Mobíc

Package leaflet: Information for the user

MOBIC 7.5 mg tablets

meloxicam
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 effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What MOBIC is and what it is used for

MOBIC contains the active substance meloxicam. Meloxicam belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), which are used to reduce inflammation and pain in the joints and muscles.
MOBIC tablets are indicated for use in adults and children over the age of 16 years.
MOBIC is indicated for:

• short-term treatment of acute exacerbations of osteoarthritis
• long-term treatment of
  • rheumatoid arthritis
  • ankylosing spondylitis

2. What you need to know before taking MOBIC

Do not take MOBIC:

• if you are allergic to meloxicam or to any of the other ingredients of this medicine (listed in section 6)
• during the last three months of pregnancy
• children and adolescents under 16 years of age
• if you have experienced any of the following symptoms after taking aspirin or other NSAIDs:
• wheezing, tightness in the chest, shortness of breath (asthma)
• nasal congestion due to swelling of the nasal mucosa (nasal polyps)
• skin rash/urticaria
• sudden swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth or throat, which may make breathing difficult (angioedema)
• after previous treatment with NSAIDs and history of:
• bleeding in the stomach or intestine
• perforation of the stomach or intestine
• ulcer or bleeding in the stomach or intestine
• recent history of peptic ulcer or gastrointestinal bleeding (ulceration or bleeding occurring at least twice)
• severe liver disease
• severe kidney disease not treated with dialysis
• recent bleeding in the brain (cerebrovascular bleeding)
• any disorder related to bleeding
• severe heart disease
• intolerance to certain sugars, as this medicine contains lactose (see also “MOBIC contains milk sugar (lactose) and sodium”)

If you think any of the events listed above apply to you, contact your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking MOBIC.
Warnings
Medicines like MOBIC may be associated with a small increased risk of heart attack (myocardial infarction) or stroke (apoplexy). The risk is greater with higher doses and prolonged treatment. Do not exceed the prescribed dose or duration of treatment (see section 3 “How to take MOBIC”).
If you have heart problems, a history of stroke, or think you may be at risk for these conditions, discuss your treatment with your doctor or pharmacist. For example, if:

• you have high blood pressure (hypertension)
• you have high blood sugar levels (diabetes mellitus)
• you have high cholesterol levels in the blood (hypercholesterolemia)
• you are a smoker

Stop treatment with MOBIC immediately if you notice bleeding (causing tar-like stools) or ulceration of the digestive tract (causing abdominal pain).
Potentially life-threatening skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of MOBIC. These initially appear as reddish spots or circular patches on the trunk, often accompanied by central blisters. Other signs to watch for include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red, swollen eyes). These potentially life-threatening skin reactions are often accompanied by flu-like symptoms. The skin rash may progress to widespread blistering or skin peeling. The highest risk of serious skin reactions occurs during the first weeks of treatment. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis while taking MOBIC, you must not take MOBIC again.
Talk to your doctor or pharmacist before taking MOBIC 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, urticaria, and itching) after taking meloxicam or other oxicams (e.g., piroxicam).
If you develop a skin reaction or the skin symptoms described above, stop taking MOBIC, seek urgent medical advice, and inform the doctor that you are taking this medicine.
MOBIC is not indicated when immediate relief from acute pain is required.
MOBIC may mask symptoms (e.g., fever) of an ongoing infection. Therefore, if you think you have contracted an infection, consult your doctor.
Precautions for use
Since dosage adjustment may be necessary, it is important that you consult your doctor before taking MOBIC if you have:

• a history of inflammation of the esophagus (esophagitis), inflammation of the stomach (gastritis), or any other disease of the digestive tract, e.g., Crohn's disease or ulcerative colitis
• high blood pressure (hypertension)
• advanced age
• heart, liver, or kidney disease
• high blood sugar levels (diabetes mellitus)
• reduced blood volume (hypovolemia), which may occur with severe blood loss, burns, surgery, or inadequate fluid intake
• diagnosed intolerance to certain sugars, as this medicine contains lactose
• previously diagnosed high levels of potassium in the blood

Your doctor will need to monitor your progress during treatment.
Other medicines and MOBIC
Since MOBIC may affect or be affected by other medicines, inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor or pharmacist if you are taking or have taken any of the following medicines:

• other NSAIDs
• potassium salts, used to prevent or treat low potassium levels in the blood
• tacrolimus, used after organ transplants
• trimethoprim, used to treat urinary tract infections
• medicines that prevent blood clotting
• medicines that break down blood clots (thrombolytics)
• medicines for heart and kidney diseases
• corticosteroids (e.g., used for inflammation or allergic reactions)
• cyclosporine, used after organ transplants or for severe skin disorders, rheumatoid arthritis, or nephrotic syndrome
• deferasirox, used to treat chronic iron poisoning due to frequent blood transfusions
• any diuretic — your doctor may monitor your kidney function if you are taking diuretics
• medicines for high blood pressure (e.g., beta-blockers)
• lithium, used to treat mood disorders
• selective serotonin reuptake inhibitors (SSRIs), used to treat depression
• methotrexate, used to treat cancer or severe uncontrolled skin disorders and active rheumatoid arthritis
• pemetrexed, used to treat cancer
• cholestyramine, used to lower cholesterol levels
• oral antidiabetics (sulfonylureas, nateglinide), used in the treatment of diabetes. Your doctor must closely monitor your blood sugar levels to prevent hypoglycemia.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take MOBIC 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 fetus. It may affect the tendency to bleed in both you and your baby and may lead to delayed or prolonged labor.
You should not take MOBIC during the first six months of pregnancy unless absolutely necessary and advised by your doctor. If you need treatment during this period or while trying to conceive, use the lowest possible dose for the shortest possible time. If taken for more than a few days starting from the 20th week of pregnancy, MOBIC may cause kidney problems in the fetus, leading 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 more than a few days is needed, your doctor may recommend additional monitoring.
If you have taken this medicine during pregnancy, contact your doctor or midwife immediately for appropriate monitoring.
Breastfeeding
This medicine is not recommended during breastfeeding.
Fertility
This medicine may affect fertility. Inform your doctor if you are planning a pregnancy or have difficulty becoming pregnant.
Driving and using machines
Visual disturbances, including blurred vision, dizziness, drowsiness, vertigo, or other central nervous system disorders may occur with this medicine. If you experience these effects, do not drive or operate machinery.
MOBIC contains milk sugar (lactose) and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them 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 MOBIC

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose is:
Acute flare-ups of osteoarthritis:
7.5 mg (one tablet) once daily. The dose may be increased to 15 mg (two tablets) once daily.
Rheumatoid arthritis:
15 mg (two tablets) once daily. The dose may be reduced to 7.5 mg (one tablet) once daily.
Ankylosing spondylitis:
15 mg (two tablets) once daily. The dose may be reduced to 7.5 mg (one tablet) once daily.
Do not exceed the maximum recommended dose of 15 mg per day.
If any of the conditions listed in section “Warnings and precautions” apply to you, your doctor may reduce your dose to 7.5 mg (one tablet) once daily.
Elderly
If you are elderly, the recommended dose for long-term treatment of rheumatoid arthritis and ankylosing spondylitis is 7.5 mg (one tablet) once daily.
Patients at increased risk of adverse reactions
If you are a patient at increased risk of adverse reactions, your doctor will start treatment with a dose of 7.5 mg (one tablet) once daily.
Renal impairment
If you are a patient undergoing dialysis or with severe renal impairment, your dose should not exceed 7.5 mg (one tablet) once daily. No dose reduction is necessary in patients with mild or moderate renal impairment.
Hepatic impairment
No dose reduction is necessary in patients with mild or moderate hepatic impairment.
Use in children and adolescents
MOBIC must not be given to children and adolescents under 16 years of age.
Contact your doctor or pharmacist if you think that the effect of MOBIC is too strong or too weak, or if you do not feel any improvement after several days.
Method of administration
For oral use.
The tablets should be swallowed with water or another liquid during a meal.
The score line is intended to facilitate breaking the tablet if you have difficulty swallowing it whole.
If you take more MOBIC than you should
If you have taken too many tablets or suspect an overdose, contact your doctor or go immediately to the nearest hospital.
Symptoms of acute NSAID overdose usually include:

• lack of energy (lethargy)
• drowsiness
• feeling unwell (nausea) and vomiting
• stomach pain (epigastric pain)
  These symptoms are generally reversible by stopping MOBIC. You may experience bleeding of the stomach or intestines (gastrointestinal bleeding).

A severe overdose may cause serious adverse drug reactions (see section 4):

• high blood pressure (hypertension)
• acute renal failure
• liver dysfunction (hepatic)
• reduced/flattened or stopped breathing (respiratory depression)
• loss of consciousness (coma)
• seizures
• circulatory collapse (cardiovascular collapse)
• cardiac arrest
• immediate allergic reactions (hypersensitivity), including:
• fainting
• shortness of breath
• skin reactions

If you forget to take MOBIC
Do not take a double dose to make up for the forgotten tablet. Take the next dose at your usual time.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Stop taking MOBIC and contact your doctor or the nearest hospital immediately if you notice:
Any allergic reaction (hypersensitivity), which may manifest as:

• skin reactions such as itching, blistering or peeling, which may be potentially life-threatening skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis), soft tissue lesions (mucosal lesions) or erythema multiforme (see section 2). Erythema multiforme is a serious allergic skin reaction causing spots, red or purple blisters, or blistered areas. It may also affect the mouth, eyes, and other moist areas of the body surface.
• swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth or throat, which may make breathing difficult, swollen ankles or legs (lower limb edema)
• shortness of breath or asthma attack
• inflammation of the liver (hepatitis). This may cause symptoms such as:
• yellowing of the skin and eyes (jaundice)
• abdominal pain
• loss of appetite

Any side effect affecting the digestive tract, especially:

• bleeding (causing tarry stools)
• ulceration of the digestive tract (causing abdominal pain)

Bleeding of the digestive tract (gastrointestinal bleeding), formation of ulcers or perforations in the digestive tract may occasionally be severe and potentially fatal, especially in elderly patients.
If you have previously experienced digestive symptoms due to long-term use of NSAIDs, inform your doctor immediately, particularly if you are elderly. Your doctor may monitor improvement during treatment.
If you experience visual disturbances, do not drive or operate machinery.
General side effects associated with non-steroidal anti-inflammatory drugs (NSAIDs)
The use of certain non-steroidal anti-inflammatory drugs (NSAIDs) may be associated with a small increased risk of arterial blockage (arterial thrombotic events), e.g. heart attack (myocardial infarction) or stroke (cerebrovascular accident), particularly at high doses and with prolonged duration of treatment.
Fluid retention (edema), high blood pressure (hypertension), and heart failure have been reported in association with NSAID therapy.
The most commonly observed side effects affect the digestive tract (gastrointestinal events):

• ulcers of the stomach and upper part of the small intestine (peptic/gastroduodenal ulcers)
• a perforation in the intestinal wall or gastrointestinal bleeding (sometimes fatal, especially in the elderly)

The following side effects have been reported after administration of NSAIDs:

• feeling unwell (nausea) and vomiting
• loose stools (diarrhea)
• flatulence
• constipation
• indigestion (dyspepsia)
• abdominal pain
• tarry stools due to bleeding in the digestive tract (melena)
• vomiting blood (haematemesis)
• inflammation with ulcer formation in the mouth (ulcerative stomatitis)
• worsening of digestive tract inflammation (such as exacerbation of colitis or Crohn’s disease)

Less frequently, inflammation of the stomach (gastritis) has been observed.
Side effects associated with meloxicam, the active substance in MOBIC
Very common: may affect more than 1 in 10 people

• gastrointestinal adverse events such as indigestion (dyspepsia), feeling unwell (nausea) and feeling unwell (vomiting), abdominal pain, constipation, flatulence, loose stools (diarrhea)

Common: may affect up to 1 in 10 people

• headache

Uncommon: may affect up to 1 in 100 people

• dizziness (mental confusion)
• sensation of spinning or dizziness (vertigo)
• drowsiness (lethargy)
• anaemia (reduced haemoglobin concentration in the blood)
• increased blood pressure (hypertension)
• flushing (temporary redness of the face and neck)
• sodium and water retention
• increased potassium levels (hyperkalaemia), which may lead to symptoms such as:
• changes in heart rhythm (arrhythmia)
• palpitations (when the heartbeat is felt more than usual)
• muscle weakness
• belching
• inflammation of the stomach (gastritis)
• gastrointestinal bleeding
• inflammation of the mouth (stomatitis)
• immediate allergic reactions (hypersensitivity)
• itching
• skin rash
• swelling due to fluid retention (edema), including swelling of the ankles/legs (lower limb edema)
• sudden swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth or throat, which may make breathing difficult (angioedema)
• transient alteration of liver function tests (e.g. increase in liver enzymes such as transaminases or an increase in the bile pigment bilirubin). Your doctor may check this with a blood test
• alteration of kidney function tests (e.g. increase in creatinine or urea)

