Consumer Information for: APO-TACROLIMUS CAPSULES

• APO-TACROLIMUS CAPSULES is used to help prevent organ rejection.

• It is used in patients who have received a kidney, a liver transplant or a heart transplant.

• It is used along with other medicines.

• APO-TACROLIMUS CAPSULES is the brand name for tacrolimus immediate release capsules.

Your immune system is your body’s defence system. Immunity is the way your body protects itself from infections and other foreign material. When you receive a transplant, your immune system recognizes the transplanted organ as foreign and will try to reject it. APO-TACROLIMUS CAPSULES is an anti-rejection drug that helps your body accept your transplanted organ.

Medicinal ingredients: tacrolimus

Non-medicinal ingredients:

APO-TACROLIMUS CAPSULES contain colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl methylcellulose, lactose monohydrate, and magnesium stearate. The capsule shells contain gelatin, iron oxide red (5 mg only), pharmaceutical ink, and titanium dioxide. The pharmaceutical ink contains ammonium hydroxide, iron oxide black, propylene glycol and shellac glaze.

APO-TACROLIMUS CAPSULES is available in 1 mg and 5 mg immediate release capsules.

• you are allergic to tacrolimus.

• you are allergic to any of the other ingredients in this medication or to a component of the container.

• have heart problems including congenital or acquired QT prolongation.

• have or have had kidney problems.

• have a rare hereditary disease of galactose intolerance, such as the Lapp lactase deficiency or glucose-galactose malabsorption, because APO-TACROLIMUS CAPSULES contain lactose.

• are taking a diuretic.

• were previously taking cyclosporine to protect your organ.

Vaccinations and other medicines:

• APO-TACROLIMUS CAPSULES is often given with other medications. Make sure you know if you are to stop, or continue, other immunosuppressive drugs you had been taking.

• Talk to your doctor if you have had or are planning to have any vaccinations including live vaccines. The vaccination may not work as well as it should or may result in serious side effects.

• You should avoid taking too much potassium while you are taking APO-TACROLIMUS CAPSULES. Talk to your doctor if you are not sure if your potassium intake is high.

New onset diabetes:

• APO-TACROLIMUS CAPSULES may cause new onset diabetes in kidney transplant patients. Your doctor may order tests to monitor your blood glucose levels.

General:

• Be sure that you are taking the correct dose and correct formulation of tacrolimus (APO-TACROLIMUS CAPSULES, immediate release capsules) prescribed by your doctor

Pregnancy:

• Tell your doctor if you are pregnant, think you might be pregnant, are planning to become pregnant, or father a child while taking APO-TACROLIMUS CAPSULES. APO-TACROLIMUS CAPSULES can cause abnormalities and malformations in an unborn baby. You should not use APO-TACROLIMUS CAPSULES if you are pregnant unless advised by your doctor. It is not known if it will harm your unborn baby.

You should use a reliable method of birth control before, during your treatment and for 6 weeks after stopping your treatment with APO-TACROLIMUS CAPSULES.

Breastfeeding:

• Tell your doctor if you are breastfeeding or planning to breastfeed your baby. APO-TACROLIMUS CAPSULES can pass into your breast milk. It is not known if this can harm your baby. You should not breastfeed your baby while you are taking APO-TACROLIMUS CAPSULES.

Skin protection:

• APO-TACROLIMUS CAPSULES may increase your chances of getting some kinds of cancer including skin cancer. You must protect your skin from sunlight and UV light. Wear protective clothing and use a sunscreen with a high sun protection factor (SPF 30 or higher) while you are taking APO-TACROLIMUS CAPSULES.

Driving and using machines:

• APO-TACROLIMUS CAPSULES may cause vision and nervous system problems. Wait until you know how APO-TACROLIMUS CAPSULES affects you before driving or using machines.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines. Tell all health professionals you see that you are taking APO-TACROLIMUS CAPSULES.

