Movalis

Package leaflet: Information for the user

Movalis 7.5 mg, tablets
Movalis 15 mg, tablets
Meloxicamum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Movalis is and what it is used for
2. Important information before taking Movalis
3. How to take 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 medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which are used to reduce inflammation and relieve joint and muscle pain.
Movalis tablets are intended for use in adults and children aged 16 years and older.
Movalis is used:

• for short-term treatment of flare-ups of osteoarthritis
• for long-term treatment of:
  • rheumatoid arthritis
  • ankylosing spondylitis.

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 16 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 obstruction due to swelling of the nasal mucosa (nasal polyps)
  • Skin rash (urticaria)
  • Sudden swelling of the skin or mucous membranes, such as around the eyes, face, lips, mouth, or throat, which may make breathing difficult (angioedema)
• If the patient has previously experienced:
  • Gastrointestinal bleeding
  • Perforation of the stomach or intestines
• If the patient currently has a peptic ulcer or gastrointestinal bleeding
• If the patient has a history of peptic ulcer disease or gastrointestinal 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 in the brain (cerebral haemorrhage)
• If the patient has any other bleeding disorders
• If the patient has severe heart failure
• If the patient has intolerance to certain sugars – the product contains lactose (see also "Movalis contains sugar (lactose) and sodium")

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, discuss this with your doctor or pharmacist:

• if the patient has ever experienced persistent redness (rash) after taking meloxicam or other oxicams (e.g. piroxicam), including round or oval, red and swollen skin patches, usually recurring in the same location(s), blisters, urticaria, or 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. 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 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 high blood sugar levels (diabetes)
• The patient has high cholesterol levels in the blood (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 typically begin as red spots or circular lesions on the trunk, often with central blisters. Additional symptoms may include ulcers in the mouth, throat, nose, or 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 widespread blistering or skin detachment. 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, 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 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, such as Crohn's disease or ulcerative colitis
• High blood pressure (hypertension)
• Use in elderly patients
• Heart, liver, or kidney disease
• High blood glucose (sugar) levels (diabetes)
• Reduced circulating blood volume (hypovolemia), which may occur due to significant blood loss or burns, surgery, or low fluid intake
• Diagnosed intolerance to certain sugars, as the medicine contains lactose
• Previously diagnosed high potassium levels in the blood.

In the above cases, the doctor will monitor treatment outcomes.
Movalis with other medicines
Movalis may affect the action of other medicines the patient is taking, and other medicines may affect the action of Movalis.
Tell your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
In particular, inform the doctor or pharmacist if any of the following medicines are being used:

• Other non-steroidal anti-inflammatory drugs (NSAIDs)
• Potassium salts – used in the treatment of low potassium levels in the blood
• Tacrolimus – used after organ transplants
• Trimethoprim – used to treat urinary tract infections
• Anticoagulants
• Medicines that dissolve blood clots (thrombolytic agents)
• Medicines used for heart and kidney diseases
• Corticosteroids (e.g. used for anti-inflammatory or 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 effects on fertility
If the patient is pregnant or 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 problems in the unborn child. It may increase the risk of bleeding in both the 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 time. From the 20th week of pregnancy, Movalis may cause kidney problems 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 breastfeeding women.
Fertility
This medicine may make it more difficult to become pregnant. Inform the doctor if the patient is planning to become pregnant or has difficulty conceiving.
Driving and operating machinery
Visual disturbances, including blurred vision, drowsiness, dizziness, or other central nervous system effects may occur after taking Movalis. If these symptoms occur, the patient should not drive or operate machinery.
Movalis contains sugar (lactose) and sodium
If the patient has been diagnosed with intolerance to certain sugars, they should contact their doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Movalis

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Recommended doses:
Osteoarthritis flare-ups:
7.5 mg once daily. The dose may be increased to 15 mg once daily.
Rheumatoid arthritis:
15 mg once daily. The dose may be reduced to 7.5 mg once daily.
Ankylosing spondylitis:
15 mg once daily. The dose may be reduced to 7.5 mg once daily.
Do not exceed the recommended maximum dose of 15 mg per day.
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 per day.
Elderly patients
The recommended dose for elderly patients undergoing long-term treatment for rheumatoid arthritis or ankylosing spondylitis is 7.5 mg per day.
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.
Renal function impairment
In dialysed patients with severe renal impairment, the dose should not exceed 7.5 mg per day. 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 should not be used in children and adolescents under 16 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 several days, consult your doctor or pharmacist.
Method of administration
Oral use.
Tablets should be swallowed whole with water, during a meal.
Movalis 7.5 mg tablets: The score line on the tablet is intended only to facilitate breaking for easier swallowing.
Movalis 15 mg tablets: The tablet may be divided into equal doses. The tablet should be split manually, not with sharp instruments (e.g. a knife).
Overdose of Movalis
In case of taking more than the recommended dose of Movalis or suspected overdose, seek immediate medical advice from a doctor or go to 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 (bleeding from the digestive tract) may occur in the patient.

