Atacand Plus 16/12.5mg
- Name:
Atacand Plus 16/12.5mg
- Company:
AstraZeneca Pharmaceuticals (Ireland) DAC
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 17/11/20

Click on this link to Download PDF directly
AstraZeneca Pharmaceuticals (Ireland) DAC
 DAC.gif)
Company Products
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 17 November 2020 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Inserted text Deleted text
[..]
4.4 Special warning and precautions for use
[..]
Choroidal effusion, Acute Myopia and Angle-Closure Glaucoma
Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in choroidal effusion with visual field defect, transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue drug intake as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.
[..]
-
- Undesirable effects
[..]
Eye disorders |
Rare |
Transient blurred vision |
Not known |
Acute myopia, acute angle-closure glaucoma, choroidal effusion |
[..]
Reporting of suspected adverse reactions
[..]
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
[..]
10. DATE OF REVISION OF THE TEXT
08th April 2019 13th November 2020
Updated on 17 November 2020 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 4 - how to report a side effect
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Inserted text Deleted text
[..]
2. What you need to know before you take Atacand Plus
[..]
Warnings and precautions
[..]
- if you experience a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase of pressure in your eye and can happen within hours to weeks of taking Atacand Plus. This can lead to permanent vision loss, if not treated. If you earlier have had a penicillin or sulfonamide allergy, you can be at higher risk of developing this.
[..]
4. Possible side effects
[..]
Not known (frequency cannot be estimated from the available data)
- Skin and lip cancer (Non-melanoma skin cancer).
- Sudden short-sightedness.
- Decrease in vision or pain in your eyes due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
Sudden eye pain (acute angle-closure glaucoma).
[..]
Reporting of side effects
[..]
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
[..]
This leaflet was last revised in February 2019 November 2020.
Updated on 16 April 2019 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 - date of revision
Updated on 16 April 2019 SPC
Reasons for updating
- 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)
Free text change information supplied by the pharmaceutical company
Section 4.4 - Additional information on non-melanoma skin cancer has been added
Section 4.8 - Adverse event ‘Neoplasms benign, malignant and unspecified (incl cysts and polyps)’ has been added
Section 5.1 - Additional information on non-melanoma skin cancer has been added
Section 10 - Date of revision updated
Updated on 8 January 2019 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 8 January 2019 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- 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
Change to section 7 – Marketing Authorisation Holder details updated
Change to section 8 – Marketing Authorisation Numbers updated
Change to section 10 – date of revision of the text updated
Updated on 9 August 2018 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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
Change to section 4.8 as per the PRAC recommendation i.e., addition of diarrhoea
Updated on 27 June 2018 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 12 May 2018 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 20 March 2018 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 20 March 2018 SPC
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 3: Addition of tablet dimensions
Section 4.2: Amendment of statement from “chronic liver disease” to “hepatic impairment”.
Section 4.3: Minor formatting changes
Section 4.5: Correction of spelling
Section 9: Addition of latest renewal date
Section 10: Updated date of revisionUpdated on 19 March 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 19 March 2018 PIL
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
- Improved presentation of PIL
Updated on 2 June 2016 SPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - MA number
- Change to section 10 - Date of revision of the text
- Change to joint SPC covering all presentations
- Change to section 4.1 - Therapeutic indications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 3 - Pharmaceutical form
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 1 – inclusion of details for other strength (combined SmPC created)
Section 2 – inclusion of details for other strength (combined SmPC created)
Section 3 - inclusion of details for other strength (combined SmPC created)
Section 4.1 – replaced “essential” with “primary” before “hypertension”.
Section 4.4 – inclusion of “co-trimoxazole also known as trimethoprim/sulfamethoxazole” under subheading “Electrolyte imbalance” and minor editorial and formatting changes.
Section 4.5 – inclusion of “co-trimoxazole also known as trimethoprim/sulfamethoxazole” and minor editorial changes.
Section 6.5 – inclusion of details for other strength (combined SmPC created)
Section 8 – inclusion of details for other strength (combined SmPC created)
Section 10 – update to date of revision of text.
Also this SmPC has been update to present information on another strength.
Updated on 2 June 2016 PIL
Reasons for updating
- Change to drug interactions
- Change to date of revision
- Addition of information on reporting a side effect.
- Correction of spelling/typing errors
Updated on 17 March 2015 SPC
Reasons for updating
- 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 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
- Improved electronic presentation
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
- Improved presentation (QRD changes)
- Section 4.3 – Addition of Aliskiren containing medicines
- Section 4.4 – Addition of informaiton on RAAS medicines
- Section 4.5 - Addition of Aliskiren containing medicines
- Section 4.8 – New side effect frequency
- Section 4.8 Adverse Event reporting statement
- Change to date of revision
Updated on 16 March 2015 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to drug interactions
- Change to date of revision
- Change to improve clarity and readability
Updated on 19 November 2012 PIL
Reasons for updating
- Change to date of revision
- Change to improve clarity and readability
Updated on 18 October 2012 SPC
Reasons for updating
- Change to section 6.1 - List of excipients
- 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
Section 6.1
List of excipients updated.
Section 6.5
Blister packs updated to include:
15x1 (single dose unit)
30x1 (single dose unit)
90 tablets
Section 10
Date of revision amended to 11th October 2012.
Updated on 17 October 2012 PIL
Reasons for updating
- Change to date of revision
- Introduction of new pack/pack size
- Correction of spelling/typing errors
Updated on 3 April 2012 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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
Addition of ADRs ‘acute myopia’ and ‘acute angle-closure glaucoma’ under SOC ‘Eye Disorders’ with frequency of ‘Not known’.
Section 10
Date of revision changed to 22nd March 2012
Updated on 30 March 2012 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 15 December 2011 SPC
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 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 26 July 2011 PIL
Reasons for updating
- Change to date of revision
- Addition of marketing authorisation holder
Updated on 22 November 2010 SPC
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 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
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 19 November 2010 PIL
Reasons for updating
- Change to date of revision
- Change due to harmonisation of patient information leaflet
Updated on 15 October 2008 PIL
Reasons for updating
- Change to further information section
Updated on 9 May 2008 PIL
Reasons for updating
- Change due to harmonisation of patient information leaflet
- Change due to user-testing of patient information
Updated on 6 July 2007 SPC
Reasons for 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
Legal category: Product subject to medical prescription which may be renewed (B)
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
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 8 June 2006 PIL
Reasons for updating
- Change to drug interactions
- Change to date of revision
Updated on 24 May 2006 SPC
Reasons for 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
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 28 November 2005 SPC
Reasons for 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
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 10 August 2004 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 9 August 2004 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 23 May 2003 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)