Prometax (Rivastigmine)
Cholinesterase inhibitor for Alzheimer's and Parkinson's dementia
Prometax (rivastigmine) is a cholinesterase inhibitor prescribed for the symptomatic treatment of mild to moderately severe Alzheimer's dementia and of mild to moderately severe dementia in patients with idiopathic Parkinson's disease. By blocking the enzymes acetylcholinesterase and butyrylcholinesterase, Prometax raises acetylcholine levels in the brain, helping to support memory, attention, and everyday functioning. It is supplied as hard capsules, an oral solution, and transdermal patches.
Quick Facts
Key Takeaways
- Prometax contains rivastigmine, a dual-action carbamate cholinesterase inhibitor that blocks both acetylcholinesterase (AChE) and butyrylcholinesterase (BuChE), increasing acetylcholine at cholinergic synapses in the brain.
- It is approved for the symptomatic treatment of mild to moderately severe Alzheimer's dementia and for dementia in patients with idiopathic Parkinson's disease; it does not cure or halt underlying neurodegeneration.
- Treatment begins at a low dose (1.5 mg twice daily for capsules, or 4.6 mg/24h for patches) and is gradually titrated upward at intervals of at least two to four weeks to minimise gastrointestinal side effects.
- The transdermal patch delivers rivastigmine continuously over 24 hours and is associated with approximately three times fewer gastrointestinal adverse reactions than capsules at comparable drug exposure.
- If Prometax therapy is interrupted for more than three consecutive days, treatment must be restarted at the lowest dose and re-titrated under medical supervision to avoid severe gastrointestinal adverse effects, including rare cases of oesophageal rupture.
What Is Prometax and What Is It Used For?
Prometax belongs to a class of medicines known as cholinesterase inhibitors, classified under ATC code N06DA03. Its active substance, rivastigmine, is a carbamate-type compound that reversibly inhibits two key enzymes in the central nervous system: acetylcholinesterase (AChE) and butyrylcholinesterase (BuChE). In patients with Alzheimer's disease, populations of cholinergic neurons in the basal forebrain progressively degenerate, leading to reduced levels of the neurotransmitter acetylcholine — a chemical messenger that is critical for attention, memory consolidation, and cortical arousal. By slowing the enzymatic breakdown of acetylcholine, Prometax helps maintain cholinergic neurotransmission and can produce measurable, if modest, benefits in cognition and global clinical impression.
Alzheimer's disease is the most common cause of dementia worldwide, accounting for an estimated 60–70% of cases according to the World Health Organization (WHO). The disease is characterised by a progressive decline in memory, thinking, orientation, comprehension, learning capacity, language, and judgement. It predominantly affects people over the age of 65, although early-onset forms occur in younger individuals, often with a stronger genetic component. Dementia in Parkinson's disease, the second main indication for Prometax, develops in roughly 25–30% of patients with Parkinson's disease and is driven by cholinergic deficits in addition to the dopaminergic degeneration that underlies motor symptoms.
Prometax is indicated for the symptomatic treatment of mild to moderately severe Alzheimer's dementia in adults, and for mild to moderately severe dementia in patients with idiopathic Parkinson's disease. Placebo-controlled clinical trials have demonstrated statistically significant benefits on cognitive scales (such as ADAS-cog), global clinical impression of change, and performance in activities of daily living. The Cochrane Collaboration's systematic review of rivastigmine in Alzheimer's disease concluded that the drug produces consistent benefits in cognition and global functioning compared with placebo. In Parkinson's disease dementia, the pivotal EXPRESS trial (Emre et al., 2004) showed that rivastigmine improved cognition and activities of daily living versus placebo over 24 weeks.
It is essential to understand that Prometax is a symptomatic treatment. It does not cure Alzheimer's disease or Parkinson's disease, nor does it halt the underlying neurodegenerative process. By temporarily strengthening cholinergic neurotransmission, however, it may help patients maintain cognitive function, independence, and quality of life for a longer period. Both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have authorised rivastigmine for these indications, and it is included in practice guidelines from the American Academy of Neurology (AAN), the International Parkinson and Movement Disorder Society (MDS), and the National Institute for Health and Care Excellence (NICE).