Severe poisoning may lead to serious adverse effects of the drug (see section 4):

• increased blood pressure (arterial hypertension)
• acute renal failure
• hepatic dysfunction
• shallow breathing or respiratory arrest (respiratory depression)
• loss of consciousness (coma)
• epileptic 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.
In case of any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You must stop taking Movalis and seek immediate medical advice from your doctor or
the nearest hospital if you experience:
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 (mucosal lesions), 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 occur in the mouth, 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 legs (peripheral oedema)
• Shortness of breath or asthma attack
• Liver inflammation. 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, and particularly:

• Bleeding (causing 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 a patient has previously experienced any gastrointestinal disorders due to long-term use of NSAIDs, the patient should seek immediate medical advice, especially if they are elderly. The doctor may monitor the progress of treatment.
If taking Movalis causes disturbances in vision, 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. heart attack 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
• Intestinal wall perforation or gastrointestinal bleeding (sometimes fatal, particularly in elderly patients).

The following adverse effects have been reported with NSAIDs:

• Nausea and vomiting
• Loose stools (diarrhoea)
• Bloating with gas release
• Constipation
• Indigestion (dyspepsia)
• Abdominal pain
• Black, tarry 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 observed less frequently.
Adverse effects of meloxicam – the active substance in Movalis
Very common: may affect more than 1 in 10 people

• Gastrointestinal disorders such as indigestion (dyspepsia), nausea and vomiting, abdominal pain, constipation, bloating, loose stools (diarrhoea).

Common: may affect less than 1 in 10 people

• Headache.

Uncommon: may affect less than 1 in 100 people

• Dizziness (feeling of emptiness in the head)
• Dizziness or spinning sensation (vestibular origin)
• Drowsiness (somnolence)
• Anaemia (reduced concentration of the red blood pigment haemoglobin)
• Increased blood pressure (hypertension)
• Facial flushing (temporary redness of the face and neck)
• Sodium and water retention
• Increased potassium levels (hyperkalaemia). This may lead to symptoms such as:
• Heart 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 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 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). Your doctor may detect these changes 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.
• Ringing in the ears (tinnitus)
• Awareness of heartbeat (palpitations)
• Gastric or duodenal ulcer disease
• Oesophagitis
• Onset of asthma attacks (in patients hypersensitive to aspirin or other NSAIDs)
• Skin blistering or epidermal peeling (Stevens-Johnson syndrome and toxic epidermal necrolysis)
• Urticaria
• Vision 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 occur in the mouth, 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 unknown: frequency cannot be estimated from available data

• Confusion
• Disorientation
• Shortness of breath and skin reactions (anaphylactic and/or 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 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-exposure to the drug, and may appear as itchy, round or oval, red and swollen skin patches 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 rarely, 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 181C, 02-222 Warsaw
Tel: +48 22 49-21-301, Fax: +48 22 49-21-309, Website: https://smz.ezdrowie.gov.pl.
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps 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 blister and outer packaging. The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Keep in the original packaging to protect from moisture.
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 Movalis contains
The active substance is meloxicam.
Each tablet contains 7.5 mg or 15 mg of meloxicam.
The other ingredients are:

• sodium citrate,
• lactose monohydrate,
• microcrystalline cellulose,
• povidone K 25,
• colloidal anhydrous silica,
• crospovidone,
• magnesium stearate.

What Movalis looks like and contents of the pack
Movalis 7.5 mg tablets are light yellow, round tablets with a diameter of 9 mm, bearing the logo of the marketing authorisation holder on one side and the code 59D/59D on the other.
Each tablet has a score line. The score line is intended only to facilitate breaking the tablet for easier swallowing.
Movalis 15 mg tablets are light yellow, round tablets with a diameter of 9 mm, bearing the logo of the marketing authorisation holder on one side and the code 77C/77C on the other.
Each tablet has a score line and can be divided into two equal doses.
Movalis is available in PVC/PVDC/Aluminium blister packs.
Movalis 7.5 mg tablets are available in packs containing 20 tablets.
Movalis 15 mg tablets are available in packs containing 10 and 20 tablets.
Not all pack sizes may be marketed.
Meloxicam is also available as an injection solution 15 mg/1.5 ml.

Marketing Authorisation Holder:
Boehringer Ingelheim International GmbH
Binger Strasse 173
D-55216 Ingelheim/Rhein
Germany

Manufacturer:
Rottendorf Pharma GmbH
Ostenfelder Strasse 51 - 61
59320 Ennigerloh
Germany

For further information, please contact the local representative of the marketing authorisation holder:
Poland
Boehringer Ingelheim Sp. z o.o.
Tel. +48 22 699 0 699