ABRILADA contains the active substance adalimumab, a medicine that acts on your body’s immune (defence) system.

ABRILADA is intended for the treatment of the following inflammatory diseases:

·            rheumatoid arthritis,

·            polyarticular juvenile idiopathic arthritis,

·            paediatric enthesitis‑related arthritis,

·            ankylosing spondylitis,

·            axial spondyloarthritis without radiographic evidence of ankylosing spondylitis,

·            psoriatic arthritis,

·            psoriasis,

·            hidradenitis suppurativa,

·            Crohn’s disease,

·            ulcerative colitis and

·            non‑infectious uveitis.

The active ingredient in ABRILADA, adalimumab, is a monoclonal antibody. Monoclonal antibodies are proteins that attach to a specific target in the body.

The target of adalimumab is another protein called tumour necrosis factor (TNFα), which is involved in the immune (defence) system and is present at increased levels in the inflammatory diseases listed above. By attaching to TNFα, ABRILADA blocks its action and reduces the inflammation in these diseases.

Rheumatoid arthritis

Rheumatoid arthritis is an inflammatory disease of the joints.

ABRILADA is used to treat rheumatoid arthritis in adults. If you have moderate to severe active rheumatoid arthritis, you may first be given other disease‑modifying medicines, such as methotrexate. If these medicines do not work well enough, you will be given ABRILADA to treat your rheumatoid arthritis.

ABRILADA can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment.

ABRILADA can slow down the damage to the cartilage and bone of the joints caused by the disease and improve physical function.

Usually, ABRILADA is used with methotrexate. If your doctor considers that methotrexate is inappropriate, ABRILADA can be given alone.

Polyarticular juvenile idiopathic arthritis

Polyarticular juvenile idiopathic arthritis is an inflammatory disease of the joints that usually first appears in childhood.

ABRILADA is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged 2 to 17 years. Patients may first be given other disease‑modifying medicines, such as methotrexate. If these medicines do not work well enough, patients will be given ABRILADA to treat their polyarticular juvenile idiopathic arthritis.

Paediatric enthesitis-related arthritis

Paediatric enthesitis-related arthritis is an inflammatory disease of the joints and the places where tendons join the bone.

ABRILADA is used to treat enthesitis‑related arthritis in children and adolescents aged 6 to 17 years. Patients may first be given other disease‑modifying medicines, such as methotrexate. If these medicines do not work well enough, patients will be given ABRILADA to treat their enthesitis‑related arthritis.

Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis

Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, are inflammatory diseases of the spine.

ABRILADA is used in adults to treat these conditions. If you have ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, you will first be given other medicines. If these medicines do not work well enough, you will be given ABRILADA to reduce the signs and symptoms of your disease.

Psoriatic arthritis

Psoriatic arthritis is an inflammation of the joints associated with psoriasis.

ABRILADA is used to treat psoriatic arthritis in adults. ABRILADA can slow down the damage to the cartilage and bone of the joints caused by the disease and to improve physical function.

Plaque psoriasis in adults and children

Plaque psoriasis is an inflammatory skin condition that causes red, flaky, crusty patches of skin covered with silvery scales. Plaque psoriasis can also affect the nails, causing them to crumble, become thickened and lift away from the nail bed which can be painful. Psoriasis is believed to be caused by a problem with the body’s immune system that leads to an increased production of skin cells.

ABRILADA is used to treat moderate to severe plaque psoriasis in adults. ABRILADA is also used to treat severe plaque psoriasis in children and adolescents aged 4 to 17 years for whom medicines applied to the skin and treatment with UV light have either not worked very well or are not suitable.

Hidradenitis suppurativa in adults and adolescents

Hidradenitis suppurativa (sometimes called acne inversa) is a long‑term and often painful inflammatory skin disease. Symptoms may include tender nodules (lumps) and abscesses (boils) that may leak pus. It most commonly affects specific areas of the skin, such as under the breasts, the armpits, inner thighs, groin and buttocks. Scarring may also occur in affected areas.

ABRILADA is used to treat hidradenitis suppurativa in adults and adolescents from 12 years of age. ABRILADA can reduce the number of nodules and abscesses you have and the pain that is often associated with the disease. You may first be given other medicines. If these medicines do not work well enough, you will be given ABRILADA.

Crohn’s disease in adults and children

Crohn’s disease is an inflammatory disease of the gut.

ABRILADA is used to treat Crohn’s disease in adults and children aged 6 to 17 years.

If you have Crohn’s disease you will first be given other medicines. If you do not respond well enough to these medicines, you will be given ABRILADA to reduce the signs and symptoms of your Crohn’s disease.

Ulcerative colitis in adults and children

Ulcerative colitis is an inflammatory disease of the large intestine.

ABRILADA is used to treat moderate to severe ulcerative colitis in adults and children aged 6 to 17 years. If you have ulcerative colitis you may first be given other medicines. If these medicines do not work well enough, you will be given ABRILADA to reduce the signs and symptoms of your disease.

Non‑infectious uveitis in adults and children

Non‑infectious uveitis is an inflammatory disease affecting certain parts of the eye. This inflammation may lead to a decrease of vision and/or the presence of floaters in the eye (black dots or wispy lines that move across the field of vision). ABRILADA works by reducing this inflammation.

ABRILADA is used to treat

·            adults with non‑infectious uveitis with inflammation affecting the back of the eye.

·            children from 2 years of age with chronic non‑infectious uveitis with inflammation affecting the front of the eye.

You may first be given other medicines. If these medicines do not work well enough, you will be given ABRILADA to reduce the signs and symptoms of your disease.

Do not use ABRILADA

·            if you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).

·            if you have a severe infection, including active tuberculosis, sepsis (blood poisoning) or opportunistic infections (unusual infections associated with a weakened immune system). It is important that you tell your doctor if you have symptoms of infections, for example, fever, wounds, feeling tired, dental problems (see “Warnings and precautions”).

·            if you have moderate or severe heart failure. It is important to tell your doctor if you have had or have a serious heart condition (see “Warnings and precautions”).

Warnings and precautions

Talk to your doctor or pharmacist before using ABRILADA.

It is important that you and your doctor record the brand name and batch number of your medication.

Allergic reactions

·            If you have allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash, do not inject more ABRILADA and contact your doctor immediately, since in rare cases, these reactions can be life‑threatening.

Infections

·            If you have an infection, including long‑term infection or an infection in one part of the body (for example, leg ulcer), consult your doctor before starting ABRILADA. If you are unsure, contact your doctor.

·            You might get infections more easily while you are receiving ABRILADA treatment. This risk may increase if you have problems with your lungs. These infections may be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other opportunistic infections (unusual infectious organisms) and sepsis (blood poisoning). In rare cases, these infections may be life‑threatening. It is important to tell your doctor if you get symptoms such as fever, wounds, feeling tired or dental problems. Your doctor may recommend temporarily stopping ABRILADA.

Tuberculosis (TB)

·            As cases of tuberculosis have been reported in patients treated with adalimumab, your doctor will check you for signs and symptoms of tuberculosis before starting ABRILADA. This will include a thorough medical evaluation including your medical history and screening tests (for example chest X‑ray and a tuberculin test). The conduct and results of these tests should be recorded on your patient reminder card.

·            It is very important that you tell your doctor if you have ever had tuberculosis, or if you have been in close contact with someone who has had tuberculosis.

·            Tuberculosis can develop during therapy even if you have had preventative treatment for tuberculosis.

·            If symptoms of tuberculosis (for example, cough that does not go away, weight loss, lack of energy, mild fever), or any other infection appear during or after therapy tell your doctor immediately.

Travel / recurrent infection

·            Tell your doctor if you have lived or travelled in regions where fungal infections such as histoplasmosis, coccidioidomycosis or blastomycosis are endemic (found).

·            Tell your doctor if you have infections which keep coming back or other conditions that increase the risk of infections.

·            You should pay special attention to signs of infection while you are being treated with ABRILADA. It is important to tell your doctor if you get symptoms of infections, such as fever, wounds, feeling tired or dental problems.

Hepatitis B virus

·            Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active HBV infection or if you think you might be at risk of getting HBV. Your doctor should test you for HBV. Adalimumab can reactivate HBV infection in people who carry this virus. In some rare cases, especially if you are taking other medicines that suppress the immune system, reactivation of HBV infection can be life‑threatening.

