Rivastigmine 2mg/Ml Oral Solution
If any of these apply to you, your doctor may need to monitor you more closely while you are on this medicine.
Rivastigmine 2 mg/ml oral solution
rivastigmine
Package leaflet: Information for the
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, pharmacist, or nurse.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
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 2mg/ml oral solution 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 treatment of adult patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour. The capsules and oral solution can also be used for the treatment of 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 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 before taking Rivastigmine:
• if you have, or have ever had, irregular or slow 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 you have not taken Rivastigmine for more than three 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.
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 or to prevent travel sickness). Rivastigmine 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 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.
Caution when Rivastigmine 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.
Pregnancy, breast-feeding and fertility
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 Rivastigmine must be assessed against the possible effects on your unborn child. Rivastigmine 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.
Important information about some of the ingredients of Rivastigmine
One of the inactive ingredients in Rivastigmine oral solution is sodium benzoate. Benzoic acid is a mild irritant to the skin, eyes and mucous membranes. This medicinal product also contains very small amounts of glucose, a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Glucose may be harmful to the teeth.
^3 How to take Rivastigmine
Always take this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse 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 the treatment
• The highest dose that should be taken is 6.0 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 more than three 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.
How to use this medicine
1. Push down and turn child resistant cap to open the bottle. (Fig 1)
2. Keep the bottle upright on a flat surface and insert the plastic bottle adapter into the open end of the bottle. The adaptor is provided so that you can fill the syringe with medicine from the bottle. (Fig 2)
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3. Insert the tip of the oral dosing syringe into opening of the bottle adapter. (Fig 3)
4. Turn the bottle upside down while holding the syringe in place.
Slowly pull back the plunger of the syringe to the numbered line on the syringe that indicates the prescribed dose (graduation mark).
For example, for a dose of 1.5 mg, withdraw the oral solution up to the 1.5 mg graduation mark. (Fig 4)
Warning: The syringe is marked in mg not ml. It should not be used with any other medicine. Keep the syringe in the original carton with your medicine.
5. Before removing the syringe from the bottle make sure that there are no large bubbles in the syringe. If large bubbles are visible depress the plunger back into syringe and withdraw the dose again (see step 4). The presence of a few tiny bubbles will not affect the dose.
6. When the required dose is withdrawn into the syringe, turn the bottle back into the upright position with the syringe still in place. Remove the syringe from the bottle. (Fig 5)
7. Put the tip of the syringe into the mouth. Point the tip of the syringe to the inside of the cheek. Slowly push the plunger of the syringe and swallow the solution. Alternatively put the tip of the syringe into a small glass of water. Slowly push the plunger. Mix the resulting solution in the glass and then drink the mixture.
8. Replace the cap and close the bottle, leaving the bottle adapter in place.
Warning: Store the bottle in the upright position.
9. Clean the syringe after each use by pulling the plunger out of the syringe and washing both parts in warm soapy water. Rinse in clean water and then allow both parts to air dry.
10. Push the plunger back into the syringe. Keep the syringe in the original carton with your medicine.
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.
Fig 3
• 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 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 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. Other side effects seen with rivastigmine transdermal patches and which may occur with the oral solution:
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 you get any of these side effects, contact your doctor as you may need medical assistance.
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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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.
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.
Keep this medicine out of the sight and reach of children.
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.
Do not use this medicine after the expiry date which is stated on the bottle and the carton after 'EXP:'. The expiry date refers to the last day of that month.
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 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 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
Store the bottle in an upright position.
Use Rivastigmine 2 mg/ml oral solution within 1 month of opening the bottle.
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 to protect the environment.
©Contents of the pack and other information
What Rivastigmine oral solution contains
• The active substance is rivastigmine (as hydrogen tartrate). Each ml of solution contains 2.0 mg of rivastigmine
• The other ingredients are sodium benzoate (E211), sodium citrate, citric acid anhydrous, purified water and yellow 06 098 dye which contains quinoline yellow (E104), glucose, sodium sulphate and silicon dioxide (E551).
What Rivastigmine 2 mg/ml oral solution looks like and contents of the pack
Rivastigmine 2 mg/ml oral solution is available as 120 ml of a clear greenish-yellow solution in a brown glass bottle closed with a child-resistant cap. The bottle of oral solution is packaged with a plastic oral dosing syringe and a plastic press-in bottle adapter.
Marketing Authorisation Holder
PLIVA Pharma Limited, Ridings Point, Whistler
Drive, Castleford, West Yorkshire, WF10 5HX
Manufacturer
Teva Operations Poland Sp. z.o.o., ul. Mogilska
80, 31-546, Krakow Poland
This leaflet was last revised in 09/ 2015.
PL 10622/0450
88346-E
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