Package Insert: Information for the User

Movalis 7.5 mg Tablets

meloxicam

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, even if they are not listed in this package insert. See section 4.

6. Contents of the pack and additional information

Movalis 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.

Movalis tablets are indicated for adults and children 16 years of age and older.

Movalis is used for:

• treatment of short-term duration of osteoarthritis crises
• treatment of long-term duration of

-rheumatoid arthritis

-ankylosing spondylitis

Do not take Movalis:

-if you are allergic to meloxicam or any of the other ingredients of this medicine (listed in section 6)

-in the last three months of pregnancy

-children and adolescents under 16 years of age

-if you have had any of the following conditions after taking aspirin or other NSAIDs:

- wheezing (asthma), chest tightness, shortness of breath

- nasal congestion due to inflammation of the inside of the nose (nasal polyps)

- skin rashes/urticaria

- sudden inflammation of the skin or mucous membranes, such as inflammation around the eyes, face, lips, mouth, or throat, which may make breathing difficult (angioedema)

-if after a previous treatment with NSAIDs you experienced:

- bleeding in your stomach or intestines

- holes (perforations) in your stomach or intestines

-ulcers or bleeding in your stomach or intestines

-if you have had stomach ulcers or bleeding (ulcers or bleeding that have occurred at least twice)

-severe liver dysfunction

-severe kidney failure not dialyzed

-recent bleeding in the brain (cerebrovascular hemorrhage)

-any type of bleeding disorder

-severe heart failure

-intolerance to some sugars since this medicine contains lactose (see also "Movalis contains lactose and sodium")

If you are unsure about any of the above situations, please contact your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Movalis.

Warnings

Medicines like Movalis may be associated with a slight increase in the risk of heart attack ("myocardial infarction") or stroke ("cerebral infarction"). Any risk is greater at high doses and with prolonged treatment. Do not take more than the recommended dose. Do not take Movalis for longer than prescribed (see section 3 "How to take Movalis").

If you have heart problems, a previous stroke, or if you think you may be at risk of these diseases, you should discuss treatment with your doctor or pharmacist. For example, if you:

- have high blood pressure (hypertension)

- have high blood sugar levels (diabetes mellitus)

- have high cholesterol levels in the blood (hypercholesterolemia)

- are a smoker

Stop taking Movalis immediately as soon as you notice bleeding (causing black stools) or ulcers in your digestive tract (causing abdominal pain).

Severe skin rashes that can be life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been described with the use of Movalis, appearing initially as red circular spots, often with a central blister. Other additional signs that may appear are mouth sores, throat, nose, genital, and conjunctivitis (swollen and red eyes). These skin rashes that can be life-threatening often occur with flu-like symptoms. The rash may progress to form widespread blisters or skin peeling. The period of highest risk of developing severe skin reactions is during the first weeks of treatment. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of Movalis, you should not use Movalis again at any time.

Consult your doctor or pharmacist before starting to take Movalis if you have ever experienced a fixed drug eruption (flat, oval-shaped patches with redness and swelling of the skin that usually reappear in the same place, blistering, urticaria, and itching) after taking meloxicam or other oxicamics (e.g., piroxicam).

If you develop a rash or these symptoms on your skin, stop taking Movalis, go immediately to a doctor, and inform them that you are taking this medicine.

Movalis is not suitable if you need to relieve acute pain immediately.

Movalis may mask the symptoms of an infection (e.g., fever). If you think you may have an infection, you should see a doctor.

Precautions for use

Since treatment will need to be adjusted, it is essential to seek advice from your doctor before taking Movalis in the following cases:

• if you have had inflammation of the throat (esophagitis), stomach inflammation (gastritis), or a history of any other digestive tract disease, e.g., Crohn's disease, ulcerative colitis
• high blood pressure (hypertension)
• advanced age
• heart, liver, or kidney disease
• high blood sugar levels (diabetes mellitus)
• low blood volume (hypovolemia) that may occur if you have had significant blood loss or severe burns, surgery, or low fluid intake
• diagnosed intolerance to some sugars by your doctor since this medicine contains lactose
• previously diagnosed high potassium levels in the blood by your doctor

Your doctor will need to monitor your progress during treatment.

