Movalis

Package Leaflet: Information for the Patient

Movalis 7.5 mg, tablets

Movalis 15 mg, tablets

Meloxicam

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Movalis and what is it used for
• 2. Important information 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 is Movalis and what is it used for

Movalis contains the active substance meloxicam. Meloxicam belongs to a group of so-called non-steroidal anti-inflammatory drugs (NSAIDs), which are used to reduce inflammation and pain in the joints and muscles.
Movalis tablets are intended for adults and children over 16 years of age.
Movalis is used:

• for short-term treatment of exacerbations of osteoarthritis
• for long-term treatment of:
• rheumatoid arthritis
• ankylosing spondylitis of the spine.

2. Important information before taking Movalis

When not to take Movalis

• If the patient is allergic to meloxicam or any of the other ingredients of this medicine (listed in section 6)
• In pregnant women in the last three months of pregnancy
• In children and adolescents under 16 years of age
• If the patient has experienced any of the following symptoms after taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs):
• wheezing, feeling of pressure in the chest, shortness of breath (asthma)
• nasal congestion due to swelling of the nasal mucosa (nasal polyps)
• skin rash (hives)
• sudden swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth or throat, which may make breathing difficult (angioedema)
• If the patient has experienced the following after previous NSAID therapy:
• gastrointestinal bleeding
• perforation of the stomach or intestines
• If the patient currently has peptic ulcer or gastrointestinal bleeding
• If the patient has had peptic ulcer or gastrointestinal bleeding (peptic ulcer or bleeding that has occurred at least twice)
• If the patient has severe liver dysfunction
• In non-dialyzed patients with severe renal impairment
• If the patient has recently experienced cerebral bleeding (cerebral hemorrhage)
• If the patient has experienced any other bleeding
• If the patient has severe heart failure
• If the patient has intolerance to some sugars - the product contains lactose (see also "Movalis contains sugar (lactose) and sodium")

If the patient is unsure whether any of the above points apply to them, they should consult a doctor.

Warnings and precautions

Before starting treatment with Movalis, the patient should discuss it with their doctor or pharmacist:

• if the patient has ever experienced a persistent rash (drug rash) after taking meloxicam or other oxicams (e.g. piroxicam), characterized by round or oval, red and swollen spots on the skin, usually recurring in the same place (in the same places), blisters, hives, and itching.

Warnings

Taking medicines like Movalis may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses of the medicine. Do not take higher doses or longer treatment than recommended (see section 3).
In case of heart problems, previous stroke, or suspected risk of these disorders, the patient should discuss the treatment with their doctor or pharmacist.
For example, when:

• the patient has high blood pressure (hypertension)
• the patient has high blood sugar (diabetes)
• the patient has high cholesterol (hypercholesterolemia)
• the patient smokes.

The patient should stop taking Movalis immediately if they notice bleeding (causing black stools) or gastrointestinal ulceration (causing abdominal pain).
With the use of Movalis, potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported, which initially appear as red spots or round patches on the torso, often with central blisters. Additional symptoms that may be observed include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red and swollen eyes). These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash can develop into generalized blisters or skin detachment. The highest risk of severe skin reactions occurs in the first few weeks of treatment. In patients who have experienced Stevens-Johnson syndrome, toxic epidermal necrolysis while taking Movalis, meloxicam treatment should not be resumed.
If a rash or the above symptoms occur, the patient should stop taking Movalis and seek medical advice immediately, informing their doctor that they are taking this medicine.
Movalis is not recommended for the treatment of acute pain attacks.
Movalis may mask the symptoms of infection (e.g. fever). If the patient suspects they have an infection, they should consult a doctor.

Precautions for use

Due to the need to modify treatment, the patient should consult a doctor before starting treatment with Movalis in case of:

• a history of esophageal inflammation, stomach inflammation, or any other gastrointestinal disease, such as Crohn's disease or ulcerative colitis
• high blood pressure (hypertension)
• use in the elderly
• heart, liver, or kidney disease
• high blood sugar (diabetes)
• reduced blood volume (hypovolemia), which may occur in case of significant blood loss or burns, surgery, or low fluid intake
• intolerance to certain sugars diagnosed by a doctor, due to the fact that the medicine contains lactose
• high potassium levels in the blood, previously diagnosed by a doctor.

In these cases, the doctor will monitor the treatment results.

Movalis and other medicines

Movalis may affect the action of other medicines taken, and other medicines may affect the action of Movalis.
The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
In particular, the patient should inform their doctor or pharmacist if they are taking any of the following medicines:

• other non-steroidal anti-inflammatory drugs (NSAIDs)
• potassium salts - used to treat low potassium levels in the blood
• tacrolimus - used after organ transplants
• trimethoprim - used to treat urinary tract infections
• anticoagulants
• medicines that dissolve blood clots (thrombolytic agents)
• medicines used to treat heart and kidney diseases
• corticosteroids (e.g. used as anti-inflammatory or to treat allergic reactions)
• cyclosporine - used after organ transplantation or in cases of severe skin diseases, rheumatoid arthritis, or nephrotic syndrome
• deferazirox - used to treat iron overload after frequent blood transfusions
• diuretics - the doctor may monitor kidney function when taking diuretics
• medicines used to treat high blood pressure (e.g. beta blockers)
• lithium - used to treat mental illnesses
• selective serotonin reuptake inhibitors (SSRIs) - used to treat depression
• methotrexate - used to treat cancer or severe uncontrolled skin diseases and active rheumatoid arthritis
• pemetrexed - used to treat cancer
• cholestyramine - used to reduce cholesterol levels
• oral anti-diabetic drugs (sulfonylurea derivatives, nateglinide) - used to treat diabetes. The doctor should ensure systematic monitoring of the patient's blood sugar levels for the occurrence of hypoglycemia.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
Pregnancy
Movalis should not be taken if the patient is in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Movalis may cause kidney and heart problems in the unborn child. It may also increase the risk of bleeding in the patient and child and cause delayed or prolonged labor. During the first 6 months of pregnancy, Movalis should not be used unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time. From the 20th week of pregnancy, Movalis may cause kidney problems in the unborn child if taken for more than a few days. This may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the baby's heart. If treatment is necessary for a longer period, the doctor may recommend additional monitoring.
Breastfeeding
This medicine is not recommended for use in breastfeeding women.
Fertility
This medicine may make it harder for women to get pregnant. The patient should tell their doctor if they are planning to get pregnant or are having trouble getting pregnant.

Driving and using machines

Visual disturbances, including blurred vision, drowsiness, dizziness, or other central nervous system disorders may occur after taking Movalis. If these symptoms occur, the patient should not drive or operate machinery.

Movalis contains sugar (lactose) and sodium

If the patient has been diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Movalis

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult a doctor or pharmacist.

Recommended doses:

Exacerbations of osteoarthritis:

7.5 mg once a day. The dose may be increased to 15 mg once a day.

Rheumatoid arthritis:

15 mg once a day. The dose may be reduced to 7.5 mg (once a day).

Ankylosing spondylitis of the spine:

15 mg once a day. The dose may be reduced to 7.5 mg (once a day).

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

If any of the conditions listed in "Warnings and precautions" apply to the patient, the doctor may reduce the dose to 7.5 mg per day.

Elderly patients

The recommended dose for elderly patients in long-term treatment of rheumatoid arthritis and ankylosing spondylitis of the spine is 7.5 mg per day.

Patients at increased risk of side effects

In patients at increased risk of side effects, treatment should be started with a dose of 7.5 mg per day.

Renal impairment

In dialyzed patients with severe renal impairment, the dose should not exceed 7.5 mg per day. Dose reduction is not necessary in patients with mild or moderate renal impairment.

Hepatic impairment

Dose reduction is not necessary in patients with mild or moderate hepatic impairment.

Use in children and adolescents

Movalis should not be used in children and adolescents under 16 years of age.
If the patient thinks that the effect of Movalis is too strong or too weak, or if they do not feel any improvement after a few days, they should consult a doctor or pharmacist.
Method of administration
Oral use.
Tablets should be swallowed with water, during a meal.
Movalis 7.5 mg: The dividing line on the tablet only makes it easier to break it into smaller pieces for easier swallowing.
Movalis 15 mg: The tablet can be divided into two equal doses. The tablet should be divided manually, not with sharp objects (e.g. a knife).

Overdose of Movalis

In case of overdose or suspected overdose of Movalis, the patient should immediately consult a doctor or go to the nearest hospital emergency department.

