KRUPIL 2.5 MG Tablets

Зміст інструкції

1. KRUPIL 2.5 mg tablets, 5 mg tablets, 10 mg tablets
   1. What is KRUPIL and what it is used for
   2. What you need to know before taking KRUPIL
   3. How to take KRUPIL
   4. Possible side effects
   5. How to store KRUPIL
   6. Package Contents and Other Information

KRUPIL 2.5 mg tablets, 5 mg tablets, 10 mg tablets

ramipril
Generic medicine

Read this leaflet carefully before you start 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 could 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 KRUPIL is and what it is used for
• 2. What you need to know before you take KRUPIL
• 3. How to take KRUPIL
• 4. Possible side effects
• 5. How to store KRUPIL
• 6. Contents of the pack and other information

1. What is KRUPIL and what it is used for

KRUPIL contains a medicine called ramipril which belongs to the group of medicines
called ACE inhibitors (Angiotensin Converting Enzyme Inhibitors).
KRUPIL 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.

KRUPIL 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 your heart when it cannot pump enough blood to 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 KRUPIL

Do not take KRUPIL:

• 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 rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue
• If you have had a serious allergic reaction called “angioedema”. The signs include itching, rash (hives), red patches on the hands, feet and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing
• If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults.
• If you are having dialysis or are undergoing any other type of blood filtration. Depending on the machine being used, KRUPIL 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 section 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 blood pressure, containing aliskiren.

Do not take KRUPIL if any of the above conditions apply to you. If you are not sure,
ask your doctor before taking KRUPIL.

Warnings and precautions
Talk to your doctor or pharmacist before taking KRUPIL:

• If you have heart, liver or kidney problems
• If you have lost a lot of salts or body fluids (due to an illness such as vomiting, diarrhoea, excessive sweating, or following a low-salt diet, or after taking diuretics for a long time or having undergone dialysis)
• If you are about to undergo treatment to reduce allergy to bee or wasp stings (desensitisation)
• If you are about to have an anaesthetic. This may be given for surgery or dental treatment. You may need to stop taking KRUPIL 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 where the levels of sodium in your blood may decrease. Your doctor may prescribe blood tests at regular intervals, particularly to check the levels of sodium in your blood, especially if you are elderly
• If you are taking medicines that can increase the risk of angioedema, a serious allergic reaction, such as mTOR inhibitors (e.g. temsirolimus, everolimus, sirolimus), vildagliptin, neprilysin inhibitors (NEP) (like racecadotril) or sacubitril/valsartan. See section 2 “Do not take KRUPIL” for sacubitril/valsartan
• If you have a connective tissue disease such as scleroderma or systemic lupus erythematosus
• You must tell your doctor if you think you may be pregnant (or might become pregnant). KRUPIL is not recommended in the first 3 months of pregnancy and can cause serious harm to the

baby after the first 3 months of pregnancy (see section 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 - 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 Krupil"

Children and adolescents
The use of KRUPIL is not recommended in children and adolescents under 18 years of age
because the safety and efficacy of KRUPIL in children have not yet been established.
If any of the above conditions apply to you (or you are not sure), ask your doctor before
taking KRUPIL.

Other medicines and KRUPIL
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines, including those available without a prescription (including
herbal medicines). This is because KRUPIL can affect the way some other medicines work. Also, some medicines can affect the
way KRUPIL works.
Tell your doctor if you are taking any of the following medicines. These medicines can
interfere with KRUPIL 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 KRUPIL, may increase the likelihood of side effects:

• Sacubitril/valsartan - used to treat a type of long-term (chronic) heart failure in adults (see section 2 “Do not take KRUPIL”)
• 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 transplantation such as cyclosporine
• 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 thin the blood)
• 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 your dose and/or take other precautions if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also the sections "Do not take Krupil" 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 KRUPIL:

• Diabetes medicines such as oral hypoglycaemics and insulin. KRUPIL can lower your blood sugar levels. Check your blood sugar levels carefully when taking KRUPIL.
• Lithium (for psychiatric problems). KRUPIL can increase the amount of lithium in your blood. Your doctor needs to check the level of lithium in your blood carefully. If any of the above conditions apply to you (or you are not sure), ask your doctor before taking KRUPIL.