Taking Movalis with other medicines

Since Movalis may affect or be affected by other medicines, inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

Specifically, please inform your doctor or pharmacist if you are taking/have taken or have used any of the following medicines:

• other NSAIDs
• potassium salts (used to prevent or treat low potassium levels in the blood)
• tacrolimus (used after organ transplantation)
• trimethoprim (used in the treatment of urinary tract infections)
• blood-thinning medicines
• clot-dissolving medicines (thrombolytics)
• medicines for heart and kidney disease
• corticosteroids (e.g., used in inflammation or allergic reactions)
• ciclosporin (used after organ transplantation or for severe skin diseases, rheumatoid arthritis, or nephrotic syndrome)
• deferasirox (used to treat chronic iron overload caused by frequent blood transfusions)
• any diuretic ("urine tablets"). Your doctor may need to monitor your kidney function if you are taking diuretics
• medicines for high blood pressure (e.g., beta-blockers)
• litium (used to treat behavioral disorders)
• selective serotonin reuptake inhibitors (SSRIs) (used to treat depression)
• metotrexate (used to treat tumors or uncontrolled severe skin and rheumatoid arthritis)
• pemetrexed (used in cancer treatment)
• colestiramine (used to reduce cholesterol levels)
• oral antidiabetic drugs (sulfonilureas, nateglinida) (used to treat diabetes. Your doctor will need to closely monitor your blood sugar levels for hypoglycemia)

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, or if you are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Do not take Movalis if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your tendency and that of your baby to bleed and delay or prolong delivery more than expected.

Do not take Movalis during the first 6 months of pregnancy unless it is clearly necessary and as indicated by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time. From week 20 of pregnancy, Movalis may cause kidney problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.

If you have taken this medicine while pregnant, you should speak immediately with your doctor/midwife to consider adequate monitoring.

Breastfeeding

This medicine is not recommended during breastfeeding.

Fertility

This medicine may make it more difficult for you to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have difficulty becoming pregnant.

Driving and operating machines

This medicine may cause visual disturbances, including blurred vision, dizziness, sleepiness, vertigo, or other central nervous system disturbances. If you notice these effects, do not drive or operate machines.

Movalis contains lactose and sodium

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

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Osteoarthritis crisis:Arthritis rheumatoid::

7.5 mg (one tablet) once a day. This may be increased to 15 mg (two tablets) once a day.

Psoriatic arthritis:

15 mg (two tablets) once a day. This may be reduced to 7.5 mg (one tablet) once a day.

Ankylosing spondylitis:

15 mg (two tablets) once a day. This may be reduced to 7.5 mg (one tablet) once a day.

Do not exceed the maximum recommended dose of 15 mg per day.

If any of the situations described under the title “Warnings and precautions” affect you, your doctor may limit your dose to 7.5 mg (one tablet) once a day.

Older adults:

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

Patients at increased risk of adverse reactions:

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

Renal insufficiency:

If you are a patient on dialysis with severe renal insufficiency, your dose should not exceed 7.5 mg (one tablet) per day. In patients with mild to moderate renal insufficiency, dose reduction is not necessary.

Liver insufficiency:

In patients with mild to moderate liver insufficiency, dose reduction is not necessary.

Use in children and adolescents:

Movalis should not be administered to children and adolescents under 16 years of age.

Consult your doctor or pharmacist if you estimate that the action of Movalis is too strong or too weak, or if after several days you do not notice any improvement.

Administration form:

Oral route.

Tablets should be swallowed with water or another beverage during a meal.

The groove is only for breaking the tablet if it is difficult to swallow it whole.

If you take more Movalis than you should:

If you have taken too many tablets or suspect an overdose, contact your doctor or go to the nearest hospital immediately.

Symptoms associated with acute overdose of NSAIDs are usually limited to:

-fatigue (lethargy)

-sleep

-nausea and vomiting

-stomach pain (epigastric pain)

These symptoms usually improve when Movalis is stopped. Gastrointestinal bleeding may occur.

