Movalis

Package leaflet: Information for the patient

Warning! Keep the 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 carefully the entire leaflet 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, please consult your doctor or pharmacist.
• This medicine has been prescribed strictly for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are identical.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet:

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 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 in the treatment of 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 previously experienced, 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 or gastrointestinal bleeding or haemorrhage (peptic ulcer or bleeding occurring at least twice).
• If the patient has severe liver function impairment.
• In non-dialysed patients with severe renal failure.
• If the patient has recently experienced bleeding within the brain (cerebral haemorrhage).
• If the patient has experienced any other bleeding episodes.
• 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, consult a doctor.

Warnings and precautions

Before starting treatment with Movalis, discuss it with your doctor or pharmacist.

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 suspected risk of these conditions, the treatment approach should be discussed with a 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 tobacco.

Treatment with Movalis should be stopped immediately if bleeding (causing tarry stools) or gastrointestinal ulceration (causing abdominal pain) occurs.

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 round lesions on the trunk, often with central blisters. Additional symptoms may include ulcers in the mouth, throat, nose, or genitals, and conjunctivitis (red, 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 must not be restarted in patients who have experienced Stevens-Johnson syndrome or toxic epidermal necrolysis while taking meloxicam.

If a rash or any of the above symptoms occur, stop using Movalis immediately and seek medical advice without delay, informing the doctor about the use of 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 a doctor.

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Precautions for use

Due to the need for treatment adjustments, consult a doctor before starting Movalis if:

• The patient has previously had oesophagitis, gastritis, or any other gastrointestinal disorder, such as 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, 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 currently taking or has recently taken, and other medicines may affect the action of Movalis.

Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.

In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• Other non-steroidal anti-inflammatory drugs (NSAIDs);
• Potassium salts – used to treat low blood potassium levels;
• 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 cancer, 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 blood glucose levels to detect hypoglycaemia.

Pregnancy, breastfeeding and fertility

If the patient is pregnant, 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

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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 risk of bleeding in both mother and child and may delay or prolong labour.

Movalis should not be used during the first six months of pregnancy 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 duration.

From week 20 of pregnancy, Movalis may cause kidney problems in the unborn child if used 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 impair fertility. Inform your doctor if you are planning to become pregnant or have difficulty conceiving.

Driving and operating machinery

Visual disturbances, including blurred vision, drowsiness, dizziness, or other central nervous system effects 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 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 exclusively 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 injected into the opposite buttock.
If the patient has a hip 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 a maximum of 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 physician may reduce the dose to 7.5 mg meloxicam per day (half of a 1.5 ml vial).
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 vial).
Patients at increased risk of adverse reactions
For patients at increased risk of adverse reactions, treatment should be initiated at a dose of 7.5 mg meloxicam per day (half of a 1.5 ml vial).
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Renal function impairment
In dialyzed patients with severe renal function impairment, the dose should not exceed 7.5 mg per day (half of a 1.5 ml vial).
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 observed after a few days, the patient should contact a physician 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 physician or the nearest hospital emergency department.
Symptoms of NSAID overdose are usually limited to:

• asthenia (feeling of lack of energy);
• drowsiness;
• nausea and vomiting;
• stomach pain (epigastric pain). These symptoms usually resolve after discontinuation of Movalis. Gastrointestinal bleeding (gastrointestinal hemorrhage) may occur in the patient.

Severe poisoning may lead to serious adverse drug reactions (see section 4):

• elevated blood pressure (arterial hypertension);
• acute renal failure;
• hepatic dysfunction;
• respiratory depression or respiratory arrest;
• 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.
If there are any further doubts regarding the use of this medicine, consult a physician or pharmacist.

4. Possible adverse effects

Like any medicine, Movalis may cause adverse effects, although not everyone will experience them.
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You should stop taking Movalis and seek immediate medical advice 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), soft tissue damage (mucosal lesions), or erythema multiforme (see section 2). Erythema multiforme is a severe allergic skin reaction causing spots, red or purple rashes, 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 around the eyes, face and lips, mouth or throat, possibly causing breathing difficulties, or swelling of the 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 be severe and potentially fatal, especially in elderly patients.
If a patient has previously experienced any gastrointestinal disorders due to long-term use of NSAIDs, they should seek immediate medical advice, especially if elderly. The doctor may monitor the progress of treatment.
If taking Movalis causes visual disturbances, do not drive or operate machinery.

General adverse effects associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs)

The 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.

Treatment with NSAIDs has been associated with the occurrence of oedema, hypertension and heart failure.

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

• Peptic ulcer disease of the stomach and duodenum;
• Intestinal 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; Page 6 of 10
• Indigestion (dyspepsia);
• Abdominal pain;
• Black, tarry stools due to gastrointestinal bleeding;
• Vomiting blood;
• Oral ulcerative inflammation;
• Exacerbation of gastrointestinal inflammation (e.g. exacerbation of colitis or Crohn’s disease).

Gastritis has been reported 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, flatulence, loose stools (diarrhoea).

Common: may affect less than 1 in 10 people

• Headache;
• Local swelling 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 vertigo (of labyrinthine origin);
• Drowsiness (somnolence);
• Anaemia (reduced concentration of haemoglobin, the red blood pigment);
• 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.
• Regurgitation (backflow of stomach contents into the oesophagus);
• Gastritis;
• Gastrointestinal bleeding;
• Inflammation of the oral mucosa;
• Immediate hypersensitivity reactions;
• Itching (pruritus);
• Skin rash;
• Fluid retention-related oedema, including swelling of ankles/legs (peripheral oedema);
• Sudden swelling of the skin or mucous membranes, such as around the eyes, face, lips, mouth or throat, possibly causing breathing difficulties (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 kidney function laboratory 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 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 (ringing in the ears);
• Palpitations (awareness of heartbeat);
• Peptic ulcer disease of the stomach or duodenum;
• 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 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 allergic skin reaction causing spots, red or purple rashes or blisters on the skin. It may also occur on 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;
• 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 treatment;
• 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 result in:
• Sudden fever;
• Sore throat;
• Infections;
• Pancreatitis;
• Infertility in women, delayed ovulation.

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).

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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 of 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 Movalis

Keep this 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 outer packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package 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 ingredients: 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 2 ml ampoules made of colourless type I glass, containing 1.5 ml of solution.
Pack sizes: 1, 3, or 5 ampoules.

Other presentations of meloxicam:
Meloxicam is also available as:

• tablets 7.5 mg
• tablets 15 mg.

For further information, please contact the responsible party or parallel importer:
Responsible party in Greece, 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 in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Authorisation number in Greece, country of export: 28381/19.04.2011
Parallel import authorisation number: 119/23
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