Remsima

Основна информация

  • Търговско наименование:
  • Remsima
  • Използвай за:
  • Хората
  • Вид на лекарството:
  • алопатични наркотици

Документи

Локализация

  • Предлага се в:
  • Remsima
    Европейски съюз
  • Език:
  • английски

Терапевтична информация

  • Терапевтична група:
  • Immunosuppressants
  • Терапевтична област:
  • Arthritis, Psoriatic, Spondylitis, Ankylosing, Colitis, Ulcerative, Psoriasis, Crohn Disease, Arthritis, Rheumatoid
  • Терапевтични показания:
  • Rheumatoid arthritisRemsima, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in:adult patients with active disease when the response to disease‑modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate;adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs.In these patient populations, a reduction in the rate of the progression of joint damage, as measured by X‑ray, has been demonstrated.Adult Crohn’s diseaseRemsima is indicated for:treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and / or an immunosuppressant or who are intolerant to or have medical contraindications for such therapies;treatment of fistulising, active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy
  • Каталог на резюме:
  • Revision: 18

Състояние

  • Източник:
  • EMA - European Medicines Agency
  • Статус Оторизация:
  • Authorised
  • Номер на разрешението:
  • EMEA/H/C/002576
  • Дата Оторизация:
  • 10-09-2013
  • EMEA код:
  • EMEA/H/C/002576
  • Последна актуализация:
  • 04-05-2020

Доклад обществена оценка

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Go to www.ema.europa.eu/contact

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© European Medicines Agency, 2019. Reproduction is authorised provided the source is acknowledged.

Classified as internal/staff & contractors by the European Medicines Agency

EMA/547143/2019

EMEA/H/C/002576

Remsima (infliximab)

An overview of Remsima and why it is authorised in the EU

What is Remsima and what is it used for?

Remsima is an anti-inflammatory medicine that contains the active substance infliximab. It is usually

used when other medicines or treatments have failed, in adults with the following immune-system

diseases:

rheumatoid arthritis (a disease causing inflammation of the joints). Remsima is used with

methotrexate (another medicine that acts on the immune system);

Crohn’s disease (a disease causing inflammation of the digestive tract), when the disease is

moderate to severe or fistulising (with the formation of fistulas, abnormal passageways between

the gut and other organs);

ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut);

ankylosing spondylitis (a disease causing inflammation and pain in the joints of the spine);

psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints);

psoriasis (a disease causing red, scaly patches on the skin).

Remsima is also used in patients aged between 6 and 17 years with severe, active Crohn’s disease or

severely active ulcerative colitis, when they have not responded to or cannot take other medicines or

treatments.

Remsima is a ‘biosimilar’ medicine. This means that Remsima is highly similar to another biological

medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for

Remsima is Remicade. For more information on biosimilar medicines, see here

How is Remsima used?

Remsima can only be obtained with a prescription and treatment should be started and supervised by

a specialised doctor who has experience in the diagnosis and treatment of the diseases that Remsima

can be used to treat.

Remsima (infliximab)

EMA/547143/2019

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Remsima is available as a powder to be made up into a solution for infusion (drip) into a vein. For

treatment of rheumatoid arthritis, Remsima is also available as a solution for injection under the skin

in a pre-filled syringe or pen.

Remsima is given as an infusion into a vein lasting one or two hours. All patients are monitored for any

reactions during the infusion and for at least one to two hours afterwards. To reduce the risk of

infusion-related reactions, patients may be given other medicines before or during treatment with

Remsima or the infusion may be slowed down. How often the treatment is repeated depends on which

disease is being treated, and on the patient’s response to the medicine.

For rheumatoid arthritis, after two treatments with infliximab have been given by infusion, Remsima

can be given by injection under the skin for subsequent treatments. Patients can inject Remsima

themselves once they have been trained.

For more information about using Remsima, see the package leaflet or contact your doctor or

pharmacist.

How does Remsima work?

