Movalis

Patient Information Leaflet

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

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your 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 non-steroidal anti-inflammatory drugs (NSAIDs), which are used to reduce inflammation and relieve joint and muscle pain.
Movalis, solution for injection, is intended for use in adults.
Movalis is used to treat acute 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 non-steroidal anti-inflammatory drugs (NSAIDs):
• Wheezing, tightness 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 around the eyes, face, lips, mouth or throat, which may possibly make breathing difficult (angioedema). Page 1 of 10
• If the patient has previously experienced, during NSAID therapy:
• Bleeding from the stomach or intestines;
• Perforation of the stomach or intestines.
• If the patient currently has peptic ulcer disease or gastrointestinal bleeding.
• If the patient has had peptic ulcer disease or gastrointestinal bleeding in the past (ulcers or bleeding occurring at least twice).
• If the patient has severe liver function impairment.
• In non-dialysed patients with severe renal insufficiency.
• If the patient has recently experienced bleeding within the brain (cerebral haemorrhage).
• If the patient has any other bleeding disorders.
• In patients treated with anticoagulant drugs (due to the risk of intramuscular haematomas).
• 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 this with your doctor or pharmacist:

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

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, a history of stroke, or suspects they may be at risk of these conditions, they should discuss treatment options with their 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 in the blood (hypercholesterolemia);
• The patient smokes tobacco.

Movalis treatment should be stopped immediately if bleeding (causing black, tarry stools) or gastrointestinal ulceration (causing abdominal pain) is observed.
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 patches on the trunk, often with central blisters. Additional symptoms may include mouth, throat, nose, or genital ulcers and conjunctivitis (red, swollen eyes). These potentially life-threatening skin reactions are often accompanied by flu-like symptoms. The rash may progress to generalized blisters 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 previously experienced Stevens-Johnson syndrome or toxic epidermal necrolysis while taking meloxicam.
If a skin rash or any of the above symptoms occur, Movalis should be discontinued immediately and medical advice sought, informing the doctor about the use of this medicine.
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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

Because treatment adjustments may be necessary, consult a doctor before starting Movalis in the following cases:

• If the patient has previously had oesophagitis, 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 (sugar) 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 being taken, and other medicines may affect the action of Movalis.
Tell your doctor or pharmacist about all medicines currently taken or 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 non-steroidal 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;
• Anticoagulants;
• Medicines that dissolve blood clots (thrombolytics);
• Medicines used for heart and kidney diseases;
• Corticosteroids (e.g. used for anti-inflammatory purposes or to treat allergic reactions);
• 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 high blood pressure (e.g. beta-blockers);
• Lithium – used to treat psychiatric disorders;
• Selective serotonin reuptake inhibitors (SSRIs) – used to treat depression;
• Methotrexate – used to treat cancers or severe uncontrolled skin diseases and active rheumatoid arthritis;
• Pemetrexed – used to treat cancer;
• Cholestyramine – used to reduce cholesterol levels;
• Oral antidiabetic medicines (sulfonylureas, nateglinide) – used to treat diabetes. The doctor should ensure regular monitoring of the patient's blood sugar levels for possible hypoglycaemia.

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Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, 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 also increase the tendency to bleeding in both the mother and the child and may delay or prolong labour.
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 week 20 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. The patient should inform the doctor if she is planning to become pregnant or is having difficulty conceiving.

Driving and using machines

Disturbances in vision, 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 sodium

The medicine contains less than 1 mmol (23 mg) of sodium per 1.5 ml ampoule, 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 is administered 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 medicine will be administered on the opposite side of the body. If the patient experiences severe pain during injection, administration of the medicine should be discontinued.
Dosage: At the beginning of treatment, one injection is administered.
Treatment may be extended by using up to one injection per day 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).
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Patients at increased risk of adverse reactions
In patients at increased risk of adverse reactions, treatment should be initiated at a dose of 7.5 mg per day (half an ampoule of 1.5 ml).
Renal function impairment
In dialysed patients with severe renal 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 impairment.
Hepatic function impairment
Dose reduction is not necessary in patients with mild or moderate hepatic impairment.
Use in children and adolescents
Movalis must not be administered to children and adolescents under 18 years of age.
If the patient considers the effect of Movalis to be too strong or too weak, or if no improvement is felt after several days, the patient should contact the doctor or pharmacist.
Overdose of Movalis
In case of ingestion of a dose higher than recommended or suspected overdose, immediate medical advice should be sought from a doctor or the nearest hospital emergency department.
Symptoms of NSAID overdose are usually limited to:

• weakness (lack of energy);
• drowsiness;
• nausea and vomiting;
• stomach pain (epigastric pain). These symptoms usually resolve after discontinuation of Movalis. Gastrointestinal bleeding (bleeding from the digestive tract) may occur in the patient.

