Movalis

Leaflet accompanying the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Movalis

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

Meloxicam

It is necessary 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 re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. 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 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 the 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) urticaria;
• 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). Page 1 of 10
• If the patient has experienced the following after previous NSAID therapy:
• gastrointestinal bleeding;
• perforation of the stomach or intestines.
• 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 formation).
• 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 Movalis, the patient should discuss it with their doctor or pharmacist.

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.
Higher doses and longer treatment periods than recommended should not be used (see section 3).
In case of heart problems, a history of stroke, or suspected risk of these disorders, the treatment should be discussed with the doctor or pharmacist.
For example, when:

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

Movalis should be discontinued immediately if bleeding occurs (causing black stools) or if gastrointestinal ulcers occur (causing abdominal pain).
With the use of Movalis, potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported, 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 peeling of the skin. The highest risk of severe skin reactions occurs in the first few weeks of treatment. In patients who have developed Stevens-Johnson syndrome, toxic epidermal necrolysis while taking Movalis, meloxicam treatment should not be resumed.
If a rash or the above symptoms occur, Movalis should be discontinued and medical advice should be sought immediately, informing the doctor about the use of 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.
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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 sugar levels (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 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;
• 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 prevent 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
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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 the 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 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 difficult to conceive. The patient should inform their doctor if they plan to conceive or have problems conceiving.

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 injected 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 for 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 the 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 the 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 the 1.5 ml ampoule).
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Kidney problems

In dialyzed patients with severe kidney problems, the dose should not exceed 7.5 mg per day (half of the 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 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.

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 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 discontinuation 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

A double dose should not be taken to make up for a missed dose. The next dose should be taken at the scheduled time.
If the patient has any further doubts about the use of 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.
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Movalis should be discontinued and the doctor or the nearest hospital should be consulted immediately if the patient experiences:

• 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), soft 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. 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 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);
• ulcers in the gastrointestinal tract (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 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.

Common side effects of NSAIDs

The use of some non-steroidal anti-inflammatory drugs (NSAIDs) may be associated with a small increased 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 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;
• constipation;
• indigestion (dyspepsia);
• abdominal pain;
• black stools due to gastrointestinal bleeding;
• bloody vomiting;
• mouth ulcers;
• exacerbation of gastrointestinal disease (e.g., exacerbation 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 more frequently than 1 in 10 people

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

Common: may occur less frequently than 1 in 10 people

• headaches;
• thickening at the injection site, pain at the injection site.

Uncommon: may occur less frequently 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);
• retention of sodium and water;
• increased 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 less frequently 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 peeling of the skin (Stevens-Johnson syndrome and toxic epidermal necrolysis);
• hives;
• visual disturbances, including:
• blurred vision;
• conjunctivitis (inflammation of the eye or eyelids).
• colitis (inflammation of the colon).

Very rare: may occur less frequently 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. It can also occur on the lips, eyes, and other moist body parts.
• 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 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 may cause:
• sudden fever;
• throat pain;
• infections;
• pancreatitis;
• infertility in women, delayed ovulation.

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);
• necrosis of some kidney cells (acute tubular necrosis);
• presence of protein in the urine (nephrotic syndrome with proteinuria).

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Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw,
phone: +48 (22) 49 21 301, fax: +48 (22) 49 21 309,
website: https://smz.ezdrowie.gov.pl
Reporting side effects can 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.
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 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 contents of the packaging

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.
Pack sizes: 1, 3, 5 ampoules.
Other possibilities for using meloxicam:

• 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 Greece, the country of export:

Boehringer Ingelheim International GmbH, Binger Str. 173
D-55216 Ingelheim am Rhein, Germany
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Manufacturer:

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

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Authorization number in Greece, the country of export: 28381/19.04.2011

Parallel import authorization number: 119/23

Date of leaflet approval: 26.06.2023

[Information about the trademark]
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