Leaflet: information for the user

MetojectPEN 7.5mg pre-filled syringe solution

MetojectPEN 10mg pre-filled syringe solution

MetojectPEN 12.5mg pre-filled syringe solution

MetojectPEN 15mg pre-filled syringe solution

MetojectPEN 17.5mg pre-filled syringe solution

MetojectPEN 20mg pre-filled syringe solution

MetojectPEN 22.5mg pre-filled syringe solution

MetojectPEN 25mg pre-filled syringe solution

MetojectPEN 27.5mg pre-filled syringe solution

MetojectPEN 30mg pre-filled syringe solution

metotrexate

Read this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section4.

Metojectis indicated for the treatment of:

• active rheumatoid arthritis in adult patients,
• severe active polyarticular juvenile idiopathic arthritis, when the response to nonsteroidal anti-inflammatory drugs (NSAIDs) has not been adequate,
• moderate to severe psoriasis in adult patients, and severe psoriatic arthritis in adults,
• mild to moderate Crohn's disease in adult patients when an adequate treatment with other medications is not possible.

Therheumatoid arthritis(RA)is a chronic collagen disease, characterized by inflammation of the synovial membranes (membranes of the joints).These membranes produce a liquid that acts as a lubricant in many joints. Inflammation causes the thickening of the membrane and swelling of the joint.

Thejuvenile arthritisaffects children and adolescents under 16 years old.The polyarticular forms are indicated if there is involvement of 5 or more joints in the first 6 months of the disease.

Thepsoriasisis a chronic and frequent skin disease, characterized by red patches covered by thick, dry, silver, and adherent scales.

Thepsoriatic arthritisis a type of arthritis with psoriatic lesions on the skin and nails, especially in the joints of the fingers and toes.

MetojectPEN modifies and slows the progression of the disease.

Crohn's disease is a type of inflammatory bowel disease that can affect any part of the gastrointestinal tract, causing symptoms such as abdominal pain, diarrhea, vomiting, or weight loss.

Do not use MetojectPEN

• If you are allergic to methotrexate or any of the other ingredients of this medicine (listed in section 6),
• If you have severe liver or kidney disease or blood disorders,
• If you regularly take large amounts of alcohol,
• If you have a serious infection, such as tuberculosis, HIV or other immunodeficiency syndromes,
• If you have mouth ulcers, stomach ulcers or intestinal ulcers,
• If you are pregnant or breastfeeding (see section «Pregnancy, breastfeeding and fertility»),
• If you are receiving vaccines made with attenuated microorganisms at the same time.

Warnings and precautions

Consult your doctor or pharmacist before starting to take MetojectPEN

• If you are elderly or generally feel unwell and weak,
• If you have liver function problems,
• If you have dehydration (loss of fluids).
• If you have diabetes mellitus and are receiving insulin treatment.

Special precautions for treatment withMetojectPEN

Methotrexate temporarily affects the production of sperm and eggs, which is usually reversible. Methotrexate can cause miscarriages and severe birth defects. If you are a woman, avoid becoming pregnant while using methotrexate and for at least 6 months after stopping treatment.If you are a man, avoid fathering a child while receiving methotrexate and for at least 3months after stopping treatment.See also section «Pregnancy, breastfeeding and fertility».

Follow-up tests and recommended precautions

Even if methotrexate is used in low doses, serious side effects can occur. To detect them in time, your doctor will need to perform tests and blood tests.

Before starting treatment

Before starting treatment, you will have blood tests to check that you have enough blood cells. You will also have blood tests to check liver function and to see if you have hepatitis. In addition, your albumin serum (a blood protein) will be checked, as well as your liver and kidney function. Your doctor may also decide to perform other liver tests; some of these may be images of the liver, and others may require a small sample of liver tissue to be examined in more detail. Your doctor will also check if you have tuberculosis, and may take a chest X-ray or a lung function test.

