DULSEVIA 60 mg. 28 capsules

What is Dulsevia and what it is used
Dulsevia contains the active substance duloxetine. Dulsevia increases the levels of serotonin and norepinephrine in the nervous system.

Dulsevia is used in adults to treat:
depression;
generalized anxiety disorder (chronic feeling of anxiety or nervousness);
diabetic neuropathic pain (often described as burning, stabbing, stinging, shooting or aching like an electric shock. There may be loss of feeling in the affected area, or sensations such as touch, heat, cold or pressure may cause pain).
Dulsevia starts to work in most people with depression or anxiety within two weeks of starting treatment, but it may take 2-4 weeks before you feel better. Tell your doctor if you start to feel better after this time. Your doctor may continue to prescribe Dulsevia when you are feeling better to prevent recurrence of your depression or anxiety.
For most people with diabetic neuropathic pain treatment may take several weeks before you feel better. Tell your doctor if you feel better after two months.

2. What you need to know before taking Dulsevia
Do not take Dulsevia if:
you are allergic to duloxetine or any of the other ingredients of this medicine (listed in section 6);
have liver disease;
have severe kidney disease;
taking or the last 14 days you are taking other medicines known as monoamine oxidase inhibitor (MAOI) (see "Other medicines and Dulsevia");
taking fluvoxamine which is usually used to treat depression, ciprofloxacin or enoxacin which are used to treat certain infections;
taking other medicines containing duloxetine (see 'Other medicines and Dulsevia ").
Consult your doctor if you have high blood pressure or heart disease. Your doctor will tell you whether you should take Dulsevia.

Warnings and Precautions
Below are reasons why Dulsevia may be unsuitable for you.
Consult your doctor before taking Dulsevia if:
taking other medicines to treat depression (see 'Other medicines and Dulsevia ");
taking St. John's wort, a herbal treatment (Hypericum perforatum);
have kidney disease;
You have had seizures (fits);
you had an obsession;
suffer from bipolar disorder;
have eye problems such as certain kinds of glaucoma (increased pressure in the eye);
have a history of disorders related to bleeding (tendency to bruise);
You are at risk of low sodium levels (for example if you are taking diuretics, especially if you are elderly);
currently being treated with another medicine that can cause liver damage;
taking other medicines containing duloxetine (see 'Other medicines and Dulsevia ").
Dulsevia can cause a sensation of restlessness or an inability to sit or stand still. You should tell your doctor if this happens to you.

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 themselves. These may be increased when first starting antidepressants, since achieving the effect these drugs need time - usually about two weeks but sometimes longer.

More likely to think like this if:
You have previously had thoughts of suicide or self-harm;
you are a young adult. Information from clinical trials has shown an increased risk for behavior associated with suicide in adults under 25 with mental health conditions who were treated with an antidepressant.
If you have thoughts of harming or killing yourself at any time, contact your doctor or go immediately to the 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.

Children or adolescents under 18 years of age
Usually Dulsevia should not be used for children and adolescents under 18 years of age. Also, you should know that patients under 18 have an increased risk of side effects such attempts and suicidal thoughts and hostility (predominantly aggression, oppositional behavior and anger) when they take this class of drugs. However, your doctor may prescribe Dulsevia for patients under 18 because he / she decides that this is in their interest. If your doctor prescribes Dulsevia a patient under 18 and want to discuss this, please contact him. You should tell your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking Dulsevia. In addition, long-term safety on the effects of duloxetine on growth, maturation and cognitive and behavioral development in this age group have not yet been established.

Other medicines and Dulsevia
Tell your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines, including medicines obtained without a prescription.

The main ingredient of Dulsevia, duloxetine, is used in other medicines for other conditions:
diabetic neuropathic pain, depression, anxiety and urinary incontinence.
Using more than one of these drugs, at the same time, should be avoided. Check with your doctor if you are already taking other medicines containing duloxetine.

Your doctor will decide whether you can take Dulsevia with other drugs. Do not start or stop taking any medicines, including those without a prescription or herbal medications before consulting with your doctor.

