METOTREXATO 2.5 мг Коатированные таблетки

Содержание инструкции

1. Metotrexato Aurobindo 2,5 mg tablets
   1. What is Metotrexato Aurobindo and what is it used for
   2. What you need to know before taking Metotrexato Aurobindo
   3. How to take Metotrexato Aurobindo
   4. Possible side effects
   5. How to store Metotrexato Aurobindo
   6. Contents of the pack and other information

Metotrexato Aurobindo 2,5 mg tablets

Generic medicine

Read this leaflet carefully before taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Metotrexato Aurobindo is and what it is used for
• 2. What you need to know before you take Metotrexato Aurobindo
• 3. How to take Metotrexato Aurobindo
• 4. Possible side effects
• 5. How to store Metotrexato Aurobindo
• 6. Contents of the pack and other information

1. What is Metotrexato Aurobindo and what is it used for

The active substance of Metotrexato Aurobindo, methotrexate, is a substance with the following properties:

• suppresses the growth of some rapidly reproducing cells in the body;
• reduces the activity of the immune system (the body's defense mechanism).

Methotrexate is used in the treatment of:

• active rheumatoid arthritis in adult patients;
• arthritis in children aged 3 years and over and in adolescents (severe active juvenile arthritis) when five or more joints are involved and the response to treatment with another class of medicines (so-called non-steroidal anti-inflammatory drugs (NSAIDs)) is insufficient;
• severe relapsing and disabling psoriasis in adult patients, who do not respond adequately to other forms of therapy such as phototherapy, PUVA and retinoids;
• severe psoriatic arthritis in adult patients;
• maintenance therapy for acute lymphoblastic leukemia (ALL) in adults, adolescents and children aged 3 years and over.

Your doctor will be able to explain how Metotrexato Aurobindo may help you in your specific
situation.

2. What you need to know before taking Metotrexato Aurobindo

Do not take Metotrexato Aurobindo

• if you are allergic (hypersensitive) to methotrexate or to any of the other ingredients of this medicine (listed in section 6);
• if you are breastfeeding and, furthermore, for non-oncological indications (for non-anticancer treatments) if you are pregnant (see section “Pregnancy, breastfeeding and fertility”);
• if you have severe liver or kidney disease (the doctor will assess the severity of the disease);
• if you have or have had a bone marrow disease or severe blood disorders;
• if you have severe acute or chronic infections;
• if you suffer from immunodeficiency syndrome;
• if you have inflammation of the oral mucosa or mouth ulcers;
• if you have ulcers in the stomach or intestines;
• if you suffer from alcoholism;
• if you have recently received or are about to receive vaccination with live vaccines.

Warnings and precautions
Important warning about the dosage of Metotrexato Aurobindo (methotrexate):
Take Metotrexato Aurobindo only once a weekfor the treatment of rheumatoid arthritis, acute lymphoblastic leukemia, psoriasis or psoriatic arthritis, juvenile idiopathic arthritis ( juvenile idiopathic arthritis, JIA). An excessive dose of Metotrexato Aurobindo (methotrexate) can be fatal. Read section 3 of this leaflet carefully. If you have any doubts, consult your doctor or pharmacist before taking this medicine.
Consult your doctor, pharmacist or nurse before taking Metotrexato Aurobindo:

• if you have ever had any liver or kidney disease;
• if you suffer from chronic inactive infections (e.g. tuberculosis, hepatitis B or C, herpes zoster) as they may recur;
• if your general health conditions are poor;
• if you have problems with lung function;
• if you are particularly overweight;
• if you have an abnormal accumulation of fluid in the abdomen (ascites) or around the lungs (pleural effusions);
• if you suffer from diabetes mellitus and are being treated with insulin;
• if you are dehydrated or suffer from conditions that cause dehydration (vomiting, diarrhea, constipation, inflammation of the oral mucosa).

Cases of acute pulmonary bleeding have been reported in patients with rheumatological disease undergoing treatment with methotrexate. If you experience symptoms such as blood in your saliva or after coughing, contact your doctor immediately.
Diarrhea may be a possible side effect of Metotrexato Aurobindo and requires discontinuation of therapy. If you suffer from diarrhea, please consult your doctor.
Methotrexate temporarily affects the production of sperm and eggs. Methotrexate can cause miscarriage and serious birth defects. If you are a woman, you should avoid getting pregnant while taking methotrexate and for at least six months after the end of treatment with methotrexate. If you are a man, you should avoid conceiving children while taking methotrexate and for at least 3 months after the end of treatment. See the section “Pregnancy, breastfeeding and fertility”.
Methotrexate can make the skin more sensitive to sunlight. Avoid prolonged sun exposure and do not use sunbeds or tanning lamps without your doctor's advice. To protect your skin from intense sunlight, wear appropriate clothing or use a sunscreen with a high protection factor.
Radiotherapy during the use of Metotrexato Aurobindo may increase the risk of soft tissue necrosis or bone necrosis. If you have had skin problems after radiotherapy (radiation dermatitis) or sunburns, these reactions may recur after therapy with methotrexate (“recall reaction”). Skin changes due to psoriasis may worsen during treatment with methotrexate if exposed to UV rays.
Probenecid reduces tubular renal transport; therefore, the concomitant administration of methotrexate with this medicine must be carefully monitored. Probenecid and weak organic acids such as pyrazoles reduce the elimination of methotrexate, resulting in increased hematological toxicity.
In patients treated with low doses of methotrexate, enlarged lymph nodes (lymphoma) may occur; in this case, therapy should be discontinued.
If you, your partner or the person assisting you notice the onset or worsening of neurological symptoms, including general muscle weakness, visual disturbances, changes in thinking, memory and orientation leading to confusion and personality changes, contact your doctor immediately as these may be symptoms of a very rare and serious brain infection called progressive multifocal leukoencephalopathy ( progressive multifocal

leukoencephalopathy, PML).
Some other brain disorders (encephalopathy/leukoencephalopathy) have been reported in oncological patients treated with methotrexate. These adverse effects cannot be ruled out when methotrexate is used to treat other diseases.
Control tests and recommended precautions
Even if methotrexate is used at low doses, serious side effects can occur. To detect them in time, the doctor must perform monitoring tests and laboratory analyses.
Before starting therapy:
Before starting treatment, your blood will be examined to verify that you have a sufficient number of blood cells. The blood will also be analyzed to verify liver function and to find out if you have hepatitis. In addition, serum albumin (a protein present in the blood), any hepatitis (liver infection) and kidney function will be checked. The doctor may also decide to perform other liver tests, some of which may involve imaging of your liver, while others may require taking a small sample of liver tissue for closer examination. The doctor may also check if you have tuberculosis and may perform a chest X-ray or a pulmonary function test.
During treatment:

• examination of the oral cavity and pharynx to identify changes in the mucosa, such as inflammation or ulceration;
• blood tests/count of the number of blood cells and measurement of serum methotrexate levels;
• blood tests to monitor liver function;
• imaging to monitor liver conditions;
• taking a small sample of tissue from the liver for closer examination;
• blood tests to monitor kidney function;
• monitoring of the respiratory tract and, if necessary, pulmonary function tests.

It is very important that you attend these scheduled tests. If the results of any of these tests are significant, the doctor will adjust the treatment accordingly.

Children, adolescents and the elderly
Children, adolescents and the elderly (65 years of age and over) treated with methotrexate must be carefully monitored by a doctor, in order to identify any adverse effects as soon as possible.
Age-related impairment of liver and kidney function, as well as lower bodily reserves of folic acid in old age, require a relatively low dose of methotrexate.
Use in children under 3 years of age is not recommended as there is insufficient experience in this age group.

