Arpimune O 50mg Capsule 5'S

Introduction About ARPIMUNE O 50MG CAPSULE

ARPIMUNE O 50MG CAPSULE contains Cyclosporine which belongs to the group of
medicines called Immunosuppressants. It is used to manage graft rejection in
patients undergoing transplantation of any organ, bone marrow or stem cells.

It can also be used to manage various auto-immune disease conditions such as
psoriasis, atopic dermatitis (or eczema), rheumatoid arthritis (joint
inflammation), nephrotic syndrome (a kidney disease) or eye inflammation (such
as endogenous uveitis, including Behçet's uveitis). It is mostly used in
combination with other immune suppressants (such as azathioprine) to achieve
maximum benefits.

Take ARPIMUNE O 50MG CAPSULE regularly as instructed by your doctor. While
undergoing therapy with ARPIMUNE O 50MG CAPSULE your doctor will periodically
monitor your blood pressure, blood cholesterol levels, liver and kidney
functions to avoid the risk of side effects.

Your doctor may also prescribe you blood tests and urine tests at regular
intervals to access the improvement in your health conditions. During management
with ARPIMUNE O 50MG CAPSULE, avoid exposing your skin towards direct sunlight.
Wear protective loose-fitting clothes and apply sunscreen while going outdoors.

Before taking ARPIMUNE O 50MG CAPSULE inform your doctor if you have any liver
problems or any signs of infections (such as fever or sore throat). You must
also inform your doctor if you have hepatitis C infection, fits, low blood
magnesium levels, gout, alcohol dependence or if you are about to receive any
vaccinations as a precaution.

ARPIMUNE O 50MG CAPSULE is not recommended for use in patients with severe
uncontrollable infections, any types of cancer or severe high blood pressure. Do
not take ARPIMUNE O 50MG CAPSULE without consulting your doctor if you are
pregnant or breastfeeding.

Avoid consuming grapefruit or drinking grapefruit juice while taking ARPIMUNE O
50MG CAPSULE as it may increase the risk of side effects. The most common side
effects of taking ARPIMUNE O 50MG CAPSULE are increase in blood sugar levels,
increase in blood cholesterol levels, increased blood potassium levels, high
blood pressure, headache, loss of appetite, acne, hot flushes, tiredness,
excessive facial hair and low blood magnesium levels in blood. Consult your
doctor if any of these side effects worsen.

Uses Of ARPIMUNE O 50MG CAPSULE

• Prevents graft rejection following organ transplantation
• Manage auto-immune skin diseases such as psoriasis or atopic dermatitis
• Manage rheumatoid arthritis (joint inflammation)
• Manage nephrotic syndrome (a kidney disease)
• Manage eye inflammation (such as endogenous uveitis, including Behçet's uveitis)

How ARPIMUNE O 50MG CAPSULE Works

ARPIMUNE O 50MG CAPSULE is an immunosuppressive agent. It works by blocking the
release of certain chemicals in the body (such as T-cells, interleukins and
cytokines) that triggers the immune response. This action suppresses your body’s
immune functions and enables your body to accept the newly transplanted organ.
It also stops the abnormal immune response in the body and manages your body
from attacking its own cells.

How to use ARPIMUNE O 50MG CAPSULE

Take ARPIMUNE O 50MG CAPSULE as directed by your physician. Swallow the medicine
with a glass of water. Do not crush or chew the medicine.

Your doctor will decide the correct dose and duration of therapy for you
depending upon your age, body weight and disease condition. Do not stop taking
ARPIMUNE O 50MG CAPSULE without consulting your doctor.

Side Effects Of ARPIMUNE O 50MG CAPSULE

Common

• high blood pressure
• headache, shakiness
• nausea, vomiting, loss of appetite, stomach pain, diarrhoea
• acne, hot flushes, fever, tiredness
• excessive facial hair
• high blood cholesterol levels
• high blood sugar levels
• tingling sensation in the body
• muscle spasm, swollen gums
• high blood levels of uric acid or potassium
• low levels of magnesium in blood

Uncommon

• lack of sleep
• oedema, weight gain

Rare

• inflammation of the pancreas, severe upper stomach pain
• menstrual irregularities, breast enlargement in men

Stop taking ARPIMUNE O 50MG CAPSULE and contact your doctor immediately if you
experience any of the following side effects:

