Coveram 5mg/10mg B/30

Perindopril arginine + Amlodipine besilate (COVERAM) is indicated as substitution therapy for treatment of essential hypertension and/or stable coronary artery disease, in patients already controlled with perindopril and amlodipine given concurrently at the same dose level.

Posology: Oral route.

• One tablet per day as a single dose, preferably to be taken in the morning and before a meal.
• The fixed dose combination is not suitable for initial therapy.
• If a change of posology is required, the dose of Perindopril arginine + Amlodipine besilate (COVERAM) could be modified or individual titration with free combination may be considered.

Special populations: Renal impairment and elderly: Elimination of perindoprilat is decreased in the elderly and in patients with renal failure. Therefore, the usual medical follow-up will include frequent monitoring of creatinine and potassium.
Perindopril arginine + Amlodipine besilate (COVERAM) can be administered in patients with Clcr ≥60 mL/min, and is not suitable for patients with Clcr < 60 mL/min. In these patients, an individual dose titration with the monocomponents is recommended.
Amlodipine used at similar doses in elderly or younger patients is equally well tolerated. Normal dosage regimens are recommended in the elderly, but increase of the dosage should take place with care. Changes in amlodipine plasma concentrations are not correlated with degree of renal impairment. Amlodipine is not dialyzable.

Hepatic impairment: Dosage recommendations have not been established in patients with mild to moderate hepatic impairment; therefore dose selection should be cautious and should start at the lower end of the dosing range. To find the optimal starting dose and maintenance dose of patients with hepatic impairment, the patients should be individually titrated using the free combination of amlodipine and perindopril. The pharmacokinetics of amlodipine have not been studied in severe hepatic impairment. Amlodipine should be initiated at the lowest dose and titrated slowly in patients with severe hepatic impairment.

Pediatric population: Perindopril arginine + Amlodipine besilate (COVERAM) should not be used in children and adolescents as the efficacy and tolerability of perindopril and amlodipine, in combination, have not been established in children and adolescents.

Missed Dose: It is important to take the medicine everyday as regular treatment works better. However, if a dose is forgotten, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

Discontinuation of Treatment: As the treatment with Perindopril arginine + Amlodipine besilate (COVERAM) is usually life-long, patient should discuss with the doctor before stopping the treatment.

THE POSSIBLE SIDE EFFECTS:

If you notice any of the following side effects, stop taking this medicine immediately and contact your doctor right away:

sudden wheezing, chest pain, shortness of breath or difficulty breathing ,

· swelling of the eyelids, face or lips,

swelling of the tongue and throat, causing great difficulty breathing,

- severe skin reactions, including intense skin rash, hives, redness of the skin all over the body, severe itching, blistering, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis ) or other allergic reactions,

· severe vertigo or dizziness,

heart attack , unusually fast or abnormal heartbeat, chest pain,

· inflammation of the pancreas which can cause severe abdominal and back pain accompanied by great discomfort.