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What Dulodet is and what it is used for
Dulodet contains the active substance duloxetine. Dudold increases levels of serotonin and noradrenaline in the nervous system.
Dulodet is used in adults to treat:
generalized anxiety disorder (chronic anxiety or nervousness);
diabetes neuropathic pain (often described as burning, stabbing, stinging, wheezing or pain, or it is similar to an electric shock.) There may be a lack of sensitivity in the affected area, or feelings such as touch, heat, cold or pressure can cause pain.
In most people with depression or anxiety, Dudel begins to work within two weeks of starting treatment, but it may take 2-4 weeks before you feel better. Tell your doctor if you do not start feeling better after this period. Your doctor may continue to appoint a Doctor when you prevent your depression or anxiety from returning.
In most people with diabetic neuropathic pain, treatment may take several weeks before they feel better. Tell your doctor if you do not feel better after 2 months.
2. What you need to know before taking Dulodet
Do not take Dulodet:
if you are allergic to duloxetine or any of the other ingredients of this medicine (listed in section 6);
if you have liver disease;
if you have severe kidney disease;
if you take or have taken another medicine called the monoamine oxidase inhibitor (MAOI) during the last 14 days (see "Other medicines and Duodenum");
if you are taking fluvoxamine, which is commonly used to treat depression, ciprofloxacin or enoxacin, used to treat certain infections;
if you are taking other medicines containing duloxetine (see "Other medicines and Dulodet").
Talk to your doctor if you have high blood pressure or heart disease. Your doctor will tell you whether you should take Dulodet.
Warnings and precautions
Below are the reasons why Dulode may be inappropriate for you. Check with your doctor before taking Dulodet if:
take medicines to treat depression (see "Other medicines and Dulodet");
take Herbal St. John's wort (Hypericum perforatum);
have kidney disease;
you have had seizures (seizures);
you have had an obsession;
you suffer from bipolar disorder;
have eye problems, such as certain types of glaucoma (increased eye pressure);
have a history of bleeding disorders (tendency to bruise);
you are at risk of low sodium levels (for example if you are taking diuretics, especially if you are elderly);
you are currently being treated with another medicine that may cause liver damage;
take other medicines containing duloxetine (see "Other medicines and Dulodet").
A dandelion can lead to a feeling of anxiety or an inability to sit or stand still. In this case you should tell your doctor.
Thoughts of suicide and worsening of your depression or anxiety disorder
If you are depressed and / or have an anxiety disorder, you may sometimes have thoughts of self-harm or suicide. These thoughts may become more frequent when you start antidepressant treatment for the first time, because it takes time to get an effect on all these medicines - usually about two weeks, and sometimes even longer.
You are more likely to think this way if:
before you had thoughts of suicide or self-harm;
you are a young adult patient. Information from clinical trials indicates an increased risk of suicidal behavior in adults under 25 years of age with psychiatric conditions treated with antidepressants.
If you have thoughts of self-harm or suicide at any time, contact your doctor or go to hospital immediately.
It may be helpful to tell a relative or close friend that you are depressed or have an anxiety disorder and ask him / her to read this leaflet. You can ask him to tell you if he thinks your depression or anxiety is getting worse or if he is concerned about changes in your behavior.
Children or adolescents under 18 years of age
Typically, Dulodet should not be used in children and adolescents under 18 years of age. You should also be aware that there is an increased risk of side effects, such as attempts and thoughts of suicide and hostility (predominantly aggression, opposition, and anger) in patients under 18 years of age when using drugs of this class. Nevertheless, your doctor may prescribe Dulodet for patients under 18 years of age if he / she considers this to be in their interest. If your doctor prescribes Dulodet to a patient under 18 and you want to discuss this, talk to your doctor. You should inform your doctor if any of the symptoms mentioned above are manifesting or aggravating when a patient under 18 years of age is taking Duoden. In addition, long-term safety with regard to the effects
You should also tell your doctor if you are taking any of the following:
Monoamine oxidase inhibitors (MAOIs): Do not take Dulodet if you are taking or have recently taken (for the last 14 days) another antidepressant medicine called a monoamine oxidase inhibitor (MAOI). Examples of MAO inhibitors are moclobemide (antidepressant) and linezolid (antibiotic). Taking MAOIs with many prescription medicines, including Dulodete, may cause serious or even life-threatening side effects. You should wait at least 14 days after you have stopped taking MAO inhibitors before you can take Dulodete. It is also necessary to wait at least 5 days after stopping taking Dulodet before taking MAO inhibitors;
Drugs that cause drowsiness: These include medicines prescribed by your doctor, including benzodiazepines, strong painkillers, antipsychotics, phenobarbital and antihistamines;
Serotonin uptake drugs: Tryptans, tramadol, tryptophan, selective serotonin reuptake inhibitors (such as paroxetine and fluoxetine), serotonin / noradrenaline reuptake inhibitors (such as venlafaxine), tricyclic antidepressants (such as clomipramine, amitriptyline) , 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 symptoms while you are taking these medicines with Dulodet, you should consult your doctor.