Rivastigmine is unique among the cholinesterase inhibitors currently available (together with donepezil and galantamine) in that it targets both AChE and BuChE. This dual mechanism may offer theoretical advantages as Alzheimer's disease advances: butyrylcholinesterase activity in the brain tends to increase with disease progression, while acetylcholinesterase activity may decrease. By inhibiting both enzymes, rivastigmine may provide more sustained cholinergic support in moderate disease stages. Because the inhibition is of the pseudo-irreversible, carbamate-mediated type, enzyme activity recovers over several hours, matching clinical dosing intervals.
What Should You Know Before Taking Prometax?
Contraindications
Prometax must not be used if you are allergic (hypersensitive) to rivastigmine, to other carbamate derivatives, or to any of the other ingredients of the capsule, oral solution, or transdermal patch. Because rivastigmine itself is a carbamate compound, cross-reactivity with other carbamates (such as certain pesticides or anaesthetic agents) should be considered when taking a patient history.
For the transdermal patch formulation, Prometax must also not be used if you have experienced a previous allergic contact dermatitis with rivastigmine patches that spreads beyond the patch area, if an intense local reaction develops (such as increasing inflammation, oedema, or blistering), or if such a reaction does not improve within 48 hours after patch removal. In these situations, discontinue the patch and consult the prescriber; switching to oral therapy may be appropriate after re-challenge testing.
Do not use Prometax if you have a known allergy to rivastigmine or to carbamate derivatives. Stop the transdermal patch and seek medical attention promptly if a rash or reaction at the application site spreads, intensifies, or persists more than 48 hours after removal.
Warnings and Precautions
Several medical conditions require particular caution when using Prometax. Before initiating therapy, discuss your complete medical and medication history with your doctor, especially if any of the following apply:
- Cardiac conditions: Sick sinus syndrome, other supraventricular conduction abnormalities, bradycardia, QTc prolongation or a family history of QTc prolongation, torsades de pointes, or uncorrected electrolyte disturbances (low potassium or magnesium). Cholinesterase inhibitors can exacerbate vagal tone and cardiac conduction disturbances.
- Gastrointestinal disease: Active or prior peptic ulcer disease, or risk factors for ulcer disease (such as concomitant non-steroidal anti-inflammatory drugs). Rivastigmine may increase gastric acid secretion.
- Urinary difficulties: Bladder outflow obstruction or urinary retention, which may be worsened by cholinergic stimulation.
- Seizure history: A personal history of epilepsy or unprovoked seizures. Cholinesterase inhibitors may lower the seizure threshold.
- Respiratory conditions: Asthma or severe chronic obstructive pulmonary disease (COPD), because increased cholinergic tone may provoke bronchospasm.
- Tremor and movement disorders: Patients with Parkinson's disease may be more sensitive to extrapyramidal and worsening of tremor. Careful titration and monitoring of motor symptoms are required.
- Low body weight: Patients weighing less than 50 kg may experience more frequent or severe adverse events and may require slower titration.
- Liver or renal impairment: Although rivastigmine is minimally metabolised by the liver, plasma concentrations are higher in patients with moderate hepatic impairment and in mild to moderate renal impairment, so titration should be cautious and individualised.
If persistent gastrointestinal adverse effects (nausea, vomiting, diarrhoea, loss of appetite) occur, dehydration may develop rapidly, particularly in elderly or frail patients. Ensure adequate fluid intake, monitor body weight, and contact your doctor if symptoms are prolonged or severe. Significant weight loss during long-term therapy is a recognised concern and should prompt clinical review.
If Prometax is interrupted for more than three consecutive days, do not resume at the previous dose. The dose must be re-titrated from the lowest starting level to avoid the risk of severe gastrointestinal reactions, including very rare cases of oesophageal rupture from protracted vomiting.
