Aceon

Name: Aceon

How should I take perindopril?

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take each dose with a full glass of water. Drink plenty of liquids while you are taking perindopril.

Perindopril can be taken with or without food.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking perindopril. This can lead to very low blood pressure, electrolyte disorders, or kidney failure.

Your blood pressure will need to be checked often. Your kidney or liver function may also need to be checked.

If you need surgery, tell the surgeon ahead of time that you are using perindopril. You may need to stop using the medicine for a short time.

If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Store at room temperature away from moisture and heat.

What other drugs will affect perindopril?

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • gold injections to treat arthritis;

  • lithium;

  • NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others;

  • a potassium supplement;

  • salt substitutes that contain potassium; or

  • a diuretic or "water pill."

This list is not complete. Other drugs may interact with perindopril, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Interactions for Aceon

Specific Drugs

Drug

Interaction

Comments

Digoxin

No effect on digoxin concentrations; effect on perindopril/perindoprilat concentrations has not been excluded1

Diuretics

Increased hypotensive effect1

If possible, discontinue diuretic before initiating perindopril1 (see Dosage under Dosage and Administration)

Diuretics, potassium-sparing (amiloride, spironolactone, triamterene)

Enhanced hyperkalemic effect1

Use with caution; monitor serum potassium concentrations frequently1

Gentamicin

Possible interaction based on animal data; no studies in humans1

Use with caution1

Lithium

Increased serum lithium concentrations; possible toxicity1

Use with caution; monitor serum lithium concentrations frequently1

Potassium supplements or potassium-containing salt substitutes

Enhanced hyperkalemic effect1

Use with caution; monitor serum potassium concentrations frequently1

Advice to Patients

  • When perindopril is used in fixed combination with amlodipine, advise patients of important precautionary information about amlodipine.46

  • Risk of angioedema, anaphylactoid reactions, or other sensitivity reactions.1 Importance of reporting sensitivity reactions (e.g., edema of face, eyes, lips, tongue, or extremities; hoarseness; swallowing or breathing with difficulty) immediately to clinician and of discontinuing the drug.1

  • Importance of reporting signs of infection (e.g., sore throat, fever).1

  • Risk of hypotension.1 Importance of informing clinicians promptly if lightheadedness or fainting occurs.1

    Importance of adequate fluid intake; risk of volume depletion with excessive perspiration, dehydration, vomiting, or diarrhea.1

  • Risks of use during pregnancy.1 (See Boxed Warning.)

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs (including salt substitutes containing potassium).1

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of advising patients of other important precautionary information.1 (See Cautions.)

Commonly used brand name(s)

In the U.S.

  • Aceon

Available Dosage Forms:

  • Tablet

Therapeutic Class: Antihypertensive

Pharmacologic Class: ACE Inhibitor

Before Using Aceon

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of perindopril in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of perindopril in the elderly.

Pregnancy

Pregnancy Category Explanation
All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Aliskiren
  • Sacubitril

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Alteplase, Recombinant
  • Amiloride
  • Azathioprine
  • Azilsartan
  • Azilsartan Medoxomil
  • Candesartan Cilexetil
  • Canrenoate
  • Cyclosporine
  • Eplerenone
  • Eprosartan
  • Everolimus
  • Irbesartan
  • Lithium
  • Losartan
  • Mercaptopurine
  • Olmesartan Medoxomil
  • Potassium
  • Sirolimus
  • Spironolactone
  • Telmisartan
  • Triamterene
  • Trimethoprim
  • Valsartan

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Aceclofenac
  • Acemetacin
  • Amtolmetin Guacil
  • Azosemide
  • Bromfenac
  • Bufexamac
  • Bumetanide
  • Bupivacaine
  • Bupivacaine Liposome
  • Capsaicin
  • Celecoxib
  • Choline Salicylate
  • Clonixin
  • Dexibuprofen
  • Dexketoprofen
  • Diclofenac
  • Diflunisal
  • Dipyrone
  • Droxicam
  • Ethacrynic Acid
  • Etodolac
  • Etofenamate
  • Etoricoxib
  • Felbinac
  • Fenoprofen
  • Fepradinol
  • Feprazone
  • Floctafenine
  • Flufenamic Acid
  • Flurbiprofen
  • Furosemide
  • Gold Sodium Thiomalate
  • Ibuprofen
  • Indomethacin
  • Ketoprofen
  • Ketorolac
  • Lornoxicam
  • Loxoprofen
  • Lumiracoxib
  • Meclofenamate
  • Mefenamic Acid
  • Meloxicam
  • Morniflumate
  • Nabumetone
  • Naproxen
  • Nepafenac
  • Nesiritide
  • Niflumic Acid
  • Nimesulide
  • Nimesulide Beta Cyclodextrin
  • Oxaprozin
  • Oxyphenbutazone
  • Parecoxib
  • Phenylbutazone
  • Piketoprofen
  • Piretanide
  • Piroxicam
  • Proglumetacin
  • Propionic Acid
  • Propyphenazone
  • Proquazone
  • Rofecoxib
  • Salicylic Acid
  • Salsalate
  • Sodium Salicylate
  • Sulindac
  • Tenoxicam
  • Tiaprofenic Acid
  • Tolfenamic Acid
  • Tolmetin
  • Torsemide
  • Valdecoxib

