METHOTREXATE 2.5 MG TABLETS

Active substance: METHOTREXATE SODIUM

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Methotrexate 2.5mg Tablets

1098
16.09.11[10]

(methotrexate sodium)
PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before you start taking this medicine.
- 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. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
- 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.
The name of your medicine is Methotrexate 2.5mg Tablets but will be
referred to as Methotrexate Tablets throughout this leaflet.
In this leaflet:
1. What Methotrexate Tablets are and what they are used for
2. Before you take Methotrexate Tablets
3. How to take Methotrexate Tablets
4. Possible side effects
5. How to store Methotrexate Tablets
6. Further information
1. WHAT METHOTREXATE TABLETS ARE AND WHAT THEY ARE
USED FOR
Methotrexate Tablets are one of a group of medicines called
antimetabolites which affect cell growth, including the growth of cancer
cells.
Methotrexate Tablets can be used to treat severe cases of psoriasis (a skin
disease) and rheumatoid arthritis (a disease of the joints). It is usually used
for patients who have tried other treatments but their illness has not
improved. It 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.
In the treatment of rheumatoid arthritis, Methotrexate Tablets is thought to
stop or reduce inflammation in the joints by altering the body's defence
mechanisms in the immune system.
Methotrexate Tablets can also be used to treat several kinds of cancer
when it can be given alone or in combination with other medicines. It is
usually used in much higher doses when it is used to treat cancer and it will
often be given as an injection rather than tablets.
2. BEFORE YOU TAKE METHOTREXATE TABLETS
Do not take Methotrexate Tablets if you:
- know that you are allergic to Methotrexate Tablets or any of the other
ingredients in the tablets (see section 6).
- are pregnant, breastfeeding or trying for a baby, you and your partner
should avoid conception (becoming pregnant or fathering children) for at
least six months after your treatment with Methotrexate Tablets has
stopped (see section 2: pregnancy and breastfeeding)
- suffer from a problem of excessive drinking (alcoholism)
- have severe liver problems, including alcoholic liver disease and recent
or active hepatitis (inflammation of the liver)
- have severe kidney problems
- have any serious blood disorders including severe anaemia or abnormal
numbers of blood cells such as low white cells (leucopenia) or low small
blood cell numbers (platelets) causing (thrombocytopenia)
- have a medical condition or are receiving medication which lowers your
resistance to infection
- have symptoms which may suggest an active infectious disease (e.g.
fever, chills, achiness)
Even though some of the above may be obvious, it is important that your
doctor is aware if any of them apply to you.
Take special care and talk to your doctor or pharmacist before taking
Methotrexate Tablets if you:
- have any mild or moderate kidney problems or blood disorders
- have stomach ulcers or suffer from inflammation and ulceration of the gut
- have severe mouth ulcers
- have diarrhoea
- are weak or infirm
- have excess fluid between the lungs and chest wall (pleural effusion)
causing breathlessness or in the abdomen causing swelling of the stomach
(ascites). These may affect the levels of Methotrexate Tablets in your blood
- are receiving or intend to receive any vaccine, as Methotrexate Tablets
can reduce their effect
- have diabetes mellitus
- are an elderly patient or a very young child
- have impaired respiratory function
- are receiving radiotherapy or ultraviolet (UV) radiation concurrently.

Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently
taken, any other medicines. This includes medicines obtained without a
prescription. The effects of these medicines may change, especially if you
are taking:
- NSAIDs (non-steroidal anti-inflammatory drugs) e.g. ibuprofen,
indomethacin, azopropazone or aspirin (for relief of pain or
inflammation) including any preparations of these bought without a
prescription. Taking these products together with Methotrexate Tablets
can increase its toxic effects
- diuretics (e.g. loop diuretics like furosemide, hydrochlorothiazide or
triamterene – water pills)
- phenytoin, carbamazepine and valproate (for seizures)
- antibiotics including penicillins, sulphonamides,
trimethoprim/sulfamethoxazole (as cotrimoxazole), neomycin,
ciprofloxacin, doxycycline, tetracyclines, chloramphenicol
- nitrous oxide-based anaesthetics
- vaccinations
- oral hypoglycaemics (lower blood sugar levels)
- olazepine used for the treatment of schizophrenia
- pyrimethamine (medication against malaria)
- digoxin (used to treat heart failure)
- corticosteroids used for the treatment of arthritis, allergic reactions or
skin diseases
- cytostatics (medication against cancer), e.g. cisplatin
- retinoids, e.g. acitretin (for psoriasis or skin disorders)
- immunosuppressant drugs such as leflunomide (used for suppression of
inflammatory conditions) or ciclosporin
- probenecid (for gout)
- omeprazole, pantoprazole (for stomach ulcers, heartburn, reflux)
- theophylline (for asthma)
- vitamin preparations containing folic acid or its derivatives.
Taking Methotrexate Tablets with food and drink
You should not drink alcohol whilst you are taking this medicine.
Pregnancy and breast feeding
Methotrexate Tablets temporarily affects sperm and egg production and
can harm unborn babies or cause miscarriages. It MUST NOT be taken
during pregnancy or breast feeding. You should avoid becoming pregnant
for at least six months after your treatment with Methotrexate Tablets has
stopped.
Men
Methotrexate Tablets affects sperm. You should avoid fathering a child for
at least six months after your treatment has stopped.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and Using Machines
Methotrexate Tablets may make you feel tired, dizzy or may give you
blurred vision. You should not drive or use machines when you first start
to take this medicine until you are certain that you are not getting these
side effects. If in any doubt, speak to your doctor before you drive or use
machines.
Important information about some of the ingredients of Methotrexate
Tablets
These tablets contain lactose (a sugar). If you have been told by your
doctor that you are intolerant to some sugars, contact your doctor before
taking this medicinal product.
3. HOW TO TAKE METHOTREXATE TABLETS
Always take your tablets exactly as your doctor has told you to. This
information will also be on the pharmacist's label. If you are not sure how to
take your tablets ask your doctor or pharmacist.
Do not take more tablets than your doctor has told you to. It will not make
you better any faster and it may harm you.
ADULTS
Patients with psoriasis
USUAL DOSE: between 10 and 25mg (4 to 10 tablets) taken once a week
on the same day each week.
Patients with rheumatoid arthritis
USUAL DOSE: between 7.5 and 20mg (3 to 8 tablets) taken once a week
on the same day each week.
These doses may alter as your condition changes

Patients with cancer
Your doctor will decide the dose depending on your condition.
Methotrexate Tablets may be the only drug given or it may be given with
other drugs.
Your doctor will want to monitor your progress, usually every 2-3 months,
whilst you are receiving Methotrexate Tablets.
Before, during and after your treatment you may have tests, such as a
chest X-ray, physical examination and blood tests to check that your liver
and kidneys are working properly.
Do not miss your appointments as these are necessary to ensure that
Methotrexate Tablets are used safely.
Your doctor may give you additional medication to help make sure that
Methotrexate Tablets does not collect in the kidneys.
If you take more Methotrexate Tablets than you should
If you have taken an overdose of Methotrexate Tablets or 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.
If you forget to take Methotrexate Tablets
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.
If you have any further questions on the use of this product ask your doctor
or pharmacist.
4. POSSIBLE SIDE EFFECT
As with all medicines, as well as helping with your illness, Methotrexate
Tablets may cause some unwanted effects although not everybody gets
them.
All medicines can cause allergic reactions although serious allergic
reactions are rare. Any sudden wheeziness, difficulty in breathing, swelling
of the eyelids, face or lips, rash or itching (especially affecting your whole
body) should be reported to a doctor immediately.
Most of the effects listed below will only be seen in patients who are
receiving high doses of Methotrexate Tablets to treat cancer. They are
not seen as often and are not as severe at the doses used in the treatment
of psoriasis or rheumatoid arthritis.
If you notice any of the following side effects stop taking the medicine and
talk to your doctor as soon as possible.
- Methotrexate can make you more likely to catch infections. If you think
you have an infection, a sore throat, mouth ulcers, fever, chills, or
achiness during treatment you should tell your doctor immediately
- Methotrexate can cause inflammation of the lung with breathlessness,
symptoms of which include persistent cough, experience of pain or
difficulty in breathing or becoming breathless
- Severe skin rash that causes blistering. These may be signs of a
condition known as Stevens Johnson Syndrome. Your doctor will stop
your treatment in these cases.
Tell your doctor straight away if you notice any of the following side
effects:
Common – (affects less than 1 in 10 people):
- headache, dizziness, fatigue
- swelling of the mouth
- anorexia (eating disorder)
- feeling sick (nausea) or vomiting
- loose stools
- raised liver enzymes
- a skin rash with reddening of the skin
- hair loss.
Uncommon – (affects less than 1 in 100 people):
- a lump in your neck, groin or armpits with associated backache, weight
loss or night sweats
- decrease in the number of blood cells
- pale skin, weakness, tiredness or difficulties in breathing
- unusual bleeding or bruising
- nose bleed
- itching
- blistering and peeling of the top layer of the skin all over the body
- Vaginal ulcers
- Kidney damage.
Rare – (affects less than 1 in 1,000 people):
- raised blood sugar levels (diabetes mellitus)
- herpes zoster (shingles) which is a viral disease characterized by a
painful skin rash with blisters
- a serious infection affecting the whole body (sepsis) characterized by
fever, chills, rapid breathing and low blood pressure
- depression, confusion

