Active ingredient
- golimumab
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
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 are: EU/1/09/546/005, EU/1/09/546/006.
Simponi 100 mg solution for injection in pre-filled pen
Package Leaflet: Information for the user
Simponi® 100 mg solution for injection in pre-filled pen
golimumab
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
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 Simponi.
What is in this leaflet
1. What Simponi is and what it is used for
2. What you need to know before you use Simponi
3. How to use Simponi
4. Possible side effects
5. How to store Simponi
6. Contents of the pack and other information
1. What Simponi is and what it is used for
Simponi contains the active substance called golimumab.
Simponi belongs to a group of medicines called ‘TNF blockers’. It is used in adults for the treatment of the following inflammatory diseases:
Simponi works by blocking the action of a protein called ‘tumour necrosis factor alpha’ (TNF-α). This protein is involved in inflammatory processes of the body, and 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 you do not respond well enough to these medicines, you may be given Simponi which you will take in combination with another medicine called methotrexate to:
Psoriatic arthritis
Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis, an inflammatory disease of the skin. If you have active psoriatic arthritis you will first be given other medicines. If you do not respond well enough to these medicines, you may be given Simponi to:
Ankylosing spondylitis and non-radiographic axial spondyloarthritis
Ankylosing spondylitis and non-radiographic axial spondyloarthritis are inflammatory diseases of the spine. If you have ankylosing spondylitis or non-radiographic axial spondyloarthritis, you will first be given other medicines. If you do not respond well enough to these medicines, you may be given Simponi to:
Ulcerative colitis
Ulcerative colitis is an inflammatory disease of the bowel. If you have ulcerative colitis you will first be given other medicines. If you do not respond well enough to these medicines, you will be given Simponi to treat your disease.
2. What you need to know before you use Simponi
Do not use Simponi
If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before using Simponi.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Simponi.
Infections
Tell your doctor straight away if you already have or get any symptoms of infection, during or after your treatment with Simponi. Symptoms of infection include fever, cough, shortness of breath, flu-like symptoms, diarrhoea, wounds, dental problems or a burning feeling when urinating.
Cancer and lymphoma
Tell your doctor if you have ever been diagnosed with lymphoma (a type of blood cancer) or any other cancer before you use Simponi.
Heart failure
Tell your doctor straight away if you get new or worsening symptoms of heart failure. Symptoms of heart failure include shortness of breath or swelling of your feet.
Nervous system disease
Tell your doctor straight away if you have ever been diagnosed with or develop symptoms of a demyelinating disease such as multiple sclerosis. Symptoms may include changes in your vision, weakness in your arms or legs or numbness or tingling in any part of your body. Your doctor will decide if you should receive Simponi.
Operations or dental procedures
Autoimmune disease
Tell your doctor if you develop symptoms of a disease called lupus. Symptoms include persistent rash, fever, joint pain and tiredness.
Blood disease
In some patients the body may fail to produce enough of the blood cells that help your body fight infections or help you to stop bleeding. If you develop a fever that does not go away, bruise or bleed very easily or look very pale, call your doctor right away. Your doctor may decide to stop treatment.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Simponi.
Vaccinations
Talk to your doctor if you have had, or are due to have a vaccine.
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).
Allergic reactions
Tell your doctor straight away if you develop symptoms of an allergic reaction after your treatment with Simponi. Symptoms of an allergic reaction may include swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing, skin rash, hives, swelling of the hands, feet or ankles.
Children and adolescents
Simponi 100 mg is not recommended for children and adolescents (younger than 18 years).
Other medicines and Simponi
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Simponi.
Pregnancy and breast-feeding
Talk to your doctor before using Simponi if:
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Simponi has minor influence on your ability to drive and use tools or machines. Dizziness may however occur after you take Simponi. If this happens, do not drive or use any tools or machines.
Simponi contains latex and sorbitol
Latex sensitivity
A part of the pre-filled pen, the needle cover, contains latex. Because latex may cause severe allergic reactions, talk to your doctor before using Simponi if you or your carer are allergic to latex.
Sorbitol intolerance
This medicine contains 41 mg sorbitol (E420) in each pre-filled pen.
3. How to use Simponi
Always use this medicine exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.