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Angioedema (swelling of the face, lips, tongue, throat, arms, or legs) with other ACE inhibitors, history of—May increase risk of this condition occurring again.
  • Collagen vascular disease (an autoimmune disease) together with kidney disease—Increased risk of blood problems.
  • Congestive heart failure, severe—Use may lead to kidney problems.
  • Diabetes or
  • Kidney problems—Increased risk of potassium levels in the body becoming too high.
  • Diabetes patients who are also taking aliskiren (Tekturna®) or
  • Hereditary or idiopathic angioedema or
  • Patients with kidney disease who are also taking aliskiren (Tekturna®)—Should not be used in patients with these conditions.
  • Electrolyte imbalance (eg, low sodium in the blood) or
  • Fluid imbalances (caused by dehydration, vomiting, or diarrhea) or
  • Liver disease—Use with caution. May make these condition worse.

What are some things I need to know or do while I take Aceon?

  • Tell all of your health care providers that you take Aceon. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
  • To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
  • Have your blood pressure checked often. Talk with your doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • If you are taking a salt substitute that has potassium, potassium-sparing diuretics, or potassium, talk with your doctor.
  • If you are on a low-salt or salt-free diet, talk with your doctor.
  • Low white blood cell counts have happened with captopril, a drug like this one. This may lead to more chance of getting an infection. Most of the time, this has happened in people with kidney problems, mainly if they have certain other health problems. Call your doctor right away if you have signs of infection like fever, chills, or sore throat. Talk with your doctor.
  • If you are taking Aceon and have high blood pressure, talk with your doctor before using OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some natural products or aids.
  • Talk with your doctor before you drink alcohol.
  • Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
  • Tell your doctor if you have too much sweat, fluid loss, throwing up, or loose stools. This may lead to low blood pressure.
  • If you are taking lithium, talk with your doctor. You may need to have your blood work checked more closely while you are taking it with this medicine.
  • This medicine may not work as well in black patients. Talk with the doctor.
  • A very bad reaction called angioedema has happened with Aceon. Sometimes, this has been deadly. The chance of angioedema may be higher in black patients. Talk with the doctor.
  • If you are 65 or older, use this medicine with care. You could have more side effects.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Use in specific populations

Pregnancy

Pregnancy Category D [see Boxed Warning and Warnings and Precautions (5.4)].

Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Aceon as soon as possible. These adverse outcomes are usually associated with use of these drugs in the second and third trimester of pregnancy. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus.

In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. Perform serial ultrasound examinations to assess the intra-amniotic environment. If oligohydramnios is observed, discontinue Aceon, unless it is considered lifesaving for the mother. Fetal testing may be appropriate, based on the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe infants with histories of in utero exposure to Aceon for hypotension, oliguria, and hyperkalemia [see Use in Specific Populations (8.4)].

Radioactivity was detectable in fetuses after administration of 14C-perindopril to pregnant rats.

Nursing Mothers

Milk of lactating rats contained radioactivity following administration of 14C-perindopril. It is not known whether perindopril is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when Aceon is given to nursing mothers.

Pediatric Use

Neonates with a history of in utero exposure to Aceon:

If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function. Perindopril, which crosses the placenta, can theoretically be removed from the neonatal circulation by these means, but limited experience has not shown that such removal is central to the treatment of these infants.

Safety and effectiveness of Aceon in pediatric patients have not been established.

Geriatric Use

The mean blood pressure effect of perindopril was somewhat smaller in patients over 60 than in younger patients, although the difference was not significant. Plasma concentrations of both perindopril and perindoprilat were increased in elderly patients compared to concentrations in younger patients. No adverse effects were clearly increased in older patients with the exception of dizziness and possibly rash.

Start at a low dose and titrate slowly as needed. Monitor for dizziness because of potential for falls.

