COPALIA Film-coated tablet Ref.[10519] Active ingredients: Amlodipine Valsartan Valsartan and Amlodipine

Posology

The recommended dose of Copalia is one tablet per day.

Copalia 5 mg/80 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 80 mg alone.

Copalia 5 mg/160 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 160 mg alone.

Copalia 10 mg/160 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 10 mg or valsartan 160 mg alone or with Copalia 5 mg/160 mg.

Copalia can be used with or without food.

Individual dose titration with the components (i.e. amlodipine and valsartan) is recommended before changing to the fixed dose combination. When clinically appropriate, direct change from monotherapy to the fixed-dose combination may be considered.

For convenience, patients receiving valsartan and amlodipine from separate tablets/capsules may be switched to Copalia containing the same component doses.

Renal impairment

There are no available clinical data in severely renally impaired patients. No dosage adjustment is required for patients with mild to moderate renal impairment. Monitoring of potassium levels and creatinine is advised in moderate renal impairment.

Hepatic impairment

Copalia is contraindicated in patients with severe hepatic impairment (see section 4.3).

Caution should be exercised when administering Copalia to patients with hepatic impairment or biliary obstructive disorders (see section 4.4). In patients with mild to moderate hepatic impairment without cholestasis, the maximum recommended dose is 80 mg valsartan. Amlodipine dosage 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 amlodipine or Copalia, the lowest available dose of amlodipine monotherapy or of the amlodipine component, respectively, should be used.

Elderly (age 65 years or over)

In elderly patients, caution is required when increasing the dosage. When switching eligible elderly hypertensive patients (see section 4.1) to amlodipine or Copalia, the lowest available dose of amlodipine monotherapy or of the amlodipine component, respectively, should be used.

Paediatric population

The safety and efficacy of Copalia in children aged below 18 years have not been established. No data are available.

Method of administration

Oral use.

It is recommended to take Copalia with some water.

Symptoms

There is no experience of overdose with Copalia. 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 up to and including shock with fatal outcome have been reported.

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

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. Clinically significant hypotension due to Copalia 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.

Both valsartan and amlodipine are unlikely to be removed by haemodialysis.

3 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: 7, 14, 28, 30, 56, 90, 98 or 280 film-coated tablets and multipacks containing 280 (4 × 70 or 20 × 14) film-coated tablets.

PVC/PVDC perforated unit dose blisters. One blister contains 7, 10 or 14 film-coated tablets.

Pack sizes: 56, 98 or 280 film-coated tablets.

Not all pack sizes may be marketed.

No special requirements.