You should also tell your doctor if you are taking any of the following:
Monoamine oxidase inhibitors (MAOIs) should not take Dulsevia if you are taking or have recently taken (within the last 14 days) another antidepressant called a monoamine oxidase inhibitor (MAOI). Examples of MAO inhibitors are moclobemide (antidepressant) and linezolid (an antibiotic). Taking a MAOI together with many prescription medicines, including Dulsevia can cause serious or even life-threatening side effects. You must wait at least 14 days after you have stopped taking an MAOI before you can take Dulsevia. It is also necessary to wait at least 5 days after you stop taking Dulsevia before taking MAO inhibitors;
Medicines that cause sleepiness: These include medicines prescribed by your doctor including benzodiazepines, strong painkillers, antipsychotics, phenobarbital and antihistamines;
Drugs that increase the level of serotonin: Triptans, tramadol, tryptophan, SSRIs (such as paroxetine and fluoxetine), SNRIs (such as venlafaxine), tricyclic antidepressants (such as clomipramine, amitriptyline), pethidine, St John's Wort and MAO inhibitors (such as moclobemide and linezolid) . These drugs increase the risk of side effects; if you get any unusual symptom taking any of these drugs Dulsevia, you should consult with your doctor;
Oral anticoagulants or antiplatelet agents: Medicines which thin the blood or prevent the blood to clot. These drugs may increase the risk of bleeding.
Dulsevia with food, drinks and alcohol
Dulsevia can be taken with or without food. Caution should be exercised if you drink alcohol while on treatment with Dulsevia.

Pregnancy and lactation
If you are pregnant or breast-feeding, you think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.
Tell your doctor if you are pregnant or if you plan to become pregnant while taking Dulsevia. You should use Dulsevia only after discussing with your doctor the potential benefits and any possible risks to the unborn child.
Make sure your midwife and / or doctor knows you are Dulsevia. When similar drugs (SSRIs) taken during pregnancy may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and appear bluish. These symptoms usually begin during the first 24 hours after the baby is born. If this happens to your baby, you should immediately contact your midwife and / or doctor.
If you take Dursevia at the end of your pregnancy, your baby might have some symptoms when it is born. They usually begin at birth or within a few days after the birth of your baby. These signs may include muscle relaxation, tremor, jitteriness, not feeding properly, trouble with breathing and seizures. If your baby has any of these symptoms at birth or worry about his health, contact your doctor or midwife who will be able to advise you.

Tell your doctor if you are breast-feeding. Not recommended for use Dulsevia during lactation. You should check with your doctor or pharmacist.

Driving and using machines
Dulsevia may make you feel sleepy or dizzy. Do not use any tools or machinery until you know how you affect Dulsevia.

Dulsevia contains sucrose
If your doctor told you that you have an intolerance to some sugars, contact your doctor before you start taking this medicine.

3. How to take Dulsevia
Always take this medicine exactly as you have been told your doctor or pharmacist. If you're not sure, ask your doctor or pharmacist.
Dulsevia is for oral use. You should swallow the capsule whole with a glass of water.

Depression and diabetic neuropathic pain:
Dulsevia usual dose of 60 mg once a day, but your doctor will prescribe the dose that is right for you.

In generalized anxiety disorder:
The usual starting dose of Dulsevia is 30 mg once daily, after which most patients will begin to receive 60 mg once a day, but your doctor will prescribe the correct dose for you. The dose may be adjusted up to 120 mg per day depending on how you respond to Dulsevia.
It is easier to take the medicine at the same time each day will help you remember about taking Dulsevia.
Talk to your doctor about this for how long it should take Dulsevia. Do not stop taking Dulsevia or alter your dose without talking to your doctor with your doctor. It is important for proper treatment of your disease to feel better. If you do not treat your condition, it may not resolved, could become more serious and more difficult to treat.

If you take more than the amount Dulsevia
Contact your doctor or pharmacist immediately if you take a large amount Dulsevia prescribed by your doctor. Symptoms of overdose include sleepiness, coma, serotonin syndrome (a rare reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating, or muscle stiffness), fits, vomiting and fast heart rate .

If you forget to take Dulsevia
If you miss a dose, take it as soon as you remember. If it's time for your next dose, skip the missed and take only a single dose as usual. Do not take a double dose to make up the missed dose. Do not take more than the daily amount Dulsevia prescribed for you in one day.

