Valsts: Malaizija
Valoda: angļu
Klimata pārmaiņas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
IRBESARTAN
RANBAXY (MALAYSIA) SDN. BHD.
IRBESARTAN
2x14 Tablets
Sun Pharmaceutical Industries Limited
IRBEL TABLETS Irbesartan Tablets (150 and 300 mg) _Consumer Medication Information Leaflet (RiMUP)_ Irbesartan Tablets Page | 1 What is in this leaflet 1. What IRBEL TABLETS are used for 2. How IRBEL TABLETS work 3. Before you use IRBEL TABLETS 4. How to use IRBEL TABLETS 5. While you are using IRBEL TABLETS 6. Side Effects 7. Storage and disposal of IRBEL TABLETS 8. Product description 9. Manufacture 10. Product registration holder 11. Date of Revision WHAT IRBEL TABLETS IS USED FOR IRBEL TABLETS contain a medicine called irbesartan. Irbesartan belongs to a group of medicines known as angiotensin-II receptor blocker. Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels causing narrowing of blood vessels. This results in an increase in blood pressure. IRBEL TABLETS are used in adult patients: • to treat high blood pressure • to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function (Nephropathy in type 2 diabetic patients). HOW IRBEL TABLETS WORKS IRBEL TABLETS prevent the binding of angiotensin-II to angiotensin-II receptors, causing the blood vessels to relax and the blood pressure to lower. Irbesartan slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes. Your doctor may give you other medicines as well as Irbel Tablets to help treat your condition. BEFORE YOU USE IRBEL TABLETS WHEN YOU MUST NOT TAKE IT Do not take IRBEL TABLETS if: • you are allergic to irbesartan or any of the other ingredients of this medicine. An allergic reaction may include rash, itching, swelling of face, lips, or hands/feet, or breathing difficulties. • you are more than 3 months pregnant. (It is also better to avoid Irbesartan in early pregnancy-see pregnancy section) • you are breast feeding. If you are not sure whether you should start taking this medicine talk to your doctor. BEFORE YOU START TO TAKE IT Tell your doctor if you have or have had any of the following medical c Izlasiet visu dokumentu
- _Body as a Whole:_ fever, chills, facial oedema, upper extremity oedema - _Cardiovascular:_ hypertension, cardiac murmur, m y o c a r d i a l i n f a r c t i o n , a n g i n a p e c t o r i s , arrhythmic/conduction disorder, cardio-respiratory arrest, heart failure, hypertensive crisis, sinus abnormality, syncope - _Dermatologic:_ pruritus, dermatitis, ecchymosis, erythema face, - _Endocrine/Metabolic/Electrolyte Imbalances:,_ gout - _Gastrointestinal:_ constipation, oral lesion, gastroenteritis, flatulence, abdominal distention - _Musculoskeletal/Connective _ _Tissue:_ extremity swelling, arthritis, , joint stiffness, bursitis, muscle weakness - _Nervous _ _System:_ sleep disturbance, numbness, somnolence, emotional disturbance, depression, paresthesia, tremor, transient ischemic attack, cerebrovascular accident, anxiety/nervousness - _Renal/Genitourinary:_ abnormal urination, prostate disorder, urinary tract infection - _Respiratory:_ epistaxis, tracheobronchitis, congestion, pulmonary congestion, dyspnea, wheezing, influenza, pharyngitis, rhinitis - _Special _ _Senses:_ vision disturbance, hearing abnormality, ear infection, ear pain, conjunctivitis, other eye disturbance, eyelid abnormality, ear abnormality _Laboratory Test Findings_ - Minor increases in blood urea nitrogen (BUN) have been reported in patients with essential hypertension receiving irbesartan. - Mean decreases in neutropenia (<1000 cells/mm3) have been reported in patients receiving irbesartan Rare cases of rhabdomyolysis have been reported in patients receiving angiotension II receptor blockers. USE IN SPECIAL POPULATIONS Ÿ PREGNANCY USE IN PREGNANCY THE USE OF ANGIOTENSIN II RECEPTOR ANTAGONISTS (AIIRAS) IS NOT RECOMMENDED DURING THE FIRST TRIMESTER OF PREGNANCY (SEE WARNINGS AND PRECAUTIONS). THE USE OF AIIRAS IS CONTRAINDICATED DURING THE SECOND AND THIRD TRIMESTERS OF PREGNANCY (SEE CONTRAINDICATIONS AND WARNINGS AND PRECAUTIONS). The use of Angiotensin II Receptor Antagonists (AIIRAs) is not recommended during the first trimester of Izlasiet visu dokumentu