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

Hadlima is intended for treatment of:

·                rheumatoid arthritis,

·                polyarticular juvenile idiopathic arthritis,

·                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 affecting the back of the eye.

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

The target of adalimumab is a protein called tumour necrosis factor (TNFα), which is present at increased levels in the inflammatory diseases listed above. By attaching to TNFα, Hadlima decreases the process of inflammation in these diseases.

Rheumatoid arthritis

Rheumatoid arthritis is an inflammatory disease of the joints.

Hadlima 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 Hadlima to treat your rheumatoid arthritis.

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

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

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

Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis

Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis are inflammatory diseases of the joints that usually first appear in childhood.

Hadlima is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged 2 to 17 years and 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 Hadlima to treat their polyarticular juvenile idiopathic arthritis or 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.

Hadlima is used to treat ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adults. 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 Hadlima to reduce the signs and symptoms of your disease.

Psoriatic arthritis

Psoriatic arthritis is an inflammatory disease of the joints associated with psoriasis.

Hadlima is used to treat psoriatic arthritis in adults. Hadlima 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.

Hadlima is used to treat moderate to severe plaque psoriasis in adults. Hadlima is also used to treat severe plaque psoriasis in children and adolescents weighing 30 kg or greater for whom topical therapy and phototherapies have either not worked very well or are not suitable.

Hidradenitis suppurativa in adults and adolescents

Hidradenitis suppurativa (sometimes called acne inversa) is a chronic 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.

Hadlima is used to treat hidradenitis suppurativa in adults and adolescents from 12 years of age. Hadlima 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 Hadlima.

Crohn’s disease in adults and children

Crohn’s disease is an inflammatory disease of the digestive tract.

Hadlima 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 these medicines do not work well enough, you will be given Hadlima to reduce the signs and symptoms of your Crohn’s disease.

Ulcerative colitis

 Ulcerative colitis is an inflammatory disease of the bowel.

Hadlima is used to treat ulcerative colitis in adults. If you have ulcerative colitis you will first be given other medicines. If these medicines do not work well enough, you will be given Hadlima 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.

Hadlima 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

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). Hadlima works by reducing this inflammation.

Do not use Hadlima

-        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 tuberculosis (see “Warnings and precautions”). It is important that you tell your doctor if you have symptoms of infections, e.g. fever, wounds, feeling tired, dental problems.

-        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 Hadlima.

Allergic reaction

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

Infection

·                If you have an infection, including long-term or localised infection (for example, leg ulcer) consult your doctor before starting Hadlima. If you are unsure, contact your doctor.

·                You might get infections more easily while you are receiving Hadlima treatment. This risk may increase if your lung function is impaired. These infections may be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, other opportunistic infections (unusual infections associated with a weakened immune system) 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 temporary discontinuation of Hadlima.

Tuberculosis

·                As cases of tuberculosis have been reported in patients treated with Hadlima, your doctor will check you for signs and symptoms of tuberculosis before starting Hadlima. 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 Alert 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 received preventative treatment for tuberculosis. If symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever), or any other infection appear during or after therapy tell your doctor immediately.

Travel/recurrent infection

·                Tell your doctor if you reside or travel in regions where fungal infections such as histoplasmosis, coccidioidomycosis or blastomycosis are endemic.

·                Tell your doctor if you have a history of recurrent infections or other conditions that increase the risk of infections.

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 contracting HBV. Your doctor should test you for HBV. Hadlima 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 Hadlima. You and your doctor should pay special attention to signs of infection while you are being treated with Hadlima. 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 procedure

·                If you are about to have surgery or dental procedures tell your doctor that you are taking Hadlima. Your doctor may recommend temporary discontinuation of Hadlima.

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 Hadlima. 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.

Vaccine

·                Certain vaccines contain weakened but live forms of disease-causing bacteria or viruses, and these vaccines should not be given while receiving Hadlima. Check with your doctor before you receive any vaccines. It is recommended that children, if possible, be given all the scheduled vaccinations for their age before they start treatment with Hadlima. If you receive Hadlima while you are pregnant, your baby may be at higher risk for getting an infection for up to about twelve months after birth. Therefore, at least twelve-month waiting period following birth is recommnded before your baby receives live vaccines. It is important that you tell your baby's doctors and other health care professionals about your Hadlima use during your pregnancy so they can decide when your baby should receive any vaccine.

Heart Failure

·                If you have mild heart failure and you are being treated with Hadlima, your heart failure status must be closely monitored by your doctor. It is important to tell your doctor if you have had or have a serious heart condition. 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. Your doctor will decide if you should receive Hadlima.

