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► Exforge 10 mg / 160 mg (amlodipine + valsartan) - Medycyna Praktyczna

Exforge 10 mg / 160 mg (amlodipine + valsartan) - coated tablets

The name of the preparation Character; dose; package Manufacturer Price 100% Price after refund In which pharmacy?
Exforge 10 mg / 160 mg coated tablets; 10 mg + 160 mg (1 tablet contains: 10 mg of amlodipine, 160 mg of valsartan); 14 tabl. Novartis Europharm 54.90 Check
Exforge 10 mg / 160 mg coated tablets; 10 mg + 160 mg (1 tablet contains: 10 mg of amlodipine, 160 mg of valsartan); 28 tabl. Novartis Europharm 72.99 Check

Note: reimbursed drug prices are in line with the regulations in force from July 1, 2018.

The preparation contains the substance:amlodipine + valsartan

The drug is available on prescription

What is Exforge ?

Combined preparation containing an angiotensin II receptor antagonist (valsartan) and a Calcium antagonist from the group of dihydropyridine derivatives (amlodipine).

What does Exforge contain and how does it work?

It is a combined preparation containing 2 active substances: valsartan and Amlodipine . Valsartan belongs to a group of medicines called angiotensin II receptor antagonists or sartans. The common mechanism of action of drugs in this group is the blocking of angiotensin II receptors which prevents them from binding to angiotensin II and inhibits its action (drugs from this group are often indicated by the abbreviation ARB, which comes from the English nameAngiotensin II Receptor Blockers). Angiotensin II plays an important role in the pathophysiology of hypertension. The effect of angiotensin II is vasoconstriction and the increase in the release of aldosterone, which leads to increased blood pressure. The effect of valsartan, like other sartans, effectively counteracts the effects of angiotensin II and leads to a decrease in blood pressure. Unlike drugs from the angiotensin-converting enzyme inhibitors, sartans do not exacerbate the effects of bradykinin-dependent, for example, cough. Sartans are used as medicines to lower blood pressure and to treat and prevent diseases of the cardiovascular system.
The second active substance is amlodipine, a dihydropyridine derivative belonging to a group of medicines called calcium channel blockers (or calcium channel blockers). Calcium antagonists act by blocking calcium channels, structures that allow the passage of calcium ions across the cell membrane. Amlodipine blocks the inflow of calcium ions from the extracellular space into the smooth muscle cells of the walls of the blood vessels and to a lesser extent into the cells of the heart muscle. Increasing the intracellular calcium concentration is necessary for the contraction of muscle cells. Amlodipine works mainly on peripheral blood vessels. Blockage of calcium channels reduces the tension of the vessel walls and vasodilation. The immediate effect of this action of amlodipine is lowering blood pressure. Enlargement of peripheral arterioles reduces peripheral vascular resistance, which relieves the heart (it reduces energy consumption by the myocardium and its oxygen demand). Coronary arteries are also likely to expand, which increases oxygen transport to the myocardium. As a result, in patients with angina pectoris, exercise tolerance increases (the time to angina pain increases during exercise) and the incidence and severity of angina pains decreases. The clinical condition of patients with angina pectoris improves and Nitroglycerin consumption decreases. In hypertensive patients, taking once daily with amlodipine provides a clinically significant reduction in blood pressure over 24 hours.
Thanks to the use of complementary mechanisms of action of both active substances, the antihypertensive effect of the preparation is stronger than in the case of the use of each of the components in monotherapy.

When should I use Exforge?

It is indicated for the treatment of essential hypertension in adults who do not achieve sufficient blood pressure reduction with amlodipine or valsartan.

When not to use this preparation?

