Norapril

PATIENT INFORMATION LEAFLET

NORAPRIL 2.5 mg, 5 mg and 10 mg Tablets

(Ramipril)
Please read all of 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 other people, even if their symptoms are the same as yours, as it may be harmful to them.
• If you experience any side effect, including 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 taking 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 NORAPRIL is and what it is used for

NORAPRIL contains a medicine called ramipril which belongs to a group of medicines known as ACE
inhibitors (Angiotensin Converting Enzyme inhibitors).
NORAPRIL 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 pump blood around the body more easily

NORAPRIL can 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 should know before taking NORAPRIL

Do not take NORAPRIL:

• If you are allergic to ramipril, to other ACE inhibitors, or to any of the other ingredients of NORAPRIL (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 previously had a severe 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 undergoing dialysis or any other type of blood filtration. Depending on the equipment 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 must assess this.
• If you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.
• 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, as this increases the risk of angioedema (rapid swelling under the skin, for example in the throat).

Do not take NORAPRIL if any of the above conditions apply to you. If you are unsure, consult 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 significant amounts of body salts or fluids (due to illness such as vomiting, diarrhea, excessive sweating, or due to a low-salt diet, or from long-term use of oral diuretics, or after dialysis).
• If you are about to undergo treatment to reduce allergy to bee or wasp stings (desensitization).
• If you are about to receive an anesthetic. This may be given during surgery or dental procedures. You may need to stop taking NORAPRIL 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, particularly to monitor blood sodium levels, especially if you are elderly.
• If you have a vascular collagen disorder such as scleroderma or systemic lupus erythematosus.
• You must inform your doctor if you think you may be pregnant (or could become pregnant). NORAPRIL is not recommended during the first trimester of pregnancy and may cause serious harm to the unborn baby after the first three months of pregnancy (see section “Pregnancy and breastfeeding”).
• If you are taking any of the following medicines for high blood pressure:
  • an “angiotensin II receptor antagonist” (AIIRA), also known as sartans (e.g., valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
  • aliskiren.
• If you are taking medicines that may increase the risk of angioedema, a severe 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 blood potassium levels (such as trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood and prevent clots).
• Your doctor may monitor 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 NORAPRIL”.

Children and adolescents
The use of NORAPRIL is not recommended in children and adolescents under 18 years of age, as there is no available information for this population.

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

Other medicines and NORAPRIL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription (including herbal medicines). This is because NORAPRIL may affect how some other medicines work. Also, some medicines may affect how NORAPRIL works.

Inform your doctor if you are taking any of the following medicines. These may reduce the effectiveness of NORAPRIL:

• 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 with NORAPRIL may increase the risk of side effects:

• Sacubitril/valsartan – used to treat a type of long-term (chronic) heart failure in adults (see also section “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 treatments (chemotherapy).
• Medicines to prevent organ transplant rejection, such as cyclosporine.
• Diuretics such as furosemide.
• Medicines that may increase blood potassium levels, 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 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 (used to treat type 2 diabetes).
• Racecadotril (used to treat diarrhea).

Your doctor may consider it necessary to adjust your dose and/or take other precautions:

• If you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections “Do not take NORAPRIL” 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 NORAPRIL:

• Medicines for diabetes such as oral hypoglycemics and insulin. NORAPRIL may lower blood sugar levels. Monitor your blood sugar levels carefully when taking NORAPRIL.
• Lithium (for psychiatric conditions). NORAPRIL may increase blood lithium levels. Your doctor must monitor your blood lithium levels closely.

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

NORAPRIL with food and alcohol

• Drinking alcoholic beverages while taking NORAPRIL may cause dizziness or lightheadedness. Discuss with your doctor how much alcohol, if any, is safe to drink while taking NORAPRIL, as blood pressure-lowering medicines and alcohol may have additive effects.
• NORAPRIL may be taken with or without food.

Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you think you may be pregnant (or could become pregnant).
You must not take NORAPRIL during the first 12 weeks of pregnancy and must not take it at all after week 13, as it may harm the unborn baby.
If you become pregnant while taking NORAPRIL, 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 NORAPRIL if you are breastfeeding.
Ask your doctor or pharmacist before taking any medicine.

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

This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult your doctor before taking this medicine.

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

3. How to take NORAPRIL

Take NORAPRIL exactly as directed by your doctor. If you have any doubts, consult your doctor or
pharmacist.
Taking this medicine

• Take the medicine orally at the same time each 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 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 NORAPRIL.

To reduce the risk of heart attack or stroke

• The initial dose is 2.5 mg once daily
• Your doctor may decide to increase your dose
• The usual dose is 10 mg once daily 4/8

Treatment to reduce or prevent 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
• 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 initial dose and adjust treatment more slowly.
If you take more NORAPRIL than you should
Inform your doctor or go to the nearest hospital emergency department. Do not drive to the hospital; have someone drive you or call an ambulance. Bring the medicine pack with you.
This is because the doctor needs to know what you have taken.
If you forget to take NORAPRIL

• 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 further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, NORAPRIL can cause side effects, although not everyone experiences them.
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 causing difficulty swallowing or breathing, as well as itching or skin rash. This could be a sign of a serious allergic reaction to NORAPRIL.
• 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
• Easy 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 appearance. These may be signs of blood or bone marrow problems
• Severe stomach pain that may radiate 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 (liver inflammation) or liver damage.

Other side effects include:
Inform your doctor if any of the following conditions become severe or persist for longer than a few days:
Common (may affect up to 1 in 10 people)

• Headache or feeling of tiredness
• Dizziness. This is more likely to occur when treatment with NORAPRIL has just started or the dose has recently been increased
• Weakness, hypotension (unusually low blood pressure), especially when standing up or getting up quickly
• Dry, persistent cough, sinus inflammation (sinusitis), bronchitis, or shortness of breath
• Stomach or intestinal pain, diarrhoea, indigestion, feeling unwell or malaise
• 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 disturbances
• Depressed mood, anxiety, increased nervousness, or irritability
• Stuffy nose, breathing difficulties, or worsening of asthma
• Intestinal swelling 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)
• Rapid 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 sexual desire in men and women
• Increased 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 and shedding of the skin, itching, rash with pustules
• Nail problems (such as nail loss or separation of the nail from its bed) 6/8
• Skin rashes or bruising
• Skin spots and cold extremities
• Red, swollen, watery, or itchy eyes
• Hearing problems and tinnitus (ringing in the ears)
• Feeling weak
• Decreased number of red blood cells, white blood cells, and platelets, or decreased 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 observed:
Inform your doctor if any of the following conditions become severe or persist for longer than a few days.

• Difficulty concentrating
• Mouth swelling
• Blood tests showing too low a number of blood cells
• Concentrated (dark-coloured) urine, feeling unwell or malaise, muscle cramps, confusion, and seizures which may be due to inappropriate ADH (antidiuretic hormone) secretion. If you experience these symptoms, contact your doctor promptly
• Blood tests showing low sodium levels in the blood
• Fingers of the hands and feet changing colour when cold, and tingling or painful upon warming (Raynaud's phenomenon)
• Breast enlargement in men
• Slowed or altered reactions
• Burning sensation
• Change in smell perception
• 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. Side effects can also be reported directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
Reporting side effects helps 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 above 25°C.
Store in the original packaging to protect the medicine from moisture.
Do not use this medicine after the expiry date stated on the carton 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 you no longer use. This will help protect the environment.

Contents of the packaging and other information
What NORAPRIL contains

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

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

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

NORAPRIL is available in the following pack sizes:
2.5 mg and 10 mg: 28 tablets
5 mg: 14 tablets
Marketing Authorization Holder
S.F. GROUP S.R.L. - Via Tiburtina, 1143 - Roma (RM)
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: 06/05/2021
This patient information leaflet does not contain all the information about this medicine. If you have any further questions or are unsure about something, consult your doctor or pharmacist.
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