MOVALIS 7.5 MG TABLETS

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Movalis 7.5 mg tablets

meloxicam

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Movalis is and what it is used for

2. What you need to know before taking Movalis

3. How to take Movalis

4. Possible side effects

5. How to store Movalis

6. Contents of the pack and other information

1. What Movalis is and what it is used for

Movalis contains the active substance meloxicam. Meloxicam belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which are used to reduce inflammation and pain in joints and muscles.

Movalis tablets are indicated for use in adults and children aged 16 years and older.

Movalis is used for:

• short-term treatment of osteoarthritis flare-ups

• long-term treatment of

  • rheumatoid arthritis
  • ankylosing spondylitis

2. What you need to know before taking Movalis

DO NOT take Movalis:

• if you are allergic to meloxicam or to any of the other ingredients of this medicine (listed in section 6)
• during the last three months of pregnancy
• children and adolescents under 16 years of age
• if you have had any of the following conditions after taking acetylsalicylic acid (aspirin) or other NSAIDs:
• wheezing, tightness in the chest, shortness of breath (asthma)
• nasal congestion due to inflammation inside the nose (nasal polyps)
• skin rash/hives
• sudden swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth or throat, possibly making breathing difficult (angioedema)
• if after previous therapy with NSAIDs you experienced:
• bleeding in your stomach or intestine
• holes (perforations) in your stomach or intestine
• ulcers or bleeding in your stomach or intestine
• if you have recently had or have ever had stomach or peptic ulcers or bleeding (ulcers or bleeding that have occurred at least twice)
• severe impairment of liver function
• severe renal failure not on dialysis
• recent bleeding in the brain (cerebrovascular hemorrhage)
• any type of bleeding disorders
• severe heart failure
• intolerance to certain sugars, as this medicine contains lactose (see also “Movalis contains lactosa and sodium”)

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Movalis.

Warnings

Medicines like Movalis may be associated with a small increased 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 think you may be at risk of developing either of these conditions, 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 treatment with Movalis immediately if you notice bleeding (causing black stools) or ulcers in your digestive tract (causing abdominal pain).

Life-threatening skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Movalis, initially appearing as red spots or circular lesions, often with a central blister. Other additional signs may include sores in the mouth, throat, nose, genitals, and conjunctivitis (swollen and red eyes). These potentially life-threatening skin reactions are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or peeling of the skin. The highest risk of serious skin reactions occurs during the first weeks of treatment. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis while taking Movalis, you must never use Movalis again.

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

If you develop a rash or these skin symptoms, stop taking Movalis immediately, seek medical attention, and inform the doctor that you are taking this medicine.

Movalis is not suitable if you need immediate relief from acute pain.

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

Precautions for use

Since treatment adjustment may be necessary, it is important to seek advice from your doctor before taking Movalis if you:

• have had inflammation of the esophagus (esophagitis), inflammation of the stomach (gastritis), or a history of any other gastrointestinal disease, e.g., Crohn’s disease, ulcerative colitis
• have high blood pressure (hypertension)
• are elderly
• have heart, liver, or kidney disease
• have high blood sugar levels (diabetes mellitus)
• have reduced blood volume (hypovolemia), which may occur after significant blood loss or severe burns, surgery, or low fluid intake
• have been diagnosed with intolerance to certain sugars, as this medicine contains lactose
• have previously diagnosed high levels of potassium in the blood

Your doctor will need to monitor your condition 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 recently taken, or might need to take any other medicines.

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 to treat urinary tract infections)
• medicines that prevent blood clotting
• medicines that dissolve blood clots (thrombolytics)
• medicines to treat heart and kidney diseases
• corticosteroids (e.g., used for inflammation or allergic reactions)
• cyclosporine (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 medicines (“water tablets”). Your doctor may monitor kidney function if you are taking diuretics
• medicines to treat high blood pressure (e.g., beta-blockers)
• lithium (used to treat behavioral disorders)
• selective serotonin reuptake inhibitors (SSRIs) (used to treat depression)
• methotrexate (used to treat tumors or severe uncontrolled skin diseases and active rheumatoid arthritis)
• pemetrexed (used in cancer treatment)
• cholestyramine (used to reduce cholesterol levels)
• oral antidiabetics (sulfonylureas, nateglinide) (used to treat diabetes. Your doctor should carefully monitor your blood sugar levels for hypoglycemia)

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Do not take Movalis during the last three months of pregnancy, as it could harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your tendency and your baby's tendency to bleed and may delay or prolong labor more than expected.

You should not take Movalis during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to become pregnant, you should take the lowest effective 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 could lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment for longer than a few days is needed, your doctor may recommend additional monitoring.

If you have taken this medicine during pregnancy, you should speak immediately with your doctor or midwife so that appropriate monitoring can be considered.

Breastfeeding

Use of this medicine during breastfeeding is not recommended.

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 using machines

This medicine may cause disturbances in vision including blurred vision, dizziness, drowsiness, vertigo, or other central nervous system effects. If you experience these effects, do not drive or operate machinery.

Movalis contains lactose and sodium

If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

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

3. How to take Movalis

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Osteoarthritis flare-up:

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

Rheumatoid arthritis:

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

Ankylosing spondylitis:

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

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

If any of the situations described under the heading "Warnings and precautions" apply to you, your doctor may limit your dose to 7.5 mg (one tablet) once daily.

Elderly patients

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

Patients at increased risk of adverse reactions

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

Renal impairment

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

Hepatic impairment

In patients with mild to moderate hepatic impairment, dose reduction is not required.

