LORNOXICAM RAPID MEIJI 8 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Lornoxicam RapidMeiji8 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet.

1. What is Lornoxicam Rapid Meiji and what is it used for.
2. What you need to know before taking Lornoxicam Rapid Meiji.
3. How to take Lornoxicam Rapid Meiji.
4. Possible side effects.
5. Storage of Lornoxicam Rapid Meiji.

1. Contents of the pack and further information.

1. What is Lornoxicam Rapid Meiji and what is it used for

Lornoxicam Rapid Meiji is a non-steroidal anti-inflammatory and antirheumatic medication (NSAID) of the oxicam group.

Lornoxicam Rapid Meiji is indicated in adults for the short-term treatment of mild to moderate acute pain.

2. What you need to know before taking Lornoxicam Rapid Meiji

Do not take Lornoxicam Rapid Meiji

• if you are allergic to the active substance lornoxicam or to any of the other ingredients of this medication (listed in section 6);
• if you are taking other NSAIDs such as acetylsalicylic acid (e.g., aspirin), ibuprofen, and COX-2 inhibitors;
• if you are hypersensitive to other NSAIDs, including acetylsalicylic acid (e.g., aspirin);
• if you have thrombocytopenia (low platelet count in the blood that increases the risk of bleeding or bruising);
• if you have severe heart disease (severe heart failure);
• if you have gastrointestinal bleeding, rupture, and bleeding of a blood vessel in the brain, or other types of bleeding;
• if you have a history of gastrointestinal perforation or bleeding associated with previous NSAID treatment;
• if you have active peptic ulcer or recurrent peptic ulcer;
• if you have severe liver disease (severe liver failure);
• if you have severe kidney disease (severe renal failure);
• if you are in the last three months of pregnancy.

Warnings and precautions

Consult your doctor or pharmacist before starting to take lornoxicam

• if you have impaired kidney function;
• if you have a history of high blood pressure and/or heart failure;
• if you have ulcerative colitis or Crohn's disease;
• if you have a history of bleeding tendency;
• if you have a history of asthma;
• if you have systemic lupus erythematosus (SLE, a rare immune system disease).

Your doctor may need to perform laboratory tests on you from time to time, if

• you have blood coagulation disorders,
• you have liver dysfunction,
• you are elderly,
• or you are going to be treated with lornoxicam for more than 3 months.

You should inform your doctor if you are going to be treated with heparin or tacrolimus while taking lornoxicam.

If you notice unusual abdominal symptoms, such as abdominal bleeding, skin reactions such as rashes, damage to the lining of the nostrils, mouth, eyelids, ears, genitals, or anus, or any other sign of hypersensitivity, stop taking lornoxicam and contact your doctor immediately.

Medications like lornoxicam may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. In cases of high doses and prolonged treatment, the probability of risk is higher. Do not exceed the recommended dose or duration of treatment.

You should talk to your doctor or pharmacist about treatment if

• you have heart problems,
• you have had a previous stroke,
• you think you may be at risk of suffering from these conditions (e.g., if you have high blood pressure, diabetes, or high cholesterol, or are a smoker).

Avoid using lornoxicam during chickenpox infections.

Other medications and Lornoxicam Rapid Meiji

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Do not take lornoxicam if you are taking other NSAIDs such as acetylsalicylic acid(e.g., aspirin), ibuprofen, and COX-2 inhibitors.Ask your doctor or pharmacist if you have any doubts.

Lornoxicam may interfere with other medications. Be especially careful if you are taking any of the following:

• Cimetidine - used to treat stomach acid and peptic ulcers.
• Anticoagulants, such as heparin or phenprocoumon - used to prevent blood clot formation.
• Corticosteroids.
• Methotrexate - used to treat cancer and immune system diseases.
• Lithium.
• Immunosuppressants, such as cyclosporine or tacrolimus.
• Heart medications, such as digoxin, ACE inhibitors, beta blockers.
• Diuretics.
• Quinolone antibiotics.
• Antiplatelet agents - medications used to prevent heart attacks and strokes.
• SSRIs (Selective Serotonin Reuptake Inhibitors) - used to treat depression.
• Sulfonylureas, e.g., glibenclamide - used to treat diabetes.
• Inducers and inhibitors of the CYP2C9 isoenzyme (such as the antibiotic rifampicin or the antifungal miconazole), as they may affect how your body breaks down lornoxicam
• Angiotensin II receptor blocker - used to treat high blood pressure, diabetic nephropathy, and congestive heart failure.
• Pemetrexed - used to treat some forms of lung cancer.

Taking Lornoxicam Rapid Meiji with food and drinks

Lornoxicam film-coated tablets are intended for oral administration. Take this medication before meals with a sufficient amount of liquid.

It is not recommended to take this medication with food, as this may reduce its effectiveness.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Do not take this medication during the last three months of pregnancy.

It may cause kidney and heart problems in your fetus. It may affect your and your baby's tendency to bleed and delay or prolong labor more than expected.

You should not take lornoxicam during the first six months of pregnancy, unless it is absolutely necessary and your doctor has explicitly indicated it. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time.

From the 20th week of pregnancy, lornoxicam may cause kidney problems in your fetus if taken for more than a few days, which may cause low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.

Breastfeeding

Treatment with lornoxicam is not recommended during breastfeeding, unless your doctor has explicitly indicated it.

Fertility

The use of lornoxicam may affect fertility, and its use is not recommended while trying to conceive or while investigating infertility.

Driving and using machines

Lornoxicam has a negligible or no influence on the ability to drive or use machines.

Lornoxicam Rapid Meiji contains potassium

Patients with renal failure or those on low-potassium diets should note that this medication contains 21.5 mg (0.55 mmol) of potassium per tablet.

Lornoxicam Rapid Meiji contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

3. How to take Lornoxicam Rapid Meiji

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

The recommended dose in adultsis 8 to 16 mg daily, divided into 8 mg doses. Take 8 mg (1 tablet) twice a day or 16 mg (2 tablets) once a day.

On the first day of treatment, an initial dose of 16 mg (2 tablets) may be administered, followed by a dose of 8 mg (1 tablet) 12 hours later.

After the first day of treatment, do not take more than 16 mg (2 tablets) per day.

Lornoxicam Rapid Meiji tablets should be swallowed with a sufficient amount of liquid.

Do not take lornoxicam with food, as food may reduce the effectiveness of lornoxicam.

Use in children and adolescents

Lornoxicam is not recommended for use in children and adolescents under 18 years of age due to the lack of data.

If you take more Lornoxicam Rapid Meiji than you should

In case of overdose or accidental ingestion, the following symptoms may occur: nausea, vomiting, symptoms associated with the central nervous system (such as dizziness or vision disturbances). Consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. Bring this package leaflet with you.

If you forget to take Lornoxicam Rapid Meiji

Do not take a double dose to make up for forgotten doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, lornoxicamcan cause side effects, although not everyone gets them.

Medications like lornoxicam may be associated with a small increased risk of heart attack or stroke.

If you experience any unusual abdominal symptoms, such as abdominal bleeding, skin reactions such as rashes, damage to the lining of the nostrils, mouth, eyelids, ears, genitals, or anus, or any other sign of hypersensitivity, stop taking lornoxicam and contact your doctor immediately.

If you start to notice any of the following side effects, stop taking lornoxicam and contact your doctor immediately or go to the nearest hospital emergency department:

• difficulty breathing, chest pain, or swelling of the ankles or worsening of it;
• severe stomach pain or continuous or black stools;
• yellowing of the skin and eyes (jaundice), which are signs of liver problems;
• an allergic reaction that can include skin problems, such as ulcers or blisters, or swelling of the face, lips, tongue, or throat that can cause difficulty breathing;
• fever, blistering rash, or inflammation, especially on hands and feet or in the mouth area (Stevens-Johnson syndrome);
• exceptionally, severe skin infections in case of chickenpox.

The side effects associated with the use of lornoxicam are listed below:

Frequent side effects (may affect 1 to 10 in every 100 patients)

• headache and mild, transient dizziness;
• nausea, abdominal pain, stomach upset, diarrhea, and vomiting.

Uncommon side effects(may affect 1 to 10 in every 1,000 patients)

• weight loss (anorexia), insomnia, depression;
• eye secretions (conjunctivitis);
• dizziness, ringing in the ears (tinnitus);
• heart failure, irregular heartbeat, rapid heartbeat, feeling of flushing;
• constipation, excess gas (flatulence), belching, dry mouth, gastritis, peptic ulcer, upper abdominal pain, duodenal ulcer, mouth ulcer;
• increased liver function tests (as observed in blood tests) and general malaise;
• rash, itching, excessive sweating, skin redness (erythema), angioedema (rapid swelling of the deeper layers of the skin, usually of the face), urticaria, edema, nasal congestion due to an allergy (rhinitis);
• hair loss;
• arthralgia (joint pain).

Rare side effects(may affect 1 to 10 in every 10,000 patients)

• throat pain;
• anemia, reduction in blood cell count (thrombocytopenia and leukopenia), weakness;
• hypersensitivity, anaphylactoid reaction, and anaphylaxis (a reaction of the body that is characterized by swelling of the face, redness, difficulty breathing, and dizziness);
• confusion, nervousness, agitation, feeling of sleep (somnolence), paresthesia (tingling sensation), alteration of taste, tremor, migraine, visual disturbances;
• high blood pressure, hot flushes;
• bleeding, hematoma (bruising), prolonged bleeding time;
• difficulty breathing (dyspnea), cough, bronchospasm;
• perforated ulcer, vomiting blood, gastrointestinal bleeding, black tarry stools;
• inflammation of the mouth, esophagitis (inflammation of the throat), gastroesophageal reflux, difficulty swallowing, aphthous stomatitis (mouth ulcers), tongue inflammation;
• abnormal liver function;
• skin conditions, such as eczema, rash;
• bone pain, muscle cramps, muscle pain;
• urinary problems, such as the need to wake up and urinate during the night (nocturia) or increased levels of creatinine and urea in the blood.

Very rare side effects(may affect less than 1 in every 10,000 patients)

• liver damage, hepatitis (inflammation of the liver), jaundice, cholestasis (interruption of bile flow from the liver);
• bruising, edema, severe skin disorder (Stevens-Johnson syndrome, toxic epidermal necrolysis);
• aseptic meningitis;
• NSAID class effects: neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia, renal toxicity.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Lornoxicam Rapid Meiji

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

Store below 25°C.

Do not use this medication after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Lornoxicam Rapid Meiji

• The active substance is lornoxicam. Each film-coated tablet contains 8 mg of lornoxicam.
• The other ingredients (excipients) are: microcrystalline cellulose/silica colloidal anhydrous, calcium hydrogen phosphate, low-substitution hydroxypropylcellulose, hydroxypropylcellulose, potassium hydrogen carbonate, sodium stearyl fumarate, Sepifilm 752 White (hypromellose, microcrystalline cellulose, polyoxyethylene stearate, titanium dioxide (E-171)).

Appearance of the product and packaging contents

Lornoxicam Rapid Meiji 8 mg are white, round, and biconvex film-coated tablets.

Lornoxicam Rapid Meiji 8 mg is presented in packs of 30 film-coated tablets, packaged in PVC-Al-PA/Al-PVC blisters and cardboard boxes.

Marketing authorization holder and manufacturer:

Meiji Pharma Spain, S.A.

Avda. de Madrid, 94

28802 Alcalá de Henares, Madrid (Spain)

Date of the last revision of this package leaflet: October 2023

Other sources of information

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): https://www.aemps.gob.es.