Information for the patient

Inspra 25 mg

Inspra 50 mg

Film-coated tablets

(eplerenone)

• The active substance is eplerenone. One tablet of Inspra contains 25 mg or 50 mg eplerenone.
• The other ingredients (excipients) are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium (E468), hypromellose (E464) , sodium laurilsulfate, talc (E553b) and magnesium stearate (E470b).

The coating of the tablet contains opadry yellow; hypromellose (E464), titanium dioxide (E171), macrogol 400, polysorbate 80 (E433), iron oxide yellow (E172), iron oxide red (E172).

1. What Inspra is and what it is used for:

Inspra film-coated tablets contain 25 mg or 50 mg eplerenone. Eplerenone is a substance, which can help prevent worsening heart failure after a heart attack, in combination with other drugs that are used to treat your heart failure.

Inspra is available in packs of 28 tablets (i.e. 28 daily doses).

Description:

The 25 mg tablet is a yellow film-coated tablet, with "Pfizer" printed on one side of tablet and "NSR" over "25"on the other side of tablet.

The 50 mg tablet is a yellow film-coated tablet, with "Pfizer" printed on one side of tablet, "NSR" over "50"on the other side of tablet.

Your body makes a substance called aldosterone. It is important for controlling blood pressure.. Sometimes, high levels of aldosterone can cause changes in our body that lead to heart failure. Inspra works by blocking the actions of aldosterone, and can help prevent heart failure from getting worse after a heart attack.

2. Before you use Inspra

Pregnancy:

Tell your doctor if you are pregnant, you think you might be pregnant, or if you are planning to become pregnant. The effect of Inspra has not been evaluated during pregnancy. Ask your doctor or pharmacist for advice before taking any medicine.

Breast-feeding:

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using medicines:

You may feel dizzy after taking this medicine. If this happens, do not drive or operate machinery.

Important information about some of the ingredients of Inspra:

One of the ingredients of Inspra is lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Using other medicines:

Please inform your doctor if you are taking any of the following medicines:

• ketoconazole, itraconazole or fluconazole (used to treat fungal infections) (see also "Do not use Inspra");
• verapamil or diltiazem (used for heart problems and high blood pressure);
• warfarin (an anti-clotting drug);
• digoxin or amiodarone (used to treat particular heart conditions including irregular heart rhythms);
• ACE inhibitors, such as enalapril or ramipril (used to treat particular heart or kidney conditions);
• alpha I blockers, such as prazosin or alfuzosin (used to treat high blood pressure and particular prostate conditions);
• angiotensin II receptor antagonists, such as candesartan or telmisartan (used for high blood pressure, or particular kidney conditions);
• potassium sparing diuretics (certain water tablets used to treat fluid retention) (see also "Do not use Inspra");
• potassium supplements (salt tablets);
• saquinavir, ritonavir or nelfinavir (antiviral medication for treating HIV);
• erythromycin, clarithromycin, telithromycin, trimethoprim or rifampicin ( antibiotics used to treat bacterial infections);
• lithium (usually given for treating manic-depressive disorder also called bipolar disorder);
• nefazadone and St John's Wort (used to treat depression);
• carbamazepine, phenytoin and phenobarbital (used to treat epilepsy);
• tricyclic antidepressants, such as amitryptyline or amoxapine;
• antipsychotic drugs, such as chlorpromazine or haloperidol;
• Non-steroidal anti-inflammatory drugs (certain pain killers, such as ibuprofen);
• tacrolimus or cyclosporin (used to treat skin conditions such as psoriasis or eczema, and to prevent rejection after organ transplantation).
• baclofen (used to treat muscle spasm caused by spinal injury or multiple sclerosis)
• glucocorticoids, such as hydrocortisone or prednisone (used to treat inflammation and particular skin conditions)
• amifostine (used during cancer chemotherapy)

Please inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those that have not been prescribed.

3. How to use Inspra:

You doctor will tell you how to take your medicine. Carefully follow the instructions given to you by your doctor.

Inspra tablets may be taken with or after a meal or on an empty stomach. Swallow the tablets with a glass of water without chewing.

Inspra tablets should always be prescribed in combination with other medications for heart failure including beta blockers. The usual dose is one 25 mg tablet once daily, increasing to one 50 mg tablet once daily in about 4 weeks, as instructed by your doctor. The maximum daily dose is 50 mg.

Inspra is not recommended for children

 

The starting dose of Inspra is 25 mg once daily in patients with mild kidney disease and patients with mild-to-moderate liver disease. If you have liver or kidney problems, you may need to be tested more frequently to check your blood potassium levels (see also "Do not use Inspra").

Certain medications (e.g. erythromycin, saquinavir, amiodarone, diltiazem, verapamil and fluconazole) can affect the way that Inspra is broken down by the body. In this situation, your doctor will limit your daily dose to one 25 mg tablet.

The starting dose of Inspra remains at 25 mg once daily in the elderly.

Blood potassium levels should be measured before starting Inspra therapy, within the first week and at one month after the start of treatment or after a change in dose. The dose may be adjusted by your doctor, depending on the potassium levels in your blood.

It is important to keep taking Inspra as prescribed unless your doctor tells you to stop your treatment.

4.Possible side effects

Like all medicines, Inspra can have side effects.

If any of the following happen, 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
• hives
• fainting
• yellowing of the skin and eyes, also called jaundice

These are all very serious side effects. If you have any of them, you may have had a serious allergic reaction to Inspra. You may need urgent medical attention or hospitalisation.

All of these very serious side effects are very rare.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• chest pain
• angina
• changes in the way your heart beats, for example, if you notice it beating faster
• difficulty breathing
• less urine than is normal for you

These are all serious side effects. You may need urgent medical attention.

Serious side effects are rare.

Tell your doctor if you notice any of the following:

• nausea (feeling sick)
• leg cramps
• headache
• dizziness
• fatigue
• light-headedness
• muscle cramps
• flatulence or wind
• diarrhoea
• vomiting
• itching
• changes in the level of fats in your body which will be detected during blood testing
• increased sweating
• changes in the blood which will be detected during blood testing
• back pain
• abdominal pain
• pain in passing urine
• fever
• low urine output
• sore throat
• feeling weak and generally unwell
• being unable to sleep
• dehydration

These are all mild side effects of Inspra.

You may need to seek medical attention as soon as possible.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

5. Storing Inspra

• Keep out of the reach and sight of children.
• No special storage instructions required.