Symptoms of NSAID overdose are usually limited to:

• weakness (feeling of lack of energy)
• drowsiness
• nausea and vomiting
• abdominal pain (in the upper abdomen). These symptoms usually disappear after stopping Movalis. The patient may experience gastrointestinal bleeding (gastrointestinal hemorrhage).

Severe poisoning can lead to serious side effects of the medicine (see section 4):

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

Missed dose of Movalis

The patient should not take a double dose to make up for a missed dose. The next dose should be taken at the scheduled time.
In case of any further doubts about taking this medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Movalis can cause side effects, although not everybody gets them.
The patient should stop taking Movalis and consult a doctor or the nearest hospital immediately if they experience:

• any allergic reactions (hypersensitivity), which may manifest as:
• skin reactions, such as itching (pruritus), blistering, and peeling of the skin, which can be life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis), tissue damage (mucosal lesions), or erythema multiforme (see section 2). Erythema multiforme is a severe allergic skin reaction causing spots, red or purple stripes or blisters on the skin, which can also occur on the lips, eyes, and other moist body parts.
• swelling of the skin or mucous membranes, such as swelling around the eyes, face, and lips, mouth or throat, which can make breathing difficult, swelling of the feet and ankles (peripheral edema)
• shortness of breath or asthma attack
• liver inflammation. This can cause symptoms such as:
• yellowing of the skin and eyes (jaundice)
• abdominal pain
• loss of appetite.

Any symptoms of gastrointestinal disorders, in particular:

• bleeding (causing black stools)
• gastrointestinal ulceration (causing abdominal pain).

Gastrointestinal bleeding, ulcers, or perforation of the gastrointestinal tract can sometimes be severe and potentially life-threatening, especially in elderly patients.
If the patient has previously experienced any gastrointestinal disorders due to long-term use of NSAIDs, they should immediately consult a doctor, especially if they are elderly. The doctor may monitor the progress of the treatment.
If taking Movalis causes visual disturbances, the patient should not drive or operate machinery.

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

The use of some non-steroidal anti-inflammatory drugs (NSAIDs) may be associated with a small increase in the risk of arterial thrombosis (e.g. myocardial infarction or stroke), especially when used in high doses and for long-term treatment.
NSAID treatment has been associated with reports of edema, hypertension, and heart failure.
The most commonly observed side effects are related to the gastrointestinal tract (stomach and intestine disorders):

• gastric ulcer
• duodenal ulcer
• perforation of the gastrointestinal tract or bleeding (sometimes fatal, especially in elderly patients).

The following side effects have been reported with NSAIDs:

• nausea (nausea) and vomiting
• diarrhea
• flatulence with gas discharge
• constipation
• indigestion (dyspepsia)
• abdominal pain
• black stools due to gastrointestinal bleeding
• bloody vomiting
• mouth ulcers
• worsening of gastrointestinal inflammation (e.g. worsening of ulcerative colitis or Crohn's disease).

Gastritis has been observed less frequently.

Side effects of meloxicam - the active substance of Movalis Very common: may occur in more than 1 in 10 people

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

Common: may occur in less than 1 in 10 people

• headaches.

Uncommon: may occur in less than 1 in 100 people

• dizziness (feeling of emptiness in the head)
• dizziness or feeling of spinning (vertigo)
• drowsiness (somnolence)
• anemia (decrease in red blood cell hemoglobin)
• high blood pressure (hypertension)
• flushing (temporary flushing of the face and neck)
• retention of sodium and water
• high potassium levels in the blood (hyperkalemia). This can lead to symptoms such as:
• heart rhythm disorders
• palpitations (when the patient feels their heartbeat more than usual)
• muscle weakness
• reflux (regurgitation of stomach contents into the esophagus)
• gastritis
• gastrointestinal bleeding
• mouth ulcers
• immediate allergic reactions (hypersensitivity)
• itching
• skin rash
• edema caused by fluid retention, including swelling of the feet and ankles (peripheral edema)
• sudden swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth or throat, which can make breathing difficult (angioedema)
• temporary changes in liver function tests (e.g. increased activity of liver enzymes, such as transaminases, or increased bilirubin levels). The doctor may detect these changes with a blood test.
• abnormal kidney function tests (e.g. increased creatinine or urea levels).

