MELOXICAM STADA 15 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Meloxicam Stada 15 mg Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Meloxicam Stada and what is it used for
2. What you need to know before you take Meloxicam Stada

1. How to take Meloxicam Stada
2. Possible side effects

1. Storage of Meloxicam Stada
2. Contents of the pack and other information

1. What is Meloxicam Stada and what is it used for

Meloxicam Stada is an anti-inflammatory and pain-relieving medicine that belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which are used to reduce inflammation and pain in the muscles and joints.

Meloxicam is used for:

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

2. What you need to know before you take Meloxicam Stada

Do not take Meloxicam Stada:

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

• In children and adolescents under 16 years of age.

• If you are allergic to meloxicam or any of the other ingredients of this medicine (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 disorder with difficulty breathing), nasal polyps (swelling produced in the nasal mucosa), swelling of the tissues, or hives after taking 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 (causing, for example, 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 stroke (bleeding from the blood vessels in 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 previous treatment with a medicine belonging to the group of non-steroidal 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 properly).

Warnings and precautions

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

Bleeding in the stomach or intestine / ulceration or perforation

If you have ever suffered from certain intestinal diseases (ulcerative colitis, Crohn's disease), your doctor will prescribe meloxicam with special care, as your condition may worsen (see section 4 Possible side effects).

Meloxicam and other medicines in the same group (NSAIDs) can cause bleeding in the stomach/intestine and ulcers or perforations, sometimes fatal, at any time during treatment, with or without warning symptoms or history.

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

The risk of bleeding in the stomach or intestine, ulcer, or perforation is higher in:

• Patient's being treated with high doses of NSAIDs.

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

These patients should start treatment with the lowest available dose. In these patients, the doctor should consider combination therapy with stomach protectors (medicines that help protect the stomach). The same precautions should be followed in patients undergoing simultaneous treatment with low doses of acetylsalicylic acid or other medicines that may increase the gastrointestinal risk. Consult your doctor.

If you have ever experienced adverse reactions in the stomach or intestine, especially in older patients, you should 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 any medicine that may increase the risk of ulcers or bleeding:

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

• Selective serotonin reuptake inhibitors (medicines for the treatment of depression).
• Antiplatelet medicines such as acetylsalicylic acid (medicines that prevent the formation of blood clots).

(See section 2 Other medicines 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 medicine.

The simultaneous use of meloxicam and other medicines belonging to the group of non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors (inhibitors of cyclooxygenase-2; medicines for the treatment of inflammation), should be avoided.

Cardiovascular and cerebrovascular effects

Medicines like meloxicam may be associated with a small increased 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 duration of treatment.

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

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

Severe skin reactions / hypersensitivity reactions

With the use of meloxicam, potentially life-threatening skin rashes (exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis; see section 4) have been reported, initially appearing on the trunk as reddish spots or patches often with blisters in the center.

Other signs to which attention should be paid are ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red and swollen eyes).

Severe skin reactions often appear accompanied by symptoms similar to the flu. The rash can progress to generalized blisters or peeling of the skin. The greatest 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, you should never take meloxicam again.

If you experience rashes, skin symptoms, or any other sign of hypersensitivity (such as difficulty breathing, narrowing of the throat, swelling of the lips, tongue, face, or appearance of hives), stop taking meloxicam, go to the doctor urgently, and inform him that you are taking this medicine.

Consult your doctor or pharmacist before starting to take meloxicam:

• If you have ever experienced a fixed drug eruption (rounded or oval patches with redness and swelling of the skin that usually reappear in the same place, formation of blisters, hives, and itching) after taking meloxicam or other oxicams (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 from pain.

Meloxicam may cause an increase in laboratory parameters. These alterations are, in most cases, mild and transient. If any alteration of laboratory tests persists or becomes significant, your doctor should indicate that you interrupt the administration of the medicine and will carry out the appropriate investigations.

At the start of treatment or after a dose increase, diuresis and renal function should be carefully monitored in the following patients:

• Older patients.

• Patient's being treated with concomitant treatments, such as ACE inhibitors, angiotensin-II antagonists, sartans, and diuretics (medicines for the treatment of high blood pressure).

• Patient's with reduced blood volume.

