7.5 mg, 10 mg, 12.5 mg, 15 mg, 17.5 mg, 20 mg, 22.5 mg, 25 mg solution for injection in pre-filled pen
methotrexate
What Nordimet is and what it is used for
Nordimet contains the active substance methotrexate, which works by:
- reduce inflammation or swelling and
- reduce the activity of the immune system (the body’s own defense mechanism). An overactive immune system has been linked to inflammatory diseases.
Nordimet is a medicine used to treat a variety of inflammatory diseases:
- active rheumatoid arthritis in adult patients. Active rheumatoid arthritis is an inflammatory disease that affects the joints;
- severe, active juvenile idiopathic arthritis of at least five joints (the disease is therefore called polyarthritic) in patients who have received insufficient treatment response to non-steroidal anti-inflammatory drugs ( NSAIDs );
- a severe form of treatment-resistant psoriasis (also called difficult-to-treat disabling psoriasis ) that can not be adequately treated with other therapies, such as phototherapy (light therapy), PUVA (ultraviolet light therapy) and retinoids (a group of drugs derived from vitamin A) and severe psoriasis that also affects joints (psoriatic arthritis) in adult patients;
- induction of improvement in adults with moderate steroid-dependent Crohn’s disease , in combination with corticosteroids;
- as the sole drug in the maintenance treatment of Crohn’s disease in adults who have responded to methotrexate.
What you need to know before using Nordimet
Do not reuse Nordimet
- you are allergic to methotrexate or any of the other ingredients of this medicine (listed in section 6)
- you have a serious kidney disease (your doctor can tell you if you have a serious kidney disease)
- you have a serious liver disease (your doctor can tell you if you have a serious liver disease)
- you have a disorder of the blood formation system
- you drink large amounts of alcohol
- your immune system is weakened
- you have a serious or existing infection , e.g. tuberculosis or HIV
- you have stomach ulcers
- you are pregnant or breast-feeding (see section “Pregnancy, breast-feeding and fertility”)
- you are simultaneously vaccinated with live vaccines.
Warnings and cautions
Acute hemorrhage from the lungs of patients with the 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.
Enlarged lymph nodes ( lymphoma ) may occur and then treatment should be stopped.
Diarrhea can be a toxic effect of Nordimet and requires interruption of treatment. Talk to your doctor if you suffer from diarrhea.
Certain brain diseases (encephalopathy/leukoencephalopathy) have been reported as a side effect in cancer patients receiving methotrexate. Nor can such side effects be ruled out when methotrexate is used to treat other diseases.
Important warning regarding dosing one of Nordimet
Methotrexate for the treatment of rheumatic diseases, skin diseases, and Crohn’s disease may only be used once a week. Improper dosing of methotrexate can lead to serious and potentially fatal side effects. Read section 3 of this leaflet very carefully.
Talk to your doctor before using Nordimet about:
- you have diabetes mellitus and are being treated with insulin
- you have an inactive, long-lasting infection (eg tuberculosis , hepatitis B or C or shingles [herpes zoster])
- you have or have had a liver or kidney disease
- you have problems with lung function
- you are very overweight
- you have abnormal accumulation of fluid in the abdomen or in the cavity between the lungs and the chest wall ( ascites , pleural effusions)
- you are dehydrated or suffer from conditions that lead to dehydration (eg dehydration due to vomiting, diarrhea or inflammation of the mouth and lips).
Skin problems after radiation therapy (radiation-induced dermatitis ) and sun damage may recur during treatment with Nordimet.
Children, adolescents and the elderly
Dosage one depends on the patient’s body weight.
Use is not recommended for children under 3 years of age as there is a lack of sufficient experience in this age group.
Children, adolescents, and the elderly who are treated with Nordimet must be monitored particularly closely by doctors so that any side effects can be identified as early as possible.
In elderly patients, the dose should be reduced due to age-related hepatic and renal impairment.
Special precautions for treatment with Nordimet
Methotrexate temporarily affects sperm and egg production, an effect that in most cases decreases. Methotrexate can cause miscarriage and severe congenital malformations. You must avoid becoming pregnant while using methotrexate and for at least six months after stopping treatment. See also the section “Pregnancy, breast-feeding and fertility”.
Skin changes caused by psoriasis may be exacerbated during treatment with Nordimet if you are exposed to ultraviolet radiation.