Rare: may occur in less than 1 in 1,000 people

• mood disorders
• nightmares
• blood disorders, including:
• abnormal blood count
• decrease in white blood cell count (leukopenia)
• decrease in platelet count (thrombocytopenia) These side effects can increase the risk of infection and symptoms such as bruising or nosebleeds.
• ringing in the ears (tinnitus)
• palpitations (heart rhythm disorders)
• gastric ulcer
• esophagitis
• appearance of asthma attacks (in people allergic to aspirin or other NSAIDs)
• blistering skin or peeling of the skin (Stevens-Johnson syndrome and toxic epidermal necrolysis)
• hives
• visual disturbances, including:
• blurred vision
• conjunctivitis (conjunctival inflammation or eyelid inflammation)
• colitis (inflammation of the colon).

Very rare: may occur in less than 1 in 10,000 people

• blistering skin reactions and erythema multiforme. Erythema multiforme is a severe allergic skin reaction causing spots, red or purple stripes or blisters on the skin, which can also occur on the lips, eyes, and other moist body parts.
• liver inflammation. This can cause symptoms such as:
• yellowing of the skin and eyes (jaundice)
• abdominal pain
• loss of appetite
• acute kidney failure, especially in patients with risk factors such as heart disease, diabetes, or kidney disease
• perforation of the intestinal wall.

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

• confusion
• disorientation
• shortness of breath and skin reactions (anaphylactic and/or anaphylactoid) skin rashes caused by exposure to sunlight (photosensitivity reactions)
• heart failure reported in association with NSAID treatment
• complete loss of certain types of white blood cells (agranulocytosis), especially in patients taking Movalis with other medicines that may have a suppressive or destructive effect on the bone marrow (myelotoxic drugs). This can cause:
• sudden fever
• throat pain
• infections
• pancreatitis
• infertility in women, delayed ovulation
• a characteristic skin allergic reaction known as fixed drug eruption, usually recurring in the same place (in the same places) after re-administration of the medicine and may appear as itching, round or oval, red and swollen spots on the skin, blisters (hives).

Side effects of non-steroidal anti-inflammatory drugs (NSAIDs) not yet reported with Movalis:

Acute kidney failure due to changes in kidney structure:

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

Reporting side effects

If side effects occur, including any not listed in this leaflet, the patient should tell their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
phone: +48 22 49-21-301, fax: +48 22 49-21-309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Movalis

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and outer packaging. The expiry date refers to the last day of the month.
Do not store above 30°C.
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Movalis contains

The active substance of Movalis is meloxicam.
One tablet contains 7.5 mg or 15 mg of meloxicam.
The other ingredients are:

• sodium citrate,
• lactose monohydrate,
• microcrystalline cellulose,
• powdered cellulose K 25,
• silica colloidal anhydrous,
• crosprolidone,
• magnesium stearate.

What Movalis looks like and contents of the pack

Movalis 7.5 mg tablets are yellow, round tablets with a diameter of 9 mm, with the marketing authorization holder's logo on one side and the code 59D/59D on the other side.
Each tablet has a dividing line. The dividing line on the tablet only makes it easier to break it into smaller pieces for easier swallowing.
Movalis 15 mg tablets are yellow, round tablets with a diameter of 9 mm, with the marketing authorization holder's logo on one side and the code 77C/77C on the other side.
Each tablet has a dividing line and can be divided into two equal doses.
Movalis is available in PVC/PVDC/Aluminum blisters.

Movalis 7.5 mg tablets are available in packs of 20 tablets.

Movalis 15 mg tablets are available in packs of 10 and 20 tablets.

Not all pack sizes may be marketed.
Meloxicam is also available as a 15 mg/1.5 ml solution for injection.

Marketing authorization holder:

Boehringer Ingelheim International GmbH
Binger Strasse 173
D-55216 Ingelheim/Rhein
Germany

Manufacturer:

Boehringer Ingelheim Pharma GmbH
Binger Strasse 173
D-55216 Ingelheim/Rhein
Germany
Boehringer Ingelheim Hellas Single Member S.A.
5 km Paiania-Markopoulo
Koropi Attiki
19441 Greece
Rottendorf Pharma GmbH
Ostenfelder Strasse 51 - 61
59320 Ennigerloh
Germany
To obtain more detailed information, the patient should contact the local representative of the marketing authorization holder:
Poland
Boehringer Ingelheim Sp. z o.o.
Tel. +48 22 699 0 699

Date of last revision of the leaflet: 06/2023