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

• elevated blood pressure (arterial hypertension);
• acute renal failure;
• hepatic dysfunction;
• shallow or stopped breathing (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
Do not take a double dose to make up for a missed dose. Take the next dose at the scheduled time.
In case of any further doubts regarding the use of the medicine, consult the doctor or pharmacist.
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4. Possible adverse effects

Like all medicines, Movalis may cause adverse effects, although not everyone will experience them.

Treatment with Movalis should be discontinued and immediate consultation with a doctor or the nearest hospital is required 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), soft tissue damage (lesions of mucous membranes) or erythema multiforme (see section 2). Erythema multiforme is a severe skin allergic reaction causing spots, red or purple patches or blisters on the skin. It may also affect 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 ankles and legs (peripheral edema);
• 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, and particularly:

• Bleeding (causing black, tarry stools);
• Gastrointestinal ulceration (causing abdominal pain).

Gastrointestinal bleeding, ulceration or perforation may sometimes 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, the patient should seek immediate medical advice, especially if elderly. The doctor may monitor progress during treatment.
If treatment with 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 when used at high doses and for prolonged periods.

Edema, hypertension and heart failure have been reported during NSAID therapy.

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

• Peptic ulcer disease of the stomach and duodenum;
• Perforation of the intestinal wall or gastrointestinal bleeding (sometimes fatal, especially in elderly patients).

The following adverse effects have been reported following administration of NSAIDs:

• Nausea and vomiting;
• Loose stools (diarrhea);
• Bloating with gas release;
• Constipation;
• Indigestion (dyspepsia);
• Abdominal pain;
• Tarry stools due to gastrointestinal bleeding;
• Vomiting blood;
• Ulcerative stomatitis;
• Exacerbation of gastrointestinal inflammation (e.g. flare-up 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 disturbances such as indigestion (dyspepsia), nausea and vomiting, abdominal pain, constipation, bloating, loose stools (diarrhea).

Common: may affect less than 1 in 10 people

• Headache;
• Hardening at the injection site, pain at the injection site.

Uncommon: may affect less than 1 in 100 people

• Dizziness (feeling of emptiness in the head);
• Dizziness or spinning sensation (vestibular origin);
• Somnolence (drowsiness);
• Anemia (reduced concentration of the red blood pigment hemoglobin);
• Increased blood pressure (hypertension);
• Facial flushing (transient redness of the face and neck);
• Sodium and water retention;
• Increased potassium levels (hyperkalemia). This may lead to symptoms such as:
• Cardiac rhythm disturbances;
• Palpitations (when the patient feels heartbeat more than usual);
• Muscle weakness.
• Regurgitation (reflux of stomach contents into the esophagus);
• Gastritis;
• Gastrointestinal bleeding;
• Inflammation of the oral mucosa;
• Immediate allergic reactions (hypersensitivity);
• Itching (pruritus);
• Skin rash;
• Fluid retention-related edema, including swelling of ankles/legs (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);
• Transient abnormalities in liver function tests (e.g. increased activity of liver enzymes such as aminotransferases or increased levels of the bile pigment bilirubin). These changes may be detected by the doctor through blood tests;
• Abnormalities in laboratory kidney function tests (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 number of white blood cells (leukopenia);
• Decreased number of platelets (thrombocytopenia). These adverse effects may lead to increased risk of infection and symptoms such as bruising or nosebleeds.
• Tinnitus (ringing in the ears);
• Palpitations (sensation of rapid or irregular heartbeat);
• Peptic ulcer disease of the stomach or duodenum;
• Esophagitis;
• Asthma attacks (in patients hypersensitive to aspirin or other NSAIDs);
• Skin blistering or peeling of the skin (Stevens-Johnson syndrome and toxic epidermal necrolysis);
• Urticaria;
• Visual disturbances, including:
• Blurred vision;
• Conjunctivitis (inflammation of the eye ball 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 skin allergic reaction causing spots, red or purple patches or blisters on the skin. It may also affect the lips, 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;
• Perforation of the intestinal wall.

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

• Confusion;
• Disorientation;
• Anaphylactic shock;
• Shortness of breath 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), especially in patients taking Movalis together with other medicines that potentially have myelosuppressive or myelotoxic effects. 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 and may appear as itchy, circular or oval, red and swollen skin lesions, blisters (urticaria).

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

Acute renal failure due to structural changes in the kidneys:

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

Reporting of adverse effects

If any adverse effects occur, including those 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,
Tel: +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 the medicine 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 in the original packaging to protect 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 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.
Other components 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 type I glass with a capacity of 2 ml, containing 1.5 ml of solution.
Pack sizes: 1, 3 or 5 ampoules.

Other available forms of meloxicam:
Meloxicam is also available as:

• 7.5 mg tablets
• 15 mg tablets. Page 9 of 10

For further information, please contact the marketing authorisation holder or the parallel importer:
Marketing authorisation holder in Austria, 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:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorisation number in Austria, country of export: 1-24199
Parallel import authorisation number: 403/25
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