Attributes
- Form
- Dosage mg
- Pack
- Description en
- Atex 10mg Capsules are taken orally Drug substance: Atomoxetine Each capsule contains 10mg of atomoxetine equivalent to atomoxetine hydrochloride. Excipients: Pregelatinized starch, Pregelatinized starch 1500, Colloidal anhydrous silica, Dimethicone, Gelatin (bovine gelatin), Titanium dioxide (E171) 1. What is Atex and what is it used for? Atex 10 mg capsules are hard gelatin capsules with an opaque white body and an opaque white cap, containing a white or off-white powder. Each box contains 28 capsules. Atex is a medicine containing the drug substance called atomoxetine, it increases the amount of noradrenaline in the brain and is used in children over 6 years of age, adolescents and adults, to treat Attention Deficit Hyperactivity Disorder (ADHD). It is used as part of a more complex treatment for this condition, as well as free treatment from other medicines such as consultation and behavioral therapy. Atex should not be used to treat ADHD in children, as it is unknown if it acts safely in children under 6 years of age. Atex is used to treat ADHD in adults who have very disturbing symptoms, such as symptoms of childhood life that affect work or social life. Noradrenaline is a natural chemical in the brain that increases attention in patients with ADHD and reduces unnecessary mobility and hyperactivity. This medicine is prescribed to control ADHD symptoms. Atex is not a stimulant and is not addictive. Once you start using the drug, it may take several weeks for your symptoms to fully recover. In children and adolescents with ADHD, it is difficult to sit still and difficult to control attention. Such behavior is not the fault of the patients. Children and adolescents try, but when they have ADHD, they can cause problems in everyday life. Children and adolescents with ADHD may have difficulty learning and doing homework. They have difficulty behaving well at home, at school, or elsewhere. ADHD does not affect the intellectual ability of children or adolescents. Adults with ADHD have difficulty doing everything that children find difficult, but this means they have problems with work, relationships, low self-esteem, and learning. 2. Before taking Atex Do not use Atex in the following conditions if: • You are allergic to atomoxetine or any of the other ingredients of Atex (if you have hypersensitivity). • You have used monoamine oxidase inhibitors (MAOIs), such as phenelzine, in the last two weeks. MAOIs are sometimes used for depression (mental depression) and other mental health problems. Using Atex with MAOIs can cause serious or life-threatening side effects (you can start using MAOIs at least 14 days after stopping Atex). • You have an eye disease called glaucoma (narrow-angle glaucoma). • You have heart disease (cardiovascular), or if you have moderate or severe blood pressure, or if you have severe heart disease (cardiovascular) disorders that may be affected by an increase in heart rate (pulse) and/or blood pressure (Atex causes an increase in heart rate and/or blood pressure). • There are any problems with the blood vessels in your brain - for example, stroke, swelling and thinning (aneurysm) of a part of the blood vessel, or narrowing or blockage of blood vessels. • You have an adrenal gland tumor (pheochromocytoma) If any of the above applies to you, do not use Atex. If you are not sure, consult your doctor or pharmacist before using Atex, as Atex can worsen these problems. Use Atex with caution in the following cases if: • You have suicidal thoughts or attempts at suicide. • Your heart problems (including heart disease) or your heart rate increases. Atex can increase your heart rate (pulse rate). Sudden death has been reported in patients with heart disorders. • You have high blood pressure. Atex can increase blood pressure. • You have low blood pressure. Atex can cause dizziness and syncope in patients with low blood pressure. • You have blood pressure problems or sudden changes in heart rate (pulse). • You have cardiovascular disease or if you have had a stroke before. • You have liver problems (you may need a lower dose). • You have high blood pressure, rapid heart rate, or heart disease (cardiovascular) or cerebrovascular disease that may be worsened by increased blood pressure or increased heart rate. • You have psychotic (schizophrenia-like) symptoms, which include hearing voices or seeing unpleasant things (hallucinations = ghosts), believing in things that are not real or being suspicious. • You are happy or overly excited (mania) and feel uncomfortable, which can lead to abnormal behaviors. • You have aggressive feelings. • You have unfriendly and angry (hostile) feelings. • You have had seizures (epilepsy) or convulsions in the past (Atex may increase the frequency of seizures). • You have abnormal feelings (sudden emotional changes) or feel very unhappy. • You have difficulty with control, have repetitive muscle spasms in