Naprilene

Package leaflet: Information for the user

Naprilene 5 mg tablets, 20 mg tablets

enalapril maleate
Please 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 give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact 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 taking 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 Naprilene is and what it is used for

Naprilene contains the active substance enalapril.
Enalapril belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors), and works by dilating blood vessels to make it easier for the heart to pump blood to all parts of 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 left ventricular dysfunction without symptoms (asymptomatic left ventricular dysfunction with ejection fraction less than or equal to 35%)

2. What you should know before taking Naprilene

Do not take Naprilene:

• if you are allergic to enalapril, to other angiotensin-converting enzyme inhibitors (ACE inhibitors), or to any of the other ingredients of this medicine (listed in section 6)
• if you have had allergic reactions with swelling of the face, lips, tongue and/or throat, difficulty swallowing or breathing after previous treatment with other angiotensin-converting enzyme inhibitors (ACE inhibitors)
• if you have hereditary or idiopathic angioedema (i.e. angioedema of unknown cause not due to external factors)
• if you are pregnant (see section “Pregnancy and breastfeeding”)
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren

If you have any doubts about whether you should start taking this medicine, contact your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Naprilene.
Inform your doctor:

• if you are elderly and have kidney problems, as your dose of Naprilene may need to be adjusted
• if you think you may be pregnant or are planning a pregnancy, as your doctor will prescribe a different medicine instead of Naprilene. Naprilene must 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 taking diuretics (medicines that increase the amount of water and salts excreted by the kidneys)
• if you are taking a particular type of diuretic called potassium-sparing diuretics, if you are using potassium supplements, medicines that increase potassium levels in the blood (e.g. heparin), or potassium-containing salt substitutes (see section “Other medicines and Naprilene”)
• if you are on 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 are undergoing haemodialysis (see section 2 “Do not take Naprilene”)
• if you have narrowing or blockage of the blood vessels supplying blood to the kidneys (bilateral renal artery stenosis or stenosis of the artery to the only functioning kidney)
• if you have kidney problems due to diabetes (diabetic nephropathy)
• if you have recently undergone a kidney transplant
• if you have a collagen vascular disease affecting blood vessels (e.g. systemic lupus erythematosus, rheumatoid arthritis), if you are receiving treatment 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 may manifest, for example, as swelling of the face, lips, mouth or throat (angioedema). Inform your doctor especially if you have experienced such reactions in the past during surgery on the respiratory tract
• if you have blood disorders
• if you have heart or brain conditions, in particular: heart failure or a condition caused by reduced blood flow in the heart's blood vessels (ischaemic cardiomyopathy), or a condition caused by reduced blood circulation in the brain (cerebrovascular disease), or narrowing of the heart valves (aortic stenosis), or a condition causing thickening of the heart muscle (hypertrophic cardiomyopathy)
• if you have diabetes and are taking oral antidiabetic medicines or insulin
• 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 or are taking aliskiren. Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also section “Do not take Naprilene”:
• if you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin, e.g. in the throat) is increased:

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

• if you are scheduled to undergo desensitisation treatment to reduce the effects of an allergy to bee or wasp stings
• if you are scheduled to undergo a treatment called LDL apheresis
• if you are scheduled for surgery or anaesthesia (including dental procedures). Your doctor and/or anaesthetist must be informed that you are being treated with Naprilene.

Inform your doctor during treatment with Naprilene:

• if you experience signs and symptoms due to excessive lowering of blood pressure, such as dizziness or lightheadedness, especially when taking the first dose of Naprilene or when the dose is increased. These episodes may occur particularly when standing up
• if you have diabetes and experience episodes of hypoglycaemia
• if you develop allergic reactions that may manifest, for example, as swelling of the face, lips, mouth or throat. Black patients have a higher risk of developing these reactions
• if you develop a dry, persistent cough, as it may be due to one of the active substances in Naprilene
• if you show any signs of infection.

If you are of Black ethnicity, it is important to know that medicines like Naprilene may be less effective in reducing blood pressure.
Children and adolescents
Naprilene must not be administered to children and adolescents for indications other than the treatment of high blood pressure.
Naprilene must not be administered to newborns and children with impaired kidney function.
Other medicines and Naprilene
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Inform your doctor if you are taking or need to take any of the following medicines:

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

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

• if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also section “Do not take Naprilene” and “Warnings and precautions”).

Diagnostic procedures
Inform your doctor during treatment with Naprilene:

• if you are scheduled to undergo desensitisation treatment to reduce the effects of an allergy to bee or wasp stings
• if you are scheduled to undergo a treatment called LDL apheresis

Naprilene with food, drinks and alcohol
Do not drink alcohol while taking the tablets, as this may cause a marked drop in blood pressure.
Food does not interfere with the absorption of Naprilene. The tablets can be taken before, during or after meals. Most people take Naprilene with a glass of water.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Naprilene must not be taken during pregnancy unless your doctor considers it strictly necessary.
Inform your doctor if you think you may be pregnant or are planning a pregnancy, as your doctor will prescribe a different medicine instead of Naprilene.
Breastfeeding
Inform your doctor if you are breastfeeding or are about to start breastfeeding. Naprilene must not be used during breastfeeding unless your doctor considers it strictly necessary.
If you wish to breastfeed, your doctor may prescribe an alternative treatment to Naprilene.
Driving and using machines
Naprilene may occasionally cause dizziness and fatigue. Exercise particular caution if you need to drive or operate machinery.
Naprilene contains lactose (a milk sugar)
If your doctor has diagnosed you 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 exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the appropriate dose of Naprilene based on your condition and other
medicines you are taking.
It is very important that you continue taking Naprilene for as long as your doctor has instructed. Do
not take more tablets than prescribed by your doctor.
The tablets can be taken before, during, or after meals. Most people take this medicine with a glass of
water.
Use in adults
Treatment of hypertension

• The recommended starting dose is 5 to 20 mg once daily.
• The recommended dose for mild high blood pressure is 5 to 10 mg once daily.
• The recommended maintenance dose is 20 mg once daily.
• The maximum maintenance dose is 40 mg once daily.

