Sevitense Plus 40/5/12.5 Mg, Antihypertensive - 28 Tablets

Product Name

• Sevitense Plus, Olmesartan Medoxomil/Amlodipine/Hydrochlorothiazide, Tablet, 40/5/12.5 Mg - 28 Tablets

Scientific Name

• Olmesartan 40 Mg + Amlodipine 5 Mg + Hydrochlorothiazide 12.5 Mg Tablets

Category Of Sevitense Plus 40/5/12.5 Tablets

• Anti-Hypertensive Drugs

Mechanism Of Action Of Olmesartan, Amlodipine & Hydrochlorothiazide

• Olmesartan is an angiotensin II receptor blocker (ARB). It works by blocking a substance in the body that causes blood vessels to constrict.
• As a result, Olmesartan relaxes the blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.
• Amlodipine inhibits calcium ion influx across cell membranes, with a greater effect on vascular smooth muscle cells. This causes vasodilation and a reduction in peripheral vascular resistance, thus lowering blood pressure.
• Hydrochlorothiazide inhibits sodium chloride transport in the distal convoluted tubule. More sodium is then excreted in the kidney with accompanying fluid.
• Thus it increases urine excretion, which by turn decreases blood volume and finally blood pressure.
• On long-term usage, thiazide diuretic (TZD)-mediated chronic reduction of arterial pressure is thought to occur through decreased total peripheral vascular resistance.

Therapeutic Indications Of Sevitense Plus 40/5/12.5 Tablets

• Olmesartan/amlodipine/hydrochlorothiazide is used for the treatment of high blood pressure:
• in adult patients whose blood pressure is not adequately controlled on the combination of olmesartan medoxomil and amlodipine taken as a fixed-dose combination
• in patients, who are already taking a fixed-dose combination of olmesartan medoxomil and hydrochlorothiazide plus the amlodipine as a single tablet or a fixed-dose combination of olmesartan medoxomil and amlodipine plus hydrochlorothiazide as a single tablet.
• High blood pressure is a common condition in which the long-term force of the blood against your artery walls is high enough that it may eventually cause health problems, such as heart disease.
• Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

Method Of Administration Of Sevitense Plus 40/5/12.5 Tablets

• Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
• The tablets should be swallowed whole with a glass of water.
• You should try to take your daily dose at about the same time each day.
• You must continue to take the drug until your doctor tells you otherwise.
• Do not break the tablet in half
• You can take the tablet with or without food.
• High blood pressure: The usual dose of the tablets is one tablet once daily, but your doctor may increase the dose to reach the targeted blood pressure
• This medicinal product is indicated for long-term treatment.
• Doses may be changed in special conditions so always follow your doctor's or pharmacist's instructions.
• If you take more than you should, talk to a doctor or go to the hospital straight away.
• If you forget to take a dose, take it as soon as you remember it unless it is nearly time for your next dose.
• Do not take a double dose (two doses at the same time) to make up for the forgotten dose.

Undesirable Side Effects Of Sevitense Plus 40/5/12.5 Tablets

• Dizziness; headache; swelling of ankles, feet, legs, hands, or arms; tiredness.
• lack of energy; tingling or numbness of hands or feet; vertigo; awareness of heartbeat; fast heartbeat.
• 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.
• 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.
• Edema (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, difficulty in 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 (pass urine); breast enlargement in men; increase or decrease in weight.
• Confusion

Pregnancy & Breastfeeding Precautions While Taking Sevitense Plus 40/5/12.5 Tablets

• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Non-Pharmacological Treatments & Advice To Reduce Blood Pressure

• To measure blood pressure correctly:

1. Don’t eat or drink anything 30 minutes before you take your blood pressure.
2. Empty your bladder before your reading.
3. Sit in a comfortable chair with your back supported for at least 5 minutes before your reading.
4. Put both feet flat on the ground and keep your legs uncrossed.
5. Rest your arm with the cuff on a table at chest height.
6. Make sure the blood pressure cuff is snug but not too tight. The cuff should be against your bare skin, not over clothing.
7. Do not talk while your blood pressure is being measured.

