MOVALIS

Package leaflet: information for the patient

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Movalis (Mobic)
10 mg/ml (15 mg/1.5 ml), solution for injection
Meloxicamum
Movalis and Mobic are different trade names for the same medicine.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. 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 adverse effects, including any not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Movalis is and what it is 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 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 nonsteroidal anti-inflammatory drugs (NSAIDs), which are used to reduce inflammation and pain in joints and muscles.
Movalis solution for injection is intended for use in adults.
Movalis is used in the treatment of flare-ups 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 during 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 nonsteroidal anti-inflammatory drugs (NSAIDs):
  • wheezing, feeling of tightness in the chest, shortness of breath (asthma)
  • nasal obstruction due to swelling of the nasal mucosa (nasal polyps)
  • skin rash and/or urticaria
  • sudden swelling of the skin or mucous membranes, such as around the eyes, face, lips, mouth, or throat, which may potentially impair breathing (angioedema)
• If the patient has previously experienced the following during NSAID therapy:
  • gastrointestinal bleeding
  • perforation of the stomach or intestines
• If the patient currently has peptic ulcer disease or gastrointestinal bleeding
• If the patient has a history of peptic ulcer disease or gastrointestinal bleeding or bleeding (ulcer disease or bleeding occurring at least twice)
• If the patient has severe liver function impairment
• In nondialyzed patients with severe renal insufficiency
• If the patient has recently experienced intracranial bleeding (cerebral hemorrhage)
• If the patient has any other bleeding disorders
• In patients treated with anticoagulant medicines (due to the risk of intramuscular hematoma)
• If the patient has severe heart failure.

If the patient is unsure whether any of the above points apply, they should contact their doctor.
Warnings and precautions
Before starting treatment with Movalis, discuss with your doctor or pharmacist:

• if the patient has ever experienced persistent drug-induced erythema (drug eruption) (circular or oval red and swollen skin patches, usually recurring in the same location(s), blisters, urticaria, and itching) after taking meloxicam or other oxicams (e.g., piroxicam).

Warnings
Taking medicines such as 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. Do not use higher doses or longer treatment duration than recommended (see section 3).
If the patient has heart problems, has had a stroke, or suspects they are at risk of these conditions, discuss the treatment approach with the doctor or pharmacist.
For example, when:

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

Treatment with Movalis should be stopped immediately if bleeding (causing tarry stools) or gastrointestinal ulceration (causing abdominal pain) occurs.
Serious, potentially life-threatening skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Movalis. These initially appear as red spots or circular lesions on the trunk, often with central blisters. Additional symptoms may include ulcers in the mouth, throat, nose, or genital area, and conjunctivitis (red and swollen eyes). These potentially life-threatening skin reactions are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or detachment of the epidermis. The highest risk of severe skin reactions occurs during the first weeks of treatment. Movalis treatment must not be restarted in patients who have experienced Stevens-Johnson syndrome or toxic epidermal necrolysis while taking meloxicam.
If a skin rash or any of the above symptoms occur, stop using Movalis immediately and seek medical advice without delay, informing the doctor that the patient is taking this medicine.
Movalis is not recommended for the treatment of acute pain attacks.
Movalis may mask signs of infection (e.g., fever). If the patient suspects an infection, they should contact their doctor.
Precautions for use
Due to the need for treatment adjustments, consult your doctor before starting Movalis if:

• the patient has previously had esophagitis, gastritis, or any other gastrointestinal disorder, e.g., Crohn's disease or ulcerative colitis
• high blood pressure (hypertension)
• use in elderly patients
• heart, liver, or kidney disease
• high blood glucose levels (diabetes)
• reduced circulating blood volume (hypovolemia), which may occur due to significant blood loss or burns, surgery, or low fluid intake
• previously diagnosed high potassium levels in the blood.

In the above cases, the doctor will monitor the patient's progress during treatment.
Movalis with other medicines
Movalis may affect the action of other medicines the patient is taking, and other medicines may affect the action of Movalis.
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In particular, inform the doctor or pharmacist if the patient is taking any of the following medicines:

• other nonsteroidal anti-inflammatory drugs (NSAIDs)
• potassium salts – used to treat low potassium levels in the blood
• tacrolimus – used after organ transplantation
• trimethoprim – used to treat urinary tract infections
• anticoagulant medicines
• medicines that dissolve blood clots (thrombolytics)
• medicines used for heart and kidney diseases
• corticosteroids (e.g., used for anti-inflammatory or allergic reaction treatment)
• cyclosporine – used after organ transplantation or in severe skin diseases, rheumatoid arthritis, or nephrotic syndrome
• deferasirox – used to treat iron overload after frequent blood transfusions
• diuretics – the doctor may monitor kidney function when diuretics are used
• medicines used to treat hypertension (e.g., beta-blockers)
• lithium – used to treat psychiatric disorders
• 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 antidiabetic medicines (sulfonylurea derivatives, nateglinide) – used to treat diabetes. The doctor should ensure regular monitoring of the patient's blood glucose levels for the occurrence of hypoglycemia.

Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Do not take Movalis 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 increase the tendency to bleeding in both the mother and child and may delay or prolong labor. During the first six months of pregnancy, Movalis should not be used unless the doctor considers it absolutely necessary. If treatment is required 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 longer than a few days. This 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 required for longer than a few days, the doctor may recommend additional monitoring.
Breastfeeding
This medicine is not recommended for use in breastfeeding women.
Fertility
This medicine may make it more difficult to become pregnant. Inform the doctor if the patient is planning to become pregnant or has problems conceiving.
Driving and operating machinery
Visual disturbances, including blurred vision, drowsiness, dizziness, or other central nervous system disorders may occur after using Movalis. If these symptoms occur, do not drive or operate machinery.
Movalis contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per 1.5 ml vial, meaning the medicine is considered "sodium-free."

3. How to use Movalis

Movalis is intended for intramuscular administration only. The medicine may be administered only by experienced medical personnel. The medicine should be given slowly, intramuscularly, usually into the buttock. If more than one injection is required, the medicine will be administered into the opposite buttock. If the patient has a hip joint prosthesis, the injection will be given on the opposite side of the body. If the patient experiences severe pain during injection, administration of the medicine should be stopped.

Dosage: At the beginning of treatment, one injection is given. Treatment may be extended by administering up to one injection for 2 to 3 days in exceptional cases (e.g. when tablets cannot be used).
The recommended maximum dose of 15 mg per day must not be exceeded.
If any of the conditions listed in section "Warnings and precautions" apply to the patient, the doctor may reduce the dose to 7.5 mg meloxicam per day (half an ampoule of 1.5 ml).

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 an ampoule of 1.5 ml).

Patients at increased risk of adverse reactions
For patients at increased risk of adverse reactions, treatment should be initiated with a dose of 7.5 mg per day (half an ampoule of 1.5 ml).

Renal function impairment
In dialysed patients with severe renal function impairment, the dose should not exceed 7.5 mg per day (half an ampoule of 1.5 ml).
Dose reduction is not necessary in patients with mild or moderate renal function impairment.

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

Use in children and adolescents
Movalis must not be administered to children and adolescents under 18 years of age.

If the patient feels that the effect of Movalis is too strong or too weak, or if no improvement is noticed after several days, the patient should contact a doctor or pharmacist.

Overdose of Movalis
In case of taking more than the recommended dose of Movalis or in case of suspected overdose, immediate medical advice should be sought from a doctor or by going to the nearest hospital emergency department.

Symptoms of NSAID overdose are usually limited to:

• weakness (feeling of lack of energy)
• drowsiness
• nausea and vomiting
• stomach pain (epigastric pain).

These symptoms usually resolve after discontinuation of Movalis. Gastrointestinal bleeding (gastrointestinal haemorrhage) may occur in the patient.

Severe poisoning may lead to serious adverse effects of the medicine (see section 4):

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

Missed 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 there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse effects

Like any medicine, Movalis can cause adverse effects, although not everyone will experience them.

Treatment with Movalis should be discontinued and medical advice should be sought immediately from a doctor or the nearest hospital if any of the following occur:

Any allergic (hypersensitivity) reactions, which may manifest as:

• Skin reactions such as itching (pruritus), blistering and peeling of the skin, which may potentially be life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis), damage to soft tissues (lesions of mucous membranes) or erythema multiforme (see section 2). Erythema multiforme is a severe allergic skin reaction causing spots, red or purple patches or blisters on the skin. 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, oral cavity or throat, which may impair breathing, swelling of ankles and legs (peripheral oedema)
• Shortness of breath or asthma attack
• Hepatitis. This may cause symptoms such as:
• Yellowing of the skin and whites of the eyes (jaundice)
• Abdominal pain
• Loss of appetite

Any adverse gastrointestinal symptoms, particularly:

• Bleeding (resulting in black, tarry stools)
• Gastrointestinal ulceration (causing abdominal pain)

Gastrointestinal bleeding, ulceration or perforation may occasionally have a severe course and potentially be fatal, especially in elderly patients.
If a patient has previously experienced any gastrointestinal disorders due to long-term use of NSAIDs, medical advice should be sought immediately, particularly if the patient is elderly. The doctor may monitor the progress of treatment.

If Movalis causes disturbances in vision, driving or operating machinery should not be undertaken.

General adverse effects associated with use of non-steroidal anti-inflammatory drugs (NSAIDs)
Use of certain non-steroidal anti-inflammatory drugs (NSAIDs) may be associated with a small increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke), particularly with high doses and prolonged treatment.
Oedema, hypertension and heart failure have been reported during NSAID therapy.

The most commonly observed adverse effects involve the gastrointestinal tract (stomach and intestinal disturbances):

• Gastric and duodenal ulcer disease
• Intestinal wall perforation or gastrointestinal bleeding (sometimes fatal, especially in elderly patients)

The following adverse effects have been reported with NSAID use:

• Nausea and vomiting
• Loose stools (diarrhoea)
• Flatulence
• Constipation
• Dyspepsia
• Abdominal pain
• Black, tarry stools due to gastrointestinal bleeding
• Vomiting blood
• Ulcerative stomatitis
• Exacerbation of gastrointestinal inflammation (e.g. exacerbation of colitis or Crohn's disease)

Gastritis has been observed less frequently.

