Eclipse

PACKAGE LEAFLET: INFORMATION FOR THE USER

ECLIPSE 2.5 mg tablets, 5 mg tablets, 10 mg tablets

Ramipril
Equivalent medicine
Please read this leaflet carefully before you start taking this medicine, because it contains important
information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:

1. What ECLIPSE is and what it is used for
2. What you need to know before taking ECLIPSE
3. How to take ECLIPSE
4. Possible side effects
5. How to store ECLIPSE
6. Contents of the pack and other information

1. What ECLIPSE is and what it is used for

ECLIPSE contains a medicine called ramipril which belongs to a group of medicines known as ACE
inhibitors (Angiotensin-Converting Enzyme inhibitors).
ECLIPSE works by:
Reducing the body's production of substances that can cause an increase in
blood pressure
Relaxing and widening your blood vessels
Helping your heart to pump blood more effectively around the body.
ECLIPSE may be used:
To treat high blood pressure (hypertension)
To reduce the risk of heart attack or stroke
To reduce the risk or delay the worsening of kidney problems (with or without diabetes)
To treat your heart when it is unable to pump an adequate amount of blood to the rest of the
body (heart failure)
As treatment after a heart attack (myocardial infarction) when associated with heart
failure.

2. What you need to know before taking ECLIPSE

Do not take ECLIPSE:
If you are allergic to ramipril, to other ACE inhibitor medicines, or to any of the other ingredients of
this medicine listed in section 6. Signs of an allergic reaction may include skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
If you have had a serious allergic reaction called "angioedema". These signs include itching, skin rash (urticaria), red spots on the hands, feet, and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing or swallowing.
If you are on dialysis or undergoing any other type of blood filtration. Depending on the equipment used, ECLIPSE may not be suitable for you.
If you have kidney problems due to insufficient blood supply to the kidney (renal artery stenosis).
During the last 6 months of pregnancy (see below "Pregnancy and breastfeeding").
If your blood pressure is excessively low or unstable. Your doctor will need to assess this.
If you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.
Do not take ECLIPSE if any of the above conditions apply to you. If you are unsure, consult your doctor before taking ECLIPSE.

Warnings and precautions
Talk to your doctor or pharmacist before taking ECLIPSE:
If you have heart, liver, or kidney problems.
If you have lost significant amounts of body salts or fluids (due to illness such as vomiting, diarrhoea, excessive sweating, following a low-salt diet, long-term use of oral diuretics, or after dialysis).
If you are about to undergo treatment to reduce allergy to bee or wasp stings (desensitisation).
If you are about to receive an anaesthetic. This may be given during surgery or dental procedures. You may need to stop taking ECLIPSE the day before; consult your doctor.
If you have high levels of potassium in your blood (shown by a blood test).
If you are taking medicines or have conditions that may cause low sodium levels in your blood. Your doctor may order regular blood tests, especially to monitor sodium levels, particularly if you are elderly.
If you are taking medicines called mTOR inhibitors (e.g. temsirolimus, everolimus, sirolimus) or vildagliptin or racecadotril, as these may increase the risk of angioedema, a serious allergic reaction.
If you have a vascular collagen disorder such as scleroderma or systemic lupus erythematosus.
You must inform your doctor if you think you are pregnant (or could become pregnant). ECLIPSE is not recommended during the first 3 months of pregnancy and may cause severe harm to the unborn child after 3 months of pregnancy (see below "Pregnancy and breastfeeding").
If you are taking any of the following medicines used to treat high blood pressure:
an "angiotensin II receptor antagonist" (AIIRA) (also known as sartans – e.g. valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
Aliskiren.
Your doctor may check your kidney function, blood pressure, and levels of electrolytes (e.g. potassium) in your blood at regular intervals. See also the section "Do not take ECLIPSE".

Children and adolescents
The use of ECLIPSE is not recommended in children and adolescents under 18 years of age, as the safety and efficacy of ECLIPSE in children have not yet been established.
If any of the above conditions apply (or if you are unsure), consult your doctor before taking ECLIPSE.

Other medicines and ECLIPSE
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because ECLIPSE may affect how some other medicines work. Also, some medicines may affect how ECLIPSE works.
Inform your doctor if you are taking any of the following medicines. These medicines may interfere with ECLIPSE and alter its effect:
Medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen, indometacin, aspirin).
Medicines used to treat low blood pressure, shock, heart failure, asthma, or allergies, such as ephedrine, noradrenaline, or adrenaline. Your doctor will need to monitor your blood pressure.
Inform your doctor if you are taking any of the following medicines. Taking these medicines together with ECLIPSE may increase the likelihood of side effects:
Medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen, indometacin, aspirin).
Medicines for cancer (chemotherapy).
Medicines to prevent organ rejection after transplantation, such as ciclosporin.
Diuretics such as furosemide.
Medicines that may increase potassium levels in the blood, such as spironolactone, triamterene, amiloride, potassium salts, trimethoprim alone or in combination with sulfamethoxazole (for infections), and heparin (used to delay blood clotting).
Steroid medicines used to treat inflammation, such as prednisolone.
Allopurinol (used to lower uric acid levels in the blood).
Procainamide (for heart rhythm problems).
Temsirolimus (for cancer).
Sirolimus, everolimus (to prevent transplant rejection).
Vildagliptin (for treatment of type 2 diabetes).
Racecadotril (used to treat diarrhoea).
Your doctor may consider it necessary to adjust the dose and/or take other precautions if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections "Do not take ECLIPSE" and "Warnings and precautions").

