Movalis

Package leaflet: Information for the patient

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

• Keep this leaflet for future reference.
• 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 others, even if their symptoms are similar.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents:

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 package 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 drugs known as
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 in the treatment of flare-ups of:

• rheumatoid arthritis
• ankylosing spondylitis, when the medicine cannot be administered by other routes of administration.

2. Important information before using the medicine 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 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, feeling of tightness in the chest, 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 possibly make breathing difficult (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 (ulcers or bleeding occurring at least twice)
• If the patient has severe liver function impairment
• In non-dialysis patients with severe renal failure
• 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, consult your doctor or pharmacist if:

• the patient has ever experienced persistent drug-induced erythema (rash) after taking meloxicam or other oxicams (e.g. piroxicam) (circular or oval red and swollen skin patches, usually recurring in the same location(s), blisters, urticaria 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 of the medicine. 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, they should discuss treatment options with their doctor or pharmacist. For example, when:

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

Treatment with Movalis 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 lesions on the trunk, often with central blisters. Additional symptoms may include ulcers in the mouth, throat, nose, genital area, and conjunctivitis (red, swollen eyes). These potentially life-threatening skin reactions are often accompanied by flu-like symptoms. The rash may progress to generalized 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, Movalis should be discontinued immediately and medical advice should be sought 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 symptoms of infection (e.g. fever). If the patient suspects they have an infection, they should contact their doctor.

Precautions for use

Due to the need for treatment adjustments, 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 levels (diabetes)
• reduced circulating blood volume (hypovolemia), which may occur due to significant blood loss or burns, surgical procedures, or low fluid intake
• previously diagnosed high blood potassium levels (hyperkalemia).

In the above cases, the doctor will monitor the patient's progress during treatment.

Movalis and 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 currently used, recently used, or planned for use.

In particular, inform your 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 blood potassium levels
• tacrolimus – used after organ transplantation
• trimethoprim – used to treat urinary tract infections
• anticoagulant drugs
• drugs that dissolve blood clots (thrombolytic agents)
• drugs used for heart or 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
• drugs 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 drugs (sulfonylurea derivatives, nateglinide) – used to treat diabetes. The doctor should ensure regular monitoring of blood glucose levels to detect hypoglycaemia.

Pregnancy, breastfeeding and effects on 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

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 function disturbances in the unborn child. It may also increase the tendency to bleeding in both mother and child and may delay or prolong labour. During the first 6 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 duration. From week 20 of pregnancy, Movalis may cause kidney function disturbances 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 impair fertility. Inform the doctor if the patient is planning to become pregnant or has difficulty becoming pregnant.

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, 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 must be administered exclusively by experienced medical personnel. The medicine should be injected 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 immediately.

Dosage: At the beginning of treatment, one injection is administered. Treatment may be extended by administering up to one injection per day for 2 to 3 days in exceptional cases (e.g. when tablets cannot be used).
The recommended maximum daily dose of 15 mg 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 an ampoule, 1.5 ml).

Elderly patients
The recommended dose for elderly patients undergoing long-term treatment for rheumatoid arthritis or ankylosing spondylitis is 7.5 mg per day (half an ampoule, 1.5 ml).

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 per day (half an ampoule, 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, 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 feels that the effect of Movalis is too strong or too weak, or if no improvement is felt after several 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, medical advice should be sought immediately from a physician 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 (gastrointestinal hemorrhage) may occur.

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 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.

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 you have any further questions about the use of this medicine, consult your physician or pharmacist.

4. Possible adverse effects

Like any medicine, Movalis may cause adverse effects, although they do not occur in everyone.
Treatment with Movalis should be discontinued and immediate medical advice sought 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 (lesions of mucous membranes), 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, inside the mouth or throat, which may cause difficulty breathing, 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 effects affecting the gastrointestinal tract, particularly:

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

Gastrointestinal bleeding, ulceration or perforation may occasionally have a severe course and could 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 vehicles or operating machinery should be avoided.

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.
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):

• 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 after administration of NSAIDs:

• Nausea and vomiting
• Loose stools (diarrhoea)
• Flatulence with passage of gas
• Constipation
• Indigestion (dyspepsia)
• Abdominal pain
• Black, tarry stools due to gastrointestinal bleeding
• Vomiting blood
• Oral ulcerative inflammation
• 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, flatulence, loose stools (diarrhoea).

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 sensation of spinning (vestibular origin)
• Somnolence (drowsiness)
• Anaemia (reduced concentration of the red blood pigment haemoglobin)
• Increased blood pressure (hypertension)
• Flushing (transient redness of the face and neck)
• Sodium and water retention
• Increased potassium levels (hyperkalaemia). 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 oesophagus)
• Gastritis
• Gastrointestinal bleeding
• Inflammation of the oral mucosa
• Immediate allergic reactions (hypersensitivity)
• 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, which may cause difficulty breathing (angioedema)
• Transient abnormalities in liver function tests (e.g., increased activity of liver enzymes such as aminotransferases or increased concentration of the bile pigment bilirubin). The doctor may detect these changes through blood tests.
• Abnormalities in renal 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 increase the 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
• Onset of 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

• Skin blistering 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 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
• 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 during NSAID therapy
• Complete loss of certain types of white blood cells (agranulocytosis), especially in patients taking Movalis together with other medicines that potentially have bone marrow suppressing or destructive 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-administration of the drug, and may appear as itchy, round or oval, red and swollen skin lesions or 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 cells within the kidneys (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 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 181 C, 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 provide more information on the safety of this medicine.

5. How to store Movalis

Keep this medicine out of the 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.
Do not store above 25°C.
Store in the outer 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 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 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 containing 1.5 ml of solution.
Pack sizes: 1, 3, and 5 ampoules.
Other available forms of meloxicam:
Meloxicam is also available as:

• 7.5 mg tablets,
• 15 mg tablets.

For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation 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 Warsaw, Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing Authorisation Number in Lithuania, the country of export: LT/1/96/1465/004
Parallel Import Authorisation Number: 42/24