During treatment

Your doctor may perform the following tests:

• Examination of the mouth and throat to identify changes in the mucous membrane, such as inflammation or ulceration.
• Blood tests/complete blood counts with white blood cell count and measurement of serum methotrexate levels.
• Blood tests to check liver function.
• Imaging tests to check liver function.
• Extraction of a small sample of liver tissue for further examination.
• Blood tests to check kidney function.
• Control of the respiratory tract, and if necessary, a lung function test.

It is very important that you attend these scheduled tests.

If the results of any of these tests are abnormal, your doctor will adjust your treatment accordingly.

Older patients

Older patients on methotrexate treatment should be closely monitored by a doctor to detect any possible side effects as soon as possible.

The deterioration of liver and kidney function related to age and low vitamin B12 reserves in older age requires a relatively low dose of methotrexate.

Other precautions

Acute pulmonary hemorrhage has been reported with methotrexate in patients with underlying rheumatological disease. If you notice blood when coughing or spitting, you should contact your doctor immediately.

Methotrexate can affect the immune system and vaccine results. It can also affect the results of immunological tests. It can reactivate chronic inactive infections (such as herpes zoster [“shingles”], tuberculosis, hepatitis B or C).During treatment with MetojectPEN, do not receive vaccines made with attenuated microorganisms.

Methotrexate can make the skin more sensitive to sunlight. Avoid intense sunlight and do not use sunbeds or ultraviolet lamps without medical advice. To protect your skin from intense sunlight, wear suitable clothing or use a high-protection sunscreen.

During methotrexate treatment, radiation-induced dermatitis and sunburn (memory reactions) may recur. Psoriatic lesions may intensify during UV radiation and simultaneous methotrexate administration.

Lymph node enlargement (lymphoma) may occur, and in this case, treatment should be suspended.

Diarrea can be a side effect ofMetojectPENand requires suspension of treatment. If you have diarrhea, talk to your doctor.

Acute pulmonary hemorrhage has been reported with methotrexate in patients with underlying rheumatological disease. If you notice blood when coughing or spitting, you should contact your doctor immediately.

Methotrexate can affect the immune system and vaccine results. It can also affect the results of immunological tests. It can reactivate chronic inactive infections (such as herpes zoster [“shingles”], tuberculosis, hepatitis B or C).During treatment with MetojectPEN, do not receive vaccines made with attenuated microorganisms.

Methotrexate can make the skin more sensitive to sunlight. Avoid intense sunlight and do not use sunbeds or ultraviolet lamps without medical advice. To protect your skin from intense sunlight, wear suitable clothing or use a high-protection sunscreen.

During methotrexate treatment, radiation-induced dermatitis and sunburn (memory reactions) may recur. Psoriatic lesions may intensify during UV radiation and simultaneous methotrexate administration.

Lymph node enlargement (lymphoma) may occur, and in this case, treatment should be suspended.

Diarrea can be a side effect ofMetojectPENand requires suspension of treatment. If you have diarrhea, talk to your doctor.

Leucoencephalopathy multifocal progressive (LMP) is a rare and serious brain infection that can occur during methotrexate treatment. If you, your partner or caregiver notice the onset or worsening of neurological symptoms, such as general muscle weakness, visual disturbances, changes in thinking, memory and orientation that cause confusion and changes in personality, contact your doctor immediately.

Use of MetojectPEN with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine. Also consider this for medicines you may takein the future.

The effect of treatment may be affected if MetojectPEN is administered at the same time as certain medicines:

•Antibioticssuch as: tetracyclines, chloramphenicol, non-absorbable broad-spectrum antibiotics, penicillins, glucopetides, sulfonamides, ciprofloxacin and cefalotin (medicines to prevent or combat certain infections).

•Non-steroidal anti-inflammatory drugsor salicylates (medicines for pain or inflammation such as aspirin, diclofenac and ibuprofen or pyrazolones).

•Metamizol (synonyms novaminsulfon and dipirona) (medicines for intense pain and/or fever).

•Probenecid(medicine for gout).

•Weak organic acids such as diuretics of the asa.

•Medicines that can cause adverse effects on the bone marrow, such as trimethoprim-sulfamethoxazole (an antibiotic) and pyrimethamine.

•Othermedicines usedto treatrheumatoid arthritissuch as leflunomide, sulfasalazine and azathioprine.

•Ciclosporina (to suppress the immune system).

•Mercaptopurine (a cytostatic medicine).

•Retinoids (medicines for psoriasis and other skin diseases).

•Theophylline (medicine for asthma and other lung diseases).

•Some medicines for stomach complaints such as omeprazole and pantoprazole.

•Hypoglycemics (medicines used to reduce blood sugar levels).

Vitamins containingfolate acidmay alter the effect of your treatment and will only be taken when advised by your doctor.

Do not avoid vaccination with vaccines made with attenuated microorganisms.

Use of MetojectPEN with food, drinks and alcohol

During treatment with MetojectPEN, avoid consuming alcohol, and large amounts of coffee, caffeinated soft drinks and black tea.

Pregnancy, breastfeeding and fertility

Pregnancy

Do not useMetojectPENduring pregnancy or if you are planning to become pregnant. Methotrexate can cause birth defects, damage the fetus or cause miscarriages. It is associated with skull, facial, heart and blood vessel malformations, brain and limb malformations. Therefore, it is very important that methotrexate is not administered to pregnant patients or those planning to become pregnant.

In women of childbearing age, any possibility of pregnancy should be excluded with appropriate measures, for example, a pregnancy test before starting treatment.

Avoid becoming pregnant while taking methotrexate and for at least 6months after stopping treatment, using reliable contraceptive methods during this time (see also section «Warnings and precautions»).

If you become pregnant during treatment or suspect you may be pregnant, consult your doctor as soon as possible. You will be offered information on the risk of harm to the child during treatment.

If you want to become pregnant, consult your doctor, who may refer you to a specialist to inform you before starting treatment.

Breastfeeding

Stop breastfeeding before and during treatment with MetojectPEN.

Male fertility

The available data do not indicate a higher risk of malformations or miscarriages if the father takes a methotrexate dose of less than 30mg/week. However, this risk cannot be ruled out completely. Methotrexate can be genotoxic, meaning it can cause genetic mutations. Methotrexate can affect sperm production and cause birth defects. Therefore, you should avoid fathering a child or donating sperm while taking methotrexate and for at least 3months after stopping treatment.

Driving and operating machinery

Treatment with MetojectPEN may cause side effects that affect the central nervous system, such as fatigue and dizziness. Therefore, your ability to drive or operate machinery may be affected in some cases. If you feel tired or drowsy, do not drive or operate machinery.

MetojectPEN contains sodium

This medicine contains less than 1mmol of sodium (23mg) per dose; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your doctor will determine the dosage, which will be adjusted individually. Normally, treatment takes between 4 and 8weeks to take effect.

Metoject PEN injection is administered subcutaneously (under the skin) by or under the supervision of a doctor or healthcare professionalonly once a week. Along with your doctor, you will choose a day of the week that suits you best to receive the injection.

Use in Children and Adolescents

Your doctor will decide what is the appropriate dose in children and adolescents with polyarticular forms of juvenile idiopathic arthritis.

MetojectPEN is not recommended for use in children under 3years of agedue to limited experience in this age group.

Duration and Form of Administration

Metoject PEN is injectedonce a week!

Your doctor will decide on the duration of treatment. The treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis vulgaris, psoriatic arthritis, and Crohn's disease with Metoject PEN is a long-term treatment.

At the beginning of treatment, Metoject PEN may be injected by medical staff. However,it is possible thatyour doctor will decide that you can learn to inject Metoject PEN yourself. You will receive the necessary training for this.

Under no circumstances should you attempt to injectyourself, unless you have been taught to do so.

Read the “Instructions for use” at the end of this leaflet to find guidance on how to use Metoject PEN correctly.

Remember that the entire contents must be used.

The way to handle and dispose of the medication and the pre-filled pen will be in accordance with local regulations.Healthcare staff who are pregnant should not handle or administer Metoject PEN.

Methotrexate should not come into contact with the skin surface or mucous membranes. If it does, the affected area should be rinsed immediately with plenty of water.

If you use more MetojectPEN than you should

If you use more Metoject PEN than you should, consult your doctor immediately.

If you suspect that you (or someone else) has administered too much Metoject PEN, contact your doctor immediately.

Go to the nearest hospital or consult the Toxicology Information Service, phone 91 562 04 20. They will decide what measures to take based on the severity of the poisoning. Bring the medication with you if you go to the doctor or hospital.

If you forget to use MetojectPEN

Do not use a double dose to compensate for the missed doses.

If you interrupt treatment with MetojectPEN

If you interrupt treatment with Metoject PEN, consult your doctor immediately.

If you feel that the effect of Metoject PEN is too strong or too weak, consult your doctor or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them.

The frequency and severity of side effects will depend on the dose and frequency of administration. It is essential that your doctor performs regular check-ups, as severe side effects can occur even with low doses.Your doctor will perform tests to detect abnormalities in the blood (such as low white blood cell count, low platelet count, or lymphoma) and kidney and liver alterations.

If you experience any of the following symptoms, contact your doctor immediately, as they may indicate a severe, potentially life-threatening side effect that requires urgent specific treatment:

• Persistent dry cough, difficulty breathing, and fever; these may be signs of lung inflammation [frequent].
• Blood when coughing or spitting; these may be signs of pulmonary hemorrhage[unknown frequency]
• Symptoms of liver damage such as yellowing of the skin or eyes; methotrexate can cause chronic liver damage (cirrhosis), formation of scar tissue in the liver (fibrosis), fatty liver degeneration [all rare], acute hepatitis [rare], and liver failure [very rare]
• Allergic symptoms such as skin rash, including itching, swelling of hands, feet, ankles, face, lips, mouth, or throat (which can cause difficulty swallowing or breathing) and dizziness;these may be signs of severe allergic reactions or anaphylactic shock [rare]
• Symptoms of kidney damage such as swelling of hands, ankles, or feet or changes in urination frequency or decreased (oliguria) or absence (anuria) of urine;these may be signs of kidney failure [rare]
• Symptoms of infections, e.g., fever, chills, pain, sore throat;methotrexate can make you more susceptible to infections. They may produce severe infections such as a specific type of pneumonia (Pneumocystis jirovecii pneumonia) or sepsis [rare]
• Symptoms such as weakness on one side of the body (stroke) or pain, swelling, redness, and unusual heat in one leg (deep vein thrombosis);this can occur when a blood clot dislodged causes a blockage of a blood vessel (thromboembolic event) [rare]
• Fever and severe deterioration of your general condition, or sudden fever accompanied by sore throat or mouth pain, or urinary problems;methotrexate can cause a sudden drop in the number of certain white blood cells (agranulocytosis) and severe myelosuppression [very rare]
• Unexpected bleeding, e.g., bleeding gums, blood in urine, vomiting with blood, or bruises;these may be signs of severe platelet count reduction caused by severe bone marrow depression [very rare]
• Symptoms such as severe headache often accompanied by fever, neck stiffness, nausea, vomiting, disorientation, and light sensitivity;these may indicate acute aseptic meningitis [very rare]
• Certain brain disorders (encephalopathy/leukoencephalopathy) have been reported in cancer patients treated with methotrexate; these side effects cannot be ruled out when methotrexate is used to treat other diseases; the signs of this type of brain disorder may bemental state alteration,movement disorders (ataxia), visual disorders, or memory disorders[unknown frequency]
• Severe skin rash or blistering of the skin (this can also affect the mouth, eyes, and genitals); these may be signs of a condition called Stevens-Johnson syndrome or toxic epidermal necrolysis (Lyell syndrome) [very rare]

Below, you will find other side effects that may occur:

Very frequent:may affect more than 1 in 10 people

•Mouth inflammation, indigestion, nausea, loss of appetite, abdominal pain.