any part of your body, or if you repeat sounds and words. Consult your doctor before using Atex. Please inform your doctor or pharmacist before starting treatment. Atex can worsen these problems. Your doctor will want to monitor how the drug affects you. Your doctor will ask you to check your blood and heart rate (pulse rate) before starting Atex and during the period you are taking Atex, and if you are using it in children or adolescents, your doctor will ask you to measure height and weight. The purpose of these checks is to determine if Atex is the right medicine for you. Your doctor will also talk to you about: • All other medications you are using. • Whether there has been a sudden unexplained death in your family in the past. • Any other medical problems you or your family may have (such as heart problems). It is important that you provide as much information as possible. This information will help your doctor decide if Atex is the right medicine for you. Your doctor may decide that other medical tests are needed before using this medication. Using Atex with food and drink Atex can be taken on an empty stomach or after a meal. Pregnancy Consult your doctor or pharmacist before using this medicine. • If you think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using Atex. • Atex should not be used during pregnancy unless recommended by your doctor. If you notice that you are pregnant during treatment, contact your doctor or pharmacist immediately. Lactation Consult your doctor or pharmacist before using this medicine. It is unknown whether Atex is excreted in breast milk or in the baby's body during pregnancy. For this reason, Atex should not be used if you are breastfeeding or should stop breastfeeding. Driving and operating machinery After using Atex, you may feel tired, sleepy, or dizzy. You should be careful when driving or operating any machinery until you are sure how Atex affects you. If you feel tired, sleepy, or dizzy, do not drive or operate machinery. Important information about some of the excipients of Atex Atex capsules should not be opened, as the contents of the capsule may cause eye irritation. If a capsule is opened and the powder comes into contact with the eyes, the affected eye should be washed immediately with water and you should consult a doctor. Hands that touch the contents of the capsule and other parts of the body should be washed immediately. Use with other medicines If you are currently using or have recently used any prescription or over-the-counter medication, please tell your doctor or pharmacist. This includes over-the-counter medications. Your doctor will decide if you can use Atex with your other medications, and in some cases your doctor may need to adjust the dose of your medication or increase the dose more slowly. Atex should not be used with drugs called MAOIs. See the section "Do not use Atex in the following conditions". If you are using other medications, Atex may affect the treatment with those medications or cause side effects. If you are using any of the medications listed below, consult your doctor or pharmacist before using Atex. • Medications that increase blood pressure or control blood pressure. • Antidepressants (used to treat depression) such as imipramine, venlafaxine, mirtazapine, fluoxetine, and paroxetine. • Some cough and cold medicines that contain substances that affect blood pressure. It is important to consult your pharmacist when purchasing any of these products. • Some medications used in the treatment of mental health. • Drugs known to increase the risk of seizures. • Some medications (such as quinidine and terbinafine) that cause Atex to stay in the body longer than normal. • When salbutamol, used to treat asthma, is taken orally or by injection, you may feel your heart beating faster, but this will worsen your asthma. The following medications, when used with Atex, may increase the risk of developing abnormal heart rhythm: • Medications used to control heart rhythm. • Medications that alter salt concentration in the blood. • Medications used for malaria prevention and treatment. • Some antibiotics (such as erythromycin and moxifloxacin). If you are not sure if you are taking any of the medications listed above, consult your doctor or pharmacist before using Atex. 3. How is Atex taken? Instructions for proper use and dosage/frequency of administration: • Always use Atex as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist. It is usually taken as 1 or 2 capsules in the morning and in the afternoon after lunch or late afternoon. • After you have been using Atex once a day and feel sleepy or unwell, your doctor may change your prescribed medication to twice a day. Children over 6 years of age and adolescents: Your doctor will tell you how much Atex to use based on your weight. Your doctor will usually start treatment with a lower dose, before increasing the dose of Atex according to the instructions below: • In patients with