COPALIA HCT Film-coated tablet Ref.[107981] Active ingredients: Amlodipine Hydrochlorothiazide Valsartan Valsartan, Amlodipine and Hydrochlorothiazide

Posology

The recommended dose of Copalia HCT is one tablet per day, to be taken preferably in the morning.

Before switching to Copalia HCT patients should be controlled on stable doses of the monocomponents taken at the same time. The dose of Copalia HCT should be based on the doses of the individual components of the combination at the time of switching.

The maximum recommended dose of Copalia HCT is 10 mg/320 mg/25 mg.

Special populations

Renal impairment

Due to the hydrochlorothiazide component, Copalia HCT is contraindicated for use in patients with anuria (see section 4.3) and in patients with severe renal impairment (glomerular filtration rate (GFR) <30 ml/min/1.73 m²) (see sections 4.3, 4.4 and 5.2).

No adjustment of the initial dose is required for patients with mild to moderate renal impairment (see sections 4.4 and 5.2).

Hepatic impairment

Due to the valsartan component, Copalia HCT is contraindicated in patients with severe hepatic impairment (see section 4.3). In patients with mild to moderate hepatic impairment without cholestasis, the maximum recommended dose is 80 mg valsartan and therefore Copalia HCT is not suitable in this group of patients (see sections 4.3, 4.4 and 5.2). Amlodipine dose recommendations have not been established in patients with mild to moderate hepatic impairment. When switching eligible hypertensive patients (see section 4.1) with hepatic impairment to Copalia HCT, the lowest available dose of the amlodipine component should be used.

Heart failure and coronary artery disease

There is limited experience with the use of Copalia HCT, particulary at the maximum dose, in patients with heart failure and coronary artery disease. Caution is advised in patients with heart failure and coronary artery disease, particularly at the maximum dose of Copalia HCT, 10 mg/320 mg/25 mg.

Elderly (age 65 years or over)

Caution, including more frequent monitoring of blood pressure, is recommended in elderly patients, particularly at the maximum dose of Copalia HCT, 10 mg/320 mg/25 mg, since available data in this patient population are limited. When switching eligible elderly hypertensive patients (see section 4.1) to Copalia HCT, the lowest available dose of the amlodipine component should be used.

Paediatric population

There is no relevant use of Copalia HCT in the paediatric population (patients below age 18 years) for the indication of essential hypertension.

Method of administration

Oral use.

Copalia HCT can be taken with or without food.

The tablets should be swallowed whole with some water, at the same time of the day and preferably in the morning.

Symptoms

There is no experience of overdose with Copalia HCT. The major symptom of overdose with valsartan is possibly pronounced hypotension with dizziness. Overdose with amlodipine may result in excessive peripheral vasodilation and, possibly, reflex tachycardia. Marked and potentially prolonged systemic hypotension, including shock with fatal outcome, have been reported with amlodipine.

Non-cardiogenic pulmonary oedema has rarely been reported as a consequence of amlodipine overdose that may manifest with a delayed onset (24-48 hours post-ingestion) and require ventilatory support. Early resuscitative measures (including fluid overload) to maintain perfusion and cardiac output may be precipitating factors.

Treatment

Amlodipine/Valsartan/Hydrochlorothiazide

Clinically significant hypotension due to Copalia HCT overdose calls for active cardiovascular support, including frequent monitoring of cardiac and respiratory function, elevation of extremities, and attention to circulating fluid volume and urine output. A vasoconstrictor may be helpful in restoring vascular tone and blood pressure, provided that there is no contraindication to its use. Intravenous calcium gluconate may be beneficial in reversing the effects of calcium channel blockade.

Amlodipine

If ingestion is recent, induction of vomiting or gastric lavage may be considered. Administration of activated charcoal to healthy volunteers immediately or up to two hours after ingestion of amlodipine has been shown to significantly decrease amlodipine absorption. Amlodipine is unlikely to be removed by haemodialysis.

Valsartan

Valsartan is unlikely to be removed by haemodialysis.

Hydrochlorothiazide

Overdose with hydrochlorothiazide is associated with electrolyte depletion (hypokalaemia, hypochloraemia) and hypovolaemia resulting from excessive diuresis. The most common signs and symptoms of overdose are nausea and somnolence. Hypokalaemia may result in muscle spasms and or accentuate arrhythmia associated with the concomitant use of digitalis glycosides or certain anti-arrhythmic medicinal products.

The degree to which hydrochlorothiazide is removed by haemodialysis has not been established.

2 years.

Do not store above 30°C.

Store in the original package in order to protect from moisture.

PVC/PVDC blisters. One blister contains 7, 10 or 14 film-coated tablets.
Pack sizes: 14, 28, 30, 56, 90, 98 or 280 film-coated tablets.
Multipacks of 280 tablets, comprising 20 cartons, each containing 14 tablets.

PVC/PVDC perforated unit dose blisters for hospital use:
Pack sizes: 56, 98 or 280 film-coated tablets
Multipacks of 280 tablets, comprising 4 cartons, each containing 70 tablets.

Not all pack sizes may be marketed.

No special requirements.