Siromus 1mg Tablet 6'S

Introduction About SIROMUS 1MG TABLET

SIROMUS 1MG TABLET contains Sirolimus which belongs to the group of medicines
called Immunosuppressants. It is used in adults to manage body from rejecting
transplanted kidneys along with other immunosuppressant medicines called
corticosteroids and initially (first 2-3 months) with ciclosporin.

SIROMUS 1MG TABLET is also used to manage sporadic lymphangioleiomyomatosis
(S-LAM) with moderate lung disease or reducing lung function.
Lymphangioleiomyomatosis (LAM) is a progressive lung disease in women caused by
the abnormal growth of smooth muscle cells, most commonly characterized by
shortness of breath.

Your doctor will perform tests to monitor SIROMUS 1MG TABLET levels in your
blood, kidney function, blood fat levels and your liver function, during this
management. They may also advise you to limit exposure to sunlight and UV light
during SIROMUS 1MG TABLET management by covering your skin with clothing and
using a sunscreen with a high protection factor as it can increase the risk for
skin cancer.

Before taking SIROMUS 1MG TABLET inform your doctor if you have liver problem,
body mass index more than 30 kg/m2 or if you previously had a failed kidney
transplant. Do not drink grapefruit juice while taking SIROMUS 1MG TABLET.
SIROMUS 1MG TABLET is not recommended for use in pregnant and breastfeeding
women.

SIROMUS 1MG TABLET is not recommended for use in children and adolescents (below
18 years of age). The most common side effects of taking SIROMUS 1MG TABLET are
pain, fever, headache, stomachache, swelling of body including hands and feet,
etc. Contact your doctor if any of the symptoms worsen or persist.

Uses Of SIROMUS 1MG TABLET

Used in:

• Adults to manage body from rejecting transplanted kidneys (along with corticosteroids and initially ciclosporin)
• Women having sporadic lymphangioleiomyomatosis (S-LAM)

How SIROMUS 1MG TABLET Works

SIROMUS 1MG TABLET helps manage organ rejection by inhibiting the activation and
multiplication of T-lymphocyte (part of immune system that protects from
infection). It does this by inhibiting their reaction to a protein which
increases immune response. SIROMUS 1MG TABLET also inhibits antibody production.

How to use SIROMUS 1MG TABLET

Take SIROMUS 1MG TABLET as advised by your physician. Swallow with a glass of
water and do not crush, split or chew it. It should be consistently taken,
either with or without food.

Your doctor will decide the right dose and duration of SIROMUS 1MG TABLET
depending upon your age, body weight and disease condition. Do not stop taking
SIROMUS 1MG TABLET unless your doctor advises you to stop.

Side Effects Of SIROMUS 1MG TABLET

Common

• fluid collection around the kidney, abdomen, lungs or heart
• swelling of the body, even hands and feet
• joint pain, fever, headache
• increased blood pressure
• stomach pain, diarrhea, constipation, nausea
• low red blood cells, white blood cells and blood platelets
• increased fat, blood sugar, low blood potassium and phosphorus, increased lactate dehydrogenase and creatinine in the blood
• acne, rashes
• urinary tract infection
• bacterial, viral or fungal infections including pneumonia
• diabetes
• abnormal tests of liver function
• raised protein in the urine
• menstrual disorders, ovarian cysts
• slow healing of wound
• rapid heart rate
• infections (including life-threatening infections)
• blood clots in the limbs or lungs
• mouth sores
• kidney damage with or without rash (hemolytic uremic syndrome)
• deterioration of bone
• nose bleeds
• skin cancer
• inflammation of the pancreas
• shingles
• cytomegalovirus infection
• weight loss

Uncommon

• cancer of the lymph tissue
• bleeding from the lung
• protein in the urine, occasionally severe and associated with swelling
• scarring in the kidney
• excess fluid collecting in the tissues due to irregular lymph function
• low blood platelets, with or without rash (thrombocytopenic purpura)
• serious allergic reactions causing peeling of the skin
• tuberculosis, Epstein-Barr virus infection
• infectious diarrhea with clostridium difficile
• serious liver damage

Rare

• excess protein in the air sacs of the lungs that may interfere with breathing
• serious allergic reactions affecting blood vessels

Stop taking SIROMUS 1MG TABLET and contact your doctor immediately if you
experience any of the following side effects:

• serious allergic reaction (swollen face, tongue, back of the mouth, difficulties in breathing, skin peeling off)
• kidney damage (bruising, rash, changes in urine, changes in behavior or any others that are serious, unusual or prolonged)
• skin, mouth, stomach, intestines, lungs and urinary tract infections

How To Manage Side Effects

Nausea or vomiting:

Take SIROMUS 1MG TABLET with or just after meals. Stick to simple meals. Avoid
eating spicy food. Drink clear or ice-cold drinks. Eat light, bland foods and
avoid fried, oily or sweet foods. If symptom persists, contact your doctor.

