Remicade 100mg powder for solution for infusion vials

Remicade is an immunosuppressant which is used to treat inflammatory conditions such as rheumatoid arthritis, ulcerative colitis, Crohn’s disease, ankylosing spondylitis, psoriatic arthritis, and psoriasis. It may be given in combination with other medicines to treat some of these inflammatory conditions. Remicade works by suppressing overactivity of the immune system and helps to reduce pain and swelling by limiting inflammation.

Due to its effects on the immune system, people who have Remicade are prone to getting infections. This includes serious infections such as tuberculosis and sepsis. It is for this reason that people who have Remicade are monitored for infections. Your prescriber will give you further information about how you can best avoid getting an infection and the signs and symptoms to look out for.

Remicade may cause allergic reactions which may be life-threatening. Some of these reactions may be serious and may need to be treated if they occur. To prevent these reactions from happening you may be given some other medicines before you have Remicade. These reactions usually occur during treatment or within hours of having Remicade. However, sometimes these reactions may be delayed as Remicade stays in the body for up to six months and the effects of this medicine will persist for some time after you have your last dose. Your medical team will monitor you for any reactions and advise you of the signs and symptoms to look out for. If you develop any of these symptoms at any time, tell your prescriber.

Other information about Remicade:

Remicade is usually given to you by a healthcare professional. The person responsible for giving you your medicine will make sure that you get the right dose.

If you feel that the medicine is making you unwell or you do not think it is working, then talk to your prescriber or someone involved in your medical care.

The person with responsibility for giving you your medicine will make sure that you have your medicine at the prescribed times.

This medicine will be given to you as an injection. If you have any concerns about this medicine or how this will be given to you, talk to someone who is involved in your medical care.

Having extra doses of some medicines can be harmful. In some cases even one extra dose can cause you problems.

In the case of Remicade, the person who is responsible for giving you your medicine will make sure that you are given the correct dose.

The person in charge of your care will make the decision about when you should stop this medicine. If you experience any problems while having this medicine, talk to someone who is involved in your medical care.

As Remicade will be given to you as an injection, it will usually be stored by the medical team.

Remicade is not suitable for everyone and some people should never use it. Other people should only use it with special care. It is important that the person prescribing this medicine knows your full medical history.

Your prescriber may only prescribe this medicine with special care or may not prescribe it at all if you:

Furthermore the prescriber may only prescribe this medicine with special care or may not prescribe it at all for someone under 18 years of age.

As part of the process of assessing suitability to take this medicine a prescriber may also arrange tests:

Over time it is possible that Remicade can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Remicade has become unsuitable, it is important that the prescriber is contacted immediately.

A medicine is only made available to the public if the clinical trials have shown that the benefits of taking the medicine outweigh the risks.

Once a medicine has been licensed, information on the medicine's effects, both intended and unintended, is continuously recorded and updated.

Some side-effects may be serious while others may only be a mild inconvenience.

Everyone's reaction to a medicine is different. It is difficult to predict which side-effects you will have from taking a particular medicine, or whether you will have any side-effects at all. The important thing is to tell your prescriber or pharmacist if you are having problems with your medicine.

Very common: More than 1 in 10 people who have Remicade:

• headaches - seek immediate medical advice if you develop a headache
• infections such as flu, respiratory tract infections, bronchitis or pneumonia - some infections could be fatal
• infusion-related reactions which may occur during the infusion or within two hours of the infusion. Symptoms include: seizures; low blood pressure; heart attack; anaphylactic reactions; shock; breathing difficulties; bronchospasm; loss of vision; urticaria; swelling of the face; lips; hands or throat; muscle and joint pain with fever and a rash; itching; swallowing difficulties; sore throat; and headaches - seek immediate medical advice if you get any of these hypersensitivity reactions at any time
• nausea
• pain including back pain, muscle or joint pain - seek medical advice if you get muscle and joint pain accompanied with a rash and fever
• sinusitis
• stomach pain

Common: More than 1 in 100 people who have Remicade:

• abnormal laboratory test results
• allergic reactions
• blood and bone marrow problems - seek immediate medical advice if you have symptoms such as persistent fever, bleeding, bruising or paleness
• certain types of dermatitis
• chest pain
• chills
• constipation
• depression
• diarrhoea
• difficulty sleeping
• dry skin
• eczema
• faster heart rate
• feeling dizzy
• fever - seek immediate medical advice if you develop a fever
• flushing
• gastrointestinal bleeding
• gastro-oesophageal reflux
• hair loss
• hot flushes
• hypoaesthesia
• increased sweating
• indigestion
• infections such as abscesses, cellulitis, urinary tract infection, infection of the mouth or sepsis - some of these infections may be fatal
• injection site problems
• liver problems - some of these liver problems may be fatal
• lowered blood pressure
• lymphadenopathy
• nose bleed
• oedema
• palpitations
• paraesthesiae
• precipitation of symptoms of psoriasis or worsening of psoriasis
• raised blood pressure
• red eye
• skin rash or rashes - seek medical advice if you get a rash
• tiredness
• vertigo

Uncommon: More than 1 in 1000 people who have Remicade:

