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Mysimba 8 mg/90 mg prolonged Release tablets

Mysimba 8 mg/90 mg prolonged Release tablets

Mysimba

Prescription Medicine
  • MHRA Authorised prescription Only medicine in the UK with an up To Date SmPC and Patient Information Leaflet.
  • Centrally authorised in the European Union via EMA (European public assessment report available).
  • Subject to additional safety monitoring in the UK/EU (black triangle medicine).
Anti-obesity / Weight Management Medicine

Description

Mysimba 8 mg/90 mg prolonged-release tablets are a prescription-only weight loss medicine containing a fixed-dose combination of naltrexone hydrochloride and bupropion hydrochloride. Used in combination with a reduced-calorie diet and increased physical activity, Mysimba helps manage weight in obese or overweight adults by acting on areas of the brain involved in appetite regulation and energy balance, reducing hunger and food cravings.

Bnefits

  • Clinically indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adults with obesity or overweight with weight-related comorbidities.
  • Combines naltrexone and bupropion, which act on central nervous system pathways that regulate appetite and reward, helping reduce hunger and cravings.
  • Oral, prolonged-release tablet formulation taken once or twice daily according to a titration schedule, offering a non-injectable weight management option.
  • Centrally authorised in the EU/UK with a clearly defined dosing, monitoring and safety framework.
  • Demonstrated weight loss benefit in clinical trials for appropriate patients when used alongside lifestyle changes.

Indications

  • Adjunct to a reduced-calorie diet and increased physical activity for the management of weight in adult patients (≥18 years) with an initial BMI ≥ 30 kg/m² (obese).
  • Adjunct to a reduced-calorie diet and increased physical activity for adult patients with BMI ≥ 27 kg/m² to < 30 kg/m² (overweight) in the presence of one or more weight-related comorbidities such as type 2 diabetes, dyslipidaemia or controlled hypertension.
  • Use only under medical supervision with regular monitoring of weight, blood pressure and overall safety.

Composition

  • Each prolonged-release tablet contains 8 mg naltrexone hydrochloride (equivalent to 7.2 mg naltrexone).
  • Each prolonged-release tablet contains 90 mg bupropion hydrochloride (equivalent to 78 mg bupropion).
  • Excipient with known effect: each tablet contains 73.2 mg lactose (anhydrous and monohydrate).
  • Other excipients (tablet core): microcrystalline cellulose, hydroxypropyl cellulose, lactose anhydrous, lactose monohydrate, cysteine hydrochloride, crospovidone type A, magnesium stearate, hypromellose, edetate disodium, colloidal silicon dioxide, indigo carmine aluminium lake (E132).
  • Film-coating excipients: poly(vinyl alcohol), titanium dioxide (E171), macrogol (3350), talc, indigo carmine aluminium lake (E132).

Formulation

  • Pharmaceutical form: prolonged-release tablet.
  • Appearance: blue, biconvex, round tablet (approximately 12–12.2 mm in diameter) debossed with “NB-890” on one side.
  • Route of administration: oral.
  • Prolonged-release formulation designed to deliver naltrexone and bupropion gradually over time.
  • ATC code: A08AA62 (anti-obesity preparations, centrally acting).

Packaging

  • Available in blister packs of 28 or 112 prolonged-release tablets (not all pack sizes may be marketed in all regions).
  • Blisters packed in cardboard cartons labelled with product name, strength (8 mg/90 mg), dosage form (prolonged-release tablet), active substances, batch number and expiry date.
  • Supplied as prescription-only medicine with patient information leaflet enclosed in each carton.

