Olmesartan Medoxomil/Amlodipine 20 mg/10 mg Film-coated Tablets

What are the uses of Olmesartan/Amlodipine?

Olmesartan/Amlodipine contains two substances called olmesartan medoxomil and amlodipine besylate. These substances help control high blood pressure.

• Olmesartan medoxomil belongs to a group of medicines called “angiotensin II receptor antagonists.”

• Amlodipine belongs to a group of substances called “calcium channel blockers.”

Do not take olmesartan/amlodipine:

• If you are allergic to olmesartan medoxomil, amlodipine, a special group of calcium channel blockers, dihydropyridines, or any of the other ingredients of this medicine.

• If you have diabetes or kidney dysfunction and are being treated with a blood pressure lowering medicine containing aliskiren.

• If you have serious liver problems, if bile secretion is poor, or if there is a blockage in the drainage of bile from the gallbladder, or

If you have any jaundice.

• If you have very low blood pressure.

• If you have poor blood flow to your tissues with symptoms such as low blood pressure, low pulse, and rapid heart rate.

• If blood flow from your heart is obstructed

• If you have decreased cardiac output (leading to shortness of breath or peripheral swelling) after a heart attack.

Warnings and Precautions:

Tell your doctor if you have any of the following health problems:

• Kidney problems or kidney transplant.

• Liver disease.

• Heart failure or problems with the heart valves or heart muscle.

• Severe vomiting, diarrhea, treatment with high doses of “water tablets” or if you are on a low-salt diet.

• Increased potassium levels in the blood.

• Adrenal gland problems.

Possible side effects:

Like all medicines, this medication can cause side effects, although not everybody gets them. When they do occur, they are usually mild and do not require stopping treatment. Although not everybody gets them, the following side effects can be serious: allergic reactions and low blood pressure.

Other possible side effects include:

• Dizziness; headache; swelling in the ankles, feet, legs, hands, or arms; fatigue.

• Lack of energy; tingling or numbness in the hands or feet; dizziness; awareness of heartbeats; rapid heartbeat.

• Some changes in blood test results have also been noted and include: increased as well as decreased blood potassium levels, increased blood creatinine levels, increased uric acid levels, increased liver and muscle function tests, increased lipid levels, and increased blood urea.

• Bronchitis; sore throat; runny or stuffy nose; cough; stomach ache; stomach flu; diarrhea; indigestion; nausea; joint or bone pain; back pain; blood in urine; urinary tract infection; chest pain; flu-like symptoms; pain.

• Low numbers of a type of blood cell known as platelets and angina (chest pain or discomfort). Itching; skin rash. Allergic rash with hives. Facial swelling. Muscle pain; feeling unwell.

• Swelling of the face, mouth, and/or larynx (voice box). Acute kidney failure and renal insufficiency. Lethargy.

• Edema (fluid retention)

• Abdominal pain; nausea; ankle swelling; feeling sleepy; flushing and warmth of the face, visual disturbances (including double vision and blurred vision), awareness of heartbeats, diarrhea, constipation, indigestion, cramps, weakness, difficulty breathing.

• Difficulty sleeping; sleep disturbances; mood changes including feeling anxious; depression; irritability; chills; taste changes; fainting; ringing in the ears; hair loss; increased need to urinate (urination); breast enlargement in men; weight gain or loss.

• Confusion

Other medications and olmesartan/amlodipine:

Tell your doctor or pharmacist if you are taking, have recently taken or might take any of the following medicines for:

• Blood pressure

• Depression

• pain

• Blood fats

• AIDS

• Fungal infections

• Heart problems

• Bacterial infections

• Body temperature disturbances

• Transplanted organ.

How to take olmesartan/amlodipine:

• Always take this medicine exactly as your doctor or pharmacist has told you. Consult your doctor or pharmacist if you are not sure.

• The recommended dose of Olmesartan/Amlodipine is one tablet per day.

• The tablets can be taken with or without food. Swallow the tablet with some liquid (such as a glass of water). The tablet should not be chewed. Do not take it with grapefruit juice.

• If possible, take your daily dose at the same time each day, for example, at breakfast time.

How to store olmesartan/amlodipine:

• Keep this medicine out of the sight and reach of children.

• Do not use this medicine after the expiry date printed on the carton after EXP. The expiry date refers to the last day of that month.

• This medicinal product does not require any special storage conditions.

• Do not dispose of medications via wastewater or household waste. Ask your pharmacist how to dispose of medications you no longer use. These measures will help protect the environment.