Twynsta pills 5mg + 80mg №28

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Description
Product Details

Indications

- arterial hypertension (for patients whose blood pressure is not sufficiently controlled by telmisartan or Amlodipine in monotherapy);

- arterial hypertension (for patients for whom combination therapy is indicated);

- in patients with arterial hypertension, receiving telmisartan and amlodipine in the form of separate tablets, as a substitute for this therapy.

Dosing regimen

Twynsta drug^® It is necessary to take 1 time / day, inside, regardless of the meal.

Twinsta^® may be administered to patients receiving the same doses of telmisartan and amlodipine as separate tablets, for ease of therapy and increased adherence to treatment.

Twinsta^® may be prescribed to patients in whom the use of one amlodipine or one telmisartan does not lead to adequate blood pressure control. Patients taking amlodipine in a dose of 10 mg, in which there are adverse reactions limiting the drug, for example, peripheral edema, can go on to receive the drug Twynsta^® at a dose of 40/5 mg 1 time / day, which will reduce the dose of amlodipine, but will not reduce the overall expected antihypertensive effect.

Treatment of hypertension the patient may begin with the use of the drug Twynsta^® in the case when it is assumed that achieving control of blood pressure with any single drug is unlikely. The usual starting dose of Twynsta^® - 40/5 mg 1 time / day. Patients who need a more significant reduction in blood pressure may start taking Twynsta^® at a dose of 80/5 mg 1 time / day.

If, at least after 2 weeks of treatment, an additional reduction in blood pressure is required, the dose of the drug can be gradually increased to a maximum dose of 80/10 mg 1 time / day.

Twinsta^® can be used with other antihypertensive drugs.

In patients with impaired renal function, including those on hemodialysis, no changes in the dosage of the drug are required. Amlodipine and telmisartan are not removed from the body during hemodialysis.

In patients with mild or moderate hepatic impairment, the drug Twynsta^® should be used with caution.The dose of telmisartan should not exceed 40 mg 1 time / day.

Dosing regimen does not require changes.

Peculiarities of the drug action at the first dose or when it is canceled

After the first dose of telmisartan, the hypotensive effect gradually develops during the first 3 hours and the effect of the drug lasts for 24 hours and remains significant until 48 hours.

In the case of abrupt withdrawal of telmisartan, blood pressure gradually returns to its original level without the development of withdrawal syndrome.

Side effect

¹⁾expected based on experience with telmisartan

²⁾ expected based on experience with amlodipine

³⁾ expected with simultaneous use of telmisartan and amlodipine

Inside the system-organ classes, the following categories are used by the frequency of occurrence of side effects: very often (≥1 / 10); often (≥1 / 100, <1/10); infrequently (≥1 / 1000, <1/100); rarely (≥1 / 10,000, <1/1000); very rarely (<1/10 000);
frequency unknown (cannot be calculated from available data).