Usage

  • Mysimba should be prescribed and supervised by a healthcare professional experienced in weight management medicines.
  • Dose titration (standard adult regimen):
  • • Week 1: One tablet once daily in the morning.
  • • Week 2: Two tablets daily – 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 onwards: Four tablets daily – two in the morning and two in the evening (maximum recommended dose).
  • Tablets should be swallowed whole with water and preferably taken with food; they must not be cut, chewed or crushed.
  • If a dose is missed, the patient should skip the missed dose and take the next dose at the usual time; a double dose must not be taken.
  • Treatment should be discontinued after 16 weeks if the patient has not lost at least 5% of their initial body weight.
  • Renal or hepatic impairment and patients over 65 years require careful benefit–risk assessment and possible dose modification in line with the SmPC/PIL.
  • Patients should minimise or avoid alcohol while taking Mysimba due to an increased risk of adverse neuropsychiatric events or seizures.
  • Use only alongside a calorie-controlled diet and increased physical activity as advised by the prescriber.

Contraindications

  • Hypersensitivity to naltrexone, bupropion or any excipient.
  • Uncontrolled hypertension.
  • Current seizure disorder or history of seizures.
  • Known central nervous system tumour.
  • Patients undergoing acute alcohol or benzodiazepine withdrawal.
  • History of bipolar disorder.
  • Current or previous diagnosis of bulimia or anorexia nervosa.
  • Current chronic opioid use, dependence on opioids or opiate agonists (e.g., methadone), or acute opiate withdrawal.
  • Concomitant therapy with other medicinal products containing bupropion or naltrexone.
  • Concomitant administration of monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping an MAOI.
  • Severe hepatic impairment.
  • End-stage renal failure.
  • Pregnancy and breastfeeding (treatment should not be used during pregnancy or in women who are breastfeeding or planning pregnancy).
  • Use in children and adolescents under 18 years of age.

Adverse Effects

  • Very common: nausea, vomiting, constipation, headache.
  • Common: anxiety, dizziness, vertigo, tremor, insomnia, abnormal dreams, dry mouth, dysgeusia (taste changes), difficulty concentrating, fatigue, somnolence or lethargy, tinnitus, palpitations or tachycardia, hot flushes, increased blood pressure, upper abdominal pain, abdominal pain, hyperhidrosis (excessive sweating), rash, pruritus, alopecia, irritability, jitteriness.
  • Uncommon: urticaria, hypersensitivity reactions, abnormal dreams, mood changes, balance disorder, amnesia, paraesthesia, motion sickness, burping, abdominal discomfort, dyspepsia, cholecystitis, increased creatinine, increased liver enzymes or bilirubin, liver disorders, erectile dysfunction, asthenia, chest pain, thirst, weight gain.
  • Rare: seizures (fits), angioedema, decreased lymphocyte count, decreased haematocrit, severe hypertension, haematochezia, hernia, liver injury due to drug toxicity, various urinary and menstrual disorders.
  • Not known (frequency cannot be estimated from available data): severe cutaneous adverse reactions such as Stevens–Johnson syndrome and acute generalised exanthematous pustulosis, erythema multiforme, rhabdomyolysis, lupus-like skin reactions or exacerbation of lupus, serotonin syndrome (especially with concomitant serotonergic drugs), mood disorders including depression, suicidal ideation and behaviour, psychosis, delusions, panic attacks, aggression, paranoia, confusion, memory impairment, movement disorders, visual disturbances, respiratory and ENT symptoms, hepatitis, acne, musculoskeletal pain, chills.
  • A boxed warning applies to bupropion-containing products regarding increased risk of suicidal thoughts and behaviour in young adults; close monitoring is recommended, particularly at treatment initiation and dose changes.

Storage Conditions

  • Keep out of the sight and reach of children.
  • Do not store above 30°C.
  • Store in the original package to protect from moisture and light.
  • Do not use after the expiry date stated on the carton and blister (expiry date refers to the last day of that month).
  • Do not dispose of via wastewater or household waste; unused or expired medicine should be returned to a pharmacist for appropriate disposal.

Duration

Evaluate response after 16 weeks; discontinue if at least 5% weight loss from baseline is not achieved. If effective and well-tolerated, the need for continued treatment should be re-evaluated at least annually.

Onset

Appetite and craving effects begin during the 4-week titration phase; clinically meaningful weight loss is typically assessed over 16 weeks of therapy alongside diet and exercise.

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