Details for: PMS-METHOTREXATE
Company: PHARMASCIENCE INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02170698 | PMS-METHOTREXATE | METHOTREXATE (METHOTREXATE DISODIUM) | 2.5 MG | TABLET | ORAL |
Summary Reports
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
pms-METHOTREXATE belongs to a group of medicines known as antimetabolites. It is used to treat certain types of cancers, severe psoriasis and severe rheumatoid arthritis.
What it does
pms-METHOTREXATE works by blocking an enzyme needed by body cells to live. This interferes with the growth of some cells, such as skin cells in psoriasis that are growing rapidly. In rheumatoid arthritis, pms-METHOTREXATE acts on the inflammatory cells that cause joint swelling. pms-METHOTREXATE therapy is used to control psoriasis and rheumatoid arthritis but it will not cure them. In cancer, pms-METHOTREXATE works by blocking an enzyme process in cancer cells so that they cannot grow. Some normal cells in the body may be affected as well.
When it should not be used
Do not take pms-METHOTREXATE if you:
- Are allergic to any component of the drug.
- Have severe kidney problems
- Are pregnant. pms-METHOTREXATE can cause harm to your unborn baby. Women of childbearing potential should not be started on pms-METHOTREXATE until pregnancy is excluded.
- Are breast feeding.
- Have psoriasis or rheumatoid arthritis and the following:
- alcoholism (drink excessive alcohol)
- chronic liver disease
- immunodeficiency (resistance to infectious diseases is reduced)
- blood disorders
- Are going to receive a general anesthetic called nitrous oxide. It is also known as laughing gas.
What the medicinal ingredient is
Methotrexate (meth-o-TREX-ate).
What the non-medicinal ingredients are
- Tablets: Corn starch, lactose, magnesium stearate, sodium hydroxide and purified water
What dosage form it comes in
- Tablet: 2.5 mg (as methotrexate disodium)
Warnings and precautions
Serious Warnings and Precautions
pms-METHOTREXATE should be prescribed by a doctor who is experienced with the use of antimetabolite therapy.
- pms-METHOTREXATE can cause serious toxic reactions which may result in death.
- pms-METHOTREXATE can cause birth defect (deformed babies) or death of an unborn baby when used in pregnant women. Pregnant women with psoriasis or rheumatoid arthritis should not take Methotrexate.
BEFORE you use pms-METHOTREXATE, talk to your doctor or pharmacist if you have any of the following conditions:
- have or have had any unusual or allergic reaction to methotrexate
- are pregnant or planning to become pregnant. pms-METHOTREXATE can cause birth defects (deformed babies) or death of an unborn baby. Both male and female patients must use effective birth control methods all the time while taking pms-METHOTREXATE and a few months after the last dose of the drug pms-METHOTREXATE may cause sterility (infertility), which could be permanent. Be sure to discuss this with your doctor before taking pms-METHOTREXATE. Tell your doctor right away if you think you have become pregnant while taking pms-METHOTREXATE.
- are breast-feeding or plan to breastfeed. pms-METHOTREXATE may cause serious side effects. Do not breastfeed while you are taking the drug
- have kidney problems
- have or have had liver problems, including hepatitis B or hepatitis C infection
- have lung problems
- have problem with your immune system, or infections
- have gastrointestinal problems such as vomiting, diarrhea, mouth sores or inflammation, ulcer, or colitis (ulcer of intestines)
- have a skin disease
- have a neurologic disorder
- drink alcohol
pms-METHOTREXATE increases sensitivity to sunlight. Avoid sun exposure and do not use a sunlamp while taking this drug.
Precautions While Using This Medicine
- Do not take pms-METHOTREXATE more than the dose prescribed. pms-METHOTREXATE can cause serious toxic reactions which may result in death.
- Do not drink alcohol.
- Do not drive a car or operate machinery until you know how pms-METHOTREXATE affects you since the drug may cause dizziness and fatigue.
- Drink extra fluid to prevent kidney problems.
- Have regular blood tests to reduce the risk of infection or bleeding. pms-METHOTREXATE can lower the number of white blood cells and there is an increased risk of infection or bleeding.
