Duloxetine increases the levels of serotonin and norepinephrine in the nervous system.
The doctor will prescribe this medicine to treat any of the following diseases:
- Depression,
- Generalized anxiety disorder (GAD) (chronic feeling of anxiety or nervousness)
- Diabetic neuropathic pain.
Neuropathic pain is a condition in which the pain is commonly described as burning, stabbing, stinging, shooting or aching or like an electric shock. There may be a loss of sensation or hypersensibility in the affected area (sensations such as touch, heat, cold or pressure can cause pain)
Duloxetine starts to work in most people with depression or anxiety two weeks after starting treatment. Your doctor may continue giving you duloxetine when you feel better, to avoid your depression or anxiety reappear.
Duloxetine's effect may be detectable in many patients with diabetic neuropathic pain in the first week of treatment.
Duloxetine is also indicated to treat urinary incontinence (SUI) in women.
Urinary incontinence (SUI) is a disease in which patients have leaks or accidental loss of urine during physical exertion or after activities such as laughing, coughing, sneezing, lifting or exercising.
Duloxetine acts by increasing the strength of the muscle that holds back urine when you laugh, sneeze, or perform physical activities.
The effectiveness of this drug is enhanced when combined with a program called pelvic floor muscle rehabilitation (AMSY).
Medizzine recommends consulting your doctor if you are unsure why has prescribed duloxetine.
Other ingredients of available commercial presentations:
Each capsule contains 20,30, 40 or 60 mg duloxetine (as hydrochloride). The other ingredients are:
Capsule contents: hypromellose, hydroxypropyl methylcellulose acetate succinate, sucrose, sugar spheres, talc, titanium dioxide (E171) and triethyl citrate.
Capsule shell: gelatin, sodium lauryl sulfate, titanium dioxide (E171), indigo carmine (E132), yellow iron oxide (E172) (60 mg only) and edible green ink (30 mg) or edible white ink (60 mg).
Edible green ink: synthetic black iron oxide (E172), synthetic yellow iron oxide (E172), propylene glycol, Shellac.
Edible white ink: titanium dioxide (E171), propylene glycol, Shellac, and povidone.
Warning:
The composition of the various presentations may vary from one country to another. We recommend you consult the information provided by your local supplier.
Do not use duloxetine
If you are allergic (hypersensitive) to duloxetine or any of the other ingredients of the medicinal product prescribed to you. If you think may be allergic, ask your doctor.
Allergy symptoms may include:
- Asthma attacks with shortness of breath, audible wheezing or rapid breathing.
- More or less sudden swelling of the face, lips, tongue or elsewhere in the body. It is especially critical if it affects the vocal cords.
- Hives, itching, rash
- Anaphylactic shock (loss of consciousness, paleness, sweating, etc.).
Nor you should take this medicine:
- If you are taking or have taken within the last 14 days, another antidepressant medicine known as monoamine oxidase inhibitors (MAOIs).
- If you have liver failure.
- If you have severe renal impairment.
- If you are taking fluvoxamine, used to treat depression, ciprofloxacin or enoxacin which are used in the treatment of some infections.
- If you are taking other medicines containing duloxetine.
- If you have a poorly controlled arterial hypertension.
Take special care with duloxetine
Duloxetine may not be suitable for you for the following reasons. If any of these affects you, tell your doctor before taking the medication:
- If you are taking other medicines to treat depression.
- If you are taking an herbal treatment containing hypericum or St. John's Wort (Hypericum perforatum).
- If you have kidney disease.
- If you have had seizures (fits).
- If you suffer or have suffered from the manic or bipolar disorder.
- If you have eye problems such as certain kinds of glaucoma (increased eye pressure).
- If you have a history of bleeding disorders (tendency to develop bruises).
- If you have a risk of low blood sodium levels.
- if you have high blood pressure.
- If you are being treated with other medicines that can cause liver damage.
