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Human medicines European public assessment report (EPAR): Jylamvo, methotrexate, Date of authorisation: 29/03/2017, Revision: 13, Status: Authorised

The most common side effects with Jylamvo (which may affect more than 1 in 10 people) are effects in the digestive system (such as inflammation of the lining of the mouth, indigestion, belly pain, feeling sick and loss of appetite) and blood tests showing changes in the liver. The most serious side effects include reduced production of blood cells, damage to the lung, liver, kidneys and nerves, thromboembolism (problems caused by clots in blood vessels), and severe allergic and skin reactions.

Jylamo must not be used in patients who abuse alcohol or those with liver or severe kidney problems, blood disorders, weakened immune system (body defences), severe or long-term infections such as tuberculosis and HIV infection, mouth ulcers, inflammation in the mouth, and ulcers in the digestive system. It must not be used if the patient is breastfeeding or is receiving live vaccines.

For the full list of side effects and restrictions of Jylamvo, see the package leaflet.

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