Movalis 15 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Movalis 15 mg tablets

meloxicam

Read the entire leaflet carefully before you start taking this medicine, as 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 others, 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 in adults and children 16 years of age 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
• in children and adolescents under 16 years of age
• if you have previously experienced 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 of the inner nasal lining (nasal polyps)
• skin rash/hives
• sudden swelling of the skin or mucous membranes, such as around the eyes, face, lips, mouth, or throat, possibly causing breathing difficulties (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 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 lactose and sodium”)

If you are unsure about any of the above conditions, 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 slight increase in the risk of heart attack (“myocardial infarction”) or stroke (“cerebral infarction”). The risk is higher with high doses and 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 history of stroke, or think you may be at risk of developing 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 possible signs 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 severe skin reactions occurs during the first weeks of treatment. If you have previously developed Stevens-Johnson syndrome or toxic epidermal necrolysis while taking Movalis, you must never use Movalis again.

Talk to your doctor or pharmacist before taking Movalis if you have ever experienced fixed drug 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 suspect you have an infection, you should see a doctor.

Precautions for use

Because dose adjustment may be necessary, it is important to consult your doctor before taking Movalis if you have:

• a history of inflammation of the throat (esophagitis), inflammation of the stomach (gastritis), or any other gastrointestinal 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 (hypovolemia), which may occur after significant blood loss or severe burns, surgery, or low fluid intake
• diagnosed intolerance to certain sugars, as this medicine contains lactose
• previously diagnosed high potassium levels 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 blood potassium levels)
• 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 your kidney function if you are taking diuretics
• medicines for 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 antidiabetic medicines (sulfonylureas, nateglinide) (used to treat diabetes. Your doctor must 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 may harm the fetus or cause delivery complications. It may cause kidney and heart problems in your unborn baby. It may affect your and your baby’s tendency to bleed and may delay or prolong labor.

You should not take Movalis during the first six months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to conceive, 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 may 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 is needed for more than a few days, your doctor may recommend additional monitoring.

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

Breastfeeding

Use of this medicine is not recommended during breastfeeding.

Fertility

This medicine may make it more difficult to become pregnant. Inform your doctor if you are planning to become pregnant or if you are having difficulty conceiving.

Driving and use of 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 with them before taking this medicine.

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

3. How to take Movalis

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

Recommended dose:

Osteoarthritis flare-up:

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

Rheumatoid arthritis:

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

Ankylosing spondylitis:

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

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

If any of the 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 daily.

Elderly patients

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

Patients at increased risk of adverse reactions

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

Renal impairment

If you are a patient on dialysis with severe renal impairment, your dose should not exceed 7.5 mg (half a 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 administered to children and adolescents under 16 years of age.

Consult your doctor or pharmacist if you feel 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 a meal.

The tablet may be divided into equal doses. The tablet should be split 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.

Symptoms associated with acute NSAID overdose are usually limited to:

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

These symptoms usually improve once 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 (heart stoppage)
• 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 experiences them.

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

Any allergic reaction (hypersensitivity), which may present as:

• Skin reactions such as itching (pruritus), blistering or peeling of the skin, which may be severe 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 allergic skin 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, or in the mouth or throat, possibly making breathing difficult; swollen ankles/legs (peripheral edema)
• Difficulty breathing or asthma attacks
• Inflammation of the liver (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, particularly in elderly individuals.

If you have previously experienced any symptoms related to the digestive tract 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 certain non-steroidal anti-inflammatory drugs (NSAIDs) may be associated with a slight increase in the risk of arterial blood vessel 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 individuals)

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

• Nausea and vomiting
• Watery 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 gastrointestinal 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, watery stools (diarrhea)

Common: may affect up to 1 in 10 people

• Headache

Uncommon: may affect up to 1 in 100 people

• Dizziness (feeling faint or lightheaded)
• 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 redness of the face and neck)
• Water and sodium retention
• Increased potassium levels (hyperkalemia). This may cause symptoms such as:
• Changes in heart rhythm (arrhythmias)
• Palpitations (feeling 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
• Fluid retention-related swelling (edema), including swollen ankles/legs (peripheral edema)
• Sudden swelling of the skin or mucous membranes, such as around the eyes, face, lips, mouth, or throat, possibly making breathing difficult (angioedema)
• Transient changes in liver function test values (e.g., increased levels of liver enzymes such as transaminases or increased levels of the bile pigment bilirubin). Your doctor may detect these through 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
• Decreased number of white blood cells (leukopenia)
• Decreased 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 heartbeat (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

• Vesicular skin reactions (blister formation) and redness (erythema) multiforme.

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

• Inflammation of the liver (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 failure) 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-related skin allergic reaction known as fixed drug eruption, which usually reappears in the same location upon re-exposure to the drug and may present 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 adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can 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 which is stated on the blister and the outer packaging. The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect it 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 Point at your pharmacy. If you are in doubt, 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 15 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 light yellow, round tablet with the company logo on one side and the imprint 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/Aluminium 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 commercially available.

Other presentations of Movalis and other forms of 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:

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 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 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/.