ECLIPSE 2.5 мг Таблетка

Содержание инструкции

1. ECLIPSE 2.5 mg tablets, 5 mg tablets, 10 mg tablets
   1. What is ECLIPSE 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

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

Ramipril
Generic medicine

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 or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms
are the same as yours, as it may be harmful.
If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is ECLIPSE and what it is used for

ECLIPSE contains a medicine called ramipril which belongs to the group of medicines called ACE
inhibitors (Angiotensin Converting Enzyme Inhibitors).
ECLIPSE works by:
Decreasing the production, by the body, of substances that can cause an increase in
blood pressure
Relaxing and widening its blood vessels
Making it easier for its heart to pump blood around the body.
ECLIPSE can be used:
To treat high blood pressure (hypertension)
To reduce the risk of a heart attack or stroke
To reduce the risk or delay the worsening of kidney problems (whether or not diabetes is present)
To treat its heart when it cannot pump enough blood around the rest of the
body (heart failure)
As treatment after a heart attack (myocardial infarction) if 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 can include skin rashes, 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 (hives), red patches on the hands, feet and throat, swelling of the throat and the
tongue, swelling around the eyes and lips, difficulty in breathing and swallowing.
If you are on dialysis or having any other type of blood filtration.
Depending on the machinery being 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 make this assessment.
If you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that
lowers your blood pressure, containing aliskiren.
Do not take ECLIPSE if any of the above conditions apply to you. If you are not sure, ask 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 a lot of salts or fluids from your body (due to an illness such as vomiting, diarrhoea,
excessive sweating, or following a low-salt diet, or after taking diuretics for a
long period of time or having undergone dialysis).
If you are about to undergo treatment to reduce your allergy to bee or wasp stings
(desensitisation).
If you are about to receive an anaesthetic. This may be given for surgery or dental treatment. It may be
necessary to stop taking ECLIPSE the day before; ask your doctor for advice.
If you have a high amount of potassium in your blood (shown by a blood test).
If you are taking medicines or are in conditions that may cause the levels of sodium in your blood to
decrease. Your doctor may prescribe blood tests at regular intervals, especially to check
the levels of sodium in your blood, particularly if you are elderly.
If you are taking medicines called mTOR inhibitors (e.g. temsirolimus, everolimus, sirolimus)
or vildagliptin or racecadotril, as they may increase the risk of angioedema, a serious
allergic reaction.
If you have a collagen vascular disease such as scleroderma or systemic lupus erythematosus.
You must tell your doctor if you think you might be pregnant (or might become pregnant). ECLIPSE is not
recommended in the first 3 months of pregnancy and can cause serious harm to the baby 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 blocker" (AIIRA) (also known as sartans - for example
valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
Aliskiren.
Your doctor may check your kidney function, blood pressure, and the amount 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 because the
safety and efficacy of ECLIPSE in children have not been established.
If any of the above conditions apply to you (or you are not sure), ask 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 can affect the way some other medicines work.
Also some medicines can affect the way ECLIPSE works.
Tell your doctor if you are taking any of the following medicines. These medicines can interfere with
ECLIPSE by altering its action:
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 check your
blood pressure.
Tell your doctor if you are taking any of the following medicines. These medicines, if taken with ECLIPSE,
can 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).
Cancer medicines (chemotherapy).
Medicines to prevent organ rejection after a transplant such as ciclosporin.
Diuretics such as furosemide.
Medicines that can increase the amount of potassium in your 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 for treating 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 type 2 diabetes).
Racecadotril (used to treat diarrhoea). Your doctor may need to adjust the dose and/or take other precautions if you are taking an angiotensin II receptor
blocker (AIIRA) or aliskiren (see also the sections "Do not take ECLIPSE" and "Warnings and
precautions”).
Tell your doctor if you are taking any of the following medicines. The mechanism of action of these medicines
may be affected by ECLIPSE:
Medicines for diabetes such as oral hypoglycaemics and insulin. ECLIPSE can lower the amount of
sugar in your blood. Check your blood sugar levels carefully when taking ECLIPSE.
Lithium (for psychiatric problems). ECLIPSE can increase the amount of lithium in your blood. The level of lithium
in your blood must be carefully monitored by your doctor.
If any of the above conditions apply to you (or you are not sure), ask your doctor before taking
ECLIPSE.

