Attributes
- Form
- Dosage mg
- Pack
- Description en
- Doxetin 30 mg gastro-resistant hard capsules Duloxetine (as hydrochloride) Read the package leaflet carefully before you start taking this medicine because it contains important information for you Keep this 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 only. Do not give it to others. It may harm them, even if their symptoms are the same as yours. If you get any side effects, or if you notice any side effects not listed in this leaflet, please tell your doctor. See section 4. Contents: 1) What Doxetin is and what it is used for 2) What you need to know before you take Doxetin 3) How to take Doxetin 4) Possible side effects 5) How to store Doxetin 6) What Doxetin contains and other information 1. What Doxetin is and what it is used for Doxetin contains the active substance duloxetine. Duloxetine increases the levels of serotonin and noradrenaline in the nervous system. Duloxetine is used in adults to treat the following conditions: Depression Generalized anxiety disorder (chronic anxiety or nervousness) Pain in diabetic neuropathy (burning, tingling, pain, electric shock-like symptoms that can cause loss of sensation in a specific area or pain caused by touch, cold, or heat). For depression or anxiety, Doxetin usually starts to work mainly two weeks after starting treatment, and in some cases 2-4 weeks. Consult your doctor if you do not feel better during this period. Even if your condition improves, your doctor may extend your treatment with Doxetin to prevent recurrence. For diabetic neuropathy with pain, the medicine may take several weeks to work. If you do not feel better within two months, consult your doctor. 2. What you need to know before you take Doxetin Do not take Doxetin if: You are allergic to duloxetine or any of the other ingredients of this medicine (listed in section 6) You have liver disease You have severe kidney disease You are taking or have taken within the last 14 days other monoamine oxidase inhibitors (MAOIs) (see "Using Doxetin with other medicines") You are taking fluvoxamine, which is mainly used to treat depression, or ciprofloxacin or enoxacin, which are used to treat various infections. You are taking other medicines containing duloxetine (see "Using Doxetin with other medicines") Consult your doctor if you have high blood pressure or heart disease. Your doctor will decide how recommended it is for you to take Doxetin. Warnings and precautions The following are cases where taking Doxetin is not recommended. Before starting treatment, consult your doctor if: You are taking other antidepressant medicines or opioids used to relieve pain or treat opioid (addiction) dependence. Taking these medicines with Doxetin may cause serotonin syndrome, a potentially life-threatening condition (see "Using Doxetin with other medicines"). You are taking the herbal preparation St. John's Wort (Hypericum perforatum) You have kidney disease You have had an epileptic seizure (convulsions) You have had mania You have bipolar disorder You have vision problems, such as glaucoma (increased pressure in the eye) You have a history of bleeding disorders (tendency to bruise easily), especially during pregnancy (see "Pregnancy and breastfeeding") There is a risk of low sodium levels in the blood (e.g., taking diuretics, especially in the elderly) You are being treated with a medicine that may damage the liver You are taking other medicines containing duloxetine (see "Using Doxetin with other medicines"). Doxetin may cause a feeling of restlessness or an inability to sit or stand still. You should inform your doctor about this. Like serotonin and norepinephrine reuptake inhibitors (SNRIs), Doxetin may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after treatment has stopped. Suicidal thoughts and worsening of depression or anxiety disorder In cases of depression and/or anxiety disorders, you may sometimes have thoughts of harming yourself or committing suicide. Such thoughts may become stronger at the beginning of antidepressant treatment, as these medicines take 2 weeks, or sometimes longer, to start working. Worsening suicidal or self-harming thoughts are most likely if: You have had thoughts of suicide or self-harm in the past You are young. Clinical studies have shown that suicide attempts are more common in young people under 25 years of age with mental disorders who are treated with antidepressants. If you have thoughts of suicide or self-harm, contact your doctor immediately or go to the nearest hospital. It will be helpful if you talk to a relative or close friend about your depression or anxiety disorder and ask them to read