Exforge 10mg/160mg 28 tablets

Form

tableti saghech i

Dosage mg

10მგ+160

Pack

28

Instructions for use Exforge 10 mg /160 mg film-coated tablet is taken orally. Active ingredients: Each film-coated tablet contains 10 mg of amlodipine base equivalent to 13.87 mg of amlodipine besylate and 160 mg of valsartan. Excipients: microcrystalline cellulose, crospovidone, colloidal anhydrous silica, magnesium stearate, hypromellose, macrogol 4000, talc, titanium dioxide (E171), iron yellow oxide (E172). Read the instructions for use carefully before using this medicine, as it contains important information for you. Keep these instructions for use. You may need to read them again. If you have any further questions, please ask your doctor or pharmacist. This medicine has been prescribed for you personally, do not give it to others. If you consult another doctor or go to a hospital, inform the doctor about the use of this medicine. Follow the instructions for use of the medicine exactly. Do not take a higher or lower dose than recommended for you. What is Exforge and what is it used for? Exforge is presented in blister packs containing 28 tablets. Each film-coated tablet contains 10 mg of amlodipine and 160 mg of valsartan. Exforge contains amlodipine, a substance belonging to the group of calcium channel blockers, and valsartan, a substance belonging to the group of angiotensin II receptor antagonists. Both of these substances are used to control high blood pressure (hypertension). Amlodipine blocks calcium channels in the smooth muscle cells of blood vessels, which prevents blood vessels from constricting. Angiotensin II, a substance produced in the body, causes blood vessels to narrow and increases blood pressure. Valsartan acts by blocking angiotensin II. These two mechanisms relax blood vessels and lower blood pressure. Exforge is used to treat high blood pressure (hypertension) in patients who are taking amlodipine or valsartan alone, but their blood pressure is not adequately controlled. If high blood pressure persists for a long time, it can damage the blood vessels of the brain, heart, and kidneys, leading to stroke, heart failure, or kidney failure. Lowering high blood pressure to normal will reduce the risk of developing these complications. What should be considered before using Exforge? Exforge should not be used in the following conditions: If you are allergic or have an unusual reaction to valsartan, amlodipine besylate, or any of the excipients in Exforge (if you think you may have an allergy, seek advice from your doctor), if you are allergic to amlodipine or other calcium channel blockers (a group of medicines used to treat high blood pressure), this condition may manifest as itching, redness of the skin, or difficulty breathing. If you have severe liver failure, cirrhosis of the bile ducts, or a disease that causes bile accumulation. If you are taking aliskiren (a medicine that lowers blood pressure) and have diabetes or kidney failure (glomerular filtration rate - GFR < 60 ml/min/1.73m2). If you are pregnant or planning to become pregnant, do not take this medicine. If you have very low blood pressure (hypotension), aortic stenosis, or your heart cannot supply enough blood to the body (cardiogenic shock), if you have had a myocardial infarction and have resulting heart failure. Exforge should be used with caution in the following conditions: If you have vomiting or diarrhea, if you have liver or kidney failure, if you have had a kidney transplant or have narrowing of the renal arteries, if you have a disease of the adrenal glands that causes a high level of the hormone aldosterone produced in the body (primary hyperaldosteronism). If you are being treated with an ACE inhibitor (a group of medicines used to treat high blood pressure) (especially if you have kidney problems related to diabetes) or aliskiren (a medicine that lowers blood pressure). (If these medicines are absolutely necessary to be used together, they can only be taken under the supervision of a specialist, and kidney function, electrolytes, and blood pressure must be strictly monitored. If you have diabetic nephropathy, a condition that develops as a result of long-term (years) diabetes, ACE inhibitors and angiotensin II receptor blockers cannot be used together). If you experience swelling of the face and throat when taking ACE inhibitors (a group of medicines used to treat high blood pressure) with other drug groups, stop taking Exforge and contact your doctor