Methotrexate Wyeth 2.5 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Metotrexate Wyeth 2.5 mg tablets

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Metotrexato Wyeth belongs to a group of medicines called antifolate antimetabolites.

High-dose Metotrexato is indicated for the treatment of certain types of cancer, such as gestational trophoblastic neoplasia (choriocarcinoma), which is the development of a tumor directly associated with pregnancy.

2. What you need to know before starting to take Metotrexate Wyeth

Before starting to use this medicine, you must consult your doctor regarding the risks and benefits of treatment with methotrexate. It is very important that you use methotrexate exactly as prescribed by your doctor. If you use methotrexate more frequently or in higher doses than prescribed by your doctor, you may experience serious adverse reactions, including death.

Do not take Metotrexate Wyeth

• If you are allergic to methotrexate or to any of the other ingredients of this medicine (listed in section 6).
• If you have impaired liver function (hepatic insufficiency).
• If you have severe impairment of kidney function (severe renal insufficiency).
• If you have liver damage due to excessive alcohol consumption (alcoholic hepatopathy), chronic liver damage (chronic hepatopathy), or if you are an alcoholic.
• If you have abnormal blood levels of red blood cells, white blood cells, or platelets.
• If you have an immune system disorder (immunodeficiency syndromes).
• Severe, acute, or chronic infections such as tuberculosis and HIV.
• If you have ulcers in the mouth, stomach, or intestine.
• If you are due to be vaccinated.
• If you are breastfeeding (see section “Pregnancy, breastfeeding, and fertility”).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take this medicine.

Your doctor will inform you about the benefits and risks of treatment with methotrexate, as well as the symptoms that may indicate possible drug-related toxicity.

Before starting treatment and while you are on methotrexate, your doctor may perform tests such as blood tests, kidney and liver function tests, hepatitis infection screening, or chest X-rays.

If you are in any of the following situations, consult your doctor before using Metotrexate Wyeth.

• If you develop signs or symptoms of possible gastrointestinal and/or neurological, liver, kidney, lung, blood, or skin toxicity from the medicine, contact your doctor.
• Strictly follow the dose as prescribed by your doctor.
• If you are of childbearing age and have a neoplastic disease, the benefit of treatment should be weighed against the risk to the fetus in each individual case.
• If you have folate deficiency, as this may increase methotrexate toxicity.
• If you experience vomiting, diarrhea, or mouth inflammation (stomatitis), inform your doctor, as you may become dehydrated. If this occurs, your doctor may interrupt your treatment until you have fully recovered. Also inform your doctor if you have peptic ulcer or any type of colitis.
• If you have abnormal blood levels of white blood cells, red blood cells, or platelets. Methotrexate may reduce white blood cells in the blood. If this happens, you should take certain precautions, including: avoiding contact with people who have infections; contacting your doctor if you suspect you have an infection due to fever or chills, cough, back pain, or difficulty urinating; consulting your doctor before undergoing dental procedures. Additionally, methotrexate may reduce the number of platelets in the blood needed for clotting. Therefore, it is important to contact your doctor if you develop prominent bruising or bleeding from gums or nose, red spots on the skin, blood in the urine, or black stools, and to inform your dentist that you are being treated with methotrexate.
• If you are being treated with NSAIDs (non-steroidal anti-inflammatory drugs).
• If you have liver problems, as methotrexate may cause acute hepatitis and chronic liver disorders. Mild liver abnormalities may occur, requiring closer monitoring by your doctor but not necessarily leading to discontinuation of treatment. Alcohol, obesity, advanced age, or use of products containing arsenic may increase the risk of liver problems.
• If you have kidney problems, as methotrexate may cause kidney damage.
• If you have any type of infectious condition.
• If you are due to be vaccinated, as this may lead to a serious infection or reduced vaccine response.
• If neurological toxicity symptoms such as headache, back pain, neck stiffness, fever, confusion, irritability, drowsiness, lack of coordination, dementia, seizures, transient blindness, abnormal reflexes, behavioral changes, or localized movement and sensory disturbances occur during or after treatment.
• If you develop dry cough, fever, chest pain, and/or difficulty breathing during treatment, inform your doctor.
• If you develop skin changes during or after treatment, consult your doctor. Skin lesions in patients with psoriasis may worsen with sun exposure. Skin lesions and previous sunburns may reappear during methotrexate treatment. Methotrexate may make your skin more sensitive to sunlight. Avoid intense sunlight and do not use tanning beds or ultraviolet lamps without medical advice. To protect your skin from intense sunlight, wear appropriate clothing or use a high-protection sunscreen.
• Acute pulmonary hemorrhage has been reported with methotrexate in patients with underlying rheumatic disease. If you notice blood when coughing or spitting, contact your doctor immediately.
• Methotrexate temporarily affects sperm and egg production. Methotrexate may cause miscarriages and severe birth defects. If you are a woman, you must avoid pregnancy during methotrexate treatment and for at least 6 months after treatment ends. If you are a man, you must avoid fathering a child while receiving methotrexate and for at least 3 months after treatment ends. See also section “Pregnancy, breastfeeding, and fertility”.
• If you, your partner, or your caregiver notice the onset or worsening of neurological symptoms such as generalized muscle weakness, vision disturbances, changes in thinking, memory, and orientation causing confusion, or personality changes, contact your doctor immediately, as these may be symptoms of a very rare but serious brain infection called progressive multifocal leukoencephalopathy (PML).

