ASENTRA 50 mg. 28 tablets
ASENTRA 50 mg. 28 tablets
ASENTRA WHAT IS AND WHAT IT IS USED FOR?
Asentra contains the active ingredient sertraline. Sertraline is a medicine of the so-called selective serotonin reuptake inhibitors SSRIs. These drugs are used to treat depression and / or anxiety disorders.
Asentra can be used for treatment of:
• Depression and prevention of relapse of depression (in adults).
• Social anxiety disorder (in adults).
• Post Traumatic Stress Disorder (PTSD) (in adults).
• Panic disorder (in adults).
• Obsessive-compulsive disorder (OCD) (adults, children and adolescents aged 6-17 years)
Depression is a clinical illness with symptoms like feeling sad, you can not sleep well or enjoy life as before.
OCD and panic disorder are diseases associated with anxiety, with symptoms like being constantly troubled by persistent ideas (obsessions) which force you to perform repetitive rituals (compulsions).
PTSD is a condition that can occur after a very emotionally traumatic experience, and there are some symptoms that resemble depression and anxiety. Social anxiety disorder (social phobia) is a disease associated with anxiety. Characterized by feelings of intense anxiety or distress in social situations (eg, talking to strangers, speaking to a group of people eating or drinking in front of others or worrying that you might behave awkwardly).
Your doctor has decided that this medicine is suitable for the treatment of your disease.
You should ask your doctor if you are unsure why you have been given Asentra.
2. BEFORE YOU TAKE ASENTRA
Do not take Asentra:
• If you are allergic (hypersensitive) to sertraline or any of the other ingredients of Asentra.
• If you are taking or have taken medicines called monoamine oxidase inhibitors (MAOIs such as selegiline, moclobemide) or MAOI-like medicines (eg linezolid). If you stop treatment with sertraline, you must wait at least one week before starting treatment with an MAOI. If you stop treatment with MAOIs, you should wait at least 2 weeks before you start treatment with sertraline.
• If you are taking another medicine called pimozide (a medicine to treat mental illness).
Take special care with Asentra
Medicines are not always suitable for everyone. Tell your doctor before taking Asentra if you have or have had in the past any of the following:
• Serotonin syndrome. In rare cases, this syndrome can occur when taking certain medications concomitantly with sertraline. (For symptoms see section 4. Possible side effects.) Your doctor should have told you if you have suffered from in the past.
• If you have low sodium in the blood, as it may occur as a result of treatment with Asentra. You should also tell your doctor if you are taking certain medicines for hypertension, as these drugs may alter the levels of sodium in your blood.
• Take special care if you are elderly as you may be at risk of low sodium in the blood (see above).
• Liver disease. Your doctor may decide to take a lower dose Asentra.
• Diabetes. Your blood sugar levels may be altered due to Asentra and may require dose adjustment of your diabetes medicines.
• Epilepsy or seizures in the past. If you have a fit (seizure), contact your doctor.
• If you have suffered from manic depressive illness (bipolar disorder) or schizophrenia. If you have a manic episode, contact your doctor.
• If you have or previously had suicidal thoughts (see below - suicidal thoughts and worsening of your depression or anxiety disorder).
• If you suffer from bleeding disorders or taking medicines that thin the blood (eg, acetylsalicylic acid (aspirin) or warfarin)) or may increase the risk of bleeding.
• If you are a child or adolescent under 18 years. Asentra should be used only for treatment of children and adolescents aged 6-17 years suffering from obsessive-compulsive disorder. If you have been treated for this disorder, your doctor will want to monitor you closely (see Use in children and adolescents below).
• If you are on electroconvulsive therapy (ECT).
Restlessness / akathisia
The use of sertraline was associated with akathisia (severe restlessness and need to move often unable to sit or stand still). It occurs most often during the first few weeks of treatment. Increased doses may be harmful to patients who develop these symptoms.
Withdrawal reactions when treatment is discontinued are common, particularly if treatment is stopped suddenly (see section 4. Possible side effects). The risk of withdrawal symptoms depends on the duration of treatment, dosage, and the speed at which the dose is reduced. Generally these symptoms are mild to moderate. In some patients, however, can be serious. Usually occur during the first few days after stopping treatment. Generally these symptoms disappear by itself and resolved within 2 weeks. Some patients may take longer (2-3 months or more). When treatment with sertraline is recommended to reduce the dose gradually over a period of several weeks or months depending on the patient's needs.