a body weight of up to 70 kg: Atex should be started at a total daily dose of approximately 0.5 mg/kg body weight and should be continued for at least 7 days. After this, the doctor may increase it to a maintenance dose of approximately 1.2 mg/kg body weight per day. • In patients with a body weight of more than 70 kg: Atex should be started at a daily dose of 40 mg and this dose should be continued for at least 7 days. After this, your doctor can increase it to a daily maintenance dose of 80 mg. The highest dose your doctor may prescribe daily is 100 mg. Adults • Atex should be started at a total dose of 40 mg per day for at least 7 days. Then your doctor can increase it to a normal maintenance dose of 80-100 mg per day. The highest dose your doctor may prescribe daily is 100 mg. If you have liver problems, your doctor may prescribe your medicine at a lower dose. Route and method of administration: • Atex is intended for oral administration. • Children should not use this medicine without the help of an adult. • Swallow your capsule whole with water. • Atex can be taken on an empty stomach or after a meal. • Taking Atex capsules at the same time every day will help you remember when you are taking this medicine. Different age groups: Use in children under 6 years of age: Atex should not be used in children under 6 years of age. Geriatric use: No adequate data. Special conditions of use: Renal insufficiency: No adequate data. Hepatic insufficiency: If you have liver problems, your doctor may prescribe your medicine at a lower dose. Your doctor will tell you how long Atex treatment will last. Do not stop treatment prematurely. If you have the impression that the effect of Atex is either too strong or too weak, consult your doctor or pharmacist. If you take more Atex than you should: If you have used more Atex than you should, consult your doctor or pharmacist. Or inform the nearest hospital how many capsules you have taken, contact through the emergency department. The most common symptoms observed in overdose are gastrointestinal symptoms, drowsiness, dizziness, tremor, and abnormal behavior. If you forget to take Atex If you miss a dose, take the missed dose immediately; but you should not take more than the recommended daily dose within 24 hours. Do not take double doses to compensate for missed doses. Possible effects when stopping Atex treatment If you stop taking Atex, you will usually not have adverse effects, but your ADHD symptoms may return. Talk to your doctor before stopping treatment. Tests that the doctor should perform during your treatment • Before starting treatment: Ensure that Atex is safe and will benefit you. • After starting treatment: Tests will be performed at least every 6 months, but possibly more often. The same tests will be performed when changing the dose. These tests are: • Measurement of height and weight of children and adolescents. • Measurement of blood pressure and heart rate. • Checking for worsening of side effects when using Atex, or if any problems develop during long-term treatment. Long-term treatment: Continuous use of Atex is not necessary. If you have been using Atex for more than a year, your doctor will review your treatment to determine if the medicine is still needed. If you have any additional questions about the use of this product, consult your doctor or pharmacist. 4. Possible side effects Side effects can occur in people who are sensitive to the components of Atex, as with all medicines. For some people, due to adverse effects, most users think that Atex helps them. Your doctor will provide you with information about these side effects. Some side effects can be serious. If you notice any of the side effects listed below, consult your doctor immediately. Uncommon effects (occur in less than 1 in 100 patients): • Very fast heartbeat or feeling of abnormal heart rhythm. • Suicidal thoughts or suicide attempts. • Aggression. • Unfriendly and angry (hostile) feelings. • Emotional lability or variability. • Severe allergic reaction with the following symptoms - swelling of the face and throat - difficulty breathing - hives (swollen, itchy rash on the skin). • Seizures. • Psychotic reactions, such as believing in things that are not true or being suspicious, hallucinations, such as hearing voices or seeing things that do not exist. In children and adolescents under 18 years of age, the risk of the following side effects increases: • Suicidal thoughts or suicide (may occur in less than 1 in 100 patients). • Emotional lability (may affect less than 1 in 10 patients). In adults, the risk of side effects such as the following decreases (may occur in less than 1 in 1000 patients): • Seizures. • Hearing voices or seeing things that do not exist (hallucinations); psychotic symptoms, including believing in things that are not true or skepticism. Rare (may occur in less than 1 in 1000 patients): • Liver damage. If you notice any of the following situations, inform