immediately. Do not take Exforge again. If your doctor has diagnosed you with aortic or mitral stenosis or obstructive hypertrophic cardiomyopathy with stenosis, if you have had heart failure or myocardial infarction, follow your doctor's recommendations for the initial dose. Your doctor will also check your kidney function at that time. Your doctor will regularly monitor your kidney function, blood pressure, and electrolyte levels (e.g., potassium) in your blood. If any of these warnings apply to you now or in the past, inform your doctor. Using Exforge with food and drink Exforge can be taken on an empty stomach or after meals. Patients being treated with Exforge should not consume grapefruit or grapefruit juice, as grapefruit and grapefruit juice can increase the levels of amlodipine, the active ingredient in this medicine, in the blood, which can lead to a sudden increase in blood pressure instead of the blood pressure-lowering effect of Exforge. Pregnancy Before taking this medicine, please consult your doctor or pharmacist. If you are pregnant or planning to become pregnant, consult your doctor. Normally, your doctor will advise you to stop using Exforge before pregnancy or immediately after confirming pregnancy and recommend another medicine instead. Using Exforge during pregnancy can cause serious harm to the unborn baby. Exforge should not be used during pregnancy. If you become pregnant during treatment, contact your doctor or pharmacist immediately. Breastfeeding-Lactation Before taking this medicine, please consult your doctor or pharmacist. It has been confirmed that small amounts of amlodipine pass into breast milk. If you are breastfeeding, inform your doctor. Breastfeeding women should not use Exforge. Effect on ability to drive and operate machinery Like other medicines used to treat high blood pressure (antihypertensives), Exforge can rarely cause dizziness and loss of concentration. Therefore, before driving or operating machinery, as well as during other activities that require attention, make sure you know how Exforge affects you. If you are unsure, do not drive or operate machinery. Information about some of the excipients in Exforge If you are not hypersensitive to any of the excipients in Exforge, no adverse effects related to these substances are expected. Use with other medicines Exforge may affect the following medicines, and vice versa, the following medicines may affect the effect of Exforge: Rifampicin, erythromycin, clarithromycin (antibiotics) Medicines used for the prevention and treatment of fungal skin infections (e.g., ketoconazole, itraconazole) Medicines used to treat AIDS or HIV infections (e.g., ritonavir, indinavir) Medicines used to treat bacterial infections (e.g., clarithromycin, telithromycin, rifampicin, erythromycin) Simvastatin (a medicine used to treat high cholesterol) Medicines used to prevent rejection of transplanted organs (cyclosporine) Lithium used to treat psychiatric disorders Diltiazem (a medicine used to treat hypertension, angina (chest pain), and some arrhythmias (heart rhythm disorders)) Medicines used for the prevention of epileptic seizures (antiepileptics, e.g., carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone) and some herbal medicines (e.g., St. John's wort - Hypericum perforatum) Medicines used to lower blood pressure, especially diuretics, ACE inhibitors, or aliskiren. Caution is advised when used with dantrolene (used for serious disorders of body temperature). The interaction of Exforge with potassium-containing foods is unknown. Caution is advised when used with potassium-sparing drugs, potassium supplements, or potassium-containing substances used as salt substitutes. Your doctor should periodically monitor potassium levels in your blood. When used with non-steroidal anti-inflammatory drugs or selective COX-2 inhibitors, the blood pressure-lowering effect of the medicine may be reduced. Caution is advised when using these medicines together. Your doctor should also check kidney function at this time. The use of other medicines used to treat high blood pressure (antihypertensives) and other medicines that cause hypotensive side effects (e.g., tricyclic antidepressants used to treat depression, alpha-blockers used to treat enlarged prostate) may enhance the blood pressure-lowering effect. If you are taking any medicine, prescription or over-the-counter, or have taken any recently, please inform your doctor or pharmacist. How is Exforge used? Correct use and dosage/frequency