What is Duxalta Medicine? Side Effects and Prospectus

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What is DUXALTA and what is it used for?

DUXALTA, with opaque light green body and opaque navy blue cover, the size of “1”, are white colored pellets in hard gelatin capsules. DUXALTA, 28-capsule Al/PVC-PVDC blisters are offered for use in packaging.

DUXALTA is a drug containing the active substance duloxetine. DUXALTA increases serotonin and noradrenaline levels in the nervous system.

DUXALTA you (adults),

  • Depression
  • Diabetes-related neuropathic network (diabetes-related neuropathic pain caused by nerve damage is the response of pain in the medical language, defined by concepts such as needle prick and leak, throbbing and electric shock. Loss of sensation may occur in the area where the pain is present or warnings such as hot, cold, pressure, touch may cause a sensation of the network.),
  • General anxiety disorder (general anxiety disorder, constant feeling anxious and irritable.),
  • Fibromyalgia (fibromyalgia is a musculoskeletal disorder characterized by the network, which can be seen in the whole body, especially in the back, neck and shoulders, and can also be accompanied by weakness.),
  • Chronic pain (chronic network felt in the bones, joints or muscles, feeling of constant, relapse, pain and/or stiffness.)

    • it is given for the treatment of the disease called.

    DUXALTA begins to work in the majority of people with depression or anxiety within two weeks, but it can be as long as 2-4 weeks until you feel better. When you feel better, your doctor may continue to give you DUXALTA to prevent recurrence of your depression and anxiety.

    What are the Side Effects?

    Like all medicines, there may be side effects in people who are sensitive to substances contained in DUXALTAazine.

    Very common:10 can be seen in at least lardin of patients.

    Common: 10 patients less than Tins, but 100 patients more than Tins.

    Uncommon: less than 100 patients can be seen in Tins, but more than 1,000 patients can be seen in Tins. Infrequent: 1,000 patients may have less than a thousand, but 10,000 patients may have more than a thousand.

    Very infrequent:10,000 patients may be less than ten.

    Unknown: cannot be guessed by movement from the data at hand.

    Very common

  • Headache, feeling sleepy
  • Nausea, dry mouth

    • Common:

  • Absent appetite
  • Difficulty sleeping, restlessness, decreased sexual desire, anxiety, difficulty orgasm or not, abnormal dreams
  • Dizziness, drowsiness (letargy), tremor, stinging and tingling on the skin with tremor
  • • gourmet fuzzy
  • Tinnitus (sound in the ear, although there is no sound from the outside)
  • Feeling of the heartbeat in the chest
  • Increase in blood pressure, fever
  • Increase in stretch
  • Constipation, diarrhea, stomach pain, vomiting, heartburn or indigestion, gas removal
  • Increase in sweating, itchy rashes
  • Muscle pain, muscle contraction
  • Painful urination, frequent urination
  • Erection difficulty, premature ejaculation
  • Falling (mostly in elderly patients), fatigue
  • Weight loss

    • Children and adolescents under 18 years of age with depression treated with duloxetine experienced some weight loss when they first started taking the drug. 6 Months after starting treatment, they reached the same weight as their other children and adolescents in their age and gender group.

    Uncommon:

  • Infection in the throat, which causes hoarseness of the voice,
  • Suicidal thoughts, sleeping difficulties, teeth grinding or clenching, feeling confusion, loss of motivation
  • Sudden contractions and rashes in the muscles, a feeling of restlessness or inability to stand in place, nervous feeling, difficulty concentrating, change in taste, difficulty in controlling movements, for example, lack of coordination or involuntary movements of muscles, restless leg syndrome, restless leg syndrome, disturbance of sleep quality,
  • Growth of the pupils (the dark center of the eye), vision problems
  • Dizziness or a feeling of turning (vertigo), ear pain
  • Rapid and/or irregular heartbeat (atrial fibrillation),
  • Fainting, dizziness, feeling of drowsiness or fainting while standing, coldness in the hands and or toes
  • Congestion in the throat, nosebleeds
  • Stool, gastroenteritis, belching, difficulty swallowing, such as blood vomiting or black tar
  • Inflammation of the liver, which causes abdominal pain and yellowing of the skin or eye whites
  • Night sweats, hives, cold sweats, sensitivity to sunlight, increased bruising tendency
  • Adale hardness, adale cruising
  • Difficult or no urination, difficulty in starting urine, the desire to urinate at night, the desire to urinate more than usual, a decrease in urine flow
  • Abnormal bleeding in the vagina area, severe, painful, abnormal menstruation in irregular or prolonged intervals, rarely little bleeding or inability to menstruate that month, pain in the testicles or testicle bags
  • Chest pain, chills, thirst sensation, tremor, fever, abnormality in the style of walking
  • Weight gain
  • DUXALTA can also cause effects that you may not notice, such as increases in liver enzymes or blood potassium, creatine phosphokinase, sugar (hyperglycemia), or cholesterol levels.