Unfortunately, even if there are indications to use the preparation, it can not always be used. You can not use the product if you are allergic (you are hypersensitive) to any of the ingredients of the preparation or to another drug from the group of dihydropyridine calcium antagonists.
You can not use the preparation if you are present:
· Severe liver problems, liver biliary cirrhosis or cholestasis
· Severe kidney problems (glomerular filtration rate GFR less than 30 ml / min / 1.73 m2) or you are undergoing dialysis
· Severe hypotension
· Shock, including cardiogenic shock
· Narrowing of the outflow path from the left ventricle (eg severe aortic valve stenosis, hypertrophic cardiomyopathy)
Hemodynamically unstable heart failure after myocardial infarction.
Do not use in parallel with aliskiren in patients with diabetes or with renal impairment (glomerular filtration rate GFR less than 60 ml / min / 1.73 m2).
The preparation is contraindicated in the second and third trimester of pregnancy and during breastfeeding. It is not recommended during the first trimester of pregnancy.

Take special care with Exforge?

Certain diseases and other circumstances may constitute a contraindication to use or indication to change the dosage of the preparation. In some situations it may be necessary to carry out specific check-ups.
There are no data on the safety and efficacy of amlodipine in the treatment of hypertensive crisis.
Special care should be taken because the preparation can rarely cause a significant, symptomatic reduction in blood pressure. An increased risk of hypotension after taking the preparation concerns in particular people with increased activation of the renin-angiotensin-aldosterone system (including those with reduced volume of circulating, dehydrated or sodium deficient, receiving previously high doses of diuretics, using a diet with low salt content, after diarrhea or vomiting). Before starting treatment, electrolyte deficits should be leveled and adequate hydration should be ensured. In this group of patients, treatment should be started under close medical supervision.
In the case of symptomatic hypotension, the patient should be placed on the back and called for medical help. The occurrence of hypotension after taking the preparation is not a contraindication for further use of the preparation, however, it is necessary to achieve stabilization of blood pressure and fluid volume.
The preparation may cause hyperkalaemia (increase in potassium in the blood). Hyperkalaemia may cause serious arrhythmias, sometimes fatal. The use of medications that may increase the level of potassium in the blood, such as, for example, potassium-sparing diuretics, potassium deficient supplements, Heparin or potassium chloride substitutes should be avoided. If your doctor considers these medicines to be necessary, he will advise you to exercise caution and monitor your blood potassium levels.
Caution should be exercised when treating patients with unilateral or bilateral renal artery stenosis or stenosis of the artery to the sole active kidney; you may experience an increase in urea and creatinine in the blood.
There are no data on the safety of the preparation in patients after recent kidney transplantation.
People with mild or moderate hepatic impairment should be treated with caution. In patients with impaired hepatic function without cholestasis, a dose of 80 mg valsartan per day should not be exceeded. The preparation is contraindicated in case of severe liver dysfunction, biliary cirrhosis or cholestasis (cholestasis, biliary obstruction).
No dose adjustment is required for adults with mild or moderate renal impairment. In patients with moderate renal impairment, monitoring of potassium and creatinine in the blood is recommended. In patients with severe renal impairment (glomerular filtration rate GFR less than 30 ml / min / 1.73 m2) and in patients undergoing dialysis, the use of the preparation is contraindicated.
Do not use the preparation in parallel with aliskiren in patients with impaired renal function (glomerular filtration rate GFR less than 60 ml / min / 1.73 m2).
It is not recommended to use the preparation in patients with primary hyperaldosteronism, because the effect of the preparation in this group of patients is not effective.
The preparation may cause angioneurotic edema (possible swelling of the face, lips, tongue, throat and larynx, which may impede breathing and constitute an immediate threat to life). In the event of the first symptoms of edema, stop using the preparation and seek medical help immediately. Hospitalization and appropriate treatment may be necessary. After the occurrence of angioneurotic edema, the preparation may not be used again. The risk of angioneurotic edema is increased in people who have had angioedema in the past.
In patients at higher risk of renal dysfunction, in which renal function depends on the activity of the renin-angiotensin-aldosterone system (eg in patients with severe congestive heart failure, after myocardial infarction) the use of drugs acting on the renin-angiotensin-aldosterone system ( such as, for example, valsartan) may be associated with a risk of renal dysfunction, including acute renal failure . In patients with heart failure or after myocardial infarction, the assessment of renal function is extremely important.
Caution should be exercised in patients with heart failure, especially severe (NYHA grade III and IV); in this group of patients, during the period of application (due to the content of amlodipine in the preparation), there is an increased risk of pulmonary edema.
In patients with congestive heart failure, calcium antagonists, including amlodipine, may increase the risk of cardiovascular events and death.
The product should be used with particular caution in people with impaired left ventricular inflow or outflow (aortic or mitral stenosis, hypertrophic cardiomyopathy).
The concurrent use of sartans (including valsartan) and other agents acting on the renin-angiotensin-aldosterone system (RAA) is not recommended. Due to the risk of hypotension, hyperkalemia and / or renal dysfunction, including acute renal failure, parallel administration of ACE inhibitors or aliskiren is not recommended. This combination treatment results in increased inhibition of the renin-angiotensin-aldosterone system and can only be used if absolutely necessary under close medical supervision. Blood pressure, renal function and electrolyte concentration should be monitored. In patients with diabetic nephropathy, ACE inhibitors and sartans should not be used in parallel.
Use of the preparation in parallel with aliskiren in patients with diabetes mellitus or with renal dysfunction (glomerular filtration rate GFR less than 60 ml / min / 1.73 m2) is contraindicated.

