NAPRILENE 20 mg Таблетки

Содержание инструкции

1. Naprilene 5 mg tablets, 20 mg tablets
   1. What is Naprilene and what is it used for
   2. What you need to know before taking Naprilene
   3. How to take Naprilene
   4. Possible side effects
   5. How to store Naprilene
   6. Contents of the pack and other information

Naprilene 5 mg tablets, 20 mg tablets

enalapril maleate

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

1. What is Naprilene and what is it used for

Naprilene contains the active substance enalapril.
Enalapril belongs to the group of medicines called angiotensin converting enzyme inhibitors
(ACE inhibitors), and it works by dilating blood vessels to make it easier for the heart to perform its function of
pumping blood throughout the body.
Naprilene is indicated for:

• the treatment of high blood pressure (hypertension)
• the treatment of symptomatic heart failure
• the prevention of symptomatic heart failure in patients with problems with the left ventricle of the heart without symptoms (asymptomatic left ventricular dysfunction with an ejection fraction less than or equal to 35%)

2. What you need to know before taking Naprilene

Do not take Naprilene:

• if you are allergic to enalapril, to other angiotensin converting enzyme (ACE) inhibitors or to any of the other components of this medicine (listed in section 6)
• if you have had allergic reactions with swelling of the face, lips, tongue and/or throat, with difficulty swallowing and breathing) after previous treatments with other medicines that inhibit the angiotensin converting enzyme (ACE-inhibitors)
• if you have hereditary or idiopathic angioedema (i.e. whose cause is not due to external factors)
• if you are pregnant (see section “Pregnancy and breastfeeding”)
• 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 doubts about whether you can start taking this medicine, contact your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Naprilene.
Tell your doctor:

• if you are elderly and have kidney problems, because it may be necessary to adjust the dose of Naprilene
• if you think you are pregnant or are planning a pregnancy because they will prescribe you another medicine instead of Naprilene. Naprilene should not be taken during pregnancy unless your doctor considers it strictly necessary (see section “Pregnancy and breastfeeding”)
• if you have or have had vomiting and/or diarrhoea
• if you are being treated with diuretics (medicines that increase the amount of water and salts eliminated through the kidneys)
• if you are being treated with a particular type of diuretics called potassium-sparing diuretics, if you are using potassium supplements, medicines that increase potassium levels in the blood (e.g. heparin) or salt substitutes containing potassium (see section “Other medicines and Naprilene”)
• if you are following a low-sodium diet
• if you have or have had liver problems (see section 2 “Do not take Naprilene”)
• if you have kidney failure or if you are undergoing hemodialysis (see section 2 “Do not take Naprilene”)
• if you have a narrowing or blockage of the blood vessels that carry blood to the kidneys (bilateral renal artery stenosis or stenosis of the artery of the only functioning kidney)
• if you have kidney problems due to diabetes (diabetic nephropathy)
• if you have recently had a kidney transplant
• if you have a collagen disease that affects blood vessels (e.g. lupus erythematosus, rheumatoid arthritis), if you are being treated with medicines that suppress the immune response, if you are taking allopurinol or procainamide, or any combination of these conditions
• if you have had allergic reactions that can manifest, for example, with swelling of the face, lips, mouth or throat (angioedema). Tell your doctor in particular if you have had this type of reaction in the past when you have undergone surgery on the airways.
• if you have blood disorders
• if you have heart or brain problems, in particular: or heart failure or a condition caused by reduced blood flow in the blood vessels of the heart (ischemic cardiomyopathy) or a condition caused by reduced blood circulation in the brain (cerebrovascular disease) or a narrowing of the heart valves (aortic stenosis), or a condition that causes thickening of the heart muscle (hypertrophic cardiomyopathy)
• if you have diabetes and are taking oral medications for diabetes or insulin
• if you are taking one of the following medicines used to treat high blood pressure: or an “angiotensin II receptor antagonist” (AIIRA) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes or aliskiren. The 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 reported in the heading “Do not take Naprilene”:
• if you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin in areas such as the throat) is greater:

o sirolimus, everolimus and other drugs belonging to the class of mTOR inhibitors (used to
prevent rejection of transplanted organs)

• if you are going to undergo a desensitization process to reduce the effects of an allergy to bee or wasp stings
• if you are going to undergo a therapy called LDL apheresis
• if you are going to undergo surgery or anesthesia (even from the dentist). The doctor and/or anesthesiologist must be informed that you are being treated with Naprilene.

