Attributes
- Form
- Dosage mg
- Pack
- Description en
- Dulsevia® 60mg hard gastro-resistant capsules Duloxetine Read the entire package leaflet carefully before you start taking this medicine, as it contains important information for you. - Keep this package leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4. This package leaflet contains: 1. What Dulsevia is and what it is used for 2. What you need to know before you take Dulsevia 3. How to take Dulsevia 4. Possible side effects 5. How to store Dulsevia 6. Contents of the pack and other information. 1. What Dulsevia is and what it is used for Dulsevia contains the active substance duloxetine. Dulsevia increases the levels of serotonin and noradrenaline in the nervous system. Dulsevia is used in adults to treat: - Depression - Generalized anxiety disorder (chronic anxiety or nervousness) - Diabetic neuropathic pain (often described as burning, tingling, stinging, cutting, or electric shock-like pain. The affected area may have a loss of sensation or pain sensation to touch, heat, cold, or pressure). In most patients with depression or anxiety, Dulsevia starts to work within two weeks of starting treatment, although it may take 2-4 weeks for your condition to improve. Tell your doctor if you do not feel better after this period. If you feel better, your doctor may recommend continuing treatment with Dulsevia to prevent the recurrence of depression or anxiety. In patients with diabetic neuropathy, it may take several weeks for your condition to improve. Tell your doctor if you do not feel better after two months. See blog: Dulsevia – a medicine for depression, anxiety, and neuropathic pain 2. What you need to know before you take 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 - are taking, or have taken within the last 14 days, another medicine called a monoamine oxidase inhibitor (MAOI) (see Taking Dulsevia with other medicines) - are taking fluvoxamine, commonly used to treat depression, ciprofloxacin or enoxacin, used to treat some infections. - are taking other medicines containing duloxetine (see Taking Dulsevia with other medicines) Talk to your doctor if you have high blood pressure or heart disease. Your doctor will decide whether you should take Dulsevia. Warnings and precautions Dulsevia may not be recommended for you for the following reasons. Talk to your doctor before taking Dulsevia if: - you are taking other medicines for depression (see Taking Dulsevia with other medicines) - you are taking herbal remedies containing St. John's Wort (Hypericum perforatum) - you have kidney disease - you have seizures (epilepsy) - you have mania - you have bipolar disorder - you have an eye condition, such as certain types of glaucoma (increased pressure in the eye) - you have a history of bleeding disorders (tendency to develop bruises) - you are at risk of low sodium levels in your blood (e.g., if you are taking diuretics, especially in the elderly). - you are currently being treated with a medicine that may cause liver damage - you are taking other medicines containing duloxetine (see Taking Dulsevia with other medicines). Medicines similar to Dulsevia (so-called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see Section 4). In some cases, these symptoms may persist after treatment has stopped. Dulsevia may cause restlessness or an inability to sit or stand still. If this happens, talk to your doctor. Suicidal thoughts and worsening of your depression or anxiety disorder If you have depression and/or an anxiety disorder, you may sometimes have thoughts of harming yourself or committing suicide. These thoughts may be more intense at the beginning of antidepressant treatment because it takes time for the medicine to work, usually two weeks, and sometimes longer. You are more likely to have these thoughts if: - you have previously had thoughts of harming yourself or committing suicide - you are a young adult. Clinical trials have shown an increased risk of suicidal behaviour in young adults under 25 years of age with mental disorders who were treated with antidepressants. If you have thoughts of harming yourself or committing suicide, contact your doctor or go to a hospital immediately. It would be helpful to inform a relative or close friend that you have depression or an anxiety disorder and ask them to read this package leaflet. Ask them to tell you if they think your depression or anxiety disorder is worsening or if they are worried about changes in your behaviour. Children and adolescents under 18 years of age Dulsevia is not usually used in adolescents under 18 years of age. You should also be aware that in