this leaflet. You can ask them to tell you if, in their opinion, your depression or anxiety disorder is getting worse, or if they notice any changes in your behavior. Children and adolescents under 18 years of age Doxetin is generally not prescribed for children and adolescents under 18 years of age. It is also important to know that in patients under 18 years of age, the risk of side effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, oppositional behavior, and anger) increases when taking medicines in this group. However, your doctor may prescribe Doxetin for patients under 18 years of age based on clinical need. If you have questions about prescribing Doxetin for a patient under 18 years of age, consult your doctor. If Doxetin is prescribed for a patient under 18 years of age, inform your doctor immediately if any of the mentioned symptoms appear or worsen. Furthermore, the long-term safety of Doxetin in this age group, its effect on growth, maturation, and cognitive and behavioral development, has not been established. Using Doxetin with other medicines Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. The main ingredient of Doxetin, duloxetine, is used under various trade names for different indications: For pain in diabetic neuropathy, depression, anxiety disorder, and urinary incontinence. These medicines must not be used together. Check with your doctor if you are taking other medicines containing duloxetine. Your doctor will decide if you can take Doxetin with other medicines. Do not start or stop taking medicine, including over-the-counter and herbal medicines, without consulting your doctor. Tell your doctor if you are taking any of the following medicines: Monoamine oxidase inhibitors (MAOIs): Do not take Doxetin if you are taking or have taken other monoamine oxidase inhibitors (MAOIs) within the last 14 days. MAOI group medicines include: moclobemide (antidepressant) and linezolid (antibiotic). Taking MAOIs with other medicines, including Doxetin, can cause serious or life-threatening side effects. Doxetin cannot be used for at least 14 days after stopping MAOI treatment. Also, at least 5 days must pass after stopping Doxetin before starting MAOI treatment. Medicines that cause drowsiness: This group includes prescription medicines, including benzodiazepines, strong painkillers, antipsychotics, phenobarbital, and antihistamines. Medicines that increase serotonin levels: Triptans, tryptophan, selective serotonin reuptake inhibitors (SSRIs) (such as paroxetine and fluoxetine), serotonin and norepinephrine reuptake inhibitors (SNRIs) (such as venlafaxine), tricyclic antidepressants (such as clomipramine, amitriptyline), St. John's Wort, MAOIs (e.g., moclobemide and linezolid), opioids (such as buprenorphine, tramadol, and pethidine). Drug interactions between these medicines and Doxetin can lead to events such as painful involuntary muscle spasms, including spasms of the eye muscles, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, muscle stiffness, and fever above 38°C. Contact your doctor immediately if any of these symptoms appear, as they may indicate a potentially life-threatening condition known as serotonin syndrome. Oral anticoagulants or antithrombotic agents: Medicines that thin the blood or prevent it from clotting. These medicines may increase the risk of bleeding. Taking Doxetin with food, drink, and alcohol Doxetin can be taken with or without food. Caution is advised with alcoholic beverages during treatment with Doxetin. Pregnancy and breastfeeding If you are pregnant or think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine. Inform your doctor if you become pregnant or plan to become pregnant during treatment with Doxetin. In this case, you should only take Doxetin after consulting your doctor and assessing the risk/benefit. Your doctor and/or gynecologist should be informed that you are being treated with Doxetin. Taking similar medicines (SSRIs) during pregnancy may increase the risk of a severe disorder in the newborn - persistent pulmonary hypertension of the newborn (PPHN), which is characterized by rapid breathing and blue skin in the newborn. These symptoms usually appear within the first 24 hours after birth. In such cases, consult your doctor and/or gynecologist immediately. If Doxetin is taken in the late stages of pregnancy, certain symptoms may appear in the baby. These symptoms usually appear at birth or within a few days after birth. These symptoms include muscle relaxation, tremors, restless movements, feeding problems, difficulty breathing, and seizures. If any symptoms appear at birth, consult your doctor and/or gynecologist. If Doxetin is