Age over 65 years

·            If you are over 65 years you may be more susceptible to infections while taking ABRILADA. You and your doctor should pay special attention to signs of infection while you are being treated with ABRILADA. It is important to tell your doctor if you get symptoms of infections, such as fever, wounds, feeling tired or dental problems.

Surgery or dental procedures

·            If you are about to have surgery or dental procedures, tell your doctor that you are taking ABRILADA. Your doctor may recommend temporarily stopping ABRILADA.

Demyelinating disease

·            If you have or develop demyelinating disease (a disease that affects the insulating layer around the nerves, such as multiple sclerosis), your doctor will decide if you should receive or continue to receive ABRILADA. Tell your doctor immediately if you get symptoms like changes in your vision, weakness in your arms or legs or numbness or tingling in any part of your body.

Vaccination

·            Certain vaccines contain living but weakened forms of disease‑causing bacteria or viruses that may cause infections and should not be given during treatment with ABRILADA. Check with your doctor before you receive any vaccines. It is recommended that, if possible, children be given all the scheduled vaccinations for their age before they start treatment with ABRILADA. If you receive ABRILADA while you are pregnant, your baby may be at higher risk for getting an infection for up to about five months after the last dose you received during pregnancy. It is important that you tell your baby’s doctors and other health care professionals about your ABRILADA use during your pregnancy so they can decide when your baby should receive any vaccine.

Heart failure

·            It is important to tell your doctor if you have had or have a serious heart condition. If you have mild heart failure and you are being treated with ABRILADA, your heart failure status must be closely monitored by your doctor. If you develop new or worsening symptoms of heart failure (e.g. shortness of breath, or swelling of your feet), you must contact your doctor immediately.

Fever, bruising, bleeding or looking pale

·            In some patients the body may fail to produce enough of the blood cells that fight off infections or help you to stop bleeding. If you develop a fever that does not go away, or you bruise or bleed very easily or look very pale, call your doctor right away. Your doctor may decide to stop treatment.

Cancer

·            There have been very rare cases of certain kinds of cancer in children and adults taking adalimumab or other TNFα blockers. People with more serious rheumatoid arthritis who have had the disease for a long time may have a higher than average risk of getting lymphoma and leukaemia (cancers that affect blood cells and bone marrow). If you take ABRILADA the risk of getting lymphoma, leukaemia, or other cancers may increase. On rare occasions, an uncommon and severe type of lymphoma has been seen in patients taking adalimumab. Some of those patients were also treated with the medicines azathioprine or mercaptopurine. Tell your doctor if you are taking azathioprine or mercaptopurine with ABRILADA.

·            In addition, cases of non‑melanoma skin cancer have been observed in patients taking adalimumab. If new areas of damaged skin appear during or after treatment or if existing marks or areas of damage change appearance, tell your doctor.

·            There have been cases of cancers, other than lymphoma in patients with a specific type of lung disease called chronic obstructive pulmonary disease (COPD) treated with another TNFα blocker. If you have COPD, or are a heavy smoker, you should discuss with your doctor whether treatment with a TNFα blocker is appropriate for you.

Autoimmune disease

·            On rare occasions, treatment with ABRILADA could result in lupus‑like syndrome. Contact your doctor if symptoms such as persistent unexplained rash, fever, joint pain or tiredness occur.

Other medicines and ABRILADA

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

ABRILADA can be taken together with methotrexate or certain disease‑modifying anti‑rheumatic agents (for example, sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), corticosteroids or pain medications including non‑steroidal anti‑inflammatory drugs (NSAIDs).

You should not take ABRILADA with medicines containing the active substances anakinra or abatacept due to increased risk of serious infection. The combination of adalimumab as well as other TNF‑antagonists and anakinra or abatacept is not recommended based upon the possible increased risk for infections, including serious infections and other potential pharmacological interactions. If you have questions, please ask your doctor.

Pregnancy and breast‑feeding

You should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last ABRILADA treatment.

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice about taking this medicine.

ABRILADA should only be used during a pregnancy if needed.

According to a pregnancy study, there was no higher risk of birth defects when the mother had received adalimumab during pregnancy compared with mothers with the same disease who did not receive adalimumab.

ABRILADA can be used during breast‑feeding.

If you receive ABRILADA 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 health care professionals about your ABRILADA use during your pregnancy before the baby receives any vaccine. For more information on vaccines see the “Warnings and precautions” section.