Rare: may affect up to 1 in 1,000 people

• mood swings
• nightmares
• altered blood cell count, including:
• altered differential blood cell count
• reduced number of white blood cells (leucopenia)
• reduced number of platelets (thrombocytopenia) These side effects may lead to an increased risk of infection and symptoms such as bruising or nosebleeds.
• ringing in the ears (tinnitus)
• sensation of feeling the heartbeat (palpitations)
• stomach or upper small intestine ulcers (peptic/gastroduodenal ulcer)
• inflammation of the oesophagus (oesophagitis)
• onset of asthma attacks (observed in people allergic to aspirin or other NSAIDs)
• severe blistering of the skin or peeling (Stevens-Johnson syndrome and toxic epidermal necrolysis)
• urticaria
• visual disturbances including:
• blurred vision
• conjunctivitis (inflammation of the eyes or eyelids)
• inflammation of the large intestine (colitis)

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

• blistering of the skin (bullous reactions) and erythema multiforme. Erythema multiforme is a serious allergic skin reaction causing spots, red or purple blisters, or blistered areas. It may also affect the mouth, eyes, and other moist areas of the body surface.
• inflammation of the liver (hepatitis), which may cause symptoms such as:
• yellowing of the skin or eyes (jaundice)
• abdominal pain
• loss of appetite
• acute kidney failure, particularly in patients with risk factors such as heart disease, diabetes or kidney disease
• a perforation in the intestinal wall

Not known: frequency cannot be estimated from the available data

• confusion
• disorientation
• shortness of breath and skin reactions (anaphylactic/anaphylactoid reactions), skin rash caused by exposure to sunlight (photosensitivity reactions)
• heart failure has been reported in association with NSAID therapy
• complete loss of a specific type of white blood cells (agranulocytosis), particularly in patients taking MOBIC in combination with other medicines that are potentially inhibitory, suppressive or destructive to a component of the bone marrow (myelotoxic medicines). This may cause:
• sudden fever
• sore throat
• infections
• inflammation of the pancreas (pancreatitis)
• infertility in women, delayed ovulation
• a specific type of skin allergic reaction known as fixed drug eruption, which typically recurs at the same site(s) upon re-exposure to the medicine and may present as round or oval patches with redness and swelling of the skin, blisters (urticaria) and itching.

Side effects caused by non-steroidal anti-inflammatory drugs (NSAIDs) but not yet observed after
taking MOBIC
Alteration in kidney structure leading to acute kidney failure:

• very rare cases of kidney inflammation (interstitial nephritis)
• death of some cells within the kidney (acute tubular or papillary necrosis)
• protein in the urine (nephrotic syndrome with proteinuria)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at: https://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 MOBIC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container and carton. The expiry date refers to the last day of that month.
Store in the original packaging to protect it from moisture. Do not store above 30°C.
Do not dispose of any medicine 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 MOBIC contains
The active substance is:

• meloxicam
• one tablet contains 7.5 mg of meloxicam

The other components are:

• sodium citrate
• lactose monohydrate
• microcrystalline cellulose
• povidone
• colloidal anhydrous silica
• crospovidone
• magnesium stearate

Description of the appearance of MOBIC and the contents of the pack
MOBIC tablets are light yellow, round, with the company logo imprinted on one side and the code 59D/59D on the other.
Each MOBIC tablet has a score line. The score line is intended solely to facilitate breaking the tablet for easier administration and is not intended to divide the tablet into equal parts.
MOBIC is available in PVC/PVDC/aluminum blisters.
Pack sizes: boxes containing 1, 2, 7, 10, 14, 15, 20, 28, 30, 50, 60, 100, 140, 280, 300, 500, 1,000 tablets.
Not all pack sizes may be marketed.

Other strengths of MOBIC and other pharmaceutical forms of meloxicam
In some countries, meloxicam is also available as:

• meloxicam 15 mg tablets
• meloxicam 15 mg/1.5 ml solution for injection

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Boehringer Ingelheim International GmbH
Binger Straße 173
55216 Ingelheim am Rhein
Germany

Manufacturer
Rottendorf Pharma GmbH
Ostenfelder Straße 51 - 61
59320 Ennigerloh
Germany

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria, Estonia, Latvia, Lithuania, Poland, Portugal, Romania, Spain: Movalis
Cyprus, Greece: Movatec
Finland, France, Italy: Mobic
Germany: Mobec

Package leaflet: information for the user

MOBIC 15 mg tablets

meloxicam
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, consult 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 could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What MOBIC is and what it is used for

MOBIC contains the active substance meloxicam. Meloxicam belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), which are used to reduce inflammation and relieve joint and muscle pain.
MOBIC tablets are indicated in adults and children aged 16 years and older.
MOBIC is indicated for:

• short-term treatment of acute exacerbations of osteoarthritis
• long-term treatment of
  • rheumatoid arthritis
  • ankylosing spondylitis

2. What you should know before taking MOBIC

Do not take MOBIC:

• if you are allergic to meloxicam or to any of the other ingredients of this medicine (listed in section 6)
• during the last three months of pregnancy
• children and adolescents under 16 years of age
• if you have experienced any of the following symptoms after taking aspirin or other NSAIDs:
• wheezing, tightness in the chest, shortness of breath (asthma)
• nasal congestion due to swelling of the nasal mucosa (nasal polyps)
• skin rash/hives
• sudden swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth or throat, which may make breathing difficult (angioedema)
• after previous NSAID therapy and history of:
• gastrointestinal bleeding (stomach or intestine)
• perforation of the stomach or intestine
• ulceration or bleeding in the stomach or intestine
• recent history of peptic ulcer or gastrointestinal bleeding (ulceration or bleeding occurring at least twice)
• severe liver disease
• severe kidney disease not treated with dialysis
• recent brain hemorrhage (cerebrovascular bleeding)
• any disorder related to bleeding
• severe heart disease
• intolerance to certain sugars, as this medicine contains lactose (see also “MOBIC contains milk sugar (lactose) and sodium”)

If you think any of the above conditions apply to you, contact your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking MOBIC.
Warnings
Medicines such as MOBIC may be associated with a small increased risk of heart attack (myocardial infarction) or stroke (cerebrovascular accident). The risk is more likely with high doses and prolonged treatment. Do not exceed the prescribed dose or duration of treatment (see section 3 “How to take MOBIC”).
If you have heart problems, a history of stroke, or think you may be at risk for these conditions, discuss your treatment with your doctor or pharmacist. For example, if:

• you have high blood pressure (hypertension)
• you have high blood sugar levels (diabetes mellitus)
• you have high cholesterol levels (hypercholesterolemia)
• you are a smoker

Stop treatment with MOBIC immediately if you notice signs of gastrointestinal bleeding (such as black, tarry stools) or ulceration of the digestive tract (such as abdominal pain).
Potentially life-threatening skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of MOBIC. These initially appear as reddish, target-like spots on the trunk, often with central blisters. Other warning signs 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 skin rash may progress to widespread blistering or skin peeling. The highest risk of severe skin reactions occurs during the first weeks of treatment.
If you have previously developed Stevens-Johnson syndrome or toxic epidermal necrolysis while taking MOBIC, you must not take MOBIC again.
Talk to your doctor or pharmacist before taking MOBIC if you have previously experienced fixed drug eruptions (round or oval patches with redness or swelling of the skin that usually recur in the same location, blisters, hives, and itching) after taking meloxicam or other oxicams (e.g., piroxicam).
If you develop a skin reaction or any of the skin symptoms described above, stop taking MOBIC immediately, seek urgent medical advice, and inform the doctor that you are taking this medicine.
MOBIC is not indicated when immediate relief from acute pain is required.
MOBIC may mask symptoms (e.g., fever) of an ongoing infection. Therefore, if you suspect you have an infection, consult your doctor.
Precautions for use
Since dosage adjustment may be necessary, it is important to consult your doctor before taking MOBIC if you have:

• a history of inflammation of the esophagus (esophagitis), stomach inflammation (gastritis), or any other gastrointestinal disorder, such as Crohn’s disease or ulcerative colitis
• high blood pressure (hypertension)
• advanced age
• heart, liver, or kidney disease
• high blood sugar levels (diabetes mellitus)
• reduced blood volume (hypovolemia), which may occur after severe blood loss, burns, surgery, or inadequate fluid intake
• diagnosed intolerance to certain sugars, as this medicine contains lactose
• previously diagnosed high potassium levels in the blood

Your doctor may need to monitor your progress during treatment.
Other medicines and MOBIC
Since MOBIC may affect or be affected by other medicines, inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor or pharmacist if you are taking or have taken any of the following medicines:

• other NSAIDs
• potassium salts, used to prevent or treat low potassium levels in the blood
• tacrolimus, used after organ transplants
• trimethoprim, used to treat urinary tract infections
• medicines that prevent blood clotting
• medicines that dissolve blood clots (thrombolytics)
• medicines for heart and kidney diseases
• corticosteroids (e.g., used for inflammation or allergic reactions)
• cyclosporine, used after organ transplants or for severe skin disorders, rheumatoid arthritis, or nephrotic syndrome
• deferasirox, used to treat chronic iron overload due to frequent blood transfusions
• any diuretic — your doctor may monitor your kidney function if you are taking diuretics
• medicines for high blood pressure (e.g., beta-blockers)
• lithium, used to treat mood disorders
• selective serotonin reuptake inhibitors (SSRIs), used to treat depression
• methotrexate, used to treat cancer, severe uncontrolled skin disorders, or active rheumatoid arthritis
• pemetrexed, used to treat cancer
• cholestyramine, used to lower cholesterol levels
• oral antidiabetic agents (sulfonylureas, nateglinide), used in diabetes treatment — your doctor should closely monitor your blood sugar levels to prevent hypoglycemia

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take MOBIC 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 fetus. It may affect bleeding tendencies in both you and the baby and may lead to delayed or prolonged labor.
You should not take MOBIC during the first six months of pregnancy unless absolutely necessary and advised by your doctor. If treatment is needed during this period or while trying to conceive, use the lowest effective dose for the shortest possible time. If taken for more than a few days starting from the 20th week of pregnancy, MOBIC may cause kidney problems in the fetus, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If longer-term treatment is needed, your doctor may recommend additional monitoring.
If you have taken this medicine during pregnancy, contact your doctor or midwife immediately for appropriate monitoring.
Breastfeeding
This medicine is not recommended during breastfeeding.
Fertility
This medicine may affect fertility. Inform your doctor if you are planning a pregnancy or are having difficulty becoming pregnant.
Driving and using machines
Visual disturbances, including blurred vision, dizziness, drowsiness, vertigo, or other central nervous system disorders may occur with this medicine. If you experience any of these effects, do not drive or operate machinery.
MOBIC contains milk sugar (lactose) and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them 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 MOBIC

Take this medicine exactly as prescribed by your doctor. If you are unsure, consult your
doctor or pharmacist.
Recommended dose:
Exacerbations of osteoarthritis:
7.5 mg (half a tablet) once daily. The dose may be increased to 15 mg (one tablet) once
daily.
Rheumatoid arthritis:
15 mg (one tablet) once daily. The dose may be reduced to 7.5 mg (half a tablet) once
daily.
Ankylosing spondylitis:
15 mg (one tablet) once daily. The dose may be reduced to 7.5 mg (half a tablet) once
daily.
Do not exceed the maximum recommended dose of 15 mg per day.
If any of the conditions listed in the section “Warnings and precautions” apply to you,
your doctor may reduce your dose to 7.5 mg (half a tablet) once daily.
Elderly patients
If you are elderly, the recommended dose for long-term treatment of rheumatoid arthritis and
ankylosing spondylitis is 7.5 mg (half a tablet) once daily.
Patients at increased risk of adverse reactions
If you are a patient at increased risk of adverse reactions, your doctor will start treatment with a
dose of 7.5 mg (half a tablet) once daily.
Renal impairment
If you are a patient undergoing dialysis or with severe renal impairment, your dose should not
exceed 7.5 mg (half a tablet) once daily. No dose reduction is required in patients with mild or
moderate renal impairment.
Hepatic impairment
No dose reduction is required in patients with mild or moderate hepatic impairment.
Use in children and adolescents
MOBIC must not be administered to children and adolescents under 16 years of age.
Contact your doctor or pharmacist if you think the effect of MOBIC is too strong or too weak, or if you
do not notice any improvement after several days.
Method of administration
For oral use.
The tablets should be swallowed with water or another liquid during a meal.
The tablet may be divided into equal parts. The tablet should be split by hand and not with a sharp object (e.g. a knife).
If you take more MOBIC than you should
If you have taken too many tablets or suspect an overdose, contact your doctor or go
immediately to the nearest hospital.
Symptoms of acute NSAID overdose usually include:

• lack of energy (lethargy)
• drowsiness
• feeling unwell (nausea) and vomiting
• stomach pain (epigastric pain)
  These symptoms are generally reversible by discontinuing MOBIC. You may experience gastrointestinal bleeding (gastrointestinal haemorrhage).

A severe overdose may cause serious adverse drug reactions (see section 4):

• high blood pressure (hypertension)
• acute renal failure
• liver dysfunction (hepatic)
• reduced/flattened or stopped breathing (respiratory depression)
• loss of consciousness (coma)
• seizures
• circulatory collapse (cardiovascular collapse)
• cardiac arrest (cardiac arrest)
• immediate allergic reactions (hypersensitivity), including:
• fainting
• shortness of breath
• skin reactions

If you forget to take MOBIC
Do not take a double dose to make up for the forgotten tablet. Take the next dose at your usual time.
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 everyone will experience them.
Stop taking MOBIC and contact your doctor or the nearest hospital immediately if you notice:
Any allergic reaction (hypersensitivity), which may present as:

• skin reactions such as itching, blistering or peeling, which may be potentially life-threatening skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis), soft tissue lesions (mucosal lesions), or erythema multiforme (see section 2). Erythema multiforme is a serious allergic skin reaction causing spots, red or purple blisters, or blistered areas. It may also affect the mouth, eyes, and other moist areas of the body surface.
• swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth or throat, which may make breathing difficult, swollen ankles or legs (peripheral oedema)
• shortness of breath or asthma attack
• inflammation of the liver (hepatitis). This may cause symptoms such as:
• yellowing of the skin and eyes (jaundice)
• abdominal pain
• loss of appetite

Any side effect affecting the digestive tract, especially:

• bleeding (causing tar-coloured stools)
• ulceration of the digestive tract (causing abdominal pain)

Bleeding in the digestive tract (gastrointestinal bleeding), formation of ulcers or perforations in the digestive tract may occasionally be severe and potentially fatal, especially in elderly patients.
If you have previously experienced digestive tract symptoms due to long-term use of NSAIDs, inform your doctor immediately, especially if you are elderly. Your doctor may monitor your improvement during treatment.
If you experience visual disturbances, do not drive or operate machinery.

General side effects associated with non-steroidal anti-inflammatory drugs (NSAIDs)
The use of certain non-steroidal anti-inflammatory drugs (NSAIDs) may be associated with a small increased risk of arterial blockage (arterial thrombotic events), e.g. heart attack (myocardial infarction) or stroke (apoplexy), particularly at high doses and with long-term treatment.
Fluid retention (oedema), high blood pressure (hypertension), and heart failure have been reported in association with NSAID treatment.
The most commonly observed side effects affect the digestive tract (gastrointestinal events):

• ulcers of the stomach and upper part of the small intestine (peptic/gastroduodenal ulcers)
• a perforation in the intestinal wall or bleeding in the digestive tract (sometimes fatal, particularly in the elderly)

The following side effects have been reported after administration of NSAIDs:

• feeling unwell (nausea) and vomiting
• loose stools (diarrhoea)
• flatulence
• constipation
• indigestion (dyspepsia)
• abdominal pain
• tar-coloured stools due to bleeding in the digestive tract (melena)
• vomiting blood (haematemesis)
• inflammation with ulcer formation in the mouth (ulcerative stomatitis)
• worsening of inflammation in the digestive tract (such as exacerbation of colitis or Crohn's disease)

Less frequently, inflammation of the stomach (gastritis) has been observed.

Side effects associated with meloxicam, the active substance in MOBIC
Very common: may affect more than 1 in 10 people

• gastrointestinal adverse events such as indigestion (dyspepsia), feeling unwell (nausea) and sickness (vomiting), abdominal pain, constipation, flatulence, loose stools (diarrhoea)

Common: may affect up to 1 in 10 people

• headache

Uncommon: may affect up to 1 in 100 people

• dizziness (confusion)
• sensation of spinning or dizziness (vertigo)
• drowsiness (lethargy)
• anaemia (reduced haemoglobin concentration in the blood)
• increased blood pressure (hypertension)
• flushing (temporary redness of the face and neck)
• sodium and water retention
• increased potassium levels (hyperkalaemia), which may lead to symptoms such as:
• changes in heart rhythm (arrhythmia)
• palpitations (when the heartbeat is felt more than usual)
• muscle weakness
• belching
• inflammation of the stomach (gastritis)
• bleeding in the digestive tract
• inflammation of the mouth (stomatitis)
• immediate allergic reactions (hypersensitivity)
• itching
• skin rash
• swelling due to fluid retention (oedema), including swelling of the ankles/legs (peripheral oedema)
• sudden swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth or throat, which may make breathing difficult (angioedema)
• transient abnormalities in liver function tests (e.g. increased liver enzymes such as transaminases or increased levels of the bile pigment bilirubin). Your doctor can check this with a blood test
• abnormalities in kidney function tests (e.g. increased creatinine or urea)

Rare: may affect up to 1 in 1,000 people

• mood swings
• nightmares
• altered blood cell count, including:
• altered differential blood cell count
• reduced number of white blood cells (leucopenia)
• reduced number of platelets (thrombocytopenia). These side effects may lead to an increased risk of infection and symptoms such as bruising or nosebleeds.
• ringing in the ears (tinnitus)
• awareness of heartbeat (palpitations)
• ulcers of the stomach or upper part of the small intestine (peptic/gastroduodenal ulcer)
• inflammation of the oesophagus (oesophagitis)
• onset of asthma attacks (observed in people allergic to aspirin or other NSAIDs)
• severe blistering of the skin or peeling (Stevens-Johnson syndrome and toxic epidermal necrolysis)
• urticaria
• visual disturbances, including:
• blurred vision
• conjunctivitis (inflammation of the eyes or eyelids)
• inflammation of the large intestine (colitis)

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

• blistering of the skin (bullous reactions) and erythema multiforme. Erythema multiforme is a serious allergic skin reaction causing spots, red or purple blisters, or blistered areas. It may also affect the mouth, eyes, and other moist areas of the body surface
• inflammation of the liver (hepatitis), which may cause symptoms such as:
• yellowing of the skin or eyes (jaundice)
• abdominal pain
• loss of appetite
• acute kidney failure (renal failure), particularly in patients with risk factors such as heart disease, diabetes or kidney disease
• a perforation in the intestinal wall

Not known: frequency cannot be estimated from the available data

• confusion
• disorientation
• shortness of breath and skin reactions (anaphylactic/anaphylactoid reactions)
• skin rash caused by exposure to sunlight (photosensitivity reactions)
• heart failure has been reported in association with NSAID treatment
• complete loss of a specific type of white blood cells (agranulocytosis), particularly in patients taking MOBIC in combination with other medicines that are potentially inhibitory, suppressive or destructive to a component of the bone marrow (myelotoxic medicines), which may cause:
• sudden fever
• sore throat
• infections
• inflammation of the pancreas (pancreatitis)
• infertility in women, delayed ovulation
• a specific type of skin allergic reaction known as fixed drug eruption, which typically recurs at the same site(s) upon re-exposure to the medicine and may present as round or oval patches with redness and swelling of the skin, blisters (urticaria) and itching.

Side effects caused by non-steroidal anti-inflammatory drugs (NSAIDs), but not yet observed after
administration of MOBIC
Alteration in kidney structure leading to acute kidney failure:

• very rare cases of kidney inflammation (interstitial nephritis)
• death of some cells within the kidney (acute tubular or papillary necrosis)
• protein in the urine (nephrotic syndrome with proteinuria)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at: https://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 MOBIC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container and carton. The expiry date refers to the last day of that month.
Store in the original packaging to protect it from moisture. Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What MOBIC contains
The active substance is:

• meloxicam
• one tablet contains 15 mg of meloxicam

The other components are:

• sodium citrate
• lactose monohydrate
• microcrystalline cellulose
• povidone
• anhydrous colloidal silica
• crospovidone
• magnesium stearate

Description of the appearance of MOBIC and contents of the pack
The MOBIC tablet is light yellow, round, with the company logo imprinted on one side and the code 77C/77C on the other. Each MOBIC tablet has a scored line and can be divided into two equal halves.
MOBIC is available in PVC/PVDC/aluminum blisters.
Packs: boxes containing 1, 2, 7, 10, 14, 15, 20, 28, 30, 50, 60, 100, 140, 280, 300, 500, 1000 tablets.
Not all pack sizes may be marketed.

Other strengths of MOBIC and other pharmaceutical forms of meloxicam
In some countries, meloxicam is also available as:

• meloxicam 7.5 mg tablets
• meloxicam 15 mg per 1.5 ml solution for injection

Marketing Authorization Holder
Boehringer Ingelheim International GmbH
Binger Straße 173
55216 Ingelheim am Rhein
Germany

Manufacturer
Rottendorf Pharma GmbH
Ostenfelder Straße 51 - 61
59320 Ennigerloh
Germany

This medicinal product is authorized in the European Economic Area countries under the following names:
Austria, Bulgaria, Croatia, Estonia, Latvia, Lithuania, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Hungary: Movalis
Belgium, Finland, France, Italy, Luxembourg: Mobic
Cyprus, Greece: Movatec
Germany: Mobec

Package leaflet: Information for the user

MOBIC 15 mg/1.5 ml solution for injection

meloxicam
Please read this leaflet carefully before using 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What MOBIC is and what it is used for

MOBIC contains the active substance meloxicam. Meloxicam belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), which are used to reduce inflammation and pain in the joints and muscles.
MOBIC injectable solution is indicated for use in adults.
MOBIC is indicated for the treatment of:

• rheumatoid arthritis
• ankylosing spondylitis, when other routes of administration, such as tablets, are not appropriate.

2. What you should know before taking MOBIC

Do not take MOBIC:

• if you are allergic to meloxicam or to any of the other ingredients of this medicine (listed in section 6)
• during the last three months of pregnancy
• children and adolescents under 18 years of age
• if you have experienced any of the following symptoms after taking aspirin or other NSAIDs:
• wheezing, tightness of the chest, shortness of breath (asthma)
• nasal obstruction due to swelling of the nasal mucosa (nasal polyps)
• skin rash/hives
• sudden swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth or throat, which may make breathing difficult (angioedema)
• after previous NSAID therapy and history of:
• bleeding in the stomach or intestine
• perforation of the stomach or intestine
• ulcer or bleeding in the stomach or intestine
• recent history of peptic ulcer or gastrointestinal bleeding (ulceration or bleeding occurring at least twice)
• severe liver disease
• severe kidney disease not treated with dialysis
• recent bleeding in the brain (cerebrovascular bleeding)
• any disorder related to bleeding
• concomitant treatment with anticoagulants (as intramuscular hematoma may occur)
• severe heart disease

If you think any of the above conditions apply to you, contact your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking MOBIC.
Warnings
Medicines such as MOBIC may be associated with a small increased risk of heart attack (myocardial infarction) or stroke (cerebrovascular accident). The risk is more likely with high doses and prolonged treatment. Do not exceed the prescribed dose or duration of treatment (see section 3 “How to take MOBIC”).
If you have heart problems, a history of stroke, or think you may be at risk for these conditions, you should discuss your treatment with your doctor or pharmacist. For example, if:

• you have high blood pressure (hypertension)
• you have high blood sugar levels (diabetes mellitus)
• you have high cholesterol levels in the blood (hypercholesterolemia)
• you are a smoker

Stop treatment with MOBIC immediately if you notice bleeding (causing black, tarry stools) or ulceration of the digestive tract (causing abdominal pain).
Potentially life-threatening skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of MOBIC. These initially present as red spots or circular patches on the trunk, often accompanied by central blisters. Other signs to watch for include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red, swollen eyes). These potentially life-threatening skin reactions are often accompanied by flu-like symptoms. The skin rash may progress to widespread blistering or skin peeling. The highest risk of severe skin reactions occurs during the first weeks of treatment.
If you have previously developed Stevens-Johnson syndrome or toxic epidermal necrolysis while taking MOBIC, you must not take MOBIC again.
Talk to your doctor or pharmacist before taking MOBIC if you have previously developed fixed drug eruption (round or oval patches with redness or swelling of the skin that usually recur in the same location, blisters, hives, and itching) after taking meloxicam or other oxicams (e.g., piroxicam).
If you develop a skin reaction or any of the above-mentioned skin symptoms, stop taking MOBIC immediately, seek urgent medical advice, and inform the doctor that you are taking this medicine.
MOBIC is not indicated when immediate relief from acute pain is required.
MOBIC may mask symptoms (e.g., fever) of an ongoing infection. Therefore, if you suspect you have an infection, consult your doctor.
Precautions for use
Since dosage adjustment may be necessary, it is important to consult your doctor before taking MOBIC if you have:

• history of inflammation of the esophagus (esophagitis), inflammation of the stomach (gastritis), or any other gastrointestinal disease, e.g., Crohn’s disease or ulcerative colitis
• high blood pressure (hypertension)
• advanced age
• heart, liver, or kidney disease
• high blood sugar levels (diabetes mellitus)
• reduced blood volume (hypovolemia), which may occur due to severe blood loss, burns, surgery, or inadequate fluid intake
• previously diagnosed high potassium levels in the blood

Your doctor will need to monitor your progress during treatment.
Other medicines and MOBIC
Since MOBIC may affect or be affected by other medicines, inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
In particular, inform your doctor or pharmacist if you are taking or have taken any of the following medicines:

• other NSAIDs
• potassium salts, used to prevent or treat low potassium levels in the blood
• tacrolimus, used after organ transplants
• trimethoprim, used to treat urinary tract infections
• medicines that prevent blood clotting
• medicines that break down blood clots (thrombolytics)
• medicines for heart and kidney diseases
• corticosteroids (e.g., used for inflammation or allergic reactions)
• cyclosporine, used after organ transplants or for severe skin disorders, rheumatoid arthritis, or nephrotic syndrome
• deferasirox, used to treat chronic iron poisoning due to frequent blood transfusions
• any diuretic — your doctor may monitor your kidney function if you are taking diuretics
• medicines for high blood pressure (e.g., beta-blockers)
• lithium, used to treat mood disorders
• selective serotonin reuptake inhibitors (SSRIs), used to treat depression
• methotrexate, used to treat cancer or severe uncontrolled skin disorders and active rheumatoid arthritis
• pemetrexed, used to treat cancer
• colestyramine, used to lower cholesterol levels
• oral antidiabetics (sulfonylureas, nateglinide), used in the treatment of diabetes — your doctor must carefully monitor your blood sugar levels to prevent hypoglycemia.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take MOBIC during the last three months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in the fetus. It may affect your or your baby’s tendency to bleed and may cause delayed or prolonged labor.
You should not take MOBIC during the first six months of pregnancy unless absolutely necessary and advised by your doctor. If treatment is needed during this period or while trying to conceive, use the lowest possible dose for the shortest possible time. If taken for more than a few days starting from the 20th week of pregnancy, MOBIC may cause kidney problems in the fetus, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If you require treatment for more than a few days, your doctor may recommend additional monitoring.
If you have taken this medicine during pregnancy, contact your doctor or midwife immediately to ensure appropriate monitoring.
Breastfeeding
This medicine is not recommended during breastfeeding.
Fertility
This medicine may affect fertility. You should inform your doctor if you are planning a pregnancy or have difficulty becoming pregnant.
Driving and using machines
Visual disturbances, including blurred vision, dizziness, drowsiness, vertigo, or other central nervous system disorders may occur with the use of this product. If you experience such effects, do not drive or operate machinery.
MOBIC contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 1.5 ml vial, i.e., essentially ‘sodium-free’.

3. How to take MOBIC

MOBIC is for intramuscular use only. The injection must be administered only by experienced healthcare personnel.
The solution must be administered slowly into a muscle, usually into a gluteal muscle. In case of repeated administration, it is recommended to alternate between the left and right side. In case of hip prosthesis, the injection must be given on the opposite side. The injection must be immediately stopped if severe pain occurs during administration.

Dosage
Treatment consists of a single daily injection during the initial therapy phase, with a maximum extension of 2 or 3 days in exceptional cases (i.e. when oral administration is not possible).
Do not exceed the recommended maximum daily dose of 15 mg.
If any of the conditions listed in the section “Warnings and precautions” apply to you, your doctor may reduce your dose to 7.5 mg (half vial of 1.5 ml) once daily.

Elderly
If you are elderly, the recommended dose for long-term treatment of rheumatoid arthritis and ankylosing spondylitis is 7.5 mg (half vial of 1.5 ml) once daily.

Patients at increased risk of adverse reactions
If you are a patient at increased risk of adverse reactions, your doctor will initiate treatment with a dose of 7.5 mg (half vial of 1.5 ml) once daily.

Renal impairment
If you are a patient undergoing dialysis or with severe renal impairment, your dose should not exceed 7.5 mg (half vial of 1.5 ml) once daily. No dose reduction is required/necessary in patients with mild or moderate renal impairment.

Hepatic impairment
No dose reduction is necessary in patients with mild or moderate hepatic impairment.

Use in children and adolescents
MOBIC must not be administered to children and adolescents under 18 years of age.

Contact your doctor or pharmacist if you think that the effect of MOBIC is too strong or too weak, or if you do not experience any improvement after several days.

If you use more MOBIC than you should
If you have administered too many vials or suspect an overdose, contact your doctor or go immediately to the nearest hospital.

Symptoms of acute NSAID overdose are usually limited to:

• lack of energy (lethargy)
• drowsiness
• feeling unwell (nausea) and vomiting
• stomach pain (epigastric pain)

These symptoms are generally reversible by discontinuing MOBIC. Gastrointestinal bleeding (gastrointestinal haemorrhage) may occur.

A severe overdose may cause serious adverse drug reactions (see section 4):

• high blood pressure (hypertension)
• acute renal failure
• liver dysfunction (hepatic)
• reduced/flattened or stopped breathing (respiratory depression)
• loss of consciousness (coma)
• convulsions
• circulatory collapse (cardiovascular collapse)
• cardiac arrest (cardiac arrest)
• immediate allergic reactions (hypersensitivity), including:
• fainting
• shortness of breath
• skin reactions

If you forget to take MOBIC
Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time.

If you have any doubts about the use of 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 MOBIC and contact your doctor or the nearest hospital immediately if you notice:
Any allergic reaction (hypersensitivity), which may manifest as:

• Skin reactions such as itching, blistering or peeling, which may be potentially life-threatening skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis), soft tissue lesions (mucosal lesions) or erythema multiforme (see section 2). Erythema multiforme is a serious allergic skin reaction causing spots, red or purple blisters, or blistered areas. It may also affect the mouth, eyes, and other moist areas of the body surface.
• Swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth or throat, which may make breathing difficult, swollen ankles or legs (peripheral edema)
• Shortness of breath or asthma attack
• Inflammation of the liver (hepatitis). This may cause symptoms such as:
• Yellowing of the skin and eyes (jaundice)
• Abdominal pain
• Loss of appetite

Any gastrointestinal side effects, especially:

• Bleeding (causing tar-colored stools)
• Ulceration of the gastrointestinal tract (causing abdominal pain)

Gastrointestinal bleeding, formation of ulcers or perforations in the gastrointestinal tract can sometimes be serious and potentially fatal, particularly in elderly patients.
If you have previously experienced gastrointestinal symptoms due to long-term use of NSAIDs, inform your doctor immediately, especially if you are elderly. Your doctor may monitor improvement during treatment.
If you experience visual disturbances, do not drive or operate machinery.

General side effects associated with non-steroidal anti-inflammatory drugs (NSAIDs)
The use of some non-steroidal anti-inflammatory drugs (NSAIDs) may be associated with a small increased risk of arterial blockage (arterial thrombotic events), e.g. heart attack (myocardial infarction) or stroke (apoplexy), particularly at high doses and with prolonged treatment duration.
Fluid retention (edema), high blood pressure (hypertension), and heart failure have been reported in association with NSAID treatment.
The most commonly observed side effects are gastrointestinal (gastrointestinal events):

• Stomach and upper small intestine ulcers (peptic/gastroduodenal ulcers)
• A perforation in the intestinal wall or gastrointestinal bleeding (sometimes fatal, especially in the elderly)

The following side effects have been reported after administration of NSAIDs:

• Feeling unwell (nausea) and vomiting
• Loose stools (diarrhea)
• Flatulence
• Constipation
• Indigestion (dyspepsia)
• Abdominal pain
• Tar-colored stools due to gastrointestinal bleeding (melena)
• Vomiting blood (hematemesis)
• Inflammation with ulcer formation in the mouth (ulcerative stomatitis)
• Worsening of gastrointestinal inflammation (such as exacerbation of colitis or Crohn's disease)

Less frequently, inflammation of the stomach (gastritis) has been observed.

Side effects associated with meloxicam, the active substance in MOBIC

Very common: may affect more than 1 in 10 people

• Gastrointestinal adverse events such as indigestion (dyspepsia), feeling unwell (nausea) and feeling unwell (vomiting), abdominal pain, constipation, flatulence, loose stools (diarrhea)

Common: may affect up to 1 in 10 people

• Headache
• Swelling at injection site, pain at injection site

Uncommon: may affect up to 1 in 100 people

• Dizziness (mental confusion)
• Sensation of spinning or dizziness (vertigo)
• Drowsiness (lethargy)
• Anaemia (reduced haemoglobin concentration in the blood)
• Increased blood pressure (hypertension)
• Flushing (temporary redness of face and neck)
• Sodium and water retention
• Increased potassium levels (hyperkalaemia), which may lead to symptoms such as:
• Changes in heart rhythm (arrhythmia)
• Palpitations (when heartbeat is felt more than usual)
• Muscle weakness
• Belching
• Inflammation of the stomach (gastritis)
• Gastrointestinal bleeding
• Inflammation of the mouth (stomatitis)
• Immediate allergic reactions (hypersensitivity)
• Itching
• Skin rash
• Swelling due to fluid retention (edema), including swelling of ankles/legs (peripheral edema)
• Sudden swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth or throat, which may make breathing difficult (angioedema)
• Transient abnormal liver function tests (e.g. increased liver enzymes such as transaminases or increased bile pigment bilirubin). Your doctor can check this with a blood test
• Abnormal kidney function tests (e.g. increased creatinine or urea)

Rare: may affect up to 1 in 1,000 people

• Mood swings
• Nightmares
• Altered blood cell count, including:
• Altered differential blood cell count
• Reduced number of white blood cells (leucopenia)
• Reduced number of platelets (thrombocytopenia). These side effects may lead to an increased risk of infection and symptoms such as bruising or nosebleeds.
• Ringing in the ears (tinnitus)
• Sensation of feeling the heartbeat (palpitations)
• Stomach or upper small intestine ulcers (peptic/gastroduodenal ulcer)
• Inflammation of the oesophagus (oesophagitis)
• Onset of asthma attacks (observed in people allergic to aspirin or other NSAIDs)
• Severe blistering or peeling of the skin (Stevens-Johnson syndrome and toxic epidermal necrolysis)
• Hives (urticaria)
• Vision disturbances including:
• Blurred vision
• Conjunctivitis (inflammation of the eyes or eyelids)
• Inflammation of the large intestine (colitis)

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

• Blistering of the skin (bullous reactions) and erythema multiforme. Erythema multiforme is a serious allergic skin reaction causing spots, red or purple blisters, or blistered areas. It may also affect the mouth, eyes, and other moist areas of the body surface.
• Inflammation of the liver (hepatitis), which may cause symptoms such as:
• Yellowing of the skin or eyes (jaundice)
• Abdominal pain
• Loss of appetite
• Acute kidney failure (renal failure), particularly in patients with risk factors such as heart disease, diabetes or kidney disease
• A perforation in the intestinal wall

Not known: frequency cannot be estimated from the available data

• Confusion
• Disorientation
• Anaphylactic shock
• Shortness of breath and skin reactions (anaphylactic/anaphylactoid reactions)
• Skin rash caused by exposure to sunlight (photosensitivity reactions)
• Heart failure has been reported in association with NSAID treatment
• Complete loss of a specific type of white blood cells (agranulocytosis), particularly in patients taking MOBIC in combination with other medicines that are potentially inhibitory, suppressive or destructive to a component of the bone marrow (myelotoxic medicines), which may cause:
• Sudden fever
• Sore throat
• Infections
• Inflammation of the pancreas (pancreatitis)
• Infertility in women, delayed ovulation
• A specific type of drug-induced skin allergy known as fixed drug eruption, which typically recurs at the same site(s) upon re-exposure to the medicine and may present as round or oval patches with redness and swelling of the skin, blisters (urticaria), and itching.

Side effects caused by non-steroidal anti-inflammatory drugs (NSAIDs) but not yet observed after taking MOBIC

Alteration of kidney structure leading to acute kidney failure:

• Very rare cases of kidney inflammation (interstitial nephritis)
• Death of some cells within the kidney (acute tubular or papillary necrosis)
• Protein in the urine (nephrotic syndrome with proteinuria)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system 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 MOBIC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container and carton. The expiry date refers to the last day of that month.
Keep the container in the outer packaging to protect it from light.
Do not dispose of any medicine 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 MOBIC contains
The active substance is:

• meloxicam
• one vial contains 15 mg of meloxicam

The other components are:

• meglumine
• glycofurole
• poloxamer 188
• sodium chloride
• glycine
• sodium hydroxide
• water for injections

Description of the appearance of MOBIC and package contents
MOBIC solution is yellow with greenish tints.
MOBIC is available in colorless glass vials of 1.5 ml in 2 ml.
Pack sizes: boxes containing 1, 2, 3, 5, 25, 30, 50 vials.
Not all pack sizes may be marketed.

Other forms of meloxicam available
In some countries, meloxicam is also available as:

• meloxicam 7.5 mg tablets
• meloxicam 15 mg tablets

Marketing Authorization Holder
Boehringer Ingelheim International GmbH
Binger Straße 173
55216 Ingelheim am Rhein
Germany

Manufacturer
Boehringer Ingelheim España SA
Prat de la Riba, 50
08174 Sant Cugat del Vallès (Barcelona)
Spain

This medicinal product is authorized in the European Economic Area countries under the following names:
Austria, Belgium, France, Italy, Luxembourg: Mobic
Austria, Bulgaria, Croatia, Estonia, Latvia, Lithuania, Poland, Portugal, Czech Republic, Romania, Slovakia, Slovenia, Spain, Hungary: Movalis
Greece: Movatec
France: Hexaphlogin