Rivetal

Rivastigmine.

Each capsule contains 1.5 mg of rivastigmine.
Each capsule contains 3.0 mg of rivastigmine.
Each capsule contains 4.5 mg of rivastigmine.
Each capsule contains 6.0 mg of rivastigmine.
The active substance is rivastigmine hydrogen tartrate.
Excipients/Inactive Ingredients: The other ingredients are Hypromellose (E464), magnesium stearate (E572), microcrystalline cellulose (E460), Silica colloidal anhydrous (E551).
Capsule shell: gelatin (E441), yellow iron oxide (E172), titanium dioxide (E171), iron oxide red, E172 (only for the 3.0, 4.5 & 6.0 mg capsule shells) and printing ink.
Printing ink contains shellac, Anhydrous ethanol, isopropyl alcohol, butyl alcohol, propylene glycol, concentrated ammonia solution, iron oxide black and potassium Hydroxide.

The active substance of Rivetal is rivastigmine. Rivastigmine belongs to a class of substances called cholinesterase inhibitors. In patients with Alzheimer's dementia or dementia due to Parkinson's disease, certain nerve cells die in the brain, resulting in low levels of the neurotransmitter acetylcholine (a substance that allows nerve cells to communicate with each other). Rivastigmine works by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase. By blocking these enzymes, Rivetal allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer's disease and dementia associated with Parkinson's disease.

Rivetal is used for the treatment of adult patients with mild to moderately severe Alzheimer's dementia and mild to moderately severe dementia associated with Parkinson's disease.

Always take this medicine exactly as described below and as the doctor has instructed. Check with the doctor, pharmacist or nurse if not sure.
How to start treatment: The doctor will tell what dose of Rivetal to take.
Treatment usually starts with a low dose.
The doctor will slowly increase the dose depending on the response to treatment.
The highest dose that should be taken is 6.0 mg twice a day.
The doctor will regularly check if the medicine is working. The doctor will also monitor the weight whilst taking this medicine.
If the patient has not taken Rivetal for more than three days, do not take the next dose until the patient talks to the doctor.
Taking this medicine: Tell the caregiver that the patient is taking Rivetal.
To benefit from the medicine, take it every day.
Take Rivetal twice a day, in the morning and evening, with food.
Swallow the capsules whole with a drink.
Do not open or crush the capsules.
If the patient forgets to take Rivetal: If the patient forgets to take the dose of Rivetal, wait and take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
For any further questions on the use of this medicine, ask the doctor or pharmacist.

If the patient takes more Rivetal than necessasry: If the patient accidentally takes more Rivetal than necessary, inform the doctor. The patient may require medical attention. Some people who have accidentally taken too much Rivetal have experienced feeling sick (nausea), being sick (vomiting), diarrhoea, high blood pressure and hallucinations. Slow heartbeat and fainting may also occur.

Do not take Rivetal: if the patient is allergic to rivastigmine (the active substance in Rivetal) or any of the other ingredients of this medicine (listed in Description).

Talk to the doctor before taking Rivetal: If the patient has, or has ever had, irregular heartbeat.
If the patient has, or has ever had, an active stomach ulcer.
If the patient has, or has ever had, difficulties in passing urine.
If the patient has, or has ever had, seizures.
If the patient has, or has ever had, asthma or severe respiratory disease.
If the patient has, or has ever had, impaired kidney function.
If the patient has, or has ever had, impaired liver function.
If the patient suffers from trembling.
If the patient has a low body weight.
If the patient has gastrointestinal reactions such as feeling sick (nausea), being sick (vomiting) and diarrhoea. The patient may become dehydrated (losing too much fluid) if vomiting or diarrhoea are prolonged.
If any of these apply, the doctor may need to monitor the patient more closely while on this medicine.
If Rivetal has not been taken for more than three days, do not take the next dose until the patient talks to the doctor.
Driving and using machines: The doctor will tell whether the illness would allow the patient to drive vehicles and use machines safely. Rivetal may cause dizziness and somnolence, mainly at the start of treatment or when increasing the dose. If the patient feels dizzy or sleepy, do not drive, use machines or perform any tasks that require attention.
Use in children and adolescents: There is no relevant use of Rivetal in the paediatric population in the treatment of Alzheimer's disease.

