HULIO 40 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE - patient leaflet, side effects, dosage

Package leaflet: Information for the patient

adalimumab

Tf This medicine is subject to additional monitoring. This will allow quick identification of new safetyinformation. You canhelp by reporting any side effects you may get. See the end of section 4 for how to report side effects.

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 that you need to be aware of before you are given Hulio and during treatment with Hulio. Keep this patient reminder card with you at all times and for 4 months after your last injection of Hulio.

• – If you have any further questions, ask your doctor or pharmacist.

• – 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 or pharmacist.This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Hulio is and what it is used for

• 2. What you need to know before you use Hulio

• 3. How to use Hulio

• 4. Possible side effects

• 5. How to store Hulio

• 6. Contents of the pack and other information

• 7. Instructions for use

1. what hulio is and what it is used for

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

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

• – 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;

• – non-infectious uveitis in adults and children.

he active ingredient in Hulio, 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 (TNFa), which is involved in the immune (defence) system and is present at increased levels in the inflammatory diseases listed above. By attaching to TNFa, Hulio decreases the process of inflammation in these diseases.

Rheumatoid arthritis

Rheumatoid arthritis is an inflammatory disease of the joints.

Hulio 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 Hulio to treat your rheumatoid arthritis.

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

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

Usually, Hulio is used with methotrexate. If your doctor considers that methotrexate is inappropriate, Hulio 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.

Hulio 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. You may first be given other disease-modifying medicines, such as methotrexate. If these medicines do not work well enough, you will be given Hulio to treat your 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.

Hulio 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 Hulio to reduce the signs and symptoms of your disease.

Psoriatic arthritis

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

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

Hulio is used to treat moderate to severe plaque psoriasis in adults. Hulio 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.

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

Crohn’s disease in adults and children

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

Hulio 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 Hulio to reduce the signs and symptoms of your Crohn’s disease.

Ulcerative colitis

Ulcerative colitis is an inflammatory disease of the bowel.

Hulio 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 Hulio 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). Hulio works by reducing this inflammation.

Hulio is used to treat:

• – adults with non-infectious uveitis with inflammation affecting the back of the eye.

• – children and adolescents aged 2 to 17 years with chronic non-infectious uveitis who have inflammation affecting the front of the eye.

2. what you need to know before you use hulio- 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 Hulio.

Allergic Reaction

If you have allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or a rash, do not inject more Hulio 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 (e.g. leg ulcer), consult your doctor before starting Hulio. If you are unsure, contact your doctor.
• You might get infections more easily while you are receiving Hulio treatment. This risk may increase if your lung function is reduced. These infections may be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other unusual infectious organisms and sepsis (blood poisoning). In rare cases, these infections may be lifethreatening. 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 Hulio.

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 Hulio. 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 (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 common.
• 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 will 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 Hulio. You and your doctor should pay special attention to signs of infection while you are being treated with Hulio. 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 Hulio. Your doctor may recommend temporarily stopping Hulio.

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 Hulio. 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 the body.

Vaccination

• Certain vaccines contain living but weakened forms of bacteria or viruses that may cause infections and should not be given during treatment with Hulio.
• 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 Hulio.

• If you received Hulio while you were pregnant, your baby may be at higher risk for getting such 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 Hulio 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 Hulio 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 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 TNFa 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 (cancers that affect blood cells and bone marrow). If you take Hulio the risk of getting lymphoma, leukaemia, or other cancers may increase. On rare occasions, a specific and severe type of lymphoma has been seen in some 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 Hulio.
• 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, reported in patients with a specific type of lung disease called chronic obstructive pulmonary disease (COPD) treated with another TNFa blocker. If you have COPD, or you are a heavy smoker, you should discuss with your doctor whether treatment with a TNFa blocker is appropriate for you.

Children and adolescents

• Do not give Hulio to children with polyarticular juvenile idiopathic arthritis and chronic non-infectious uveitis below the age of 2 years.
• Do not give Hulio to children with enthesitis-related arthritis and Crohn's disease below the age of 6 years.
• Do not give Hulio to children with plaque psoriasis below the age of 4 years.
• Do not give Hulio to children with hidradenitis suppurativa below the age of 12 years.
• Do not use the 40 mg pre-filled syringe if doses other than 40 mg are recommended.

Other medicines and Hulio

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

You should not take Hulio with medicines containing the active substances anakinra or abatacept. The combination of Hulio 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.

Hulio 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).

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 Hulio 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.
• Hulio 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.
• Hulio can be used during breast-feeding.
• If you received Hulio 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 Hulio use during your pregnancy before the baby receives any vaccine. For more information on vaccines see the “Warnings and precautions”.

Driving and using machines

Hulio 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 Hulio.

Hulio contains sodium and sorbitol

Each Hulio pre-filled syringe contains 38.2 mg of sorbitol. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.

Also this medicine contains less than 1 mmol of sodium (23 mg) per pre-filled syringe, that is to say essentially ‘sodium-free’.

