Leaflet: information for the user

Meloxicam pensa 15 mg tablets EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.

If you experience any side effects, consult your doctor, even if they are not listed in this leaflet. See section 4.

• 1. What Meloxicam pensa is and what it is used for

• 2. What you need to know before you start taking Meloxicam pensa

• 3. How to take Meloxicam pensa

• 4. Possible side effects

• 5. Storage of Meloxicam pensa

• 6. Contents of the pack and additional information

Meloxicam belongs to a group of medications called nonsteroidal anti-inflammatory drugs (NSAIDs)

used to reduce inflammation and pain in joints and muscles.

Meloxicam is indicated for adults and children 16 years of age and older.

Meloxicam is used for:

• treatment of short-term crises of osteoarthritis
• long-term treatment of:

- rheumatoid arthritis

- ankylosing spondylitis.

Do not take Meloxicam Pensa if:

• You are allergic to meloxicam or any of the other ingredients in this medication (listed in section 6)
• During the last three months of pregnancy
• Children and adolescents under 16 years of age
• You have had any of the following conditions after taking acetylsalicylic acid or other NSAIDs
• Wheezing (asthma), chest tightness, shortness of breath
• Nasal congestion due to inflammation of the nasal passages (nasal polyps)
• Rashes or urticaria
• Sudden inflammation of the skin or mucous membranes, such as inflammation around the eyes, face, lips, mouth, or throat, which may make breathing difficult (angioedema)
• If after previous therapy with NSAIDs you experienced:
• • Bleeding in your stomach or intestines
  • Perforations in your stomach or intestines

• Ulcers or bleeding in your stomach or intestines
• You have had recent or past stomach ulcers or bleeding (ulcers or bleeding that have occurred at least twice)
• Severe liver dysfunction
• Severe kidney failure not on dialysis
• Recent bleeding in the brain (cerebrovascular hemorrhage)
• Any type of bleeding disorder
• Severe heart failure
• Intolerance to some sugars since this medication contains lactose (see also "Meloxicam Pensa contains lactose")

If you are unsure about any of the above situations, please contact your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Meloxicam Pensa.

Warnings

Medications like Meloxicam Pensa may be associated with a slight increase in the risk of heart attack ("myocardial infarction") or stroke ("cerebral infarction"). Any risk is greater at high doses and with prolonged treatment. Do not take more than the recommended dose. Do not take Meloxicam Pensa for longer than prescribed (see section 3 "How to take Meloxicam Pensa").

If you have heart problems, a previous stroke, or if you think you may be at risk of these diseases, you should discuss treatment with your doctor or pharmacist. For example, if you:

• Have high blood pressure (hypertension)
• Have high blood sugar levels (diabetes mellitus)
• Have high cholesterol levels in the blood (hypercholesterolemia)
• Are a smoker

Stop taking Meloxicam Pensa immediately as soon as you notice bleeding (causing black stools) or ulcers in your digestive system (causing abdominal pain).

Severe skin eruptions that can be life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been described with the use of Meloxicam Pensa, appearing initially as red, circular spots with a central blister.

Other signs that may appear include mouth, throat, nasal, genital, and conjunctivitis (swollen and red eyes).

These life-threatening skin eruptions, often accompanied by flu-like symptoms, may progress to form widespread blisters or skin peeling.

The highest risk period for the appearance of severe skin reactions is during the first weeks of treatment.

If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of Meloxicam Pensa, do not use Meloxicam Pensa again at any time. If you develop a rash or these symptoms on your skin, stop taking Meloxicam Pensa and immediately see a doctor and inform them that you are taking this medication.

Meloxicam Pensa is not suitable if you need to relieve acute pain immediately.

Meloxicam Pensa may mask the symptoms of an infection (e.g., fever). If you think you may have an infection, you should see a doctor.

If you have ever experienced a fixed drug eruption (round or oval patches with redness and swelling of the skin that often reappear in the same place, blistering, urticaria, and itching) after taking meloxicam or other oxicam derivatives (e.g., piroxicam).