Before starting treatment and recommended examinations and precautions for follow-up
Before starting treatment, you may submit blood samples so that the doctor can, among other things, check your liver and kidney function. You may also have to undergo a chest X-ray. Additional tests can be done during and after treatment. Do not miss any blood sampling sessions.
If the result of any test is abnormal, treatment will not be resumed until all results are normal again.
Even when Nordimet is used in low doses, serious side effects can occur. Your doctor will perform blood and urine tests to ensure that any side effects are detected quickly.
Other medicines and Nordimet
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is especially important to tell your doctor if you are taking:
- other treatment for rheumatoid arthritis or psoriasis , such as leflunomide, sulfasalazine (a medicine used to treat arthritis and psoriasis and also ulcerative colitis ), acetylsalicylic acid , phenylbutazone or amidopyrine
- ciclosporin (to suppress the immune system)
- azathioprine (prevents rejection during organ transplants)
- retinoids (used to treat psoriasis and other skin problems)
- anticonvulsant drugs (used to prevent seizures), such as phenytoin , valproate or carbamazepine
- cancer treatment
- barbiturate is (sleep injection)
- tranquilizer
- birth control pills
- probenecid (used to treat gout )
- antibiotics (eg penicillin , glycopeptides, trimethoprim / sulfamethoxazole, sulfonamides , ciprofloxacin , cephalotin, tetracyclines , chloramphenicol)
- pyrimethamine (used to prevent and treat malaria )
- vitamin preparations containing folic acid
- proton pump inhibitors (medicines that reduce the production of stomach acid and are used to treat severe heartburn and stomach ulcers ), such as omeprazole or pantoprazole
- theophylline (used to treat asthma )
- cholestyramine (used to treat high cholesterol , itching or diarrhea)
- NSAIDs , non-steroidal anti-inflammatory drugs (to treat pain or inflammation )
- p-aminobenzoic acid (for the treatment of skin diseases)
- vaccination with a live vaccine (must be avoided), such as measles, mumps or jaundice.
- other medicines that may have a serious blood effect (eg metamizole)
- nitrous oxide (a gas used in general anesthesia (anesthesia))
Nordimet with food, drink and alcohol
During treatment with Nordimet, do not drink alcohol and avoid excessive consumption of coffee, soft drinks containing caffeine, and black tea, as it may intensify side effects or affect the effect of Nordimet. Also be sure to drink plenty of fluids during treatment with Nordimet, as dehydration (reduced amount of water in the body) can increase the toxicity of one of Nordimet.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, 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 Nordimet during pregnancy or if you are trying to get pregnant. Methotrexate can cause birth defects, birth defects, or miscarriages. It is linked to malformations of the skull, face, heart and blood vessels, brain, and limbs. It is therefore very important that methotrexate is not given to pregnant patients or patients planning to become pregnant. Infertile women, existing pregnancies must be ruled out with certainty through appropriate measures, such as pregnancy tests, before starting treatment. You must avoid becoming pregnant while taking methotrexate and for at least six months after stopping treatment by using a reliable method of contraception throughout this time (see also section “Warnings and precautions”).
If you become pregnant during treatment or suspect that you may be pregnant, contact your doctor as soon as possible. You should be offered advice on the risk of harmful effects on the child due to the treatment.
If you want to get pregnant, you should contact a doctor who can refer you to a specialist for advice before the planned start of treatment.
Breast-feeding
You must not breastfeed during treatment, as methotrexate is transferred to breast milk. If your doctor considers it necessary that you receive methotrexate treatment during breastfeeding, you must stop breastfeeding.
Fertility in men
The available research evidence does not indicate an increased risk of malformations or miscarriages if the father takes methotrexate in doses of less than 30 mg/week. However, the risk can not be completely ruled out. Methotrexate may be genotoxic. This means that the drug can cause gene mutations. Methotrexate can affect sperm production and thus cause malformations. Therefore, you should not make a woman pregnant or donate sperm while taking methotrexate and for at least six months after stopping treatment.
Driving and using machines
Treatment with Nordimet can cause side effects that affect the central nervous system,
for example, fatigue and dizziness. Therefore, in some cases, the ability to drive and/or use machines may be impaired. If you feel tired or dizzy, do not drive or use machines.
Nordimet contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose and is therefore essentially ‘sodium-free’.
How to use Nordimet
| Important warning regarding the dosing of Nordimet (methotrexate): 343Nordimet should only be used once a week in the treatment of rheumatoid arthritis, active juvenile idiopathic arthritis, psoriasis , psoriatic arthritis, and Crohn’s disease. Using too much Nordimet (methotrexate) can be life-threatening. Read section 3 of this leaflet very carefully. If you have any further questions, ask your doctor or pharmacist. |
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Nordimet is given only once a week. Together with your doctor, you decide on a suitable day each week when you receive your injection.
If Nordimet is given incorrectly, it can lead to serious side effects that can be fatal.
The recommended dose is:
Adult patients with rheumatoid arthritis
The recommended starting dose is 7.5 mg methotrexate once a week.
Your doctor may increase the dose if the dose used is not effective but is well tolerated. The average weekly dose is 15-20 mg. In general, the weekly dose should not exceed 25 mg. Once Nordimet has started working, the doctor can reduce the dose to a gradual to the lowest possible effective maintenance dose.
It usually takes 4-8 weeks before symptoms improve. Symptoms may recur if treatment with Nordimet is stopped.
Adults with severe forms of psoriasis Vulgaris and psoriatic arthritis
Your doctor will give you a test dose of 5-10 mg to assess any side effects.
If the test dose is well tolerated, treatment is continued after one week with a dose of approximately 7.5 mg.
It usually takes 2-6 weeks before the treatment works. The doctor then decides whether to continue or discontinue treatment, depending on the treatment effect and the results of blood and urine tests.
Dosage in adult patients with Crohn’s disease:
Your doctor will start with a dose of 25 mg a week. Treatment response can generally be expected after about 8-12 weeks. Depending on the treatment effect over time, your doctor may reduce the dose to one to 15 mg a week.
Children and adolescents under 16 years of age with polyarthritic forms of juvenile idiopathic arthritis
The doctor calculates the appropriate dose based on the child’s body surface area (m 2 ). The dose is expressed as mg / m 2.
Use is not recommended in children under 3 years of age, as there is a lack of experience in this age group.
Method of administration and duration of treatment
Nordimet is given as an injection under the skin ( subcutaneously ). The medicine must be injected once a week and it is recommended that Nordimet always be injected on the same day of the week.
At the beginning of your treatment, Nordimet can be injected by healthcare professionals. However, the doctor may think that you can learn to inject Nordimet yourself. In that case, you will receive instructions on how to proceed. If you have not been taught the injection technique, you must under no circumstances try to inject Nordimet yourself.
The duration of treatment is determined by the attending physician. Treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis Vulgaris, psoriatic arthritis, and Crohn’s disease with Nordimet is a long-term treatment.
How to inject Nordimet yourself
If you have difficulty handling the pen, consult your doctor or pharmacist. Do not try to give yourself an injection unless you have been given instructions on how to proceed. If you are not sure what to do, talk to your doctor or nurse immediately.
Before you give yourself an injection one
- Check the expiry date on the medicine. Do not use this medicine after the expiration date.
- Check that the pen is not damaged and that the medicine in the pen is a clear, yellow solution. If not, replace the pen .
- Check your last injection site and look for redness , discoloration, swelling or if it becomes liquid or still hurts. In that case, talk to your doctor or nurse.
- Decide where to inject the medicine. Change to a new injection site each time.
Instructions for injecting yourself with Nordimet
1) Wash your hands thoroughly with soap and water.
2) Sit or lie in a relaxed, comfortable position. Make sure you can see the area of skin where you are going to inject.
3) The pen is pre-filled and ready to use. Look at what the pen looks like. You should see a yellow liquid through the inspection window. Sometimes a small air bubble appears, but it does not affect injection one and is not harmful to you.
It is possible that a small drop can be seen at the top of the needle. This is normal.
4) Choose an injection site and clean with the alcohol swab provided. For effective disinfection, 30-60 seconds are required. The skin on the front of the abdominal wall and the skin on the front of the thigh are suitable injection sites.
5) Pull off the protective cap while holding the pen. After removing the protective cap, hold the pen in your hand. Do not allow the pen to come into contact with anything else. This ensures that the needle stays clean and that the pen is not accidentally activated.
6) Make a skin fold by gently pinching the skin at the injection site with your index finger and thumb. You need to keep the skin fold during the entire injection one.
