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.
Update section 4.1, 4.2, 4.8 & 5.1 of SPC following the HEAAL Study.
Correct lactose content i.e. change from 12.5mg to 25.25mg Each COZAAR 12.5 mg tablet contains 25.25 mg lactose monohydrate
4.9 Overdose
Symptoms of intoxication Limited data are available with regard to overdose in humans. The most likely manifestation of overdose would be hypotension and tachycardia. Bradycardia could occur from parasympathetic (vagal) stimulation. Treatment of intoxication If symptomatic hypotension should occur, supportive treatment should be instituted.Measures are depending on the time of medicinal product intake and kind and severity of symptoms. Stabilisation of the cardiovascular system should be given priority. After oral intake, the administration of a sufficient dose of activated charcoal is indicated. Afterwards, close monitoring of the vital parameters should be performed. Vital parameters should be corrected if necessary.
Treatment of intoxication
If symptomatic hypotension should occur, supportive treatment should be instituted.Measures are depending on the time of medicinal product intake and kind and severity of symptoms. Stabilisation of the cardiovascular system should be given priority. After oral intake, the administration of a sufficient dose of activated charcoal is indicated. Afterwards, close monitoring of the vital parameters should be performed. Vital parameters should be corrected if necessary.
Neither losartan nor the active metabolite can be removed by haemodialysis.
6.1 List of excipients microcrystalline cellulose (E460) lactose monohydrate pregelatinized maize starch magnesium stearate (E572)
microcrystalline cellulose (E460) lactose monohydrate pregelatinized maize starch magnesium stearate (E572)
hyprolose (E463) hypromellose (E464) COZAAR 12.5 mg, 50 mg and 100 mg contain potassium in the following amounts: 1.06 mg (0.027 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq) respectively. COZAAR 12.5 mg tablets also contain carnauba wax (E903), titanium dioxide (E171), indigo carmine (E132) aluminum lake. 6.5 Nature and contents of container COZAAR 12.5 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in cartons containing 7, 14, 21, 28, 50, 98, 210 or 500 tablets and a unit-dose package of 28 tablets for hospital use. HDPE bottles of 100 tablets. COZAAR 50 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in cartons containing 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 280 or 500 tablets and unit-dose packages of 28, 56 and 98 tablets for hospital use. HDPE bottles of 100 or 300 tablets. COZAAR 100 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in cartons containing 7, 10, 14, 15, 20, 28, 30, 50, 56, 84, 90, 98 or 280 tablets and unit-dose packages of 28, 56 and 98 tablets for hospital use. HDPE bottles of 100 tablets. 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Cozaar 12.5mg 6th March 2009 / 31 December 2009 Cozaar 50mg 6th June 1995 / 31 December 2009 Cozaar 100mg 16th November 2001 / 31 December 2009
COZAAR 12.5 mg, 50 mg and 100 mg contain potassium in the following amounts: 1.06 mg (0.027 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq) respectively.
COZAAR 12.5 mg tablets also contain carnauba wax (E903), titanium dioxide (E171), indigo carmine (E132) aluminum lake.
6.5 Nature and contents of container COZAAR 12.5 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in cartons containing 7, 14, 21, 28, 50, 98, 210 or 500 tablets and a unit-dose package of 28 tablets for hospital use. HDPE bottles of 100 tablets. COZAAR 50 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in cartons containing 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 280 or 500 tablets and unit-dose packages of 28, 56 and 98 tablets for hospital use. HDPE bottles of 100 or 300 tablets. COZAAR 100 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in cartons containing 7, 10, 14, 15, 20, 28, 30, 50, 56, 84, 90, 98 or 280 tablets and unit-dose packages of 28, 56 and 98 tablets for hospital use. HDPE bottles of 100 tablets. 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Cozaar 12.5mg 6th March 2009 / 31 December 2009 Cozaar 50mg 6th June 1995 / 31 December 2009 Cozaar 100mg 16th November 2001 / 31 December 2009
COZAAR 50 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in cartons containing 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 280 or 500 tablets
and unit-dose packages of 28, 56 and 98 tablets for hospital use. HDPE bottles of 100 or 300 tablets. COZAAR 100 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in cartons containing 7, 10, 14, 15, 20, 28, 30, 50, 56, 84, 90, 98 or 280 tablets and unit-dose packages of 28, 56 and 98 tablets for hospital use. HDPE bottles of 100 tablets. 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Cozaar 12.5mg 6th March 2009 / 31 December 2009 Cozaar 50mg 6th June 1995 / 31 December 2009 Cozaar 100mg 16th November 2001 / 31 December 2009
COZAAR 100 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in cartons containing 7, 10, 14, 15, 20, 28, 30, 50, 56, 84, 90, 98 or 280 tablets
and unit-dose packages of 28, 56 and 98 tablets for hospital use. HDPE bottles of 100 tablets.
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Cozaar 12.5mg 6th March 2009 /
31 December 2009 Cozaar 50mg 6th June 1995 / 31 December 2009 Cozaar 100mg 16th November 2001 / 31 December 2009