Headache:

Apply hot or cold-water bag on your head. Take enough rest in a quiet
environment and don’t involve yourself in any exertional activities. Apply pain
relieving balm on the forehead. If symptom persists, contact your doctor.Constipation:

Eat a lot of fiber rich foods such as fresh fruits, vegetables and cereals and
drink enough water. Exercise more regularly. If symptom persists, contact your
doctor.

Diarrhea:

Drink lots of water or fruit juice to keep yourself hydrated. If symptom
persists, contact your doctor.

Warning & Precautions

!### Pregnancy

SIROMUS 1MG TABLET is not recommended for use if you are pregnant or planning to
have a baby unless clearly necessary. Consult your doctor before taking it.

!### Breastfeeding

Patients taking SIROMUS 1MG TABLET should discontinue breastfeeding as it is not
known if it is excreted in the breastmilk. Consult your doctor before taking it.

!### Driving and Using Machines

SIROMUS 1MG TABLET is not known to affect your ability to drive or use machines.

!### Kidney

SIROMUS 1MG TABLET should be used with caution in patients who are at a high
risk of kidney rejection or have previously had a failed kidney transplant.
Consult your doctor before taking it.

!### Liver

SIROMUS 1MG TABLET should be used with caution in patients with liver disease.
Consult your doctor before taking it.

!### Allergy

Do not take SIROMUS 1MG TABLET if you are allergic to Sirolimus or any of the
other ingredients of this medicine.

Others

Before taking SIROMUS 1MG TABLET, inform your doctor if you:

• have a body mass index (BMI) greater than 30 kg/m² (increased risk of abnormal wound healing)
• have intolerance to certain sugars

Use in Pediatrics:

SIROMUS 1MG TABLET is not recommended for use in children and adolescents (below
18 years of age). Consult your child’s doctor for advice.

Use in Geriatrics:

SIROMUS 1MG TABLET should be used with caution in elderly patients above 65
years of age. Consult your doctor before taking it.

Interactions

A. Drug - Drug interactions:

Before taking SIROMUS 1MG TABLET, inform your doctor if you are taking any of
the following medicines:

• any other immunosuppressant medicines (Ex. tacrolimus, everolimus)
• medicines used to manage infections (Ex. clarithromycin, erythromycin, telithromycin, troleandomycin, rifabutin, clotrimazole, fluconazole, itraconazole, rifampicin, ketoconazole, voriconazole)
• medicines used for heart problems (Ex. enalapril, nicardipine, verapamil, diltiazem, simvastatin, fenofibrate)
• medicines used for fits (Ex. carbamazepine, phenobarbital, phenytoin)
• medicines to manage ulcers or other gut disorders (Ex. cisapride, cimetidine, metoclopramide)
• bromocri
• danazol (used to manage gynaecological disorders)
• medicines used for HIV and hepatitis C (Ex. ritonavir, indinavir, boceprevir, telaprevir, letermovir)
• St. John’s Wort (used in depression)
• live vaccines

B. Drug - Food interaction:

Do not drink grapefruit juice while taking SIROMUS 1MG TABLET.

Overdosage:

If you or anyone else accidentally take too much of SIROMUS 1MG TABLET, consult
your doctor immediately or visit the nearby hospital.

Synopsis

Drug	:	Sirolimus
Pharmacological Category	:	mTOR Inhibitors
Therapeutic Indication	:	Prevention of transplant rejection
Dosage Forms	:	Tablet

More Information

• Keep SIROMUS 1MG TABLET out of reach of children
• Store SIROMUS 1MG TABLET below 25°C

FAQs About SIROMUS 1MG TABLET

Does SIROMUS 1MG TABLET affect male fertility?

Decreased sperm count has been associated with the use of SIROMUS 1MG TABLET and
it usually returns to normal once management is discontinued. Consult your
doctor for further queries.

What if I miss a dose of SIROMUS 1MG TABLET?

If you miss a dose of SIROMUS 1MG TABLET, take it as soon as you remember.
However, skip that dose if it's almost time for the next one. Do not take
SIROMUS 1MG TABLET two times to make up for the missed dose. Remember to always
take SIROMUS 1MG TABLET and ciclosporin approximately 4 hours apart.

Can I stop taking SIROMUS 1MG TABLET on my own?

Do not stop taking SIROMUS 1MG TABLET unless your doctor tells you to, as doing
so might increase the risk of losing your transplant. Consult your doctor for
further queries.

What are the precautionary measures to follow while taking SIROMUS 1MG
TABLET?

Do not drink grapefruit juice while taking SIROMUS 1MG TABLET. Inform your
doctor if you have liver problem, body mass index more than 30 kg/m2,
intolerance to certain sugars or had a previously failed kidney transplant.
Patients should also tell if they are pregnant, breast-feeding or allergic to
anything.

Can SIROMUS 1MG TABLET be given to children?

No. SIROMUS 1MG TABLET is used for adults and not recommended for children and
adolescents below 18 years of age. Consult your child’s doctor for advice. The
physician will determine a proper dose or select a suitable alternative
management for your child.

Useful Diagnostic Tests

• Blood tests
• Kidney function test
• Liver function test