Other medicines and Metotrexato Aurobindo
Taking other medicines at the same time can affect the effectiveness and safety of this medicine. Metotrexato Aurobindo can also affect the effectiveness and safety of other medicines.
Tell your doctor or pharmacist if you are taking, have recently taken or may take other medicines. Remember to inform the doctor about the treatment with Metotrexato Aurobindo if you are prescribed another medicine while the treatment is still ongoing. It is particularly important to inform the doctor if you are taking:

• metamizole (synonyms: novaminsulfon, dipyrone) (medicine for severe pain and/or fever);
• antibiotics (medicines to prevent/fight certain infections) such as penicillins, sulfonamides, ciprofloxacin, cefalotin, trimethoprim/sulfamethoxazole, tetracycline and chloramphenicol. For example, antibiotics such as amoxicillin can reduce the excretion of methotrexate, potentially increasing adverse reactions;
• other medicines used to treat rheumatoid arthritis such as leflunomide, sulfasalazine and azathioprine;
• some medicines for pain and/or inflammation known as non-steroidal anti-inflammatory drugs (e.g. ibuprofen, diclofenac, salicylates such as acetylsalicylic acid);
• pyrimethamine (for the prevention and treatment of malaria);
• anticancer agents (e.g. mercaptopurine, 5-fluorouracil, doxorubicin, olaparib and procarbazine);
• antiepileptic drugs (prevention of epileptic seizures);
• omeprazole or pantoprazole (medicines used to block stomach acid production);
• diuretics;
• medicines to lower blood sugar levels such as metformin;
• cholestyramine (a medicine that binds bile acids and can be used, for example, to lower cholesterol levels);
• cyclosporine (a medicine that can suppress or prevent the immune response);
• retinoids (for the treatment of psoriasis and other skin diseases);
• oral contraceptives;
• barbiturates (sleeping pills);
• sedatives;
• nitrous oxide (used for general anesthesia);
• probenecid (a medicine used for gout);
• theophylline (a medicine used for respiratory diseases);
• vitamin preparations or other products containing folic acid and derivatives;
• live vaccines (see section 2 “Do not take Metotrexato Aurobindo”).

Metotrexato Aurobindo with food, drinks and alcohol
During treatment with Metotrexato Aurobindo, the consumption of alcohol, as well as large amounts of coffee, caffeinated beverages and black tea, should be avoided. Make sure to drink plenty of fluids during treatment with Metotrexato Aurobindo tablets as dehydration (reduction of body fluids) can increase the side effects of methotrexate.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not use Metotrexato Aurobindo during pregnancy unless your doctor has prescribed it as cancer treatment.
Methotrexate can cause birth defects, be harmful to the fetus or cause miscarriage. It is associated with malformations of the skull, face, heart and blood vessels, brain and limbs.
Therefore, it is essential that methotrexate is not administered to pregnant women or women planning a pregnancy, except in cases of cancer treatments.
For non-oncological indications, in women of childbearing potential, the possibility of pregnancy must be excluded before starting treatment, for example by performing a pregnancy test.
Do not use Metotrexato Aurobindo if you are trying to get pregnant. During treatment with methotrexate and for at least 6 months after the end of treatment, you must avoid becoming pregnant. Therefore, you must ensure that you use an effective method of contraception for the entire period (see also the section “Warnings and precautions”).
If you become pregnant during treatment, contact your doctor as soon as possible.
If you become pregnant, you will be given advice on the risk of harmful effects on the fetus due to treatment.
If you wish to become pregnant, you should talk to your doctor, who may refer you to a specialist before the planned start of treatment.
Breastfeeding
Do not breastfeed during treatment, as methotrexate passes into breast milk. If the doctor considers that treatment with methotrexate is absolutely necessary during breastfeeding, breastfeeding must be discontinued.
Male fertility
Available evidence does not indicate an increased risk of birth defects or miscarriage if the father takes methotrexate at a dose of less than 30 mg/week. However, the risk cannot be completely excluded and there is no information regarding higher doses of methotrexate. Methotrexate can have a genotoxic effect. This means that the drug can cause genetic mutations. Methotrexate can affect sperm production, with the possibility of causing birth defects.
You should avoid conceiving children or donating sperm during treatment with methotrexate and for at least 3 months after the end of treatment. Because treatment with methotrexate at higher doses, commonly used in cancer therapy, can cause infertility and genetic mutations, sperm preservation may be recommended for male patients treated with doses of methotrexate greater than 30 mg/week (see also the section “Warnings and precautions”).
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
During treatment with Metotrexato Aurobindo, you may experience fatigue and dizziness. Do not drive vehicles and do not use machines if you experience these symptoms.

