Oprymea 0.088mg 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:

88microgram

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04090100; GTIN: 5391512451202

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OPRYMEA 0.088 MG TABLETS
OPRYMEA 0.18 MG TABLETS
OPRYMEA 0.35 MG TABLETS
OPRYMEA 0.7 MG TABLETS
OPRYMEA 1.1 MG 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 or have had or develop any
medical conditions or symptoms, especially any of the following:
-
Kidney disease.
-
Hallucinations (seeing, hearing or feeling things that are not there).
Most hallucinations are
visual.
-
Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs). If
you have advanced
Parkinson’s disea

Summary of Product characteristics

OBJECT 1
OPRYMEA 0.088MG TABLETS
Summary of Product Characteristics Updated 20-May-2016 | Consilient
Health Ltd
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Oprymea 0.088 mg tablets
2. Qualitative and quantitative composition
Each tablet contains 0.088 mg pramipexole (as 0.125 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
Tablet.
White, round, with bevelled edges and imprint "P6" on one side of the
tablet.
4. Clinical particulars
4.1 Therapeutic indications
Oprymea is indicated 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