taken in the late stages of pregnancy, the risk of severe postpartum bleeding increases, especially in patients with a history of bleeding disorders. Your doctor or gynecologist should be informed that you are taking duloxetine. Data on the use of Doxetin in the first three months of pregnancy do not indicate an increased risk of general birth defects in the child. If Doxetin is taken in the second half of pregnancy, the risk of premature birth may increase (6 fewer days of gestation per 100 women taking Doxetin in the second half of pregnancy), mainly between 35 and 36 weeks of pregnancy. Inform your doctor if you are breastfeeding. Taking Doxetin during breastfeeding is not recommended. Consult your doctor or pharmacist. Driving or operating machinery Doxetin may cause drowsiness or dizziness. Refrain from driving or operating machinery until you know how Doxetin affects you. Doxetin contains sucrose Doxetin contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicinal product. Information about sodium content This medicinal product contains less than 1 mmol of sodium (23 mg) per capsule, i.e., it is essentially "sodium-free". 3. How to take Doxetin Always take this medicine exactly as prescribed by your doctor. If you are unsure, check with your doctor. Doxetin is taken orally. Swallow the capsules whole with water. For depression and pain in diabetic neuropathy: The usual dose of Doxetin is 60 mg once a day, but your doctor will choose the appropriate dose for you. For generalized anxiety disorder: The usual starting dose of Doxetin is 30 mg once a day, followed by an increase to 60 mg once a day, but your doctor will choose the appropriate dose for you. The daily dose can be increased up to 120 mg. Try to take Doxetin at the same time every day. The duration of treatment with Doxetin will be determined by your doctor. Do not stop taking Doxetin or change the dose without consulting your doctor. Taking treatment as prescribed is important for improving your condition. Without treatment, your condition may worsen and become more difficult to treat in the future. Overdose If you take more than the prescribed dose, contact your doctor or pharmacist immediately. Symptoms of overdose may include drowsiness, coma, serotonin syndrome (a rare reaction that can cause intense happiness, drowsiness, carelessness, restlessness, feeling drunk, fever, sweating, or muscle rigidity), seizures, vomiting, and rapid heartbeat. Missed dose If you forget to take the medicine, take it as soon as you remember. If it is almost time for your next dose, wait and take it at the scheduled time. Do not take a double dose to make up for a missed dose. Do not exceed the recommended dose. Stopping treatment Do not stop taking the capsules without consulting your doctor, even if you feel better. If your doctor decides that you do not need long-term treatment, they will gradually reduce your dose over at least two weeks before stopping treatment. Some patients who stopped taking Doxetin abruptly experienced the following symptoms: Dizziness, tingling or electric shock-like sensations (especially in the head), sleep disturbances (nightmares, insomnia), fatigue, drowsiness, restlessness or agitation, anxiety, nausea or vomiting, tremor, headache, muscle pain, irritability, diarrhea, excessive sweating, or vertigo. 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 the use of 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 effects are usually mild to moderate and often disappear within a few weeks. Very common (may affect more than 1 in 10 people) Headache, drowsiness Nausea, dry mouth Common (may affect up to 1 in 10 people) Loss of appetite Insomnia, agitation, decreased libido, anxiety, anorgasmia, unusual dreams Dizziness, drowsiness, tremor, numbness, tingling sensation Blurred vision Tinnitus (ringing in the ears) Palpitations Hypertension, flushing Frequent yawning Constipation, diarrhea, abdominal pain, nausea (vomiting), heartburn or indigestion, bloating Excessive sweating, (itching) rash Muscle pain, muscle spasms Painful urination, frequent urination Erectile dysfunction, ejaculation disorders Weakness (mainly in the elderly), feeling tired Weight loss In children and adolescents under 18 years of age who were treated with this medicine, weight loss was observed at the beginning of treatment. After 6 months of treatment, weight usually normalizes. Uncommon (may affect up to 1 in 100 people) Sore throat, which causes hoarseness Suicidal thoughts, sleep disturbances, teeth grinding, disorientation, indifference Painful involuntary muscle spasms, feeling of restlessness or inability to sit or stand still, nervousness, difficulty