MOBIC 15 mg /1,5 Ml Injectable Solution

Зміст інструкції

1. MOBIC 7,5 mg tablets
   1. What is MOBIC and what is it 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. Package contents and other information
2. MOBIC 15 mg tablets
   1. What is MOBIC 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. Package contents and other information
3. MOBIC 15 mg/1,5 ml injectable solution
   1. What is MOBIC and what is it 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

MOBIC 7,5 mg tablets

Meloxicam

Read this leaflet carefully before you start 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 they have the same symptoms as you, 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 MOBIC is and what it is used for
• 2. What you need to know before you take 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 is MOBIC and what is it used for

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

• short-term treatment of osteoarthritis flare-ups
• 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 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 signs after taking aspirin or other NSAIDs
• wheezing, chest tightness, shortness of breath (asthma)
• nasal obstruction 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 that can make breathing difficult (angioedema)
• after a previous therapy with NSAIDs and a history of:
• bleeding in the stomach or intestines
• perforations in the stomach or intestines
• ulcer or bleeding in the stomach or intestines
• recent history of peptic ulcer or bleeding in the stomach (ulceration or bleeding that has occurred at least twice)
• severe liver disease
• severe kidney disease not treated with dialysis
• recent bleeding in the brain (cerebrovascular haemorrhage)
• any bleeding disorder
• severe heart disease
• intolerance to certain sugars as this medicine contains lactose (see also “MOBIC contains lactose”)

If you think any of these apply to you, contact your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking MOBIC.

Warnings
Medicines such as MOBIC can be associated with a modest increase in the risk of
heart attack (myocardial infarction) or stroke. Any risk is more likely with
high doses and prolonged treatments. Do not exceed the dose or duration of treatment prescribed
(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 therapy 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 your blood (hypercholesterolemia)
• you are a smoker

Stop taking MOBIC immediately if you experience bleeding
(causing tarry stools) or ulceration of the digestive tract (causing abdominal pain).
Life-threatening skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of MOBIC, which initially manifest as reddish spots or circular patches on the trunk, often accompanied by central blisters. Further
signs to watch out for include ulcers in the mouth, throat, nose, genitals and conjunctivitis
(red and swollen eyes). These potentially life-threatening skin reactions are often accompanied by
flu-like symptoms. The rash may progress with the formation of widespread blisters
or peeling of the skin. The highest risk of developing severe skin reactions occurs in the
first weeks of treatment.
If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of MOBIC,
you must not reuse MOBIC.
If you develop a skin reaction or the skin symptoms described above, stop taking
MOBIC, urgently contact a doctor and report that you are taking this medicine.
MOBIC is not indicated when immediate relief from acute pain is required.
MOBIC can mask the symptoms (e.g. fever) of an ongoing infection. Therefore, if you think you
have an infection, consult your doctor.

Precautions for use
Because the dosage may need to be adjusted, it is important that you ask your doctor for advice before
taking MOBIC if you have:

• a history of inflammation of the esophagus (esophagitis), of the stomach (gastritis) or a history of 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 can occur in case of severe blood loss or a burn, surgery or poor fluid intake
• intolerance diagnosed by a doctor to certain sugars, as this medicine contains lactose
• high levels of potassium in the blood, previously diagnosed by a doctor

The doctor will need to monitor your progress during treatment.

Other medicines and MOBIC
Because MOBIC can affect or be affected by other medicines, tell your doctor or
pharmacist if you are taking, have recently taken or might take any other
medicines.
In particular, tell 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 the treatment of heart and kidney diseases
• corticosteroids (e.g. used against inflammation or allergic reactions)
• cyclosporine, used after organ transplants or for severe skin conditions, rheumatoid arthritis or nephrotic syndrome
• deferasirox, used to treat chronic iron poisoning due to frequent blood transfusions
• any diuretic. The doctor may monitor your kidney function if you are taking diuretics
• medicines for the treatment of 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 tumors or severe non-controlled skin conditions 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 should carefully monitor your blood sugar levels to prevent hypoglycemia.

If you have any doubts, ask your doctor or pharmacist.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
During the first and second trimester of pregnancy, your doctor will prescribe this medicine
only if strictly necessary due to the potential risk of miscarriage or
malformation. In this case, the dose should be kept as low as possible and the duration of
treatment should be as short as possible.
During the last three months of pregnancy, this medicine is contraindicated: you must NEVER
take this medicine as it can have serious or even fatal consequences for the fetus,
even after a single dose, especially on the heart, lungs and/or kidneys.
If you have taken this medicine during pregnancy, contact your doctor or
midwife immediately to undergo appropriate monitoring.

Breastfeeding
This medicine is not recommended during breastfeeding.

Fertility
This medicine may alter fertility. You should inform your doctor if you are planning a
pregnancy or have difficulty getting pregnant.

Driving and operating machinery
Visual disturbances, including blurred vision, dizziness, drowsiness, vertigo or other disturbances at the level
of the central nervous system can occur with the intake of this product. If you experience
such effects, do not drive vehicles or use machinery.

MOBIC contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking
this medicine.

3. How to take MOBIC

Take this medicine following exactly the instructions of your doctor. If you have doubts
consult your doctor or pharmacist.