Pregnancy and Breastfeeding
There are no adequate data from the use of rivastigmine in pregnant women. Animal studies have shown some reproductive toxicity at high doses. Because Prometax is almost exclusively used in elderly patients, exposure in pregnancy is rare; however, if you are pregnant, think you may be pregnant, or plan to become pregnant, you should not use Prometax unless your doctor considers it clearly essential and the expected benefit outweighs potential risks to the foetus.
It is not known whether rivastigmine is excreted in human breast milk, although animal studies show excretion into milk. Women taking Prometax should not breastfeed.
Driving and Operating Machinery
Alzheimer's disease and Parkinson's disease themselves can significantly impair the ability to drive and to operate complex machinery. Prometax may cause additional adverse effects such as dizziness, drowsiness, syncope, and confusion, especially at the start of therapy or after a dose increase. The prescribing physician should assess fitness to drive on an individual basis; patients should not drive or use machinery while experiencing these symptoms.
Children and Adolescents
There is no relevant use of Prometax in the paediatric population for the treatment of dementia. The medicine is intended exclusively for adults and should not be used in children or adolescents.
How Does Prometax Interact with Other Drugs?
Drug interactions are an important consideration when taking Prometax, particularly because the typical patient population is elderly and often takes multiple medicines for comorbidities. Rivastigmine is minimally metabolised by cytochrome P450 enzymes, so the majority of interactions are pharmacodynamic rather than pharmacokinetic, meaning they arise from opposing or additive effects on cholinergic pathways, cardiac conduction, or the gastrointestinal tract.
Major Interactions
| Drug / Drug Class | Type of Interaction | Clinical Significance |
|---|---|---|
| Metoclopramide | Pharmacodynamic — additive extrapyramidal effects | Concurrent use can produce rigidity, tremor, and extrapyramidal symptoms. Avoid the combination where possible. |
| Beta-blockers (e.g., atenolol, bisoprolol, metoprolol) | Pharmacodynamic — additive bradycardic effect | Combined use may cause excessive slowing of the heart rate, potentially leading to syncope or asystole. Monitor heart rate, and consider ECG before initiation in high-risk patients. |
| Succinylcholine-type muscle relaxants | Pharmacodynamic — prolonged neuromuscular blockade | Rivastigmine may markedly prolong the action of succinylcholine during general anaesthesia. Inform your anaesthesiologist before any planned surgery. |
| QT-prolonging drugs (e.g., certain antiarrhythmics, macrolides, quinolones, antipsychotics) | Pharmacodynamic — additive cardiac conduction effects | Potential risk of torsades de pointes in predisposed patients. Use with caution; consider ECG monitoring. |
| Other cholinesterase inhibitors (donepezil, galantamine) | Pharmacodynamic — additive cholinergic effect | Combination is not recommended. Excessive cholinergic stimulation may cause a cholinergic crisis (profuse salivation, diarrhoea, bradycardia, seizures). |
Minor Interactions
| Drug / Drug Class | Type of Interaction | Clinical Significance |
|---|---|---|
| Anticholinergic agents (e.g., oxybutynin, tolterodine, hyoscine, benztropine, amitriptyline) | Pharmacodynamic — opposing mechanisms | Anticholinergics directly counteract the therapeutic action of Prometax. Avoid unnecessary concurrent use and periodically review the medication list in elderly patients. |
| Antihistamines with anticholinergic activity (e.g., diphenhydramine, chlorphenamine) | Pharmacodynamic — reduced efficacy | May reduce rivastigmine efficacy. Prefer non-sedating, non-anticholinergic antihistamines when treatment is needed. |
| Non-steroidal anti-inflammatory drugs (NSAIDs) | Pharmacodynamic — additive gastrointestinal risk | Combined use increases the risk of peptic ulceration and gastrointestinal bleeding. Consider gastroprotection where NSAIDs are unavoidable. |
| Nicotine | Pharmacokinetic — increased rivastigmine clearance | Heavy smokers may have approximately 23% higher rivastigmine clearance, potentially reducing plasma levels. Dose may need to be optimised on clinical response. |
| Beta2-agonists, theophylline | Pharmacodynamic — airway effects in asthma/COPD | Clinical response should be monitored in patients with obstructive airway disease, as cholinergic stimulation may partly oppose bronchodilation. |
This list is not exhaustive. Always provide your healthcare team with a complete, up-to-date list of prescription drugs, over-the-counter medicines, vitamins, and herbal supplements before starting Prometax and at every subsequent medication review. Pharmacist-led medication reconciliation is strongly recommended in elderly patients, since polypharmacy increases both interaction risk and the anticholinergic burden.
