Amlodipine Besylate and Olmesartan Medoxomil

1. What Bizoran® is and what it is used for?
Bizoran® is a combination product containing Amlodipine, a calcium channel blocker and Olmesartan, an angiotensin II receptor blocker. Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle & cardiac muscle. Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance & a reduction in blood pressure. Olmesartan is an angiotensin II receptor blocker that acts on AT1 subtype. By blocking the action of angiotensin II, Olmesartan dilates blood vessels and reduces blood pressure without affecting pulse rate.

2. Before you take Bizoran®
Let your doctor know if you have these, or any other, medical conditions:

  • Kidney or liver problems
  • Heart problems (including coronary heart disease and narrowing of the aortic valve)
  • A lot of diarrhea or are vomiting

If you take Bizoran®, tell your doctor if you also take:

  • Water pills (diuretics)
  • Other medicines for high blood pressure or a heart problem
  • Potassium supplements or a salt substitute that contains potassium
  • Pain or arthritis medicines, such as aspirin and nonsteroidal anti-inflammatory drug
  • Simvastatin, a cholesterol-lowering drug
  • Lithium for certain types of depression

Do not take this medicine and tell your doctor if:
You are taking medicine that contains aliskiren and you have diabetes or kidney problems
Before taking Bizoran®, tell your doctor if you are pregnant or plan to become pregnant. Also tell your doctor if you are breast-feeding or plan to breast-feed. You and your doctor should decide if you will take BizoranBizoran® or breast-feed. You should not do both.

Take special care with Bizoran® (Precautions as short form)

  • Fetal/Neonatal Morbidity and Mortality: When pregnancy is detected, this combination should be discontinued as soon as possible.
  • Hypotension in Volume- or Salt-Depleted Patients: Symptomatic hypotension may occur after initiation of treatment.
  • Patients with Hepatic Impairment: Caution should be exercised when administering the drug to patients with severe hepatic impairment.

Check with your doctor before taking this medicine if:
Before taking Bizoran®, tell your doctor if you are pregnant or plan to become pregnant. Also tell your doctor if you are breast-feeding or plan to breast-feed. You and your doctor should decide if you will take Bizoran® or breast-feed. You should not do both.

Taking other medicines
Some of your other medicines and Bizoran® could effect each other. This may cause serious side effects. Take Bizoran® as prescribed by your doctor. Talk with your doctor before you stop taking Bizoran®.

Pregnancy and breast-feeding
When pregnancy is detected, discontinue Bizoran® as soon as possible. When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus.
Nursing Mothers: Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug.

3. How to take Bizoran®?
Taking this medicine (Do not need to change)
Always use Bizoran® exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

How much to take?
The usual starting dose of Bizoran® is one tablet (5/20 mg) once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum dose of two tablets of Bizoran® (5/20 mg) once daily as needed to control blood pressure. Maximum antihypertensive effects are attained within 2 weeks after a change in dose.
Bizoran® may be taken with or without food. Bizoran® may be administered with other antihypertensive agents.

If you take more Bizoran® than you should
If you have too much of this medicine, talk to your doctor straight away.

If you forget to take Bizoran®
If you forget to take a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose

If you stop taking Bizoran®
Do not stop taking this medicine without talking to your doctor. You should not stop taking Bizoran® just because you feel better. This is because the problem may come back or get worse again.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
In rare cases, amlodipine and Olmesartan can cause a condition that result in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Tell your doctor if any of the side effects gets serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet

5. How to store Bizoran® ?
Store in a cool and dry place, away from light.
Keep out of reach of children

Bizoran Prescribing Information

Located in: Cardiovascular