Pregnancy, breast-feeding and fertility: If the patient is pregnant or breast-feeding, thinks she may be pregnant or is planning to have a baby, ask the doctor or pharmacist for advice before taking this medicine.
If the patient is pregnant, the benefits of using Rivetal must be assessed against the possible effects on the unborn child. Rivetal should not be used during pregnancy unless clearly necessary. The patient should not breast-feed during treatment with Rivetal.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects may be more often when starting the medicine or when the dose is increased. Usually, the side effects will slowly go away as the body gets used to the medicine.
Very common (may affect more than 1 in 10 people): Feeling dizzy, Loss of appetite, Stomach problems such as feeling sick (nausea) or being sick (vomiting), diarrhoea.
Common (may affect up to 1 in 10 people): Anxiety, Sweating, Headache, Heartburn, Weight loss, Stomach pain, Feeling agitated, Feeling tired or weak, Generally feeling unwell, Trembling or feeling confused, Decreased appetite, Nightmares.
Uncommon (may affect up to 1 in 100 people): Depression, Difficulty in sleeping, Fainting or accidentally falling, Changes in how well the liver is working.
Rare (may affect up to 1 in 1,000 people): Chest pain; Rash, itching; Fits (seizures); Ulcers in the stomach or intestine.
Very rare (may affect up to 1 in 10,000 people): High blood pressure; Urinary tract infection; Seeing things that are not there (hallucinations); Problems with the heartbeat such as fast or slow heartbeat; Bleeding in the gut - shows as blood in stools or when being sick; Inflammation of the pancreas - the signs include serious upper stomach pain, often with feeling sick (nausea) or being sick (vomiting); The signs of Parkinson's disease get worse or getting similar signs - such as stiff muscles, difficulty in carrying out movements.
Not known (frequency cannot be estimated from the available data): Being violently sick (vomiting) that can cause tearing of the tube that connects the mouth with the stomach (oesophagus); Dehydration (losing too much fluid); Liver disorders (yellow skin, yellowing of the whites of the eyes, abnormal darkening of the urine or unexplained nausea, vomiting, tiredness and loss of appetite); Aggression, feeling restless; Uneven heartbeat.
Patients with dementia and Parkinson's disease: These patients have some side effects more often. They also have some additional side effects: Very common (may affect more than 1 in 10 people): Trembling, Fainting, Accidentally falling.
Common (may affect up to 1 in 10 people): Anxiety; Feeling restless; Slow and fast heartbeat; Difficulty in sleeping; Too much saliva and dehydration; Unusually slow movements or uncontrollable movements; The signs of Parkinson's disease get worse or getting similar signs - such as stiff muscles, difficulty in carrying out movements and muscle weakness.
Uncommon (may affect up to 1 in 100 people): Uneven heartbeat and poor control of movements.
Other side effects seen with Rivastigmine transdermal patches and which may occur with the hard capsules: Common (may affect up to 1 in 10 people): Fever, Severe confusion, Urinary incontinence (inability to retain adequate urine).
Uncommon (may affect up to 1 in 100 people): Hyperactivity (high level of activity, restlessness).
Not known (frequency cannot be estimated from the available data): Allergic reaction where the patch was used, such as blisters or skin inflammation.
If any of these side effects occur, contact the doctor as medical assistance may be needed.
Reporting Side effects: If any side effects occur, talk to the doctor, pharmacist or nurse. This includes any possible side effects not listed. Side effects can also be reported directly via the national reporting system.

Tell the doctor or pharmacist if the patient is taking, has recently taken or might take any other medicines, including medicines obtained without a prescription.
Rivetal should not be given at the same time as other medicines with similar effects to Rivetal. Rivetal might interfere with anticholinergic medicines (medicines used to relieve stomach cramps or spasms, to treat Parkinson's disease or to prevent travel sickness).
Rivetal should not be given at the same time as metoclopramide (a medicine used to relieve or prevent nausea and vomiting). Taking the two medicines together could cause problems such as stiff limbs and trembling hands.
If the patient has to undergo surgery whilst taking Rivetal, tell the doctor before the patient is given any anaesthetics, because Rivetal may exaggerate the effects of some muscle relaxants during anaesthesia.
Caution when Rivetal is taken together with beta-blockers (medicines such as atenolol used to treat hypertension, angina and other heart conditions). Taking the two medicines together could cause problems such as slowing of the heartbeat (bradycardia) leading to fainting or loss of consciousness.

Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer used. These measures will help protect the environment.

Neurodegenerative Disease Drugs

N06DA03 - rivastigmine ; Belongs to the class of anticholinesterases. Used in the management of dementia.

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