NORAPRIL 2.5 mg Coated tablet

Зміст інструкції

1. NORAPRIL Tablets 2.5 mg, 5 mg and 10 mg
   1. What is NORAPRIL and what is it used for
   2. What you need to know before taking NORAPRIL
   3. How to take NORAPRIL
   4. Possible side effects
   5. How to store NORAPRIL

NORAPRIL Tablets 2.5 mg, 5 mg and 10 mg

(Ramipril)

Read this leaflet carefully before 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 pass it on to others, even if they have the same symptoms as you, 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 NORAPRIL is and what it is used for
• 2. What you need to know before you take NORAPRIL
• 3. How to take NORAPRIL
• 4. Possible side effects
• 5. How to store NORAPRIL
• 6. Contents of the pack and other information

1. What is NORAPRIL and what is it used for

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

NORAPRIL 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 NORAPRIL

Do not take NORAPRIL:

• If you are allergic to ramipril, to other ACE inhibitor medicines or to any of the other ingredients of NORAPRIL (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, 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 are in dialysis or undergoing any other type of blood filtration. Depending on the machinery being used, NORAPRIL 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.
• If you have taken or are taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin in areas such as the throat). .Do not take NORAPRIL if any of the above conditions apply to you. If you are unsure, ask your doctor before taking NORAPRIL.

Warnings and precautions
Talk to your doctor or pharmacist before taking NORAPRIL

• 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 going to receive an anaesthetic. This may be given for surgery or dental treatment. You may need to stop taking NORAPRIL 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, particularly to check the levels of sodium in your blood, especially if you are elderly.
• If you have a connective tissue disease such as scleroderma or systemic lupus erythematosus
• You must inform your doctor if you think you might be pregnant (or could become pregnant). NORAPRIL is not recommended during the first trimester of pregnancy and can cause serious harm to the baby after the first three months of pregnancy (see section “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.
• If you are taking medicines that may increase the risk of angioedema, a serious allergic reaction, such as mTOR inhibitors (e.g. temsirolimus, everolimus, sirolimus), vildagliptin, neprilysin inhibitors (NEP) (such as racecadotril) or sacubitril/valsartan. For sacubitril/valsartan see section 2 “Do not take Norapril”.
• Potassium supplements (including salt substitutes), potassium-sparing diuretics and other medicines that may increase the amount of potassium in your blood (such as trimethoprim and co-trimoxazole for treating bacterial infections; cyclosporine, an immunosuppressant medicine used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent blood clots)
• 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 what is stated under "Do not take NORAPRIL” Children and adolescentsThe use of NORAPRIL is not recommended in children and adolescents under the age of 18 because there is no information available for this population.

If any of the above conditions apply to you (or you are unsure), ask your doctor before taking
NORAPRIL.

Other medicines and NORAPRIL
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 NORAPRIL can affect the way some other medicines work. Also some
medicines can affect the way NORAPRIL works.
Tell your doctor if you are taking any of the following medicines. These may make NORAPRIL
less effective:

• 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 NORAPRIL,
can increase the likelihood of side effects:

• Sacubitril/valsartan - used to treat a type of long-term (chronic) heart failure in adults (see also what is stated under "Do not take Norapril”).
• 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 rejection of organs 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 make the blood more fluid)
• Steroid medicines for treating inflammation such as prednisolone
• Allopurinol (used to lower the amount of uric acid in the blood)
• Procainamide (for heart rhythm problems)
• Temsirolimus (for cancer)
• Sirolimus, everolimus (to prevent transplant rejection)
• Vildagliptin (used to treat type 2 diabetes)
• Racecadotril (used to treat diarrhoea)

Your doctor may need to change your dose and/or take other precautions:

• If you are taking an angiotensin II receptor blocker (AIIRA) or aliskiren (see also what is stated under "Do not take NORAPRIL" 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 NORAPRIL:

• Diabetes medicines such as oral hypoglycaemics and insulin. NORAPRIL can lower the amount of sugar in your blood. Carefully check your blood sugar levels when taking NORAPRIL.
• Lithium (for psychiatric problems). NORAPRIL can increase the amount of lithium in your blood. Your doctor must carefully check the level of lithium in your blood. If any of the above conditions apply to you (or you are unsure), ask your doctor before taking NORAPRIL.

NORAPRILwith food and alcohol

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

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

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

This medicine contains lactose, if your doctor has told you that you have an intolerance to some sugars,
contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, that is to say essentially
‘sodium-free’.

