Movalis

Package Leaflet: Information for the Patient

Movalis 7.5 mg, tablets

Movalis 15 mg, tablets

Meloxicam

Read the package leaflet carefully before taking 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 those not listed in this leaflet, please inform 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 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 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 tablets are intended for adults and children over 16 years of age.
Movalis is used:

• for the short-term treatment of exacerbations of osteoarthritis
• for the long-term treatment of:
• rheumatoid arthritis
• ankylosing spondylitis of the spine.

2. Important information before taking Movalis

When not to take Movalis

• If you are allergic to meloxicam or any of the other ingredients of this medicine (listed in section 6)
• In the last three months of pregnancy
• In children and adolescents under 16 years of age
• If you have ever had 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 (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 you have had any of the following after previous NSAID therapy:
• stomach or intestinal bleeding
• perforation of the stomach or intestine
• If you currently have stomach or intestinal ulcers or bleeding
• If you have had stomach or intestinal ulcers or bleeding (ulcers or bleeding that have occurred at least twice)
• If you have severe liver dysfunction
• In non-dialysed patients with severe renal impairment
• If you have recently had bleeding in the brain (cerebral bleeding)
• If you have had any other bleeding
• If you have severe heart failure
• If you have intolerance to some sugars - the product contains lactose (see also "Movalis contains sugar (lactose) and sodium")

If you are not sure if any of the above points apply to you, consult your doctor.

Warnings and precautions

Before starting treatment with Movalis, discuss with your doctor or pharmacist:

• if you have ever had 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 take higher doses or longer treatment than recommended (see section 3).
In case of heart problems, previous stroke or suspected risk of these disorders, discuss treatment with your doctor or pharmacist.
For example, when:

• you have high blood pressure (hypertension)
• you have high blood sugar (diabetes)
• you have high cholesterol (hypercholesterolemia)
• you smoke.

Stop taking Movalis immediately if you notice bleeding (causing black stools) or gastrointestinal ulceration (causing abdominal pain).
With the use of 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 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 can develop into generalized blisters or skin shedding. The highest risk of severe skin reactions occurs in the first few weeks of treatment. In patients who have developed Stevens-Johnson syndrome, toxic epidermal necrolysis while taking Movalis, meloxicam treatment should not be resumed.
If a rash or the above symptoms occur, stop taking Movalis and seek medical attention immediately, informing your doctor that you 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 you suspect you have an infection, consult your doctor.

Precautions for use

Due to the need to modify treatment, consult your doctor before starting Movalis if:

• you have had esophagitis, gastritis or any other gastrointestinal disease, such as Crohn's disease or ulcerative colitis
• you have high blood pressure (hypertension)
• you are elderly
• you have heart, liver or kidney disease
• you have high blood sugar (diabetes)
• you have decreased blood volume (hypovolemia), which may occur with significant blood loss or burns, surgery or low fluid intake
• you have been diagnosed with intolerance to some sugars by your doctor, as the medicine contains lactose
• you have high potassium levels in your blood, previously diagnosed by your doctor.

In these cases, your doctor will monitor your treatment progress.

Movalis and other medicines

Movalis may affect the action of other medicines, and other medicines may affect the action of Movalis.
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
In particular, inform your doctor or pharmacist if you 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
• anticoagulants
• medicines that dissolve blood clots (thrombolytic agents)
• medicines used to treat heart and kidney diseases
• corticosteroids (e.g. used anti-inflammatory or to treat allergic reactions)
• cyclosporine - 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
• diuretics - your doctor may monitor kidney function when taking diuretics
• 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. Your doctor should ensure regular monitoring of your blood sugar levels for signs of hypoglycemia.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take Movalis if you are in the last 3 months of pregnancy, as it may harm your unborn baby or cause complications during delivery. Movalis may cause kidney and heart problems in the unborn baby. It may also increase the risk of bleeding in you and your baby and prolong labor. During the first 6 months of pregnancy, do not take Movalis unless your doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, use the lowest possible dose for the shortest possible time. From the 20th week of pregnancy, Movalis may cause kidney problems in the unborn baby if taken for more than a few days. This can 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, your doctor may recommend additional monitoring.
Breastfeeding
This medicine is not recommended for use in breastfeeding women.
Fertility
This medicine may make it more difficult for women to become pregnant. Inform your doctor if you are planning 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 taking Movalis. If these symptoms occur, do not drive or operate machinery.

Movalis contains sugar (lactose) and sodium

If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to take Movalis

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Recommended doses:

Exacerbations of osteoarthritis:

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 of the spine:

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 "Warnings and precautions" apply to you, your doctor may reduce the dose to 7.5 mg per day.

Elderly patients

The recommended dose for elderly patients in the long-term treatment of rheumatoid arthritis and ankylosing spondylitis of the spine is 7.5 mg per day.

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.

