Rowasa 4gm Kit (28 X 60ml)

Mesalamine is an aminosalicylate that exerts its anti-inflammatory action locally in the colon. Its exact mechanism is not fully understood but is thought to involve inhibition of prostaglandin and leukotriene synthesis (via inhibition of cyclooxygenase and lipoxygenase pathways), scavenging of free radicals, and inhibition of neutrophil chemotaxis and adhesion. It may also modulate immune cell function and cytokine production.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to urinate or changes in urine output
+ Blood in the urine or significant weight gain
+ Back pain, abdominal pain, or blood in the urine (which may indicate a kidney stone)
Chest pain or pressure, rapid or irregular heartbeat
Fever, chills, sore throat, unexplained bruising or bleeding, or feeling extremely tired or weak
Rectal bleeding or pain
Symptoms that may resemble ulcerative colitis, such as:
+ New or worsening stomach pain or cramps
+ Bloody stools
+ Fever
+ Headache
+ Itching or rash
+ Red or pink eyes
+ General feeling of illness
Liver problems, which can be rare but potentially life-threatening, characterized by:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Nausea or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Heart problems, which can be rare but potentially life-threatening, characterized by:
+ Shortness of breath
+ Significant weight gain
+ Swelling in the arms or legs
Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which can be life-threatening and may affect internal organs. Seek medical help immediately if you experience:
+ Red, swollen, blistered, or peeling skin
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, eyes, genitals, or skin
+ Fever
+ Chills
+ Body aches
+ Shortness of breath
+ Swollen glands

Other Possible Side Effects

Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

Constipation
Diarrhea
Stomach pain or upset stomach
Vomiting
Heartburn
Gas
Burping
Nose or throat irritation
Dizziness or headache
Back pain
Cough
* Rectal irritation

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
Certain health conditions, including:
+ Kidney disease or liver disease
+ Stomach or bowel ulcers
+ Narrowing of your stomach valve or other types of stomach blockages
+ Blockages in your urinary tract (consult with your healthcare provider)
Although this is not an exhaustive list, it is crucial to discuss all your health problems and medications with your doctor.

To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Natural products and vitamins you are using
Any health problems you have

Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug, consult with your doctor to confirm it is safe to do so.

Important Information to Share with Your Healthcare Team

Inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure you receive proper care and avoid potential interactions.

Monitoring Your Health

Follow your doctor's instructions for regular blood tests to monitor your health while taking this medication. Discuss any concerns or questions you have with your doctor.

Lab Tests and Results

Be aware that this medication may affect the results of certain lab tests. Inform all your healthcare providers and lab personnel that you are taking this medication to ensure accurate test results.

Staying Hydrated

Drink plenty of non-caffeinated fluids, unless your doctor advises you to limit your fluid intake.

Sulfite Allergy

If you have a sulfite allergy, consult with your doctor before taking this medication, as some products may contain sulfites.

Urine Color Change

While taking this medication, your urine may turn reddish-brown when it comes into contact with surfaces or water that have been treated with bleach (such as in a toilet). If you notice a color change, observe your urine flow. Only contact your doctor if your urine is reddish-brown before it comes into contact with any surfaces or water that may have been treated with bleach.

Sun Protection

You may be more susceptible to sunburn while taking this medication. Avoid exposure to the sun, sunlamps, and tanning beds. Use sunscreen and wear protective clothing and eyewear to minimize your risk of sunburn.

Special Considerations for Older Adults

If you are 65 or older, use this medication with caution, as you may be more likely to experience side effects.

Use in Children

Not all products are suitable for use in children. Consult with your doctor before giving this medication to a child. Do not give this medication to children or teenagers who have or are recovering from flu symptoms, chickenpox, or other viral infections, as it may increase the risk of Reye's syndrome, a rare but serious condition that can cause brain and liver damage.

Potential Staining

This medication may stain certain surfaces, including fabric, flooring, painted surfaces, marble, granite, vinyl, and enamel.

Pregnancy and Breastfeeding

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You will need to discuss the potential benefits and risks of taking this medication to you and your baby.

• Azathioprine
• Mercaptopurine (6-MP)

• Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
• Nephrotoxic agents (e.g., tacrolimus, cyclosporine)

• Abdominal pain
• Rectal bleeding
• Diarrhea
• Fever
• Rash
• Chest pain (pericarditis/myocarditis)
• Shortness of breath
• Unexplained fatigue
• Dark urine
• Yellowing of skin/eyes (jaundice)
• Changes in urination (e.g., decreased output)

Mesalamine is generally considered safe for use during pregnancy. Studies in animals have not shown harm to the fetus, and human data suggest a low risk. However, it should be used only if clearly needed.

Mesalamine and its metabolite are excreted in breast milk in small amounts. While generally considered compatible with breastfeeding, monitor the infant for diarrhea or other adverse effects.

Safety and efficacy have not been established in pediatric patients. Use in children should be based on careful consideration of risks and benefits by a specialist.

Use with caution in elderly patients, especially those with pre-existing renal or hepatic impairment, due to increased susceptibility to adverse reactions. Monitor renal function closely.

• Instruct patients to administer the enema at bedtime and retain it for as long as possible (preferably overnight, 8 hours) to maximize local contact and efficacy.
• Ensure proper administration technique: shake the bottle well, lie on the left side with the lower leg extended and the upper leg flexed forward, insert the applicator tip gently, and squeeze the bottle slowly.
• Mesalamine rectal enema is primarily for distal ulcerative colitis (proctitis, proctosigmoiditis) and may not be effective for more extensive disease.
• Patients should be advised that the enema may stain fabrics.
• Monitor for signs of mesalamine-induced acute intolerance syndrome (e.g., cramping, acute abdominal pain, bloody diarrhea, fever, headache, rash), which may mimic a flare of inflammatory bowel disease.

• Corticosteroid rectal preparations (e.g., hydrocortisone enema, budesonide rectal foam)
• Oral 5-aminosalicylates (e.g., oral mesalamine, sulfasalazine)
• Immunomodulators (e.g., azathioprine, mercaptopurine) for more severe or refractory disease
• Biologic agents (e.g., infliximab, adalimumab) for moderate to severe disease
• Janus kinase (JAK) inhibitors (e.g., tofacitinib)

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.