first What is Cipralex and what is it used?
contains Cipralex escitalopram and is used to treat depressive disorders (major depression) and anxiety disorders (such as panic disorder with or without agoraphobia, social anxiety disorder, generalized anxiety disorder and obsessive compulsive disorder).
Escitalopram belongs to a class of antidepressants, the selective are serotonin reuptake inhibitors (SSRIs) called. 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 are hypersensitive (allergic) to escitalopram or any of the other ingredients of Cipralex (see section 6 "Further information").
- if you take other drugs from the group known as MAO inhibitors take, including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depressive disorders) and linezolid (an antibiotic).
suicidal ideation and worsening of your depression / anxiety disorder
If you are depressed or have anxiety disorders you can sometimes have thoughts of hurting yourself or suicide to . commit 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.
if at any point you thought of it To develop self-injure or commit suicide.
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. Ask them to tell you if they have the impression that worsen your depression or anxiety, or if they are worried about changes in your behavior.
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
- from epilepsy . Suffer 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.
- is if you have an increased tendency to bleeding or bruising.
- if you have a Elektrokrampftheraphie is carried out.
- if you suffer from coronary heart disease.
As with other medicines used to treat depression or other disorders, an improvement does not occur immediately. After starting treatment with Cipralex it may take several weeks before you notice an improvement. In the treatment of panic disorder, it generally takes 2-4 weeks, may be determined to be better. At the beginning of therapy may occur in some patients to an increase in anxiety, which subside somewhat during further treatment. It is therefore very important that you just follow the instructions of your doctor and do not leave the treatment or change the dose without consulting your doctor.
Occasionally, the symptoms of a depressive disorder or panic disorder with thoughts of suicide (suicide) or self-injury associated. It is possible that these symptoms persist or worsen, until the full antidepressant effect of the drug is visible. This is even more likely if you are in young adults, ie under 30 years of age.
Some patients with manic-depressive illness can find themselves in 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 if you experience such symptoms.
Sometimes you are perhaps unaware of the symptoms above, so it may be helpful to ask a friend or relative to help you to pay attention to these possible signs of changes in your behavior.
Immediately notify your doctor or go into the nearest hospital if you have troubling thoughts or experiences or if one or more of the above symptoms occur during treatment.
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 drug in the 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 are using any other medicines / or have recently taken any medicines, even those obtained without a prescription.
Tell your doctor if you are taking one or more of the following medicines:
- contain "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 any of the above Medicines.
- "Reversible selective MAO-A inhibitors ", containing moclobemide (used for treatment of depressive disorders).
- "Irreversible MAO-B inhibitors", containing selegiline (used to treat Parkinson's disease). These increase the risk of side effects.
- linezolid (an antibiotic).
- lithium (used to treat manic-depressive disorder) and tryptophan. Imipramine and desipramine
- (both drugs for the treatment of 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.
- 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 anticoagulant drugs should be adjusted.
- Mefloquine (a medicine to treat Malaria), bupropion (an antidepressant) and tramadol (a strong pain killer) because of the potential risks of the seizure threshold is lowered.
- neuroleptics (medicines to treat schizophrenia, psychosis) due to the potential risk that the seizure threshold is lowered, as well as antidepressants.
- flecainide, propafenone and metoprolol (used in cardiovascular diseases), Clomipramine and nortriptyline (antidepressants), and also risperidone, thioridazine and haloperidol (antipsychotics). The dose of Cipralex must then be adjusted.
Cipralex can be taken with food (see Section 3, "How to take Cipralex?")
As with many drugs is taking Cipralex not related to alcohol 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 be. Do not take Cipralex not if you are pregnant, 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 Please contact your doctor immediately.
If you are taking escitalopram during pregnancy, you should never suddenly stop treatment.
Take Cipralex not apply if you are breastfeeding, unless you have discussed the risks and benefits with your doctor.
questions before taking any medicine your doctor or pharmacist for advice
drive and use machines
It is advisable not to drive or operate machinery until you know how to Cipralex . respond
third How to take Cipralex?
Take Cipralex exactly as directed by your doctor. Please You should check with your doctor or pharmacist if you are not sure.
adults
Depression
is the usual recommended dose of Cipralex 10 mg once daily. The dose may be prescribed by your doctor to increase up to 20 mg per day.
panic disorder
The starting dose of Cipralex in the first week of treatment is 5 mg once a day before being increased to 10 mg per day. The dose may be prescribed by your doctor to a maximum of 20 mg per day increased further.
Social anxiety disorder
The usual recommended dose of Cipralex is 10 mg once daily. Your doctor may lower the dose of either 5 mg per day or increase to a maximum of 20 mg per day, depending on how you respond to the medicine.
Generalized anxiety disorder
is the usual recommended dose of Cipralex 10 mg once daily. The dose may be prescribed by your doctor to increase up to 20 mg per day.
OCD
is the usual recommended dose of Cipralex 10 mg once daily. The mg dose may by your doctor to a maximum of 20 increase per day.
Elderly (over 65)
is the usual recommended starting dose of Cipralex 5 mg once daily.
children and adolescents (under 18)
Cipralex should normally not be given to children and young people. For more information, see section 2 "What you should consider before taking Cipralex?
you can take escitalopram with or without food. Swallow the tablets with sufficient water. Chew it not because they taste bitter.
If necessary, the tablets may be split, by being initially loaded with the score line down on a flat surface. The tablets can be shared by the two ends of the tablet, as shown in the figure, with his index fingers pressed down.
duration of treatment
It may take several weeks before you begin to feel better. Continue to take Cipralex, even if it takes some time before you notice an improvement in your condition.
Do not change the dosage of your medicine without first talking to your doctor about it.
they expose the Cipralex for as long as your doctor recommends. If the treatment stop too soon, your symptoms return. It is recommended that treatment be continued at least 6 months after you feel well again.
