Description and Brand NamesBefore UsingProper UsePrecautionsSide Effects Avelable Brandfrom Medikaloka Apotheca : Norvasc, Exforge US Brand Name Norvasc Descriptions Amlodipine is used alone or together with other medicines to treat angina (chest pain) and high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled. Amlodipine is a calcium channel blocker. It affects the movement of calcium into the cells of the heart and blood vessels. As a result, amlodipine relaxes blood vessels and increases the supply of blood and oxygen to the heart while reducing its workload. This medicine is available only with your doctor’s prescription. This product is available in the following dosage forms: Tablet Tablet, Disintegrating In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered: Allergies Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully. Pediatric Appropriate studies have not been performed on the relationship of age to the effects of amlodipine to treat high blood pressure in children younger than 6 years of age. Safety and efficacy have not been established. Geriatric Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of amlodipine in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving amlodipine. Pregnancy Information about this amlodipine-oral-route Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breastfeeding There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding. Drug Interactions Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Amiodarone Atazanavir Carbamazepine Ceritinib Clarithromycin Clopidogrel Conivaptan Dabrafenib Dantrolene Domperidone Droperidol Eslicarbazepine Acetate Fentanyl Idelalisib Mitotane Piperaquine Primidone Siltuximab Simvastatin St John’s Wort Tegafur Telaprevir Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Acebutolol Aceclofenac Acemetacin Alprenolol Amtolmetin Guacil Aspirin Atenolol Avanafil Betaxolol Bevantolol Bisoprolol Bromfenac Bucindolol Bufexamac Carteolol Carvedilol Celecoxib Celiprolol Choline Salicylate Clonixin Dalfopristin Dexibuprofen Dexketoprofen Diclofenac Diflunisal Dilevalol Diltiazem Dipyrone Esmolol Etodolac Etofenamate Etoricoxib Felbinac Fenoprofen Fepradinol Feprazone Floctafenine Fluconazole Flufenamic Acid Flurbiprofen Ibuprofen Ibuprofen Lysine Imatinib Indinavir Indomethacin Itraconazole Ketoconazole Ketoprofen Ketorolac Labetalol Levobunolol Lornoxicam Loxoprofen Lumiracoxib Meclofenamate Mefenamic Acid Meloxicam Mepindolol Metipranolol Metoprolol Morniflumate Nabumetone Nadolol Naproxen Nebivolol Nepafenac Niflumic Acid Nimesulide Oxaprozin Oxprenolol Oxyphenbutazone Parecoxib Penbutolol Phenylbutazone Piketoprofen Pindolol Piroxicam Pranoprofen Proglumetacin Propranolol Propyphenazone Proquazone Quinupristin Rifapentine Ritonavir Rofecoxib Salicylic Acid Salsalate Sodium Salicylate Sotalol Sulindac Talinolol Tenoxicam Tertatolol Tiaprofenic Acid Timolol Tolfenamic Acid Tolmetin Valdecoxib Other Interactions Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco. Other Medical Problems The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially: Angina (chest pain) or Heart attack, acute or Heart or blood vessel disease (e.g., coronary artery disease) or Hypotension (low blood pressure)—Use with caution. May make these conditions worse. Heart disease or other heart problems (e.g., aortic stenosis)—Use with caution. The blood pressure-lowering effects of this medicine may be increased. Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body. Take this medicine exactly as directed even if you feel well and do not notice any chest pain. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Do not miss any doses. For patients taking this medicine for high blood pressure: In addition to the use of the medicine, treatment for your high blood pressure may include weight control and a change in the types of food you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet. Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well. Remember that this medicine will not cure your high blood pressure but it does help control it. Therefore, you must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life . If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease. You may take this medicine with or without food. Take this medicine at the same time each day. Dosing The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. For oral dosage form (tablets): For angina (chest pain): Adults—5 to 10 milligrams (mg) once a day. Children—Use and dose must be determined by your doctor. For high blood pressure: Adults—At first, 2.5 to 5 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 10 mg once a day. Children 6 to 17 years of age—2.5 to 5 mg once a day. Children younger than 6 years of age—Use and dose must be determined by your doctor. Missed Dose If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses. Do not take this medicine if it has been more than 12 hours since you missed your last dose. Storage Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use. It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects. a Dizziness, lightheadedness, or fainting may also occur if you exercise or if the weather is hot. Heavy sweating can cause loss of too much water and result in low blood pressure. Use extra care during exercise or hot weather. If you have been using this medicine regularly for several weeks, do not suddenly stop using it. Stopping suddenly may cause your chest pain or high blood pressure to come back or get worse. Check with your doctor for the best way to reduce