2.5 mg and 10 mg methotrexate tablets
What Methotrexate Orion Pharma is and what it is used for
Methotrexate Orion Pharma is a medicine with the following properties:
- it interferes with the growth of certain cells in the body that are newly formed quickly, and thus slows down the growth of tumor cells
- it reduces the activity of the immune system (the body’s own defense system)
- it has anti-inflammatory effects
Methotrexate Orion Pharma is used to treat:
- active rheumatoid arthritis in adult patients
- Difficult-to-treat, debilitating psoriasis that does not respond adequately to other therapies such as light therapy, PUVA and retinoids
- severe psoriatic arthritis in adult patients
- acute lymphocytic leukemia as maintenance treatment.
Your doctor will be able to explain how Methotrexate Orion Pharma can help with your condition.
Methotrexate which is the active substance in Methotrexate Orion Pharma may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.
What you need to know before using Methotrexate Orion Pharma
Do not use Methotrexate Orion Pharma
- if you are allergic (hypersensitive) to methotrexate or any of the other ingredients of this medicine (listed in section 6)
- if you are breast-feeding (see section “Pregnancy, breast-feeding and fertility”)
- if you are pregnant and being treated for a disease other than cancer (see section “Pregnancy, breast-feeding and fertility”)
- if you have severe liver or kidney disease (your doctor will determine the severity of your illness)
- if you have or have had a bone marrow disease or severe blood disorders
- if you have severe acute or chronic infection and a weakened immune system
- if you have inflamed mucous membranes in the oral cavity or cold sores
- if you have ulcers in your stomach or intestines
- if you suffer from alcoholism
- if you have recently been vaccinated or are about to be vaccinated with a live vaccine.
Warnings and cautions
| Important warning about dosing one of Methotrexate Orion Pharma (methotrexate)Take Methotrexate Orion Pharma only once a week for the treatment of rheumatoid arthritis , psoriasis or psoriatic arthritis. Taking too much Methotrexate Orion Pharma can be fatal. Read section 3 of this leaflet very carefully. If you have any further questions, ask your doctor or pharmacist before taking this medicine. |
Tell your doctor, pharmacist or nurse before taking Methotrexate Orion Pharma:
- if you have had any liver or kidney disease
- if you have inactive, chronic infections (eg tuberculosis , hepatitis B or C, shingles [herpes zoster]), as these can flare up
- if you have deteriorated general condition
- if you have problems with lung function
- if you have abnormal accumulations of fluid in the abdomen (ascites) or around the lungs (pleural effusion) if you have diabetes mellitus treated with insulin
- if you are dehydrated or suffer from any ailment that leads to dehydration (vomiting, diarrhea, constipation, inflammation of the oral mucosa).
Acute haemorrhage from the lungs of patients with underlying rheumatic disease has been reported with methotrexate. If you experience symptoms such as blood in the saliva or bloody cough, contact your doctor immediately.
Diarrhea can be a side effect of Methotrexate Orion Pharma and means that treatment must be stopped. Talk to your doctor if you have diarrhea.
Methotrexate temporarily affects sperm and egg production. Methotrexate can cause miscarriage and severe congenital malformations. You and your partner should avoid having children while you are receiving methotrexate and for at least 6 months after stopping treatment with methotrexate. See also section “Pregnancy, breast-feeding and fertility”.
Radiation therapy using Methotrexate Orion Pharma may increase the risk of soft tissue or skeletal necrosis (tissue death). If you have had skin problems after radiation therapy (radiation dermatitis) or received sun damage, these reactions may recur when you are treated with methotrexate (“recall” reaction). Skin changes due to psoriasis may be exacerbated during treatment with methotrexate if you are treated with UV light.
Enlarged lymph nodes ( lymphoma ) can occur in patients receiving methotrexate in low doses and if this occurs, treatment must be stopped.
Certain diseases of the brain (encephalopathy / leukoencephalopathy) have been reported in cancer patients receiving methotrexate. Such side effects can not be ruled out when methotrexate is used to treat other diseases.