3. How to take Metotrexato Aurobindo

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.

• Patients suffering from rheumatoid arthritis, acute lymphoblastic leukemia, psoriasis or psoriatic arthritis, or juvenile idiopathic arthritis (JIA), must take the tablets orally only oncea week, on the same day of the week.
• Do not take the tablets more often than prescribed by your doctor.
• Daily administration may lead to serious adverse effects, includingdeath.
• Take the tablets with a glass of water, while sitting or standing.

Dosage for rheumatoid arthritis
Take the tablets once a week, always on the same day of the week. The usual dose
is between 7.5 and 20 mg once a week.
Dosage for severe psoriasis and psoriatic arthritis
Take the tablets once a week, always on the same day of the week. The usual dose
is between 7.5 and 15 mg once a week.
Dosage for maintenance therapy in acute lymphoblastic leukemia
Take the tablet once a week, always on the same day of the week. The doctor
will calculate the necessary dose based on your body surface area. The doctor will determine the correct dose for
you. For further information, consult your doctor.
Dosage for juvenile idiopathic arthritis (JIA)
Take the tablet once a week, always on the same day of the week. The recommended initial
dose is 10 mg/m of body surface area per week in a single administration.
Special populations
Usually, in elderly patients and patients with renal or hepatic insufficiency, a reduced dose is used
according to the doctor's prescription. See also paragraph 2 “Do not take Metotrexato
Aurobindo”.

Use in children and adolescents
For children and adolescents undergoing maintenance therapy for acute lymphoblastic leukemia, the
doctor will calculate the required dose individually, based on body surface area.

Safe handling of Metotrexato Aurobindo
Appropriate procedures for the safe handling of cytotoxic agents must be adopted.
Anyone handling methotrexate must wash their hands before and after administering a dose. It is
necessary to use disposable gloves when handling methotrexate tablets. Women who are
pregnant, planning a pregnancy or breastfeeding should avoid handling methotrexate tablets, if
possible.
Contact with skin or mucous membranes must be avoided. If contact with skin or mucous membranes occurs,
wash immediately and thoroughly with water and soap.
Parents, caregivers and patients should be advised to keep
methotrexate out of the reach of children, preferably in a locked cabinet.
Accidental ingestion can be fatal to children.

If you take more Metotrexato Aurobindo than you should
If you take (or someone else has taken) more medicine than prescribed, seek immediate medical
attention or go to the nearest hospital emergency room.
An overdose of methotrexate can cause serious toxic reactions, including
death. Overdose symptoms may include a tendency to bruise or
bleed, unusual weakness, mouth sores, nausea, vomiting, black or bloody stools, coughing
up blood or vomiting coffee-ground-like material, and decreased urination. See also section
4 “Possible side effects”.
Bring the medicine packaging with you when you go to the doctor or hospital. If you have taken a
methotrexate overdose, you will be given calcium folinate to mitigate its
adverse effects.

If you forget to take Metotrexato Aurobindo
Take the forgotten dose as soon as you remember, if this happens within two days. However, if you
have forgotten a dose for more than two days, contact your doctor for advice. Do not take a
double dose to make up for the missed dose.
Before a holiday or trip, make sure you have a sufficient supply of medicine.

If you stop taking Metotrexato Aurobindo
Do not stop taking Metotrexato Aurobindo unless your doctor has told you to.
If it is necessary to stop treatment with Metotrexato Aurobindo, your doctor
will decide which method is most suitable for you.
If you have any doubts about using this medicine, 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 adverse reactions to methotrexate are related to the
dose and frequency of administration. Most adverse reactions are reversible if detected early.

