AceryCal 5/5: 10/10 Tablets

Administration

• Should be taken on an empty stomach. Preferably taken in the morning & before a meal.

Contraindications

• Hypersensitivity to perindopril, amlodipine, other dihydropyridines and ACE inhibitors or to any of the excipients of AceryCal.

• Due to the presence of lactose, patients with rare hereditary problems of galactose intolerance, glucose-galactose malabsorption, or the Lapp-lactase deficiency should not take AceryCal.

• Perindopril: History of angioedema associated with previous ACE inhibitor therapy; hereditary or idiopathic angioedema.

• Amlodipine: Severe hypotension; shock including cardiogenic shock; obstruction of the outflow-tract of the left ventricle (eg, high-grade aortic stenosis); unstable angina pectoris (excluding Prinzmetal's angina); heart failure after acute myocardial infarction (during the first 28 days).

• All contraindications related to each monocomponent should also apply to the fixed combination of AceryCal.

• Use in pregnancy: AceryCal should not be initiated during pregnancy. Unless continued AceryCal 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 AceryCal should be stopped immediately, and if appropriate, alternative therapy should be started.

• Perindopril: The use of AceryCal is not recommended during the 1st trimester of pregnancy. The use of AceryCal is contraindicated during the 2nd and 3rd trimesters of pregnancy. Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the 1st trimester of pregnancy has not been conclusive; however, a small increase in risk cannot be excluded. Unless continued ACE inhibitor therapy 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.

• ACE inhibitors therapy exposure during the 2nd and 3rd trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).

• Should exposure to ACE inhibitors have occurred from the 2nd trimester of pregnancy, ultrasound check of renal function and skull is recommended.

• Infants whose mothers have taken ACE inhibitors should be closely observed for hypotension.

• Amlodipine: Data on a limited number of exposed pregnancies indicate no adverse effects of amlodipine and other calcium-receptor antagonists on the health of the foetus. However, there may be a risk of prolonged delivery. Animal studies have not shown teratogenic effect.

• Consequently, AceryCal is not recommended during the 1st trimester of pregnancy. When a pregnancy is planned or confirmed, the switch to an alternative treatment should be initiated as soon as possible. AceryCal is contraindicated during the 2nd and 3rd trimesters of pregnancy. Should exposure to AceryCal have occurred from the 2nd trimester of pregnancy, ultrasound check of renal function and skull is recommended.

• Infants exposed in utero to ACE inhibitors should be closely observed for hypotension, oliguria and hyperkalemia. 

Warnings

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

• Perindopril: Hypersensitivity/Angioedema: 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. 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 symptoms.
• 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 Contraindications).
• 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.
• Anaphylactoid Reactions During Low-Density Lipoprotein (LDL) Apheresis: Rarely, patients receiving ACE inhibitors during LDL apheresis with dextran sulfate have experienced life-threatening anaphylactoid reactions. These reactions were avoided by temporarily withholding ACE inhibitor therapy prior to each apheresis.
• Anaphylactoid Reactions During Desensitisation: Patients receiving ACE inhibitors during desensitisation treatment (eg, hymenoptera venom) have experienced anaphylactoid reactions. In the same patients, these reactions have been avoided when the ACE inhibitors were temporarily withheld, but they reappeared upon inadvertent rechallenge.
• Neutropenia/Agranulocytosis/Thrombocytopenia/Anaemia: Neutropenia/agranulocytosis, thrombocytopenia and anaemia have been reported in patients receiving ACE inhibitors. In patients with normal renal function and no other complicating factors, neutropenia occurs rarely. Perindopril should be used with extreme caution in patients with collagen vascular disease, immunosuppressant therapy, treatment with allopurinol or procainamide or a combination of these complicating factors, especially if there is preexisting impaired renal function. Some of these patients developed serious infections, which in a few instances did not respond to intensive antibiotic therapy. If perindopril is used in such patients, periodic monitoring of white blood cell counts is advised and patients should be instructed to report any sign of infection.

How to store Acerycal

• Store below 30°C. Protect from moisture.
• Shelf-Life: 2 years.

If you have any more questions please ask your Pharmacist.

Remember to keep all medicines out of reach of children

Please Note: We have made every effort to ensure that the content of this information sheet is correct at time of publish, but remember that information about drugs may change. This sheet does not list all the uses and side-effects associated with this drug. For full details please see the drug information leaflet which comes with your medicine. Your doctor will assess your medical circumstances and draw your attention to any information or side-effects which may be relevant in your particular case.

References:

http://www.mims.com/hongkong/drug/info/AceryCal/?type=full

http://www.medicines.ie/medicine/13742/SPC/ACERYCAL+5+10/

http://www.medicines.ie/medicine/13726/PIL/ACERYCAL/

http://www.imb.ie/images/uploaded/documents/DoctorLetter_PROOF-5%2011%2009%2009%20FINAL.pdf

http://www.imb.ie/EN/Publications/Publications/Acerycal-perindopril-amlodipine--Important-Safety-Information-from-Les-Laboratoires-Servier-.aspx

http://www.imb.ie/images/uploaded/documents/DoctorLetter_PROOF-5%2011%2009%2009%20FINAL.pdf

http://www.drugs.com/uk/acerycal-10mg-10mg-tablet-leaflet.html