Methotrexat-ebeve

Leaflet accompanying the packaging: patient information

Methotrexat-Ebewe 2.5 mg, tablets
Methotrexat-Ebewe 5 mg, tablets
Methotrexat-Ebewe 10 mg, tablets
Methotrexatum

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

Keep this leaflet, so you can read it again if you need to.

If you have any doubts, consult your doctor or pharmacist.

This medicine has been prescribed specifically for you. Do not pass it on to others.

The medicine may harm another person, even if their symptoms are the same.

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Methotrexat-Ebewe and what is it used for
• 2. Important information before taking Methotrexat-Ebewe
• 3. How to take Methotrexat-Ebewe
• 4. Possible side effects
• 5. How to store Methotrexat-Ebewe
• 6. Contents of the packaging and other information

1. What is Methotrexat-Ebewe and what is it used for

Methotrexat-Ebewe contains the active substance methotrexate. Methotrexate is a derivative of folic acid, it is a cytostatic medicine from the group of antimetabolites, it inhibits the proliferation of rapidly dividing cells (such as cancerous, bone marrow, fetal, mucous membrane of the mouth, small intestine, bladder).
Methotrexat-Ebewe is used in combination chemotherapy for malignant tumors and acute leukemias, when there are indications for oral treatment. If cancer cells divide much faster than normal cells, methotrexate may inhibit the development of cancer cells without causing irreversible damage to healthy tissues.
Methotrexat-Ebewe is used in the most severe, treatment-resistant form of generalized psoriasis (psoriasis vulgaris), including psoriatic arthritis - so-called psoriatic arthritis. The proliferation of skin epithelial cells is significantly greater in patients with psoriasis than in healthy individuals; this symptom is the basis for the use of methotrexate in these indications.
Methotrexat-Ebewe is also used in other autoimmune diseases, e.g. in rheumatoid arthritis. The mechanism of action in rheumatoid arthritis is most likely related to the immunosuppressive action of the medicine.

2. Important information before taking Methotrexat-Ebewe

When not to take Methotrexat-Ebewe

• if the patient is allergic (hypersensitive) to methotrexate or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has:
• severe liver function disorders
• severe kidney function disorders
• blood cell production disorders, including bone marrow function disorders (leukopenia, thrombocytopenia, anemia), changes in blood count

has a low platelet count, anemia, or changes in blood count

• severe and/or active infections
• mouth ulcers, oral ulcers, and/or diagnosed active peptic ulcer disease of the stomach or duodenum
• fresh surgical wounds
• if the patient consumes large amounts of alcohol, has been diagnosed with post-alcoholic liver disease, or has other liver disease;
• if the patient has reduced immunity;
• during breastfeeding and also during pregnancy, if the patient is taking the medicine for non-oncological indications (in the treatment of non-cancerous disease) (see section "Pregnancy, breastfeeding, and fertility").

The medicine should not be used in children under 3 years of age.
During treatment with Methotrexat-Ebewe, vaccines containing live microorganisms should not be used.

Warnings and precautions

Methotrexate should only be used under the supervision of a doctor specializing in cancer chemotherapy and immunosuppressive therapy.
Before taking Methotrexat-Ebewe, the patient should discuss with their doctor if they have:

• changes in blood count and abnormal hematological parameters, especially if they have previously undergone radiation therapy or received other cytostatics;
• are undergoing radiation therapy;
• have diabetes and are being treated with insulin;
• have lung function disorders;
• have or have had kidney or liver disease in the past;
• are dehydrated or have diarrhea, vomiting, or mouth ulcers;
• have ulcerative stomatitis;
• have ulcerative colitis;
• are in poor general condition;
• have been diagnosed with shingles, tuberculosis, or viral hepatitis (type B or C);
• have been diagnosed with fluid accumulation in the abdominal cavity or in the space between the lungs and the chest wall (ascites, pleural effusion).

The doctor will closely monitor the patient's condition to detect any potential side effects as early as possible.
If the patient experiences symptoms of toxic effects on the digestive system, such as mouth ulcers, diarrhea, bloody vomiting, black or bloody stools, or blood in the stool, the doctor will decide whether to discontinue treatment. Continuing treatment may lead to hemorrhagic enteritis and death due to perforation of the intestines.
If the patient, their partner, or caregiver notices new or worsening neurological symptoms, including general muscle weakness, vision disturbances, changes in thinking, memory, and orientation leading to disorientation and personality changes, they should contact their doctor immediately, as these may be symptoms of a very rare, serious brain infection called progressive multifocal leukoencephalopathy (PML).
Due to its effect on the immune system, methotrexate may weaken the response to vaccination and disrupt the results of immunological tests.
Vaccinations performed during methotrexate treatment may be ineffective.
During methotrexate treatment, cases of acute bleeding from the lungs have been reported in patients with underlying rheumatologic disease. If the patient experiences hemoptysis, i.e., coughing up bloody sputum, they should immediately consult their doctor.
Recommended tests and precautions
Even with small doses of Methotrexat-Ebewe, severe side effects may occur. To detect these effects early, the doctor must perform control tests and laboratory tests.
Before starting treatment
Before starting treatment, the doctor will order blood tests to check the number of blood cells and liver function, and to detect hepatitis. Tests will be performed to determine the level of albumin in the blood, liver inflammation, and kidney function. The doctor may also recommend other liver tests - imaging tests or tests that require taking a small tissue sample from the liver for further examination. They may also recommend a chest X-ray or lung function test to check for tuberculosis. Further tests may also be performed during and after treatment.
During treatment:
The doctor may order the following tests:

• examination of the mouth and throat to rule out changes in the mucous membranes, such as inflammation or ulcers.
• blood tests and/or complete blood count with assessment of the number of individual blood cell types and measurement of methotrexate levels in the blood
• blood tests to monitor liver function
• imaging tests to monitor liver condition
• taking a small liver biopsy for detailed examination
• blood tests to monitor kidney function
• monitoring of respiratory system function and, if necessary, lung function tests.

The patient should attend all scheduled blood tests and other tests recommended by their doctor.
If the result of any of these tests is abnormal, treatment will not be resumed until all tested parameters return to normal.
In patients with rheumatoid arthritis, the doctor will pay special attention to the possibility of methotrexate-induced side effects in the respiratory system. If coughing or shortness of breath occurs, the patient should immediately consult their doctor.
Exposure to UV radiation during Methotrexat-Ebewe therapy may exacerbate skin lesions associated with psoriasis.
Methotrexate may increase skin sensitivity to sunlight. The patient should avoid intense sun exposure and not use a sunbed or tanning lamp without consulting their doctor.
To protect the skin from intense sunlight, the patient should wear appropriate clothing or use a sunscreen with a high protection factor.
During treatment, methotrexate or its metabolites may precipitate in the renal tubules. To prevent this, the doctor will recommend drinking plenty of fluids and administering urine alkalizing agents.
Any significant decrease in white blood cell or platelet count, as well as signs of infection, should be reported to the doctor.
During treatment, it is necessary to follow the rules for handling cytotoxic substances.
Methotrexate temporarily disrupts the production of sperm and egg cells. Methotrexate may cause miscarriage and severe birth defects. Female patients should avoid becoming pregnant while taking methotrexate and for at least 6 months after treatment. Male patients should avoid fathering a child while taking methotrexate and for at least 3 months after treatment (see also section "Warnings and precautions").
Elderly patients
Elderly patients treated with methotrexate should be closely monitored by their doctor to detect any potential side effects as early as possible.
Age-related liver and kidney function disorders, as well as low folate reserves in older adults, require the use of relatively small doses of methotrexate.

Methotrexat-Ebewe and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
It is especially important to inform the doctor about taking the following medicines:

• other medicines used to treat rheumatoid arthritis or psoriasis, such as gold salts, leflunomide, sulfasalazine (also used to treat ulcerative colitis), acetylsalicylic acid, phenylbutazone, or aminophenazone;
• azathioprine (used to prevent transplant rejection);
• retinoids (used to treat psoriasis and other skin disorders);
• antiepileptic drugs (used to prevent seizures);
• anticancer drugs (e.g., mercaptopurines, doxorubicin);
• asparaginase (a medicine used to treat leukemia);
• cytarabine (a medicine used to treat certain lymphomas);
• barbiturates (sedatives);
• tranquilizers;
• oral contraceptives;
• probenecid (used to treat gout);
• antibiotics or sulfonamides, ciprofloxacin;
• pyrimethamine (a medicine used to treat malaria);
• vitamin preparations containing folic acid;
• proton pump inhibitors (used to treat severe heartburn or ulcers);
• theophylline (used to treat asthma);
• Vincaalkaloids;
• non-steroidal anti-inflammatory drugs, salicylates;
• metamizole (synonyms: novaminsulfone and dipyrone) [a strong pain reliever and/or antipyretic];
• calcium folinate;
• folate antagonists (trimethoprim with sulfamethoxazole);
• etretinate (used to treat psoriasis);
• corticosteroids;
• hydroxychloroquine;
• penicillamine;
• cyclosporine;
• theophylline;
• triamterene;
• levetiracetam;
• live vaccines.

These medicines may increase the concentration of methotrexate in the blood or in cells, disrupt its excretion, and thus increase the toxicity of methotrexate and change the effectiveness of treatment, as well as increase the risk of treatment-related side effects.
Penicillins may decrease the excretion of methotrexate, potentially leading to increased side effects.
During methotrexate treatment, the immune system's response to concurrent vaccinations may be weakened.
If the patient is to undergo surgery under anesthesia, they should inform the anesthesiologist about taking Methotrexat-Ebewe.
If the patient has any doubts about taking any of the listed medicines, they should consult their doctor or pharmacist.

Methotrexat-Ebewe with food, drink, and alcohol

Tablets should be taken on an empty stomach, with a small amount of water.
During treatment with Methotrexat-Ebewe, the patient should avoid consuming alcohol, as well as excessive amounts of coffee, caffeinated beverages, and black tea.
During treatment, the patient should drink plenty of fluids, as dehydration (reduced water content in the body) may increase the toxic effects of the medicine.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
Pregnancy
Methotrexat-Ebewe should not be used during pregnancy, unless the doctor has recommended it for oncological indications. Methotrexate may cause birth defects, harm the unborn child, or cause miscarriage. This is associated with developmental abnormalities of the skull, face, heart, and blood vessels, brain, and limbs. Therefore, it is very important that female patients who are pregnant or planning to become pregnant do not take methotrexate, unless it is for oncological indications.
If the patient is taking methotrexate for oncological indications, they should plan to become pregnant no earlier than 1-2 years after the end of treatment.
If the patient is of childbearing age, before starting treatment for non-oncological indications, it should be confirmed that they are not pregnant, e.g., by performing a pregnancy test. Methotrexat-Ebewe should not be used if the patient is pregnant or trying to become pregnant. Female patients should avoid becoming pregnant while taking methotrexate and for at least 6 months after treatment. During this time, effective contraception is necessary (see also section "Warnings and precautions").
If the patient becomes pregnant while taking methotrexate, they should consult their doctor as soon as possible to discuss the potential harmful effects of treatment on the child.
If the patient plans to become pregnant, they should consult their treating doctor, who may refer them to a specialist for advice before planned treatment begins.
Breastfeeding
The patient should not breastfeed while taking Methotrexat-Ebewe, as methotrexate passes into breast milk. If the treating doctor considers it necessary to use Methotrexat-Ebewe during this time, breastfeeding should be discontinued.
Male fertility
Available data do not indicate an increased risk of birth defects or miscarriages after the father has taken methotrexate at a dose below 30 mg/week. However, this risk cannot be completely ruled out; there is also no information on higher doses of methotrexate. Methotrexate may have genotoxic effects, meaning it may cause genetic mutations. Methotrexate may affect sperm production, which is associated with the possibility of birth defects.
Male patients should avoid fathering a child while taking methotrexate and for at least 3 months after treatment. Due to the potential risk of infertility and genetic mutations associated with higher doses of methotrexate typically used in cancer treatment, it may be recommended that male patients treated with methotrexate at doses above 30 mg/week have their sperm frozen before starting treatment (see also section "Warnings and precautions").

Driving and operating machinery

Methotrexate may cause fatigue and dizziness, which can impair the ability to drive and operate machinery.

Methotrexat-Ebewe contains lactose

If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking the medicine.

3. How to take Methotrexat-Ebewe

Methotrexat-Ebewe may only be used under the supervision of a doctor with experience in cancer chemotherapy or immunosuppressive therapy.
Depending on the indication and treatment regimen, the dose of Methotrexat-Ebewe may vary within very wide limits, so the medicine should always be taken according to the doctor's instructions.

Recommended dose

Treatment-resistant generalized psoriasis, psoriatic arthritis, and other autoimmune diseases
The dosage and duration of therapy depend on the severity of the disease and tolerance to methotrexate.
The weekly dose is usually between 10 and 25 mg of methotrexate taken orally.
Dosage depends on the results of therapy and the occurrence of side effects. Therefore, the doctor will usually start treatment with a dose of 2.5-5 mg per week. This dose may be increased to 7.5-25 mg per week.

Important warning regarding Methotrexat-Ebewe dosing (methotrexate):

In the treatment of treatment-resistant generalized psoriasis, psoriatic arthritis, and other autoimmune diseases, Methotrexat-Ebewe (methotrexate) should be taken only once a week. Taking more Methotrexat-Ebewe (methotrexate) than prescribed may be fatal. The patient should carefully read section 3 of this leaflet. If they have any questions, they should consult their doctor or pharmacist before taking the medicine.
The doctor will instruct the patient to take the weekly dose once, on an empty stomach, directly before a meal.
The doctor will write the designated day of taking the medicine on the prescription.
Tablets should be swallowed with water.
Malignant tumors and acute leukemias
The dosage of methotrexate will be determined by the doctor based on the indication, the patient's health status, and the results of blood morphology. The most commonly used small (single dose not exceeding 100 mg/m² body surface area), medium (single dose between 100 and 1000 mg/m² body surface area), or large (single dose exceeding 1000 mg/m² body surface area) doses of methotrexate depend on the chemotherapy regimen used.
Oral methotrexate is usually used as a supplement to extraintestinal treatment and is used only in small doses.

Taking a higher dose of Methotrexat-Ebewe than recommended

The patient should take the dose prescribed by their doctor. They should never change it themselves.
If it is suspected that the patient (or someone else) has taken a higher dose of the medicine than they should have, they should immediately contact their doctor or the emergency department of the nearest hospital. They should take the medicine packaging with them so that it is known which medicine was taken.
Overdose of methotrexate can cause severe toxic reactions. Symptoms of overdose include: easy bruising or bleeding, weakness, mouth sores, nausea, vomiting, black or bloody stools, coughing up blood or vomiting coffee grounds, and decreased urine output. See also section 4.
Only a doctor can decide on the type of treatment to be undertaken, depending on the severity of the poisoning symptoms.
The antidote used in case of methotrexate poisoning is calcium folinate.

Missing a dose of Methotrexat-Ebewe

The patient should not take a double dose to make up for a missed tablet.

Stopping Methotrexat-Ebewe treatment

The patient should not stop treatment without their doctor's advice.
If they have any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Methotrexat-Ebewe can cause side effects, although not everybody gets them.
It is believed that the frequency and severity of side effects are related to the size of the dose, the method, and frequency of administration of the medicine. The following side effects were reported mainly after the use of high doses of methotrexate in chemotherapy. These effects occur less frequently and are less severe after the use of low doses of methotrexate in the treatment of psoriasis and other autoimmune diseases.
The patient should immediately inform their doctor if they experience sudden wheezing, difficulty breathing, swelling of the eyelids, face, or lips, rash, or itching (especially if it affects the whole body).

Severe side effects

The patient should immediately contact their doctor if they experience the following side effects:

• respiratory problems (symptoms may include general malaise; dry, irritating cough, shortness of breath, chest pain, or fever);
• severe skin peeling or blistering;
• unexplained bleeding (including bloody vomiting) or bruising;
• severe diarrhea;
• mouth ulcers;
• black or bloody stools;
• blood in urine or stool;
• small red spots on the skin;
• fever;
• jaundice (yellowing of the skin);
• pain or difficulty urinating;
• thirst and/or frequent urination;
• seizures (convulsions);
• loss of consciousness;
• blurred vision or vision disturbances;
• coughing up blood, i.e., coughing up sputum with blood*

*(reported during methotrexate treatment in patients with underlying rheumatologic disease)

Other side effects:

Very common side effects(may occur in more than 1 in 10 people):

• reduced immunity to infections;
• throat inflammation;
• decreased platelet count (thrombocytopenia), decreased white blood cell count (leukopenia);
• headache, dizziness;
• cough;
• loss of appetite;
• diarrhea, abdominal pain, nausea, vomiting;
• ulcerative stomatitis;
• increased liver enzyme activity (ASAT, ALAT), alkaline phosphatase;
• increased bilirubin levels in the blood;
• decreased creatinine clearance;
• hair loss;
• fatigue, weakness, malaise.

Common side effects(may occur in less than 1 in 10 people):

• shingles;
• anemia, pancytopenia, agranulocytosis;
• bone marrow suppression;
• drowsiness;
• conjunctivitis;
• pulmonary complications due to interstitial pneumonia, pneumonitis (may be fatal), acute pulmonary edema;
• rash, erythema, itching;
• photosensitivity.

Uncommon side effects(may occur in less than 1 in 100 people):

• life-threatening opportunistic infections;
• malignant lymphoma;
• allergic reactions up to anaphylactic shock;
• immunosuppression;
• diabetes;
• depression;
• hemiparesis;
• confusion;
• seizures;
• encephalopathy/leukoencephalopathy;
• vasculitis, allergic vasculitis;
• pulmonary fibrosis, pleural effusion;
• ulceration of the mucous membranes of the stomach and intestines;
• bleeding;
• pancreatitis;
• toxic effects on the liver;
• fatty liver;
• chronic fibrosis and cirrhosis of the liver;
• decreased albumin levels in the blood;
• skin eruptions, herpes-like skin eruptions;
• Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome);
• urticaria;
• increased skin pigmentation;
• reactions similar to sunburn due to increased skin sensitivity to sunlight;
• methotrexate-induced lesions;
• impaired wound healing;
• painful psoriatic lesions;
• joint pain, muscle pain;
• osteoporosis;
• nephropathy, kidney failure;
• inflammation and ulceration of the bladder;
• hematuria;
• urination disorders, painful urination, oliguria, anuria;
• birth defects in the fetus;
• inflammation and ulceration of the vagina;
• fever.

Rare side effects(may occur in less than 1 in 1000 people):

• herpes simplex hepatitis;
• cryptococcosis, histoplasmosis, nocardiosis;
• cytomegalovirus infections (including pneumonitis);
• disseminated herpes simplex infection;
• Pneumocystis jiroveciipneumonia;
• tumor lysis syndrome (in patients treated for cancer);
• skin cancer (in patients treated for psoriasis);
• aplastic anemia;
• eosinophilia, neutropenia;
• lymphadenopathy;
• lymphoproliferative disorders (overproduction of white blood cells);
• hypogammaglobulinemia;
• myasthenia;
• limb pain;
• numbness or tingling or reduced reaction to stimuli;
• taste disorders (metallic taste);
• acute aseptic meningitis with cerebrospinal fluid reaction;
• meningitis symptoms without infection (paralysis, vomiting);
• cranial nerve disorders;
• periorbital edema;
• blepharitis;
• excessive tearing due to insufficient drainage of the tear film;
• photophobia;
• transient blindness, loss of vision;
• pericarditis, pericardial tamponade, pericardial effusion;
• chronic obstructive pulmonary disease;
• reactions similar to asthma with cough, shortness of breath, and changes in lung function tests;
• hematemesis;
• acute liver failure, acute liver atrophy, liver failure;
• acne, telangiectasia, acute paronychia;
• hematuria, proteinuria;
• fetal death;
• disorders of sperm and egg production, infertility;
• menstrual cycle disorders;
• loss of libido;
• impotence;
• leukorrhea;
• gynecomastia;
• chills.