If surgery requiring general anaesthesia is planned, inform your surgeon and anaesthesiologist that you are taking Prometax. Rivastigmine can markedly prolong the action of depolarising muscle relaxants such as suxamethonium (succinylcholine). In many cases Prometax is continued perioperatively, but the anaesthetic plan must account for this interaction.
What Is the Correct Dosage of Prometax?
Prometax dosing follows a gradual titration schedule to minimise gastrointestinal adverse effects and to identify the highest well-tolerated dose for each patient. Always use Prometax exactly as prescribed; do not adjust the dose on your own. Dose titration should be performed under supervision of a prescriber experienced in diagnosing and treating dementia.
Adults — Oral Capsules and Solution
| Phase | Dose | Duration at Step | Notes |
|---|---|---|---|
| Starting dose | 1.5 mg twice daily | Minimum 2 weeks | Take with the morning and evening meal to improve tolerability. |
| First increase | 3 mg twice daily | Minimum 2 weeks | Increase only if the previous dose was well tolerated. |
| Second increase | 4.5 mg twice daily | Minimum 2 weeks | Monitor for nausea, vomiting, and weight loss. |
| Maximum dose | 6 mg twice daily (12 mg/day) | Long-term maintenance | Highest effective dose; aim for this if tolerated, as efficacy increases with dose. |
Prometax capsules should always be taken with food to improve absorption and reduce gastrointestinal side effects. The capsules must be swallowed whole — do not crush, chew, or open them, because the contents are bitter-tasting and may irritate the mucosa. For patients with swallowing difficulties, the oral solution (2.0 mg/mL) can be used: the prescribed volume is drawn up with the graduated syringe and may be swallowed directly or first mixed with a small amount of water, cold fruit juice, or soda. Mix well and drink within four hours.
Adults — Transdermal Patches
| Phase | Patch Strength | Duration at Step | Notes |
|---|---|---|---|
| Starting dose | 4.6 mg/24 h (5 cm²) | Minimum 4 weeks | Apply one patch daily to clean, dry, hairless skin. |
| Recommended effective dose | 9.5 mg/24 h (10 cm²) | Long-term maintenance | Increase only if the starting dose is well tolerated. |
| Higher dose (selected patients) | 13.3 mg/24 h (15 cm²) | Long-term maintenance | Consider only if 9.5 mg/24 h has been tolerated for at least 6 months and clinical response declines. |
When using transdermal patches, apply only one patch at a time and replace it with a new patch after 24 hours. Rotate the application site daily (upper or lower back, upper arm, or upper chest) and do not apply a new patch to the same skin area within 14 days. Ensure the skin is clean, dry, intact, and free from lotions, powders, or oils. Press the patch firmly for at least 30 seconds to secure adhesion around the edges. Showering is permitted while the patch is in place, but prolonged hot baths, saunas, or direct sun exposure on the patch should be avoided, as heat can increase drug release.
Patients stable on 3 mg twice daily or 6 mg/day capsules can switch to 4.6 mg/24h patches; those stable on 4.5–6 mg twice daily (9–12 mg/day) capsules can switch directly to 9.5 mg/24h patches. Apply the first patch on the day after the last oral dose. Switching should always be done under medical supervision.
