Rivastigmine 2mgml oral solution sugar free

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktif bileşen:

Rivastigmine hydrogen tartrate

Mevcut itibaren:

Rosemont Pharmaceuticals Ltd

ATC kodu:

N06DA03

INN (International Adı):

Rivastigmine hydrogen tartrate

Doz:

2mg/1ml

Farmasötik formu:

Oral solution

Uygulama yolu:

Oral

Sınıf:

No Controlled Drug Status

Reçete türü:

Valid as a prescribable product

Ürün özeti:

BNF: 04110000; GTIN: 5016119316791

Bilgilendirme broşürü

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
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Keep this leaflet. You may need to read it again.
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If you have any further questions, ask your doctor, pharmacist or
nurse.
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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.
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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 N

Ürün özellikleri

OBJECT 1
RIVASTIGMINE ROSEMONT 2MG/ML ORAL SOLUTION
Summary of Product Characteristics Updated 09-Mar-2016 | 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 current
dose and may be considered after a
minimum of two weeks of treatment at that dose level.
If adverse reactions (e.g. nausea, vomiting, abdominal pain or loss of
appetite), weight decrease or
worsening of extrapyramidal symptoms (