• signs of infections (such as fever or sore throat)
• signs of brain infection called progressive multifocal leukoencephalopathy (such as vision changes, loss of coordination, being clumsy, memory loss, problems in speaking or understanding, muscle weakness)
• brain problems (causing seizures, confusion, disorientation, lack of response, behavioural changes, agitation, sleeplessness, vision changes, paralysis, stiff neck, loss of coordination with or without unusual speech or eye movements)
• swelling at the back of the eye with blurred vision
• signs of liver problems (such as yellow skin and eyes, nausea, loss of appetite and dark urine)
• low urine output, kidney problems
• low level of red blood cells or platelets (causing pale skin, tiredness, breathlessness, having dark urine, bruising or bleeding with no obvious reasons, confusion, disorientation, being less alert and having kidney problems)

How To Manage Side Effects

Nausea or vomiting:

Try to take ARPIMUNE O 50MG CAPSULE with or just after meals. Stick to simple
meals and avoid oil rich or spicy foods. Consult your doctor if nausea worsens.

Headache:

Rest and relax. Keep yourself hydrated by drinking plenty of fluids such as
water or electrolytes. Applying a pain-relieving balm on your forehead can be
beneficial. Do not consume excessive alcohol, as it could aggravate your
headache. Consult your doctor if your headache worsens.

Warning & Precautions

!### Pregnancy

ARPIMUNE O 50MG CAPSULE is not recommended for use in pregnant women unless
considered necessary by the physician. Therefore, consult your doctor before
taking it.

!### Breastfeeding

ARPIMUNE O 50MG CAPSULE may pass through the breast milk. Therefore, it is not
recommended for use in breastfeeding woman. However, consult your doctor before
taking it.

!### Driving and Using Machines

Do not drive or operate any heavy tools or machines if your ability is affected
by ARPIMUNE O 50MG CAPSULE.

!### Alcohol

Avoid consum
worsen your condition.

!### Kidney

ARPIMUNE O 50MG CAPSULE is not recommended for use in patients with other kidney
problems (except for nephrotic syndrome). Therefore, consult your doctor before
taking it.

!### Liver

ARPIMUNE O 50MG CAPSULE should be used with caution in patients with liver
problems (including Hepatitis C infection). Therefore, consult your doctor
before taking it.

!### Allergy

Talk to your doctor before taking ARPIMUNE O 50MG CAPSULE if you are allergic to
cyclosporine.

Others

ARPIMUNE O 50MG CAPSULE is not recommended for use if you:

• have severe infections in the body which is unable to control
• have any type of cancer
• have uncontrollably high blood pressure

Before taking ARPIMUNE O 50MG CAPSULE inform your doctor if you:

• have any signs of infection, such as fever or sore throat
• have low levels of magnesium in the body
• have high blood potassium levels
• have gout (joint pain caused due to fluid accumulation)
• are about to receive any vaccination
• have or ever had alcohol-related problems
• have epilepsy

Use in paediatrics:

ARPIMUNE O 50MG CAPSULE should only be used to manage nephrotic syndrome in
children. It is generally not recommended for managing graft rejection or for
managing other auto-immune disease condition apart from nephrotic syndrome in
children. Therefore, consult your doctor before taking it.

Use in geriatrics:

ARPIMUNE O 50MG CAPSULE should be used with caution in elderly patients.
Therefore, consult your doctor before taking it. Proper dose adjustments and
careful monitoring are required in such patients.

Interactions

A. Drug - Drug interactions:

Before taking ARPIMUNE O 50MG CAPSULE, inform your doctor if you are taking any
of the following medicines such as:

• St. John’s Wort (an herbal medicine used to manage depression)
• dabigatran etexilate (a medicine used to manage blood clots after surgery)
• bosentan or aliskiren (medicines used to manage high blood pressure)
• vaccines
• medicines that can increase blood potassium levels in the body (such as potassium supplements or potassium-sparing diuretics (Ex. amiloride, triamterene or spironolactone))
• methotrexate (a medicine used to manage cancer and severe rheumatoid arthritis)
• medicines used to manage bacterial infections (Ex. erythromycin, azithromycin, gentamycin, tobramycin, ciprofloxacin)
• medicines used to manage fungal infections (Ex. voriconazole, itraconazole, terbinafine, amphotericin B)
• medicines used for heart problems or high blood pressure (Ex. diltiazem, nicardipine, verapamil, digoxin, amiodarone)
• metoclopramide (a medicine used to stop nausea and vomiting)
• danazol (a medicine used to manage overgrowth in the uterus)
• oral contrace
• medicines used to manage gout (Ex. colchicine, allopurinol)
• medicines used to manage gallstones (Ex. ursodiol)
• medicines used to manage leukaemia and other cancers (Ex. imatinib, melphalan, etoposide, doxorubicin)
• barbiturates (used to reduce anxiety and to induce sleep) Ex. phenobarbital
• medicines used to manage epilepsy (Ex. carbamazepine, phenytoin, cannabidiol)
• octreotide (a medicine used to manage hormonal disorder, (acromegaly) and tumours)
• orlistat (a medicine that helps in weight loss)
• ticlopidine (a medicine used to manage blood clots due to platelet aggregation)
• other medicines used to supress immune system (Ex. everolimus, sirolimus, tacrolimus)
• medicine used to reduce pain and inflammation Ex. diclofenac
• medicines used to lower cholesterol levels (Ex. fenofibrate, atorvastatin, Fluvastatin)
• medicines used to manage tuberculosis (Ex. isoniazid, rifampicin)
• medicines used to manage HIV infections (Ex. acyclovir, ritonavir, nelfinavir, saquinavir, efavirenz, etravirine, nevirapine)
• medicines used to manage hepatitis C infection (Ex. telaprevir, boceprevir, the combination ombitasvir/paritaprevir/ritonavir with or without dasabuvir, elbasvir/grazoprevir and glecaprevir/pibrentasvir)
• medicines used to manage gastric problems (Ex. omeprazole, cimetidine, magnesium hydroxide, aluminum hydroxide)
• trimethoprim or cotrimoxazole (used to manage bacterial infections)
• corticosteroids (used to manage allergic or autoimmune diseases) Ex. prednisolone, methylprednisolone
• medicines used to manage diabetes (Ex. repaglinide)

B. Drug – food interactions

Avoid consuming grapes or grapefruit juice while taking ARPIMUNE O 50MG CAPSULE
as it may increase the risk of side effects.

Overdosage:

If you or anyone else accidentally took more ARPIMUNE O 50MG CAPSULE, consult
your doctor immediately or visit the nearby hospital. Symptoms of overdosage
might include vomiting, drowsiness, headache, fast heartbeat and kidney damage.

Synopsis

Drug	:	Cyclosporine
Pharmacological Category	:	Calcineurin inhibitors
Therapeutic Indication	:	Graft rejection, Autoimmune diseases
Dosage Forms	:	Tablet, Capsule, Injection, Infusion, Oral Solution, Oral Suspension, Eye Drops, Ophthalmic Emulsion

More Information

• Keep ARPIMUNE O 50MG CAPSULE out of reach of children
• Store ARPIMUNE O 50MG CAPSULE at room temperature

FAQs About ARPIMUNE O 50MG CAPSULE

What is the use of ARPIMUNE O 50MG CAPSULE?

ARPIMUNE O 50MG CAPSULE is used to manage graft rejection in patients undergoing
transplantation of any organ, bone marrow or stem cells. It can also be used to
manage various auto-immune disease conditions such as psoriasis, atopic
dermatitis (or eczema), rheumatoid arthritis, nephrotic syndrome or eye
inflammation (such as endogenous uveitis, including Behçet's uveitis).

How ARPIMUNE O 50MG CAPSULE works?

ARPIMUNE O 50MG CAPSULE is an immunosuppressive agent. It works by blocking the
release of certain chemicals in the body (such as T-cells, interleukins and
cytokines) that triggers the immune response. This action suppresses your body’s
immune functions and enables your body to accept the newly transplanted organ.
It also stops the abnormal immune response in the body and manages your body
from attacking its own cells.

How to take ARPIMUNE O 50MG CAPSULE?

Take ARPIMUNE O 50MG CAPSULE as directed by your physician. Swallow the medicine
with a glass of water. Do not crush or chew the medicine.

Is ARPIMUNE O 50MG CAPSULE an antibiotic?