concentrating, altered sense of taste, coordination disorders, involuntary muscle movements, restless legs syndrome, poor quality sleep Dilated pupils, visual impairment Feeling of dizziness or "spinning" (vertigo), ear pain Fast and/or irregular heartbeat Weakness, dizziness, fainting when standing up, coldness of fingers or toes Difficulty swallowing, nosebleeds Vomiting blood or black stools, gastroenteritis, belching, difficulty swallowing Inflammation of the liver, which can cause abdominal pain and yellowing of the skin or whites of the eyes Night sweats, hives, cold sweats, sensitivity to sunlight, tendency to bruise Muscle stiffness, muscle cramps Difficulty or inability to urinate, difficulty urinating, nocturia, frequent urination, passing small amounts of urine Vaginal bleeding disorders, menstrual cycle disorders, menstrual pain, heavy menstrual bleeding, testicular pain Chest pain, feeling cold, thirst, tremor, feeling hot, gait disturbance Weight gain Doxetin may cause side effects that you may not notice, for example: increased liver enzymes or levels of potassium, creatine kinase, sugar, or cholesterol in the blood. Rare (may affect up to 1 in 1,000 people) Serious allergic reaction causing difficulty breathing or dizziness, swelling of the tongue or lips, allergic reactions Decreased thyroid function, which can cause fatigue or weight gain Dehydration, low sodium levels in the blood (mainly in the elderly; symptoms include: dizziness, weakness, confusion, drowsiness or fatigue, or nausea or vomiting; more serious symptoms include: weakness, seizures, or falls), syndrome of inappropriate secretion of antidiuretic hormone (SIADH) Suicidal behavior, mania (hyperactivity, racing thoughts, and insomnia), hallucinations, aggression, and anger Serotonin syndrome (a rare reaction that can cause intense happiness, drowsiness, carelessness, restlessness, feeling drunk, fever, sweating, or muscle rigidity), seizures Increased intraocular pressure (glaucoma) Inflammation of the mouth, bloody stools, bad breath, inflammation of the large intestine (causing diarrhea) Liver failure, yellowing of the skin or whites of the eyes Stevens-Johnson syndrome (a serious condition causing blistering of the skin, especially around the mouth, eyes, and genitals), serious allergic reaction causing swelling of the face or throat (angioedema). Spasm of the chewing muscles Unusual smell of urine Menopausal symptoms, milk secretion in women and men Cough, wheezing, and shortness of breath, which may be accompanied by high fever Severe postpartum bleeding (postpartum hemorrhage) Very rare (may affect up to 1 in 10,000 people) Inflammation of subcutaneous blood vessels (vasculitis of the skin) Reporting of side effects If you notice any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system. By reporting side effects, you can help provide more information about the safety of this medicine. 5. How to store Doxetin Keep this medicine out of the reach of children. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month. 30 mg: PVC/PVDC-Alu blister: Store at a temperature not exceeding 25°C. Keep the blister in the outer carton in order to protect from light. Do not throw away 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. What Doxetin contains and other information What Doxetin contains - The active substance is duloxetine (as hydrochloride). Each capsule contains 30 mg or 60 mg of duloxetine (as hydrochloride). - The other ingredients are: Capsule content: hypromellose, talc, titanium dioxide, methacrylic acid - ethyl acrylate copolymer dispersion 30% (sodium lauryl sulfate and polysorbate 80), triethyl citrate, sugar spheres (corn starch and sucrose) and sucrose (see the last part of section 2 for more information about sucrose). Capsule shell: gelatin, titanium dioxide (E171), FD&C Blue 2/Indigo carmine (E132), printing ink (black iron oxide (E172), potassium hydroxide and shellac) and yellow iron oxide (E172) (only for 60 mg). Appearance of Doxetin and contents of the pack Doxetin is a gastro-resistant hard capsule. Each capsule of duloxetine contains duloxetine hydrochloride granules coated with a film, which protects them from stomach acid. Doxetin is available as: 30 mg 30 mg capsules are opaque blue and opaque white, size 3, printed (cap E/body 127), with whitish-cream/orange-pink spherical granules. Doxetin 30 mg is available as: PVC/PVDC-Alu blister pack containing 28 gastro-resistant hard capsules. Not all pack sizes may be marketed. Dispensing category: Pharmaceutical product group II, dispensed with prescription form №3. See also: Dulexa cap. 30mg N28
- Active
- duloxetine
What is it?