gradually the amount you are taking before stopping completely. Chest pain resulting from exercise or physical exertion is usually reduced or prevented by this medicine. This may tempt you to be too active. Make sure you discuss with your doctor a safe amount of exercise for your medical problem. After taking a dose of this medicine you may get a headache that lasts for a short time. This should become less noticeable after you have taken this medicine for a while. If this effect continues, or if the headaches are severe, check with your doctor. In some patients, tenderness, swelling, or bleeding of the gums may appear soon after treatment with this medicine is started. Brushing and flossing your teeth carefully and regularly and massaging your gums may help prevent this. See your dentist regularly to have your teeth cleaned. Check with your doctor or dentist if you have any questions about how to take care of your teeth and gums, or if you notice any tenderness, swelling, or bleeding of your gums. Do not take other medicines unless they have been discussed with your doctor. This especially includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may increase your blood pressure. Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor immediately if any of the following side effects occur: More common Swelling of the ankles or feet Less common Difficult or labored breathing dizziness fast, irregular, pounding, or racing heartbeat or pulse feeling of warmth redness of the face, neck, arms, and occasionally, upper chest shortness of breath tightness in the chest wheezing Rare Black, tarry stools bleeding gums blistering, peeling, or loosening of the skin blood in the urine or stools blurred vision burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings chest pain or discomfort chills cold and clammy skin cold sweats confusion dark yellow urine cough diarrhea dilated neck veins dizziness or lightheadedness when getting up from a lying or sitting position extra heartbeats extreme fatigue fainting fever itching of the skin joint or muscle pain large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs numbness and tingling of the face, fingers, or toes pain in the arms, legs, or lower back, especially pain in the calves or heels upon exertion painful or difficult urination pale, bluish-colored, or cold hands or feet pinpoint red or purple spots on the skin red, irritated eyes redness of the face, neck, arms, and occasionally, upper chest redness, soreness or itching skin shakiness in the legs, arms, hands, or feet slow or irregular heartbeat sore throat sores, ulcers, or white spots on the lips or in the mouth sores, welting, or blisters sudden sweating sweating swelling of the face, fingers, feet, or lower legs swollen glands trembling or shaking of the hands or feet unsteadiness or awkwardness unusual bleeding or bruising unusual tiredness or weakness weak or absent pulses in the legs weakness in the arms, hands, legs, or feet weight gain yellow eyes or skin Incidence not known Abdominal or stomach pain clay-colored stools diarrhea headache loss of appetite nausea rash unpleasant breath odor vomiting of blood yellow eyes or skin Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: Less common Acid or sour stomach belching heartburn indigestion lack or loss of strength muscle cramps sleepiness or unusual drowsiness stomach discomfort, upset, or pain Rare Abnormal dreams anxiety back pain bad unusual or unpleasant (after) taste bleeding gums blistering, crusting, irritation, itching, or reddening of the skin bloating bloody nose burning feeling in the chest or stomach burning while urinating burning, dry, or itching eyes change in color of the treated skin change in sense of smell change in taste changes in vision constipation continuing ringing or buzzing or other unexplained noise in the ears cracked, dry, or scaly skin decreased sexual performance or desire depression difficulty with moving difficulty with swallowing discharge, excessive tearing double vision dry mouth dryness of the skin excess air or gas in the stomach or intestines excessive muscle tone eye pain feeling of constant movement of self or surroundings feeling of unreality feeling unusually cold flushed, dry skin fruit-like breath odor full feeling general feeling of discomfort or illness hair loss or thinning of the hair headache, severe and throbbing hearing loss hyperventilation increased appetite increased hunger increased sweating increased thirst increased urge to urinate during the night increased urination irritability irritation in the mouth lack of feeling or emotion loose stools loss of memory muscle pains or stiffness muscle tension or tightness muscle weakness nervousness pain pains in the stomach, side, or abdomen, possibly radiating to the back passing gas problems with memory redness and swelling of the gums redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid restlessness runny nose seeing double sensation of spinning sense of detachment from self or body shakiness and unsteady walk shivering sleeplessness sneezing stuffy nose sweating swollen joints tenderness in the stomach area thirst trouble in holding or releasing urine trouble sleeping twitching unable to sleep uncaring unexplained weight loss unsteadiness, trembling, or other problems with muscle control or coordination waking to urinate at night weight loss Incidence not known Swelling of the breasts or breast soreness in both females and males Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects.