Movatec

Leaflet accompanying the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Movatec

10 mg/ml (15 mg/1.5 ml), solution for injection

Meloxicam

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Movatec and what is it used for
• 2. Important information before using Movatec
• 3. How to use Movatec
• 4. Possible side effects
• 5. How to store Movatec
• 6. Contents of the packaging and other information

1. What is Movatec and what is it used for

Movatec 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.
Movatec solution for injection is intended for adults.
Movatec is used to treat exacerbations of:

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

2. Important information before using Movatec

When not to use Movatec

• 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 pressure 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 swelling around the eyes, face, lips, mouth or throat, which may make breathing difficult (angioedema)
• If the patient has experienced:
• gastrointestinal bleeding or perforation
• If the patient currently has peptic ulcer or gastrointestinal bleeding
• If the patient has had peptic ulcer or gastrointestinal bleeding (peptic ulcer or bleeding that has occurred at least twice)
• If the patient has severe liver dysfunction
• In non-dialyzed patients with severe renal impairment
• If the patient has recently experienced cerebral bleeding (cerebral hemorrhage)
• 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 a doctor.

Warnings and precautions

Before starting treatment with Movatec, the patient should discuss it 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 Movatec 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, a history of stroke, or suspected risk of these disorders, the patient should discuss the treatment with their doctor or pharmacist.
For example, when:

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

The patient should stop using Movatec immediately if they notice bleeding (causing black stools) or gastrointestinal ulceration (causing abdominal pain).
There have been reports of potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) associated with the use of Movatec, which initially appear as red spots or round patches on the torso, often with central blisters. Additional symptoms that may be observed include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (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 Movatec, meloxicam treatment should not be restarted.
If a rash or the above symptoms occur, the patient should stop using Movatec and seek medical attention immediately, informing their doctor that they are taking this medicine.
Movatec is not recommended for the treatment of acute pain attacks.
Movatec may mask the symptoms of infection (e.g. fever). If the patient suspects they have an infection, they should consult a doctor.

Precautions for use

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

• if the patient has a history of esophagitis, gastritis, or any other gastrointestinal disease, such as Crohn's disease or ulcerative colitis
• high blood pressure (hypertension)
• use in elderly patients
• 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
• previously diagnosed high potassium levels in the blood (hyperkalemia).

In these cases, the doctor will monitor the patient's progress.

Movatec and other medicines

Movatec may affect the action of other medicines, and other medicines may affect the action of Movatec.
The patient should tell their doctor or pharmacist about all medicines they are currently taking, or have recently taken, and about 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 medications)
• medicines used to treat heart and kidney diseases
• corticosteroids (e.g. used as anti-inflammatory or to treat allergic reactions)
• cyclosporine - used after organ transplants 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 medications (sulfonylurea derivatives, nateglinide) - used to treat diabetes. The doctor should ensure regular monitoring of the patient's blood sugar levels to detect hypoglycemia.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before using this medicine.
Pregnancy
Movatec should not be taken if the patient is in the last three months of pregnancy, as it may harm the unborn baby or cause complications during delivery. Movatec may cause kidney and heart problems in the unborn baby. It may also increase the risk of bleeding in the patient and the baby, and cause delayed or prolonged labor. During the first six months of pregnancy, Movatec 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, Movatec may cause kidney problems in the unborn baby if used 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 harder for women 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 Movatec. If these symptoms occur, the patient should not drive or operate machinery.

Movatec contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per 1.5 ml ampoule, which means it is considered "sodium-free".

3. How to use Movatec

Movatec is intended for intramuscular use only. The medicine may only be administered by experienced medical personnel. The medicine is administered slowly, intramuscularly, usually in the buttocks. If it is necessary to administer more than one injection, 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 feels severe pain during injection, the administration of the medicine should be stopped.
Dosage:One injection is administered at the start of treatment. Treatment can be extended using a maximum of one injection every 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).

Kidney problems

In dialyzed patients with severe kidney problems, 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 kidney problems.

Liver problems

Dose reduction is not necessary in patients with mild or moderate liver problems.

Use in children and adolescents

Movatec should not be administered to children and adolescents under 18 years of age.
If the patient thinks that the effect of Movatec 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.

Using more than the recommended dose of Movatec

In case of taking more than the recommended dose of Movatec or suspected overdose, the patient should immediately consult a doctor or go to the nearest hospital emergency department.