- If you are taking other medicines containing duloxetine.
- If you are intolerant to some sugars.
- If you are considering stopping treatment with this medicine.
Duloxetine may cause a sensation of restlessness or inability to sit or stand still (akathisia). If this happens, tell your doctor.
Suicidal thoughts and worsening of your depression or anxiety disorder
If you are depressed and/or suffer from an anxiety disorder, can sometimes have thoughts of harming or killing yourself. These thoughts may be increased at the beginning of antidepressant treatment, as all these medicines take a time to exert its effect, usually about two weeks, but sometimes longer.
It is more likely to have this kind of thoughts:
- If you have had previously thoughts of harming or killing yourself .
- If you are a young adult. Data from clinical trials have shown an increased risk of suicidal behavior in adults under age 25 who have a psychiatric disorder and are being treated with antidepressants.
Tell your doctor or go directly to the hospital if you have any thoughts of harming or killing yourself.
It may be helpful to tell a relative or close friend that you are depressed or suffering an anxiety disorder, and ask them to read the medicine leaflet. You might ask them to tell you if they believe your depression or anxiety is getting worse, or if they are worried about changes in your behavior.
Use in children and adolescents under 18
This medicine should not normally be used in children and adolescents under 18 years. Also, you should know that patients under age 18, when they take this class of drugs, have an increased risk of side-effects such as suicide attempt, suicidal thoughts, and hostility (predominantly aggression, oppositional behavior and anger). Despite this risk, your doctor may prescribe duloxetine for patients under 18, because he or she may decide that it may be beneficial to the patient. If your doctor has prescribed this medicine for a patient under 18 and you want more information about this, consult your doctor.
Inform your doctor if any of the symptoms listed above appear or worsen when patients under 18 are taking duloxetine. Moreover, in this age group have not yet demonstrated long-term safety of this antidepressant regarding growth, maturation, behavior and cognitive development.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including herbal products or drugs obtained without a prescription.
Duloxetine is used together with other medicines to treat different disorders (diabetic neuropathic pain, depression, anxiety and urinary incontinence). Avoid using more than one of these other medicines simultaneously. Check with your doctor if you are already taking other medicines containing duloxetine.
Your doctor will decide whether you can take duloxetine with other medicines. Do not start or stop taking any medicines, including those obtained without a prescription and herbal remedies without first checking with your doctor.
- Monoamine oxidase inhibitors (MAOIs): Duloxetine should not be taken if you are taking or have taken within the last 14 days, another antidepressant medicine called monoamine oxidase inhibitor (MAOIs).
Taking a MAOI together with many prescription medicines, including duloxetine, can cause serious side effects, even endanger your life.
You must wait at least 14 days after discontinuation of treatment with a MAOI before taking duloxetine. Similarly, you must wait at least 5 days after stopping treatment with duloxetine before starting a MAOI.
Drugs that may cause drowsiness:
Tell your doctor if you are taking any medication that makes you drowsy. These include medicines prescribed by your doctor as benzodiazepines, strong painkillers, antipsychotics, phenobarbital, and antihistamines.
Serotonin syndrome:
You should tell your doctor if you are taking any of the medicines that act in a similar way to duloxetine. Examples of these drugs include
triptans, tramadol, tryptophan, selective inhibitors of serotonin reuptake (SSRIs, such as paroxetine and fluoxetine), tricyclic antidepressants (such as clomipramine, amitriptyline), pethidine, St. John's Wort (Hypericum perforatum) and venlafaxine.
These medicines increase the risk of producing side effects; if you get any unusual symptom taking any of these medicines together with duloxetine, you should see your doctor.
Oral anticoagulants: Tell your doctor if you are taking oral anticoagulants (drugs that thin the blood). These drugs increase the risk of bleeding.
Use with food and beverages
Duloxetine may be taken with or without food. You must have caution if you drink alcohol when treated with duloxetine.
