Package Insert: Information for the Patient

Meloxicam Stada 7.5 mg Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.

• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert.See section 4.

1. How to Take Meloxicam Stada
2. Possible Adverse Effects

1. Storage of Meloxicam Stada
2. Contents of the Package and Additional Information

Meloxicam Stada is a nonsteroidal anti-inflammatory medication and pain treatment that belongs to a group of medications called nonsteroidal anti-inflammatory drugs (NSAIDs) used to reduce inflammation and pain in muscles and joints.

Meloxicam is used for:

• Short-term symptomatic treatment of acute osteoarthritis (degenerative joint disease) attacks.
• Long-term symptomatic treatment of rheumatoid arthritis or ankylosing spondylitis (chronic inflammation of the joints that may lead to loss of mobility).

Do not take Meloxicam Stada:

• During the last three months of pregnancy (see section 2Pregnancy and breastfeeding).

• In children and adolescents under 16 years old.

• If you are allergic to meloxicam or to any of the other components of this medication (listed in section 6) or to other substances with similar action (e.g., NSAIDs, acetylsalicylic acid). Meloxicam should not be taken by patients who have developed symptoms of asthma (respiratory alteration with difficulty breathing), nasal polyps (swelling produced in the nasal mucosa), swelling of tissues or urticaria after administration of acetylsalicylic acid or other NSAIDs.

• If you have an active gastrointestinal ulcer (peptic ulcer: inflammation and ulcers in the stomach and intestine) or bleeding in the stomach or intestine (e.g., causing black stools).

• If you have a history of recurrent gastrointestinal ulcers or bleeding in the stomach or intestine (two or more distinct episodes of ulcers or bleeding).
• If you have had a cerebral hemorrhage (bleeding of the blood vessels of the brain).

• If you have any type of bleeding disorder.

• History of bleeding in the stomach or intestine or perforation of the stomach or intestine, related to a previous treatment with a medication belonging to the group of nonsteroidal anti-inflammatory drugs (NSAIDs).

• If you have severe liver disease.
• If you have severe kidney disease and are not undergoing dialysis.

• If you have severe congestive heart failure (when your heart does not function correctly).

Warnings and precautions

If you have a history of esophagitis (inflammation of the esophagus), gastritis (inflammation of the stomach) and/or peptic ulcer, inform your doctor to ensure the cure of your digestive problems before starting treatment with meloxicam.

Gastrointestinal bleeding / ulceration or perforation

If you have ever had certain diseases related to the intestine (ulcerative colitis, Crohn's disease), your doctor will prescribe meloxicam with special care, as your condition may worsen (see section 4Possible adverse effects).

Meloxicam and other medications in the same group (NSAIDs) may cause gastrointestinal bleeding and ulcers or perforations, sometimes fatal, at any time during treatment, with or without warning symptoms or history.

If you have ever had gastrointestinal symptoms or have a history of gastrointestinal alterations (ulcerative colitis, Crohn's disease), your doctor will monitor your digestive alterations, especially gastrointestinal bleeding (bleeding of the stomach and intestine that causes black stools).

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

• Patients taking high doses of NSAIDs.

• Patients who have ever had an ulcer, particularly combined with bleeding or perforation (see section 2Do not take Meloxicam Stada).
• Older patients.

These patients should start treatment with the lowest available dose. In these patients, the doctor should consider a combined therapy with stomach protectors (medications that help protect the stomach). The same precautions should be followed in patients taking small doses of acetylsalicylic acid or other medications that may increase the risk of gastrointestinal bleeding. Consult your doctor.

If you have ever had adverse reactions in the stomach or intestine, especially in older patients, inform your doctor of any unusual gastrointestinal symptoms (especially black stools or stools with blood, or vomiting with blood), particularly during the first month of treatment.

Be especially careful if you are taking another medication that may increase the risk of ulcers or bleeding:

• Oral corticosteroids (medications for the treatment of inflammation such as rheumatism).
• Anticoagulants such as warfarin.

• Inhibitors of serotonin reuptake (medications for the treatment of depression).
• Antiplatelet medications such as acetylsalicylic acid (medications that prevent blood clotting).

(See section 2Other medications and Meloxicam Stada)

If you experience bleeding in the stomach or intestine (causing black stools or stools with blood, or vomiting with blood), or ulcers during treatment with meloxicam, inform your doctor immediately and stop taking this medication.

