Irbesartan 150 mg. 28 tablets

WHAT irbesartan ACCORD AND WHAT IT IS USED
Irbesartan Accord belongs to a group of medicines called receptor antagonists of angiotensin-II.
Angiotensin -II is produced in the body component, which binds to receptors in blood vessels causing them to contract. Thus increasing the blood pressure. Accord Irbesartan prevents the binding of angiotensin-II to these receptors, thus blood vessels relax and blood pressure is lowered. Irbesartan Accord prevents deterioration of renal function in patients with hypertension and type 2 diabetes.

Irbesartan Accord used:
for the treatment of hypertension (essential hypertension);
to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired renal function.

2. BEFORE YOU TAKE Irbesartan ACCORD
Do not take Irbesartan Accord:
If you are allergic (hypersensitive) to irbesartan or any other ingredients of Irbesartan Accord;
If you are in the second or third trimester of pregnancy;
If you are breastfeeding.
Irbesartan Accord should not be taken by children and adolescents under 16 years of age.

Take special care with Irbesartan Accord:
Tell your doctor before taking Irbesartan Accord if:
Suffer from severe vomiting or diarrhea;
Have kidney disease;
Suffer from heart disease;
Get Irbesartan Accord for diabetic nephropathy. In this case, your doctor may order laboratory tests, especially for measuring the levels of sodium in the blood in cases of impaired renal function.
Suffer from primary aldosteronism, a condition in which your adrenal glands produce too much hormone aldosterone is reason to retain sodium and lose potassium.
Suffer from arterial stenosis (constriction or blockage of the artery that supplies blood to the kidneys).

Taking other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Irbesartan Accord not usually interact with other medicines.
You have to do laboratory tests if you are taking:
potassium supplements;
salt substitutes that contain potassium;
Potassium-sparing medicines (such as certain diuretics);
Drugs that contain lithium.

If you take certain painkillers called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.

Taking Irbesartan Accord with food and drink
Irbesartan Accord tablets can be taken with or without food. The tablets should be swallowed with water.

Pregnancy and lactation:
Ask your doctor or pharmacist before taking any medicine. Tell your doctor if you are pregnant or plan to become pregnant. Your doctor will normally advise you to take another medicine instead of Irbesartan Accord as Irbesartan Accord is not recommended in early pregnancy and may cause serious harm to your baby if used after the third month of pregnancy. Appropriate antihypertensive drug must usually replace Irbesartan Accord before pregnancy. The product should not be used during the 2nd and H-quarter of pregnancy and during lactation.
Your doctor will normally advise you to stop taking Irbesartan Accord as you know you are pregnant. If you become pregnant during treatment with Irbesartan Accord, please tell your doctor and see him immediately.

breastfeeding
You should not take Irbesartan Accord if you are breastfeeding (see "Before you take Irbesartan Accord").

Driving and using machines
No studies on the effects on ability to drive and use machines. Accord irbesartan is unlikely to affect your ability to drive or operate machinery. Sometimes may occur dizziness or fatigue during the treatment of high blood pressure. If you experience them, you should consult your doctor before performing such activities.

Important information about some of the ingredients of Irbesartan Accord
This medicinal product contains lactose. If your doctor tells you that you have an intolerance to some sugars, contact before taking this medicine. Patients with rare hereditary enzyme defects of galactose intolerance, hereditary lactase deficiency or poor absorption of glucose and galactose should not use this medicine.

3. HOW TO TAKE Irbesartan ACCORD
Always take Irbesartan Accord exactly as prescribed by your doctor. If you are not sure, ask your doctor or pharmacist.
The usual dose is 150 mg once daily. In the course of treatment, the dose may be increased to 300 mg once a day, depending on the blood pressure values. The optimal blood pressure will be reached at 4 to 6 weeks after initiating treatment.
In patients with high blood pressure and type 2 diabetes, 300 mg once daily is recommended maintenance dose for the treatment of related renal disease.
The doctor may recommend a lower dose, especially when starting treatment in certain patients such as those on hemodialysis or patients older than 75 years.
Irbesartan Accord tablets are for oral use. The tablets should be swallowed with a sufficient amount of fluid (eg one glass of water). You can take Irbesartan Accord with or without food. You should try to take your daily dose at the same time each day. It is important to continue to take Irbesartan Accord until your doctor tells you to stop or change treatment.