Before starting treatment
Before starting treatment, your doctor may take blood samples and also check how well your kidneys and liver are working. You may also have a chest X-ray. Additional tests can be done during and after treatment. Do not miss any opportunities for blood sampling.
Recommended follow-up and precautionary measures
Serious side effects may occur even if methotrexate is given in low doses . To detect side effects as early as possible, your doctor will take blood and urine samples.
Children, adolescents and the elderly
Children, adolescents and the elderly should be kept under special close medical supervision during treatment with Methotrexate Orion Pharma, in order to detect any possible side effects as early as possible. Use in children under 3 years of age is not recommended due to insufficient experience in this age group.
Other medicines and Methotrexate Orion Pharma
Other concomitant medications may affect the efficacy and safety of this medicine. Methotrexate Orion Pharma may also affect the efficacy and safety of other medicines.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Remember to talk to your doctor about your treatment with Methotrexate Orion Pharma if you are prescribed another medication while the treatment is still in progress. It is especially important that you tell your doctor if you are taking:
- antibiotics (medicines to prevent / treat certain infections ) such as penicillins , sulfonamides , ciprofloxacin , cephalotin, trimethoprim / sulfamethoxazole, tetracycline and chloramphenicol
- other drugs used to treat rheumatoid arthritis such as leflunomide, sulfasalazine and azatriopine
- certain medicines for pain and / or inflammation so-called non-steroidal anti-inflammatory medicines (eg ibuprofen , diclofenac , salicylates such as acetylsalicylic acid and pyrazoles such as metamizole)
- pyrimethamine (to prevent and treat malaria )
- cancer treatments (eg mercaptopurine, 5-fluorouracil, doxorubicin and procarbazine)
- antiepileptic drugs (to prevent seizures)
- omeprazole or pantoprazole (medicines used to inhibit the production of acid in the stomach)
- diuretics (diuretics)
- drugs to lower blood sugar levels such as metformin
- cholestyramine (a drug that binds bile acids and can be used, for example, to lower cholesterol levels)
- ciclosporin (medicines that can suppress or inhibit the immune system)
- retinoids (for the treatment of psoriasis and other skin diseases)
- birth control pills
- barbiturates (sleeping pills)
- sedatives
- nitrous oxide (used under anesthesia)
- probenecid (medicine used to treat gout )
- theophylline (drug used to treat lung disease)
- vitamin preparations or other products containing folic acid
- live vaccines.
Methotrexate Orion Pharma with food, drink and alcohol
Alcohol as well as large amounts of coffee, caffeinated soft drinks and black tea should be avoided during treatment with Methotrexate Orion Pharma.
Pregnancy, breastfeeding and fertility
If you are pregnant, breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not use Methotrexate Orion Pharma during pregnancy unless your doctor prescribes it for cancer treatment.
Methotrexate can cause congenital malformations, birth defects and miscarriages. It is associated with malformations of the skull, face, heart and blood vessels, brain and arms and legs. It is therefore very important that methotrexate is not given to pregnant women or to women planning to become pregnant unless used for cancer treatment.
For indications other than cancer, a possible pregnancy in fertile women must be ruled out, e.g. through pregnancy tests, before starting treatment.
Do not use Methotrexate Orion Pharma if you are trying to get pregnant. You must avoid becoming pregnant during treatment with methotrexate and for at least 6 months after stopping treatment. Be sure to use effective contraception throughout this time (see also section “Warnings and Precautions”).
If you become pregnant during treatment or suspect you may be pregnant, talk to your doctor as soon as possible. If you become pregnant during treatment, you should be offered medical advice on the risk of harmful effects on the baby due to the treatment.
If you want to get pregnant, talk to your doctor, who can refer you to specialist advice before the planned start of treatment.
Breast-feeding
You should not breast-feed during treatment, as methotrexate passes into breast milk. If your doctor thinks that treatment with methotrexate is absolutely necessary during the breast-feeding period, you must stop breast-feeding.
Fertility in men
Available data do not indicate an increased risk of malformations or miscarriages if the father takes less methotrexate than 30 mg / week. However, a risk can not be completely ruled out and there is no information on higher doses of methotrexate. Methotrexate may have genotoxic effects. This means that the drug can cause gene mutations. Methotrexate can affect sperm production, which is associated with the risk of congenital malformations.
You should avoid getting a woman pregnant and donating sperm during treatment with methotrexate and for at least 6 months after stopping treatment. Because treatment with methotrexate may cause infertility and gene mutations at higher doses that are common in cancer treatment, male patients treated with methotrexate at doses above 30 mg / week should consider sperm preservation before starting treatment (see also section “Warnings and precautions”).
Talk to your doctor or pharmacist before taking any medicine.
Driving and using machines
You may feel tired and dizzy while taking Methotrexate Orion Pharma. Do not drive or use machines if you experience such symptoms.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and or side effects . Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Methotrexate Orion Pharma contains lactose
These tablets contain lactose . If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to use Methotrexate Orion Pharma
Always take Methotrexate Orion Pharma exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
- Patients with rheumatoid arthritis , psoriasis or psoriatic arthritis should take the tablets only once a week , on the same day each week.
- Do not take the tablets more often than your doctor has told you to do.
- Daily administration can lead to serious toxic effects, including death
- Take the tablets with a glass of water while sitting or standing up.
Dosage for rheumatoid arthritis , psoriasis and psoriatic arthritis:
Take the tablets once a week on the same day each week. The usual dose is between 7.5 and 15 mg once a week.
Dosage for maintenance treatment of acute lymphocytic leukemia
Your doctor will calculate the dose required based on your body surface area. Your doctor will determine the right dose for you. Ask your doctor if you want more information.
Special patient groups
The dose is usually reduced according to the doctor’s prescription for elderly patients and for patients with renal or hepatic impairment. See also section 2. “Do not take Methotrexate Orion Pharma”.
Use for children and adolescents
For children and adolescents with acute lymphocytic leukemia who receive maintenance treatment, the doctor calculates the dose individually depending on the body surface area.
Safe handling of Methotrexate Orion Pharma tablets
Proper handling of cytotoxic drugs should be applied. Everyone taking methotrexate should wash their hands before and after a dose has been given. Disposable gloves should be used when handling methotrexate tablets. Women who are pregnant, planning to become pregnant or breast-feeding should, if possible, avoid taking methotrexate tablets.
Contact with skin and mucous membranes must be avoided. If methotrexate comes into contact with skin or mucous membranes, wash the area immediately with soap and water.
Parents, caregivers and patients should keep methotrexate out of the reach of children, preferably in a locked cupboard.
Accidental ingestion can be fatal to children.
If you use more Methotrexate Orion Pharma than you should
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor, hospital or the Poison Information Center (tel. 112) for risk assessment and advice.
An overdose of methotrexate can lead to serious toxic reactions, including death. Symptoms of overdose may include bruising or bleeding, abnormal weakness, cold sores, nausea, vomiting, black or bloody stools, bloody coughs or vomiting similar to coffee grounds and decreased urination. See also section 4 “Possible side effects”.
Bring the medicine pack with you if you see a doctor or hospital. If you have used too much methotrexate, you will be given calcium folinate to reduce the side effects of methotrexate.
If you forget to use Methotrexate Orion Pharma
Take the missed dose one as soon as possible when you remember if it is within two days. If you have missed a dose for more than two days, consult your doctor for advice. Do not take a double dose to make up for a forgotten dose .
Make sure you have enough medicine before your holiday or trip.
If you stop using Methotrexate Orion Pharma
Do not stop taking Methotrexate Orion Pharma unless your doctor tells you to. Should you need to stop taking Methotrexate Orion Pharma, your doctor will decide which method is best for you.
If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects , although not everybody gets them. In general, the incidence and severity of methotrexate side effects are dose related and how often the tablets are taken. Most side effects are transient if they are detected early.