If you are being treated with a diuretic, your doctor will instruct you to stop taking it 2–3 days before
starting Naprilene, or will consider starting Naprilene therapy at a lower dose.
Treatment and prevention of symptomatic heart failure in patients with left ventricular problems
(asymptomatic left ventricular dysfunction)

• The recommended starting dose is 2.5 mg once daily. Your doctor will gradually increase the dose until the appropriate dose for you is reached.
• The recommended maintenance dose is 20 mg once daily, given in one or two doses.
• The maximum dose is 40 mg daily, given in two divided doses. Inform your doctor if you experience dizziness or lightheadedness when taking the first dose of Naprilene or when your dose is increased.

Use in children and adolescents
Your doctor will determine the appropriate dose of Naprilene based on the child's condition and other
medicines being taken.
Children and adolescents with body weight between 20 and 50 kg

• The recommended starting dose is 2.5 mg once daily. Your doctor may gradually increase the dose according to the child's needs.
• The maximum dose is 20 mg once daily.

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

• The recommended starting dose is 5 mg once daily. Your doctor may gradually increase the dose according to the child's needs.
• The maximum dose is 40 mg once daily.

Neonates
Naprilene must not be used in neonates.
Use in patients with kidney problems
Naprilene must not be used in children and adolescents with kidney problems.
The dosing interval and dose of Naprilene should be reduced in patients with kidney problems.
If you take more Naprilene than you should
If you accidentally take too much Naprilene, contact your doctor immediately or go to the nearest
hospital.
Taking an excessive dose may cause dizziness or lightheadedness due to a sudden or excessive drop in
blood pressure, excessive thirst, cough, confusion, shortness of breath, anxiety, reduced urine output,
and changes in heart rate.
If you forget to take Naprilene
Take this medicine as prescribed by your doctor. However, if you forget your daily dose, skip the
missed dose and take the next dose at the usual time the following day.
Do not take a double dose to make up for the missed tablet.
If you have any doubts about how to use 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 how to use 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.
Stop taking 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
• 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)

• Diarrhea, abdominal pain
• Altered taste
• Headache
• Fatigue
• Depression
• Fainting
• Increased potassium levels in the blood
• Reduced blood pressure
• Heart attack or stroke (TIA, "mini-stroke")
• Heart rhythm disorders
• Chest pain (angina pectoris)
• Chest discomfort
• 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
• Ringing or buzzing in the ears (tinnitus)
• Reduced blood sugar levels (hypoglycaemia)
• Nervousness, confusion, insomnia, drowsiness
• Pins and needles sensation or similar feelings
• Dizziness
• Reduced blood pressure when standing up (orthostatic hypotension)
• Palpitations
• Sore throat, voice changes (hoarseness), runny nose, bronchospasm/asthma
• Altered intestinal motility (ileus)
• Inflammation of the pancreas (pancreatitis), vomiting, indigestion, constipation, loss of appetite, stomach irritation, dry mouth, stomach lesions (peptic ulcer), hives, itching, sweating
• Hair loss
• Impaired kidney function, including kidney failure, accumulation in the blood of substances normally eliminated by the kidneys (uraemia), presence of protein in the urine
• Reduced 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)

• Reduction in white blood cells
• Reduction in the number of platelets in the blood
• Reduction in all blood cells (pancytopenia)
• Bone marrow suppression, i.e. a decrease in blood cells due to malfunction of the blood cell production system
• Enlarged lymph nodes
• Autoimmune diseases
• Decreased levels of blood cells (haematocrit) and haemoglobin
• Abnormal dreams, sleep disorders
• Poor blood circulation in limbs (Raynaud's phenomenon)
• Lung problems, including pneumonia, allergic alveolitis, cold-like symptoms
• Inflammation of the mouth mucosa, mouth ulcers and aphthae, 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 liver cell death which may be potentially fatal
• Increased liver enzyme levels (a sign of liver damage)
• Increased bilirubin levels
• Severe allergic reactions with high fever, appearance of red skin patches (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis), skin rash with peeling (erythroderma), appearance of small fluid-filled blisters on the skin (pemphigus)
• Reduced urine output
• Breast enlargement in males

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

• Intestinal swelling due to fluid accumulation

Side effects with unknown frequency (frequency cannot be estimated from the available data)

• A group of symptoms including: either fever or inflammation of a specific type of membrane lining certain organs (serositis) or inflammation of blood vessels or muscle, joint and bone pain or elevated ESR (visible in blood tests) or increased levels of certain types of white blood cells in the blood (eosinophilia, leucocytosis) or skin reactions including photosensitivity
• An endocrine disorder has also been reported, namely the syndrome of inappropriate antidiuretic hormone secretion (SIADH).

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater 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 Naprilene contains
Naprilene 5 mg tablets

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

Naprilene 20 mg tablets

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

Description of the appearance of Naprilene and pack contents
Naprilene 5 mg tablets
Each pack contains one blister with 28 tablets of 5 mg.
Naprilene 20 mg tablets
Each pack contains one blister with 14 or 28 tablets of 20 mg.
Marketing Authorization Holder and Manufacturer
Marketing Authorization 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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