The recommended dose is:
Flare-ups of osteoarthritis:
7.5 mg (one tablet) once a day. The dose may be increased to 15 mg (two
tablets) once a day.

Rheumatoid arthritis:
15 mg (two tablets) once a day. The dose may be reduced to 7.5 mg (one tablet)
once a day.

Ankylosing spondylitis:
15 mg (two tablets) once a day. The dose may be reduced to 7.5 mg (one tablet)
once a day.

Do not exceed the recommended maximum dose of 15 mg per day.
If any of the conditions listed in the chapter “ Warnings and precautions” applies to your
case, your doctor may reduce your dose to 7.5 mg (one tablet) once a day.

Elderly
If you are elderly, the recommended dose for the long-term treatment of rheumatoid arthritis and
ankylosing spondylitis is 7.5 mg (one tablet) once a day.

Patients with increased risk of adverse reactions
If you are a patient with an increased risk of adverse reactions, your doctor will start treatment with
a dose of 7.5 mg (one tablet) once a day.

Renal impairment
If you are a patient undergoing dialysis, with severe renal impairment, your dose should not
exceed 7.5 mg (one tablet) once a day. No dose reduction is necessary in
patients with mild or moderate kidney damage.

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

Use in children and adolescents
MOBIC should not be administered 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 after several days you do not feel any improvement.
Method of administration
Oral use.
The tablets should be swallowed with water, or other liquid, during a meal.
The score line is 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.
The symptoms of acute NSAID overdose are usually limited to:

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

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

• high blood pressure (hypertension)
• acute renal failure
• liver dysfunction (hepatic)
• reduction/flattening or cessation of breathing (respiratory depression)
• loss of consciousness (coma)
• convulsions
• collapse of blood circulation (cardiovascular collapse)
• heart failure (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 missed tablet. Take the next
dose at the usual time.
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.

Stop taking MOBIC and immediately consult a doctor or the nearest hospital if you notice:
Any allergic reaction (hypersensitivity), which may manifest in the form of:

• skin reactions such as itching, the appearance of blisters or peeling, which can 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 severe allergic skin reaction that causes spots, red blisters or purplish or blistering areas. It can also affect the mouth, eyes and other moist areas of the body.
• swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth or throat, which can make breathing difficult, swollen ankles or legs (edema of the lower limbs)
• shortness of breath or asthma attack
• inflammation of the liver (hepatitis). This can cause symptoms such as:
• yellowing of the skin and eyes (jaundice)
• abdominal pain
• loss of appetite

Any adverse effect of the gastrointestinal tract, especially:

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

Bleeding from the gastrointestinal tract (gastrointestinal bleeding), the formation of ulcers or perforations in the gastrointestinal tract can sometimes be serious and potentially fatal, especially in elderly patients.
If you have previously suffered from symptoms of the gastrointestinal tract due to long-term use of NSAIDs, tell your doctor immediately, especially if you are elderly. The doctor may monitor improvement during treatment.
If you experience vision disturbances, do not drive vehicles or operate machinery.

Side effects generally 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 blockage of the arteries (thrombotic arterial events), e.g. heart attack (myocardial infarction) or stroke (apoplexy), particularly at high doses and for long periods of treatment.
Fluid retention (edema), high blood pressure (hypertension) and heart failure (cardiac insufficiency) have been reported in association with treatment with NSAIDs.
The most commonly observed side effects affect the gastrointestinal tract (gastrointestinal events):

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

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

• feeling unwell (nausea) and vomiting
• loose stools (diarrhea)
• flatulence
• constipation
• indigestion (dyspepsia)
• abdominal pain
• tarry stools due to bleeding in the gastrointestinal tract (melena)
• vomiting blood (hematemesis)
• inflammation with ulceration in the mouth (ulcerative stomatitis)
• worsening of inflammation of the gastrointestinal 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 ingredient of MOBIC
Very common: may affect more than 1 in 10 people

• gastrointestinal adverse events such as indigestion (dyspepsia), feeling unwell (nausea) and malaise (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 head spinning or rotating (vertigo)
• drowsiness (torpor)
• anemia (reduction in hemoglobin concentration in the blood)
• increased blood pressure (hypertension)
• flushing (temporary redness of the face and neck)
• sodium and water retention
• increased levels of potassium (hyperkalemia), which can lead to symptoms such as:
• changes in heartbeat (arrhythmia)
• palpitations (when the heartbeat is felt more than usual)
• muscle weakness
• belching
• inflammation of the stomach (gastritis)
• bleeding from the gastrointestinal tract
• inflammation of the mouth (stomatitis)
• immediate allergic reactions (hypersensitivity)
• itching
• skin rash
• swelling caused by fluid retention (edema), including swelling of the ankles/legs (edema of the lower limbs)
• sudden swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth or throat that can make breathing difficult (angioedema)
• temporary changes in liver function tests (e.g. increased liver enzymes such as transaminases or an increase in bile pigment bilirubin). The doctor can verify this by means of a blood test
• changes 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 (leukocytopenia)
• reduced number of platelets (thrombocytopenia) These side effects can lead to an increased risk of infection and symptoms such as bruising or nosebleeds.
• ringing in the ears (tinnitus)
• feeling of a racing heartbeat (palpitations)
• ulcers of the stomach or the upper part of the small intestine (peptic/gastroduodenal ulcer)
• inflammation of the esophagus (esophagitis)
• onset of asthma attacks (found in people who are allergic to aspirin or other NSAIDs)
• severe blistering of the skin or peeling (Stevens-Johnson syndrome and toxic epidermal necrolysis)
• hives
• 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

