Bi-Prestarium 10mg/5mg 30 tablets — Made in Ireland — Free Delivery
(Bi-Prestarium)
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Description Bi-Prestarium 10mg/5mg 30 tablets — Made in Ireland — Free Delivery
Product description
Bi-Prestarium is prescribed for the treatment of arterial hypertension and / or coronary heart disease (if treatment with perindopril and amlodipine is necessary).
Compound
active ingredients: perindopril arginine / amlodipine;
1 tablet contains perindopril arginine 5 mg (corresponding to 3.395 mg of perindopril) and amlodipine besylate 13.870 mg (corresponding to 10 mg of amlodipine)
Contraindications
- Hypersensitivity to the active substances (or to any other ACE inhibitors or dihydropyridine derivatives) or to the excipient;
- history of angioedema associated with previous treatment with ACE inhibitors
- congenital or idiopathic angioedema
- severe arterial hypotension
- shock, including cardiogenic shock
- obstruction of the exit from the left ventricle (for example, severe aortic stenosis);
- heart failure after acute myocardial infarction with unstable hemodynamics;
- pregnancy or planning pregnancy (see section "Use during pregnancy or lactation");
- simultaneous use with preparations that contain the active ingredient aliskiren in patients with diabetes mellitus or renal insufficiency (glomerular filtration rate <60 ml / min / 1.73 m 2) (see section "Interaction with other preparations and other forms of interaction") ;
- simultaneous use with sacubitril / valsartan (see sections "Peculiarities of use" and "Interaction with other preparations and other types of interactions");
- extracorporeal therapies that lead to blood contact with negatively charged surfaces (see section "Interaction with other medicinal products and other forms of interaction");
- significant bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney (see section "Peculiarities of use").
Dosage and administration
For oral use.
Adults should take 1 tablet once a day, preferably in the morning before meals. The tablet is not subject to division.
The dose should be selected individually for each patient, taking into account the indications for use, the course of the disease and blood pressure indicators. The maximum daily dose is 1 tablet Bi-Prestarium ® 10 mg / 10 mg per day.
Application features
Use during pregnancy or lactation
The use of Bi-Prestarium ® is contraindicated during pregnancy.
The use of the preparation Bi-Prestarium ® is not recommended during lactation. If necessary, the use of the preparation breast-feeding should be discontinued.
Children
Bi-Prestarium ® is not recommended for children due to the lack of studies involving this group of patients.
The ability to influence the reaction rate when driving vehicles or operating other mechanisms
Studies on the effect of the preparation Bi-Prestarium ® on the ability to drive vehicles and work with other mechanisms have not been conducted. Amlodipine may have minor or moderate effects on the ability to drive and use machines. Driver reaction may be impaired if dizziness, headache, weakness, fatigue or nausea occur. Caution is advised, especially at the start of treatment.
Overdose
No cases of overdose of Bi-Prestarium ® have been reported. Data on conscious overdose of amlodipine are limited. Symptoms: Available data suggest that very large doses may lead to excessive peripheral vasodilation and the possible occurrence of reflex tachycardia. Severe, possibly prolonged, systemic hypotension and fatal shock have been reported.
Adverse reactions
The most common adverse reactions reported with the separate use of perindopril and amlodipine are: edema, drowsiness, dizziness, headache (especially at the beginning of treatment), taste perversion (dysgeusia), paresthesia, visual disturbances (including double vision), tinnitus , vertigo, palpitation, flushing, hypotension (and associated symptoms), dyspnea, cough, abdominal pain, nausea, vomiting, dyspepsia, change in bowel habits, diarrhea, constipation, pruritus, rash, rash, swelling of the joints (swelling of the ankles) , muscle spasms, increased US, asthenia.
Interaction with other medicinal products and other forms of interaction
Data from clinical studies suggest that dual renin-angiotensin-(RAAS) blockade by concomitant administration of ACE inhibitors, angiotensin II receptor blockers, or aliskiren is associated with a higher incidence of adverse reactions such as hypotension, hyperkalemia, and decreased renal function (including acute renal failure) , compared with the use of a single preparation that affects the RAAS.
Preparations that cause hyperkalemia. Some 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 cyclosporine or tacrolimus, trimethoprim and fixed combination of sulfamethoxazole (co-trimoxazole). The simultaneous use of these preparations increases the risk of hyperkalemia.
Storage conditions
Store tablets in a tightly closed container. Does not require special temperature storage conditions.
Shelf life - 3 years.
Tags: Prestarium
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