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Pramipexole Mylan 0.088 mg tablets

  • Name:

    Pramipexole Mylan 0.088 mg tablets

  • Company:
    info
  • Active Ingredients:

    Pramipexole dihydrochloride monohydrate

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 03/12/18

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Summary of Product Characteristics last updated on medicines.ie: 3/12/2018

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Gerard Laboratories

Gerard Laboratories

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Medicine Name Atorvastatin Mylan 10 mg, 20 mg, 40 mg & 80 mg film-coated tablets Active Ingredients Atorvastatin calcium trihydrate
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Medicine Name Azromax 250mg Film-coated tablets Active Ingredients Azithromycin monohydrate
Medicine Name Baclopar Tablets 10 mg Active Ingredients Baclofen
Medicine Name Bisoprolol Mylan Active Ingredients Bisoprolol Fumarate
Medicine Name Brabio 20mg/ml solution for injection, pre-filled syringe Active Ingredients Glatiramer Acetate
Medicine Name Brabio 40mg/ml solution for injection, pre-filled syringe Active Ingredients Glatiramer Acetate
Medicine Name Cifloxager 250 mg Film-coated Tablets Active Ingredients Ciprofloxacin hydrochloride
Medicine Name Cifloxager 500 mg Film-coated Tablets Active Ingredients Ciprofloxacin hydrochloride
Medicine Name Ciprager 10mg & 20mg Film Coated Tablets Active Ingredients citalopram hydrobromide
Medicine Name Ciprager 40mg Film Coated Tablets Active Ingredients citalopram hydrobromide
Medicine Name Ciprofloxacin Mylan 2mg/1ml solution for infusion Active Ingredients Ciprofloxacin
Medicine Name Clopidogrel Mylan 75 mg film-coated tablets Active Ingredients clopidogrel hydrochloride
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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 3 December 2018 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - excipient warnings
  • Change to section 3 - dose and frequency
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 3 December 2018 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 8 January 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 8 January 2018 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.4 Special warnings and precautions for use

Dystonia

Axial dystonia including antecollis, camptocormia and pleurothotonus (Pisa Syndrome) has occasionally been reported in patients with Parkinson’s disease following initiation or incremental dose increase of pramipexole. Although dystonia may be a symptom of Parkinson’s disease, the symptoms in these patients have improved after reduction or withdrawal of pramipexole. If dystonia occurs, the dopaminergic medication regimen should be reviewed and an adjustment in the dose of pramipexole considered.


10. DATE OF REVISION OF THE TEXT

AugustNovember 2017

Updated on 4 January 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 4 January 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 3 October 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 3 October 2017 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.088 mg pramipexole.

Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.18 mg pramipexole.

Each tablet contains 1.0 mg pramipexole dihydrochloride monohydrate equivalent to 0.7 mg pramipexole.

3. PHARMACEUTICAL FORM

Tablet

0.088 mg: A white to off white, 6.35mm, round, flat-faced tablet debossed with ‘PX1’ on one side of the tablet and ‘M’ on the other side.

0.18 mg: A white to off white, 9.0mm x 4.5mm biconvex oval shaped tablet debossed with ‘PX2’ on one side of the tablet and ‘M’ on one side of the breakline on the other side.
The tablets can be divided into equal doses.

0.7 mg: A white to off white, 8.0mm, round, flat-faced tablet debossed with ‘M’ over ‘PX4’ on one side of the tablet and a breakline on the other side.
The tablets can be divided into equal doses.
 
4. CLINICAL PARTICULARS

Dopamine dysregulation Syndrome
Dopamine dysregulation Syndrome (DDS) is an addictive disorder resulting in excessive use of the product seen in some patients treated with dopaminergic medications, including pramipexole. Before initiation of treatment, patients and caregivers should be warned of the potential risk of developing DDS.

Neuroleptic malignant syndrome
Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy (see section 4.2).

Dopamine agonist withdrawal syndrome
To discontinue treatment in patients with Parkinson’s disease, pramipexole should be tapered off (see section 4.2). Non-motor adverse effects may occur when tapering or discontinuing dopamine agonists including pramipexole. Symptoms include apathy, anxiety, depression, fatigue, sweating and pain which may be severe. Patients should be informed about this before tapering the dopamine agonist, and monitored regularly thereafter. In case of persistent symptoms, it may be necessary to increase the pramipexole dose temporarily (see section 4.8).