Experience with Aceon in elderly patients at daily doses exceeding 8 mg is limited.

Renal Impairment

Dosage adjustment may be necessary in renally impaired patients [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3)].

Hepatic Impairment

The bioavailability of perindoprilat is increased in patients with impaired hepatic function [see Clinical Pharmacology (12.3)].

Aceon Description

Aceon® (perindopril erbumine) Tablets contain the tert-butylamine salt of perindopril, the ethyl ester of a non-sulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Perindopril erbumine is chemically described as (2S,3∝S,7∝S)-1-[(S)-N-[(S)-1-Carboxy-butyl]alanyl]hexahydro-2-indolinecarboxylic acid, 1-ethyl ester, compound with tert-butylamine (1:1). Its molecular formula is C19H32N2O5C4H11N. Its structural formula is:

Perindopril erbumine is a white, crystalline powder with a molecular weight of 368.47 (free acid) or 441.61 (salt form). It is freely soluble in water (60% w/w), alcohol and chloroform.

Perindopril is the free acid form of perindopril erbumine, is a pro-drug and metabolized in vivo by hydrolysis of the ester group to form perindoprilat, the biologically active metabolite.

Aceon is available in 2 mg, 4 mg and 8 mg strengths for oral administration. In addition to perindopril erbumine, each tablet contains the following inactive ingredients: colloidal silica (hydrophobic), lactose, magnesium stearate and microcrystalline cellulose. The 4 mg and 8 mg tablets also contain iron oxide.

How Supplied/Storage and Handling

Tablets are oblong with a score on one side.

Tablets Appearance NDC (Bottles of 100)
2 mg White, debossed "ACN 2" on unscored side NDC 61894-000-02
4 mg Pink, debossed "ACN 4" on unscored side NDC 61894-001-02
8 mg Salmon-colored, debossed "ACN 8" on unscored side NDC 61894-002-02

Keep out of the reach of children.

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Protect from moisture.

For further information, please call our medical communications department toll-free at 888-985-7657.

Patient Counseling Information

Female patients of childbearing age should be told about the consequences of exposure to Aceon during pregnancy. Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible.

Tell patients to report promptly any indication of infection (e.g., sore throat, fever) which could be a sign of neutropenia.


Manufactured by:
Patheon Pharmaceuticals, Inc.
Cincinnati, OH 45237 USA

Marketed by:
Symplmed, LLC.
Cincinnati, OH 45227 USA

3-030615.9

Rev Jan 2015

70029867

Revised: 03, 2015

symplmed™

PRINCIPAL DISPLAY PANEL –2mg 100 Tablet Bottle Label

100 Tablets

NDC 61894-000-02

Aceon®

perindopril erbumine Tablets

2mg

Rx ONLY

Keep out of reach of children

symplmed™

PRINCIPAL DISPLAY PANEL –4mg 100 Tablet Bottle Label

100 Tablets

NDC 61894-001-02

Aceon®

perindopril erbumine Tablets

4mg

Rx ONLY

Keep out of reach of children

symplmed™

PRINCIPAL DISPLAY PANEL –8mg 100 Tablet Bottle Label

100 Tablets

NDC 61894-002-02

Aceon®

perindopril erbumine Tablets

8mg

Rx ONLY

Keep out of reach of children

symplmed™

Aceon 
perindopril erbumine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:61894-000
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
perindopril erbumine (perindoprilat) perindopril erbumine 2 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide  
lactose  
magnesium stearate  
cellulose, microcrystalline  
Product Characteristics
Color white (white) Score 2 pieces
Shape OVAL (OVAL) Size 8mm
Flavor Imprint Code ACN;2
Contains     
Packaging
# Item Code Package Description
1 NDC:61894-000-02 100 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020184 10/10/2014
Aceon 
perindopril erbumine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:61894-001
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
perindopril erbumine (perindoprilat) perindopril erbumine 4 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide  
lactose  
magnesium stearate  
cellulose, microcrystalline  
ferric oxide red  
Product Characteristics
Color pink (pink) Score 2 pieces
Shape OVAL (OVAL) Size 8mm
Flavor Imprint Code ACN;4
Contains     
Packaging
# Item Code Package Description
1 NDC:61894-001-02 100 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020184 10/10/2014
Aceon 
perindopril erbumine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:61894-002
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
perindopril erbumine (perindoprilat) perindopril erbumine 8 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide  
lactose  
magnesium stearate  
cellulose, microcrystalline  
ferric oxide red  
Product Characteristics
Color red (salmon) Score 2 pieces
Shape OVAL (OVAL) Size 8mm
Flavor Imprint Code ACN;8
Contains     
Packaging
# Item Code Package Description
1 NDC:61894-002-02 100 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020184 10/10/2014
Labeler - Symplmed, LLC (079198402)
Establishment
Name Address ID/FEI Operations
Oril Industrie 501890719 API MANUFACTURE(61894-000, 61894-001, 61894-002)
Establishment
Name Address ID/FEI Operations
Patheon Pharmaceuticals Inc. 005286822 MANUFACTURE(61894-000, 61894-001, 61894-002), ANALYSIS(61894-000, 61894-001, 61894-002), PACK(61894-000, 61894-001, 61894-002), LABEL(61894-000, 61894-001, 61894-002)
Revised: 05/2015   Symplmed, LLC