• You will also find the following Non-Pharmacological treatments effective in blood pressure reduction:

1. Lose extra pounds and watch your waistline
2. Exercise regularly
3. Eat a healthy diet
4. Reduce sodium in your diet
5. Quit smoking
6. Reduce caffeine
7. Reduce your stress
8. Monitor your blood pressure at home using for example Beurer, Blood Pressure Monitor or Omron Blood Pressure Measuring Device
9. See your doctor regularly

Warnings & Special Precautions while Taking Sevitense Plus 40/5/12.5 Tablets

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

1. Kidney problems or a kidney transplant.
2. Liver disease.
3. Heart failure or problems with your heart valves or heart muscle.
4. Severe vomiting, diarrhea, treatment with high doses of “water tablets” or if you are on a low salt diet.
5. Increased levels of potassium in your blood.
6. Problems with your adrenal glands
7. Diabetes.
8. Lupus erythematosus
9. Allergies or asthma.
10. Skin reactions such as sunburn or rash after being in the sun or using a sunbed.
11. If you have had skin cancer or if you develop an unexpected skin lesion during the treatment. Treatment with hydrochlorothiazide, particularly long-term use with high doses, may increase the risk of some types of skin and lip cancer. Protect your skin from sun exposure and UV rays while taking Olmesartan/amlodipine/hydrochlorothiazide.

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

1. Other blood pressure-lowering medicines
2. Lithium, a medicine used to treat mood swings and some types of depression
3. Diltiazem, verapamil, used for heart rhythm problems and high blood pressure.
4. antibiotics used for tuberculosis and other infections.
5. John’s wort is a herbal remedy for the treatment of depression.
6. Cisapride, used to increase food movement in the stomach and gut.
7. Diphemanil, used to treat a slow heartbeat or reduce sweating.
8. Halofantrine, used for malaria.
9. Vincamine IV, used to improve circulation to the nervous system.
10. Amantadine, used for Parkinson’s disease.
11. Potassium supplements and drugs alter potassium levels in the blood.
12. Non-Steroidal Anti-Inflammatory Drugs
13. Sleeping tablets, sedatives, and antidepressant medicines
14. Colesevelam hydrochloride, a drug that lowers the level of cholesterol in your blood
15. Certain antacids
16. Certain muscle-relaxing medicines such as baclofen and tubocurarine.
17. Anticholinergic agents such as atropine and biperiden.
18. Calcium supplements.

Storage Conditions Of Sevitense Plus 40/5/12.5 Tablets

• Store below 25°c
• Don’t refrigerate
• Keep this medicine out of the sight and reach of children.
• Store in the original package to protect from moisture.
• Do not use this medicine after the expiry date which is stated on the box/blisters/label. The expiry date refers to the last day of the month.

Normal Ranges

• Normal: Blood pressure numbers of less than 120/80 mm Hg
• Elevated: is when readings consistently range from 120-129 systolic and less than 80 mm Hg diastolic.
• Hypertension Stage 1: is when blood pressure consistently ranges from 130-139 systolic or 80-89 mm Hg diastolic.
• Hypertension Stage 2: is when blood pressure consistently ranges at 140/90 mm Hg or higher.
• Hypertensive crisis: This stage of high blood pressure requires medical attention. If your blood pressure readings suddenly exceed 180/120 mm Hg, wait five minutes and then test your blood pressure again. If your readings are still unusually high, contact your doctor immediately. You could be experiencing a hypertensive crisis.

For More Information About Olmesartan, Amlodipine & Hydrochlorothiazide

• Ask your physician or pharmacist
• Visit SFDA website
• Visit Medscape at Information About Olmesartan, Amlodipine & Hydrochlorothiazide
• Visit Drugs.com at Information About Olmesartan, Amlodipine & Hydrochlorothiazide