The active substance in Remsima, infliximab, is a monoclonal antibody, a type of protein that has been

designed to recognise and attach to a specific structure (called an antigen) in the body. Infliximab has

been designed to attach to a chemical messenger in the body called tumour necrosis factor-alpha

(TNF-alpha). This messenger is involved in causing inflammation and is found at high levels in patients

with the diseases that Remsima is used to treat. By blocking TNF-alpha, infliximab improves the

inflammation and other symptoms of the diseases.

What benefits of Remsima have been shown in studies?

Laboratory studies comparing Remsima with Remicade have shown that the active substance in

Remsima is highly similar to that in Remicade in terms of structure, purity and biological activity. In

addition, Remsima and Remicade given by infusion into a vein were compared in one main study

involving 606 adults with rheumatoid arthritis. Patients received either Remsima or Remicade in

addition to methotrexate for 30 weeks. The main measure of effectiveness was the change in

symptoms. After 30 weeks of treatment, Remsima was as effective as Remicade with around 60% of

patients responding to treatment with either medicine.

A study was also carried out in 250 patients with ankylosing spondylitis to show that Remsima given by

infusion into a vein produces levels of the active substance in the body that are comparable to the

reference medicine, Remicade.

Because Remsima is a biosimilar medicine, the studies on effectiveness and safety of infliximab carried

out with Remicade do not all need to be repeated for Remsima.

Remsima injection to be given under the skin was shown to be as effective as Remsima given by

infusion into a vein in a study involving 343 patients with rheumatoid arthritis. Patients received

Remsima by infusion twice, two weeks apart and subsequent treatments were given either by infusion

or injection under the skin. After 22 weeks, the reduction of symptoms was comparable for treatment

given by infusion into a vein and by injection under the skin.

What are the risks associated with Remsima?

The safety of Remsima has been evaluated, and on the basis of all the studies carried out, the side

effects of the medicine are considered to be comparable to those of the reference medicine Remicade.

Remsima (infliximab)

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The most common side effects with Remsima (which may affect more than 1 in 10 people) are viral

infections (such as flu or cold sores), headache, upper respiratory-tract infection (nose and throat

infections), sinusitis (inflammation of the sinuses), nausea (feeling sick), abdominal pain (stomach

ache), infusion-related reactions and pain. Some side effects, including infections, may be more

common in children than in adults. For the full list of all side effects of Remsima, see the package

leaflet.

Remsima must not be used in patients who have experienced hypersensitivity (allergy) to infliximab in

the past, or who are hypersensitive (allergic) to mouse proteins or any of the other ingredients of

Remsima. Remsima must not be used in patients with tuberculosis, other severe infections, or

moderate or severe heart failure (an inability of the heart to pump enough blood around the body).

Why is Remsima authorised in the EU?

The European Medicines Agency decided that, in accordance with EU requirements for biosimilar

medicines, Remsima has a highly similar structure, purity and biological activity to Remicade and is

distributed in the body in the same way. In addition, studies in rheumatoid arthritis and ankylosing

spondylitis have shown that the safety and effectiveness of Remsima are equivalent to those of

Remicade in the conditions.

All these data were considered sufficient to conclude that Remsima will behave in the same way as

Remicade in terms of effectiveness and safety in its authorised uses. Therefore, the Agency’s view was

that, as for Remicade, the benefits of Remsima outweigh the identified risks and it can be authorised

for use in the EU.

Remsima given by injection under the skin for rheumatoid arthritis is as effective as Remsima given by

infusion and the safety profile is acceptable. It also allows patients the convenience of having their

treatment at home.

What measures are being taken to ensure the safe and effective use of

Remsima?

The company that markets Remsima will provide a card to patients that includes information about the

medicine and can be used to record tests they have taken.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe

and effective use of Remsima have also been included in the summary of product characteristics and

the package leaflet.

As for all medicines, data on the use of Remsima are continuously monitored. Side effects reported

with Remsima are carefully evaluated and any necessary action taken to protect patients.

