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2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of Captopril and 25 mg of Hydrochlorothiazide.
Excipients: Each tablet contains 70.20 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORMform Tablet. A White to off-white oval, biconvex talet with possible slight mottling. One side of the tablet is engraved 'SQUIBB 390'tablets, with a bisect breakbar on one side and engraved "CH" on the oppositeother side. The tablet can be divided into equal halves. 4.2 Posology and method of administration Capozide 50mg/25mg Tablets can be administered in a single or two divided doses/day with or without food in patients whose blood pressure is not adequately controlled by captopril alone or hydrochlorothiazide alone. A maximum daily dose of 10050 mg captopril/3025 mg hydrochlorothiazide should not be exceeded. If satisfactory reduction of blood pressure has not been achieved, additional antihypertensive medication may be added (see section 4.5). Adults: The the administration of the fixed combination of captopril and hydrochlorothiazide is usually recommended after dosage titration with the individual components. The usual maintenance dose is 50 mg/25 25 mg, once a day, in the morning. When clinically appropriate a direct change from monotherapy to the fixed combination may be considered. The 25/25mg* strength may be used once a day for patients whose blood pressure is not adequately controlled by hydrochlorothiazide 25 mg monotherapy and before titration of the captopril component. The 50/25mg and 25/25mg strengths are intended to be used once daily, as two tablets would result in an inappropriately high dose of hydrochlorothiazide (50mg/day). The 50/15* mg strength may be administered to start the fixed combination in patients whose blood pressure is not adequately controlled by 50 mg captopril monotherapy, and/or when a lower dose of hydrochlorothiazide is preferred. Renal impairment: Creatinine clearance between 30 and 80 ml/min: the initial dose is usually 25 mg/12.5 5 mg once a day, in the morning. The combination captopril/hydrochlorothiazide is contraindicated in patients with severe renal impairment (creatinine clearance < 30 < 30 ml/min). Special populations: In in salt/volume depleted patients, elderly patients, and diabetic patients, the usual starting dose is 25 mg/12.5 5 mg once a day. Children: The safety and efficacyThere is no relevant indication for use of Capozide 50mg/25mg Tablets in children has not been established. 4.4 Warnings and Precuations Angioedema: Angiangioneurotic oedema of the face, extremities, face, lips, mucous membranes, tongue, glottis and/or larynx may occur has been reported in patients treated with ACEangiotensin converting enzyme inhibitors, particularlyincluding Captopril. This may occur at any time during the first weeks of treatment. However, in rare In such cases, severe angioedema may develop after long-term treatment with an ACE inhibitor. Treatment Captopril should be discontinued promptly. Angioedema involving the tongue, glottis or larynx may be fatal. Emergency therapy and appropriate monitoring should be instituted. The patient should be hospitalised and observed for at least 12 to 24 hours and should not be discharged untilensure complete resolution of symptoms prior to dismissing the patient. In those instances where swelling has occurredbeen confined to the face and lips the condition generally resolved without treatment, although antihistamines have been useful in relieving symptoms. Cough: Cough Angioneurotic oedema associated with laryngeal edema may be fatal. Where there is involvement of the tongue, glottis or larynx, likely to cause airway obstruction, appropriate therapy, which may include subcutaneous epinephrine solution 1:1000 (0.3 ml to 0.5 ml) and/or measures to ensure a patent airway, should be administered promptly. Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks. 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). 4.5 Drug interactions Alpha blocking agents: concomitant use of alpha blocking agents may increase the antihypertensive effects of captopril and increase the risk of orthostatic hypotension. Carbamazepine: concomitant use of carbamazepine and hydrochlorothiazide has been associated with the risk of symptomatic hyponatraemia. Electrolytes should be monitored during concomitant use. If possible, another class of diuretics should be used. 4.6 Pregnancy Because of the potential for serious adverse reactions in nursing infants from both drugs, a decision should be made on whether to continue/discontinue nursingbreast-feeding or to continue/discontinue therapy, with Capozide 50mg/25mg Tablets should be made taking into account the importancebenefit of thisbreast-feeding to the child and the benefit of Capozide 50mg/25mg Tablets therapy to the motherwoman. 6.3 Shelf life 36 months. 3 years. 6.4 Special precautions for storage Do not store above 25°C. Store in the original package. 6.5 Nature and contents of container The tablets are packaged in foil strips or PVC/PVDC blisters in packs of 28 tablets. PVC/PVDC/Aluminium foil blisters, containing 10, 12, 20, 28, 30, 42, 60, 84, 90, 98, 100 tablets. Not all pack sizes may be marketed.
Tablet.
A
White to off-white oval, biconvex talet with possible slight mottling.
One side of the tablet is engraved 'SQUIBB 390'tablets, with a bisect breakbar on one side and engraved "CH" on the oppositeother side.
The tablet can be divided into equal halves.
4.2 Posology and method of administration
Capozide 50mg/25mg Tablets can be administered in a single or two divided doses/day with or without food in patients whose blood pressure is not adequately controlled by captopril alone or hydrochlorothiazide alone.
