Package Insert: Information for the User

Lornoxicam RapidMeiji8 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

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

6. Contents of the pack and additional information.

Lornoxicam RapidMeijiis a nonsteroidal anti-inflammatory and antirheumatic (NSAID) drug of the oxicam group.

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

Do not take Lornoxicam Rapid Meiji

• if you are allergic to the active ingredient lornoxicam or any of the other components 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 perforation or gastrointestinal bleeding related to previous NSAID treatments;
• if you have active or recurrent peptic ulcers;
• if you have severe liver disease (severe liver failure);
• if you have severe kidney disease (severe kidney 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 tendencies;
• if you have a history of asthma;
• if you have systemic lupus erythematosus (a rare autoimmune disease).

Your doctor may need to perform laboratory tests with some frequency if

• you have blood clotting disorders;
• you have liver dysfunction;
• you are elderly;
• or if you are being treated with lornoxicam for more than 3 months.

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

If you notice unusual abdominal symptoms, such as abdominal bleeding, skin reactions such as skin eruptions, damage to the mucous membranes of the nose, 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 increase in the risk of heart attack (myocardial infarction) or stroke. In cases of high doses and prolonged treatment, the risk probability is higher.Do not exceed the recommended dose or treatment duration.

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 these conditions (e.g. if you have high blood pressure, diabetes, or high cholesterol, or if you 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 used recently, or may need to use any other medication.

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

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

• Cimetidine - used in the treatment of stomach acid and peptic ulcers.
• Anticoagulants, such as heparin or phenprocoumon - used to prevent blood clot formation.
• Corticosteroids.
• Methotrexate - used in the treatment of cancer and autoimmune 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 in the treatment of depression.
• Sulfonylureas, such as glibenclamide - used in the treatment of diabetes.
• Inducers and inhibitors of CYP2C9 isoenzymes (such as the antibiotic rifampicin or the antifungal miconazole), as they may affect how your body breaks down lornoxicam.
• Angiotensin II receptor blockers - used to treat high blood pressure, diabetic kidney damage, and congestive heart failure.
• Pemetrexed - used to treat certain types of lung cancer.

Taking Lornoxicam Rapid Meiji with food and drinks

The coated tablets of lornoxicam are indicated for oral administration. Take this medication before meals with sufficient liquid.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be 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 predisposition and that of your baby to bleed and delay or prolong delivery more than expected.

Do 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 week 20 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 a period longer than a few days, your doctor may recommend additional monitoring.

Breastfeeding

It is not recommended to treat with lornoxicam while breastfeeding, unless your doctor has explicitly indicated it.

Fertility

The use of lornoxicam may affect fertility and is not recommended for use while trying to conceive or while studying a fertility problem.

Driving and operating machinery

Lornoxicam has an insignificant or no effect on the ability to drive or operate machinery.

Lornoxicam Rapid Meiji contains potassium

Patients with kidney failure or those on a low-potassium diet should note that this medication contains 21.5 mg (0.55 mmol) of potassium pertablet.

Lornoxicam Rapid Meiji contains sodium

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

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

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

On the first day of treatment, a starting dose of 16 mg(2 tablets)may be administered, followed by a dose of8 mg(1tablet)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 forusein children and adolescents under 18 years of age due to the lack of data.

If you take more Lornoxicam RapidMeiji 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 visual disturbances).Consulteimmediately your doctor or pharmacist or callthe Poison Information Service, phone 91 562 04 20,indicating the medication and the amount ingested.Bring this leaflet with you.

If you forgot to take Lornoxicam Rapid Meiji

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

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

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

Medicines like lornoxicam may be associated with a small increase in the risk ofheart attack or stroke.

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

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

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

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

Frequent side effects (may affect between 1 and 10 of every 100 patients)

• light and transient headache and dizziness;
• nausea, abdominal pain, stomach discomfort, diarrhea, and vomiting.

Rare side effects(may affect between 1 and 10 of every 1,000 patients)

• weight loss (anorexia), inability to sleep, depression;
• eye secretions (conjunctivitis);
• sensation of dizziness, ringing in the ears (tinnitus);
• heart failure, irregular heartbeat, rapid heart rate, sensation of flushing;
• constipation, excessive gas (flatulence), belching, dry mouth, gastritis, peptic ulcer, upper abdominal pain, duodenal ulcer, oral ulcer;
• increased liver function tests(such as those observed in blood tests) and general discomfort;
• eruption, 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).

Very rare side effects(may affect fewer than 1 of every 10,000 patients)

• sore throat;
• anemia, reduction in blood cell count (thrombocytopenia and leucopenia), weakness;
• hypersensitivity, anaphylactoid reaction, and anaphylaxis (organ reaction that is usually characterized by swelling of the face, redness, difficulty breathing, and dizziness);
• confusion, nervousness, agitation, feeling of sleepiness (somnolence), paresthesia (tingling sensation), alteration of taste, tremor, migraine, visual disturbances;
• high blood pressure, heat intolerance;
• bleeding, hematoma (bruise), increased bleeding time;
• difficulty breathing (dyspnea), cough, bronchospasm;
• perforated ulcer, vomiting blood, gastrointestinal bleeding, stools that are black as coal;
• inflammation in the mouth, esophagitis (inflammation of the throat), gastroesophageal reflux, difficulty swallowing, aphthous stomatitis (mouth ulcers), inflammation of the tongue;
• abnormal liver function;
• skin conditions, such as eczema, rash;
• bone pain, muscle cramps, muscle pain;
• urinary problems, such as needing to wake up and urinate at night (nocturia) or an increase in creatinine and urea levels in the blood.

Extremely rare side effects(may affect fewer than 1 of every 10,000 patients)

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

Reporting side effects

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

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

Store below 25°C.

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

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

Composition of Lornoxicam Rapid Meiji

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

Appearance of the product and content of the packaging

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

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

Holder of the marketing authorization and responsible for manufacturing:

Meiji Pharma Spain, S.A.

Avda. de Madrid, 94

28802 Alcalá de Henares, Madrid (Spain)

Last review date of this leaflet: October 2023

Other sources of information

The detailed information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS):https://www.aemps.gob.es.