System organ class	By-effect	Frequency of occurrence
Infections and invasions	Cystitis³⁾	Seldom
	Urinary tract infections¹⁾	Infrequently
	Upper respiratory tract infections¹⁾	Infrequently
	Sepsis, incl. fatal¹⁾	Seldom
Psychotic disorders	Depression³⁾, anxiety³⁾insomnia³⁾	Seldom
Psychotic disorders	Mood lability²⁾confused consciousness²⁾	Frequency unknown
Nervous system disorders	Dizziness³⁾	Often
	Drowsiness³⁾migraine³⁾, headache³⁾, paresthesias³⁾	Infrequently
	Decreased sensitivity or resistance to external factors³⁾taste disturbance³⁾faint³⁾tremor³⁾peripheral neuropathy³⁾	Seldom
Immune system disorders	Anaphylactic reaction¹⁾	Seldom
Immune system disorders	Hypersensitivity^1),2)	Seldom¹⁾, Frequency unknown¹⁾
Violations of the organs of sight	Blurred vision³⁾	Seldom
Hearing impairment	Vertigo³⁾	Infrequently
Hearing impairment	Noise in ears²⁾	Frequency unknown
Violations by cardiovascular systems	Bradycardia³⁾palpitations³⁾	Infrequently
	Tachycardia¹⁾	Infrequently
	Myocardial infarction²⁾	Seldom
	Arrhythmia²⁾ventricular tachycardia²⁾atrial fibrillation²⁾	Frequency unknown
	A pronounced decrease in blood pressure³⁾orthostatic hypotension³⁾	Infrequently
Respiratory disorders	Cough³⁾	Infrequently
	Dyspnea^1),2)	Infrequently¹⁾ Frequency unknown²⁾
	Rhinitis²⁾	Frequency unknown
Violations by gastrointestinal tract	Abdominal pain³⁾diarrhea³⁾nausea³⁾flatulence¹⁾	Infrequently
	Vomiting³⁾dyspepsia³⁾stomach discomfort¹⁾	Seldom
	Defecation rhythm changes²⁾, pancreatitis²⁾gastritis²⁾	Frequency unknown
	Liver function disorders¹⁾	Seldom
	Hepatitis²⁾jaundice²⁾	Frequency unknown
	Increased liver transaminase activity (mainly reflecting cholestasis)²⁾	Frequency unknown
	Increased liver enzymes³⁾	Seldom
Violations of the skin and subcutaneous tissue	Eczema³⁾erythema³⁾rash^1),3)medicinal rash¹⁾toxic rash¹⁾	Seldom
	Pruritus³⁾	Infrequently
	Angioedema^1),2)	Seldom¹⁾, frequency unknown²⁾
	Hyperhidrosis^1),2)	Infrequently¹⁾, frequency unknown²⁾
	Hives^1),2)	Seldom¹⁾, frequency unknown²⁾
	Alopecia²⁾purple²⁾skin discoloration²⁾erythema multiforme²⁾exfoliative dermatitis²⁾, Stevens-Johnson syndrome²⁾photosensitization reaction²⁾vasculitis²⁾	Frequency unknown
Violations of the musculoskeletal system	Arthralgia³⁾, backache³⁾, muscle spasms (spasms of the calf muscles)³⁾myalgia³⁾	Infrequently
Violations of the musculoskeletal system	Pain in lower limbs³⁾, pain in tendons (symptoms resembling tendonitis)¹⁾	Seldom
Violations of the genitourinary system	Nocturia³⁾	Seldom
	Impaired renal function, including acute renal failure ¹⁾urination disorders²⁾frequent urination²⁾	Frequency unknown
	erectile disfunction³⁾	Infrequently
General violations	Peripheral edema³⁾	Often
	Asthenia (weakness)³⁾chest pain³⁾fatigue³⁾, swelling³⁾	Infrequently
	Malaise³⁾flu-like syndrome¹⁾feeling a rush of blood³⁾gingival hypertrophy³⁾dryness of the oral mucosa³⁾	Seldom
	Pain²⁾weight gain²⁾weight loss²⁾, gynecomastia²⁾	Frequency unknown
Reactions identified by special research	Increasing the concentration of uric acid in the blood³⁾increase in blood creatinine¹⁾ and creatine phosphokinase (CPK)¹⁾, hemoglobin reduction¹⁾ (anemia, weakness), hypoglycemia (in patients with diabetes)¹⁾, eosinophilia¹⁾	Seldom
	Leukopenia²⁾hyperglycemia²⁾	Frequency unknown
	Hyperkalemia¹⁾	Infrequently
	Thrombocytopenia^1),2)	Seldom¹⁾, frequency unknown ²⁾

Additional information on individual components

Side effects previously reported with the use of one of the components of the drug (amlodipine or telmisartan) may increase with the use of the drug Twint^®, even if they were not observed in clinical studies or during the post-marketing period.

Additional information regarding the combination of components

Peripheral edema, a dose-dependent side effect of amlodipine, was observed in patients who received the combination of telmisartan and amlodipine, less frequently than in patients who received only amlodipine.

Contraindications

- obstructive diseases of the biliary tract;

- severe hypotension;

- obstruction of the outgoing tract of the left ventricle (including a high degree of aortic stenosis);

- hemodynamically unstable heart failure after acute myocardial infarction;

- severe liver failure;

- shock;

- fructose intolerance and glucose / galactose absorption absorption syndrome or sucrase / isomaltase deficiency;

- pregnancy;

- breastfeeding period;

- age up to 18 years (efficiency and safety have not been established);

- Hypersensitivity to active ingredients or auxiliary substances;

- Hypersensitivity to other dihydropyridine derivatives.

The drug should be prescribed with caution patients with:

- obstructive diseases of the biliary tract or liver failure;

- bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney;

- condition after kidney transplantation;

- reduced bcc and / or hyponatremia;

- double blockade of the renin-angiotensin-aldosterone system (RAAS);

- other conditions characterized by activation of the RAAS;

- primary aldosteronism;

- aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy;

- heart failure;

- hyperkalemia;

- diabetes mellitus with additional cardiovascular risk (i.e., concomitant coronary artery disease (IHD) /);

- after 1 month after acute myocardial infarction and unstable angina pectoris.

Use during pregnancy and lactation

Special studies drug Twynsta^® during pregnancy and during lactation were not carried out.The effects associated with the individual components of the drug are described below.

Pregnancy

The use of angiotensin II receptor antagonists (ARA II) is contraindicated during pregnancy. When diagnosing pregnancy, the drug should be immediately discontinued. If necessary, alternative therapy should be prescribed.

It is known that the use of ARA II during the II and III trimesters of pregnancy has a fetotoxic effect (reduced kidney function, oligohydramnios, delayed ossification of the fetal skull), and neonatal toxicity (renal failure, arterial hypotension and hyperkalemia) is also observed.