Driving and using machines

ABRILADA may have a small effect on your ability to drive, cycle or use machines. Room spinning sensation (vertigo) and vision disturbances may occur after taking ABRILADA.

ABRILADA contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose, that is to say essentially ‘sodium‑free’.

• Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor may prescribe another strength of ABRILADA if you need a different dose.

   

  ABRILADA is injected under the skin (subcutaneous use).

   

  Adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis

   

  The usual dose for adults with rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, and for patients with psoriatic arthritis is 40 mg adalimumab given every other week as a single dose.

   

  In rheumatoid arthritis, methotrexate is continued while using ABRILADA. If your doctor determines that methotrexate is inappropriate, ABRILADA can be given alone.

   

  If you have rheumatoid arthritis and you do not receive methotrexate with your ABRILADA therapy, your doctor may decide to give 40 mg adalimumab every week or 80 mg every other week.

   

  Children, adolescents and adults with polyarticular juvenile idiopathic arthritis

   

  Children and adolescents from 2 years of age weighing 10 kg to less than 30 kg

   

  The recommended dose of ABRILADA is 20 mg every other week.

   

  Children, adolescents and adults from 2 years of age weighing 30 kg or more

   

  The recommended dose of ABRILADA is 40 mg every other week.

   

  Children, adolescents and adults with enthesitis‑related arthritis

   

  Children and adolescents from 6 years of age weighing 15 kg to less than 30 kg

   

  The recommended dose of ABRILADA is 20 mg every other week.

   

  Children, adolescents and adults from 6 years of age weighing 30 kg or more

   

  The recommended dose of ABRILADA is 40 mg every other week.

   

  Adults with psoriasis

   

  The usual dose for adults with psoriasis is an initial dose of 80 mg (as two 40 mg injections in one day), followed by 40 mg given every other week starting one week after the initial dose. You should continue to inject ABRILADA for as long as your doctor has told you. If this dose does not work well enough, your doctor may increase the dosage to 40 mg every week or 80 mg every other week.

   

  Children and adolescents with plaque psoriasis

   

  Children and adolescents from 4 to 17 years of age weighing 15 kg to less than 30 kg

   

  The recommended dose of ABRILADA is an initial dose of 20 mg, followed by 20 mg one week later. Thereafter, the usual dose is 20 mg every other week.

   

  Children and adolescents from 4 to 17 years of age weighing 30 kg or more

   

  The recommended dose of ABRILADA is an initial dose of 40 mg, followed by 40 mg one week later. Thereafter, the usual dose is 40 mg every other week.

   

  Adults with hidradenitis suppurativa

   

  The usual dose regimen for hidradenitis suppurativa is an initial dose of 160 mg (as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by an 80 mg dose (as two 40 mg injections in one day) two weeks later. After two further weeks, continue with a dosage of 40 mg every week or 80 mg every other week, as prescribed by your doctor. It is recommended that you use an antiseptic wash daily on the affected areas.

   

  Adolescents with hidradenitis suppurativa from 12 to 17 years of age weighing 30 kg or more

   

  The recommended dose of ABRILADA is an initial dose of 80 mg (as two 40 mg injections in one day), followed by 40 mg every other week starting one week later. If this dose does not work well enough, your doctor may increase the dosage to 40 mg every week or 80 mg every other week.

   

  It is recommended that you use an antiseptic wash daily on the affected areas.

   

  Adults with Crohn’s disease

   

  The usual dose regimen for Crohn’s disease is 80 mg (as two 40 mg injections in one day) initially followed by 40 mg every other week starting two weeks later. If a faster response is required your doctor may prescribe an initial dose of 160 mg (as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg (as two 40 mg injections in one day) two weeks later, and thereafter as 40 mg every other week. If this dose does not work well enough, your doctor may increase the dosage to 40 mg every week or 80 mg every other week.

   

  Children and adolescents with Crohn’s disease

   

  Children and adolescents from 6 to17 years of age weighing less than 40 kg

   

  The usual dose regimen is 40 mg initially followed by 20 mg two weeks later. If a faster response is required, your doctor may prescribe an initial dose of 80 mg (as two 40 mg injections in one day) followed by 40 mg starting two weeks later.