How much Simponi is given
Rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis, including ankylosing spondylitis and non-radiographic axial spondyloarthritis:
Ulcerative colitis
Initial treatment
A starting dose of 200 mg (the contents of 2 pre-filled pens) followed by 100 mg (the contents of 1 pre-filled pen) 2 weeks later.
Maintenance treatment
How Simponi is given
Talk to your doctor if you have any questions about giving yourself an injection. You will find detailed “Instructions for Use” at the end of this leaflet.
If you use more Simponi than you should
If you have used or been given too much Simponi (either by injecting too much on a single occasion, or by using it too often), talk to your doctor or pharmacist straight away. Always take the outer carton and this leaflet with you, even if it is empty.
If you forget to use Simponi
If you forget to use Simponi on your planned date, inject the forgotten dose as soon as you remember.
Do not use a double dose to make up for a forgotten dose.
When to inject your next dose:
If you are not sure what to do, talk to your doctor or pharmacist.
If you stop using Simponi
If you are considering stopping Simponi, talk to your doctor or pharmacist first.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Some patients may experience serious side effects and may require treatment. The risk of certain side effects is greater with the 100 mg dose compared with the 50 mg dose. Side effects may appear up to several months after the last injection.
Tell your doctor straight away if you notice any of the following serious side effects of Simponi which include:
Tell your doctor straight away if you notice any of the above symptoms.
The following additional side effects have been observed with Simponi:
Very common side effects (may affect more than 1 in 10 people):
Common side effects (may affect up to 1 in 10 people):
Uncommon side effects (may affect up to 1 in 100 people):
Rare side effects (may affect up to 1 in 1,000 people):
Side effects of which the frequency is not known:
Reporting of side effects
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.
5. How to store Simponi
6. Contents of the pack and other information
What Simponi contains
The active substance is golimumab. One 1 mL pre-filled pen contains 100 mg of golimumab.
The other ingredients are sorbitol (E420), histidine, histidine hydrochloride monohydrate, polysorbate 80 and water for injections. For more information on sorbitol (E420), see Section 2.
What Simponi looks like and contents of the pack
Simponi is supplied as solution for injection in a single-use pre-filled pen. Simponi is available in packs containing 1 pre-filled pen and multipacks containing 3 (3 packs of 1) pre-filled pens. Not all pack sizes may be marketed.
The solution is clear to slightly opalescent (having a pearl-like shine), colourless to light yellow and may contain a few small translucent or white particles of protein. Do not use Simponi if the solution is discoloured, cloudy or you can see foreign particles in it.
Marketing Authorisation Holder and Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in October 2020
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
INSTRUCTIONS FOR USE
If you would like to self inject Simponi, you must be trained by a healthcare professional to prepare an injection and give it to yourself. If you have not been trained, please contact your doctor, nurse or pharmacist to schedule a training session.
In these instructions:
1. Preparing for use of the pre-filled pen
2. Choosing and preparing the injection site
3. Injecting the medicine
4. After the injection
The information below describes what the “SmartJect” pre-filled pen looks like.
The "SmartJect" pre-filled pen is a pen with a fixed needle and a safety sleeve at one end. A viewing window is directly below the safety sleeve, followed further down by the button. The Expiration date can also be found on the back of the pen. The pen has a cap which is sealed to the pen with a security seal.
1. Preparing for use of the pre-filled pen
Check the number of pre-filled pens
Check the pre-filled pens to make sure
Check expiry date
Check security seal
Wait 30 minutes to allow pre-filled pen to reach room temperature
Get the rest of your equipment ready
Check the liquid in the pre-filled pen
2. Choosing and preparing the injection site
Injection site selection for caregivers if you are not administering the injection yourself
Preparing injection site
3. Injecting the medicine
Remove the cap
Push the pre-filled pen firmly against the skin
Press button to inject
Do not lift the pre-filled pen away from your skin. If you pull the pre-filled pen away from your skin, you may not get your full dose of medicine.
Continue to hold until the second ‘click’
4. After the injection
Use a cotton ball or gauze
Check the window – a yellow indicator confirms proper administration
Throw the pre-filled pen away
If you feel that something has gone wrong with the injection or if you are not sure, talk to your doctor or pharmacist.
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