• Patient's with congestive heart failure.
• Patient's with kidney disorder (renal insufficiency, nephrotic syndrome, neuropathy with lupus).

• Patient's with severe liver disease.

In patients with diabetes or being treated with medicines to increase potassium levels, careful monitoring of potassium levels should be performed.

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 if you have difficulty becoming pregnant.

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

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

Older patients

The risk of suffering adverse reactions (in particular, gastrointestinal bleeding or perforation), which can even be fatal, is higher in older patients. Gastrointestinal bleeding or ulcers/perforations have, in general, more severe consequences in older patients. Therefore, the doctor should monitor carefully.

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

Other medicines and Meloxicam Stada

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The following medicines may increase the riskof suffering adverse reactions in the stomach or intestine:

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

Interactions may also occur with the following medicines:

• Oral anticoagulants. NSAIDs may increase the effect of anticoagulantssuch as warfarin. The simultaneous use of NSAIDs, such as meloxicam, and oral anticoagulants is not recommended. Consult your doctor if you are being treated with oral anticoagulants.
• Heparin (an injectable anticoagulant).
• Medicines that inhibit the immune response of the body or inhibit defense reactions after organ transplantation (cyclosporine, tacrolimus). These may increase the risk of kidney damage (nephrotoxicity) when administered with meloxicam.

• Medicines to reduce blood pressure (e.g., diuretics, ACE inhibitors, angiotensin-II antagonists, beta-blockers). Meloxicam may reduce the anti-hypertensive effect of these medicines.

• Intrauterine devices (IUDs) that are small, flexible devices made of metal and/or plastic that prevent pregnancy when inserted into the woman's uterus. Meloxicam may reduce the effect of these devices.

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

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

These medicines may have their levels increased by meloxicam.

• Medicines to reduce cholesterol (cholestyramine). These decrease 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 other liquid.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

During the first 6 months of pregnancy, your doctor may prescribe meloxicam if he considers it necessary.

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

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

Breast-feeding

This medicine is not recommended during breast-feeding.

Driving and using machines

Meloxicam does not seem to have an influence on the ability to drive and use machines; however, when taking meloxicam, some alterations of the central nervous system (e.g., visual disturbances, somnolence, vertigo, or other symptoms) may appear. If you are affected, do not drive or operate machines.

Meloxicam Stada contains lactose and sodium

If your doctor has told you that you have an intolerance to some sugars, consult with him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially, "sodium-free".

3. How to take Meloxicam Stada

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

The recommended dose is:

Acute crises of osteoarthritis

½ tabletper day (7.5 mg of meloxicam).

If necessary, in the absence of effect or in case of wanting to increase the effect, the dose may be increased to 1 tabletper day (15 mg of meloxicam).

Rheumatoid arthritis or ankylosing spondylitis

1 tabletper day (15 mg of meloxicam) (see section “special populations”).

According to the therapeutic response, your doctor may reduce the dose to ½ tabletper day (7.5 mg of meloxicam).

In no case should the dose of 1 tabletof meloxicam 15 mg (equivalent to 15 mg of meloxicam) per day be exceeded.

Route of administration

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

Elderly patients and patients at high risk of suffering adverse reactions

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

Patients at high risk of suffering adverse reactions should start treatment with ½ tablet of meloxicam 15 mg (7.5 mg of meloxicam) per day.

Patients with kidney disorders

In patients on hemodialysis with severe renal insufficiency, the dose should not exceed ½ tablet of meloxicam 15 mg (7.5 mg of meloxicam) per day.

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

Patients with liver disorders

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

Children and adolescents (<16 years)< p>

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

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 Toxicology 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 part of the abdomen), generally reversible with supportive treatment
• stomach and/or intestinal bleeding

A severe overdose can lead to serious reactions:

• high blood pressure (hypertension)

• acute kidney failure

• liver dysfunction
• reduction/decrease or respiratory arrest (respiratory depression)

• seizures
• loss of consciousness (coma)

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

• fainting

• difficulty breathing
• skin reactions

If you forget to take Meloxicam Stada

Do not take a double dose to make up for forgotten doses, but continue taking it as your doctor indicated.

If you interrupt treatment with Meloxicam Stada

Do not interrupt treatment without consulting your doctor.

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

4. Possible adverse effects

Like all medications, this medication can produce adverse effects, although not all people suffer from 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 hives

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

• yellowish skin and eyes
• excessive itching
• flu-like symptoms

• muscle cramps, numbness, or tingling
• seizures

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

Any adverse effect on the digestive tract, especially:

• abdominal cramps, heartburn, or indigestion

• softening or abdominal pain
• bloody or black stools
• blood in vomit

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

Most frequent adverse effects of non-steroidal anti-inflammatory drugs (NSAIDs)

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

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

The most frequently observed adverse effects affect the stomach or intestine. Gastrointestinal ulcers (peptic ulcers), perforation, or bleeding may appear, which in some cases can be fatal, particularly in elderly patients. (See section 2 Warnings and precautions).

The following adverse effects have been described after NSAID administration:

• nausea and vomiting
• diarrhea
• flatulence

• constipation
• indigestion (dyspepsia)

• abdominal pain
• dark stools due to bleeding in the digestive tract (melena)
• bloody vomit (hematemesis)

• inflammation with ulceration in the mouth (ulcerative stomatitis)
• worsening of intestinal inflammation (exacerbation of colitis)

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

Less frequently, stomach inflammation (gastritis) has been observed

Adverse effects of meloxicam – active ingredient of Meloxicam Stada

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

• gastrointestinal disorders such as:

• indigestion (dyspepsia)
• feeling of dizziness (nausea) and vomiting

• abdominal pain
• constipation

• gas (flatulence)
• diarrhea
• mild gastrointestinal bleeding, which can produce a reduction in the number of red blood cells (anemia) in very rare cases

Common (may affect 1 in 10 people):

• headache

Uncommon (may affect 1 in 100 people):

• low number of red blood cells (anemia)

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

• high blood pressure (hypertension)
• flushing

• stomach or intestinal bleeding and ulcers (can produce black stools or bloody vomit)
• stomach inflammation (gastritis)

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

• inflammation of the skin and mucous membranes (angioedema)
• allergic reactions
• hives (itching)

• skin rash
• water and sodium retention

• increase in blood potassium levels (hyperkalemia)
• transient alterations in renal and liver function tests

• formation of clots or thrombi in blood vessels, which can lead to heart or brain diseases (cardiovascular or cerebrovascular thromboembolic accidents)

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

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

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

• nightmares and insomnia
• visual disturbances including blurred vision

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

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

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

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

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

• acute kidney failure, especially 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, lip or tongue swelling, 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 clots or thrombi in the veins, obstructing blood flow through the circulatory system (peripheral venous thrombotic disorders)
• inflammation of the lungs due to an allergic reaction (pulmonary eosinophilia)
• confusion

• disorientation
• photosensitivity reactions
• pancreatitis (inflammation of the pancreas)
• a characteristic skin allergic reaction known as fixed drug eruption, which usually reappears in the same area in case of re-exposure to the medication and can appear as rounded or oval plaques with redness and swelling of the skin, blistering (hives), and itching

Adverse effects caused by non-steroidal anti-inflammatory drugs (NSAIDs) that have not yet been observed after taking meloxicam

Changes in kidney structure that cause acute kidney failure:

• very rare cases of kidney inflammation (interstitial nephritis)

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

• protein in the urine (nephrotic syndrome with proteinuria)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Meloxicam Stada

Keep this medication out of 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 thrown away through the sewers or in the trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Meloxicam Stada

• The active ingredient is meloxicam.

1 tablet contains 15 mg of meloxicam.

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

Appearance of the product and package contents

Tablets are pale yellow, flat, beveled, with a central score line on one side 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 manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

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

BE: Meloxicam 15 mg tablets

DE: Meloxicam AL 15 mg tablets

DK: Meloxicam STADA

EE: MELOXISTAD 15 mg tablets

ES: Meloxicam STADA 15 mg EFG tablets

IT: Meloxicam EG 15 mg tablets

LT: MELOXISTAD 15 mg tablets

LU: Meloxicam EG 15 mg tablets

LV: MELOXISTAD 15 mg tablets

PL: Meloxistad

PT: Meloxicam Ciclum 15 mg tablets

Date of the last revision of this prospectus:June 2023

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/