Adverse effects of meloxicam – the active substance in Movalis

Very common: may affect more than 1 in 10 people

• Gastrointestinal disorders such as dyspepsia, nausea and vomiting, abdominal pain, constipation, flatulence, loose stools (diarrhoea)

Common: may affect less than 1 in 10 people

• Headache
• Induration at injection site, pain at injection site

Uncommon: may affect less than 1 in 100 people

• Dizziness (feeling of emptiness in the head)
• Dizziness or vertigo (vestibular origin)
• Somnolence (drowsiness)
• Anaemia (reduced concentration of the red blood pigment haemoglobin)
• Increased blood pressure (hypertension)
• Facial flushing (transient redness of the face and neck)
• Sodium and water retention
• Increased potassium levels (hyperkalaemia). This may lead to symptoms such as:
• Cardiac arrhythmias
• Palpitations (when the patient feels the heartbeat more than usual)
• Muscle weakness
• Gastro-oesophageal reflux
• Gastritis
• Gastrointestinal bleeding
• Mucositis
• Immediate hypersensitivity reactions (hypersensitivity)
• Itching (pruritus)
• Skin rash
• Fluid retention-related oedema, including ankle/leg swelling (peripheral oedema)
• Sudden swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, oral cavity or throat, which may impair breathing (angioedema)
• Transient abnormalities in liver function tests (e.g. increased liver enzyme activity such as aminotransferases, or increased levels of the bile pigment bilirubin). These changes may be detected by the doctor via blood tests.
• Renal function laboratory test abnormalities (e.g. increased creatinine or urea levels)

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

• Mood disturbances
• Nightmares
• Blood morphology disorders, including:
• Abnormal blood smear
• Decreased white blood cell count (leukopenia)
• Decreased platelet count (thrombocytopenia). These adverse effects may lead to an increased risk of infection and symptoms such as bruising or nosebleeds.
• Tinnitus
• Palpitations
• Gastric or duodenal ulcer disease
• Oesophagitis
• Asthma attacks (in patients hypersensitive to aspirin or other NSAIDs)
• Skin blistering or epidermal detachment (Stevens-Johnson syndrome and toxic epidermal necrolysis)
• Urticaria
• Visual disturbances, including:
• Blurred vision
• Conjunctivitis (inflammation of the eyeball or eyelids)
• Colitis

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

• Bullous skin reactions and erythema multiforme. Erythema multiforme is a severe allergic skin reaction causing spots, red or purple patches or blisters on the skin. It may also affect the mouth, eyes and other moist areas of the body.
• Hepatitis. This may cause symptoms such as:
• Yellowing of the skin and whites of the eyes (jaundice)
• Abdominal pain
• Loss of appetite
• Acute renal failure, particularly in patients with risk factors such as heart disease, diabetes or kidney disease
• Intestinal wall perforation

Frequency not known: frequency cannot be estimated from available data

• Confusion
• Disorientation
• Anaphylactic shock
• Dyspnoea and skin reactions (anaphylactic/anaphylactoid), skin rashes caused by exposure to sunlight (photosensitivity reactions)
• Heart failure reported in association with NSAID therapy
• Complete loss of certain types of white blood cells (agranulocytosis), particularly in patients taking Movalis together with other medicines that potentially have myelosuppressive or bone marrow-damaging effects (myelotoxic drugs). This may cause:
• Sudden fever
• Sore throat
• Infections
• Pancreatitis
• Infertility in women, delayed ovulation
• A characteristic allergic skin reaction known as fixed drug eruption, usually recurring in the same location(s) upon re-exposure to the drug, which may appear as itchy, round or oval, red and swollen skin patches or blisters (urticaria)

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

Acute renal failure due to structural kidney changes:

• Very rarely, cases of kidney inflammation (interstitial nephritis)
• Death of certain kidney cells (acute necrosis of glomeruli or renal papillae)
• Presence of protein in urine (nephrotic syndrome with proteinuria)

Reporting of adverse effects

If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration 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 adverse effects helps to provide more information 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 stated month.
Store ampoules in their outer packaging to protect them from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What the medicine Movalis contains
The active substance is meloxicam.
One ml of 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 yellow solution with a greenish tint.
Movalis is available in ampoules made of colourless glass with a capacity of 2 ml, containing
1.5 ml of solution.
Pack sizes: packs of 3 ampoules.
Other forms of meloxicam available:
Meloxicam is also available in the following forms:

• tablets 7.5 mg
• tablets 15 mg.

For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in France, the country of export:
Boehringer Ingelheim France
100-104 avenue de France
75013 Paris
France
Manufacturer:
Boehringer Ingelheim Espana S.A.
Prat de la Riba, 50
08174 Sant Cugat del Vallés
Barcelona
Spain
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged by:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorisation number in France, the country of export: 34009 353 974 5 4
353 974-5
Parallel import authorisation number: 322/25