Doxetin 30 mg gastro-resistant hard capsules Duloxetine (as hydrochloride) Read the package leaflet carefully before you start taking this medicine because it contains important information for you Keep this 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 only. Do not give it to others. It may harm them, even if their symptoms are the same as yours. If you get any side effects, or if you notice any side effects not listed in this leaflet, please tell your doctor. See section 4. Contents: 1) What Doxetin is and what it is used for 2) What you need to know before you take Doxetin 3) How to take Doxetin 4) Possible side effects 5) How to store Doxetin 6) What Doxetin contains and other information 1. What Doxetin is and what it is used for Doxetin contains the active substance duloxetine. Duloxetine increases the levels of serotonin and noradrenaline in the nervous system. Duloxetine is used in adults to treat the following conditions: Depression Generalized anxiety disorder (chronic anxiety or nervousness) Pain in diabetic neuropathy (burning, tingling, pain, electric shock-like symptoms that can cause loss of sensation in a specific area or pain caused by touch, cold, or heat). For depression or anxiety, Doxetin usually starts to work mainly two weeks after starting treatment, and in some cases 2-4 weeks. Consult your doctor if you do not feel better during this period. Even if your condition improves, your doctor may extend your treatment with Doxetin to prevent recurrence. For diabetic neuropathy with pain, the medicine may take several weeks to work. If you do not feel better within two months, consult your doctor. 2. What you need to know before you take Doxetin Do not take Doxetin if: You are allergic to duloxetine or any of the other ingredients of this medicine (listed in section 6) You have liver disease You have severe kidney disease You are taking or have taken within the last 14 days other monoamine oxidase inhibitors (MAOIs) (see "Using Doxetin with other medicines") You are taking fluvoxamine, which is mainly used to treat depression, or ciprofloxacin or enoxacin, which are used to treat various infections. You are taking other medicines containing duloxetine (see "Using Doxetin with other medicines") Consult your doctor if you have high blood pressure or heart disease. Your doctor will decide how recommended it is for you to take Doxetin. Warnings and precautions The following are cases where taking Doxetin is not recommended. Before starting treatment, consult your doctor if: You are taking other antidepressant medicines or opioids used to relieve pain or treat opioid (addiction) dependence. Taking these medicines with Doxetin may cause serotonin syndrome, a potentially life-threatening condition (see "Using Doxetin with other medicines"). You are taking the herbal preparation St. John's Wort (Hypericum perforatum) You have kidney disease You have had an epileptic seizure (convulsions) You have had mania You have bipolar disorder You have vision problems, such as glaucoma (increased pressure in the eye) You have a history of bleeding disorders (tendency to bruise easily), especially during pregnancy (see "Pregnancy and breastfeeding") There is a risk of low sodium levels in the blood (e.g., taking diuretics, especially in the elderly) You are being treated with a medicine that may damage the liver You are taking other medicines containing duloxetine (see "Using Doxetin with other medicines"). Doxetin may cause a feeling of restlessness or an inability to sit or stand still. You should inform your doctor about this. Like serotonin and norepinephrine reuptake inhibitors (SNRIs), Doxetin may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after treatment has stopped. Suicidal thoughts and worsening of depression or anxiety disorder In cases of depression and/or anxiety disorders, you may sometimes have thoughts of harming yourself or committing suicide. Such thoughts may become stronger at the beginning of antidepressant treatment, as these medicines take 2 weeks, or sometimes longer, to start working. Worsening suicidal or self-harming thoughts are most likely if: You have had thoughts of suicide or self-harm in the past You are young. Clinical studies have shown that suicide attempts are more common in young people under 25 years of age with mental disorders who are treated with antidepressants. If you have thoughts of suicide or self-harm, contact your doctor immediately or go to the nearest hospital. It will be helpful if you talk to a relative or close friend about your depression or anxiety disorder and ask them to read this leaflet. You can ask them to