Thoughts of suicide and worsening of your depression or anxiety disorder
If you are depressed and / or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines start to work, usually about two weeks but sometimes longer. You may be more likely to think like this:
• If you have previously had thoughts about killing or harming yourself
• If you are a young man. Information from clinical trials has shown an increased risk of suicidal behavior in people under 25 years with psychiatric disorders treated with antidepressants.
If you have thoughts of harming or killing yourself at any time, contact your doctor immediately and go to the nearest hospital.
You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behavior.
Use in children and adolescents:
Asentra should generally not be used in children and adolescents, of less than 18, except in patients with obsessive-compulsive disorder. In patients under 18 have an increased risk of side effects such as suicide attempt, suicidal thoughts and hostility (mainly aggression, oppositional behavior and anger) when treated with drugs of this class. However, it is possible for your doctor to prescribe Asentra a patient under 18 years if the interest of the patient. If your doctor has prescribed Asentra a patient under 18 and you want to discuss this, please contact him / her. In addition, the onset or worsening of any of the above symptoms when patients under 18 are taking Asentra, you should tell your doctor. Also safety Asentra for an extended period in terms of growth, maturation and cognitive and behavioral development in this group have not yet been established.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Some medicines may affect the way you act or Asentra Asentra may reduce the effectiveness of other medicines taken at the same time.
Adoption of Asentra with the following medicines may cause serious side effects:
• Medicines called monoamine oxidase inhibitors (MAOIs) such as moclobemide (for depression) and selegiline (to treat disease Parkinson) and the antibiotic linezolid. Do not use Asentra with MAOIs.
• Medicines to treat mental disorders (pimozide). Do not use with pimozide Asentra.
Tell your doctor if you are taking the following medicines:
• Drugs of plant origin containing St. John's wort (Hypericum perforatum). The effects of St. John's wort can last for 1-2 weeks. Talk to your doctor.
Products containing the amino acid tryptophan. Drugs to treat severe pain (eg tramadol). Medicines to treat migraines (eg sumatriptan). Medicines to thin the blood (warfarin).
Medicines to treat pain / arthritis (nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, acetylsalicylic acid (aspirin). Sedatives (tranquilizers) drugs (diazepam). Diuretics (drugs that increase the excretion of urine). Medicines for epilepsy (phenytoin ). Medicines to treat diabetes (tolbutamide).
Medicines to treat excessive stomach acid and ulcers (cimetidine). Drugs for treatment of mania and depression (lithium).
Other drugs for the treatment of depression (such as amitriptyline, nortriptyline). Drugs for the treatment of schizophrenia and other mental illnesses (such as perphenazine, olanzapine levomepromazine).
Taking Asentra with food and drink
Asentra tablets can be taken with or without food.
During the intake Asentra should be avoided alcohol. Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine.
The safety of sertraline has not been fully established in pregnant women. Sertraline should not be given to pregnant women only if the physician considers that the benefits to the mother outweighs any possible risk to the fetus. Women of childbearing potential must use adequate contraception if taking sertraline.
There is evidence that sertraline is excreted in breast milk. Asentra should be used in nursing mothers only if the physician considers that the benefits to the mother outweighs any possible risk to the baby.
Driving and using machines
Psychotropic drugs such as sertraline may affect your ability to drive or operate machinery. Therefore, you should not drive or operate machinery until you know how this medication affects your ability to perform these activities.
3. HOW TO TAKE ASENTRA?
Always take Asentra exactly as your doctor tells you.
Asentra tablets can be taken with or without food.
Take your medication once daily in the morning or evening.
If you are not sure, ask your doctor or pharmacist.
The usual dose is:
Depression and obsessive-compulsive disorder:
For depression and OCD usual effective dose is 50 mg / day. The daily dosage can be increased by increments of 50 mg at intervals and at least one week, for a period of weeks. The maximum recommended dose is 200 mg / day.
Panic disorder, social anxiety disorder and PTSD:
For panic disorder, social anxiety disorder and PTSD treatment should be started at a dose 25 mg / day and increased to 50 mg / day after one week.
The daily dose can be increased by increments of 50 mg over a period of weeks. The maximum recommended dose is 200 mg / day.
Children and adolescents:
Asentra should be used only for the treatment of children and adolescents suffering from obsessive-compulsive disorder (OCD), aged 6-17 years: Obsessive-Compulsive Disorder
Children aged 6 to 12 years: The recommended starting dose is 25 mg daily. After one week, your doctor may increase the dose to 50 mg daily. The maximum dose is 200 mg daily.