Immediately inform your doctorif you notice any of the following symptoms, as they could
indicate a serious, potentially life-threatening side effect that requires specific treatment:

• Inflammation of the lungs (symptoms may include general malaise, dry and irritating cough, shortness of breath, breathlessness at rest, chest pain or fever).
• Blood in saliva or following coughing.
• Unusual bleeding (including vomiting blood), bruising or nosebleeds.
• Nausea, vomiting, abdominal discomfort or severe diarrhoea.
• Mouth ulcers.
• Black or tarry stools.
• Severe allergic reaction causing fever, rash, swelling and sometimes a drop in blood pressure. An extremely intense allergic reaction with skin rashes, commonly in the form of blisters or sores in the oral cavity, eyes and other mucous membranes such as, for example, the genitals (Stevens-Johnson syndrome, toxic epidermal necrolysis - Lyell's syndrome).
• Any symptom of infection, such as fever or a marked worsening of general health, or fever with local signs of infection, such as sore throat/inflammation of the throat or mouth or difficulty urinating; consult your doctor immediately. Methotrexate may reduce the number of white blood cells and thus weaken the immune defenses. A blood test will be performed to check for a decrease in white blood cells (agranulocytosis).
• Jaundice (yellowing of the skin).
• Pain or difficulty urinating.
• Thirst and/or frequent urination.
• Blurred or reduced vision.

Most of the side effects listed below will only be observed in patients treated with high doses
of methotrexate for the treatment of cancer. They are not observed with the same frequency and severity at the
doses used for the treatment of psoriasis or rheumatoid arthritis.

Very common(may affect more than 1 in 10 people)

• Loss of appetite, feeling unwell (nausea), vomiting, indigestion, stomach pain, stomatitis (pain in the mouth and lips).
• Increased liver enzymes.
• Macrocytosis

Common(may affect up to 1 in 10 people)

• Infections.
• Reduced formation of blood cells with a decrease in white blood cells and/or red blood cells and/or platelets (leukocytopenia, anemia, thrombocytopenia).
• Headache, dizziness, unusual fatigue, drowsiness.
• Lung infection (pneumonia), dry cough.
• Diarrhoea.
• Skin rash, redness of the skin, itching.
• Alopecia (hair loss).

Uncommon(may affect up to 1 in 100 people)

• Cancer of the lymph nodes (or tissues).
• Diabetes mellitus.
• Depression, confusion.
• Convulsions, vertigo.
• Gastrointestinal ulcers and bleeding.
• Non-infectious peritonitis.
• Glossitis (inflammation of the tongue).
• Nosebleeds.
• Formation of excess fibrous connective tissue in an organ (fibrosis).
• Decreased levels of serum albumin.
• Inflammation of blood vessels, often with skin rash (vasculitis), increased skin pigmentation, slow wound healing, increased rheumatic nodules.
• Ulcers and inflammation of the bladder, urinary disorders.
• Liver damage.
• Joint or muscle pain, decreased bone mineral density, a type of bone disease (osteoporosis).
• Inflammation and ulceration of the vagina.
• Chills.
• Sunburn-like reactions due to increased skin sensitivity to sunlight.

Rare(may affect up to 1 in 1,000 people)

• General inflammation with fatal outcome (sepsis), herpes zoster infection.
• A blood disease characterized by the appearance of very large red blood cells (megaloblastic anemia).
• Mood changes.
• Weakness in movements (even limited to the left or right side of the body).
• Severe visual disturbances.
• Fluid in the sac surrounding the heart. This can cause what is called cardiac tamponade, a potentially life-threatening condition in which the heart is unable to pump properly due to external pressure. Medical intervention may be necessary to drain the fluid and reduce the pressure.
• Hypotension, thromboembolism.
• Complete or severe weakness of the respiratory muscles, shortness of breath, inflammation of the back of the throat, asthma.
• Inflammation of the pancreas, inflamed gums.
• Inflammation of the liver (acute hepatitis).
• Skin reactions (acne, skin depigmentation, urticaria, erythema multiforme, burning in psoriasis skin lesions, skin ulcers, red or purple spots due to bleeding of the vessels), detachment of nails, dark areas on the nails.
• Stress fractures.
• Decreased or absence of urine production, electrolyte disorders.
• Menstrual disorders, impotence.

