SEVIKAR HCT 40/5/12.5 MG 28TAB

contains three active substances called olmesartan medoxomil, amlodipine besilate and hydrochlorothiazide. All three substances help to 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”

•    Hydrochlorothiazide is one of a group of medicines called thiazide diuretics

Do not take Olmesartan/amlodipine/hydrochlorothiazide:

•    if you are allergic to olmesartan medoxomil, to amlodipine or a special group of calcium channel blockers (the dihydropyridines) to hydrochlorothiazide or to substances similar to hydrochlorothiazide (sulfonamides) or to any of the other ingredients of this medicine if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

•    you have severe kidney problems.

•    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.

•    if you have very low blood pressure.

•    if you are suffering from insufficient blood supply to your tissues with symptoms like low blood pressure, low pulse, fast heartbeat.

•    if the blood flow from your heart is obstructed

•    if you suffer from low heart output (resulting in shortness of breath or peripheral swellings) after a heart attack.

Warnings and precautions

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

•    Kidney problems or a kidney transplant.

•    Liver disease.

•    Heart failure or problems with your 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 levels of potassium in your blood.

•    Problems with your adrenal glands

•    Diabetes.

•    Lupus erythematosus

•    Allergies or asthma.

•    Skin reactions such as sunburn or rash after being in the sun or using a sunbed.

•    If you have had skin cancer or if you develop an unexpected skin lesion during the treatment.

Possible side effects

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.

Other possible side effects with Olmesartan/amlodipine/hydrochlorothiazide:

•    Dizziness; headache; swelling of ankles, feet, legs, hands, or arms; tiredness.

•    lack of energy; tingling or numbness of hands or feet; vertigo; awareness of heart beat; fast heartbeat.

•    Some changes in blood test results.

•    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.

•    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.

•    Swelling of the face, mouth and/or larynx, acute kidney failure and kidney insufficiency; lethargy.

•    Oedema (fluid retention)

•    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.

•    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; breast enlargement in men; increase or decrease in weight.

•    Confusion

Other medicines and Olmesartan/amlodipine/hydrochlorothiazide

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 fat

•    AIDS

•    Fungal infections

•    Heart problems

•    Bacterial infections

•    body temperature abnormalities

•    transplanted organ.

•    Sleep

•    Cancer

•    psychiatric disorders

•    heart problems

•    diabetes

•    gout

•    viruses

•    stomach acid

•    food movement in the stomach and gut.

•    malaria.

How to take Olmesartan/amlodipine/hydrochlorothiazide

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

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