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Malarone Film Coated Tablets

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Pharmacy Only: Prescription

Updated on 11 January 2022

File name

ie-pl-malaroneissue6draft2- Master.pdf

Reasons for updating

  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Art 61(3) Notification –To update the PIL in the EU common annexes to reflect the latest QRD update

Updated on 04 January 2021

File name

ie-pl-malaroneissue5draft1_medicines.ie.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Section 2: addition of sodium warning - excipent warning
Section 6 - date of PIL
 

Updated on 04 January 2021

File name

ie-spc-malaroneissue6draft1_medicines.ie.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4: addition of sodium warning (excipients warning)

Section 4.2 - admin changes
Section 10-: Revision date
 

Updated on 27 July 2017

File name

PIL_10590_278.pdf

Reasons for updating

  • New PIL for new product

Updated on 27 July 2017

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 15 May 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 15 May 2017

Reasons for updating

  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Correction of SPC section 9, date of first authorisation to 02 December 2005 (from the incorrect 21 October 1996)

Updated on 14 April 2016

Reasons for updating

  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

SPC #6.5 Nature and contents of container

 

Updated to include ‘paper child-resistant’, to read:

PVC-aluminium/paper child-resistant foil blister pack/s containing 12 tablets.

Updated on 17 July 2015

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 7 - change to address of the Irish MA Holder from Stonemasons Way, Rathfarnham, Dublin 16 to 12 Riverwalk, Citywest Business Campus, Dublin 24.


Section 10 - change to date of revision of text. 

Updated on 16 July 2015

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 15 June 2015

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.8 – update from IMB to HPRA contact details

Updated on 12 June 2015

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 23 January 2014

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company


Editorial changes to sections 2, 4.2, 4.3, 4.6 and 5.2 due to QRD template update.

 

4.2     Posology and method of administration

Under the subheading ‘Dosage in Adults’ added the clarification:

Malarone paediatric tablets are recommended for malaria prophylaxis in persons weighing <40 kg.

 

4.8         Undesirable effects

·        Changed frequency of ‘hallucinations’ from ‘not known’ to ‘rare’

·        Added ‘Psychotic disorder’ with the frequency ‘not known’

·        Added the contact details for the IMB regarding the reporting of side effects

 

5.1     Pharmacodynamic properties

Under the subheading ‘Microbiology’, amended the upper limit of in vitro IC50 against P. falciparum from 1.4 to 1.43, i.e.:

Atovaquone has potent activity against Plasmodium spp (in vitro IC50 against P. falciparum 0.23-1.43 ng/mL).

 

6.6     Special precautions for disposal

Added the following statement:

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

Updated on 23 January 2014

Reasons for updating

  • Change to, or new use for medicine
  • Change to side-effects

Updated on 28 September 2012

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

  

SPC UPDATES

 

4.2     Posology and method of administration

Under the subheadings, Posology, Prophylaxis, removed the statement that the period of stay ‘should not exceed 28 days’ to read:

 

Prophylaxis should

·           commence 24 or 48 hours prior to entering a malaria-endemic area,

·           continue during the period of the stay.

·           continue for 7 days after leaving the area.

 

In residents (semi-immune subjects) of endemic areas, the safety and effectiveness of Malarone has been established in studies of up to 12 weeks.

 

Added the following statement regarding the average duration of exposure in clinical studies in non-immune subjects:

In non-immune subjects, the average duration of exposure in clinical studies was 27 days.

 

Updated on 17 September 2012

Reasons for updating

  • Change to dosage and administration

Updated on 01 June 2012

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 4.9 - Overdose

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Changes to:

Section 4.2 - Posology and method of administration,
Section 4.3 - Contraindications,
Section 4.4 - Special warnings and precautions for use,
Section 4.5 - Interaction with other medicinal products and other forms of interaction, Section 4.6 - Pregnancy and lactation,
Section 4.8 - Undesirable effects,
Section 4.9 - Overdose

Updated on 31 May 2012

Reasons for updating

  • Change of manufacturer
  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 13 December 2010

Reasons for updating

  • Change of manufacturer

Updated on 18 March 2010

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

SPC UPDATE

 

Section 4.8 Undesirable effects

·         Added the term ‘seizure’ in the system organ class ‘nervous system disorders’ with frequency classification ‘unknown’.

