INSPRA. 25 mg. 30 tablets
INSPRA. 25 mg. 30 tablets
INSPRA WHAT IS AND WHAT IT IS USED FOR ?
INSPRA tablet contains 25 mg or 50 mg eplerenone . Eplerenone is a substance that has the ability to prevent worsening of heart failure after a heart attack in combination with other medicines used to treat heart failure.
INSPRA is available in packs of 20,28 , 30, 50 , 100, 200 tablets. It is possible that the market does not offer all types of packaging.
25 mg tablet is a yellow film-coated tablet imprinted with "Pfizer", printed on one side of the tablet and "NSR" over "25" on the other side of the tablet.
The tablet of 50 mg film-coated tablet is yellow indicating "Pfizer", printed on one side of the tablet and "NSR" over "50 " on the other side of the tablet .
Your body produces a substance called aldosterone. It is important to control blood pressure . Sometimes high aldosterone levels can cause changes in the body that lead to heart failure . INSPRA works by blocking the effects of aldosterone, and can help prevent worsening of heart failure after myocardial infarction.
2 . BEFORE YOU TAKE INSPRA
Do not use INSPRA :
• If you are hypersensitive (allergic) to INSPRA or to any of the excipients of the tablets for INSPRA ;
• If you have hyperkalemia (high levels of potassium in your blood) ;
• If you are taking Capi -sparing diuretics ( certain water tablets ) ;
• If you are taking ketoconazole or itraconazole ( medicines used to treat fungal infections) ;
• If you have moderate to severe kidney disease ;
• If you have severe liver disease ;
• If you are taking ritonavir or nelfinavir ( antiviral medicines to treat HIV) ;
• If a clarithromycine or teHthromycine ( antibiotic used to treat bacterial infections) ;
• If you are taking nefazadone ( used to treat depression) .
Take special care before taking INSPRA :
• If you have kidney or liver disease (see also " Do not use INSPRA " ) ;
• If you are taking diuretics ( water pills ) ;
• If you are taking lithium ( usually given in manic- depressive disorder , also called bipolar disorder) ;
• If you use potassium supplements , they are not recommended while taking INSPRA ;
• If you are taking tacrolimus or cyclosporine (used to treat skin diseases such as psoriasis or eczema, and for prophylaxis of graft rejection after transplantation ( grafting ) of organs ) .
Please consult your doctor if you are taking or have taken in the past any of the aforementioned drugs.
Tell your doctor if you are pregnant , think you may be pregnant shi plan to become pregnant . The effect of INSPRA during pregnancy has not been evaluated . Seek advice your doctor or pharmacist before taking any medicine .
Seek advice your doctor or pharmacist for advice before taking any medicine .
Driving and using machines:
After taking this medicine you may feel dizzy. If this happens , do not drive or operate machinery.
Important information about some of the ingredients of Inspra :
One of the excipients in the formulation of INSPRA is lactose monohydrate. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Using other medicines:
Please tell your doctor if you are taking any of these medicines:
• Ketoconazole, itraconazole or fluconazole ( used to treat fungal infections ( see also section " Do not use INSPRA " ) ;
• Verapamil or diltiazem ( used for heart problems and high blood pressure) ;
• Warfarin ( an anti- drug) ;
• Digoxin or amiodarone ( used to treat specific heart conditions , incl. Irregular heartbeat ) ;
• ACE inhibitors such as enalapril ( used to treat certain heart or kidney disease ) ;
• alpha- 1 blockers such as prazosin or alfuzosin ( used to treat high blood pressure and some diseases of the prostate) ;
• Angiotensin II receptor blockers , such as candesartan ( used for high blood pressure or certain kidney diseases ) ;
• Potassium-sparing diuretics ( certain 'water tablets used to treat fluid retention ) (see also section " Do not use INSPRA " ) ;
• Potassium supplements ( tablets containing a potassium salt ) ;
• Saquinavir, ritonavir or nelfinavir ( antiviral drugs for the treatment of HIV ) ;
• Erythromycin, clarithromycin, telithromycin, trimethroprim or rimfampicin ( antibiotic used to treat bacterial infections) ;
• Lithium ( usually given for the treatment of manic- depressive disorder , also known as bipolar disorders ) ;
• nefazadone and St. John's wort (used to treat depression) ;
• Carbamazepine, phenitoin and phenobarbital ( used to treat epilepsy)
• Tricyclic antidepressants such as amitryptyline or amoxapine;
• Antipsychotic medications such as chlorpromazine or haloperidol;
• Non-steroidal anti-inflammatory drugs ( painkillers, eg . As ibuprofen);
• Tacrolimus or cyclosporin ( used to treat skin diseases such as psoriasis or eczema, and for prevention of rejection reaction after organ transplantation ) ;
• Baclofen ( used to treat muscle spasms caused by spinal injuries or multiple sclerosis ) ;
• Glucocorticoids , such as hydrocortisone or prednisone ( used to treat inflammation and some skin diseases) ;
• Amifostine ( used during cancer chemotherapy ) .
