METHOTREXATE 10MG TABLETS

Active substance: METHOTREXATE

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Methotrexate 10mg Tablets
Package Leaflet: Information for the User
Your medicine is known by the above name but will be referred to as
Methotrexate throughout this leaflet.
Read all of this leaflet carefully before you start taking 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, pharmacist or nurse.
 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 you get any side effects talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1) What Methotrexate is and what it is used for
2) What you need to know before you take Methotrexate
3) How to take 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
The active substance of Methotrexate tablets, methotrexate, is an
antimetabolite and immunosuppressant (medicine which affects the
reproduction of the body’s cells and reduces the activity of the immune
system).
Methotrexate is used to treat:
- active rheumatoid arthritis,
- severe psoriasis, especially plaque-type,
- psoriatic arthritis in adult patients who have tried other treatments but their
illness has not improved.
Your doctor will be able to explain how Methotrexate might help in your
particular condition.

2) What you need to know before you take Methotrexate
Do not take Methotrexate
- if you have significant liver disease (your doctor decides the severity of
your disease).
- if you have significant kidney disease (your doctor decides the severity of
your disease).
- if you have or have had a bone marrow disease or serious blood
disorders.
- if you are allergic (hypersensitive) to methotrexate or any of the other
ingredients of Methotrexate tablets.
- if you are pregnant or breast-feeding (see also section “Pregnancy,
breastfeeding and fertility”).
- if you have severe acute or chronic infections or immunodeficiency
syndrome.
- if you suffer from alcoholism.
Warnings and precautions
Please tell your doctor or pharmacist if any of the following conditions concern
or have concerned you:
- Diabetes mellitus treated with insulin.
- You have received any vaccinations recently or are you due to have any
- You are using any other medicines or vitamin products (Please see section
“Other medicines and Methotrexate”)
- You have infections
- You have ulcerations in your stomach or bowel (peptic ulcer or ulcerative
colitis)
- You are in poor general condition
- You have or have had any liver or kidney disease.
Methotrexate temporarily affects sperm and egg production. You and your
partner should avoid conception (becoming pregnant or fathering children) if
currently receiving methotrexate and for at least six months after your
treatment with methotrexate has stopped. See also section “Pregnancy,
breast-feeding and fertility”.
Before treatment is started your doctor may carry out blood tests, and also to
check how well your kidneys and liver are working. You may also have a
chest X-ray. Further tests may also be done during and after treatment. Do
not miss appointments for blood tests.

Other medicines and Methotrexate
Other concomitant medication may affect the efficacy and safety of this
medicine. Methotrexate may also affect the efficacy and safety of other
medications.
Please tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines, including medicines obtained without a
prescription and herbal or natural medicinal products. Remember to tell your
doctor about your treatment with Methotrexate, if you are prescribed another
medicine while the treatment is still ongoing. It is especially important to tell
your doctor if you are using:
- certain
antibiotics
(such
as
penicillins,
sulphonamides,
trimethoprim/sulfamethoxazole, tetracycline and chloramphenicol);
- agents that may be harmful to kidneys and liver [e.g. sulphasalazine and
leflunomide (medicines for rheumatic diseases), vitamin A and its
derivatives, alcohol];
- anticancer agents (e.g. cisplatin, mercaptopurine);
- phenytoin (medicine often used to treat epilepsy);
- aspirin or similar medicines (known as salicylates);
- non-steroidal anti-inflammatory medicines (medicines taken for pain relief)
e.g. ibuprofen and pyrazoles;
- medicines taken to help control rheumatism e.g. azathioprine;
- omeprazole or pantoprazole (medicine used to stop the production of
stomach acid);
- diuretics, triamterene (water tablets);
- probenecid (medicine used to treat gout);
- folic acid (vitamin preparation);
- theophylline (medicine used to treat respiratory diseases);
- cyclosporine (an agent that can suppress or prevent the immune response).
Tell your physician about use of Methotrexate during your next visits.
Methotrexate with food, drink and alcohol
Alcohol should be avoided during methotrexate therapy.
Pregnancy, breast-feeding and fertility
Pregnancy
Do not use Methotrexate during pregnancy or if you are trying to become
pregnant.
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.
Therefore, in women of child-bearing age any possibility of pregnancy must
be excluded with appropriate measures, e.g. a pregnancy test, before starting
treatment. You must avoid becoming pregnant whilst taking methotrexate and
for at least 6 months after treatment is stopped. Therefore you must ensure
reliable contraception during this whole period (see also section “Take special
care with Methotrexate”).
If you do become pregnant during treatment, you should be offered advice
regarding the risk of harmful effects on the child through treatment.
If you wish to become pregnant you should consult a genetic information
centre before the planned start of treatment, because methotrexate may be
genotoxic, which means that the medicine may cause genetic mutation.
Breast-feeding
Do not breastfeed during treatment, because methotrexate passes into breast
milk. If your attending doctor considers treatment with methotrexate
absolutely necessary during the lactation period, you must stop breastfeeding.
Fertility
Male fertility
Methotrexate may be genotoxic. This means that the medicine may cause
genetic mutation. Methotrexate can affect sperm and egg production with
the potential to cause birth defects.
Therefore, you must avoid fathering a child whilst taking methotrexate and for
at least 6 months after treatment is stopped. 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
(see also section “Take special care with Methotrexate”).
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
You can feel fatigue and dizziness during Methotrexate treatment. Do not
drive or use machines if you have such symptoms.

skin psoriatic lesions, skin ulcers), appearance of skin nodules, Herpes
zoster, sepsis, osteoporosis, pain in joints or muscles, menstrual disorders,
impotence, decrease of libido.

