Movalis

Leaflet attached to the packaging: patient information

Movalis, 15 mg/1.5 ml, solution for injection

Meloxicam

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. 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 pack 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 given 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 hives
• 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)
• If the patient has experienced:
• gastrointestinal bleeding or perforation
• peptic ulcer or gastrointestinal bleeding (ulcer or bleeding occurring at least twice)
• severe liver dysfunction
• In non-dialysed patients with severe renal impairment
• If the patient has recently experienced bleeding in the brain (cerebral haemorrhage)
• If the patient has experienced any other bleeding
• In patients treated with anticoagulant medications (due to the risk of hematoma)
• 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 treatment with Movalis, the patient should discuss the following with their doctor or pharmacist:

• if the patient has ever experienced a persistent rash (drug eruption) after taking meloxicam or other oxicams (e.g. piroxicam), characterized by round or oval, red and swollen patches on the skin, usually recurring in the same place (in the same places), blisters, hives and itching.

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. Do not exceed the recommended dose and duration of treatment (see section 3).
In case of heart problems, previous stroke or suspected risk of these disorders, the patient should discuss the treatment with their doctor or pharmacist.
For example, if the patient has:

• high blood pressure (hypertension)
• high blood sugar (diabetes)
• high cholesterol (hypercholesterolemia)
• smokes.

Stop using Movalis immediately if bleeding (causing black stools) or gastrointestinal ulceration (causing abdominal pain) occurs.
With 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 mouth ulcers, throat, nose, genital and conjunctival inflammation (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 skin peeling. The highest risk of severe skin reactions occurs in the first few weeks of treatment. In patients who have experienced Stevens-Johnson syndrome, toxic epidermal necrolysis while taking Movalis, meloxicam treatment should not be restarted.
If a rash or the above symptoms occur, the patient should stop using Movalis and seek medical attention immediately, informing their doctor that they are taking 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.

Precautions for use

Due to the need to modify treatment, the patient should consult their doctor before starting treatment with Movalis in the following cases:

• if the patient has a history of oesophageal inflammation, stomach inflammation or any other gastrointestinal disease, such as Crohn's disease or ulcerative colitis
• high blood pressure (hypertension)
• use in the elderly
• heart, liver or kidney disease
• high blood sugar (diabetes)
• reduced blood volume (hypovolemia), which may occur in case of significant blood loss or burns, surgery or low fluid intake
• high potassium levels in the blood, previously diagnosed by the doctor.

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 agents)
• medicines used to treat heart and kidney diseases
• corticosteroids (e.g. used as anti-inflammatory or to treat allergic reactions)
• cyclosporin - used after organ transplantation 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 drugs (sulfonylurea derivatives, nateglinide) - used to treat diabetes. The doctor should ensure regular monitoring of the patient's blood sugar levels to detect hypoglycaemia.

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
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 increase the risk of bleeding in the mother and child and cause delayed or prolonged labour. 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 baby (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the baby'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 more difficult to become pregnant. The patient should inform their doctor if they plan to become pregnant or are having trouble becoming pregnant.

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, i.e. 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 administered slowly, intramuscularly, usually in the buttock. 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 administered on the other side of the body. If the patient experiences severe pain during injection, the administration of the medicine should be stopped.
Dosage:One injection is given 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 a 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 a 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 a 1.5 ml ampoule).

Renal impairment

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

Hepatic impairment

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

Use in children and adolescents

Movalis should not be given 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.

Overdose of Movalis

In case of overdose 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 disappear after stopping the use of Movalis. The patient may experience gastrointestinal bleeding (gastrointestinal bleeding).

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

Do not take a double dose to make up for a missed dose. Take the next dose at the scheduled time.
If the patient has any further questions about using 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.
Stop using Movalis and consult your doctor or the nearest hospital immediately if you experience:

• 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 may also occur on 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 the ankles and feet (peripheral oedema)
• 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)
• ulceration of the gastrointestinal tract (causing abdominal pain).