Precautions for use

Since treatment will need to be adjusted, it is essential to seek advice from your doctor before taking Meloxicam Pensa in the following cases:

• You have had inflammation of the throat (esophagitis), stomach inflammation (gastritis), or a history of any other digestive system disease, e.g., Crohn's disease, ulcerative colitis
• High blood pressure (hypertension)
• Advanced age
• Heart, liver, or kidney disease
• High blood sugar levels (diabetes mellitus)
• Reduced blood volume (hypovolemia) that may occur if you have had significant blood loss, severe burns, surgery, or low fluid intake
• Diagnosed intolerance to some sugars by your doctor since this medication contains lactose
• Previously diagnosed high potassium levels in the blood by your doctor. Your doctor will need to monitor your progress during treatment.

Taking Meloxicam Pensa with other medications

Since Meloxicam Pensa may affect or be affected by other medications, inform your doctor or pharmacist if you are taking, have taken, or may need to take any other medication.

Specifically, please inform your doctor or pharmacist if you are taking/have taken or have used any of the following medications:

• Other NSAIDs
• Potassium salts (used to prevent or treat low potassium levels in the blood)

• Tacrolimus (used after organ transplantation)
• • Trimethoprim (used in the treatment of urinary tract infections)
  • Medications that prevent blood clotting
  • Medications that dissolve blood clots (thrombolytics)
  • Medications for heart and kidney disease
  • Corticosteroids (e.g., used in inflammation or allergic reactions)
  • Ciclosporin (used after organ transplantation or for severe skin diseases, rheumatoid arthritis, or nephrotic syndrome)

• Deferasirox (used to treat chronic iron overload caused by frequent blood transfusions)
• • Any diuretic ("urine tablets"). Your doctor may need to monitor your kidney function if you are taking diuretics
  • Medications for high blood pressure (e.g., beta-blockers)
  • Lithium (used to treat behavioral disorders)
  • Selective serotonin reuptake inhibitors (SSRIs) (used to treat depression)
  • Methotrexate (used to treat tumors or severe skin diseases or active rheumatoid arthritis)
  • Pemetrexed (used in cancer treatment)
  • Colestiramine (used to reduce cholesterol levels)
  • Oral antidiabetic medications (sulfonilureas, nateglinida) (used to treat diabetes. Your doctor will need to closely monitor your blood sugar levels for hypoglycemia)

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

The recommended dose is:

Acute osteoarthritis:

7.5 mg (half tablet) once a day. This can be increased to 15 mg (one tablet) once a day.

Rheumatoid arthritis:

15 mg (one tablet) once a day. This can be reduced to 7.5 mg (half tablet) once a day.

Ankylosing spondylitis:

15 mg (one tablet) once a day. This can be reduced to 7.5 mg (half tablet) once a day.

Do not exceed the maximum recommended daily dose of 15 mg.

If any of the situations described under the title “Warnings and precautions” affect you, your doctor may limit your dose to 7.5 mg (half tablet) once a day.

Older patients

If you are an older person, the recommended dose in long-term treatment for rheumatoid arthritis and ankylosing spondylitis is 7.5 mg (half tablet) once a day.

Patients at increased risk of adverse reactions

If you are a patient at increased risk of adverse reactions, your doctor will start treatment at a dose of 7.5 mg (half tablet) per day.

Renal insufficiency

If you are a patient on dialysis with severe renal insufficiency, your dose should not exceed 7.5 mg (half tablet) per day. In patients with mild to moderate renal insufficiency, dose reduction is not necessary.

Hepatic insufficiency

In patients with mild to moderate hepatic insufficiency, dose reduction is not necessary.

Use in children and adolescents

Meloxicam should not be administered to children and adolescents under 16 years old.

Consult your doctor or pharmacist if you estimate that meloxicam's action is too strong or weak, or if after several days you do not notice any improvement.

Administration form

Oral route.

Tablets should be swallowed with water or other beverage during meals in a single daily dose.

If you take more Meloxicam than you should

If you have taken too many tablets or suspect an overdose, contact your doctor or go to the nearest hospital immediately.