Severe intoxication may cause severe adverse reactions (see section 4):

- high blood pressure (hypertension)

- acute kidney failure (renal failure)

- liver dysfunction (hepatic dysfunction)

- respiratory depression (respiratory depression)

- loss of consciousness (coma)

- seizures (convulsions)

- cardiovascular collapse (cardiovascular collapse)

- cardiac arrest (cardiac arrest)

- immediate allergic reactions (hypersensitivity), including:

- fainting

- shortness of breath

- skin reactions

If you forget to take Movalis:

Do nottake a double dose to compensate for the missed doses. Simply take the next dose at the usual time.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking Movalis and consult your doctor or the nearest hospital immediately if you notice:

Any allergic reaction (hypersensitivity) that may appear in the form of:

• skin reactions, such as itching (pruritus), skin blistering or peeling, which can be life-threatening skin conditions (Stevens-Johnson syndrome and toxic epidermal necrolysis), soft tissue lesions (mucosal lesions) or multiform erythema (see section 2).

Multiform erythema is a severe skin allergic reaction that causes patches, red rashes or purple areas with blisters. It can also affect the mouth, eyes, and other moist areas of the body.

-skin or mucous membrane inflammation, such as eye, face, and lip inflammation, mouth or throat, possibly making breathing difficult, swollen legs/ankles (lower extremity edema)

-difficulty breathing or asthma attacks

-inflammation of the liver (hepatitis). This can cause symptoms such as:

-yellowing of the skin and eyes (jaundice)

-abdominal pain

-loss of appetite

Any gastrointestinal side effect, especially:

• bleeding (causing black stools)
• ulcers in the digestive tract (causing abdominal pain)

Gastrointestinal bleeding (gastrointestinal hemorrhage), ulcer formation or a hole in the digestive tract (perforation) can sometimes be severe and potentially fatal, especially in older people.

If you have previously experienced any gastrointestinal symptoms due to long-term use of NSAIDs, seek medical advice immediately, especially if you are an older person. Your doctor may monitor your progress while you are on treatment.

If you experience vision changes, do not drive or use machines.

General side effects of nonsteroidal anti-inflammatory drugs (NSAIDs)

The use of some nonsteroidal anti-inflammatory drugs (NSAIDs) may be associated with a slight increase in the risk of arterial vessel occlusion (arterial thrombotic events), such as heart attack (myocardial infarction) or stroke (apoplexy), particularly at high doses and with long-term treatment.

Cases of fluid retention (edema), high blood pressure (hypertension), and heart failure (cardiac failure) have been reported associated with NSAID treatment.

The most commonly observed adverse reactions affect the gastrointestinal tract (gastrointestinal events):

- stomach and upper small intestine ulcers (peptic/gastroduodenal ulcers)

- a hole in the intestinal wall (perforation) or gastrointestinal bleeding (sometimes fatal, especially in older people)

After NSAID administration, the following adverse reactions have been reported:

- nausea and vomiting

- liquid stools (diarrhea)

- flatulence

- constipation

- indigestion (dyspepsia)

- abdominal pain

- black stools due to gastrointestinal bleeding (melena)

- vomiting blood (hematemesis)

- inflammation with ulcer formation in the mouth (ulcerative stomatitis)

- worsening of gastrointestinal inflammation (e.g. exacerbation of colitis or Crohn's disease)

Less frequently, gastric inflammation (gastritis) has been observed.

Side effects of meloxicam - active substance of Movalis

Very common: may affect more than 1 in 10 people

• gastrointestinal side effects such as indigestion (dyspepsia), nausea and vomiting, abdominal pain, constipation, flatulence, liquid stools (diarrhea)

Common: may affect up to 1 in 10 people

• headache

Rare: may affect up to 1 in 100 people

• dizziness (sense of drowsiness)
• sensation of dizziness or rotation (vertigo)
• drowsiness (somnolence)
• anemia (decrease in the amount of the pigment in red blood cells called hemoglobin)
• increase in blood pressure (hypertension)
• temporal flushing (sudden redness of the face and neck)
• fluid and sodium retention
• increased potassium levels (hyperkalemia). This can cause symptoms such as:
• changes in heartbeats (arrhythmias)
• palpitations (when you notice your heartbeats more than usual)
• muscle weakness
• eructation
• gastritis (inflammation of the stomach)
• gastrointestinal bleeding
• inflammation of the mouth (stomatitis)
• immediate allergic reactions (hypersensitivity)
• itching (pruritus)
• skin reaction
• inflammation caused by fluid retention (edema), including swollen legs/ankles (lower extremity edema)
• sudden inflammation of the skin or mucous membranes, such as eye, face, and lip inflammation, mouth or throat, possibly making breathing difficult (angioedema)
• transient alterations in liver function test values (e.g. increase in liver enzyme levels such as transaminases or an increase in bilirubin). Your doctor may detect them by blood test
• alterations in kidney function test values (e.g. increase in creatinine or urea)

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

-mood changes

• nightmares
• abnormal blood count, including:
• abnormal differential blood count
• decrease in the number of white blood cells (leucopenia)
• decrease in the number of platelets (thrombocytopenia)

These side effects may increase the risk of infection and cause symptoms such as bruises or nasal bleeding.

