RIVASTIGMINE ROSEMONT 2 MG / ML ORAL SOLUTION - patient leaflet, side effects, dosage

5. how to store rivastigmine rosemont oral solution

n Keep this medicine out of the sight and reach of children.

n Do not use this medicine after the expiry date which is stated on the carton and the bottle label after EXP. The expiry date refers to the last day of that month.

n Do not store above 30°C. Do not refrigerate or freeze.

n Use within 1 month of opening the bottle.

n 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.

6. contents of the pack and other information

What Rivastigmine Rosemont Oral Solution contains

n The active substance is rivastigmine hydrogen tartrate. Each ml contains rivastigmine hydrogen tartrate corresponding to rivastigmine base 2.0 mg.

n The other ingredients are sodium benzoate (E211), citric acid monohydrate (E330), sodium citrate (E331), quinoline yellow (E104) and purified water.

What Rivastigmine Rosemont Oral Solution looks like and contents of the pack

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.

Marketing Authorisation Holder and Manufacturer

Rosemont Pharmaceuticals Ltd, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK.

Tel: + 44 (0) 113 244 1400

This leaflet was last revised in 09/2019.

Rosemont^

Rivastigmine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

n Keep this leaflet. You may need to read it again.

n If you have any further questions, ask your doctor, pharmacist or nurse.

n 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.

n 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 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

1. what rivastigmine rosemont oral solution is and what it is used for

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 Rosemont 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 oral solution can also be used for the treatment of dementia in adult patients with Parkinson’s di­sease.

2. what you need to know before you take rivastigmine rosemont oral solution

Do not take Rivastigmine Rosemont

n if you are allergic to rivastigmine or any of the other ingredients of this medicine (listed in section 6)

n 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.

Warnings and precautions

Talk to your doctor before taking Rivastigmine Rosemont: n if you have, or have ever had, irregular or slow heartbeat

n if you have, or have ever had, an active stomach ulcer

n if you have, or have ever had, difficulties in passing urine

n if you have, or have ever had, seizures

n if you have, or have ever had, asthma or severe respiratory disease n if you have, or have ever had, impaired kidney function

n if you have, or have ever had, impaired liver function

n if you suffer from trembling n if you have a low body weight n 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.

Children and adolescents

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

Other medicines and Rivastigmine Rosemont

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. Continued overleaf

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 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.

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.

Rivastigmine Rosemont Oral Solution contains:

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

• – 1 mg sodium benzoate in each ml.

3. how to take rivastigmine rosemont oral solution

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 Rosemont to take.

n Treatment usually starts with a low dose.

n Your doctor will slowly increase your dose depending on how you respond to the treatment.

n 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.

Taking this medicine

n Tell your caregiver that you are taking Rivastigmine Rosemont.

n To benefit from your medicine, take it every day.

n Take Rivastigmine Rosemont twice a day, in the morning and evening, with food.

Measuring your dose

Instructions for use

n Open the bottle: press the cap and turn it anticlockwise (Figure 1).

n Insert the syringe adaptor into the bottle neck (Figure 2).

n Take the syringe and put it in the adaptor opening (Figure 3).

n Turn the bottle upside down (Figure 4).

n 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).

n Turn the bottle the right way up (Figure 5A).

n Remove the syringe from the adaptor (Figure 5B).

n 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.

n Wash the syringe with water and let it dry before you use it again (Figure 6).

n Close the bottle with the plastic screw cap – leave the syringe adaptor in the bottle.

If you take more Rivastigmine Rosemont Oral Solution than you should

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 forget to take Rivastigmine Rosemont Oral Solution

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.

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.

Very common (may affect more than 1 in 10 people)

n Feeling dizzy

n Loss of appetite

n Stomach problems such as feeling sick (nausea) or being sick (vomiting), diarrhoea.

Common (may affect up to 1 in 10 people) n Anxiety n Sweating n Headache n Heartburn n Weight loss n Stomach pain n Feeling agitated n Feeling tired or weak n Generally feeling unwell n Trembling or feeling confused n Decreased appetite n Nightmares.

Uncommon (may affect up to 1 in 100 people) n Depression

n Difficulty in sleeping

n Fainting or accidentally falling

n Changes in how well your liver is working.

Rare (may affect up to 1 in 1,000 people)

n Chest pain

n Rash, itching

n Fits (seizures)

n Ulcers in your stomach or intestine.

Very rare (may affect up to 1 in 10,000 people)

n High blood pressure

n Urinary tract infection

n Seeing things that are not there (hallucinations)

n Problems with your heartbeat such as fast or slow heartbeat

n Bleeding in the gut – shows as blood in stools or when being sick

n Inflammation of the pancreas – the signs include serious upper stomach pain, often with feeling sick (nausea) or being sick (vomiting)

n 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)

n Being violently sick (vomiting) that can cause tearing of the tube that connects your mouth with your stomach (oesophagus)

n Dehydration (losing too much fluid)

n 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)

n Aggression, feeling restless

n 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)

n Trembling

n Fainting

n Accidentally falling.

Common (may affect up to 1 in 10 people)

n Anxiety

n Feeling restless

n Slow and fast heartbeat

n Difficulty in sleeping

n Too much saliva and dehydration

n Unusually slow movements or movements you cannot control

n 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) n 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)

n Fever

n Severe confusion

n Urinary incontinence (inability to retain adequate urine).

Uncommon (may affect up to 1 in 100 people)

n Hyperactivity (high level of activity, restlessness).

Not known (frequency cannot be estimated from the available data)

n 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.

Continued overleaf