Common symptoms associated with acute NSAID overdose are:

• lack of energy (lethargy)
• sleep
• nausea and vomiting
• stomach pain (epigastric pain).

These symptoms usually improve when meloxicam is stopped.Gastrointestinal bleeding may occur.

Severe intoxication may cause severe adverse reactions (see section 4):

• high blood pressure (hypertension)
• acute kidney failure (renal failure)

• liver function impairment (hepatic insufficiency)
• respiratory depression (respiratory depression)
• loss of consciousness (coma)
• seizures (convulsions)
• circulatory collapse (cardiovascular collapse)
• cardiac arrest (cardiac arrest)
• immediate allergic reactions (hypersensitivity), including:

• syncope
• shortness of breath

skin reactions

If you have taken more meloxicam than you should, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount used. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Meloxicam

Do not take a double dose to compensate for the missed doses.Simply take the next dose at the usual time.

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 Pensa and consult your doctor or the nearest hospital immediately if you notice:

Any allergic reaction (hypersensitivity) that may appear in the form of:

• skin reactions such as itching (pruritus), skin blistering or peeling, which can be life-threatening skin eruptions (Stevens-Johnson syndrome and toxic epidermal necrolysis), mucous membrane lesions or erythema multiforme (see section 2).

Erythema multiforme is a severe skin allergic 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.

• skin or mucous membrane inflammation such as inflammation around the eyes, face, and lips, mouth or throat, possibly making it difficult to breathe, swollen ankles/legs (lower extremity edema)
• difficulty breathing or asthma attacks
• inflammation of the liver (hepatitis). This can cause symptoms such as:

• yellowing of the skin and eyes (jaundice)
• abdominal pain
• loss of appetite

Any gastrointestinal side effect, especially:

• bleeding (causing black stools)
• ulcers in your digestive system (causing abdominal pain)

Bleeding in the digestive tract (gastrointestinal hemorrhage), the formation of ulcers or a hole in the digestive system (perforation) can sometimes be severe and potentially fatal, especially in older people.

If you have previously experienced any symptoms of the digestive system due to prolonged use of NSAIDs, seek medical advice immediately, especially if you are an elderly person. Your doctor may monitor your progress while you are on treatment.

If you experience vision changes, do not drive or use machines.

General 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), particularly at high doses and with long-term treatment.

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

The most common side effects observed affect the gastrointestinal tract (gastrointestinal events):

• stomach and upper small intestine ulcers (peptic/gastroduodenal ulcers)
• a hole in the intestinal wall (perforation) or bleeding in the digestive tract (sometimes fatal, especially in older people)

After NSAID administration, the following side effects have been reported:

• nausea and vomiting
• liquid stools (diarrhea)
• flatulence
• constipation
• indigestion (dyspepsia)
• abdominal pain
• black stools due to bleeding in the digestive tract (melena)
• vomiting blood (hematemesis)
• inflammation with the appearance of ulcers in the mouth (ulcerative stomatitis)
• worsening of inflammation of the digestive tract (e.g. exacerbation of colitis or Crohn's disease)

Less frequently, gastric inflammation (gastritis) has been observed.

Side effects of meloxicam - active substance of Meloxicam Pensa

Very common: may affect more than 1 in 10 people

• gastrointestinal side effects such as indigestion (dyspepsia), nausea and vomiting, abdominal pain, constipation, flatulence, liquid stools (diarrhea)

