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.
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,
"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."
"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."
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
"Additional information linked to amlodipine
Exceptional cases of extrapyramidal syndrome have been reported with calcium channel blockers."
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:
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.