   

  Thereafter, the usual dose is 20 mg every other week. If this dose does not work well enough, your doctor may increase the dose frequency to 20 mg every week.

   

  Children and adolescents from 6 to 17 years of age weighing 40 kg or more

   

  The usual dose regimen is 80 mg (as two 40 mg injections in one day) initially followed by 40 mg two weeks later. If a faster response is required, your doctor may prescribe an initial dose of 160 mg (as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) followed by 80 mg (as two 40 mg injections in one day) two weeks later.

   

  Thereafter, the usual dose is 40 mg every other week. If this dose does not work well enough, your doctor may increase the dosage to 40 mg every week or 80 mg every other week.

   

  Adults with ulcerative colitis

   

  The usual ABRILADA dose for adults with ulcerative colitis is 160 mg initially (as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), then 80 mg (as two 40 mg injections in one day) two weeks later, and then 40 mg every other week. If this dose does not work well enough, your doctor may increase the dosage to 40 mg every week or 80 mg every other week.

   

  Children and adolescents with ulcerative colitis

   

  Children and adolescents from 6 years of age weighing less than 40 kg

   

  The usual ABRILADA dose is 80 mg (as two 40 mg injections in one day) initially followed by 40 mg (as one 40 mg injection) two weeks later. Thereafter, the usual dose is 40 mg every other week.

   

  Patients who turn 18 years of age while on 40 mg every other week, should continue their prescribed dose.

   

  Children and adolescents from 6 years of age weighing 40 kg or more

   

  The usual ABRILADA dose is 160 mg (as four 40 mg injections in one day or two 40 mg injections per day for two consecutive days) initially, followed by 80 mg (as two 40 mg injections in one day) two weeks later. Thereafter the usual dose is 80 mg every other week.

   

  Patients who turn 18 years of age while on 80 mg every other week, should continue their prescribed dose.

   

  Adults with non‑infectious uveitis

   

  The usual dose for adults with non‑infectious uveitis is an initial dose of 80 mg (as two 40 mg injections in one day), followed by 40 mg given every other week starting one week after the initial dose. You should continue to inject ABRILADA for as long as your doctor has told you.

   

  In non‑infectious uveitis, corticosteroids or other medicines that influence the immune system may be continued while using ABRILADA. ABRILADA can also be given alone.

   

  Children and adolescents with chronic non‑infectious uveitis from 2 years of age

   

  Children and adolescents from 2 years of age weighing less than 30 kg

   

  The usual dose of ABRILADA is 20 mg every other week with methotrexate.

   

  Your doctor may also prescribe an initial dose of 40 mg which may be administered one week prior to the start of the usual dose.

   

  Children and adolescents from 2 years of age weighing 30 kg or more

   

  The usual dose of ABRILADA is 40 mg every other week with methotrexate.

   

  Your doctor may also prescribe an initial dose of 80 mg which may be administered one week prior to the start of the usual dose.

   

  Method and route of administration

   

  ABRILADA is administered by injection under the skin (by subcutaneous injection).

   

  Detailed instructions on how to inject ABRILADA, the Instructions for Use, are provided at the end of this leaflet.

   

  If you use more ABRILADA than you should

   

  If you accidentally inject ABRILADA more frequently than you should, call your doctor or pharmacist and explain that you have taken more than required. Always take the outer carton of the medicine with you, even if it is empty.

   

  If you forget to use ABRILADA

   

  If you forget to give yourself an injection, you should inject the next dose of ABRILADA as soon as you remember. Then take your next dose as you would have on your originally scheduled day, had you not forgotten a dose.

   

  If you stop using ABRILADA

   

  The decision to stop using ABRILADA should be discussed with your doctor. Your symptoms may return upon stopping treatment.

   

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

   

• Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild to moderate. However, some may be serious and require treatment. Side effects may occur at least up to 4 months after the last ABRILADA injection.

   

  Seek medical attention urgently, if you notice any of the following signs:

   

  ·            severe rash, hives or other signs of allergic reaction;

  ·            swollen face, hands, feet;

  ·            trouble breathing, swallowing;

  ·            shortness of breath with exertion or upon lying down or swelling of the feet.