children and adolescents under 18 years of age, there is an increased risk of side effects such as suicide attempts, suicidal thoughts and harmful behaviour (mainly aggression, oppositional behaviour and anger) when taking medicines of this class. However, a doctor may prescribe Dulsevia for patients under 18 years of age if they decide it is necessary. If your doctor has prescribed Dulsevia for a patient under 18 years of age and you want to discuss this with the doctor, please consult your doctor again. If a patient under 18 years of age is taking Dulsevia, inform the doctor about any of the above-mentioned symptoms or worsening. In addition, the long-term safety of Dulsevia on growth, maturation and behavioural development in this age group has not been established. Taking Dulsevia with other medicines Tell your doctor or pharmacist if you are taking, have recently taken, or plan to take any other medicines, including medicines obtained without a prescription. The active substance of Dulsevia, duloxetine, is used in other medicines for the following conditions: • Diabetic neuropathic pain, depression, anxiety, and urinary incontinence. You should avoid taking several of these medicines at the same time. Tell your doctor if you are taking other medicines containing duloxetine. Your doctor will decide whether to use Dulsevia with other medicines. Do not start or stop taking any medicines, including herbal medicines and over-the-counter medicines, without consulting your doctor. Also tell your doctor if you are taking the following medicines: Monoamine oxidase inhibitors (MAOIs): Dulsevia should not be used if you are taking or have recently taken (within the last 14 days) other antidepressants called monoamine oxidase inhibitors (MAOIs). MAOIs include, for example, moclobemide (an antidepressant) and linezolid (an antibiotic). Taking MAOIs with other prescription medicines, including Dulsevia, can cause serious or potentially life-threatening side effects. At least 14 days should pass after stopping MAOIs before starting Dulsevia. Also, at least 5 days should pass after stopping Dulsevia before starting MAOIs. Medicines that cause drowsiness: These include prescription medicines, including benzodiazepines, strong painkillers, antipsychotics, phenobarbital, and antihistamines. Medicines that increase serotonin levels: Triptans, tramadol, tryptophan, selective serotonin reuptake inhibitors (such as paroxetine and fluoxetine), serotonin and noradrenaline reuptake inhibitors (such as venlafaxine), tricyclic antidepressants (such as clomipramine, amitriptyline), pethidine, St. John's Wort preparations, and MAOIs (such as moclobemide and linezolid). These medicines increase the risk of side effects; consult your doctor if you experience any unusual symptoms when taking these medicines with Dulsevia. Oral anticoagulants or antiplatelet agents: Blood-thinning or anti-clotting medicines. These medicines may increase the risk of bleeding. Taking Dulsevia with food, drink and alcohol Dulsevia can be taken with or without food. Caution is advised if you consume alcoholic beverages while being treated with Dulsevia. Pregnancy and breastfeeding If you are pregnant or breastfeeding, or think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. - Tell your doctor if you become pregnant or plan to become pregnant while being treated with Dulsevia. Dulsevia should only be taken after your doctor has assessed the potential benefit to you and the potential risk to the fetus. Inform your midwife and/or doctor that you are taking Dulsevia. Taking similar medicines (SSRIs) during pregnancy may increase the risk of developing a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes increased breathing and bluish skin in newborns. These symptoms usually appear within 24 hours of birth. If these symptoms occur, contact your midwife or doctor. If you take Dulsevia in the last stages of pregnancy, your baby may experience some symptoms. These usually appear at birth or within a few days of birth. Symptoms may include muscle weakness, tremors, excitability, feeding difficulties, breathing difficulties, and seizures. If your baby has these symptoms at birth or you are concerned about your baby's health, consult your doctor or midwife. - Tell your doctor if you are breastfeeding. Dulsevia is not recommended during breastfeeding. Consult your doctor or pharmacist for advice. Driving and operating machinery Dulsevia may cause drowsiness and dizziness. Do not drive or operate machinery until you know how Dulsevia affects you. Dulsevia contains sucrose If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. 