Oral anticoagulants or anti-aggregates: Medicines that dilute the blood or prevent the blood from clotting. These medicines can increase the risk of bleeding.
Doodle with food, drinks and alcohol
Dulodet can be taken with or without food. Caution should be exercised if you are taking alcohol while on Dulodete.
Pregnancy and breastfeeding
If you are pregnant or are breast-feeding, think you may be pregnant or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Tell your doctor if you become pregnant or if you plan to get pregnant while taking Dulodate. Use Dulodet only after discussing with your doctor the potential benefits and all possible risks for the unborn child.
Make sure your midwife and / or doctor know you are getting a Dudel. When such drugs (SSRIs) are taken during pregnancy, the risk of serious condition in babies, called persistent pulmonary hypertension in the infant (PPHH), may be increased, in which the baby breathes rapidly and looks bluish. These signs usually occur during the first 24 hours after the birth of the baby. If this happens to your baby, you should immediately contact your midwife and / or doctor.
If you are taking Dulodet as your baby is pregnant, your baby may have some signs when he is born. They usually start at birth or within a few days after the birth of your baby. These signs may include relaxed muscles, trembling, nervousness, poor nutrition, difficulty in breathing and seizures. If your baby has any of these signs at birth or worries about his or her health, contact your doctor or midwife who will be able to advise you.
Tell your doctor if you are breast-feeding. It is not recommended to use Dulodet during the lactation period. You should talk to your doctor or pharmacist.
Driving and using machines
Dulodate can cause drowsiness or dizziness. Do not use tools and machines until you know how Dudelode affects you.
Dudlock contains sucrose
Dudlock contains sucrose. If your doctor has told you that you have an intolerance to any sugars, talk to your doctor before taking this medicinal product.
3. How to take Dulodet
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Dulodate is for oral use. You must swallow the capsule whole with a glass of water.
For depression and diabetic neuropathic pain:
The usual dose of Dulodet is 60 mg once a day, but your doctor will prescribe the dose that is right for you.
In generalized anxiety disorder:
The recommended starting dose of Dulodet is 30 mg once a day, after which most patients take 60 mg once a day, but your doctor will prescribe the appropriate dose for you. The dose can be adjusted to 120 mg per day depending on how you respond to Dulodete.
Do not forget to take Dulodet can make it easier if you take the medicine at the same time each day. Talk to your doctor for how long you should take Dulodet. Do not stop taking Dulodet and do not change your dose without consulting your doctor. It is important to properly treat your illness to make you feel better. If you do not treat your condition, it may not go away, but it can become more serious and harder to treat.
If you have taken more than necessary
If you stop taking Dulodet
Do not stop taking your capsules without your doctor's advice, even if you feel better. If your doctor thinks that you no longer need a Dulodate, he / she will advise you to reduce your dose for at least 2 weeks before stopping treatment.
Some patients who stop taking Dulodet suddenly have received symptoms such as:
dizziness, dizziness, tingling, tingling or tingling sensations (especially in the head area), sleep disturbances (vivid dreams, nightmares, insomnia), tiredness, drowsiness, feeling anxious or agitated, feeling anxious , nausea or vomiting, trembling (tremor), headache, muscle pain, irritability, 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, talk to your doctor.
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 everyone 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):
nausea (feeling sick), dry mouth.
Common side effects (may affect up to 1 in 10 people):
Lack of appetite;
sleep problems, feeling of anxiety, reduced sexual attraction, anxiety, difficulty reaching or lacking orgasm, unusual dreams;
dizziness, feeling weak, tremor, tingling, including numbness, tingling or tingling of the skin;
tinnitus (hearing tinnitus when there is no external sound source);
feeling heart beats in the chest;
increased blood pressure, redness;
more frequent yawning;
constipation, diarrhea, stomach pain, nausea (vomiting), heartburn or indigestion, gassing;
increased sweating, (itchy) rash;
muscle pain, muscle spasm;
painful urination, frequent urination;
problems with reaching erection, changes in ejaculation;
seizures (mainly in the elderly), fatigue;
In children and adolescents aged under 18 years with depression who are being treated with this medicine, there is little weight loss when they first start taking it. The weight is increased to that of other children and adolescents of their age and gender after 6 months of treatment.
