Meloxicam Mylan Generics: detailed information

Patient Information Leaflet

Meloxicam Mylan Generics 7.5 mg Tablets, 15 mg Tablets

Meloxicam
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. 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 their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Meloxicam Mylan Generics is and what it is used for
What you need to know before taking Meloxicam Mylan Generics
How to take Meloxicam Mylan Generics
Possible side effects
How to store Meloxicam Mylan Generics
Contents of the pack and other information

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

Meloxicam Mylan Generics 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 Generics is used for:

short-term treatment of acute exacerbations of osteoarthritis (joint disease).
long-term treatment of pain associated with rheumatoid arthritis (inflammation of the joints).
long-term treatment of symptoms of ankylosing spondylitis (inflammation of the spine).

2. What you need to know before taking Meloxicam Mylan Generics

Do not take Meloxicam Mylan Generics

During the last three months of pregnancy
If you are a child or adolescent under 16 years of age
If you are allergic to meloxicam or to any of the ingredients of this medicine (listed in section 6)
If you are allergic to acetylsalicylic acid (e.g. aspirin) or to other non-steroidal anti-inflammatory drugs (NSAIDs)
If you previously experienced symptoms such as wheezing, tightness in the chest, shortness of breath (asthma), swelling inside the nose due to blockage (nasal polyps), swelling around the eyes, face, lips, mouth or throat causing difficulty in breathing (angioedema), or hives (urticaria) after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs)
If you currently have stomach or intestinal bleeding
If you have or have had two or more episodes of stomach or intestinal ulcer or bleeding
If you have ever had stomach or intestinal bleeding or perforation after using NSAIDs
If you have or have had bleeding problems or bleeding of blood vessels in the brain (cerebrovascular bleeding)
If you have severe liver problems
If you have severe kidney failure and are not undergoing dialysis
If you suffer from severe heart failure

Warnings and precautions
Talk to your doctor or pharmacist before taking Meloxicam Mylan Generics:

If you have previously developed fixed drug eruptions (round or oval patches with redness or swelling of the skin that usually recur in the same spot/s, blisters, hives and itching) after taking meloxicam or other oxicams (e.g. piroxicam)
If you have a history of inflammation of the oesophagus (oesophagitis); inflammation of the stomach lining (gastritis) and/or gastric ulcers, because your doctor will need to check that you no longer have these conditions before starting treatment
If you have a history of stomach or intestinal problems (such as Crohn’s disease or ulcerative colitis)
If you are elderly (due to an increased risk of side effects)
If you have very low blood volume (you may have had significant blood loss, recent surgery, or reduced fluid intake)
If you have other liver, kidney or heart problems
If you have high levels of potassium in your blood
If you are trying to become pregnant or undergoing fertility testing

Medicines such as Meloxicam Mylan Generics may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. The risk is greater with higher 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 stroke, or think you may be at risk of these conditions (for example, if you have high blood pressure, diabetes, high cholesterol levels or are a smoker), you should discuss your treatment with your doctor or pharmacist.
Potentially life-threatening skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Meloxicam Mylan Generics. These initially appear as round red spots or circular patches, often with blisters in the central trunk area.
Other signs to watch for include mouth, throat, nose, genital ulcers and conjunctivitis (red, swollen eyes).
These potentially life-threatening skin reactions are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or skin peeling.
The highest risk of severe skin reactions occurs within the first weeks of treatment.
If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis while using Meloxicam Mylan Generics, you must never use meloxicam again. If a skin rash or these symptoms occur, stop taking Meloxicam Mylan Generics immediately and seek urgent medical advice, informing the doctor that you are taking this medicine.

During treatment
If you have intestinal problems, especially if you are elderly, speak to your doctor immediately if you experience stomach or intestinal problems (particularly bleeding) in the first days after starting treatment with Meloxicam Mylan Generics. This is more likely if you have had previous intestinal problems or are elderly. Intestinal bleeding may be indicated by black, tarry stools or vomiting blood or dark particles resembling coffee grounds (see section 4).
This medicine may affect the results of certain blood or urine tests. Always inform your doctor or hospital staff that you are taking this medicine if you are due to have any tests.
This medicine may mask symptoms of certain infections. For example, it may mask fever. If you feel unwell and suspect you may have an infection, speak to your doctor.

Other medicines and Meloxicam Mylan Generics
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 interact with or be affected by Meloxicam Mylan Generics:

Anticoagulants (medicines used to reduce blood clotting), such as warfarin, heparin, clopidogrel, dabigatran, apixaban and ticlopidine, because meloxicam may increase their effect or increase the risk of bleeding
Other non-steroidal anti-inflammatory drugs (NSAIDs) such as acetylsalicylic acid (aspirin) or other medicines known as "COX-2 inhibitors" such as celecoxib
Lithium (a medicine used to treat mental health conditions)
Methotrexate (a medicine used for psoriasis, inflammation and certain types of cancer)
Thrombolytics (medicines used to dissolve blood clots in certain heart conditions)
Cholestyramine (a medicine used to lower 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 (tablets that increase water elimination)
Medicines for high blood pressure, such as ACE inhibitors, angiotensin II receptor antagonists (sartans) or beta-blockers
Corticosteroids (for asthma, inflammation and after organ transplant surgery), because the risk of ulcers or bleeding is higher
Selective serotonin reuptake inhibitors (SSRIs) (medicines used for depression)
Pemetrexed, a medicine used to treat certain types of cancer. This medicine may need to be stopped for at least 5 days before, during and for 2 days after pemetrexed treatment
Medicines that may increase potassium levels in the blood. These include potassium salts or supplements, certain diuretics (e.g. spironolactone) or the antibiotic trimethoprim
Deferasirox, a medicine used to reduce iron levels in the blood
Oral antidiabetic agents (sulfonylureas, nateglinide) – medicines used to treat diabetes. Your doctor should closely monitor your blood glucose levels due to the risk of hypoglycaemia

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, suspect you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Do not take this medicine during the last three months of pregnancy, as it may harm the unborn baby or cause problems during delivery. It may cause kidney and heart problems in the unborn baby. It may affect your and your baby’s tendency to bleed and delay or prolong labour beyond the expected time.
You should not take Meloxicam Mylan Generics during the first six months of pregnancy unless absolutely necessary and under medical advice. If treatment is needed during this period or during attempts to conceive, the lowest effective dose for the shortest possible time should be used.
From week 20 of pregnancy, Meloxicam Mylan Generics may cause kidney problems in the unborn baby if taken for more than a few days, thereby reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or cause narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is required for more than a few days, your doctor may recommend additional monitoring.

Breastfeeding
NSAIDs can pass into breast milk. You must not breastfeed while taking this medicine.

Fertility
This medicine may make it more difficult to become pregnant. Inform your doctor if you are planning a pregnancy or undergoing fertility testing.

Driving and using machines
Meloxicam may cause side effects that could impair your ability to drive or operate machinery.
Examples of such side effects include visual disturbances such as blurred vision, drowsiness, dizziness, vertigo or other brain-related problems. If you experience any of these side effects, refrain from driving or operating machinery.

Meloxicam Mylan Generics contains lactose and sodium
If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".

3. How to take Meloxicam Mylan Generics

Always take this medicine exactly as instructed by your doctor or pharmacist. Ask your
doctor or pharmacist if you are unsure.
Your doctor will prescribe the lowest possible dose for the shortest duration necessary to treat your symptoms.
If your condition does not improve or if you experience any side effects, inform your doctor. Your
doctor must monitor your condition and treatment.
Use in adults and adolescents over 16 years of age
Exacerbation of osteoarthritis: The recommended dose is 7.5 mg once daily. This dose may
be increased by your doctor to 15 mg once daily if no improvement has occurred.
Treatment of pain due to rheumatoid arthritis or ankylosing spondylitis: The recommended dose is 15 mg
once daily. Your doctor may reduce the dose to 7.5 mg daily if symptoms improve.
Do not exceed a dose of 15 mg per day.
Renal and hepatic impairment:
In patients undergoing dialysis or with severe renal impairment, the recommended dose must not exceed 7.5 mg per
day.
Patients with mild renal or hepatic impairment may take the normal recommended adult doses mentioned above.
Meloxicam Mylan Generics is not recommended for use in patients with severe renal impairment not
undergoing dialysis or with severe hepatic impairment.
Use in the elderly:
If you are elderly, your doctor may advise you to take a lower dose. The recommended dose for the treatment
of rheumatoid arthritis and ankylosing spondylitis is 7.5 mg daily.
Use in children and adolescents:
Children under 16 years of age must not take Meloxicam Mylan Generics.
Take Meloxicam Mylan Generics orally as a single dose with water or another beverage and with food.
For Meloxicam Mylan Generics 7.5 mg tablets: the score line is intended only to facilitate breaking the
tablet if you have difficulty swallowing it whole.
For Meloxicam Mylan Generics 15 mg tablets: the tablet may be divided into two equal doses.
If you take more Meloxicam Mylan Generics than you should
Contact your doctor or the nearest hospital emergency department. Take this leaflet and any remaining
tablets with you.
You may experience an allergic reaction (see section 4), or feel weak, tired, nauseous, or vomit, have
stomach pain or gastrointestinal bleeding. More serious effects may include increased
blood pressure, renal failure, liver problems, coma, seizures, or cardiac problems.
If you forget to take Meloxicam Mylan Generics
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 a forgotten dose.
If you stop taking Meloxicam Mylan Generics
Do not stop taking this medicine without first talking to your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking this medicine and contact your doctor immediately or go to the nearest hospital Emergency Department
if you experience any of the following side effects:
Uncommon (may affect up to 1 in 100 people)

Bleeding in the stomach or intestines, which you may notice as blood in your stools, tar-like stools, or vomiting blood or dark particles resembling coffee grounds; bloated stomach, burning pain or tenderness in the stomach or abdominal area, loss of appetite, nausea with or without vomiting. These may also be symptoms of a stomach or intestinal ulcer or perforation.

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

Increased risk of infections, shown as fever, severe chills, sore throat, or mouth ulcers (these signs may indicate that you have a low white blood cell count)
Potentially life-threatening skin reactions, such as widespread redness of the skin, blisters, peeling, or bleeding of the lips, eyes, genitals, or mouth (which may include Stevens-Johnson Syndrome or toxic epidermal necrolysis).

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

Yellowing of the skin or whites of the eyes, dark urine, pale stools, and a general feeling of being unwell (these symptoms may indicate serious liver problems)
Production of little or no urine, pain or difficulty passing urine, cloudy or dark urine, blood in the urine, or back pain (these symptoms may indicate serious kidney problems, observed in patients with risk factors such as reduced blood volume, elderly patients, or serious heart, kidney, or liver problems)
Signs of a heart attack or stroke, which may be caused by a blood clot
signs of a heart attack include: chest pain that may spread to the upper body, or a feeling of tightness or heaviness in the chest, accompanied by sweating, nausea, vomiting, or dizziness
signs of a stroke include: weakness or numbness of the face, arms, or legs, sudden severe headache, sudden change in speech or confusion, sudden disturbances in balance, coordination, or walking, or loss of consciousness or seizures.

Not known (frequency cannot be estimated from the available data)

Severe allergic reaction causing swelling of the face, eyes, mouth, lips, tongue, or throat, which may cause difficulty in swallowing or breathing.
A specific skin allergic reaction known as fixed drug eruption, which usually recurs at the same site(s) upon re-exposure to the medicine and may appear as round or oval patches with redness and swelling of the skin, blisters (urticaria), and itching.

Other side effects include:
Very common (may affect more than 1 in 10 people)

Indigestion
Nausea
Vomiting
Stomach pain
Constipation
Bloating
Diarrhoea.

Common (may affect up to 1 in 10 people)

Headache

Uncommon (may affect up to 1 in 100 people)

Paleness with headache, shortness of breath during physical activity, or unusual tiredness (these may indicate a low red blood cell count)
Other allergic reactions such as skin rash, hives, or itching
Dizziness
Vertigo
Fatigue
Increased blood pressure
Flushing sensations
Inflammation of the stomach or intestines
Belching
Elevated levels of potassium or sodium in the blood
Mouth ulcers
Changes in kidney or liver function observed in blood tests
Swelling (fluid retention), especially in the feet or ankles

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

Unexplained bruising or prolonged bleeding (these may indicate a low platelet count)
Blood abnormalities observed in laboratory tests
Mood disturbances
Nightmares
Ringing in the ears
Rapid heartbeat that feels like pounding in the chest (palpitations)
Vision problems, including blurred vision or itchy, watery eyes (conjunctivitis)
Chest tightness, shortness of breath, or wheezing (you may have asthma, especially if you are allergic to other NSAIDs such as aspirin)
Heartburn, which may be a sign of inflammation of the oesophagus (oesophagitis)
Watery and persistent diarrhoea, possibly containing blood

Not known (frequency cannot be estimated from the available data)

Skin sensitivity to light, e.g. increased risk of sunburn
Confusion
Disorientation
Pancreatitis (inflammation of the pancreas)
Female infertility, delayed ovulation

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

Heart failure
Other serious kidney problems.

Medicines such as meloxicam may be associated with a small increased risk of heart attack or stroke.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the Italian Medicines Agency (Agenzia Italiana del Farmaco) at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Meloxicam Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and outer carton. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Meloxicam Mylan Generics contains

The active substance is meloxicam. Each tablet contains 7.5 mg or 15 mg of meloxicam.
The other ingredients are: Microcrystalline cellulose, pregelatinized corn starch, lactose monohydrate, corn starch, sodium citrate, colloidal anhydrous silica, magnesium stearate.

Description of the appearance of Meloxicam Mylan Generics and package contents
Meloxicam Mylan Generics 7.5 mg Tablets: pale yellow, round tablets with a line impressed on one side.
Meloxicam Mylan Generics 15 mg Tablets: pale yellow, round tablets with a line impressed on one side.
Available in pack sizes 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 S.p.A. - Via Vittor Pisani, 20 – 20124 Milan, Italy

Manufacturers
Chanelle Medical Limited
Loughrea, Co Galway – Ireland
McDermott Laboratories t/a Gerard Laboratories
Baldoyle Industrial Estate, Grange Road, Dublin 13 – Ireland
Generics [UK] Ltd
Station Close, Potters Bar, Hertfordshire, EN6 1TL – United Kingdom
Mylan Hungary Kft
H-2900 Komarom, Mylan utca 1 - Hungary

This medicinal product is authorised in the European Economic Area Member States under the following names:
Belgium Meloxicam Viatris 7.5 mg & 15 mg tablets
Italy Meloxicam Mylan Generics 7.5 mg & 15 mg
United Kingdom Meloxicam 7.5 mg & 15 mg Tablets
Czech Republic Meloxicam Viatris 15 mg
Slovakia Meloxicam Viatris 7.5 mg & 15 mg