Description
Buy MYSIMBA 8 mg/90 mg near you
active ingredients
- 90 mg bupropion hydrochloride
- 8 mg naltrexone hydrochloride
Buy MYSIMBA 8 mg/90 mg near you
- L-cysteine hydrochloride
- cellulose, microcrystalline
- hyprolose
- magnesium stearate
- lactose-1 water
- 73.2 mg lactose in total
- crospovidone
- Indigodisulfonic acid, aluminum salt
- hypromellose
- disodium edetat-2 water
- Silica, colloidal
- poly(vinyl alcohol)
- titanium dioxide
- Macrogol 3350
- talc
indication
- The medicine contains 2 active substances: naltrexone hydrochloride and bupropion hydrochloride and is used in obese or overweight adults together with a calorie restricted diet and exercise for weight management. This medicine affects the areas in the brain that control food intake and energy expenditure.
- Obesity in adults over 18 years of age is defined as a body mass index greater than or equal to 30, and overweight in adults over 18 years of age is defined as a body mass index greater than or equal to 27 and less than 30. The body mass index is calculated from body weight (kg) divided by the square of the height in meters (m 2 ).
- The drug is approved for patients with a baseline body mass index of 30 or greater; it can also be given to people with a body mass index between 27 and 30 if they have additional weight-related comorbidities, such as controlled high blood pressure (hypertension), type 2 diabetes, or high levels of lipids (fat) in the blood.
- Treatment with this drug can be stopped by your doctor after 16 weeks if you have not lost at least 5 percent of your original body weight. Your doctor may also recommend stopping treatment if there are concerns about increased blood pressure or other concerns about the safety or tolerability of this medicine.
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dosage
- Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
- The starting dose is usually one tablet (8 mg naltrexone hydrochloride / 90 mg bupropion hydrochloride) once a day in the morning. The dose is then gradually adjusted as follows:
- Week 1: One tablet once a day, in the morning
- Week 2: One tablet twice a day, one in the morning and one in the evening
- Week 3: Three tablets daily, two in the morning and one in the evening
- Week 4 and following: Two tablets twice a day, two in the morning and two in the evening
- The recommended maximum daily dose of the drug is two tablets twice a day.
- Your doctor will check whether you should continue taking the medicine 16 weeks after the start of treatment and then once a year.
- If you have liver or kidney problems, or if you are over 65 years old and depending on the severity of your problems, your doctor may carefully consider whether this medicine is right for you, or may recommend a different dose and advise you in more detail monitor possible side effects. If you have high blood sugar levels (diabetes) or if you are older than 65 years your doctor may do a blood test before you start treatment with this medicine to decide whether you should take this medicine or a different dose.
- If you take more than you should
- If you take too many tablets, you are more likely to have a seizure or have other side effects similar to those described in the side effects section. Do not wait, tell your doctor or the nearest hospital emergency department immediately.
- If you forget to take a dose
- Skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose
- If you stop taking it
- You may need to take the medicine for at least 16 weeks for it to have its full effect. Do not stop taking it without first talking to your doctor.
- If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
way
- This medicine is for oral use. Swallow the tablets whole. Do not cut, chew or crush. The tablets should preferably be taken with food.
side effects
- Like all medicines, this medicine can cause side effects, although not everybody gets them.
- Serious side effects
- Tell your doctor or pharmacist straight away if you notice any of the following serious side effects:
- Seizures (epileptic seizures):
- Rare – may affect up to 1 in 1,000 people taking this medicine who are at risk of seizures.
- Symptoms of seizures include B. Convulsions and usually loss of consciousness. If someone has had a seizure, they may be confused afterwards and have no memory of what happened. Seizures are more likely if you take too much, if you take some other medicines, or if you have an increased risk of seizures.