    • Sparse:

  • Severe allergic reactions that cause dizziness or difficulty breathing, accompanied by swelling of the lip or tongue,
  • Decrease in thyroid gland activities that can cause weight gain or fatigue
  • Dehydration, low level of sodium in the blood (especially in elderly patients, symptoms: dizziness, weakness, confusion, feeling sleepy or very tired, feeling unwell, more serious symptoms, fainting, seizures and falls), etc, syndrome of inadequate release of anti-diuretic hormone (SIADH),
  • Suicidal behavior, mania (a disease in which the vaccine is reduced in activity, burning thoughts and the need for sleep), hallucinations, aggression and resentment, etc,
  • Serotonin syndrome (a rare reaction that can cause feelings of extreme happiness, dizziness, clumsiness, restlessness, feeling drunk, flare-ups, sweating, or muscle stiffness), seizures
  • Increased intraocular pressure (glaucoma);
  • Crisis due to high blood pressure (hypertensive crisis)
  • Infection in the mouth, smearing bright red blood in the stool, smell of breath
  • Liver failure, yellowing of the skin or eye whites (public),
  • Stevens-Johnson syndrome (a serious disease with blisters in the skin, mouth, eyes and genital area), angioedema (serious allergic reactions that cause swelling in the face and throat),
  • Contraction in the chin muscle,
  • • odor of abnormal urine
  • Menopausal symptoms include abnormal milk from the breast in a man or woman

    • How is DUXALTA Used?

    Always use this medicine as recommended by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

    For the treatment of depression, diabetic neuropathic pain, fibromyalgia and chronic pain:

    The recommended DUXALTA dose is 60 mg once a day.

    For the treatment of general anxiety disorder:

    The usual starting dose of DUXALTA ⁇ mn is 30 mg once a day. The majority of patients then continue their treatment with a dose of 60 mg once a day, but your doctor will prescribe you the dose that works best for you. According to your response to DUXALTA, the dose can be adjusted up to 120 mg per day.

    If you think the effect of DUXALTA is too much or too little, talk to your doctor.

    Application form:

    DUXALTA is for oral use. Swallow your capsule whole with water.

    To help you remember to take DUXALTA, it may be easier to take the medication at the same time every day.

    Talk to your doctor about how long you should use DUXALTA for. Do not stop using DUXALTA or change your dose without talking to your doctor. If left untreated, your condition may not improve and treatment may become more serious and more difficult.

    Use in children and adolescence:

    DUXALTA izmn should not normally be used in children and adolescents under 18 years of age.

    Use in the elderly:

    There is no specific dosage recommendation for patients aged 65 and over.

    Special Use Cases

    Renal failure:

    DUXALTA should not be used in patients with end-stage kidney disease (requiring dialysis) or severe kidney disorder (estimated creatinine clearance <30 mL/min).

    Liver failure:

    DUXALTA should not be used in patients with any hepatic insufficiency.

    If you have an impression that the effect of DUXALTA ’ is too strong or weak, talk to your doctor or pharmacist.

    DUXALTA

    What to Do in case of Overdose?

    Patients using DUXALTA more than they should use may experience the following symptoms: sleepiness, coma, serotonin syndrome (excessive feeling of happiness, drowsiness, clumsiness, restlessness, feeling like drunk, flare-up, flare-ups, etc, a rare reaction that can cause sweating or a feeling of muscle stiffness), seizures, vomiting and heart palpitations.

    If you have used more than you should use DUXALTA ’, talk to a doctor or pharmacist.

    What Should I Do When I Forget to Use DUXALTA?

    Do not take double doses to offset forgotten doses.

    When you notice that you have forgotten, take your capsule immediately. But if it is time for the next dose, skip the missed dose and take your next dose at the scheduled time. Within a day, do not use DUXALTA more than the amount prescribed for you on a daily basis.