Other information about Remsima

Remsima received a marketing authorisation valid throughout the EU on 10 September 2013.

Further information on Remsima can be found on the Agency’s website:

ema.europa.eu/medicines/human/EPAR/remsima

This overview was last updated in 11/2019.

Листовка за пациента: състав, показания, Нежелани лекарствени реакции, дозиране, взаимодействия, бременност, кърмене

B. PACKAGE LEAFLET

Package leaflet: Information for the user

Remsima 100 mg powder for concentrate for solution for infusion

infliximab

Read all of this leaflet carefully before you start using this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

Your doctor will also give you a patient reminder card, which contains important safety

information you need to be aware of before and during your treatment with Remsima.

When starting a new card, keep this card as a reference for 4 months after your last dose of

Remsima.

If you have any further questions, ask your doctor.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor. This includes any possible side effects not listed

in this leaflet. See section 4.

What is in this leaflet

What Remsima is and what it is used for

What you need to know before you use Remsima

How Remsima will be given

Possible side effects

How to store Remsima

Contents of the pack and other information

1.

What Remsima is and what it is used for

Remsima 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.

Remsima belongs to a group of medicines called ‘TNF blockers’. It is used in adults for the following

inflammatory diseases:

Rheumatoid arthritis

Psoriatic arthritis

Ankylosing spondylitis (Bechterew’s disease)

Psoriasis.

Remsima is also used in adults and children 6 years of age or older for:

Crohn’s disease

Ulcerative colitis.

Remsima 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

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

Remsima which you will take with another medicine called methotrexate to:

reduce the signs and symptoms of your disease,

slow down the damage in your joints,

improve your physical function.

Psoriatic arthritis

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 Remsima to:

reduce the signs and symptoms of your disease,

slow down the damage in your joints,

improve your physical function.

Ankylosing spondylitis (Bechterew’s disease)

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

Remsima to:

reduce the signs and symptoms of your disease,

improve your physical function.

Psoriasis

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 Remsima to reduce the signs and symptoms of

your disease.

Ulcerative colitis

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 Remsima to

treat your disease.

Crohn’s 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 Remsima to:

treat active Crohn’s disease,

reduce the number of abnormal openings (fistulae) between your bowel and your skin that have

not been controlled by other medicines or surgery.

2.

What you need to know before you use Remsima

You must not be given Remsima if

you are allergic to infliximab or any of the other ingredients of this medicine (listed in

section 6),

you are allergic to proteins that come from mice,

you have tuberculosis (TB) or another serious infection such as pneumonia or sepsis (serious

bacterial infection of the blood),

you have heart failure that is moderate or severe.

Do not use Remsima if any of the above applies to you. If you are not sure, talk to your doctor before

you are given Remsima.

Warnings and precautions

Talk to your doctor before or during treatment with Remsima if you have:

Had treatment with any medicine containing infliximab before

Tell your doctor if you have had treatment with medicines containing infliximab in the past and

are now starting Remsima treatment again.

If you have had a break in your treatment with infliximab of more than 16 weeks, there is a

higher risk for allergic reactions when you start the treatment again.

Infections

Tell your doctor before you are given Remsima if you have an infection even if it is a very

minor one.

Tell your doctor before you are given Remsima if you have ever lived in or travelled to an area

where infections called histoplasmosis, coccidioidomycosis, or blastomycosis are common.

These infections are caused by specific types of fungi that can affect the lungs or other parts of

your body.

You may get infections more easily when you are being treated with Remsima. If you are

65 years of age or older, you have a greater risk.

These infections may be serious and include tuberculosis, infections caused by viruses, fungi,

bacteria or other organisms in the environment and sepsis that may be life-threatening.

Tell your doctor straight away if you get signs of infection during treatment with Remsima. Signs

include fever, cough, flu-like signs, feeling unwell, red or hot skin, wounds or dental problems. Your

doctor may recommend temporarily stopping Remsima.

Tuberculosis (TB)

It is very important that you tell your doctor if you have ever had TB or if you have been in

close contact with someone who has had or has TB.

Your doctor will test you to see if you have TB. Cases of TB have been reported in patients

treated with infliximab, even in patients who have already been treated with medicines for TB.

Your doctor will record these tests on your patient reminder card.

If your doctor feels that you are at risk for TB, you may be treated with medicines for TB before

you are given Remsima.

Tell your doctor straight away if you get signs of TB during treatment with Remsima. Signs include

persistent cough, weight loss, feeling tired, fever, night sweats.

Hepatitis B virus

Tell your doctor before you are given Remsima if you are a carrier of hepatitis B or have ever

had it.

Tell your doctor if you think you might be at risk of contracting hepatitis B.

Your doctor should test you for hepatitis B virus.

Treatment with TNF blockers such as Remsima may result in reactivation of hepatitis B virus in

patients who carry this virus, which can be life-threatening in some cases.

If you experience reactivation of hepatitis B, your doctor may need to stop your treatment and

may give you medicines such as effective antiviral therapy with supportive treatment.

Heart problems

Tell your doctor if you have any heart problems, such as mild heart failure.

Your doctor will want to closely monitor your heart.

Tell your doctor straight away if you get new or worsening signs of heart failure during treatment with

Remsima. Signs include shortness of breath or swelling of your feet.

Cancer and lymphoma

Tell your doctor before you are given Remsima if you have or have ever had lymphoma (a type

of blood cancer) or any other cancer.

Patients with severe rheumatoid arthritis, who have had the disease for a long time, may be at

higher risk of developing lymphoma.

Children and adults taking Remsima may have an increased risk of developing lymphoma or

another cancer.

Some patients who have received TNF-blockers, including infliximab have developed a rare

type of cancer called hepatosplenic T-cell lymphoma. Of these patients, most were teenage boys

or young men and most had either Crohn’s disease or ulcerative colitis. This type of cancer has

usually resulted in death. Almost all patients had also received medicines containing

azathioprine or mercaptopurine in addition to TNF-blockers.

Some patients treated with infliximab have developed certain kinds of skin cancer. If there are

any changes in your skin or growths on the skin during or after therapy, tell your doctor.

Some women being treated for rheumatoid arthritis with infliximab have developed cervical

cancer. For women taking Remsima including those over 60 years of age, your doctor may

recommend regular screening for cervical cancer.

Lung disease or heavy smoking

Tell your doctor before you are given Remsima if you have a lung disease called chronic

obstructive pulmonary disease (COPD) or if you are a heavy smoker.

Patients with COPD and patients who are heavy smokers may have a higher risk of developing

cancer with Remsima treatment.

Nervous system disease

Tell your doctor before you are given Remsima if you have or have ever had a problem that

affects your nervous system. This includes multiple sclerosis, Guillain-Barré syndrome, if you

have fits or have been diagnosed with ‘optic neuritis’.

Tell your doctor straight away if you get symptoms of a nerve disease during treatment with Remsima.

Signs include changes in your vision, weakness in your arms or legs, numbness or tingling in any part

of your body.

Abnormal skin openings

Tell your doctor if you have any abnormal skin openings (fistulae) before you are given

Remsima.

Vaccinations

Talk to your doctor if you recently have had or are due to have a vaccine.

You should receive recommended vaccinations before starting Remsima treatment. You may

receive some vaccines during treatment with Remsima but you should not receive live vaccines

(vaccines that contain a living but weakened infectious agent) while using Remsima because

they may cause infections.

If you received Remsima while you were pregnant, your baby may also be at higher risk for

getting an infection with live vaccines for up to six months after birth. It is important that you

tell your baby's doctors and other health care professionals about your Remsima use so they can

decide when your baby should receive any vaccine, including live vaccines such as BCG (used

to prevent tuberculosis). For more information see section on Pregnancy and breast-feeding.

Therapeutic infectious agents

Talk to your doctor if you have recently received or are scheduled to receive treatment with a

therapeutic infectious agent (such as BCG instillation used for the treatment of cancer).

Operations or dental procedures

Tell your doctor if you are going to have any operations or dental procedures.

Tell your surgeon or dentist that you are having treatment with Remsima by showing them your

patient reminder card.

Liver problems

Some patients receiving infliximab have developed serious liver problems.

Tell your doctor straight away if you get symptoms of liver problems during treatment with

Remsima. 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

In some patients receiving infliximab, the body may not make enough of the blood cells that

help fight infections or help stop bleeding.

Tell your doctor straight away if you get symptoms of low blood counts during treatment with

Remsima. 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

Some patients receiving infliximab have developed symptoms of an immune system disorder

called lupus.

Tell your doctor straight away if you develop symptoms of lupus during treatment with

Remsima. Signs include joint pain or a rash on cheeks or arms that is sensitive to the sun.

Children and adolescents

The information above also applies to children and adolescents. In addition:

Some children and teenage patients who have received TNF-blockers such as infliximab have

developed cancers, including unusual types, which sometimes resulted in death.

More children taking infliximab developed infections as compared to adults.

Children should receive recommended vaccinations before starting Remsima treatment.

Children may receive some vaccines during treatment with Remsima but should not receive live

vaccines while using Remsima.

Remsima 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.

If you are not sure if any of the above applies to you, talk to your doctor before you are given

Remsima.

Other medicines and Remsima

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 Remsima.

Tell your doctor if you are using, have recently used or might use 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:

Medicines that affect your immune system.

Kineret (which contains anakinra). Remsima and Kineret should not be used together.

Orencia (which contains abatacept). Remsima and Orencia should not be used together.

While using Remsima you should not receive live vaccines. If you were using Remsima during

pregnancy, tell your baby’s doctor and other health care professionals caring for your baby about your

Remsima use before the baby receives any vaccines.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using

Remsima.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby,

ask your doctor for advice before taking this medicine. Remsima

should only be used during

pregnancy if your doctor feels it is necessary for you.

You should avoid getting pregnant when you are being treated with Remsima and for 6 months

after you stop being treated with it. Discuss the use of contraception during this time with your

doctor.

Do not breast-feed when you are being treated with Remsima or for 6 months after your last

treatment with Remsima.

If you received Remsima during your pregnancy, your baby may have a higher risk for getting

an infection.

It is important that you tell your baby’s doctors and other healthcare professionals about your

Remsima use before your baby is given any vaccine. If you received Remsima while pregnant,

giving BCG vaccine (used to prevent tuberculosis) to your baby within 6 months after birth may

result in infection with serious complications, including death. Live vaccines such as BCG

should not be given to your baby within 6 months after birth. For more information see section

on vaccination.

Severely decreased numbers of white blood cells have been reported in infants born to women

treated with infliximab during pregnancy. If your baby has continual fevers or infections,

contact your baby’s doctor immediately.

Driving and using machines

Remsima is not likely to affect your ability to drive or use tools or machines. If you feel tired, dizzy,

or unwell after having Remsima, do not drive or use any tools or machines.

Remsima contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.

However, before Remsima 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.

3.

How to use Remsima

Rheumatoid arthritis

The usual dose is 3 mg for every kg of body weight.

Psoriatic arthritis, ankylosing spondylitis (Bechterew’s disease), psoriasis, ulcerative colitis and

Crohn's disease

The usual dose is 5 mg for every kg of body weight.

How Remsima is given

Remsima will be given to you by your doctor or nurse.

Your doctor or nurse will prepare the medicine for infusion.

The medicine will be given as an infusion (drip) (over 2 hours) into one of your veins, usually in

your arm. After the third treatment, your doctor may decide to give your dose of Remsima over

1 hour.

You will be monitored while you are given Remsima and also for 1 to 2 hours afterwards.

How much Remsima is given

The doctor will decide your dose and how often you will be given Remsima. This will depend

on your disease, weight and how well you respond to Remsima.

The table below shows how often you will usually have this medicine after your first dose.

dose

2 weeks after your 1

dose

dose

6 weeks after your 1

dose

Further doses

Every 6 to 8 weeks depending on your disease

Use in children and adolescents

In children (6 years of age or older) treated for Crohn’s disease or ulcerative colitis, the recommended

dose is the same as for adults.

If you are given too much Remsima

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 Remsima.

If you forget or miss your Remsima infusion

If you forget or miss an appointment to receive Remsima, make another appointment as soon as

possible.

If you have any further questions on the use of this medicine, ask your doctor.

4.

Possible side effects

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 Remsima has stopped.

Tell your doctor straight away if you notice any of the following:

Signs of an allergic reaction

such as swelling of your face, lips, mouth or throat which may

cause difficulty in swallowing or breathing, skin rash, hives, swelling of the hands, feet or

ankles. Some of these reactions may be serious or life-threatening. An allergic reaction could

happen within 2 hours of your injection or later. More signs of allergic side effects that may

happen up to 12 days after your injection include pain in the muscles, fever, joint or jaw pain,

sore throat or headache.

Signs of a heart problem

such as chest discomfort or pain, arm pain, stomach pain, shortness

of breath, anxiety, lightheadedness, dizziness, fainting, sweating, nausea (feeling sick),

vomiting, fluttering or pounding in your chest, a fast or a slow heartbeat, and swelling of your

feet.

Signs of infection (including TB)

such as fever, feeling tired, cough which may be persistent,

shortness of breath, flu-like symptoms, weight loss, night sweats, diarrhoea, wounds, collection

of pus in the gut or around the anus (abscess), dental problems or burning sensation when

urinating.

Possible signs of cancer

including but not limited to swelling of lymph nodes, weight loss,

fever, unusual skin nodules, changes in moles or skin colouring, or unusual vaginal bleeding.

Signs of a lung problem

such as coughing, breathing difficulties or tightness in the chest.

Signs of a nervous system problem (including eye problems)

such as signs of a stroke

(sudden numbness or weakness of your face, arm or leg, especially on one side of your body;

sudden confusion, trouble speaking or understanding; trouble seeing in one or both eyes, trouble

walking, dizziness, loss of balance or coordination or a severe headache), fits,

tingling/numbness in any part of your body, or weakness in arms or legs, changes in eyesight

such as double vision or other eye problems.

Signs of a liver problem

(including hepatitis B infection when you have had hepatitis B in the

past) such as yellowing of the skin or eyes, dark-brown coloured urine, pain or swelling in the

upper right side of the stomach area, joint pain, skin rashes, or fever.

Signs of an immune system disorder called lupus

such as joint pain or a rash on cheeks or

arms that is sensitive to the sun (lupus) or cough, shortness of breath, fever or skin rash

(sarcoidosis).

Signs of low blood counts

such as persistent fever, bleeding or bruising more easily, small red

or purple spots caused by bleeding under the skin, or looking pale.

Signs of serious skin problems

such as reddish-target-like spots or circular patches often with

central blisters on the trunk, large areas of peeling and shedding (exfoliating) skin, ulcers of

mouth, throat, nose, genitals and eyes or small pus-filled bumps that can spread over the body.

These skin reactions can be accompanied by fever.

Tell your doctor straight away if you notice any of the above.

The following side effects have been observed with Remsima:

Very common:

may affect more than 1 in 10 people

Stomach pain, feeling sick

Viral infections such as herpes or flu

Upper respiratory infections such as sinusitis

Headache

Side effect due to an infusion

Pain.