Renal 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 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 you think that the effect of Movalis is too strong or too weak, or if you do not feel any improvement after a few days, consult your doctor or pharmacist.
Method of administration
Oral use.
Swallow the tablets with water, during a meal.
Movalis 7.5 mg: The score line on the tablet is only to facilitate breaking the tablet to make it easier to swallow.
Movalis 15 mg: The tablet can be divided into equal doses. The tablet should be broken by hand, not with sharp objects (e.g. a knife).

Overdose of Movalis

In case of overdose or suspected overdose of Movalis, seek medical attention immediately 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 resolve after stopping Movalis. The patient may experience gastrointestinal bleeding (gastrointestinal hemorrhage).

Severe poisoning can lead to serious side effects of Movalis (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.

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 taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Movalis can cause side effects, although not everybody gets them.
Stop taking 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 patches, red or purple stripes or blisters on the skin. It 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 can 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, ulcers or perforation can sometimes be severe and potentially life-threatening, especially in elderly patients.
If you have previously had gastrointestinal disorders due to long-term use of NSAIDs, you should immediately consult your doctor, especially if you are elderly. Your doctor may monitor your treatment progress.
If Movalis causes visual disturbances, do 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 reports of oedema, hypertension and heart failure.
The most commonly observed side effects are gastrointestinal disorders (stomach and intestinal disorders):

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

The following side effects have been reported with NSAIDs:

• nausea (nausea) and vomiting
• diarrhoea
• flatulence with gas discharge
• 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 Movalis Very common: may affect more than 1 in 10 people

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

Common: may affect up to 1 in 10 people

• headaches.

Uncommon: may affect up to 1 in 100 people

• dizziness (feeling of emptiness in the head)
• dizziness or feeling of spinning (of vestibular origin)
• drowsiness (somnolence)
• anaemia (reduced haemoglobin levels in the blood)
• 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 can lead to symptoms such as:
• heart rhythm disorders
• palpitations (when you feel your heart beating more than usual)
• muscle weakness
• reflux (regurgitation of stomach contents into the oesophagus)
• gastritis
• gastrointestinal bleeding
• mouth ulcers
• immediate allergic reactions (hypersensitivity)
• itching
• skin rash
• oedema caused by fluid retention, including swelling of the feet and ankles (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)
• liver function test abnormalities (e.g. increased liver enzyme activity, such as transaminases, or increased bilirubin levels). Your doctor may detect these changes with a blood test.
• abnormal kidney function tests (e.g. increased creatinine or urea levels).

Rare: may affect up to 1 in 1,000 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 (heart rhythm disorders)
• gastric or duodenal ulcers
• oesophagitis
• asthma attacks (in aspirin or other NSAID-sensitive patients)
• blistering skin reactions or skin peeling (Stevens-Johnson syndrome and toxic epidermal necrolysis)
• hives
• visual disturbances, including:
• blurred vision
• conjunctivitis (inflammation of the conjunctiva of the eye or eyelids)
• colitis (inflammation of the colon).

Very rare: may affect up to 1 in 10,000 people

• blistering skin reactions and erythema multiforme. Erythema multiforme is a severe allergic skin reaction causing patches, red or purple stripes or blisters on the skin. It can also occur on the lips, eyes and other moist body parts.
• liver inflammation. This can 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
• shortness of breath and skin reactions (anaphylactic and/or anaphylactoid) sun-induced skin reactions (photosensitivity reactions)
• heart failure reported 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 can 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 interstitial nephritis (inflammation of the kidney tissue)
• 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 those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Aleje 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 this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and outer packaging. The expiry date refers to the last day of the month stated.
Do not store above 30°C.
Store in the original package to protect from moisture.
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 of Movalis is meloxicam.
One tablet contains 7.5 mg or 15 mg of meloxicam.
The other ingredients are:

• sodium citrate,

What Movalis looks like and contents of the pack

Movalis 7.5 mg tablets are yellow, round tablets with a diameter of 9 mm, with the marketing authorisation holder's logo on one side and the code 59D/59D on the other side.
Each tablet has a score line. The score line on the tablet is only to facilitate breaking the tablet to make it easier to swallow.
Movalis 15 mg tablets are yellow, round tablets with a diameter of 9 mm, with the marketing authorisation holder's logo on one side and the code 77C/77C on the other side.
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 of 20 tablets.

Movalis 15 mg tablets are available in packs of 10 and 20 tablets.

Not all pack sizes may be marketed.
Meloxicam is also available as a 15 mg/1.5 ml solution for injection.

Marketing authorisation holder:

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

Manufacturer:

Boehringer Ingelheim Pharma GmbH
Binger Strasse 173
D-55216 Ingelheim/Rhein
Germany
Boehringer Ingelheim Hellas Single Member S.A.
5 km Paiania-Markopoulo
Koropi Attiki
19441 Greece
Rottendorf Pharma GmbH
Ostenfelder Strasse 51 - 61
59320 Ennigerloh
Germany
To obtain more detailed information, contact your 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