Meloxistad

Patient Information Leaflet: User Information

Meloxistad, 15 mg tablets

(Meloxicam)

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

• Keep this leaflet, so you can read it again if you need to.
• Consult your doctor or pharmacist if you have any further questions.
• 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 as yours.
• If any of the side effects get worse or if you notice any not listed in the leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Meloxistad and what is it used for
• 2. Important information before taking Meloxistad
• 3. How to take Meloxistad
• 4. Possible side effects
• 5. How to store Meloxistad
• 6. Contents of the pack and other information

1. What is Meloxistad and what is it used for

Meloxistad is a pain-relieving and anti-inflammatory medicine belonging to the group of non-steroidal anti-inflammatory drugs (NSAIDs), used to reduce inflammation and pain in joints and muscles.

Meloxistad is used:

• For short-term symptomatic treatment of osteoarthritis (degenerative joint disease) flare-ups.
• For long-term treatment of rheumatoid arthritis or ankylosing spondylitis (chronic inflammatory joint disease causing loss of mobility).

2. Important information before taking Meloxistad

When not to take Meloxistad:

• during the last three months of pregnancy (see section 2. Pregnancy and breastfeeding),
• in children and adolescents under 16 years of age,
• if the patient is allergic to meloxicam or any of the other ingredients of this medicine (listed in section 6) or to substances with a similar mechanism of action (e.g. non-steroidal anti-inflammatory drugs (NSAIDs), acetylsalicylic acid). Meloxicam should not be used in patients who have had asthma symptoms (breathing difficulties with shortness of breath), nasal polyps (swelling of the nasal mucosa), angioedema, or urticaria after taking acetylsalicylic acid (e.g. aspirin) or other NSAIDs,
• if the patient has active peptic ulcer disease of the gastrointestinal tract (gastric ulcer, inflammation, and ulceration of the stomach or intestines) or gastrointestinal bleeding (bleeding from the stomach, which can cause black stools),
• if the patient has a history of recurrent peptic ulcers of the stomach or duodenum or bleeding (two or more confirmed episodes of ulceration or bleeding),
• if the patient has had a cerebral hemorrhage (bleeding from brain vessels)
• if the patient has any other bleeding,
• if the patient has had a gastrointestinal bleed or perforation (rupture) caused by previous use of non-steroidal anti-inflammatory drugs (NSAIDs),
• if the patient has severe liver dysfunction,
• if the patient has severe kidney dysfunction and is not undergoing dialysis,
• if the patient has severe heart failure (if the heart does not work properly).

Warnings and precautions

The doctor must ensure that if the patient has had diseases such as esophagitis (inflammation of the esophagus), gastritis (inflammation of the stomach), and/or gastric ulcer, they must be completely healed before starting treatment with meloxicam.

Gastrointestinal bleeding/ulceration or perforation (rupture)

NSAIDs should be used with caution in patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn's disease), as their condition may worsen (see section 4. Possible side effects). As with other NSAIDs, gastrointestinal bleeding or ulceration/perforation of the gastrointestinal tract has been reported during meloxicam treatment, sometimes fatal, with or without warning symptoms, and in patients with or without a history of serious gastrointestinal events.

The risk of gastrointestinal bleeding, ulceration, or perforation is higher in:

• patients treated with high doses of NSAIDs,
• patients with a history of ulceration, especially if complicated by bleeding or perforation (see section 2. When not to take Meloxistad),
• elderly patients.

In these patients, treatment should be initiated with the lowest possible dose. In these patients, as well as in patients taking low-dose aspirin or other medications that may increase the risk of gastrointestinal complications, the doctor may decide to use concomitant treatment with protective medications (medicines that help protect the stomach). This also applies to patients taking low doses of acetylsalicylic acid or other medications that may increase the risk of gastrointestinal complications when used together.

If the patient has had gastrointestinal side effects in the past, especially if they are elderly, they should report any unexpected gastrointestinal symptoms (especially gastrointestinal bleeding, causing bloody or black stools or vomiting blood) to their doctor, especially during the first few months of treatment.

Care should be taken if the patient is taking medications that may increase the risk of gastrointestinal ulceration or bleeding:

• oral corticosteroids (medicines used to treat inflammation, e.g. rheumatism),
• anticoagulant medications, such as warfarin (used to thin the blood),
• selective serotonin reuptake inhibitors (medicines used to treat depression),
• antiplatelet agents, such as acetylsalicylic acid (medicines that prevent blood clotting) (see also section 2. Other medicines and Meloxistad).