Fever, bruising, bleeding or looking pale

·                In some patients the body may fail to produce enough of the blood cells to 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 Hadlima 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 (a cancer that affects the lymph system), and leukaemia (a cancer that affects the blood and bone marrow). If you take Hadlima the risk of getting lymphoma, leukaemia, or other cancers may increase. On rare occasions, a specific and severe type of lymphoma has been observed in patients taking Hadlima. Some of those patients were also treated with the medicines azathioprine or mercaptopurine. Tell your doctor if you are taking azathioprine or mercaptopurine with Hadlima.

·                In addition, cases of non-melanoma skin cancer have been observed in patients taking Hadlima. If new areas of damaged skin appear during or after therapy 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 you are a heavy smoker, you should discuss with your doctor whether treatment with a TNFα blocker is appropriate for you.

Lupus-like syndrome

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

Children and adolescents

·                Do not give Hadlima to children with polyarticular juvenile idiopathic arthritis below the age of 2 years.

·                Do not use the 40 mg pre-filled pen if doses other than 40 mg are recommended.

Other medicines and Hadlima

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

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

You should not take Hadlima with medicines containing the active substances anakinra or abatacept due to increased risk of serious infection.. 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 Hadlima injection.

·                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.

·                Hadlima 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.

·                Hadlima can be used during breast-feeding.

·                If you received Hadlima 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 Hadlima 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

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

Hadlima contains sodium and sorbitol

This medicinal product contains 20 mg sorbitol in each pre-filled pen. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Also this medicinal product contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose, i.e. 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.

Hadlima is only available as 40 mg pre-filled syringe or pre-filled pen. Thus, it is not possible to use Hadlima for children who require less than a full 40 mg dose. If an alternate dose is required, other adalimumab products offering such an option should be used.

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

Hadlima is injected under the skin (subcutaneous use). 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 two weeks as a single dose.

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

If you have rheumatoid arthritis and you do not receive methotrexate with your Hadlima 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, adolescents and adults from 2 years of age weighing 30 kg or more

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

Children, adolescents and adults with enthesitis-related arthritis

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

The recommended dose of Hadlima 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 Hadlima for as long as your doctor has told you. Depending on your response, 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 30 kg or more

The recommended dose of Hadlima 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 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 Hadlima 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 to Hadlima 40 mg every other week, 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 effect is required your doctor may prescribe an initial dose of 160 mg (as four 40 mg injections in one day or 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 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 Hadlima 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) followed by 80 mg (as two 40 mg injections in one day) two weeks later and thereafter 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 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 Hadlima 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 Hadlima. Hadlima 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 30 kg or more

The usual dose of Hadlima 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

Hadlima is given by injection under the skin (by subcutaneous injection). For instructions for use, refer to section 7.

If you use more Hadlima than you should

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

If you forget to use Hadlima

If you forget to give yourself an injection, you should inject the next dose of Hadlima 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 Hadlima

The decision to stop using Hadlima 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 up to 4 months or more after the last Hadlima injection.

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

·                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 of infection such as fever, feeling sick, wounds, dental problems, burning on urination;

·                feeling weak or tired;

·                coughing;

·                tingling;

·                numbness;

·                double vision;

·                arm or leg weakness;

·                a bump or open sore that doesn't heal;

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

The symptoms described above can be signs of the below listed side effects, 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.

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 eyelid and eye swelling;

·                vertigo (sensation of the 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 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 of 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;

·                neuropathy  (nerve damage);

·                stroke;

·                hearing loss, buzzing;

·                sensation of heart beating irregularly such as skipped beats;

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

·                myocardial infarction;

·                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;

·                gallbladder inflammation, gallbladder stones;

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

·                night sweats;

·                scar;

·                abnormal muscle breakdown;

·                systemic lupus erythematosus (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;

·                hepatitis;

·                reactivation of hepatitis B;

·                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 (early symptoms include malaise, fever, headache and rash);

·                facial oedema associated with allergic reactions;

·                erythema multiforme (inflammatory skin rash);

·                lupus-like syndrome;

·                angioedema (localized 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);

·                liver failure;

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

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 potasium.

Uncommon (may affect up to 1 in 100 people)

·               elevated 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.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

To reports any side effect(s):

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

Do not use this medicine after the expiry date which is stated on the label of 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 pen in the outer carton in order to protect from light.

Alternative Storage:

When needed (for example when you are travelling), a single Hadlima pre-filled pen may be stored at room temperature (up to 25°C) for a maximum period of 28 days – be sure to protect it from light. Once removed from the refrigerator for room temperature storage, the pen must be used within 28 days or discarded, even if it is returned to the refrigerator.

You should record the date when the 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 pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.