Miramel 0.088 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Pramipexole

Available from:

Clonmel Healthcare Ltd

ATC code:

N04BC; N04BC05

INN (International Name):

Pramipexole

Dosage:

0.088 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Dopamine agonists; pramipexole

Authorization status:

Marketed

Authorization date:

2009-03-06

Patient Information leaflet

Page 1 of 9
Package leaflet: Information for the user
MIRAMEL 0.088MG TABLETS
MIRAMEL 0.18MG TABLETS_ _
MIRAMEL 0.7MG 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 Miramel is and what it is used for
2. What you need to know before you take Miramel
3. How to take Miramel
4. Possible side effects
5. How to store Miramel
6. Contents of the pack and other information
1. WHAT MIRAMEL IS AND WHAT IT IS USED FOR
Miramel 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. MIRAMEL 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 MIRAMEL
DO NOT TAKE MIRAMEL
•
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 Miramel. 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 hallucinations are visual.
•
Dyskinesia (e.g. abnormal, uncontr

Summary of Product characteristics

Health Products Regulatory Authority
22 March 2024
CRN00F3SD
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Miramel 0.088 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 0.125 mg pramipexole dihydrochloride monohydrate
equivalent to 0.088 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.
White to off-white, round tablet, plain on both sides.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Miramel 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).
Miramel is indicated in adults for symptomatic treatment of moderate
to severe idiopathic Restless Legs Syndrome in doses up
to 0.54 mg of base (0.75 mg of salt) (see section 4.2).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Parkinson's disease
The daily dose is administered in equally divided doses 3 times a day.
_Initial treatment_
Doses should be increased gradually from a starting dose of 0.264 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 Miramel
​
​
​
​
Week
Dose (mg of base)
Total Daily Dose (mg of base)
Dose (mg of salt)
Total Daily Dose (mg of salt)
1
3 x 0.088
0.264
3 x 0.125
0.375
2
3 x 0.18
0.54
3 x 0.25
0.75
3
3 x 0.35
1.1
3 x 0.5
1.50
If a further dose increase is necessary the daily dose should be
increased by 0.54 mg of base (0.75 mg of salt) at