Rivastigmine 3mg Capsules
TEVA UK Ref: 231-30-64201-F LEA RIVASTIGMINE A/S CAPS TUK <TORR Version: 1 04 August 2015
Rivastigmine 1.5 mg Capsules Rivastigmine 3 mg Capsules Rivastigmine 4.5 mg Capsules Rivastigmine 6 mg Capsules
Rivastigmine
If any of these apply to you, your doctor may need to monitor you more closely while you are on this medicine.
Package leaflet: Information for the user
Placement for Pharmacode no.
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Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
If you have not taken Rivastigmine for several days, do not take the next dose until you have talked to your doctor.
Children and adolescents There is no relevant use of Rivastigmine in the paediatric population in the treatment of Alzheimer's disease.
WHAT IS IN THIS LEAFLET:
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
OWHAT RIVASTIGMINE IS AND WHAT IT IS USED FOR
The active substance of Rivastigmine 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.
Rivastigmine is used for the symptomatic treatment of in adult patients with mild to moderately severe Alzheimer's demetia, a progression brain disorder that gradually affects memory, intellectual ability and behaviour. The capsules can also be used for the symptomatic treatment of mild to moderately severe dementia in adult patients with Parkinson's disease.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RIVASTIGMINE
Do not take Rivastigmine
• if you are allergic to rivastigmine (the active substance in Rivastigmine), to other substances related to rivastigmine or any of the other ingredients of this medicine (listed in section 6).
• if you have had a previous skin reaction suggestive of allergic contact dermatitis with rivastigmine patches.
If this applies to you, tell your doctor and do not take Rivastigmine.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Rivastigmine.
• if you have, or have ever had, irregular heartbeat.
• if you have, or have ever had, an active stomach ulcer
• if you have, or have ever had, difficulties in passing urine.
• if you have, or have ever had, seizures.
• if you have, or have ever had, asthma or severe respiratory disease.
• if you have, or have ever had impaired kidney function
• if you have, or have ever had, impaired liver function.
• if you suffer from trembling.
• if you have a low body weight.
• if you have gastrointestinal reactions such as feeling sick (nausea), being sick (vomiting) and diarrhoea. You may become dehydrated (losing too much fluid) if vomiting or diarrhoea are prolonged.
Other medicines and Rivastigmine
Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines, including medicines obtained without a prescription.
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 or to prevent travel sickness).
If you have to undergo surgery whilst taking Rivastigmine, tell your doctor before you are given any anaesthetics, because Rivastigmine may exaggerate the effects of some muscle relaxants during anaesthesia.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, thick 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 Rivastigmine must be assessed against the possible effects on your unborn child. Rivastigmin should not be used during pregnancy unless clearly necessary. You should not breast-feed during treatment with Rivastigmine
Driving and using machines Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely. Rivastigmine may cause dizziness and somnolence, 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 has told you. Check with your doctor or pharmacist if you are not sure.
How to start treatment
Your doctor will tell you what dose of Rivastigmine to take
• Treatment usually starts with a low dose.
• Your doctor will slowly increase your dose depending on how you respond to treatment.
The highest dose that should be taken is 6 mg twice a day.
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 Rivastigmine for several days, do not take the next dose until you have talked to your doctor.
Taking this medicine
• Tell your caregiver that you are taking Rivastigmine.
• To benefit from your medicine, take it every day.
• Take Rivastigmine 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 you take more Rivastigmine than you should
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 feeling sick (nausea), being sick (vomiting), diarrhoea, high blood pressure and hallucinations. Slow heart-beat and fainting may also occur.
If you forget to take Rivastigmine
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.
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If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
^ POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You may have side effects more often when you start your medicine or when your dose is increased. Usually, the side effects will slowly go away as your 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
Uncommon (may affect up to 1 in 100 people)
• Depression
• Difficulty in sleeping
• Fainting or accidentally falling
• Changes in how well your liver is working Rare (may affect up to 1 in 1,000 people)
• Chest pain
• Rash, itching
• Fits (seizures)
• Ulcers in your stomach or intestine
Very rare (may affect up to 1 in 10,000 people)
• High blood pressure
• Urinary tract infection
• Seeing and hearing things that are not there (hallucinations)
• Problems with your 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 your mouth with your 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
• Depression
• Seeing things that are not there (hallucinations, visual)
• High blood pressure
• Slow and fast heartbeat
• Difficulty in sleeping
• Too much saliva and dehydration
• Unusually slow movements or movements you cannot control
• 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
• Low blood pressure
Other side effects seen with rivastigmine-containing transdermal patches and which may occur with the hard capsules:
Common (may affect up to 1 in 10 people)
• Fever
• Severe confusion
• Decreased appetite
• 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 you get any of these side effects, contact your doctor as you may need medical assistance.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible 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 reach and sight of children.
Do not use this medicine after the expiry date which is stated on the outer carton and the blister. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
What Rivastigmine contains
The active substance is rivastigmine.
Each capsule contains 1.5 mg, 3 mg, 4.5 mg or 6 mg rivastigmine as rivastigmine hydrogen tartrate.
The other ingredients are:
Capsule shell:
1.5 mg:
Gelatin, Sodium Lauril Sulfate, Titanium Dioxide (E171), Yellow Iron Oxide (E172)
3 mg, 4.5 mg, 6 mg:
Gelatin, Sodium Lauril Sulfate, Titanium Dioxide (E171), Yellow Iron Oxide (E172), Red Iron Oxide (E172)
Contents:
Microcrystalline Cellulose, Hypromellose, Silica colloidal anhydrous, Magnesium Stearate
What Rivastigmine looks like and contents of the pack
1.5 mg: Yellow capsules, hard.
3 mg: Orange capsules, hard.
4.5mg: Red capsules, hard.
6 mg: Capsules, hard with orange body and red cap.
Rivastigmine is available in packs containing 20, 28, 30, 56, 60, 100, 112 or 120 capsules, hard.
Not all pack sizes may be marketed.
Marketing authorisation holder
Teva UK Limited, Eastbourne, BN22 9AG, United
Kingdom
Manufacturer
Merckle GMBH Ludwig-Merckle-StraRe 3, 89143
Blaubeuren-weiler, Germany
This leaflet was last revised in July 2015
PL 00289/1688
PL 00289/1689
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64201-F