• Antacids: magnesium aluminum hydrochloride

• Medicines used to treat irregular heart rhythm such as amiodarone

• Medicines used for fungal infections such as clotrimazole, fluconazole, ketoconazole, itraconazole, voriconazole

• Medicines used to treat circulation and heart problems such as diltiazem, nicardipine, nifedipine, verapamil

• Medicines used to treat stomach disorders such as cisapride, metoclopramide, lansoprazole, omeprazole

• Medicines used for bacterial infections such as erythromycin, clarithromycin, troleandomycin

• Other drugs such as bromocriptine, cimetidine, chloramphenicol, cyclosporine, danazol, ethinyl estradiol, methylprednisolone, nefazodone

• Medicines used to treat HIV infection such as ritonavir, nelfinavir, and saquinavir

• Medicines used to treat HCV infection such as sofosbuvir, telaprevir and boceprevir

• Cytomegalovirus (CMV) antiviral medicines such as letermovir

• Anticonvulsant medicines used to control seizure such as carbamazepine, phenobarbital, phenytoin

• Anti-infective medicines used to treat tuberculosis such as rifampin, rifabutin, caspofungin

• Sirolimus, a medicine used to avoid rejection of the kidney transplant

• Potassium sparing diuretics such as amiloride, triamterene, or spironolactone

• St. John’s wort (Hypericum perforatum), an herbal product used for depression

• Schisandra sphenanthera extracts, an herbal product with various uses

• Grapefruits or grapefruit juice

• Take APO-TACROLIMUS CAPSULES exactly as your doctor has told you to. Your doctor will tell you when and how many times a day to take APO-TACROLIMUS CAPSULES.

• Try to take your doses at the same time every day. This will help keep the same amount of tacrolimus in your body so it can continue to protect your transplanted organ.

• Space your doses of APO-TACROLIMUS CAPSULES as evenly as you can throughout the day. For example, if you take APO-TACROLIMUS CAPSULES twice a day, doses should be 12 hours apart. Ask your transplant nurse or pharmacist about a dosing schedule that best fits your lifestyle.

• APO-TACROLIMUS CAPSULES may be taken with or without food, but it is best to be consistent. Once you decide when you are going to take it in relation to food, do it the same way each time.

• Swallow the capsules whole. Do not cut, crush, or chew the APO-TACROLIMUS CAPSULES.

• Avoid contact of your skin or mucous membranes with the tacrolimus powder inside the APO-TACROLIMUS CAPSULES. If such contact occurs, wash the skin and eyes.

Make sure that you receive the same tacrolimus medicine every time you collect your prescription. If the appearance of APO-TACROLIMUS CAPSULES is not the same as usual, if dosage instructions have changed or if the brand name has changed, speak to your doctor or pharmacist as soon as possible to make sure that you have the right medicine. Serious side effects can occur if you do not take the exact tacrolimus medication that you are supposed to take. You need to be taking the exact tacrolimus medicine prescribed to you by your doctor to ensure that your organ is protected.

Your doctor will give you specific instructions about how much APO-TACROLIMUS CAPSULES you should take each day. Your doctor has decided the dose you should take based on your medical condition and response to the drug. It is very important to take the exact amount of APO-TACROLIMUS CAPSULES that your doctor has told you.

Blood tests are one of the ways your doctor decides how much APO-TACROLIMUS CAPSULES you need. Based on these tests and your response to APO-TACROLIMUS CAPSULES, your doctor may change your dose from time to time. Do not change your dose on your own.

Missing even a few doses of APO-TACROLIMUS CAPSULES may cause your body to reject your transplanted organ. That is why it is very important to take each dose as your doctor prescribed. If you have trouble remembering doses, or if you are not sure how to take them, talk to your doctor. Be sure to discuss any concerns you have about taking APO-TACROLIMUS CAPSULES as prescribed.

If you do miss a dose of APO-TACROLIMUS CAPSULES, do not try to catch up on your own and take a missed dose. Instead, call your doctor or pharmacist right away for advice. Ask your doctor ahead of time what to do about missed doses.

Never allow your medication to run out between refills. Be sure to take enough medication with you when you will be away from home for a long period of time.

These are not all the possible side effects you may feel when taking APO-TACROLIMUS CAPSULES. If you experience any side effects not listed here, contact your healthcare professional.

Common side effects may include:

• Anxiety

• Constipation

• Diarrhea

• Edema (swelling) of the legs and arms

• Headache

• Insomnia

• Tremor (shaking), especially of the hands

APO-TACROLIMUS CAPSULES can cause abnormal blood test results. Your doctor may perform blood tests and will interpret the results.

Like other medicines, APO-TACROLIMUS CAPSULES may cause side effects in some people. If you think that you are having side effects, talk to your doctor right away. DO NOT stop taking APO-TACROLIMUS CAPSULES on your own.

It is important to regularly tell your doctor how you are feeling and if you have developed any new symptoms while taking APO-TACROLIMUS CAPSULES.

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Keep APO-TACROLIMUS CAPSULES out of the reach and away from children. A child who accidentally takes APO-TACROLIMUS CAPSULES may be seriously harmed. All drugs should be kept in a locked drawer or cupboard if there are children who may accidentally take your drugs. Should anyone accidentally or mistakenly take APO-TACROLIMUS CAPSULES, contact your physician immediately.

Always store APO-TACROLIMUS CAPSULES at controlled room temperature 15°C to 30°C in the container or package that was dispensed by your pharmacist. Protect from light and moisture.

• Talk to your healthcare professional

• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (http://www.apotex.ca/products), or by calling 1-800-667-4708.

This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.

Last Revised: DEC 07, 2023

• APO-TACROLIMUS CAPSULES is used to treat rheumatoid arthritis (RA) in adult patients.

• It is used in patients whose RA could not be treated with other medicines, called disease modifying anti-rheumatic drugs (DMARDs).

• It is used alone or in combination with other medicines.

A normal immune system leaves healthy body tissues alone. In people with rheumatoid arthritis, the immune system attacks normal body tissues causing damage and inflammation, especially in the tissues of your joints.

The way tacrolimus works in rheumatoid arthritis is not known. Approximately 8 weeks of treatment with APO-TACROLIMUS CAPSULES may be required before any significant improvement is seen in your symptoms of rheumatoid arthritis.

Medicinal ingredients: tacrolimus

Non-medicinal ingredients:

APO-TACROLIMUS CAPSULES contain colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl methylcellulose, lactose monohydrate, and magnesium stearate. The capsule shells contain gelatin, iron oxide red (5 mg only), pharmaceutical ink, and titanium dioxide. The pharmaceutical ink contains ammonium hydroxide, iron oxide black, propylene glycol and shellac glaze.

APO-TACROLIMUS CAPSULES is available in 1 mg and 5 mg immediate release capsules.

• you are allergic to tacrolimus.

• you are allergic to any of the other ingredients in this medication or to a component of the container.

• have heart problems including congenital or acquired QT prolongation.

• have or have had kidney problems.

• have a rare hereditary disease of galactose intolerance, such as the Lapp lactase deficiency or glucose-galactose malabsorption, because APO-TACROLIMUS CAPSULES contain lactose.

• are taking a diuretic.

• were previously taking cyclosporine to protect your organ.

Vaccinations and other medicines:

• APO-TACROLIMUS CAPSULES is often given with other medications. Make sure you know if you are to stop, or continue, other drugs you had been taking.

• Talk to your doctor if you have had or are planning to have any vaccinations including live vaccines. The vaccination may not work as well as it should or may result in serious side effects.

Pregnancy:

• Tell your doctor if you are pregnant, think you might be pregnant, are planning to become pregnant, or father a child while taking APO-TACROLIMUS CAPSULES. APO-TACROLIMUS CAPSULES can cause abnormalities and malformations in an unborn baby. You should not use APO-TACROLIMUS CAPSULES if you are pregnant unless advised by your doctor. It is not known if it will harm your unborn baby. You must use a reliable method of birth control before, during your treatment and for 6 weeks after stopping your treatment with APO-TACROLIMUS CAPSULES.

Breastfeeding:

• Tell your doctor if you are breastfeeding or planning to breastfeed your baby. APO-TACROLIMUS CAPSULES can pass into your breast milk. It is not known if this can harm your baby. You should not breastfeed your baby while you are taking APO-TACROLIMUS CAPSULES.

Skin protection:

• APO-TACROLIMUS CAPSULES may increase your chances of getting some kinds of cancer including skin cancer. You must protect your skin from sunlight and UV light. Wear protective clothing and use a sunscreen with a high sun protection factor (SPF 30 or higher) while you are taking APO-TACROLIMUS CAPSULES.

Driving and using machines:

• APO-TACROLIMUS CAPSULES may cause vision and nervous system problems. Wait until you know how APO-TACROLIMUS CAPSULES affects you before driving or using machines.