Common: may affect up to 1 in 10 people

• headache

Rare: may affect up to 1 in 100 people

• dizziness (sense of drowsiness)
• sense of dizziness or rotation (vertigo)
• drowsiness (somnolence)
• anemia (decrease in the amount of the pigment in red blood cells called hemoglobin)
• increased blood pressure (hypertension)
• flushing (enrojecimiento temporal in the face and neck)
• water and sodium retention
• increased potassium levels (hyperpotassemia). This can cause symptoms such as:
• changes in heartbeats (arrhythmias)
• palpitations (when you notice your heartbeats more than usual)
• muscle weakness
• eructation
• gastritis (inflammation of the stomach)
• bleeding in the digestive system
• inflammation of the mouth (stomatitis)
• immediate allergic reactions (hypersensitivity)
• itching (pruritus)
• skin reaction
• inflammation caused by fluid retention (edema), including swollen ankles/legs (lower extremity edema)
• sudden inflammation of the skin or mucous membranes, such as inflammation around the eyes, face, lips, mouth or throat, possibly making it difficult to breathe (angioedema)
• transient changes in liver function tests (e.g. increased levels of liver enzymes such as transaminases or increased bilirubin). Your doctor may detect them by doing a blood test
• changes in kidney function tests (e.g. increased creatinine or urea)

Rare: may affect up to 1 in 10,000 people

• mood changes
• nightmares
• abnormal blood count, including:
• abnormal differential blood count
• decreased white blood cell count (leucopenia)
• decreased platelet count (thrombocytopenia)

These side effects may increase the risk of infection and cause symptoms such as bruises or nosebleeds.

• tinnitus (ringing in the ears)
• noticing heartbeats (palpitations)
• stomach or upper small intestine ulcers (peptic/gastroduodenal ulcers)
• inflammation of the throat (esophagitis)
• onset of asthma attacks (observed in people allergic to aspirin or other NSAIDs)
• severe blistering of the skin or peeling (Stevens-Johnson syndrome and toxic epidermal necrolysis)
• urticaria
• vision changes, including:
• blurred vision
• conjunctivitis (inflammation of the eye or eyelid)
• inflammation of the large intestine (colitis)

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

• vesicular skin reactions (blistering) and multiform erythema.
• Erythema multiforme is a severe skin allergic 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.
• inflammation of the liver (hepatitis). This can cause symptoms such as:

• yellowing of the skin and eyes (jaundice)
• abdominal pain
• loss of appetite

• acute kidney failure (renal failure) in particular in patients with risk factors such as heart disease, diabetes or kidney disease.
• a hole in the intestinal wall (perforation)

Frequency not known: the frequency cannot be estimated from the available data

• confusion
• disorientation
• shortness of breath and skin reactions (anaphylactic/anaphylactoid reactions) due to exposure to sunlight (photosensitivity reactions)
• heart failure (cardiac failure) associated with NSAID treatment has been described
• complete loss of certain types of white blood cells (agranulocytosis), especially in patients taking Meloxicam Pensa with other drugs that may inhibit, depress or potentially destroy a component of the bone marrow (myelotoxic drugs). This can cause:
• sudden fever
• throat pain
• infections
• pancreatitis (inflammation of the pancreas)

• infertility in women, delayed ovulation

• a characteristic skin allergic reaction known as fixed drug eruption, which usually reappears in the same place upon re-exposure to the drug and may appear as rounded or oval plaques with redness and swelling of the skin, blistering (urticaria) and itching.

Side effects caused by other nonsteroidal anti-inflammatory drugs (NSAIDs), which have not yet been seen after taking Meloxicam Pensa

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, pharmacist or nurse, 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 Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine

Keepthis medicationout of the sight and reach of children.

No special storage conditions are required.

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

Do not dispose of medications through the drains or in the trash. Dispose of the containers and

any unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and unused medications. By doing

this, you will help protect the environment.

Composition of Meloxicam pensa

The active ingredient is meloxicam. Each tablet contains 15 mg of meloxicam

The other components (excipients) are: sodium citrate, microcrystalline cellulose, lactose monohydrate, povidone, anhydrous colloidal silica, magnesium stearate, carboxymethylcellulose sodium (potato type A).

Appearance of the product and content of the packaging

Yellow, biconvex, scored, and marked with the code “M1” on one face, cylindrical tablets

Meloxicam Pensa 15 mg tablets are presented in packs containing 20 tablets.

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

Laboratorios Cinfa, S.A. c/Olaz-Chipi, 10. 31620 Huarte- Pamplona

Last review date of this leaflet: May 2023

The detailed information of this medicine is available on the website of the Spanish Agency of Medicaments and Sanitary Products (AEMPS)

http://www.aemps.es/