Avoid simultaneous use of meloxicam and other medications belonging to the group of nonsteroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors (inhibitors of cyclooxygenase-2; medications for the treatment of inflammation).

CARDIOVASCULAR AND CEREBROVASCULAR EFFECTS

Medications such as meloxicam may be associated with a small increase in the risk of suffering a heart attack (“myocardial infarction”) or a stroke. Any risk is increased with high doses and prolonged treatments. Do not exceed the recommended dose or treatment duration.

If you have heart problems, have had a stroke, or consider yourself at risk (e.g., if you have high blood pressure, diabetes, elevated cholesterol levels, or are a smoker), consult your treatment with your doctor or pharmacist.

If you have a history of hypertension (high blood pressure) or congestive heart failure (difficulty of the heart to pump enough blood in the body), your doctor will monitor you closely.

SEVERE SKIN REACTIONS / HYPERSENSITIVITY REACTIONS

With the use of meloxicam, severe skin reactions potentially fatal (dermatitis exfoliativa, Stevens-Johnson syndrome, toxic epidermal necrolysis; see section 4) have been reported, appearing initially on the trunk as red spots or red patches often with blisters in the center.

Other signs to pay attention to are mouth ulcers, throat, nose, genitals, and conjunctivitis (red and swollen eyes).

Severe skin reactions potentially fatal appear frequently accompanied by symptoms similar to the flu. The rash may progress to generalized blisters or skin peeling. The highest risk of severe skin reactions is in the first weeks of treatment.

If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of meloxicam, do not take meloxicam again in any case.

If you develop rashes, skin symptoms, or any other sign of hypersensitivity (such as difficulty breathing, throat constriction, swelling of lips, tongue, face, or appearance of urticaria), stop taking meloxicam, go to the doctor urgently, and inform them that you are taking this medication.

Consult your doctor or pharmacist before starting to take meloxicam:

• If you have ever had a fixed drug eruption (round or oval plaques with redness and swelling of the skin that usually reappear in the same place, blistering, urticaria, and itching) after taking meloxicam or other oxicamics (e.g., piroxicam).

OTHER PRECAUTIONS

Meloxicam has a delayed onset of action, inform your doctor if the effect of meloxicam is very weak or if you need rapid relief of pain.

Meloxicam may cause an increase in laboratory parameters. These alterations are, in most cases, mild and transient. If any laboratory alteration persists or becomes significant, your doctor will instruct you to stop taking the medication and perform the necessary investigations.

At the beginning of treatment or after an increase in dose, carefully monitor urine output and renal function in the following patients:

• Older patients.

• Patients taking concomitant treatments, such as ACE inhibitors, angiotensin II antagonists, sartans, and diuretics (medications for the treatment of high blood pressure).

• Patients with reduced blood volume.

• Patients with cardiac alteration (congestive heart failure).
• Patients with renal alteration (renal insufficiency, nephrotic syndrome, neuropathy with lupus).

• Patients with severe liver disease.

In patients with diabetes or taking medications to increase potassium levels, carefully monitor potassium levels.

Meloxicam may mask the symptoms of an underlying infection.

The use of meloxicam may reduce fertility. Inform your doctor if you intend to become pregnant or have difficulty becoming pregnant.

Adverse effects may be reduced by using the lowest effective dose for the shortest period necessary to control symptoms.

The maximum recommended daily dose should not be exceeded in case of insufficient therapeutic effect, nor should another NSAID be added to the treatment. If no improvement is observed after several days, consult your doctor.

Older patients

The risk of adverse reactions (particularly gastrointestinal bleeding or perforation), which may be fatal, is higher in older patients. Gastrointestinal bleeding or ulcers/perforations usually have more severe consequences in older patients. Therefore, your doctor will closely monitor you.

Your doctor will closely monitor you, especially if you have renal, liver, or heart failure (difficulty of the heart to pump enough blood in the body).

Other medications and Meloxicam Stada

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

The following medicationsmay increase the riskof gastrointestinal bleeding:

• Other nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g., ibuprofen).
• COX-2 inhibitors (medications for the treatment of inflammation).
• Corticosteroids (medications for the treatment of inflammation or allergies).
• Antiplatelet medications such as acetylsalicylic acid.
• Certain medications for the treatment of depression (selective serotonin reuptake inhibitors, SSRIs).

Interactions may also occur with the following medications:

• Oral anticoagulants. NSAIDs may increase the effect of oral anticoagulantssuch as warfarin.The simultaneous use of NSAIDs, such as meloxicam, and oral anticoagulants is not recommended. Consult your doctor if you are taking oral anticoagulants.
• Heparin (an injectable anticoagulant).
• Medications that inhibit the immune response of the body or inhibit the defense reactions after organ transplantation (ciclosporin, tacrolimus). Thesemay increase the risk of renal toxicity when administered with meloxicam.

• Medications for reducing blood pressure (e.g., diuretics, ACE inhibitors, angiotensin II antagonists, beta-blockers).Meloxicam may reduce theanti-hypertensive effect of these medications.

• Intrauterine devices (IUDs) that are small, flexible devices made of metal and/or plastic that prevent pregnancy when placed in the uterus of the woman.Meloxicammay reduce the effect of these devices.

• Certain medications used for the treatment of psychiatric disorders and depression (lithium).

• Certain medications for the treatment of rheumatic diseases and tumors (methotrexate).

The levels of these medications may be increased by meloxicam.

• Medications for reducing cholesterol (cholestyramine). Thesedecrease the blood levels of meloxicam and therefore its effect.

Taking Meloxicam Stada with food and drinks

The tablets should be taken during meals with water or another liquid.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Pregnancy

Your doctor may prescribe meloxicam during the first 6 months of pregnancy if necessary.

Do not takemeloxicam during thelast three months of pregnancybecause meloxicam may cause severe effects in your child, particularly cardiovascular and renal effects (see section 2Do not take Meloxicam Stada).

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

Breastfeeding

This medication is not recommended during breastfeeding.

Driving and operating machines

Meloxicam does not appear to have an influence on driving and operating machines, however, taking meloxicam may cause some alterations in the central nervous system (e.g., visual disturbances, drowsiness, dizziness, or other symptoms). If you are affected, do not drive or operate machines.

Meloxicam Stada contains lactose and sodium

If your doctor has indicated that you have an intolerance to certain sugars, consult them before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Acute osteoarthritis crises

1 tablet per day (7.5 mg of meloxicam)

In case of need, in the absence of effect or to increase the effect, the dose can be increased up to2 tablets per day (15 mg of meloxicam)

Rheumatoid arthritis or ankylosing spondylitis

2 tablets per day (15 mg of meloxicam)(see “special populations” section).

Your doctor may reduce the dose to1 tablet per day (7.5 mg of meloxicam)according to the therapeutic response.

In no case should the dose exceed2 tablets of meloxicam 7.5 mg (equivalent to 15 mg of meloxicam) per day.

Administration route

Oral route

Take the tablets once a day with a sufficient amount of liquid (e.g., a glass of water) during a meal.

Since the risks of meloxicam may increase with the dose and duration of exposure, your doctor will choose the shortest possible duration and the lowest effective daily dose. Therefore, you should visit your doctor periodically.

Special populations

Older patients and patients at high risk of adverse reactions

The recommended dose for long-term treatments in older patients is 1 tablet of meloxicam 7.5 mg (7.5 mg of meloxicam) per day.

Patients at high risk of adverse reactions should start treatment with 1 tablet of meloxicam 7.5 mg (7.5 mg of meloxicam) per day.

Patients with kidney impairment

In patients undergoing hemodialysis with severe renal failure, the dose should not exceed 1 tablet of meloxicam 7.5 mg (7.5 mg of meloxicam) per day.

Meloxicam should not be taken by patients with severe renal failure without dialysis (see “Do not take Meloxicam Stada”).

Patients with liver impairment

In patients with moderate to severe hepatic insufficiency, no dose reduction is required. Patients with severe hepatic insufficiency should not take meloxicam (see “Do not take Meloxicam Stada”).

Children and adolescents (<16

This medication should not be used in children under 16 years old.

If you take more Meloxicam Stada than you should

If you have taken more tablets than you should, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 915 620 420.

The symptoms of meloxicam overdose include:

• nausea

• vomiting
• drowsiness

• lack of energy (lethargy)
• epigastric pain (pain in the upper abdomen), usually reversible with supportive treatment
• gastrointestinal and/or intestinal bleeding

A severe intoxication may lead to severe reactions:

• high blood pressure (hypertension)

• acute renal failure

• hepatic dysfunction
• respiratory depression (respiratory failure)

• seizures
• loss of consciousness (coma)

• cardiovascular collapse
• cardiac arrest
• immediate allergic reactions (hypersensitivity), including:

• syncope

• difficulty breathing
• skin reactions

If you forgot to take Meloxicam Stada

Do not take a double dose to compensate for the missed doses, but continue taking it as your doctor instructed.

If you interrupt treatment with Meloxicam Stada

Do not stop treatment without consulting your doctor.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking meloxicam and consult your doctor immediately or go to the nearest hospital if you notice:

Any allergic reaction (hypersensitivity), which can appear in the form of:

• difficulty breathing; throat closure; swelling of the lips, tongue, or face; or urticaria

• swelling or rapid weight gain (fluid retention)
• mouth ulcers (open sores)

• yellow skin or eyes
• excessive itching
• flu-like symptoms

• muscle cramps, numbness, or tingling
• seizures

• decreased hearing ability or ringing in the ears
• unusual fatigue or weakness

Any gastrointestinal side effect, especially:

• abdominal cramps, stomach burning, or indigestion

• soft or painful abdomen
• bloody or black stools
• blood in vomit

These symptoms may indicate side effects that can sometimes be severe (e.g., peptic ulcer, hemorrhage, or stomach or intestinal perforation), especially in elderly patients. These side effects can occur at any time during treatment, with or without warning symptoms or a history of severe gastrointestinal disorders, and the consequences may be more severe in elderly patients.

Common side effects of nonsteroidal anti-inflammatory drugs (NSAIDs)

The use of some nonsteroidal anti-inflammatory drugs (NSAIDs) may be associated with a slight increase in the risk of arterial occlusion (arterial thrombotic events), such as heart attack (myocardial infarction) or stroke (apoplexy), especially at high doses and with long-term treatment.

There have been reports of fluid retention (edema), high blood pressure (hypertension), and heart failure (cardiac failure) associated with NSAID treatment.

The most frequently observed side effects affect the stomach or intestines. They can cause gastrointestinal ulcers (peptic ulcers), perforation, or hemorrhage, which in some cases can be fatal, particularly in elderly patients. (See section 2Warnings and precautions).

The following side effects have been described after administration of NSAIDs:

• nausea and vomiting
• liquid stools (diarrhea)
• flatulence

• constipation
• indigestion (dyspepsia)

• abdominal pain
• dark stools due to gastrointestinal hemorrhage (melena)
• vomiting blood (hematemesis)

• inflammation with the appearance of ulcers in the mouth (stomatitis ulcerativa)
• worsening of intestinal inflammation (exacerbation of colitis)

• worsening of gastrointestinal tract inflammation (exacerbation of Crohn's disease)

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

Side effects of meloxicam – active ingredient of Meloxicam Stada

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

• Gastrointestinal changes such as:

Common (may affect 1 in 10 people):

• headache

Uncommon (may affect 1 in 100 people):

• low red blood cell count (anemia)

• feeling of spinning or rotation (vertigo)
• dizziness
• drowsiness

• high blood pressure (hypertension)
• flushing

• gastrointestinal hemorrhage and ulcers (may cause black stools or vomiting blood)
• gastritis (inflammation of the stomach)

• eructation
• mouth pain, inflammation of the mucous membrane of the mouth (stomatitis)

• inflammation of the skin and mucous membranes (angioedema)
• allergic reactions
• urticaria (pruritus)

• skin rash
• fluid and sodium retention

• high potassium levels (hyperkalemia)
• transient alterations in liver and kidney function tests

• formation of blood clots or thrombi in blood vessels, which can cause cardiovascular or cerebrovascular diseases (thromboembolic cardiovascular or cerebrovascular events)

• fluid retention (edema), for example, with swelling of the lower extremities

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

• vesicular skin eruptions, potentially fatal, with redness and blisters (e.g., Stevens-Johnson syndrome and toxic epidermal necrolysis/syndrome of Lyell) (see section 2)
• urticaria
• perception of heartbeats (palpitations)
• mood changes

• nightmares and insomnia
• visual disturbances, including blurred vision

• eye irritation (conjunctivitis)
• tinnitus or ringing in the ears
• asthma attacks in certain individuals allergic to acetylsalicylic acid (e.g., aspirin) or other NSAIDs
• intestinal inflammation (colitis)

• throat inflammation (esophagitis)
• blood disorders (alterations in the number of blood cells, such as leucopenia, thrombocytopenia)

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

• perforation of the stomach and intestinal walls (gastrointestinal perforation). This causes peritonitis (inflammation within the abdomen) and requires immediate surgery
• severe decrease in the number of white blood cells, which increases the risk of infections (agranulocytosis)
• liver inflammation (hepatitis)

• vesicular skin reactions (bullous reactions) and erythema multiforme. Erythema multiforme is a severe allergic skin reaction that causes patches, red rashes, or purple areas with blisters. It can also affect the mouth, eyes, and other moist areas of the body

• acute kidney failure, particularly in patients with risk factors

Unknown (frequency cannot be estimated from available data):

• anaphylactic reactions (acute allergic reactions), including symptoms such as skin inflammation or burning, swelling of the lips or tongue), difficulty breathing, low blood pressure, and fainting. If you experience any of these symptoms, consult your doctor immediately
• worsening of gastrointestinal disease (colitis and Crohn's disease; see section 2 (Warnings and precautions))
• formation of blood clots or thrombi in veins, obstructing blood flow through the circulatory system (peripheral venous thrombotic changes)
• lung inflammation due to a probable allergic reaction (eosinophilic pneumonia)
• confusion

• disorientation
• photosensitivity reactions
• pancreatitis (inflammation of the pancreas)
• a characteristic skin allergic reaction known as fixed drug eruption, which usually reappears at the same site upon re-exposure to the drug and may appear as rounded or oval plaques with redness and swelling of the skin, formation of blisters (urticaria), and itching.

Side effects caused by nonsteroidal anti-inflammatory drugs (NSAIDs) that have not yet been observed after taking meloxicam

Changes in the structure of the kidney that cause acute kidney failure:

• very rare cases of kidney inflammation (interstitial nephritis)

• death of some kidney cells (acute tubular necrosis or papillary necrosis)

• proteins in the urine (nephrotic syndrome with proteinuria)

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and on the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Meloxicam Stada

• The active ingredient is meloxicam.

1 tablet contains 7.5 mg of meloxicam.

• The other components are microcrystalline cellulose, pregelatinized cornstarch (corn), cornstarch, sodium citrate, anhydrous colloidal silica, magnesium stearate, lactose monohydrate (see section 2Meloxicam Stada contains lactose).

Appearance of the product and contents of the package

Yellowish pale tablets, flat, bisected, with a central groove on one face and flat on the other, in PVC/PVDC/Aluminum blisters. Packages of 7, 10, 14, 15, 20, 28, 30, 50, 60, 100, 140, 280, 300, 500, or 1,000 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible manufacturer

Chanelle Medical Ltd.

Loughrea, Co. Galway

Ireland

or

STADA Arzneimittel AG

Stadastrasse 2-18,

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Wien

Austria

or

Clonmel Healthcare Ltd.

Waterford Road, Clonmel

Co. Tipperary

Ireland

or

Doppel Farmaceutici S.r.L.

Via Volturno, 48

20089 Quinto dè Stampi, Rozzano - MI

Italy

or

Cosmo S.p.A.

Via C. Colombo, 1

20045 Lainate-Milano

Italy

or

Genus Pharmaceuticals Limited

View House, 65 London Road, Newbury

Berkshire, RG141JN

United Kingdom

or

Sanico N.V.

Veedijk 59, Industriezone 4

2300 Turnhout

Belgium

This medicine has been authorized in the EEA member states with the following names:

DE:Meloxicam AL 7.5 mg Tabletten

DK:Meloxicam STADA

EE:MELOXISTAD 7.5 mg tabletid

ES:Meloxicam STADA 7.5 mg comprimidos EFG

IT:Meloxicam EG 7.5 mg Compresse

LT:MELOXISTAD 7.5 mg tabletés

LV:MELOXISTAD 7.5 mg tabletes

PT:Meloxicam Ciclum 7.5 mg comprimidos

Last review date of this leaflet:June 2023

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicaments and Health Products (AEMPS)http://www.aemps.gob.es/