Common:

may affect up to 1 in 10 people

Changes in how your liver works, increase in liver enzymes (shown in blood tests)

Lung or chest infections such as bronchitis or pneumonia

Difficult or painful breathing, chest pain

Bleeding in the stomach or intestines, diarrhoea, indigestion, heartburn, constipation

Nettle-type rash (hives), itchy rash or dry skin

Balance problems or feeling dizzy

Fever, increased sweating

Circulation problems such as low or high blood pressure

Bruising, hot flush or nosebleed, warm, red skin (flushing)

Feeling tired or weak

Bacterial infections such as blood poisoning, abscess or infection of the skin (cellulitis)

Infection of the skin due to a fungus

Blood problems such as anaemia or low white blood cell count

Swollen lymph nodes

Depression, problems sleeping

Eye problems, including red eyes and infections

Fast heart beat (tachycardia) or palpitations

Pain in the joints, muscles or back

Urinary tract infection

Psoriasis, skin problems such as eczema and hair loss

Reactions at the injection site such as pain, swelling, redness or itching

Chills, a build-up of fluid under the skin causing swelling

Feeling numb or having a tingling feeling.

Uncommon:

may affect up to 1 in 100 people

Shortage of blood supply, swelling of a vein

Collection of blood outside the blood vessels (haematoma) or bruising

Skin problems such as blistering, warts, abnormal skin colouration or pigmentation, or swollen

lips, or thickening of the skin, or red, scaly, and flaky skin

Severe allergic reactions (e.g. anaphylaxis), an immune system disorder called lupus, allergic

reactions to foreign proteins

Wounds taking longer to heal

Swelling of the liver (hepatitis) or gall bladder, liver damage

Feeling forgetful, irritable, confused, nervous

Eye problems including blurred or reduced vision, puffy eyes or sties

New or worsening heart failure, slow heart rate

Fainting

Convulsions, nerve problems

A hole in the bowel or blockage of the intestine, stomach pain or cramps

Swelling of your pancreas (pancreatitis)

Fungal infections such as yeast infection, or fungal infection of the nails

Lung problems (such as oedema)

Fluid around the lungs (pleural effusion)

Narrowed airway in the lungs, causing difficulty breathing

Inflamed lining of the lung, causing sharp chest pains that feel worse with breathing (pleurisy)

Tuberculosis

Kidney infections

Low platelet count, too many white blood cells

Infections of the vagina

Blood test result showing ‘antibodies’ against your own body.

Rare:

may affect up to 1 in 1,000 people

A type of blood cancer (lymphoma)

Your blood not supplying enough oxygen to your body, circulation problems such as narrowing

of a blood vessel

Inflammation of the lining of the brain (meningitis)

Infections due to a weakened immune system

Hepatitis B infection when you have had hepatitis B in the past

Inflamed liver caused by a problem with the immune system (autoimmune hepatitis)

Liver problem that causes yellowing of the skin or eyes (jaundice)

Abnormal tissue swelling or growth

Severe allergic reaction that may cause loss of consciousness and could be life-threatening

(anaphylactic shock)

Swelling of small blood vessels (vasculitis)

Immune disorders that could affect the lungs, skin and lymph nodes (such as sarcoidosis)

Collections of immune cells resulting from an inflammatory response (granulomatous lesions)

Lack of interest or emotion

Serious skin problems such as toxic epidermal necrolysis, Stevens-Johnson syndrome and acute

generalised exanthematous pustulosis

Other skin problems such as erythema multiforme, blisters and peeling skin, or boils

(furunculosis)

Serious nervous system disorders such as transverse myelitis, multiple sclerosis-like disease,

optic neuritis and Guillain-Barré syndrome

Inflammation in the eye that may cause changes in the vision, including blindness

Fluid in the lining of the heart (pericardial effusion)

Serious lung problems (such as interstitial lung disease)

Melanoma (a type of skin cancer)

Cervical cancer

Low blood counts, including a severely decreased number of white blood cells

Small red or purple spots caused by bleeding under the skin

Abnormal values of a blood protein called ‘complement factor’ which is part of the immune

system

Lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on

mucous membranes).