Amlessa tablets 4 mg + 10 mg blister No. 30

Amlessa tablets are indicated for arterial hypertension and/or ischemic heart disease (if treatment with perindopril and amlodipine is necessary).

Composition

Active ingredients: perindopril tert-butylamine and amlodipine;

1 tablet contains 4 mg perindopril tert-butylamine (equivalent to 3.34 mg perindopril) and 5 mg amlodipine (equivalent to 6.935 mg amlodipine besylate), or;

4 mg perindopril tert-butylamine (equivalent to 3.34 mg perindopril) and 10 mg amlodipine (equivalent to 13.870 mg amlodipine besylate), or;

8 mg perindopril tert-butylamine (equivalent to 6.68 mg perindopril) and 5 mg amlodipine (equivalent to 6.935 mg amlodipine besylate), or;

8 mg perindopril tert-butylamine (equivalent to 6.68 mg perindopril) and 10 mg amlodipine (equivalent to 13.870 mg amlodipine besylate);

Excipients: microcrystalline cellulose, corn starch, sodium starch, calcium chloride, hexahydrate, sodium bicarbonate, colloidal silicon dioxide, magnesium stearate.

Contraindication

Method of application

Start with 1 tablet per day, preferably taken in the morning before meals.

The tablets cannot be divided. The dosage range allows for flexibility in the ratio of components depending on clinical needs. The dose should be selected individually for each patient, taking into account the indications for use, the course of the disease and blood pressure.

The use of a fixed combination is not suitable for initial therapy.

The maximum daily dose is 1 tablet of Amless 8 mg / 10 mg per day.

Application features

Pregnant women

Contraindicated during pregnancy.

Children

It is not recommended for use in children due to the lack of studies involving this group of patients.

Drivers

Caution is recommended, especially at the beginning of treatment.

Overdose

No cases of overdose have been reported.

Side effects

The most common adverse reactions with the separate use of perindopril and amlodipine are: edema, drowsiness, dizziness, headache (especially at the beginning of treatment), taste distortion (dysgeusia), paresthesia, visual disturbances (including diplopia), tinnitus, palpitations, flushing, hypotension (and related symptoms), shortness of breath, cough, abdominal pain, nausea, vomiting, dyspepsia, change in bowel habits, diarrhea, constipation, itching, rash, joint swelling (ankle swelling), smooth muscle spasms, fatigue, asthenia.

Interaction

Simultaneous use is contraindicated.

Aliskiren: In patients with diabetes mellitus or patients with impaired renal function, the risk of hyperkalemia, worsening of renal function, and cardiovascular morbidity and mortality is increased.

Extracorporeal therapies. Extracorporeal therapies that result in contact of blood with negatively charged surfaces, such as dialysis or hemofiltration using certain membranes with high hydraulic permeability (e.g. polyacrylonitrile) and low-density lipoprotein apheresis using dextran sulfate, due to an increased risk of severe anaphylactoid reactions. If such treatments are necessary, consideration should be given to using a different type of dialysis membrane or a different class of antihypertensive agent.

Sacubitril/valsartan. Concomitant use of perindopril with sacubitril/valsartan is contraindicated because concomitant inhibition of neprilysin and ACE may increase the risk of angioedema. Sacubitril/valsartan should not be started until 36 hours after the last dose of perindopril. Perindopril therapy should not be started until 36 hours after the last dose of sacubitril/valsartan.

Storage conditions

Store at a temperature not exceeding 30 °C in the original packaging.

Keep out of reach of children.

Shelf life - 3 years.