Jiax Semanal 2 mg/ml oral solution

Patient Information Leaflet

Introduction

Package Leaflet: Information for the patient

Jiax Weekly 2mg/ml oral solution

Methotrexate

DO NOT EXCEED THE RECOMMENDED DOSE BY YOUR DOCTOR. THE DOSE MUST BE ADMINISTERED ONCE WEEKLY. CASES OF DEATH HAVE BEEN REPORTED RELATED TO DAILY ADMINISTRATION INSTEAD OF WEEKLY ADMINISTRATION OF THIS MEDICINE. CONSULT YOUR DOCTOR OR PHARMACIST IF YOU ARE UNSURE ABOUT THE DOSE OR THE FREQUENCY OF ADMINISTRATION OF THIS MEDICINE.

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it 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, pharmacist, or nurse, even if the adverse effects are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Jiax Semanal is and what it is used for
2. What you need to know before taking Jiax Semanal
3. How to take Jiax Semanal
4. Possible adverse effects
5. Storage of Jiax Semanal
6. Contents of the pack and other information

1. What Jiax Semanal is and what it is used for

Metotrexate is the active substance in Jiax Semanal. It works by reducing inflammation or swelling and by decreasing the activity of the immune system (the body's natural defense mechanism). Overactivity of the immune system has been associated with inflammatory diseases.

Low doses of Jiax Semanal are indicated for:

• Treating active, severe polyarticular juvenile idiopathic arthritis (when five or more joints are affected), after failure of non-steroidal anti-inflammatory drugs (NSAIDs).

2. What you need to know before taking Jiax Weekly

Consult your doctor about the risks and benefits of methotrexate treatment before starting this medicine. Follow exactly the dosing instructions for methotrexate provided by your doctor. You may experience adverse effects or even death if you take methotrexate more frequently or in higher doses than prescribed by your doctor.

Do not take Jiax Weekly:

• If you are allergic to methotrexate or to any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant or breastfeeding (see section "Pregnancy, breastfeeding and fertility").
• If you have liver disease (hepatic insufficiency) or severe kidney disease (severe renal insufficiency).
• If you have alcoholic liver damage (alcoholic hepatopathy), chronic liver damage (chronic hepatopathy), or if you drink alcohol excessively.
• If you have an immune system disorder (immunodeficiency syndromes).
• If you have abnormal levels of red blood cells, white blood cells, or platelets in your blood.
• If you have mouth, stomach, or intestinal ulcers.
• If you have a serious infection.
• If you need to be vaccinated.

Warnings and precautions

Important warning regarding Jiax Weekly (methotrexate) dosing:

This oral solution contains 2 mg of methotrexate in 1 ml of solution, and the syringe graduations are in ml, not mg.

Take Jiax Weekly only once per week for the treatment of juvenile idiopathic arthritis.

Overuse of Jiax Weekly (methotrexate) can be fatal.

Read section 3 of this leaflet very carefully.

If you have any doubts, consult your doctor or pharmacist before taking this medicine.

Consult your doctor, pharmacist, or nurse before starting Jiax Weekly:

• If you have insulin-treated diabetes mellitus.
• If you have inactive chronic infections (e.g., tuberculosis, hepatitis B or C, zoster [shingles]), as these may reactivate.
• If you have had kidney or liver disease.
• If you have problems with your lung function.
• If you are significantly overweight.
• If you have abnormal fluid accumulation in the abdomen (ascites) or around the lungs (pleural effusions).
• If you are dehydrated or have conditions that cause dehydration (vomiting, diarrhea, constipation, inflammation of the mucous membrane of the mouth).

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 have had skin problems after radiation therapy (radiation dermatitis) or sunburn, as these reactions may reappear after methotrexate treatment (recall reaction).

Patients receiving low-dose methotrexate may develop enlarged lymph nodes (lymphoma), in which case treatment should be discontinued.

Diarrhea may be a possible adverse effect of Jiax Weekly and requires treatment interruption. If you experience diarrhea, consult your doctor.

Certain brain disorders (encephalopathy/leukoencephalopathy) have been reported in cancer patients receiving methotrexate. These adverse effects cannot be ruled out when using methotrexate to treat other conditions.

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

Skin changes in cases of psoriasis may worsen during methotrexate treatment if exposed to UV light.

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

Special precautionary measures for Jiax Weekly treatment

Methotrexate temporarily affects sperm and egg production, which is reversible in most cases. Methotrexate may cause miscarriages and severe birth defects. If you are a woman, you must avoid becoming pregnant while using methotrexate and for at least six months after stopping treatment. 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."