Inform your doctor if you are taking any of the following medicines. The action of these medicines may be affected by ECLIPSE:
Medicines for diabetes, such as oral hypoglycaemics and insulin. ECLIPSE may lower blood sugar levels. Monitor your blood sugar levels carefully when taking ECLIPSE.
Lithium (for psychiatric conditions). ECLIPSE may increase lithium levels in the blood. Your doctor must closely monitor your blood lithium levels.

If any of the above conditions apply (or if you are unsure), consult your doctor before taking ECLIPSE.

ECLIPSE with food, drinks, and alcohol
Drinking alcohol together with ECLIPSE may cause dizziness or lightheadedness. If you want to know how much alcohol you can drink while taking ECLIPSE, discuss this with your doctor, as blood pressure-lowering medicines and alcohol may have additive effects.
ECLIPSE may be taken with or without food.

Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you think you are pregnant (or could become pregnant).
You must not take ECLIPSE during the first 12 weeks of pregnancy and must not take it at all after week 13, as its use during pregnancy may harm the unborn child.
If you become pregnant while taking ECLIPSE, inform your doctor immediately. Before planning a pregnancy, you should switch to another medicine more suitable for use during pregnancy.

Breastfeeding
You must not take ECLIPSE if you are breastfeeding.

Ask your doctor or pharmacist before taking any medicine.

Driving and using machines
You may experience dizziness while taking ECLIPSE. This is more likely when you first start taking ECLIPSE or when your dose has just been increased. If this occurs, do not drive or operate tools or machinery.

3. How to take ECLIPSE

Always take this medicine exactly as instructed by your doctor. If you are unsure, you should ask your doctor or pharmacist for advice.
How much to take
Treatment of high blood pressure
The usual starting dose is 1.25 mg or 2.5 mg once daily.
Your doctor will adjust your dose until your blood pressure is under control.
The maximum daily dose is 10 mg.
If you are already taking diuretics, your doctor may stop or reduce them before starting treatment with ECLIPSE.
To reduce the risk of heart attack or stroke
The usual starting dose is 2.5 mg once daily.
Your doctor may decide to increase your dose.
The usual dose is 10 mg once daily.
Treatment to reduce or delay worsening of kidney problems
You may be started on a dose of 1.25 mg or 2.5 mg once daily.
Your doctor will adjust your dose accordingly.
The usual dose is 5 mg or 10 mg once daily.
Treatment of heart failure
The usual starting dose is 1.25 mg once daily.
Your doctor will adjust your dose.
The maximum dose is 10 mg per day. It is preferable to divide the dose into two daily administrations.
Treatment after a heart attack
The usual starting dose ranges from 1.25 mg once daily to 2.5 mg twice daily.
Your doctor will adjust your dose accordingly.
The usual dose is 10 mg per day. It is preferable to divide the dose into two daily administrations.
Elderly population
Your doctor will reduce the starting dose and adjust treatment more slowly.
How to take this medicine
Take the medicine orally at the same time each day.
Swallow the tablets with liquid.
Do not break or chew the tablets.
If you take more ECLIPSE than you should
Contact your doctor or go to the nearest hospital emergency department. Do not drive yourself—have someone take you or call an ambulance. Take the medicine pack with you. This is important so the doctor knows what you have taken.
If you forget to take ECLIPSE
If you miss a dose, take your usual dose at the next scheduled time.
Do not take a double dose to make up for the missed tablet.
If you have any doubts 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.

Stop taking ECLIPSE and contact your doctor immediately if you experience any serious side effect – you may need urgent medical treatment:

Swelling of the face, lips or throat causing difficulty swallowing or breathing, as well as itching or skin rash. These could be signs of a serious allergic reaction to ECLIPSE.

Severe skin reactions including rash, mouth ulcers, worsening of a pre-existing skin condition, redness, blistering and peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme).

Contact your doctor immediately if you experience:

Rapid heartbeat, irregular or forceful heartbeat (palpitations), chest pain, feeling of tightness in the chest, or more serious problems including heart attack and stroke.

Shortness of breath or cough. These may be signs of lung problems.

Easier bruising, prolonged bleeding more than usual, any sign of bleeding (e.g. bleeding gums), purple spots on the skin, or increased susceptibility to infections, sore throat and fever, feeling tired, weakness, dizziness or pale appearance. These may be signs of circulatory or bone marrow problems.