    Post Treatment For DUXALTA Users

    Even if you feel better, don't stop using your capsules without your doctor telling you to. When your doctor thinks you no longer need to use DUXALTA, he or she will ask you to reduce your dose for at least a 2-week period before discontinuing the treatment completely. Some patients who suddenly cut DUXALTA may have the following symptoms;

    Tingling sensations, such as dizziness, prickling or tingling sensations, or electric shock-like sensations (especially in your head), sleep disorders (live dreams, nightmares, inability to sleep), fatigue, drowsiness, feeling uncomfortable or irritated, anxiety, anxiety, etc, symptoms such as nausea or vomiting, tremor, headache, muscle pain, restlessness, diarrhea, excessive sweating or vertigo (turnover caused by balance disorder) have been observed.

    These symptoms are usually not serious and disappear within a few days, but if you are going to experience symptoms that are causing problems for you, you should consult your doctor for their advice.

    Things to consider before using DUXALTA

    Who should DUXALTA not be used by?

    If,

  • If you are allergic to duloxetine or any of the other substances contained in this drug (“See the ” portion of the auxiliary substances), you can,
  • If you have liver disease,
  • If you have serious kidney disease,
  • If you are currently using drugs known as monoamine oxidase inhibitor (MAOI) or have used them within the last 14 days (“See the ” section for use with other drugs)
  • If you are using fluvoxamine, which is often used to treat depression, ciprofloxacin and enoxacin, which are used to treat certain infections, you should,
  • If you are taking other drugs that contain duloxetine (“See section”, which uses it in combination with other drugs)
  • If you have narrow-angle glaucoma that is not under control (severe pain and visual impairment with sudden increase in intraocular pressure)

    • If you have high blood pressure or heart disease, tell your doctor. Your doctor will tell you if you can take DUXALTA.

    What Should DUXALTA Users Pay Attention to?

    The following are reasons why DUXALTAnm may not be suitable for you. If you have any of the following, talk to your doctor before using DUXALTA:

    If,

  • If you are using other drugs to treat depression (“See the ”Used section with other drugs)
  • Cantarone used for herbal treatment (St. If you are using Johns Wort),
  • ■ If you have kidney disease, you,
  • If you have had a seizure before
  • If you have a condition of flooding (mania)
  • If you are suffering from bipolar disorder (two-pronged disorder, manic depressive illness), you should,
  • If you have eye problems, such as some types of glaucoma (increased pressure in the eye),
  • If you have a history of bleeding disorders (tendency to develop caries), you,
  • If you are at risk of low sodium levels (for example, if you are on diuretic medication, especially if you are older)
  • If you are currently taking a medication that may cause liver failure
  • If you are taking another drug that contains duloxetine (“See the section” for its use with other drugs)
  • If you have akathisia characterized by unwanted or painful restlessness and inability to sit up

    • DUXALTA can cause feelings of restlessness or difficulty sitting or standing still. If this happens, let your doctor know.

    Increased suicidal thinking and depression or anxiety disorders

    If you are depressed and/or have an anxiety disorder, you may have thoughts of harming yourself or killing yourself from time to time. Since it usually takes 2 weeks but sometimes more time to fully show the effects of these drugs, this may increase when antidepressant medications are first used.

    If you have the following, you are more likely to think this way:

  • If you have had thoughts about killing or harming yourself before
  • If you are a young adult. Data from clinical studies have shown that adults younger than 25 years of age with psychiatric illness who have been treated with antidepressants tend to commit more suicide.

    • If you have had or have had any disturbing thoughts or actions at any time, report them to your doctor immediately.

    You can tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this instruction. This can be useful for yourself. You may ask if your depression or anxiety disorder is getting worse or if they are worried about the change in your behavior.

    Use in children and adolescents under 18 years:

    DUXALTA ⁇ nm should not normally be used in children and adolescents under 18 years of age. When this type of medication is used in patients under 18 years of age, you should also know that there is an increased risk of side effects such as suicide attempts, suicidal thoughts and a feeling of hostility (aggressiveness, resisting and anger are at the forefront). Despite this, your doctor may recommend DUXALTA to patients under 18 years of age, in the belief that it will help. If your doctor has prescribed DUXALTA to a patient under 18 years of age and you want to discuss this issue, please go back to your doctor when patients under 18 years of age are using DUXALTA, if any of the aforementioned symptoms occur and get worse, you should let your doctor know. The long-term safety effects of DUXALTA on growth, maturation, cognitive and behavioral development in patients in this age group have not yet been demonstrated.

    If this applies to you even at any time in the past, please consult your doctor.

    Food and Beverage Consumption Together With DUXALTA

    What are the foods and drinks that are inconvenient to be consumed with the specified medication? What should we eat or not eat?