The limited data available on the effects of amlodipine or other Calcium receptor antagonists do not indicate the presence of negative effects on the fetus. However, there is a risk of slowing down the process of childbirth.

Breastfeeding period

Special studies on the allocation telmisartan and / or amlodipine with breast milk in women was not carried out. Animal studies have shown that telmisartan is excreted in milk from lactating animals. Given the possible adverse reactions, the decision to continue breastfeeding or to cancel therapy should be made taking into account its importance to the mother. Studies on the effect on human fertility were not conducted.

Application for violations of the liver

In patients with mild or moderate hepatic impairment, the drug Twynsta^® should be used with caution. The dose of telmisartan should not exceed 40 mg 1 time / day.

Application for violations of kidney function

Use in children

Contraindicated in children and adolescents under 18 years of age.

Use in elderly patients

Dosing regimen does not require changes.

special instructions

The drug should be administered with caution if the patient has the following conditions:

- abnormal liver function;

- bilateral renal artery stenosis or arterial stenosis of a single kidney, severe renal dysfunction.In some patients, due to the suppression of the RAAS, especially when using a combination of agents acting on this system, renal function is impaired (including acute renal failure). Therefore, therapy, accompanied by a similar double blockade of the RAAS, should be carried out strictly individually and with careful monitoring of renal function (including periodic monitoring of the content of potassium and creatinine in blood serum). In cases of dependence of the vascular tone and kidney function, mainly on the activity of the RAAS (for example, in patients with chronic heart failure or kidney diseases, including stenosis of the renal arteries, or stenosis of the artery of a single kidney), the administration of drugs affecting this system, may be accompanied by the development of acute arterial hypotension, hyperasotemia, oliguria, and, in rare cases, acute renal failure;

- condition after kidney transplantation (no experience);

- reduction of bcc and / or hyponatremia due to prior diuretic therapy, restriction of salt, diarrhea or vomiting;

- double blockade of RAAS;

- other conditions characterized by RAAS activation;

- primary aldosteronism;

- Aortic and mitral valve stenosis, idiopathic hypertrophic subaortic stenosis;

- heart failure;

- hyperkalemia;

- hereditary intolerance to fructose;

- in patients with diabetes mellitus and additional cardiovascular risk, i.e. Patients with diabetes mellitus and concomitant coronary artery disease (IHD), the risk of fatal myocardial infarction and sudden cardiovascular death may be increased when treated with antihypertensive drugs such as angiotensin II receptor antagonists and ACE inhibitors. In patients with diabetes, IHD may be asymptomatic, as a result of which it cannot be diagnosed. Patients with diabetes should undergo an appropriate diagnosis, for example, an exercise test, for the diagnosis and treatment of coronary artery disease, respectively, before starting treatment with Twynsta^®.

Other indications

Twinsta^® less effective in treating patients of the Negroid race (renin activity in the blood is usually reduced in this population).

No data on the use of the drug Twynsta^® in patients with unstable angina, with acute myocardial infarction and in the period of one month after the development of myocardial infarction.

Influence on ability to drive motor transport and control mechanisms

Studies of the impact on the ability to drive vehicles and control mechanisms were not conducted. However, it should be taken into account that during treatment such undesirable effects as syncope, drowsiness or dizziness may occur. Therefore, when driving a vehicle or machinery, care should be taken. If patients experience these sensations, they should avoid performing such potentially dangerous activities as driving a car or operating machinery.

Overdose

Symptoms

No overdose cases have been identified. Possible symptoms of overdose consist of symptoms from the individual components of the drug.

Telmisartan - a pronounced decrease in blood pressure, tachycardia, possibly bradycardia, dizziness, an increase in serum creatinine concentration, acute renal failure.

Amlodipine - excessive peripheral vasodilation and, possibly, reflex tachycardia. There may be severe and probably prolonged systemic hypotension, up to the development of a fatal shock.

Treatment

Hemodialysis is not effective. Monitoring the patient's condition, therapy should be symptomatic and supportive.

In order to counteract the blockade of calcium channels, intravenous administration of Calcium gluconate may be useful.

Overdose treatment methods can be used, such as induction of vomiting, gastric lavage, the use of Activated carbon , transferring the patient to the "supine-lying position" and the introduction of plasma substituting solutions in the case of a pronounced decrease in blood pressure.

Drug interaction

The interactions between the two active components that are included in fixed doses in the composition of this drug in clinical studies was not observed.

Special studies of drug interactions drug Twynsta^® with other drugs was not carried out.

With simultaneous use of the drug Twynsta^® With the preparations listed below, the following information should be taken into account.

Other antihypertensive drugs

With simultaneous use with other antihypertensive drugs, the hypotensive effect of the drug Twynsta^® may increase.