• tinnitus (ringing in the ears)
• noticing heartbeats (palpitations)
• stomach or upper small intestine ulcers (peptic/gastroduodenal ulcers)
• inflammation of the throat (esophagitis)
• initiation 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
• vision changes, including:
• blurred vision
• conjunctivitis (inflammation of the eye or eyelid)
• inflammation of the large intestine (colitis)

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

• vesicular skin reactions (blistering) and multiform erythema.

Multiform erythema is a severe skin allergic reaction that causes patches, red rashes or purple areas with blisters. It can also affect the mouth, eyes, and other moist areas of the body.

-inflammation of the liver (hepatitis). This can cause symptoms such as:

-yellowing of the skin and eyes (jaundice)

-abdominal pain

-loss of appetite

• acute kidney failure (renal failure) in particular in patients with risk factors such as heart disease, diabetes or kidney disease
• a hole in the intestinal wall (perforation)

Frequency not known: the frequency cannot be estimated from available data

• confusion
• disorientation
• shortness of breath and skin reactions (anaphylactic/anaphylactoid reactions) due to exposure to sunlight (photosensitivity reactions)
• heart failure (cardiac failure) has been associated with NSAID treatment
• complete loss of certain types of white blood cells (agranulocytosis), especially in patients taking Movalis with other medications that may inhibit, depress or potentially destroy a component of the bone marrow (myelotoxic drugs). This can cause:
• sudden fever
• throat pain
• infections
• pancreatitis (inflammation of the pancreas)
• infertility in women, delayed ovulation
• a characteristic skin allergic reaction known as fixed drug eruption, which usually reappears in the same place upon re-exposure to the drug and may appear as rounded or oval plaques with redness and swelling of the skin, blistering (urticaria) and itching.

Side effects caused by other nonsteroidal anti-inflammatory drugs (NSAIDs) that have not been seen after taking Movalis

Changes in kidney structure that cause acute kidney failure:

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

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the blister pack and on the outer packaging. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.Do not store at a temperature above 30°C.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Movalis Composition

The active ingredient is:

-meloxicam

-one tablet contains 7.5 mg of meloxicam

The other components are:

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

Product appearance and packaging contents

Movalis is a yellowish clear round tablet with the company logo on one side and a mark with 59D/59D on the other.

Each Movalis tablet has a groove. The groove is only for splitting and facilitating swallowing, but not for dividing into equal doses.

Movalis is available in PVC/PVDC/Aluminum blisters.

Packaging sizes:boxes of 1, 2, 7, 10, 14, 15, 20, 28, 30, 50, 60, 100, 140, 280, 300, 500, 1,000 tablets.

Only some packaging sizes may be commercially available.

Other Movalis presentations and meloxicam forms

Meloxicam is also available in some countries as:

- meloxicam 15 mg tablets

- meloxicam 15 mg / 1.5ml injectable solution

Marketing authorization holder and manufacturer

Marketing authorization holder:

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

Manufacturer:

Boehringer Ingelheim Hellas Single Member S.A.

5th km Paiania – Markopoulo

194 41 Koropi, Attiki

Greece

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Strasse 173,

55216 Ingelheim am Rhein

Germany

Rottendorf Pharma GmbH

Ostenfelder Strasse 51 - 61

59320 Ennigerloh

Germany

Local representative:

Boehringer Ingelheim España, S.A.

Prat de la Riba, 50

08174 Sant Cugat del Vallès (Barcelona)

Spain

This medicine is authorized in the European Economic Area member states with the following names:

Austria, Estonia, Latvia, Lithuania, Poland, Portugal, Romania, Spain: Movalis®

Cyprus, Greece:Movatec®

Finland, France, Italy:Mobic®

Germany:Mobec®

Last review date of this leaflet:

The detailed and updated information about this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.