3. How to take NORAPRIL

Take NORAPRIL following your doctor’s instructions exactly. If you have any doubts, consult 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 liquid.
• Do not break or chew the tablets.

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 you on NORAPRIL.

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 a starting 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 treatment more slowly.

If you take more NORAPRILthan 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 packaging with you. This
is because the doctor needs to know what you have taken.

If you forget to take NORAPRIL

• If you forget a dose, take your usual dose when it is time.
• Do not take a double dose to make up for a missed tablet.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Stop taking NORAPRIL 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 rash. This could be a sign of a severe allergic reaction to NORAPRIL.
• Severe skin reactions including rash, mouth sores, worsening of a pre-existing skin condition, redness, blistering and peeling skin (such as Stevens-Johnson Syndrome, toxic epidermal necrolysis or erythema multiforme).

Tell your doctor immediately if you experience:

• Fast heartbeat, irregular or strong 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 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 increased susceptibility to infections, sore throat and fever, feeling tired, weak, dizzy or pale skin. These can be signs of problems with blood circulation or bone marrow
• Severe stomach pain that may extend to the back. This can 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 lasts 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 NORAPRIL 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 sick or unwell
• Rash with or without swelling
• Chest pain
• Muscle cramps or pain
• Blood tests show a higher than normal level of potassium

Uncommon(may affect up to 1 in 100 people)

• Problems with balance (dizziness)
• Itching and unusual skin sensations such as numbness, tingling, burning, prickling or creeping sensations (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 can be a sign that your body is retaining more water than usual
• Hot flushes
• Blurred vision
• Joint pain
• Fever
• Impotence in men, reduced sexual drive in men and women
• Increased number of white blood cells (eosinophilia) found during blood tests
• Changes in liver, pancreas or kidney function as shown by blood tests

Rare(may affect up to 1 in 1000 people)

• Feeling faint or confused
• Swollen and red tongue
• Severe flaking and peeling of the skin, itching, rash characterized by pustules
• Problems with nails (such as loss or separation of the nail from its bed)
• Rashes or bruising
• Spots on the skin and cold extremities
• Red, swollen, watery or itchy eyes
• Hearing disturbances and tinnitus (ringing in the ear)
• Feeling weak
• Decrease in the number of red blood cells, white blood cells and platelets or hemoglobin concentration, shown 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 lasts for more than a few
days.

• Difficulty concentrating
• Swelling of the mouth
• Blood tests showing too few blood cells
• 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
• Blood tests showing a low level of sodium in the blood
• Fingers and toes that change color when they get cold and tingle or hurt when they warm up (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. Side effects can also be reported directly through the
national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
Reporting side effects helps to provide more information on the safety of
this medicine.

5. How to store NORAPRIL

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 25°C.
Store in the original package to protect the medicine from moisture.
Do not use this medicine after the expiry date which is stated on the package and on the blister after Exp.. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in the drain or in household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

Package contents and other information
What NORAPRIL contains

• The active ingredient is ramipril.
• The excipients are dibeenate glycerol, anhydrous lactose, sodium starch glycolate, sodium stearyl fumarate.
• Yellow iron oxide E172 (only 2.5 mg tablets)
• Red iron oxide E172 (only 5 mg tablets)

Description of the appearance of NORAPRIL and package contents
Tablets.
NORAPRIL is available in the following dosages: 2.5 mg, 5 mg and 10 mg.

• 2.5 mg tablets are biconvex, pale yellow, capsule-shaped tablets with a dividing line on one side
• 5 mg tablets are biconvex, pale pink, capsule-shaped tablets with a dividing line on one side
• 10 mg tablets are biconvex, white, capsule-shaped tablets with a dividing line on one side

NORAPRIL is available in the following formats:
2.5 mg and 10 mg: 28 tablets
5 mg: 14 tablets
Marketing Authorisation Holder
S.F. GROUP S.R.L. - Via Tiburtina, 1143 - Rome (RM)

Manufacturers responsible for batch release:
Special Product's Line S.p.A. – Via Fratta Rotonda Vado Largo, 1, 03012 Anagni (Frosinone), Italy
Lachifarma Srl – S.S. 16 Adriatica Zona industriale – 73010 Zollino (Lecce)

This leaflet was last updated on
if you are unsure about something, ask your doctor or pharmacist.