Details for: SANDOZ CYCLOSPORINE
Company: SANDOZ CANADA INCORPORATED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02247073 | SANDOZ CYCLOSPORINE | CYCLOSPORINE | 25 MG | CAPSULE | ORAL |
| 02247074 | SANDOZ CYCLOSPORINE | CYCLOSPORINE | 50 MG | CAPSULE | ORAL |
| 02242821 | SANDOZ CYCLOSPORINE | CYCLOSPORINE | 100 MG | CAPSULE | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Your doctor has prescribed the drug Sandoz Cyclosporine. It is
used after organ or bone marrow transplantations to help prevent
organ rejection, or to treat autoimmune conditions such as severe
psoriasis, severe rheumatoid arthritis and nephrotic syndrome.
Sandoz Cyclosporine is the brand name for a drug called
"cyclosporine". It belongs to a family of drugs known as
"immunosuppressants". These drugs work to "suppress" or
reduce the body's immune response.
What it does
Your body's immune system normally works to protect you from
infections and other foreign material. When you receive a
transplant, this system does not recognize the new organ, and
will try to reject it.
Sandoz Cyclosporine works to reduce this response, so your
body is more likely to accept the new organ.
Sandoz Cyclosporine does not completely suppress the immune
system, so your body will still have some infection-fighting
ability.
Sandoz Cyclosporine may be given alone, but is often given with
other drugs which also suppress your immune system. Together
these help prolong the life of an organ transplant, or to suppress
certain function of your immune system to treat your psoriasis,
rheumatoid arthritis or nephrotic syndrome.
When it should not be used
Do not use Sandoz Cyclosporine if you have ever had a bad,
unusual or allergic reaction to cyclosporine or any of the nonmedicinal
ingredients of Sandoz Cyclosporine. (See “What the
non-medicinal ingredients are”)
For the treatment of psoriasis, rheumatoid arthritis and nephrotic
syndrome, do not take Sandoz Cyclosporine if you have one of
the following conditions:
- abnormal kidney function (except for nephrotic syndrome);
- uncontrolled blood pressure;
- any type of cancer (except a skin cancer which is not a melanoma);
- uncontrolled infection (not treated or cured);
- inherited or acquired immune deficiency.
What the medicinal ingredient is
Cyclosporine.
What the non-medicinal ingredients are
Dehydrated alcohol, d-α tocopheryl polyethylene glycol 1000
succinate, macrogol-glycerol hydroxystearate, polyethylene
glycol 400.
Capsule shell: gelatin, glycerin, sorbitol.
What dosage form it comes in
Sandoz Cyclosporine comes in a form of soft gelatin capsule.
Sandoz Cyclosporine capsules come with 25 mg, 50 mg or
100 mg of cyclosporine. Each capsule is contained in a foil strip
of 10 capsules, 30 capsules per box.
Warnings and precautions
Medicines which suppress the immune system, such as Sandoz
Cyclosporine may influence your body’s ability to fight against
infection and may increase the risk of developing cancers,
particularly of the skin and lymphoid system. Therefore you
should limit your exposure to sunlight and UV light by wearing
appropriate protective clothing and frequently applying a
sunscreen with a high protection factor.
Tell all health professionals you see (doctor, dentists, nurses,
pharmacists) that you are taking Sandoz Cyclosporine. It is also
a good idea to wear a Medic-Alert bracelet.
Before you use and because of the alcohol contained in
Sandoz Cyclosporine talk to your doctor or pharmacist if:
- You have or had alcohol related problems
- You have epilepsy or have any liver problems
- You are pregnant
- You breast-feed your child
- The medicine is given to a child
- You have any current or have had past health conditions.
- You are taking other drugs: Do not take any other drugs without asking your doctor or pharmacist first including over-the-counter medicines and herbal or home remedies. Sandoz Cyclosporine is often given with other medicines. Make sure you know if you are to stop, or to continue, other immunosuppressant drugs you had been taking.
- You are to receive vaccinations: Sandoz Cyclosporine may make vaccinations less effective or increase your risk of getting an illness from a live vaccine. Always discuss this possibility with your doctor before you get any vaccinations or immunizations.
