2.5 mg, 7.5 mg, 10 mg tablet
methotrexate
What Metotab is and what it is used for
Metotab is used for:
- severe, active rheumatoid arthritis in adults
- severe and generalized psoriasis vulgaris, especially of the plaque type, in adults.
Rheumatoid arthritis (RA) is a chronic autoimmune disease, characterized by joint inflammation that causes swollen joints, reduced mobility, and pain.
Psoriasis Vulgaris is a chronic autoimmune skin disease characterized by patches of red, thickened, and dry skin, often covered with silvery scales.
Metab affects and slows the course of the disease.
Methotrexate contained in Metotab may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Metotab
| Important warning about dose one of Metotab (methotrexate): Take Metotab only once a week for the treatment of rheumatoid arthritis and psoriasis. Taking too much Metotab (methotrexate) 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. |
Do not take Metotab:
- if you are allergic to methotrexate or any of the other ingredients of this medicine (listed in section 6)
- if you have any serious liver or kidney disease or blood disease
- if you drink large amounts of alcohol
- if you have a severe infection , such as tuberculosis or HIV or other immune deficiency syndromes
- if you have sores in your mouth, stomach or intestines
- if you are pregnant or breast-feeding (see section “Pregnancy, breast-feeding and fertility”)
- if you are being vaccinated with live vaccines at the same time.
Warnings and cautions
Talk to your doctor or pharmacist before taking Metotab
- if you are elderly or in general poor condition
- if you have impaired liver or kidney function
- if you have dehydration.
Special precautions for use with Metotab
Methotrexate temporarily affects sperm and egg production, an effect that in most cases decreases after the end of treatment. Methotrexate can cause miscarriage and severe congenital malformations. You must avoid becoming pregnant while using methotrexate and for at least 6 months after stopping treatment. See also section “Pregnancy, breast-feeding and fertility”.
Recommended follow-up examinations and safety measures
Even if Metotab is given in low doses, there is a risk of serious side effects. To detect these in time, checks and laboratory tests must be performed at regular intervals.
Before treatment
Before starting treatment, you will take blood samples to do certain tests, for example, you will check your liver values and your kidney function. Your doctor will also check that you do not have tuberculosis or inflammation of the liver.
During treatment
- Various examinations will be performed at least once a month for the first 6 months and then at least once every three months: examination of the mouth and throat to see if there have been any changes in the mucous membrane, blood tests, check of liver function, check of kidney function, control of the respiratory system and, if necessary, lung function tests.
- Contact your doctor if you experience persistent cough or shortness of breath.
- 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.
- Methotrexate may affect your immune system and some vaccines may not work properly with methotrexate. If you have inactive or chronic infections (eg herpes zoster [shingles], tuberculosis , hepatitis B or C), these infections may flare up or worsen during treatment with methotrexate.
- If you have previously had skin problems after radiation therapy (radiation-induced dermatitis ) and burns to the skin after sunbathing, these symptoms may recur during methotrexate treatment (re-reaction). Skin changes caused by psoriasis may be exacerbated during treatment with methotrexate with concomitant UV radiation.
- Enlarged lymph nodes ( lymphoma ) can occur and if this happens, treatment must be stopped.
- Diarrhea may be a possible side effect of Metotab and requires discontinuation of treatment. If you have diarrhea, you should talk to your doctor.
- Stop taking Metotab and contact a doctor immediately if swelling of, among other things. a. face, tongue and / or throat and / or difficulty swallowing or hives that occur together with difficulty breathing (allergic shock ).
- Certain brain diseases (encephalopathy / leukoencephalopathy) have occurred in cancer patients treated with methotrexate. Such side effects can not be ruled out when methotrexate is used against other diseases.
- If you, your partner or your healthcare provider discover new or worsening neurological symptoms, such as general muscle weakness, visual disturbances, changes in thinking ability, memory and orientation that lead to confusion and personality changes, you should contact your doctor immediately as these may be symptoms of a very rare , severe brain infection called progressive multifocal leukoencephalopathy (PML).
Other medicines and Metotab
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of the treatment can be affected if Metotab is taken at the same time as certain other medicines:
- antibiotics such as: tetracyclines , chloramphenicol and non-absorbable broad-spectrum antibiotics, penicillins , glycopeptides, sulfonamides , ciprofloxacin and cephalothin (medicines that prevent / fight certain infections )
- non-steroidal anti-inflammatory drugs or salicylates (medicines for pain and / or inflammation ) such as acetylsalicylic acid , diclofenac and ibuprofen or pyrazole
- probenecid (anti- gout medicine )
- weak organic acids such as loop diuretics (“diuretic tablets”)
- drugs that may have adverse effects on bone marrow , such as trimethoprim-sulfamethoxazole (an antibiotic ) and pyrimethamine
- other drugs used to treat rheumatoid arthritis such as leflunomide, sulfasalazine and azathioprine
- mercaptopurine (a drug used to treat cancer in the blood)
- retinoids (medicines for psoriasis and other skin diseases)
- theophylline (medicine for bronchial asthma and other lung diseases)
- certain medicines for stomach problems such as omeprazole and pantoprazole
- hypoglycaemic agents (medicines used to lower blood sugar ).
Vitamins containing folic acid can reduce the effectiveness of your treatment and should only be taken on the advice of your doctor.
Vaccination with live vaccines must be avoided while you are being treated with Metotab.
Metotab with food, drink and alcohol
- Alcohol should be avoided during treatment with this drug.
- Excessive intake of coffee, caffeinated beverages and black tea should be avoided during treatment with Metotab.
Pregnancy, breastfeeding and fertility
Pregnancy
Do not use Metotab during pregnancy or if you are trying to get pregnant. 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 patients or patients planning to become pregnant. Infertile women, pregnancy must be ruled out by appropriate measures, e.g. a pregnancy test before starting treatment. You must avoid becoming pregnant while taking methotrexate and for at least 6 months after stopping treatment, using reliable contraception during 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. You should be offered medical advice on the risk of harmful effects on the child due to the treatment.
If you wish to become pregnant, consult your doctor, who may refer you to specialist advice before the planned start of treatment.
Breast-feeding
Breast-feeding should be discontinued before and during treatment with Metotab.
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, risk can not be completely ruled out. Methotrexate may be genotoxic. This means that the drug can cause gene mutation. Methotrexate can affect sperm production and can cause congenital malformations. Therefore, you should avoid getting a woman pregnant and donating sperm while taking methotrexate and for at least 6 months after stopping treatment.
Driving and using machines
Side effects that affect the central nervous system such as fatigue and dizziness may occur during treatment with Metotab. Therefore, the ability to drive or use machines may be impaired in some cases. If you feel tired or dizzy, do not drive or use machines.
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.
Metotab contains lactose monohydrate
Metotab contains lactose monohydrates. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to take Metotab
Recommended dose:
Dose for rheumatoid arthritis and psoriasis
Take Metotab only once a week. You and your doctor will decide on a suitable day of the week for taking the tablet.
The tablets should be swallowed whole with a glass of water, in a straight-up or standing position. The notch is not intended for splitting the tablet.
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Your doctor will decide on a dose that is tailor-made for you. It usually takes 4 – 8 weeks before the treatment has any effect in rheumatoid arthritis and 2 – 6 weeks in psoriasis Vulgaris. The treatment time is determined by your doctor.
If you have the impression that the effect of Metotab is too strong or too weak, talk to your doctor or pharmacist.
If you take more Metotab than you should
Follow your doctor’s dose recommendations. Do not change the dose yourself.
The doctor will decide which treatment is appropriate depending on the severity of the poisoning.
If you forget to take Metotab
Do not take a double dose to make up for a forgotten tablet. Consult your doctor. Take the dose prescribed by your doctor as soon as possible and every week thereafter.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of side effects as well as the severity of side effects depends on the dose level and the frequency with which Metotab is given. As serious side effects can occur even with low doses, you must be checked regularly by your doctor. Your doctor will perform tests to check for abnormalities in your blood (such as low white blood cell count, low platelet count, lymphoma ) and changes in your kidneys and liver.
The most relevant side effects are effects on blood formation and the gastrointestinal tract.
Tell your doctor immediately if you get any of the following symptoms, as these may indicate a serious, possibly life-threatening side effect, which requires urgent, special treatment:
- persistent dry, unproductive cough, shortness of breath and fever; its symptoms may be signs of pneumonia [common].
- blood in saliva or cough; these symptoms may be signs of bleeding from the lungs [no known frequency].
- symptoms of liver damage, such as yellowing of the skin and whites of the eyes; methotrexate can cause cirrhosis of the liver, scar tissue formation in the liver (liver fibrosis), fatty liver [all uncommon], hepatitis ( acute hepatitis ) [rare] and liver failure [very rare].
- allergic reactions such as rash including red, itchy skin, swollen hands, feet, ankles, face, lips, mouth or throat (which may make it difficult to swallow or breathe) and you will feel dizzy; these symptoms may be signs of a severe allergic reaction [rare].
- symptoms of kidney damage such as swollen hands, ankles or feet, altered urination frequency, decreased urine output ( oliguria ) or lack of urine ( anuria ); these symptoms may be signs of kidney failure [rare].
- symptoms of infection are, e.g. fever, chills, diffuse pain, sore throat; Methotrexate may make you more susceptible to infection . Severe infections such as a certain type of pneumonia ( Pneumocystis jirovecii pneumonia ) or sepsis can occur [rare].
- symptoms such as weakness / paralysis in one side of the body ( stroke ) or pain, swelling, redness and abnormal heat in one of the legs (deep vein thrombosis ). These symptoms can occur in connection with a detached blood clot blocking a blood vessel (thromboembolic event) [rare].
