Imeth 22.5 mg/0.9 ml solution for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

IMETH 22.5 mg/0.9 ml solution for injection in pre-filled syringe

Methotrexate

Read the entire 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 pass it on to others, even if they have the same symptoms as you, because it could harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What IMETH is and what it is used for
2. What you need to know before using IMETH
3. How to use IMETH
4. Possible side effects
5. How to store IMETH
6. Contents of the pack and other information

1. What IMETH is and what it is used for

IMETH is a medication with the following properties:

• It interferes with the growth of certain rapidly multiplying cells in the body (antitumoral agent).
• It reduces unwanted reactions of the body's own defense mechanisms (immunosuppressant).
• It has anti-inflammatory effects.

IMETH is indicated for the treatment of:

• Active rheumatoid arthritis in adult patients.

• Severe active polyarticular forms of juvenile idiopathic arthritis when the response to non-steroidal anti-inflammatory drugs (NSAIDs) has been inadequate.

• Severe, disabling, recalcitrant psoriasis that does not respond adequately to other treatments such as phototherapy, PUVA, and retinoids, and severe psoriasis affecting the joints (psoriatic arthritis) in adult patients.

• Mild to moderate Crohn's disease in adult patients who are refractory or intolerant to thiopurines.

2. What you need to know before using IMETH

Important notice regarding methotrexate administration:

Methotrexate should only be used once a week for the treatment of rheumatic diseases or skin disorders. Inappropriate administration of methotrexate may cause serious adverse effects, including fatal outcomes. Read section 3 of this leaflet very carefully.

Ask your doctor or pharmacist if you have any questions before using Imeth.

Do not use IMETH:

• If you are allergic (hypersensitive) to methotrexate or to any of the other ingredients of this medicine (see section 6).
• If you have significant kidney disease (your doctor determines the severity of the condition).
• If you have significant liver disease (your doctor determines the severity of your condition).
• If you have disorders of the hematopoietic system.
• If your alcohol consumption is high.
• If your immune system is impaired.
• If you have a serious or existing infection; e.g., tuberculosis and HIV.
• If you have gastrointestinal ulcers.
• If you are pregnant or breastfeeding (see section "Pregnancy, breastfeeding and fertility").
• If you are simultaneously receiving vaccines containing live microorganisms.

Warnings and precautions

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

If you, your partner, or caregiver notice the onset or worsening of neurological symptoms such as generalized muscle weakness, visual disturbances, changes in thinking, memory, and orientation leading to confusion and personality changes, contact your doctor immediately, as these may be symptoms of a very rare, serious brain infection called progressive multifocal leukoencephalopathy (PML).

Methotrexate may make your skin more sensitive to sunlight. Avoid strong sunlight and do not use sunbeds or ultraviolet lamps without medical advice. To protect your skin from intense sunlight, wear appropriate clothing or use a sunscreen with a high protection factor.

Consult your doctor before starting to use Imeth

• If you have insulin-treated diabetes mellitus.
• If you have inactive chronic infections (e.g., tuberculosis, hepatitis B or C, herpes [herpes zoster]).
• If you have or have had any liver or kidney disease.
• If you have problems with lung function.
• If you have severe obesity.
• If you have abnormal fluid accumulation in the abdomen or in the cavity between the lungs and the chest wall (ascites, pleural effusion).
• If you are dehydrated or have any condition that may cause dehydration (vomiting, diarrhea, stomatitis).

Treatment must be administered once a week.

Incorrect administration of methotrexate may cause serious adverse effects, including potentially fatal adverse effects. Read section 3 of this leaflet carefully.

If you have had skin problems after radiotherapy (radiation-induced dermatitis) or sunburns, these conditions may reappear during treatment with methotrexate (recall reaction).

Use in children, adolescents, and elderly patients

Dosing instructions depend on the patient's body weight. Use in children under 3 years of age is not recommended due to insufficient experience in this age group.

Children and elderly patients receiving Imeth should undergo particularly frequent medical monitoring to detect possible adverse effects as early as possible.

Elderly patients receiving methotrexate must be closely monitored by a physician to detect possible adverse effects early.

In elderly patients, due to age-related hepatic and renal impairment and low body stores of folic acid, a relatively low dose of methotrexate is required.

Special precautions during treatment with Imeth

Imeth should only be prescribed by physicians with sufficient experience in treating your condition with methotrexate.

Methotrexate temporarily affects the production of sperm and ova. Methotrexate may cause miscarriages and severe birth defects. If you are a woman, you must avoid becoming pregnant while receiving methotrexate and for at least 6 months after stopping treatment with methotrexate. If you are a man, you must avoid fathering a child while receiving methotrexate and for at least 3 months after stopping treatment.

See also section "Pregnancy, breastfeeding and fertility".

Skin changes caused by psoriasis may worsen during treatment with Imeth if you are simultaneously exposed to UV radiation.

Recommended follow-up examinations and precautions:

Even when methotrexate is used at low doses, serious adverse effects may occur. To detect them early, your doctor will perform regular check-ups and laboratory tests.

Before starting treatment:

Before starting treatment, you will have a blood test to determine whether you have sufficient blood cells. You will also have a blood test to check liver function and to detect whether you have hepatitis. Additionally, serum albumin levels (a blood protein), hepatitis status (liver infection), and kidney function will be checked. Your doctor may also decide to perform additional liver tests, which may include imaging of the liver or taking a small tissue sample from the liver for more detailed examination. Your doctor may also check whether you have tuberculosis and may perform a chest X-ray or a lung function test.

During treatment:

Your doctor may perform the following examinations:

• Examination of the oral cavity and pharynx to detect changes in the mucosa, such as inflammation or ulcers.
• Blood tests/full blood count with blood cell count and measurement of serum methotrexate levels.
• Blood tests to monitor liver function.
• Imaging tests to monitor liver status.
• Taking a small tissue sample from the liver for more detailed examination.
• Blood tests to monitor kidney function.
• Monitoring of the respiratory tract and, if necessary, lung function tests.

It is very important that you attend these scheduled examinations.

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

Other medicines and Imeth

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including medicines obtained without a prescription, herbal remedies, or natural products.

It is especially important that you inform your doctor if you are using:

• Other treatments for rheumatoid arthritis or psoriasis, such as leflunomide, sulfasalazine (also used for ulcerative colitis), aspirin, phenylbutazone, or amidopyrine.
• Alcohol (should be avoided).
• Vaccines containing live microorganisms.
• Azathioprine (used to prevent organ transplant rejection).
• Retinoids (used to treat psoriasis and other skin diseases).
• Anticonvulsant medicines (to prevent seizures).
• Cancer treatments.
• Barbiturates (injection for sleep).
• Tranquilizers.
• Oral contraceptives.
• Probenecid (for gout).
• Antibiotics.
• Pyrimethamine (used to prevent and treat malaria).
• Vitamin preparations containing folic acid.
• Proton pump inhibitors (used to treat severe stomach acidity or ulcers).
• Theophylline (used to treat asthma).
• Metamizole (synonyms: novaminsulfone and dipyrone) (a medicine for severe pain and/or fever).

Use of IMETH with food, drinks, and alcohol

During treatment with Imeth, consumption of alcohol and excessive intake of coffee, caffeinated soft drinks, and black tea should be avoided.

Also ensure you drink plenty of fluids during treatment with Imeth, as dehydration (reduction in body water) may increase the toxicity of Imeth.

Pregnancy, breastfeeding and fertility If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Pregnancy

Do not use Imeth during pregnancy or if you are trying to become pregnant. Methotrexate may cause birth defects, harm the fetus, or cause miscarriages. It is associated with malformations of the skull, face, heart and blood vessels, brain, and limbs. Therefore, it is very important that methotrexate is not given to pregnant patients or those planning to become pregnant. In women of childbearing potential, pregnancy must be excluded by appropriate measures, for example, a pregnancy test before starting treatment. You must avoid becoming pregnant while taking methotrexate and for at least 6 months after stopping treatment, using reliable contraceptive methods throughout this period (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 should be provided with information about the risk of harmful effects on the child during treatment.