Does this preparation affect the ability to drive vehicles?
It should be remembered that the preparation may cause dizziness, headache, drowsiness, fatigue, nausea or other symptoms that may impair psychophysical fitness and the ability to drive vehicles and operate machines / machines.

Dosage of Exforge

The preparation is in the form of coated tablets for oral use. The preparation should be taken once a day with water. Can be taken regardless of meals. Do not exceed the recommended doses because it will not increase the effectiveness of the drug and may harm your health and life. If you have any doubts regarding the use of the preparation, consult a physician.
Adults: 1 tablet once a day.
Before using a fixed combination with a fixed content of active substances, it is recommended that the doctor adjusts the dosage of amlodipine and valsartan individually in the form of separate preparations. In some cases, however, the doctor may recommend a direct change of the treatment method from monotherapy to a combined preparation.
No dose adjustment is required for adults with mild or moderate renal impairment. In patients with moderate renal impairment, monitoring of potassium and creatinine in the blood is recommended. In patients with severely impaired renal function and in patients undergoing dialysis, the use of the preparation is contraindicated.
Use of the preparation in parallel with aliskiren in patients with diabetes mellitus or with renal dysfunction (glomerular filtration rate GFR less than 60 ml / min / 1.73 m2) is contraindicated.
People with mild or moderate hepatic impairment should be treated with caution. In patients with impaired hepatic function without cholestasis, a dose of 80 mg valsartan per day should not be exceeded. The preparation is contraindicated in case of severe liver dysfunction, biliary cirrhosis or cholestasis (cholestasis).
Elderly, caution should be advised when increasing the dose.
Children and youth:
There are insufficient data on the safety and efficacy of the preparation in children and adolescents up to 18 years of age. For this reason, the preparation should not be used in this age group.

Can I use Exforge during pregnancy and breastfeeding?

During pregnancy, do not use any medicine without consulting your doctor!
It is very important that before using any medicine during pregnancy or breastfeeding, consult a physician and explain beyond any doubt the potential risks and benefits associated with the use of the drug. If you are pregnant or plan to become pregnant, please inform the doctor prescribing the prescription for this medicine.
Medicines from the sartane group can have a detrimental effect on pregnancy, fetus and newborn development. The preparation should not be used during the first trimester of pregnancy. The use of the preparation in the second and third trimester of pregnancy is contraindicated. If a woman is planning a pregnancy, it is recommended to change the way of antihypertensive treatment. If you suspect pregnancy during the period of taking the preparation, stop taking it immediately and consult a physician. Your doctor may prescribe other antihypertensive agents.
The use of the preparation is contraindicated during breast-feeding.

Can I use other preparations in parallel?

Tell your doctor about all medicines you have recently taken, including those that are over the counter.
Caution should be exercised because the antihypertensive effect may be exacerbated if other antihypertensive agents, vasodilators, diuretics or other drugs that lower blood pressure (eg some antidepressants, antipsychotics, hypnotics, sedatives, barbiturates, opioids) are used in combination with the preparation , nitrates, baclofen, alpha-blockers used to treat prostatic hyperplasia and others). Intensification of hypotension and hypotension may occur.
Use of the preparation in parallel with aliskiren in patients with diabetes mellitus or with renal dysfunction (glomerular filtration rate GFR less than 60 ml / min / 1.73 m2) is contraindicated.
The parallel use of sartans (including valsartan) and other agents acting on the renin-angiotensin-aldosterone system (including angiotensin converting enzyme or aliskiren inhibitors) is not recommended. This combination treatment results in increased inhibition of the renin-angiotensin-aldosterone system and can only be used if absolutely necessary under close medical supervision. Blood pressure, renal function and electrolyte concentration should be monitored.
Due to the content of amlodipine in the preparation, it is not recommended to use the preparation in parallel with:
· Dantrolene (infusion); Avoid calcium antagonists such as amlodipine in parallel with dantrolene (including those susceptible to malignant hyperthermia and the treatment of malignant hyperthermia), because of the risk of fatal arrhythmia
· Grapefruit or grapefruit juice; Grapefruit juice in some people may cause an increase in the antihypertensive effect contained in the preparation of amlodipine.
Due to the content of amlodipine in the preparation, particular caution is required if the preparation is used with any of the following drugs:
· Preparations that increase the activity of the cytochrome P450 3A4 isoenzyme (such asrifampicin, St. John's wort, phenobarbital, primidone, fosfentyin, phenytoin and carbamazepine) may cause a decrease in amlodipine in the blood and reduce its effect; Caution should be exercised because the dosage of amlodipine may need to be adjusted by the doctor
· Preparations that reduce the activity of cytochrome P450 3A4 isoenzyme (such as diltiazem, Verapamil , ketoconazole, itraconazol and other azole antifungals, ritonavir and other protease inhibitors, Erythromycin and other macrolide antibiotics) can inhibit the metabolism of amlodipine and increase its concentration in the blood and significant intensification of its operation; be careful and be under the supervision of a doctor; it may be necessary to adjust the dosage by your doctor
· Simvastatin - in parallel, the use of amlodipine and simvastatin may increase systemic exposure to statins and increase the risk of myopathy and rhabdomyolysis; the necessary dose reduction of simvastatin (as prescribed by your doctor).
Due to the content of valsartan in the preparation, it is not recommended to use the preparation in parallel with:
· Lithium, due to the risk of increased neurotoxic effects of lithium; if necessary, the combination of lithium in the blood should be monitored
· With drugs that increase the level of potassium in the blood (potassium salts, potassium-sparing diuretics eg spironolactone, triamteren, amiloride, some antihypertensives, potassium supplements, trimethoprim, tacrolimus, cyclosporine, heparin) and with potassium-containing salt substitutes; these preparations increase the risk of hyperkalemia; if it is necessary to use them, the doctor will advise you to closely monitor the level of potassium in your blood.
Due to the content of valsartan in the preparation, caution should be exercised if the preparation is used with any of the following drugs:
· Non-steroidal anti-inflammatory drugs (eg Acetylsalicylic acid , Ibuprofen , Ketoprofen , selective COX-2 inhibitors) may reduce the antihypertensive effect of the preparation and lead to renal dysfunction, including acute renal failure and increase in potassium in the blood; caution is required, especially in the elderly and monitoring of renal function and ensuring adequate hydration of the patient
· Rifampicin, cyclosporin, ritonavir; possible increase in the effect of valsartan.

What side effects can occur?

Like all medicines, Exforge 5 mg / 80 mg, 5 mg / 160 mg, 10 mg / 160 mg, may cause side effects, although they will not occur in all patients taking this medicine. Remember that the expected benefits of using the drug are usually greater than the damage resulting from the occurrence of side effects.
Adverse effects associated with the use of the preparation include: frequent or uncommon possible headaches and dizziness, impaired coordination of movements, tingling and numbness (paresthesia), drowsiness, blurred vision, palpitations, increased heart rate, diarrhea, nausea, vomiting , indigestion, lack of appetite, constipation, abdominal pain, gastritis, dry mouth, inflammation of the nose and throat, flu-like symptoms, hypotension associated with a change in body position, cough, sore throat and larynx, erythema, rash, pains joints, weakness, fatigue, mood changes, malaise, hot flushes / facial flushing, facial edema, peripheral edema, swelling of the joints (including swelling of the ankles), increase in blood lipids, increase in uric acid in the blood, increase in calcium in the blood, reducing the concentration of sweat asu and sodium in the blood; rarely or very rarely possible: anxiety, tinnitus, syncope, hypotension, hypersensitivity reactions, pruritus, skin eruptions, excessive sweating, muscle spasms, pollakiuria, polyuria, sexual dysfunction (impotence).
In addition, adverse reactions previously reported for each component of the preparation used independently can not be excluded. Side effects associated with the use of valsartan include dizziness, fatigue, cough, abdominal pain, increased potassium in the blood (hyperkalemia), thrombocytopenia,reduction of neutrophil counts (neutropenia), anemia, decrease in hematocrit and hemoglobin, increased bilirubin, renal impairment, renal failure, increased creatinine and urea in the blood, angioneurotic edema (swelling of the face, lips, tongue, throat, larynx in sporadic cases that may cause narrowing of the airways, impede breathing and threaten life), rash, pruritus, bullous dermatitis, muscular pains, vasculitis, hypersensitivity reactions, including serum sickness.
Frequently or rarely occurring side effects associated with the use of amlodipine include: headache and dizziness, fatigue, fainting, tingling or numbness (paresthesia), tremors, mood changes (including anxiety), sleep disorders / drowsiness / insomnia, depression, taste disorders, visual disturbances (including double vision), tinnitus, flushing, palpitations, hypotension, chest pain, weakness, swelling (especially around the ankles), shortness of breath, rhinitis, dry mucous membrane mouth, nausea, abdominal pain, indigestion, vomiting, diarrhea, constipation, baldness, profuse sweating, rash, pruritus, skin discoloration, purpura, muscle pains and spasms, joint pain, impaired urination frequency, impotence, ginekomastia, increase / weight loss. Rare or very rare: confusion / confusion, increased muscle tone, peripheral neuropathy, myocardial infarction, arrhythmias, increased liver enzymes, jaundice, hepatitis, increased bilirubin in the blood, gastritis, pancreatitis, gingival hyperplasia, inflammation vascular thrombocytopenia, thrombocytopenia, reduced white blood cell count (leukopenia), increased blood Glucose (hyperglycaemia), cough, urticaria, photosensitivity, angioneurotic edema (swelling of the face, lips, tongue, throat, larynx in occasional cases that may cause narrowing of the airways) , impede breathing and threaten life), severe skin reactions (Stevens and Johnson syndrome, erythema multiforme, exfoliative dermatitis).

Other preparations on the Polish market containing amlodipine + valsartan

Avasart Plus (coated tablets)
Dipperam (coated tablets)
Exforge 5 mg / 80 mg (coated tablets)
Exforge 5 mg / 160 mg (coated tablets)