MOVALIS 15 mg TABLETS

2. What you need to know before you take Movalis

Do not take Movalis:

• 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 had any of the following disorders after taking acetylsalicylic acid (aspirin) or other NSAIDs:
• wheezing (bronchospasm), chest tightness, shortness of breath (asthma)
• nasal polyps
• skin rash/urticaria
• sudden inflammation of the skin or mucous membranes, such as inflammation around the eyes, face, lips, mouth, or throat, which may cause difficulty breathing (angioedema)
• if you have had:
• stomach or intestinal bleeding
• holes (perforations) in your stomach or intestine
• ulcers or bleeding in your stomach or intestine
• if you have had stomach or duodenal ulcers or bleeding (ulcers or bleeding that have occurred at least twice)
• severe liver function impairment
• severe non-dialysed renal failure
• recent cerebral bleeding (cerebrovascular haemorrhage)
• any type of bleeding disorder
• severe heart failure
• intolerance to some sugars, as this medicine contains lactose (see also “Movalis contains lactose and sodium”)

If you are not sure about any of the above, please contact your doctor.

Warnings and precautions

Consult your doctor or pharmacist before taking Movalis.

Warnings

Medicines like Movalis may be associated with a slightly increased risk of heart attack (“myocardial infarction”) or stroke (“cerebral infarction”). Any risk is greater at high doses and with long-term treatment. Do not take more than the recommended dose. Do not take Movalis for longer than you have been prescribed (see section 3 “How to take Movalis”).

If you have heart problems, previous stroke, or 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 (hypercholesterolaemia)
• are a smoker

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

Life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Movalis, initially appearing as red spots or circular patches, often with a central blister. Other additional signs that may appear are sores in the mouth, throat, nose, genitals, and conjunctivitis (swollen and red eyes). These life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to form widespread blisters or peeling of the skin. The period of highest risk for the onset of serious skin reactions is within the first weeks of treatment. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of Movalis, you should not take Movalis again at any time.

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

If you develop a rash or these symptoms on the 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

As treatment will need to be adjusted, it is important to ask your doctor for advice before taking Movalis in case of:

• having suffered from inflammation of the throat (oesophagitis), 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)
• reduced blood volume (hypovolaemia) that may occur if you have suffered significant blood loss or severe burns, surgery, or low fluid intake
• intolerance to some sugars diagnosed by your doctor, as this medicine contains lactose
• previously diagnosed high potassium levels in the blood

Your doctor will need to monitor your progress during treatment.

Taking Movalis with other medicines

As Movalis 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, 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)
• medicines that prevent blood clotting
• medicines that dissolve blood clots (thrombolytics)
• medicines for treating heart and kidney diseases
• corticosteroids (e.g., used in inflammation or allergic reactions)
• cyclosporin (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 medicine (“water tablets”). Your doctor may monitor your kidney function if you are taking diuretics
• medicines for treating high blood pressure (e.g., beta-blockers)
• lithium (used to treat behavioural disorders)
• selective serotonin reuptake inhibitors (SSRIs) (used to treat depression)
• methotrexate (used to treat tumours or uncontrolled severe skin diseases and active rheumatoid arthritis)
• pemetrexed (used in the treatment of cancer)
• colestyramine (used to reduce cholesterol levels)
• oral antidiabetics (sulphonylureas, nateglinide) (used to treat diabetes. Your doctor should carefully monitor your blood sugar levels for hypoglycaemia)

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

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

Do not take Movalis during the first 6 months of pregnancy unless clearly necessary and as directed 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 the 20th week of pregnancy, Movalis may cause kidney problems in your baby if taken for more than a few days, which may cause low levels of the fluid 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 talk to your doctor/midwife immediately so that adequate monitoring can be considered.

Breast-feeding

This medicine is not recommended during breast-feeding.

Fertility

This medicine may make it more difficult for you to become pregnant. You should tell your doctor if you are planning to become pregnant or if you are having trouble becoming pregnant.

Driving and using machines

This medicine may cause changes in vision, including blurred vision, dizziness, drowsiness, vertigo, or other central nervous system disorders. If you experience these effects, do not drive or use machines.

Movalis contains lactose and sodium

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

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

3. How to take Movalis

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

The recommended dose is:

Osteoarthritis flare-ups:

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

Rheumatoid arthritis:

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

Ankylosing spondylitis:

15 mg (one tablet) once a day. This 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 situations described under the heading “Warnings and precautions” apply to you, your doctor may limit your dose to 7.5 mg (half a tablet) once a day.

Elderly people

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

Renal impairment

If you are a patient on dialysis with severe renal impairment, your dose should not exceed 7.5 mg (half a tablet) per day. In patients with mild to moderate renal impairment, no dose reduction is necessary.

Hepatic impairment

In patients with mild to moderate hepatic impairment, no dose reduction is 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 think the action of Movalis is too strong or too weak or if, after several days, you do not notice any improvement.

Method of administration

Oral use.

The tablets should be swallowed with water or another drink during a meal.

The tablet can be divided into equal doses. The tablet should be broken by hand and not with a sharp object (e.g., a knife).

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.