Tell your doctor during treatment with Naprilene:

• if you experience signs and symptoms due to excessive lowering of blood pressure, for example, you feel dizzy or lightheaded, especially when taking the first dose of Naprilene and when increasing the dose. These episodes can occur in particular when you get up
• if you have diabetes and notice episodes of hypoglycemia
• if you develop allergic reactions that can manifest, for example, with swelling of the face, lips, mouth or throat. Patients of black race have a higher risk of developing these reactions
• if you have a dry, unproductive and persistent cough because it may be due to one of the active ingredients contained in Naprilene
• if you have any signs of infection.

If you are a patient of black race, it is important that you know that medicines like Naprilene can
be less effective in lowering blood pressure.

Children and adolescents
Naprilene should not be given to children and adolescents for indications other than
the treatment of high blood pressure.
Naprilene should not be given to infants and children with impaired kidney function.

Other medicines and Naprilene
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Tell your doctor if you are taking or are going to take the following medicines:

• other medicines to lower blood pressure because they can further reduce blood pressure
• allopurinol (a medicine for gout)
• procainamide (a medicine for heart rhythm disturbances)
• diuretics (medicines that increase the amount of water and salts eliminated through the kidneys)
• medicines for depression (antidepressants)
• medicines used in severe mental disorders (antipsychotics)
• medicines used for anesthesia
• medicines for diabetes e.g. insulin and other oral medicines
• medicines that retain potassium or that can increase potassium levels: o potassium supplements or salt substitutes containing potassium o blood pressure medicines called potassium-sparing diuretics e.g. amiloride, triamterene, spironolactone o heparin o cotrimoxazole also known as trimethoprim/sulfamethoxazole
• lithium (medicine for mood disorders)
• non-steroidal anti-inflammatory drugs e.g. acetylsalicylic acid
• medicines usually used to prevent rejection of transplanted organs (sirolimus, everolimus and other drugs belonging to the class of mTOR inhibitors). See section “Warnings and precautions”.

The doctor may need to adjust the dose and / or take other precautions:

• if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also what is reported in the heading “Do not take Naprilene” and “Warnings and precautions”).

Diagnostic tests
Tell your doctor during treatment with Naprilene:

• if you are going to undergo a desensitization process to reduce the effects of an allergy to bee or wasp stings.
• if you are going to undergo a therapy called LDL apheresis.

Naprilene with food, drinks and alcohol
Do not drink alcohol while taking the tablets because a sharp drop in
blood pressure may occur.
Food does not interfere with the absorption of Naprilene. The tablets can be taken
before, during and after meals. Most people take Naprilene with a glass
of water.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Naprilene should not be taken during pregnancy unless your doctor considers it strictly
necessary.
Tell your doctor if you think you are pregnant or are planning a pregnancy because they will prescribe you
another medicine instead of Naprilene.
Breastfeeding
Tell your doctor if you are breastfeeding or are about to start breastfeeding. Naprilene should
not be used during breastfeeding unless your doctor considers it strictly necessary.
If you wish to breastfeed, your doctor may prescribe you another treatment instead of Naprilene.

Driving and using machines
Naprilene can occasionally cause dizziness and fatigue, be particularly careful if you
are driving vehicles or using machines.

Naprilene contains lactose (a sugar from milk)
If you have been diagnosed with an intolerance to certain sugars, contact your doctor before taking this
medicine.
Naprilene contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially “sodium-free”.