Severe stomach pain that may extend to the back. This could be a sign of pancreatitis (inflammation of the pancreas).

Fever, chills, fatigue, loss of appetite, stomach pain, feeling unwell, yellowing of the skin or eyes (jaundice). These may be signs of liver problems such as hepatitis (inflammation of the liver) or liver damage.

Other side effects include:

Inform your doctor if any of the following conditions become severe or persist for more than a few days:

Common (may affect up to 1 in 10 people)

Headache or feeling tired.

Dizziness. This is more likely when treatment with ECLIPSE has just started or when the dose has just been increased.

Weakness, low blood pressure (hypotension), especially when standing up or getting up quickly.

Dry, irritating cough, inflammation of the sinuses (sinusitis) or bronchitis, shortness of breath.

Stomach or intestinal pain, diarrhoea, indigestion, feeling unwell or malaise.

Skin rash, with or without swelling.

Chest pain.

Muscle cramps or muscle pain.

Blood tests show higher than normal potassium levels.

Uncommon (may affect up to 1 in 100 people)

Balance problems (dizziness).

Itching and unusual skin sensations such as numbness, tingling, burning, prickling or crawling sensations (paresthesia).

Loss or change in taste.

Sleep problems.

Depressed mood, anxiety, increased nervousness or irritability.

Stuffy nose, difficulty breathing or worsening of asthma.

Swelling in the intestine called "intestinal angioedema", presenting with symptoms such as abdominal pain, vomiting and diarrhoea.

Heartburn, constipation or dry mouth.

Increased amount of urine during the day.

Increased sweating.

Loss or decrease in appetite (anorexia).

Fast or irregular heartbeat.

Swollen arms and legs. This may be a sign that your body is retaining more fluid than usual.

Hot flushes.

Blurred vision.

Joint pain.

Fever.

Impotence in men, reduced sex drive in men and women.

Increase in the number of white blood cells (eosinophilia) detected in blood tests.

Changes in liver, pancreas or kidney function as shown by blood tests.

Rare (may affect up to 1 in 1,000 people)

Feeling faint or confused.

Swollen and red tongue.

Severe peeling or shedding of the skin, itching, skin rash with pustules.

Nail problems (such as loss or separation of the nail from its bed).

Skin rash or bruising.

Spots on the skin and cold extremities.

Red, swollen, watery or itchy eyes.

Hearing disturbances and ringing in the ears (tinnitus).

Feeling weak.

Decrease in the number of red blood cells, white blood cells and platelets, or in haemoglobin concentration, as shown by blood tests.

Very rare (may affect up to 1 in 10,000 people)

Increased sensitivity to sunlight.

Other side effects reported:

Inform your doctor if any of the following conditions become severe or persist for more than a few days.

Difficulty concentrating.

Mouth swelling.

Blood tests showing too low a number of blood cells.

Blood tests showing low sodium levels in the blood.

Concentrated urine (dark in colour), feeling unwell or malaise, muscle cramps, confusion or seizures, which may be due to inappropriate ADH (antidiuretic hormone) secretion. If you experience these symptoms, contact your doctor promptly.

Fingers of hands and feet changing colour when cold, and tingling or pain when warmed (Raynaud's phenomenon).

Breast enlargement in men.

Slowed or altered reactions.

Burning sensation.

Changes in the perception of smells.

Hair loss.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa

Reporting side effects can help provide more information on the safety of this medicine.

5. How to store ECLIPSE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of that month.
Store below 25°C.
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 ECLIPSE contains
The active substance is ramipril.
ECLIPSE 2.5 mg tablets
One divisible tablet contains:
Active substance: ramipril 2.5 mg.
Excipients: hypromellose, pregelatinized maize starch, microcrystalline cellulose, sodium stearyl fumarate,
yellow iron oxide E172.
ECLIPSE 5 mg tablets
One divisible tablet contains:
Active substance: ramipril 5 mg.
Excipients: hypromellose, pregelatinized maize starch, microcrystalline cellulose, sodium stearyl fumarate,
red iron oxide E172.
ECLIPSE 10 mg tablets
One divisible tablet contains:
Active substance: ramipril 10 mg.
Excipients: hypromellose, pregelatinized maize starch, microcrystalline cellulose, sodium stearyl fumarate.

Description of the appearance of ECLIPSE and contents of the pack
ECLIPSE 2.5 mg tablets
Divisible tablets. Box containing 28 tablets.
ECLIPSE 5 mg tablets
Divisible tablets. Box containing 14 tablets.
ECLIPSE 10 mg tablets
Divisible tablets. Box containing 28 tablets.
The tablets can be divided into two equal halves.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
S.F. Group S.r.l.,
Via Tiburtina 1143
00156 - Rome, Italy

Manufacturer
DOPPEL FARMACEUTICI SRL, Via Volturno, 48 Quinto de Stampi - 20089 Rozzano (MI)