3. how to use hulio

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 Hulio if you need a different dose.

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

The usual dose for adults with these conditions is 40 mg adalimumab given every two weeks as a single dose.

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

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

Children and adolescents with polyarticular juvenile idiopathic arthritis

Children and adolescents from 2 to 17 years of age weighing 10 kg to less than 30 kg:

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

Children and adolescents from 2 to 17 years of age weighing 30 kg or more: The recommended dose of Hulio is 40 mg every other week.

Children and adolescents with enthesitis-related arthritis

Children and adolescents from 6 to 17 years of age weighing 15 kg to less than 30 kg:

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

Children and adolescents from 6 to 17 years of age weighing 30 kg or more:

The recommended dose of Hulio 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 Hulio for as long as your doctor has told you. If this dose does not work well enough, your doctor may increase the dose frequency to 40 mg every week or 80 mg every other week.

Children or 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 Hulio 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 Hulio 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 on the same day) two weeks later. After two further weeks, continue with a dose 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 at least 30 kg

The recommended dose of Hulio is an initial dose of 80 mg (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 then your child’s doctor may increase this to 40 mg every week or 80 mg every other week.

It is recommended that your child uses 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 dose frequency to 40 mg every week or 80 mg every other week.

Children or adolescents with Crohn's disease

Children or adolescents from 6 to 17 years 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 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 or adolescents from 6 to 17 years 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 frequency to 40 mg every week or 80 mg every other week.

Patients requiring a dose less than 40 mg should use the 40 mg vial presentation of Hulio.

Adults with ulcerative colitis

The usual Hulio dose for adults with ulcerative colitis is 160 mg initially (given 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 then 40 mg every other week. If this dose does not work well enough, your doctor may increase the dose frequency to 40 mg every week or 80 mg every other week.

Adults with non-infectious uveitis affecting the back of the eye

The usual dose for adults with non-infectious uveitis is an initial dose of 80 mg (as two injections in one day), followed by 40 mg given every other week starting one week after the initial dose. You should continue to inject Hulio 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 Hulio. Hulio can also be given alone.

Children and adolescents with chronic non-infectious uveitis

Children and adolescents from 2 to 17 years of age weighing less than 30 kg:

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

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

Children and adolescents from 2 to 17 years of age weighing 30 kg or more:

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

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

For patients who are prescribed a dose less than 40 mg, Hulio 40 mg/0.8 ml solution for injection in a vial (available from your pharmacist) should be used.

Method and route of administration

Hulio is administered by injection under the skin (subcutaneous use).

Detailed instructions on how to inject Hulio are provided in Instructions for use.

If you use more Hulio than you should

If you accidentally inject Hulio 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 Hulio

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

The decision to stop using Hulio 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.

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 may be serious and require urgent medical treatment.

Side effects may occur up to 4 months or more after the last Hulio injection.

Seek medical attention urgently if you develop any of the following signs of allergic reaction or heart failure:

• severe rash, hives;
• swollen face, hands or feet;
• trouble breathing or swallowing;
• shortness of breath with physical activity or upon lying down or swelling of the feet;
• pale complexion, dizziness, persistent fever, bruising or bleeding very easily.

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 doesn't 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, throat infection, pneumonia);
• abnormal blood results;
• headache;
• abdominal (belly) pain;
• nausea and vomiting;
• rash;
• pain in bone and 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;
• oral infections (including tooth infections and cold sores);
• reproductive tract infections;
• urinary tract infection;
• fungal infections;
• joint infections;
• benign tumours;
• skin cancer;
• mild allergic reactions (including seasonal allergy);
• dehydration;
• mood swings (including depression);
• anxiety;
• difficulty sleeping;
• sensation disorders such as tingling, prickling or numbness;
• migraine;
• nerve root compression (including low back pain and leg pain);
• vision disturbances;
• eye/eyelid inflammation or swelling;
• vertigo (sensation of the room spinning);
• sensation of heart beating rapidly;
• high blood pressure;
• skin flushing;
• haematoma (collection of blood outside of blood vessels);
• cough;
• asthma;
• shortness of breath;
• gastrointestinal bleeding;
• indigestion, bloating, heart burn;
• acidity/acid reflux;
• sicca syndrome (including dry eyes and dry mouth;
• bruising;
• itchy rash;
• itching, inflammation of the skin (including eczema);
• breaking of finger nails and toe nails;
• increased sweating;
• hair loss;
• new or worsening psoriasis (red, flaky skin);
• muscle spasms;
• blood in urine;
• kidney problems;
• chest pain;
• oedema (swelling);
• fever;
• reduction in blood platelets which increases risk of bleeding or bruising
• slow healing of wounds.