Your doctor will regularly monitor your condition to ensure the medicine is having the intended effect.

Other medicines and Metotrexate Wyeth

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

It is especially important that you inform your doctor if you are taking any of the following medicines:

• Medicines used to treat certain types of cancer, such as cisplatin, mercaptopurine, cytarabine, and L-asparaginase.
• Non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin and other salicylates, and especially ketoprofen.
• Proton pump inhibitors (used to treat gastrointestinal ulcers).
• Leflunomide (a medicine for the treatment of arthritis).
• Metamizole (synonyms: novaminsulfone and dipyrone) (a medicine for severe pain and/or fever).
• Medicines with high plasma protein binding (such as salicylates, phenylbutazone, phenytoin, sulfonamides, sulfonylureas, para-aminobenzoic acid, certain antibiotics, and medicines for abnormal cholesterol and lipid levels such as cholestyramine).
• Probenecid (a medicine used to reduce uric acid levels).
• Antibiotics (ciprofloxacin, penicillins, sulfonamides, tetracyclines, chloramphenicol, pyrimethamine, trimethoprim/sulfamethoxazole) and broad-spectrum antibiotics not absorbed in the gastrointestinal tract.
• Medicines that cause liver toxicity (such as leflunomide, azathioprine, sulfasalazine, and retinoids).
• Theophylline (a medicine for the treatment of asthma).
• Vitamins or vitamin preparations containing folic acid or its derivatives.
• Nitrous oxide (an anaesthetic).
• Amiodarone (a medicine for the treatment of heart disorders).
• Diuretics (such as triamterene).

Additionally, certain therapies may interact with methotrexate. This includes PUVA therapy (psoralen and ultraviolet light) in patients with psoriasis or a condition called mycosis fungoides, as well as radiotherapy.

During methotrexate treatment, caution should be exercised when receiving red blood cell transfusions.

Use of Metotrexate Wyeth with food, drinks, and alcohol

While taking methotrexate, you should avoid alcohol consumption, as this may increase the likelihood of adverse effects, particularly on the liver.

You should avoid excessive consumption of coffee, caffeinated beverages, and black tea. Your doctor may advise you to drink more fluids than usual. This will help eliminate the medicine and prevent kidney problems.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Consult your doctor or pharmacist before using any medicine.

• Pregnancy:

Do not use this medicine during pregnancy unless your doctor has prescribed it as oncological treatment (cancer treatment). Methotrexate may cause birth defects, harm the fetus, or cause miscarriage. It is associated with malformations of the skull, face, heart and blood vessels, brain, and limbs. Therefore, it is very important that it is not administered to pregnant women or women planning to become pregnant, except when used as oncological treatment.

For non-oncological indications (not related to cancer) in women of childbearing age, pregnancy must be ruled out before starting treatment, for example, by a pregnancy test.

Do not use this medicine if you are trying to become pregnant. You must avoid becoming pregnant while taking methotrexate and for at least 6 months after treatment ends. To achieve this, you must ensure you are using reliable contraceptive methods throughout this period (see also section “Warnings and precautions”).

If you become pregnant during treatment or suspect you may be pregnant, consult your doctor as soon as possible. If you become pregnant during treatment, you should receive information about the risk of harmful effects on the child during treatment.