Consult your doctor or pharmacist before taking any medicine.
Special physiological situations
Pregnancy and lactation
Always consult your doctor or pharmacist before taking any medicine during pregnancy or lactation.
Tell your doctor if you become pregnant or are trying to become pregnant while being treated with duloxetine. Duloxetine should be used only after your doctor has evaluated its potential benefits and any potential risk to the fetus.
Ask for advice from your doctor or pharmacist if you are breastfeeding.
The use of duloxetine is not recommended during lactation.
Driving and using machines
During treatment with duloxetine, you may feel drowsy or dizzy. Do not drive or operate any tools or machines until you know how you react to this treatment .
Like all medicines, duloxetine can cause side effects, although not everybody gets them.
The frequency of side effects is classified into:
Very common: affect 1 out of 1-10 patients
Common: affect 1 out of 10-100 patients
Uncommon: affect 1 out of 100-1.000 patients
Rare: affect 1 out of 1.000-10.000 patients
Very Rare: affect less than 1 in 10,000 patients
Incidence not known: Can not be established the true incidence from the available data
Very common side effects
Nausea, headache, dry mouth, drowsiness, fatigue, dizziness and constipation.
Common side effects
- Tiredness, sleep disturbances, anxiety, agitation or abnormal dreams
- Tremors or numbness, including numbness or tingling of the skin.
- Diarrhea, vomiting, heartburn, flatulence, stomach ache.
- Tinnitus (perception of sound in the ear when there is no sound on the outside).
- Blurred vision.
- Chest palpitations, hot flushes, increased sweating, nocturnal sweating.
- Problems getting an erection (erectile dysfunction), decreased sex drive.
- Rash (itching).
- Muscle pain, muscle tension or spasm.
- Increased yawning.
- Lack of appetite, weight loss.
Uncommon side effects
- Throat inflammation.
- Disorientation, drowsiness, lack of motivation.
- Dysgeusia (food tastes differently than usual), impaired attention, rigidity, Spasms and involuntary muscle movements, Pulled muscles, impaired gait.
- Sleeping poorly (poor quality sleep).
- Belching, indigestion, gastroenteritis.
- Vertigo and earache.
- Inflammation of the liver, which can cause abdominal pain.
- Dilation of the pupils (the black point at the center of the eye), visual disturbances.
- Fast or irregular heartbeat.
- Sexual problems, including changes in ejaculation, orgasm.
- Abnormal periods, including heavy or prolonged periods.
- Allergic reactions, increased tendency to bruise, skin blisters or Photosensitivity (increased sensitivity to
sunlight and UV radiation).
- Increased blood pressure, feeling cold in fingers of hands and/or feet, dizziness (especially when standing up too quickly), cold sweats, chills o fainting.
ยท Increased blood sugar level.
- Need to pass more urine than normal (polyuria), need to urinate at night (nocturia), difficulty or inability to urinate (dysuria), or decreased the flow of urine.
- Gnashing of teeth, feeling hot/cold, thirst, throat tightness, nosebleeds.
- Weight gain.
Rare side effects
- Decreased activity of the thyroid gland.
- Dehydration.
- Mania (a disorder whose symptoms are hyperactivity, accelerated thought and less need for sleeping) , aggressiveness and anger.
- Halitosis (bad breath).
- Increased pressure in the eye.
- Menopausal symptoms.
- Lockjaw (muscle contractions of the jaw) .
- Increased blood cholesterol level, low blood sodium level (symptoms include confusion, feeling sick and unwell with weak muscles), (Syndrome of inappropriate secretion of antidiuretic hormone).
Other possible side effects
- Hallucinations, suicidal thoughts or behavior.
- Restlessness or an inability to sit or stand still (akathisia) , serotonin syndrome (a rare reaction which may cause drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or muscular stiffness) , seizures.
- Bright red blood in the stool, vomiting blood or black stools.
- Abnormal urine odor.
