Patient Information Leaflet: Instructions for the User

Eplerenone TecniGen 25 mg film-coated tablets

Equivalent medicine
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Eplerenone TecniGen is and what it is used for
What you need to know before taking Eplerenone TecniGen
How to take Eplerenone TecniGen
Possible side effects
How to store Eplerenone TecniGen
Contents of the pack and other information

1. What Eplerenone TecniGen is and what it is used for

Eplerenone TecniGen belongs to a class of medicines known as selective aldosterone blockers.
These agents inhibit the action of aldosterone, a substance produced by the body that regulates
blood pressure and heart function. Elevated levels of aldosterone can cause changes
in the body that lead to heart failure.
Eplerenone TecniGen is used to treat your heart failure, to prevent its worsening, and to reduce
hospitalisations, if:

you have recently had a heart attack, in combination with other medicines used to treat heart failure, or
you have moderate and persistent symptoms despite the treatment you have received up to now.

2. What you need to know before taking Eplerenone TecniGen

Do not take Eplerenone TecniGen

If you are allergic to eplerenone or to any of the other ingredients of this medicine (listed in section 6).
If you have high levels of potassium in your blood (hyperkalaemia)
If you are taking medicines that help eliminate excess body fluids (potassium-sparing diuretics) or "salt tablets" (such as 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 for the treatment of HIV (nelfinavir or ritonavir)
If you are taking antibiotics for the treatment of bacterial infections (clarithromycin or telithromycin)
If you are taking nefazodone for the treatment of depression
If you are taking medicines for the treatment of certain heart conditions or hypertension (called angiotensin-converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers (ARBs)) together.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Eplerenone TecniGen

If you have kidney or liver disease (see also “Do not take Eplerenone TecniGen”)
If you are taking lithium (commonly used for manic-depressive disorders, also known as bipolar disorders)
If you are taking tacrolimus or cyclosporine (used to treat skin conditions such as psoriasis or eczema and to prevent organ transplant rejection)

Children and adolescents
The safety and efficacy of eplerenone in children and adolescents have not been established.
Other medicines and Eplerenone TecniGen
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
You must not take Eplerenone TecniGen with the following medicines (see section “Do not take Eplerenone TecniGen”):

Itraconazole or ketoconazole (for treatment of fungal infections), ritonavir, nelfinavir (antiviral medicines for treatment of HIV), clarithromycin, telithromycin (for treatment of bacterial infections), or nefazodone (for depression), as these medicines reduce the elimination of eplerenone, prolonging its effect.
Potassium-sparing diuretics (medicines that help eliminate excess body fluids) and potassium supplements (salt tablets), as these medicines increase the risk of high potassium levels in the blood.
Angiotensin-converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers (ARBs) together (used in the treatment of high blood pressure, heart diseases, or certain kidney conditions), because these medicines can increase the risk of high potassium levels in the blood.

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

Lithium (usually used for manic-depressive disorders, also known as bipolar disorders). It has been shown that using lithium together with diuretics and ACE inhibitors (used in the treatment of high blood pressure and heart disorders) increases lithium levels in the blood, which may cause the following adverse effects: loss of appetite, vision disturbances, fatigue, muscle weakness, muscle cramps.
Cyclosporine or tacrolimus (used to treat skin conditions such as psoriasis or eczema and to prevent rejection after organ transplantation). These medicines can cause kidney problems and thus increase the risk of high potassium levels in the blood.
Non-steroidal anti-inflammatory drugs (NSAIDs – some painkillers such as ibuprofen, used to relieve pain, stiffness, and inflammation). These medicines can cause kidney problems and thus increase the risk of high potassium levels in the blood.
Trimethoprim (used to treat bacterial infections) may increase the risk of high potassium levels in the blood.
Alpha-1-blockers, such as prazosin or alfuzosin (used to treat high blood pressure and certain prostate conditions), may cause a drop in blood pressure and dizziness when standing up.
Tricyclic antidepressants such as amitriptyline or amoxapine (for treatment of depression), antipsychotics (also known as neuroleptics) such as chlorpromazine or haloperidol (for treatment of psychiatric disorders), amifostine (used in anticancer chemotherapy), and baclofen (used to treat muscle spasms). These medicines may cause a drop in blood pressure and dizziness when standing up.
Glucocorticoids, such as hydrocortisone or prednisone (used to treat inflammations and certain skin conditions) and tetracosactide (mainly used for diagnosis and treatment of adrenal cortex disorders), may reduce the effect of Eplerenone TecniGen.
Digoxin (used in the treatment of heart disorders). Digoxin levels in the blood may increase when administered together with Eplerenone TecniGen.
Warfarin (an anticoagulant medicine): caution is recommended with warfarin, as high levels of warfarin in the blood may alter the effects of Eplerenone TecniGen.
Erythromycin (used to treat bacterial infections), saquinavir (an antiviral medicine for the treatment of HIV), fluconazole (used to treat fungal infections), amiodarone, diltiazem, and verapamil (for the treatment of heart disorders and high blood pressure) reduce the elimination of Eplerenone TecniGen, prolonging its effect.
St. John’s Wort (a herbal medicine), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (also used to treat epilepsy) may increase the elimination of Eplerenone TecniGen and thus reduce its effects.

