Rivastigmine Rosemont 2mg/ml Oral Solution

• 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.

1. What Rivastigmine Rosemont Oral Solution is and what it is used for
2. What you need to know before you take Rivastigmine Rosemont Oral Solution
3. How to take Rivastigmine Rosemont Oral Solution
4. Possible side effects
5. How to store Rivastigmine Rosemont Oral Solution
6. Contents of the pack and other information

• 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 Rosemont.

Talk to your doctor before taking Rivastigmine Rosemont:

• 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 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 Rosemont for more than three days, do not take the next dose until you have talked to your doctor.

There is no relevant use of Rivastigmine Rosemont in the paediatric population in the treatment of Alzheimer’s disease.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Rivastigmine Rosemont should not be given at the same time as other medicines with similar effects to Rivastigmine Rosemont. 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 Rosemont 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 Rosemont, tell your doctor before you are given any anaesthetics, because Rivastigmine may exaggerate the effects of some muscle relaxants during anaesthesia.

Caution when Rivastigmine Rosemont 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.

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 Rosemont must be assessed against the possible effects on your unborn child. Rivastigmine Rosemont should not be used during pregnancy unless clearly necessary.

You should not breast-feed during treatment with Rivastigmine Rosemont.

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.

• less than 1 mmol sodium (23mg) per 1ml, that is to say essentially ‘sodium-free’
• 1 mg sodium benzoate in each ml.

Your doctor will tell you what dose of Rivastigmine Rosemont 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 Rosemont for more than three days, do not take the next dose until you have talked to your doctor.

• Tell your caregiver that you are taking Rivastigmine Rosemont.
• To benefit from your medicine, take it every day.
• Take Rivastigmine Rosemont twice a day, in the morning and evening, with food.

Instructions for use

• Open the bottle: press the cap and turn it anticlockwise (Figure 1).
• Insert the syringe adaptor into the bottle neck (Figure 2).
• Take the syringe and put it in the adaptor opening (Figure 3).
• Turn the bottle upside down (Figure 4).
• Fill the syringe with a small amount of solution by pulling the piston down (Figure 4A). Then push the piston upward in order to remove any possible bubbles (Figure 4B). Finally, pull the piston down to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor (Figure 4C).
• Turn the bottle the right way up (Figure 5A).
• Remove the syringe from the adaptor (Figure 5B).
• Put the end of the syringe into your mouth and push the piston slowly back in to take the medicine. Alternatively, dispense the solution into a small glass of water and take your medicine straight away.
• Wash the syringe with water and let it dry before you use it again (Figure 6).
• Close the bottle with the plastic screw cap - leave the syringe adaptor in the bottle.

If you accidentally take more Rivastigmine Rosemont 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 heartbeat and fainting may also occur.

If you find you have forgotten to take your dose of Rivastigmine Rosemont, wait and take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

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.

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 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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

• The active substance is rivastigmine hydrogen tartrate. Each ml contains rivastigmine hydrogen tartrate corresponding to rivastigmine base 2.0 mg.
• The other ingredients are sodium benzoate (E211), citric acid monohydrate (E330), sodium citrate (E331), quinoline yellow (E104) and purified water.

Rivastigmine Rosemont Oral Solution is a clear yellow solution. It comes in a brown glass bottle holding 120ml of solution with a 3ml oral syringe and bottle adaptor.