<div><b>Olmesartan medoxomil/amlodipine 40mg/5mg film-coated tablets<br></b></div><div><br></div><div><b>What Olmesartan/amlodipine is used for:</b></div><div><b><br></b></div><div>Olmesartan/amlodipine contains two substances called olmesartan medoxomil and amlodipine besilate. Both of these substances help to control high blood pressure.&nbsp;</div><div>• Olmesartan medoxomil belongs to a group of medicines called “angiotensin-II receptor antagonists”&nbsp;</div><div>• Amlodipine belongs to a group of substances called “calcium channel blockers”</div><div>Do not take Olmesartan/amlodipine:</div><div>•<span style="white-space:pre"> </span>if you are allergic to olmesartan medoxomil or to amlodipine or a special group of calcium channel blockers, the dihydropyridines, or to any of the other ingredients of this medicine.</div><div>•<span style="white-space:pre"> </span>if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.&nbsp;</div><div>•<span style="white-space:pre"> </span>if you have severe liver problems, if bile secretion is impaired or drainage of bile from the gallbladder is blocked or if you are experiencing any jaundice.&nbsp;</div><div>•<span style="white-space:pre"> </span>if you have very low blood pressure.&nbsp;</div><div>•<span style="white-space:pre"> </span>if you are suffering from insufficient blood supply to your tissues with symptoms like low blood pressure, low pulse, fast heartbeat.</div><div>•<span style="white-space:pre"> </span>if the blood flow from your heart is obstructed&nbsp;</div><div>•<span style="white-space:pre"> </span>if you suffer from low heart output (resulting in shortness of breath or peripheral swellings) after a heart attack.</div><div><br></div><div><b>Warnings and precautions:</b></div><div><b><br></b></div><div>Tell your doctor if you have any of the following health problems:&nbsp;</div><div>•<span style="white-space:pre"> </span>Kidney problems or a kidney transplant.&nbsp;</div><div>•<span style="white-space:pre"> </span>Liver disease.&nbsp;</div><div>•<span style="white-space:pre"> </span>Heart failure or problems with your heart valves or heart muscle.&nbsp;</div><div>•<span style="white-space:pre"> </span>Severe vomiting, diarrhea, treatment with high doses of “water tablets” or if you are on a low salt diet.&nbsp;</div><div>•<span style="white-space:pre"> </span>Increased levels of potassium in your blood.&nbsp;</div><div>•<span style="white-space:pre"> </span>Problems with your adrenal glands.&nbsp;</div><div>Possible side effects</div><div>Like all medicines, this medicine can cause side effects, although not everybody gets them. If they do occur, they are often mild and do not require treatment to be stopped. Although not many people may get them, the following two side effects can be serious: allergic reactions and drop in the blood pressure.</div><div>Other possible side effects with Olmesartan/amlodipine:</div><div>•<span style="white-space:pre"> </span>Dizziness; headache; swelling of ankles, feet, legs, hands, or arms; tiredness.&nbsp;</div><div>•<span style="white-space:pre"> </span>lack of energy; tingling or numbness of hands or feet; vertigo; awareness of heart beat; fast heartbeat.</div><div>•<span style="white-space:pre"> </span>Some changes in blood test results have also been seen and include the following: increased as well as decreased blood potassium levels, increased blood creatinine levels, increased uric acid levels, increases in a test of liver and muscle function, increased fat levels, blood urea increased.</div><div>•<span style="white-space:pre"> </span>Bronchitis; sore throat; runny or stuffy nose; cough; abdominal pain; stomach flu; diarrhea; indigestion; nausea; pain in the joints or bones; back pain; blood in the urine; infection of the urinary tract; chest pain; flu-like symptoms; pain.&nbsp;</div><div>•<span style="white-space:pre"> </span>Reduced number of a type of blood cells, known as platelets, angina (pain or uncomfortable feeling in the chest); itching; eruption of the skin; allergic skin rash; rash with hives; swelling of the face; muscular pain; feeling unwell.&nbsp;</div><div>•<span style="white-space:pre"> </span>Swelling of the face, mouth and/or larynx (voice box); acute kidney failure and kidney insufficiency; lethargy.&nbsp;</div><div>•<span style="white-space:pre"> </span>Oedema (fluid retention)&nbsp;</div><div>•<span style="white-space:pre"> </span>Abdominal pain; nausea; ankle swelling; feeling sleepy; redness and warm feeling of the face, visual disturbance (including double vision and blurred vision), awareness of heartbeat, diarrhea, constipation, indigestion, cramps, weakness, difficult breathing.&nbsp;</div><div>•<span style="white-space:pre"> </span>Trouble sleeping; sleep disturbances; mood changes including feeling anxious; depression; irritability; shiver; taste changes; fainting; ringing in the ears; loss of hair; increased need to urinate (pass urine); breast enlargement in men; increase or decrease in weight.&nbsp;</div><div>•<span style="white-space:pre"> </span>Confusion&nbsp;</div><div><br></div><div><b>Other medicines and Olmesartan/amlodipine:</b></div><div><b><br></b></div><div>Tell your doctor or pharmacist if you are taking, have recently taken or might take any of the following medicines for:&nbsp;</div><div>•<span style="white-space:pre"> </span>Blood pressure</div><div>•<span style="white-space:pre"> </span>Depression</div><div>•<span style="white-space:pre"> </span>Pain</div><div>•<span style="white-space:pre"> </span>Blood fat</div><div>•<span style="white-space:pre"> </span>AIDS</div><div>•<span style="white-space:pre"> </span>Fungal infections</div><div>•<span style="white-space:pre"> </span>Heart problems</div><div>•<span style="white-space:pre"> </span>Bacterial infections</div><div>•<span style="white-space:pre"> </span>body temperature abnormalities</div><div>•<span style="white-space:pre"> </span>transplanted organ.</div><div><br></div><div><b>How to take Olmesartan/amlodipine:</b></div><div><b><br></b></div><div>•<span style="white-space:pre"> </span>Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.&nbsp;</div><div>•<span style="white-space:pre"> </span>The recommended dose of Olmesartan/amlodipine is one tablet per day.&nbsp;</div><div>•<span style="white-space:pre"> </span>The tablets can be taken with or without food. Swallow the tablet with some fluid (such as a glass of water). The tablet should not be chewed. Do not take them with grapefruit juice.&nbsp;</div><div>•<span style="white-space:pre"> </span>If possible, take your daily dose at the same time each day, for example at breakfast time.</div><div><br></div><div><b>How to store Olmesartan/amlodipine:</b></div><div><b><br></b></div><div>•<span style="white-space:pre"> </span>Keep this medicine out of the sight and reach of children.&nbsp;</div><div>•<span style="white-space:pre"> </span>Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.&nbsp;</div><div>•<span style="white-space:pre"> </span>This medicinal product does not require any special storage condition.&nbsp;</div><div>•<span style="white-space:pre"> </span>Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.</div><p> </p>