Maxtrex tablets 2.5 mg – patient leaflet, side effects, dosage

1. What Maxtrex Tablets are and what they are used for

Maxtrex Tablets contain the active ingredient methotrexate. Methotrexate is referred to as a cytotoxic medicine. It is most commonly used to kill cells in tumours.

Maxtrex Tablets can be used to treat rheumatoid arthritis. It is usually used for patients who have tried other treatments but their illness has not improved. In the treatment of rheumatoid arthritis, methotrexate is thought to stop or reduce inflammation by altering the body’s defences.

Maxtrex Tablets can also be used to treat severe, uncontrolled psoriasis. It is usually used for patients who have tried other treatments but their condition has not improved. Methotrexate helps patients with psoriasis by killing the cells in the skin, which are growing too quickly. It is these fast growing cells, which cause the raised patches of skin in psoriasis. Maxtrex is used to treat a wide range of tumours, in particular:

• acute leukaemias,
• Non-Hodgkin’s lymphoma,
• soft tissue and bone sarcomas,
• solid tumours like breast, lung, head and neck, bladder, cervical, ovarian and testicular cancer.

Maxtrex can be given alone or in combination with other medicines.

You should consult your doctor if you are unsure why you have been given Maxtrex 2.5 mg Tablets.

You must talk to a doctor if you do not feel better or if you feel worse.

2. What you need to know before you take Maxtrex Tablets

Your doctor may perform several tests such as blood tests, x-rays and physical examinations before treatment with Maxtrex tablets is started, and at regular intervals during treatment.

Do not take Maxtrex Tablets if you:

• are allergic to methotrexate, or any of the other ingredients of this medicine (listed in section 6).

• are breast-feeding and additionally, for non-oncologic indications (for non-cancer treatment) if you are pregnant (see section on Pregnancy, breast-feeding and fertility). You and your partner should avoid conception (becoming pregnant or fathering children) for at least three months after your treatment with methotrexate has stopped.

• have severe liver problems, including fibrosis, cirrhosis and recent or active hepatitis.
• have severe kidney problems, including conditions requiring kidney dialysis.
• have any serious blood problems including severe anaemia and clotting problems.

• have an alcohol dependency.

• have a medical condition or are receiving medication which lowers your resistance to infection.
• are taking antibiotics which prevent the production of folic acid (vitamin B9) such as co-trimoxazole, which are used to treat bacterial infections.
• have an active infectious disease (e.g. fever, chills, joint pain).
• are being treated with live vaccines.
• ulcer of the oral cavity and gut.
• inflammation of mouth or lips.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Maxtrex Tablets if you have any of the following conditions. This will help them decide if Maxtrex Tablets are suitable for you:

• have any mild or moderate kidney disease
• have a stomach ulcer or ulcerative colitis (inflammation and ulceration of the gut)
• have any blood disorders or anaemia
• have diarrhoea
• have gastro-intestinal (digestive) problems
• have severe mouth ulcers
• have or have ever suffered from mental illness
• received or you are receiving radiotherapy (x-ray treatment) or UV radiation
• have received any vaccinations recently or you are due to have any, as methotrexate can reduce their effect
• have any symptoms or signs of infection
• have excess fluid, between the lungs and chest wall (pleural effusion) or abdominal swelling (ascites) causing breathlessness
• develop a persistent cough or develop shortness of breath as it may be associated with serious lung disease
• special care is also needed in children, the elderly and in those who are in poor physical condition
• have or have ever had liver damage, dependence on alcohol or abnormal liver function tests
• have diabetes and are being treated with insulin
• have an inactive chronic infection, such as herpes zoster, tuberculosis, hepatitis B or C
• methotrexate temporarily affects sperm and egg production. Methotrexate can cause miscarriage and severe birth defects. You and your partner should avoid having a baby if you are being given methotrexate at the time and for at least 6 months after the end of your treatment with methotrexate. See also section “Pregnancy, breast-feeding and fertility”. Acute bleeding from the lungs in patients with underlying rheumatologic disease has been reported with methotrexate. If you experience symptoms of spitting or coughing up blood you should contact your doctor immediately.

If you, your partner or your caregiver notice new onset or worsening of neurological symptoms including general muscle weakness, disturbance of vision, changes in thinking, memory and orientation leading to confusion and personality changes contact your doctor immediately because these may be symptoms of a very rare, serious brain infection called progressive multifocal leukoencephalopathy (PML). Recommended follow-up examinations and precautions Even if methotrexate is used in low doses, serious side effects can occur. In order to detect them in time, your doctor must perform monitoring examinations and laboratory tests. Prior to the start of therapy:

Before you start treatment, your blood will be checked to see if you have enough blood cells. Your blood will also be tested to check your liver function and to find out if you have hepatitis. Furthermore, serum albumin (a protein in the blood), hepatitis (liver infection) status and kidney function will be checked.

