Nordimet is a medicine used to treat a variety of inflammatory diseases:<\/p>\n\n\n\n
- active rheumatoid arthritis in adult patients. Active rheumatoid arthritis is an inflammatory disease that affects the joints;<\/li>
- 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 );<\/li>
- 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;<\/li>
- induction of improvement in adults with moderate steroid-dependent Crohn’s disease , in combination with corticosteroids;<\/li>
- as the sole drug in the maintenance treatment of Crohn’s disease in adults who have responded to methotrexate.<\/li><\/ul>\n\n\n\n
What you need to know before using Nordimet<\/h2>\n\n\n\n
Do not reuse Nordimet<\/h2>\n\n\n\n
- you are allergic to methotrexate or any of the other ingredients of this medicine (listed in section 6)<\/li>
- you have a serious kidney disease (your doctor can tell you if you have a serious kidney disease)<\/li>
- you have a serious liver disease (your doctor can tell you if you have a serious liver disease)<\/li>
- you have a disorder of the blood formation system<\/li>
- you drink large amounts of alcohol<\/li>
- your immune system is weakened<\/li>
- you have a serious or existing infection , e.g. tuberculosis or HIV<\/li>
- you have stomach ulcers<\/li>
- you are pregnant or breast-feeding (see section \u201cPregnancy, breast-feeding and fertility\u201d)<\/li>
- you are simultaneously vaccinated with live vaccines.<\/li><\/ul>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
Acute\u00a0hemorrhage from the lungs of patients with the underlying rheumatic disease has been reported with methotrexate.\u00a0If you experience symptoms such as blood in the saliva or bloody cough, contact your doctor immediately.<\/p>\n\n\n\n
Enlarged lymph nodes ( lymphoma ) may occur and then treatment should be stopped.<\/p>\n\n\n\n
Diarrhea can be a toxic effect of Nordimet and requires interruption of treatment. Talk to your doctor if you suffer from diarrhea.<\/p>\n\n\n\n
Certain brain diseases (encephalopathy\/leukoencephalopathy) have been reported as a side effect in cancer patients receiving methotrexate.\u00a0Nor can such\u00a0side effects\u00a0be ruled out when methotrexate is used to treat other diseases.<\/p>\n\n\n\n
Important warning regarding dosing one of Nordimet<\/p>\n\n\n\n
Methotrexate for the treatment of rheumatic diseases, skin diseases, and\u00a0Crohn’s disease\u00a0may only be used\u00a0once a week.\u00a0Improper\u00a0dosing\u00a0of methotrexate can lead to serious\u00a0and potentially fatal\u00a0side effects.\u00a0Read section 3 of this leaflet very carefully.<\/p>\n\n\n\n
Talk to your doctor before using Nordimet about:<\/p>\n\n\n\n
- you have diabetes mellitus and are being treated with insulin<\/li>
- you have an inactive, long-lasting infection (eg tuberculosis , hepatitis B or C or shingles [herpes zoster])<\/li>
- you have or have had a liver or kidney disease<\/li>
- you have problems with lung function<\/li>
- you are very overweight<\/li>
- you have abnormal accumulation of fluid in the abdomen or in the cavity between the lungs and the chest wall ( ascites , pleural effusions)<\/li>
- you are dehydrated or suffer from conditions that lead to dehydration (eg dehydration due to vomiting, diarrhea or inflammation of the mouth and lips).<\/li><\/ul>\n\n\n\n
Skin problems after radiation therapy (radiation-induced dermatitis ) and sun damage may recur during treatment with Nordimet.<\/p>\n\n\n\n
Children, adolescents and the elderly<\/h2>\n\n\n\n
Dosage one depends on the patient’s body weight.<\/p>\n\n\n\n
Use is not recommended for children under 3 years of age as there is a lack of sufficient experience in this age group.<\/p>\n\n\n\n
Children, adolescents, and the elderly who are treated with Nordimet must be monitored particularly closely by doctors so that any\u00a0side effects\u00a0can be identified as early as possible.<\/p>\n\n\n\n
In elderly patients, the dose should be reduced due to age-related hepatic and renal impairment.<\/p>\n\n\n\n
Special precautions for treatment with Nordimet<\/p>\n\n\n\n
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”.<\/p>\n\n\n\n
Skin changes caused by psoriasis may be exacerbated during treatment with Nordimet if you are exposed to ultraviolet radiation.<\/p>\n\n\n\n
Before starting treatment and recommended examinations and precautions for follow-up<\/p>\n\n\n\n
Before starting treatment, you may submit blood samples so that the doctor can, among other things, check your liver and kidney function.\u00a0You may also have to undergo a chest X-ray.\u00a0Additional tests can be done during and after treatment.\u00a0Do not miss any blood sampling sessions.<\/p>\n\n\n\n
If the result of any test is abnormal, treatment will not be resumed until all results are normal again.<\/p>\n\n\n\n
Even when Nordimet is used in low\u00a0doses, serious\u00a0side effects\u00a0can occur.\u00a0Your doctor will perform blood and urine tests to ensure that any\u00a0side effects\u00a0are detected quickly.<\/p>\n\n\n\n
Other medicines and Nordimet<\/h2>\n\n\n\n
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n
It is especially important to tell your doctor if you are taking:<\/p>\n\n\n\n
- 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<\/li>
- ciclosporin (to suppress the immune system)<\/li>
- azathioprine (prevents rejection during organ transplants)<\/li>
- retinoids (used to treat psoriasis and other skin problems)<\/li>
- anticonvulsant drugs (used to prevent seizures), such as phenytoin , valproate or carbamazepine<\/li>
- cancer treatment<\/li>
- barbiturate is (sleep injection)<\/li>
- tranquilizer<\/li>
- birth control pills<\/li>
- probenecid (used to treat gout )<\/li>
- antibiotics (eg penicillin , glycopeptides, trimethoprim \/ sulfamethoxazole, sulfonamides , ciprofloxacin , cephalotin, tetracyclines , chloramphenicol)<\/li>
- pyrimethamine (used to prevent and treat malaria )<\/li>
- vitamin preparations containing folic acid<\/li>
- 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<\/li>
- theophylline (used to treat asthma )<\/li>
- cholestyramine (used to treat high cholesterol , itching or diarrhea)<\/li>
- NSAIDs , non-steroidal anti-inflammatory drugs (to treat pain or inflammation )<\/li>
- p-aminobenzoic acid (for the treatment of skin diseases)<\/li>
- vaccination with a live vaccine (must be avoided), such as measles, mumps or jaundice.<\/li>
- other medicines that may have a serious blood effect (eg metamizole)<\/li>
- nitrous oxide (a gas used in general anesthesia (anesthesia))<\/li><\/ul>\n\n\n\n
Nordimet with food, drink and alcohol<\/h2>\n\n\n\n
During treatment with Nordimet, do not drink alcohol and avoid excessive consumption of coffee, soft drinks containing caffeine<\/a>, and black tea, as it may intensify\u00a0side effects\u00a0or affect the effect of Nordimet.\u00a0Also be sure to drink plenty of fluids during treatment with Nordimet, as dehydration (reduced amount of water in the body) can increase the\u00a0toxicity\u00a0of one of Nordimet.<\/p>\n\n\n\n
Pregnancy, breastfeeding and fertility<\/h2>\n\n\n\n
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.<\/p>\n\n\n\n
Pregnancy<\/p>\n\n\n\n
Do not use Nordimet during pregnancy or if you are trying to get pregnant.\u00a0Methotrexate can cause birth defects, birth defects, or miscarriages.\u00a0It is linked to malformations of the skull, face, heart and blood vessels, brain, and limbs.\u00a0It is therefore very important that methotrexate is not given to pregnant patients or patients planning to become pregnant.\u00a0Infertile women, existing pregnancies must be ruled out with certainty through appropriate measures, such as pregnancy tests, before starting treatment.\u00a0You 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 \u201cWarnings and precautions\u201d).<\/p>\n\n\n\n
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.<\/p>\n\n\n\n
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.<\/p>\n\n\n\n
Breast-feeding<\/p>\n\n\n\n
You must not breastfeed during treatment, as methotrexate is transferred to breast milk.\u00a0If your doctor considers it necessary that you receive methotrexate treatment during breastfeeding, you must stop breastfeeding.<\/p>\n\n\n\n
Fertility in men<\/p>\n\n\n\n
The available research evidence does not indicate an increased risk of malformations or miscarriages if the father takes methotrexate in\u00a0doses\u00a0of less than 30 mg\/week.\u00a0However, the risk can not be completely ruled out.\u00a0Methotrexate may be genotoxic.\u00a0This means that the drug can cause gene mutations.\u00a0Methotrexate can affect sperm production and thus cause malformations.\u00a0Therefore, you should not make a woman pregnant or donate sperm while taking methotrexate and for at least six months after stopping treatment.<\/p>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
Treatment with Nordimet can cause\u00a0side effects\u00a0that affect the\u00a0central nervous system,<\/p>\n\n\n\n
for example,\u00a0fatigue and dizziness.\u00a0Therefore, in some cases, the ability to drive and\/or use machines may be impaired.\u00a0If you feel tired or dizzy, do not drive or use machines.<\/p>\n\n\n\n
Nordimet contains sodium<\/h2>\n\n\n\n
This medicine contains less than 1 mmol sodium (23 mg) per dose and is therefore essentially ‘sodium-free’.<\/p>\n\n\n\n
How to use Nordimet<\/h2>\n\n\n\n
Important warning regarding\u00a0the <\/strong>dosing\u00a0of Nordimet (methotrexate): 343Nordimet\u00a0\u00a0should only be used once a week\u00a0in the treatment of\u00a0rheumatoid arthritis, active\u00a0juvenile idiopathic arthritis,\u00a0psoriasis\u00a0, psoriatic arthritis, and\u00a0Crohn’s disease.\u00a0Using too much Nordimet (methotrexate) can be life-threatening.\u00a0Read section 3 of this leaflet very carefully.\u00a0If you have any further questions, ask your doctor or pharmacist.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.<\/p>\n\n\n\n
Nordimet is given\u00a0only once a week<\/strong>.\u00a0Together with your doctor, you decide on a suitable day each week when you receive your\u00a0injection.<\/p>\n\n\n\n
If Nordimet is given incorrectly, it can lead to serious side effects that can be fatal.<\/p>\n\n\n\n
The recommended dose is:<\/p>\n\n\n\n
Adult patients with rheumatoid arthritis<\/p>\n\n\n\n
The recommended starting dose is 7.5 mg methotrexate\u00a0once a week<\/strong>.<\/p>\n\n\n\n
Your doctor may increase the\u00a0dose\u00a0if the\u00a0dose\u00a0used is not effective but is well tolerated.\u00a0The average weekly dose is 15-20 mg.\u00a0In general, the weekly dose should not exceed 25 mg.\u00a0Once Nordimet has started working, the doctor can reduce the\u00a0dose\u00a0to a gradual to the lowest possible effective maintenance dose.<\/p>\n\n\n\n
It usually takes 4-8 weeks before symptoms improve. Symptoms may recur if treatment with Nordimet is stopped.<\/p>\n\n\n\n
Adults with severe forms of\u00a0psoriasis\u00a0Vulgaris and psoriatic arthritis<\/p>\n\n\n\n
Your doctor will give you a test dose of 5-10 mg to assess any\u00a0side effects.<\/p>\n\n\n\n
If the test dose is well tolerated, treatment is continued after one week with a dose of approximately 7.5 mg.<\/p>\n\n\n\n
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.<\/p>\n\n\n\n
Dosage in adult patients with Crohn’s disease:<\/p>\n\n\n\n
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.<\/p>\n\n\n\n
Children and adolescents under 16 years of age with polyarthritic forms of juvenile idiopathic arthritis<\/p>\n\n\n\n
The doctor calculates the appropriate\u00a0dose\u00a0based on the child’s body surface area (m\u00a02<\/sup>\u00a0).\u00a0The dose\u00a0is expressed as mg \/ m\u00a02.<\/p>\n\n\n\n
Use is not recommended in children under 3 years of age, as there is a lack of experience in this age group.<\/p>\n\n\n\n
Method of administration and duration of treatment<\/p>\n\n\n\n
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.<\/p>\n\n\n\n
At the beginning of your treatment, Nordimet can be injected by healthcare professionals.\u00a0However, the doctor may think that you can learn to inject Nordimet yourself.\u00a0In that case, you will receive instructions on how to proceed.\u00a0If you have not been taught the injection technique, you must under no circumstances try to inject Nordimet yourself.<\/p>\n\n\n\n
The duration of treatment is determined by the attending physician.\u00a0Treatment of\u00a0rheumatoid arthritis,\u00a0juvenile idiopathic arthritis,\u00a0psoriasis\u00a0Vulgaris, psoriatic arthritis, and\u00a0Crohn’s disease\u00a0with Nordimet is a long-term treatment.<\/p>\n\n\n\n
How to inject Nordimet yourself<\/strong><\/p>\n\n\n\n
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.<\/p>\n\n\n\n
Before you give yourself an injection one<\/strong><\/p>\n\n\n\n
- Check the expiry date on the medicine. Do not use this medicine after the expiration date.<\/li>
- Check that the pen is not damaged and that the medicine in the pen is a clear, yellow solution. If not, replace the pen .<\/li>
- 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.<\/li>
- Decide where to inject the medicine. Change to a new injection site each time.<\/li><\/ul>\n\n\n\n
Instructions for injecting yourself with Nordimet<\/strong><\/p>\n\n\n\n
1) Wash your hands thoroughly with soap and water.<\/em><\/p>\n\n\n\n
2) Sit or lie in a relaxed, comfortable position. Make sure you can see the area of \u200b\u200bskin where you are going to inject.<\/p>\n\n\n\n
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.<\/p>\n\n\n\n
It is possible that a small drop can be seen at the top of the needle. This is normal.<\/p>\n\n\n\n
4) Choose an injection site and clean with the alcohol swab provided.\u00a0For effective\u00a0disinfection, 30-60 seconds are required.\u00a0The skin on the front of the abdominal wall and the skin on the front of the thigh are suitable injection sites.<\/p>\n\n\n\n
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.<\/p>\n\n\n\n
<\/a><\/figure>\n\n\n\n
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.<\/p>\n\n\n\n
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.<\/p>\n\n\n\n
<\/a><\/figure>\n\n\n\n
8) Push the pen down towards the skin until you hear and feel a “click”.<\/p>\n\n\n\n
Then the pen is activated and the solution is automatically injected into the skin.<\/p>\n\n\n\n
<\/a><\/figure>\n\n\n\n
9) Injection takes a maximum of 10 seconds. You will feel and hear a second “click” when injection one is complete.<\/p>\n\n\n\n
<\/a><\/figure>\n\n\n\n