- You receive Sandoz Cyclosporine: the level of cyclosporine in your blood (especially for transplant patients), your liver and kidney function and your blood lipids should be checked regularly. Your blood pressure should be checked before initiation of therapy and regularly thereafter. If high blood pressure develops during therapy and cannot be controlled, treatment should be stopped.
- You have high levels of potassium in your blood.
- You suffer from gout.
- You have had a transplant or just after your operation, your doctor may give you magnesium supplements due to the fact that Sandoz Cyclosporine may reduce the amount of magnesium in your body.
- You are or become pregnant: There is an increased
risk of difficult pregnancies (up to 25% of pregnancies)
in patients who have taken cyclosporine during
pregnancy. These difficult pregnancies have resulted in
an increased risk to the babies during and immediately
after birth. As well, some babies have been born with
abnormalities.
For these reasons it is recommended that you do not take Sandoz Cyclosporine if you are, or become, pregnant. During your treatment with Sandoz Cyclosporine and for 2 months after stopping your Sandoz Cyclosporine treatment, you must use a reliable method of birth control. Should you become pregnant during the time you are taking your Sandoz Cyclosporine you should inform your doctor at once. You will want to discuss the possible benefits and risks of continuing with this drug. - You are breast-feeding: Do not breast feed your baby if you are taking Sandoz Cyclosporine as it passes into breast milk and may harm your baby.
Do not stop taking Sandoz Cyclosporine on your own even if you have been taking it for several years. Transplant patients: Although you may not notice any symptoms of rejection for several weeks, missing even a few doses of Sandoz Cyclosporine may lead to rejection of your transplanted organ.
Interactions with this medication
Make sure your doctor knows if you are taking, or begin to take, any other medicines, including drugs, or herbal (natural) products that you can buy without a prescription while you take Sandoz Cyclosporine. Some medicines may interact with Sandoz Cyclosporine such as:
- medicines that may impact your potassium levels such as potassium containing medicines or potassium sparing medicines (e.g. potassium sparing diuretics, angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists)
- certain blood pressure reducing agents of the calcium antagonist type
- methotrexate, a medicine to treat tumors, severe psoriasis and severe rheumatoid arthritis
- medicines which may increase or reduce the blood levels of Sandoz Cyclosporine. The doctor might check the cyclosporine concentration in your blood when initiating or discontinuing other medical treatment.
- medicines which may decrease Sandoz Cyclosporine concentrations: barbiturates (medicines used to help to sleep), certain anticonvulsives (e.g carbamazepine, phenytoin), octreotide, antibacterial medicines used to treat tuberculosis, orlistat (used to help weight loss), herbal medicines containing St. John’s Wort, ticlopidine (used after stroke), certain blood pressure reducing agents (bosentan), and an antifungal medicine used to treat infections of the toes and nails (terbinafine).
- medicines which may increase Sandoz Cyclosporine concentrations: antibiotics of the macrolides type (e.g erythromycin, azithromycin), antifungal medicine of the azole type (voriconazole, itraconazole), medicines used for heart problems or high blood pressure (diltiazem, nicardipine, verapamil, amiodarone), metoclopramide (used to stop sickness), oral contraceptives, danazol (used to treat menstrual disorders), medicines used to treat gout (allopurinol), cholic acid and derivatives (used to treat gallstones), protease inhibitors used to treat HIV, imatinib (used to treat leukaemia or tumors), colchicines
- other medicines which may affect the kidneys, such as antibacterial agents (gentamycine, tobramycine, ciprofloxacin), antifungal agents containing amphotericine B, antibacterial agents containing ciprofloxacin, agents against urinary tract infection containing trimetoprim, anti-cancer agents containing melphalan, medicines used to reduce the amount of acid in your stomach (acid secretion inhibitors of the H2- receptor antagonist type), tacrolimus, pain killers (nonsteroid anti-inflammatory medicines such as diclofenac), fibric acid derivatives (e.g. bezafibrate, fenofibrate) used to lower fat in the blood.
- nifedipine (used to treat high blood pressure and heart pain), you might get swollen gums that spread over your teeth.
