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AstraZeneca Pharmaceuticals (Ireland) Ltd
College Park House, 20 Nassau Street, Dublin 2,
Telephone: +353 1 609 7100
Fax: +353 1 679 6650
Medical Information e-mail: Irelandinfo@astrazeneca.com
Summary of Product Characteristics last updated on medicines.ie: 15/12/2011
SPC Atacand Plus 16/12.5mg

When a pharmaceutical company changes an SPC or PIL, 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 15/12/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   09-Dec-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


Section 6.5

 

Text updated to:


16/12.5 mg tablets: PVC-PVDC/Al blister packs of 7, 14, 15, 28, 28x1 (single dose unit), 30, 50, 50x1 (single dose unit), 56, 56x1 (single dose unit), 98, 98x1 (single dose unit), 100 and 300 tablets.

16/12.5 mg tablets: HDPE bottles of 100 tablets.

Section 10

 

Date of Revision amended to: 9th December 2011

 
Updated on 22/11/2010 and displayed until 15/12/2011
Reasons for adding or 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 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • 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
Date of revision of text on the SPC:   10-Nov-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


SPC Changes due to Harmonisation – Atacand Plus 16mg/12.5mg

 

 

Section 1

Now reads,

“Atacand Plus 16/12.5 mg tablets.”

 

Section 2

Now reads,

” One Atacand Plus tablet contains 16 mg candesartan cilexetil and 12.5 mg hydrochlorothiazide.

Each tablet contains 68 mg lactose monohydrate.

For a full list of excipients, see 6.1.”

 

Section 3

Now reads,

“Tablet.

Atacand  Plus are peach, oval, biconvex tablets with a score on both sides and engraved on one side.”

 

Section 6.1

Now reads,

“Carmellose calcium, hydroxypropylcellulose, iron oxide reddish-brown (E 172), iron oxide yellow (E 172), lactose monohydrate, magnesium stearate, maize starch and macrogol.”

 

Section 6.2

Now reads,

“Not applicable.”

 

Section 6.3

“3 years.”

 

Section 6.5

Now reads,

“16/12.5 mg tablet: PVC/PVDC blister packs of 7, 14, 15, 28, 28x1 (single dose unit), 30, 50, 50x1 (single dose unit), 56, 56x1 (single dose unit), 98, 98x1 (single dose unit), 100 and 300 tablets.

HDPE bottles of 100 tablets.

Not all pack sizes may be marketed.”

 

Section 10

Now reads,

“10th November 2010”
Updated on 06/07/2007 and displayed until 22/11/2010
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.8 - Undesirable effects
  • 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
Date of revision of text on the SPC:   06/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 2

Following new text added (in bold) to Section 2:

Each tablet contains 68 mg lactose monohydrate.

For a full list of excipients, see 6.1.

 

 

 

Section 4.8

Undesired events are now listed by body system and frequencies in a table. Text is as follows:

 

The frequencies used in the tables throughout this section are: very common (¡Ý 1/10) common (¡Ý1/100 <1/10), uncommon (¡Ý1/1000, <1/100 ), rare (¡Ý1/10 000, <1/1000) and very rare (<1/10 000):

System Organ Class

Frequency

Undesirable Effect

Nervous system disorders

Common

Dizziness/vertigo

 

The following adverse reactions have been reported with candesartan cilexetil in post marketing experience:

System Organ Class

Frequency

Undesirable Effect

Blood and lymphatic system disorders

Very rare

Leukopenia, neutropenia and agranulocytosis

Metabolism and nutrition disorders

Very rare

Hyperkalaemia, hyponatraemia

Nervous system disorders

Very rare

Dizziness, headache

Gastrointestinal disorders

Very rare

Nausea

Hepatobiliary disorders

Very rare

Increased liver enzymes, abnormal hepatic function or hepatitis

Skin and subcutaneous tissue disorders

Very rare

Angioedema, rash, urticaria, pruritus

Musculoskeletal, connective tissue and bone disorders

Very rare

Back pain, arthralgia, myalgia

Renal and urinary disorders

Very rare

Renal impairment, including renal failure in susceptible patients (see section 4.4)

 

The following adverse reactions have been reported with hydrochlorothiazide monotherapy, usually with doses of 25 mg or greater.

  

System Organ Class

Frequency

Undesirable Effect

Blood and lymphatic system disorders

Rare

 

Leucopenia, neutropenia/agranulocytosis, thrombocytopenia, aplastic anaemia, bone marrow depression, haemolytic anaemia

Immune system disorders

Rare

Anaphylactic reactions

Metabolism and nutrition disorders

Common

Hyperglycaemia, hyperuricaemia, electrolyte imbalance (including hyponatraemia and hypokalaemia)

Psychiatric disorders

Rare

 

Sleep disturbances, depression, restlessness

Nervous system disorders

Common

Light-headedness, vertigo

 

Rare

Paraesthesia

Eye disorders

Rare

Transient blurred vision

Cardiac disorders

Rare

Cardiac arrhythmias

Vascular disorders

Uncommon

Postural hypotension

 

Rare

Necrotising angiitis (vasculitis, cutaneous vasculitis)

Respiratory, thoracic and mediastinal disorders

Rare

Respiratory distress (including pneumonitis and pulmonary oedema)

Gastrointestinal disorders

Uncommon

 

Anorexia, loss of appetite, gastric irritation, diarrhoea, constipation

 

Rare

Pancreatitis

Hepatobiliary disorders

Rare

Jaundice (intrahepatic cholestatic jaundice)

Skin and subcutaneous tissue disorders

Uncommon

Rash, urticaria, photosensitivity reactions

 

Rare

 

Toxic epidermal necrolysis, cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus erythematosus

Musculoskeletal, connective tissue and bone disorders

Rare

 

Muscle spasm

Renal and urinary disorders

Common

Glycosuria

 

Rare

Renal dysfunction and interstitial nephritis

General disorders and administration site conditions

Common

Weakness

Rare

Fever

Investigations

Common

Increases in cholesterol and triglycerides

 

Rare

Increases in BUN and serum creatinine

 

 

Section 6.1

Hyprolose deleted from the list of excipients and replaced by hydroxypropylcellulose
 

 

 

Section 6.6

Heading of section 6.6 changed from ¡®Instructions for use and handling and disposal¡¯ to ¡®Special precautions for disposal and other handling¡¯

 
 

 

Section 9

Date changed to

23rd June 2000/ 28th April 2007

 

 
 

Section 10

Date changed to 8th June 2007
Updated on 24/05/2006 and displayed until 06/07/2007
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text
Updated on 28/11/2005 and displayed until 24/05/2006
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
Updated on 10/08/2004 and displayed until 28/11/2005
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
Updated on 23/05/2003 and displayed until 10/08/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Hydrochlorothiazide
  Candesartan Cilexetil