No. ARPIMUNE O 50MG CAPSULE is an immunosuppressive agent. It suppresses your
body’s immune functions and enables your body to accept the transplanted organ.
It also stops the abnormal immune response in the body and manages your body
from attacking its own cells.

What precautions must be followed while taking ARPIMUNE O 50MG CAPSULE?

Before taking ARPIMUNE O 50MG CAPSULE inform your doctor if you have any liver
problems or any signs of infections (such as fever or sore throat). You must
also inform your doctor if you have hepatitis C infection, fits, low blood
magnesium levels, gout, alcohol dependence, severe uncontrollable infections,
any types of cancer, severe high blood pressure or if you are about to receive
any vaccinations as a precaution. Inform your doctor before taking ARPIMUNE O
50MG CAPSULE if you are pregnant or breastfeeding.

How long should I take ARPIMUNE O 50MG CAPSULE?

You need to take ARPIMUNE O 50MG CAPSULE for the stipulated duration prescribed
by your doctor. Your doctor will decide the correct dose and duration of therapy
for you depending upon your age, body weight and disease condition.

What to do if I forgot to take a dose of ARPIMUNE O 50MG CAPSULE?

If you forgot to take a dose of ARPIMUNE O 50MG CAPSULE, take it as soon as you
remember. However, if it is time for the next dose of ARPIMUNE O 50MG CAPSULE,
skip the missed dose and take the next one regularly. Do not take a double dose
of ARPIMUNE O 50MG CAPSULE to compensate the missed ones.

Is ARPIMUNE O 50MG CAPSULE safe?

The most common side effects of taking ARPIMUNE O 50MG CAPSULE are increase in
blood sugar levels, increase in blood cholesterol levels, increased blood
potassium levels, high blood pressure, headache, loss of appetite, acne, hot
flushes, tiredness, excessive facial hair and low blood magnesium levels in
blood. Consult your doctor if any of these side effects worsen.

Can I stop taking ARPIMUNE O 50MG CAPSULE without consulting your doctor?

No. You should not stop taking ARPIMUNE O 50MG CAPSULE without consulting your
doctor because your body’s immune system may once again attempt to reject the
newly transplanted organ. Therefore, take ARPIMUNE O 50MG CAPSULE for the
stipulated duration recommended by your doctor to achieve maximum results.

What happens if I take too more of ARPIMUNE O 50MG CAPSULE?

If you or anyone else accidentally took more ARPIMUNE O 50MG CAPSULE, consult
your doctor immediately or visit the nearby hospital. Symptoms of overdosage
might include vomiting, drowsiness, headache, fast heartbeat and kidney damage.

Can I use ARPIMUNE O 50MG CAPSULE if I suffer from kidney diseases?

ARPIMUNE O 50MG CAPSULE is not recommended for use in patients with other kidney
problems (except for nephrotic syndrome). Therefore, consult your doctor before
taking it.

Will taking a higher dose of ARPIMUNE O 50MG CAPSULE be more effective?

No, taking a higher dose of ARPIMUNE O 50MG CAPSULE will not be effective rather
it can lead to toxicity. Always take the dose prescribed by your doctor. If the
prescribed dose is not effective for you, consult your doctor for advice. Your
doctor might increase the dose or suggest an alternative therapy.

Can I take medication for high blood pressure along with ARPIMUNE O 50MG
CAPSULE?

It is not advisable to take medicines to control blood pressure while taking
ARPIMUNE O 50MG CAPSULE without consulting your doctor as they have known
interactions with ARPIMUNE O 50MG CAPSULE.

Can ARPIMUNE O 50MG CAPSULE be used in pregnant women?

ARPIMUNE O 50MG CAPSULE is not recommended for use in pregnant women unless
considered necessary by the physician. Therefore, consult your doctor before
taking it.

How much ARPIMUNE O 50MG CAPSULE should I take?

ARPIMUNE O 50MG CAPSULE should be used only under medical supervision. Your
doctor will decide the correct dose and duration of therapy for you depending
upon your age, body condition and severity of the disease condition.

Is ARPIMUNE O 50MG CAPSULE a steroid?

No. ARPIMUNE O 50MG CAPSULE is an immunosuppressive agent. It suppresses your
body’s immune functions and enables your body to accept the transplanted organ.
It also stops the abnormal immune response in the body and manages your body
from attacking its own cells.