your doctor immediately or go to the emergency department of the nearest hospital: • Darkening of urine. • Yellowing of the whites of the eyes and skin. • Abdominal pain (tenderness) when pressing on the right side of the ribs with your hand. • Unexplained nausea. • Fatigue. • Itching. • Feeling of depression with flu-like symptoms. Other reported side effects include: If these effects become serious, please inform your doctor or pharmacist. Very common side effects (may occur in more than 1 in 10 patients) Side effects observed in children over 6 years of age and adolescents: • Headache. • Abdominal pain. • Loss of appetite (lack of feeling of hunger). • Nausea. • Vomiting. • Drowsiness. • Increased blood pressure. • Increased heart rate (faster pulse). In most patients, these events disappear after a short time. Adults: • Nausea. • Dry mouth. • Headache. • Loss of appetite (lack of feeling of hunger). • Drowsiness, falling asleep, difficulty waking up early in the morning. • Increased blood pressure. • Increased heart rate (faster pulse). Common side effects (may occur in less than 1 in 10 patients) Side effects mentioned in children over 6 years of age and adolescents: • Nervousness or tension. • Drowsiness, including problems waking up early in the morning. • Depression. • Feeling of sadness or despair. • Anxiety. • Tics. • Dilated pupils (dark center of the eye). • Dizziness. • Constipation. • Loss of appetite. • Stomach upset, indigestion. • Swelling, redness, and itching of the skin. • Rash. • Weakness (lethargy). • Fatigue. • Chest pain. • Weight loss. Adults: • Tension. • Decreased sexual interest. • Sleep disturbances. • Depression. • Feeling of sadness or despair. • Anxiety. • Dizziness. • Abnormal taste or change in taste. • Tremor. • Tingling or numbness in hands and feet. • Drowsiness, numbness, fatigue. • Constipation. • Stomach pain. • Indigestion. • Abdominal bloating due to gas. • Vomiting. • Flushing or redness of the skin. • Very fast heartbeat or feeling. • Swelling, redness, and itching of the skin. • Increased sweating. • Rash. • Inability to urinate, frequent urination or intermittent urination, pain during urination. • Inflammation of the prostate gland (prostatitis). • Groin pain in men. • Inability to achieve an erection. • Delayed orgasm. • Difficulty maintaining an erection. • Menstrual cramps. • Lack of strength or energy. • Fatigue. • Lethargy. • Feeling of cold. • Nervousness, tension. • Feeling of thirst. • Weight loss. Uncommon side effects (may occur in less than 1 in 100 patients) In children over 6 years of age and adolescents: • Fatigue. • Tremor. • Migraine. • Blurred vision. • Abnormal sensations, such as burning in the digestive tract, numbness, itching, or tingling. • Tingling or numbness in hands and feet. • Seizures. • Very fast heartbeat or feeling. • Shortness of breath. • Increased sweating. • Itching of the skin. • Lack of strength or energy. Adults: • Restlessness. • Tics. • Fatigue. • Migraine. • Blurred vision. • Abnormal heart rhythm. • Coldness in hands and fingers. • Chest pain. • Shortness of breath. • Swollen, red, itchy rash (hives). • Muscle spasms. • Reduced urination. • Abnormal orgasm or anorgasmia. • Irregular menstruation. • Inability to ejaculate. Rare side effects (may occur in less than 1 in 1000 patients) In children and adolescents over 6 years of age: • Poor blood circulation, causing numbness and pale color of fingers and toes (Raynaud's disease). • Urinary problems, such as frequent urination or intermittent urination, pain during urination. • Prolonged erection or painful erection. • Groin pain in men. Adults: • Poor blood circulation, causing numbness and pale color of fingers and toes (Raynaud's disease). • Prolonged erection or painful erection. Effect on growth: When using Atex, some children experience growth retardation (height and weight). However, with long-term treatment, children's height and weight return to normal levels for their age. Your doctor will monitor your child's height and weight over time. If your child is not gaining weight or growing as expected, the doctor may adjust your child's dose or decide to temporarily stop treatment with Atex. If you notice a side effect that is not described in this leaflet, inform your doctor or pharmacist. Reporting side effects If you have any side effects, listed or not listed in these instructions for use, consult your doctor, pharmacist, or nurse. By reporting side effects, you can help provide more information about the safety of this medicine. 5. How is Atex stored? Store Atex in its original packaging and out of reach and sight of children. Store below 25ºC. Use according to the expiry date. Do not use Atex after the expiry date indicated on the packaging. If you notice a defect in the product and/or packaging, do not use Atex. For environmental protection, do not dispose of unused Atex in running water or in the trash. Please consult your pharmacist regarding this.
