Rivastigmine 1.5mg Capsules
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PACKAGE LEAFLET: INFORMATION FOR THE USER
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.
The use of Rivastigmine in children and adolescents (age below 18 years) is not recommended.
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.
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.
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.
Rivastigmine is used for the treatment of memory disorders in patients with Alzheimer's disease.
It is also used for the treatment of dementia in 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 a skin reaction spreading beyond the patch size, if there is a more intense local reaction (such as blisters, increasing skin inflammation, swelling) and if it does not improve within 48 hours after removal of the transdermal patch.
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.
If any of these apply to you, your doctor may need to monitor you more closely while you are on this medicine.
If you have not taken Rivastigmine for several days, do not take the next dose until you have talked to your doctor.
Pregnancy and breast-feeding
Tell your doctor if you become pregnant during treatment. It is preferable to avoid the use of Rivastigmine during pregnancy, unless clearly necessary. You should not breast-feed during treatment with Rivastigmine.
Ask your doctor or pharmacist for advice before taking any medicine.
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.
3 | HOW TO TAKE RIVASTIGMINE
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.
Placement for Pharmacode no.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
^4 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.
The frequencies are defined as:
Very common (affects more than 1 patient in 10).
Common (affects 1 to 10 patients in 100). Uncommon (affects 1 to 10 patients in 1,000). Rare (affects 1 to 10 patients in 10,000).
Very rare (affects less than 1 patient in 10,000). Not known (frequency cannot be estimated from the available data).
Very common
• Feeling dizzy
• Loss of appetite
• Stomach problems such as feeling sick (nausea) or being sick (vomiting), diarrhoea.
Common
• Anxiety
• Sweating
• Headache
• Heartburn
• Weight loss
• Stomach pain
• Feeling agitated
• Feeling tired or weak
• Generally feeling unwell
• Trembling or feeling confused.
Uncommon
• Depression
• Difficulty in sleeping
• Fainting or accidentally falling
• Changes in how well your liver is working.
Rare
• Chest pain
• Rash, itching
• Fits (seizures)
• Ulcers in your stomach or intestine.
Very rare
• 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
• 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 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
• Trembling
• Fainting
• Accidentally falling.
Common
• 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
• 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
• Fever
• Severe confusion.
If you get any of these side effects, contact your doctor as you may need medical assistance.
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.
5 | HOW TO STORE RIVASTIGMINE
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.
©CONTENTS OF THE PACK AND OTHER INFORMATION
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.
4.5 mg: 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-StraGe 3, 89143 Blaubeuren-weiler, Germany.
This leaflet was last revised in January 2013.
PL 00289/1688 PL 00289/1689 PL 00289/1690 PL 00289/1691
195732.03-GB
TEVA UK LIMITED 64201-E