of use and instructions: The recommended daily dose of Exforge is: One film-coated tablet once a day. Take the medicine every day at the same time, preferably in the morning. Your doctor will explain the exact dose, i.e., how many tablets to take and how many times a day. Based on your response to treatment (result), your doctor will recommend a higher or lower dose. For best results and to reduce the risk of side effects, it is important to follow your doctor's recommendations and take Exforge as directed by your doctor. If you have questions about the duration of Exforge treatment, consult your doctor. Do not exceed the recommended dose. Route and method of administration: Exforge is for oral use only. Exforge can be taken on an empty stomach or with food. Swallow the tablet with a glass of water. Do not take with grapefruit or grapefruit juice. Different age groups: Use in children (under 18 years of age) Exforge is not recommended for use in children and adolescents. Use in the elderly: There are no special dose recommendations for patients aged 65 and over. Use with caution when increasing the dose. Special conditions of use: Kidney failure: Use with caution if you have kidney failure. Do not use if you have severe kidney failure. Liver failure: Use with caution if you have liver failure. Do not use if you have severe liver failure. If your doctor gives you other instructions, follow the existing recommendations. Do not forget to take the medicine on time. Your doctor will inform you about the duration of Exforge treatment. Do not stop treatment early, as stopping Exforge treatment may worsen your condition. If you think the effect of Exforge is too strong or too weak, talk to your doctor or pharmacist. If you take more Exforge than you should: If you take more Exforge than you should, contact your doctor or pharmacist immediately. If you forget to take Exforge: If you forget to take the medicine, take the missed dose as soon as you remember, and take the next dose at the usual time. If you remember to take the medicine late, close to the time for the next dose, skip the missed dose and do not take it. Do not take a double dose to make up for a missed dose. Possible side effects after completing Exforge treatment: Do not stop taking Exforge without your doctor's advice. Stopping Exforge treatment may worsen your condition. What are the possible side effects? As with all medicines, sensitivity and side effects may occur with the substances in Exforge. Side effects are categorized below: Very common: occurs in at least 1 out of 10 patients. Common: occurs in at least 1 out of 10 patients, but may occur in more than 1 out of 100 patients. Uncommon: occurs in less than 1 out of 100 patients, but may occur in more than 1 out of 1,000 patients. Rare: occurs in less than 1 out of 1,000 patients, but may occur in more than 1 out of 10,000 patients. Very rare: may occur in less than 1 out of 10,000 patients. Unknown: cannot be estimated from available data. If any of the following occur, stop taking Exforge and contact your doctor immediately or go to the emergency department of the nearest hospital. Skin rash, hives, redness of the entire body, severe itching, blisters, peeling and swelling of the skin, purulent inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other skin reactions with signs of allergy, swelling of the eyelids, face, lips or tongue, difficulty breathing or shortness of breath, low blood pressure (feeling of fainting, dizziness), sudden shortness of breath, chest pain, severe abdominal and back pain characteristic of pancreatitis, myocardial infarction, heart rhythm disorder. All of these are serious side effects. If any of the following occur, it means you are allergic to Exforge. You may need urgent medical attention or hospitalization. The following side effects may occur as a result of using Exforge: Common: Flu, nasal congestion, sore throat and discomfort when swallowing, low potassium levels in the blood (hypokalemia), headache, swelling of the hands, arms, legs, ankles and feet, fatigue, weakness, redness and warmth of the face and/or neck, swelling, pitting edema (temporary indentation when pressed with a finger), facial swelling. Uncommon: Loss of appetite, low calcium levels in the blood (hypocalcemia), increased lipid levels in the blood (hyperlipidemia), increased uric acid levels in the blood (hyperuricemia), low sodium levels in the blood (hyponatremia), coordination disorder, dizziness, drowsiness, loss of