2022-0000038B drowsiness, loss of co-ordination or blurred vision. If you experience these symptoms, do not drive or use any tools or machinery. The full list of side effects are listed in section 4. Maxtrex Tablets contain lactose

These tablets contain lactose monohydrate (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Maxtrex Tablets

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Alcohol should be avoided while receiving methotrexate. Important warning about the dose of Maxtrex tablets(methotrexate):

Use Maxtrex tablets only once a week for the treatment of psoriasis and rheumatoid arthritis. Using too much of Maxtrex tablets (methotrexate) may be fatal. Please read section 3 of this leaflet very carefully. If you have any questions, please talk to your doctor or pharmacist before you take this medicine.

The recommended dose is:

Dosage for rheumatoid arthritis:

Take Maxtrex only once a week.

Adults

You will usually take your tablets once a week on the same day each week. The dose usually starts at 7.5 - 15 mg per week but may rise to 25 mg per week. The dose must be given all at once. The dose may be changed depending upon your response to treatment.

Children

Not recommended for use in children.

Dosage for psoriasis:

Take Maxtrex only once a week.

Adults

You will usually take your tablets once a week on the same day each week. Patients may be given a test dose of 2.5-5 mg by their doctor first to exclude unexpected toxicities. For severe psoriasis, the dose usually starts at 7.5 - 15 mg per week but may rise to 25 mg per week. The dose must be given all at once. The dose should be adjusted according to your response to treatment and side effects.

Elderly

Elderly patients may need smaller doses of methotrexate. Children:

Not recommended for use in children.

Dosage for treatment of cancer:

Adults, the Elderly and Children

• Your doctor should give you a test dose of 5 to 10 mg by injection one week before starting treatment.
• The doctor will calculate the dosage required from your body surface area (m²), and the dose expressed as mg/m².
• Maxtrex Tablets are usually given as single doses, not exceeding 30 mg/m², for up to five days.
• A rest period of at least two weeks is advised between treatments, to allow recovery from any side effects.
• Doses in excess of 100 mg are usually given by injection by your doctor or physician.
• Doses of more than 70 mg/m² should not be administered without calcium folinate rescue therapy or blood levels of methotrexate being checked 24 to 48 hours after taking your medicine.
• These doses may be reduced if you are receiving other medication. Your doctor will decide the correct dose for you, if you want more information you should ask your doctor.

If you have the impression that the effect of Maxtrex Tablets is too strong or too weak, talk to your doctor or pharmacist. If you take more Maxtrex Tablets than you should

If you accidentally take too many Maxtrex Tablets contact your doctor at once or go to the nearest hospital casualty department. Always take the labelled medicine package with you, whether there are any Maxtrex Tablets left or not. Overdose symptoms may include easy bruising or bleeding, unusual weakness, mouth sores, nausea, vomiting, black or bloody stools, coughing up blood or vomit that looks like coffee grounds, and decreased urinating.

Inappropriate intake resulting in overdose can sometimes lead to death.

The antidote in case of an overdose is calcium folinate. If you forget to take Maxtrex Tablets

If you forget to take a dose, take it as soon as you remember if this is within two days. However, if you have missed a dose by more than two days, please contact your doctor for advice. Do not take a double dose to make up for a forgotten dose.

If you stop taking Maxtrex Tablets

Do not stop taking Maxtrex Tablets unless your doctor tells you to. Should you need to stop taking Maxtrex Tablets, your doctor will have decided which is the best method for you. If you have any further questions on the use of 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. However, Methotrexate is a very toxic medicine and some patients have died, or become very ill whilst being treated with it.

Tell your doctor immediately if you experience any of the following symptoms after taking this medicine. Although they are very rare, these symptoms can be serious.

• Severe skin rash that causes blistering, (this can affect the mouth and tongue). These may be signs of a condition known as Stevens Johnson Syndrome. Your doctor will stop your treatment in these cases.
• Persistent cough, pain or difficulty breathing or become breathless; methotrexate can cause diseases of the lungs e.g. fluid in lungs.
• Spitting or coughing blood; this has been reported for methotrexate used in patients with underlying rheumatologic disease.
• Skin rash and fever with swollen glands, particularly in the first two months of treatment, as these may be signs of a hypersensitivity reaction.
• Sore throat, fever, chills or achiness; methotrexate can make you more likely to catch infections.
• Severe allergic reaction (anaphylactic reaction) –although very rare you may experience a sudden itchy skin rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), wheeze, and you may feel you are going to faint. If this happens you should seek medical attention immediately. Other side effects that may occur are:
• Severe mouth ulcers and ulcers of the gut
• Reduction in red blood cells which can make the skin pale and cause weakness or breathlessness
• Reduction in blood platelets which increases risk of bleeding or bruising
• Lung infection (Pneumonia)
• Drowsiness
• Severe skin reaction
• Inflammation of vessels, often with skin rash
• Itchy skin
• Shingles (Herpes Zoster)
• Ringing in the ears
• Abdominal pain
• Indigestion