- Seizures (epileptic seizures):
- Tell your doctor or pharmacist straight away if you notice any of the following serious side effects:
- Other possible side effects are:
- Very common (may affect more than 1 in 10 people)
- nausea, vomiting
- stomach pain
- constipation
- headache
- Trouble sleeping (you should not take this supplement just before bedtime)
- fear, restlessness
- joint and muscle pain
- Common (may affect up to 1 in 10 people):
- low number of certain white blood cells (low lymphocyte count)
- Dizziness or spinning sensation
- feeling “shaky” (tremor)
- increased energy, irritability
- feeling depressed, mood disorder
- chills, fever
- decreased appetite, diarrhea
- Altered sense of taste (taste disturbance), dry mouth, toothache
- difficulty concentrating
- Feeling tired, sleepy or lacking in energy (lethargy)
- ringing in the ears (tinnitus)
- fast or irregular heartbeat;
- hot flashes
- teary eyes
- pain in the upper abdomen
- delayed ejaculation
- chest pain changes in the electrocardiogram (recording of the electrical activity of the heart)
- excessive sweating (hyperhidrosis)
- hives, rash, itching (pruritus)
- hair loss (alopecia)
- Uncommon (may affect up to 1 in 100 people):
- Cold sores (oral herpes)
- itching, blisters, cracking, peeling of the skin between the toes (athlete’s foot or tinea pedis)
- swollen glands in the neck, armpit or groin (lymphadenopathy)
- excessive loss of body fluid (dehydration)
- loss of appetite (anorexia)
- increased appetite, weight gain
- unusual dreams, nightmares
- Blush
- Nervousness, feeling “out of the way”, tension, restlessness, mood swings, hallucinations, confusion, severe suspiciousness (paranoia), disorientation
- loss of sexual desire,
- shaking of the head or a limb that gets worse when you try to perform a specific function (intention tremor)
- balance disorders
- loss of memory (amnesia), mental impairment,
- almost fainting (presyncope)
- travel sickness
- ear pain, ear discomfort
- visual disturbances, blurred vision, eye irritation, pain or swelling, increased sensitivity to light (photophobia)
- nasal discomfort, nasal congestion, runny nose, sneezing, sinus disorders
- Sore throat, increase in mucus that is coughed up, difficulty breathing, voice disturbances, coughing, yawning
- fluctuating or high blood pressure (sometimes severe)
- pain in the lower abdomen
- burping
- swelling of the lips
- Appearance of fresh blood from the anus usually in or with the stool (haematochezia)
- Perforation of an organ or the tissues surrounding the organ through the wall of the body cavity in which it normally lies (hernia)
- Wind (bloating), hemorrhoids, ulcers, tooth decay
- Inflammation of the gallbladder (cholecystitis)
- A problem with the spine where the disc comes out between two bones (vertebral bodies/herniated disc)
- Pain in jaw and groin
- A disorder characterized by a sudden, irresistible urge to urinate (urge), unusually frequent urination, painful urination
- irregular menstrual periods, vaginal bleeding, dryness of the female vulva and vagina
- Difficulty getting or keeping an erection
- feeling sick, weakness (asthenia)
- thirst, feeling hot
- Feeling cold in the extremities (hands, feet)
- increased blood creatinine (indicating loss of kidney function)
- Elevated liver enzymes and bilirubin levels, liver disease, hepatitis
- Decreased hematocrit (indicating a lack of red blood cells)
- Acne, oily skin
- Rare (may affect up to 1 in 1,000 people)
- unusual bleeding or bruising under the skin
- changes in blood sugar levels
- feeling irritable or hostile
- Suicidal thoughts or attempts, feeling like you are watching yourself from outside the body, or feeling that the surroundings are unreal (depersonalisation)
- Muscle stiffness, uncontrolled movements, problems walking or coordination
- memory impairment
- fainting
- Tingling or numbness in the hands or feet
- Widening of blood vessels, low blood pressure when you get up from sitting or lying down (orthostatic hypotension)
- your skin or the whites of your eyes turn yellow (jaundice)
- Erythema multiforme (a serious skin disease that can affect the mouth and other parts of the body, with red, often itchy patches starting on the limbs), Stevens-Johnson syndrome (a rare skin disease with severe blistering and bleeding of the lips, eyes, mouth, nose and genitals)
- Worsening of psoriasis (thickened red patches on the skin)
- muscle twitching
- urinary retention
- Very rare (may affect up to 1 in 10,000 people)
- swelling of the eyelids, face, lips, tongue or throat which can make breathing very difficult (angioedema) sudden life-threatening allergic reaction (anaphylactic shock)
- fixed, irrational ideas (delusions), aggression
- abnormal muscle breakdown that can lead to kidney problems (rhabdomyolysis)
- Not known (cannot be estimated from the available data):
- psychosis
- discomfort in the abdomen
- Digestive problems (Indigestion)
- Very common (may affect more than 1 in 10 people)
- If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not specified.
