This site is intended for patients who have been prescribed Remicade (infliximab). If you are a Healthcare Professional then please visit the HCP site, or if you are a member of the public please visit our public site. This site is not a substitute for the Patient Information Leaflet (PIL). The information provided is general education information and does not take place of professional medical advice.


Safety Information

This section contains important safety information and side-effects that you should look out for. You should also read the Patient Information Leaflet and patient reminder card before taking Remicade (infliximab).

Further information, including the Patient Information Leaflet can be found at www.medicines.org.uk/emc/medicine.

As with all medicines, you might experience side effects with Remicade (infliximab). Some of these might happen during treatment, and some in between your treatments. It is important to know what the possible side effects are, so that if you do experience any you can let your healthcare professional know.

Common side effects of Remicade (infliximab)

  • Increased risk of infections
  • Pain in the joints, muscles or back
  • Reactions where the drip enters your arm such as pain, swelling, redness or itching
  • Changes in blood tests, including a fall in number of red or white cells, or both and an increase in liver enzymes
  • Changes in blood pressure or heart rate (this will be monitored during your treatment)
  • Headache
  • Eye problems, including red eyes and infections
  • Feeling tired or weak
  • Stomach pain, feeling sick, diarrhoea, indigestion, heartburn, constipation
  • Changes in sensation such as feeling dizzy, numb, tingling and balance problems
  • Having problems sleeping, depression
  • Skin problems such as dry skin, rash, eczema, psoriasis and hair loss
  • Rarely, some patients treated with Remicade (infliximab) have developed certain kinds of skin cancer, therefore you should have your skin examined from time to time. Please inform your healthcare professional if you notice any changes in the appearance of the skin or growths on the skin during or after therapy
  • Difficult or painful breathing, chest pain
  • Bleeding in the stomach or intestines
  • Fever, increased sweating, hot flush, warm, bruising, nosebleed, chills
  • Swollen lymph nodes

Please refer to the Patient Information Leaflet for further information on side effects.


Talk to your healthcare professional

Before you take Remicade (infliximab), your healthcare professional will test you for tuberculosis (TB). You should also contact your healthcare professional urgently if you notice any of the following:

Signs of infection (including TB)

  • fever
  • tiredness
  • cough, which may be persistent
  • shortness of breath
  • flu-like symptoms
  • weight loss
  • night sweats
  • diarrhoea
  • wounds
  • dental problems
  • burning feeling when urinating
  • collection of pus in the gut or around the anus (abscess)

Signs of heart problems

  • pain in the chest, arm or stomach
  • shortness of breath
  • fainting, feeling dizzy or light-headed
  • fluttering or pounding in your chest
  • a fast or a slow heartbeat
  • swelling of your feet
  • sweating
  • nausea or vomiting
  • anxiety

Signs of liver problems

(including hepatitis B infection when you’ve had hepatitis B in the past)

  • yellowing of the skin and eyes
  • dark brown-coloured urine
  • right-sided abdominal pain or swelling
  • fever
  • feeling sick or being sick
  • feeling very tired
  • joint pain
  • skin rashes

Signs of allergic reaction

  • swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing
  • skin rash or hives (bumps on the skin)
  • swelling of the hands, feet or ankles

Signs of a lung problem

  • coughing
  • breathing difficulties
  • tightness in the chest

Signs of a nervous system problem*

  • fits, tingling or numbness in any part of your body
  • weakness in arms or legs
  • changes in eyesight such as double vision
  • other eye problems

* (including eye problems)

Signs of an immune system disorder

  • joint pain
  • rash on cheeks or arms that is sensitive to the sun (lupus)
  • cough
  • shortness of breath
  • fever
  • skin rash (sarcoidosis)

Signs of a low blood count

  • persistent fever
  • bleeding or bruising more easily
  • looking pale
  • small red or purple spots caused by bleeding under the skin

Signs of cancer

  • swelling of lymph nodes
  • weight loss
  • fever
  • unusual skin nodules
  • changes in moles or skin colouring
  • unusual vaginal bleeding

If you experience any side effects (including any not listed here), talk to your healthcare professional as soon as possible for advice. You can also report side effects via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard – this helps to provide more information on the safety of this medicine.


Patient reminder card

Your patient reminder card contains important safety information. This should be read and carried with you and shown to any healthcare professional who is involved in your care. Please ask your healthcare professional for a patient reminder card if you do not have one.


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References

  1. Kanai T et al. Korean J Intern Med 2014; 29(4): 409-15
  2. Olendzki BC et al. Nutr J 2014; 13(5): 1-7.
  3. Brown AC et al. Expert Rev. Gastroenterol. Hepatol 2011; 5(3): 411-25
  4. Pituch-Zdanowksa A et al. Prz Gastroenterol 2015; 10(3): 135-41.
  5. Oliviero F et al. Swiss Med Wkly 2015; 145: w14190.
  6. Clinton CM et al. Arthritis 2015; 2015: Article ID 708152.
  7. Narula N, Fedorak RN. Can J Gastroenterol 2008; 22 (5): 497-504
  8. Bilski J et al. BioMed Res Int 2014; Volume 2014 (Article ID 429031): 1-14.
  9. Benatti FB, Pedersen BK. Nat Rev Rheumatol 2015; 11: 86-97
  10. Nolte K et al. S Afr Fam Pract 2013; 55: 345-9
  11. Metsios GA et al. Expert Rev Clin Immunol 2015 [Epub ahead of print]
  12. Brophy S et al. Semin Arthritis Rheum 2013; 42: 619-26

Contact

For further information about Remicade (infliximab) please contact our Medical Information Department at:

Medical Information Department

Merck Sharp & Dohme Ltd.

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

Tel: 01992 467272

E-mail: medicalinformationuk@merck.com