Please tell your doctor or pharmacist if you are taking now or have recently taken any - other medicines, including those you have not been prescribed.
3 . HOW TO TAKE INSPRA ?
Your doctor will tell you how to take your medicine. Carefully follow the instructions given to you by your doctor.
INSPRA tablets can be taken during or after a meal or in fasted state. Swallow the tablets with a glass of water without chewing .
INSPRA tablets should always be prescribed in combination with other drugs for heart failure , including beta-blockers. The usual dose is one tablet of 25 mg once daily, increased to one tablet of 50 mg once daily after about 4 weeks as directed by your doctor. The maximum daily dose is 50 mg .
INSPRA not recommended for children.
The starting dose is 25 mg INSPRA once daily in patients with mild renal disease and patients with mild to moderate liver disease. If you have liver or kidney problems , you may need more frequent testing to check potassium levels in the blood ( see also " Do not use INSPRA " ) .
Some drugs (e.g., erythromycin, saquinavir , amiodarone, diltiazem , verapamil and fluconazole ) can influence the way in which Inspra degrade in the body. In this situation, your doctor will limit your daily dose to 25 mg ednatabletka .
The starting dose of 25 mg INSPRA remains once daily in elderly patients .
Serum potassium levels should be measured prior to initiation of treatment with INSPRA in the first week and one month after the start of treatment or dose adjustment . The dose may be adjusted by your doctor depending on the amount of potassium in your blood.
It is important to continue taking INSPRA in the prescribed manner , unless your doctor tells you to stop.
If you take more than the displayed amount INSPRA :
If you take more than the prescribed amount INSPRA , report it immediately to your doctor or pharmacist.
If you forget to take INSPRA :
If you forget to take a dose , take it as soon as you remember . If it is almost time to take the next dose , do not take the tablet that you have missed. Instead, take the next dose on time and then continue to take your tablets as prescribed by your doctor. Do not take a double dose to make up for a forgotten tablet.
4 . POSSIBLE SIDE EFFECTS
Like all medicines, INSPRA can have side effects .
If you happen to any of the following conditions listed below, stop taking INSPRA and tell your doctor immediately or go to the casualty department at your nearest hospital :
• swelling of the hands, feet, ankles , face, lips , mouth or throat which may cause difficulty in swallowing or breathing ;
• Rash ;
• Loss of consciousness ;
• Yellowing of the skin and eyes , also called jaundice
These are very serious side effects . If any of them could have had a serious allergic reaction to INSPRA . You may need urgent medical attention or hospitalization.
All of these serious side effects are very rare .
Tell your doctor immediately or go to the emergency room of the nearest hospital if you notice any of the following:
• Pain in the chest ;
• angina ( chest pain ) ;
• Changes in the way your heart beats , for example, if you notice increased heart activity;
• Difficulty in breathing ;
• Reduce the amount of urine as usual ;
These are serious side effects . You may need urgent medical attention. These serious side effects are rare.
Tell your doctor if you notice the following:
• Nausea (feeling sick) ;
• Cramps ( painful perception ) of the lower limbs
• Headache ;
• Dizziness ;
• Fatigue ;
• Dizziness ;
• Muscle cramps ;
• Enhanced gasification or release of gases;
• Diarrhea ;
• Vomiting ;
• Itching ;
• Changes in the level of fat in your body , which can be detected in a blood test ;
• Excessive sweating ;
• Change of blood tests that can be detected in blood;
• Back pain ;
• Pain in the abdomen ;
• Pain when urinating ;
• Reduce the amount of urine you spend ;
• Sore throat
• Weakness and malaise ;
• Difficulty in sleeping ;
• Dehydration .
These are mild side effects of INSPRA . You may need to seek medical attention as soon as possible . If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5 . KEEPING INSPRA
Keep out of the reach of children.
No special storage requirements .
Shelf life :
Do not use the tablets for INSPRA after the expiry date stated on the carton and blister.
The name of this medicine is ISPRA . The active substance is eplerenone ( eplerenone ) . Each tablet contains 25 mg INSPRA or 50 mg of the active ingredient . Excipients are lactose monohydrate, microcrystalline cellulose (E460I), croscarmellose sodium ( E466 ) , (E464 ) , sodium lauryl sulfate , talc ( E553b ) and magnesium stearate ( E470b ) .
The tablet coating contains Opadry yellow (E464 ) , yutaniev dioxide (E171) , macrogol 400, polysorbate 80 ( E433 ), yellow iron oxide ( E172 ), red iron oxide (E 172).