Very rare(may affect up to 1 in 10,000 people)

• Immunodeficiency (hypogammaglobulinemia), increased susceptibility to infections.
• Lymphoproliferative disorders (excessive growth of white blood cells).
• Insomnia.
• Swelling of the brain, difficulty speaking (dysarthria), irritation, drowsiness, fatigue (lethargy), mild temporary problems with intellectual functions (“mental fog”),

having unusual sensations in the head, muscle weakness, sensation of numbness or
tingling/decreased sensitivity to stimuli than normal, changes in the sense of taste
(metallic taste).

• Redness and irritation of the thin membrane lining the eye (conjunctivitis), impaired vision, damage to the retina.
• Inflammation of blood vessels (vasculitis), vomiting blood.
• Reactivation of chronic liver inflammation, liver failure.
• Enlargement of the colon associated with inflammation/infection.
• Infection around a nail, deep infection of hair follicles (furuncles), bruising, acne.
• Protein in the urine, painful urination, inflammation of the bladder.
• Low sperm count, breast enlargement in men, vaginal bleeding, loss of libido.
• Fever.
• Sudden death.

The following side effects have also been reported, but the frequency is unknown:
Sepsis with resulting death, unusually low number of blood cells, pulmonary bleeding*, bone damage of the jaw (secondary to excessive growth of white blood cells),
brain disease, tumor lysis syndrome, pathological alteration of white matter in the brain
(leukoencephalopathy), increased pressure of cerebrospinal fluid, dementia, arachnoiditis,
alveolitis, physical weakness, chest pain, hypoxia, ataxia, increased risk of toxic reactions
during radiotherapy, redness and peeling of the skin, swelling, hypersensitivity.
The scaly and red skin patches associated with psoriasis can worsen with exposure to
ultraviolet light sources, such as the sun, and with the use of methotrexate. Skin problems after
radiotherapy (radiation-induced dermatitis) or sunburns can recur during
the use of methotrexate.
* (side effect reported for methotrexate used in patients with underlying rheumatological disease).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Metotrexato Aurobindo

Keep this medicine out of the sight and reach of children, preferably in a locked cabinet. Accidental ingestion may be fatal to children.
Do not use this medicine after the expiry date which is stated on the pack and blister after
“EXP.”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Appropriate procedures must be adopted for the safe handling of cytotoxic agents.
Anyone handling methotrexate must wash their hands after administering a dose. It is
recommended to use disposable gloves when handling methotrexate tablets. Pregnant women, those planning a pregnancy or those breastfeeding should not
handle methotrexate.
Unused medicine and waste medicine must be disposed of in accordance with
current local regulations on cytotoxic agents.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Metotrexato Aurobindo contains
The active ingredient is methotrexate.
Each tablet contains 2.5 mg of methotrexate.
The other ingredients are: microcrystalline cellulose (grade 101), corn starch, pregelatinized starch,
microcrystalline cellulose (grade 102), anhydrous colloidal silica, magnesium stearate,
polysorbate 80.

Description of the appearance of Metotrexato Aurobindo and contents of the pack
Tablets.

Metotrexato Aurobindo 2.5 mg tablets:
Round, biconvex, yellow tablet, with ‘2.5’ imprinted on one side and smooth on the other side.

Packs:

Blister packs: 10, 12, 20, 24, 25, 30 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Eugia Pharma (Malta) Ltd
Vault 14, Level 2, Valletta Waterfront,
Floriana FRN 1914
Malta

Manufacturer
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000
Malta
Generis Farmacêutica SA
Rua João de Deus, 19,
2700-487 Amadora
Portugal
Arrow Génériques
26 Avenue Tony Garnier
Lyon, 69007
France

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
France: Methothrexate Arrow 2.5 mg, comprimé
Methotrexate Arrow 10 mg, comprimé sécable
Italy: Metotrexato Aurobindo
Netherlands: Methotrexaat Eugia 2.5 mg tabletten
Methotrexaat Eugia 10 mg tabletten