MELOXICAM 7.5 mg Coated tablets

Зміст інструкції

1. Meloxicam Mylan Generics 7.5 mg Tablets, 15 mg Tablets
   1. What is Meloxicam Mylan Generics and what is it used for
   2. What you need to know before taking Meloxicam Mylan Generics
   3. How to take Meloxicam Mylan Generics
   4. Possible side effects
   5. How to store Meloxicam Mylan Generics
   6. Contents of the pack and other information

Meloxicam Mylan Generics 7.5 mg Tablets, 15 mg Tablets

Meloxicam

Generic equivalent medicine

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Meloxicam Mylan Generics is and what it is used for
• 2. What you need to know before you take Meloxicam Mylan Generics
• 3. How to take Meloxicam Mylan Generics
• 4. Possible side effects
• 5. How to store Meloxicam Mylan Generics
• 6. Contents of the pack and other information

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

Meloxicam Mylan Generics contains the active ingredient meloxicam. Meloxicam belongs to the group of
non-steroidal anti-inflammatory drugs (NSAIDs) used for the treatment of pain and inflammation in
muscles and joints.
Meloxicam Mylan Generics is used for:

• short-term treatment of osteoarthritis flare-ups (joint disease).
• long-term treatment of pain associated with rheumatoid arthritis (joint inflammation).
• long-term treatment of the 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 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 previously experienced symptoms of wheezing, chest tightness, shortness of breath (asthma), swelling inside the nose caused by a blockage (nasal polyps), swelling around the eyes, face, lips, mouth or throat, which causes difficulty breathing (angioedema) or urticarial rash (hives) following treatment with acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
• If you currently have a bleeding stomach or intestine
• If you have had two or more episodes of ulcers or bleeding in the stomach or intestine.
• If you have ever had bleeding or perforations in the stomach or intestine after using NSAIDs
• If you have or have had bleeding problems or bleeding in the brain (cerebrovascular haemorrhage).
• 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 developed a fixed drug eruption in the past (round or oval patches with redness or swelling of the skin that usually reappear in the same point(s), blisters, hives and itching) after taking meloxicam or other oxicams (e.g. piroxicam)
• If you have a history of inflammation of the esophagus (esophagitis); inflammation of the stomach lining (gastritis) and/or gastric ulcers, because the doctor will need to check that you no longer have these disorders before starting treatment
• If you have a history of problems with the stomach or intestine (such as Crohn's disease or ulcerative colitis)
• If you are elderly (due to an increase in undesirable effects)
• If you have a very low blood volume (you may have had significant blood loss, surgery or reduced fluid intake)
• If you have other problems with the liver, kidneys or heart
• If you have high levels of potassium in your blood
• If you are trying to become pregnant or are undergoing fertility tests

Medicines like Meloxicam Mylan Generics can be associated with a small increased risk of heart attacks (“myocardial infarction”) or stroke. The risk is more likely with high doses and with prolonged treatment. Do not exceedthe recommended dose or duration of treatment. If you have heart problems (including angina or reduced circulation), a history of stroke or think you might be at risk of these conditions (e.g. if you have high blood pressure, diabetes, high cholesterol levels or are a smoker), you should talk to your doctor or pharmacist about your treatment.
Life-threatening skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Meloxicam Mylan Generics, these initially appear as red, round spots or circular patches that are often accompanied by blisters on the central part of the trunk.
Further signs to note include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes).
These life-threatening skin reactions are often accompanied by flu-like symptoms. The rash may progress with the development of widespread blisters or peeling of the skin.
The highest risk of developing severe skin reactions occurs within the first weeks of treatment.
If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of Meloxicam Mylan Generics, you should not reuse meloxicam. If a rash or these symptoms occur, stop taking Meloxicam Mylan Generics and seek urgent medical advice and inform them that you are taking this medicine.

During treatment
If you have had problems with the intestine, especially if you are elderly, tell your doctor immediately if you have stomach or intestinal problems (especially bleeding) in the first few days after starting treatment with Meloxicam Mylan Generics. This is more likely to happen if you have had intestinal problems in the past or if you are elderly. Intestinal bleeding can be identified by the presence of tarry stools or if you vomit, they may contain red or dark particles that resemble coffee grounds (see section 4).
This medicine can affect the results of some blood or urine tests. Always tell your doctor or hospital staff that you are taking this medicine if you are going to have tests.
This medicine can mask the symptoms of some infections. For example, it can mask fever. If you are feeling unwell and think you may have an infection, talk to your doctor.

Other medicines and Meloxicam Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken or might take other medicines, including those obtained without a prescription. The following medicines can affect 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 may increase the possibility 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 conditions related to mental health)
• Methotrexate (a medicine used for psoriasis, inflammation and some forms of cancer)
• Thrombolytics (medicines used to dissolve blood clots in certain heart diseases)
• Cholestyramine (a medicine used to reduce cholesterol levels in the blood)
• Calcineurin inhibitors (medicines used to treat autoimmune diseases such as rheumatoid arthritis or used after an organ transplant) such as cyclosporine or tacrolimus
• Diuretics (pills that promote the elimination of water)
• Medicines to treat high blood pressure, such as ACE inhibitors, angiotensin II receptor blockers (sartans) or beta-blockers
• Corticosteroids (for asthma, inflammation and after organ transplant surgery) because you are more likely to have ulcers or bleeding
• Selective serotonin reuptake inhibitors (SSRIs) (medicines used for depression)
• Pemetrexed, a medicine used to treat some types of cancer. This medicine may need to be stopped for at least 5 days before, during and for 2 days after treatment with pemetrexed
• Medicines that can increase potassium levels in the blood. These include potassium salts or supplements, some diuretics (e.g. spironolactone) or the antibiotic trimethoprim
• Deferasirox, a medicine used to reduce iron levels in the blood.
• Oral antidiabetics (sulfonylureas, nateglinide) - medicines used to treat diabetes. The doctor should carefully monitor blood sugar for the risk of hypoglycemia.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, if you suspect or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take this medicine during the last 3 months of pregnancy because it could harm the fetus or cause problems during childbirth. It may cause problems with the fetus's kidneys and heart. It may affect your and your baby's tendency to bleed and delay or prolong labor more than expected.
You should not take Meloxicam Mylan Generics during the first 6 months of pregnancy unless absolutely necessary and under the advice of your doctor. If you need treatment during this period or during attempts to conceive, the minimum dose should be used for the shortest possible time. From the 20th week of pregnancy, Meloxicam Mylan Generics can cause kidney problems in the fetus, if taken for more than a few days, reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or causing the narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
NSAIDs can pass into breast milk. You should not breastfeed while taking this medicine.
Fertility
This medicine may make it more difficult to become pregnant. Tell your doctor if you are planning a pregnancy or are undergoing fertility tests.

Driving and using machines
Meloxicam can cause side effects that can alter your ability to drive or use machines.
Examples of 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 using machines.

Meloxicam Mylan Generics contains lactose and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact 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 your doctor or pharmacist has told you. Ask your
doctor or pharmacist if you are not sure.
Your doctor will give you the lowest possible dose, for the shortest time, to treat your symptoms.
If your condition does not improve or if you suffer any undesirable effect, inform your doctor. Your
doctor needs to monitor your condition and the treatment.

Use in adults and adolescents over 16 years of age

Flare-up of osteoarthritis: The recommended dose is 7.5 mg once a day. This dose may
be increased by your doctor to 15 mg once a day if there has been no improvement.

Treatment of pain from rheumatoid arthritis or ankylosing spondylitis: The recommended dose is 15 mg
once a day. Your doctor may reduce the dosage to 7.5 mg per day if symptoms improve.
Never exceed a dose of 15 mg per day.

Renal and hepatic impairment:
In patients undergoing dialysis, with severe renal failure, the recommended dose should not exceed 7.5 mg
per day.
Patients with non-severe renal or hepatic problems may take the normal doses recommended for
adults mentioned above.
Meloxicam Mylan Generics is not recommended for use in patients with severe renal failure not
undergoing dialysis or with severe hepatic failure.

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 per day

Use in children and adolescents:
Children under 16 years of age should not take Meloxicam Mylan Generics.
Take Meloxicam Mylan Generics orally as a single dose with water or another beverage and
in conjunction with meals.
For Meloxicam Mylan Generics 7.5 mg tablets: the score line is only to facilitate breaking the
tablet if you have difficulty swallowing it whole.
For Meloxicam Mylan Generics 15 mg tablets: the tablet can be divided into two equal doses.

If you take more Meloxicam Mylan Genericsthan you should
the tablets that remain with you.
You may have an allergic reaction (see section 4) or feel weak, tired, with nausea or vomiting, have
stomach pain or bleeding in the stomach or intestines. More serious effects may be increased
blood pressure, kidney failure, liver problems, coma, convulsions or heart 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
to take the next dose. Do not take a double dose to make up for a forgotten one.

If you stop taking Meloxicam Mylan Generics
Do not stop taking the medicine without talking to your doctor first.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

Stop taking this medicine and contact your doctor immediately or go to the nearest hospital emergency room
if the following side effects occur:
Uncommon(may affect up to 1 in 100 people)

• Bleeding from the stomach or intestine which you may notice with blood in your stools or tarry stools, or if your vomit contains red or dark particles of blood that look like coffee grounds, swollen stomach, burning or sensitivity in the stomach or abdomen, loss of appetite, nausea with or without vomiting. These can also be symptoms of an ulcer or perforation of the stomach or intestine.

Rare(may affect up to 1 in 1000)

• Increased infections which manifest with fever, severe chills, sore throat or mouth ulcers (these signs may indicate that you have a low number of white blood cells in your body)
• Skin reactions with potential risk of life, such as large areas of skin reddened, with blisters or peeling and 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)

• Yellowing of the skin or whites of the eyes, dark urine, pale stools and a general feeling of being unwell (these symptoms may indicate that you have serious liver problems)
• Production of a small or no amount of urine, pain or difficulty urinating, cloudy or dark urine, blood in the urine or back pain (these symptoms may indicate that you have serious kidney problems, observed in patients with risk factors such as reduced blood volume, elderly, serious heart, kidney or liver problems)
• Signs of a heart attack or stroke, which may be caused by a blood clot
• the 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, with sweating, nausea, vomiting or dizziness
• the signs of stroke include weakness or numbness of the face, arms or legs, sudden severe headache, sudden alteration of speech or confusion, sudden changes in balance, coordination or gait, or loss of consciousness or convulsions.

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 can cause difficulty swallowing or breathing.
• A particular allergic skin reaction known as fixed drug eruption, which typically reappears in the same point(s) with re-exposure to the medicine and which may manifest as round or oval patches with redness and swelling of the skin, blisters (hives) and itching.

Other side effects include:

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

• Indigestion
• Nausea
• Vomiting
• Stomach pain
• Constipation
• Flatulence
• 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 on exertion or feeling unusually tired (these may indicate a low number of red blood cells)
• Other allergic reactions such as skin rash, hives or itching
• Dizziness
• Vertigo
• Fatigue
• Increased blood pressure
• Sensations of hot flushes
• Inflammation of the stomach or intestine
• Belching
• Elevated levels of potassium or sodium in the blood
• Mouth ulcers
• Changes in kidney or liver function observed with blood tests
• Swelling (fluid retention) especially of the feet or ankles

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

• Unexplained bruising or bleeding for longer than normal (these may indicate a low number of platelets in the blood)
• Changes in blood observed in laboratory tests
• Mood disturbances
• Nightmares
• Tinnitus (ringing in the ears)
• Fast heartbeat that feels like hammering in the chest (palpitations)
• Problems with vision, including blurred vision or itchy, watery eyes (conjunctivitis)
• Tightness in the chest, shortness of breath or wheezing (may have asthma, especially if you are allergic to other NSAIDs such as aspirin)
• Heartburn which may be a sign that you have inflammation of the esophagus (esophagitis)
• Watery and persistent diarrhea, possibly containing blood

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

• Skin sensitivity to light, e.g. with easier appearance 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 like meloxicam may be associated with a small increased risk of heart attack or stroke.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the Italian
Medicines Agency at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side
effects you 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 which is stated on the blister and the 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 any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Meloxicam Mylan Generics contains

• The active ingredient 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, Anhydrous colloidal silica, Magnesium stearate.

Description of the appearance of Meloxicam Mylan Generics and contents of the pack
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
They are available in packs 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 Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan S.p.A. - Via Vittor Pisani, 20 – 20124 Milan, Italy
Manufacturer
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 Member States of the European Economic Area with 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