Oprymea 0.52mg modified-release tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Pramipexole dihydrochloride monohydrate

Available from:

Consilient Health Ltd

ATC code:

N04BC05

INN (International Name):

Pramipexole dihydrochloride monohydrate

Dosage:

520microgram

Pharmaceutical form:

Modified-release tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04090100; GTIN: 5391512452414

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OPRYMEA 0.26 MG PROLONGED-RELEASE TABLETS
OPRYMEA 0.52 MG PROLONGED-RELEASE TABLETS
OPRYMEA 1.05 MG PROLONGED-RELEASE TABLETS
OPRYMEA 1.57 MG PROLONGED-RELEASE TABLETS
OPRYMEA 2.1 MG PROLONGED-RELEASE TABLETS
OPRYMEA 2.62 MG PROLONGED-RELEASE TABLETS
OPRYMEA 3.15 MG PROLONGED-RELEASE TABLETS
Pramipexole
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 or pharmacist.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Oprymea is and what it is used for
2.
What you need to know before you take Oprymea
3.
How to take Oprymea
4.
Possible side effects
5.
How to store Oprymea
6.
Contents of the pack and other information
1.
WHAT OPRYMEA IS AND WHAT IT IS USED FOR
Oprymea contains the active substance pramipexole and belongs to a
group of medicines known as
dopamine agonists, which stimulate dopamine receptors in the brain.
Stimulation of the dopamine
receptors triggers nerve impulses in the brain that help to control
body movements.
Oprymea is used to treat the symptoms of primary Parkinson’s disease
in adults. It can be used alone
or in combination with levodopa (another medicine for Parkinson’s
disease).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE OPRYMEA
DO NOT TAKE OPRYMEA:
-
if you are allergic to pramipexole or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Oprymea. Tell your doctor if you
have (had) or develop any medical
conditions or symptoms, especially any of the following:
-
Kidney disease.
-
Hallucinations (seeing, hearing or feel

Summary of Product characteristics

OBJECT 1
OPRYMEA 0.52 MG PROLONGED-RELEASE TABLETS
Summary of Product Characteristics Updated 20-May-2016 | Consilient
Health Ltd
1. Name of the medicinal product
Oprymea 0.52 mg prolonged-release tablets
2. Qualitative and quantitative composition
Each prolonged-release tablet contains 0.52 mg pramipexole (as 0.75 mg
pramipexole dihydrochloride
monohydrate).
_Please note:_
Pramipexole doses as published in the literature refer to the salt
form.
Therefore, doses will be expressed in terms of both pramipexole base
and pramipexole salt (in brackets).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged-release tablet
White or almost white, round (diameter 10 mm), slightly biconvex
tablets engraved with P2 on one side,
with bevelled edges and possible spots.
4. Clinical particulars
4.1 Therapeutic indications
Oprymea is indicated in adults for treatment of the signs and symptoms
of idiopathic Parkinson's disease,
alone (without levodopa) or in combination with levodopa, i.e. over
the course of the disease, through to
late stages when the effect of levodopa wears off or becomes
inconsistent and fluctuations of the
therapeutic effect occur (end of dose or "on off" fluctuations).
4.2 Posology and method of administration
Posology
Oprymea prolonged-release tablets are a once-a-day oral formulation of
pramipexole.
_Initial treatment_
Doses should be increased gradually from a starting dose of 0.26 mg of
base (0.375 mg of salt) per day
and then increased every 5 - 7 days. Providing patients do not
experience intolerable undesirable effects,
the dose should be titrated to achieve a maximal therapeutic effect.
Ascending dose schedule of Oprymea prolonged-release tablets
Week
Daily dose (mg of base)
Daily dose (mg of salt)
1
0.26
0.375
2
0.52
0.75
3
1.05
1.5
If a further dose increase is necessary the daily dose should be
increased by 0.52 mg of base (0.75 mg of
salt) at weekly intervals up to a maximum dose of 3.15 mg of base (4.5
mg of salt) per day. However, it
should be noted that the incide