Symptoms of overdose of NSAIDs 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 Movatec. The patient may experience gastrointestinal bleeding (gastrointestinal hemorrhage).

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 Movatec

The patient should not take a double dose to make up for a missed dose. They should take the next dose at the scheduled time.
In case of any further doubts about the use of the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Movatec can cause side effects, although not everybody gets them.
The patient should stop using Movatec and consult their doctor or the nearest hospital immediately if they 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), 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, which can also occur on the lips, eyes, and other moist body parts.
• 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 feet and ankles (peripheral edema)
• 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)
• gastrointestinal ulceration (causing abdominal pain).

Gastrointestinal bleeding or perforation may sometimes have a severe course and can be life-threatening, especially in elderly patients.
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 the use of Movatec 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 increase in the 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 reports of edema, hypertension, and heart failure.
The most commonly observed side effects 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 elderly patients).

The following side effects have been reported with NSAID use:

• nausea (nausea) and vomiting
• diarrhea
• flatulence with gas release
• constipation
• indigestion (dyspepsia)
• abdominal pain
• black stools due to gastrointestinal bleeding
• bloody vomiting
• mouth ulcers
• worsening of gastrointestinal 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 Movatec

Very common: may occur in more than 1 in 10 people

• gastrointestinal disorders, such as indigestion (dyspepsia), nausea (nausea), and vomiting, abdominal pain, constipation, flatulence, diarrhea.

Common: may occur in less than 1 in 10 people

• headaches
• thickening at the injection site, pain at the injection site.

Uncommon: may occur in less than 1 in 100 people

• dizziness (feeling of emptiness in the head)
• dizziness or feeling of spinning (vertigo)
• drowsiness (somnolence)
• anemia (reduced hemoglobin levels in the blood)
• high blood pressure (hypertension)
• flushing (temporary redness of the face and neck)
• retention of sodium and water
• high potassium levels in the blood (hyperkalemia). This may lead to symptoms such as:
• heart rhythm disorders
• palpitations (feeling of heartbeat)
• muscle weakness
• reflux (regurgitation of stomach contents into the esophagus)
• gastritis
• gastrointestinal bleeding
• mouth ulcers
• immediate allergic reactions (hypersensitivity)
• itching (pruritus)
• skin rash
• edema caused by fluid retention, including swelling of the feet and ankles (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)
• 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.
• abnormal kidney function tests (e.g. increased creatinine or urea levels).

Rare: may occur in less than 1 in 1000 people

• mood disorders
• nightmares
• blood disorders, including:
• abnormal blood smear
• 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)
• feeling of heartbeat (palpitations)
• gastric or duodenal ulcer
• esophagitis
• asthma attacks (in patients allergic to aspirin or other NSAIDs)
• blistering skin reactions or skin peeling (Stevens-Johnson syndrome and toxic epidermal necrolysis)
• hives
• visual disturbances, including:
• blurred vision
• conjunctivitis (red and swollen eyes)
• colitis (inflammation of the colon).

Very rare: may occur in less 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, which can also occur on the lips, eyes, and other moist body parts.
• 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 Movatec with other medications that may have a suppressive or destructive effect on the bone marrow (myelotoxic medications). 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 itching, round or oval, red and swollen patches on the skin, blisters (hives).

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

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 side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Movatec

The medicine should be stored 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 month.
Store in the outer packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Movatec contains

The active substance of Movatec is meloxicam.
One ml of the solution contains 10 mg of meloxicam.
One ampoule 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 Movatec looks like and what the packaging contains

Movatec is a yellow solution with a greenish tint.
Movatec is available in ampoules made of colorless glass type I, with a capacity of 2 ml, containing 1.5 ml of solution.
Pack sizes: 1, 3, 5 ampoules.

Other possibilities for using meloxicam:

Meloxicam is also available in:

• 7.5 mg tablets
• 15 mg tablets.

For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Greece, the country of export:

Boehringer Ingelheim International GmbH
Binger Straße 173
D-55216 Ingelheim am Rhein
Germany

Manufacturer:

Boehringer Ingelheim Espana SA
Prat de la Riba, 50
San Cugat del Vallés
Barcelona
Spain

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Greece, the country of export:28381/19-04-2011
Parallel import authorization number:118/23

Date of leaflet approval: 21.08.2024

[Information about the trademark]