- Active
- atomoxetin
What is it?
Atex 10mg Capsules are taken orally Drug substance: Atomoxetine Each capsule contains 10mg of atomoxetine equivalent to atomoxetine hydrochloride. Excipients: Pregelatinized starch, Pregelatinized starch 1500, Colloidal anhydrous silica, Dimethicone, Gelatin (bovine gelatin), Titanium dioxide (E171) 1. What is Atex and what is it used for? Atex 10 mg capsules are hard gelatin capsules with an opaque white body and an opaque white cap, containing a white or off-white powder. Each box contains 28 capsules. Atex is a medicine containing the drug substance called atomoxetine, it increases the amount of noradrenaline in the brain and is used in children over 6 years of age, adolescents and adults, to treat Attention Deficit Hyperactivity Disorder (ADHD). It is used as part of a more complex treatment for this condition, as well as free treatment from other medicines such as consultation and behavioral therapy. Atex should not be used to treat ADHD in children, as it is unknown if it acts safely in children under 6 years of age. Atex is used to treat ADHD in adults who have very disturbing symptoms, such as symptoms of childhood life that affect work or social life. Noradrenaline is a natural chemical in the brain that increases attention in patients with ADHD and reduces unnecessary mobility and hyperactivity. This medicine is prescribed to control ADHD symptoms. Atex is not a stimulant and is not addictive. Once you start using the drug, it may take several weeks for your symptoms to fully recover. In children and adolescents with ADHD, it is difficult to sit still and difficult to control attention. Such behavior is not the fault of the patients. Children and adolescents try, but when they have ADHD, they can cause problems in everyday life. Children and adolescents with ADHD may have difficulty learning and doing homework. They have difficulty behaving well at home, at school, or elsewhere. ADHD does not affect the intellectual ability of children or adolescents. Adults with ADHD have difficulty doing everything that children find difficult, but this means they have problems with work, relationships, low self-esteem, and learning. 2. Before taking Atex Do not use Atex in the following conditions if: • You are allergic to atomoxetine or any of the other ingredients of Atex (if you have hypersensitivity). • You have used monoamine oxidase inhibitors (MAOIs), such as phenelzine, in the last two weeks. MAOIs are sometimes used for depression (mental depression) and other mental health problems. Using Atex with MAOIs can cause serious or life-threatening side effects (you can start using MAOIs at least 14 days after stopping Atex). • You have an eye disease called glaucoma (narrow-angle glaucoma). • You have heart disease (cardiovascular), or if you have moderate or severe blood pressure, or if you have severe heart disease (cardiovascular) disorders that may be affected by an increase in heart rate (pulse) and/or blood pressure (Atex causes an increase in heart rate and/or blood pressure). • There are any problems with the blood vessels in your brain - for example, stroke, swelling and thinning (aneurysm) of a part of the blood vessel, or narrowing or blockage of blood vessels. • You have an adrenal gland tumor (pheochromocytoma) If any of the above applies to you, do not use Atex. If you are not sure, consult your doctor or pharmacist before using Atex, as Atex can worsen these problems. Use Atex with caution in the following cases if: • You have suicidal thoughts or attempts at suicide. • Your heart problems (including heart disease) or your heart rate increases. Atex can increase your heart rate (pulse rate). Sudden death has been reported in patients with heart disorders. • You have high blood pressure. Atex can increase blood pressure. • You have low blood pressure. Atex can cause dizziness and syncope in patients with low blood pressure. • You have blood pressure problems or sudden changes in heart rate (pulse). • You have cardiovascular disease or if you have had a stroke before. • You have liver problems (you may need a lower dose). • You have high blood pressure, rapid heart rate, or heart disease (cardiovascular) or cerebrovascular disease that may be worsened by increased blood pressure or increased heart rate. • You have psychotic (schizophrenia-like) symptoms, which include hearing voices or seeing unpleasant things (hallucinations = ghosts), believing in things that are not real or being suspicious. • You are happy or overly excited (mania) and feel uncomfortable, which can lead to abnormal behaviors. • You have aggressive feelings. • You have unfriendly and angry (hostile) feelings. • You have had seizures (epilepsy) or convulsions in the past (Atex may increase the frequency of seizures). • You have abnormal feelings (sudden emotional changes) or feel very unhappy. • You have difficulty with control, have repetitive muscle spasms in any part of your