If you wish to become pregnant, consult your doctor, who may refer you to a specialist for counseling before the planned start of treatment.

• Breastfeeding:

Do not breastfeed during treatment, as methotrexate passes into breast milk. If your doctor considers it absolutely necessary to continue methotrexate treatment during breastfeeding, you must stop breastfeeding.

• Male fertility:

Available data do not indicate an increased risk of malformations or miscarriages if the father takes a methotrexate dose below 30 mg/week. However, this risk cannot be completely ruled out, and there is no information regarding higher methotrexate doses. Methotrexate may be genotoxic, meaning it can cause genetic mutations. Methotrexate may affect sperm production, which is associated with the possibility of birth defects.

For this reason, you must avoid fathering a child or donating semen during methotrexate treatment and for at least 3 months after treatment ends. Since methotrexate treatment at higher doses, commonly used in cancer treatment, may cause infertility and genetic mutations, men receiving methotrexate doses above 30 mg/week are advised to consider sperm preservation before starting treatment (see also section “Warnings and precautions”).

Driving and use of machines

Driving vehicles or operating machinery is not recommended after administration of Metotrexate Wyeth, as some of the possible adverse effects, such as dizziness and fatigue, may impair your ability to drive or operate machinery.

Metotrexate Wyeth contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Metotrexate Wyeth

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

IT IS VERY IMPORTANT THAT YOU USE METHOTREXATE EXACTLY AS PRESCRIBED BY YOUR DOCTOR. IF YOU USE METHOTREXATE MORE FREQUENTLY OR IN HIGHER DOSES THAN INDICATED, YOU MAY EXPERIENCE SERIOUS ADVERSE REACTIONS, INCLUDING DEATH.

Recommended dose:

The usual dose is 15–30 mg (6–12 tablets) taken orally daily for 5 days, repeated every 12–14 days depending on toxicity.

Metotrexato Wyeth is supplied in a pack containing 2 blisters, each with 12 tablets. Each tablet contains a dose of 2.5 mg of methotrexate.

Use in patients with kidney or liver problems

Consult your doctor, as dose adjustment may be necessary and in some cases the medicine may be contraindicated.

Children and adolescents

Children and adolescents treated with methotrexate must be placed under close medical supervision to detect possible adverse effects as early as possible.

Use in children under 3 years of age is not recommended, as there are insufficient efficacy and safety data available in this patient group.

If you take more Metotrexato Wyeth than you should

If you have taken more Metotrexato Wyeth than you should, contact your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

An overdose of methotrexate may cause serious toxic reactions. Symptoms of overdose may include rapid bruising or bleeding, unusual weakness, mouth sores, nausea, vomiting, black or bloody stools, coughing up blood, vomit resembling coffee grounds, and decreased urination (emptying of urine from the bladder). See also section 4.

If you receive more methotrexate than you should, administration of leucovorin (folinic acid) is recommended as soon as possible, along with hydration and urinary alkalinization.

If you forget to take Metotrexato Wyeth

Do not take a double dose to make up for missed doses. Take the next dose at the scheduled time.

If you stop taking Metotrexato Wyeth

Do not discontinue treatment unless instructed by your doctor. If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Contact your doctor immediately if you experience whistling when breathing, difficulty breathing, swelling of the eyelids, face or lips, skin rash or itching (especially if it affects your whole body).

Contact your doctor immediately if you notice any of the following adverse effects:

• breathing problems (symptoms may include general feeling of discomfort, dry and irritating cough, shortness of breath, difficulty breathing, chest pain or fever)
• coughing up blood*
• severe peeling or blisters on the skin
• bleeding (including blood in vomit) or unusual bruising or nosebleeds
• nausea, vomiting, severe abdominal discomfort or diarrhea
• mouth ulcers
• black or tarry stools
• blood in urine or stools
• red spots on the skin
• fever, sore throat, flu-like symptoms
• yellowing of the skin (jaundice) or dark-colored urine
• pain or difficulty urinating
• thirst and/or frequent need to urinate
• seizures
• loss of consciousness
• restricted vision or blurred vision
• extreme tiredness

*Reported with methotrexate when used in patients with underlying rheumatological disease.

The following adverse effects have also been reported:

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

• loss of appetite, nausea (feeling sick), vomiting, abdominal pain, indigestion, inflammation and ulcers in the mouth and throat
• blood tests showing increased liver enzymes.

