ACERYCAL

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 10/10/19

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Summary of Product Characteristics last updated on medicines.ie: 10/10/2019

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Servier Laboratories Ireland Ltd

Servier Laboratories Ireland Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name ACERYCAL Active Ingredients Amlodipine besilate, Perindopril arginine
Medicine Name Cosimprel 10mg/10mg film-coated tablets Active Ingredients Bisoprolol Fumarate, Perindopril arginine
Medicine Name Cosimprel 10mg/5mg film-coated tablets Active Ingredients Bisoprolol Fumarate, Perindopril arginine
Medicine Name Cosimprel 5mg/10mg film-coated tablets Active Ingredients Bisoprolol Fumarate, Perindopril arginine
Medicine Name Cosimprel 5mg/5mg film-coated tablets Active Ingredients Bisoprolol Fumarate, Perindopril arginine
Medicine Name Coverdine Active Ingredients Amlodipine, Indapamide, Perindopril
Medicine Name Coversyl Arginine 10mg Active Ingredients Perindopril arginine
Medicine Name Coversyl Arginine 10mg orodispersible tablets Active Ingredients Perindopril arginine
Medicine Name Coversyl Arginine 5mg Active Ingredients Perindopril arginine
Medicine Name Coversyl Arginine 5mg orodispersible tablets Active Ingredients Perindopril arginine
Medicine Name Coversyl Arginine Plus 10mg/2.5mg film-coated tablets Active Ingredients Indapamide, Perindopril arginine
Medicine Name Coversyl Arginine Plus 2.5mg/0.625mg film-coated tablets Active Ingredients Indapamide, Perindopril arginine
Medicine Name Coversyl Arginine Plus 5 mg/1.25 mg film-coated tablets Active Ingredients Indapamide, Perindopril arginine
Medicine Name Diamicron MR 30 mg Active Ingredients Gliclazide
Medicine Name Diamicron MR 60mg Active Ingredients Gliclazide
Medicine Name LIPOCOMB Active Ingredients ezetimibe, Rosuvastatin Calcium
Medicine Name LONSURF Active Ingredients Tipiracil hydrochloride, Trifluridine
Medicine Name Lonsurf 15mg/6.14mg, 20mg/8.19mg film-coated tablets Active Ingredients Tipiracil hydrochloride, Trifluridine
Medicine Name Natrilix SR Active Ingredients Indapamide
Medicine Name Oncaspar (solution) Active Ingredients pegaspargase
Medicine Name Oncaspar Lyophilisate (Powder) Active Ingredients pegaspargase
Medicine Name Pixuvri 29 mg Active Ingredients Pixantrone dimaleate
Medicine Name Procoralan film-coated tablets Active Ingredients Ivabradine hydrochloride
Medicine Name Protelos 2 g granules for oral suspension Active Ingredients Strontium Ranelate
Medicine Name Valdoxan 25mg Film-coated Tablets Active Ingredients Agomelatine
1 - 0 of 26 items.Total: Infinity pages

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 10 October 2019 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Updated on 10 October 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 13 March 2019 PIL

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects

Updated on 13 March 2019 SmPC

Reasons for updating

  • 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

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

Updated on 20 November 2018 PIL

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product looks like and pack contents

Updated on 20 November 2018 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 6.4 - Special precautions for storage

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

Updated on 29 May 2018 SmPC

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 - how to report a side effect

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

Updated on 29 May 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 7 September 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 7 September 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - excipient warnings
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose

Updated on 15 August 2017 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • 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

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

Free text change information supplied by the pharmaceutical company

1.      1.  NAME OF THE MEDICINAL PRODUCT

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

4.    CLINICAL PARTICULARS

5.    PHARMACOLOGICAL PROPERTIES

 

Updated on 15 August 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 27 April 2015 SmPC

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 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

In section4.3 (Contraindications), the following text has been inserted:
“Concomitant use ofAcerycal with aliskiren-containing products in patients with diabetes mellitusor renal impairment (GFR < 60 ml/min/1.73 m²) (see sections 4.5 and 5.1).”
In section4.4 (Special warnings and precautions for use), additional information on ‘Dualblockade of the renin-angiotensin-aldosterone system (RAAS) has been included'.
In section4.5 (Interaction with other medicinal products and other forms of interaction),additional information on dual blockade of the renin-angiotensin-aldosteronesystem (RAAS) has been included.
In section5.1 (Pharmacodynamic properties), clinical trial data has been included.