3. How to take Dulsevia Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure about anything, ask your doctor or pharmacist. Dulsevia is taken orally. Swallow the capsule whole with water. For depression and pain caused by diabetic neuropathy, the recommended dose of Dulsevia is 60 mg once a day, but your doctor may prescribe a different dose for you. Generalized anxiety disorder The usual starting dose of Dulsevia is 30 mg once a day, then for most patients it is increased to 60 mg once a day, but your doctor will prescribe the dose that is right for you. Depending on your response to Dulsevia, the dose may be increased to 120 mg once a day. To help you remember to take Dulsevia, take it at the same time each day. Ask your doctor how long you should take Dulsevia for. Do not stop taking Dulsevia or change the dose without consulting your doctor. Proper treatment of your condition is important for improvement. Without treatment, your condition will not improve and may become more severe and difficult to treat. If you take more Dulsevia than you should Tell your doctor or pharmacist if you have taken more Dulsevia than prescribed by your doctor. Symptoms of overdose include drowsiness, coma, serotonin syndrome (a rare reaction that can cause intense feelings of happiness, drowsiness, clumsiness, restlessness, a feeling of being "drunk", fever, sweating or muscle stiffness), seizures, vomiting, and rapid heartbeat. If you forget to take Dulsevia If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take the dose only once as usual. Do not take a double dose to make up for a missed dose. Do not take more than the daily dose of Dulsevia prescribed by your doctor. If you want to stop taking Dulsevia Do not stop taking the capsules without your doctor's advice, even if you feel better. If your doctor decides that you no longer need to take Dulsevia, they will first reduce the dose gradually over at least 2 weeks before stopping treatment completely. Some patients who have stopped taking Dulsevia suddenly have experienced the following symptoms: - dizziness, tingling or electric shock-like sensations (especially in the head), sleep disturbances (strange dreams, nightmares or insomnia), fatigue, drowsiness, restlessness or irritability, anxiety, nausea or vomiting, tremor (shaking), headache, muscle pain, irritability, diarrhoea, excessive sweating or dizziness. These symptoms are usually not serious and disappear within a few days, but if the symptoms are bothersome, consult your doctor. If you have any further questions about this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine may cause side effects, although not everybody gets them. These reactions are usually mild or moderate and often disappear within a few weeks. Very common side effects (affect more than 1 in 10 people) - Headache, insomnia - Feeling unwell (nausea), dry mouth Common side effects (affect less than 1 in 10 people) - Decreased appetite - Sleep disturbances, irritability, decreased libido, anxiety, anorgasmia or difficulty achieving orgasm, unusual dreams - Dizziness, lack of energy, tremor, loss of sensation, including loss of skin sensation or tingling - Blurred vision - Tinnitus (ringing in the ears in the absence of external sound) - Palpitations (feeling your heart beat) in the chest area, - Increased blood pressure, hot flushes - Increased yawning - Constipation, diarrhoea, stomach pain, feeling unwell (vomiting), heartburn or indigestion, frequent passing of gas - Excessive sweating, rash (itchy) - Muscle pain, muscle spasms - Painful urination, frequent urination - Difficulty with erection, changes in ejaculation - Falls (especially in the elderly), fatigue - Weight loss In children and adolescents under 18 years of age with depression, weight loss was observed at the start of treatment with this medicine. Weight gain was similar in children and adolescents of the same sex and age 6 months after starting treatment. Uncommon side effects (affect less than 1 in 100 people) - Inflammation of the throat, causing hoarseness - Suicidal thoughts, difficulty sleeping, teeth grinding, disorientation, lack of motivation - Muscle spasms or involuntary muscle movements, feeling of restlessness or inability to sit or stand still, nervousness, attention disturbance, taste changes, difficulty controlling movement, e.g. impaired coordination or involuntary muscle movements, restless legs syndrome, poor quality sleep - Dilated pupils (dark centre of the eye), visual disturbances - Feeling dizzy or spinning (vertigo), ear pain - Rapid and/or irregular heartbeat - Fainting, dizziness or light-headedness upon standing, feeling