Uncommon side effects (may affect up to 1 in 100 people):
inflammation of the throat causing a hoarse voice;
suicidal thoughts, sleeping problems, teething or teeth, feelings of disorientation, lack of motivation;
sudden involuntary convulsions or twitching of the muscles, feeling anxiety or inability to sit or stand still, feeling nervous, difficulty concentrating, changes in taste sensations, difficulty in controlling movement, for example, lack of coordination or involuntary movements of the muscles, restlessness syndrome legs, bad sleep;
enlarged pupils (dark center of the eye), vision problems;
feeling dizzy or "dizzy" (vertigo), ear pain;
rapid and / or irregular heartbeat;
fainting, dizziness, blackout or fainting, cold hands and / or feet;
sore throat, nose bleeds;
vomiting of blood or tar-black faeces (faeces), gastroenteritis, eruption, difficulty in swallowing;
inflammation of the liver which may cause abdominal pain and yellowing of the skin or whites of the eyes;
night sweats, rash, cold sweat, sensitivity to sunlight, increased tendency to bruising;
muscle tension, muscle twitching;
difficulty or inability to urinate, difficulty in starting urination, need to urinate at night, need for more frequent urination than usual, low urine flow;
abnormal vaginal bleeding, menstrual disorder including severe, painful, irregular or prolonged menstrual cycles, abnormally light or absent menstrual cycles, testicular pain or scrotum;
chest pain, feeling cold, thirst, shaking, feeling warm, unusual gait;
Dulodate can cause effects you may not experience, such as elevation of liver enzymes or potassium, creatinine phosphokinase, sugar or cholesterol levels in the blood.
Rare side effects (may affect up to 1 in 1,000 people):
severe allergic reaction that causes difficulty breathing or dizziness, swollen tongue or lips, allergic reactions;
reduced thyroid function, which may cause fatigue or weight gain;
dehydration, low levels of sodium in the blood (mainly in the elderly, symptoms may include feeling dizzy
hepatic insufficiency, yellow skin or white eyes (jaundice);
Stevens-Johnson syndrome (serious skin swelling, mouth, eyes, and genital organs), a serious allergic reaction that causes swelling of the face or throat (angioedema);
cramps of jaw muscles;
altered urine smell;
menopausal symptoms, abnormal breast or male breast excretion.
Very rare side effects (may affect up to 1 in 10,000 people):
inflammation of the blood vessels of the skin (cutaneous vasculitis)
How to Store a Dudel
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton. This medicinal product does not require any special storage conditions.
Do not dispose of medicines in the sewage system or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Package Contents and Additional Information
What Dulodete contains
The active substance is: duloxetine hydrochloride.
Each capsule contains 30 mg of duloxetine (as hydrochloride).
Each capsule contains 60 mg duloxetine (as hydrochloride).
The other ingredients are:
Capsule contents: sugar spheres, corn starch, methacrylic acid-ethyl acrylate copolymer (1: 1) 30% dispersion (Eudragit L30D55), hypromellose, sucrose, colloidal anhydrous silica, talc, triethyl citrate, triethyl citrate, polysorbate 80 and water);
Body of the capsule:
30 mg capsules: titanium dioxide (E171), gelatin, FD & C blue 2, water;
60 mg capsules: titanium dioxide (E171), gelatin, FD & amp; C blue 2, yellow iron oxide (E172), water;
Green Ink: Shellac, Propylene Glycol, Potassium Hydroxide, Black Iron Oxide (E172), Yellow Iron Oxide (E172);
White ink: shellac, propylene glycol, povidone, titanium dioxide (E171).
What Dulodet looks like and what the package contains
Dulodet is a hard gastro-resistant capsule. Each capsule contains pellets of duloxetine hydrochloride, which have a coating to protect them from stomach acid.
Dulodate 30 mg capsules are hard gelatin capsules with yellow ink "DLX" on the opaque blue cap and "30 mg" on the opaque white body.
Dulodet 60 mg capsules are hard gelatin capsules, white ink "DLX" on the opaque blue cap and "60 mg" on the opaque green body.
Dulodet 30 mg hard gastro-resistant capsule is available in packs of 7, 10, 14, 28, 30, 56, 60, 84, 98 and 100 capsules.
Dulodet 60 mg hard gastro-resistant capsule is available in packs of 7, 10, 14, 28, 30, 56, 60, 84, 98 and 100 capsules.
Not all pack sizes may be marketed.
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