Movalis

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Movalis, 10 mg/ml (15 mg/1.5 ml), solution for injection

Meloxicam

It is essential to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for the patient. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Movalis and what is it used for
• 2. Important information before using Movalis
• 3. How to use Movalis
• 4. Possible side effects
• 5. How to store Movalis
• 6. Contents of the packaging 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 joints and muscles.
Movalis solution for injection is intended for adults.
Movalis is used to treat exacerbations of:

• rheumatoid arthritis
• ankylosing spondylitis, when the medicine cannot be administered by other routes.

2. Important information before using Movalis

When not to use 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 18 years of age
• If the patient has experienced any of the following symptoms after taking aspirin or other non-steroidal anti-inflammatory drugs:
• wheezing, feeling of pressure in the chest, shortness of breath (asthma)
• nasal congestion due to swelling of the nasal mucosa (nasal polyps)
• skin rash and/or 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:
• gastrointestinal bleeding or perforation
• If the patient currently has a stomach or intestinal ulcer or bleeding
• If the patient has had a stomach or intestinal ulcer or bleeding (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
• In patients treated with anticoagulants (due to the risk of hematoma)
• If the patient has severe heart failure.

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 eruption) 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. The patient should not take higher doses or use the medicine for longer than recommended (see section 3).
In case of heart problems, a history of stroke, or suspected risk of these disorders, the patient should discuss the treatment with their doctor or pharmacist.
For example, if:

• 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 using Movalis immediately if they notice bleeding (causing black stools) or gastrointestinal ulceration (causing abdominal pain).
There have been reports of potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) associated with Movalis, initially appearing 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 may develop into generalized blisters or skin peeling. The highest risk of severe skin reactions occurs in the first few weeks of treatment. In patients who have experienced Stevens-Johnson syndrome or toxic epidermal necrolysis while taking Movalis, meloxicam should not be restarted.
If a rash or the above symptoms occur, the patient should stop using 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 their doctor.

Precautions for use

Due to the need to modify treatment, the patient should consult their doctor before starting Movalis if:

• they have a history of esophagitis, gastritis, or any other gastrointestinal disease, such as Crohn's disease or ulcerative colitis
• they have high blood pressure (hypertension)
• they are elderly
• they have heart, liver, or kidney disease
• they have high blood glucose (diabetes)
• they have reduced blood volume (hypovolemia), which may occur in case of significant blood loss or burns, surgery, or low fluid intake
• they have previously diagnosed high potassium levels in the blood.

In these cases, the doctor will monitor the patient's progress.

Movalis and other medicines

Movalis may affect the action of other medicines, 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 their doctor or pharmacist before using this medicine.
Pregnancy
Movalis should not be taken if the patient is in the last three 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 the child and cause delayed or prolonged labor. During the first six 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 child (oligohydramnios) or narrowing of the arterial duct in the child'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 become pregnant. The patient should inform their doctor if they plan to become pregnant or are having trouble becoming pregnant.

Driving and using machines

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

Movalis contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per 1.5 ml ampoule, which means the medicine is considered "sodium-free".

3. How to use Movalis

Movalis is intended for intramuscular injection only. The medicine should only be administered by experienced medical personnel. The medicine is injected slowly, intramuscularly, usually in the buttock. If more than one injection is necessary, the medicine will be injected into the other buttock. If the patient has a hip prosthesis, the medicine will be injected on the other side of the body. If the patient feels severe pain during the injection, the administration of the medicine should be stopped.
Dosage:One injection is given at the start of treatment. Treatment can be extended using a maximum of one injection every 2 to 3 days in exceptional cases (e.g., when tablets cannot be used).

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

If any of the conditions listed in the "Warnings and precautions" section apply to the patient, the doctor may reduce the dose to 7.5 mg of meloxicam per day (half of a 1.5 ml ampoule).

Elderly patients

The recommended dose for elderly patients in long-term treatment of rheumatoid arthritis and ankylosing spondylitis is 7.5 mg per day (half of a 1.5 ml ampoule).

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 (half of a 1.5 ml ampoule).

Renal impairment

In dialyzed patients with severe renal impairment, the dose should not exceed 7.5 mg per day (half of a 1.5 ml ampoule).
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 given to children and adolescents under 18 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 their doctor or pharmacist.

