Olmesan Plus

Olmesartan Medoxomil and Hydrochlorothiazide
Tablet

1. What Olmesan® Plus is and what it is used for?
It is a combination of an angiotensin II receptor antagonist (AT1 subtype), Olmesartan Medoxomil, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Olmesartan Medoxomil, a prodrug, is hydrolyzed to Olmesartan during absorption from the gastrointestinal tract.

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

  • Have less urine than normal or if you cannot urinate
  • Are allergic to other sulfonamide type medicines
  • Have severe kidney disease

If you take Olmesan® Plus, 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 Olmesan® Plus 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 Olmesan® or breast-feed. You should not do both.

Take special care with Olmesan® Plus

  • 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 Olmesan® Plus, 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 Olmesan® Plus or breast-feed. You should not do both.

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

Pregnancy and breast-feeding
When pregnancy is detected, discontinue Olmesan® Plus 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 Olmesan® Plus?
Taking this medicine (Do not need to change)
Always use Olmesan® Plus exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

How much to take?
Dosing should be individualized. The usual recommended starting dose is one tablet of Olmesan® Plus (20/12.5) once daily. Depending on the blood pressure response, the dose may be titrated at intervals of 2-4 weeks to two tablets of Olmesan® Plus (40/25) once daily.
Olmesan® Plus may be taken with or without food. Olmesan® Plus may be administered with other antihypertensive agents.

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

If you forget to take Olmesan® Plus
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 Olmesan® Plus
Do not stop taking this medicine without talking to your doctor. You should not stop taking Olmesan® Plus 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, 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.
Because of the thiazide diuretic (water pill), an ingredient in Olmesan® Plus, other serious side effects may include allergic reactions and changes in body salts (such as sodium and potassium) and fluids. Tell your doctor if you have these signs and symptoms: dry mouth, thirst, weakness, tiredness or sleepiness, restlessness, confusion, seizures, muscle pains or cramps, muscle tiredness, dizziness or fainting, having little or no urine output, fast heartbeat, or nausea and vomiting.

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 Tearon?
Store in a cool and dry place, away from light.
Keep out of reach of children.


Olmesan Plus Prescribing Information

Located in: Cardiovascular