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METHOTREXATE 2.5MG TABLETS BP

Active substance(s): METHOTREXATE / METHOTREXATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Methotrexate 2.5 mg Tablets
Methotrexate 10 mg Tablets
Methotrexate

Read all of this leaflet carefully before you start using this medicine because it
contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may
harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effect not listed in this leaflet.
In this leaflet:
1. What Methotrexate is and what it is used for
2. What you need to know before you use Methotrexate
3. How to use Methotrexate
4. Possible side effects
5. How to store Methotrexate
6. Contents of the pack and other information
1. WHAT METHOTREXATE IS AND WHAT IT IS USED FOR
Methotrexate tablets contain the active ingredient methotrexate. Methotrexate is referred
to as a cytotoxic, most commonly used to kill cells in tumours.
Methotrexate tablets are used to treat rheumatoid arthritis and severe uncontrolled
psoriasis. 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.
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.
Methotrexate is used to treat acute leukaemia.
Methotrexate can be given alone or in combination with other medicines.
Your doctor will be able to explain how Methotrexate tablets might help in your particular
condition.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE METHOTREXATE

Warnings and precautions
Talk to your doctor or pharmacist before using Methotrexate
- if you have blood disorders or anaemia
- if you have diabetes mellitus treated with insulin
- if you have –mild or moderate kidney disease
- if you have gastro-intestinal disorders such as gastric ulcer, inflammation of the guts,
inflammation of the mucous membrane of the mouth
- if you are dehydrated or suffer from conditions leading to dehydration(vomiting,
diarrhoea, stomatitis)
- if you have or have ever suffered from mental illness
- if you have problem with your lung function
- if you are severely overweight
- if you have inactive, prolonged infections (e.g. tuberculosis, hepatitis B or C, shingles
(herpes zoster)
- if you have a medical condition which causes a build-up of fluid in the lining of
your lungs or in your abdomen (the fluid will need to be drained before methotrexate
treatment is started)
- if you have received or are receiving radiotherapy (x-ray treatment)
- if you have received any vaccinations recently or you are due to have any, as
methotrexate can reduce their effect.
If you have experienced problems with your skin after radiation therapy (radiation induced
dermatitis) and sun-burn these conditions can reappear under methotrexate therapy
(recall-reaction).
Methotrexate should only be used in children and elderly with extreme caution.
Methotrexate can cause inflammation of the lung with breathlessness. If you develop
a persistent cough, experience pain or difficulty breathing, or become breathless, you
should seek medical attention.
Whilst being treated your doctor will want to monitor your progress on a weekly basis until
therapy is stable. Thereafter you will be monitored every 2-3 months, whilst taking the
medicine.
These checks may include taking blood and urine samples to check your blood cells and
to make sure that your liver and kidneys are working properly. It is important that you do
not miss any blood tests. There may also be a chest x-ray and a physical examination
to check for swellingof your lymph nodes (glands in your neck, armpits and groin). Any
unusual swellings should also be reported to your doctor.
Methotrexate must only be given to you under the supervision of a doctor experienced in
its use.

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Do not use Methotrexate
- if you are allergic to methotrexate (active substance) or any of the other ingredients
of Methotrexate Tablets listed in section 6.
- if you are pregnant, trying to become pregnant or breast-feeding. Methotrexate
may harm your baby (see section on pregnancy). You and your partner should avoid
conception (becoming pregnant or fathering children) for at least three months after
your treatment with methotrexate has stopped
- if you have severe liver problems including fibrosis, cirrhosis and recent or active
hepatitis (or doctor decides the severity of the disease)
- if you have severe kidney problems, including conditions requiring kidney dialysis (or
doctor decides the severity of the disease)
- if you have any serious blood problems including severe anaemia (low levels of white
and red blood cells) and clotting problems
- if you have a medical condition or are receiving medication which lowers your
resistance to infection
- if you are taking antibiotics which prevent the production of folic acid(vitamin B9) such
as tri-moxazole, which are used to treat bacterial infections
- if you have an active infectious disease (e.g. fever, chills, joint pain)
- if you have a severe or existing infection, e.g. tuberculosis and HIV
- if you receive vaccinations with live vaccines at the same time
- if your alcohol consumption is high

Other medicines and Methotrexate
Tell your doctor or pharmacist if you are taking, have recently taken or might take any of
the following medicines:
- NSAIDs (non-steroidal anti-inflammatory drugs) e.g. ibuprofen, indomethacin or aspirin
(for pain relief or inflammation
- antibiotics (used to treat bacterial infections e.g chloramphenicol, penicillin,
sulphonamides, trimethoprim/sulfamethoxazole, ciprofloxacin and tetracyclines)
- p-aminobenzoic acid, acitretin (treatment for psoriasis or skin disorders)
- other treatments for rheumatoid arthritis or psoriasis such as leflunomide,
sulphasalazine ( also used for ulcerative colitis), phenylbutazone, or amidopyrine
- diphenylhydantoins, phenytoin (used to treat epilepsy)
- probenecid, sulfinpyrazone(used to treat gout)
- cancer treatments
- barbiturates (sleeping injection)
- live vaccinations
- vitamin preparations or oral iron preparations containing folic acid
- tranquilisers, nitrous oxide ( a gas used in general anaesthesia)
- azathioprine (used to prevent rejection after an organ transplant)
- anticonvulsant drugs (prevent fits)
- oral contraceptives
- pyrimethamine (used to prevent and treat malaria)
- proton pump inhibitors (used to treat severe heartburn or ulcers)
- theophylline (used to treat asthma)
Methotrexate with food, drink and alcohol
Alcohol should be avoided while receiving methotrexate. Excessive consumption of
coffee, soft drinks containing caffeine and black tea should be avoided.

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Pregnancy, breast-feeding and fertility
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
Do not use Methotrexate during pregnancy. Methotrexate can cause birth defects, harm
unborn babies or cause miscarriages and so it is very important that it is not given to
pregnant patients or patients planning to become pregnant. It may also affect women’s
periods; they may become less frequent or stop completely. Methotrexate can affect
sperm and egg production with the potential to cause birth defects. You and your partner
should avoid conception (becoming pregnant or fathering children) for at least three
months after your treatment with methotrexate has stopped.
Breast-feeding
Do not use Methotrexate when you breast-feed.
Male fertility
Since treatment with methotrexate may lead to infertility, it might be advisable for male
patients to look into the possibility of sperm preservation before starting treatment.
Driving and using machines
Side effects affecting the central nervous system, such as tiredness and dizziness, may
occur during treatment with Methotrexate. In some cases, the ability to drive vehicles and/
or use machines may therefore be impaired. If you feel tired or dizzy, you should not drive
or use machines.
Methotrexate contains lactose monohydrate
If you have been told that you have an intolerance to some sugars, contact your doctor
before taking this medicinal product.
3. HOW TO USE METHOTREXATE
Take Methotrexate tablets once a week.
Always take Methotrexate exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.
The tablets must be taken 1 hour prior to or 1½ to 2 hours following a meal.
The recommendeddose is:
Dosage for rheumatoid arthritis:
You will usually take your tablets once a week on the same day each week. The dose will
normally be between 7.5 and 20 mg. However, this may be changed depending upon your
response to treatment.
Dosage for psoriasis:
For severe psoriasis, the usual start dose is 2.5 mg three times per week with intervals of
12 hours or 1 single dose of 7.5 mg once weekly.
Dosage for treatment of tumours:
The doctor will calculate the dosage required from your body surface. Your doctor will
decide the correct dose for you, if you want more information you should ask your doctor.
Elderly patients may need smaller doses of methotrexate.
During treatment your doctor will carry out blood tests, to check your blood cells and to
make sure that your liver and kidneys are working properly. It is important that you do not
miss any blood tests.
If you have the impression that the effect of Methotrexate is too strong or too weak, talk to
your doctor or pharmacist.
If you use more Methotrexate than you should
If you have taken more tablets than the doctor has told you to, you should get medical
help immediately either by calling your doctor or by going to the nearest hospital casualty
department. Always take the labelled medicine container with you, whether there are
any Methotrexate tablets left or not. Inappropriate intake resulting in overdose can lead
to severe toxic reactions or death. 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. See
also section 4. The antidote in case of an overdose is calcium folinate.
If you forget to use Methotrexate
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 missed dose.
If you stop using Methotrexate
Do not stop taking Methotrexate tablets unless your doctor tells you to. Should you need
to stop taking Methotrexate tablets, your doctor will have decided which is the best
method for you.
If you have any further questions on the use of this product, ask your doctor or
pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Methotrexate can cause side effects, although not everybody gets
them.
Tell your doctor straight away if you get any sudden wheeziness, difficulty in breathing,
swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body).

