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

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell 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 of administration.

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 chest tightness, 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 bleeding in the brain (cerebral hemorrhage)
• If the patient has experienced any other bleeding
• In patients treated with anticoagulant medications (due to the possibility 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 their 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 patches 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 exceed the recommended dose and duration of treatment (see section 3).
In case of heart problems, a history of stroke, or suspected risk of these disorders, the patient should discuss their 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.

Stop using Movalis immediately if bleeding (causing black stools) or gastrointestinal ulceration (causing abdominal pain) occurs.
There have been reports of potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) associated with Movalis, 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 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, toxic epidermal necrolysis while taking Movalis, meloxicam treatment should not be resumed.
If a rash or the above symptoms occur, the patient should stop using Movalis and seek medical attention immediately, informing their doctor that they are taking this medicine.
Movalis is not recommended for the treatment of acute pain attacks.
Movalis may mask 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 treatment with Movalis if:

• they have a history of esophageal inflammation, stomach inflammation, 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 sugar (diabetes)
• they have decreased blood volume (hypovolemia), which may occur in case of significant blood loss or burns, surgery, or low fluid intake
• they have previously been diagnosed with high potassium levels in the blood (hyperkalemia) by their doctor.

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
• anticoagulant medications
• medicines that dissolve blood clots (thrombolytic medications)
• medicines used to treat heart and kidney diseases
• corticosteroids (e.g., used as anti-inflammatory or to treat allergic reactions)
• cyclosporine - used after organ transplants or in cases of severe skin diseases, rheumatoid arthritis, or nephrotic syndrome
• deferazirox - used to treat iron overload after frequent blood transfusions
• diuretic medications - the doctor may monitor kidney function when taking diuretic medications.
• 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 medications (sulfonylurea derivatives, nateglinide) - used to treat diabetes. The doctor should ensure regular monitoring of the patient's blood sugar levels to detect 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

Do not take Movalis if you are in the last 3 months of pregnancy, as it may harm the unborn baby or cause complications during delivery. Movalis may cause kidney and heart problems in the unborn baby. It may also increase the risk of bleeding in the mother and baby and prolong labor. During the first 6 months of pregnancy, do not use Movalis unless your doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, use the lowest possible dose for the shortest possible time. From the 20th week of pregnancy, Movalis may cause kidney problems in the unborn baby if used 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 to get pregnant. The patient should inform their doctor if they plan 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 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 buttocks. 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 administered on the other side of the body. If the patient feels severe pain during injection, the administration of the medicine should be stopped.
Dosage:One injection is administered 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).

Kidney problems

In dialyzed patients with severe kidney problems, 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 kidney problems.

Liver problems

Dose reduction is not necessary in patients with mild or moderate liver problems.

Use in children and adolescents

Movalis should not be administered to children and adolescents under 18 years of age.
If the patient thinks 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.

Using more than the recommended dose of Movalis

In case of taking more than the recommended dose of Movalis or suspected overdose, the patient should immediately consult their doctor or go to the nearest hospital emergency department.

Symptoms of overdose of NSAIDs 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 the use of 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.

Missing a dose of Movalis

Do not take a double dose to make up for a missed dose. 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.
Stop using Movalis and consult your doctor or the nearest hospital immediately if you 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 patches, red or purple stripes, or blisters on the skin. It 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 may 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 ulcers (causing abdominal pain).

Gastrointestinal bleeding or ulcers may 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 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 (diarrhea)
• flatulence with gas release
• constipation
• indigestion (dyspepsia)
• abdominal pain
• black stools due to gastrointestinal bleeding
• bloody vomiting
• mouth ulcers
• worsening of inflammatory bowel disease (e.g., worsening 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 (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 in the blood)
• high blood pressure (hypertension)
• flushing (temporary redness of the face and neck)
• retention of sodium and water
• increased potassium levels in the blood (hyperkalemia). This can lead to symptoms such as:
• heart rhythm disorders
• palpitations (feeling of heartbeat)
• muscle weakness
• reflux (regurgitation of stomach contents into the esophagus)
• gastritis
• gastrointestinal bleeding
• mouth ulcers
• immediate allergic reactions (hypersensitivity)
• itching (pruritus)
• 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 may make breathing difficult (angioedema)
• liver function test abnormalities (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 test results (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 (conjunctival 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 patches, red or purple stripes, or blisters on the skin. It 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 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 medications that may have a suppressive or destructive effect on the bone marrow (myelotoxic medications). 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 itchy, round or oval, red and swollen patches on the skin, blisters (hives).

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

Acute kidney failure due to changes in kidney structure:

• very rare cases of kidney inflammation (interstitial 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 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 Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181 C, 02-222 Warszawa, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Movalis

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Do not store above 25°C.
Store in the outer packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. 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 contents of the pack

Movalis is a yellowish-green solution.
Movalis is available in ampoules made of colorless glass type I containing 1.5 ml of solution.
Pack 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 parallel importer.

Marketing authorization holder in Lithuania, the country of export:

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

Manufacturer:

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

Parallel importer:

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

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warszawa
Lithuanian marketing authorization number, in the country of export:LT/1/96/1465/004

Parallel import authorization number: 42/24

Date of leaflet approval: 25.01.2024

[Information about the trademark]