The symptoms associated with acute overdoses of NSAIDs are normally limited to:

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

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

Severe poisoning may cause serious adverse reactions (see section 4):

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

If you forget to take Movalis

Do not take a double dose to make up for forgotten doses. Simply take the next dose at the usual time.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from 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), blistering of the skin or peeling, which can be life-threatening skin rashes (Stevens-Johnson syndrome and toxic epidermal necrolysis), soft tissue injuries (mucosal lesions) or erythema multiforme (see section 2).

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

• inflammation of the skin or mucous membranes such as inflammation around the eyes, face, and lips, mouth or throat, possibly making breathing difficult, swollen ankles/legs (edema of the lower limbs)
• difficulty breathing or asthma attacks
• liver inflammation (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 black stools)
• ulcers of the digestive tract (causing abdominal pain)

Digestive tract bleeding (gastrointestinal hemorrhage), the formation of ulcers or a hole in the digestive tract (perforation) can sometimes be serious and potentially life-threatening, especially in elderly people.

If you have previously suffered from any digestive tract symptoms due to prolonged use of NSAIDs, seek medical advice immediately, especially if you are an elderly person. Your doctor may monitor your progress while you are being treated.

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

General Adverse Effects of Non-Steroidal Anti-Inflammatory Medicines (NSAIDs)

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

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

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

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

After taking NSAIDs, the following adverse reactions have been reported:

• nausea and vomiting
• diarrhea
• flatulence
• constipation
• indigestion (dyspepsia)
• abdominal pain
• black stools due to bleeding in the digestive tract (melena)
• vomiting blood (hematemesis)
• inflammation with ulcer formation in the mouth (ulcerative stomatitis)
• worsening of digestive tract inflammation (e.g., exacerbation of colitis or Crohn's disease)

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

Adverse Effects of Meloxicam - Active Substance of Movalis

Very Common: may affect more than 1 in 10 people

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

Common: may affect up to 1 in 10 people

• headache

Uncommon: may affect up to 1 in 100 people

• dizziness (feeling of dizziness)
• feeling of dizziness or rotation (vertigo)
• drowsiness (somnolence)
• anemia (decrease in the amount of hemoglobin in red blood cells)
• increased blood pressure (hypertension)
• hot flashes (temporary redness in the face and neck)
• water 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
• belching
• stomach inflammation (gastritis)
• digestive tract bleeding
• mouth inflammation (stomatitis)
• allergic reactions (hypersensitivity)
• itching (pruritus)
• skin reaction
• inflammation caused by fluid retention (edema), including swollen ankles/legs (edema of the lower limbs)
• sudden inflammation of the skin or mucous membranes, such as inflammation around the eyes, face, lips, mouth, or throat, possibly making breathing difficult (angioedema)
• transient changes in liver function values (e.g., increased liver enzyme levels such as transaminases or increased bilirubin). Your doctor may detect them by performing a blood test
• changes in kidney function laboratory tests (e.g., increased 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 (leukopenia)
• decrease in the number of platelets (thrombocytopenia)

These adverse effects can increase the risk of infection and cause symptoms such as bruising or nosebleeds.

• ringing in the ears (tinnitus)
• noticing heartbeats (palpitations)
• stomach or upper small intestine ulcers (peptic/gastroduodenal ulcers)
• throat inflammation (esophagitis)
• onset of asthma attacks (observed in people allergic to acetylsalicylic acid (aspirin) or other NSAIDs)
• severe blistering of the skin or peeling (Stevens-Johnson syndrome and toxic epidermal necrolysis)
• hives
• 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 multiforme erythema.

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

• liver inflammation (hepatitis). This can cause symptoms such as:
• yellowing of the skin and eyes (jaundice)
• abdominal pain
• loss of appetite
  • acute kidney failure (renal failure) especially in patients with risk factors such as heart disease, diabetes, or kidney disease
  • a hole in the intestine wall (perforation)

Frequency Not Known: frequency cannot be estimated from available data

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

Adverse Effects Caused by Other Non-Steroidal Anti-Inflammatory Medicines (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)
• proteins in the urine (nephrotic syndrome with proteinuria)

Reporting of Adverse Effects

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

5. Storage of Movalis

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

Do not use this medicine after the expiration date that appears on the blister pack and 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 above 30°C.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Movalis

The active ingredient is:

• meloxicam
• one tablet contains 15 mg of meloxicam

The other ingredients are:

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

Appearance of the Product and Package Contents

Movalis is a yellow, round tablet with the company logo on one side and a mark with 77C/77C on the other. Each Movalis tablet has a score line and can be divided into two equal halves.

Movalis is available in PVC/PVDC/Aluminum blister packs.

Package Sizes:boxes of 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 Presentations of Movalis and Other Forms of Taking Meloxicam

In some countries, meloxicam is also available as:

• meloxicam 7.5 mg tablets
• meloxicam 15 mg/1.5 ml 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 Member States of the European Economic Area under the following names:

Austria, Bulgaria, Croatia, Estonia, Hungary, Latvia, Lithuania, Poland, Portugal, Romania, Slovakia, Slovenia, Spain: Movalis

Belgium, Finland, France, Italy, Luxembourg: Mobic

Cyprus, Greece: Movatec

Germany: Mobec

Date of Last Revision of this Leaflet:

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.