- Talk to your doctor if you need a vaccination. Live vaccines may cause severe infections. Live vaccines or contact with any individual who has had a live vaccination should be avoided, since your ability to fight an infection (immune system) is decreased while taking pms-METHOTREXATE.
Interactions with this medication
Talk to your healthcare professional about all the medicines you take or have recently taken, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
pms-METHOTREXATE may interact with the following drugs:
- non-steroidal anti-inflammatory drugs (NSAIDs) and salicylate (acetylsalicylic acid or ASA)
- Disease Modifying Antirheumatic drugs (DMARDs), such as gold, penicillamine, hydroxychloroquine, or sulfasalazine
- drugs that may cause harm to the liver (leflunomide, azathioprine, sulfasalazine, retinoid)
- phenylbutazone
- phenytoin (to treat seizures)
- probenecid
- amphotericine B (may cause harm to kidneys)
- certain antibiotics such as penicillins, tetracycline, vancomycin, nystatin, neomycin, trimethoprim/ sulfamethoxazole, ciprofloxacin, pristinamycin, chloramphenicol
- theophylline
- mercaptopurine
- folic acid or folinic acid
- cytarabine and other chemotherapy agents
- radiotherapy
- L-asparaginase, a drug used to treat cancer
- Proton pump inhibitors, drugs used to treat acid-related stomach problems
- Pyrimethamine, an anti-parasitic drug
- Nitrous oxide, an inhaled gas used to prevent pain during medical procedures
- Amiodarone, a drug used to treat abnormal heart rhythms
- Sulfonylureas, drugs used to lower blood sugar levels, aminobenzoic acid, sulfonamides, also known as “sulfa drugs”
- Packed red blood cells, used for blood transfusions
- PUVA therapy, a type of ultraviolet light treatment for severe skin conditions
- Triamterene, a drug used to reduce blood pressure and decrease swelling
The absorption of pms-METHOTREXATE when taken orally is reduced by food, particularly milk.
Proper use of this medication
Take pms-METHOTREXATE only as directed by your doctor. Do not take more or less of it, and do not take it more often than your doctor ordered. The exact amount of medicine you need has been carefully worked out. Taking too much may increase the chance of side effects, while taking too little may not improve your condition. You should check with your doctor if you are not certain how to take the medication.
- In most cases, pms-METHOTREXATE is taken once weekly; the prescribed dose is taken on a single day of the week.
- In some cases, your healthcare professional may instruct you to take pms-METHOTREXATE every 12 hours for 3 doses; you should only do this once a week, and should not take more than 3 doses each week.
- It should never be taken every day of the week when used to treat psoriasis or rheumatoid arthritis. As well, in most cases of cancer, methotrexate should not be taken every day of the week.
- Taking pms-METHOTREXATE daily, or in a dose larger than prescribed can result in serious complications, often requiring hospitalization, and sometimes resulting in death. Taking even small doses of pms-METHOTREXATE daily for less than a week can result in serious consequences, including death.
- Select a day of the week when you are most likely to remember to take pms-METHOTREXATE, and take it on that same day each week.
- Each time you refill your prescription, check to see whether the dose and/or the number of tablets you need to take have changed.
pms-METHOTREXATE is often given together with certain other medicines. If you are using a combination of medicines, make sure that you take each one at the proper time and do not mix them. Ask your doctor or pharmacist to help you plan a way to remember to take your medicines at the right times.
While you are using pms-METHOTREXATE, your doctor may want you to drink extra fluids so that you will pass more urine. This will help the drug to pass from the body, and will prevent kidney problems and keep your kidneys working well.
If you vomit shortly after taking a dose of pms-METHOTREXATE, check with your doctor. You will be told whether to take the dose again or to wait until the next scheduled dose.
Usual dose
The dose of pms-METHOTREXATE will be different for different patients. The dose that is used may depend on a number of things, including what the medicine is being used for, the patient's size, and whether or not other medicines are also being taken. If you are taking or receiving pms-METHOTREXATE at home, follow your doctor's orders or the directions on the label. If you have any questions about the proper dose of pms-METHOTREXATE, ask your doctor.