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);
• melanoma;
• lymphoma (cancer of the lymph system);
• 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;
• hearing loss, buzzing;
• irregular heart beat;
• lung diseases causing shortness of breath (including inflammation);
• pulmonary embolism (blockage in an artery of the lung);
• excessive fluid around the lung;
• inflammation of the pancreas;
• difficulty in swallowing;
• gallbladder inflammation, gallbladder stones;
• fatty liver (build up of fat in liver cells);
• night sweats;
• scarring;
• 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-Barre syndrome, a condition that may cause muscle weakness, abnormal sensations, tingling in the arms and upper body);
• heart attack heart stop pumping);
• pulmonary fibrosis (scarring of the lung);
• intestinal perforation( (hole/tear in the intestine);
• hepatitis (inflammation of the liver);
• reactivation of hepatitis B;
• autoimmune hepatitis (inflammation of the liver caused by the body’s own immune disease);
• cutaneous vasculitis (inflammation of blood vessels in the skin);
• Stevens-Johnson syndrome;
• Facial oedema (swelling of the face) associated with allergic reactions
• 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 the available data):

• hepatosplenic T-cell lymphoma (a rare blood cancer);
• 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 skin rash with muscle weakness.

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. You can also report side effects directly via Yellow Card Scheme.

Website:

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 hulio

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/blister/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 in the outer carton in order to protect from light.

Alternative Storage :

When needed (for example when you are travelling), a single Hulio pre-filled syringe may be stored at room temperature (up to 25°C) for a maximum period of 14 days – be sure to protect it from light. Once removed from the refrigerator for room temperature storage, the syringe must be used within 14 days or discarded , even if it is returned to the refrigerator.

You should record the date when the syringe 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.

6. contents of the pack and other information- the active substance is adalimumab.

• – The other ingredients are monosodium glutumate, sorbitol, methionine, polysorbate 80, hydrochloric acid and water for injections.

What Hulio looks like and contents of the pack

Hulio 40 mg solution for injection (injection) in pre-filled syringe is supplied as a sterile solution of 40 mg adalimumab dissolved in 0.8 ml clear or slightly opalescent, colourless to pale brownish-yellow solution (see section 2 – Hulio contains sodium and sorbitol).

The Hulio pre-filled syringe is made of plastic syringe with a stopper and a needle with a needle cap. Each pack contains 1, 2 or 6 pre-filled syringes with 2, 2 or 6 alcohol pads. Not all pack sizes may be marketed.

Hulio is also available as a vial for paediatric use or a pre-filled pen.

Marketing Authorisation Holder

Mylan Products Ltd

Station Close

Potters Bar

Hertfordshire,

EN6 1TL, UK

Manufacturer

McDermott laboratories T/A Mylan Dublin Biologics

Newenham Court, Northern Cross, Malahide Road

Dublin 17

Ireland

Mylan Germany GmbH

BenzstraBe 1

61352 Bad Homburg v. d. Hohe

Germany

This leaflet was last revised in 12/2021

Instructions for use

Read the instructions carefully and follow them step by step. Your doctor, nurse or other healthcare professional will first show you how to inject Hulio pre-filled syringe. Ask your doctor or nurse if there is anything you do not understand.

Do not attempt to self-inject until you are sure that you understand how to prepare and administer the injection. After proper training, the injection can be self-administered or given by another person, for example a family member or carer.

Each pre-filled syringe is for single-use only and contains one 40 mg dose of adalimumab.

Do not mix the Hulio solution with any other medicine.

To help you remember which day(s) of the week Hulio should be injected, it may be helpful to make a note on a calendar or in a diary.

Before you start

Find a quiet area with a well-lit, clean and flat work surface and gather all the supplies you will need to give yourself or receive the injection.

Supplies you will need:

• 1 pre-filled syringe
• 1 alcohol swab
• 1 sharps disposal container (not included in Hulio pack)
• 1 gauze pad or cotton ball (not included in Hulio pack)

If you do not have all the supplies you need, ask your nurse or pharmacist.

Preparing the pre-filled syringe

The pre-filled syringes should be stored in the fridge (between 2°C to 8°C).

• Take a single pre-filled syringe out of the fridge at least 30 minutes before you intend to use it to allow the contents to reach room temperature.

o DO NOT use other heat sources such as a microwave oven or hot water to warm the syringe.

o DO NOT put the syringe back in the fridge after it has reached room temperature.

• Check the expiry date printed on the syringe.

o DO NOT use the syringe if past the expiry date.

• Check syringe to make sure the medication is at or near the Fill Marker (you may need to shake

gently to see the liquid), and the liquid is clear, colourless and has no particles.

o DO NOT use the syringe if the medication is not near the Fill Marker.

o DO NOT use the syringe if the liquid is cloudy, discoloured, or has particles in it.

Needle Cap Fill Marker Plunger Rod

Step 1 - Choose and prepare injection site

Step 2 - Wash hands

________Wash your hands with soap and water. _____________­________

Step 3 – Prepare injection site

Wipe the skin at the chosen injection site with an alcohol swab.

Step 4 - Uncap needle

Step 9 - Dispose syringe and cap

Dispose of the used syringe and cap in an approved sharps disposal container.

• DO NOT recycle your used sharps disposal container.
• Always keep your sharps container out of the sight and reach of children.

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