SfRowasa

Name: SfRowasa

Other uses for this medicine

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

Before Using sfRowasa

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 mesalamine 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 mesalamine in the elderly. However, elderly patients are more likely to have blood problems (eg, neutropenia, pancytopenia) and age-related kidney disease, which may require caution and an adjustment in the dose for patients receiving mesalamine.

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 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.

  • Aceclofenac
  • Acemetacin
  • Amtolmetin Guacil
  • Bromfenac
  • Bufexamac
  • Celecoxib
  • Clonixin
  • Dexibuprofen
  • Dexketoprofen
  • Diclofenac
  • Dipyrone
  • Droxicam
  • Etodolac
  • Etofenamate
  • Etoricoxib
  • Felbinac
  • Fenoprofen
  • Fepradinol
  • Feprazone
  • Floctafenine
  • Flufenamic Acid
  • Flurbiprofen
  • Ibuprofen
  • Indomethacin
  • Ketoprofen
  • Lornoxicam
  • Loxoprofen
  • Lumiracoxib
  • Meclofenamate
  • Mefenamic Acid
  • Meloxicam
  • Mercaptopurine
  • Morniflumate
  • Nabumetone
  • Naproxen
  • Nepafenac
  • Niflumic Acid
  • Nimesulide
  • Nimesulide Beta Cyclodextrin
  • Oxaprozin
  • Oxyphenbutazone
  • Parecoxib
  • Phenylbutazone
  • Piketoprofen
  • Piroxicam
  • Proglumetacin
  • Propyphenazone
  • Proquazone
  • Rofecoxib
  • Sulindac
  • Tenoxicam
  • Tiaprofenic Acid
  • Tolfenamic Acid
  • Tolmetin
  • Valdecoxib
  • Varicella Virus Vaccine

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.

  • Tamarind
  • Warfarin

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:

  • Allergy to salicylates (eg, aspirin) or
  • Allergy to saturated vegetable fat—Should not be used in patients with these conditions.
  • Allergy to sulfasalazine (Azulfidine®) or
  • Kidney disease, or history of or
  • Liver disease or
  • Myocarditis (heart disease), history of or
  • Pericarditis (heart disease), history of or
  • Stomach blockage—Use with caution. May make these conditions worse.

sfRowasa Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common or rare
  • Abdominal or stomach cramps or pain (severe)
  • anxiety
  • back pain (severe)
  • bloody, black, or tarry stools
  • blue or pale skin
  • bright red blood in the stool
  • chest pain, possibly moving to the left arm, neck, or shoulder
  • chills
  • diarrhea (severe)
  • fast heartbeat
  • fever
  • headache (severe)
  • nausea or vomiting
  • skin rash
  • stomach cramps, tenderness, or pain
  • swelling of the stomach
  • unusual tiredness or weakness
  • watery or bloody diarrhea
  • yellow eyes or skin
Incidence not known
  • Blood in the urine
  • change in the frequency of urination or amount of urine
  • cough
  • dark-colored urine
  • difficulty with breathing
  • drowsiness
  • general feeling of tiredness or weakness
  • high fever
  • increased thirst
  • light-colored stools
  • loss of appetite
  • lower back or side pain
  • painful or difficult urination
  • pale skin
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • stomach pain, continuing
  • swelling of the feet or lower legs
  • swollen glands
  • troubled breathing
  • unexplained or unusual bleeding or bruising
  • weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Abdominal or stomach cramps or pain (mild)
  • bloated or full feeling
  • excess air or gas in the stomach or intestines
  • gas or flatulence
  • headache (mild)
  • passing gas
Less common
  • Acne
  • diarrhea
  • dizziness
  • leg or joint pain
  • loss of hair
  • rectal pain or irritation

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Uses of sfRowasa

  • It is used to treat mild to moderate disease at the far end of the colon.
  • It may be given to you for other reasons. Talk with the doctor.

How is this medicine (sfRowasa) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Keep taking sfRowasa as you have been told by your doctor or other health care provider, even if you feel well.
  • To gain the most benefit, do not miss doses.
  • You could be on both a tablet or capsule and a rectal product at the same time.
  • Use enema rectally.
  • Shake suspension well before use.
  • Keep suspension in your rectum as long as you can.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out sfRowasa?

  • Store rectal suspension in foil until ready to use. Do not refrigerate.
  • Protect rectal suspension from heat.
  • Do not use if suspension changes color.
  • Protect from light.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Contraindications

sfRowasa® (mesalamine) Rectal Suspension is contraindicated for patients known to have hypersensitivity to the drug or any component of this medication.

How is sfRowasa Supplied

sfRowasa® (mesalamine) Rectal Suspension for rectal administration is an off-white to tan colored suspension. Each disposable bottle contains 4.0 grams of mesalamine in 60 mL aqueous suspension. Bottles are supplied in boxed, foil-wrapped trays as follows:

NDC 0037-0022-60……… Sample – 1 bottle
NDC 0037-0022-07……… Carton of 7 Bottles
NDC 0037-0022-14……… Carton of 14 Bottles
NDC 0037-0022-28……… Carton of 28 Bottles

sfRowasa® (mesalamine) Rectal Suspension is for rectal use only.

KEEP OUT OF REACH OF CHILDREN

Patient instructions are included.

Storage

Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted, please refer to current USP. Once the foil-wrapped unit of seven bottles is opened, any bottles remaining after 14 days should be discarded. Contents of product removed from the foil pouch may darken with time. Slight darkening will not affect potency, however, product with dark brown contents should be discarded.

** Clinical studies were performed using ROWASA® (mesalamine) Rectal Suspension Enema, 4g/60mL, the original formulation, which contains the ingredient potassium metabisulfite.

NOTE: sfRowasa® (mesalamine) Rectal Suspension will cause staining of direct contact surfaces, including but not limited to fabrics, flooring, painted surfaces, marble, granite, vinyl, and enamel. Take care in choosing a suitable location for administration of this product.

Rx Only

Distributed by:

MEDA
PHARMACEUTICALS®

Somerset, New Jersey 08873-4120

©2017 Meda Pharmaceuticals Inc.

U.S. Patent No. 7,645,801

MEDA PHARMACEUTICALS and sfRowasa are registered trademarks of Meda AB or a related entity.

www.sfRowasa.com

IN-003260-02     Rev. 6/2017

For Medical Inquiries, Call Toll-Free: 1-866-210-5950

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