- medicines whose concentrations may increase when used together with Sandoz Cyclosporine including aliskiren (to treat high blood pressure), digoxin (used to treat heart problems), cholesterol lowering agents (HMG-CoA reductase inhibitors (also called statins), prednisolone, etoposide (used to treat cancer), dabigatran (oral anticoagulant used to prevent stroke), repaglinide (oral antidiabetic agent), immunosuppressives (everolimus, sirolimus), ambrisentan and specific anticancer medicines called anthracyclines (e.g. doxorubicine).
- caspofungin
- lercanidipine
- oxcarbazepine
- nefazodone
Sandoz Cyclosporine is also used in combination with other immunosuppressive agents. However, do not use it together with other calcineurin inhibitors such as tacrolimus.
Use of Sandoz Cyclosporine with aliskiren is not recommended and use of Sandoz Cyclosporine with dabigatran should be avoided.
Proper use of this medication
Usual Dose
- Always take Sandoz Cyclosporine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure. Do not change the dose on your own, no matter how you are feeling. Blood tests are one of the ways your doctor tells how much Sandoz Cyclosporine you need. Based on these tests, and on your response to this drug, your doctor may change your dose from time to time.
- Space your doses of Sandoz Cyclosporine as evenly as you can throughout the day. For example, if you take the drug 2 times a day, leave about 12 hours between each dose.
- Try to take your dose(s) at the same time(s) each day. This will help keep a constant amount of drug in your body and will also help you remember each dose. Sandoz Cyclosporine 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.
- Never take Sandoz Cyclosporine with grapefruit juice.
- Leave the capsules in the foil until you need a dose. When you are ready to take a dose, remove the number of capsules you need to make up the dose your doctor prescribed.
- Swallow the capsules whole. You may use any kind of drink except grapefruit juice.
- If you were previously taking a different oral formulation of cyclosporine, your doctor will monitor you more closely for a short period following transfer from one oral formulation to another to ensure that cyclosporine blood levels are in the correct range. Never adjust the dose yourself unless the doctor has told you to.
- For the treatment of nephrotic syndrome, the total daily dose is usually within the range of 2.5 mg/kg body weight per day and 5 mg/kg body weight per day.
- For the treatment of severe rheumatoid arthritis, the total daily dose is usually within the range of 3 mg/kg body weight per day and 5 mg/kg body weight per day divided in two doses.
- For the treatment of psoriasis and eczema, the total dose is usually within the range of 2.5 mg/kg body weight per day and 5.0 mg/kg body weight per day divided in two doses.
Overdose
Missed Dose
- For transplant patients, missing even a few doses of Sandoz Cyclosporine may lead to rejection of your transplanted organ. That is why it is so important to take each of the doses your doctor prescribes.
- Talk to your doctor, nurse or pharmacist if you have trouble remembering doses, or if you are uncertain about how to take them. Also be sure to discuss any concerns you have about taking this drug as prescribed. These people can often suggest ways to overcome problems you have taking your medication.
- Never allow your medication to run out between refills. Plan to order your refills about one week ahead of time — that way you will always have a supply in case the pharmacy is closed or out of the drug. Also be sure to take enough medication with you when you go on a holiday.
Be sure to keep all appointments at your clinic. Some of these visits will be used to check the level of cyclosporine in your blood. For transplant patients, levels that are too low can cause transplant rejection, while levels that are too high may cause damage to other organs. It is therefore very important not to miss any tests or check-ups your doctor orders.
Side effects and what to do about them
Like all medicines, Sandoz Cyclosporine can cause side effects,
although not everybody gets them. Be sure to talk to your doctor
if you have any concerns about this.
The most common side effects noted were:
- high blood pressure;
- kidney or liver problems;
- headache (including migraine);
- increased levels of lipids (e.g. cholesterol) in the blood;
- loss of appetite, nausea, vomiting, constipation or diarrhea;
- acne or oily skin;
- slight trembling of the hands;
- increased growth of fine hairs on the body;
- muscle or joint pains or cramping;
- weakness, anxiety;
- tingling in the fingers, toes or mouth;
- night sweats; hearing loss; swelling of the face;
- increased potassium in the body (your doctor may instruct you to avoid high dietary potassium intake);
- tender or swollen gums
- decreased ability to fight infection
- low level of white blood cells
- high level of sugar in the blood
- hot flushes
- stomach ulcer
- rash
- If you develop liver problems while taking this drug, which could occur with or without the following symptoms: jaundice (yellowing of the skin and/or eyes and/or dark urine), abdominal pain, vomiting and nausea, contact your doctor immediately.
