The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 00242/0746.
Remicade 100mg powder for concentrate for solution for infusion
Remicade® 100 mg powder for concentrate for solution for infusion
1. What Remicade is and what it is used for
2. What you need to know before you use Remicade
3. How Remicade will be given
4. Possible side effects
5. How to store Remicade
6. Contents of the pack and other information
Remicade contains the active substance infliximab. Infliximab is a monoclonal antibody – a type of protein that attaches to a specific target in the body called TNF (tumour necrosis factor) alpha.
Remicade belongs to a group of medicines called ‘TNF blockers’. It is used in adults for the following inflammatory diseases:
Remicade is also used in adults and children 6 years of age or older for:
Remicade works by selectively attaching to TNF alpha and blocking its action. TNF alpha is involved in inflammatory processes of the body so blocking it can reduce the inflammation in your body.
Rheumatoid arthritis is an inflammatory disease of the joints. If you have active rheumatoid arthritis you will first be given other medicines. If these medicines do not work well enough, you will be given Remicade which you will take in combination with another medicine called methotrexate to:
Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis. If you have active psoriatic arthritis you will first be given other medicines. If these medicines do not work well enough, you will be given Remicade to:
Ankylosing spondylitis is an inflammatory disease of the spine. If you have ankylosing spondylitis you will first be given other medicines. If these medicines do not work well enough, you will be given Remicade to:
Psoriasis is an inflammatory disease of the skin. If you have moderate to severe plaque psoriasis, you will first be given other medicines or treatments, such as phototherapy. If these medicines or treatments do not work well enough, you will be given Remicade to reduce the signs and symptoms of your disease.
Ulcerative colitis is an inflammatory disease of the bowel. If you have ulcerative colitis you will first be given other medicines. If these medicines do not work well enough, you will be given Remicade to treat your disease.
Crohn’s disease is an inflammatory disease of the bowel. If you have Crohn’s disease you will first be given other medicines. If these medicines do not work well enough, you will be given Remicade to:
Do not use Remicade if any of the above applies to you. If you are not sure, talk to your doctor before you are given Remicade.
Talk to your doctor before or during treatment with Remicade if you have:
Had treatment with Remicade before
If you have had a break in your Remicade treatment of more than 16 weeks, there is a higher risk for allergic reactions when you start the treatment again.
Tell your doctor straight away if you get signs of infection during treatment with Remicade. Signs include fever, cough, flu-like signs, feeling unwell, red or hot skin, wounds or dental problems. Your doctor may recommend temporarily stopping Remicade.
Tell your doctor straight away if you get signs of TB during treatment with Remicade. Signs include persistent cough, weight loss, feeling tired, fever, night sweats.
Hepatitis B virus
Tell your doctor straight away if you get new or worsening signs of heart failure during treatment with Remicade. Signs include shortness of breath or swelling of your feet.
Cancer and lymphoma
Lung disease or heavy smoking
Nervous system disease
Tell your doctor straight away if you get symptoms of a nerve disease during treatment with Remicade. Signs include changes in your vision, weakness in your arms or legs, numbness or tingling in any part of your body.
Abnormal skin openings
Therapeutic infectious agents
Operations or dental procedures
Tell your doctor straight away if you get symptoms of liver problems during treatment with Remicade. Signs include yellowing of the skin and eyes, dark-brown coloured urine, pain or swelling in the upper right side of the stomach area, joint pain, skin rashes, or fever.
Low blood counts
Tell your doctor straight away if you get symptoms of low blood counts during treatment with Remicade. Signs include persistent fever, bleeding or bruising more easily, small red or purple spots caused by bleeding under the skin, or looking pale.
Immune system disorder
Tell your doctor straight away if you develop symptoms of lupus during treatment with Remicade. Signs include joint pain or a rash on cheeks or arms that is sensitive to the sun.
The information above also applies to children and adolescents. In addition:
If you are not sure if any of the above apply to you, talk to your doctor before you are given Remicade.
Patients who have inflammatory diseases already take medicines to treat their problem. These medicines may cause side effects. Your doctor will advise you what other medicines you must keep using while you are having Remicade.
Tell your doctor if you are using or have recently used any other medicines, including any other medicines to treat Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis or psoriasis or medicines obtained without a prescription, such as vitamins and herbal medicines.
In particular, tell your doctor if you are using any of the following medicines:
While using Remicade you should not receive live vaccines. If you were using Remicade during pregnancy or if you are receiving Remicade while breast-feeding, tell your baby’s doctor and other healthcare professionals caring for your baby about your Remicade use before the baby receives any vaccines.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using Remicade.
Remicade is not likely to affect your ability to drive or use tools or machines. If you feel tired, dizzy, or unwell after having Remicade, do not drive or use any tools or machines.
Remicade contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’. However, before Remicade is given to you, it is mixed with a solution that contains sodium. Talk to your doctor if you are on a low salt diet.
The usual dose is 3 mg for every kg of body weight.
The usual dose is 5 mg for every kg of body weight.
2nd dose: 2 weeks after your 1st dose
3rd dose: 6 weeks after your 1st dose
Further doses: Every 6 to 8 weeks depending on your disease
Remicade should only be used in children if they are being treated for Crohn’s disease or ulcerative colitis. These children must be 6 years of age or older.
As this medicine is being given by your doctor or nurse, it is unlikely that you will be given too much. There are no known side effects of having too much of Remicade.
If you forget or miss an appointment to receive Remicade, make another appointment as soon as possible.
If you have any further questions on the use of this medicine, ask your doctor.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild to moderate. However some patients may experience serious side effects and may require treatment. Side effects may also occur after your treatment with Remicade has stopped.
Tell your doctor straight away if you notice any of the above.
The following side effects have been observed with Remicade:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Not known: frequency cannot be estimated from the available data
Children who took Remicade for Crohn’s disease showed some differences in side effects compared with adults who took Remicade for Crohn's disease. The side effects that happened more in children were: low red blood cells (anaemia), blood in stool, low overall levels of white blood cells (leucopenia), redness or blushing (flushing), viral infections, low levels of white blood cells that fight infection (neutropenia), bone fracture, bacterial infection and allergic reactions of the breathing tract.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard 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.
Remicade will generally be stored by the health professionals. The storage details should you need them are as follows:
Remicade is supplied as a glass vial containing a powder for concentrate for solution for infusion. The powder is a freeze-dried white pellet.
Remicade is produced in packs of 1, 2, 3, 4 or 5 vials. Not all pack sizes may be marketed.
For any additional information about this medicine, please contact:
For information in large print, tape, CD or Braille, telephone 0800 7318450
This leaflet was last revised in August 2022.