If you stop taking Dulsevia
DO NOT stop taking your capsules without the advice of your doctor even if you feel better. If your doctor determines that you no longer need Dulsevia, he / she will ask you to reduce your dose over at least 2 weeks before stopping treatment altogether.

Some patients who stop taking Dulsevia suddenly have had symptoms such as:
dizziness, fatigue, feelings of numbness or sensation like an electrical current passes (especially the head), sleep disturbances (vivid dreams, nightmares, insomnia), fatigue, sleepiness, feeling restless or agitated, feeling anxious, feeling sick (nausea) or being sick (vomiting), shaking (tremor), headache, muscle pain, feeling irritable, diarrhea, excessive sweating or dizziness.
These symptoms are usually not serious and disappear within a few days, but if you have symptoms that worry you, ask your doctor for advice.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. These reactions are usually mild to moderate and often disappear after a few weeks.

Very common side effects (may affect more than 1 in 10 people):
headache, sleepiness;
feeling sick (nausea), dry mouth.
Common side effects (may affect up to 1 in 10 people):
lack of appetite;
trouble sleeping, feeling agitated, less sex drive, anxiety, difficulty or failure to experience orgasm, unusual dreams;
dizziness, feeling of weakness, tremor, numbness, including numbness, pricking or tingling of the skin;
blurred vision;
tinnitus (hearing sound in the ears when no external sound);
feeling the heart pumping in the chest;
increased blood pressure, flushing;
more frequent yawning;
constipation, diarrhea, stomach pain, being sick (vomiting), heartburn or indigestion, flatulence;
increased sweating, (itchy) rash;
muscle pain, muscle spasm;
painful urination, frequent urination;
problems getting an erection, changes in ejaculation;
fainting (mainly in the elderly), fatigue;
weight loss.
Children and adolescents under the age of 18 years with depression who were treated with this medicine have some weight loss when you first start to accept it. The weight was raised to the appropriate with other children and adolescents from age and gender after 6 months of treatment.

Uncommon side effects (may affect up to 1 in 100 people):
sore throat, causing hoarseness;
suicidal thoughts, difficulty sleeping, grinding or clenching of teeth, feeling disorientated, lack of motivation;
sudden involuntary jerks or twitches of the muscles, sensation of restlessness or inability to sit or stand still, feeling nervous, difficulty concentrating, changes in sense of taste, difficulty controlling movement, for example. lack of coordination or involuntary movements of the muscles, restless legs syndrome, poor sleep;
dilated pupils (the dark center of the eye), vision problems;
feeling drowsy or "spinning" (vertigo), ear pain;
rapid and / or irregular heartbeat;
fainting, dizziness, lightheadedness or fainting on standing up, cold fingers and / or feet;
tightness in the throat, nose bleeds;
vomiting blood, or black tarry stools (faeces), gastroenteritis, burping, difficulty swallowing;
inflammation of the liver that may cause abdominal pain and yellowing of the skin or of the whites of the eyes;
night sweats, hives, cold sweats, sensitivity to sunlight, increased tendency to bruise;
muscle tension, muscle twitching;
difficulty or inability to urinate, difficulty starting urination, the need to urinate at night, a need for more frequent urination than usual, weak urinary stream;
abnormal vaginal bleeding, abnormal periods, including heavy, painful, irregular or prolonged periods, unusually light or missed periods, pain in the testicles or scrotum;
chest pain, feeling cold, thirst, shivering, feeling hot, abnormal gait;
weight gain.
Dulsevia may cause effects that you may not feel as increases in liver enzymes or blood levels of potassium, creatinine phosphokinase, sugar or cholesterol in the blood.

Rare side effects (may affect up to 1 in 1000 people):
serious allergic reaction which causes difficulty in breathing or dizziness, swelling of the tongue or lips, allergic reactions;
underactive thyroid gland, which may cause fatigue or weight gain;
dehydration, low sodium levels in the blood (mainly in the elderly);
symptoms may include feeling dizzy, weakness, confusion, sleepiness or fatigue, or nausea or vomiting;