4.8 Undesirable effects

Expected adverse reactions
The following adverse reactions are expected under the use of Pramipexole Mylan: abnormal dreams, amnesia, behavioural symptoms of impulse control disorders and compulsions such as binge eating, compulsive shopping, hypersexuality and pathological gambling; cardiac failure, confusion, constipation, delirium, delusion, dizziness, dyskinesia, dyspnoea, fatigue, hallucinations, headache, hiccups, hyperkinesia, hyperphagia, hypotension, inappropriate antidiuretic hormone secretion, insomnia, libido disorders, mania, nausea, paranoia, peripheral oedema, pneumonia, pruritus, rash and other hypersensitivity; restlessness, somnolence, sudden onset of sleep, syncope, visual impairment including diplopia, vision blurred and visual acuity reduced, vomiting, weight decrease including decreased appetite, weight increase.

Based on the analysis of pooled placebo-controlled trials, comprising a total of 1,923 patients on pramipexole and 1,354 patients on placebo, adverse drug reactions were frequently reported for both groups. 63% of patients on pramipexole and 52% of patients on placebo reported at least one adverse drug reaction.

Tables 1 and 2 display the frequency of adverse drug reactions from placebo-controlled clinical trials in Parkinson’s disease and other indication. The adverse drug reactions reported in these tables are those events that occurred in 0.1% or more of patients treated with pramipexole and were reported significantly more often in patients taking pramipexole than placebo, or where the event was considered clinically relevant. The majority of adverse drug reactions were mild to moderate, they usually start early in therapy, and most tended tend to disappear even as therapy was is continued.

Table 1: Parkinson’s disease

General disorders and administration site conditions

Common

fatigue, peripheral oedema

Not known

dopamine agonist withdrawal syndrome including apathy, anxiety, depression, fatigue, sweating and pain


Table 2: Other Indication

 

General disorders and administration site conditions

Common

fatigue

Uncommon

peripheral oedema

Not known

dopamine agonist withdrawal syndrome including apathy, anxiety, depression, fatigue, sweating and pain


Dopamine agonist withdrawal syndrome
Non-motor adverse effects may occur when tapering or discontinuing dopamine agonists including pramipexole. Symptoms include apathy, anxiety, depression, fatigue, sweating and pain (see section 4.4).

Cardiac failure
In clinical studies and post-marketing experience cardiac failure has been reported in patients with pramipexole. In a pharmaco-epidemiological study pramipexole use was associated with an increased risk of cardiac failure compared with non-use of pramipexole (observed risk ratio 1.86; 95% CI, 1.21-2.85).

8. MARKETING AUTHORISATION NUMBER(S)

PA0577/138/001
PA0577/138/002
PA0577/138/003

10. DATE OF REVISION OF THE TEXT

August 2015April 2017August 2017











Updated on 18 August 2015 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 8 - MA number
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 1
Pramipexole Mylan 0.088 mg Tabletstablets

Section 2
For a the full list of excipients, see section 6.1.

Section 3
A white to off white, 6.35mm, round, flat-faced, beveled edge tablet debossed with ‘PX1’ on one side of the tablet and ‘M’ on the other side.

Section 4.2
Parkinson’s disease
The tablets should be taken orally, swallowed with water, and can be taken either with or without food. The daily dosage dose is administered in equally divided doses 3 times a day.

Initial treatment
Dosages 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 side- undesirable effects, the dosage dose should be titrated to achieve a maximal therapeutic effect.

Paediatric Populationpopulation
Pramipexole Mylan is not recommended for use in children and adolescents below 18 years due to a lack of data on The safety and efficacy of pramipexole in children below 18 years have not been established. There is no relevant use of Pramipexole Mylan in the paediatric population in Parkinson’s disease.

Method of administration
For oral use.
The tables tablets should be taken orally, swallowed with water, and can be taken either with or without food.

Section 4.4

Mania and delirium

Patients should be regularly monitored for the development of mania and delirium. Patients and carers should be made aware that mania and delirium can occur in patients treated with pramipexole. Dose reduction/tapered discontinuation should be considered if such symptoms develop.

