Rivastigmine Rosemont 2mg/ml Oral Solution

Country: United Kingdom

Language: English

Source: myHealthbox

Active ingredient:

Rivastigmine hydrogen tartrate

Available from:

Rosemont Pharmaceuticals Ltd

ATC code:

N06DA03

INN (International Name):

Rivastigmine hydrogen tartrate

Dosage:

2mg for ml

Pharmaceutical form:

Oral Solution

Administration route:

Oral use

Units in package:

Bottle of 120 ml

Prescription type:

POM - Prescription Only Medicine

Manufactured by:

Rosemont Pharmaceuticals Ltd

Therapeutic group:

Psychoanaleptics, anticholinesterases

Therapeutic indications:

Symptomatic treatment of mild to moderately severe Alzheimer's dementia; symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.

Authorization status:

Authorised

Authorization date:

2015-01-21

Patient Information leaflet

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�

Summary of Product characteristics

Rivastigmine Rosemont 2mg/ml Oral Solution
Summary of Product Characteristics Updated 29­Jun­2015 | Rosemont Pharmaceuticals Limited
1. Name of the medicinal product
Rivastigmine Rosemont 2mg/ml Oral Solution
2. Qualitative and quantitative composition
Each ml contains rivastigmine hydrogen tartrate corresponding to 2 mg rivastigmine.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral solution
A clear yellow solution
4. Clinical particulars
4.1 Therapeutic indications
Symptomatic treatment of mild to moderately severe Alzheimer's dementia.
Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.
4.2 Posology and method of administration
Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer's
dementia or dementia associated with Parkinson's disease. Diagnosis should be made according to current guidelines.
Therapy with rivastigmine should only be started if a caregiver is available who will regularly monitor intake of the
medicinal product by the patient.
Posology
Rivastigmine oral solution should be administered twice a day, with morning and evening meals. The prescribed amount
of solution should be withdrawn from the container using the oral dosing syringe supplied. Rivastigmine oral solution
may be swallowed directly from the syringe. Rivastigmine oral solution and rivastigmine capsules may be interchanged
at equal doses.
Initial dose
1.5 mg twice a day
Dose titration
The starting dose is 1.5 mg twice a day. If this dose is well tolerated after a minimum of two weeks of treatment, the
dose may be increased to 3 mg twice a day. Subsequent increases to 4.5 mg and then 6 mg twice a day should also be
based on good tolerability of the curr