- Chest pain.
- Yellowing of the skin and white of eyes (jaundice), liver failure, Stevens-Johnson syndrome, Sudden swelling of skin or mucosa (angioedema).
This list does not include all adverse reactions associated with the use of duloxetine, both well established as those that are under consideration or confirmation. In case you feel unwell, should immediately consult with the doctor who prescribed this medicine.
If you notice any side effects not listed in this website or in the leaflet accompanying the package, ask your doctor or pharmacist.
If any of the side effects gets serious, tell your doctor or pharmacist.
This page contains a list of brands of authorized pharmaceutical specialties of the active principle duloxetine in the countries listed below:
[ Australia] [ Brazil] [ Canada] [ France] [ Germany] [ India] [ Italy] [ Japan] [ Korea] [ Mexico] [ Puerto Rico] [ Spain] [ Turkey] [ United Kingdom] [ U.S.A]
Given the nature of the pharmaceutical market, some specialties may be unavailable, have been removed from the pharmaceutical market or have changed its name. So that, in no case can take decisions based on the information contained in the page. MEDIZZINE is not responsible for any damage arising from the information provided, which may be incomplete or outdated.
Warning:
With exceptions expressly indicated, these lists do not include active principle associations with other drugs or clinical use containers.
Australia: ▲
ANDEPRA 30 mg, 28 capsules
ANDEPRA 60 mg, 28 capsules
APO-DULOXETINE 30 mg, 28 capsules
APO-DULOXETINE 60 mg, 28 capsules
CHEM MART DULOXETINE 30 mg, 28 capsules
CHEM MART DULOXETINE 60 mg, 28 capsules
COPERIN 30 mg, 28 capsules
COPERIN 60 mg, 28 capsules
CYMBALTA 30 mg, 28 capsules
CYMBALTA 60 mg, 28 capsules
DRULOX 30 mg, 28 capsules
DRULOX 60 mg, 28 capsules
DULOXETINE GH 30 mg, 28 capsules
DULOXETINE GH 60 mg, 28 capsules
DULOXETINE-DRLA 30 mg, 28 capsules
DULOXETINE-DRLA 60 mg, 28 capsules
TERRY WHITE CHEMIST DULOXETINE 30 mg, 28 capsules
TERRY WHITE CHEMIST DULOXETINE 60 mg, 28 capsules
Brazil: ▲
CYMBALTA 30 mg, 7, 14 and 28 extended release capsules
CYMBALTA 60 mg, 7, 14 and 28 extended release capsules
Canada: ▲
CYMBALTA 30 mg, 7, 14, 30, 60, 90 and 180 extended release capsules
CYMBALTA 60 mg, 7, 14, 30, 60, 90 y 180 extended release capsules
France: ▲
CYMBALTA 30 mg, 28 capsules
CYMBALTA 60mg, 28 capsules
Germany: ▲
ARICLAIM 30 mg, 28 and 98 capsules
ARICLAIM 60 mg, 28 and 98 capsules
CYMBALTA 30 mg, 28 and 98 capsules
CYMBALTA 30 mg, 28 and 98 capsules
YENTREVE 20 mg, 28 and 98 capsules
YENTREVE 40 mg, 28 and 98 capsules
India: ▲
2-DEP 20 mg, tablets