Very rare side effects(may occur in less than 1 in 10,000 people):

• hepatitis caused by herpes simplex virus;
• cryptococcosis, histoplasmosis, nocardiosis;
• cytomegalovirus infections (including pneumonitis);
• disseminated herpes simplex infection;
• Pneumocystis jiroveciipneumonia;
• tumor lysis syndrome (in patients treated for cancer);
• skin cancer (in patients treated for psoriasis);
• aplastic anemia;
• eosinophilia, neutropenia;
• lymphadenopathy;
• lymphoproliferative disorders (overproduction of white blood cells);
• hypogammaglobulinemia;
• myasthenia;
• ból w kończynach;
• uczucie drętwienia lub mrowienia lub odczuwanie słabszej niż zwykle reakcji na bodźce;
• zaburzenia smaku (metaliczny posmak);
• ostre jałowe zapalenie opon mózgowo-rdzeniowych z odczynem oponowym;
• objawy zapalenia opon mózgowo-rdzeniowych bez zakażenia (porażenie, wymioty);
• zaburzenia nerwów czaszkowych;
• obrzęk okołooczodołowy;
• zapalenie brzegów powiek;
• łzawienie na skutek niedostatecznego odprowadzania filmu łzowego;
• światłowstręt;
• przemijająca ślepota, utrata wzroku;
• zapalenie osierdzia, tamponada osierdzia, wysięk osierdziowy;
• przewlekła obturacyjna choroba płuc;
• reakcje przypominające astmę oskrzelową z kaszlem, dusznością i zmianami widocznymi w badaniach czynności płuc;
• krwawe wymioty;
• ostra martwica wątroby, ostre zwyrodnienie wątroby, niewydolność wątroby;
• czyraczność, teleangiektazje, ostra zanokcica;
• krwiomocz, białkomocz;
• śmierć płodu;
• zaburzenia wytwarzania plemników, zaburzenia wytwarzania komórek jajowych;
• niepłodność;
• zaburzenia cyklu miesiączkowego;
• utrata libido;
• impotencja;
• upławy;
• ginekomastia;
• dreszcze.

Side effects with unknown frequency(frequency cannot be estimated from available data):

• pneumonia;
• reactivation of hepatitis B virus;
• worsening of hepatitis C virus;
• neurotoxicity;
• leptomeningeal sclerosis;
• transverse myelitis;
• stupor;
• ataxia;
• dementia;
• increased intracranial pressure;
• chest pain;
• hypoxia;
• hemorrhagic alveolitis (reported during methotrexate treatment in patients with underlying rheumatologic disease);
• non-infectious peritonitis;
• intestinal perforation;
• glossitis;
• acute colonic dilatation;
• drug reaction with eosinophilia and systemic symptoms (DRESS);
• dermatitis;
• erythema, exfoliative dermatitis;
• exacerbation of psoriatic lesions after concurrent UV radiation exposure;
• skin ulceration (in patients with psoriasis);
• edema;
• bone necrosis;
• jawbone necrosis (due to increased white blood cell count);
• retinopathy;
• chills;
• seizures, neurotoxicity, leptomeningeal sclerosis, paralysis, stupor, ataxia (movement disorders), dementia, increased intracranial pressure, encephalopathy (brain damage).

If the patient experiences diarrhea or mouth ulcers, they should immediately inform their doctor, as treatment may need to be discontinued due to the risk of intestinal perforation or hemorrhagic enteritis.
Methotrexate treatment may cause recurrence of skin inflammation and sunburn (so-called recall reactions).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Methotrexat-Ebewe

• The medicine should be stored out of sight and reach of children.
• Methotrexat-Ebewe should not be used after the expiration date stated on the packaging after EXP. The expiration date refers to the last day of the specified month.
• Store at a temperature below 25°C.
• Store in the original packaging to protect from light.
• Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the packaging and other information

What Methotrexat-Ebewe contains

The active substance of the medicine is methotrexate. One tablet contains 2.5 mg, 5 mg, or 10 mg of methotrexate.
Other ingredients are: lactose monohydrate, cornstarch, microcrystalline cellulose, magnesium stearate, colloidal anhydrous silica.

What Methotrexat-Ebewe looks like and contents of the pack

Methotrexat-Ebewe tablets are light yellow and may have yellow or red speckles.
The 5 mg and 10 mg tablets can be divided into halves.
Packaging contains 30 or 50 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder
EBEWE Pharma Ges.m.b.H. Nfg.KG
Mondseestrasse 11
A-4866 Unterach, Austria
Manufacturer
EBEWE Pharma Ges.m.b.H. Nfg.KG
Mondseestrasse 11
A-4866 Unterach, Austria
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
To obtain more detailed information, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00

Date of last revision of the leaflet:

EBEWE logo