Elderly Patients
No dose adjustment based on age alone is required, as the indication itself is almost exclusive to elderly patients. However, elderly individuals (especially those over 80 years, with low body weight, or with multiple comorbidities) are more susceptible to gastrointestinal, cardiac, and CNS adverse effects. Titration should proceed cautiously, with careful monitoring of heart rate, weight, and nutritional status. Slower titration than the minimum two-week interval is acceptable and often prudent.
Patients with Hepatic or Renal Impairment
Patients with mild to moderate hepatic impairment, and those with renal impairment, may have higher plasma exposure to rivastigmine. In these groups, begin with the usual 1.5 mg twice daily starting dose but titrate according to individual tolerability, which may result in lower maintenance doses than in patients without organ impairment. No formal data are available for severe hepatic or severe renal impairment, and clinical judgement is required.
Missed Dose
If you miss a dose of Prometax capsules or oral solution, take the next dose at the normally scheduled time. Do not take a double dose to make up for the missed one. If you forgot to apply a patch, apply a new patch as soon as you remember and replace it at the regular time the next day. Do not apply two patches simultaneously to catch up.
If Prometax (capsules, oral solution, or patches) has been interrupted for more than three consecutive days, do not restart at the previous dose. Contact your doctor immediately. Therapy must be re-initiated at the lowest starting dose and carefully titrated upward to avoid potentially severe gastrointestinal adverse effects, including isolated reports of oesophageal rupture secondary to severe vomiting.
Overdose
Most cases of accidental overdose with Prometax have not been associated with clinical signs or symptoms; nearly all affected patients continued treatment 24 hours after the overdose. However, cholinergic toxicity can occur, with symptoms including severe nausea, vomiting, profuse diarrhoea, hypersalivation, sweating, bradycardia, hypotension, respiratory depression, collapse, and convulsions. Muscle weakness may lead to fatal respiratory failure. With patches, applying more than one patch simultaneously (or failing to remove the previous patch) is a typical cause of unintentional overdose.
If an overdose is suspected, remove all patches, discontinue oral dosing, and seek emergency medical care. Because rivastigmine has an elimination half-life of only about one hour and an AChE inhibition duration of approximately nine hours, further doses should generally be withheld for 24 hours in symptomatic patients. Atropine sulfate 1–2 mg intravenously is the antidote for severe cholinergic symptoms, titrated to effect; glycopyrrolate is not recommended because it does not cross the blood–brain barrier. Dialysis is not useful.
What Are the Side Effects of Prometax?
Like all medicines, Prometax can cause side effects, although not everyone experiences them. Adverse reactions are most likely to occur at the start of treatment or after each dose increase, and generally diminish as the body adjusts. Taking capsules with food, slowing the titration pace, or switching to the transdermal patch can substantially reduce the gastrointestinal burden. Frequencies below are categorised using the standard CIOMS terminology.
Very Common
May affect more than 1 in 10 patients
- Nausea
- Vomiting
- Diarrhoea (especially with oral formulations during titration)
- Loss of appetite
- Dizziness (particularly in Parkinson's disease dementia)
Common
May affect up to 1 in 10 patients
- Headache
- Drowsiness or somnolence
- Tremor (particularly in Parkinson's disease dementia)
- Fatigue, weakness, or malaise
- Weight loss
- Abdominal pain and dyspepsia
- Heartburn
- Increased salivation
- Sweating
- Confusion
- Depression
- Anxiety or agitation
- Nightmares or abnormal dreams
- Urinary tract infection
- Urinary incontinence
- Syncope (fainting)
- Skin rash (oral forms); local application-site reactions such as erythema, itching, or oedema (patch)
- Fever
Uncommon
May affect up to 1 in 100 patients
- Cardiac conduction disturbances (bradycardia, atrioventricular block, atrial fibrillation, tachycardia)
- Gastric or duodenal ulcers
- Dehydration
- Hyperactivity, restlessness
- Aggression
- Insomnia
- Accidental injury or falls
- Dystonia (movement disorder) in Parkinson's disease dementia
Rare
May affect up to 1 in 1,000 patients
- Seizures (convulsions)
- Angina pectoris
- Duodenal or small intestinal ulcers
- Hallucinations (visual or auditory)
Very Rare
May affect up to 1 in 10,000 patients
- Extrapyramidal symptoms (worsening muscle stiffness, rigidity)
- Pancreatitis (severe upper abdominal pain radiating to the back, with vomiting)
- Hypertension
- Gastrointestinal haemorrhage
- Oesophageal rupture (linked to severe, prolonged vomiting)
Frequency Not Known
Cannot be estimated from available data
- Worsening of Parkinson's disease symptoms (motor fluctuations, on-off phenomena)
- Sick sinus syndrome
- QTc prolongation
- Liver function test abnormalities, hepatitis
- Pisa syndrome (sustained lateral flexion of the trunk and head)
- Neuroleptic malignant syndrome
- Allergic contact dermatitis (patch), widespread skin rash
- Dyskinesia
Contact your doctor or emergency services immediately if you experience: difficulty breathing, swelling of the face/lips/tongue, widespread rash or blistering (potentially severe allergic reaction); severe upper abdominal pain with vomiting (possible pancreatitis); seizures; jaundice, very dark urine, or unexplained bruising (possible liver injury); very slow, very fast, or irregular pulse or a fainting episode; severe persistent vomiting that prevents fluid intake; or a patch application site reaction that spreads beyond the patch or worsens after removal.
If gastrointestinal side effects appear during dose escalation, the prescriber may temporarily reduce the dose, extend the titration interval, or switch to a lower-GI-burden formulation such as the transdermal patch. For many patients, symptoms resolve within days of dose adjustment. Persistent adverse effects, significant weight loss (>7% of baseline body weight), or a decline in functional status warrant reassessment of the benefit–risk balance.
All suspected adverse reactions should be reported to the national pharmacovigilance system (for example, MHRA Yellow Card in the UK, FDA MedWatch in the US, or EudraVigilance in the EU via your local competent authority). Reporting helps regulators continuously monitor the benefit–risk balance of approved medicines and identify rare or long-term effects not detected in pre-marketing trials.
How Should You Store Prometax?
Proper storage is essential to maintain the potency and safety of Prometax. Follow the instructions on the outer carton and in the patient information leaflet supplied with your pack, and observe the following general guidance:
- Temperature: Store all formulations at or below 25 °C (77 °F). Do not freeze the oral solution or the patches.
- Packaging: Keep capsules in their original blister strip. Keep transdermal patches sealed in their individual sachets until immediately before use. Keep the oral solution bottle in its original carton, stored upright.
- Oral solution shelf-life after opening: Use within one month of first opening. Do not mix with anything other than cold water, fruit juice, or soda at the time of administration.
- Light and moisture: Protect capsules and patches from excessive moisture and direct sunlight. Do not transfer capsules to a different container.
- Child and pet safety: Used patches still contain significant amounts of rivastigmine and can cause serious harm if handled, chewed, or swallowed. Store new and used patches out of sight and reach of children and pets at all times.
- Expiry date: Do not use Prometax after the expiry date printed on the carton, blister, or sachet (EXP / MM-YYYY). The expiry date refers to the last day of that month.
Disposing of Used Patches Safely
After removing a used patch, fold it firmly in half with the adhesive sides pressed together so that the active drug layer is sealed inside. Place the folded patch back in its original sachet and dispose of it in a household waste bin that children and pets cannot access. Wash your hands thoroughly with soap and water after handling a patch, and avoid touching your eyes. If the patch contacts the eyes, or if your eyes become red after handling a patch, rinse immediately with plenty of water and seek medical advice if symptoms persist.
Do not dispose of medicines through the household drain or toilet. Ask your pharmacist how to dispose of unused or expired Prometax correctly; many countries operate drug-return schemes that help protect the environment and prevent accidental ingestion.