·         Corrected the reference on the side effect ‘Pancytopenia in patients with severe renal impairment’ from ‘observed from post-marketing spontaneous reports and the frequency is therefore unknown’ to ‘observed with proguanil and the frequency is therefore unknown’.

 

Updated on 22 January 2010

Reasons for updating

  • Change to side-effects

Updated on 13 October 2009

Reasons for updating

  • Change to section 3 - Pharmaceutical form

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 3

 

The SPC was updated to include the following description of engraving on the tablet: 'engraved ‘GX CM3’ on one side.'

Updated on 26 August 2009

Reasons for updating

  • Change to side-effects
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to date of revision
  • Changes to therapeutic indications
  • Change to instructions about overdose

Updated on 25 August 2009

Reasons for updating

  • 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 6.1 - List of excipients

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Malarone 250mg/100mg Film-coated Tablets (PA 1077/111/1, UK/H/0170/001)

Changes made in Red

 

UK/H/0170/001/II/040

IMB CRN 2053333

Updates to QRD format throughout the SPC and PL. Safety updates to sections 4.3 and 4.8 of the SPC, with corresponding updates to the PL. Pharamceutical update to section 6.1.

 

UK/H/0170/001/II/041

IMB CRN 2058832

Update statement in section 4.4 regarding severe allergic reactions and correction to side effects in section 4.8

 

 

Updates to SUMMARY OF PRODUCT CHARACTERISTICS

 

Minor editorial changes to sections 1, 2, 3, 4.1, 4.2, 4.4, 4.5, 4.9, 5.1, 5.2, 5.3, 6.4, 10 with the specific updates to the following sections:

 

 

 

Section 4.3 Contraindications

Statement regarding hypersensitivity updated from:

Malarone is contra-indicated in individuals with known sensitivity to atovaquone or proguanil hydrochloride or any component of the formulation.

 

to:

Hypersensitivity to the active substances or to any of the excipients.

 

 

 

Section 4.4 Special warnings and special precautions for use

Inserted the following paragraph regarding severe allergic reactions:

Occasionally, severe allergic reactions (including anaphylaxis) have been reported in patients taking Malarone.  If patients experience an allergic reaction (see section 4.8) Malarone should be discontinued promptly and appropriate treatment initiated.

 

 

 

Section 4.8 Undesirable effects

-          Rash and urticaria reclassified under ‘Skin and subcutaneous tissue disorders’ previously listed under ‘Immune system disorders’, with no change to frequency classification.

-          Stevens-Johnson Syndrome, Erythema multiforme, Blister, Skin exfoliation added under ‘Skin and subcutaneous tissue disorders’.

-          Source of frequency determination for the side effect ‘palpitations’ corrected from footnote 3 to footnote 1

 

Section 6.1 List of excipients

-          Pharmacopoeial references (BP, Ph. Eur., USNF) removed

-          Sodium Starch Glycollate specified as (Type A)

-          ‘Methylhydroxypropyl cellulose’ updated to ‘Hypromellose’

-          E numbers added for Titanium Dioxide (E171) and Iron Oxide Red (E172)

 

 

Updated on 10 October 2008

Reasons for updating

  • Change to side-effects

Updated on 22 September 2008

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

 
 
Addition to :
 
Section 4.8
Undesirable Effects added: Psychiatric: abnormal dreams, depression, anxiety, panic attacks, crying, hallucination, nightmares.

Cardiac: palpitations, tachycardia.

Updated on 30 May 2008

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Complete revision of PL layout and implementation of warnings/listing of safety issues interaction with anti-coagulants and hepatitis

Updated on 30 May 2008

Reasons for updating

  • Change due to harmonisation of patient information leaflet
  • Change due to user-testing of patient information
  • Change to side-effects
  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 27 August 2007

Reasons for updating

  • Improved electronic presentation

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 08 December 2005

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 06 December 2005

Reasons for updating

  • New PIL for new product