Co-Amlessa tablets are indicated for the treatment of hypertension in patients who need treatment with perindopril, indapamide and amlodipine in a dose, available in a fixed combination.
Active ingredients: perindopril tert-butylamine, indapamide, amlodipine;
1 tablet contains:
2 mg perindopril tert-butylamine, 0.625 mg indapamide and 5 mg amlodipine (as amlodipine besylate), or
4 mg perindopril tert-butylamine, 1.25 mg indapamide and 5 mg amlodipine (as amlodipine besylate), or
4 mg perindopril tert-butylamine, 1.25 mg indapamide and 10 mg amlodipine (as amlodipine besylate), or
8 mg perindopril tert-butylamine, 2.5 mg indapamide and 5 mg amlodipine (as amlodipine besylate), or
8 mg perindopril tert-butylamine, 2.5 mg indapamide and 10 mg amlodipine (as amlodipine besylate).
Excipients: microcrystalline cellulose calcium chloride, hexahydrate; corn starch; sodium starch (type A) sodium bicarbonate; silicon dioxide water; magnesium stearate.
1 tablet of the preparation Co-Amlessa once a day, preferably in the morning before meals.
The use of a fixed combination is not intended for initial therapy.
If necessary, the dose of the preparation Co-Amlessa can be changed or an individual selection of doses can be recommended separately for each component.
If necessary, the patient can divide the Ko-Amless tablet 4 mg / 1.25 mg / 10 mg or 8 mg / 2.5 mg / 10 mg at the dose level, placing it on a flat surface with a line up and pressing with two fingers from both parties from risks.
The maximum recommended dose of Ko-Amless is 8 mg / 2.5 mg / 10 mg per day.
Pregnant
Contraindicated.
Children
Not applicable.
Drivers
Carefully.
There are no data on overdose with Co-Amlessa.
For the combination of perindopril / indapamide, a frequent adverse reaction in overdose is arterial hypotension, which can sometimes be accompanied by nausea, vomiting, convulsions, dizziness, drowsiness, confusion, oliguria, which can progress to anuria (due to hypovolemia). Water-electrolyte imbalance may occur (a decrease in the level of potassium and sodium in the blood plasma).
First aid measures include the rapid elimination of the preparation from the body: gastric lavage and / or the appointment of activated charcoal, and then restoring the water and electrolyte balance in a hospital setting until these indicators return to normal limits.
If significant hypotension occurs, the patient should be placed in a horizontal position with a low headboard. If necessary, an isotonic solution is administered intravenously or any other method of restoring blood volume is used.
Perindoprilat, the active form of perindopril, can be removed from the body by hemodialysis.
The most common adverse reactions that were observed with the use of perindopril, indapamide and amlodipine separately are: dizziness, headache, paresthesia, vertigo, drowsiness, blurred vision, ringing in the ears, palpitation, hot flashes, arterial hypotension (and related symptoms), cough, shortness of breath, disorders of the gastrointestinal tract (abdominal pain, constipation, diarrhea, taste perversion (dysgeusia), dyspepsia, nausea, vomiting), itching, skin rashes, maculopapular rashes, muscle cramps, asthenia, ankle edema, edema and fatigue.
Aliskiren. Patients with diabetes mellitus or those with impaired renal function are at increased risk of hyperkalemia, impaired renal function, and cardiovascular morbidity and mortality.
Medicines that cause hyperkalemia. Certain preparations or therapeutic classes of preparations can cause hyperkalemia, namely: aliskiren, potassium salts, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non-steroidal anti-inflammatory preparations (NSAIDs), heparin, immunosuppressants such as cycloimusosporine, or tachoprimoprimrol. Concomitant use of these preparations increases the risk of hyperkalemia.
Store at a temperature not exceeding 30 ° C in its original packaging to protect from light and moisture.
Keep out of the reach of children.
Shelf life is 2 years.
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