What Does Prometax Contain?
Hard Capsules
Prometax hard capsules contain rivastigmine hydrogen tartrate as the active substance, expressed below in terms of rivastigmine base:
- 1.5 mg capsule: rivastigmine hydrogen tartrate equivalent to 1.5 mg rivastigmine — yellow capsule
- 3 mg capsule: rivastigmine hydrogen tartrate equivalent to 3 mg rivastigmine — orange capsule
- 4.5 mg capsule: rivastigmine hydrogen tartrate equivalent to 4.5 mg rivastigmine — red capsule
- 6 mg capsule: rivastigmine hydrogen tartrate equivalent to 6 mg rivastigmine — red and orange capsule
Excipients of the capsule content include hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, and silica (colloidal anhydrous). The capsule shell contains gelatin, titanium dioxide (E171), and iron oxide colourants (E172). The printing ink contains shellac and iron oxide (E172).
Oral Solution
Prometax oral solution is a clear, yellow solution containing 2.0 mg rivastigmine per mL (as rivastigmine hydrogen tartrate). It is supplied in a 50 mL or 120 mL amber glass bottle with a child-resistant closure, an oral dosing syringe, and a dispensing tube that is inserted into the bottle after first opening. Excipients include sodium benzoate (E211), citric acid monohydrate, sodium citrate, quinoline yellow (E104), and purified water. The solution is useful for patients with dysphagia or for caregivers who cannot reliably give capsules.
Transdermal Patches
Prometax transdermal patches are thin, opaque, beige, four-layer matrix patches that release rivastigmine continuously through the skin over a 24-hour period. The three available patch strengths are defined by the nominal amount of active substance released per 24 hours:
- 4.6 mg/24 hours patch: 5 cm², containing 9 mg rivastigmine
- 9.5 mg/24 hours patch: 10 cm², containing 18 mg rivastigmine
- 13.3 mg/24 hours patch: 15 cm², containing 27 mg rivastigmine
The patches contain additional inactive components: lacquered polyethylene terephthalate (PET) backing film, alpha-tocopherol (as antioxidant), poly(butyl methacrylate, methyl methacrylate), acrylic copolymer, silicone oil, dimethicone, and a fluoropolymer-coated polyester release liner. The patches are latex-free.
Prometax is manufactured for Novartis by sites including Novartis Pharma GmbH (Nürnberg, Germany) and Novartis Farmacéutica, S.A. (Barcelona, Spain), and marketed by Novartis Europharm Limited (Dublin, Ireland). Pack sizes vary by market; typical presentations are 28, 56, or 112 capsules per pack, 50 or 120 mL for the oral solution, and 7 or 30 patches per pack.
Frequently Asked Questions About Prometax
Prometax (rivastigmine) is used for the symptomatic treatment of mild to moderately severe Alzheimer's dementia and of mild to moderately severe dementia in patients with idiopathic Parkinson's disease. It is a cholinesterase inhibitor that raises acetylcholine levels in the brain to help support memory, thinking, and daily functioning. Prometax does not cure either disease but can help maintain cognitive function and independence for a longer period. It is available as hard capsules, an oral solution (2.0 mg/mL), and transdermal patches (4.6, 9.5, or 13.3 mg/24 hours).
The most common side effects of Prometax are gastrointestinal: nausea, vomiting, diarrhoea, loss of appetite, and weight loss. Dizziness, headache, tremor (especially in Parkinson's disease dementia), drowsiness, and fatigue are also frequent. These effects are most pronounced during dose titration and usually improve with time, with food, or after a temporary dose reduction. Transdermal patches cause approximately three times fewer gastrointestinal reactions than capsules at comparable exposure, and may be preferred in patients with significant intolerance.
Prometax capsules are taken twice daily with the morning and evening meal. Treatment starts at 1.5 mg twice daily and is gradually increased by 1.5 mg per dose at intervals of at least two weeks, up to a maximum of 6 mg twice daily (12 mg per day). Capsules should be swallowed whole with water and should never be crushed, chewed, or opened. If swallowing capsules is a problem, ask your doctor about switching to the Prometax oral solution or the transdermal patch.