Overdose of Movalis

In case of overdose or suspected overdose of Movalis, the patient should immediately consult their 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 resolve 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. They should take the next dose at the scheduled time.
If the patient has any further doubts about using the medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Movalis can cause side effects, although not everybody gets them.
The patient should stop using Movalis and consult their 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 areas of the body.
• swelling of the skin or mucous membranes, such as swelling around the eyes, face, and lips, mouth, or throat, which may make breathing difficult, swelling of the feet and ankles (peripheral edema)
• shortness of breath or asthma attack
• liver inflammation. This may 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)
• ulceration of the gastrointestinal tract (causing abdominal pain).

Gastrointestinal bleeding, ulceration, or perforation may sometimes have a severe course and can be life-threatening, especially in elderly patients.
If the patient has previously experienced gastrointestinal disorders due to long-term use of NSAIDs, they should immediately consult their doctor, especially if they are elderly. The doctor may monitor the patient's progress.
If 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 or duodenal ulcer
• perforation of the intestinal wall or gastrointestinal bleeding (sometimes fatal, especially in elderly patients).

The following side effects have been reported with NSAIDs:

• nausea (nausea) and vomiting
• diarrhea
• flatulence
• constipation
• indigestion (dyspepsia)
• abdominal pain
• black stools due to gastrointestinal bleeding
• bloody vomiting
• mouth ulcers
• exacerbation of inflammatory bowel disease (e.g., exacerbation of ulcerative colitis or Crohn's disease).

Liver inflammation 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

• headache
• thickening at the injection site, pain at the injection site.

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 (reduced hemoglobin levels)
• high blood pressure (hypertension)
• flushing (temporary flushing of the face and neck)
• fluid and sodium retention
• high potassium levels in the blood (hyperkalemia). This may lead to symptoms such as:
• heart rhythm disorders
• palpitations (feeling of heartbeat)
• muscle weakness
• reflux (regurgitation of food from the stomach into the esophagus)
• gastritis
• gastrointestinal bleeding
• mouth ulcers
• immediate allergic reactions (hypersensitivity)
• itching (pruritus)
• skin rash
• edema due to fluid retention, including edema 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 may make breathing difficult (angioedema)
• temporary changes in liver function tests (e.g., increased liver enzyme activity, 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 1000 people

• mood disorders
• nightmares
• blood disorders, including:
• abnormal blood smear
• reduced white blood cell count (leukopenia)
• reduced platelet count (thrombocytopenia) These side effects may increase the risk of infection and symptoms such as bruising or nosebleeds.
• ringing in the ears (tinnitus)
• palpitations (feeling of heartbeat)
• gastric or duodenal ulcer
• esophagitis
• asthma attacks (in patients allergic to aspirin or other NSAIDs)
• blistering skin reactions or skin peeling (Stevens-Johnson syndrome and toxic epidermal necrolysis)
• hives
• visual disturbances, including:
• blurred vision
• conjunctivitis (inflammation of the eye or eyelid)
• 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 areas of the body.
• liver inflammation. This may 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 available data

• confusion
• disorientation
• anaphylactic shock
• shortness of breath and skin reactions (anaphylactic/anaphylactoid) rash 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 may 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 kidney inflammation (interstitial nephritis)
• necrosis 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 side effects not listed in this leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting side effects will help 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.
The medicine should not be used after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
The medicine should be stored in its original packaging to protect it from light.
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 packaging and other information

What Movalis contains

The active substance of Movalis is meloxicam.
One ml of the solution contains 10 mg of meloxicam.
One ampoule (1.5 ml of solution) contains 15 mg of meloxicam in the form of an enol salt formed during the manufacturing process.
The other ingredients are:

• meglumine,
• glycofurol,
• poloxamer 188,
• sodium chloride,
• glycine,
• sodium hydroxide,
• water for injections.

What Movalis looks like and what the pack contains

Movalis is a yellow solution with a greenish tint.
Movalis is available in ampoules made of colorless glass type I, with a capacity of 2 ml, containing 1.5 ml of solution.
Package sizes: 1, 3, 5 ampoules.

Other possibilities for using meloxicam:

Meloxicam is also available in:

• 7.5 mg tablets
• 15 mg tablets.

For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Austria, the country of export:

Boehringer Ingelheim RCV GmbH & Co KG
Dr. Boehringer-Gasse 5-11, 1121 Vienna, Austria

Manufacturer:

Boehringer Ingelheim Espana S.A.
Prat de la Riba, 50, 08174 Sant Cugat del Vallés, Barcelona, Spain

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Austrian marketing authorization number:1-24199

Parallel import authorization number: 243/23

Date of leaflet approval: 25.10.2023

[Information about the trademark]