Updated on 23 April 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 16 November 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about overdose
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to how the medicine works
  • Change to dosage and administration

Updated on 26 September 2012 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • 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 improve clarity and readability

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

Free text change information supplied by the pharmaceutical company

Section 4.2 

Formatting changes. 

The following sentences have been added “Amlodipine used at similar doses in elderly or younger patients is equally well tolerated. Normal dosage regimens are recommended in the elderly, but increase of the dosage should take place with care.” and “Amlodipine is not dialyzable”

More detailed information has been added regarding patients with hepatic impairment.

The heading Paediatric populations has been added and the words "..or alone "removed.

Section 4.3

Formatting changes

"Unstable angina pectoris (excluding Prinzmetal's angina)" has been removed.

"Haemodynamically unstable" has been added before the words "heart failure..

Section 4.4

Under Linked to amlodipine, Precautions for use, the sentence "The safety and efficacy of amlodipine in hypertensive crisis has not been established" has been added and information on use in elderly patients and use in renal failure has been added.

Information has been added and other information deleted under the heading Use in patients with cardiac failure.

Information has been edited regarding use in patients with impaired hepatic function.

Formatting changes.

Section 4.5 

Under Linked to amlodipine changes have been made to information on Dantrolene, CYP3A4 inducers and CYP34Ainhibitors. Significant changes have also been made under the heading Concomitant use to be taken in to consideration.

Formatting changes.

Section 4.6 

Under Pregnancy, changes have been made under the heading Linked to amlodipine and under Lactation , changes have been made under the heading Linked to amlodipine. Under Fertility the sentences "Clinical data are insufficient regarding the potential effect of amlodipine on fertility. In one rat study, adverse effects were found on male fertility (see section 5.3)." have been added and the words ".which can impair fecundation" have been removed.

Formatting changes.

Section 4.7 

Information was been edited regarding the ability to drive and use machines.

Section 4.8

The table of undesirable effects has been edited. Some new effects have added and some deleted. Information regarding frequency of certain effects has also changed.

Section 4.9

Information on over dosage with amlodipine was been changed.

Section 5.1

New information has been added under the heading Amlodipine. New paragraphs have been created under the headings: Patients with coronary artery disease (CAD), Use in patients with heart failure and Treatment to prevent heart attack trial (ALLHAT).

Section 5.2

A number of changes have been made under the heading Amlodipine.

Formatting changes.

Section 5.3

Formatting changes.

Under the heading Amlodipine more detailed information has been added regarding reproductive toxicology, impairment of fertility and carcinogenesis, mutagenesis.

Updated on 14 June 2012 SmPC

Reasons for updating

  • 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

Date of revision of the text changed

Updated on 30 May 2012 SmPC

Reasons for updating

  • 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 date of revision of the text

Updated on 20 February 2012 SmPC

Reasons for updating

  • Change to MA holder contact details

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

Free text change information supplied by the pharmaceutical company

$0Change of MAHaddress from:$0$0LesLaboratoires Servier$0$022, rueGarnier$0$092200Neuilly-sur-Seine$0$0France$0$0to:$0$0Les Laboratoires Servier$0$050, rue Carnot$0$092284 Suresnes cedex$0$0France$0

Updated on 15 February 2012 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 15 October 2010 SmPC

Reasons for updating

  • 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

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

Free text change information supplied by the pharmaceutical company

Section 4.4 Special warnings and precautions for use, in the subsection dealing with special warnings linked to perindopril, under Neutropenia/Agranulocytosis/Thrombocytopenia/Anaemia, the words "(e.g. sore throat, fever)" have been added.