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

Pregnancy and breastfeeding
Pregnancy
You must tell your doctor if you think you might be pregnant (or might become pregnant).
You must not take ECLIPSE in the first 12 weeks of pregnancy and must not take it at all after the 13th week because its use during pregnancy can harm the baby.
If you become pregnant while taking ECLIPSE, tell your doctor immediately. Before planning
a pregnancy, you must switch to another medicine that is more suitable.
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 feel dizzy while taking ECLIPSE. This is more likely when you first
start taking ECLIPSE or have just increased the dose. If this happens, do not drive or use
tools or machines.

3. How to take ECLIPSE

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are not sure.

How much to take

Treatment of high blood pressure
The usual starting dose is 1.25 mg or 2.5 mg once a day.
Your doctor will adjust the amount you take until your blood pressure is under control.
The maximum daily dose is 10 mg.
If you are already taking diuretics, your doctor may stop them or reduce the amount before
starting treatment with ECLIPSE.

To reduce the risk of a heart attack or stroke
The usual starting dose is 2.5 mg once a day.
Your doctor may decide to increase the dosage you take.
The usual dose is 10 mg once a day.

Treatment to reduce or delay the worsening of kidney problems
You may be given to start a dose of 1.25 mg or 2.5 mg once a day.
Your doctor will adjust the amount you are taking.
The usual dose is 5 mg or 10 mg once a day.

Treatment of heart failure
The usual starting dose is 1.25 mg once a day.
Your doctor will adjust the amount you take.
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 is from 1.25 mg once a day to 2.5 mg twice a day.
Your doctor will adjust the amount you take.
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 the treatment more slowly.

Taking this medicine
Take the medicine by mouth at the same time of day, every day.
Swallow the tablets with some liquid.
Do not break or chew the tablets.

If you take more ECLIPSE than you should
Inform your doctor or go to the emergency room of the nearest hospital. Do not drive to the hospital, get
someone to take you or call an ambulance. Bring the medicine package with you. This
is because the doctor needs to know what you have taken.

If you forget to take ECLIPSE
If you forget a dose, take your usual dose when it is time.
Do not take a double dose to make up for the missed tablet.
If you have any questions about 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.
manifest them.

Stop taking ECLIPSE and contact your doctor immediately if you notice the onset of any
serious side effect - you may need urgent medical treatment:
Swelling of the face, lips or throat making it difficult to swallow or breathe, as well as
itching or rash. This could be a sign of a severe allergic reaction to ECLIPSE.
Severe skin reactions including rash, mouth sores, 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).

Tell your doctor immediately if you experience:
Increased heart rate, irregular or strengthened 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, weak, dizzy or pale.
These may be signs of circulatory or bone marrow problems.
Severe stomach pain that may extend to the back. This may be a sign of pancreatitis
(inflammation of the pancreas).
Fever, chills, fatigue, loss of appetite, stomach pain, feeling unwell,
jaundice 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:
Tell your doctor if any of the following conditions becomes severe or persists for more than
a few days:

Common(may affect up to 1 in 10 people)
Headache or feeling tired.
Feeling dizzy. This is more likely to happen when therapy with ECLIPSE is just
started or the dose has just been increased.
Weakness, hypotension (unusually low blood pressure), especially when standing up or getting up quickly.
Dry, tickly cough, sinus inflammation (sinusitis) or bronchitis, shortness of breath.
Stomach or intestinal pain, diarrhea, indigestion, feeling unwell or malaise
Rash with or without swelling.
Chest pain.
Cramps or muscle pain.
Blood tests show a higher than normal potassium level.