• formation of blisters on the skin (bullous reactions) and erythema multiforme. Erythema multiforme is a severe allergic skin reaction that causes spots, red blisters or purplish or blistering areas. It can also affect the mouth, eyes and other moist areas of the body.
• inflammation of the liver (hepatitis), which can cause symptoms such as:
• yellowing of the skin or eyes (jaundice)
• abdominal pain
• loss of appetite
• acute kidney failure (renal insufficiency) particularly in patients with risk factors such as heart disease, diabetes or kidney disease
• a perforation in the wall of the intestine

Not known: frequency cannot be estimated based on available data

• state of confusion
• sense of disorientation
• shortness of breath and skin reactions (anaphylactic/anaphylactoid reactions) skin rash caused by exposure to sunlight (photosensitivity reactions)
• heart failure (cardiac insufficiency) has been reported associated with treatment with NSAIDs
• total loss of a specific type of white blood cells (agranulocytosis), especially in patients taking MOBIC in association with other medicines that are potentially inhibitors, suppressors or destructive of a component of the bone marrow (myelotoxic medicines). This can cause:
• sudden fever
• sore throat
• infections
• inflammation of the pancreas (pancreatitis)
• infertility in women, delayed ovulation

Side effects caused by non-steroidal anti-inflammatory drugs (NSAIDs), but not yet found after taking MOBIC
Alteration of the structure of the kidney which determines acute renal failure:

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

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at the website of the Italian Medicines Agency: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
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 which is stated on the packaging and the carton.
The expiry date refers to the last day of that month.
Store in the original packaging to protect it from moisture.
Do not dispose of any medicine in 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 ingredient is:

• meloxicam
• one tablet contains 7.5 mg of meloxicam

The other ingredients are:

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

Description of the appearance of MOBIC and package contents
MOBIC tablets are light yellow in color, round with the company logo imprinted on one side and the code 59D/59D on the other.
Each MOBIC tablet has a fracture line. The fracture line is only intended to allow the tablet to be broken to facilitate swallowing and not to be divided 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 per 1.5 ml injectable solution

Marketing authorization holder and manufacturer
Marketing authorization holder
Boehringer Ingelheim International GmbH
Binger Straße 173
D-55216 Ingelheim am Rhein
Germany

Representative for sales in Italy
Boehringer Ingelheim Italia S.p.A.
Via Lorenzini, 8
20139 Milano

Manufacturer
Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Straße 173
D-55216 Ingelheim am Rhein
Germany
Boehringer Ingelheim Ellas A.E.
5th km Paiania - Markopoulo
194 00 Koropi
Greece

This medicinal product is authorised in the Member States of the European Economic Area under the following denominations:
Austria: Mobic 7.5 mg Tabletten; Movalis 7.5 mg Tabletten
Belgium: Mobic
Bulgaria: Movalis
Cyprus: Movatec

• Denmark: -- Estonia: Movalis Finland: Mobic 7.5 mg tabletti France: Mobic Germany: Mobec 7,5 mg Tabletten Greece: Movatec Iceland: -- Ireland: Mobic Italy: Mobic ; Leutrol Latvia: Movalis 7.5 mg Liechtenstein: -- Lithuania: Movalis 7.5 mg tabletes Luxembourg: Mobic Malta: Mobic

Norway: --
Netherlands: Movicox
Poland: Movalis
Portugal: Movalis
United Kingdom: --
Czech Republic --
Romania: Movalis 7.5 mg, comprimate
Slovakia: --
Slovenia: --
Spain: Movalis 7.5 mg comprimidos
Sweden: --
Hungary: --

MOBIC 15 mg tablets

Meloxicam

Read this leaflet carefully before you start taking this medicinebecause 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 may 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 MOBIC is and what it is used for
• 2. What you need to know before you take 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 is MOBIC and what it is used for

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

• the short-term treatment of osteoarthritis flare-ups
• the 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 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 signs after taking aspirin or other NSAIDs:
• wheezing, chest tightness, shortness of breath (asthma)
• nasal obstruction 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 that can make breathing difficult (angioedema)
• after a previous therapy with NSAIDs and a history of:
• bleeding in the stomach or intestines
• perforations in the stomach or intestines
• ulcer or bleeding in the stomach or intestines
• recent history of peptic ulcer or bleeding in the stomach (ulceration or bleeding that has occurred at least twice)
• severe liver disease
• severe kidney disease not treated with dialysis
• recent brain bleeding (cerebrovascular hemorrhage)
• any bleeding disorder
• severe heart disease
• intolerance to certain sugars as this medicine contains lactose (see also “MOBIC contains lactose”)

If you think that any of the above events 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 modest increase in the risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses
and prolonged treatments. Do not exceed the dose or duration of treatment prescribed (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 therapy 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 your blood (hypercholesterolemia)
• you are a smoker