body, or if you repeat sounds and words. Consult your doctor before using Atex. Please inform your doctor or pharmacist before starting treatment. Atex can worsen these problems. Your doctor will want to monitor how the drug affects you. Your doctor will ask you to check your blood and heart rate (pulse rate) before starting Atex and during the period you are taking Atex, and if you are using it in children or adolescents, your doctor will ask you to measure height and weight. The purpose of these checks is to determine if Atex is the right medicine for you. Your doctor will also talk to you about: • All other medications you are using. • Whether there has been a sudden unexplained death in your family in the past. • Any other medical problems you or your family may have (such as heart problems). It is important that you provide as much information as possible. This information will help your doctor decide if Atex is the right medicine for you. Your doctor may decide that other medical tests are needed before using this medication. Using Atex with food and drink Atex can be taken on an empty stomach or after a meal. Pregnancy Consult your doctor or pharmacist before using this medicine. • If you think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using Atex. • Atex should not be used during pregnancy unless recommended by your doctor. If you notice that you are pregnant during treatment, contact your doctor or pharmacist immediately. Lactation Consult your doctor or pharmacist before using this medicine. It is unknown whether Atex is excreted in breast milk or in the baby's body during pregnancy. For this reason, Atex should not be used if you are breastfeeding or should stop breastfeeding. Driving and operating machinery After using Atex, you may feel tired, sleepy, or dizzy. You should be careful when driving or operating any machinery until you are sure how Atex affects you. If you feel tired, sleepy, or dizzy, do not drive or operate machinery. Important information about some of the excipients of Atex Atex capsules should not be opened, as the contents of the capsule may cause eye irritation. If a capsule is opened and the powder comes into contact with the eyes, the affected eye should be washed immediately with water and you should consult a doctor. Hands that touch the contents of the capsule and other parts of the body should be washed immediately. Use with other medicines If you are currently using or have recently used any prescription or over-the-counter medication, please tell your doctor or pharmacist. This includes over-the-counter medications. Your doctor will decide if you can use Atex with your other medications, and in some cases your doctor may need to adjust the dose of your medication or increase the dose more slowly. Atex should not be used with drugs called MAOIs. See the section "Do not use Atex in the following conditions". If you are using other medications, Atex may affect the treatment with those medications or cause side effects. If you are using any of the medications listed below, consult your doctor or pharmacist before using Atex. • Medications that increase blood pressure or control blood pressure. • Antidepressants (used to treat depression) such as imipramine, venlafaxine, mirtazapine, fluoxetine, and paroxetine. • Some cough and cold medicines that contain substances that affect blood pressure. It is important to consult your pharmacist when purchasing any of these products. • Some medications used in the treatment of mental health. • Drugs known to increase the risk of seizures. • Some medications (such as quinidine and terbinafine) that cause Atex to stay in the body longer than normal. • When salbutamol, used to treat asthma, is taken orally or by injection, you may feel your heart beating faster, but this will worsen your asthma. The following medications, when used with Atex, may increase the risk of developing abnormal heart rhythm: • Medications used to control heart rhythm. • Medications that alter salt concentration in the blood. • Medications used for malaria prevention and treatment. • Some antibiotics (such as erythromycin and moxifloxacin). If you are not sure if you are taking any of the medications listed above, consult your doctor or pharmacist before using Atex. 3. How is Atex taken? Instructions for proper use and dosage/frequency of administration: • Always use Atex as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist. It is usually taken as 1 or 2 capsules in the morning and in the afternoon after lunch or late afternoon. • After you have been using Atex once a day and feel sleepy or unwell, your doctor may change your prescribed medication to twice a day. Children over 6 years of age and adolescents: Your doctor will tell you how much Atex to use based on your weight. Your doctor will usually start treatment with a lower dose, before increasing the dose of Atex according to the instructions below: • In patients with a body