   

  Tell your doctor as soon as possible, if you notice any of the following:

   

  ·            signs and symptoms of infection such as fever, feeling sick, wounds, dental problems, burning on urination, feeling weak or tired or coughing;

  ·            symptoms of nerve problems such as tingling, numbness, double vision, or arm or leg weakness;

  ·            signs of skin cancer such as a bump or open sore that does not heal;

  ·            signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding, paleness

   

  The signs and symptoms described above can represent the side effects listed below, which have been observed with adalimumab:

   

  Very common (may affect more than 1 in 10 people)

   

  ·            injection site reactions (including pain, swelling, redness or itching);

  ·            respiratory tract infections (including cold, runny nose, sinus infection, pneumonia);

  ·            headache;

  ·            abdominal (belly) pain;

  ·            nausea and vomiting;

  ·            rash;

  ·            pain in the muscles or joints.

   

  Common (may affect up to 1 in 10 people)

   

  ·            serious infections (including blood poisoning and influenza);

  ·            intestinal infections (including gastroenteritis);

  ·            skin infections (including cellulitis and shingles);

  ·            ear infections;

  ·            mouth infections (including tooth infections and cold sores);

  ·            reproductive tract infections;

  ·            urinary tract infection;

  ·            fungal infections;

  ·            joint infections;

  ·            benign tumours;

  ·            skin cancer;

  ·            allergic reactions (including seasonal allergy);

  ·            dehydration;

  ·            mood swings (including depression);

  ·            anxiety;

  ·            difficulty sleeping;

  ·            sensation disorders such as tingling, prickling or numbness;

  ·            migraine;

  ·            symptoms of nerve root compression (including low back pain and leg pain);

  ·            vision disturbances;

  ·            eye inflammation;

  ·            inflammation of the eye lid and eye swelling;

  ·            vertigo (sensation of room spinning);

  ·            sensation of heart beating rapidly;

  ·            high blood pressure;

  ·            flushing;

  ·            haematoma (a solid swelling with clotted blood);

  ·            cough;

  ·            asthma;

  ·            shortness of breath;

  ·            gastrointestinal bleeding;

  ·            dyspepsia (indigestion, bloating, heart burn);

  ·            acid reflux disease;

  ·            sicca syndrome (including dry eyes and dry mouth);

  ·            itching;

  ·            itchy rash;

  ·            bruising;

  ·            inflammation of the skin (such as eczema);

  ·            breaking of finger nails and toe nails;

  ·            increased sweating;

  ·            hair loss;

  ·            new onset or worsening of psoriasis;

  ·            muscle spasms;

  ·            blood in urine;

  ·            kidney problems;

  ·            chest pain;

  ·            oedema (a build‑up of fluid in the body which causes the affected tissue to swell);

  ·            fever;

  ·            reduction in blood platelets which increases risk of bleeding or bruising;

  ·            impaired healing.

   

  Uncommon (may affect up to 1 in 100 people)

   

  ·            opportunistic (unusual) infections (which include tuberculosis and other infections) that occur when resistance to disease is lowered;

  ·            neurological infections (including viral meningitis);

  ·            eye infections;

  ·            bacterial infections;

  ·            diverticulitis (inflammation and infection of the large intestine);

  ·            cancer, including cancer that affects the lymph system (lymphoma) and melanoma (a type of skin cancer);

  ·            immune disorders that could affect the lungs, skin and lymph nodes (most commonly as a condition called sarcoidosis);

  ·            vasculitis (inflammation of blood vessels);

  ·            tremor (shaking);

  ·            neuropathy (nerve damage);

  ·            stroke;

  ·            double vision;

  ·            hearing loss, buzzing;

  ·            sensation of heart beating irregularly such as skipped beats;

  ·            heart problems that can cause shortness of breath or ankle swelling;

  ·            heart attack;

  ·            a sac in the wall of a major artery, inflammation and clot of a vein; blockage of a blood vessel;

  ·            lung diseases causing shortness of breath (including inflammation);

  ·            pulmonary embolism (blockage in an artery of the lung);

  ·            pleural effusion (abnormal collection of fluid in the pleural space);

  ·            inflammation of the pancreas which causes severe pain in the abdomen and back;

  ·            difficulty in swallowing;

  ·            facial oedema (swelling of the face);

  ·            gallbladder inflammation, gallbladder stones;

  ·            fatty liver (build up of fat in liver cells);

  ·            night sweats;

  ·            scar;

  ·            abnormal muscle breakdown;

  ·            systemic lupus erythematosus (an immune disorder including inflammation of skin, heart, lung, joints and other organ systems);

  ·            sleep interruptions;

  ·            impotence;

  ·            inflammations.