7) Hold the pen against the skin fold (injection site) so that the needle cover points directly towards the injection site. Place the yellow needle cover against the injection site so that the edge of the needle cover contacts the skin all the way around.
8) Push the pen down towards the skin until you hear and feel a “click”.
Then the pen is activated and the solution is automatically injected into the skin.
9) Injection takes a maximum of 10 seconds. You will feel and hear a second “click” when injection one is complete.
10) Wait another 2-3 seconds before removing the pen from the skin. The needle guard on the pen is now locked to prevent needle stick injuries. Now you can let go of the skin fold.
11) Look in the pen’s inspection window. You should now see green plastic. This means that all liquid has been injected. Dispose of the used pen in the supplied needle container. Close the lid of the container tightly and place it out of sight and reach of children. If you accidentally get methotrexate on your skin or soft tissue, rinse with plenty of water.
If you use more Nordimet than you should
Follow your doctor’s dosing recommendations. Do not change the dose on your own.
If you suspect that you have used too much Nordimet, you must contact your doctor immediately or go to the nearest hospital. If you go to a doctor or hospital, take the medicine pack and this brochure with you.
An overdose of methotrexate can lead to severe poisoning reactions. Symptoms of overdose are e.g. bruising or bleeding, unusual weakness, cold sores, nausea, vomiting, black or bloody stools, blood cough or vomiting that looks like coffee grounds, decreased amount of urine. See also section 4.
If you forget to use Nordimet
Do not take a double dose to make up for a forgotten dose, but continue to take the prescribed dose as usual. Ask your doctor for advice.
If you stop taking Nordimet
You should not stop treatment with Nordimet without first discussing it with your doctor. If you suspect that you have had any side effects, talk to your doctor immediately.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you suddenly experience wheezing and wheezing, difficulty breathing, swelling of the eyelids, face or lips, rash or itching (especially if your whole body is affected).
Serious side effects are
If you get any of the following side effects, talk to your doctor straight away:
- pneumonia (symptoms may be general malaise, dry, irritating cough, shortness of breath, even at rest, chest pain or fever)
- blood in saliva or cough
- severe peeling or blistering of the skin
- unusual bleeding (including vomiting) or bruising
- severe diarrhea
- sores in the mouth
- black or tarry stools
- blood in urine or feces
- small red dots on the skin
- fever
- yellowish skin (jaundice)
- pain or difficulty urinating
- thirst and / or frequent water yields
- seizures (convulsions)
- unconsciousness
- blurred or impaired vision
The following side effects have also been reported:
Very common (may affect more than 1 in 10 people)
Decreased appetite, nausea, stomach pain, inflammation of the mucous membranes of the mouth, abnormal digestion, and increase in liver enzymes.
Common (may affect up to 1 in 10 people)
Reduced blood cell formation with decreased number of white and/or red blood cells and/or platelets ( leukopenia, anemia , thrombocytopenia ), headache, fatigue, drowsiness, pneumonia with dry, non-productive cough, shortness of breath and fever, cold sores, diarrhea, rash, diarrhea, reddening of the skin, itching.
Uncommon (may affect up to 1 in 100 people)
Decreased number of red blood cells and platelets, inflammation of the throat, dizziness, confusion, depression, inflammation of the blood vessels, ulcers and bleeding in the gastrointestinal tract, intestinal inflammation, vomiting, inflammation of the pancreas, liver disease, diabetes, decreased blood protein, herpes-like rash, hives. photosensitivity, hair loss, increased number of rheumatic nodules, skin ulcers, shingles, joint or muscle pain, osteoporosis (decreased bone mass), inflammation and ulcers in the bladder (sometimes with blood in the urine), impaired kidney function, urination pain, inflammations and wounds in the vagina.
Rare (may affect up to 1 in 1,000 people)
Infection (incl. Reactivation of inactive chronic infection ), sepsis, red eyes, allergic reactions, anaphylactic shock, decreased number of antibodies in the blood, inflammation of the pericardium, fluid accumulation in the pericardium, obstruction of heart-filling due to fluid in the pericardium, visual disturbances, visual disturbances, low blood pressure, blood clots, formation of scar tissue in the lungs ( pulmonary fibrosis ), Pneumocystis jiroveci pneumonia, respiratory arrest, asthma, fluid accumulation in the alveoli, inflamed gums, acute hepatitis(hepatitis), brown skin, acne, red or purple dots due to bleeding in blood vessels, allergic inflammation of blood vessels, bone fractures, kidney failure, decrease or lack of urine, electrolyte disturbances, fever, slow wound healing.