No, Prometax does not cure Alzheimer's disease or Parkinson's disease. It is a symptomatic treatment that temporarily raises acetylcholine levels in the brain and may help slow the progression of cognitive symptoms for a period. The underlying neurodegenerative processes — loss of cholinergic neurons in Alzheimer's disease and of dopaminergic and cholinergic neurons in Parkinson's disease — continue regardless of treatment, although some patients experience meaningful symptomatic benefit that can translate into maintained independence for months or years.
If Prometax treatment is interrupted for more than three consecutive days, do not resume at the previous dose. Contact your doctor. Treatment must be re-initiated at the lowest starting dose (1.5 mg twice daily for capsules/solution, or 4.6 mg/24h for the patch) and then titrated upward again. Restarting at a higher dose after a treatment gap can cause severe gastrointestinal side effects, including intense vomiting that has in very rare cases led to oesophageal rupture.
Prometax capsules are taken orally twice daily and produce peaks of rivastigmine shortly after each dose. Prometax transdermal patches deliver rivastigmine continuously through the skin over 24 hours, producing steadier plasma levels and around three times fewer gastrointestinal adverse events at comparable exposure. The patch is often preferred for patients with swallowing difficulties, significant nausea with capsules, or caregivers who benefit from a once-daily routine. Both forms contain the same active substance and require the same gradual titration.
Yes, essentially. Prometax and Exelon are two different trade names used by Novartis for the same active ingredient, rivastigmine, produced under the same European regulatory authorisation. Prometax has historically been used in some European markets, while Exelon is the more widely recognised brand globally. The formulations, strengths, indications, and dosage recommendations are identical. Generic rivastigmine from manufacturers such as Sandoz, Teva, and STADA is also therapeutically equivalent.
References
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- Emre M, Aarsland D, Albanese A, et al. Rivastigmine for dementia associated with Parkinson's disease (EXPRESS study). New England Journal of Medicine. 2004;351(24):2509-2518. doi:10.1056/NEJMoa041470
- European Medicines Agency (EMA). Prometax — Summary of Product Characteristics. Available at: www.ema.europa.eu
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- Livingston G, Huntley J, Sommerlad A, et al. Dementia prevention, intervention, and care: 2020 report of the Lancet Commission. The Lancet. 2020;396(10248):413-446. doi:10.1016/S0140-6736(20)30367-6
- Winblad B, Cummings J, Andreasen N, et al. A six-month double-blind, randomized, placebo-controlled study of a transdermal patch in Alzheimer's disease — rivastigmine patch versus capsule. International Journal of Geriatric Psychiatry. 2007;22(5):456-467. doi:10.1002/gps.1788
- Grossberg GT, Farlow MR, Meng X, Velting DM. Evaluating high-dose rivastigmine patch in severe Alzheimer disease: analyses with concomitant memantine usage as a factor. Current Alzheimer Research. 2015;12(1):53-60.
- U.S. Food and Drug Administration (FDA). Exelon (rivastigmine) Prescribing Information. Available at: www.fda.gov
- British National Formulary (BNF). Rivastigmine. Available at: bnf.nice.org.uk
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About the Medical Review Team
This article has been medically reviewed by the iMedic Medical Review Board, an independent panel of specialists in neurology, geriatric medicine, movement disorders, and clinical pharmacology. Our editorial process follows international standards for medical content, including the GRADE evidence framework and guidelines from WHO, EMA, AAN, MDS, and NICE.
All information is based on peer-reviewed research, systematic reviews, and current clinical practice guidelines. Evidence level 1A is used wherever applicable, with lower levels clearly flagged.
iMedic receives no commercial funding and maintains complete editorial independence. No pharmaceutical company sponsorship or advertising influences our content. Conflicts of interest of individual reviewers are declared internally.