General:

• Be sure that you are taking the correct dose and correct formulation of tacrolimus (APO-TACROLIMUS CAPSULES, immediate release capsules) prescribed by your doctor

• Tell all doctors you see that you are taking APO-TACROLIMUS CAPSULES.

• Antacids: magnesium aluminum hydrochloride

• Medicines used to treat irregular heart rhythm such as amiodarone

• Medicines used for fungal infections such as clotrimazole, fluconazole, ketoconazole, itraconazole, voriconazole

• Medicines used to treat circulation and heart problems such as diltiazem, nicardipine, nifedipine, verapamil

• Medicines used to treat stomach disorders such as cisapride, metoclopramide, lansoprazole, omeprazole

• Medicines used for bacterial infections such as erythromycin, clarithromycin, troleandomycin

• Other drugs such as bromocriptine, cimetidine, chloramphenicol, cyclosporine, danazol, ethinyl estradiol, methylprednisolone, nefazodone

• Medicines used to treat HIV infection such as ritonavir, nelfinavir, and saquinavir

• Medicines used to treat HCV infection such as sofosbuvir, telaprevir and boceprevir

• Cytomegalovirus (CMV) antiviral medicines such as letermovir

• Anticonvulsant medicines used to control seizure such as carbamazepine, phenobarbital, phenytoin

• Anti-infective medicines used to treat tuberculosis such as rifampin, rifabutin, caspofungin

• Sirolimus, a medicine used to avoid rejection of the kidney transplant

• Potassium sparing diuretics such as amiloride, triamterene, or spironolactone

• St. John’s wort (Hypericum perforatum), an herbal product used for depression

• Schisandra sphenanthera extracts, an herbal product with various uses

• Grapefruits or grapefruit juice

APO-TACROLIMUS CAPSULES may be taken with or without food, but it is best to be consistent. Once you decide when you are going to take it in relation to food, do it the same way each time.

Swallow the capsules whole. Do not cut, crush, or chew the APO-TACROLIMUS CAPSULES.

Avoid contact of your skin or mucous membranes with the tacrolimus powder inside the APO-TACROLIMUS CAPSULES. If such contact occurs, wash the skin and eyes.

Try to take your doses at the same time every day.

Your doctor will decide the dosage. The usual adult dosage is 3 mg taken once daily.

Make sure that you receive the same tacrolimus medicine every time you collect your prescription. If the appearance of APO-TACROLIMUS CAPSULES is not the same as usual, speak to your doctor or pharmacist as soon as possible to make sure that you have the right medicine.

If you do miss a dose of APO-TACROLIMUS CAPSULES, skip this dose and take the next one at the regular scheduled time; do not take twice your dose. Call your doctor or pharmacist right away for advice. It is also a good idea to ask your doctor ahead of time what to do about missed doses.

Do not allow your medication to run out between refills. Be sure to take enough medication with you when you will be away from home for a long extended period of time.

These are not all the possible side effects you may feel when taking APO-TACROLIMUS CAPSULES. If you experience any side effects not listed here, contact your healthcare professional.

Common side effects may include:

• Anxiety

• Constipation

• Diarrhea

• Edema (swelling) of the legs and arms

• Headache

• Insomnia

• Tremor (shaking), especially of the hands

APO-TACROLIMUS CAPSULES can cause abnormal blood test results. Your doctor may perform blood tests and will interpret the results.

Like other medicines, APO-TACROLIMUS CAPSULES may cause side effects in some people. If you think that you are having side effects, talk to your doctor right away.

It is important to regularly tell your doctor how you are feeling and if you have developed any new symptoms while taking APO-TACROLIMUS CAPSULES.

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Keep APO-TACROLIMUS CAPSULES out of the reach and away from children. A child who accidentally takes APO-TACROLIMUS CAPSULES may be seriously harmed. All drugs should be kept in a locked drawer or cupboard if there are children who may accidentally take your drugs. Should anyone accidentally or mistakenly take APO-TACROLIMUS CAPSULES, contact your physician immediately.

Always store APO-TACROLIMUS CAPSULES at controlled room temperature 15°C to 30°C in the container or package that was dispensed by your pharmacist. Protect from light and moisture.

• Talk to your healthcare professional

• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (http://www.apotex.ca/products), or by calling 1-800-667-4708.

This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.

Last Revised: DEC 18, 2023