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Aimpart XL 4mg prolonged-release tablets

Last Updated on eMC 25-Mar-2013 View document  | Zentiva Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 25-Mar-2013 and displayed until Current

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.6 - Special precautions for disposal and other handling

Date of revision of text on the SPC: 16-Jan-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



1.           QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Each tablet contains 2mg ropinirole (as ropinirole hydrochloride).

 

Excipients with known effect:

Each 2 mg prolonged-release tablet contains 1.7100mg of lactose.

 

For the full list of excipients, see section 6.1.

4.3        Contraindications

 

-    Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

-    Severe renal impairement (creatinine clearance < 30 ml/min) without regular haemodialysis.

-    Hepatic impairment

 

4.4        Special warnings and precautions for use

 

Ropinirole has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinson's disease. Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported uncommonly. Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with ropinirole. Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines. A reduction of dosage or termination of therapy may be considered.

 

Patients with major psychiatric or psychotic disorders, or a history of these disorders, should not be treated with dopamine agonists unless the potential benefits outweigh the risks.

 

Impulse control disorders

Patients should be regularly monitored for the development of impulse control disorders. Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, increased libido,  and hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur and increased libido, have been reported in patients treated with dopamine agonists, including ropinirole., principally for Parkinson’s disease. Those disorders were reported especially at high doses and were generally reversible upon reduction of the dose or treatment discontinuation. Risk factors such as a history of compulsive behaviours were present in some cases (see section 4.8). Dose reduction/tapered discontinuation should be considered if such symptoms develop.

 

Due to the risk of hypotension, blood pressure monitoring is recommended, particularly at the start of treatment, in patients with severe cardiovascular disease (in particular coronary insufficiency).

 

Aimpart XL 2mg contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Impulse control disorders:

 including pPathological gambling, increased libido,  and

 

hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists including ropinirole and increased libido, have been reported in post

marketing reports (see section 4.4).

 

5.1        Special precautions for disposal and other handling

 

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

 

 

 

 

Updated on 16-Oct-2012 and displayed until 25-Mar-2013

Reasons for adding or updating:

  • New SPC for new product

Legal Category:POM

Black Triangle (CHM): NO

Company contact details

Zentiva

Company image
Address

One Onslow Street, Guildford, Surrey, GU1 4YS

Fax

+44 (0) 1483 554831

Medical Information e-mail
Telephone

+44 (0)1483 505 515

Medical Information Direct Line

+44 (0)845 372 7101

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Active ingredients

ropinirole hydrochloride

Legal categories

POM - Prescription Only Medicine

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