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The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 04569/0942.
Rivastigmine Mylan 1.5 mg, 3 mg, 4.5 mg, 6 mg hard capsules
Rivastigmine 1.5 mg capsules
Rivastigmine 3 mg capsules
Rivastigmine 4.5 mg capsules
Rivastigmine 6 mg capsules
(rivastigmine)
1. What Rivastigmine is and what it is used for
2. What you need to know before you take Rivastigmine
3. How to take Rivastigmine
4. Possible side effects
5. How to store Rivastigmine
6. Contents of the pack and other information
The active substance of this medicine 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, rivastigmine 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.
This medicine is used for the treatment of adult patients with mild to moderately severe Alzheimer’s dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.
This medicine can also be used for the treatment of mild to moderately severe dementia in adult patients with Parkinson’s disease.
Before taking this medicine it is important that you read the following section and discuss any questions you might have with your doctor.
If this applies to you, tell your doctor and do not take Rivastigmine.
Talk to your doctor or pharmacist before taking Rivastigmine:
If any of these apply to you, your doctor may need to monitor you more closely while you are on this medicine.
During treatment
Contact your doctor if you notice any of the following:
If you have not taken Rivastigmine for three days, do not take the next dose until you have talked to your doctor.
There is no relevant use of this medicine for the treatment of Alzheimer’s disease in the paediatric population.
Other medicines and Rivastigmine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Rivastigmine should not be given at the same time as other medicines with similar effects to rivastigmine. Rivastigmine might interfere with anticholinergic medicines (medicines used to relieve stomach cramps or spasms, to treat Parkinson’s disease, to relieve bladder problems (needing to pass water more often or incontinence) e.g. oxybutynin, tolterodine or to prevent travel sickness).
If you have to undergo surgery whilst taking Rivastigmine, you should inform your doctor before you are given any anaesthetics, because rivastigmine may exaggerate the effects of some muscle relaxants during anaesthesia.
Caution should be exercised when rivastigmine is taken together with medicines known as betablockers e.g. atenolol (used to treat high blood pressure, angina and other heart conditions) or timolol (used in eye drops to treat glaucoma). Caution is also required with other medicines which may lower heart rate or rhythm e.g. diltiazem, sotalol, digoxin, pilocarpine. Taking the two medicines together could cause problems such as slowing of the heartbeat (bradycardia) leading to fainting or loss of consciousness.
If you are taking other medicines known to affect the normal rhythm of the heart e.g. chlorpromazine, levomepromazine, sulpiride, sultopride, amisulpride, tiapride, veralipride, pimozide, haloperidol, droperidol (used to treat some mental health conditions), cisapride (used to treat stomach and gut problems), citalopram (used to treat depression), diphemanil (used to treat in stomach disorders), erythromycin IV, moxifloxacin, (antibiotics), halofantrine (used to treat malaria), mizolastine (used to treat allergies), methadone (used for pain and to treat heroin addiction) and pentamidine (a medicine used to treat pneumonia), your doctor may want to carry out regular checks on your heart.
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 taking this medicine.
If you are pregnant, the benefits of using this medicine must be assessed against the possible effects on your unborn child. This medicine should not be used during pregnancy, unless clearly necessary.
You should not breast-feed during treatment with Rivastigmine.
Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely. Rivastigmine may cause dizziness and somnolence (feeling sleepy), mainly at the start of treatment or when increasing the dose. If you feel dizzy or sleepy, do not drive, use machines or perform any tasks that require your attention.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will tell you what dose of this medicine to take.
Your doctor will regularly check if the medicine is working for you. Your doctor will also monitor your weight whilst you are taking this medicine.
If you have not taken this medicine for three days, do not take the next dose until you have talked to your doctor.
If you accidentally take more Rivastigmine than you should, inform your doctor. You may require medical attention. Some people who have accidentally taken too much Rivastigmine have experienced a decrease in the size of the pupils, flushing, stomach pain, difficulty in breathing and increase in phlegm, increased sweating, loss of control of bowel movements, incontinence, increase in production of saliva, increase in tear production, low blood pressure, feeling sick (nausea), being sick (vomiting), diarrhoea, high blood pressure and hearing, seeing and feeling things that are not there (hallucinations). Slow heartbeat and fainting may also occur. In severe cases, muscular weakness, twitching, fits and stopping breathing which may be fatal have occurred. Additionally there have also been reports of dizziness, shaking, headache, excessive sleepiness, confusion, and a general feeling of discomfort (malaise).
If you find you have forgotten to take your dose of Rivastigmine, wait and take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
Do not stop taking your capsules. It is important that you carry on taking Rivastigmine for as long as your doctor tells you. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You may have side effects more often when you start taking your medicine or when your dose is increased. Usually, the side effects will slowly go away as your body gets used to the medicine.
If any of the following serious side effects occur, tell your doctor or seek medical advice immediately:
Rare (may affect up to 1 in 1,000 people):
Very rare (may affect up to 1 in 10,000 people):
Not known (frequency cannot be estimated from the available data):
Other possible side effects:
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1,000 people):
Very rare (may affect up to 1 in 10,000 people):
Not known (frequency cannot be estimated from the available data):
These patients have some side effects more often. They also have some additional side effects:
If any of the following serious side effects occur, tell your doctor or seek medical advice immediately:
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Not known (frequency cannot be estimated from the available data):
Other possible side effects
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
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):
Uncommon (may affect up to 1 in 100 people):
Not known (frequency cannot be estimated from the available data):
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP) that is stated on the blister/bottle and the carton. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is rivastigmine.
Each Rivastigmine 1.5 mg capsule contains 1.5 mg of rivastigmine.
Each Rivastigmine 3 mg capsule contains 3 mg of rivastigmine.
Each Rivastigmine 4.5 mg capsule contains 4.5 mg of rivastigmine.
Each Rivastigmine 6 mg capsule contains 6 mg of rivastigmine.
The other ingredients are:
Contents of Capsule: Cellulose, microcrystalline, Hypromellose, Magnesium stearate, Silica, colloidal anhydrous
Capsule Shell: Yellow iron oxide (E172), Red iron oxide (E172) (3 mg, 4.5 mg, and 6 mg only), Titanium dioxide (E171), Gelatin
Printing Ink:
Red Ink (1.5 mg, 3 mg and 4.5 mg): Iron oxide red (E172), Shellac, Propylene glycol (E1520), Ammonia, Potassium hydroxide.
White Ink (6 mg only): Shellac, Titanium dioxide (E171), Propylene glycol (E1520).
Your medicine comes as a hard capsule containing a white powder.
The 1.5 mg capsule has a yellow body marked “RG 15” in red ink, and a yellow cap marked with “G” in red ink.
The 3 mg capsule has an orange body marked “RG 30” in red ink, and an orange cap marked with “G” in red ink.
The 4.5 mg capsule has a reddish-brown body marked “RG 45” in red ink, and a reddish-brown cap marked with “G” in red ink.
The 6 mg capsule has an orange body marked “RG 60” in white ink, and a reddish-brown cap marked with “G” in white ink, containing a white powder.
Rivastigmine capsules are available in blister and bottle packs of 10, 28, 30, 56, 60, 90, 112, 250 and 500. Not all pack sizes will be marketed.
Marketing Authorisation Holder:
Manufacturer:
This leaflet was last revised in 04/2021.