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Serious side effects
If you develop any of the following side effects, contact your doctor as soon as you can:
• lung complaints (symptoms may be general illness, dry, irritating cough, shortness of
breath, breathlessness at rest, chest pain, or fever)
• severe peeling or blistering of the skin(this can affect the mouth and tongue). These
may be a sign of a condition known as Stevens Johnson Syndrome. Your doctor will
stop your treatment in these cases.
• 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
• Skin rash and fever with swollen glands, particularly in the first two months of
treatment, as these may be signs of a hypersensitivity reaction
• unusual bleeding (including vomiting blood) or bruising
• severe diarrhoea
• ulcers in mouth
• black or tarry stools
• blood in the urine or stools
• tiny red spots on the skin
• fever
• yellowing of the skin (jaundice) and whites of the eyes. This is a sign of liver damage.
• pain or difficulty in passing urine
• thirst and/or frequent urination
• fits (convulsions)
• loss of coordination
• loss of ability to speak or understand speech
• weakness and inability to move one side of the body or the whole body
• loss of consciousness
• blurred or decreased vision
• swelling of the hands, ankles and feet(which may be a sign of kidney damage)
• Brain disorder
Methotrexate may cause a reduction in the number of white blood cells and your
resistance to infection may be decreased. If you experience an infection with symptoms
such as fever and serious deterioration of your general condition, or fever with local
infection symptoms such as sore throat/sore pharynx/sore mouth or urinary problems
you should see your doctor immediately. A blood test will be taken to check for possible
reduction of white blood cells (agranulocytosis). It is important to inform your doctor about
your medicine.
Methotrexate may cause serious (sometimes life-threatening) side effects. Therefore, your
doctor will do tests to check for abnormalities developing in the blood (e.g. low white
blood cells, low platelets, lymphoma) and changes in the kidney and the liver.
The following side effects have also been reported:
Very common
• loss of appetite
• nausea (feeling sick)
• vomiting
• tummy pain
• inflammation and ulcers in the throat
• increase in liver enzymes,
Common (it occurs in between 1 and 10 out of 100 patients)
• reduced blood cell formation with decrease in white and/or red blood cells and/or
platelets (leukopenia, anaemia, thrombocytopenia)
• headache
• tiredness
• drowsiness
• inflammation of the lungs (pneumonia) with dry, non-productive cough
• shortness of breath
• diarrhoea
• rash
• reddening of the skin
• itching.
Uncommon (it occurs in between 1 and 10 out of 1000 patients)
• decrease in the number of blood cells and platelets
• dizziness
• confusion
• depression
• fits
• inflammation of blood vessels
• lung damage
• ulcers and bleeding in the digestive tract
• liver disorders
• diabetes
• decreased blood protein
• nettle rash (alone)
• light sensitivity
• brown skin
• hair loss
• increase of rheumatic nodules
• shingles
• painful psoriasis
• joint or muscle pain
• osteoporosis (reduction of bone mass)
• inflammation and ulcers of the bladder (possibly with blood in the urine)
• painful urination
• severe allergic reactions
• inflammation and ulcers of the vagina
• slow wound healing.
Rare (it occurs in less than 1 and 10 out of 10,000 patients)
• inflammation of the sac around the heart
• fluid in the sac around the heart
• severe visual disturbance
• mood fluctuation
• slow blood pressure
• blood clots
• sore throat
• interruption of breathing
• asthma
• inflammation of the digestive tract
• bloody stools
• inflamed gums
• abnormal digestion
• acute hepatitis (inflammation of the liver)
• changed colour of nails
• acne
• red or purple spots due to vessel bleeding
• bone fracture
• kidney failure
• decrease or absence of urine
• electrolyte disturbances
• defective sperm formation
• menstruation disorders.
Very rare (it occurs in less than 1 out of 10,000 patients)
• infections
• severe failure of the bone marrow
• liver failure
• swollen glands
• sleeplessness
• pain
• muscle weakness
• pins and needles
• changes in sense of taste (metallic taste)
• inflammation of the lining of the brain causing paralysis or vomiting
• red eyes
• damage to the retina of the eye
• fluid in the lungs
• vomiting blood
• cold sores
• protein in the urine
• fever
• loss of sex drive
• problems having an erection
• infection around a fingernail
• severe complication of the digestive tract
• boils
• small blood vessels in the skin
• fungal infections
• damage to the blood vessels of the skin
• vaginal discharge
• infertility
• male breast enlargement (gynaecomastia).
If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE METHOTREXATE
Keep out of the sight and reach of children.
Do not use this medicinal product after the expiry date which is stated on the carton after
EXP. The expiry date refers to the last day of that month.
Do not throw away any medicine and its packaging 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 OTHERINFORMATION
What Methotrexate Tablets contain
– The active substance is methotrexate.
– The other ingredients are lactose monohydrate, maize starch, potato starch,
microcrystalline cellulose, magnesium stearate and colloidal anhydrous silica.
What Methotrexate Tablets look like and contents of the pack
2.5 mg: Light yellow round shaped tablets with a diameter of 7 mm; may contain yellow to
red sprinkles.
10 mg: Light yellow, capsule shaped tablets with a score on one side, with a major axis of
15 mm and a minor axis of 7 mm; may contain yellow to red sprinkles.
Methotrexate 2.5 mg and 10 mg Tablets are available in pack sizes of 4, 8, 10, 12, 16, 20,
24, 28, 50 and 100 tablets in white polypropylene tablet containers sealed with a white
polyethylene lid in cartons.
Methotrexate 2.5 mg Tablets are also available in pack sizes of 4, 8, 10, 12, 16, 20, 24, 28,
50 and 100 tablets in PVC/PVDC blisters sealed with aluminium foil in cartons.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
EBEWE Pharma Ges.m.b.H. Nfg.KG
A-4866 Unterach, AUSTRIA
Manufacturer
EBEWE Pharma Ges.m.b.H. Nfg.KG
A-4866 Unterach, AUSTRIA
or
Salutas Pharma GmbH,
Otto-von-Guericke Allee 1,
39179 Barleben,
Germany
This leaflet was last revised in 11/2016.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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