Tacrolimus 0.5mg Capsule 10'S

Introduction About TACROLIMUS 0.5MG CAPSULE

TACROLIMUS 0.5MG CAPSULE contains Tacrolimus which belongs to the group of
medicines called Immunosuppressants. It is used to manage graft rejection in
patients undergoing organ transplantation. It can also be used to manage an
ongoing graft rejection of the newly transplanted organ. It is mostly used in
combination with other immune suppressants to achieve maximum benefits.

Tacrolimus suppresses your body’s immune functions and enables your body to
accept the transplanted organ. Take TACROLIMUS 0.5MG CAPSULE regularly as
instructed by your doctor. While undergoing therapy with TACROLIMUS 0.5MG
CAPSULE your doctor will periodically monitor your heart functions and nerve
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 TACROLIMUS 0.5MG CAPSULE, avoid exposing your skin towards direct sunlight.
Wear protective loose-fitting clothes and apply sunscreen while going outdoors.

Before taking TACROLIMUS 0.5MG CAPSULE inform your doctor if you have any liver,
kidney or heart problems. Avoid consuming grapefruit or drinking grapefruit
juice while taking TACROLIMUS 0.5MG CAPSULE as it may increase the risk of side
effects.

Do not take TACROLIMUS 0.5MG CAPSULE without consulting your doctor if you are
pregnant or breastfeeding. Both men and women taking TACROLIMUS 0.5MG CAPSULE
must use a suitable contrace
pills) to avoid pregnancy while undergoing therapy with TACROLIMUS 0.5MG
CAPSULE.

The most common side effects of taking TACROLIMUS 0.5MG CAPSULE are an increase
in blood sugar levels, increased blood cholesterol levels, difficulty in falling
asleep, increased blood potassium levels, high blood pressure, headache,
dizziness, indigestion, oedema and increased infections. Consult your doctor if
any of these side effects worsen.

Uses Of TACROLIMUS 0.5MG CAPSULE

• Prevents graft rejection following organ transplantation

How TACROLIMUS 0.5MG CAPSULE Works

TACROLIMUS 0.5MG CAPSULE is an immunosuppressive agent. It works by blocking the
release of certain chemicals in the body (such as T-cells) that triggers the
immune response. It suppresses your body’s immune functions and enables your
body to accept the transplanted organ. As a result, it manages the risk of graft
rejection and increases the survival of the newly transplanted organ.

How to use TACROLIMUS 0.5MG CAPSULE

Take TACROLIMUS 0.5MG CAPSULE 1 hour before meals or 2-3 hours after meals or 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 on your age, body weight and disease condition. Do not stop taking
TACROLIMUS 0.5MG CAPSULE without consulting your doctor.

Side Effects Of TACROLIMUS 0.5MG CAPSULE

Common

• increased blood sugar levels (diabetes)
• increased blood pressure
• increased potassium levels in the blood
• difficulty in falling asleep
• feeling shaky or trembling
• headache, dizziness
• liver problems, kidney problems
• nausea, vomiting
• stomach pain, diarrhea, constipation, bloating
• mouth ulcers
• low RBC and platelet count
• oedema (swelling of body parts)
• increased blood cholesterol levels
• feeling anxious, confused, disoriented or depressed
• fits, tingling and numbness of hands and feet
• eye sensitivity towards light, ringing sound in the ears
• abnormal or faster heartbeat
• skin rash and itching, acne, hair loss
• increased sweating
• pain in joints, limbs, back and feet, muscle spasms
• weight gain
• increased acidity in the blood

Rare

Stop taking TACROLIMUS 0.5MG CAPSULE and contact your doctor immediately if you
experience any of the following side effects such as:

• severe stomach pain with or without fever, chills, nausea and vomiting
• signs of skin cancer (such as growth or lump on the skin, dark patches on the skin, flesh-coloured or scar-like lesions, scaly patches on sun-exposed areas)
• signs of lymph cancer (enlarged lymph nodes with tiredness, fever, night sweats, itchy skin, weight loss)
• increased frequency of opportunistic infections (including skin infections, urinary tract infections, respiratory tract infections, stomach infections, oral infections, etc.)
• flu-like symptoms (such as fever, sore throat, cold, cough, feeling unwell)
• signs of brain infection (such as memory loss, difficulty in thinking, trouble in walking or vision loss)
• signs of kidney damage such as Haemolytic uraemic syndrome causing low urine output, extreme tiredness, yellowing of the skin or eyes and abnormal bruising or bleeding with signs of infection
• blurred vision, changes in colour of the vision or vision loss
• signs of allergic reactions (such as severe skin rash with itching, blistering and peeling of the skin, mouth, eyes, throat, genitals, swelling of the face and tongue, bleeding under the skin causing the appearance of red-pin point dots on the skin, skin swelling, along with fever, tiredness, confusion or jaundice)
• signs of heart problems (such as chest pain, vertigo, fainting, nausea, palpitations and difficulty in breathing)

How To Manage Side Effects

Nausea or vomiting:

Try to take TACROLIMUS 0.5MG CAPSULE with or just after meals. Stick to simple
meals and avoid oil-rich or spicy foods. Consult your doctor if the 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.

Dizziness:

Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or
machines completely while you are feeling dizzy. Do not consume excessive
alcohol, as it could aggravate your dizziness. Consult your doctor if your
dizziness worsens.

Constipation:

Taking TACROLIMUS 0.5MG CAPSULE with meals may reduce the chances of
constipation. However, if you experience constipation, eat plenty of fiber-rich
foods such as fresh fruits, vegetables and cereals. Drink plenty of fluids.
Exercise more regularly. Consult your doctor if this side effect bothers you.

Warning & Precautions

!### Pregnancy

TACROLIMUS 0.5MG CAPSULE should be used in pregnant women only if it is
considered necessary by the physician. Therefore, inform your doctor before
taking it. Women of childbearing potential must use a suitable contrace
method to avoid pregnancy while undergoing therapy with TACROLIMUS 0.5MG
CAPSULE.

!### Breastfeeding

TACROLIMUS 0.5MG CAPSULE may pass through 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 you experience dizziness
or sleepiness after taking TACROLIMUS 0.5MG CAPSULE.

!### Alcohol

Avoid consum
make you feel dizzier or sleepy.

!### Kidney

TACROLIMUS 0.5MG CAPSULE should be used with caution in patients with kidney
problems. Therefore, consult your doctor before taking it.

!### Liver

TACROLIMUS 0.5MG CAPSULE should be used with caution in patients with liver
problems. Therefore, consult your doctor before taking it.

!### Allergy

Talk to your doctor before taking TACROLIMUS 0.5MG CAPSULE if you are allergic
to Tacrolimus or to any macrolide antibiotics (such as erythromycin,
azithromycin).

!### Heart Disease

TACROLIMUS 0.5MG CAPSULE should be used with caution in patients with heart
problems (such as prolonged QT interval). Therefore, consult your doctor before
taking it.

Others

Before taking TACROLIMUS 0.5MG CAPSULE inform your doctor if you:

• are scheduled for any vaccination in the upcoming days
• high blood cholesterol levels
• have high blood potassium levels

Use in pediatrics:

The safety and effectiveness of TACROLIMUS 0.5MG CAPSULE have not been
established in children and adolescents (aged below 18 years) undergoing
transplantation. Therefore, consult your doctor before taking it.

Use in geriatrics:

TACROLIMUS 0.5MG CAPSULE should be used with caution in elderly patients.
Therefore, consult your doctor before taking it.

Interactions

A. Drug-Drug interactions:

Before taking TACROLIMUS 0.5MG CAPSULE inform your doctor if you are taking the
following medicines such as:

• St. John’s Wart (an herbal medicine used to manage depression)
• vaccinations
• cyclosporin, mycophenolic acid (other medicines used to suppress immune functions)
• medicines used to manage fungal infections (Ex. ketoconazole, fluconazole, clotrimazole, amphotericin B)
• macrolide antibiotics (Ex. erythromycin, clarithromycin, azithromycin, flucloxacillin)
• medicines used to manage tuberculosis (Ex. isoniazid, rifampicin)
• medicines used to manage HIV infections (Ex. acyclovir, ritonavir, nelfinavir, saquinavir, efavirenz, etravirine, nevirapine)
• Letemovir (a medicine used to manage human cytomegalovirus)
• medicines to manage fever and pain (Ex. metamizole, ibuprofen)
• medicines used to manage cancer (Ex. imatinib, crizotinib, nilotinib)
• 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)
• medicines used to manage nausea and vomiting (Ex. metoclopramide)
• medicines that can increase blood potassium levels (such as potassium supplements or potassium-sparing diuretics (Ex. amiloride, triamterene or spironolactone))
• trimethoprim or cotrimoxazole (used to manage bacterial infections)
• oral contrace
• medicines used to manage heart problems (Ex. nifedipine, verapamil, diltiazem, amiodarone)
• medicines used to control blood cholesterol levels (Ex. atorvastatin, fluvastatin)
• medicines used to manage fits (Ex. carbamazepine, phenytoin, cannabidiol)
• corticosteroids (used to manage allergic or autoimmune diseases) Ex. prednisolone, methylprednisolone
• medicines used to manage depression (Ex. nefazodone)
• medicines used to manage diabetes (Ex. metformin, glimepiride)
• extracts of Schisandra sphenanthera (used to manage mental illness)
• anticoagulants (used for blood thinning) Ex. warfarin, heparin

B. Drug-food interactions:

TACROLIMUS 0.5MG CAPSULE may interact with food. To avoid this, take TACROLIMUS
0.5MG CAPSULE 1 hour before meals or 2-3 hours after meals. Avoid consuming
grapes or grapefruit juice while taking TACROLIMUS 0.5MG CAPSULE as it may
increase the risk of side effects.

Overdosage:

If you or anyone else accidentally took more TACROLIMUS 0.5MG CAPSULE, consult
your doctor immediately or visit the nearby hospital. Symptoms of overdose might
include tremors, abnormal kidney function results in less or no urine output,
increased blood pressure, leg swelling and lack of energy.

Synopsis

Drug	:	Tacrolimus
Pharmacological Category	:	Calcineurin Inhibitors
Therapeutic Indication	:	Prevents graft rejection
Dosage Forms	:	Capsules, Tablets, Ointment, Lotion, solution, Topical Solution, Oral gel, eye ointment

More Information

• Keep TACROLIMUS 0.5MG CAPSULE out of reach of children
• Store TACROLIMUS 0.5MG CAPSULE at room temperature

FAQs About TACROLIMUS 0.5MG CAPSULE

What is the use of TACROLIMUS 0.5MG CAPSULE?

TACROLIMUS 0.5MG CAPSULE is used to manage graft rejection in patients
undergoing organ transplantation. It can also be used to manage an ongoing graft
rejection of the newly transplanted organ.

How TACROLIMUS 0.5MG CAPSULE works?

TACROLIMUS 0.5MG CAPSULE is an immunosuppressive agent. It works by blocking the
release of certain chemicals in the body (such as T-cells) that triggers the
immune response. It suppresses your body’s immune functions and enables your
body to accept the transplanted organ. As a result, it manages the risk of graft
rejection and increases the survival of the newly transplanted organ.

How to take TACROLIMUS 0.5MG CAPSULE?

Take TACROLIMUS 0.5MG CAPSULE 1 hour before meals or 2-3 hour after meals or as
directed by your physician. Swallow the medicine with a glass of water. Do not
crush or chew the medicine.

What is the best time to take TACROLIMUS 0.5MG CAPSULE?

Take TACROLIMUS 0.5MG CAPSULE 1 hour before meals or 2-3 hours after meals or as
directed by your physician. It is usually taken twice daily. However, your
doctor will decide the correct dose, duration of therapy and time of
administration for you depending on your age, body weight and disease condition.

Is TACROLIMUS 0.5MG CAPSULE an antibiotic?

No. TACROLIMUS 0.5MG CAPSULE is an immunosuppressive agent. It suppresses your
body’s immune functions and enables your body to accept the transplanted organ.

What precautions must be followed while taking TACROLIMUS 0.5MG CAPSULE?

TACROLIMUS 0.5MG CAPSULE must be taken 1 hour before meals or 2-3 hour after
meals. Avoid drinking grapefruit juice while taking TACROLIMUS 0.5MG CAPSULE.
During management with TACROLIMUS 0.5MG CAPSULE, avoid exposing your skin
towards direct sunlight. Wear protective loose-fitting clothes and apply
sunscreen while going outdoors. Before taking TACROLIMUS 0.5MG CAPSULE inform
your doctor if you have any liver, kidney or heart problems or if you are
pregnant or breastfeeding. Both men and women taking TACROLIMUS 0.5MG CAPSULE
must use a suitable contrace
pills) to avoid pregnancy while undergoing therapy with TACROLIMUS 0.5MG
CAPSULE.

How long should I take TACROLIMUS 0.5MG CAPSULE?

You need to take TACROLIMUS 0.5MG CAPSULE for the stipulated duration prescribed
by your doctor. Your doctor will decide the correct dose and duration of therapy
for you depending on your age, body weight and disease condition.

What to do if I forgot to take a dose of TACROLIMUS 0.5MG CAPSULE?

If you forgot to take a dose of TACROLIMUS 0.5MG CAPSULE, take it as soon as you
remember. However, if it is time for the next dose of TACROLIMUS 0.5MG CAPSULE,
skip the missed dose and take the next one regularly. Do not take a double dose
of TACROLIMUS 0.5MG CAPSULE to compensate for the missed ones.

Is TACROLIMUS 0.5MG CAPSULE safe?

The most common side effects of taking TACROLIMUS 0.5MG CAPSULE are an increase
in blood sugar levels, increased blood cholesterol levels, difficulty in falling
asleep, increased blood potassium levels, high blood pressure, headache,
dizziness, indigestion, oedema and increased infections. Consult your doctor if
any of these side effects worsen.

Can I stop taking TACROLIMUS 0.5MG CAPSULE without consulting your doctor?

No. You should not stop taking TACROLIMUS 0.5MG CAPSULE without consulting your
doctor because your body’s immune system may once again attempt to reject the
newly transplanted organ. Therefore, take TACROLIMUS 0.5MG CAPSULE for the
stipulated duration recommended by your doctor to achieve maximum results.

What happens if I take too more of TACROLIMUS 0.5MG CAPSULE?

If you or anyone else accidentally took more TACROLIMUS 0.5MG CAPSULE, consult
your doctor immediately or visit the nearby hospital. Symptoms of overdose might
include tremors, abnormal kidney function results in less or no urine output,
increased blood pressure, leg swelling and lack of energy.

Can I use TACROLIMUS 0.5MG CAPSULE if I suffer from kidney diseases?

TACROLIMUS 0.5MG CAPSULE should be used with caution in patients with kidney
problems. Therefore, consult your doctor before taking it.

Will taking a higher dose of TACROLIMUS 0.5MG CAPSULE be more effective?

No, taking a higher dose of TACROLIMUS 0.5MG 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 TACROLIMUS 0.5MG
CAPSULE?

It is not advisable to take medicines to control blood pressure while taking
TACROLIMUS 0.5MG CAPSULE without consulting your doctor as they have known
interactions with TACROLIMUS 0.5MG CAPSULE.

Can TACROLIMUS 0.5MG CAPSULE be used in pregnant women?

TACROLIMUS 0.5MG CAPSULE should be used in pregnant women only if it is
considered necessary by the physician. Therefore, consult your doctor before
taking it.

How much TACROLIMUS 0.5MG CAPSULE should I take?

TACROLIMUS 0.5MG 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.

Can TACROLIMUS 0.5MG CAPSULE cause constipation?

Yes. Constipation is a common side effect of using TACROLIMUS 0.5MG CAPSULE. Eat
plenty of fiber-rich foods such as fresh fruits, vegetables, cereals as well as
drink plenty of water and exercise more regularly when taking this medicine.
Contact your doctor if this side effect bothers you.

Can the use of TACROLIMUS 0.5MG CAPSULE affect fertility?

TACROLIMUS 0.5MG CAPSULE may affect fertility in both men and women. Therefore,
try to avoid pregnancy while undergoing therapy with TACROLIMUS 0.5MG CAPSULE.
Both men and women must use a suitable contrace
oral contrace
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