• circulation problems
• collection of blood under the skin
• collection of fluid around the lungs
• confusion
• eye or eyesight problems
• fainting or brief loss of consciousness
• feeling agitated
• feeling nervous
• gallbladder problems
• gastrointestinal problems
• healing problems
• heart problems or worsening of heart problems - these could be fatal
• inflammation or cracking of the lips
• inflammation or infection of the eyelid
• irregular heart rate
• irritation or inflammation of the vagina
• kidney problems
• lung problems
• lupus or lupus-like problem
• memory problems
• nail problems
• neuropathies
• pancreatitis
• production of antibodies to Remicade
• pulmonary oedema
• serum-sickness or serum-sickness like reaction
• skin problems such as skin colour changes, seborrhea, rosacea or thickening of the skin
• sleepiness
• slower heart rate
• swelling around the eyes
• thrombophlebitis
• tuberculosis - this may be fatal. Seek immediate medical advice if you get a persistent cough, fever or weight loss

Rare: More than 1 in 10,000 people who have Remicade:

• apathy
• autoimmune problems
• boils
• collection of fluid around the heart
• cyanosis
• demyelinating problems such as multiple sclerosis and Guillain Barr syndrome or worsening of such existing disorders
• erythema multiforme
• Hodgkin's lymphoma
• inflammatory reactions such as sarcoid-like reaction or formation of granulomatous lesions
• jaundice - seek medical advice if you develop jaundice
• leukaemia
• lymphoma - this may be fatal
• meningitis
• petechiae
• reactivation of hepatitis B - this may be fatal. You must seek medical advice if your symptoms return or if they become worse
• Stevens-Johnson syndrome
• toxic epidermal necrolysis
• unexplained or easy bruising of the skin or mucous membranes
• vasculitis
• vasospasm

The frequency of these side-effects is unknown:

• cancer - this may be fatal
• hiding symptoms of infection such as fever

If you feel unwell or if you have concerns about a side-effect, you will need to seek advice. If you feel very ill, get medical help straight away. Contact your prescriber, pharmacist, nurse or call NHS Direct on 0845 46 47.

If you are taking more than one medicine they may interact with each other. At times your prescriber may decide to use medicines that interact, in other cases this may not be appropriate.

The decision to use medicines that interact depends on your specific circumstances. Your prescriber may decide to use medicines that interact, if it is believed that the benefits of taking the medicines together outweigh the risks. In such cases, it may be necessary to alter your dose or monitor you more closely.

Tell your prescriber the names of all the medicines that you are taking so that they can consider all possible interactions. This includes all the medicines which have been prescribed by your GP, hospital doctor, dentist, nurse, health visitor, midwife or pharmacist. You must also tell your prescriber about medicines which you have bought over the counter without prescriptions.

The following medicines may interact with Remicade:

The following types of medicine may interact with Remicade:

If you are taking Remicade and one of the above medicines or types of medicines, make sure your prescriber knows about it.

Medicines can interact with complementary preparations and vitamins. In general, there is not much information available about interactions between medicines and complementary preparations or vitamins.

If you are planning to take or are already taking any complementary preparations and vitamins you should ask your prescriber whether there are any known interactions with Remicade.

Your prescriber can advise whether it is appropriate for you to take combinations that are known to interact. They can also discuss with you the possible effect that the complementary preparations and vitamins may have on your condition.

If you experience any unusual effects while taking this medicine in combination with complementary preparations and vitamins, you should tell your prescriber.

When taking any medicine you should be aware that it might interfere with your ability to drive or operate machinery safely.

In the case of Remicade:

You should see how this medicine affects you before you judge whether you are safe to drive or operate machinery. If you are in any doubt about whether you should drive or operate machinery, talk to your prescriber.

Medicines can interact with certain foods. In some cases, this may be harmful and your prescriber may advise you to avoid certain foods.

In the case of Remicade:

Alcohol can interact with certain medicines.

In the case of Remicade:

Most medicines, in some way, can affect the development of a baby in the womb. The effect on the baby differs between medicines and also depends on the stage of pregnancy that you have reached when you take the medicine.

In the case of Remicade:

You should discuss your personal circumstances with your doctor if you are pregnant or want to become pregnant. This is so that together you can make a decision about what treatment you may need during your pregnancy.

You should discuss whether there are any other medicines which you could take during pregnancy which would treat your condition.

Certain medicines can pass into breast milk and may reach your baby through breast-feeding.

In the case of Remicade:

Before you have your baby you should discuss breast-feeding with your doctor or midwife. They will help you decide what is best for you and your baby based on the benefits and risks associated with this medicine. If you wish to breast-feed you should discuss with your prescriber whether there are any other medicines you could take which would also allow you to breast-feed. You should not stop this medicine without taking advice from your doctor.

Medicines contain active ingredients. They may also contain other, additional ingredients that help ensure the stability, safety and effectiveness of the medicine. Some may be used to prolong the life of the medicine.

Remicade contains:

If you are not able to take any of the ingredients in your medicine, talk to your prescriber or pharmacist to see if they can suggest an alternative medicine. If you have reacted badly to Remicade before, do not have Remicade. Talk to your prescriber, pharmacist or nurse as soon as possible.