Methotrexate contains lactose
These tablets contain lactose. If you have been told by your doctor that you
have an intolerance to some sugars, contact your doctor before taking this
medicinal product.

If you notice any of the following, please contact your doctor immediately:
- 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
- an allergic reaction such as skin rash or swelling of your lips or tongue
- fever
- yellowing of the skin (jaundice)
- pain or difficulty in passing urine
- thirst and/or frequent urination
- chest pain
- a dry cough and/or pain or difficulty in breathing or shortness of breath
- fits (convulsions)
- loss of consciousness
- blurred or decreased vision.

3) How to take Methotrexate
Always take Methotrexate exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
- Take Methotrexate once a week
- Patients with rheumatoid arthritis or psoriasis will usually take their tablets
orally once a week on the same day each week.
- Do not take tablets more often than your doctor has told you to.
- Daily administration can lead to serious toxic effects.
- Take the tablets with a glass of water whilst sitting upright or standing.
Dosage for rheumatoid arthritis, psoriasis and psoriatic arthritis:
The recommended dose is 7.5 - 15 mg orally, once weekly.
This should be adjusted according to your response to treatment and sideeffects.
If you take more Methotrexate than you should
If you take (or someone else has taken) more of the medicine than you
should, a physician or nearest hospital casualty department must be
contacted immediately.
An overdose of methotrexate can lead to severe toxic reactions. 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.
Take your medicine package with you if you go to a doctor or hospital.
If you forget to take Methotrexate
Take the forgotten dose 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 a forgotten
dose.
Make sure before your holiday or trip that you have enough of your medicine.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.

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

5) How to store Methotrexate
 Keep all medicines out of the sight and reach of children.
 Do not use Methotrexate after the expiry date which is stated on the tablet
container and the outer carton. The expiry date refers to the last day of that
month.
 Keep the tablet container in the outer carton in order to protect from light.
 If the tablets become discoloured or show any other signs of deterioration,
you should seek the advice of your pharmacist who will tell you what to do.
 Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment

6) Contents of the pack and other information
What Methotrexate contains
The active substance is methotrexate. Each tablet contains 10 milligrams
(mg) of methotrexate.

4) Possible side effects

The other ingredients are maize starch, lactose monohydrate, potato starch
pregelatinised, polysorbate 80, microcrystalline cellulose and magnesium
stearate.

Like all medicines, this medicine can cause side effects, although not
everybody gets them. In general, the incidence and severity of adverse
reactions of methotrexate are related to dose and frequency of administration.
Most adverse reactions are reversible if detected early.

What Methotrexate looks like and contents of the pack
Methotrexate 10mg Tablets are yellow, convex, capsule-shaped tablets,
scored and engraved with M10 on one side.

Most of the effects listed below will only be seen in patients who are receiving
high doses of methotrexate 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.
Common side effects (occurs in more than 1 of 100 patients and less than 1
of 10 patients): Decreased resistance to infections, leucosytopenia
(decreased number of white blood cells)*, nausea, vomiting, diarrhoea,
unusual fatigue, headache, dizziness, loss of appetite, erythematous rashes,
alopecia, stomatitis (soreness of the mouth and lips) and increase of liver
transaminases (enzymes)*.
Uncommon side effects (occurs in more than 1 of 1000 patients and less
than 1 of 100 patients): Bone marrow depression manifested by
thrombocytopenia and other abnormalities developing in the blood*, anemia,
nosebleed, anaphylactic reactions, severe pulmonary illnesses, severe skin
rashes, pruritus, kidney dysfunction, vaginal ulceration.
*) Only detected by your doctor.
Rare side-effects (occurs in more than 1 of 10,000 patients and less than 1
of 1000 patient): Depression, confusion, hemiparesis (impairment of motor
function affecting only one side of the body), diabetes mellitus, hypotension,
thromboembolia, dyspnoea, inflammation of gums, pharynx or small intestine,
gastrointestinal ulceration and bleeding, liver damage (hepatic toxicity,
periportal fibrosis, hepatic cirrhosis, acute hepatitis), skin reactions (acne, skin
depigmentation, urticaria, photosensitivity, erythema multiforme, burning in

Methotrexate 10mg Tablets are available in bottles of 100 tablets.
PL 10383/2039

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Orion Corporation, Tengstrominkatu 8,
FI – 20360 Turku, Finland. Procured from within the EU and repackaged by
the Product Licence Holder: Primecrown Ltd., 4/5 Northolt Trading Estate,
Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 12.02.2013

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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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