Adolescents 13 to 17 years: The recommended starting dose is 50 mg daily. The maximum dose is 200 mg daily.
If you have liver or kidney problems, please tell your doctor and follow the doctor's instructions.
Your doctor will advise you on how long to take this medicine. This will depend on the nature of your illness and how well you respond to treatment.
It may take several weeks before your symptoms begin to improve.
If you take more dose Asentra
If you accidentally take too much Asentra, contact your doctor immediately or go to the nearest hospital emergency room. Always carry a pack of medicine, whether or not any medication.
Symptoms of overdose may include drowsiness, nausea and vomiting, fast heart rate, tremors, agitation, dizziness, and in rare cases, unconsciousness.
If you forget to take Asentra
If you forget to take a dose, do not take the missed dose. Take the next dose at the right time.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Asentra
Do not stop taking Asentra unless your doctor tells you to do so. Your doctor will want to gradually reduce your dose Asentra for several weeks before finally stop taking this medicine. If you suddenly stop taking this medicine, you may experience side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headache, fainting, sick and shaking. If you experience any of these side effects or any other side effects while stop taking Asentra, please talk to your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Asentra can cause side effects, although not everybody gets them.
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
Nausea is the most common side effect. Adverse drug reactions are dose dependent and are often transient with continued therapy.
Tell your doctor immediately:
If you have any of these symptoms after taking this medicine, these symptoms can be serious:
• If you develop a severe skin rash that causes blistering (erythema multiforme) (this can affect the mouth and tongue). These may be signs of a condition known as Syndrome Stevens-Johnson or toxic epidermal necrolysis (TEN). In these cases, your doctor will stop your treatment.
• Allergic reaction or allergy, which may include symptoms such as itchy skin rash, trouble breathing, wheezing, swollen eyelids, face or lips.
• If you experience agitation, confusion, have diarrhea, fever, and blood pressure, excessive sweating and rapid heartbeat. These are symptoms of serotonin syndrome. In rare cases, this syndrome can occur when taking certain medications at the same time as sertraline. Your doctor may stop your treatment.
• If you experience yellowing of the skin and eyes, which may indicate liver damage.
• If you experience depressive symptoms with suicidal ideas.
• If you start to get feelings of anxiety and you are not able to sit or stand still after you start taking Asentra. You should tell your doctor if you start to feel anxiety.
The following adverse reactions have been observed in clinical trials in adults.
Very common side effects (occur in more than 1 patient in 10):
- Insomnia, dizziness, drowsiness, headache, diarrhea, nausea, dry mouth, lack of Common side effects (seen in between 1 and 10 patients in 100):
- Sore throat, anoreksnya, increased appetite, depression, strange feeling, nightmares, anxiety, excitement, nervousness, decreased sexual interest, teeth grinding, numbness and tingling, trembling, muscle tension, abnormal taste, forgetfulness, visual disturbances, ringing in the ears , palpitations, flushing, yawning, abdominal pain, vomiting, constipation, upset stomach, gas, rash, increased sweating, muscle pain, sexual dysfunction, erectile dysfunction, chest pain.
Uncommon side effects (occurs in between 1 and 10 of 1000 patients):
- Chest cold, fever, hallucinations, feeling too happy, a sense of caring, thinking abnormal, convulsions, involuntary muscle contractions, abnormal coordination, movement, amnesia, decreased sensation, speech disorder, postural dizziness, migraine, pain ear, fast heartbeat, high blood pressure, flushing, difficulty breathing, wheezing possible, shortness of breath, nosebleeds, problems with the esophagus, difficulty swallowing, haemorrhoids, increased salivation, tongue disorder, belching, swollen eyes, purple spots skin, hair loss, cold sweat, dry skin, osteoarthritis, muscle weakness, back pain, muscle twitching, nighttime urination, inability to urinate, increased urination, increased frequency of urination, problem urinating, vaginal bleeding, sexual dysfunction in women malaise, chills, fever, weakness, thirst, weight loss, weight gain.
Rare side effects (occurs in between 1 and 10 per 10,000 patients):
- Intestinal problems, ear infection, cancer, swollen glands, high cholesterol, low blood sugar, physical symptoms caused by stress or emotions, drug dependence, psychotic disorder, aggression, paranoia, suicidal thoughts, sleep walking, premature ejaculation,