-

inability to move one half of the body
fall in blood pressure
tenderness and swelling of the lower extremities (clot in the veins)
throat infection
swelling of the gums
stomach or intestinal ulcers, bleeding or inflammation of the intestine
a discolouration or yellowing of the skin and whites of the eyes
(jaundice) that could indicate liver damage
sensitivity to light
acne
appearance of lightened patches on the skin
skin ulcers and painful erosions of inflamed areas, in psoriasis patients
muscle pain, joint pain
weakening or softening of bones
an increase in rheumatic nodules
loss of interest in, or inability to have sex
menstrual disorders.

Very Rare – (affects less than 1 in 10,000 people):
- drowsiness
- irritation
- difficulty with speech
- blurred vision
- eye infection
- chest pain or tightness of chest, with difficulty in breathing
- lung infection
- vomiting blood
- small bruises on the skin caused by blood leaking from broken blood
vessels
- boils
- vasculitis (pain or redness of the blood vessels)
- dilatation of small blood vessels causing focal red lesions
- pain or difficulty in passing urine
- blood in urine
- elevation of urea and/or creatinine in the blood
- infertility
- enlargement of breasts
- vaginal bleeding
In a small number of patients methotrexate may cause serious side effects
and on rare occasions, death. You should contact your doctor immediately
if you notice any serious side effects.
Certain other unwanted effects can only be detected by your doctor, these
include blood disorders, and changes in liver and kidney function or bone
density.
5. HOW TO STORE METHOTREXATE TABLETS
o
Do not store above 25 C.
Keep out of the reach and sight of children.
Methotrexate Tablets should not be used after the expiry date printed on
the box.
If your doctor tells you to stop taking this medicine, return any unused
tablets to your doctor for safe disposal. Only keep the tablets if your doctor
tells you to.
If your tablets become discoloured or show any other signs of deterioration,
consult your doctor or pharmacist who will tell you what to do.
Medicines should not be disposed of via wastewater or household waste.
Ask you pharmacist how to dispose of medicine no longer required.
These measures will help to protect the environment
6. FURTHER INFORMATION
What Methotrexate Tablets contain
Each tablet contains methotrexate sodium equivalent to 2.5mg
methotrexate as the active ingredient.
The other ingredients are maize starch, lactose and magnesium stearate.
What Methotrexate Tablets look like and contents of the pack
Methotrexate Tablets are yellow, round, convex tablets marked ‘2.5’ on one
side and ‘M’ breakline ‘1’ on the other side.
Methotrexate Tablets are available in amber coloured glass bottles
containing 50 tablets.
PRODUCT LICENCE HOLDER AND MANUFACTURER
Manufactured by Haupt Pharma GmbH, Pfaffenreider Strasse 7, D - 82515
Wolfratshausen, Germany and are procured from the EU by Product
Licence holder: Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow,
Middlesex, HA1 1XD.
POM

PL No: 20636/1098

Leaflet revision and issue date (Ref) 16.09.11[10]

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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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