Things you should do
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Remind any doctor, pharmacist or dentist you visit that you are using ABRILADA.
Check with your doctor before you receive any vaccines.
Call your doctor straight away if you become pregnant while using ABRILADA.
It is important to tell your doctor if you get symptoms of an infection.
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Things you should not do
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Do not stop using ABRILADA, without checking with your doctor.
Do not take ABRILADA and anakinra (Kineret) or ABRILADA and abatacept (Orencia) together.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how ABRILADA
affects you.
ABRILADA may have a minor influence on the ability to drive and use machines.
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Looking after your medicine
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Keep ABRILADA in a refrigerator (2°C to 8°C). Do not freeze.
Keep your medicine in the pack until it is time to use it in order to protect it from
light.
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Do not use ABRILADA if:
1. you are allergic to adalimumab, or any of the ingredients listed at the end of this leaflet.Symptoms of an allergic reaction may include:
2. Always check the ingredients to make sure you can use this medicine.
3. you have a severe infection including an infection of the blood (sepsis), active tuberculosis or other severe infections that can be caused by viruses, fungi, parasites or bacteria.Infections can occur when the body's natural defences are lowered.
4. you are already using anakinra (Kineret). Anakinra is a medicine for rheumatoid arthritis, JIA and conditions associated with a defect in a protein called cryoprin.
5. you have moderate to severe heart failure.
6. ABRILADA is a clear, colourless to very light brown solution. If particulates or discolourations are noted, do not use the product.
Check with your doctor if you:
If you are over 65, you may be more likely to get an infection while taking ABRILADA. It is important that you and your doctor pay special attention to signs of infection while you are being treated with ABRILADA
Tuberculosis can develop during therapy even if you have received treatment for the prevention of tuberculosis.
If symptoms of tuberculosis (for example a cough that doesn't go away, weight loss, lack of energy, mild fever), or any other infections appear during or after therapy, tell your doctor immediately.
In people who carry HBV, ABRILADA can cause the virus to become active again. In some rare cases, especially if you are taking other medicines that suppress the immune system, reactivation of HBV can be life threatening.
Certain vaccines may cause infections and should not be given while patients are receiving ABRILADA.
Wherever possible, it is recommended that children, be brought up to date with all immunisations according to current immunisation guidelines prior to starting on ABRILADA therapy. Patients receiving ABRILADA should not receive live vaccines.
Pregnancy and breastfeeding
How much to use
How to use ABRILADA
How long to use ABRILADA
If you forget to use ABRILADA
If you use too much ABRILADA
(by calling 13 11 26), or
Things you should do
Call your doctor straight away if you:
Things you should not do
Things to be careful of
Driving or using machines
Looking after your medicine
When to discard your medicine
Getting rid of any unwanted medicine
Common side effects
Common side effects
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What to do
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Blood related issues
Bleeding or bruising more easily than usual
Mouth ulcers, pain or excessive bleeding from the gums
Eye disorders
Pain or inflammation of the eye or eye lid or changes to your vision
General disorders and administration site conditions
Pain, swelling, redness or itching at the site of injection
Fatigue, tiredness, lack of energy
Muscle or Bone related issues
Muscle weakness or numbness, difficulty balancing
Muscle, joint or bone pain
Nervous system
Headache or migraine, dizziness, vertigo
Psychiatric
Feeling overwhelmed or sad, or lacking motivation (depression)
Feeling anxious, especially fearful or worried (anxiety)
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Speak to your doctor if you have any of these more common side effects and they worry
you.
They are usually mild and short- lived.
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Common side effects (continued)
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What to do
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Heart related issues
Chest pain
Increased heart rate
Infections
Cold, runny nose, sinus infection, sore throat cough, congestion on the chest, asthma
or worsening of asthma symptoms
Lower respiratory tract infections (such as bronchitis, pneumonia)
Pain in the ear which could suggest an ear infection
Fever, flushing, increased sweating
Viral infections (including the flu, cold sore blisters, chicken pox and shingles)
Bacterial infections (including Urinary Tract Infection)
Fungal Infections
Renal and Urinary related issues
Burning or pain when passing urine, or blood in the urine
Skin related issues
Skin bumps or sores that don't heal
Rash, itching, redness or scaly patches
Problems with your finger or toe nails
Hair loss
Stomach related issues
Nausea, vomiting, abdominal pain
Reflux or heartburn
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Speak to your doctor if you have any of these more common side effects and they worry
you.
They are usually mild and short- lived.
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Serious side effects
Serious side effects
|
What to do
|
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Allergic type reactions
Chest tightness
Shortness of breath, wheezing or difficulty breathing
Swelling of the face, lips, tongue or other parts of the body
Hives, itching or skin rash.
Heart related issues
Signs and symptoms suggestive of heart failure such as shortness of breath with exertion
or upon lying down or swelling of the feet.
Blood related issues
Signs and symptoms suggestive of a blood disorder such as persistent fever, bruising,
bleeding very easily, paleness.
Blood clots
Signs suggesting a blood clot such as swelling, tenderness, redness and a warm feeling
of an area of the arm or leg.
Infections
Signs of tuberculosis such as persistent cough, weight loss, listlessness, fever
Signs of infection such as fever, lack of energy, skin sores, problems with your teeth
or gums, burning when you pass urine.
You might get infections more easily while you are receiving ABRILADA treatment.
Signs of soft tissue infection, such as a bump or open sore that doesn't heal
Liver related issues
Yellow skin and eyes
Abdominal pain
Fatigue, fever and joint pain
Dark urine and pale stool
Loss of appetite and unexplained weight loss
Nervous system
Signs of nervous system disorders such as numbness or tingling throughout your body,
arm or leg weakness, double vision.
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Reporting side effects
What ABRILADA contains
Active ingredient
(main ingredient)
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Adalimumab
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Other ingredients
(inactive ingredients)
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Histidine
Histidine hydrochloride monohydrate
Disodium edetate
Sucrose
Methionine
Polysorbate 80
Water for injections
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