weight of up to 70 kg: Atex should be started at a total daily dose of approximately 0.5 mg/kg body weight and should be continued for at least 7 days. After this, the doctor may increase it to a maintenance dose of approximately 1.2 mg/kg body weight per day. • In patients with a body weight of more than 70 kg: Atex should be started at a daily dose of 40 mg and this dose should be continued for at least 7 days. After this, your doctor can increase it to a daily maintenance dose of 80 mg. The highest dose your doctor may prescribe daily is 100 mg. Adults • Atex should be started at a total dose of 40 mg per day for at least 7 days. Then your doctor can increase it to a normal maintenance dose of 80-100 mg per day. The highest dose your doctor may prescribe daily is 100 mg. If you have liver problems, your doctor may prescribe your medicine at a lower dose. Route and method of administration: • Atex is intended for oral administration. • Children should not use this medicine without the help of an adult. • Swallow your capsule whole with water. • Atex can be taken on an empty stomach or after a meal. • Taking Atex capsules at the same time every day will help you remember when you are taking this medicine. Different age groups: Use in children under 6 years of age: Atex should not be used in children under 6 years of age. Geriatric use: No adequate data. Special conditions of use: Renal insufficiency: No adequate data. Hepatic insufficiency: If you have liver problems, your doctor may prescribe your medicine at a lower dose. Your doctor will tell you how long Atex treatment will last. Do not stop treatment prematurely. If you have the impression that the effect of Atex is either too strong or too weak, consult your doctor or pharmacist. If you take more Atex than you should: If you have used more Atex than you should, consult your doctor or pharmacist. Or inform the nearest hospital how many capsules you have taken, contact through the emergency department. The most common symptoms observed in overdose are gastrointestinal symptoms, drowsiness, dizziness, tremor, and abnormal behavior. If you forget to take Atex If you miss a dose, take the missed dose immediately; but you should not take more than the recommended daily dose within 24 hours. Do not take double doses to compensate for missed doses. Possible effects when stopping Atex treatment If you stop taking Atex, you will usually not have adverse effects, but your ADHD symptoms may return. Talk to your doctor before stopping treatment. Tests that the doctor should perform during your treatment • Before starting treatment: Ensure that Atex is safe and will benefit you. • After starting treatment: Tests will be performed at least every 6 months, but possibly more often. The same tests will be performed when changing the dose. These tests are: • Measurement of height and weight of children and adolescents. • Measurement of blood pressure and heart rate. • Checking for worsening of side effects when using Atex, or if any problems develop during long-term treatment. Long-term treatment: Continuous use of Atex is not necessary. If you have been using Atex for more than a year, your doctor will review your treatment to determine if the medicine is still needed. If you have any additional questions about the use of this product, consult your doctor or pharmacist. 4. Possible side effects Side effects can occur in people who are sensitive to the components of Atex, as with all medicines. For some people, due to adverse effects, most users think that Atex helps them. Your doctor will provide you with information about these side effects. Some side effects can be serious. If you notice any of the side effects listed below, consult your doctor immediately. Uncommon effects (occur in less than 1 in 100 patients): • Very fast heartbeat or feeling of abnormal heart rhythm. • Suicidal thoughts or suicide attempts. • Aggression. • Unfriendly and angry (hostile) feelings. • Emotional lability or variability. • Severe allergic reaction with the following symptoms - swelling of the face and throat - difficulty breathing - hives (swollen, itchy rash on the skin). • Seizures. • Psychotic reactions, such as believing in things that are not true or being suspicious, hallucinations, such as hearing voices or seeing things that do not exist. In children and adolescents under 18 years of age, the risk of the following side effects increases: • Suicidal thoughts or suicide (may occur in less than 1 in 100 patients). • Emotional lability (may affect less than 1 in 10 patients). In adults, the risk of side effects such as the following decreases (may occur in less than 1 in 1000 patients): • Seizures. • Hearing voices or seeing things that do not exist (hallucinations); psychotic symptoms, including believing in things that are not true or skepticism. Rare (may occur in less than 1 in 1000 patients): • Liver damage. If you notice any of the following situations, inform your