Stop taking MOBIC immediately as soon as you experience bleeding
(causing tarry stools) or ulceration of the digestive tract (causing abdominal pain).
Life-threatening skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of MOBIC, which initially manifest as reddish spots or circular patches on the trunk, often accompanied by central blisters. Further
signs to watch out for include ulcers in the mouth, throat, nose, genitals and conjunctivitis
(red and swollen eyes). These potentially life-threatening skin reactions are often accompanied by
flu-like symptoms. The rash may progress with the formation of widespread blisters
or peeling of the skin. The highest risk of developing severe skin reactions occurs in the
first weeks of treatment.
If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of MOBIC,
you should no longer reuse MOBIC.
If you develop a skin reaction or the skin symptoms described above, stop taking
MOBIC, urgently contact a doctor and report that you are taking this medicine.
MOBIC is not indicated when immediate relief from acute pain is required.
MOBIC may mask the symptoms (e.g. fever) of an ongoing infection. Therefore, if you think you
have an infection, consult your doctor.

Precautions for use
Because the dosage may need to be adjusted, it is important to ask your doctor for advice before
taking MOBIC in case of:

• history of inflammation of the esophagus (esophagitis), inflammation of the stomach (gastritis) or a history of 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 can occur in case of severe blood loss or a burn, surgery or poor fluid intake
• intolerance diagnosed by your doctor to certain sugars, as this medicine contains lactose
• high levels of potassium in the blood, previously diagnosed by your doctor

The doctor will need to monitor your progress during treatment.

Other medicines and MOBIC
Since MOBIC can influence or be influenced by other medicines, tell your doctor or
pharmacist if you are taking, have recently taken or might take any other
medicines.
In particular, tell 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 the treatment of heart and kidney diseases
• corticosteroids (e.g. used against inflammation or allergic reactions)
• cyclosporine, used after organ transplants or for severe skin conditions, rheumatoid arthritis or nephrotic syndrome
• deferasirox, used to treat chronic iron poisoning due to frequent blood transfusions
• any diuretic. The doctor may monitor your kidney function if you are taking diuretics.
• medicines for the treatment of 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 tumors or severe uncontrolled skin conditions 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 should carefully monitor your blood sugar levels to prevent hypoglycemia

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
During the first and second trimester of pregnancy, your doctor will prescribe this medicine
only if strictly necessary due to the potential risk of miscarriage or
malformation. In this case, the dose should be kept as low as possible and the duration of
treatment should be as short as possible.
During the last three months of pregnancy, this medicine is contraindicated: you should NEVER
take this medicine as it can have serious or even fatal consequences for the fetus,
even after a single dose. If you
have taken this medicine during pregnancy, contact your doctor or midwife immediately
in order to undertake appropriate monitoring.

Breastfeeding
This medicine is not recommended during breastfeeding.

Fertility
This medicine may alter fertility. You should inform your doctor if you are planning a
pregnancy or have difficulty getting pregnant.

Driving and operating machinery
Visual disturbances, including blurred vision, dizziness, drowsiness, vertigo or other disturbances at the level
of the central nervous system can occur with the intake of this product. If you experience
such effects, do not drive vehicles or use machinery.

MOBIC contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking
this medicine.

3. How to take MOBIC

Take this medicine following exactly the instructions of your doctor. If you have doubts
consult your doctor or pharmacist.

The recommended dose is:
Exacerbations of osteoarthritis:
7.5 mg (half a tablet) once a day. The dose may be increased to 15 mg (1
tablet) once a day.

Rheumatoid arthritis:
15 mg (1 tablet) once a day. The dose may be reduced to 7.5 mg (half a tablet)
once a day.

Ankylosing spondylitis:
15 mg (1 tablet) once a day. The dose may be reduced to 7.5 mg (half a tablet)
once a day.

Do not exceed the maximum recommended dose of 15 mg per day.
If any of the conditions listed in the chapter “ Warnings and precautions” applies to your
case, your doctor may reduce your dose to 7.5 mg (half a tablet) once a day.

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

Patients with increased risk of adverse reactions
If you are a patient with an increased risk of adverse reactions, your doctor will start treatment with
a dose of 7.5 mg (half a tablet) once a day.

Renal impairment
If you are a patient undergoing dialysis, with severe renal impairment, your dose should not
exceed 7.5 mg (half a tablet) once a day. No dose reduction is necessary
in patients with mild or moderate kidney damage.

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

Use in children and adolescents
MOBIC should not be administered to children and adolescents under the age of 16 years.
Contact your doctor or pharmacist if you feel that the effect of MOBIC is too strong or too weak
or if after several days you do not feel any improvement.
Method of administration
Oral use.
The tablets should be swallowed with water, or other liquid, during a meal.
The tablet can be divided into equal parts. The tablet must be broken by hand and not from
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.
The symptoms of acute NSAID overdose are usually limited to:

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

A severe overdose may induce serious adverse drug reactions (see paragraph 4):

• high blood pressure (hypertension)
• acute kidney failure
• liver dysfunction (hepatic)
• reduction/flattening or cessation of breathing (respiratory depression)
• loss of consciousness (coma)
• convulsions
• collapse of blood circulation (cardiovascular collapse)
• heart failure (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 missed tablet. Take the next
dose at the usual time.
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.