interactions
- Taking with other medicines
- Tell your doctor or pharmacist if you are taking/using any other medicines, have recently taken/used or might take/use any other medicines.
- This preparation must not be taken together with
- Monoamine oxidase inhibitors (medicines used to treat depression or Parkinson’s disease) e.g. B. phenelzine, selegiline or rasagiline. You must stop taking these medicines at least 14 days before you start taking this supplement.
- Opioids and medicines containing opiates, for example to treat cough and cold (e.g. mixtures containing dextromethorphan or codeine), opiate dependence (e.g. methadone), pain (e.g. morphine and codeine), diarrhoea (e.g. Peregoric). You must have stopped taking opiates and medicines containing opiates at least 7 to 10 days before you start taking this medicine. Your doctor may do a blood test to make sure your body is clear of these medicines before starting the treatment. Naltrexone blocks the effects of opiates; if you take higher doses of an opiate to bypass the blocking effect of naltrexone you can get acute opioid poisoning, which can be life-threatening.
- Tell your doctor if you are taking any of the following medicines, as your doctor will monitor you closely for side effects,
- Medicines that increase the risk of seizures when taken alone or in combination with naltrexone/bupropion, such as B.
- medicines for depression and other mental health problems;
- steroids (except drops, creams or lotions for eye and skin problems or inhalers for breathing problems such as asthma);
- medicines for the prevention of malaria;
- quinolones (antibiotics such as ciprofloxacin used to treat infections);
- tramadol (painkiller, belongs to the class of opiates);
- theophylline (used to treat asthma);
- antihistamines (medicines used to treat hay fever, itching and other allergic reactions) that may cause drowsiness (e.g. chlorphenamine); medicines to lower blood sugar levels (e.g. insulin, sulphonylureas such as glyburide or glibenclamide, and meglitinides such as nateglinide or repaglinide);
- Medicines to help you sleep (sedatives such as diazepam).
- medicines to treat depression (e.g. desipramine, venlafaxine, imipramine, paroxetine, citalopram) or other mental health problems (e.g. risperidone, haloperidol, thioridazine);
- Some medicines used to treat high blood pressure (beta-blockers such as metoprolol and clonidine, a centrally acting medicine that lowers blood pressure);
- Some medicines used to treat irregular heart rhythms (e.g. propafenone, flecainide);
- Some medicines used to treat cancer (e.g. cyclophospamide, ifosphamide, tamoxifen);
- Some medicines used to treat Parkinson’s disease (e.g. levodopa, amantadine or orphenadrine);
- ticlopidine or clopidogrel, which are mainly used to treat heart disease or stroke;
- medicines to treat HIV infection and AIDS, such as efavirenz and ritonavir;
- Medicines used to treat epilepsy such as valproate, carbamazepine, phenytoin or phenobarbital.
- Medicines that increase the risk of seizures when taken alone or in combination with naltrexone/bupropion, such as B.
- Your doctor will monitor you closely for side effects and/or may adjust the dose of your other medicines or of this product.
- Consumed with alcohol
- Excessive alcohol consumption during treatment with this drug may mean an increased risk of seizures (fits), mental disorders or may reduce your alcohol tolerance. Your doctor may recommend that you do not drink alcohol or drink as little as possible while taking the preparation. If you are currently drinking heavily, do not stop abruptly as this increases the risk of seizures.