Common (may affect up to 1 in 10 people):

• infections
• reduced production of red blood cells, white blood cells or platelets (leucopenia, anemia, thrombocytopenia)
• headache, fatigue, dizziness
• lung inflammation (pneumonitis) with dry cough, difficulty breathing and fever
• diarrhea
• skin rash, skin redness and itching.

Uncommon (may affect up to 1 in 100 people):

• lymphoma (lump in neck, groin or armpits, accompanied by back pain, weight loss or night sweats)
• severe allergic reactions
• diabetes
• depression
• dizziness, confusion, seizures
• lung damage
• ulcers and bleeding in the digestive tract
• liver disease, decreased blood proteins
• urticaria, sunburn-like reactions due to increased skin sensitivity to sunlight
• brown skin discoloration, hair loss, increase in number of rheumatoid nodules, shingles, painful psoriasis, slow wound healing
• joint or muscle pain, osteoporosis (reduced bone strength)
• kidney disease, inflammation or ulcers of the bladder (possibly with blood in urine), pain when urinating
• vaginal inflammation and ulcers.

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

• blood disorder characterized by the presence of very large red blood cells (megaloblastic anemia)
• mood disturbances
• weakness in movement, sometimes limited only to the right or left side of the body
• significant visual disturbances
• inflammation of the sac surrounding the heart, fluid accumulation in the sac surrounding the heart
• low blood pressure, blood clots
• tonsillitis, respiratory arrest, asthma
• pancreatitis, inflammation of the digestive tract, blood in stools, gum inflammation, digestive problems
• acute hepatitis (liver inflammation)
• change in nail color, acne, red or purple spots due to bleeding in blood vessels
• worsening of psoriasis during UV irradiation treatment
• skin lesions similar to sunburn or radiation-induced dermatitis
• bone fractures
• kidney failure, decreased or absent urine production, abnormal blood electrolyte levels
• defective sperm formation, menstrual disorders.

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

• systemic viral, fungal or bacterial infections
• serious bone marrow disorder (anemia), gland inflammation
• lymphoproliferative disorders (excessive white blood cell growth)
• insomnia
• muscle pain, muscle weakness, changes in taste sensation (metallic taste), inflammation of the membrane covering the brain with paralysis or vomiting, numbness or tingling sensation/reduced sensitivity to stimuli
• impaired movement of muscles used for speech, difficulty speaking, language impairment, drowsiness or fatigue, confusion, abnormal sensations in the head, brain inflammation, ringing in the ears
• eye redness, retinal damage
• fluid accumulation in the lungs, lung infections
• vomiting blood, serious complications in the digestive tract
• liver failure
• nail infections, nail detachment from the nail bed, boils, dilation of small blood vessels, damage to blood vessels in the skin, allergic inflammation of blood vessels
• protein in urine
• decreased libido, erectile dysfunction, vaginal discharge, infertility, breast enlargement in men (gynecomastia)
• fever.

Frequency not known (cannot be estimated from available data):

• pathological changes in the white matter of the brain (leukoencephalopathy)
• bleeding
• pulmonary hemorrhage*
• redness and peeling of the skin
• Jaw bone damage (secondary to excessive white blood cell growth)
• swelling

*Reported with methotrexate when used in patients with underlying rheumatological disease.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Metotrexate Wyeth

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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Unwanted medicines and their containers should be returned to the SIGRE collection point at your pharmacy. If you are unsure how to dispose of unused medicines and their packaging, ask your pharmacist. This helps protect the environment.

6. Contents of the pack and other information

Composition of Metotrexato Wyeth

• The active substance is methotrexate.
• The other components are: maize starch, monohydrate lactose, magnesium stearate and sodium hydroxide.

Appearance of the product and contents of the pack

Metotrexato Wyeth 2.5 mg tablets are presented in PVC/aluminum blisters containing 24 tablets for oral administration.

Marketing Authorization Holder

WYETH FARMA, S.A.

Ctra. Burgos, Km. 23

San Sebastián de los Reyes

28700 – Madrid

Spain

Manufacturer

Excella GmbH & Co. KG

Nürnberger Strasse 12,

90537 Feucht,

Germany

For further information on this medicine, please contact the local representative of the Marketing Authorization Holder:

Pfizer, S.L.

Avda. de Europa, 20-B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Spain

Date of the most recent review of this leaflet: March 2025.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/