If gastrointestinal bleeding occurs during treatment with Meloxistad, or if ulcers occur, the use of the medicine should be discontinued.

It is recommended to avoid concomitant use of Meloxistad with other non-steroidal anti-inflammatory drugs (NSAIDs), including cyclooxygenase-2 (COX-2) inhibitors, which are used to treat inflammation.

Impact on the cardiovascular system and blood vessels

Taking medications like Meloxistad 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 maximum daily dose or use an additional NSAID if the effect of the medicine seems too weak. If there is no improvement after several days of taking the medicine, consult your doctor again!

In case of heart problems, previous stroke, or suspected risk of these disorders (e.g. high blood pressure, diabetes, high cholesterol, smoking), discuss the treatment with your doctor or pharmacist.

If the patient has a history of high blood pressure or heart failure (impaired ability of the heart to pump enough blood to the body), the doctor will closely monitor the treatment.

Severe skin reactions / hypersensitivity reactions

There have been reports of potentially life-threatening skin rashes after taking meloxicam (exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, see section 4), initially appearing as reddish, patchy spots or round patches with blisters in the center, located on the torso.

Additional symptoms that may occur include ulcers in the mouth, throat, nose, and genitals, as well as conjunctivitis (redness and tearing of the eyes). These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash can lead to extensive blistering or skin peeling.

The greatest risk of severe skin reactions occurs within the first few weeks of treatment.

Never re-administer Meloxistad to a patient who has experienced Stevens-Johnson syndrome or toxic epidermal necrolysis associated with Meloxistad.

If a rash occurs, or any of the above skin symptoms, or any symptoms of hypersensitivity (such as difficulty breathing, feeling of constriction in the throat, swelling of the lips, tongue, or face, or urticaria), discontinue Meloxistad and consult a doctor immediately for assistance and inform them of the use of this medicine.

Other recommendations

The onset of meloxicam's effective action is delayed. Ask your doctor what to do if the effect of Meloxistad is too weak or if you need quick pain relief.

Meloxicam may increase laboratory test values. These disorders are usually mild and transient. If significant, persistent laboratory test abnormalities occur, the doctor will discontinue the medicine and recommend appropriate tests.

At the start of treatment or when increasing the dose, careful monitoring of urine output and kidney function is recommended in the following patients:

• the elderly,
• those taking angiotensin-converting enzyme (ACE) inhibitors, angiotensin II antagonists, sartans, diuretics (medicines used to treat high blood pressure),
• those with hypovolemia (low blood volume),
• those with congestive heart failure,
• those with kidney disease (kidney failure, nephrotic syndrome, nephropathy in systemic lupus erythematosus),
• those with severe liver disease.

In patients with diabetes or taking medications that increase potassium levels, regular monitoring of potassium levels in the blood is recommended.

Taking meloxicam may mask the symptoms of an existing infection.

Taking meloxicam may make it difficult to become pregnant. If a woman is planning to become pregnant or is having trouble becoming pregnant, she should inform her doctor.

Side effects can be reduced by using the smallest effective dose for the shortest possible time necessary to control symptoms.

Do not exceed the recommended maximum daily dose or use an additional NSAID if the effect of the medicine seems too weak. If there is no improvement after several days of taking the medicine, consult your doctor again!

Elderly patients

The risk of side effects, especially gastrointestinal bleeding and perforation, which can be fatal, is increased in elderly patients. In elderly patients, gastrointestinal bleeding or ulceration/perforation tends to have more severe consequences. Therefore, these patients require careful monitoring by their doctor.

The doctor will closely monitor the patient, especially if they have kidney or liver dysfunction or heart failure (impaired ability of the heart to pump enough blood to the body).

Other medicines and Meloxistad

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

The following medicines may increase the riskof side effects related to the gastrointestinal tract:

• other non-steroidal anti-inflammatory drugs (NSAIDs) (e.g. ibuprofen),
• selective cyclooxygenase-2 (COX-2) inhibitors (medicines used to treat inflammation),
• corticosteroids (medicines used to treat inflammation or allergies),
• antiplatelet agents, such as acetylsalicylic acid,
• certain medicines used to treat depression (selective serotonin reuptake inhibitors, SSRIs).