Eplerenone TecniGen with food, drinks, and alcohol
Eplerenone TecniGen can be taken with or without food.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
The effect of Eplerenone TecniGen has not been evaluated during pregnancy in humans.
It is not known whether eplerenone is excreted in breast milk. Together with your doctor, you must decide whether to discontinue breastfeeding or to stop taking the medicine.
Driving and using machines
After taking Eplerenone TecniGen, you may experience dizziness. If this occurs, do not drive or operate machinery.
For athletes: using the drug without therapeutic need constitutes doping and may result in a positive anti-doping test.
Eplerenone TecniGen contains lactose
One of the components of Eplerenone TecniGen is monohydrate lactose (a type of sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Eplerenone TecniGen

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The Eplerenone TecniGen tablets can be taken with or without food. Swallow the tablets whole with a full glass of water.
Eplerenone TecniGen is generally administered together with other medicines for heart failure, such as beta-blockers. The usual starting dose is one 25 mg tablet once daily, which is then increased after 4 weeks to 50 mg once daily (one 50 mg tablet or two 25 mg tablets).
The maximum daily dose is 50 mg.
Serum potassium levels should be measured before starting treatment with Eplerenone TecniGen, within the first week, within the first month of treatment, and after any dose adjustment. The dose may be adjusted by your doctor based on serum potassium levels.
If you have mild kidney disease, treatment should be initiated with one 25 mg tablet once daily. If you have moderate kidney disease, treatment should be initiated with one 25 mg tablet every other day. Depending on your doctor's assessment and serum potassium levels, these doses may be adjusted.
Eplerenone TecniGen is not recommended in patients with severe kidney disease.
In patients with mild to moderate liver impairment, no initial dose adjustment is required. If you have kidney or liver problems, you may require more frequent monitoring of serum potassium levels (see also “Do not take Eplerenone TecniGen”).
For elderly patients: no initial dose adjustment is required.
For children and adolescents: the use of Eplerenone TecniGen is not recommended.
If you take more Eplerenone TecniGen than you should
If you have taken too many Eplerenone TecniGen tablets, contact your doctor or pharmacist immediately.
If you have taken an overdose, the most likely symptoms are low blood pressure (feeling dizzy, lightheaded, blurred vision, weakness, sudden loss of consciousness) or hyperkalaemia (high potassium levels in the blood), which may present as muscle cramps, diarrhoea, nausea, dizziness, or headache.
If you forget to take Eplerenone TecniGen
If you forget to take a dose of Eplerenone TecniGen and it is almost time for your next dose, skip the missed dose and take the next dose at the scheduled time. Otherwise, take it as soon as you remember, provided that at least 12 hours remain before the next scheduled dose. Then continue taking the medicine as directed.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Eplerenone TecniGen
It is important to take Eplerenone TecniGen exactly as prescribed, unless your doctor tells you to stop treatment.
If you have any questions about how to use this medicine, consult 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 symptoms:
Contact your doctor immediately

Swelling of the face, tongue or throat
Difficulty swallowing
Hives and breathing difficulties

These are symptoms of angioedema. Other reported side effects include:

Common (may affect from 1 to 10 in 100 people):