If you take more Irbesartan dose Accord
If you take more tablets than your doctor has appointed nezabavnose contact your doctor or visit the nearest hospital. Symptoms of overdose fall in blood pressure (hypotension) and fast heartbeat (tachycardia).

If you forget to take Irbesartan Accord
If you accidentally miss a daily dose, just take your next dose as usual. Do not take a double dose to make up for a missed dose.

If you stop taking Irbesartan Accord:
Do not stop treatment without consulting your doctor. It is important to take Irbesartan Accord as long as your doctor has prescribed. This will keep your blood pressure within normal limits and / or to protect your kidneys from damage.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Irbesartan Accord can cause side effects, although not everybody gets them.
Within each grouping, depending on the frequency of adverse reactions are presented in order of decreasing seriousness.

Adverse reactions are ranked under the following frequency:
Very common: More than 1 in 10 patients treated;
Common: 1 to 10 of 100 treated patients;
Uncommon: 1 to 10 of 1000 patients treated;
Rare: 1 to 10 of 10,000 patients treated;
Very rare: less than 1 in 10,000 patients treated.

Very common:
  If you suffer from high blood pressure and diabetic nephropathy in type 2 diabetes, your doctor will notice an increase in potassium levels in the blood.

common:
dizziness;
Nausea / vomiting, and fatigue;
In patients with hypertension and diabetic nephropathy in type 2 diabetes were also reported dizziness when getting up from a lying or sitting position, low blood pressure when you stand up from a lying or sitting position, and pain in the joints or muscles;
Unusual changes in your blood chemistry as an increase in creatine kinase;
If you suffer from high blood pressure and diabetic nephropathy in type 2 diabetes, your doctor will notice a reduction in the content of hemoglobin.

Uncommon:
palpitations;
flushing;
cough;
diarrhea;
Indigestion / heartburn;
Sexual dysfunction (problems with sexual performance);
Chest pain.

Some side effects have been reported since marketing of Irbesartan Accord, but the frequency with which they occur is not known. These side effects are:
headache;
Taste disturbance;
Tinnitus;
Muscle spasms;
Pain in joints and muscles;
Abnormal kidney function;.
Elevated levels of potassium in the blood;
Impaired renal function;
Inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis).

As with similar medicines, rare cases of allergic skin reactions such as:
rash;
Hives (urticaria);
Localized swelling of the face, lips and / or tongue
have been reported in patients taking irbesartan. If you are having a reaction or feel short of breath, stop taking Irbesartan Accord and seek immediate medical attention.
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE irbesartan ACCORD
Keep out of the reach and sight of children.
Do not use Irbesartan Accord after the expiry date stated on the carton and blister. The expiry date refers to the last day of that month.
This product does not require any special storage conditions.
Do not remove the tablet from the blister pack until you are ready to take the medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

                                                                  
6. FURTHER INFORMATION
What Irbesartan Accord:
The active substance is irbesartan: Each tablet contains 150 mg irbesartan.
Other ingredients are:
Tablet core: lactose monohydrate, croscarmellose sodium (E468), microcrystalline cellulose (E460), hypromellose E5 (E464), colloidal silica anhydrous (E551), magnesium stearate (E572).
Film coating: hypromellose E5 (E464), macrogol 400, lactose monohydrate, titanium dioxide (E171).

Irbesartan Accord looks like tablets and contents of the pack:
Irbesartan 150 mg Accord is a white to off-white, oval, biconvex, film-coated tablet, debossed "I150" on one side and plain on the other.
Accord irbesartan 150 mg film-coated tablets are packed in PVC-PVDC / AL blisters placed into cardboard box.
Cartons contain 8, 14, 28, 56, 64 or 98 tablets.
Not all pack sizes may be marketed.