Patient Information Leaflet: Information for the Patient

Meloxicam Mylan 15 mg Tablets

Read this leaflet carefully before you start taking 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. Do not give it to others, even 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 leaflet. See section 4.

6.Contents of the pack and additional information

Meloxicam Mylan contains the active ingredient meloxicam. Meloxicam belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) used to treat pain and inflammation in muscles and joints.

Meloxicam Mylan is indicated in adults and adolescents over 16 years old for:

-Treatment of short duration of acute attacks of osteoarthritis (joint disease).

-Treatment of long-term pain associated with rheumatoid arthritis (inflammation of the joints).

-Treatment of long-term disease called ankylosing spondylitis (inflammation of the spine).

Do not take Meloxicam Mylan:

• During the last trimester of pregnancy.
• If you are a child or adolescent under 16 years old.
• If you are allergic to meloxicam or any of the other components of this medication (listed in section 6).
• If you are allergic to acetylsalicylic acid (for example, aspirin) or other nonsteroidal anti-inflammatory drugs (NSAIDs).
• If you have a history of asthma, chest tightness, shortness of breath, nasal congestion due to inflammation of the inside of the nose (nasal polyps), swelling around the eyes, face, lips, mouth, or throat that makes it difficult to breathe (angioneurotic edema) or itching (urticaria) after taking acetylsalicylic acid or other NSAIDs.
• If you currently have a bleeding in the stomach or intestine.
• If you have or have had two or more episodes of ulcers or bleeding in the stomach or intestine. If you have ever had bleeding or perforations (tears) in the stomach or intestine after taking an NSAID.
• If you have or have had a bleeding disorder or a cerebral hemorrhage (cerebrovascular hemorrhage).
• If you have severe liver problems.
• If you have severe kidney problems and are not receiving dialysis.
• If you have a serious heart disease.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Meloxicam Mylan:

• If you have ever experienced a fixed drug eruption (flat, oval-shaped patches with redness and swelling of the skin that usually reappear in the same place, blistering, urticaria, and itching) after taking meloxicam or other oxycam derivatives (for example, piroxicam).
• If you have previously had esophagitis (inflammation of the esophagus); gastritis (inflammation of the stomach lining) and/or stomach ulcers, as your doctor will need to check that you no longer have any of these conditions before starting treatment.
• If you have a history of stomach or intestinal problems (such as ulcerative colitis or Crohn's disease).
• If you are an elderly person (due to the increase in adverse effects).
• If you have a very low blood volume (you may have had a significant loss of blood, undergone surgery, or had a low intake of fluids).
• If you have other kidney, liver, or heart problems.
• If your blood potassium levels are elevated.
• If you are trying to become pregnant or are having fertility tests.

Medicines like meloxicam can be associated with a moderate increase in the risk of suffering heart attacks ("myocardial infarctions") or strokes. Any risk is greater at high doses and prolonged treatment. Do not exceed the recommended dose or treatment duration.

If you have heart problems (including angina or reduced circulation), a history of strokes, or think you may be at risk of these conditions (for example, you have high blood pressure, diabetes, high cholesterol, or are a smoker), you should consult this treatment with your doctor or pharmacist.

Severe skin reactions that can be life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis) have been described with the use of meloxicam, which initially appear as red, circular patches with a central blister, often accompanied by mouth, throat, nasal, genital, and conjunctivitis (inflamed, red eyes).

These severe skin reactions often occur with flu-like symptoms. The skin rash can progress to widespread blistering or skin peeling. The highest risk period for severe skin reactions is during the first weeks of treatment.

If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of meloxicam, you should not use meloxicam again at any time. If you develop a rash or these symptoms on your skin, stop taking meloxicam, go to a doctor immediately, and inform them that you are taking this medication.

During treatment

Talk to your doctor immediately if you experience stomach or intestinal problems (especially bleeding) during the first few days after starting meloxicam. This can occur if you have had intestinal problems or are an elderly person. You may detect intestinal bleeding if your stools are black like tar or if you feel sick, they may contain red or dark red blood particles that look like coffee grounds (see section 4).

This medication can affect the results of certain blood or urine tests. Inform your doctor or hospital staff that you are taking this medication if you need to have tests.

This medication can mask the symptoms of certain infections. For example, it can mask fever. If you do not feel well and think you may have an infection, talk to your doctor.

Other medications and Meloxicam Mylan

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription. The following medications can affect or be affected by meloxicam:

• Anticoagulants (medicines used to prevent blood clotting) such as warfarin, heparin, clopidogrel, dabigatran, apixaban, and ticlopidine, as meloxicam can increase their effect or increase the risk of bleeding.
• Other nonsteroidal anti-inflammatory drugs (NSAIDs) such as acetylsalicylic acid (aspirin) or medications known as "COX-2 inhibitors" such as celecoxib.
• Lithium (medication used for mental disorders).
• Methotrexate (medication used for psoriasis, inflammation, and some cancers).
• Thrombolytics (medicines used to dissolve blood clots in heart diseases).
• Colestiramine (medication used to reduce blood cholesterol levels).
• Inhibitors of calcineurin (medications used to treat autoimmune diseases such as rheumatoid arthritis or used after organ transplantation) such as cyclosporine or tacrolimus.
• Diuretics (to increase urine elimination).
• Medications intended to reduce blood pressure, called ACE inhibitors, angiotensin II antagonists (sartanes), or beta-blockers.
• Corticosteroids (for asthma, inflammation, and after organ transplantation), as the risk of ulcers or bleeding may be higher.
• Selective serotonin reuptake inhibitors (SSRIs) (medications used for depression).
• Pemetrexed, medication used to treat certain types of cancer. You may need to stop taking this medication for at least 5 days before, during, and 2 days after receiving pemetrexed.
• Medications that can increase blood potassium levels. This includes potassium salts or supplements, certain diuretics (for example, spironolactone), or the antibiotic trimethoprim.
• Deferasirox, medication used to reduce iron levels in the body.

• Oral antidiabetic medications (sulfonilureas and nateglinida). Medications used to treat diabetes. Your doctor should carefully monitor your blood glucose levels to determine the risk of hypoglycemia.

Pregnancy, breastfeeding, and fertility

Pregnancy

Do not take this medication during the last trimester of pregnancy, as it may harm the fetus or cause complications during delivery. It can cause heart and kidney problems in the fetus. It may also affect the baby's bleeding tendency or cause a delayed or prolonged delivery. You should not take Meloxicam Mylan during the first 6 months of pregnancy, unless it is absolutely necessary and your doctor has recommended it.

If you need treatment during this period or while trying to become pregnant, the lowest dose should be administered for the shortest possible time. If you take it for more than a few days after 20 weeks of pregnancy and beyond, Meloxicam Mylan may cause kidney problems in the fetus, which may result in low amniotic fluid levels surrounding the baby (oligohydramnios) or narrowing of the blood vessels (ductus arteriosus) in the baby's heart. If you need to administer the treatment for more than a few days, your doctor may recommend additional monitoring.

Breastfeeding

NSAIDs can pass into breast milk. Do not breastfeed while taking this medication.

Fertility

You may find it more difficult to become pregnant with this medication. Talk to your doctor if you are thinking of becoming pregnant or if you are having fertility tests.

Driving and operating machinery

Meloxicam can cause adverse effects that may affect your ability to drive and operate machinery. Some examples of these effects include blurred vision, drowsiness, dizziness, a spinning sensation (vertigo), and other problems affecting the brain. If you experience any of these effects, it is recommended that you abstain from driving or operating machinery.

Meloxicam Mylan contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have doubts.

Your doctor will give you the lowest possible dose, for the shortest possible time, to treat your symptoms. If you do not improve or if you experience any adverse effect, tell your doctor. Your doctor will monitor your condition and treatment.

Use in adults and adolescents over 16 years

Acute arthritis attacks:The recommended dose is 7.5 mg per day. Your doctor may increase this dose to 15 mg once a day if you do not see improvements.

Rheumatoid arthritis or ankylosing spondylitis treatment:The recommended dose is 15 mg per day.

Your doctor may reduce your dose to 7.5 mg per day if your symptoms improve.

You should never exceed a dose of 15 mg per day.

Renal and liver function decrease:

In patients undergoing dialysis with severe renal failure, the dose should not exceed 7.5 mg per day.

Patients with non-severe kidney or liver problems can be administered the normal adult doses as described above.

It is not recommended to use meloxicam in patients with severe renal failure not undergoing dialysis or severe liver failure.

Use in elderly patients

If you are an elderly patient, your doctor may recommend a lower dose. The recommended dose for the treatment of rheumatoid arthritis and ankylosing spondylitis is 7.5 mg per day.

Use in children and adolescents

Children and adolescents under 16 years should not take meloxicam.

Take meloxicam as a single oral dose with water or other liquids during a meal.

For 7.5 mg tablets: The scored line is only for breaking the tablet if it is difficult to swallow whole.

For 15 mg tablets: The tablet can be broken into two equal doses.

If you take more Meloxicam Mylan than you should

If you have taken more meloxicam than you should, consult your doctor immediately, call the Toxicology Information Service, phone 91 562 04 20or go to the nearest hospital emergency room.Bring this leaflet and the tablets you still have.You may experience an allergic reaction (see section 4) or feel weak, drowsy, unwell (nausea), or vomit, experience stomach pain or gastrointestinal bleeding. The most severe effects can behigh blood pressure, renal insufficiency,liver problems, respiratory problems,coma, seizures, or cardiac problems.

If you forgot to take Meloxicam Mylan

If you forgot to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Meloxicam Mylan

Do not stop taking the medication without telling your doctor.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Stop taking this medicine and seek immediate medical attention or go to the nearest hospital emergency department if you experience any of the following:

Uncommon(may affect up to 1 in 100 people)

• Skin reactions such as hives or facial, eye, mouth, lip, tongue, or throat swelling, which may make swallowing or breathing difficult.
• Stomach or intestinal bleeding, which may be detected by observing blood in the stool, black stools resembling tar, or feeling unwell, which may contain red or dark blood particles that resemble coffee grounds.

Rare(may affect up to 1 in 1,000 people)

• An increase in infections, which may be observed as fever, intense chills, sore throat, or mouth ulcers (this may indicate a low white blood cell count).
• Potentially life-threatening skin reactions such as widespread red skin areas, blisters, or peeling, and bleeding from the lips, genitals, eyes, or mouth (these may include Stevens-Johnson syndrome or toxic epidermal necrolysis).
• A skin reaction with itching, red rash.
• A stomach or intestinal ulcer. You may notice stomach swelling, painful or burning sensation, or sensitivity in the stomach or intestinal area, loss of appetite, dizziness (nausea) with or without vomiting. You may also notice stomach or intestinal bleeding.

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

• Yellowing of the skin or white of the eyes, dark urine, pale stools, and general feeling of discomfort (this may indicate severe liver problems).
• Scant or no urine production, painful or difficult urination, cloudy or dark urine, blood in the urine, or lower back pain (these may indicate severe kidney problems, which are observed in patients with risk factors such as low blood volume, advanced age, and severe cardiac, renal, or hepatic problems).
• A tear in the stomach or intestine. You may experience severe pain or bleeding in the stomach or intestine.
• A drastic reduction in white blood cells in the blood. You may notice an increase in infections.
• A widespread rash like measles on the entire body.
• Blisters that form between the skin layers, usually on the legs and arms, which may burst.

Medicines like meloxicam may be associated with a small increase in the risk of heart attack or stroke.

• If you experience severe chest pain, which may radiate to the jaw and arm, feel sweaty, or have difficulty breathing, these may be signs of a heart attack.
• If you experience numbness or weakness on one side of the body, notice one side of the face drooping, have trouble speaking, blurred or lost vision, these may be signs of a stroke.

Frequency not known(cannot be estimated from available data)

• Severe allergic reactions, which may cause skin itching, red rash, facial, eye, mouth, lip, tongue, or throat inflammation, which may cause difficulty swallowing or breathing, dizziness, or nausea, wheezing, collapse, or loss of consciousness.
• A characteristic skin allergic reaction known as fixed drug eruption, which usually reappears at the same site upon re-exposure to the medication and may appear as rounded or oval-shaped skin patches with redness and swelling, blistering (urticaria), and itching.

Other side effects are:

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

• Indigestion.
• Nausea (feeling sick).
• Vomiting (being sick).
• Stomach pain.
• Constipation.
• Gas.
• Diarrhea.

Common (may affect up to 1 in 10 people)

• Headache.

Uncommon (may affect up to 1 in 100 people)

• Pale complexion with headache, difficulty breathing during exercise, or feeling abnormally tired (may indicate a low red blood cell count).
• Other allergic reactions, which may cause sneezing and eye itching.
• Dizziness.
• A sensation of spinning (vertigo).
• Somnolence.
• Increased blood pressure.
• Sensation of flushing.
• Stomach or intestinal inflammation.
• Belching.
• Elevated potassium or sodium levels in the blood.
• Mouth ulcers.
• Abnormalities in renal or hepatic function, detected in a blood test.
• Swelling (fluid retention), especially in the feet or ankles.
• Rash.

Rare (may affect up to 1 in 1,000 people)

• Unexplained petechiae or bleeding that lasts longer than usual (may indicate a low platelet count in the blood).
• Abnormalities in the blood, detected in a blood test.
• Mood changes.
• Nightmares.
• Tinnitus.
• Fast heartbeats, which may feel like stabbing in the chest (palpitations).
• Visual problems such as blurred vision or tearing, eye itching (conjunctivitis).
• Chest tightness, difficulty breathing, or wheezing (it is possible that you may have asthma, especially if you are allergic to other NSAIDs like aspirin).
• Acid reflux, which may be a sign of esophagitis.
• Inflammation of the large intestine, which may cause pain, cramps, and diarrhea.

Frequency not known(cannot be estimated from available data)

• Sensitivity to light, increased risk of sunburn.
• Confusion.
• Disorientation.
• Pancreatitis (inflammation of the pancreas).
• Female infertility, delayed ovulation.

Other side effects observed in other nonsteroidal anti-inflammatory drugs (NSAIDs), but which have not yet been observed with meloxicam:

• Heart failure.
• Other severe kidney problems.

Reporting of 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 the Vigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not take this medication after the expiration date that appears on the blister pack and the outer carton after CAD or EXP. The expiration date is the last day of the month indicated.

Store in the original packaging.

Medications should not be disposed of through drains or in the trash. Dispose of the 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 the packaging and medications you no longer need.This will help protect the environment.

Composition of Meloxicam Mylan

• The active ingredient is meloxicam. Each tablet contains 15 mg of meloxicam.
• The other components are microcrystalline cellulose, pregelatinized cornstarch, lactose monohydrate, cornstarch, sodium citrate, anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and contents of the packaging

Yellowish pale, round, and flat tablets with a breaking line on one face.

PVC/PVdC/Al blisters containing 7, 10, 14, 15, 20, 28, 30, 50, 60, 100, 140, 280, 300, 500, or 1000 tablets. Some packaging sizes may only be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Mylan Pharmaceuticals, S.L.

C/ Plom, 2-4, 5th floor

08038 - Barcelona

Spain

Responsible manufacturer:

McDermott Laboratories Ltd. t/a Gerard Laboratories

35/36 Baldoyle Industrial Estate. Grange Road, 13

Dublin

Ireland

Or

Chanelle Medical Limited

IDA Ind Estate, Loughrea, Co. Galway

Ireland

Or

Mylan Hungary Kft./Mylan Hungary Ltd.

Mylan utca 1.

Komárom, 2900

Hungary

This medicine is authorized in the member states of the European Economic Area with the following names:

SpainMeloxicam Mylan 15 mg tablets EFG

IrelandAreloger

PortugalMeloxicam Mylan

Last review date of this leaflet:July 2023

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