2-DEP 30 mg, tablets
C-PACT 20 mg, capsules
C-PACT 40 mg, capsules
COMBAC 20 mg, tablets
COMBAC 30 mg, tablets
COMBAC 40 mg, tablets
COMBAC 60 mg, tablets
DELOK 20 mg, capsules
DELOK 30 mg, capsules
DENEURONE 20 mg, capsules
DENEURONE 30 mg, capsules
DENEURONE 60 mg, capsules
DETINE 20 mg, capsules
DETINE 30 mg, capsules
DLX 20 mg, tablets
DLX 40 mg, tablets
DULANE 20 mg, capsules
DULANE 30 mg, capsules
DULEX 20 mg, capsules
DULEX 30 mg, capsules
DULIFE 20 mg, capsules
DULIFE 30 mg, capsules
DULOJOY 20 mg, tablets
DULOJOY 30 mg, tablets
DULOK 20 mg, tablets
DULOK 30 mg, tablets
DULOTIN 20 mg, tablets
DULOTIN 30 mg, tablets
DULOXEE 20 mg, tablets
DULOXEE 30 mg, tablets
DULTIN 20 mg, tablets
DULTIN 30 mg, tablets
DULTIN 40 mg, tablets
DULTIN 60 mg, tablets
DULX 20 mg, tablets
DULX 30 mg, tablets
DULX 40 mg, tablets
DULX 60 mg, tablets
DUMORE 20 mg, capsules
DUMORE 30 mg, capsules
DUMORE 6 mg, capsules
DUPACT 20 mg, capsules
DUPACT 30 mg, capsules
DUPACT 60 mg, capsules
DUREEP 20 mg, capsules
DUTIN 20 mg, capsules
DUTIN 30 mg, capsules
DUTIN 60 mg, capsules
DUTINE 40 mg, capsules
DUTINE 60 mg, capsules
DUXET 20 mg, capsules
DUXET 30 mg, capsules
DUZAC 20 mg, capsules
DUZELA 20 mg, capsules
DUZELA 30 mg, capsules
DXT 20 mg, tablets
DXT 30 mg, tablets
DXT 40 mg, tablets
DXT 60 mg, tablets
NUDEP 20 mg, capsules
NUDEP 30 mg, capsules
NUDEP 40 mg, capsules
SYLONEX 20 mg, tablets
SYLONEX 30 mg, tablets
SYLONEX 40 mg, tablets
SYMBAL 20 mg, tablets
SYMBAL 30 mg, tablets
SYMBAL 40 mg, tablets
SYMBAL 60 mg, tablets
SYMBAL-M 20 mg, tablets
SYMBAL-M 40 mg, tablets
SYMPTA 20 mg, tablets
SYMPTA 30 mg, tablets
SYMPTA 40 mg, tablets
SYMPTA 60 mg, tablets
ULOZET 20 mg, capsules
Italy: ▲
CYMBALTA 30 mg, 7 capsules
CYMBALTA 60 mg, 28 capsules
XERISTAR 30 mg, 7 capsules
XERISTAR 60 mg, 28 capsules
YENTREVE 20 mg, 56 capsules
YENTREVE 40 mg, 28 and 56 capsules
Japan: ▲
CYMBALTA 20 mg, capsules
CYMBALTA 30 mg, capsules
Korea: ▲
Information not available
Mexico: ▲
CYMBALTA 30 mg, 7, 14 and 28 capsules
CYMBALTA 60 mg, 14 and 28 capsules
Spain: ▲
CYMBALTA 30 mg, 28 capsules
CYMBALTA 60 mg, 28 capsules
XERISTAR 30 mg, 28 capsules
XERISTAR 60 mg, 28 capsules
Turkey: ▲
CYMBALTA 30 mg, 28 capsules
CYMBALTA 60 mg, 28 capsules
DUXET 30 mg, 28 capsules
DUXET 60 mg, 28 capsules
NEXETIN 20 mg, 28 capsules
NEXETIN 40 mg, 28 capsules
United Kingdom: ▲
CYMBALTA 30 mg, 28 capsules
CYMBALTA 60 mg, 28 capsules
YENTREVE 20 mg, 28 capsules
YENTREVE 40 mg, 56 capsules
U.S.A. and Puerto Rico: ▲
CYMBALTA 20 mg, 60 capsules
CYMBALTA 30 mg, 7, 30 and 90 capsules
CYMBALTA 60 mg, 7 y 30 capsules
Date page update: December 17, 2010.