TACRORITE 1mg Capsule 10's

Introduction About TACRORITE 1MG CAPSULE

TACRORITE 1MG 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 TACRORITE 1MG CAPSULE regularly as
instructed by your doctor. While undergoing therapy with TACRORITE 1MG 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 TACRORITE 1MG CAPSULE, avoid exposing your skin towards direct sunlight.
Wear protective loose-fitting clothes and apply sunscreen while going outdoors.

Before taking TACRORITE 1MG CAPSULE inform your doctor if you have any liver,
kidney or heart problems. Avoid consuming grapefruit or drinking grapefruit
juice while taking TACRORITE 1MG CAPSULE as it may increase the risk of side
effects.

Do not take TACRORITE 1MG CAPSULE without consulting your doctor if you are
pregnant or breastfeeding. Both men and women taking TACRORITE 1MG CAPSULE must
use a suitable contrace
pills) to avoid pregnancy while undergoing therapy with TACRORITE 1MG CAPSULE.

The most common side effects of taking TACRORITE 1MG 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 TACRORITE 1MG CAPSULE

• Prevents graft rejection following organ transplantation

How TACRORITE 1MG CAPSULE Works

TACRORITE 1MG 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 TACRORITE 1MG CAPSULE

Take TACRORITE 1MG 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
TACRORITE 1MG CAPSULE without consulting your doctor.

Side Effects Of TACRORITE 1MG 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 TACRORITE 1MG 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 TACRORITE 1MG 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 TACRORITE 1MG 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

TACRORITE 1MG 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
avoid pregnancy while undergoing therapy with TACRORITE 1MG CAPSULE.

!### Breastfeeding

TACRORITE 1MG 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 TACRORITE 1MG CAPSULE.

!### Alcohol

Avoid consum
you feel dizzier or sleepy.

!### Kidney

TACRORITE 1MG CAPSULE should be used with caution in patients with kidney
problems. Therefore, consult your doctor before taking it.

!### Liver

TACRORITE 1MG 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 TACRORITE 1MG CAPSULE if you are allergic to
Tacrolimus or to any macrolide antibiotics (such as erythromycin, azithromycin).

!### Heart Disease

TACRORITE 1MG 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 TACRORITE 1MG 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 TACRORITE 1MG 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:

TACRORITE 1MG CAPSULE should be used with caution in elderly patients.
Therefore, consult your doctor before taking it.

Interactions

A. Drug-Drug interactions:

Before taking TACRORITE 1MG 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:

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

Overdosage:

If you or anyone else accidentally took more TACRORITE 1MG 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 TACRORITE 1MG CAPSULE out of reach of children
• Store TACRORITE 1MG CAPSULE at room temperature

FAQs About TACRORITE 1MG CAPSULE

What is the use of TACRORITE 1MG CAPSULE?

TACRORITE 1MG 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 TACRORITE 1MG CAPSULE works?

TACRORITE 1MG 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 TACRORITE 1MG CAPSULE?

Take TACRORITE 1MG 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 TACRORITE 1MG CAPSULE?

Take TACRORITE 1MG 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 TACRORITE 1MG CAPSULE an antibiotic?

No. TACRORITE 1MG 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 TACRORITE 1MG CAPSULE?

TACRORITE 1MG CAPSULE must be taken 1 hour before meals or 2-3 hour after meals.
Avoid drinking grapefruit juice while taking TACRORITE 1MG CAPSULE. During
management with TACRORITE 1MG CAPSULE, avoid exposing your skin towards direct
sunlight. Wear protective loose-fitting clothes and apply sunscreen while going
outdoors. Before taking TACRORITE 1MG 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 TACRORITE 1MG CAPSULE must use a suitable contrace
method (such as condoms or oral contrace
undergoing therapy with TACRORITE 1MG CAPSULE.

How long should I take TACRORITE 1MG CAPSULE?

You need to take TACRORITE 1MG 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 TACRORITE 1MG CAPSULE?

If you forgot to take a dose of TACRORITE 1MG CAPSULE, take it as soon as you
remember. However, if it is time for the next dose of TACRORITE 1MG CAPSULE,
skip the missed dose and take the next one regularly. Do not take a double dose
of TACRORITE 1MG CAPSULE to compensate for the missed ones.

Is TACRORITE 1MG CAPSULE safe?

The most common side effects of taking TACRORITE 1MG 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 TACRORITE 1MG CAPSULE without consulting your doctor?

No. You should not stop taking TACRORITE 1MG CAPSULE without consulting your
doctor because your body’s immune system may once again attempt to reject the
newly transplanted organ. Therefore, take TACRORITE 1MG CAPSULE for the
stipulated duration recommended by your doctor to achieve maximum results.

What happens if I take too more of TACRORITE 1MG CAPSULE?

If you or anyone else accidentally took more TACRORITE 1MG 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 TACRORITE 1MG CAPSULE if I suffer from kidney diseases?

TACRORITE 1MG CAPSULE should be used with caution in patients with kidney
problems. Therefore, consult your doctor before taking it.

Will taking a higher dose of TACRORITE 1MG CAPSULE be more effective?

No, taking a higher dose of TACRORITE 1MG 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 TACRORITE 1MG
CAPSULE?

It is not advisable to take medicines to control blood pressure while taking
TACRORITE 1MG CAPSULE without consulting your doctor as they have known
interactions with TACRORITE 1MG CAPSULE.

Can TACRORITE 1MG CAPSULE be used in pregnant women?

TACRORITE 1MG 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 TACRORITE 1MG CAPSULE should I take?

TACRORITE 1MG 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 TACRORITE 1MG CAPSULE cause constipation?

Yes. Constipation is a common side effect of using TACRORITE 1MG 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 TACRORITE 1MG CAPSULE affect fertility?

TACRORITE 1MG CAPSULE may affect fertility in both men and women. Therefore, try
to avoid pregnancy while undergoing therapy with TACRORITE 1MG CAPSULE. Both men
and women must use a suitable contrace
contrace
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