Interactions may also occur with the following medicines:

• oral anticoagulants. NSAIDs may enhance the effect of anticoagulants, such as warfarin. It is not recommended to use NSAIDs, such as meloxicam, and oral anticoagulants concomitantly. If you are taking oral anticoagulants, inform your doctor!
• heparin (an anticoagulant medication administered by injection).
• medicines that suppress the immune system or suppress defensive reactions after organ transplantation (cyclosporine, tacrolimus) may increase the risk of kidney damage (nephrotoxicity)if meloxicam is used at the same time.
• medicines that lower blood pressure (e.g. diuretics, ACE inhibitors, angiotensin II antagonists, beta blockers). Meloxicam may reduce the antihypertensive effect of these medicines.
• intrauterine device (IUD), a small metal and/or plastic device used to prevent pregnancy, inserted into the uterus. Their effect may be reduced by meloxicam.
• certain medicines used to treat mental illnesses and depression (lithium),
• certain medicines used to treat rheumatic diseases and cancer (methotrexate). The levels of these medicines may increase when used concomitantly with meloxicam.
• medicines that lower cholesterol levels (cholestyramine) reduce meloxicam levels in the blood and, consequently, its effect.

Taking Meloxistad with food and drink

Tablets should be taken once a day, with a meal, washed down with a sufficient amount of liquid (e.g. a glass of water).

Pregnancy and breastfeeding

In pregnancy, during breastfeeding, or if you suspect you are pregnant, or if you are planning to become pregnant, consult your doctor before taking this medicine.

Pregnancy

Do not take Meloxistad if you are in the last 3 months of pregnancy, as it may harm the unborn baby or cause problems during delivery. The medicine may cause kidney and heart problems in the unborn baby. This may affect the mother's and baby's tendency to bleed and may cause the delivery to be later or longer than expected.

Do not take Meloxistad during the first 6 months of pregnancy, unless it is absolutely necessary and recommended by your doctor. If you need treatment during this period or when trying to become pregnant, use the lowest dose for the shortest possible time.

If Meloxistad is taken for more than a few days from the 20th week of pregnancy, it may cause kidney problems in the unborn baby, which 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 you need treatment for more than a few days, your doctor may recommend additional monitoring.

Taking meloxicam may make it difficult to become pregnant (see section 2. Warnings and precautions).

Breastfeeding

It is not recommended to use Meloxistad during breastfeeding.

Driving and using machines

Meloxistad has no or negligible influence on the ability to drive and use machines. However, during meloxicam treatment, central nervous system disorders (vision disturbances, drowsiness, dizziness, or other symptoms) may occur. If such symptoms occur, do not drive vehicles or operate machinery.

Meloxistad contains lactose

If you have been diagnosed with intolerance to some sugars, contact your doctor before taking the medicine.

3. How to take Meloxistad

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor again.

15 mg tablets:

Osteoarthritis flare-up

1/2 tabletper day (7.5 mg meloxicam).

If necessary, in case of no improvement, the dose of the medicine can be increased to 1 tabletper day (15 mg meloxicam).

Rheumatoid arthritis or ankylosing spondylitis

1 tabletper day (15 mg meloxicam)(see also section Special patient groups).

Depending on the treatment outcome, the doctor may reduce the dose to 1/2 tabletper day (7.5 mg meloxicam).

Do not exceed the dose of 1 tabletof Meloxistad 15 mg (dose of 15 mg meloxicam) per day.

Method of administration

For oral use.

Tablets should be taken once a day, washed down with a sufficient amount of liquid (e.g. a glass of water), with a meal.

Since the risk associated with meloxicam use increases with dose and duration of treatment, the doctor will decide on the shortest possible treatment time and the smallest effective dose. Therefore, consult your doctor periodically.

Special patient groups

Elderly patients and patients at increased risk of side effects:

The recommended dose for long-term therapy in elderly patients is ½ tablet of Meloxistad 15 mg per day (7.5 mg meloxicam).

Patients at increased risk of side effects should start treatment with ½ tablet of Meloxistad 15 mg per day (7.5 mg meloxicam).

Patients with kidney dysfunction:

In patients undergoing dialysis, with severe kidney failure, do not exceed the dose of ½ tablet of Meloxistad 15 mg per day (7.5 mg meloxicam).

Do not use meloxicam in patients with severe kidney failure not undergoing dialysis (see section When not to take Meloxistad).

Patients with liver dysfunction:

No dose adjustment is necessary in patients with mild to moderate liver failure. Do not use meloxicam in patients with severe liver failure (see section When not to take Meloxistad).

Children and adolescents (under 16 years of age):

Do not use this medicine in children under 16 years of age.

Overdose of Meloxistad

In case of overdose, immediatelyconsult a doctor or pharmacist.

Symptoms of meloxicam overdose may include:

• nausea (nausea),
• vomiting,
• drowsiness,
• lethargy (lack of energy),
• abdominal pain (upper abdomen), which subsides after supportive treatment,
• gastrointestinal bleeding.

Severe poisoning can lead to serious side effects:

• high blood pressure (hypertension),
• acute kidney failure,
• liver disorders,
• shallow breathing or respiratory arrest (respiratory depression),
• seizures (convulsions),
• loss of consciousness (coma),
• circulatory collapse (cardiovascular collapse),
• cardiac arrest,
• anaphylactic reactions (acute allergic reactions), including:
• fainting
• shortness of breath
• skin reactions.

Missed dose of Meloxistad

Do not take a double dose to make up for a missed dose. Continue taking the medicine as prescribed by your doctor.

Stopping Meloxistad treatment

Do not stop taking the medicine or discontinue treatment without consulting your doctor.

In case of doubts about the treatment, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Meloxistad and consult a doctor or the nearest hospital immediately if you experience:

Any allergic reactions (hypersensitivity), which may manifest as:

• difficulty breathing, feeling of constriction in the throat, swelling of the lips, tongue, or face, or urticaria,
• edema or sudden weight gain (fluid retention),
• ulcers in the mouth,
• jaundice (yellowing of the skin or eyes),
• intensified itching,
• flu-like symptoms,
• muscle spasms, numbness, or tingling,
• seizures (convulsions),
• hearing loss or ringing in the ears,
• unusual feeling of fatigue or weakness.

Any side effects from the gastrointestinal tract, especially:

• abdominal cramps, heartburn, or indigestion,
• abdominal pain or tension,
• bloody, black, or tarry stools,
• blood in vomit.

These symptoms may indicate serious side effects (e.g. gastric ulcers, perforation, or gastrointestinal bleeding), which can be severe, especially in elderly patients. Symptoms may occur at any stage of treatment, with or without warning symptoms, in patients with or without a history of serious gastrointestinal events.

Symptoms may have more severe consequences in elderly patients.

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 (arterial blockage), such as myocardial infarction or stroke, especially when used in high doses and for long-term treatment.

Fluid retention (edema), high blood pressure (hypertension), and heart failure have been reported during NSAID treatment.

The most common side effects are related to the gastrointestinal tract. Gastrointestinal ulcers (gastric ulcers), perforation (rupture), or gastrointestinal bleeding may occur, sometimes fatal, especially in elderly patients (see section 2. Warnings and precautions).

The following side effects have been reported with NSAIDs:

• nausea (nausea) and vomiting
• diarrhea (loose stools)
• flatulence (gas) with belching
• constipation
• indigestion (dyspepsia)
• abdominal pain
• tarry stools due to gastrointestinal bleeding
• bloody vomit
• mouth ulcers (stomatitis)
• worsening of ulcerative colitis
• worsening of Crohn's disease (inflammatory bowel disease)

Less commonly, gastritis (inflammation of the stomach) has been observed.

Meloxicam side effects – the active substance of Meloxistad

Very common (may affect more than 1 in 10 people):

• gastrointestinal disorders, such as:
• indigestion (dyspepsia),
• nausea (nausea) and vomiting,
• abdominal pain,
• constipation,
• flatulence (gas) with belching,
• diarrhea (loose stools),
• mild gastrointestinal bleeding, which may rarely cause a decrease in red blood cell count (anemia).

Common (may affect up to 1 in 10 people):

• headache.

Uncommon (may affect up to 1 in 100 people):

• decrease in red blood cell count (anemia)
• dizziness or vertigo (of vestibular origin),
• dizziness,
• drowsiness (somnolence),
• high blood pressure (hypertension),
• hot flashes,
• gastrointestinal bleeding (which may cause black stools or vomiting blood),
• gastritis (inflammation of the stomach),
• belching,
• mouth ulcers (stomatitis),
• angioedema (swelling of the skin or mucous membranes),
• allergic reactions,
• itching (pruritus),
• rash,
• fluid retention (edema),
• high potassium levels in the blood (hyperkalemia),
• transient liver or kidney function test abnormalities,
• formation of blood clots or emboli in blood vessels, which can cause certain heart or brain diseases (thromboembolic events in cardiac or cerebral vessels),
• fluid retention (edema), such as swelling of the lower limbs.

Rare (may affect up to 1 in 1,000 people):

• potentially life-threatening blistering skin rashes with redness and peeling (e.g. Stevens-Johnson syndrome and toxic epidermal necrolysis / Lyell's syndrome) (see section 2),
• urticaria (hives),
• palpitations (heart palpitations),
• mood changes,
• insomnia and nightmares,
• vision disturbances, including blurred vision,
• eye irritation (conjunctivitis),
• ringing or buzzing in the ears (tinnitus),
• asthma attacks in people allergic to acetylsalicylic acid (e.g. aspirin) or other NSAIDs,
• colitis (inflammation of the colon),
• esophagitis (inflammation of the esophagus),
• blood disorders (reduced blood cell count, such as leukopenia, thrombocytopenia).

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

• perforation of the gastrointestinal tract (perforation of the stomach or intestinal wall). This can cause peritonitis (inflammation of the abdominal cavity) and requires immediate surgery,
• significant reduction in white blood cell count, which can increase the risk of infection,
• hepatitis (inflammation of the liver),
• skin reactions in the form of peeling (bullous reactions) and erythema multiforme. Erythema multiforme is a severe allergic skin reaction, the symptoms of which include spots, red patches, or areas of discoloration, which may also affect the mouth, eyes, and other mucous membranes,
• acute functional kidney failure, especially in patients with risk factors.

Unknown frequency (cannot be estimated from the available data):

• anaphylactic reactions (acute allergic reactions), including symptoms such as skin or mucous membrane inflammation or peeling, swelling of the lips or tongue, difficulty breathing, low blood pressure, and fainting. If you experience such symptoms, consult a doctor immediately,
• worsening of gastrointestinal disease (colitis and Crohn's disease; see section 2. Warnings and precautions),
• formation of blood clots or emboli in the veins, which can block blood flow through the circulatory system (peripheral venous thromboembolism),
• pulmonary inflammation caused by an allergic reaction (eosinophilic pneumonia),
• confusion,
• disorientation,
• hypersensitivity to light,
• pancreatitis (inflammation of the pancreas).

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

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),
• presence of protein in the urine (nephrotic syndrome with proteinuria).

Reporting side effects

If you experience any side effects, including any not listed in the leaflet, tell 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:

Al. Jerozolimskie 181C, 02-222 Warsaw

Phone: +48 22 49 21 301

Fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Meloxistad

Keep the medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after the statement "Expiry date". The expiry date refers to the last day of the month.

No special precautions for storage are necessary.

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 Meloxistad contains

The active substance is meloxicam.

Meloxistad 15 mg: 1 tablet contains 15 mg meloxicam.

The other ingredients are: microcrystalline cellulose, pre-gelatinized (corn) starch, corn starch, sodium citrate, colloidal anhydrous silica, magnesium stearate, lactose monohydrate (see section 2. Meloxistad contains lactose).

What Meloxistad looks like and contents of the pack

Light yellow tablet, with a flat beveled edge and a central groove on one side, smooth on the other side. PVC/PVDC/Aluminum blisters. The packs contain 7, 10, 14, 15, 20, 28, 30, 50, 60, 100, 140, 280, 300, 500, or 1,000 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder:STADA Arzneimittel AG, Stadastr. 2 – 18, 61118 Bad Vilbel, Germany

Manufacturers:

Chanelle Medical Unlimited Company, Dublin Road, Loughrea, H62 FH90, Ireland

STADA Arzneimittel AG, Stadastr. 2 – 18, 61118 Bad Vilbel, Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

CZ: MELOXISTAD 15

DE: Meloxicam AL 15mg Tabletten

DK: Meloxicam STADA

EE: MELOXISTAD 15 mg tabletid

ES: Meloxicam STADA 15 mg comprimidos EFG

HU: MELOXISTAD 15 mg tabletta

IT: Meloxicam EG 15 mg Compresse

LT: MELOXISTAD 15 mg tabletés

LV: MELOXISTAD 15 mg tabletes

PL: Meloxistad

PT: Meloxicam Ciclum 15 mg comprimidos

Date of revision of the leaflet: 05/2023