturbances, ringing in the ears (tinnitus)
- hair loss
- vaginal bleeding
- weight loss
- rapid heartbeat
- swelling of the arms or legs
- nosebleeds
- aggression, feelings of alienation , hallucinations
- langsamer Herzschlag
- Suizidale Gedanken, suizidales Verhalten*
- herabgesetzte Natriumkonzentration im Blut (Anzeichen sind Unwohlsein mit Muskelschwäche oder Verwirrtheit)
- Schwindelgefühl beim Aufstehen aufgrund eines niedrigen Blutdruckes (orthostatische Hypotonie)
- anormale Ergebnisse von Leberfunktionstests (vermehrte Anzahl von Leberenzymen im Blut)
- Bewegungsstörungen (unwillkürliche Muskelbewegungen)
- schmerzhafte Erektionen (Priapismus)
- Blutungsstörungen einschließlich Haut- und Schleimhautblutungen (Ekchymosen) und niedriger Blutplättchen-Spiegel (Thrombozytopenie)
- plötzliche Schwellungen der Haut oder Schleimhaut (Angioödeme)
- vermehrtes Wasserlassen (anormale Ausschüttung des antidiuretischen Hormons)
- Absonderungen von Milch bei Frauen, die nicht stillen
- Manie
Daneben gibt es noch eine Reihe von Nebenwirkungen, die bei Arzneimitteln auftreten, die ähnlich wie Escitalopram (dem Wirkstoff effect of Cipralex) and include:
- psychomotor restlessness (akathisia)
- appetite
5th As Cipralex store
medicines away from children.
the medicine after the use is no longer on the bottle label and carton after "EXP" expiration date. The expiry date refers to the last day of the month. After
dem Öffnen der Flasche sollten die Tropfen innerhalb von 8 Wochen aufgebraucht und nicht über 25°C gelagert werden.
Das Arzneimittel darf nicht im Abwasser oder Haushaltsabfall entsorgt werden. Fragen Sie Ihren Apotheker, wie das Arzneimittel zu entsorgen ist, wenn Sie es nicht mehr benötigen. Diese Maßnahme hilft die Umwelt zu schützen.
6. Weitere Informationen
Was Cipralex enthält
Der Wirkstoff ist Escitalopram. 1 ml Cipralex Tropfen zum Einnehmen enthält 20 mg Escitalopram (als Escitalopramoxalat).
1 Tropfen enthält 1 mg Escitalopram.
Die sonstigen Bestandteile sind:
Propylgallat (Ph.Eur.)
citric
ethanol 96% sodium hydroxide
Purified water
As Cipralex looks like and contents of the pack
Cipralex oral drops, solution is available in a brown glass bottle with dropper with 15 ml (N1) content.
Cipralex oral drops, solution is a clear, almost colorless to yellow solution.
Authorisation Holder and Manufacturer
H. Lundbeck A / S
Ottiliavej 9
DK-2500 Copenhagen-Valby
Denmark
co-marketing:
Lundbeck GmbH
Karnapp 25
21079 Hamburg
Phone: 040 / 2 36 49 -0
Fax: 040 / 2 36 49-2 55
E-mail: info@lundbeck.de
This medicine is in the Member States of the European Economic Area (EEA) under the following names approved:
Denmark, Germany
Cipralex: Cipralex
Finland: Cipralex
France : Seroplex
UK: Cipralex
Ireland: Lexapro
Iceland: Cipralex
Italy: Cipralex
Norway: Cipralex
Portugal: Cipralex
Sweden: Cipralex
Spain: Cipralex
Czech Republic: Cipralex
This leaflet was last approved in April 2008 .
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