Drugs that can reduce blood pressure

It can be expected that some drugs, such as Baclofen and amifostine, due to their pharmacological properties, will enhance the hypotensive effect of all antihypertensive drugs, including the drug Twynsta^®. In addition, orthostatic hypotension may be enhanced by ethanol, barbiturates, narcotic drugs or antidepressants.

Corticosteroids (systemic use)

Perhaps a decrease in the hypotensive effect.

With simultaneous use of telmisartan with:

— other antihypertensives: may increase the hypotensive effect. In one study, the combined use of telmisartan and Ramipril showed an increase in AUC._0-24 and C_maxramipril and ramiprilata 2.5 times. The clinical significance of this interaction has not been established.

— digoxin, Warfarin , hydrochlorothiazide, glibenclamide, Simvastatin and amlodipine: no clinically significant interaction has been identified. An increase in the average concentration of Digoxin in the blood plasma was noted on average by 20% (in one case by 39%). With the simultaneous appointment of telmisartan and digoxin, it is advisable to periodically determine the concentration of digoxin in the blood.

— lithium preparations: There was a reversible increase in the concentration of lithium in the blood, accompanied by toxic effects when taking ACE inhibitors. In rare cases, such changes have been reported with the appointment of angiotensin II receptor antagonists, in particular, telmisartan. With the simultaneous appointment of lithium preparations and angiotensin II receptor antagonists, it is recommended to determine the content of lithium in the blood.

— NSAIDs, including Acetylsalicylic acid in doses, used as an anti-inflammatory agent, cyclooxygenase-2 inhibitors (COX-2) and non-selective NSAIDs , can cause the development of acute renal failure in patients with reduced BCC. Preparations affecting the activity of the renin-angiotensin system, incl. telmisartan may have a synergistic effect.In patients receiving NSAIDs and telmisartan, at the beginning of treatment, BCC should be compensated and renal function should be monitored.

With the simultaneous use of NSAIDs and antihypertensive drugs like telmisartan, a decrease in the antihypertensive effect by inhibiting the vasodilator effect of prostaglandins has been reported.

With simultaneous use of amlodipine with:

— grapefruit and grapefruit juice: at the same time, the use of the drug with grapefruit or grapefruit juice is not recommended, because in some patients, as a result of the increased bioavailability of amlodipine, its antihypertensive effects may increase;

— inhibitors of the isoenzyme CYP3A4 : In a study in elderly patients, diltiazem was shown to inhibit amlodipine metabolism, probably affecting CYP3A4 (amlodipine plasma concentrations increase by about 50% and the effect of amlodipine increases). It is possible that more active inhibitors of CYP3A4 (such as Ketoconazole , itraconazole, ritonavir) may increase plasma concentrations of amlodipine more than diltiazem.

— CYP3A4 isoenzyme inducers - anticonvulsant drugs (for example, Carbamazepine , phenobarbital, phenytoin, phosphenytoin, primidon), rifampicin, St. John's wort (Hypericum perforatum): combined use may lead to a decrease in plasma concentrations of amlodipine. Regular medical surveillance is indicated. During the use of CYP3A4 inducers, as well as after their cancellation, it is recommended (if possible) to change the dose of amlodipine;

- combined use Simvastatin 80 mg with amlodipine, regardless of the dose, increases the exposure of simvastatin up to 77% compared with simvastatin monotherapy. Therefore, the dose of simvastatin should not exceed 40 mg / day.

With the simultaneous use of the following drugs should take into account the following information

The safety of combined use of amlodipine with thiazide diuretics, beta-blockers, ACE inhibitors, long-acting nitrates, Nitroglycerin (used sublingually), NSAIDs, antibiotics and hypoglycemic agents for oral administration has been established.

With simultaneous use of amlodipine and Sildenafil , it was shown that each drug had an independent hypotensive effect.

Additional Information

The simultaneous use of 20 ml of grapefruit juice with a single dose of amlodipine 10 mg taken orally in 20 healthy volunteers did not lead to a significant effect on the pharmacokinetic properties of amlodipine.

The simultaneous use of amlodipine with cimetidine had no significant effect on the pharmacokinetics of amlodipine.

The simultaneous use of amlodipine with Atorvastatin , digoxin, warfarin or cyclosporin did not significantly affect the pharmacokinetics or pharmacodynamics of these drugs.

Based on the experience of using other agents that affect the RAAS, the simultaneous use of the drug Twynsta^® and potassium-saving diuretics, potassium-containing additives, potassium-containing food salt, other drugs that increase the potassium content in the blood (for example, heparin), can lead to hyperkalemia, so this indicator should be monitored in patients. In this regard, their simultaneous use with telmisartan requires caution.

Terms and conditions of storage

The drug should be stored in its original packaging, out of the reach of children at a temperature not exceeding 25 ° C