Overdose
- Do this even if you have no signs of discomfort.
- Always take the labelled medicine bottle with you, even if it is empty.
Missed Dose
- If you missed a scheduled dose, contact your doctor for instruction.
Side effects and what to do about them
Along with their needed effects, medicines like pms-METHOTREXATE can cause unwanted effects. Also, because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These delayed effects may include certain types of cancer, such as leukemia. Discuss these possible effects with your doctor.
pms-METHOTREXATE commonly causes nausea and vomiting. Even if you begin to feel ill, do not stop using this medicine without first checking with your doctor. Ask your doctor for ways to lessen these effects.
The most common side effects include;
- Upset stomach, stomach pain, vomiting, nausea, loss of appetite, dizziness, chills and fever, diarrhea or sores on lips or mouth.
- A fall in the number of white blood cells. This may reduce your resistance to infection and increase your chances of cold sores, blood poisoning or swelling of blood vessels.
- Tiredness (fatigue).
Less common side effects are:
- Headaches, hair loss, mood changes, confusion, ringing in the ears, sore eyes, skin rashes, increased sensitivity to sunlight or unexplained weight loss.
- A fall in the number of other blood cells. This may increase your chances of bruising, bleeding or tiredness.
- Damage to the lungs.
- Harm to the unborn baby.
- Convulsions
Rarely, pms-METHOTREXATE can cause other side effects including:
- Liver damage, kidney damage, pain or difficulty urinating, lower back or side pain, blood in urine or stools, dark urine
- Fits, blurred vision, short term blindness
- Drowsiness, weakness
- Hoarseness
- Bloody vomit, black, tarry stools or pin-point red spots on the skin
- Reddening or whitening of the skin, acne, boils, itching yellow skin or eyes
- Impotence or loss of interest in sex, decreased fertility, abortion
- Diabetes, thinning of the bones, painful muscles and joints
- Low blood pressure
- Gastrointestinal ulcers
More rarely, it can cause:
- Skin rash and other skin disorders.
- Cancer of lymph glands, sudden death
- Severe allergic reactions.
- Leukoencephalopathy
- Damage to heart
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| Common | |||
| Diarrhea, vomiting, abdominal pain, or mouth ulcers | ✔ | ||
| Sore throat, fever, chills, or swelling of glands | ✔ | ||
| Less common | |||
| Chest pain, cough, shortness of breath or fever. | ✔ | ||
| Unusual bleeding or bruising | ✔ | ||
| Severe headaches | ✔ | ||
| Rare | |||
| Signs of severe allergic reaction: Skin rash, itching, chest tightness, wheezing, dizziness, hives, faintness, rapid heartbeat, shortness of breath, and/or a swollen face, lips, or tongue | ✔ | ||
| Pain or difficulty urinating, lower back or side pain, blood in urine or stools, dark urine | ✔ | ||
| Yellow colour of eyes or skin | ✔ | ||
| Unknown | |||
| Gastrointestinal Related: Severe abdominal pain, tenderness, chills, fever, nausea, vomiting, extreme thirst, difficulty passing urine or bowel movement | ✔ | ||
| Central Nervous System Related: Behaviour changes, decreased consciousness, headache, weakness, numbness, vision loss or double vision, seizures, vomiting, loss of memory | ✔ | ||
| DRESS (allergic reactions): Fever, rash, hives, swelling of eyes, lips or tongue | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking pms-METHOTREXATE contact your doctor or pharmacist.
How to store
- Keep out of the reach and sight of children.
- Store pms-METHOTREXATE tablet between 15-30°C and away from heat and direct light.
- Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach and sight of children.
Reporting side effects
To monitor drug safety, Health Canada through the Canada Vigilance Program collects information on serious and unexpected side effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance:
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 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 1908C
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ 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
NOTE: This Consumer Information leaflet provides you with the most current information at the time of printing.
This document plus the full product monograph, prepared for health professionals can be obtained by contacting Pharmascience Inc., at 1-888-550-6060.
This leaflet was prepared by
Pharmascience Inc.
Montréal, Canada
H4P 2T4
www.pharmascience.com
Dernière révision : 16 mai 2019