Label: information for the user

Metoject 7.5mg/0.15ml pre-filled syringe solution for injection

Metoject 10mg/0.20ml pre-filled syringe solution for injection

Metoject 12.5mg/0.25ml pre-filled syringe solution for injection

Metoject 15mg/0.30ml pre-filled syringe solution for injection

Metoject 17.5mg/0.35ml pre-filled syringe solution for injection

Metoject 20mg/0.40ml pre-filled syringe solution for injection

Metoject 22.5mg/0.45ml pre-filled syringe solution for injection

Metoject 25mg/0.50ml pre-filled syringe solution for injection

Metoject 27.5mg/0.55ml pre-filled syringe solution for injection

Metoject 30mg/0.60ml pre-filled syringe solution for injection

methotrexate

Read this label carefully before starting to use this medication, as it contains important information for you.

•Keep this label, as you may need to read it again.

•If you have any questions, consult your doctor or pharmacist.

•This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.

•If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section4.

1.What is Metoject and for what it is used

2.What you need to know before starting to use Metoject

3.How to use Metoject

4.Possible adverse effects

5.Maintenance of Metoject

6.Contents of the package and additional information

Metoject contains methotrexate as the active ingredient.

Methotrexate is a substance with the following properties:

•interferes with the growth of certain cells in the body that reproduce quickly,

•reduces the activity of the immune system (the body's own defense mechanism),

•has anti-inflammatory effects.

Metoject is indicated for the treatment of:

•active rheumatoid arthritis inadult patients,

•polyarticular forms of juvenile idiopathic arthritis in severe active form, when the response to nonsteroidal anti-inflammatory drugs (NSAIDs) has not been adequate,

•severe and incapacitating psoriasis that does not respond adequately to other treatments such as phototherapy, PUVA, and retinoids,and severe psoriatic arthritis in adult patients,

•mild to moderate Crohn's disease in adult patients when it is not possible to use other medications appropriately.

Rheumatoid 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 membrane to thicken and the joint to swell.

years old. Polyarticular forms are indicated if there is involvement of 5 or more joints in the first 6months of the disease.

Psiatic arthritis is a type of arthritis with psoriatic lesions on the skin and nails, especially in the joints of the fingers of the hands and feet.

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

Metoject 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 Metoject:

•If you are allergic to methotrexate or any of the other ingredients in 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 severe infection, for example 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 use Metoject if:

•You are elderly or generally feel unwell and weak,

•You have impaired liver function,

•You have dehydration (loss of fluids).

•You have diabetes mellitus and are receiving insulin treatment.

Special precautions for treatment with Metoject

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 3 months 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 adverse reactions can occur. To detect them in time, your doctor will need to perform tests and blood analyses.of control.

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 levels (a protein in the blood), hepatitis status (liver infection), and kidney function will be checked. 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 perform a chest X-ray or lung function test.

During treatment

Your doctor may perform the following tests:

•Oral cavity and pharyngeal examination to identify changes in the mucous membrane, such as inflammation or ulceration.

•Blood tests/ complete blood counts with blood cell counts and measurement of methotrexate serum levels.

•Blood tests to check liver function.

•Imaging tests to check liver function.

• Biopsy of a small liver tissue sample for further examination.

•Blood tests to check kidney function.

•Respiratory tract examination, 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 adverse effects as soon as possible.

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

Other precautions

There have been reports of acute pulmonary hemorrhage in patients with underlying rheumatological disease treated with methotrexate. 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 immunological test results. It can intensify chronic inactive infections (e.g., herpes zoster [“shingles”], tuberculosis, hepatitis B or C). During Metoject treatment, 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 UV lamps without medical advice. To protect your skin from intense sunlight, wear suitable clothing or use a high-protection sunscreen.

During methotrexate treatment, dermatitis caused by radiation and sunburn (memory reactions) may recur. Psoriatic lesions can worsen during UV radiation and simultaneous methotrexate administration.

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

Diarrea can be a toxic effect of Metoject that requires treatment suspension. If you have diarrhea, consult your doctor.

There have been reports of certain brain disorders (encephalopathy/leucoencephalopathy) in cancer patients treated with methotrexate. It cannot be ruled out that these adverse effects may occur when methotrexate is used to treat other diseases.

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, as these may be symptoms of a rare and severe brain infection called progressive multifocal leukoencephalopathy (PML).

Other medicines and Metoject

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

The effect of treatment may be affected if Metoject 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 (pain-relieving or anti-inflammatory medicines like aspirin, diclofenac, and ibuprofen or pirazolones).

•Metamizol (synonyms novaminsulfon and dipirona) (pain-relieving and fever-reducing medicine).

•Probenecid(gout medicine).

•Weak organic acids such as diuretics of the asa.

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

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

•Ciclosporina (immunosuppressant).

•Mercaptopurine (chemotherapeutic agent).

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

•Theophylline (medicines 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 as advised by your doctor.

Do not vaccinate with vaccines made with attenuated microorganisms.

Use of Metoject with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

Pregnancy

Do not use Metoject during pregnancy or if you are planning to become pregnant. Methotrexate can cause birth defects, harm 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 women or those planning to become pregnant.

In fertile women, 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 6 months 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 Metoject treatment.

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 30 mg/week. However, this risk cannot be completely ruled out. Methotrexate can be genotoxic, meaning it can cause genetic mutations. Methotrexate can affect sperm production and cause birth defects. Therefore, avoid fathering a child or donating semen while taking methotrexate and for at least 3 months after stopping treatment.

Driving and operating machinery

Metoject treatment can cause adverse reactions affecting 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.

Metoject 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, the treatment takes between 4 and 8weeks to take effect.

Metoject will be administered by or under the supervision of your doctor or healthcare professional in the form of a subcutaneous injectiononly 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

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

Metojectis not recommendedfor use in children under3years of age due to limited experience in this age group.

Duration and Administration Form

Metoject is administered subcutaneouslyonce a week.

Your doctor in charge 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 is a long-term treatment.

At the beginning of treatment, Metoject may be injected by medical personnel. However, your doctor may decide that you can learn to inject Metoject yourself under the skin. You will receive the necessary training for this.

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

See the usage instructions at the end of the prospectus.

The form of handling and eliminating the product will be done in accordance with the guidelines for other cytotoxic preparations in accordance with local regulations. Pregnant healthcare personnel should not handle or administer Metoject.

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

If you use more Metoject than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 915620420.

If you forget to use Metoject

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

If you interrupt treatment with Metoject

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

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

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

The frequencyand severity of side effects will depend on thedose and frequency of administration. It is important that your doctor performs regular check-ups, as severe side effects can occur even with low doses. Your doctor will performtests to control abnormalitiesthat occur in the blood (such as low white blood cell counts (leukopenia), low platelet counts, and lymphoma) and changes in the kidneys and liver.

Inform your doctor immediatelyif you experience any of the following symptoms, as they may indicate a severe or potentially life-threatening side effect that may require urgent specific treatment:

•dry cough, no sputum, difficulty breathing, and fever; they may be signs of lung inflammation [frequent]

•blood when coughing or spitting; they may be signs ofpulmonary 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 (hepatic fibrosis), fatty liver degeneration [all rare], acute hepatitis [rare], and liver failure [very rare]

•allergic symptoms, such as skin rash including itching and redness of the skin, swelling of the hands, feet, ankles, face, lips, mouth, and throat (which can cause difficulty swallowing or breathing) and feeling of fainting;these may be signs of severe allergic reactions or anaphylactic shock [rare]

•kidney damage symptoms, such as inflammation of the hands, ankles, or feet or changes in urination frequency or decrease (oliguria) or absence (anuria) of urine;these may be signs of kidney failure [rare]

•infection symptoms, such as fever, chills, muscle pain, sore throat;methotrexate may make you more susceptible to infections. Severe infections, such as a type of pneumonia (Pneumocystis jirovecii pneumonia) or blood infection (sepsis) [rare] may occur

•such symptoms as weakness on one side of the body (stroke) or pain, swelling, redness, and unusual heat in one leg (deep vein thrombosis); this can happen when a blood clot dislodged causes a blockage of a blood vessel(thromboembolic event) [rare]

•sudden fever and severe deterioration of your general condition, or sudden fever accompanied by sore throat or mouth, 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, p.e.g., bleeding gums, blood in the urine, vomiting with blood or hematomas,these may be signs of a severe decrease in platelet count caused by severe bone marrow depression [very rare]

•such symptoms as severe headache often in combination with fever, neck stiffness, nausea, vomiting, disorientation, and light sensitivitymay indicate acute aseptic meningitis [very rare]

•cases of 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 appearance of blisters on the skin (this can also affect your 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 can find otherside effects that may occur:

Very frequent:may affect more than 1 in 10 people

•inflammation of the oral mucosa, 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.

•skin rash, redness of the skin, itching.

•headache, fatigue, drowsiness.

•decrease in the formation of blood cells with decrease in the number of white blood cells, red blood cells, or platelets.

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

•inflammation of the gum tissue.

•increase in skin pigmentation, acne, bruises on the skin due to bleeding of the blood vessels(ecchymoses, petechiae), allergic inflammation of the blood vessels.

•decrease in the number of antibodies in the blood.

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

•mood changes (mood alterations).

•visual disorders.

•inflammation of the sac surrounding the heart, accumulation of fluid in the sac surrounding the heart,obstruction of cardiac filling due to the presence of fluid in the sac surrounding the heart.

•low blood pressure.

•formation of scar tissue in the lungs (pulmonary fibrosis), difficulty breathing, and asthma, accumulation of fluid in the sac surrounding the lung.

•stress fracture.

•electrolyte imbalances.

•fever, alterations in wound healing.

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

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

•increase in nail pigmentation, inflammation of the cuticles(paronychia acute), deep infection of the hair follicles (furunculosis), visible enlargement of small blood vessels.

•local lesion at the injection site (formation of sterile abscesses, changes in fatty tissue).

•pain, loss of strength or sensation of numbness or tingling/sensitivity to minor stimuli, alterations in taste (metallic taste), convulsions, paralysis, meningism.

•vision alteration, non-inflammatory eye disorder(retinopathy).

•loss of sexual appetite, impotence, increase in male breast tissue, formation of altered sperm (oligospermia), menstrual disorders, vaginal discharge.

•increase in the size of lymph nodes (lymphoma).

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

Unknown frequency:cannot be estimated from available data

•increase in the number of certain white blood cells.

•nosebleed.

•protein in the urine.

•sensation of weakness.

•damage to the jaw bones (secondary to excessive increase in white blood cells).

•destruction of tissue at the injection site.

•erythema and desquamation of the skin.

•hypersensitivity.

The subcutaneous administration of methotrexate is well tolerated locally. Only mild local skin reactions were observed, which decreased during treatment.

Reporting of side effects

If you experienceany type of side effect,consult your doctor or pharmacist,evenifit is a possible side effect thatdoes not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products 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.

Storepre-filled syringesin the outer packaging to protect them from light.

Do not usethis medicationafter the expiration date that appears on the packaging.The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection pointat the pharmacy. Ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition ofMetoject

•The active ingredient ismetotrexate. 1ml of solution contains metotrexate disodium corresponding to 50mg of metotrexate.

•The other components aresodium chloride, sodium hydroxide, water for injection.

Appearance of the product and contents of the package

Metoject pre-filled syringes contain a yellow-brown transparent solution.

ExclusivelyThe syringe is equipped with a safety system to prevent needlestick injuries and the reuse of the needle.

The following package sizes are commercially available:

Pre-filled syringes graduated with subcutaneous injection needles attached, packaged in blisters, containing0.15ml, 0.20ml, 0.25ml, 0.30ml, 0.35ml, 0.40ml, 0.45ml, 0.50ml, 0.55ml and 0.60mlof injectable solution available in packages of 1,4, 5, 6, 10, 11, 12 and 24pre-filled syringes with safety system.

Pre-filled syringes graduated with subcutaneous injection needles attached, packaged in blisters, containing0.15ml, 0.20ml, 0.25ml, 0.30ml, 0.35ml, 0.40ml, 0.45ml, 0.50ml, 0.55ml and 0.60mlof injectable solution availablein calendar packs of 6and 12pre-filled syringes with safety system.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstr.6

22880Wedel

Germany

Tel.:+49 4103 8006-0

Fax:+49 4103 8006-100

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Laboratorios Gebro Pharma, S.A.

Avenida Tibidabo n° 29

08022 Barcelona

Spain

Tel. +34 93 205 86 86

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Austria, Belgium, Czech Republic, Finland, Greece, Hungary, Iceland, Netherlands, Slovakia, Slovenia, Spain, Sweden: Metoject

Germany, Denmark, Estonia, Latvia, Lithuania, Norway, Poland and Portugal: Metex

Italy: Reumaflex

Last review date of this leaflet: August 2024

For detailed and updated information about this medicinal product, please visit 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 medicinal product by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet addresses:

Metoject 7.5 mg/0.15 ml solution for injection in pre-filled syringe:

https://cima.aemps.es/info/71107

Metoject 10 mg/0.20 ml solution for injection in pre-filled syringe:

https://cima.aemps.es/info/71108

Metoject 12.5 mg/0.25 ml solution for injection in pre-filled syringe:

https://cima.aemps.es/info/73716

Metoject 15 mg/0.30 ml solution for injection in pre-filled syringe:

https://cima.aemps.es/info/71109

Metoject 17.5 mg/0.35 ml solution for injection in pre-filled syringe:

https://cima.aemps.es/info/73717

Metoject 20 mg/0.40 ml solution for injection in pre-filled syringe:

https://cima.aemps.es/info/71110

Metoject 22.5 mg/0.45 ml solution for injection in pre-filled syringe:

https://cima.aemps.es/info/73718

Metoject 25 mg/0.50 ml solution for injection in pre-filled syringe:

https://cima.aemps.es/info/71111

Metoject 27.5 mg/0.55 ml solution for injection in pre-filled syringe:

https://cima.aemps.es/info/73719

Metoject 30 mg/0.60 ml solution for injection in pre-filled syringe:

https://cima.aemps.es/info/72384

Exclusively

Instructions for use for subcutaneous administration

Metoject is administered as an injection under the skin once a week exclusively.Read carefully the instructions before starting to administer the injection, and always use the recommended application technique advised by your doctor, nurse or pharmacist.

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

Preparation

Choose a clean, flat and well-lit working surface.

Wash your hands thoroughly.

Open the box containing the pre-filled syringe of metotrexate and read the leaflet carefully. Remove the pre-filled syringe from the package at room temperature.

Before using it, inspect the Metoject syringe for visible defects (or cracks). If there is a small visible air bubble in the solution, this will not affect your dose or cause any harm.

Injection site

The best places for injection are:

- the upper part of the thigh,

- the abdomen, except the area around the navel.

• If someone is helping you with the injection, you can also apply the injection to the back of the arm, just below the shoulder.
• Change the injection site each time. This may reduce the risk of developing skin irritation at the injection site.
• Never inject into skin that is painful, discolored, red, hardened, or with scars or stretch marks. If you have psoriasis, do not attempt to inject directly into lesions or patches of raised, thickened, red or scaly skin.

Injecting the solution

1. Choose an injection site and clean the selected site and the surrounding area with water and soap or disinfectant.

1. Remove the plastic protective cap

Remove the grey plastic cap from the needle by pulling it off the syringe. If you have difficulty removing the cap, turn it gently with a outward movement.

Important:Do not touch the needle of the pre-filled syringe.

Note: Once the cap is removed, administer the injection without delay.

1. Insertion of the needle

With two fingers, form a fold in the skin and quickly insert the needle at a 90-degree angle.

1. Injection

Insert the needle completely into the skin fold. Push the plunger slowly and inject the liquid under the skin. Hold the skin firmly until the injection is complete.

Remove the needle carefully in a straight line.

1. Dispose of the used syringe, including the needle, in a sharps container. Do not throw it in household waste.

Metotrexate should not come into contact with the skin surface or mucous membranes. If this happens, wash immediately with plenty of water.

If you or someone in your environment is injured with the needle, contact your doctor immediately and do not use this pre-filled syringe.

Disposal and other handling

The handling and disposal of the medicinal product and the pre-filled syringe will be carried out in accordance with local regulations. Pregnant healthcare personnel should not handle or administer Metoject.

Exclusively

Instructions for use for subcutaneous administration

Metoject is administered as an injection under the skin once a week exclusively. Read carefully the instructions before starting to administer the injection, and always use the recommended application technique advised by your doctor, nurse or pharmacist.

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

Preparation

Choose a clean, flat and well-lit working surface.

Wash your hands thoroughly.

Open the box containing the pre-filled syringe of metotrexate with safety system and read the leaflet carefully. Remove the pre-filled syringe from the package at room temperature.

Before using it, inspect the Metoject syringe for visible defects (or cracks). If there is a small visible air bubble in the solution, this will not affect your dose or cause any harm.

Injection site

The best places for injection are:

- the upper part of the thigh,

- the abdomen, except the area around the navel.

• If someone is helping you with the injection, you can also apply the injection to the back of the arm, just below the shoulder.
• Change the injection site each time. This may reduce the risk of developing skin irritation at the injection site.
• Never inject into skin that is painful, discolored, red, hardened, or with scars or stretch marks. If you have psoriasis, do not attempt to inject directly into lesions or patches of raised, thickened, red or scaly skin.

Injecting the solution

1.Choose an injection site and clean the selected site and the surrounding area with water and soap or disinfectant.

2.Remove the plastic protective cap

Remove the grey plastic cap from the needle by pulling it off the syringe. If you have difficulty removing the cap, turn it gently with a outward movement.

Important: Do not touch the needle of the pre-filled syringe.

Nota: Once the cap is removed, administer the injection without delay.

3.Insertion of the needle

With two fingers, form a fold in the skin and quickly insert the needle at a 90-degree angle.

4.Injection

Insert the needle completely into the skin fold. Push the plunger slowly and inject the liquid under the skin.

5.Retiro of the needle

Hold the skin firmly until the injection is complete..

Remove the needle carefully in a straight line..

A protective cap will enclose the needle automatically.

Nota: The safety system that activates when the syringe is emptied completely by pushing the plunger to the bottom can only be activated.

1. Dispose of the used syringe, including the needle, in a sharps container. Do not throw it in household waste.

Metotrexate should not come into contact with the skin surface or mucous membranes. If this happens, wash immediately with plenty of water.

Si usted u otra persona de su entorno se lastiman con la aguja, consulte de inmediato a su médico y no utilice esta jeringa precargada.

Eliminación y otras manipulaciones

La manipulación y la eliminación del medicamento y la jeringa precargada se realizarán de acuerdo con la normativa local. El personal sanitariogestanteno deberá manipular ni administrar Metoject.