- Because Sandoz Cyclosporine reduces the function of your immune system, you are more likely to get bacterial, fungal or viral infections. To help reduce complications from these infections, tell your doctor right away about any cold or flulike symptoms (such as a fever or sore throat), any boils on your skin, or pain when you urinate (pass your water).
- The decreased function of your immune system may also increase your chances of developing cancer. Although very rare, cancers of the white blood cells (lymphomas) and other types of cancer have occurred in people taking cyclosporine. The following are some possible warning signs of cancer. To help detect any cancers as soon as possible, report any of these symptoms to your doctor right away: a change in your bowel or bladder habits; any sore that doesn't heal; unusual bleeding or discharge; the appearance of a lump or thickened areas in your breast or anywhere else on your body; unexplained stomach upset or any trouble with swallowing; an obvious change in a wart or a mole; a nagging cough or hoarseness; night sweats.
- If you experience vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, and muscle weakness, these can be the signs and symptoms of an infection of the brain called progressive multifocal leukoencephalopathy. Contact your doctor right away if these symptoms occur.
- Vomiting or diarrhea may stop Sandoz Cyclosporine from being absorbed (going) into your body.
- Low levels of magnesium in the blood
- Vomiting and sensitivity to light
- Inflammation of the pancreas with severe upper stomach pain
- Muscle spasm
- Pain in legs and feet
- Breast enlargement in men
- Tiredness and weight gain
- High level of acid uric in the blood
| Symptom / effect | Talk with your doctor or pharmacist only if severe | Talk with your doctor or pharmacist in all cases | Stop taking drug and talk with your doctor or pharmacist |
|---|---|---|---|
| Common | |||
| Tremor | ✔ | † | |
| High blood pressure | ✔ | † | |
| Tingling | ✔ | † | |
| Bacterial, fungal or viral infection | ✔ | † | |
| Vomiting or diarrhea | ✔ | † | |
| Muscle or joint pains or cramping | ✔ | † | |
| Weakness | ✔ | † | |
| Anxiety | ✔ | † | |
| Swelling at the back of the eyes which may be associated with blurred vision and possible visual impairment due to an increase in pressure inside the head (benign intracranial hypertension); | ✔ | † | |
| High level of potassium in the blood; | ✔ | † | |
| Low level of red blood cells or platelets, which may be associated with pale skin, tiredness, breathlessness, dark urine (sign of breakdown of red blood cells), bruising or bleed with no obvious reasons, confusion, disorientation, decreased alertness, and kidney problems | ✔ | † | |
| Uncommon | |||
| Ulcers | ✔ | † | |
| Convulsions | ✔ | † | |
| Brain disorder with signs such as seizures, confusion, disorientation, decreased responsiveness, personality changes, agitation, sleeplessness, sight disturbances, blindness, coma, paralysis of part or all of the body, stiff neck, loss of coordination with or without abnormal speech and eye movements | ✔ | † | |
| Allergic reactions | ✔ | † | |
| Rare | |||
| Abnormal menstrual cycle | ✔ | ||
| Very rare | |||
| Tumours/ malignancies | ✔ | † | |
† Do not stop your medicines unless you have discussed this
with your doctor first.
This is not a complete list of side effects. For any unexpected
effects while taking Sandoz Cyclosporine, contact your doctor
or pharmacist.
How to store
- Keep Sandoz Cyclosporine out of the reach and sight of children. A child who accidentally takes this drug may be seriously harmed. A locked drawer or cupboard is best if you have small children in the house.
- Sandoz Cyclosporine capsules should be kept in a dry place, at room temperature between 15 and 30°C. Remember to leave each capsule in its foil pack until you need to take it.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
This document, plus the full Product Monograph prepared for
health professionals, can be obtained by contacting the sponsor,
Sandoz Canada Inc., at: 1-800-361-3062
or
by written request at:
145, Jules-Léger
Boucherville, (QC), Canada
J4B 7K8
or by e-mail at:
medinfo@sandoz.com
This leaflet was prepared by Sandoz Canada Inc.
Date revised: March 13, 2015