Heart attack
High levels of potassium in the blood (symptoms include muscle cramps, diarrhoea, nausea, dizziness or headache)
Dizziness
Fainting
Infections
Cough
Constipation
Low blood pressure
Diarrhoea
Nausea
Impaired kidney function
Rash
Itching
Muscle spasms
Increased levels of urea in the blood

Uncommon (may affect up to 1 in 1,000 people):

Eosinophilia (increase in certain white blood cells)
Dehydration
Increased levels of cholesterol or triglycerides (fats) in the blood
Low levels of sodium in the blood
Insomnia (difficulty sleeping)
Headache
Heart problems, e.g. irregular heartbeat, rapid heartbeat, heart failure
Inflammation of the gallbladder
Decreased blood pressure which may cause dizziness when standing up
Blood clots (thrombosis) in the legs
Sore throat
Flatulence
Vomiting
Reduced thyroid function
Increased blood glucose
Reduced sensitivity to touch
Increased sweating
Back pain
Muscle and skeletal pain
Feeling of weakness and general malaise
Increased levels of creatinine in the blood, which may indicate kidney problems
Kidney inflammation
Breast enlargement in men
Changes in blood test values

If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report side effects directly via the national reporting system at: www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Eplerenone TecniGen

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the pack and blister after EXP. The
expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Eplerenone TecniGen contains

The active substance is eplerenone. Each tablet contains 25 mg of eplerenone.
The other components are: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose,

hypromellose, sodium lauryl sulfate, talc and magnesium stearate.

The yellow opadry coating contains: hypromellose, titanium dioxide (E171), macrogol, polysorbate 80, yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Eplerenone TecniGen and contents of the pack
Eplerenone TecniGen 25 mg are yellow, film-coated, round and biconvex tablets.
Eplerenone TecniGen 25 mg film-coated tablets are available in blisters containing 30 tablets.
Marketing Authorization Holder
TECNIGEN S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI), Italy
Manufacturer:
West Pharma – Produções de Especialidades Farmacêuticas, S.A.
Rua João de Deus, n.º 11, Venda Nova, 2700-486 Amadora, Portugal
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2; Abrunheira, 2710-089 Sintra, Portugal
This medicinal product is authorized in the European Economic Area Member States under the following names:
Italy: Eplerenone TecniGen
Portugal: Eplerenona Biofarmoz

Package leaflet: Information for the user

Eplerenone TecniGen 50 mg film-coated tablets

Equivalent medicine
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

What Eplerenone TecniGen is and what it is used for
What you need to know before taking Eplerenone TecniGen
How to take Eplerenone TecniGen
Possible side effects
How to store Eplerenone TecniGen
Contents of the pack and other information

1. What Eplerenone TecniGen is and what it is used for
Eplerenone TecniGen belongs to a class of medicines known as selective aldosterone blockers.
These agents inhibit the action of aldosterone, a substance produced by the body that regulates blood pressure and heart function. Elevated levels of aldosterone can cause changes in the body that lead to heart failure.
Eplerenone TecniGen is used to treat your heart failure, to prevent its worsening, and to reduce hospitalization, if:

you recently had a heart attack, in combination with other medicines used to treat heart failure, or
you have moderate and persistent symptoms despite your current treatment.

2. What you need to know before taking Eplerenone TecniGen

Do not take Eplerenone TecniGen

If you are allergic to eplerenone or to any of the other ingredients of this medicine (listed in section 6).
If you have high levels of potassium in your blood (hyperkalaemia).
If you are taking medicines that help eliminate excess body fluids (potassium-sparing diuretics) or “salt tablets” (such as 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 for the treatment of HIV (nelfinavir or ritonavir).
If you are taking antibiotics for bacterial infections (clarithromycin or telithromycin).
If you are taking nefazodone for the treatment of depression.
If you are taking medicines for certain heart conditions or hypertension (called angiotensin-converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers (ARBs)) together.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Eplerenone TecniGen

If you have kidney or liver disease (see also “Do not take Eplerenone TecniGen”).
If you are taking lithium (commonly used for manic-depressive disorders, also known as bipolar disorders).
If you are taking tacrolimus or cyclosporine (used to treat skin conditions such as psoriasis or eczema and to prevent organ transplant rejection).

Children and adolescents
The safety and efficacy of eplerenone in children and adolescents have not been established.