3. How to take Naprilene

Take this medicine following the instructions of your doctor or pharmacist exactly. If you
have any doubts, consult your doctor or pharmacist.
The doctor will establish the appropriate dose of Naprilene, based on your condition and any other medicines you
are taking.
It is very important that you continue to take Naprilene for the entire time that your doctor has told you. Do not
take more tablets than those prescribed by your doctor.
The tablets can be taken before, during and after meals. Most people
take this medicine with a glass of water.

Use in adults
Treatment of hypertension

• The recommended initial dose is 5 to 20 mg per day, in a single administration.
• The recommended dose in cases of mild high blood pressure is 5 to 10 mg.
• The recommended maintenance dose is 20 mg per day, in a single administration.
• The maximum maintenance dose is 40 mg per day.

If you are being treated with a diuretic, your doctor will tell you to stop it 2-3 days before starting treatment with Naprilene or will assess whether to start therapy with Naprilene with lower doses.

Treatment and prevention of symptomatic heart failure in patients with problems
to the left ventricle of the heart without symptoms (asymptomatic left ventricular dysfunction)

• The recommended initial dose is 2.5 per day, in a single administration. The doctor will gradually increase the dose until reaching the dose suitable for you.
• The recommended maintenance dose is 20 mg per day, in one or two administrations.
• The maximum dose is 40 mg per day in two separate administrations. Tell your doctor if you feel dizzy or lightheaded when you take the first dose of Naprilene and when you increase the dose.

Use in children and adolescents
The doctor will establish the appropriate dose of Naprilene, based on the child's condition and any other
medicines they are taking.

Children and adolescents with a body weight between 20 and 50 kg

• The recommended initial dose is 2.5 mg per day, in a single administration. The doctor may gradually increase the dose according to the child's needs.
• The maximum dose is 20 mg per day.

Children and adolescents with a body weight equal to or greater than 50 kg

• The recommended initial dose is 5 mg per day, in a single administration. The doctor may gradually increase the dose according to the child's needs.
• The maximum dose is 40 mg per day.

Newborns
Naprilene should not be used in newborns.

Use in patients with kidney problems
Naprilene should not be used in children and adolescents with kidney problems.
The interval between administrations and doses of Naprilene must be reduced in patients with kidney
problems.

If you take more Naprilene than you should
In case of accidental ingestion of an excessive dose of Naprilene, immediately inform your doctor
or go to the nearest hospital.
Ingestion of an excessive dose may cause dizziness or lightheadedness due to a
sudden or excessive decrease in blood pressure, excessive thirst, cough, confusion,
shortness of breath, anxiety, decreased amount of urine, changes in heart rate.

If you forget to take Naprilene
Take this medicine following your doctor's prescription. However, if you forget your daily
dose, skip the missed tablet and take the next tablet at the scheduled time the next
day.
Do not take a double dose to make up for the missed tablet.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

If you stop taking Naprilene
Do not stop treatment with this medicine unless your doctor tells you to.
If you have any doubts about the use of 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.
manifest.

Stop treatment with Naprilene and contact your doctor immediately if you develop:

• swelling of the face, lips, tongue and/or throat which may cause difficulty breathing or swallowing
• swelling of the hands, feet or ankles
• urticaria (hives)

Very common side effects (may affect more than 1 in 10 people)

• Blurred vision
• Dizziness
• Cough
• Nausea
• Muscle weakness

Common side effects (may affect up to 1 in 10 people)

• Diarrhoea, abdominal pain
• Taste alteration
• Headache
• Fatigue
• Depression
• Fainting
• Increased potassium levels in the blood
• Decreased blood pressure
• Heart attack or stroke (TIA, "mini-stroke")
• Heart rhythm disorders
• Chest pain (angina pectoris)
• Chest pain
• Difficulty breathing
• Skin rashes, allergic reactions
• Swelling of the face, tongue, lips and extremities
• Increased creatinine levels in the blood

Uncommon side effects (may affect up to 1 in 100 people)

