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Information leaflet

                                                   Irish Medicines Board

                               Summary of Product Characteristics

 Acerycal 5mg/5mg tablets


 One tablet contains 3.395 mg perindopril equivalent to 5 mg perindopril arginine and 6.935 mg amlodipine besilate
 equivalent to 5 mg amlodipine
 Excipient : lactose monohydrate.
 For a full list of excipients, see section 6.1


 White, rod-shaped tablet engraved with 5/5 on one face and        on the other face.


 4.1 Therapeutic Indications

 Acerycal is indicated as substitution therapy for treatment of essential hypertension and/or stable coronary artery
 disease, in patients already controlled with perindopril and amlodipine given concurrently at the same dose level.

 4.2 Posology and method of administration

 Oral route.
 One tablet per day as a single dose, preferably to be taken in the morning and before a meal.

 The fixed dose combination is not suitable for initial therapy.
 If a change of posology is required, the dose of Acerycal could be modified or individual titration with free
 combination may be considered.

 Patients with renal impairment and elderly (see sections 4.4 and 5.2)
 Elimination of perindoprilat is decreased in the elderly and in patients with renal failure. Therefore, the usual medical
 follow-up will include frequent monitoring of creatinine and potassium.
 Acerycal can be administered in patients with Clcr 60ml/min, and is not suitable for patients with Clcr < 60ml/min.
 In these patients, an individual dose titration with the monocomponents is recommended.

 Changes in amlodipine plasma concentrations are not correlated with degree of renal impairment.

 Patients with hepatic impairment: see sections 4.4 and 5.2
 A dosage regimen for patients with hepatic impairment has not been established. Therefore, Acerycal should be
 administered with caution.

 Children and adolescents
 Acerycal should not be used in children and adolescents as the efficacy and tolerability of perindopril and amlodipine,
 alone or in combination, have not been established in children and adolescents.

Date Printed 08/06/2011                               CRN 2096062                                         page number: 1
                                                     Irish Medicines Board

 4.3 Contraindications

 Linked to perindopril:
 - Hypersensitivity to perindopril or to any other ACE inhibitor,
 - History of angioedema associated with previous ACE inhibitor therapy,
 - Hereditary or idiopathic angioedema,
 - Second and third trimesters of pregnancy (see sections 4.4 and 4.6).

 Linked to amlodipine:
 -   Severe hypotension,
 -   Hypersensitivity to amlodipine or to any other dihydropyridines,
 -   Shock, including cardiogenic shock,
 -   Obstruction of the outflow-tract of the left ventricle (e.g. high grade aortic stenosis),
 -   Unstable angina pectoris (excluding Prinzmetal's angina),
 -   Heart failure after acute myocardial infarction (during the first 28 days).

 Linked to Acerycal:
 All contraindications related to each monocomponent, as listed above, should apply also to the fixed combination of
 -   Hypersensitivity to any of the excipients.

 4.4 Special warnings and precautions for use

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

 Linked to perindopril

 Special warnings
 Angioedema of the face, extremities, lips, mucous membranes, tongue, glottis and/or larynx has been reported rarely in
 patients treated with ACE inhibitors, including perindopril (see section 4.8). This may occur at any time during therapy.
 In such cases, Acerycal should promptly be discontinued and appropriate monitoring should be initiated and continued
 until complete resolution of symptoms has occurred. In those instances where swelling was confined to the face and
 lips the condition generally resolved without treatment, although antihistamines have been useful in relieving
 Angioedema associated with laryngeal oedema may be fatal. Where there is involvement of the tongue, glottis or
 larynx, likely to cause airway obstruction, emergency therapy should be administered promptly. This may include the
 administration of adrenaline and/or the maintenance of a patent airway. The patient should be under close medical
 supervision until complete and sustained resolution of symptoms has occurred.
 Patients with a history of angioedema unrelated to ACE inhibitor therapy may be at increased risk of angioedema while
 receiving an ACE inhibitor (see section 4.3).
 Intestinal angioedema has been reported rarely in patients treated with ACE inhibitors. These patients presented with
 abdominal pain (with or without nausea or vomiting); in some cases there was no prior facial angioedema and C-1
 esterase levels were normal. The angioedema was diagnosed by procedures including abdominal CT scan, or
 ultrasound or at surgery and symptoms resolved after stopping the ACE inhibitor. Intestinal angioedema should be
 included in the differential diagnosis of patients on ACE inhibitors presenting with abdominal pain (see section 4.8).

 Anaphylactoid reactions during low-density lipoproteins (LDL) apheresis:
 Rarely, patients receiving ACE inhibitors during low-density lipoprotein (LDL) apheresis with dextran sulphate have
 experienced life-threatening anaphylactoid reactions. These reactions were avoided by temporarily withholding ACE
 inhibitor therapy prior to each apheresis.

Date Printed 08/06/2011                               CRN 2096062                                         page number: 2
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