vision, pain in the area between the pharynx and larynx. Discomfort in the abdomen, dizziness, nausea and abdominal pain, dry mouth, numbness, tingling sensation in the hands and feet, numbness, feeling of irregular and rapid rotation of surroundings or oneself (vertigo), increased heart rate, palpitations, dizziness starting when standing up, cough, diarrhea, constipation, skin rash, redness, joint swelling, back pain, joint pain. Rare: Anxiety (agitation), ringing in the ears, loss of consciousness, increased or frequent urination, erectile dysfunction, feeling of heaviness. Dizziness, low blood pressure with symptoms similar to dizziness, excessive sweating, widespread skin rash, itching, muscle spasms, visual disturbances, increased sensitivity. Other side effects Amlodipine If any of the following very rare side effects occur after taking this medicine, contact your doctor immediately. Common: Dizziness, headache, abdominal discomfort, fatigue, swelling, dizziness, drowsiness, palpitations (feeling of heart beating, fluttering), flushing, joint swelling (edema), abdominal pain, nausea. Uncommon: Changes in mental state, anxiety, sensation of ants crawling on the skin, difficulty breathing, changes in bowel habits, diarrhea, dry mouth, redness and rash on the skin, photosensitivity, joint pain, back pain, fatigue, weakness, feeling unwell, weakness, chest pain not related to the heart, weight gain or loss, depression, insomnia, tremor, change in taste sensation, loss of consciousness, loss of sensation of pain, visual disturbances, loss of vision, ringing in the ears, low blood pressure, sneezing/runny nose (rhinitis) due to purulent inflammation of the nasal passages, dyspepsia, vomiting (nausea), hair loss, excessive sweating, itching of the skin, change in skin color, urination disorders, increased need to urinate at night, frequent urination, erectile dysfunction, discomfort in the mammary glands or breast enlargement in men, pain, feeling of malaise, muscle pain, muscle cramps, weight loss or gain. Rare: Confusion. Very rare: Reduction in the number of white blood cells, damage to red blood cells - platelets, leading to easy bruising and contusions, high blood sugar levels (hyperglycemia), increased sensitivity, inflammation of the pancreas (pancreatitis), discomfort in the legs, feeling of heaviness (peripheral neuropathy), heart rhythm disorder, cough, especially swelling in the face and throat area (possible symptoms of angioedema), sudden and constricting chest pain (possible signs of myocardial infarction), rash, redness of the skin, blisters on the lips, eyes or mouth area, peeling of the skin (possible symptoms of erythema multiforme), skin rash, redness of the skin, blisters on the lips, eyes or mouth, peeling of the skin, fever (possible symptoms of Stevens-Johnson syndrome), swelling of the subcutaneous tissue of any part of the body, especially the lips, eyelids and genital area (Quincke's edema), gum swelling, abdominal bloating (gastritis), liver dysfunction, liver inflammation (abscess) (hepatitis), yellowing of the skin (jaundice), increased liver enzymes, which affects the results of some medical tests, increased muscle tension, inflammatory process of blood vessels, mainly accompanied by skin rash (purulent skin inflammation), increased sensitivity to light, stiffness of the limbs, tremor and/or movement disorders. Unknown: Movement disorders (extrapyramidal syndrome). Valsartan: Uncommon: Feeling of irregular and rapid rotation of surroundings or oneself (vertigo), cough, abdominal discomfort and pain in the upper abdomen, fatigue. Frequency unknown: Increased sensitivity, reduction in hematocrit and hemoglobin levels, reduction in red blood cells, reduction in platelets and white blood cells in the blood, increased creatinine in the blood, fever associated with infection, sore throat and mouth sores, inflammation of blood vessels, spontaneous bruising or contusions, high potassium levels in the blood, liver dysfunction, decreased kidney function and severe decrease in kidney function, especially swelling of the face and throat, muscle pain, rash, bluish-red spots, fever, itching, allergic reactions, blisters on the skin (signs of bullous dermatitis). If any side effect occurs, whether mentioned or not in the instructions for use, consult your doctor or pharmacist. Storage of Exforge Store Exforge out of reach of children in its packaging. Store Exforge at room temperature below 30°C. Use according to the expiry date.