Use in children and adolescents

Movalis must not be given to children and adolescents under 16 years of age.

Consult your doctor or pharmacist if you think that the effect of Movalis is too strong or too weak, or if you notice no improvement after several days.

Method of administration

Oral use.

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

The tablet's score line is intended only for breaking the tablet if you have difficulty swallowing 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 NSAID overdose are usually limited to:

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

These symptoms usually improve when Movalis is discontinued. Gastrointestinal bleeding (bleeding in the stomach or intestines) may occur.

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

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

If you forget to take Movalis

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

If you have any further questions about 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 everyone will experience them.

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

Any allergic reaction (hypersensitivity) which may appear as:

• skin reactions such as itching (pruritus), blistering or peeling of the skin, which may include skin rashes that can be life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis), lesions in soft tissues (mucosal lesions), or erythema multiforme (see section 2).

Erythema multiforme is a serious skin allergic reaction causing spots, red rashes, or purple areas with blisters. It may 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, and lips, mouth or throat, possibly making breathing difficult, swollen ankles/legs (edema of the lower extremities)
• difficulty breathing or asthma attacks
• liver inflammation (hepatitis). This may cause symptoms such as:
• yellowing of the skin and eyes (jaundice)
• abdominal pain
• loss of appetite

Any adverse effect affecting the digestive tract, especially:

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

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

If you have previously experienced any digestive tract symptoms due to prolonged use of NSAIDs, seek immediate medical advice, especially if you are elderly. Your doctor may monitor your condition during treatment.

If you experience vision disturbances, do not drive or operate machinery.

General adverse effects of non-steroidal anti-inflammatory drugs (NSAIDs)

The use of some non-steroidal anti-inflammatory drugs (NSAIDs) may be associated with a slight increase in the risk of arterial blockage (arterial thrombotic events), e.g., heart attack (myocardial infarction) or stroke (cerebrovascular accident), 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 in association 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 bleeding from the digestive tract (sometimes fatal, especially in elderly people)

The following adverse reactions have been reported after administration of NSAIDs:

• nausea and vomiting
• loose stools (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, inflammation of the stomach (gastritis) has been observed.

Adverse effects of meloxicam - the active substance in 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, loose stools (diarrhea)

Common: may affect up to 1 in 10 people

• headache

Uncommon: may affect up to 1 in 100 people

• dizziness (feeling of lightheadedness)
• sensation of dizziness or spinning (vertigo)
• drowsiness (somnolence)
• anemia (decrease in the amount of the red blood cell pigment called hemoglobin)
• increased blood pressure (hypertension)
• hot flushes (temporary reddening of the face and neck)
• water and sodium retention
• increased potassium levels (hyperkalemia). This may cause symptoms such as:
• changes in heartbeats (arrhythmias)
• palpitations (when you notice your heartbeat 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 (pruritus)
• skin reaction
• swelling due to fluid retention (edema), including swollen ankles/legs (edema of the lower extremities)
• sudden swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth or throat, possibly making breathing difficult (angioedema)
• transient abnormalities in liver function tests (e.g., increase in liver enzyme levels such as transaminases or an increase in the bile pigment bilirubin). Your doctor may detect these through a blood test
• abnormalities in laboratory tests of kidney function (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 (leukopenia)
  • decrease in the number of platelets (thrombocytopenia)

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

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

• blistering skin reactions (vesicular eruptions) and redness (erythema) multiforme.

Erythema multiforme is a serious skin allergic reaction causing spots, red rashes, or purple areas with blisters. It may also affect the mouth, eyes, and other moist areas of the body.

• liver inflammation (hepatitis). This may cause symptoms such as:
• yellowing of the skin and eyes (jaundice)
• abdominal pain
• loss of appetite
  • acute kidney failure (renal failure), particularly in patients with risk factors such as heart disease, diabetes, or kidney disease
  • a hole in the intestinal 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 exposure to sunlight (photosensitivity reactions)
• heart failure (cardiac insufficiency) has been described in association with NSAID treatment
• complete loss of certain types of white blood cells (agranulocytosis), especially in patients taking Movalis together with other drugs that may inhibit, suppress, or potentially destroy a component of the bone marrow (myelotoxic drugs). This may cause:
• sudden fever
• sore throat
• infections
• inflammation of the pancreas (pancreatitis)
• infertility in women, delayed ovulation
• a characteristic drug-induced skin allergic reaction known as fixed drug eruption, which usually recurs at the same site upon re-exposure to the drug and may appear as round or oval-shaped patches with redness and swelling of the skin, blister formation (urticaria), and itching.

Adverse effects caused by other non-steroidal anti-inflammatory drugs (NSAIDs) not yet observed after taking Movalis

Changes in kidney structure leading to 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 adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the blister pack and the outer packaging. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Movalis

The active substance is:

• meloxicam
  one tablet contains 7.5 mg of meloxicam

The other components are:

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

Appearance of the product and contents of the pack

Movalis is a round, light yellow tablet with the company logo on one side and a mark with 59D/59D on the other.

Each Movalis tablet has a score line. The score line is intended solely to facilitate breaking the tablet for ease of swallowing and does not guarantee equal division of the dose.

Movalis 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.

Only certain pack sizes may be marketed.

Other presentations of Movalis and other forms of meloxicam administration

In some countries, meloxicam is also available as:

• meloxicam 15 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:

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 medicinal product is authorized in the European Economic Area member states under the following names:

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

Cyprus, Greece: Movatec®

Finland, France, Italy: Mobic®

Germany: Mobec®

Date of the most recent review of this leaflet:

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.