tell you if, in their opinion, your depression or anxiety disorder is getting worse, or if they notice any changes in your behavior. Children and adolescents under 18 years of age Doxetin is generally not prescribed for children and adolescents under 18 years of age. It is also important to know that in patients under 18 years of age, the risk of side effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, oppositional behavior, and anger) increases when taking medicines in this group. However, your doctor may prescribe Doxetin for patients under 18 years of age based on clinical need. If you have questions about prescribing Doxetin for a patient under 18 years of age, consult your doctor. If Doxetin is prescribed for a patient under 18 years of age, inform your doctor immediately if any of the mentioned symptoms appear or worsen. Furthermore, the long-term safety of Doxetin in this age group, its effect on growth, maturation, and cognitive and behavioral development, has not been established. Using Doxetin with other medicines Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. The main ingredient of Doxetin, duloxetine, is used under various trade names for different indications: For pain in diabetic neuropathy, depression, anxiety disorder, and urinary incontinence. These medicines must not be used together. Check with your doctor if you are taking other medicines containing duloxetine. Your doctor will decide if you can take Doxetin with other medicines. Do not start or stop taking medicine, including over-the-counter and herbal medicines, without consulting your doctor. Tell your doctor if you are taking any of the following medicines: Monoamine oxidase inhibitors (MAOIs): Do not take Doxetin if you are taking or have taken other monoamine oxidase inhibitors (MAOIs) within the last 14 days. MAOI group medicines include: moclobemide (antidepressant) and linezolid (antibiotic). Taking MAOIs with other medicines, including Doxetin, can cause serious or life-threatening side effects. Doxetin cannot be used for at least 14 days after stopping MAOI treatment. Also, at least 5 days must pass after stopping Doxetin before starting MAOI treatment. Medicines that cause drowsiness: This group includes prescription medicines, including benzodiazepines, strong painkillers, antipsychotics, phenobarbital, and antihistamines. Medicines that increase serotonin levels: Triptans, tryptophan, selective serotonin reuptake inhibitors (SSRIs) (such as paroxetine and fluoxetine), serotonin and norepinephrine reuptake inhibitors (SNRIs) (such as venlafaxine), tricyclic antidepressants (such as clomipramine, amitriptyline), St. John's Wort, MAOIs (e.g., moclobemide and linezolid), opioids (such as buprenorphine, tramadol, and pethidine). Drug interactions between these medicines and Doxetin can lead to events such as painful involuntary muscle spasms, including spasms of the eye muscles, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, muscle stiffness, and fever above 38°C. Contact your doctor immediately if any of these symptoms appear, as they may indicate a potentially life-threatening condition known as serotonin syndrome. Oral anticoagulants or antithrombotic agents: Medicines that thin the blood or prevent it from clotting. These medicines may increase the risk of bleeding. Taking Doxetin with food, drink, and alcohol Doxetin can be taken with or without food. Caution is advised with alcoholic beverages during treatment with Doxetin. Pregnancy and breastfeeding If you are pregnant or think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine. Inform your doctor if you become pregnant or plan to become pregnant during treatment with Doxetin. In this case, you should only take Doxetin after consulting your doctor and assessing the risk/benefit. Your doctor and/or gynecologist should be informed that you are being treated with Doxetin. Taking similar medicines (SSRIs) during pregnancy may increase the risk of a severe disorder in the newborn - persistent pulmonary hypertension of the newborn (PPHN), which is characterized by rapid breathing and blue skin in the newborn. These symptoms usually appear within the first 24 hours after birth. In such cases, consult your doctor and/or gynecologist immediately. If Doxetin is taken in the late stages of pregnancy, certain symptoms may appear in the baby. These symptoms usually appear at birth or within a few days after birth. These symptoms include muscle relaxation, tremors, restless movements, feeding problems, difficulty breathing, and seizures. If any symptoms appear at birth, consult your doctor and/or gynecologist. If Doxetin is taken in