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- Excessive alcohol consumption during treatment with this drug may mean an increased risk of seizures (fits), mental disorders or may reduce your alcohol tolerance. Your doctor may recommend that you do not drink alcohol or drink as little as possible while taking the preparation. If you are currently drinking heavily, do not stop abruptly as this increases the risk of seizures.
Contraindications
- The drug must not be taken
- if you are allergic to naltrexone, bupropion or any of the other ingredients of this medicine,
- if you have abnormally high blood pressure (hypertension) that is not controlled with a medicine;
- if you have a disease that causes seizures (seizures) or have ever had seizures;
- if you have a brain tumor;
- if you normally drink a lot of alcohol and have just stopped or are about to stop while taking this medicine
- if you have recently stopped or plan to stop taking sedatives or medicines to treat anxiety (especially benzodiazepines) while you are taking this medicine;
- if you have bipolar disorder (extreme mood swings);
- if you are taking other medicines containing bupropion or naltrexone;
- if you have or have had an eating disorder (e.g. bulimia or anorexia);
- if you are currently dependent on opiates or opiate agonists (e.g. methadone) or in the acute withdrawal phase (“cold turkey”);
- if you are taking or have taken in the last 14 days medicines for depression or Parkinson’s disease called monoamine oxidase inhibitors (MAOIs);
- if you suffer from severe liver disease;
- if you suffer from end-stage renal disease.
pregnancy and breast feeding period
- The drug should not be used during pregnancy or breastfeeding.
- If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
patient notes
- Warnings and Precautions
- Please talk to your doctor or pharmacist before taking this medicine.
- This is important because some medical conditions make it more likely that you will experience side effects.
- If you are feeling depressed, have thoughts of suicide, have attempted suicide or have mental health problems, you should tell your doctor before taking this medicine.
- seizures (epileptic seizures)
- The medicine has been shown to cause seizures (fits) in up to 1 in 1,000 people. You should tell your doctor before taking this medicine
- if you have had a severe head injury or trauma;
- if you drink alcohol regularly;
- if you regularly use medicines to help you sleep (sedatives);
- if you are currently dependent on or addicted to cocaine or other stimulants;
- if you have diabetes and therefore use insulin or oral medicines that can cause low blood sugar (hypoglycaemia); or
- if you are taking medicines that may increase the risk of seizures
- If you have a fit (seizures), stop taking it and tell your doctor straight away.
- The medicine has been shown to cause seizures (fits) in up to 1 in 1,000 people. You should tell your doctor before taking this medicine
- You must stop taking it and tell your doctor immediately if you experience any symptoms of an allergic reaction after taking this medicine, such as swelling of your throat, tongue, lips or face, difficulty swallowing or breathing, dizziness, fever, rash, muscle pain or Joint pain, itching or hives.
- You should talk to your doctor, especially if:
- you have high blood pressure before taking this medicine as it can get worse. Your blood pressure and heart rate will be measured before and while you are taking this medicine. If your blood pressure or heart rate increases significantly, you may need to stop taking it.
- you have uncontrolled coronary artery disease (a heart condition caused by poor blood flow in the vessels in the heart) with symptoms such as angina (characterized by chest pain) or have recently had a heart attack.
- you have or have had a disease that affects blood flow in the brain (cerebrovascular disease).
- you had liver problems before taking the medicine.
- you had kidney problems before taking it.
- You are prone to mania (feeling high, high which leads to unusual behavior).
- Elderly people
- If you are 65 years or older, you should be careful when taking it.
- This supplement is not recommended if you are over 75 years old.
- children and young people
- No studies have been conducted in children and adolescents under 18 years of age. Therefore, the preparation should not be used in children and adolescents under 18 years of age.
- Ability to drive and use machines
- The medicine can cause dizziness, which can reduce your ability to concentrate and react.
- If you feel dizzy, do not drive or use machines.
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