cold in fingers and toes - Tightness in the throat, nosebleeds - Bloody vomit or black, tarry stools, gastroenteritis, belching, difficulty swallowing - Inflammation of the liver, which may cause severe abdominal pain and yellowing of the skin or eyes - Night sweats, hives, cold sweats, sensitivity to light, increased tendency to bruise - Muscle stiffness, muscle spasms - Difficulty passing urine or retaining urine, difficulty starting to urinate, urinating at night, frequent urination, reduced urine output, - Abnormal vaginal bleeding, abnormal menstruation, including heavy, painful, irregular or prolonged periods, unusually light periods or missed menstrual periods, pain in the testicles or scrotum - Chest pain, feeling cold, thirst, chills, feeling hot, impaired gait - Weight gain - Dulsevia may cause effects that you do not notice, such as increased levels of liver enzymes or potassium, creatine kinase, sugar, or cholesterol in the blood. Rare side effects (affect less than 1 in 1000 people) - Severe allergic reactions, which may cause difficulty breathing or dizziness with 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 (especially in the elderly; symptoms include dizziness, weakness, confusion, drowsiness or severe fatigue, nausea or vomiting, or more serious symptoms such as fainting, seizures or falls), syndrome of inappropriate secretion of antidiuretic hormone (SIADH) - Suicidal behaviour, mania (a disorder with symptoms such as hyperactivity, rapid changes in mood and decreased need for sleep), hallucinations, aggression and anger - "Serotonin syndrome" (a rare reaction that can cause intense feelings of happiness, drowsiness, inflexibility, restlessness, a feeling of being "drunk", fever, sweating or muscle stiffness), seizures - Increased pressure in the eye (glaucoma) - Cough, wheezing or shortness of breath, which may be accompanied by a high temperature - Inflammation of the mouth, red blood in stools, bad breath, inflammation of the large intestine (causing diarrhoea) - Liver failure, yellowing of the skin or eyes (jaundice) - Stevens-Johnson syndrome (a severe disorder with ulcers on the skin, mouth, eyes, and genitals), a serious allergic reaction causing swelling of the face and throat (angioneurotic oedema) - Jaw muscle stiffness - Unusual smell of urine - Menopausal symptoms, pathological milk secretion in women and men. Very rare: affects less than 1 in 10,000 people - Inflammation of the blood vessels in the skin (vasculitis) Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly via the national reporting system, details of which can be found on the website of the National Agency of Medicines and Medical Devices at http://www.anm.ro/. By reporting side effects, you can help provide more information about the safety of this medicine. 5. How to store Dulsevia Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Store at a temperature not exceeding 25°C. Keep in the original packaging to protect from moisture. Do not dispose of medicines down the drain or with household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment. 6. Contents of the pack and other information What Dulsevia contains - The active substance is duloxetine. - Each capsule contains 30 mg or 60 mg of duloxetine (as hydrochloride). The other ingredients are: Capsule content: Sugar spheres (sugar, corn starch), hypromellose 6cP, sucrose, hypromellose phthalate, talc and triethyl citrate (see section 2 for more information on sucrose). Capsule shell: Gelatin, titanium dioxide (E171), indigo carmine (E132), yellow iron oxide (E172) (only in 60 mg capsules), colouring (shellac, black iron oxide (E172)). Description and contents of the pack Dulsevia is a gastro-resistant capsule. Each Dulsevia capsule contains duloxetine hydrochloride granules coated with a film, which protects them from stomach acid. Dulsevia is available in two strengths: 30 mg and 60 mg. Dulsevia 30 mg hard gelatin capsule, size 3 (length: 15.9 mm) contains white to off-white spheres. The capsule body is white and the cap is dark blue. The number 30 is printed in black on the capsule body. Dulsevia 60 mg hard gelatin capsule, size 1 (length: 19.4 mm) contains white to off-white spheres. The capsule body is yellowish-green and the cap is dark blue. The number 60 is printed in black on the capsule body. Dulsevia 30 mg packs contain 7, 10, 14, 28, 30, 56, 60, 90 and 100 capsules. Dulsevia 60 mg packs contain 7, 10, 14, 28, 30, 56, 60, 90 and 100 capsules. Not all pack sizes may be marketed. Conditions of supply Group II pharmaceutical product, dispensed with prescription form No. 3
- Active
- duloxetine
What is it?