Aceon Precautions

Serious side effects have been reported with Aceon including:

  • Hypotension. Excessive perspiration and dehydration may lead to an excessive fall in blood pressure (hypotension). Vomiting or diarrhea may also lead to a fall in blood pressure.
  • Decline in kidney function. Your doctor may need to perform tests to determine the stability of the function of your kidneys, especially in patients who already have kidney dysfunction.
  • Hyperkalemia. Aceon may lead to increased levels of potassium, which could lead to side effects such as heart arrhythmias (irregular heartbeat) and nausea.
  • Cough: Persistent dry cough has been reported with all ACE inhibitors, and will resolve after discontinuation of therapy.
  • Valvular Stenosis. Those with aortic stenosis (stiffening of the main artery that carries blood away from the heart) might be at risk of decreased blood flow to the rest of the body.
  • Angioedema. Tell your healthcare profession right away if you have signs or symptoms of angioedema, which include:
    • swelling of face, eyes, lips, tongue, larynx and extremities
    • difficulty in swallowing or breathing
    • hoarseness (having difficulty making sounds when trying to speak)
  • Neutropenia. Report any sign of infection such as sore throat or fever, which may be a sign of neutropenia (a decreased amount of white blood cells).
  • Edema: report any sign of edema (increase in swelling of the arms or legs), which may be a sign of declining kidney function.
  • Heart failure patients. Caution is advised against rapid increases in exercise or physical activity for those who are being treated for heart failure.
  • Intestinal Angioedema. Intestinal angioedema (swelling within the gut) has been reported in patients treated with ACE inhibitors. Report signs and symptoms of intestinal angioedema, including abdominal (stomach-area) pain, with or without nausea or vomiting.
  • Liver failure. This is a rare occurrence. Nevertheless, report any signs or symptoms of hepatic failure, including:
    • yellowing of the skin or eyes
    • nausea
    • vomiting
    • fatigue
    • itching

Aceon can cause dizziness. Do not drive or operate heavy machinery until you know how Aceon affects you.

Do not take Aceon if you are hypersensitive to this product. Signs of a hypersensitivity reaction include:

  • chest pain
  • swelling of the face, eyes, lips, tongue, arms, or legs
  • difficulty breathing or swallowing
  • fainting
  • rash

What is Aceon?

Aceon (perindopril) is an ACE inhibitor. ACE stands for angiotensin converting enzyme.

Aceon is used to treat high blood pressure (hypertension) and to prevent heart attack in people with coronary artery disease.

Aceon may also be used for purposes not listed in this medication guide.

How should I take Aceon?

Take Aceon exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take each dose with a full glass of water. Drink plenty of liquids while you are taking Aceon.

Aceon can be taken with or without food.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking Aceon. This can lead to very low blood pressure, electrolyte disorders, or kidney failure.

Your blood pressure will need to be checked often. Your kidney or liver function may also need to be checked.

If you need surgery, tell the surgeon ahead of time that you are using Aceon. You may need to stop using the medicine for a short time.

If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Store at room temperature away from moisture and heat.

Perindopril Pregnancy Warnings

AU: Use is contraindicated. UK: Use is not recommended during the first trimester of pregnancy and is contraindicated during the second and third trimesters. US: This drug should not be used during pregnancy unless there are no alternatives and the benefit outweighs the risk to the fetus. AU TGA pregnancy category: D US FDA pregnancy category: D Comments: Adequate methods of contraception should be encouraged.

Animal studies have revealed evidence of fetotoxicity. In humans, use of drugs that act on the renin angiotensin system (RAS) during the second and third trimesters increases fetal and neonatal morbidity and death. There are no controlled data in human pregnancy. AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details. US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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