Section 4.8
Expected adverse eventsreactions
The following adverse reactions are expected under the use of Pramipexole Mylan: abnormal dreams, amnesia, behavioural symptoms of impulse control disorders and compulsions such as binge eating, compulsive shopping, hypersexuality and pathological gambling; cardiac failure, confusion, constipation, delirium, delusion, dizziness, dyskinesia, dyspnoea, fatigue, hallucinations, headache, hiccuphiccups, hyperkinesia, hyperphagia, hypotension, inappropriate antidiuretic hormone secretion, insomnia, libido disorders, mania, nausea, paranoia, peripheral oedema, pneumonia, pruritus, rash and other hypersensitivity; restlessness, somnolence, sudden onset of sleep, syncope, visual disturbance impairment including diplopia, vision blurred and visual acuity reduced, vomiting, weight decrease including decreased appetite, weight increase.

Table 1:

Endocrine disorders

 

Uncommon

inappropriate antidiuretic hormone secretion1


Psychiatric disorders

Common

abnormal dreams, behavioural symptoms of impulse control disorders and compulsions; confusion, hallucinations, insomnia

Uncommon

binge eating1, compulsive shopping, delusion, hyperphagia1, hypersexuality, libido disorder, paranoia, pathological gambling, restlessness, delirium

Rare

mania

Table 2:

Endocrine disorders

 

Uncommon

inappropriate antidiuretic hormone secretion1


Psychiatric disorders

Common

abnormal dreams, insomnia

Uncommon

behavioural symptoms of impulse control disorders and compulsions such as, binge eating, compulsive shopping, hypersexuality, and pathological gambling1; delusion1, hyperphagia1, paranoia1, confusion, hallucination, libido disorder, restlessness, mania1, delirium1

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; e-mail: medsafety@hpra.ie.

Section 4.9
There is no clinical experience with massive overdosageoverdose. The expected adverse events reactions would be those related to the pharmacodynamic profile of a dopamine agonist, including nausea, vomiting, hyperkinesia, hallucinations, agitation and hypotension. There is no established antidote for overdosage overdose of a dopamine agonist. If signs of central nervous system stimulation are present, a neuroleptic agent may be indicated. Management of the overdose may require general supportive measures, along with gastric lavage, intravenous fluids, administration of activated charcoal and electrocardiogram monitoring.

Section 5.1
Mechanism of action
Pramipexole is a dopamine agonist that binds with high selectivity and specificity to the D2 subfamily of dopamine receptors of which it has a preferential affinity to D3 receptors, and has full intrinsic activity.

Pharmacodynamic effects
In human volunteers, a dose-dependent decrease in prolactin was observed. In a clinical trial with healthy volunteers, where pramipexole prolonged-release tablets were titrated faster (every 3 days) than recommended up to 3.15 mg pramipexole base (4.5 mg of salt) per day, an increase in blood pressure and heart rate was observed. Such effect was not observed in patient studies.

Clinical trials efficacy and safety in Parkinson’s disease 


Paediatric population
The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing pramipexole in all subsets of the paediatric population in Parkinson’s disease (see section 4.2 for information on paediatric use).

Section 5.2

MetabolismBiotransformation

ExcretionElimination

Section 6.1

Mannitol (E421)
Maize starch pregelatinised
Sodium citrate anhydrous
Silica, colloidal anydrous
Magnesium stearate
Hydroxypropylcellulose
Crospovidone Type type A

Section 6.4

Do not store above 25ºC.
Blister: Store in the original package in order to protect from light.
Bottle: Keep the bottle tightly closed in order to protect from light.

Updated on 11 August 2015 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to instructions about missed dose
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about drinking alcohol
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to further information section
  • Change to date of revision
  • Change to dosage and administration
  • Change of special precautions for disposal
  • Discontinuation of one or more strengths
  • Addition of information on reporting a side effect.

Updated on 1 April 2014 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 6.3, the shelf-life has been changed form 2 years to 3 years.

Updated on 10 May 2013 SmPC

Reasons for updating

  • Change to separate SPCs covering individual presentations

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

0.18mg & 0.7mg strengths no longer marketed

Updated on 10 April 2013 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Sections 4.4 and 4.8 updated in line with PhVWP July 2012 agreed wording regarding dopamine agonists and the risk of impulse control disorders (ICDs). 
Also extensive updates to the SPC in line with the brand leader Sifrol and the current QRD template.

Updated on 2 April 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to further information section
  • Change to date of revision

Updated on 8 October 2012 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Addition of manufacturer

Updated on 8 October 2012 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 6.3, the shelf-life for 0.088mg blisters changed from 18 months to 24 months.
In section 6.5, an additonal pack size of 200 was added for both blisters and bottles.

Updated on 26 April 2011 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 26 April 2011 PIL

Reasons for updating

  • New PIL for new product