CO - IRBESAN 300 mg. / 12.5 mg. 28 tablets

What is Co-IRBESAN 300 mg / 12,5 mg tablets is and what it is used
CO-IRBESAN is a combination of two active substances - irbesartan and hydrochlorothiazide. Each tablet KO-IRBESAN 300 mg / 12,5 mg contains 300 mg of irbesartan and hydrochlorothiazide 12,5 mg.
Irbesartan belongs to the group of drugs known as antagonists of angiotensin -II receptors.
Angiotensin-II is formed in the body and bind to the receptors in the blood vessels, causing them to tighten. This leads to an increase in blood pressure. Irbesartan prevents the binding of angiotensin-II to these receptors, causing the blood vessels and lowers blood pressure.
Hydrochlorothiazide causes increased urine output and thus lowers blood pressure.
CO-IRBESAN is used to treat high blood pressure.

2. What you need to know before taking Co-IRBESAN 300 mg / 12,5 mg tablets
Do not take Co-IRBESAN tablets:
if you are allergic to the active substances, irbesartan and hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6);
if you are pregnant more than 3 months (in early pregnancy is also better to avoid the use of CO-IRBESAN - see the section on pregnancy and lactation)
if you have severe liver or kidney problems;
if have difficulty passing urine;
if you suffer from the disease associated with persistently high calcium or low potassium levels in your blood.
Take special care with Co-IRBESAN:
If you are pregnant or think you may be pregnant, consult your doctor before taking this medicine.
CO-IRBESAN not recommended in early pregnancy and must not be taken if you are pregnant after the third month, as this can seriously harm your baby (see the section on pregnancy and lactation).

Warnings and Precautions
Talk to your doctor before taking Co-IRBESAN:
if you have problems with heart, liver, kidney, or you are on dialysis;
if you have a kidney transplant;
If you vomit or have diarrhea;
if you have diabetes;
if you have lupus erythematosus (also known as lupus or CLE);
if you suffer from primary aldosteronism (a condition associated with increased secretion of the hormone aldosterone, which causes an increase in blood pressure.
Hydrochlorothiazide may test positive for doping.

Children and adolescents
CO-IRBESAN should not be taken by children and adolescents (under 18 years).

Other medicines and Co-IRBESAN
Tell your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines.
Tell your doctor if you take:
other medicines to lower blood pressure;
nonsteroidal antiinflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, etc .;
acetylsalicylic acid more than 3 grams per day;
potassium supplements or salt substitutes containing potassium;
antiplatelet drugs, for example heparin;
water tablets (diuretics)
medicines to treat psychiatric disorders containing lithium.
CO-IRBESAN food, beverages and alcohol
Food does not affect the operation of Co-IRBESAN.
Drinking alcohol during treatment with CO-IRBESAN can cause weakness or dizziness.

Pregnancy, lactation and fertility
Pregnancy
If you are pregnant or breast-feeding, you think you may be pregnant or planning to become pregnant, contact your doctor.
Your doctor will advise you to stop taking Co-IRBESAN and will offer appropriate treatment.
CO-IRBESAN not recommended in early pregnancy and must not be accepted after 3 months of pregnancy because it can seriously harm your baby.

Breastfeeding
Tell your doctor if you are breastfeeding or are breast-feeding.
CO-IRBESAN tablets are not recommended for mothers who breastfeed, especially if their baby is newborn or preterm.

Driving and using machines
Not expected CO-IRBESAN tablets affect your ability to drive and use machines. The use of CO-IRBESAN® may be the reason for the appearance of fatigue or dizziness.

If you feel like this:
do not drive;
do not use any tools or machines.
CO-IRBESAN tablets contain lactose monohydrate.
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this product.

3. How to take Co-IRBESAN 300 mg / 12,5 mg tablets
Always take this medicine exactly as you have been told by your doctor. If you are not sure ask your doctor or pharmacist.
The recommended dose is one or two tablets a day.
Try taking CO-IRBESAN at the same time each day.
Taking CO-IRBESAN not dependent on food intake.

If you take more than the amount of CO-IRBESAN
If you take more than the amount of CO-IRBESAN immediately contact your doctor.

If you forget to take Co-IRBESAN
If you forget to take Co-IRBESAN, take the tablet as soon as you remember unless it is very close to the next dose. If this happens, skip the intake and take the next tablet as you follow the prescribed treatment.
Do not take a double dose to make up for a forgotten tablet.

If you stop taking Co-IRBESAN
Do not stop the treatment before you have completed the full course of treatment even though you feel better. Some of the symptoms to recur.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
In this leaflet, when side effects are described as "common" this means that they have been reported in more than 1 in every 100 patients, but less than 1 in every 10 patients.
When side effects are described as "uncommon", this means that they were reported in more than 1 in 1000 patients but less than 1 out of 100 patients.
When side effects are described as "rare", this means that they were reported in more than 1 in 10 000 patients, but less than 1 in 1000 patients.
When side effects are described as "very rare", this means that they have been reported in less than 1 in every 10,000 patients.

Common: nausea, vomiting, frequent urination, fatigue, dizziness (including upon standing or sitting position), elevated levels of an enzyme that measures the muscle and heart function (creatine kinase), increased levels of substances that measure kidney function (nitrogen , blood urea, creatinine).

Uncommon: diarrhea, low blood pressure, dizziness, palpitations, sweating, problems with sexual activity, reduced levels of potassium and sodium in the blood.

Usual side effects whose frequency has not been determined are: headache, ringing in the ears, cough, abnormal taste perceptions, indigestion, pain in muscles and joints, impaired kidney and liver, increased levels of potassium in the blood, allergic skin reactions.

5. How to store CO-IRBESAN 300 mg / 12,5 mg tablets
Keep out of reach of children.
Do not store above 25 ° C.
Store in the original container.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of that month.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and further information
What CO-IRBESAN 300 mg / 12,5 mg tablets
The active substances are irbesartan and hydrochlorothiazide. Each tablet contains 300 mg of irbesartan and hydrochlorothiazide 12,5 mg.
The other ingredients are lactose monohydrate, powdered cellulose, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, Opadry OY-34948 pink (hypromellose, macrogol, titanium dioxide - E171, red iron oxide - E172).

How does CO-IRBESAN 300 mg / 12,5 mg tablets and contents of the pack
Pink, oval, biconvex film-coated tablets, scored on one side.

Pack sizes:
28 tablets (2 pcs. Blister x 14 film-coated tablets).
90 film-coated tablets (9 pcs. Blister x 10 film-coated tablets).