Eplerium 25 mg. 30 tablets

What is Eplerium and what it is used for
Eplerium belongs to a group of medicines called selective aldosterone blockers. These blockers suppress the action of aldosterone, a substance that is produced in the body and controls your blood pressure and heart function. High levels of aldosterone can cause changes in your body that lead to heart failure.

Eplerium is used to treat your heart failure to prevent worsening and reduce the risk of hospitalization if you:
you have recently had a heart attack, in combination with other medicines to treat heart failure or heart failure
you have persistent mild symptoms despite the treatment you have received so far.

2. What you need to know before you take Eplerium

Do not take Eplerium

if you are hypersensitive (allergic) to eplerenone or any of the other ingredients of this medicine (listed in section 6);
if you have high levels of potassium in your blood (hyperkalemia);
if you are taking a group of medicines that help you remove excess fluid from your body (potassium-sparing diuretics) or "salt tablets" (potassium supplements);
if you have severe kidney disease;
if you have severe liver disease;
if you are taking medicines used to treat fungal infections (ketoconazole or itraconazole);
if you are taking antiviral medicines to treat HIV (nelfinavir or ritonavir);
if you are taking antibiotics that are used to treat bacterial infections (clarithromycin or telithromycin);
if you are taking nefazodone used to treat depression;
If you are taking medicines used to treat certain heart conditions or hypertension (so-called angiotensin converting enzyme (ACE) inhibitors) or angiotensin receptor blockers (ACB) at the same time.
Warnings and precautions
Talk to your doctor or pharmacist before taking Eplerium

if you have kidney or liver disease (see also "Do not take Eplery");
if you are taking lithium (usually prescribed for manic-depressive disorders, also called bipolar disorders);
if you are taking tacrolimus or ciclosporin (used to treat skin disorders such as psoriasis and eczema or to prevent rejection after organ transplantation).
Children and adolescents
The safety and efficacy of eplerenone in children and adolescents have not been established.

Other medicines and Eplerium
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

You should not take Eplerium with the following medicines (see also "Do not take Eplery"):

Itraconazole or ketoconazole (used to treat fungal infections), ritonavir, nelfinavir (antiviral medicines to treat HIV), clarithromycin, telithromycin (used to treat bacterial infections) or nefazodone (used to treat depression) these drugs reduce the degradation of Eplerius, thus prolonging its effects in the body;
Potassium-sparing diuretics (medicines to help you remove excess fluid from your body) and potassium supplements (salt tablets) as these drugs increase the risk of high levels of potassium in your blood;
Angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ACB) at the same time (used to treat high blood pressure and heart disease or certain kidney disease) as they may increase the risk of high levels of potassium in your blood.
Please tell your doctor if you are using any of the following medicines:

Lithium (usually prescribed for manic-depressive disorders, also called bipolar disorder). Lithium use, together with diuretics and ACE inhibitors (used to treat high blood pressure and heart disease), has been shown to cause excessive increases in lithium levels in the blood, which may cause side effects such as loss of appetite, impaired vision , fatigue, muscle weakness, muscle twitching;
Ciclosporin or tacrolimus (used to treat skin diseases such as psoriasis and eczema or to prevent rejection after organ transplantation). These medicines can cause kidney problems and therefore lead to an increased risk of high levels of potassium in your blood;
Non-steroidal anti-inflammatory drugs (NSAIDs - a certain type of painkillers such as ibuprofen, which are used to relieve pain, stiffness and inflammation). These medicines can cause kidney problems and therefore increase the risk of high levels of potassium in your blood;
Trimethoprim (used to treat bacterial infections) may lead to an increased risk of high potassium levels in your blood;
Alpha-1 blockers, such as prazosin or alfuzosin (used to treat high blood pressure and certain prostate conditions), may lead to lower blood pressure
Eplerium with food, drink and alcohol
Eplerium can be taken with or without food.

Pregnancy, breastfeeding and fertility
If you are pregnant or are breast-feeding, think you may be pregnant or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Ask your doctor or pharmacist for advice before taking any medicine. The effect of Epplerium is assessed during pregnancy in humans.
It is not known whether eplerenone is excreted in human breast milk. You should decide with your doctor whether to stop breast-feeding or stop taking the medicine.

Driving and using machines
You may experience dizziness after taking Eplerium. If this happens, do not drive or use machines.

Epplerium contains lactose.
One of the ingredients of Eplerium is lactose monohydrate (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product.

3. How to take Eplerium

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Epplerium tablets can be taken with food or on fasting. Swallow the tablets whole with plenty of water.

