WHAT IS AND WHAT IT USED ASENTRA
Asentra contains the active substance sertraline. Sertraline belongs to a group of selective serotonin reuptake inhibitors (SSRIs), these drugs are used to treat depression and anxiety disorders.
Asentra is used to treat:
Depression and prevent recurrence of depression (in adults).
Social anxiety disorder (in adults).
Post traumatic stress disorder (PTSD) (in adults).
Panic disorder (in adults).
Obsessive compulsive disorder (OCD) (in adults and adolescents aged 6 to 17 years).
BEFORE YOU TAKE ASENTRA
Do not use Asentra
•If you are allergic (hypersensitive) to sertraline or any of the other components of Asentra.
•If you are taking or have been treated with drugs called monoamine oxidase (MAO) inhibitors (such as selegiline, moclobemide) or with drugs like MAOIs (such as linezolid). If you stop taking sertraline, you must wait at least one week before starting treatment with MAOIs. After stopping treatment with MAOIs, you should wait at least 2 weeks before you start treatment with sertraline.
•If you are taking another medicine containing pimozide (an antipsychotic medication).
Take special care with Asentra
Not every product is suitable for everyone. Please tell your doctor before using Asentra, if you have or have recently undergone one of the following states:
•Serotonin syndrome. In rare cases, this syndrome can occur when using some drugs the same with sertraline. (For symptoms, see section 4. Possible side effects). Inform your doctor if you have this syndrome in the past.
•Low sodium in the blood, because this can occur as a result of treatment with Asentra. Also, you should tell your doctor if you use certain drugs for high blood pressure, since these drugs can alter the concentration of sodium in the blood.
•Be careful if you are elderly, because you can present a higher risk of having low blood sodium (see above).
•Liver disease, your doctor can decide if the Asentra dose reduction.
•Diabetes blood sugar levels can be modified by Asentra and diabetes medication will be adjusted.
•Epilepsy or epileptic seizures. If you have a fit (seizure), contact your doctor immediately.
•If you have suffered from manic-depressive illness (bipolar disorder) or schizophrenia. If you have a manic episode, contact your doctor immediately.
•If you have or previously had suicidal thoughts (see below - thoughts of suicide and worsening of your depression or anxiety).
•If you have bleeding disorders or if taking medicines such as aspirin or warfarin
•If you are a child or adolescent under 18 years. Asentra should only be used to treat children and adolescents aged 6 to 17 years, suffering from obsessive compulsive disorder. If you are treated for this condition, your doctor will want to monitor you closely (see below Use in children and adolescents)
•If you are receiving electroconvulsive therapy (ECT)
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
Some medicines may affect Asentra action; can reduce the effectiveness of other drugs used at the same time.
Medicines called monoamine oxidase (MAO) inhibitors such as moclobemide (for depression) and selegiline (for Parkinson's disease) and the antibiotic linezolid. Do not use Asentra with MAOIs.
Medications used to treat mental disorders (pimozide). Do not use Asentra with pimozide.
Tell your doctor if you use the following drugs:
•Herbal medicines containing St John's wort (Hypericum perforatum). Effect of St. John's wort may take up to 1-2 weeks. Tell your doctor.
•Products containing the amino acid tryptophan.
•Medicines to treat severe pain (eg tramadol).
•Medicines to treat migraines (eg sumatriptan)
•Drugs that prevent normal blood clotting (warfarin).
•Medicines to treat pain / arthritis (inflammatory drugs (NSAIDs) such as ibuprofen, aspirin).
•Medicines for epilepsy (phenytoin).
•Medications to treat diabetes (tolbutamide).
•Medicines to treat ulcers and reduce excessive stomach acid (cimetidine)
•Medicines to treat mania and depression (lithium).
•Other drugs to treat depression (such as amitriptyline, nortriptyline).
•Medicines to treat schizophrenia and other mental disorders (such as perphenazine, levomepromazine and olanzapine).
Asentra use with food and drink
Asentra tablets can be taken with or without food.
You should not drink alcohol while taking Asentra.
Pregnancy and lactation
Ask your doctor or pharmacist for advice before taking any medicine.
The safety of sertraline in pregnant women has not been fully established. Sertraline should not be used during pregnancy unless the physician considers that the benefit to the mother outweigh any possible risks to the fetus.Women who may become pregnant and sertraline are advised to use appropriate methods of contraception.
It has been shown that the drug is excreted into breast milk. Sertraline should not be used during lactation unless the physician considers that the benefit to the mother outweigh any possible risks to the baby.
Driving and using machines
Psychotropic drugs such as sertraline may influence your ability to drive or operate machinery. Therefore, do not drive or use machines until you know whether this drug change your ability to perform these activities.
HOW TO USE ASENTRA
Always Asentra exactly as your doctor has told you.
Your medicine should be administered once daily in the morning or evening.
You should check with your doctor or pharmacist if you are unsure.
If you use more than you should Asentra
If you accidentally take more than prescribed Asentra, ask your doctor or head to the nearest medical facility. Take the medicine pack with you always, whether or not there is any medication left.
Symptoms of overdose may include drowsiness, nausea and vomiting, rapid heartbeat, tremor, agitation, dizziness and in rare cases, unconsciousness.
If you forget to Asentra
If you miss a dose, do not take the dose you forgot it. Take your next dose at the usual times.
Do not take a double dose to make up the missed dose.
If you stop taking Asentra
Do not stop taking unless your doctor Asentra says. Your doctor may tell you to reduce the dose of Asentra for several weeks, before stopping treatment completely. The abrupt discontinuation may occur, dizziness, numbness, sleep disturbances, agitation or anxiety, headache, malaise, vomiting and shivering.If you notice any of these side effects or other side effects after you have stopped using Asentra, please tell your doctor.
If you have any further questions regarding this product, ask your doctor or pharmacist.
POSSIBLE SIDE EFFECTS
Like all medicines, Asentra can cause side effects, although not everybody gets them.
If any side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
The most common side effect is nausea. Side effects depend on dose and often disappear with continued treatment.
Tell your doctor immediately:If you notice any of the following symptoms after using the drug, these symptoms can be severe.
•If you develop severe skin rash that causes blistering (erythema multiforme) (which can affect the mouth and tongue). These may be signs of a condition known as Stevens Johnson syndrome or toxic epidermal necrolysis (TEN). Your doctor will stop your treatment in this situation.
•Allergic reaction or allergy, which can include symptoms such as rash with itching, difficulty breathing, wheezing, face, lips or eyelids swollen.
•If you experience agitation, confusion, diarrhea, increased body temperature 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 together with sertraline. Your doctor may want to stop treatment.
•If you develop yellow skin and eyes, which may indicate liver damage.
•If depressive symptoms with suicidal thoughts appear.
•If you start to have feelings of anxiety and you can not stay quiet or you can not sit down after you start using Asentra. You should tell your doctor if you start to feel agitated.
HOW TO STORE ASENTRA
Keep out of reach and sight of children.
Do not use Asentra after expiry date written the box.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
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