doctor immediately or go to the emergency department of the nearest hospital: • Darkening of urine. • Yellowing of the whites of the eyes and skin. • Abdominal pain (tenderness) when pressing on the right side of the ribs with your hand. • Unexplained nausea. • Fatigue. • Itching. • Feeling of depression with flu-like symptoms. Other reported side effects include: If these effects become serious, please inform your doctor or pharmacist. Very common side effects (may occur in more than 1 in 10 patients) Side effects observed in children over 6 years of age and adolescents: • Headache. • Abdominal pain. • Loss of appetite (lack of feeling of hunger). • Nausea. • Vomiting. • Drowsiness. • Increased blood pressure. • Increased heart rate (faster pulse). In most patients, these events disappear after a short time. Adults: • Nausea. • Dry mouth. • Headache. • Loss of appetite (lack of feeling of hunger). • Drowsiness, falling asleep, difficulty waking up early in the morning. • Increased blood pressure. • Increased heart rate (faster pulse). Common side effects (may occur in less than 1 in 10 patients) Side effects mentioned in children over 6 years of age and adolescents: • Nervousness or tension. • Drowsiness, including problems waking up early in the morning. • Depression. • Feeling of sadness or despair. • Anxiety. • Tics. • Dilated pupils (dark center of the eye). • Dizziness. • Constipation. • Loss of appetite. • Stomach upset, indigestion. • Swelling, redness, and itching of the skin. • Rash. • Weakness (lethargy). • Fatigue. • Chest pain. • Weight loss. Adults: • Tension. • Decreased sexual interest. • Sleep disturbances. • Depression. • Feeling of sadness or despair. • Anxiety. • Dizziness. • Abnormal taste or change in taste. • Tremor. • Tingling or numbness in hands and feet. • Drowsiness, numbness, fatigue. • Constipation. • Stomach pain. • Indigestion. • Abdominal bloating due to gas. • Vomiting. • Flushing or redness of the skin. • Very fast heartbeat or feeling. • Swelling, redness, and itching of the skin. • Increased sweating. • Rash. • Inability to urinate, frequent urination or intermittent urination, pain during urination. • Inflammation of the prostate gland (prostatitis). • Groin pain in men. • Inability to achieve an erection. • Delayed orgasm. • Difficulty maintaining an erection. • Menstrual cramps. • Lack of strength or energy. • Fatigue. • Lethargy. • Feeling of cold. • Nervousness, tension. • Feeling of thirst. • Weight loss. Uncommon side effects (may occur in less than 1 in 100 patients) In children over 6 years of age and adolescents: • Fatigue. • Tremor. • Migraine. • Blurred vision. • Abnormal sensations, such as burning in the digestive tract, numbness, itching, or tingling. • Tingling or numbness in hands and feet. • Seizures. • Very fast heartbeat or feeling. • Shortness of breath. • Increased sweating. • Itching of the skin. • Lack of strength or energy. Adults: • Restlessness. • Tics. • Fatigue. • Migraine. • Blurred vision. • Abnormal heart rhythm. • Coldness in hands and fingers. • Chest pain. • Shortness of breath. • Swollen, red, itchy rash (hives). • Muscle spasms. • Reduced urination. • Abnormal orgasm or anorgasmia. • Irregular menstruation. • Inability to ejaculate. Rare side effects (may occur in less than 1 in 1000 patients) In children and adolescents over 6 years of age: • Poor blood circulation, causing numbness and pale color of fingers and toes (Raynaud's disease). • Urinary problems, such as frequent urination or intermittent urination, pain during urination. • Prolonged erection or painful erection. • Groin pain in men. Adults: • Poor blood circulation, causing numbness and pale color of fingers and toes (Raynaud's disease). • Prolonged erection or painful erection. Effect on growth: When using Atex, some children experience growth retardation (height and weight). However, with long-term treatment, children's height and weight return to normal levels for their age. Your doctor will monitor your child's height and weight over time. If your child is not gaining weight or growing as expected, the doctor may adjust your child's dose or decide to temporarily stop treatment with Atex. If you notice a side effect that is not described in this leaflet, inform your doctor or pharmacist. Reporting side effects If you have any side effects, listed or not listed in these instructions for use, consult your doctor, pharmacist, or nurse. By reporting side effects, you can help provide more information about the safety of this medicine. 5. How is Atex stored? Store Atex in its original packaging and out of reach and sight of children. Store below 25ºC. Use according to the expiry date. Do not use Atex after the expiry date indicated on the packaging. If you notice a defect in the product and/or packaging, do not use Atex. For environmental protection, do not dispose of unused Atex in running water or in the trash. Please consult your pharmacist regarding this.