25 mg or 50 mg film-coated tablets
eplerenone
1. What Inspra is and what it is used for
Inspra belongs to a group of medicines called selective aldosterone antagonists. These antagonists inhibit the effect of aldosterone, a substance that the body produces to regulate blood pressure and heart function. High levels of aldosterone can cause changes in the body that lead to heart failure.
Inspra is used to treat your heart failure to prevent worsening and reduce the number of hospital stays if you have:
- have had a recent heart attack, in combination with other medicines used to treat your heart failure , or
- had persistent, mild symptoms despite the treatment you have received so far.
Eplerenone contained in Inspra may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
2. What you need to know before using Inspra
Do not take Inspra:
- if you are hypersensitive (allergic) to eplerenone or any of the other ingredients of this medicine (listed in section 6)
- if you have elevated levels of potassium in your blood ( hyperkalaemia )
- if you take diuretics that reduce the body’s excess fluid (potassium-sparing diuretics )
- if you have severe kidney disease
- if you have severe liver disease
- if you are taking medicines for fungal infections ( ketoconazole or itraconazole)
- if you take medicines to prevent viruses to treat HIV (nelfinavir or ritonavir)
- if you are taking antibiotics to treat bacterial infections (clarithromycin or telithromycin)
- if you are taking nefazodone to treat depression
- if you are taking medicines to treat certain heart conditions or high blood pressure (so-called angiotensin converting enzyme (ACE) inhibitors and an angiotensin receptor blocker (ARB)) together.
Warnings and cautions
Talk to a doctor, pharmacist, or nurse before taking Inspra :
- if you have impaired kidney or liver function (see also “ Do not take Inspra ”)
- if you are taking lithium (commonly used for manic-depressive illness, also called bipolar disorder)
- if you are taking tacrolimus or cyclosporine (to treat skin conditions such as psoriasis or eczema , and to prevent organ rejection after organ transplantation)
Children and young people
The safety and efficacy of eplerenone in children and adolescents have not been established.
Other medicines and Inspra
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
- Itraconazole or ketoconazole (for the treatment of fungal infections), ritonavir, nelfinavir (medicines to prevent infections by HIV – infection ), clarithromycin, telithromycin (drugs for bacterial infections) or nefazadone (depression), since these drugs can reduce the degradation of INSPRA and thus prolong its effect in the body.
- Potassium-sparing diuretics (medicines that help reduce the body’s excess fluid) and potassium supplements (salt tablets), as these medicines increase the risk of elevated levels of potassium in the blood.
- Angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) together (which are used to treat high blood pressure , heart disease or certain kidney conditions), as these medicines may increase the risk of high levels of potassium in your blood.
- Lithium (commonly used to treat manic-depressive illness, also known as bipolar disorder) The use of lithium with diuretics and ACE inhibitors (for the treatment of high blood pressure and heart disease) has been shown to cause high levels of lithium in the blood, which can cause side effects. : loss of appetite, visual disturbances, fatigue, muscle weakness, muscle twitching.
- Cyclosporine or tacrolimus (to treat skin conditions such as psoriasis or eczema , and to prevent organ rejection after organ transplantation). These drugs can cause problems with the kidneys and thus increase the risk of elevated levels of potassium in the blood.
- Non-steroidal anti-inflammatory drugs (so-called NSAIDs – painkillers such as ibuprofen , for the treatment of pain, stiffness and inflammation ). These drugs can lead to kidney problems and thus increase the risk of elevated levels of potassium in the blood.
- Trimethoprim (a medicine used to treat bacterial infections) may increase the risk of high levels of potassium in the blood.
- Alpha 1 receptor blockers, such as prazosin or alfuzosin (used for high blood pressure and certain prostate conditions) can cause a drop in blood pressure and dizziness when standing up.
- Tricyclic antidepressants such as amitriptyline or amoxapine (for the treatment of depression), antipsychotics (also called neuroleptics ) such as chlorpromazine or haloperidol (for the treatment of mental illness), amifostine (used during cancer treatment) and baclofen (for the treatment of muscle spasms). These medicines can cause a drop in blood pressure and dizziness when standing up.
- Glucocorticoids , such as hydrocortisone or prednisone (used to treat inflammation and certain skin conditions) and tetracosactide (used mainly to diagnose and treat disorders of the adrenal cortex ) may reduce the effect of Infra blood pressure lowering.
- Digoxin (for heart disease). Levels of digoxin in the blood may increase when taken with Inspra .
- Warfarin (medicine for blood clots): Caution is warranted with warfarin treatment as high levels of warfarin in the blood may cause changes in the effect of Inspra in the body.
- Erythromycin (for bacterial infections), saquinavir (medicines to prevent infections by HIV ), fluconazole (antifungal), amiodarone , diltiazem and verapamil (for cardiac problems, high blood pressure ) decreases degradation of INSPRA and extends Inspras effect in the body.
- St. John’s wort ((traditional) herbal medicines), rifampicin (for bacterial infections), carbamazepine, phenytoin and phenobarbital (medicines for epilepsy, among others ) can increase the breakdown of Inspra and thus reduce its effect.
Inspire with food, drink and alcohol
Inspra can be taken with or without food.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. The effect of Inspra during human pregnancy has not been studied.
It is not known whether eplerenone is excreted in human breast milk. Discuss with your doctor before deciding whether to stop breastfeeding or stop taking the medicine.