Tell your doctor immediately if you notice any of the following symptoms as they may indicate a serious, potentially life-threatening, side effect that requires special treatment:
- a dry cough and / or pain or difficulty breathing or shortness of breath, chest pain or fever
- blood in saliva or cough *
- unusual bleeding (including bloody vomiting), bruising or nosebleeds
- nausea, vomiting, abdominal discomfort or severe diarrhea
- sores in the mouth
- black or tar-colored stools
- hypersensitivity reaction that causes fever, rash, swelling and sometimes a drop in blood pressure
- an extremely severe allergic reaction with skin rash usually in the form of blisters or sores in the oral cavity and eyes and other mucous membranes such as the genitals (Steven-Johnson syndrome, toxic epidermal necrolysis )
- other symptoms of an infection such as fever or severe general deterioration or fever with local signs of infection such as sore throat / inflammation of the throat or mouth or difficulty urinating, seek medical attention immediately. Methotrexate can reduce the number of white blood cells and therefore weaken your immune system. Blood samples will be taken to examine a possible decrease in white blood cells ( agranulocytosis ).
- yellowing of the skin (jaundice)
- pain or difficulty urinating
- thirst and / or frequent urination
- blurred or impaired vision
Most of the effects listed below are seen only in patients receiving high- dose methotrexate to treat cancer. They are not seen as often and are not as severe at the doses used in the treatment of psoriasis or rheumatoid arthritis .
Very common (may affect more than 1 in 10 people)
- loss of appetite, nausea, vomiting, dyspepsia , abdominal pain, stomatitis (soreness in the mouth and lips)
- increase in liver enzyme
Common (may affect up to 1 in 10 people):
- infection is
- decreased blood cell formation with a decreased number of white and / or red blood cells and / or platelets (leukocytopenia, anemia , trobmocytopenia)
- headache, dizziness, abnormal fatigue, drowsiness
- lung infection ( pneumonia ), dry cough
- diarrhea
- rash, reddening of the skin, itching
- hair loss.
Uncommon (may affect up to 1 in 100 people):
- cancer of the lymph nodes (or tissues )
- diabetes mellitus
- depression, confusion
- seizures, fraud
- ulcers and bleeding in the gastrointestinal tract
- nosebleeds
- the formation of excess connective tissue in an organ ( fibrosis )
- decreased levels of serum albumin
- inflammation of blood vessels, often with skin rash ( vasculitis ), increased pigmentation of the skin, slow wound healing, increased rheumatic nodules
- ulcers and inflammation of the bladder, disturbed urination
- liver damage
- renal impairment
- pain in joints or muscles, a type of bone disease with reduced bone density ( osteoporosis )
- vaginal inflammation and ulcers
- overindulge.
Rare (may affect up to 1 in 1,000 people):
- inflammation throughout the body that can be fatal ( sepsis ), herpes zoster ( shingles )
- a blood disease characterized by very large red blood cells (megaloblastic anemia )
- Mood swings
- impairment of mobility (may also be limited to the left or right side of the body only)
- severe visual disturbances
- fluid in the sac around the heart. May cause cardiac tamponade which is a life threatening condition where the heart cannot pump properly due to external pressure. May require surgery to drain fluid and remove pressure.