• Anaemia
• Hot flushes
• Muscle cramps
• Tinnitus (ringing in the ears)
• Decreased blood sugar levels (hypoglycaemia)
• Nervousness, confusion, insomnia, drowsiness
• Pins and needles sensation or similar sensation
• Vertigo
• Decreased blood pressure when standing up (orthostatic hypotension)
• Palpitations
• Sore throat, altered voice (hoarseness), runny nose, bronchospasm/asthma
• Alteration of intestinal motility (ileus)

irritation of the stomach, dry mouth, lesions of the stomach (peptic ulcer), urticaria, itching,
sweating

• Hair loss
• Impairment of kidney function, including kidney failure, accumulation in the blood of substances that should be eliminated through the kidneys (uremia), presence of protein in the urine
• Decreased sodium levels in the blood
• Impotence
• General feeling of being unwell (malaise), fever

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

• Decreased white blood cells
• Decreased number of platelets in the blood
• Decreased number of all blood cells (pancytopenia)
• Bone marrow depression, i.e. a decrease in the number of blood cells caused by a malfunction of the system that produces blood cells
• Enlarged lymph nodes
• Autoimmune diseases
• Decreased levels of cells in the blood (haematocrit) and haemoglobin levels
• Abnormal dreams, sleep disorders
• Poor blood circulation in the extremities (Raynaud's phenomenon)
• Lung problems, including pneumonia, allergic alveolitis, cold
• Inflammation of the oral mucosa, ulcers and sores in the mouth, inflammation of the tongue
• Liver problems including liver failure, inflammation of the liver (hepatitis), yellowing of the skin, mucous membranes and eyes (jaundice), inflammation of the gallbladder and death of liver cells which may be potentially fatal
• Increased levels of liver enzymes (sign of liver damage)
• Increased levels of bilirubin
• Severe allergic reactions with high fever, appearance of red spots on the skin (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis), rash with peeling (erythroderma), appearance of small blisters filled with fluid on the skin (pemphigus)
• Decreased urine output
• Enlargement of the breasts in males

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

• Swelling from accumulation of fluids in the intestine

Side effects with unknown frequency (frequency cannot be estimated on the basis of
available data)

• A set of symptoms including: o fever o inflammation of a particular type of membrane lining some organs (serositis) o inflammation of blood vessels o pain in muscles, joints and bones o elevated ESR (visible in blood tests) o increased number of particular types of white blood cells in the blood (eosinophilia, leucocytosis) o reactions at the skin level including reactions of the skin to sunlight
• A hormonal disorder consisting of inappropriate secretion of the antidiuretic hormone (SIADH) has also been reported.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any 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 Naprilene

Keep this medicine out of sight and reach of children.
This medicine does not require any particular storage conditions.
Do not use this medicine after the expiry date that is reported on the packaging after “Scad.”. The
expiry date refers to the last day of that month.
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 Naprilene contains
Naprilene 5 mg tablets

• The active ingredient is enalapril maleate. Each tablet contains 5 mg of enalapril maleate.
• The other ingredients are sodium bicarbonate, lactose monohydrate, corn starch, pregelatinized starch, magnesium stearate.

Naprilene 20 mg tablets

• The active ingredient is enalapril maleate. Each tablet contains 20 mg of enalapril maleate.
• The other ingredients are sodium bicarbonate, lactose monohydrate, corn starch, pregelatinized starch, red iron oxide, yellow iron oxide, magnesium stearate.

Description of the appearance of Naprilene and contents of the pack
Naprilene 5 mg tablets
Each pack contains a blister of 28 tablets of 5 mg.
Naprilene 20 mg tablets
Each pack contains a blister of 14 or 28 tablets of 20 mg.

Marketing Authorisation Holder and manufacturer
Marketing Authorisation Holder
Alfasigma S.p.A. - Via Ragazzi del ’99, n. 5 - 40133 Bologna (BO)

Manufacturer
Alfasigma S.p.A. - Via Pontina km 30,400 - 00071 Pomezia (RM)

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