Lornoxicam Rapid Meiji 8 mg film-coated tablets EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Lornoxicam RapidMeiji 8 mg Film-Coated Tablets EFG

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 or pharmacist.
• This medicine has been prescribed for you only, and must not be given to other people, 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 adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

3. How to take Lornoxicam Rapid Meiji.

4. Possible adverse effects.

5. How to store Lornoxicam Rapid Meiji.

6. Contents of the pack and other information.

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

Lornoxicam Rapid Meiji is a non-steroidal anti-inflammatory and anti-rheumatic drug (NSAID) belonging to 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 medicine (listed in section 6);
• if you are taking other NSAIDs such as acetylsalicylic acid (e.g., aspirin), ibuprofen, or 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, increasing 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 related to previous NSAID treatment;
• if you have active peptic ulcer or previous recurrent peptic ulcer;
• if you have severe liver disease (severe hepatic insufficiency);
• if you have severe kidney disease (severe renal insufficiency);
• if you are in the last three months of pregnancy.

Warnings and precautions

Consult your doctor or pharmacist before starting 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 tendency to bleeding;
• if you have a history of asthma;
• if you have SLE (systemic lupus erythematosus, a rare immune disease).

Your doctor may need to carry out laboratory tests periodically if

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

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

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

Medicines such as lornoxicam may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. The risk is greater with high doses and prolonged treatment. 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 previously had a stroke,
• you think you may be at risk of these conditions (for example, if you have high blood pressure, diabetes, high cholesterol, or are a smoker).

Avoid using lornoxicam during chickenpox infections.

Other medicines and Lornoxicam Rapid Meiji

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

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

Lornoxicam may interfere with other medicines. Take special care if you are taking any of the following:

• Cimetidine – used in the treatment of stomach acidity and peptic ulcers.
• Anticoagulants, such as heparin or phenprocoumon – used to prevent blood clots.
• Corticosteroids.
• Methotrexate – used in the treatment of cancer and immunological diseases.
• Lithium.
• Immunosuppressants, such as cyclosporine or tacrolimus.
• Heart medications, such as digoxin, ACE inhibitors, beta-blockers.
• Diuretics.
• Quinolone antibiotics.
• Antiplatelet agents – medicines used to prevent heart attacks and strokes.
• SSRIs (Selective Serotonin Reuptake Inhibitors) – used in the treatment of depression.
• Sulfonylureas, for example, 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 metabolizes lornoxicam.
• Angiotensin II receptor blockers – used to treat high blood pressure, kidney damage caused by diabetes, and congestive heart failure.
• Pemetrexed – used to treat certain types of lung cancer.

Taking Lornoxicam Rapid Meiji with food and drinks

Lornoxicam coated tablets are intended for oral administration. Take this medicine before meals with sufficient liquid.

It is not recommended to take this medicine 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 if you plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Do not take this medicine 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 6 months of pregnancy unless absolutely necessary and specifically prescribed by your doctor. If treatment is needed during this period or while trying to conceive, you should take the lowest effective 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 lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment for longer than a few days is needed, your doctor may recommend additional monitoring.

Breastfeeding

Treatment with lornoxicam is not recommended during breastfeeding unless specifically advised by your doctor.

Fertility

The use of lornoxicam may affect fertility and its use is not recommended while trying to conceive or while being evaluated for infertility.

Driving and using machines

Lornoxicam has negligible or no influence on the ability to drive or operate machinery.

Lornoxicam Rapid Meiji contains potassium

Patients with impaired renal function or those on potassium-restricted diets should be aware that this medicine contains 21.5 mg (0.55 mmol) of potassium per tablet.

Lornoxicam Rapid Meiji contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.

3. How to take Lornoxicam Rapid Meiji

Follow exactly the instructions for use of this medicine provided by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose in adults is 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 sufficient 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 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, central nervous system-related symptoms (such as dizziness or visual disturbances). Contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested. Bring this 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 further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

Medicines such as 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 inner lining of the nasal passages, mouth, eyelids, ears, genitals, or anus, or any other sign of hypersensitivity, you must stop taking lornoxicam immediately and contact your doctor without delay.

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

• difficulty breathing, chest pain, or developing swollen ankles or worsening swelling;
• severe or persistent stomach pain or black stools;
• yellowing of the skin and eyes (jaundice), which are signs of liver problems;
• an allergic reaction that 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 swelling, especially in the hands and feet or around the mouth (Stevens-Johnson syndrome);
• very rarely, severe skin infections in case of chickenpox.

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

Common adverse effects (may affect between 1 and 10 out of every 100 patients)

• headache and mild, transient dizziness;
• nausea, abdominal pain, indigestion, diarrhoea, and vomiting.

Uncommon adverse effects (may affect between 1 and 10 out of every 1,000 patients)

• weight loss (anorexia), inability to sleep, depression;
• eye discharge (conjunctivitis);
• dizziness, ringing in the ears (tinnitus);
• heart failure, irregular heartbeat, rapid heartbeat, sensation of flushing;
• constipation, excess gas (flatulence), belching, dry mouth, gastritis, peptic ulcer, upper abdominal pain, duodenal ulcer, oral ulcer;
• increase in liver function tests (as seen 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, oedema, nasal congestion due to allergy (rhinitis);
• hair loss;
• arthralgia (joint pain).

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

• sore throat;
• anaemia, reduction in blood cell count (thrombocytopenia and leucopenia), weakness;
• hypersensitivity, anaphylactoid reaction and anaphylaxis (a reaction of the body generally characterized by facial swelling, redness, difficulty breathing, and dizziness);
• confusion, nervousness, agitation, drowsiness (somnolence), paraesthesia (tingling sensation), altered sense of taste, tremor, migraine, visual disturbances;
• high blood pressure, flushing;
• bleeding, bruising (haematoma), prolonged bleeding time;
• difficulty breathing (dyspnoea), cough, bronchospasm;
• perforated ulcer, vomiting blood, gastrointestinal bleeding, black tarry stools;
• inflammation in the mouth, oesophagitis (inflammation of the throat), gastroesophageal reflux, difficulty swallowing, aphthous stomatitis (mouth ulcers), inflammation of the tongue;
• abnormal liver function;
• skin disorders such as eczema, rash;
• bone pain, muscle cramps, muscle pain;
• urinary problems, such as the need to wake up at night to urinate (nocturia) or increased levels of creatinine and urea in the blood.

Very rare adverse effects (may affect fewer than 1 in every 10,000 patients)

• liver injury, hepatitis (inflammation of the liver), jaundice, cholestasis (interruption of bile flow from the liver);
• bruising, oedema, severe skin disorder (Stevens-Johnson syndrome, toxic epidermal necrolysis);
• aseptic meningitis;
• class effects of NSAIDs: neutropenia, agranulocytosis, aplastic anaemia, haemolytic anaemia, renal toxicity.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lornoxicam Rapid Meiji

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

Store below 25°C.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If in doubt, 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 Lornoxicam Rapid Meiji

• The active substance is lornoxicam. Each film-coated tablet contains 8 mg of lornoxicam.
• The other components (excipients) are: microcrystalline cellulose/anhydrous colloidal silica, calcium hydrogen phosphate, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, potassium hydrogen carbonate, sodium stearyl fumarate, Sepifilm 752 White (hypromellose, microcrystalline cellulose, polyoxyl 40 stearate, titanium dioxide (E-171)).

Appearance of the product and contents of the pack

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

Lornoxicam Rapid Meiji 8 mg is available 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 most recent revision of this leaflet: October 2023

Other sources of information

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