the late stages of pregnancy, the risk of severe postpartum bleeding increases, especially in patients with a history of bleeding disorders. Your doctor or gynecologist should be informed that you are taking duloxetine. Data on the use of Doxetin in the first three months of pregnancy do not indicate an increased risk of general birth defects in the child. If Doxetin is taken in the second half of pregnancy, the risk of premature birth may increase (6 fewer days of gestation per 100 women taking Doxetin in the second half of pregnancy), mainly between 35 and 36 weeks of pregnancy. Inform your doctor if you are breastfeeding. Taking Doxetin during breastfeeding is not recommended. Consult your doctor or pharmacist. Driving or operating machinery Doxetin may cause drowsiness or dizziness. Refrain from driving or operating machinery until you know how Doxetin affects you. Doxetin contains sucrose Doxetin contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicinal product. Information about sodium content This medicinal product contains less than 1 mmol of sodium (23 mg) per capsule, i.e., it is essentially "sodium-free". 3. How to take Doxetin Always take this medicine exactly as prescribed by your doctor. If you are unsure, check with your doctor. Doxetin is taken orally. Swallow the capsules whole with water. For depression and pain in diabetic neuropathy: The usual dose of Doxetin is 60 mg once a day, but your doctor will choose the appropriate dose for you. For generalized anxiety disorder: The usual starting dose of Doxetin is 30 mg once a day, followed by an increase to 60 mg once a day, but your doctor will choose the appropriate dose for you. The daily dose can be increased up to 120 mg. Try to take Doxetin at the same time every day. The duration of treatment with Doxetin will be determined by your doctor. Do not stop taking Doxetin or change the dose without consulting your doctor. Taking treatment as prescribed is important for improving your condition. Without treatment, your condition may worsen and become more difficult to treat in the future. Overdose If you take more than the prescribed dose, contact your doctor or pharmacist immediately. Symptoms of overdose may include drowsiness, coma, serotonin syndrome (a rare reaction that can cause intense happiness, drowsiness, carelessness, restlessness, feeling drunk, fever, sweating, or muscle rigidity), seizures, vomiting, and rapid heartbeat. Missed dose If you forget to take the medicine, take it as soon as you remember. If it is almost time for your next dose, wait and take it at the scheduled time. Do not take a double dose to make up for a missed dose. Do not exceed the recommended dose. Stopping treatment Do not stop taking the capsules without consulting your doctor, even if you feel better. If your doctor decides that you do not need long-term treatment, they will gradually reduce your dose over at least two weeks before stopping treatment. Some patients who stopped taking Doxetin abruptly experienced the following symptoms: Dizziness, tingling or electric shock-like sensations (especially in the head), sleep disturbances (nightmares, insomnia), fatigue, drowsiness, restlessness or agitation, anxiety, nausea or vomiting, tremor, headache, muscle pain, irritability, diarrhea, excessive sweating, or vertigo. 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 the use of 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 effects are usually mild to moderate and often disappear within a few weeks. Very common (may affect more than 1 in 10 people) Headache, drowsiness Nausea, dry mouth Common (may affect up to 1 in 10 people) Loss of appetite Insomnia, agitation, decreased libido, anxiety, anorgasmia, unusual dreams Dizziness, drowsiness, tremor, numbness, tingling sensation Blurred vision Tinnitus (ringing in the ears) Palpitations Hypertension, flushing Frequent yawning Constipation, diarrhea, abdominal pain, nausea (vomiting), heartburn or indigestion, bloating Excessive sweating, (itching) rash Muscle pain, muscle spasms Painful urination, frequent urination Erectile dysfunction, ejaculation disorders Weakness (mainly in the elderly), feeling tired Weight loss In children and adolescents under 18 years of age who were treated with this medicine, weight loss was observed at the beginning of treatment. After 6 months of treatment, weight usually normalizes. Uncommon (may affect up to 1 in 100 people) Sore throat, which causes hoarseness Suicidal thoughts, sleep disturbances, teeth grinding, disorientation, indifference Painful involuntary muscle spasms, feeling of restlessness or inability to sit or stand