Stop taking MOBIC and immediately consult a doctor or the nearest hospital if you notice:
Any allergic reaction (hypersensitivity), which may manifest in the form of:

• skin reactions such as itching, the appearance of blisters or peeling, which can be potentially life-threatening skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis), soft tissue lesions (mucous membrane lesions) or erythema multiforme (see paragraph 2). Erythema multiforme is a severe allergic skin reaction that causes spots, red blisters or purpura or blistering areas. It can 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 can make breathing difficult, swollen ankles or legs (edema of the lower limbs)
• shortness of breath or asthma attack
• inflammation of the liver (hepatitis). This can cause symptoms such as:
• yellowing of the skin and eyes (jaundice)
• abdominal pain
• loss of appetite

Any adverse effect of the gastrointestinal tract, especially:

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

Bleeding from the gastrointestinal tract (gastrointestinal bleeding), the formation of ulcers or perforations in the gastrointestinal tract can sometimes be serious and potentially fatal, especially in elderly patients.
If you have previously suffered from symptoms of the gastrointestinal tract due to long-term use of NSAIDs, tell your doctor immediately, especially if you are elderly. The doctor may monitor the improvement during treatment.
If you experience vision disturbances, do not drive vehicles or use machinery.

Side effects generally 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 blockage of the arteries (thrombotic arterial events), e.g. heart attack (myocardial infarction) or stroke (apoplexy), particularly at high doses and for long periods of treatment.
Fluid retention (edema), high blood pressure (hypertension) and heart failure (cardiac insufficiency) have been reported in association with treatment with NSAIDs.
The most commonly observed side effects affect the gastrointestinal tract (gastrointestinal events):

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

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

• feeling unwell (nausea) and vomiting
• loose stools (diarrhea)
• flatulence
• constipation
• indigestion (dyspepsia)
• abdominal pain
• tarry stools due to bleeding in the gastrointestinal tract (melena)
• vomiting blood (hematemesis)
• inflammation with ulceration in the mouth (ulcerative stomatitis)
• worsening of inflammation of the gastrointestinal 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 ingredient of MOBIC
Very common: may affect more than 1 in 10 people

• gastrointestinal adverse events such as indigestion (dyspepsia), feeling unwell (nausea) and malaise (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 (confusion of the mind)
• sensation of spinning or whirling (vertigo)
• drowsiness (torpor)
• anemia (reduction in hemoglobin concentration in the blood)
• increased blood pressure (hypertension)
• flushing (temporary redness of the face and neck)
• sodium and water retention
• increased levels of potassium (hyperkalemia), which can lead to symptoms such as:
• changes in heartbeat (arrhythmia)
• palpitations (when the heartbeat is felt more than usual)
• muscle weakness
• belching
• inflammation of the stomach (gastritis)
• bleeding from the gastrointestinal tract
• inflammation of the mouth (stomatitis)
• immediate allergic reactions (hypersensitivity)
• itching
• skin rash
• swelling caused by fluid retention (edema), including swelling of the ankles/legs (edema of the lower limbs)
• sudden swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth or throat that can make breathing difficult (angioedema)
• temporary changes in liver function tests (e.g. increased liver enzymes such as transaminases or an increase in bile pigment bilirubin). The doctor can check this by means of a blood test
• changes in kidney function tests (e.g. increased creatinine or urea)

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

• mood swings
• nightmares
• altered count of blood cells, including:
• altered differential blood cell count
• reduced number of white blood cells (leukocytopenia)
• reduced number of platelets (thrombocytopenia) These side effects can lead to an increased risk of infection and symptoms such as bruising or nosebleeds.
• ringing in the ears (tinnitus)
• feeling of heartbeat (palpitations)
• ulcers of the stomach or the upper part of the small intestine (peptic/gastroduodenal ulcer)
• inflammation of the esophagus (esophagitis)
• onset of asthma attacks (found in people who are 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 severe allergic skin reaction that causes spots, red blisters or purpura or blistering areas. It can also affect the mouth, eyes and other moist areas of the body surface
• inflammation of the liver (hepatitis), which can cause symptoms such as:
• yellowing of the skin or eyes (jaundice)
• abdominal pain
• loss of appetite
• acute kidney failure (renal insufficiency) particularly in patients with risk factors such as heart disease, diabetes or kidney disease
• a perforation in the wall of the intestine

Not known: frequency cannot be estimated on the basis of available data

• state of confusion
• sense of disorientation
• shortness of breath and skin reactions (anaphylactic/anaphylactoid reactions) skin rash caused by exposure to sunlight (photosensitivity reactions)
• heart failure (cardiac insufficiency) has been reported associated with treatment with NSAIDs
• total loss of a specific type of white blood cells (agranulocytosis), especially in patients who take MOBIC in association with other medicines that are potentially inhibitors, suppressors or destructive of a component of the bone marrow (myelotoxic medicines), this can cause:
• sudden fever
• sore throat
• infections
• inflammation of the pancreas (pancreatitis)
• Infertility in women, delayed ovulation

Side effects caused by non-steroidal anti-inflammatory drugs (NSAIDs), but not yet
observed after taking MOBIC
Alteration of the structure of the kidney which determines acute renal failure:

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at the website of the Italian Medicines Agency: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
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 which is stated on the packaging and the carton.
The expiry date refers to the last day of that month.
Store in the original packaging to protect it from moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Package contents and other information

What MOBIC contains
The active ingredient is:

• meloxicam
• one tablet contains 15 mg of meloxicam

The other ingredients are:

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

Description of the appearance of MOBIC and package contents
The MOBIC tablet is light yellow in color, round with the company logo imprinted on one side
and the code 77C/77C on the other. Each MOBIC tablet has a score line and can be divided into
two equal halves.
MOBIC is available in PVC/PVDC/aluminum blisters

Package sizes:boxes containing 1, 2, 7, 10, 14, 15, 20, 28, 30, 50, 60, 100, 140, 280, 300, 500, 1,000
tablets.
Not all package 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 injectable solution

Marketing authorization holder and manufacturer
Marketing authorization holder
Boehringer Ingelheim International GmbH
Binger Straße 173
D-55216 Ingelheim am Rhein
Germany

Representative for sales in Italy
Boehringer Ingelheim Italia S.p.A.
Via Lorenzini 8, 20139 Milano

Manufacturer
Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Straße 173
D-55216 Ingelheim am Rhein
Germany
Boehringer Ingelheim Ellas A.E.
5th km Paiania - Markopoulo
194 00 Koropi
Greece

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Austria: Mobic 15 mg Tabletten; Movalis 15 mg Tabletten
Belgium: Mobic
Bulgaria: Movalis
Croatia: Movalis® 15 mg tablete
Cyprus: Movatec
Czech Republic Movalis 15 mg
Denmark: --
Estonia: Movalis
Finland: Mobic 15 mg tabletti
France: Mobic
Germany: Mobec 15 mg Tabletten
Greece: Movatec
Hungary: Movalis 15 mg tabletta
Iceland: --
Ireland: Mobic
Italy: Mobic ; Leutrol
Latvia: Movalis 15 mg
Liechtenstein: --
Lithuania: Movalis 15 mg tabletes
Luxembourg: Mobic
Malta: Mobic
Netherlands: Movicox
Norway: --
Poland: Movalis
Portugal: Movalis
Romania: Movalis 15 mg, Comprimate
Slovakia: Movalis 15 mg
Slovenia: Movalis 15 mg tablete
Spain: Movalis 15 mg comprimidos; Parocin 15 mg comprimidos
Sweden: --
United Kingdom:

MOBIC 15 mg/1,5 ml injectable solution

Meloxicam

Read this leaflet carefully before you start to take this medicinebecause 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 they have the same symptoms as you, as it may 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 MOBIC is and what it is used for
• 2. What you need to know before you take 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 is MOBIC and what is it used for

MOBIC contains the active ingredient meloxicam. Meloxicam belongs to a group of medicines
called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) used to reduce inflammation and
pain in the joints and muscles.
MOBIC injectable solution is indicated 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 need to know before taking MOBIC

Do not take MOBIC:

• if you are allergic to meloxicam or 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 signs after taking aspirin or other NSAIDs:
• wheezing, chest tightness, shortness of breath (asthma)
• nasal obstruction 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 that can make breathing difficult (angioedema)
• after a previous therapy with NSAIDs and a history of:
• bleeding in the stomach or intestines
• perforations in the stomach or intestines
• ulcer or bleeding in the stomach or intestines
• recent history of peptic ulcer or bleeding in the stomach (ulceration or bleeding that has occurred at least twice)
• severe liver disease
• severe kidney disease not treated with dialysis
• recent bleeding in the brain (cerebrovascular hemorrhage)
• any bleeding disorder
• concomitant treatment with anticoagulants (as a hematoma may form intramuscularly)
• severe heart disease

If you think any of the above applies 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 modest increase in the risk of
heart attack (myocardial infarction) or stroke (apoplexy). Any risk is more likely with
high doses and prolonged treatments. Do not exceed the dose or duration of treatment prescribed
(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 therapy 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 your blood (hypercholesterolemia)
• you are a smoker

Stop taking MOBIC immediately if you experience bleeding
(causing 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, which initially manifest as reddish spots or circular patches on the trunk, often accompanied by central blisters. Further
signs to watch out for include ulcers in the mouth, throat, nose, genitals and conjunctivitis
(red and swollen eyes). These potentially life-threatening skin reactions are often accompanied by
flu-like symptoms. The rash may progress with the formation of widespread blisters
or peeling of the skin. The highest risk of developing severe skin reactions occurs in the
first weeks of treatment.
If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of MOBIC,
you must not reuse MOBIC.
If you develop a skin reaction or the skin symptoms described above, stop taking
MOBIC, urgently consult a doctor and report that you are taking this medicine.
MOBIC is not indicated when immediate relief from acute pain is required.
MOBIC may mask the symptoms (e.g. fever) of an ongoing infection. Therefore, if you think you
have an infection, consult your doctor.

Precautions for use
Because the dosage may need to be adjusted, it is important to ask your doctor for advice before
taking MOBIC if you have:

• a history of inflammation of the esophagus (esophagitis), of the stomach (gastritis) or a history of 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) that may occur in case of severe blood loss or a burn, surgery or poor fluid intake
• high levels of potassium in the blood, previously diagnosed by the doctor

The doctor will need to monitor your progress during treatment.

Other medicines and MOBIC
Since MOBIC can affect or be affected by other medicines, tell your doctor or
pharmacist if you are taking, have recently taken or might take any other
medicines.
In particular, tell 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 up blood clots (thrombolytics)
• medicines for the treatment of heart and kidney diseases
• corticosteroids (e.g. used against inflammation or allergic reactions)
• cyclosporine, used after organ transplants or for severe skin conditions, rheumatoid arthritis or nephrotic syndrome
• deferasirox, used to treat chronic iron poisoning due to frequent blood transfusions
• any diuretic The doctor may monitor your kidney function if you are taking diuretics
• medicines for the treatment of 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 tumors or severe non-controlled skin diseases 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 should carefully monitor your blood sugar level to prevent hypoglycemia.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
During the first and second trimester of pregnancy, your doctor will prescribe this medicine
only if strictly necessary due to the potential risk of miscarriage or
malformation. In this case, the dose should be kept as low as possible and the duration of
treatment should be as short as possible.
During the last three months of pregnancy, this medicine is contraindicated: you must NEVER
take this medicine as it can have serious or even fatal consequences for the fetus,
even after a single dose, especially on the heart, lungs and/or kidneys. If you have
taken this medicine during pregnancy, contact your doctor or midwife immediately
in order to undertake appropriate monitoring.

Breastfeeding
This medicine is not recommended during breastfeeding.

Fertility
This medicine may alter fertility. You should inform your doctor if you are planning a
pregnancy or have difficulty getting pregnant.

Driving and using machines
Visual disturbances, including blurred vision, dizziness, drowsiness, vertigo or other disturbances at the level
of the central nervous system may occur with the intake of this product. If you experience
such effects do not drive vehicles or use 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 only for intramuscular use. The injection must only be performed by experienced healthcare personnel.
The solution must be administered slowly into a muscle, usually into a buttock. In the
case of repeated administration, it is recommended to alternate the left and right sides. In the case of
hip prosthesis, the injection must be performed on the other side. The injection must be
immediately stopped in case of severe pain during the injection itself.

Dosage
Treatment should consist of a single injection once a day in the initial phase of therapy,
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 dose of 15 mg per day.
If any of the conditions listed in the chapter “ Warnings and precautions” applies to your
case, the doctor may reduce your dose to 7.5 mg (half an ampoule of 1.5 ml) once a day.

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

Patients with increased risk of adverse reactions
If you are a patient with an increased risk of adverse reactions, the doctor will start treatment with
a dose of 7.5 mg (half an ampoule of 1.5 ml) once a day.

Renal impairment
If you are a patient undergoing dialysis, with severe renal impairment, your dose should not
exceed 7.5 mg (half an ampoule of 1.5 ml) once a day. 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 should not be administered to children and adolescents under the age of 18.
Contact your doctor or pharmacist if you feel that the effect of MOBIC is too strong or too weak
or if, after several days, you do not feel any improvement.

If you take more MOBIC than you should
If you have taken too many ampoules or suspect an overdose, contact your doctor or go
immediately to the nearest hospital.
The symptoms of acute NSAID overdose are usually limited to:

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

A severe overdose can induce serious adverse reactions to the drug (see paragraph 4.):

• high blood pressure (hypertension)
• acute renal failure
• liver (hepatic) dysfunction
• reduction/flattening or cessation of breathing (respiratory depression)
• loss of consciousness (coma)
• seizures
• collapse of blood circulation (cardiovascular collapse)
• heart failure (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 missed dose. Take the next
dose at the usual time.
If you have any questions about using this medicine, ask 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 immediately consult your doctor or the nearest hospital if you notice:
Any allergic reaction (hypersensitivity), which may manifest in the form of:

• skin reactions such as itching, the appearance of blisters or peeling, which can be potentially life-threatening skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis), lesions of soft tissues (mucosal lesions) or erythema multiforme (see paragraph 2). Erythema multiforme is a severe allergic skin reaction that causes spots, red blisters or purplish or blistering areas. It can 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 can make breathing difficult, swollen ankles or legs (edema of the lower limbs)
• shortness of breath or asthma attack
• inflammation of the liver (hepatitis). This can cause symptoms such as:
• yellowing of the skin and eyes (jaundice)
• abdominal pain
• loss of appetite

Any adverse effect of the digestive tract, especially:

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

Bleeding from the digestive tract (gastrointestinal bleeding), the formation of ulcers or perforations in the digestive tract can sometimes be serious and potentially fatal, especially in elderly patients.
If you have previously suffered from symptoms of the digestive tract due to long-term use of NSAIDs, inform your doctor immediately, especially if you are elderly. The doctor may monitor improvement during treatment.
If you experience vision disturbances, do not drive vehicles 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 blockage of the arteries (thrombotic arterial events), e.g. heart attack (myocardial infarction) or stroke (apoplexy), particularly at high doses and for long periods of treatment.
Fluid retention (edema), high blood pressure (hypertension) and heart failure (cardiac insufficiency) have been reported in association with treatment with NSAIDs.
The most commonly observed side effects affect the digestive tract (gastrointestinal events):

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

The following side effects have been reported after the 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 (hematemesis)
• inflammation with ulceration in the mouth (ulcerative stomatitis)
• worsening of inflammation of 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 ingredient of MOBIC
Very common: may affect more than 1 in 10 people

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

Common: may affect up to 1 in 10 people

• headache
• swelling at the injection site, pain at the injection site

Uncommon: may affect up to 1 in 100 people

• dizziness (mental confusion)
• feeling of spinning or whirling (vertigo)
• drowsiness (torpor)
• anemia (reduction in hemoglobin concentration in the blood)
• increased blood pressure (hypertension)
• flushing (temporary redness of the face and neck)
• sodium and water retention
• increased levels of potassium (hyperkalemia), which can lead to symptoms such as:
• changes in heartbeat (arrhythmia)
• palpitations (when the heartbeat is felt more than usual)
• muscle weakness
• belching
• inflammation of the stomach (gastritis)
• bleeding from the digestive tract
• inflammation of the mouth (stomatitis)
• immediate allergic reactions (hypersensitivity)
• itching
• skin rash
• swelling caused by fluid retention (edema), including swelling of the ankles/legs (edema of the lower limbs)
• sudden swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth or throat that can make breathing difficult (angioedema)
• temporary changes in liver function tests (e.g. increased liver enzymes such as transaminases or an increase in bile pigment bilirubin). The doctor can check this by means of a blood test
• changes 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
• decreased number of white blood cells (leukocytopenia)
• decreased number of platelets (thrombocytopenia) These side effects can lead to an increased risk of infection and symptoms such as bruising or nosebleeds.
• ringing in the ears (tinnitus)
• feeling of heartbeat (palpitations)
• ulcers of the stomach or the upper part of the small intestine (peptic/gastroduodenal ulcer)
• inflammation of the esophagus (esophagitis)
• onset of asthma attacks (found in people who are 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

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

Not known: frequency cannot be estimated based on available data

• state of confusion
• sense of disorientation
• anaphylactic shock
• shortness of breath and skin reactions (anaphylactic/anaphylactoid reactions) skin rash caused by exposure to sunlight (photosensitivity reactions)
• heart failure (cardiac insufficiency) has been reported associated with treatment with NSAIDs
• loss of a specific type of white blood cells (agranulocytosis), especially in patients taking MOBIC in combination with other medicines that are potentially inhibitors, suppressors or destructive of a component of the bone marrow (myelotoxic medicines), this can cause:
• sudden fever
• sore throat
• infections
• inflammation of the pancreas (pancreatitis)
• infertility in women, delayed ovulation

Side effects caused by non-steroidal anti-inflammatory drugs (NSAIDs), but not yet
observed after taking MOBIC
Alteration of the structure of the kidney that determines acute renal failure:

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

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at the website of the Italian Medicines Agency: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-
avversa .
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 which is stated on the packaging and on the 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 in wastewater 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 MOBIC contains
The active ingredient is:

• meloxicam
• one vial contains 15 mg of meloxicam

The other ingredients are:

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

Description of the appearance of MOBIC and contents of the pack
The solution of MOBIC is yellow in colour with greenish hues.
MOBIC is available in 1.5 ml clear glass vials in 2 ml.

Packs:boxes containing 1, 2, 3, 5, 25, 30, 50 vials.
Not all pack sizes may be marketed.

Other ways to take meloxicam
In some countries meloxicam is also available as:

• meloxicam 7.5 mg tablets
• meloxicam 15 mg tablets

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

Representative for sales in Italy
Boehringer Ingelheim Italia SpA
Via Lorenzini 8
20139 Milano

Manufacturer
Boehringer Ingelheim España SA
Prat de la Riba, 50 San Cugat del Vallés
Barcelona

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Austria: Mobic 15 mg/1.5 ml Injektionslösung; Movalis 15 mg/1.5 ml
Injektionslösung
Belgium: Mobic
Bulgaria: Movalis
Cyprus: --
Croatia: Movalis 15 mg/1,5ml otopina za injekciju
Denmark: --
Estonia: Movalis
Finland: --
France: Mobic ; Hexaphlogin 15 mg/1.5 ml
Germany: --
Greece: Movatec
Iceland: --
Ireland: --
Italy: Mobic 15 mg/1.5 ml solution for injection
Latvia: Movalis 15 mg/1.5 ml
Liechtenstein: --
Lithuania: Movalis 15 mg/1.5 ml injekcinis tirpalas
Luxembourg: Mobic
Malta: --
Norway: --
Netherlands: --
Poland: Movalis
Portugal: Movalis
United Kingdom: --
Czech Republic: Movalis
Romania: Movalis, solutie injectabila, 15 mg /1.5 ml
Slovakia: Movalis 15 mg/1.5 ml
Slovenia: Movalis 15 mg/1.5 ml raztopina za injiziranje
Spain: Movalis 15 mg/1.5 ml solucion inyectable
Sweden: --
Hungary: Movalis injekció