•Abnormal results in liver function tests (ASAT, ALAT, bilirubin, alkaline phosphatase).

Frequent:may affect up to 1 in 10 people

•Mouth ulcers, diarrhea.

•Rash, skin redness, itching.

•Headache, fatigue, drowsiness.

•Decreased blood cell formation with decreased white blood cell, red blood cell, or platelet count.

Poorly frequent:may affect up to 1 in 100 people

•Throat inflammation.

•Intestinal inflammation, vomiting, pancreatitis, black or tar-like stools, ulcers, and bleeding.

•Sunburn-like reactions due to increased skin sensitivity to sunlight, hair loss, increased number of rheumatoid nodules, skin ulcers, herpes zoster, inflammation of blood vessels, herpes-like rash, urticaria.

•Appearance of diabetes mellitus.

•Dizziness, confusion, depression.

•Decreased serum albumin.

•Decreased number of all blood cells and platelets.

•Urinary or vaginal inflammation and ulcers, decreased renal function, urinary disorders.

•Joint pain, muscle pain, bone mass reduction.

Rare:may affect up to 1 in 1,000 people

•Periodontal inflammation.

•Increased skin pigmentation, acne, bruises on the skin due to blood vessel hemorrhage (ecchymosis, petechiae), allergic inflammation of blood vessels.

•Decreased number of antibodies in the blood.

•Infection (including reactivation of chronic inactive infections), red eyes (conjunctivitis).

•Mood changes (mood alterations).

•Visual disorders.

•Pericardial inflammation, fluid accumulation in the pericardial sac, cardiac filling obstruction due to fluid in the pericardial sac.

•Low blood pressure.

•Pulmonary fibrosis, respiratory difficulty, and bronchial asthma, fluid accumulation in the pleural sac.

•Stress fracture.

•Electrolyte imbalances.

•Fever, wound healing alterations.

Very rare:may affect up to 1 in 10,000 people

•Toxic and acute dilation of the intestine (megacolon).

•Increased nail pigmentation, acute paronychia, deep follicular hair infection (furunculosis), visible enlargement of small blood vessels.

•Pain, loss of strength or numbness or tingling/sensitivity to minor stimuli, altered taste (metallic taste), convulsions, paralysis, meningism.

•Visual disturbances, non-inflammatory eye disorders (retinopathy).

•Loss of appetite, impotence, increased male breast tissue, altered sperm formation (oligospermia), menstrual disorders, vaginal discharge.

•Increased size of lymph nodes (lymphoma).

•Lymphoproliferative disorders (excessive increase in white blood cells).

Unknown frequency:cannot be estimated from available data

•Increased number of certain white blood cells.

•Nasal bleeding.

•Protein in the urine.

•Feeling of weakness.

•Damage to the jaw bones (secondary to excessive white blood cell increase).

•Tissue destruction at the injection site.

•Redness and peeling of the skin.

•Swelling.

The subcutaneous administration of methotrexate is well tolerated at the local level. Only local skin reactions were observed (such as burning sensations, erythema, swelling, color change, severe itching, pain), which decreased during treatment.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly tothrough the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Store below 25°C. Do not freeze.

Store the preloaded syringes in the outer packaging to protect them from light.

Do not use this medication after the expiration date that appears on the box and on the preloaded syringe after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of MetojectPEN

• The active ingredient is methotrexate.

1 preloaded syringe with 0.15ml of solution contains 7.5mg of methotrexate.