    DUXALTA can be used on hungry or full cam. Care should be taken if alcohol is taken while being treated with DUXALTA.

    Is it Used During Pregnancy (Pregnancy) Period?

    Consult your doctor or pharmacist before using the medicine.

    After discussing DUXALTA with your doctor the potential benefits and potential risks for your unborn child, you can use it only with the decision of your doctor. Do not use DUXALTA during pregnancy unless necessary.

    Make sure your doctor knows that you are using DUXALTA. When you take medication while pregnant, similar medications (S SRI group drugs) can increase the risk of having a serious smoky called neonatal persistent pulmonary hypertension (PPHN), which causes the baby to appear bluish, accelerating breathing. These symptoms usually begin within the first 24 hours after the baby is born. If your baby is in such a situation, contact your doctor immediately.

    If you have started using DUXALTA towards the end of your pregnancy, your baby may show some symptoms when it is born. These symptoms can usually begin immediately after birth or within a few days after your baby is born. These symptoms can be loose muscles, tremors, excitability, inability to fully feed, difficulty breathing and seizures. If your baby has any of these symptoms when he or she is born, or if you are concerned about the health of your baby, call your doctor who can advise you.

    If you notice that you are pregnant during your treatment or plan to become pregnant, consult your doctor or pharmacist immediately.

    Can it be Used During Breastfeeding?

    Consult your doctor or pharmacist before using the medicine.

    If you are breastfeeding, tell your doctor. The use of DUXALTA when breastfeeding is not recommended.

    Vehicle and machinery use

    DUXALTA can make you feel drowsy and drowsy.

    Do not use tools or any tools or machines without knowing how DUXALTAarnm affects you.

    What is DUXALTA Active Agent?

    DUXALTA contains sugar globules. Sugar globules contain sucrose. If you have previously been told by your doctor that you have an intolerance to certain sugars (impairedness), contact your doctor before taking this medicinal product.

    DUXALTA contains isopropyl alcohol. At this dose, no side effects due to isopropyl alcohol are expected.

    Is It Used With Other Drugs?

    Duloxetine, which is the active substance DUXALTA, can also be found in other drugs and used in the following situations:

    Diabetic neuropathic pain, fibromyalgia, chronic pain of bones, joints or muscles, depression, anxiety and urinary incontinence.

    Avoid using multiple such drugs at the same time. Check with your doctor whether you currently take any other medication that contains duloxetine.

    Your doctor should decide if you should use DUXALTA along with other medications. Do not start using any medications, including over-the-counter and herbal remedies, before checking with your doctor, and do not stop taking the medication you are using.

    Tell your doctor if you are taking any of the following medications:

    Monoamyrin oxidase inhibitors (MAOIs): If you are currently taking other antidepressant drugs called monoamine oxidase inhibitors (MAOIs), you should not use DUXALTA (or if you have used them within the last 14 days). Examples of MAOIs include moclobemide, an antidepressant, and linezolid, an antibiotic. Using an MAOI along with many prescription medications, including DUXALTA, can cause serious and even life-threatening side effects. It is necessary to discontinue the use of MAOI drugs at least 14 days before using DUXALTA. Likewise, you must stop using DUXALTA 5 days before using an MAOI.

    Sleeping medications: These may include medications prescribed by your doctor, including benzodiazepines, strong painkillers, antipsychotics, phenobarbital, and antihistamines.

    Drugs that increase serotonin levels. Triptans, tramadol, tryptophan, SSRTS (such as paroxetine and fluoxetine), SNRIs (such as fenlafaxine), tricyclic antidepressants (such as clomipramine, amitriptyline), pethidine, SSRTs, cantarone (St.Johns Wort) and MAOIs (such as moclobemide and linezolid) can be given as examples. These medications increase the risk of side effects. If you experience any unusual symptoms by taking any of these medications with DUXALTA, contact your doctor.

    Oral anticoagulants or antiplatelet agents. Blood-thinning medications or blood-clotting medications can increase the risk of bleeding.

    CYP1A2 inhibitors such as fluvoxamine: DUXALTA should not be used with inhibitors of CYPlA2’nin, such as fluvoxamine.

    CYP1A2 inducers: Smoking causes increased activity of the enzyme CYP1A2, which is involved in the metabolism of duloxetine. For this reason, 50% lower duloxetine concentrations have been shown in plasma compared to non-smokers.

    To download DUXALTA prospectus as PDF file here
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