Uncommon(may affect up to 1 in 100 people)
Balance problems (dizziness).
Itching and unusual skin sensations such as numbness, tingling, burning, prickling
or rubbing (paresthesia).
Loss or change of taste.
Sleep problems.
Depressed mood, anxiety, increased nervousness than usual or irritability.
Blocked nose, difficulty breathing or worsening of asthma.
Swelling of the intestine called "intestinal angioedema" and which presents with symptoms such as abdominal
pain, vomiting and diarrhea.
Heartburn, constipation or dry mouth.
Increased amount of urine during the day.
Increased sweating than usual.
Loss or decrease of appetite (anorexia).
Fast or irregular heartbeat.
Swollen arms and legs. This may be a sign that your body is retaining more water than usual.
Hot flashes.
Blurred vision.
Joint pain.
Fever.
Impotence in men, reduced sexual desire in men and women.
Increased number of white blood cells (eosinophilia) found during blood tests.
Changes in liver, pancreas or kidney function highlighted by blood tests.

Rare(may affect up to 1 in 1000 people)
Feeling faint or confused.
Swollen and red tongue.
Severe flaking or peeling of the skin, itching, rash characterized by pustules.
Problems with nails (such as loss or separation of the nail from its bed).
Rash or bruising.
Spots on the skin and cold extremities.
Red, swollen, watery or itchy eyes.
Hearing problems and ringing in the ears.
Feeling weak.
Decrease in the number of red blood cells, white blood cells and platelets or hemoglobin concentration, highlighted by blood tests.

Very rare(may affect up to 1 in 10,000 people)
Increased sensitivity to the sun.

Other side effects observed:
Tell your doctor if any of the following conditions becomes severe or persists for more than
a few days.
Difficulty concentrating.
Swelling of the mouth.
Blood tests showing a low number of blood cells.
Blood tests showing a low level of sodium in the blood.
Concentrated urine (dark in color), feeling unwell or malaise, muscle cramps, confusion
or convulsions that may be due to inappropriate secretion of ADH (antidiuretic hormone). If
you experience these symptoms, contact your doctor promptly.
Fingers of the hands and feet that change color when cooled and tingle or hurt
when warmed (Raynaud's phenomenon).
Increased breast volume in men.
Slowed or altered reactions.
Burning sensation.
Change in the perception of smells.
Hair loss.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at the address . www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-
reazione-avversa
By reporting side effects you 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 which is stated on the label. The expiry date refers to the last day of that month.
Store at a temperature not exceeding 25°C
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ECLIPSE contains
The active ingredient is ramipril

ECLIPSE 2.5 mg tablets
One divisible tablet contains:

Active ingredient: ramipril 2.5 mg.

Excipients: hypromellose, pregelatinized corn starch, microcrystalline cellulose, sodium stearylfumarate,
yellow iron oxide E172.

ECLIPSE 5 mg tablets
One divisible tablet contains:

Active ingredient: ramipril 5 mg.

Excipients: hypromellose, pregelatinized corn starch, microcrystalline cellulose, sodium stearylfumarate,
red iron oxide E172.

ECLIPSE 10 mg tablets
One divisible tablet contains:

Active ingredient: ramipril 10 mg.

Excipients: hypromellose, pregelatinized corn starch, microcrystalline cellulose, sodium stearylfumarate.

Description of the appearance of ECLIPSE and contents of the pack

ECLIPSE 2.5 mg tablets.
Divisible tablets. Pack of 28 tablets.

ECLIPSE 5 mg tablets
Divisible tablets. Pack of 14 tablets.

ECLIPSE 10 mg tablets
Divisible tablets. Pack of 28 tablets.
The tablets can be divided into two equal halves

Marketing authorisation holder and manufacturer
Marketing Authorisation Holder
S.F. Group S.r.l.,
Via Tiburtina 1143

• 00156 - Rome

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