Very rare (may affect up to 1 in 10,000 people)
Decrease in certain white blood cells ( agranulocytosis ), severe bone marrow inhibition, liver failure, swollen lymph nodes, insomnia, pain, muscle weakness, feeling numb or crawling / less sensitive to stimulation than normal, taste changes (metal taste), seizures, meningitis, inflammation of the meninges, meningitis impaired vision, damage to the retina of the eyes, vomiting of blood, toxic megacolon (enlargement of the colon associated with severe pain), defective sperm production (oligospermia), Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome), increased pigmentation the nails, decreased sexual drive, erection problems, infection around the fingernails, severe complications in the gastrointestinal tract, abscesses, visible enlargement of small blood vessels in the skin, menstrual disorders, discharge from the vagina, infertility, enlargement of the mammary glands in men ( gynecomastia ), lymphoproliferative disease vigorous growth of white blood cells).
No known frequency (can not be calculated from the available data)
Elevation of certain white blood cells ( eosinophilia ), certain brain diseases (encephalopathy/leukoencephalopathy), nosebleeds, bleeding from the lungs, bone damage in the jaw (secondary to excessive growth of white blood cells ), protein in the urine, feeling of weakness, tissue damage and tissue damage skin, swelling.
Only mild local skin reactions (such as burning, reddening of the skin, swelling, discoloration, severe itching, pain) have been observed with Nordimet and decreased during treatment.
Nordimet may cause a decrease in white blood cells and poorer resistance to infection. If you get an infection with symptoms such as fever and severe worsening of the general condition or get a fever with symptoms of a local infection such as sore throat/throat/mouth or urination problems, you should contact a doctor immediately. A blood sample will be taken to check if the number of white blood cells has decreased ( agranulocytosis ). It is important to tell your doctor if you are using Nordimet.
It is known that methotrexate can cause bone-related disorders such as joint and muscle pain and osteoporosis. It is unknown how great the risk is that children will be affected by this.
Nordimet can cause serious (sometimes life-threatening) side effects. The doctor will take samples to check if abnormalities develop in the blood (eg low white blood cell count, low platelet count, lymphoma ) and if changes occur in the kidneys and liver.
How to store Nordimet
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label on the pre-filled pen and the carton. The expiration date is the last day of the specified month.
Do not store above 25 ° C.
Keep the pen in the outer carton. Sensitive to light.
Do not use this medicine if you notice that the solution is not clear and contains particles.
Nordimet is for single use only. Used pens must be discarded.
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.
Contents of the pack and other information
Content declaration
The active substance is methotrexate. 1.0 ml solution contains 25 mg methotrexate.
The other ingredients are sodium chloride, sodium hydroxide, and water for injections.
The following pens are available:
Pre-filled pens of 0.3 ml containing 7.5 mg methotrexate
Pre-filled pens of 0.4 ml containing 10 mg methotrexate
Pre-filled pencils with 0.5 ml containing 12.5 mg methotrexate
Pre-filled pencils with 0.6 ml containing 15 mg methotrexate
Pre-filled pencils with 0.7 ml containing 17.5 mg methotrexate
Pre-filled pencils with 0.8 ml containing 20 mg methotrexate
Pre-filled pencils with 0.9 ml containing 22.5 mg methotrexate
Pre-filled pens of 1.0 ml containing 25 mg methotrexate
What the medicine looks like and contents of the pack
Nordimet pre-filled pens contain a clear, yellow solution for injection.
Nordimet is available in packs containing 1 or 4 pre-filled pens and 1 or 4 alcohol wipers, as well as in multi-packs consisting of 4 or 6 cartons, each containing 1 pre-filled pen and 1 alcohol dryer.
Nordimet is also available in a multi-pack consisting of 3 cartons, each containing 4 pre-filled pens and an alcohol dryer per carton.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Nordic Group BV
Siriusdreef 41
2132 WT Hoofddorp
Netherlands
Manufacturer
CENEXI – Thissen Laboratories
Rue de la Papyrée 2-6
B-1420 Braine-l’Alleud
Belgium