Gastrointestinal bleeding or perforation may have a severe course and can be life-threatening, especially in the elderly.
If the patient has previously experienced any 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.

General side effects of non-steroidal anti-inflammatory drugs (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 oedema, hypertension and heart failure.
The most commonly observed adverse reactions are related to the gastrointestinal tract (stomach and intestine disorders):

• gastric or duodenal ulcer
• perforation of the intestinal wall or gastrointestinal bleeding (sometimes fatal, especially in the elderly).

The following side effects have been reported with NSAIDs:

• nausea (nausea) and vomiting
• diarrhoea
• flatulence
• constipation
• indigestion (dyspepsia)
• abdominal pain
• black stools due to gastrointestinal bleeding
• bloody vomiting
• mouth ulcers
• worsening of inflammatory bowel disease (e.g. worsening of ulcerative colitis or Crohn's disease)

Liver inflammation 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, diarrhoea

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)
• anaemia (reduced haemoglobin levels)
• high blood pressure (hypertension)
• flushing (temporary flushing of the face and neck)
• retention of sodium and water
• high potassium levels in the blood (hyperkalaemia). This may lead to symptoms such as:
• heart rhythm disorders
• palpitations (feeling of heartbeat more than usual)
• muscle weakness
• reflux (regurgitation of stomach contents into the oesophagus)
• gastritis
• gastrointestinal bleeding
• mouth ulcers
• immediate allergic reactions (hypersensitivity)
• itching (pruritus)
• skin rash
• oedema due to fluid retention, including ankle and foot swelling (peripheral oedema)
• 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.
• changes in 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 count
• 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 more than usual)
• gastric or duodenal ulcer
• oesophagitis
• asthma attacks (in patients allergic to aspirin or other NSAIDs)
• blistering skin reactions or 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 may also occur on the lips, eyes and other moist areas of the body.
• 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 the available data

• confusion
• disorientation
• anaphylactic shock
• shortness of breath and skin reactions (anaphylactic/anaphylactoid) 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 with other medicines that may have a suppressive or destructive effect on the bone marrow (myelotoxic agents). This may cause:
• sudden fever
• throat pain
• infections
• pancreatitis
• infertility in women, delayed ovulation
• a characteristic skin allergic reaction, known as fixed drug eruption, usually recurring in the same place (in the same places) after re-administration of the medicine and may appear as itchy, round or oval, red and swollen patches on the skin, blisters (hives).

Side effects of non-steroidal anti-inflammatory drugs (NSAIDs) not yet reported with Movalis:

Acute kidney failure due to changes in kidney structure:

• very rare cases of kidney inflammation (interstitial nephritis)
• death of some kidney cells (acute tubular necrosis or renal papillary necrosis)
• presence of protein in the urine (nephrotic syndrome with proteinuria).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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.
Side effects can also be reported to the marketing authorisation holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Movalis

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and outer packaging. The expiry date refers to the last day of the month.
Store in a carton 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 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 contains 15 mg of meloxicam.
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 2 ml glass ampoules containing 1.5 ml of solution.
Pack sizes: 1, 3, 5 ampoules.
Not all pack sizes may be marketed.
Other uses of meloxicam:
Meloxicam is also available in:

• 7.5 mg tablets
• 15 mg tablets

Marketing authorisation holder:

Boehringer Ingelheim International GmbH
Binger Strasse 173
D-55216 Ingelheim/Rhein
Germany

Manufacturer:

Boehringer Ingelheim España SA
Prat de la Riba, 50
08174 Sant Cugat del Vallés
(Barcelona)
Spain
To obtain more detailed information, please contact the local representative of the marketing authorisation holder:
Poland
Boehringer Ingelheim Sp. z o.o.
Tel. +48 22 699 0 699

Date of last revision of the leaflet: 06/2023

Detailed information about this medicine, including information intended only for healthcare professionals, is available in the Summary of Product Characteristics on the website: www.urpl.gov.pl.