A maximum daily dose of 10050 mg captopril/3025 mg hydrochlorothiazide should not be exceeded. If satisfactory reduction of blood pressure has not been achieved, additional antihypertensive medication may be added (see section 4.5).
Adults: The the administration of the fixed combination of captopril and hydrochlorothiazide is usually recommended after dosage titration with the individual components. The usual maintenance dose is 50 mg/25 25 mg, once a day, in the morning. When clinically appropriate a direct change from monotherapy to the fixed combination may be considered.
The 25/25mg* strength may be used once a day for patients whose blood pressure is not adequately controlled by hydrochlorothiazide 25 mg monotherapy and before titration of the captopril component. The 50/25mg and 25/25mg strengths are intended to be used once daily, as two tablets would result in an inappropriately high dose of hydrochlorothiazide (50mg/day). The 50/15* mg strength may be administered to start the fixed combination in patients whose blood pressure is not adequately controlled by 50 mg captopril monotherapy, and/or when a lower dose of hydrochlorothiazide is preferred.
Renal impairment: Creatinine clearance between 30 and 80 ml/min: the initial dose is usually 25 mg/12.5 5 mg once a day, in the morning.
The combination captopril/hydrochlorothiazide is contraindicated in patients with severe renal impairment (creatinine clearance < 30 < 30 ml/min).
Special populations: In in salt/volume depleted patients, elderly patients, and diabetic patients, the usual starting dose is 25 mg/12.5 5 mg once a day.
Children: The safety and efficacyThere is no relevant indication for use of Capozide 50mg/25mg Tablets in children has not been established.
4.4 Warnings and Precuations
Angioedema: Angiangioneurotic oedema of the face, extremities, face, lips, mucous membranes, tongue, glottis and/or larynx may occur has been reported in patients treated with ACEangiotensin converting enzyme inhibitors, particularlyincluding Captopril. This may occur at any time during the first weeks of treatment. However, in rare In such cases, severe angioedema may develop after long-term treatment with an ACE inhibitor. Treatment Captopril should be discontinued promptly. Angioedema involving the tongue, glottis or larynx may be fatal. Emergency therapy and appropriate monitoring should be instituted. The patient should be hospitalised and observed for at least 12 to 24 hours and should not be discharged untilensure complete resolution of symptoms prior to dismissing the patient. In those instances where swelling has occurredbeen confined to the face and lips the condition generally resolved without treatment, although antihistamines have been useful in relieving symptoms.
Cough: Cough
Angioneurotic oedema associated with laryngeal edema may be fatal. Where there is involvement of the tongue, glottis or larynx, likely to cause airway obstruction, appropriate therapy, which may include subcutaneous epinephrine solution 1:1000 (0.3 ml to 0.5 ml) and/or measures to ensure a patent airway, should be administered promptly.
Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks.
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).
4.5 Drug interactions
Alpha blocking agents: concomitant use of alpha blocking agents may increase the antihypertensive effects of captopril and increase the risk of orthostatic hypotension.
Carbamazepine: concomitant use of carbamazepine and hydrochlorothiazide has been associated with the risk of symptomatic hyponatraemia. Electrolytes should be monitored during concomitant use. If possible, another class of diuretics should be used. 4.6 Pregnancy
4.6 Pregnancy
Because of the potential for serious adverse reactions in nursing infants from both drugs, a decision should be made on whether to continue/discontinue nursingbreast-feeding or to continue/discontinue therapy, with Capozide 50mg/25mg Tablets should be made taking into account the importancebenefit of thisbreast-feeding to the child and the benefit of Capozide 50mg/25mg Tablets therapy to the motherwoman.
6.3 Shelf life
36 months. 3 years. 6.4 Special precautions for storage Do not store above 25°C. Store in the original package. 6.5 Nature and contents of container The tablets are packaged in foil strips or PVC/PVDC blisters in packs of 28 tablets. PVC/PVDC/Aluminium foil blisters, containing 10, 12, 20, 28, 30, 42, 60, 84, 90, 98, 100 tablets. Not all pack sizes may be marketed.
3 years. 6.4 Special precautions for storage Do not store above 25°C. Store in the original package. 6.5 Nature and contents of container The tablets are packaged in foil strips or PVC/PVDC blisters in packs of 28 tablets. PVC/PVDC/Aluminium foil blisters, containing 10, 12, 20, 28, 30, 42, 60, 84, 90, 98, 100 tablets. Not all pack sizes may be marketed.
3 years.
6.4 Special precautions for storage
Do not store above 25°C. Store in the original package.
6.5 Nature and contents of container
The tablets are packaged in foil strips or PVC/PVDC blisters in packs of 28 tablets.
PVC/PVDC/Aluminium foil blisters, containing 10, 12, 20, 28, 30, 42, 60, 84, 90, 98, 100 tablets.
Not all pack sizes may be marketed.
A white oval biconvex tablet with possible slight mottling.
One side of the tablet is engraved 'SQUIBB 390' with a bisect bar on the opposite side.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Intestinal angioedema has also been reported very rarely in patients treated with ACE inhibitors and should be included in the differential diagnosis of patients on ACE inhibitors presenting with abdominal pain.