Norwich Aspirin

Name: Norwich Aspirin

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Before Using Norwich Aspirin

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 aspirin extended-release capsules 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 aspirin extended-release capsules in the elderly.

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.

Defibrotide
Dichlorphenamide
Influenza Virus Vaccine, Live
Ketorolac

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.

Acarbose
Aceclofenac
Acemetacin
Alipogene Tiparvovec
Alteplase, Recombinant
Amiloride
Amineptine
Amitriptyline
Amitriptylinoxide
Amoxapine
Amtolmetin Guacil
Anagrelide
Anisindione
Apixaban
Argatroban
Bendroflumethiazide
Benzthiazide
Betrixaban
Bivalirudin
Bromfenac
Bufexamac
Bumetanide
Celecoxib
Chlorothiazide
Chlorpropamide
Chlorthalidone
Choline Salicylate
Cilostazol
Citalopram
Clomipramine
Clonixin
Clopamide
Clopidogrel
Cyclopenthiazide
Cyclosporine
Dabigatran Etexilate
Danaparoid
Desipramine
Desirudin
Desmopressin
Desvenlafaxine
Dexibuprofen
Dexketoprofen
Diazoxide
Dibenzepin
Diclofenac
Dicumarol
Diflunisal
Digoxin
Dipyrone
Dothiepin
Doxepin
Droxicam
Duloxetine
Edoxaban
Eplerenone
Eptifibatide
Escitalopram
Ethacrynic Acid
Etodolac
Etofenamate
Etoricoxib
Felbinac
Fenoprofen
Fepradinol
Feprazone
Feverfew
Floctafenine
Flufenamic Acid
Fluoxetine
Flurbiprofen
Fluvoxamine
Fondaparinux
Furosemide
Ginkgo
Glimepiride
Glipizide
Glyburide
Gossypol
Heparin
Hydrochlorothiazide
Hydroflumethiazide
Ibuprofen
Imipramine
Indapamide
Indomethacin
Ketoprofen
Lepirudin
Levomilnacipran
Lithium
Lofepramine
Lornoxicam
Loxoprofen
Lumiracoxib
Meclofenamate
Mefenamic Acid
Melitracen
Meloxicam
Metformin
Methotrexate
Methyclothiazide
Metolazone
Milnacipran
Morniflumate
Nabumetone
Naproxen
Nateglinide
Nefazodone
Nepafenac
Nicorandil
Niflumic Acid
Nimesulide
Nimesulide Beta Cyclodextrin
Nortriptyline
Opipramol
Oxaprozin
Oxyphenbutazone
Parecoxib
Paroxetine
Pemetrexed
Pentosan Polysulfate Sodium
Pentoxifylline
Phenindione
Phenprocoumon
Phenylbutazone
Piketoprofen
Piracetam
Piroxicam
Polythiazide
Pralatrexate
Pranoprofen
Prasugrel
Proglumetacin
Propyphenazone
Proquazone
Protein C
Protriptyline
Repaglinide
Reteplase, Recombinant
Rivaroxaban
Rofecoxib
Salicylic Acid
Salsalate
Sertraline
Sodium Salicylate
Spironolactone
Sulindac
Tacrolimus
Tenoxicam
Tianeptine
Tiaprofenic Acid
Ticagrelor
Ticlopidine
Tirofiban
Tolazamide
Tolbutamide
Tolfenamic Acid
Tolmetin
Torsemide
Treprostinil
Triamterene
Trichlormethiazide
Trimipramine
Valdecoxib
Varicella Virus Vaccine
Venlafaxine
Vilazodone
Vortioxetine
Warfarin
Xipamide

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.

Acebutolol
Atenolol
Betamethasone
Betaxolol
Bisoprolol
Captopril
Carteolol
Carvedilol
Celiprolol
Cortisone
Delapril
Dexamethasone
Enalaprilat
Enalapril Maleate
Esmolol
Imidapril
Labetalol
Levobunolol
Lisinopril
Methylprednisolone
Metipranolol
Metoprolol
Nadolol
Nebivolol
Nitroglycerin
Oxprenolol
Paramethasone
Penbutolol
Pindolol
Practolol
Prednisolone
Prednisone
Probenecid
Propranolol
Sotalol
Streptokinase
Tamarind
Temocapril
Tenecteplase
Timolol
Triamcinolone
Valproic Acid

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. 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 may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Proper Use of aspirin

This section provides information on the proper use of a number of products that contain aspirin. It may not be specific to Norwich Aspirin. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Take the capsule with a full glass of water at the same time each day.

Swallow the extended-release capsule whole. Do not crush, break, or chew it.

Do not take Durlaza™ 2 hours before or 1 hour after drinking alcohol.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (extended-release capsules):
- To lower risk of heart attack and stroke:
  - Adults—162.5 milligrams (mg) (one capsule) once a day.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

For Healthcare Professionals

Applies to aspirin: compounding powder, oral capsule extended release, oral delayed release capsule, oral delayed release tablet, oral gum, oral powder for reconstitution, oral tablet, oral tablet chewable, oral tablet disintegrating, oral tablet dispersible, oral tablet extended release, rectal suppository

Gastrointestinal

Common (1% to 10%): Dyspepsia,
Frequency not reported: GI bleeding, ulceration, perforation, nausea, vomiting, pancreatitis, gastric irritation, GI erosions, gastritis, melena, hematemesis, gingival bleeding[Ref]

Renal

Frequency not reported: Interstitial nephritis, papillary necrosis, renal insufficiency and failure[Ref]

Hematologic

Common (1% to 10%): Increased bleeding tendencies
Rare (0.01% to 0.1%): Aplastic anemia agranulocytosis, thrombocytopenia
Frequency not reported: Prolongation of prothrombin time, disseminated intravascular coagulation, coagulopathy, antepartum and postpartum bleeding, anemia[Ref]

Hypersensitivity

Rare (0.01% to 0.1%): Anaphylactic reactions including shock
Frequency not reported: Urticaria, angioedema, skin rashes[Ref]

Dermatologic

Uncommon (0.1% to 1%): Urticaria
Rare (0.01% to 0.1%): Steven-Johnson syndrome, Lyell's syndrome, erythema nodosum, erythema multiforme
Frequency not reported: Purpura, hives[Ref]

Hepatic

Frequency not reported: Transient elevations of hepatic enzymes, hepatitis, Reye's syndrome, hepatic insufficiency[Ref]

Metabolic

Frequency not reported: Thirst, dehydration, hyperkalemia, metabolic acidosis, respiratory alkalosis, hypoglycemia, hyperglycemia, hyperuricemia, salt and water retention[Ref]

Cardiovascular

Rare (0.01% to 0.1%): Hemorrhagic vasculitis
Frequency not reported: Dysrhythmias, hypotension, tachycardia[Ref]

Nervous system

Frequency not reported: Cerebral edema, coma headache, subdural or intracranial hemorrhage, seizures, lethargy, dizziness[Ref]

Other

Frequency not reported: Fever, hypothermia, hearing loss, tinnitus (at high doses), hearing disturbances[Ref]

Musculoskeletal

Frequency not reported: Rhabdomyolysis[Ref]

Respiratory

Frequency not reported: Hyperpnea, pulmonary edema, tachypnea, epistaxis, dyspnea, bronchospasm, asthma[Ref]

General

The more commonly experienced adverse effects include indigestion, dyspepsia, bleeding, and bruising.[Ref]

Genitourinary

Rare (0.01% to 0.1%): Menorrhagia
Frequency not reported: Proteinuria[Ref]

Psychiatric

Frequency not reported: Agitation, confusion[Ref]

Some side effects of Norwich Aspirin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.