If you wish to become pregnant, consult your doctor, who may refer you to a specialist for counseling before the intended start of treatment.

Breastfeeding

You must not breastfeed during treatment, as methotrexate passes into breast milk. If your doctor considers treatment with methotrexate absolutely necessary during breastfeeding, you must stop breastfeeding.

Male fertility

Available data do not indicate an increased risk of birth defects or miscarriages if the father takes a methotrexate dose below 30 mg/week. However, this risk cannot be completely ruled out. Methotrexate may be genotoxic, meaning it may cause genetic mutations. Methotrexate may affect sperm production and cause birth defects. Therefore, you must avoid fathering a child or donating semen while taking methotrexate and for at least 3 months after stopping treatment.

Driving and using machines

During treatment with Imeth, adverse effects affecting the central nervous system, such as fatigue and dizziness, may occur. Therefore, in some cases, your ability to drive vehicles and/or operate machinery may be impaired. If you feel tired or dizzy, you should not drive or operate machinery.

IMETH contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., essentially "sodium-free".

3. How to use IMETH

Important warning about the dose of Imeth (methotrexate):

Use Imeth only once a week for the treatment of rheumatoid arthritis, active juvenile idiopathic arthritis, psoriasis, psoriatic arthritis, and Crohn's disease. Overuse of Imeth (methotrexate) can be fatal. Please read section 3 of this leaflet very carefully. If you have any doubts, consult your doctor or pharmacist before taking this medicine.

Always follow exactly the instructions for using this medicine as given by your doctor. In case of doubt, please consult your doctor or pharmacist again.

Imeth is administered only once a week. You may, together with your doctor, decide on a suitable day of the week for each weekly injection.

Incorrect administration of Imeth may cause serious adverse effects, including potentially life-threatening adverse effects.

The usual dosage is:

Dosage in patients with rheumatoid arthritis

The recommended initial dose is 7.5 mg of methotrexate once weekly. Imeth is administered as a single injection under the skin (see section "Method and duration of administration").

If this dose is inadequate and well tolerated, the dose of Imeth may be increased. The average weekly dose is 15–20 mg. Generally, a weekly dose exceeding 25 mg of Imeth should not be used. Once the desired therapeutic effect has been achieved, the dose should be gradually reduced, if possible, to the lowest effective maintenance dose.

Dosage in children and adolescents under 16 years of age with polyarticular forms of juvenile idiopathic arthritis

The recommended dose is 10–15 mg/m² body surface area per week. In cases of inadequate response, the weekly dose may be increased up to 20 mg/m² body surface area/week. However, more frequent medical check-ups should be performed. It should be administered via subcutaneous injection (under the skin).

Use in children under 3 years of age is not recommended due to insufficient experience in this age group.

Adults with severe forms of psoriasis vulgaris or psoriatic arthritis

A single test dose of 5–10 mg is recommended to assess potential harmful effects. This dose can be administered subcutaneously (under the skin).

If, one week later, no changes in blood counts have been observed, treatment should continue with a dose of approximately 7.5 mg. The dose may be gradually increased (in increments of 5–7.5 mg weekly, with monitoring of blood counts) until optimal therapeutic results are achieved. Generally, a weekly dose of 20 mg may be associated with a significant increase in toxicity. A weekly dose exceeding 30 mg should not be exceeded. Once the desired therapeutic results have been achieved, the dose should be reduced weekly to the lowest effective maintenance dose possible for the patient.

Dosage in adult patients with Crohn's disease

The duration of treatment will be determined by the physician. Treatment of Crohn's disease with Imeth is a long-term treatment.

• Induction treatment:

25 mg/week administered subcutaneously.

A response to treatment can generally be expected after approximately 8 to 12 weeks.

• Maintenance treatment:

15 mg/week administered subcutaneously.

This medicine is not indicated for pediatric patients with Crohn's disease.

Patients with renal impairment

Patients with renal impairment may require a reduced dose.

Method and duration of administration

Your doctor will determine the duration of treatment. Imeth is injected once a week. It is recommended to designate a specific day of the week as the injection day. Imeth is administered as an injection under the skin. Treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis vulgaris, and psoriatic arthritis with Imeth is long-term.

Rheumatoid arthritis

Improvement in symptoms can generally be expected after 4–8 weeks of treatment. Symptoms may reappear after discontinuation of Imeth treatment.

Severe forms of psoriasis vulgaris and psoriatic arthritis (psoriatic arthritis)

A response to treatment can generally be expected after 2–6 weeks. Depending on the clinical picture and changes in laboratory parameters, treatment will be continued or discontinued.

At the beginning of treatment, Imeth may be administered by medical personnel. However, your doctor may decide that you can learn to self-inject Imeth. You will receive appropriate training for this. Under no circumstances should you attempt to self-inject unless you have been taught how to do so.

How to administer an IMETH injection

If you do not know how to handle the syringe, ask your doctor or pharmacist. Do not attempt to self-inject unless you have received proper training. If you are unsure about what to do, speak immediately with your doctor or nurse.

Before injecting IMETH

• Check the medicine's expiry date. Do not use it if the expiry date has passed.
• Check that the syringe is undamaged and that the medicine appears as a clear solution. If not, use another syringe.
• Inspect the previous injection site to see if the last injection caused redness, skin discoloration, swelling, discharge, or persistent pain; if so, speak with your doctor or nurse.
• Decide where you will inject the medicine. Change the injection site each time you administer an injection.

Instructions on how to self-inject IMETH

1. Wash your hands thoroughly with soap and water.

2. Sit or lie down in a comfortable, relaxed position. Make sure you can see the area of skin where you will administer the injection.

3. The syringe is pre-filled and ready to use. Open the blister pack by completely peeling back the top layer of the blister as shown.

1. Caution: DO NOT hold the product by the plunger or the needle cap. Remove the syringe from the pack by holding it by the body as shown in the image below.

1. Visually inspect the syringe. You should see a yellow liquid through the viewing window. A small air bubble may be visible; this will not affect the injection and will not harm you.

2. Choose an injection site and disinfect it with the alcohol swab provided. Allow 30 to 60 seconds for the alcohol to take effect. Suitable injection sites include the skin on the front of the abdominal wall and the skin on the front of the thigh.

3. While holding the body of the syringe, remove the cap.

Do not press the plunger before self-injecting to remove air bubbles. Doing so may result in loss of medication. After removing the cap, keep the syringe in hand. Avoid contact with any other surfaces. This ensures the needle remains clean.

1. Hold the syringe with your writing hand (as if holding a pencil), and with your other hand, gently pinch the skin at the injection site between your index finger and thumb to form a skin fold. Be sure to hold the skin fold throughout the injection.

2. Bring the syringe toward the skin fold (injection site) with the needle shield pointing directly at the injection site. Insert the needle fully into the skin fold.

3. Press the plunger down with your finger until the syringe is empty. This will deliver the medication under the skin.

1. Remove the needle by pulling it straight out. The safety shield will automatically cover the needle to prevent needlestick injuries. You may now release the skin fold.

Note: The safety mechanism that activates the needle shield can only be triggered once the syringe has been fully emptied by pressing the plunger completely down. To avoid bruising, do not rub the injection site after injecting.

1. Dispose of the syringe in the sharps container provided. Close the lid tightly and keep the container out of reach of children. In case of accidental contact of methotrexate with the skin or soft tissues, rinse the area thoroughly with water. When the container is full, return it to your doctor or nurse for proper disposal. Do not throw it in the household waste.

If you use more IMETH than you should

Follow your doctor's administration instructions. Do not change the dose on your own.

If you suspect that you (or someone else) have administered too much Imeth, contact your doctor or go immediately to the nearest hospital. They will determine which therapeutic measures are necessary depending on the severity of the overdose.

An overdose of methotrexate can cause serious toxic reactions. Symptoms of overdose may include bruising or bleeding, unusual weakness, mouth sores, nausea, vomiting, black or bloody stools, coughing up blood, coffee-ground-like vomit, and decreased urine output. See also section 4.

Take the medicine packaging with you if you visit your doctor or hospital.

The antidote in case of overdose is calcium folinate.

If you forget to use IMETH

Do not take a double dose to make up for a missed dose, but continue with your prescribed dose. Seek advice from your doctor.

If you stop using IMETH

Do not interrupt or stop treatment with Imeth unless agreed with your doctor. If you suspect serious adverse effects, contact your doctor immediately.

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Inform your doctor immediately if you experience sudden weakness; difficulty breathing; swelling of the eyelids, face or lips; rash or itching (especially if affecting the whole body).

Serious adverse effects

If you develop any of the following adverse effects, contact your doctor immediately:

• Lung problems (symptoms may include general discomfort, irritating dry cough, difficulty breathing, shortness of breath at rest, chest pain or fever).
• Blood in sputum or when coughing.
• Development of blisters or severe skin peeling.
• Unusual bleeding (including vomiting blood) or bruising.
• Severe diarrhoea.
• Mouth ulcers.
• Black or tarry stools.
• Blood in urine or stools.
• Small red spots on the skin.
• Fever.
• Yellowing of the skin (jaundice).
• Pain or difficulty urinating.
• Thirst and/or frequent need to urinate.
• Seizures (convulsions).
• Loss of consciousness.
• Blurred vision or decreased vision.

The following adverse effects have also been reported:

Very common:	affect more than 1 in 10 people.
Common:	affect 1 to 10 in 100 people.
Uncommon:	affect 1 to 10 in 1,000 people.
Rare:	affect 1 to 10 in 10,000 people.
Very rare:	affect less than 1 in 10,000 people.
Frequency not known:	cannot be estimated from the available data.

Very common:

Loss of appetite, nausea (dizziness), vomiting, stomach pain, inflammation and ulcers in the mouth and throat, and increased liver enzymes.

Common:

Reduced formation of blood cells with a decrease in white blood cells and/or red blood cells and/or platelets (leucopenia, anaemia, thrombocytopenia), headache, fatigue, drowsiness, lung inflammation (pneumonitis) with dry non-productive cough, difficulty breathing and fever, diarrhoea, skin rash, redness of the skin and itching.

Uncommon:

Decrease in the number of blood cells and platelets, dizziness, confusion, depression, seizures, inflammation of blood vessels, lung damage, ulcers and bleeding in the digestive tract, liver disorders, diabetes, decrease in blood proteins, urticaria (alone), sunburn-like reactions due to increased sensitivity of the skin to sunlight, brown skin discolouration, hair loss, increase in rheumatoid nodules, herpes, painful psoriasis, joint or muscle pain, osteoporosis (reduction in bone mass), inflammation and ulcers in the bladder (possibly with blood in the urine), painful urination, severe allergic reactions, inflammation and ulcers in the vagina, and slow wound healing.

Rare:

Inflammation of the sac surrounding the heart, fluid in the sac surrounding the heart, severe vision disturbances, mood swings, low blood pressure, blood clots, sore throat, breathing interruption, asthma, inflammation of the digestive tract, bloody stools, gum inflammation, abnormal digestion, acute hepatitis (liver inflammation), nail colour changes, acne, red or purple spots due to bleeding from blood vessels, bone fractures, kidney failure, decreased or absence of urine, electrolyte disturbances, defective sperm formation, and menstrual disorders.

Very rare:

Infections, severe bone marrow failure, liver failure, swollen glands, insomnia, pain, muscle weakness, numbness or tingling sensation/reduced sensitivity to stimuli, taste disturbances (metallic taste), inflammation of the lining of the brain causing paralysis or vomiting, red eyes, damage to the retina of the eye, fluid in the lungs, vomiting with blood, hot flushes, protein in the urine, fever, loss of sexual desire, erection problems, nail infections, serious digestive tract complications, boils, small blood vessels visible on the skin, fungal infections, damage to blood vessels of the skin, vaginal discharge, infertility and breast enlargement in men (gynaecomastia), lymphoproliferative disorders (excessive increase in white blood cells).

Frequency not known:

Some brain infections (leukoencephalopathy), pulmonary haemorrhage, damage to the jaw bones (secondary to excessive increase in white blood cells), tissue destruction at the injection site, skin redness and peeling, swelling.

When methotrexate is administered intramuscularly, local adverse effects (burning sensation) or damage (formation of sterile abscesses, fatty tissue destruction) at the injection site may frequently occur. Subcutaneous administration of methotrexate is well tolerated locally. Only mild local skin reactions were observed, which decreased during treatment.

Methotrexate may cause a reduction in the number of white blood cells and may lower resistance to infection. If you experience an infection with symptoms such as fever and a significant deterioration in your general health, or fever with symptoms of local infection such as sore throat, pharyngitis, mouth pain, or urinary problems, you should contact your doctor immediately. A blood test will be performed to check for possible reduction in white blood cells (agranulocytosis). It is important that you inform your doctor about your medication.

Methotrexate may cause serious adverse effects (sometimes life-threatening). Therefore, your doctor will carry out tests to monitor for blood abnormalities (e.g., low white blood cells, low platelets, lymphoma) and changes in the kidneys and liver.

Reporting of adverse reactions If you experience any type of adverse reaction, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. You may also report them directly through the national reporting system included in the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of IMETH.

Keep this medicine out of sight and reach of children.

Store below 25°C.

Keep the syringe in the outer carton to protect it from light.

Do not freeze.

Do not use this medicine after the expiry date stated on the label of the pre-filled syringe and the carton, following EXP. The expiry date refers to the last day of the month indicated.

The product should be used immediately after opening.

Do not use Imeth if the solution is not clear or contains particles.

For single use only. Discard any unused solution. Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of IMETH

• The active substance is methotrexate. 1 ml of solution contains 25 mg of methotrexate.

• The other components are sodium chloride, sodium hydroxide and water for injections.

Appearance of IMETH and contents of the pack

IMETH pre-filled syringes contain a clear, yellowish solution. The pre-filled syringes are equipped with an injection needle and a safety device to prevent needlestick injuries and reuse.

The following pack sizes are available:

Pre-filled syringes of 0.3 ml containing 7.5 mg of methotrexate.

Pre-filled syringes of 0.4 ml containing 10 mg of methotrexate.

Pre-filled syringes of 0.5 ml containing 12.5 mg of methotrexate.

Pre-filled syringes of 0.6 ml containing 15 mg of methotrexate.

Pre-filled syringes of 0.7 ml containing 17.5 mg of methotrexate.

Pre-filled syringes of 0.8 ml containing 20 mg of methotrexate.

Pre-filled syringes of 0.9 ml containing 22.5 mg of methotrexate.

Pre-filled syringes of 1.0 ml containing 25 mg of methotrexate.

Injectable solution in packs of 1, 4, 6 and 24 pre-filled syringes.

Each pack of 1, 4, 6 and 24 pre-filled syringes contains 2, 8, 12 and 48 alcohol swabs, respectively.

Some pack sizes may not be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Nordic Group B.V.

Siriusdreef 41

2132 WT Hoofddorp

The Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Nordic Pharma SAU

Adolfo Pérez Esquivel 3, 2º Of 17.

28232 Las Rozas (Madrid)

Spain

Manufacturer

Cenexi - Laboratoires Thissen SA

Rue de la Papyree 2-6, Braine-L'Alleud, Brabant Wallon

B-1420

Belgium

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

France:

iMETH 22.5 mg/0.9 ml, solution injectable en seringue préremplie

The Netherlands

Methotrexaat Nordic 22.5 mg Oplossing voor injectie in een voorgevulde spuit

United Kingdom

Zlatal 22.5 mg, solution for injection in pre-filled syringe

Date of the most recent revision of this leaflet: August 2024

The detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es.