Dulsevia® 60mg hard gastro-resistant capsules Duloxetine Read the entire package leaflet carefully before you start taking this medicine, as it contains important information for you. - Keep this package leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4. This package leaflet contains: 1. What Dulsevia is and what it is used for 2. What you need to know before you take Dulsevia 3. How to take Dulsevia 4. Possible side effects 5. How to store Dulsevia 6. Contents of the pack and other information. 1. What Dulsevia is and what it is used for Dulsevia contains the active substance duloxetine. Dulsevia increases the levels of serotonin and noradrenaline in the nervous system. Dulsevia is used in adults to treat: - Depression - Generalized anxiety disorder (chronic anxiety or nervousness) - Diabetic neuropathic pain (often described as burning, tingling, stinging, cutting, or electric shock-like pain. The affected area may have a loss of sensation or pain sensation to touch, heat, cold, or pressure). In most patients with depression or anxiety, Dulsevia starts to work within two weeks of starting treatment, although it may take 2-4 weeks for your condition to improve. Tell your doctor if you do not feel better after this period. If you feel better, your doctor may recommend continuing treatment with Dulsevia to prevent the recurrence of depression or anxiety. In patients with diabetic neuropathy, it may take several weeks for your condition to improve. Tell your doctor if you do not feel better after two months. See blog: Dulsevia – a medicine for depression, anxiety, and neuropathic pain 2. What you need to know before you take 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 - are taking, or have taken within the last 14 days, another medicine called a monoamine oxidase inhibitor (MAOI) (see Taking Dulsevia with other medicines) - are taking fluvoxamine, commonly used to treat depression, ciprofloxacin or enoxacin, used to treat some infections. - are taking other medicines containing duloxetine (see Taking Dulsevia with other medicines) Talk to your doctor if you have high blood pressure or heart disease. Your doctor will decide whether you should take Dulsevia. Warnings and precautions Dulsevia may not be recommended for you for the following reasons. Talk to your doctor before taking Dulsevia if: - you are taking other medicines for depression (see Taking Dulsevia with other medicines) - you are taking herbal remedies containing St. John's Wort (Hypericum perforatum) - you have kidney disease - you have seizures (epilepsy) - you have mania - you have bipolar disorder - you have an eye condition, such as certain types of glaucoma (increased pressure in the eye) - you have a history of bleeding disorders (tendency to develop bruises) - you are at risk of low sodium levels in your blood (e.g., if you are taking diuretics, especially in the elderly). - you are currently being treated with a medicine that may cause liver damage - you are taking other medicines containing duloxetine (see Taking Dulsevia with other medicines). Medicines similar to Dulsevia (so-called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see Section 4). In some cases, these symptoms may persist after treatment has stopped. Dulsevia may cause restlessness or an inability to sit or stand still. If this happens, talk to your doctor. Suicidal thoughts and worsening of your depression or anxiety disorder If you have depression and/or an anxiety disorder, you may sometimes have thoughts of harming yourself or committing suicide. These thoughts may be more intense at the beginning of antidepressant treatment because it takes time for the medicine to work, usually two weeks, and sometimes longer. You are more likely to have these thoughts if: - you have previously had thoughts of harming yourself or committing suicide - you are a young adult. Clinical trials have shown an increased risk of suicidal behaviour in young adults under 25 years of age with mental disorders who were treated with antidepressants. If you have thoughts of harming yourself or committing suicide, contact your doctor or go to a hospital immediately. It would be helpful to inform a relative or close friend that you have depression or an anxiety disorder and ask them to read this package leaflet. Ask them to tell you if they think your depression or anxiety disorder is worsening or if they are worried about changes in your behaviour. Children and adolescents under 18 years of age Dulsevia is not usually used in adolescents under 18 years of age. You should also be aware that in children and adolescents under 18 years of age, there is an increased risk of side effects such as suicide attempts, suicidal thoughts and harmful behaviour (mainly aggression, oppositional behaviour and anger) when taking medicines of this class. However, a doctor may prescribe Dulsevia for patients under 18 years of age if they decide it is necessary. If your doctor has prescribed Dulsevia for a patient under 18 years of age and you want to discuss this with the doctor, please consult your doctor again. If a patient under 18 years of age is taking Dulsevia, inform the doctor about any of the above-mentioned symptoms or worsening. In addition, the long-term safety of Dulsevia on growth, maturation and behavioural development in this age group has not been established. Taking Dulsevia with other medicines Tell your doctor or pharmacist if you are taking, have recently taken, or plan to take any other medicines, including medicines obtained without a prescription. The active substance of Dulsevia, duloxetine, is used in other medicines for the following conditions: • Diabetic neuropathic pain, depression, anxiety, and urinary incontinence. You should avoid taking several of these medicines at the same time. Tell your doctor if you are taking other medicines containing duloxetine. Your doctor will decide whether to use Dulsevia with other medicines. Do not start or stop taking any medicines, including herbal medicines and over-the-counter medicines, without consulting your doctor. Also tell your doctor if you are taking the following medicines: Monoamine oxidase inhibitors (MAOIs): Dulsevia should not be used if you are taking or have recently taken (within the last 14 days) other antidepressants called monoamine oxidase inhibitors (MAOIs). MAOIs include, for example, moclobemide (an antidepressant) and linezolid (an antibiotic). Taking MAOIs with other prescription medicines, including Dulsevia, can cause serious or potentially life-threatening side effects. At least 14 days should pass after stopping MAOIs before starting Dulsevia. Also, at least 5 days should pass after stopping Dulsevia before starting MAOIs. Medicines that cause drowsiness: These include prescription medicines, including benzodiazepines, strong painkillers, antipsychotics, phenobarbital, and antihistamines. Medicines that increase serotonin levels: Triptans, tramadol, tryptophan, selective serotonin reuptake inhibitors (such as paroxetine and fluoxetine), serotonin and noradrenaline reuptake inhibitors (such as venlafaxine), tricyclic antidepressants (such as clomipramine, amitriptyline), pethidine, St. John's Wort preparations, and MAOIs (such as moclobemide and linezolid). These medicines increase the risk of side effects; consult your doctor if you experience any unusual symptoms when taking these medicines with Dulsevia. Oral anticoagulants or antiplatelet agents: Blood-thinning or anti-clotting medicines. These medicines may increase the risk of bleeding. Taking Dulsevia with food, drink and alcohol Dulsevia can be taken with or without food. Caution is advised if you consume alcoholic beverages while being treated with Dulsevia. Pregnancy and breastfeeding If you are pregnant or breastfeeding, or think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. - Tell your doctor if you become pregnant or plan to become pregnant while being treated with Dulsevia. Dulsevia should only be taken after your doctor has assessed the potential benefit to you and the potential risk to the fetus. Inform your midwife and/or doctor that you are taking Dulsevia. Taking similar medicines (SSRIs) during pregnancy may increase the risk of developing a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes increased breathing and bluish skin in newborns. These symptoms usually appear within 24 hours of birth. If these symptoms occur, contact your midwife or doctor. If you take Dulsevia in the last stages of pregnancy, your baby may experience some symptoms. These usually appear at birth or within a few days of birth. Symptoms may include muscle weakness, tremors, excitability, feeding difficulties, breathing difficulties, and seizures. If your baby has these symptoms at birth or you are concerned about your baby's health, consult your doctor or midwife. - Tell your doctor if you are breastfeeding. Dulsevia is not recommended during breastfeeding. Consult your doctor or pharmacist for advice. Driving and operating machinery Dulsevia may cause drowsiness and dizziness. Do not drive or operate machinery until you know how Dulsevia affects you. Dulsevia contains sucrose If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. 3. How to take Dulsevia Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure about anything, ask your doctor or pharmacist. Dulsevia is taken orally. Swallow the capsule whole with water. For depression and pain caused by diabetic neuropathy, the recommended dose of Dulsevia is 60 mg once a day, but your doctor may prescribe a different dose for you. Generalized anxiety disorder The usual starting dose of Dulsevia is 30 mg once a day, then for most patients it is increased to 60 mg once a day, but your doctor will prescribe the dose that is right for you. Depending on your response to Dulsevia, the dose may be increased to 120 mg once a day. To help you remember to take Dulsevia, take it at the same time each day. Ask your doctor how long you should take Dulsevia for. Do not stop taking Dulsevia or change the dose without consulting your doctor. Proper treatment of your condition is important for improvement. Without treatment, your condition will not improve and may become more severe and difficult to treat. If you take more Dulsevia than you should Tell your doctor or pharmacist if you have taken more Dulsevia than prescribed by your doctor. Symptoms of overdose include drowsiness, coma, serotonin syndrome (a rare reaction that can cause intense feelings of happiness, drowsiness, clumsiness, restlessness, a feeling of being "drunk", fever, sweating or muscle stiffness), seizures, vomiting, and rapid heartbeat. If you forget to take Dulsevia If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take the dose only once as usual. Do not take a double dose to make up for a missed dose. Do not take more than the daily dose of Dulsevia prescribed by your doctor. If you want to stop taking Dulsevia Do not stop taking the capsules without your doctor's advice, even if you feel better. If your doctor decides that you no longer need to take Dulsevia, they will first reduce the dose gradually over at least 2 weeks before stopping treatment completely. Some patients who have stopped taking Dulsevia suddenly have experienced the following symptoms: - dizziness, tingling or electric shock-like sensations (especially in the head), sleep disturbances (strange dreams, nightmares or insomnia), fatigue, drowsiness, restlessness or irritability, anxiety, nausea or vomiting, tremor (shaking), headache, muscle pain, irritability, diarrhoea, excessive sweating or dizziness. These symptoms are usually not serious and disappear within a few days, but if the symptoms are bothersome, consult your doctor. If you have any further questions about this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine may cause side effects, although not everybody gets them. These reactions are usually mild or moderate and often disappear within a few weeks. Very common side effects (affect more than 1 in 10 people) - Headache, insomnia - Feeling unwell (nausea), dry mouth Common side effects (affect less than 1 in 10 people) - Decreased appetite - Sleep disturbances, irritability, decreased libido, anxiety, anorgasmia or difficulty achieving orgasm, unusual dreams - Dizziness, lack of energy, tremor, loss of sensation, including loss of skin sensation or tingling - Blurred vision - Tinnitus (ringing in the ears in the absence of external sound) - Palpitations (feeling your heart beat) in the chest area, - Increased blood pressure, hot flushes - Increased yawning - Constipation, diarrhoea, stomach pain, feeling unwell (vomiting), heartburn or indigestion, frequent passing of gas - Excessive sweating, rash (itchy) - Muscle pain, muscle spasms - Painful urination, frequent urination - Difficulty with erection, changes in ejaculation - Falls (especially in the elderly), fatigue - Weight loss In children and adolescents under 18 years of age with depression, weight loss was observed at the start of treatment with this medicine. Weight gain was similar in children and adolescents of the same sex and age 6 months after starting treatment. Uncommon side effects (affect less than 1 in 100 people) - Inflammation of the throat, causing hoarseness - Suicidal thoughts, difficulty sleeping, teeth grinding, disorientation, lack of motivation - Muscle spasms or involuntary muscle movements, feeling of restlessness or inability to sit or stand still, nervousness, attention disturbance, taste changes, difficulty controlling movement, e.g. impaired coordination or involuntary muscle movements, restless legs syndrome, poor quality sleep - Dilated pupils (dark centre of the eye), visual disturbances - Feeling dizzy or spinning (vertigo), ear pain - Rapid and/or irregular heartbeat - Fainting, dizziness or light-headedness upon standing, feeling cold in fingers and toes - Tightness in the throat, nosebleeds - Bloody vomit or black, tarry stools, gastroenteritis, belching, difficulty swallowing - Inflammation of the liver, which may cause severe abdominal pain and yellowing of the skin or eyes - Night sweats, hives, cold sweats, sensitivity to light, increased tendency to bruise - Muscle stiffness, muscle spasms - Difficulty passing urine or retaining urine, difficulty starting to urinate, urinating at night, frequent urination, reduced urine output, - Abnormal vaginal bleeding, abnormal menstruation, including heavy, painful, irregular or prolonged periods, unusually light periods or missed menstrual periods, pain in the testicles or scrotum - Chest pain, feeling cold, thirst, chills, feeling hot, impaired gait - Weight gain - Dulsevia may cause effects that you do not notice, such as increased levels of liver enzymes or potassium, creatine kinase, sugar, or cholesterol in the blood. Rare side effects (affect less than 1 in 1000 people) - Severe allergic reactions, which may cause difficulty breathing or dizziness with 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 (especially in the elderly; symptoms include dizziness, weakness, confusion, drowsiness or severe fatigue, nausea or vomiting, or more serious symptoms such as fainting, seizures or falls), syndrome of inappropriate secretion of antidiuretic hormone (SIADH) - Suicidal behaviour, mania (a disorder with symptoms such as hyperactivity, rapid changes in mood and decreased need for sleep), hallucinations, aggression and anger - "Serotonin syndrome" (a rare reaction that can cause intense feelings of happiness, drowsiness, inflexibility, restlessness, a feeling of being "drunk", fever, sweating or muscle stiffness), seizures - Increased pressure in the eye (glaucoma) - Cough, wheezing or shortness of breath, which may be accompanied by a high temperature - Inflammation of the mouth, red blood in stools, bad breath, inflammation of the large intestine (causing diarrhoea) - Liver failure, yellowing of the skin or eyes (jaundice) - Stevens-Johnson syndrome (a severe disorder with ulcers on the skin, mouth, eyes, and genitals), a serious allergic reaction causing swelling of the face and throat (angioneurotic oedema) - Jaw muscle stiffness - Unusual smell of urine - Menopausal symptoms, pathological milk secretion in women and men. Very rare: affects less than 1 in 10,000 people - Inflammation of the blood vessels in the skin (vasculitis) Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly via the national reporting system, details of which can be found on the website of the National Agency of Medicines and Medical Devices at http://www.anm.ro/. By reporting side effects, you can help provide more information about the safety of this medicine. 5. How to store Dulsevia Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Store at a temperature not exceeding 25°C. Keep in the original packaging to protect from moisture. Do not dispose of medicines down the drain or with household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment. 6. Contents of the pack and other information What Dulsevia contains - The active substance is duloxetine. - Each capsule contains 30 mg or 60 mg of duloxetine (as hydrochloride). The other ingredients are: Capsule content: Sugar spheres (sugar, corn starch), hypromellose 6cP, sucrose, hypromellose phthalate, talc and triethyl citrate (see section 2 for more information on sucrose). Capsule shell: Gelatin, titanium dioxide (E171), indigo carmine (E132), yellow iron oxide (E172) (only in 60 mg capsules), colouring (shellac, black iron oxide (E172)). Description and contents of the pack Dulsevia is a gastro-resistant capsule. Each Dulsevia capsule contains duloxetine hydrochloride granules coated with a film, which protects them from stomach acid. Dulsevia is available in two strengths: 30 mg and 60 mg. Dulsevia 30 mg hard gelatin capsule, size 3 (length: 15.9 mm) contains white to off-white spheres. The capsule body is white and the cap is dark blue. The number 30 is printed in black on the capsule body. Dulsevia 60 mg hard gelatin capsule, size 1 (length: 19.4 mm) contains white to off-white spheres. The capsule body is yellowish-green and the cap is dark blue. The number 60 is printed in black on the capsule body. Dulsevia 30 mg packs contain 7, 10, 14, 28, 30, 56, 60, 90 and 100 capsules. Dulsevia 60 mg packs contain 7, 10, 14, 28, 30, 56, 60, 90 and 100 capsules. Not all pack sizes may be marketed. Conditions of supply Group II pharmaceutical product, dispensed with prescription form No. 3