- fever and severe deterioration of the general condition or sudden fever together with sore throat or mouth, or urination problems; methotrexate can cause a sharp decrease in the number of white blood cells ( agranulocytosis ) and severe bone marrow inhibition [very rare].
- unexpected bleeding, e.g. bleeding gums, blood in the urine, bloody vomiting or bruising; these symptoms may be signs of a sharp decrease in the number of platelets caused by severe bone marrow suppression [very rare].
- symptoms such as very severe headache often in combination with fever, stiff neck, nausea, vomiting, confusion and sensitivity to light may indicate an inflammation of the meninges ( acute aseptic meningitis ) [very rare].
- Certain brain diseases (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. Signs of this type of brain disease can be altered mental state, movement disorders ( ataxia ), visual disturbances or memory disorders [no known frequency].
- severe skin rash or blisters on the skin (this can also affect the mouth, eyes and genitals); these symptoms can be signs of a condition called Stevens-Johnson syndrome or burn-like condition (toxic epidermal necrolysis / Lyell’s syndrome) [very rare].
Listed below are all other side effects that may occur:
Very common (may affect more than 1 user in 10)
- inflammation of the oral mucosa, stomach upset, nausea, loss of appetite, abdominal pain
- abnormal liver function values ( AST , ALT , bilirubin , alkaline phosphatase).
Common (may affect up to 1 in 10 people)
- sores in the mouth, diarrhea
- rash, redness of the skin, itching
- headache, fatigue, drowsiness
- impaired blood cell formation with decreased number of white blood cells , decreased number of red blood cells , decreased number of platelets .
Uncommon (may affect up to 1 in 100 people)
- inflammation of the pharynx
- inflammation of the intestines, vomiting, pancreatitis, black or tar-like stools, ulcers and bleeding in the gastrointestinal tract
- increased photosensitivity, hair loss, increased number of rheumatic nodules, skin ulcers, shingles ( herpes zoster), inflammation of the blood vessels, herpes-like skin rash, hives
- trigger of diabetes mellitus
- dizziness, impaired thinking ( cognitive dysfunction ), confusion, depression
- decreased level of serum albumin
- decreased number of all blood cells and platelets
- inflammation and ulcers in the bladder or vagina, impaired renal function, disturbed urination
- joint pain, muscle pain, decreased bone mass.
Rare (may affect up to 1 in 1,000 people)
- poor absorption of nutrients, gingivitis
- increased skin pigmentation, acne , blue spots due to bleeding from blood vessels ( ecchymosis , petechiae ), allergic inflammation of blood vessels
- decreased amount of antibody in the blood
- infection (incl. reactivation of inactive chronic infection ), red eyes (conjunctivitis)
- Mood swings
- visual disturbances
- pericarditis, accumulation of fluid in the pericardium, prevented blood filling of the heart due to fluid in the pericardium
- low blood pressure
- formation of scar tissue in the lungs ( pulmonary fibrosis ), shortness of breath and bronchial asthma , accumulation of fluid in the alveoli
- fracture as a result of stress or overload of the skeleton (stress fracture)
- electrolyte disturbances
- fever, impaired wound healing.
Very rare (may affect up to 1 in 10,000 people)
- sudden sharp enlargement of the intestine (toxic megacolon)
- increased pigmentation of the nails, cuticle inflammation ( acute paronychia ), deep infection of the hair follicles ( furunculosis ), visible dilation of small blood vessels
- pain, decreased muscle strength or a feeling of numbness or tingling / lower sensitivity to stimulation than normal, taste changes (metallic taste), cramps, paralysis, meninigism
- impaired vision, non- inflammatory eye disease ( retinopathy )
- loss of sexual drive, impotence , enlargement of the mammary glands in men, defective spermatogenesis (oligospermia), impaired ovulation, impaired spermatogenesis, sterility, menstrual disorders, vaginal discharge
- enlargement of the lymph nodes ( lymphoma )
- lymphoproliferative disorders (abnormal growth of white blood cells ).
Has been reported (occurs in an unknown number of users)
- increased white blood cell count
- nosebleeds
- protein is in the urine
- impotence
- bone damage in the jaw (as a result of abnormal growth of white blood cells )
- reddening of the skin and scaly skin
- swelling.
How to store Metotab
Keep this medicine out of the sight and reach of children.
Do not store above 25 ° C. Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiration date is the last day of the specified month.
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: 2.5 mg; 7.5 mg and 10 mg methotrexate respectively (as methotrexate disodium).
- The other ingredients are lactose monohydrate , pregelatinized starch , magnesium stearate.
What the medicine looks like and contents of the pack
Yellow, slightly speckled, round, biconvex tablets. The 10 mg tablet has a score that is for identification purposes only.
PVC / PVDC / aluminum blister, containing 10, 30, 50 or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
medac society for clinical specialties mbH
Theater. 6
22880 Wedel
Germany
tel: +49 4103 8006 0
fax: +49 4103 8006 100
This medicinal product is authorized under the European Economic Area under the names: