InfoCons Consumer Protection informs you – Olumiant – Package Leaflet

Before anything else

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, or pharmacist or nurse.
• 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

ℹ️ 1. What Olumiant is and what it is used for

Olumiant 2 mg/mL oral suspension contains the active substance baricitinib. It belongs to a group of medicines called Janus kinase inhibitors, which help to reduce inflammation.

Rheumatoid arthritis Olumiant is used to treat adults with moderate to severe rheumatoid arthritis, an inflammatory disease of the joints, if previous therapy did not work well enough or was not tolerated. Olumiant can be used alone or together with some other medicines, such as methot rexate.

Olumiant works by reducing the activity of an enzyme in the body called ‘Janus kinase’, which is involved in inflammation. By reducing the activity of this enzyme, Olumiant helps to reduce pain, stiffness and swelling in your joints, tiredness, and helps t o slow damage to the bone and cartilage in the joints. These effects can help you to do normal daily activities and so improve the health- related quality of life for patients with rheumatoid arthritis.

Atopic dermatitis Olumiant is used to treat children from the age of 2 years, adolescents and adults with moderate to severe atopic dermatitis, also known as atopic eczema. Olumiant may be used with eczema medicines that you apply to the skin or it may be used on its own.

Olumiant works by reducing the activity of an enzyme in the body called ‘Janus kinase’, which is involved in inflammation. By reducing the activity of this enzyme, Olumiant helps to improve the condition of your skin and reduce itching. In addition, Olumiant helps improve your sleep disturbance (due to itch) and overall quality of life. Olumiant has also been shown to improve symptoms of skin pain, anxiety, and depression associated with atopic dermatitis.

Alopecia areata Olumiant is used to treat adolescents from the age of 12 years and adults with severe alopecia areata, an autoimmune disease characterized by inflammatory, nonscarring hair loss on the scalp, face and sometimes on other areas of the body that can be recurrent and progressive.

Olumiant works by reducing the activity of an enzyme in the body called ‘Janus kinase’, which is involved in inflammation. By reducing the activity of this enzyme, Olumiant helps hair to regrow on scalp, face and other areas of the body impacted by the dis ease.

Polyarticular juvenile idiopathic arthritis, enthesitis -related arthritis and juvenile psoriatic arthritis Olumiant is used for the treatment of active polyarticular juvenile idiopathic arthritis, an inflammatory disease of the joints, in children 2 years of age and older.

Olumiant is also used for the treatment of active enthesitis- related arthritis, an inflammatory disease of the joints and the places where tendons join the bone, in children 2 years of age and older.

Olumiant is also used for the treatment of active juvenile psoriatic arthritis, a condition that is an inflammatory disease of the joints often accompanied by psoriasis, in children 2 years of age and older.

Olumiant can be used alone or together with methotrexate.

⚠️ 2. What you need to know before you take Olumiant

Do not take Olumiant

• if you are allergic to baricitinib or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or think you may be pregnant.

Warnings and precautions

Talk to your doctor or pharmacist before and during treatment with Olumiant if you:

• are older than 65. Patients aged 65 years and older may be at increased risk of infections, heart problems including heart attack and some types of cancer. Your doctor will discuss with you if Olumiant is appropriate for you
• have an infection, or if you often get infections. Tell your doctor if you get symptoms such as fever, wounds, feeling more tired than usual or dental problems as these can be signs of infection. Olumiant can reduce your body’s ability to fight infections and may make an existing infection worse or increase the chance of you getting a new infection. If you have diabetes or are older than 65 you may have an increased chance of getting infections
• have, or have previously had, tuberculosis. You may need tests to check for tuberculosis before you are given Olumiant. Tell your doctor if you get persistent cough, fever, night sweats and weight loss during Olumiant treatment as these can be signs of tub erculosis
• have had a herpes infection (shingles), because Olumiant may allow it to come back. Tell your doctor if you get painful skin rash with blisters during Olumiant treatment as these can be signs of shingles
• have, or have previously had, hepatitis B or C
• are due to have a vaccine. You should not be given certain (live) vaccines while using Olumiant
• have or have had cancer, smoke or have smoked in the past, because your doctor will discuss with you if Olumiant is appropriate for you
• have poor liver function
• have, or have had, heart problems, because your doctor will discuss with you if Olumiant is appropriate for you
• have previously had blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism), or have an increased risk for developing this (for example: if you had recent major surgery, if you use hormonal contraceptives \hormonal replacement therapy, or if a coagulation defect is identified in you or your close relatives). Your doctor will discuss with you if Olumiant is appropriate for you. Tell your doctor if you get sudden shortness of breath or difficulty breathing, chest pain or pain in upper back, swelling of the leg or arm, leg pain or tenderness, or redness or discoloration in the leg or ar m as these can be signs of blood clots in the veins
• have had diverticulitis (a type of inflammation of the large intestine) or ulcers in stomach or intestines (see section 4)
• Non-melanoma skin cancer has been observed in patients taking Olumiant. Your doctor may recommend that you have regular skin examinations while taking Olumiant. If new skin lesions appear during or after therapy or if existing lesions change appearance, te ll your doctor.

If you notice any of the following serious side effects, you need to tell a doctor straight away:

• wheezing
• severe dizziness or light -headedness
• swelling of the lips, tongue or throat
• hives (itching or skin rash)
• severe abdominal pain especially accompanied with fever, nausea and vomiting.
• severe chest pain or tightness (that may spread to arms, jaw, neck, back)
• shortness of breath
• cold sweat
• one-sided weakness in arm and/or leg
• slurred speech You may need blood tests before you start Olumiant, or while you are taking it, to check if you have a low red blood cell count (anaemia), low white blood cell count (neutropenia or lymphopenia) , high blood fat (cholesterol) or high levels of liver enzymes, to ensure that treatment with Olumiant is not causing problems.

Children and adolescents

If possible, children and adolescents should be up to date with all vaccinations before using Olumiant.

Do not give this medicine to children younger than 2 years of age.

Do not give this medicine to children with alopecia areata under 12 years old, or weighing < 30 kg, because there is no information on use in this disease.

Other medicines and Olumiant

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

In particular, tell your doctor or pharmacist before taking Olumiant if you are taking any other medicine such as:

• probenecid (for gout), since this medicine may increase the levels of Olumiant in your blood. If you are taking probenecid, the recommended dose of Olumiant for adults is 2 mg once a day and for children and adolescents the dose should be reduced by half.
• injectable anti- rheumatic medicine
• injectable medicines that depress the immune system, including so called targeted biologic (antibody) therapies
• medicines which are used to control the body’s immune response, such as azathioprine, tacrolimus or ciclosporin
• other medicines belonging to the group of Janus kinase inhibitors
• medicines that may increase your risk of diverticulitis such as a non- steroidal anti -inflammatory medicines (usually used to treat painful and/or inflammatory conditions of muscle or joints) and/or opioids (used to treat severe pain), and/or corticosteroids (usually used to treat inflammatory conditions) (see section 4)
• medicines to treat diabetes or if you have diabetes. Your doctor may decide if you need less anti-diabetic medicine while taking Olumiant.

Pregnancy and breast -feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should use an effective method of contraception to avoid becoming pregnant during treatment with Olumiant and for at least one week after the last Olumiant treatment . You must tell your doctor if you become pregnant as Olumiant should not be used during pregnancy.

You should not use Olumiant while breast -feeding as it is not known if this medicine passes into milk.

You and your doctor should decide if you will breast-feed or use Olumiant. You should not do both.

Driving and using machines

Olumiant has no effect on the ability to drive and use machines.

Olumiant contains sodium benzoate (E211) This medicine contains 2.09 mg sodium benzoate in each mL.

Olumiant contains sorbitol (E420)

This medicine contains 105 mg sorbitol in each mL. 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.

Olumiant contains benzyl alcohol (E1519)

This medicine contains 0.24 mg benzyl alcohol in each mL. Benzyl alcohol may cause allergic reactions. Ask your doctor, nurse or pharmacist for advice if you have a liver or kidney disease. This is because large amounts of benzyl alcohol can build -up in your body and may cause side effects (called “metabolic acidosis”). Do not use for more than a week in young children (less than 3 years old), unless advised by your doctor or pharmacist.

Olumiant contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per mL, that is to say essentially “sodium- free”.

💊 3. How to take Olumiant

Treatment should be started by a doctor experienced in the diagnosis and treatment of your condition.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Olumiant oral suspension is supplied in a bottle. This is part of a pack which also includes a dosing device containing an oral syringe marked in 0.25 mL increments and a press- in-bottle adaptor. Read the instructions for use booklet, which is included in the carton for instructions on how to use the adaptor and the syringe.

Adults with rheumatoid arthritis, atopic dermatitis and alopecia areata The recommended dose is 4 mg (2 mL) once a day. Your doctor may give you a lower dose of 2 mg (1 mL) once a day, particularly if you are over 65 years old or if you have an increased risk of infections, of blood clots, major cardiovascular events or cancer.

If the medicine is working well, your doctor may decide the dose can be reduced.

If you have reduced kidney function, the recommended dose of Olumiant is 2 mg (1 mL) once a day.

Use in children and adolescents Children and adolescents with atopic dermatitis, polyarticular juvenile idiopathic arthritis, enthesitis – related arthritis and juvenile psoriatic arthritis The recommended dose is 4 mg (2 mL) once a day for patients ≥ 30 kg. For patients 10 kg to < 30 kg the recommended dose is 2 mg (1 mL) once a day.

If you have reduced kidney function, the recommended dose of Olumiant should be reduced by half.

Adolescents with alopecia areata The recommended dose is 4 mg (2 mL) once a day for patients ≥ 30 kg.

If you have reduced kidney function, the recommended dose of Olumiant should be reduced by half.

Method of administration Olumiant is for oral use.

You can take Olumiant with or without food. Your doctor or pharmacist will advise you how the medicine can be mixed with milk, orange juice or water . To help you remember to take Olumiant, you may find it easier to take it at the same time every day.

The prescribed dose can be administered via enteral feeding tubes. Follow your doctor and/or pharmacist’s instructions for giving Olumiant through a feeding tube.

If you take more Olumiant than you should

If you take more Olumiant than you should, contact your doctor. You may get some of the side effects described in section 4.

If you forget to take Olumiant

• If you miss a dose, take it as soon as you remember.
• If you forget your dose for an entire day, just skip the missed dose and take only a single dose as usual the following day.
• Do not take a double dose to make up for a forgotten dose.

If you stop taking Olumiant

Do not stop taking Olumiant unless your doctor tells you to stop taking it.

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.

Serious side effects

Infection such as shingles and pneumonia , which may affect up to 1 in 10 people:

Tell your doctor or seek medical help immediately if you get the following symptoms, which may be signs of:

• shingles (herpes zoster): painful skin rash with blisters and fever (this was very rare in atopic dermatitis and uncommon in alopecia areata)
• pneumonia: persistent cough, fever, shortness of breath, and tiredness (this was uncommon in atopic dermatitis and alopecia areata) Serious pneumonia and serious herpes zoster were uncommon.

Other side effects

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

• throat and nose infections
• high levels of blood fat (cholesterol) shown by blood test

Common (may affect up to 1 in 10 people)

• cold sores (herpes simplex)
• infection causing a sick stomach or diarrhoea (gastroenteritis)
• urinary infection
• high number of platelets (cells involved in blood clotting), shown by blood test (this was uncommon in atopic dermatitis and alopecia areata)
• headache
• feeling sick in the stomach (nausea; this was uncommon in atopic dermatitis)
• stomach pain (this was uncommon in alopecia areata)
• high levels of liver enzymes, shown by blood test (this was uncommon in atopic dermatitis)
• rash
• acne (this was uncommon in rheumatoid arthritis)
• increase in an enzyme called creatine kinase, shown by a blood test (this was uncommon in rheumatoid arthritis)
• inflammation (swelling) of the hair follicles particularly in the scalp region associated with hair regrowth (observed in alopecia areata)

Uncommon (may affect up to 1 in 100 people)

• low number of white bloods cells (neutrophils), shown by blood test
• high levels of blood fat (triglycerides), shown by blood test
• high levels of liver enzymes, shown by blood test (this was common in alopecia areata)
• weight gain
• swelling of the face
• urticaria
• blood clots in the blood vessels of the lungs
• blood clot in the veins of the legs or pelvis, called a deep vein thrombosis (DVT)
• diverticulitis (painful inflammation of small pockets in the lining of your intestine)

Children and adolescents

‒ Polyarticular juvenile idiopathic arthritis, enthesitis -related arthritis and juvenile psoriatic arthritis: In a study of children 2 years of age and older with polyarticular juvenile idiopathic arthritis, enthesitis -related arthritis and juvenile psoriatic arthritis, headache was very common, low number of white blood cells and blood clots in the lungs were common (1 out of 82 children each). ‒ Paediatric atopic dermatitis: In a study of children 2 years of age and older with atopic dermatitis, side effects were consistent with those seen in adult patients with the exception of low number of white bloods cells (neutrophils), which was more common compared to adults. ‒ Adolescents with alopecia areata: In a study of adolescents 12 years of age and older with alopecia areata, side effects were consistent with those seen in adult patients with the exception of acne and low number of white bloods cells (neutrophils), which were more common compared to adults.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V . By reporting side effects you can help provide more information on the safety of this medicine.

🌡️ 5. How to store Olumiant

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 bottle and carton after ‘EXP’. The expiry date refers to the last day of that month.

Do not use the medicine if the bottle has been open for more than 90 days.

After first opening, store the bottle upright and store this medicine between 10°C and 30°C.

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

What Olumiant contains

• The active substance is baricitinib. Each mL contains 2 mg of baricitinib.
• The other ingredients are: xanthan gum [(E415)], microcrystalline cellulose [(E460)], carmellose sodium [(E466)], citric acid monohydrate [(E330)], sodium citrate [(E331)], sodium benzoate [(E211)], silica colloidal anhydrous [(E551)], sorbitol liquid (crystallising ) [(E420)], polysorbate 80 [(E433)], sucralose [(E955)], simethicone emulsion 30% (containing dimethylpolysiloxane [(E900)], methylcellulose [(E461)], sorbic acid [E200]), water), orange flavour [(contains propylene glycol [(E1520)], benzyl alcoh ol [(E1519), and flavouring agents)], purified water. See section 2 “Olumiant contains” for more information about sodium benzoate, sorbitol, benzyl alcohol and sodium.

What Olumiant looks like and contents of the pack

Olumiant 2 mg/mL oral suspension is a white to practically white aqueous suspension.

Olumiant 2 mg/mL oral suspension 7.5 mL bottle : Olumiant is packaged in a bottle containing 7.5 mL of oral suspension and child- resistant closure, inside a carton. Each carton contains one bottle, a 1 mL graduated syringe with 0.25 mL graduations and a press -in-bottle adaptor.

Olumiant 2 mg/mL oral suspension 30 mL bottle : Olumiant is packaged in a bottle containing 30 mL of oral suspension and child- resistant closure, inside a carton. Each carton contains one bottle, a 2 mL graduated syringe with 0.25 mL graduations and a press -in-bottle adaptor.

Marketing Authorisation Holder

Eli Lilly Nederland B.V., Orteliuslaan 1000, 3528 BD, Utrecht, The Netherlands.

Manufacturer

Delpharm Huningue S.A.S, 26 rue de la Chapelle, Huningue, 68330, France.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgique/België/Belgien Eli Lilly Benelux S.A./N.V.

Tél/Tel: + 32 -(0)2 548 84 84 Lietuva Eli Lilly Lietuva Tel. +370 (5) 2649600 България ТП “Ели Лили Недерланд ” Б.В. – България тел. + 359 2 491 41 40 Luxembourg/Luxemburg Eli Lilly Benelux S.A./N.V.

Tél/Tel: + 32 -(0)2 548 84 84 Česká republika ELI LILLY ČR, s.r.o.

Tel: + 420 234 664 111 Magyarország Lilly Hungária Kft.

Tel: + 36 1 328 5100 Danmark Eli Lilly Danmark A/S Tlf.: +45 45 26 60 00 Malta Charles de Giorgio Ltd.

Tel: + 356 25600 500 Deutschland Lilly Deutschland GmbH Tel. + 49- (0) 6172 273 2222 Nederland Eli Lilly Nederland B.V.

Tel: + 31 -(0) 30 60 25 800 Eesti Eli Lilly Nederland B.V.

Tel: +372 6 817 280 Norge Eli Lilly Norge A.S.

Tlf: + 47 22 88 18 00 Ελλάδα ΦΑΡΜΑΣΕΡΒ -ΛΙΛΛΥ Α.Ε.Β.Ε.

Τηλ: +30 210 629 4600 Österreich Eli Lilly Ges.m.b.H.

Tel: + 43 -(0) 1 711 780 España Lilly S.A.

Tel: + 34 -91 663 50 00 Polska Eli Lilly Polska Sp. z o.o.

Tel: +48 22 440 33 00 France Lilly France Tél: +33 -(0) 1 55 49 34 34 Portugal Lilly Portugal Produtos Farmacêuticos, Lda Tel: + 351- 21-4126600 Hrvatska Eli Lilly Hrvatska d.o.o.

Tel: +385 1 2350 999 România Eli Lilly România S.R.L.

Tel: + 40 21 4023000 Ireland Eli Lilly and Company (Ireland) Limited Tel: + 353- (0) 1 661 4377 Slovenija Eli Lilly farmacevtska družba, d.o.o.

Tel: +386 (0)1 580 00 10 Ísland Icepharma hf.

Sími + 354 540 8000 Slovenská republika Eli Lilly Slovakia s.r.o.

Tel: + 421 220 663 111 Italia Eli Lilly Italia S.p.A.

Tel: + 39 – 055 42571 Suomi/Finland Oy Eli Lilly Finland Ab Puh/Tel: + 358- (0) 9 85 45 250 Κύπρος Phadisco Ltd Τηλ: +357 22 715000 Sverige Eli Lilly Sweden AB Tel: + 46 -(0) 8 7378800 Latvija Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā Tel: +371 67364000

This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu .

Please remove this portion of the package leaflet and keep it with you. ————————————————————————————————————————– Information for Patients about OLUMIANT (baricitinib)

This document contains important information you should be aware of before and

during treatment with Olumiant.

Keep this information with you and share it with other healthcare professionals involved in your medical care or treatment.

Your name: _______________________________________ Doctor’s name (who prescribed Olumiant): _______________________________________ Doctor’s phone number: _______________________________________

Pregnancy

• Do not take Olumiant if you are pregnant or suspect you may be pregnant.
• Use effective contraception while taking Olumiant (and for 1 week after, if you stop treatment).
• Tell your doctor immediately if you become (or wish to become) pregnant.

Infections:

Olumiant may make an existing infection worse or increase the chance of you getting a new infection or increase the chance of viral reactivation. If you have diabetes or are older than 65 you may have an increased chance of getting infections. The infection can become serious if not treated . Inform your doctor immediately if you get symptoms of infection, such as:

• Fever, wounds, feeling more tired than usual, or dental problems.
• A cough that won’t go away, night sweats, and weight loss. These could be symptoms of tuberculosis (an infectious disease of the lungs).
• A painful skin rash with blisters. This could be a sign of a herpes zoster infection.

Non-melanoma skin cancer:

Non-melanoma skin cancer has been observed in patients taking Olumiant. If new skin lesions appear during or after therapy or if existing lesions change appearance, tell your doctor.

Blood clots:

Olumiant may cause a condition in which a blood clot forms in your leg that may travel to your lungs. Inform your doctor immediately if you experience any of the following symptoms:

• Swelling or pain in one leg or arm
• Warmth or redness in one leg or arm
• Shortness of breath which is unexpected
• Rapid breathing
• Chest pain Heart attack or stroke:

Inform your doctor immediately if you experience any of the following:

• Severe chest pain or tightness (that may spread to arms, jaw, neck, back)
• Shortness of breath
• Cold sweat
• One-sided weakness in arm and/or leg
• Slurred speech INSTRUCTIONS FOR USE Olumiant 2 mg/mL oral suspension baricitinib Before you use OLUMIANT oral suspension, read and carefully follow all the step-by- step instructions.

This instructions for use contains information on how to use OLUMIANT oral suspension.

Parts of the Olumiant oral suspension delivery system IMPORTANT INFORMATION YOU NEED TO KNOW BEFORE USING OLUMIANT ORAL SUSPENSION The adaptor represents a CHOKING HAZARD – small parts. Do not attach the oral dosing syringe to the adaptor until the adaptor is fully inserted into the bottle. It must be inserted completely into the bottle for safe use. Use only under adult supervision.

Do not let your child take the medicine without your help.

Do not use if bottle, adaptor, or oral dosing syringe is damaged.

Do not use the medicine if the bottle has been open for more than 90 days . See the Disposal section to find out what to do with the medicine you don’t use.

Record date of first opening of bottle here: _________________________ Do not wash the oral dosing syringe with soap or detergent. Please see steps 4b – 4c for cleaning instructions.

Do not put the oral dosing syringe in the dishwasher. The syringe may not work as well as it should.

Use a new oral dosing syringe after 30 days . If you need an additional oral dosing syringe call Lilly Child -resistant cap Adaptor Medicine Medicine bottle Plunger Flange Oral dosing syringe Syringe tip Your doctor or pharmacist will advise you how the medicine can be mixed with milk, orange juice or water.

Give OLUMIANT oral suspension using only the oral dosing syringe supplied with the medicine.

The medicine is white. Air gaps may be difficult to see in the oral dosing syringe when preparing the dose and may result in an incorrect dose. Instructions are provided below if air gaps are observed.

In case of overdose, contact your doctor, pharmacist or nurse immediately. Quick medical attention is important even if you do not notice any signs or symptoms.

STEP 1: PREPARE THE BOTTLE 1a Gather the medicine bottle and adaptor.

Wash your hands with soap and water.

1b Remove the cap from the bottle.

Firmly push the cap down while twisting it counterclockwise.

Remove the cap from the bottle.

1c Prior to the first use only, push the adaptor all the way down into the opening of the bottle .

The adaptor represents a CHOKING HAZARD – small parts. It must be inserted completely into the bottle for safe use.

Do not attach the oral dosing syringe to the adaptor until the adaptor is fully inserted into the bottle.

Do not twist the adaptor.

1d Screw the cap back on the bottle tightly.

The cap will fit over the adaptor .

STEP 2: PREPARE THE DOSE 2a Gather the medicine bottle with adaptor inserted and oral dosing syringe.

Make sure the cap is on tightly.

Wash your hands with soap and water.

2b Shake the bottle.

Shake the medicine bottle well for at least 10 seconds before each use to fully mix the suspension.

Shake again if the bottle sits longer than 15 minutes.

2c Remove the cap from the bottle.

2d Firmly insert the oral dosing syringe into the opening of the adaptor.

Make sure the syringe tip is fully inside the adaptor and the plunger is pushed all the way to the syringe tip.

2e Turn the bottle and oral dosing syringe upside down while holding the syringe in place.

Make sure that the bottle is upside down.

Make sure the oral dosing syringe stays completely inserted in the adaptor.

2f Draw the dose.

Slowly pull the plunger down until the mL graduation mark is visible below the bottom of the flange for the dose prescribed for your child.

The graduation mark is located on the plunger of the oral dosing syringe.

Make sure the top edge of the graduation mark is aligned to the bottom of the flange.

2g Turn the bottle upright and check closely for air gaps in the oral dosing syringe.

An air gap may result in an incorrect dose.

The medicine is white, the same colo ur as the syringe. Air gaps may be difficult to see.

If there is an air gap, empty the medicine back into the bottle and repeat steps 2d through 2g.

2h Remove the oral dosing syringe from the bottle.

Do not touch the plunger.

STEP 3: GIVE THE DOSE Put the oral dosing syringe into a corner of your child’s mouth. Tell your child not to bite the syringe.

Do not squirt the medicine into the back of the throat.

Slowly and gently push down the plunger to the end of the syringe so that all of the medicine is in your child’s mouth.

Make sure your child swallows all of the medicine.

STEP 4: CLEAN UP 4a Screw the cap back on the bottle tightly.

Do not remove the adaptor. The cap will fit over it.

4b Fill the oral dosing syringe with clean water.

Do not wash the oral dosing syringe with soap or detergent.

Do not remove the plunger from the oral dosing syringe.

Fill a cup with clean water, insert the oral dosing syringe, and pull the plunger up to fill the syringe with water.

4c Push the plunger down and squirt the water into the cup or into the sink.

Make sure to remove the water from the syringe.

Shake excess water from the syringe and dry it with a paper towel.

Store the oral dosing syringe and bottle in the original carton.

Wash your hands with soap and water.

DISPOSAL OF MEDICINE Do not throw away any medicines via wastewater or household w aste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

DISPOSAL OF ORAL DOSING SYRINGE Ask your doctor, pharmacist or nurse how to dispose of your oral dosing syringe.

HOW TO STORE YOUR MEDICINE After first opening, s tore the bottle standing upright and store between 10°C and 30°C.

Keep the bottle and oral dosing syringe out of sight and reach of children.

COMMONLY ASKED QUESTIONS Q. What if I see air gaps in my oral dosing syringe?

A. Do not give the medicine. Air gaps may result in an incorrect dose. Empty the medicine back into the bottle and repeat steps 2d through 2g.

Q. What if there is too much medicine in the oral dosing syringe?

A. Keep the syringe tip in the bottle. Hold the bottle upright. Push the plunger down until the correct dose is in the syringe.

Q. What if there is not enough medicine in the oral dosing syringe?

A. Keep the syringe in the bottle. Hold the bottle upside down. Pull the plunger down until the correct dose is in the syringe.

Q. What if I get the medicine in my eye or in my child’s eye?

A. Flush the eye immediately with water and call your doctor, pharmacist or nurse . As soon as possible, wash hands and surfaces that may have come in contact with the medicine.

Q. How do I travel with this medicine?

A. Make sure you have enough medicine for the entire trip. Take the oral dosing syringe and medicine in its original container. After first opening, s tore the medicine in a safe place upright and store between 10 °C and 30°C.

Q. Can I mix this medicine with food or water before I give it to my child?

A. Your doctor or pharmacist will advise you how the medicine can be mixed with milk, orange juice or water. You can give your child a glass of water to drink after he or she takes the entire dose of medicine.

Q. What if my child spits up the medicine?

A. Do not give additional medicine to your child. Contact your doctor, pharmacist or nurse.

Q. What if my child does not swallow all of the medicine?

A. Contact your doctor, pharmacist or nurse.

Q. What if my child swallows too much medicine?

A. Immediately contact your doctor, pharmacist or nurse.

FOR QUESTIONS OR MORE INFORMATION ABOUT OLUMIANT ORAL SUSPENSION For questions or more information about O LUMIANT

• Call your doctor, pharmacist or nurse
• Call Lilly Read the full package leaflet for OLUMIANT inside the carton to learn more about your medicine.

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Olumiant (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/16/1170).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.