   

  Rare (may affect up to 1 in 1,000 people)

   

  ·            leukaemia (cancer affecting the blood and bone marrow);

  ·            severe allergic reaction with shock;

  ·            multiple sclerosis;

  ·            nerve disorders (such as inflammation of the optic nerve to the eye, and Guillain‑Barré syndrome, a condition that may cause muscle weakness, abnormal sensations, tingling in the arms and upper body);

  ·            heart stops pumping;

  ·            pulmonary fibrosis (scarring of the lung);

  ·            intestinal perforation (hole in the wall of the gut);

  ·            hepatitis (liver inflammation);

  ·            reactivation of hepatitis B infection;

  ·            autoimmune hepatitis (inflammation of the liver caused by the body’s own immune system);

  ·            cutaneous vasculitis (inflammation of blood vessels in the skin);

  ·            Stevens‑Johnson syndrome (life‑threatening reaction with flu‑like symptoms and blistering rash);

  ·            facial oedema (swelling of the face) associated with allergic reactions;

  ·            erythema multiforme (inflammatory skin rash);

  ·            lupus‑like syndrome;

  ·            angioedema (localised swelling of the skin);

  ·            lichenoid skin reaction (itchy reddish‑purple skin rash).

   

  Not known (frequency cannot be estimated from available data)

   

  ·            hepatosplenic T‑cell lymphoma (a rare blood cancer that is often fatal);

  ·            Merkel cell carcinoma (a type of skin cancer);

  ·            Kaposi’s sarcoma, a rare cancer related to infection with human herpes virus 8. Kaposi’s sarcoma most commonly appears as purple lesions on the skin.

  ·            liver failure;

  ·            worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness);

  ·            weight gain (for most patients, the weight gain was small).

   

  Some side effects observed with adalimumab may not have symptoms and may only be discovered through blood tests. These include:

   

  Very common (may affect more than 1 in 10 people)

   

  ·            low blood measurements for white blood cells;

  ·            low blood measurements for red blood cells;

  ·            increased lipids in the blood;

  ·            raised liver enzymes.

   

  Common (may affect up to 1 in 10 people)

   

  ·            high blood measurements for white blood cells;

  ·            low blood measurements for platelets;

  ·            increased uric acid in the blood;

  ·            abnormal blood measurements for sodium;

  ·            low blood measurements for calcium;

  ·            low blood measurements for phosphate;

  ·            high blood sugar;

  ·            high blood measurements for lactate dehydrogenase;

  ·            autoantibodies present in the blood;

  ·            low blood potassium.

   

  Uncommon (may affect up to 1 in 100 people)

   

  ·       raised bilirubin measurement (liver blood test).

   

  Rare (may affect up to 1 in 1,000 people)

   

  ·            low blood measurements for white blood cells, red blood cells and platelet count.

   

  Reporting of side effects

  If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects, you can help provide more information on the safety of this medicine.

   

  To Report side effects

   

  ·       Saudi Arabia

   

  National Pharmacovigilance Centre (NPC) ·   Call center: 19999 ·   E-mail: npc.drug@sfda.gov.sa ·   Website: https://ade.sfda.gov.sa/

   

  ·       Other GCC States

   

  -   Please contact the relevant competent authority.

   

Keep this medicine out of the sight and reach of children.

Shelf-life: 3 years

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C –8°C). Do not freeze.

Keep the pre‑filled syringe or pre‑filled pen in the outer carton in order to protect from light.

Alternative Storage:

When needed (for example, when you are travelling), a single ABRILADA pre‑filled syringe or pre‑filled pen may be stored at room temperature (up to 30°C) for a maximum period of 30 days – be sure to protect it from light. Once removed from the refrigerator for room temperature storage, the syringe or pen must be used within 30 days or discarded, even if it is returned to the refrigerator.

You should record the date when the syringe or pen is first removed from refrigerator and the date after which it should be discarded.

Do not throw away any medicines via wastewater or household waste. Ask your doctor or pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.