KRUPIL with food and alcohol

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

Pregnancy and breastfeeding
Pregnancy
You must tell your doctor if you think you may be pregnant (or might become pregnant).
You should not take KRUPIL during the first 12 weeks of pregnancy and must not
take it after the 13th week because it can harm your baby. If you become pregnant while taking KRUPIL, tell
your doctor immediately. Before planning a pregnancy, you should switch to another medicine that is more suitable.
Breastfeeding
You should not take KRUPIL if you are breastfeeding. Ask your doctor or pharmacist before
taking any medicine.

Driving and using machines.
You may feel dizzy while taking KRUPIL. This is more likely
when you first start taking KRUPIL or when you have just increased the dose. If this
happens, do not drive or use tools or machines.

KRUPIL contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e.
it is essentially ‘sodium-free’.

3. How to take KRUPIL

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your doctor or pharmacist.

Taking this medicine

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

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 you on KRUPIL. To reduce the risk of a heart attack or stroke
• The 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 prevent 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
Your doctor will reduce the starting dose and adjust the treatment more slowly.

If you take more KRUPIL than you should
Inform your doctor or go to the nearest hospital emergency room. Do not drive to the hospital, have someone accompany 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 KRUPIL

• 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 further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, KRUPIL can cause side effects, although not everybody gets them.

Stop taking KRUPIL and contact your doctor immediately if you notice any of the following
serious side effects – 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 skin rash. This could be a sign of a severe allergic reaction to KRUPIL
• Severe skin reactions including skin 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:

• Fast heartbeat, 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 and cough. These can 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 easy onset of infections, sore throat and fever, feeling tired, weak, dizziness or pale skin. These can be signs of circulatory or bone marrow problems
• Severe stomach pain that can 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, yellowing of the skin or eyes (jaundice). These can 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 you first start taking KRUPIL or have just increased the dose
• Weakness, low blood pressure (unusually low blood pressure), especially when standing up or getting up quickly
• Dry, irritating cough, sinus inflammation (sinusitis) or bronchitis, shortness of breath
• Stomach or intestinal pain, diarrhea, indigestion, feeling unwell or generally unwell
• Skin rash with or without swelling
• Chest pain
• Cramps or muscle pain
• Blood tests show a higher than normal level of potassium

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 (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 flushes
• 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 as 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, skin rash characterized by 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 or watery, itchy eyes
• Hearing problems and ringing in the ears
• Feeling weak
• Decrease in the number of red blood cells, white blood cells and platelets in the blood 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 reported:
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 too low number of cells in the blood
• Blood tests showing a low level of sodium in the blood
• Concentrated urine (dark in color), feeling unwell or sick, muscle cramps, confusion and convulsions which may be due to inappropriate secretion of ADH (antidiuretic hormone). If you experience these symptoms, contact your doctor promptly
• Fingers and toes that change color when cooled and tingle or hurt when warmed (Raynaud's phenomenon)
• Increase in 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, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly through the national reporting
system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side
effects, you can help provide more information on the safety of this
medicine.

5. How to store KRUPIL

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 after Exp.
The expiry date refers to the last day of that month.
Do not store at a temperature above 25 °C
Do not dispose of any medicine in waste water 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 KRUPIL contains
The active ingredient is ramipril

2.5 mg:each tablet contains ramipril 2.5 mg

5 mg:each tablet contains ramipril 5 mg

10 mg:each tablet contains ramipril 10 mg
The other ingredients are:

2.5 mg tablets and 5 mg tablets
Hypromellose, pregelatinized starch, microcrystalline cellulose, sodium stearylfumarate,
yellow iron oxide E172.

10 mg tablets
Hypromellose, pregelatinized starch, microcrystalline cellulose, sodium stearylfumarate.

Description of the appearance of KRUPIL and package contents
2.5 mg tablets
The tablet can be divided into equal parts. KRUPIL 2.5 mg tablets is available in
packages of 28 tablets in PVC/aluminum blisters.

5 mg tablets
The tablet can be divided into equal parts. KRUPIL 5 mg tablets is available in
packages of 14 and 28 tablets in PVC/aluminum blisters.

10 mg tablets
The tablet can be divided into equal parts. KRUPIL 10 mg tablets is available in
packages of 28 tablets in PVC/aluminum blisters.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00071 Pomezia (Roma)

Manufacturer
Special Product’s Line S.p.a.
Via Fratta Rotonda Vado Largo 1
03012 Anagni (FR) – Italy