• Convulsions

  • Loss of coordination
  • Asthma
  • Confusion
  • Liver damage (seen as yellowing of the skin and whites of the eye)
  • Liver failure
  • Kidney damage
  • Low levels of white cell count (leukopenia) and red blood cells and cells that clot blood
  • Infection, reduced resistance to infection
  • Abnormal red blood cell function
  • Lung damage/scarred
  • Build-up of excess fluid in the lung
  • Build-up of fluid or excess fluid in the double layer around the heart
  • Abnormal low blood pressure
  • Inability to move
  • Inability to move in one half of the body
  • Dizziness
  • Headaches, Blurred vision
  • Difficulty sleeping
  • Raised blood sugar levels (diabetes mellitus)
  • Sensation of numbness or tingling, having less sensitivity to stimulation than normal (frequency very rare)
  • Change in sense of taste
  • Loss of ability to speak or understand speech
  • Impaired vision
  • Brittle bones
  • Muscular pain
  • Slow thought process
  • Mood alteration
  • Black or tarry stools
  • Skin ulcers and erosions of inflamed areas, in psoriasis patients
  • Damaged skin becomes inflamed on re-exposure to radiation and sunlight
  • Reduced ability to become pregnant and reduced ability to father children
  • Inflammation of the vagina
  • Vaginal bleeding
  • Menstrual disorders
  • Blood in the urine
  • Raised liver enzymes
  • Weakening or softening of bones
  • Unusual sensations in the head
  • Anorexia (eating disorders)
  • Loss of interest in, or inability to have sex
  • Stomach pains and soreness of the mouth, throat and lips
  • Inflamed blood vessels
  • Feeling sick, being sick and/or diarrhoea, decreased absorption from intestines
  • Irritation or swelling of the vaginal tissues
  • Vaginal ulcers
  • Pain or difficulty in passing urine
  • The need to pass urine more often than usual
  • Ulcers in urinary bladder
  • Joint and muscle pain
  • Chills and fever
  • Changes in skin and nail colouration
  • Bacteria or fungal infection of hand and feet
  • Hair loss
  • Red spots on the skin, skin lesions, acne, boils
  • Redness and shedding of skin (frequency not known)
  • Itchiness and rash
  • Sensitivity to light
  • Eye infection
  • Tiredness and lack of energy
  • General feeling of illness
  • Other metabolic changes
  • Nose bleed (frequency not known)
  • Bleeding from the lungs (frequency not known) – this has been reported for methotrexate used in patients with underlying rheumatologic disease
  • Lymphoproliferative disorders (excessive growth of white blood cells) (frequency very rare)
  • Bone damage in the jaw (secondary to excessive growth of white blood cells) (frequency not known)
  • Swelling (frequency not known).

Methotrexate may lead to problems with your blood, liver and kidneys. Your doctor will take blood samples to check for these problems and may ask you to have a small sample of your liver taken for testing (liver biopsy).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Maxtrex Tablets

Keep this medicine out of the sight and reach of children. Accidental ingestion can be lethal for children.

Keep the blister in the outer carton in order to protect from light.

Do not use this medicine after the expiry date which is printed on the carton and label after EXP. The expiry date refers to the last day of that month.

Anyone handling methotrexate should wash their hands after administering a dose. To decrease the risk of exposure, parents and care givers should wear disposable gloves when handling methotrexate.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Maxtrex Tablets contains

The active substance is methotrexate. Each tablet contains 2.5 mg of the active ingredient methotrexate.

The other ingredients are maize starch, lactose monohydrate (see section 2 “Maxtrex Tablets contains lactose”), pregelatinised starch, polysorbate 80, microcrystalline cellulose, magnesium stearate and purified water. What Maxtrex Tablets looks like and contents of the pack

Maxtrex 2.5 mg Tablets are yellow, round in shape and have ‘M2.5’ printed on one side of the tablets.

Maxtrex 2.5 mg Tablets are available in plastic bottles containing 100 tablets or carton containing 2 blisters with 12 tablets in each blister.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder

Pfizer Limited

Ramsgate Road

Sandwich

Kent, CT13 9NJ

United Kingdom

Manufacturer

Orion Corporation

Orion Pharma

Orionintie 1

FI-02200

Espoo

Finland

For further information please contact Medical Information at Pfizer Limited on 01304 616161.

This leaflet was last revised in 01/2022.

Ref: MX 22_0