still, nervousness, difficulty concentrating, altered sense of taste, coordination disorders, involuntary muscle movements, restless legs syndrome, poor quality sleep Dilated pupils, visual impairment Feeling of dizziness or "spinning" (vertigo), ear pain Fast and/or irregular heartbeat Weakness, dizziness, fainting when standing up, coldness of fingers or toes Difficulty swallowing, nosebleeds Vomiting blood or black stools, gastroenteritis, belching, difficulty swallowing Inflammation of the liver, which can cause abdominal pain and yellowing of the skin or whites of the eyes Night sweats, hives, cold sweats, sensitivity to sunlight, tendency to bruise Muscle stiffness, muscle cramps Difficulty or inability to urinate, difficulty urinating, nocturia, frequent urination, passing small amounts of urine Vaginal bleeding disorders, menstrual cycle disorders, menstrual pain, heavy menstrual bleeding, testicular pain Chest pain, feeling cold, thirst, tremor, feeling hot, gait disturbance Weight gain Doxetin may cause side effects that you may not notice, for example: increased liver enzymes or levels of potassium, creatine kinase, sugar, or cholesterol in the blood. Rare (may affect up to 1 in 1,000 people) Serious allergic reaction causing difficulty breathing or dizziness, swelling of the tongue or lips, allergic reactions Decreased thyroid function, which can cause fatigue or weight gain Dehydration, low sodium levels in the blood (mainly in the elderly; symptoms include: dizziness, weakness, confusion, drowsiness or fatigue, or nausea or vomiting; more serious symptoms include: weakness, seizures, or falls), syndrome of inappropriate secretion of antidiuretic hormone (SIADH) Suicidal behavior, mania (hyperactivity, racing thoughts, and insomnia), hallucinations, aggression, and anger Serotonin syndrome (a rare reaction that can cause intense happiness, drowsiness, carelessness, restlessness, feeling drunk, fever, sweating, or muscle rigidity), seizures Increased intraocular pressure (glaucoma) Inflammation of the mouth, bloody stools, bad breath, inflammation of the large intestine (causing diarrhea) Liver failure, yellowing of the skin or whites of the eyes Stevens-Johnson syndrome (a serious condition causing blistering of the skin, especially around the mouth, eyes, and genitals), serious allergic reaction causing swelling of the face or throat (angioedema). Spasm of the chewing muscles Unusual smell of urine Menopausal symptoms, milk secretion in women and men Cough, wheezing, and shortness of breath, which may be accompanied by high fever Severe postpartum bleeding (postpartum hemorrhage) Very rare (may affect up to 1 in 10,000 people) Inflammation of subcutaneous blood vessels (vasculitis of the skin) Reporting of side effects If you notice any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system. By reporting side effects, you can help provide more information about the safety of this medicine. 5. How to store Doxetin Keep this medicine out of the reach of children. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month. 30 mg: PVC/PVDC-Alu blister: Store at a temperature not exceeding 25°C. Keep the blister in the outer carton in order to protect from light. Do not throw away 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. What Doxetin contains and other information What Doxetin contains - The active substance is duloxetine (as hydrochloride). Each capsule contains 30 mg or 60 mg of duloxetine (as hydrochloride). - The other ingredients are: Capsule content: hypromellose, talc, titanium dioxide, methacrylic acid - ethyl acrylate copolymer dispersion 30% (sodium lauryl sulfate and polysorbate 80), triethyl citrate, sugar spheres (corn starch and sucrose) and sucrose (see the last part of section 2 for more information about sucrose). Capsule shell: gelatin, titanium dioxide (E171), FD&C Blue 2/Indigo carmine (E132), printing ink (black iron oxide (E172), potassium hydroxide and shellac) and yellow iron oxide (E172) (only for 60 mg). Appearance of Doxetin and contents of the pack Doxetin is a gastro-resistant hard capsule. Each capsule of duloxetine contains duloxetine hydrochloride granules coated with a film, which protects them from stomach acid. Doxetin is available as: 30 mg 30 mg capsules are opaque blue and opaque white, size 3, printed (cap E/body 127), with whitish-cream/orange-pink spherical granules. Doxetin 30 mg is available as: PVC/PVDC-Alu blister pack containing 28 gastro-resistant hard capsules. Not all pack sizes may be marketed. Dispensing category: Pharmaceutical product group II, dispensed with prescription form №3. See also: Dulexa cap. 30mg N28