Eplerium is commonly used with other heart failure medicines, such as beta-blockers. The usual starting dose is one 25 mg tablet once a day, increasing after about 4 weeks to 50 mg once a day (or as a 50 mg or two 25 mg tablet). The maximum daily dose is 50 mg.

Blood potassium levels should be measured before starting treatment with Eplerium, the first week and the first month after starting treatment or after dose adjustment. Depending on the level of potassium in your blood, your doctor may adjust your dose.
If you have mild kidney disease, you should start with one 25 mg tablet a day. If you have moderate kidney disease, you should start with one 25 mg tablet a day. These doses may change if your doctor recommends and depending on the levels of potassium in your blood.
In patients with severe renal disease, Eplerium is not recommended. In patients with mild to moderate liver disease, no adjustment of the initial dose is required. If you have liver or kidney problems, you may have to do a blood potassium test (see also "Do not take Eplery").

In the elderly: no initial dose adjustment is required.

Use in children and adolescents
In children and adolescents: Eplerium is not recommended.

If you take more Eplarium than you should
If you have taken more Epilepsy than you should, you should tell your doctor or pharmacist immediately. If you have taken too much of your medicine, the most likely symptoms will be lowering your blood pressure (a slight headache, dizziness, blurred vision, weakness, acute loss of consciousness) or hyperkalaemia, high potassium levels in the blood (such as muscle cramps, diarrhea, nausea, dizziness or headache).

If you forget to take Eplerium
If it's almost time to take the next tablet, skip the forgotten tablet and take the next tablet at the usual time.

Otherwise, take the tablet as soon as you remember, provided there is an interval of more than 12 hours until you take the next tablet. Then continue to take your medicine in the usual way.

Do not take a double dose to make up for the missed dose.

If you stop taking Eplerium
It is important to continue taking Eplerius for as long as prescribed, unless the doctor tells you to stop treatment.
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 everyone gets them.
If you experience any of the following side effects, you should immediately seek medical attention:

swelling of the face, tongue or throat;
difficulty swallowing;
hives and difficulty breathing.
These are symptoms of angioneurotic edema, uncommon side effects (affects 1 to 100 patients).

Other reported side effects include:

Common side effects: affects 1 to 10 patients

increased levels of potassium in your blood (symptoms include muscle cramps, diarrhea, nausea, dizziness or headache);
dizziness;
seizure;
elevated cholesterol levels in the blood;
insomnia (sleep problems);
headache;
heart complaints, e.g. irregular heart rhythm and heart failure;
coughing;
constipation;
low blood pressure;
diarrhea;
nausea;
vomiting;
poor functioning of your kidneys;
rash;
itching;
back pain;
feeling weak;
muscle spasm;
elevated blood urea levels;
increased blood creatinine levels, which may indicate kidney problems.
Uncommon side effects: affects up to 1 in 100 patients

infections;
eosinophilia (increased number of white blood cells);
Dehydration (dehydration);
increased amount of triglycerides (fats) in your blood;
low sodium levels in the blood;
palpitations;
inflammation of the gall bladder;
decreased blood pressure, which may cause dizziness when getting up;
blood clot (thrombosis) in the lower limbs;
sore throat;
flatulence;
decreased activity of the thyroid gland;
elevated blood glucose levels;
decreased sense of touch;
increased sweating;
musculoskeletal pain;
general malaise;
inflammation of the kidneys;
breast enlargement in men;
change in blood test results.
How to Store Epleium

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not dispose of medicines in the sewers or in the household waste container. Ask your pharmacist how to dispose of your unnecessary medicines. These measures will help to protect the environment.

6. Package Contents and Additional Information

What Epleium contains

The active substance is eplerenone. Each film-coated tablet contains 25 mg or 50 mg of eplerenone.
The other ingredients are:
Tablet core: lactose monohydrate, cellulose, microcrystalline (type 101), croscarmellose sodium, hypromellose (type 2910), cellulose, microcrystalline (type 102), sodium lauryl sulfate, talc, magnesium stearate.
Tablet coating: lactose monohydrate, hypromellose (type 2910), titanium dioxide (K171), macrogol 4000.
What Epilerium looks like and what the package contains
Epilerium 25 mg tablet is a white or off-white, round, biconvex film-coated tablet. One side is engraved: "CG3", there are no labels on the other side.

Epilerium 50 mg tablet is a white or off-white, round, biconvex film-coated tablet. One side is engraved: "CG4", there are no labels on the other side.

30, 50, 60 and 90 film-coated tablets are packed in a PVC / Aluminum blister and cartons.

Not all pack sizes may be marketed.

 

 

 

 

 

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