Section 4.5 Interaction with other medicinal products and other forms of interaction, in the subsection linked to perindopril,

in the subsection linked to perindopril,
  • in the section 'under concomitant use not recommended: Potassium sparing diuretics, potassium supplements or potassium-containing salt substitutes', the following paragraph has been inserted:

"Although serum potassium usually remains within normal limits, hyperkalaemia may occur in some patients treated with perindopril. Potassium sparing diuretics (e.g. spironolactone, triamterene, or amiloride), potassium supplements, or potassium-containing salt substitutes may lead to significant increases in serum potassium. Therefore the combination of perindopril with the above-mentioned drugs is not recommended (see section 4.4). If concomitant use is indicated because of demonstrated hypokalaemia they should be used with caution and with frequent monitoring of serum potassium."

  • in the section 'concomitant use which requires special care' the following paragraph has not been inserted:

"Non-steroidal anti-inflammatory medicinal products (NSAIDs) including aspirin 3 g/day:

When ACE-inhibitors are administered simultaneously with non-steroidal anti-inflammatory drugs (i.e. acetylsalicylic acid at anti-inflammatory dosage regimens, COX-2 inhibitors and non-selective NSAIDs), attenuation of the antihypertensive effect may occur. Concomitant use of ACE-inhibitors and NSAIDs may lead to an increased risk of worsening of renal function, including possible acute renal failure, and an increase in serum potassium, especially in patients with poor pre-existing renal function. The combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy, and periodically thereafter."

in Section 4.8 Undesirable effects

  • under 'Metabolism and Nutrition Disorders', hypoglycaemia has been added as a 'frequency not known' side effect of perindopril
  • under 'Vascular Disorders', vasculitis has been changed to a 'frequency not known' side effect of perindopril
  • the following text has been added:

      "Additional information linked to amlodipine

       

      Exceptional cases of extrapyramidal syndrome have been reported with calcium channel blockers."

Updated on 13 October 2010 PIL

Reasons for updating

  • Change to side-effects

Updated on 4 September 2009 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation

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

Free text change information supplied by the pharmaceutical company



The following has been added to section 4.4

Pregnancy

ACE inhibitors should not be initiated during pregnancy. Unless continued ACE inhibitors is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).

 

Linked to Acerycal

 

All warnings related to each monocomponent, as listed above, should apply also to the fixed combination of Acerycal.

 

“serum potassium” replaces “kalaemia”

 

Section 4.6

The following has been added:

 

Given the effects of the individual components in this combination product on pregnancy and lactation:

Acerycal is not recommended during the first trimester of pregnancy. Acerycal is contraindicated during the second and third trimesters of pregnancy.

Acerycal is not recommended during lactation. A decision should therefore be made whether to discontinue nursing or to discontinue Acerycal taking account the importance of this therapy for the mother.

 

Pregnancy:

Linked to perindopril

The use of ACE inhibitors is not recommended during the first trimester of pregnancy (see section 4.4). The use of ACE inhibitors is contraindicated during the second and third trimester of pregnancy (see sections 4.3 and 4.4).

 

Lactation:

Linked to perindopril

Because no information is available regarding the use of perindopril during breastfeeding, perindopril is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.

 

Linked to amlodipine

It is not known whether amlodipine is excreted in breast milk.  Similar calcium channel blockers of the dihydropyridine type are excreted in breast milk.

Therefore, as a precaution, lactation is not recommended during the treatment with amlodipine.

 

Fertility :

Reversible biochemical changes in the head of spermatozoa which can impair fecundation have been reported in some patients treated by calcium channel blockers.

 

 

 

 

Updated on 3 September 2009 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 8 October 2008 SmPC

Reasons for updating

  • New SPC for new product

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

Updated on 6 October 2008 PIL

Reasons for updating

  • New PIL for new product