This site is intended for patients prescribed Simponi (golimumab). If you are a Healthcare Professional then go to the HCP site or if you are a member of the public, please visit our public site.

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 Alert Card before taking Simponi.

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

You should not take Simponi if you:

  • Are allergic to golimumab or another ingredient in Simponi
  • Have tuberculosis (TB) or another severe infection
  • Have moderate or severe heart failure
  • Are pregnant or breast-feeding

Before you take Simponi, you must tell your doctor if you:

  • Recently had, or are due, a vaccine
  • Are going to have an operation, including dental procedures
  • Are planning to get pregnant
  • Have severe asthma, COPD (a type of lung disease) or are a heavy smoker
  • Have a congestive heart condition
  • Have travelled to areas where fungal, TB or other infections are common
  • Are allergic to sugars or latex
  • Have Hepititis B, or carry the Hepatitis B virus
  • Have ever been diagnosed with any form of cancer
  • Have or get any symptoms of infection
  • Have or develop any heart problems, such as mild heart failure
  • Have or develop problems that affects your nervous system
  • Develop symptoms of lupus
  • Have a fever that does not go away, bruise or bleed easily

Talk to your doctor

Before you take Simponi, your doctor will test you for TB. You should also let your doctor know immediately if you notice any of the following during or after your treatment:

Signs of infection (including TB)

  • A persistent cough
  • Weight loss
  • Shortness of breath
  • Tirednesss
  • Fever
  • Night sweats
  • Diarrhoea
  • Dental problems
  • Flu-like symptoms
  • Burning sensation when passing urine
  • Wounds

Signs of allergic reaction

  • Swelling of the face, lips, mouth and throat
  • Swelling of the hand, feet or ankles
  • Difficulty swallowing or breathing
  • Skin rash, including hives

Signs of liver problems

  • Yellowing of the skin or eyes
  • Dark brown urine
  • Right-sided abdominal pain
  • Fever
  • Nausea and vomiting
  • Tiredness

Signs of heart failure

  • Shortness of breath
  • Swelling of the feet

If you experience any side effects (including any not listed above), talk to your healthcare professional. You can report side effects via the Yellow Card Scheme at https://yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store – this helps to provide more information on the safety of this medicine.

If you notice anything unusual, contact your healthcare professional, especially if:

  • The injection site continues to bleed
  • The injection is very painful
  • A rash develops around the injection site
  • You get a fever or develop signs of an allergic reaction

Simponi is a prescription-only medicine and must be used under medical supervision.

Reporting side effects

If you experience any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at https://yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Merck Sharp & Dohme Limited (tel: 01992 467272).

Merck Sharp & Dohme Limited Registered Office:

Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU.

A company registered in England and Wales.

Company Registration Number: 820771

Patient Information Leaflet for people with Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Non-Radiographic Axial Spondyloarthritis or Ulcerative Colitis

Patient Information Pack for people with Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis

Patient Information Pack for people with Ulcerative Colitis

© Merck Sharp and Dohme Limited. All rights reserved. 2018

MULT-1233761-0003 | Date of preparation: May 2018

Contact

For further information about Simponi (golimumab) 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

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References

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