MELOXICAM MYLAN 15 mg TABLETS

1. What is Meloxicam Mylan and what is it used for

Meloxicam Mylan contains the active substance 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 of age for:

• Short-term treatment of acute attacks of osteoarthritis (joint disease).
• Long-term treatment of pain associated with rheumatoid arthritis (inflammation of the joints).
• Long-term treatment of a similar disease called ankylosing spondylitis (inflammation of the spine).

2. What you need to know before you take Meloxicam Mylan

Do not take Meloxicam Mylan:

• During the last trimester of pregnancy.
• If you are a child or adolescent under 16 years of age.
• If you are allergic to meloxicam or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to acetylsalicylic acid (e.g. aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs).
• If you have a history of wheezing, chest tightness, shortness of breath (asthma), nasal polyps, swelling around the eyes, face, lips, mouth, or throat that leads to difficulty breathing (angioedema) or itching (urticaria) after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
• If you currently have a stomach or intestinal bleed.
• 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 perforation of the stomach or intestine after using 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 on dialysis.
• If you have severe 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 (rounded or oval patches with redness and swelling of the skin that usually recur in the same place, blistering, urticaria, and itching) after taking meloxicam or other oxicams (e.g. piroxicam).
• If you have previously had esophagitis (inflammation of the esophagus); gastritis (inflammation of the stomach lining) and/or stomach ulcers, as your doctor should check that you no longer have any of these diseases before you start 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 increased risk of adverse effects).
• If you have a very low blood volume (you may have had significant blood loss, undergone surgery, or have low fluid intake).
• If you have other kidney, liver, or heart problems.
• If your blood potassium levels are high.
• If you are trying to become pregnant or are having your fertility investigated.

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

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

Life-threatening skin rashes (Stevens-Johnson syndrome and toxic epidermal necrolysis) have been reported with the use of meloxicam, which initially appear as red, circular, or oval patches, often with a central blister. Other additional signs that may appear are sores in the mouth, throat, nose, genitals, and conjunctivitis (swollen and red eyes).

These life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or peeling of the skin. The period of greatest risk of serious 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, stop taking meloxicam, go immediately to a doctor, and inform them that you are taking this medicine.

During treatment

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

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

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

Other medicines and Meloxicam Mylan

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. The following medicines may affect or be affected by meloxicam:

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

• Oral antidiabetics (sulfonylureas and nateglinide). Medicines used to treat diabetes. Your doctor should carefully monitor your blood sugar levels to determine the risk of hypoglycemia.

Pregnancy, breastfeeding, and fertility

Pregnancy

Do not take this medicine during the last trimester of pregnancy, as it may harm the fetus or cause complications during delivery. It may cause heart or kidney problems in the fetus. It may also affect the baby's tendency to bleed 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, you should be given the lowest dose for the shortest possible time. If you take it for more than a few days at 20 weeks of pregnancy or later, Meloxicam Mylan may cause kidney problems in the fetus, leading to low levels of the fluid that surrounds the baby (oligohydramnios) or narrowing of the blood vessels (ductus arteriosus) in the baby's heart. If you need to take the treatment for more than a few days, your doctor may recommend additional monitoring.

Breastfeeding

NSAIDs may pass into breast milk. You should not breastfeed while taking this medicine.

Fertility

It may be more difficult to become pregnant with this medicine. Talk to your doctor if you are planning to become pregnant or if you are having your fertility investigated.

Driving and using machines

Meloxicam may cause side effects that can affect your ability to drive or use machines. Some examples of these effects include visual disturbances such as blurred vision, drowsiness, dizziness, a spinning sensation (vertigo), and other problems that affect the brain. If you experience any of these effects, you should avoid driving or using machines.

Meloxicam Mylan contains lactose

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

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

3. How to take Meloxicam Mylan

Follow exactly the instructions of administration of this medicine given by your doctor or pharmacist. Consult your doctor or pharmacist if you have any 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 side effects, tell your doctor. Your doctor will monitor your condition and treatment.

Use in adults and adolescents over 16 years of age

Acute attacks of osteoarthritis:The recommended dose is 7.5 mg per day. Your doctor may increase this dose to 15 mg once a day if no improvement is observed.

Treatment of rheumatoid arthritis or ankylosing spondylitis: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.

Reduced kidney and liver function:

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

Patients with non-severe kidney or liver problems may be given the usual recommended doses for adults, as described above.

The use of meloxicam is not recommended in patients with severe kidney failure who are not on dialysis or with severe liver failure.

Use in elderly patients

If you are an elderly person, 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 of age 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 score line is only to facilitate breaking the tablet if you find it difficult to swallow whole.

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

If you take more Meloxicam Mylan than you should

If you have taken more meloxicam than you should, talk to your doctor immediately, call the Toxicology Information Service, phone 91 562 04 20, or go to the emergency department of the nearest hospital. Bring this leaflet and any remaining tablets. You may experience an allergic reaction (see section 4) or feel weak, drowsy, nauseous, or vomit, or experience stomach pain or stomach or intestinal bleeding. The most serious effects can be high blood pressure, kidney failure, liver problems, respiratory problems, coma, seizures, or heart problems.

If you forget to take Meloxicam Mylan

If you forget 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 forgotten doses.

If you stop taking Meloxicam Mylan

Do not stop taking this medicine without talking to your doctor.

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

4. Possible Adverse Effects

Like all medicines, this medicine can have adverse effects, although not all people suffer from them.

Stop taking this medicine and contact your doctor or go to the emergency department of the nearest hospital immediately if you experience any of theseeffects:

Uncommon(may affect up to 1 in 100 people)

• Skin reactions such as rash with itching or swelling of the face, eyes, mouth, lips, tongue, or throat, which can make swallowing or breathing difficult.
• Stomach or intestinal bleeding, which can be detected by observing blood in the stool, black stools resembling tar, or feeling sick, 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 can be observed as fever, severe chills, sore throat, or mouth ulcers (this may indicate that you have a low white blood cell count).
• Potentially life-threatening skin reactions such as widespread areas of red skin, with blisters or peeling, and bleeding of the lips, genitals, eyes, or mouth (these may include Stevens-Johnson syndrome or toxic epidermal necrolysis).
• A skin reaction with red, itchy rash.
• An ulcer in the stomach or intestine. You may notice stomach swelling, burning pain, or sensitivity in the stomach or intestinal area, loss of appetite, feeling of 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 the whites of the eyes, dark urine, pale stools, and a feeling of general malaise (this may indicate that you have serious liver problems).
• Low or no urine production, pain or difficulty urinating, cloudy or dark urine, blood in the urine, or lower back pain (may indicate serious kidney problems, which are observed in patients with risk factors such as low blood volume, advanced age, and severe heart, kidney, or liver 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 all over the body.
• Blisters that form between the layers of the skin, usually on the legs and arms, which can burst.

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

• If you experience severe chest pain that 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 that one side of your face is drooping, have trouble speaking, or experience blurred vision or loss of vision, these may be signs of a stroke.

Frequency Not Known(cannot be estimated from the available data)

• Severe allergic reactions, which can cause skin itching, red skin rash, swelling of the face, eyes, mouth, lips, tongue, or throat, which can cause difficulty swallowing or breathing, feeling of fainting or dizziness, wheezing, collapse, or loss of consciousness.
• A characteristic skin allergic reaction known as fixed drug eruption, which usually recurs in the same location in case of re-exposure to the medicine and may appear as rounded or oval patches with redness and swelling of the skin, blister formation (hives), and itching.

Other adverse 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 skin with headache, difficulty breathing when exercising, or feeling abnormally tired (may indicate a low red blood cell count).
• Other allergic reactions, which can cause sneezing and itching eyes.
• Dizziness.
• A spinning sensation (vertigo).
• Drowsiness.
• Increased blood pressure.
• Feeling of flushing.
• Stomach or intestinal inflammation.
• Belching.
• High levels of potassium or sodium in the blood.
• Mouth ulcers.
• Alterations in kidney or liver function, detected in a blood test.
• Swelling (fluid retention), especially of the feet or ankles.
• Rash.

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

• Unexplained bruising or bleeding that lasts longer than usual (may indicate a low platelet count in the blood).
• Blood alterations, detected in a blood test.
• Mood changes.
• Nightmares.
• Ringing in the ears.
• Fast heartbeats, which feel like stabbing in the chest (palpitations).
• Vision problems such as blurred vision or tearing, eye itching (conjunctivitis).
• Chest tightness, difficulty breathing, or wheezing (you may have asthma, especially if you are allergic to other NSAIDs like acetylsalicylic acid).
• Acidity, may be a sign that you have esophagitis (inflammation of the esophagus).
• Inflammation of the large intestine, which can cause pain, cramps, and diarrhea.

Frequency Not Known(cannot be estimated from the available data)

• Skin sensitivity to light, sunburn with greater ease.
• Confusion.
• Disorientation.
• Pancreatitis (inflammation of the pancreas).
• Female infertility, delayed ovulation.

Other adverse effects observed in other non-steroidal anti-inflammatory drugs (NSAIDs), but not yet observed with meloxicam:

• Heart failure.
• Other serious kidney problems.

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 that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Meloxicam Mylan

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

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

Store in the original package.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Meloxicam Mylan

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

Appearance of the Product and Package Contents

Round, flat tablets with a pale yellow color, with a break line on one side.

PVC/PVdC/Al blisters of 7, 10, 14, 15, 20, 28, 30, 50, 60, 100, 140, 280, 300, 500, or 1000 tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Mylan Pharmaceuticals, S.L.

C/ Plom, 2-4, 5th floor

08038 - Barcelona

Spain

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 under the following names:

SpainMeloxicam Mylan 15 mg tablets EFG

IrelandAreloger

PortugalMeloxicam Mylan

Date of the Last Revision of this Leaflet:July 2023

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