Other medicines and Eplerenone TecniGen
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You must not take Eplerenone TecniGen with the following medicines (see section “Do not take Eplerenone TecniGen”):

itraconazole or ketoconazole (for fungal infections), ritonavir, nelfinavir (antiviral medicines for HIV), clarithromycin, telithromycin (for bacterial infections), or nefazodone (for depression), as these medicines reduce the elimination of eplerenone, prolonging its effect.
potassium-sparing diuretics (medicines that help eliminate excess body fluids) and potassium supplements (salt tablets), as these medicines increase the risk of high potassium levels in the blood.
angiotensin-converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers (ARBs) taken together (used to treat high blood pressure, heart disease, or certain kidney conditions), because these medicines can increase the risk of high potassium levels in the blood.

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

Lithium (commonly used for manic-depressive disorders, also known as bipolar disorders). The use of lithium together with diuretics and ACE inhibitors (used to treat high blood pressure and heart conditions) has been shown to increase lithium levels in the blood, which may cause side effects such as loss of appetite, blurred vision, fatigue, muscle weakness, and muscle cramps.
Cyclosporine or tacrolimus (used to treat skin conditions such as psoriasis or eczema and to prevent organ transplant rejection). These medicines can cause kidney problems and thus increase the risk of high potassium levels in the blood.
Non-steroidal anti-inflammatory drugs (NSAIDs – some painkillers like ibuprofen, used to relieve pain, stiffness, and inflammation). These medicines can cause kidney problems and thus increase the risk of high potassium levels in the blood.
Trimethoprim (used to treat bacterial infections), which may increase the risk of high potassium levels in the blood.
Alpha-1 blockers, such as prazosin or alfuzosin (used to treat high blood pressure and certain prostate conditions), which may cause a drop in blood pressure and dizziness upon standing.
Tricyclic antidepressants such as amitriptyline or amoxapine (for depression), antipsychotics (also known as neuroleptics) such as chlorpromazine or haloperidol (for psychiatric disorders), amifostine (used in anticancer chemotherapy), and baclofen (used to treat muscle spasms). These medicines may cause low blood pressure and dizziness upon standing.
Glucocorticoids, such as hydrocortisone or prednisone (used to treat inflammation and certain skin conditions), and tetracosactide (mainly used for diagnosis and treatment of adrenal cortex disorders), which may reduce the effect of Eplerenone TecniGen.
Digoxin (used to treat heart conditions). Digoxin levels in the blood may increase when administered together with Eplerenone TecniGen.
Warfarin (an anticoagulant medicine): caution is recommended with warfarin, as high warfarin levels in the blood may alter the effects of Eplerenone TecniGen.
Erythromycin (used to treat bacterial infections), saquinavir (an antiviral medicine for HIV), fluconazole (used to treat fungal infections), amiodarone, diltiazem, and verapamil (used to treat heart conditions and high blood pressure), which reduce the elimination of Eplerenone TecniGen, thereby prolonging its effect.
St. John’s Wort (herbal medicine), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (also used to treat epilepsy), which may increase the elimination of Eplerenone TecniGen and thus reduce its effectiveness.

Eplerenone TecniGen with food, drinks and alcohol
Eplerenone TecniGen can be taken with or without food.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
The effect of Eplerenone TecniGen during pregnancy has not been evaluated in humans.
It is not known whether eplerenone is excreted in breast milk. Together with your doctor, you must decide whether to stop breastfeeding or discontinue the medicine.

Driving and using machines
After taking Eplerenone TecniGen, you may experience dizziness. If this occurs, do not drive or operate machinery.
For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

Eplerenone TecniGen contains lactose
One of the components of Eplerenone TecniGen is monohydrated lactose (a type of sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Eplerenone TecniGen
Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Eplerenone TecniGen tablets can be taken with or without food. Swallow the tablets whole with a sufficient amount of water.
Eplerenone TecniGen is generally administered together with other medicines for heart failure, such as beta-blockers. The usual starting dose is one 25 mg tablet once daily, increasing after 4 weeks to 50 mg once daily (one 50 mg tablet or two 25 mg tablets).
The maximum daily dose is 50 mg.
Potassium levels in the blood must be measured before starting treatment with Eplerenone TecniGen, within the first week and within the first month of treatment, or after any dose adjustment. Your doctor may adjust the dose based on your blood potassium levels.
If you have mild kidney disease, start treatment with one 25 mg tablet once daily. If you have moderate kidney disease, start treatment with one 25 mg tablet every other day. Your doctor may adjust these doses based on your serum potassium levels.
Eplerenone TecniGen is not recommended in patients with severe kidney disease.
In patients with mild to moderate liver function impairment, no initial dose adjustment is required. If you have kidney or liver problems, you may require more frequent monitoring of blood potassium levels (see also “Do not take Eplerenone TecniGen”).
For elderly patients: no initial dose adjustment is required.
For children and adolescents: use of Eplerenone TecniGen is not recommended.