If you take more of Cipralex, as they should
If you take more than the prescribed dose, notify your doctor immediately or go to the emergency room of the nearest hospital. Do this even if you have no complaints. Signs of overdose may include dizziness, tremor, agitation, convulsions, coma, nausea, vomiting, heart rhythm disturbances, low blood pressure and changes be in the 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
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, by itself in some patients sie jedoch auch mit starker Intensität oder über einen längeren Zeitraum auftreten (2 bis 3 Monate oder länger). Wenn Sie schwerwiegende Absetzsymptome nach Beendigung der Cipralex-Einnahme bemerken, informieren Sie bitte Ihren Arzt. Er oder sie wird Sie vielleicht bitten, die Tabletten zunächst wieder einzunehmen und die Dosis dann langsamer zu verringern.
Absetzsymptome können sein: Schwindelgefühl (unsicheres Gefühl oder Gleichgewichtsstörungen), Nadelstich-ähnliche Empfindungen, brennende oder (weniger häufig) Stromschlag-ähnliche Empfindungen (auch im Kopf), Schlafstörungen (lebhafte Träume, Alpträume, Unfähigkeit zu schlafen), Angstgefühle, Kopfschmerzen, Feeling sick (nausea), sweating (including night sweats), feeling of restlessness or agitation, 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 also due to your illness can be and therefore 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 stomach GI 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 go directly to 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 also section
- Yellowish discoloration of the Skin and white 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)
- Decreased or increased appetite
- anxiety, restlessness, abnormal dreams, difficulty sleeping, drowsiness, dizziness, yawning, trembling, tingling of the skin
- diarrhea, constipation, Erbrechen, Mundtrockenheit
- Vermehrtes Schwitzen
- Schmerzen in Muskeln und Gelenken (Myalgie und Arthralgie)
- Störungen der Sexualfunktion (verzögerte Ejakulation, Erektionsstörungen, Minderung des sexuellen Interesses und bei Frauen Orgasmusstörungen)
- Müdigkeit, Fieber
- Gewichtszunahme
- Nesselausschlag (Urtikaria), Ausschlag, Juckreiz (Pruritus)
- Zähneknirschen, Aufgeregtheit, Nervosität, Panikattacken, verwirrter Zustand
- Schlafstörungen, Geschmacksstörungen, Ohnmacht (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, hallucination
- slow heartbeat
- suicide-related events, see also section
- reduced sodium concentration in the blood (the symptoms are feeling unwell with weak muscles or confused)
- dizziness when standing up due to low blood pressure (orthostatic hypotension)
- abnormal results of liver function tests (increased number of liver enzymes in the blood)
- movement disorders sudden (involuntary muscle movements)
- painful erections (priapism)
- bleeding disorders including skin and mucous bleeding (ecchymosis) and low platelet levels (thrombocytopenia)
- swelling of the skin or mucous membranes (angioedema)
- increased urination (abnormal secretion of antidiuretic hormone)
- secretion of milk in women who are not breast
- mania
- suicidal thoughts, suicidal behavior
There are also a number of side effects that occur with drugs that act similarly to escitalopram (the active ingredient of Cipralex) and include:
- psychomotor agitation (Akathisia)
- appetite
5th As Cipralex store
medicines away from children.
the medicine after the use is no longer on the blister and the carton after "EXP" expiration date. The expiry date refers to the last day of the month.
For this no special storage conditions required.
Medicines should not waste water or household waste will be disposed of. Ask your pharmacist how to dispose of medicines, if you no longer need. These measures will help protect the environment.
6th For more information
What does Cipralex 10 mg tablets
The active ingredient is escitalopram. A tablet Cipralex 10 mg tablets contains 10 mg escitalopram (as oxalate).
The other ingredients are:
Tablet core: microcrystalline cellulose, colloidal silicon dioxide, talc, croscarmellose sodium and magnesium stearate.
Coating: Hypromellose, Macrogol 400 und Titandioxid (E 171).
Wie Cipralex 10 mg Filmtabletten aussieht und Inhalt der Packung
Ovale, weiße Filmtabletten mit Bruchrille, markiert mit „E“ auf der einen und „L“ auf der anderen Seite der Bruchrille, auf einer Seite der Tablette.
Cipralex 10 mg Filmtabletten ist in folgenden Packungsgrößen erhältlich:
Blister (weiß) im Umkarton verpackt, 50 N2 und 100 N3 Tabletten.
Einfuhr, Umpackung und Vertrieb:
ACA Müller ADAG Pharma AG, Gewerbestr. 10, 78244 Gottmadingen
Hersteller
H. Lundbeck A / S, Ottiliavej 9, DK-2500 Valby, Copenhagen, Denmark
This medicine is in the Member States of the European Economic Area (EEA) under the following names approved:
Belgium: Sipralexa
Bulgaria: Cipralex
Denmark: Cipralex
Germany: Cipralex
Estonia: Cipralex
Finland: Cipralex
France: Seroplex
Greece: Cipralex
UK: Cipralex
Ireland: Lexapro
Iceland: Cipralex
Italy: Cipralex
Latvia: Cipralex
Lithuania: Cipralex
Luxembourg: Sipralexa
Malta: Cipralex
Netherlands: Norway
Cipralex: Cipralex
Österreich: Cipralex
Polen: Cipralex
Portugal: Cipralex
Rumänien: Cipralex
Schweden: Cipralex
Slowakei: Cipralex
Slowenien: Cipralex
Spanien: Cipralex
Tschechische Republik: Cipralex
Ungarn: Cipralex
Zypern: Cipralex
Diese Gebrauchsinformation wurde zuletzt überarbeitet im Juni 2009.
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