Mirapexin 0.35mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Pramipexole dihydrochloride monohydrate

Available from:

Boehringer Ingelheim Ltd

ATC code:

N04BC05

INN (International Name):

Pramipexole dihydrochloride monohydrate

Dosage:

350microgram

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04090100; GTIN: 5012816086104 5012816086111

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
MIRAPEXIN® 0.088 MG TABLETS
MIRAPEXIN® 0.18 MG TABLETS
MIRAPEXIN® 0.35 MG TABLETS
MIRAPEXIN® 0.7 MG TABLETS
MIRAPEXIN® 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 of the 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 MIRAPEXIN is and what it is used for
2. What you need to know before you take
MIRAPEXIN
3. How to take MIRAPEXIN
4. Possible side effects
5. How to store MIRAPEXIN
6. Contents of the pack and other information
1. WHAT MIRAPEXIN IS AND WHAT IT IS USED FOR
MIRAPEXIN 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.
MIRAPEXIN 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).
- treat the symptoms of moderate to severe
primary Restless Legs Syndrome in adults.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MIRAPEXIN
DO NOT TAKE MIRAPEXIN:
- if you are allergic to pramipexole or to any of
the other ingredients of this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking MIRAPEXIN. 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 feeling things
that are not there). Most ha

Summary of Product characteristics

OBJECT 1
MIRAPEXIN 0.088 MG TABLETS
Summary of Product Characteristics Updated 16-Feb-2018 | Boehringer
Ingelheim Limited
1. Name of the medicinal product
MIRAPEXIN 0.088 mg tablets
MIRAPEXIN 0.18 mg tablets
MIRAPEXIN 0.35 mg tablets
MIRAPEXIN 0.7 mg tablets
MIRAPEXIN 1.1 mg tablets
2. Qualitative and quantitative composition
MIRAPEXIN 0.088 mg tablets
Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate
equivalent to 0.088 mg
pramipexole.
MIRAPEXIN 0.18 mg tablets
Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate
equivalent to 0.18 mg
pramipexole.
MIRAPEXIN 0.35 mg tablets
Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate
equivalent to 0.35 mg
pramipexole.
MIRAPEXIN 0.7 mg tablets
Each tablet contains 1.0 mg pramipexole dihydrochloride monohydrate
equivalent to 0.7 mg pramipexole.
MIRAPEXIN 1.1 mg tablets
Each tablet contains 1.5 mg pramipexole dihydrochloride monohydrate
equivalent to 1.1 mg pramipexole.
_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
MIRAPEXIN 0.088 mg tablets
The tablets are white, flat, of round shape, and have a code embossed
(one side with the code P6, and one
side with the Boehringer Ingelheim company symbol).
MIRAPEXIN 0.18 mg tablets
The tablets are white, flat, of oval shape, scored on both sides, and
have a code embossed (one side with
the code P7, and one side with the Boehringer Ingelheim company
symbol).
Tablets can be divided into equal halves.
MIRAPEXIN 0.35 mg tablets
The tablets are white, flat, of oval shape, scored on both sides, and
have a code embossed (one side with
the code P8, and one side with the Boehringer Ingelheim company
symbol).
Tablets can be divided into equal halves.
MIRAPEXIN 0.7 mg tablets
The tablets are white, flat, of round shape, scored on both sides, and
have a code embossed (one