1 preloaded syringe with 0.2ml of solution contains 10mg of methotrexate.

1 preloaded syringe with 0.25ml of solution contains 12.5mg of methotrexate.

1 preloaded syringe with 0.3ml of solution contains 15mg of methotrexate.

1 preloaded syringe with 0.35ml of solution contains 17.5mg of methotrexate.

1 preloaded syringe with 0.4ml of solution contains 20mg of methotrexate.

1 preloaded syringe with 0.45ml of solution contains 22.5mg of methotrexate.

1 preloaded syringe with 0.5ml of solution contains 25mg of methotrexate.

1 preloaded syringe with 0.55ml of solution contains 27.5mg of methotrexate.

1 preloaded syringe with 0.6ml of solution contains 30mg of methotrexate.

• The other components are sodium chloride, sodium hydroxide, and hydrochloric acid to adjust the pH and water for injection.

Appearance of the product and contents of the package

This medicine is presented as a solution for injection in a preloaded syringe.

The solution is yellow-brown transparent.

The preloaded syringe MetojectPEN is a three-step auto-injector with a yellow cap and a yellow injection button.

The preloaded syringe MetojectPEN is a two-step auto-injector with a transparent cap and a blue safety guard for the needle.

The following package sizes are available:

MetojectPEN available in packages of 1, 2, 4, 5, 6, 10, 11, 12, 14, 15, and 24 preloaded syringes.

Only some package sizes may be available.

Holder of the marketing authorization and responsible for manufacturing

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6

22880 Wedel

Germany

Phone:+49 4103 8006-0

Fax:+49 4103 8006-100

You can request more information about this medicine by contacting the local representative of the holder of the marketing authorization:

Laboratorios Gebro Pharma, S.A.

Avenida Tibidabo n° 29

08022 Barcelona

Spain

Phone +34 93 205 86 86

This medicine is authorized in the member states of the European Economic Areaand in the United Kingdom (Northern Ireland)with the following names:

Austria, Slovakia, Slovenia, Spain, Finland, Greece, Hungary, Netherlands,United Kingdom (Northern Ireland),Republic of Czech:

Metoject PEN

Island, Sweden: Metojectpen

Germany: metex PEN

Estonia, Latvia, Lithuania, Norway: Metex

Poland, Portugal:

Metex PEN

Denmark:

Metex Pen

Belgium:

Metoject

Last review date of this leaflet:August2024.

More detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es

You can access detailed and updated information on how to administer this medicine by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet addresses:

MetojectPEN 7.5mg solution for injection in preloaded syringe:

https://cima.aemps.es/info/78639

MetojectPEN 10mg solution for injection in preloaded syringe:

https://cima.aemps.es/info/78632

MetojectPEN 12.5mg solution for injection in preloaded syringe:

https://cima.aemps.es/info/78633

MetojectPEN 15mg solution for injection in preloaded syringe:

https://cima.aemps.es/info/78634

MetojectPEN 17.5mg solution for injection in preloaded syringe:

https://cima.aemps.es/info/78704

MetojectPEN 20mg solution for injection in preloaded syringe:

https://cima.aemps.es/info/78638

MetojectPEN 22.5mg solution for injection in preloaded syringe:

https://cima.aemps.es/info/78635

MetojectPEN 25mg solution for injection in preloaded syringe:

https://cima.aemps.es/info/78636

MetojectPEN 27.5mg solution for injection in preloaded syringe:

https://cima.aemps.es/info/78637

MetojectPEN 30mg solution for injection in preloaded syringe:

https://cima.aemps.es/info/78631

Instructions for use

Recommendations

• Read the following instructions carefully before starting to administer the injection.
• Always use the injection technique recommended by your doctor, pharmacist, or nurse.

Additional information

The way to handle and dispose of the medicine and the preloaded syringe will be in accordance with local regulations. Healthcare personnel who are pregnant should not handle or administer MetojectPEN.