Driving and using machines
You may feel dizzy after taking Inspra. In this case, do not drive, use any tools or machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Inspra contains lactose
Inspra contains lactose monohydrate lactose (a sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Inspra contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free.
3. How to use Inspra
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Inspra can be taken with food or on an empty stomach. Swallow the tablets whole along with a copious amount of liquid.
Inspra is normally given together with other medicines for heart failure, such as beta-blockers. The usual starting dose is 25 mg once a day, which after about 4 weeks is increased to 50 mg once a day (either as a 50 mg tablet or two 25 mg tablets). The maximum dosage is 50 mg daily.
Potassium levels in the blood should be checked before treatment with Inspra, during the first week of treatment, and one month after starting a treatment or changing the dose.
Dose one may need to be adjusted by your doctor, depending on the potassium levels in your blood.
If you have mild renal impairment, you should start with a 25 mg tablet every day. And if you have moderate renal impairment, you should start with a 25 mg tablet every other day. These doses can be adjusted if your doctor recommends so and based on the levels of potassium in your blood.
Inspra is not recommended for patients with severe renal impairment.
The starting dose does not need to be adjusted in patients with mild to moderate hepatic impairment. If you have liver or kidney problems, your potassium levels in the blood may need to be checked more often (see also “Do not take Inspra “).
Elderly: No adjustment of the starting dose is required.
Children and adolescents: Inspra is not recommended.
If you use too much of Inspra
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
If you have taken too much of your medicine, the most likely symptoms will be low blood pressure (may manifest as a “slight” feeling in your head, dizziness, blurred vision, weakness, acute unconsciousness) or hyperkalemia, elevated levels of potassium in the blood. (may manifest as muscle cramps, diarrhea, nausea, dizziness, or headache).
If you forget to use Inspra
If it is soon time for your next dose, skip the missed tablet and take the next one as usual.
Otherwise, take it as soon as you remember, provided it takes more than 12 hours for you to take the next tablet. Then return to your regular medication.
Do not take a double dose to make up for a forgotten tablet.
If you stop using Inspra
It is important to continue taking Inspra as prescribed unless your doctor tells you to stop your treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following:
Should you seek immediate medical attention:
- swelling of the face, tongue or throat
- difficulty swallowing
- hives and difficulty breathing
These are symptoms of angioneurotic edema, a less common (affects up to 1 in 100 people) side effect.
Other reported side effects include:
Common side effects are (may affect up to 1 in 10):
- high potassium levels in the blood (symptoms include muscle cramps, diarrhea, nausea, dizziness or headache)
- fainting
- dizziness
- increased level of cholesterol in the blood
- insomnia (difficulty sleeping)
- headache
- heart problems such as irregular heartbeat and heart failure
- cough
- constipation
- low blood pressure
- diarrhea
- nausea
- vomiting
- impaired renal function
- rash
- itching
- back pain
- impotence
- muscle twitching
- increased level of urea in the blood
- increased content of creatinine in the blood which may indicate problems with the kidneys
Less common side effects are (may affect up to 1 in 100):
- infection
- eosinophilia (increase in certain white blood cells )
- decreased sodium levels in the blood
- dehydration
- increased levels of triglycerides (fats) in the blood
- fast heartbeat
- inflammation of the gallbladder
- lowered blood pressure which can sometimes cause dizziness for example if you get up too fast
- thrombosis (blood clot) in the legs
- sore throat
- gas formation
- underactive thyroid gland
- increase in blood sugar
- decreased sensation on touch
- increased sweating
- pain in muscles and bones
- feeling sick
- kidney inflammation
- breast augmentation in men
- changes in certain blood test results
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Inspra
Keep out of sight and reach of children.
No special storage instructions.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. dat ”or“ EXP ”. The expiration date is the last day of the specified month.
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. Contents of the packaging and other information
Content declaration
The active substance in Inspra film-coated tablets is eplerenone. One tablet contains 25 mg or 50 mg of eplerenone.
The other ingredients are lactose monohydrate, microcrystalline cellulose (E460), croscarmellose sodium (E468), hypromellose (E464), sodium lauryl sulphate, talc (E553b), and magnesium stearate (E470b).
The tablet coating of Inspra consists of hypromellose (E464), titanium dioxide (E171), macrogol 400, polysorbate 80 (E433), yellow iron oxide (E172), and red iron oxide (E172).
What the medicine looks like and contents of the pack
Inspra 25 mg tablet is yellow and film-coated. The tablets are marked with “Pfizer” on one side of the tablet and “NSR” over “25” on the other side.
Inspra 50 mg tablet is yellow and film-coated. The tablets are marked with “Pfizer” on one side of the tablet and “NSR” above “50” on the other side.
Inspra 25 mg and 50 mg film-coated tablets are available in opaque PVC / Al pressure packs of 10, 20, 28, 30, 50, 90, 100 and 200 tablets respectively and in opaque PVC / Al perforated unit dose blisters containing 10×1, 20×1, 30×1, 50×1, 90×1, 100×1 or 200×1 (10 packs of 20×1) tablets. However, not all pack sizes will be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Upjohn EESV
Rivium Westlaan 142
2909 LD Capelle aan den IJssel
Netherlands
Local representative:
Pfizer AB
191 90 Sollentuna
Tel: 08-550 520 00
Email: eumedinfo@pfizer.com
Manufacturer:
Fareva Amboise
Industrial Zone
29 route des Industries
37530 Pocé-sur-Cisse
France