Recommended monitoring examinations and precautions

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

Before starting treatment:

Before starting treatment, you will have blood tests to ensure you have adequate blood cell counts. You will also have blood tests to assess liver function and check for hepatitis. Additionally, serum albumin (a blood protein), hepatitis status (liver infection), and kidney function will be monitored. Your doctor may also decide to perform further liver tests; some may include liver imaging, while others may require taking a small sample of liver tissue for detailed examination. Your doctor may also check for tuberculosis and may order a chest X-ray or lung function test.

During treatment

Your doctor may perform the following examinations:

• Examination of the oral cavity and pharynx to identify changes in the mucous membrane, such as inflammation or ulceration.
• Blood tests / blood counts to measure blood cell counts and serum levels of methotrexate.
• Blood tests to monitor liver function.
• Imaging tests to monitor liver function.
• Liver biopsy (removal of a small tissue sample for detailed examination).
• Blood tests to monitor kidney function.
• Respiratory tract monitoring and, if necessary, lung function tests.

It is very important that you attend these scheduled check-ups.

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

Elderly patients

Elderly patients receiving methotrexate should be closely monitored by a doctor to detect possible adverse effects as early as possible.

Age-related decline in liver and kidney function and low body stores of folic acid in older age require a relatively low dose of methotrexate.

Children and adolescents

Use is not recommended in children under 3 years of age, as there are insufficient efficacy and safety data in this patient group.

Other medicines and Jiax Weekly

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

Some medicines may interact with methotrexate. It is important that you inform your doctor if you are taking the following medicines:

• Medicines to treat certain types of cancer, such as cisplatin, mercaptopurine, cytarabine, and L-asparaginase.
• Non-steroidal anti-inflammatory drugs or salicylates (pain and/or inflammation medicines such as acetylsalicylic acid and other salicylates, diclofenac, ibuprofen, and ketoprofen).
• Proton pump inhibitors, such as omeprazole (medicines that reduce gastric acid production and are used to treat stomach acidity or gastrointestinal ulcers).
• Leflunomide (used to treat arthritis).
• Medicines with high plasma protein binding capacity (including salicylates, phenylbutazone, phenytoin, sulfonamides, sulfonylureas, aminobenzoic acid, some antibiotics, and medicines to treat abnormal cholesterol and lipid levels, such as cholestyramine).
• Probenecid (a medicine used to reduce uric acid levels).
• Antibiotics (ciprofloxacin, penicillins, sulfonamides, tetracyclines, chloramphenicol, pyrimethamine, trimethoprim/sulfamethoxazole) and broad-spectrum antibiotics not absorbed in the gastrointestinal tract.

Penicillins may reduce methotrexate excretion and potentially increase adverse effects.

• Medicines causing liver toxicity (including leflunomide, azathioprine, sulfasalazine, and retinoids).
• Theophylline (used to treat lung conditions such as asthma).
• Vitamins or vitamin supplements containing folic acid or its derivatives.
• Nitrous oxide (anesthetic).
• Amiodarone (used to treat heart conditions).
• Diuretics (such as triamterene).
• Metamizole (synonyms: novaminsulfone and dipyrone) (a medicine for severe pain and/or fever).

Administration of certain vaccines is not recommended during methotrexate treatment, for example, live attenuated vaccines such as measles, mumps, influenza, or yellow fever vaccines.

In addition, some treatments may interact with methotrexate, such as PUVA (psoralen and ultraviolet light) in patients with psoriasis or a condition known as mycosis fungoides, as well as radiotherapy.

Caution is required if receiving a red blood cell transfusion during methotrexate treatment.

Use of Jiax Weekly with food, drinks, and alcohol

Do not consume alcohol while taking methotrexate, as it may increase the likelihood of adverse effects, especially those affecting the liver. Your doctor may recommend drinking more fluids than usual. This will help eliminate the medicine from your body and prevent kidney problems.

Pregnancy, breastfeeding and fertility

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

Consult your doctor or pharmacist before using any medicine.

Pregnancy

Do not use Jiax Weekly during pregnancy or if you are trying to become pregnant. Methotrexate may cause birth defects, harm the fetus, or cause miscarriage. 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 administered to pregnant patients or those planning to become pregnant. In women of childbearing age, pregnancy must be excluded using 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 planned start of treatment.

Breastfeeding

Methotrexate has been shown to be excreted in breast milk; therefore, it is contraindicated during 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.

As methotrexate treatment may cause infertility, it may be advisable for male patients to preserve sperm before starting treatment (see also section "Warnings and precautions").

Driving and use of machines

Driving and operating machinery are not recommended after taking Jiax Weekly, as some of the possible adverse effects, such as dizziness and fatigue, may affect your ability to drive and operate machinery.

Jiax Weekly contains methylparaben (sodium salt), ethylparaben (sodium salt), and sulfites (flavorings).

This medicine may cause allergic reactions (possibly delayed), as it contains methylparaben, sodium salt (E219), and ethylparaben, sodium salt (E215).

Rarely, this medicine may cause hypersensitivity reactions and bronchospasm (sudden shortness of breath) because it contains sulfites.

3. How to take Jiax Weekly

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist. You may experience adverse effects and even death if you take methotrexate more frequently or in higher doses than prescribed by your doctor.

Follow exactly the administration instructions for this medicine given by your doctor. It is very important to check whether the prescribed dose is indicated in ml or mg.

Recommended dose:

TAKE JIAX WEEKLY ONLY ONCE PER WEEK.

The recommended initial dose for polyarticular juvenile idiopathic arthritis in children and adolescents is 10–15 mg/m² of body surface area once weekly by oral route. Your doctor may adjust the dose depending on your response to treatment and any adverse effects you may experience.

How to take this medicine correctly

Jiax Weekly is supplied in a 35 ml or 65 ml container for oral administration.

Wash your hands before and after administering a dose. If you are a parent or caregiver administering the medicine, you must wear disposable gloves when handling methotrexate.

If methotrexate comes into contact with the skin, eyes, or nose, wash the affected area thoroughly with water and soap.

Clean up any spillage immediately.

Pregnant women, women intending to become pregnant, or women who are breastfeeding must not handle methotrexate.

Keep this medicine out of sight and reach of children, preferably in a locked cabinet. Accidental ingestion may be fatal in children.

Keep the bottle tightly closed to prevent leakage of the medicine and reduce the risk of accidental spillage.

Remember that Jiax Weekly MUST ONLY BE ADMINISTERED ONCE PER WEEK. Note the day of the week on which you have decided to take the medicine using the space provided on the container.

IT IS VERY IMPORTANT THAT YOU TAKE THIS MEDICINE EXACTLY AS PRESCRIBED BY YOUR DOCTOR AND THAT YOU ONLY TAKE THE AMOUNT PRESCRIBED FOR YOUR CONDITION.

You may not experience all the benefits of the medicine until several months have passed. Do not increase the dose or take this medicine more frequently or for longer than prescribed. Your condition will not improve more quickly. In fact, you may increase the risk of adverse effects, which could be potentially fatal.

How to take the oral solution: illustrated instructions

Instructions for use

• Shake the bottle.

• Open the bottle by pressing the cap down and turning it counterclockwise (Figure 1).

• Insert the adapter into the neck of the bottle (Figure 2).

• Take the syringe and insert it into the opening of the adapter (Figure 3).

• Turn the bottle upside down (Figure 4).

• Fill the syringe with a small amount of solution by pulling the plunger down (Figure 4A). Then, push the plunger up to remove any air bubbles (Figure 4B). Finally, pull the plunger down to the graduation mark corresponding to the dose in milliliters (ml) prescribed by your doctor. The top of the plunger should align with the mark corresponding to the prescribed dose (Figure 4C).

• Return the bottle to an upright position (Figure 5A).

• Remove the syringe from the adapter (Figure 5B).

• Place the tip of the syringe in the mouth and slowly push the plunger to administer the medicine.
• Then, fill the syringe with water and swallow it to ensure that all the medicine has been ingested.
• Afterwards, drink a glass of water to remove any residual methotrexate from the mouth and lips.
• Leave the syringe adapter in the bottle and close the bottle with the plastic cap.
• Wash the syringe with soap and lukewarm water and rinse thoroughly. To clean the inside of the syringe, immerse it in water and move the plunger up and down several times. Allow it to dry before reusing. Store the syringe in a clean place together with the medicine (Figure 6).

• WASH YOUR HANDS THOROUGHLY with soap and lukewarm water IMMEDIATELY after use.

Use in patients with renal and hepatic impairment

Consult your doctor, as dose adjustment may be necessary. In some cases, the medicine may be contraindicated.

If you take more Jiax Weekly than you should

If you have taken more Jiax Weekly than you should, contact your doctor or pharmacist immediately or go immediately to the nearest hospital emergency department.

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

An overdose of methotrexate can cause serious reactions. Symptoms of overdose may include bleeding, unusual weakness, mouth ulcers, nausea, vomiting, black or bloody stools, coughing up or vomiting blood that looks like coffee grounds, and reduced urine volume.

If you forget to take Jiax Weekly

Do not take a double dose to make up for the missed dose. Take the next dose as prescribed.

If you stop taking Jiax Weekly

Do not stop treatment unless instructed by your doctor.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Immediately inform your doctor if you experience wheezing, difficulty breathing, swelling of the eyelids, face or lips, skin rash or itching (especially if it affects your whole body) suddenly.

Serious adverse effects

Immediately tell your doctor if you notice any of the following adverse effects:

• Inflammation of the lungs (symptoms may include general malaise, dry irritating cough, difficulty breathing, shortness of breath at rest, chest pain or fever)
• Coughing up blood
• Severe cases of skin peeling or blistering
• Bleeding (including vomiting blood) or unusual bruising
• Severe diarrhoea
• Mouth ulcers
• Black or tar-like stools
• Blood in the urine or faeces
• Small red spots on the skin
• Fever
• Yellowing of the skin (jaundice)
• Pain or difficulty urinating
• Thirst and/or frequent urination
• Seizures
• Loss of consciousness
• Blurred or reduced vision

The following adverse effects have also been reported:

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

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

Common (may affect up to 1 in 10 people):

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

Uncommon (may affect up to 1 in 100 people):

Reduction 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, reduction in blood proteins, urticaria, sunburn-like reactions due to increased skin sensitivity to sunlight, brown skin, alopecia, increase in rheumatoid nodules, shingles, painful psoriasis, muscle or joint pain, osteoporosis (loss of bone mass), inflammation and ulcers of the bladder (possibly with blood in the urine), painful urination, severe allergic reactions, inflammation and ulcers in the vagina, slow wound healing.

Rare (may affect up to 1 in 1,000 patients):

Inflammation of the sac around the heart, fluid in the sac around the heart, serious visual disorder, mood changes, low blood pressure, blood clots, sore throat, breathing interruption, asthma, inflammation of the digestive tract, bloody stools, gum inflammation, digestive problems, acute hepatitis (liver inflammation), nail discoloration, acne, red or purple spots due to vascular bleeding, bone fracture, kidney failure, reduced or absent urine output, electrolyte disturbances, defective sperm production, menstrual disorders.

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

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

Frequency not known (cannot be estimated from available data):

Pulmonary haemorrhage, jaw bone injury (secondary to excessive increase in white blood cells), redness and peeling of the skin, swelling.

Jiax Semanal may cause a decrease in the number of white blood cells, which can reduce resistance to infections. If you develop an infection with symptoms such as fever and severe deterioration in your general condition, or fever with signs of local infection such as sore throat/pharynx/mouth or urinary problems, you must immediately contact your doctor. A blood test will be performed to determine whether there has been a reduction in white blood cells (agranulocytosis). It is important that you inform your doctor if you are taking Jiax Semanal.

It is known that methotrexate causes bone disorders such as joint and muscle pain and osteoporosis. The frequency of these risks in children is unknown.

Jiax Semanal can cause serious adverse effects (sometimes potentially fatal). Your doctor will carry out tests to detect abnormalities in the blood (e.g. low white blood cell and platelet counts, lymphoma) and changes in the kidneys and liver.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist or nurse, even if it is an adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Jiax Weekly

Keep this medicine out of the sight and reach of children, preferably in a locked cabinet.

Do not store above 25 °C.

Do not refrigerate.

Keep the bottle in the outer packaging to protect it from light.

Do not use this medicine after the expiry date stated on the bottle after "EXP". The expiry date refers to the last day of the month indicated. This product is stable for 6 months after opening.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point in your pharmacy. 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 Jiax Semanal

• The active substance is methotrexate disodium. Each ml of solution contains 2.19 mg of methotrexate disodium, equivalent to 2 mg of methotrexate.

• The other components are: methylparaben (sodium salt) (E219), ethylparaben (sodium salt) (E215), disodium hydrogen phosphate dihydrate, citric acid monohydrate, raspberry flavouring, sucralose and purified water.

Appearance of the product and contents of the container

Jiax Semanal is a yellow, clear solution.

It is supplied in an amber glass bottle containing 35 or 65 ml of oral solution, with a child-resistant cap. Each package contains one bottle, one bottle adapter and one dosing syringe.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Laboratorios Gebro Pharma, S.A.

Av. Tibidabo, 29

08022 Barcelona

Spain

Manufacturer responsible for manufacturing

Jenson R+ (Ireland) Ltd,

Unit 15, Daingean Hall,

N4 Axis Centre,

Longford,

N39 W6K0

Ireland

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Spain: Jiax Semanal 2 mg/ml oral solution

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

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