Movatec

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Movatec
10 mg/ml (15 mg/1.5 ml), solution for injection
Meloxicamum
Please read carefully the entire leaflet before using this 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 for a specific individual. Do not pass it on to others. This medicine 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 or pharmacist. See section 4.

Table of contents:

1. What Movatec is and what it is 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 pack and other information

1. What Movatec is and what it is used for

Movatec 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 pain in joints and muscles.
Movatec, solution for injection, is intended for use in adults.
Movatec is used to treat flare-ups 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 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 urticaria
  • Sudden swelling of the skin or mucous membranes, such as around the eyes, face, lips, mouth or throat, which may possibly impair breathing (angioedema)
• If the patient has previously experienced:
  • Gastrointestinal bleeding
  • Perforation of the stomach or intestines
  • While the patient currently has a peptic ulcer or gastrointestinal bleeding
  • If the patient has had a peptic ulcer or gastrointestinal bleeding or bleeding (peptic ulcer or bleeding occurring at least twice)
  • If the patient has severe liver function impairment
  • In non-dialyzed patients with severe renal failure
  • If the patient has recently experienced bleeding within the brain (cerebral hemorrhage)
  • If the patient has any other bleeding disorders
  • In patients treated with anticoagulant drugs (due to the risk of intramuscular hematoma)
  • 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 to use Movatec, discuss this with your doctor or pharmacist:

• If the patient has ever experienced a persistent drug eruption (rash) after taking meloxicam or other oxicams (e.g., piroxicam), such as round or oval red and swollen patches on the skin, usually recurring in the same location(s), blisters, urticaria, and itching.

Warnings
Taking medicines such as 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. 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 cholesterol levels in the blood (hypercholesterolemia)
• The patient smokes tobacco

The use of Movatec should be stopped immediately if bleeding (causing tarry stools) or gastrointestinal ulceration (causing abdominal pain) is observed.
Serious, potentially life-threatening skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Movatec. These initially appear as red spots or round patches on the trunk, often with central blisters. Additional symptoms may include ulcers in the mouth, throat, nose, or genital area, and conjunctivitis (red and 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. Movatec 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, the use of Movatec should be discontinued immediately and medical advice should be sought, informing the doctor about the use of this medicine.
Movatec is not recommended for the treatment of acute pain attacks.
Movatec may mask signs 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 Movatec in the following cases:

• If the patient has previously had esophagitis, 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 potassium levels in the blood

In the above cases, the doctor will monitor the patient's progress.
Movatec and other medicines
Movatec may affect the action of other medicines the patient is currently taking or has recently taken, and other medicines may affect the action of Movatec.
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan 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 transplants
• Trimethoprim – used to treat urinary tract infections
• Anticoagulant drugs
• Drugs that dissolve blood clots (thrombolytic agents)
• Medicines used for heart and kidney diseases
• Corticosteroids (e.g., used for anti-inflammatory purposes or treating 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 taken
• 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 drugs (sulfonylurea derivatives, nateglinide) – used to treat diabetes. The doctor should ensure regular monitoring of blood glucose levels to detect hypoglycemia.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Do not take Movatec if the patient is in the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. Movatec 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 labor. Movatec should not be used during the first six months of pregnancy unless the doctor considers its use 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, Movatec 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 the doctor if the patient plans to become pregnant or has difficulty becoming pregnant.
Driving and operating machinery
Visual disturbances, including blurred vision, drowsiness, dizziness, or other central nervous system effects 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, meaning the medicine is considered "sodium-free".

3. How to use Movatec

Movatec 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 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 up to one injection every 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 of 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).

Patients at increased risk of adverse reactions
In patients at increased risk of adverse reactions, treatment should be initiated with a dose of 7.5 mg per day (half an ampoule of 1.5 ml).

Renal function disorders
In dialysed patients with severe renal function 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 function impairment.

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

Use in children and adolescents
Movatec should not be administered to children and adolescents under 18 years of age.

If the patient feels that the effect of Movatec is too strong or too weak, or if no improvement is felt after several days, the patient should contact a doctor or pharmacist.

Overdose of Movatec
In case of administration 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 (feeling of lack of energy)
• drowsiness
• nausea and vomiting
• stomach pain (epigastric pain).

These symptoms usually resolve after discontinuation of Movatec. Gastrointestinal bleeding (gastrointestinal hemorrhage) 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 function disorders
• shallow breathing or respiratory arrest (respiratory depression)
• loss of consciousness (coma)
• seizures (convulsions)
• circulatory collapse (cardiovascular collapse)
• cardiac arrest
• immediate hypersensitivity reactions (hypersensitivity), including:
• fainting
• shortness of breath
• skin reactions.

Missed dose of Movatec
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 the medicine, consult a doctor or pharmacist.

4. Possible adverse effects

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

Treatment with Movatec should be discontinued and immediate medical advice should be 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), damage to soft tissues (lesions of mucous membranes), or erythema multiforme (see section 2). Erythema multiforme is a severe allergic skin 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, inside the mouth or throat, which may make breathing difficult, 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 sometimes be severe and potentially fatal, especially in elderly patients.
If the 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 the progress of treatment.
If treatment with Movatec 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 (arterial blockage), such as 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):

• Gastric and duodenal ulcer disease
• Perforation of the intestinal wall 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)
• Bloating with gas release
• Constipation
• Indigestion (dyspepsia)
• Abdominal pain
• Black 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 reported less frequently.

Adverse effects of meloxicam – the active substance in Movatec

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 (diarrhoea).

Common: may affect less than 1 in 10 people

• Headache
• Swelling at injection site, pain at 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 the heartbeat more than usual)
• Muscle weakness
• Regurgitation (reflux of stomach contents into the oesophagus)
• Gastritis
• Gastrointestinal bleeding
• Inflammation of the oral mucosa
• Immediate hypersensitivity reactions (allergy)
• 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 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 kidney function laboratory tests (e.g. increased levels of creatinine or urea).

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 increased risk of infection and symptoms such as bruising or nosebleeds.
• Ringing in the ears (tinnitus)
• Sensation of heart palpitations
• Gastric or duodenal ulcer disease
• Oesophagitis
• Onset of asthma attacks (in patients hypersensitive to aspirin or other NSAIDs)
• Development of skin blisters or peeling of the epidermis (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

• Bullous skin reactions and erythema multiforme. Erythema multiforme is a severe allergic skin 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 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 therapy
• Complete loss of certain types of white blood cells (agranulocytosis), particularly in patients receiving Movatec together with other medicines that potentially have myelosuppressive or myelotoxic 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-exposure to the drug, and may appear as itchy, circular or oval, red and swollen skin patches or blisters (urticaria).

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

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 any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can 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 to provide more information on the safety of the medicine.

5. How to store Movatec

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.
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 in use. This will help protect the environment.

6. Contents of the pack and other information

What Movatec contains
The active substance is meloxicam.
Each ml of 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.
Other ingredients are:

• meglumine,
• glycofurol,
• poloxamer 188,
• sodium chloride,
• glycine,
• sodium hydroxide,
• water for injections.

What Movatec looks like and contents of the pack
Movatec is a solution with a yellow hue and a greenish tint.
Movatec 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, 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 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 Authorisation Number in Greece, the country of export: 28381/19-04-2011
Parallel Import Licence Number: 118/23