Methotrexate should not come into contact with the skin or mucous membranes. If it does, the affected area should be washed immediately with plenty of water.

Nota

To avoid any injury,do not insert your fingers into the protective tubethat covers the needle. Do not destroy the syringe.

With whom to contact in case of need

• If you have any doubts or problems, contact your doctor, pharmacist, or nurse.

If you or someone around you is injured with the needle, consult your doctor immediately and dispose of the preloaded syringe Metoject PEN.

INSTRUCTIONS FOR USE

The following “Instructions for use” contain information on how to inject the preloaded syringe MetojectPEN.

Read these “Instructions for use” until the end before using the syringe for subcutaneous injection. Read the “Instructions for use” each time you receive a new prescription and keep them for future reference if you need to refer to them again after the injection.

Each time you receive a new medicine or a different dose of the medicine, make sure it matches what your doctor has prescribed. Before starting to use the syringe, the healthcare professional will show you or your caregiver how to use it correctly.

Do notuse the syringe unless the healthcare professional has shown you how to do it. If you or your caregiver have any questions, contact the healthcare professional.

Storage of the preloaded syringe MetojectPEN

•Store below 25°C.

•Transport and store the syringe in the outer packaging to protect it from light.

•Store the syringe in a safe place out of sight and reach of children.

Do notfreeze.

Do notstore at a temperature above 25°C.

Preloaded syringe MetojectPEN (FigureA)

The preloaded syringe MetojectPEN is a disposable two-step auto-injector for single use with a fixed dose. It is available in 10different doses ranging from 7.5mg to 30mg.

FigureA

Material needed for the injection (FigureB)

On the day of the weekly injection, find a comfortable place and make sure the area is well lit and has a flat and clean working surface (e.g., a table) to place all the material needed for the injection.

You will need:

•the preloaded syringe MetojectPEN.

Make sure you have the following additional materials to administer the injection, as they are not included in the packaging:

•your calendar to check the day of the weekly injection,

•a product for cleaning the skin, such as an alcohol-based disinfectant; if you don't have one, you can use water and soap,

•a cotton ball or gauze to treat the injection site,

•a container for disposing of medical waste in accordance with local regulations.

FigureB

3. Choose the injection site (FigureE)

• You can administer the injection in:
• • the upper part of the thighs,
  • the lower part of the abdomen, except around the navel.
• If your caregiver is administering the injection, they can also use the upper part of the back of the arm.
• Choose a different injection site each time you administer the injection.

When choosing the injection site:

Do notadminister the injection in other areas of the body.

Do notadminister the injection in areas where the skin is bruised, sensitive, red, or hard, or where there are scars or stretch marks.

Do notadminister the injection through clothing.

FigureE

4. Clean the injection site (FigureF)

• Clean the injection site with an alcohol-based disinfectant; if you don't have one, you can use water and soap.
• Let the skin dry.

Do notblow on the area that has just been cleaned.

Do nottouch the injection site until you have finished administering the injection.

FigureF

Injection of the dose

5. Remove the cap (FigureG)

Do not remove the cap until you are ready to administer the injection.

Do notput the cap back on the syringe after removing it.

• Hold the syringe with the cap pointing upwards and pull it off firmly.

Do notbend or twist the cap while pulling it off.

• Dispose of the cap immediately.
• You may see some medicine droplets. This is normal.
• Administer the injection immediately after removing the cap.

Do nottouch the blue safety guard for the needle with your fingers. If you touch it, you may accidentally start the injection and cause an injury.

FigureG

6. Place the syringe (FigureH)

• Place the blue safety guard for the needle uncovered over the skin, forming a 90-degree angle and with the inspection window facing you so you can see it.
• You may feel more comfortable if you pinch the skin gently by pressing the area around the injection site with your thumb and index finger before administering the injection, although this is not necessary with this syringe.

FigureH

7. Start