- low blood pressure , blood clot
- complete or severe weakness of the respiratory muscles, shortness of breath, inflammation of the throat, asthma
- inflammation of the pancreas, inflamed gums
- inflammation of the liver ( acute hepatitis )
- skin reactions ( acne , depigmentation of the skin, hives , photosensitivity, erythema multiforme, burning sensation in psoriasis ulcers, skin ulcers, red or purple dots due to vascular bleeding), nail discharge, dark areas on the nails
- stress fractures
- decreased or no urine production, disturbances in the electrolyte balance
- menstrual disorders, impotence
Very rare (may affect up to 1 in 10,000 people)
- immunodeficiency ( hypogammaglobulinemia ), increased susceptibility to infection
- lymphoproliferative disorders (abnormal growth of white blood cells )
- insomnia
- brain swelling, speech difficulties ( dysarthria ), irritation, drowsiness, fatigue ( lethargy ), mild temporary problems with intellectual functions (“brain fog”), unusual sensations in the head, muscle weakness, feeling numb or crawling / lower sensitivity to stimulation than normal, altered sense of taste (metallic taste)
- redness and irritation of the thin membrane covering the eye ( conjunctivitis ), visual impairment, damage to the retina of the eye
- inflammation of blood vessels ( vasculitis ), bloody vomiting
- reactivation of chronic hepatitis, liver failure
- enlarged colon associated with inflammation / infection
- infection around the fingernails, deep infection of hair follicles ( furunculosis ), bruising, acne
- protein or blood in the urine, painful urination, bladder inflammation
- low sperm count, breast augmentation in men, vaginal bleeding, lost sex drive
- fever.
The following side effects have been reported but occur in an unknown number of users:
Fatal sepsis , abnormally low number of blood cells, bleeding from the lungs *, bone damage in the jaw (due to abnormal growth of white blood cells ) brain disease, pathological changes in the white brain substance (leukoencephalopathy), inflammation of the alveoli (alveolitis), physical weakness, increased risk for toxic reactions during radiation therapy, reddening of the skin and scaly skin, swelling. Flaking, red spots on the skin associated with psoriasis that can get worse if exposed to ultraviolet light, such as the sun, and by taking methotrexate. Skin problems after radiation therapy (radiation dermatitis) or sun damage can recur when taking methotrexate.
* (has been reported when methotrexate has been used in patients with underlying rheumatic disease)
Reporting of side effects ar
If you get any side effects , talk to your doctor, pharmacist or nurse. This also applies to side effects that are not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects , you can help increase the safety of medicines.
The Medical Products Agency
Box 26
751 03 Uppsala
5. How to store Methotrexate Orion Pharma
Keep this medicine out of the sight and reach of children, preferably in a locked cupboard. Accidental ingestion can be fatal to children.
Do not use this medicine after the expiry date which is stated on the can, blister and outer carton. The expiration date is the last day of the specified month.
This medicine does not require any special storage temperature.
Store the tablet jar / blister in the outer carton. Sensitive to light.
Proper handling of cytotoxic drugs should be applied. Everyone taking methotrexate should wash their hands before and after a dose has been given. Disposable gloves should be used when handling methotrexate tablets. Women who are pregnant, planning to become pregnant or breast-feeding should not take methotrexate tablets.
Any unused product or waste material should be disposed of in accordance with local requirements .
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information
Content declaration
- The active substance is methotrexate, each tablet contains 2.5 mg or 10 mg methotrexate (as methotrexate disodium).
- The other ingredients are lactose monohydrate , microcrystalline cellulose and magnesium stearate
What the medicine looks like and contents of the pack
Methotrexate Orion Pharma 2.5 mg tablets: Yellow, round, uncoated, flat tablet with a score line and marked with ORN 57 on one side, diameter 6 mm. The breaker is not there to divide the tablet into equal doses , but only to facilitate swallowing.
Methotrexate Orion Pharma 10 mg tablets: Yellow, capsule-shaped, convex, uncoated tablet, marked ORN 59 on one side and breaker on the other side, length 14 mm and width 6 mm. The tablet can be divided into two equal doses .
Pack sizes:
Jar with lid, with or without child protection mechanism.
2.5 mg: 10, 12, 24, 28, 30, 50 and 100 tablets.
10 mg: 10, 15, 25, 50 and 100 tablets.
Blister pack
2.5 mg: 24, 50 and 100 tablets.
10 mg: 4 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Manufacturer
Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Orion Corporation Orion Pharma
Connector current 8
FI-20360 Turku
Finland
For further information on this medicine, please contact your local representative:
Orion Pharma AB, Danderyd
medinfo@orionpharma.com