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Indications - This combination is indicated as substitution therapy for the treatment of hypertension and/or stable coronary heart disease in patients already controlled with separate doses of perindopril and amlodipine, given concurrently at the same dose level. Treatment should not be initiated with this combination.

Dosage & Administration - perindopril arginine & amlodipine is as substitution therapy for patients already controlled with separate doses of perindopril (5 or 10 mg) and amlodipine (5 or 10 mg), given concurrently at the dose level. Treatment should not be initiated with this combination. Food intake may reduce hepatic biotransformation of perindopril to perindoprilat. Recommended treatment is one tablet per day as a single dose, preferably to be taken in the morning and before a meal. As perindopril and amlodipine may be used for different clinical indications, dose adjustments should be based on clinical judgment and the individual patient profile. Adjustments can be made by decreasing or increasing the dose of either perindopril and/or amlodipine using separate perindopril and/or amlodipine products within the recommended dose range until clinical stability is re-established. Consult the Product Information of the individual perindopril and/or amlodipine products being used when adjusting the dose. In the event that down-titration is required, adjustments using amlodipine 2.5 mg or a dose of perindopril equivalent to perindopril arginine 2.5 mg, as separate products should be considered until clinical stability is re-established.

Side Effects - The most commonly reported adverse reactions with perindopril and amlodipine given separately are: oedema, somnolence, dizziness, headache (especially at the beginning of the treatment), dysgeusia, paraesthesia, visual impairment (including diplopia), tinnitus, vertigo, palpitations, flushing, hypotension (and effects related to hypotension), dyspnoea, cough, abdominal pain, nausea, vomiting, dyspepsia, change of bowel habit, diarrhoea, constipation, pruritus, rash, exanthema, joint swelling (ankle swelling), muscle spasms, fatigue, asthenia.

Contraindications - This combination is contraindicated: In patients with a history of previous hypersensitivity to either of the active ingredients; perindopril or amlodipine, ACE inhibitors, dihydropyridines or excipient ingredients present in this combination. During pregnancy and for lactating women.

Others - Pregnancy & Lactation This combination should not be initiated during pregnancy and lactation. Patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with this combination should be stopped immediately, and, if appropriate, alternative treatment should be started. Precautions & Warnings As this combination contains lactose monohydrate, patients with rare hereditary problems of galactose intolerance, glucose galactose malabsorption, or total lactase deficiency should not take This combination. Since ACE inhibitors reduce angiotensin II formation resulting in decreased production of aldosterone, increases in serum potassium have been observed in some patients treated with ACE inhibitors including perindopril. Serum electrolytes (including sodium potassium and urea) should be measured from time to time when ACE inhibitors are given especially in combination with diuretics. Use in Special Populations Paediatric use: Use of this combination in children is not recommended as no data establishing safety or effectiveness in children are available.