If you take more Eplerenone TecniGen than you should
If you have taken too many Eplerenone TecniGen tablets, contact your doctor or pharmacist immediately.
Symptoms of overdose may include low blood pressure (dizziness, lightheadedness, blurred vision, weakness, sudden loss of consciousness) or hyperkalaemia (high potassium levels in the blood), which may cause muscle cramps, diarrhoea, nausea, dizziness, or headache.

If you forget to take Eplerenone TecniGen
If you forget to take a dose and it is almost time for your next dose, skip the missed dose and take the next dose at the usual time. Otherwise, take it as soon as you remember, ensuring that at least 12 hours pass before taking the next dose. Then continue as normal.
Do not take a double dose to make up for a missed dose.

If you stop taking Eplerenone TecniGen
It is important to take Eplerenone TecniGen as prescribed unless your doctor tells you to stop.
If you have any doubts about using this medicine, contact 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 symptoms, contact your doctor immediately:

Swelling of the face, tongue or throat
Difficulty swallowing
Hives and breathing difficulties
These are symptoms of angioedema.

Other reported side effects include:

Common (may affect up to 1 in 10 people):

Heart attack
High potassium levels in the blood (symptoms include muscle cramps, diarrhoea, nausea, dizziness or headache)
Dizziness
Fainting
Infections
Cough
Constipation
Low blood pressure
Diarrhoea
Nausea
Impaired kidney function
Skin rash
Itching
Muscle spasms
Increased blood urea levels

Uncommon (may affect up to 1 in 1,000 people):

Eosinophilia (increase in certain white blood cells)
Dehydration
Increased levels of cholesterol or triglycerides (fats) in the blood
Low sodium levels in the blood
Insomnia (difficulty sleeping)
Headache
Heart problems, e.g. irregular heartbeat, rapid heartbeat, heart failure
Inflammation of the gallbladder
Low blood pressure causing dizziness upon standing
Thrombosis (blood clots in the legs)
Sore throat
Flatulence
Vomiting
Reduced thyroid function
Increased blood glucose levels
Reduced sensitivity to touch
Increased sweating
Back pain
Musculoskeletal pain
Feeling of weakness and general malaise
Increased creatinine levels in the blood, which may indicate kidney problems
Kidney inflammation
Breast enlargement in men
Changes in blood test values

If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at: www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you help provide more information on the safety of this medicine.

5. How to store Eplerenone TecniGen
Keep this medicine out of the sight and reach of children.
No special storage conditions are required for this medicine.
Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This helps protect the environment.

6. Contents of the pack and other information

What Eplerenone TecniGen contains

The active substance is eplerenone. Each tablet contains 50 mg of eplerenone.
Other components: monohydrated lactose, microcrystalline cellulose, croscarmellose sodium, hypromellose, sodium lauryl sulfate, talc, and magnesium stearate.
The yellow Opaque coating contains: hypromellose, titanium dioxide (E171), macrogol, polysorbate 80, yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Eplerenone TecniGen and contents of the pack
Eplerenone TecniGen 50 mg are yellow, film-coated, round, convex tablets.
Eplerenone TecniGen 50 mg film-coated tablets are available in blisters containing 30 tablets.

Marketing Authorization Holder
TECNIGEN S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI), Italy

Manufacturer:
West Pharma – Produções de Especialidades Farmacêuticas, S.A.
Rua João de Deus, n.º 11, Venda Nova, 2700-486 Amadora, Portugal
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2; Abrunheira, 2710-089 Sintra, Portugal

This medicine is authorized in the European Economic Area member states under the following names:
Italy: Eplerenone TecniGen
Portugal: Eplerenona Biofarmoz

Eplerenone Tecnigen